Health / Medical Law & Bioethics

This section includes literature on:
  • public health
  • mental health
  • the ethics of discrimination in relation to treatment
  • the rationing and allocation of equipment such as ventilators in hospitals
  • medical malpractice / liability (including liability for damage caused by vaccines and vaccine injury compensation)
  • vaccines: access to vaccines, mandatory vaccinations and vaccine development and testing
    • literature on mandatory vaccines in workplaces is listed in the Labour Law section
    • literature on intellectual property aspects of vaccine development is listed in the Intellectual Property section
  • mask mandates
    • literature on mask mandates in workplaces is listed in the Labour Law section
Literature on:
  • international health law regulations and institutions, including the World Health Organisation and the International Health Regulations (IHR) is listed in the International Law section.
  • health and medical liability insurance is listed in the Insurance Law section.
  • privacy of medical data is listed in the Privacy section.
Abbas, Hafiz Ghulam, Muhammad Asad and Muhammad Sajjad, ‘Covid-19 Pandemic and Mental Health of Persons with Disabilities: In a Legal Perspective’ (2021) 20(4) Elementary Education Online 2040–2044
Abstract: COVID-19 has a significant threat to global health, which has peculiar implications for people suffering from mental health and disabilities. Considering this issue, this research paper examines laws on persons with mental disabilities in Pakistan protecting their rights especially mental health. It addresses the main question whether the legal framework on persons with mental disabilities is sufficient to deal with present challenges. The current findings show that the current legal framework and policies are inadequate and insufficient in nature and based on the archaic and outmoded laws that do not meet the needs of modern health crises like Coid-19 pandemic. It concludes that Pakistan needs to amend laws on the subject to overcome the present challenges. The qualitative and analytical method of research has been followed.

Abbas, Muhammad Zaheer, ‘Practical Implications of “Vaccine Nationalism”: A Short-Sighted and Risky Approach in Response to COVID-19’ (SSRN Scholarly Paper No 4536868, 1 November 2020)
Abstract: To end the COVID-19 pandemic and ensure a return of normalcy, an effective and safe vaccine is the best hope. The vaccine nationalism approach, adopted by some countries to gain preferential access to emerging COVID-19 vaccines, poses a threat to the fair and equitable distribution of the potential vaccines across the globe. This article critically evaluates the approach of vaccine nationalism and argues that this self-centred political behaviour of leaving others behind is short-sighted, potentially risky, morally indefensible, and practically inefficient in containing the pandemic. This article highlights why it is important for national governments to support the collaborative and coordinated effort of the COVID-19 Vaccines Global Access (COVAX) facility for the timely development and efficient delivery of potential COVID-19 vaccines. It concludes that an effective response to the current health and economic crisis should be guided by values of international solidarity, multilateralism, equality, and global collaboration. It proposes the adoption of an enforceable global framework to address the concerns arising from the combination of vaccine nationalism and intellectual property exclusivities.

Abbas, Muhammad Zaheer, ‘Treatment of the Novel COVID-19: Why Costa Rica’s Proposal for the Creation of a Global Pooling Mechanism Deserves Serious Consideration?’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa049
Abstract: The COVID-19 is causing not only deaths and fear but also economic and social harm across the globe. Lockdowns, travel restrictions, quarantines, social distancing, and other strict public health measures are playing their part in delaying the spread of infection, but a safe and potent vaccine, effective therapeutics, point-of-care diagnostics, and other health products are desperately needed because it may not be practically possible for governments to extend these measures for an indefinite period of time. On March 23, Costa Rica submitted a proposal to the Director-General of the World Health Organization for the creation of a global pooling mechanism in order to facilitate access to and use of intellectual property, trade-secret know-how, regulatory data, cell lines, product blueprints, and other proprietary data for technologies that are useful for the detection, prevention, control, and treatment of the COVID-19 pandemic. This study critically evaluates Costa Rica’s proposal and endeavors to briefly answer the following questions: Why Costa Rica’s proposal deserves serious consideration? To what extent this proposal addresses some of the key concerns related to the COVID-19? To what extent this proposal is practically feasible?

Abdi, Muhammad Mahendra, ‘Legal Protection for Vaccine Recipients Covid-19 in Indonesia’ (2021) 3(2) International Journal of Law and Public Policy 75–82
Abstract: Regulation of the Minister of Health of the Republic of Indonesia Number 10 of 2021 concerning the Implementation of Vaccination in the Context of Combating the Corona Virus Disease 2019 (COVID-19) Pandemic, this Minister of Health Regulation is a government step in carrying out the legality of administering the COVID-19 vaccine because the spread of the COVID-19 virus is very fast. Occurs in humans, thus creating great concern for human life because it can lead to death. Therefore, the government took a response action by providing vaccinations for the people of Indonesia, the purpose of this vaccination is to overcome the high spread of COVID-19, the provision of the covid-19 vaccine given to the Indonesian people must also fulfill the proper rights for the recipients of the COVID-19 vaccine, so that when there is an impact on the administration of the Covid-19 vaccine, the government can handle it quickly. The problems in this paper are how is legal protection for people who receive the COVID-19 vaccine, the extent to which the government provides legal protection rights to people who receive the COVID-19 vaccine.

Abdullah, Juwita Rizkiyawati, ‘The Urgency of Mandatory Provision of Covid-19 Vaccination Public Services’ (2022) 4(2) Estudiante Law Journal 322–336
Jurisdiction: Indonesia
Abstract: The purpose of this study is to find out and analyze the covid-19 vaccination against the provision of public services in Talaga Jaya District and the urgency of providing covid-19 vaccination requirements for the provision of public services by the Talaga Jaya District government This type of research is qualitative field research and uses random sampling. The population in the study is the people who have carried out the covid-19 vaccination. Data collection was carried out with interviews, literature studies, and documentation. The results showed that in the process of implementing the COVID-19 vaccination, there were problems. Therefore, to reach the implementation of the COVID-19 vaccination evenly, the sub-district government and village government carry out mass and door-to-door vaccinations. In the implementation of the covid-19 vaccination, it has been regulated in presidential regulation number 14 of 2021 where people who refuse the vaccine will be subject to sanctions. The policy raises polemics because vaccinations are supposed to be voluntary because they relate to the individual freedom of citizens.

Aboyeji, Faith O, ‘Access to Health and Medical Research: Lessons from the COVID-19 Pandemic’ (2020) 27(4) Journal of Law and Medicine 901
Abstract: The outbreak of COVID-19 in China and the resulting global pandemic have necessitated vigorous research into how this new virus works, how it can be cured and prevented, what kind of vaccine will work, and various other issues. To facilitate this research and enable quick scientific progress, rapid and immediate knowledge sharing among researchers globally became essential, including access to existing and new coronavirus-related research publications. This article discusses international responses to the need for immediate and rapid access to global health and medical research to combat the COVID-19 pandemic, and demonstrates how the exercise of copyright control restricts widespread access to knowledge, especially when published in journals. Ultimately, it recommends open access publishing as an effective way of circumventing copyright restrictions on health and medical research.

Abramson, Brian Dean, ‘Preparing Health Care Providers for a COVID-19 Vaccine’ (2020) 13(3) Journal of Health & Life Sciences Law 2–11
Abstract: Even as the COVID-19 pandemic places intense stress on both American health care providers and legal institutions, one area of law is uniquely poised to chart the way out of this crisis: vaccine law. The single most effective thing that can be done to bring an end to the sicknesses and deaths that mark the occurrence of a pandemic is the development and deployment of an effective vaccine. Although it will be many months before a COVID-19 vaccine is ready for distribution to the public, when available, such a vaccine will have an immediate impact on the practice of medicine and the legal liabilities of both individual and institutional health care providers. Attorneys advising such individuals and entities should take time now to prepare for the legal issues that will ultimately arise once a vaccine is available.

Abugu, Uwakwe, Chukwudi Henry Okeke and Chidinma Therese Odaghara, ‘Legal Imperative for Patients’ Safety under Covid-19 Care and Treatment Protocol in Nigeria’ (2021) 3(1) International Journal of Comparative Law and Legal Philosophy (IJOCLLEP) 117–124
Abstract: The principle of patients’ safety is fundamental to any modern health care system in the world today. It seeks to ensure that patients get adequate attention and prevention of any adverse physical, social, emotional or psychological events due to medical errors or inadequate medical facilities or improper environment while undergoing treatment in a health facility. In Nigeria this principle is more adhered to in breach than in observance in healthcare delivery and, particularly, in the care and treatment protocols of the COVID-19 patients. In this paper, attempt is made to espouse the general principle of patients’ safety and to set out the law, the exceptions and the various aspects of violation of the principles of patients’ safety in the care and treatment of Covid-19 patients in Nigeria. A case is finally made for the establishment of a legal framework for patients’ safety in Nigeria to enhance the application of the principle in Nigerian healthcare delivery system and particularly in the treatment and care of the Covid-19 patients.

Adewumi, Afolasade A, ‘Jurisprudential Basis of the Attitude of Traditional Healers in South-West Nigeria on COVID-19 Infection in Ibadan, Oyo State, Nigeria’ (2023) 10(2: Special Edition on COVID-19) KNUST Law Journal 127–136
Abstract: Health is seen as the most basic asset every human being has. The health of an individual and that of his family members and close associates has always been a source of concern to individuals over the years, making well-being to be synonymous with health. The COVID-19 infection outbreak has affected the whole world and the medical profession is yet to understand it fully. All over the world, attempts have been made and are still being made to provide a cure for the infection. Inasmuch as medical practitioners are pulling their weight in responding to the pandemic, traditional medicine ought not to be ignored since traditional healers’ concept of disease is wider than that of medical practitioners. Moreover, traditional healers are believed by their communities to represent the symbol of their health and prosperity. This case study carried out in Ibadan, the largest city in West Africa, brings to fore the jurisprudential angle to the attitude of the traditional healers to the COVID-19 infection and states how they can assist in enforcing the safety precautions to prevent community spread of the virus.

Agarwal, Harshita, ‘The Urgency for Improvisation of Existing Public Healthcare Law in the Battle against Pandemic’ (SSRN Scholarly Paper No ID 3636139, 26 June 2020)
Abstract: The continuous pandemic of COVID-19, because of the novel coronavirus or SARS-CoV-2 has uncovered conspicuous holes in India’s union laws. Missing a reasonably organized enactment to swear by, the Union government in March exhorted states to summon the Epidemic Diseases Act of 1897 to handle the pandemic in their dominion. The 123-year-old pilgrim law, be that as it may, doesn’t characterize what a disease is, endemic, or a pandemic. Public Health (Prevention, Control, and Management of Epidemics, Bio-Terrorism, and Disasters) Bill had been drafted in 2017, proposed to supplant the old Epidemic Diseases Act of 1897. The Bill presently can’t seem to be postponed in Parliament. This short requires the production of a sound lawful design to bargain more adequately with the outbreak of infectious disease, particularly pandemics of the range of COVID-19.

Aghamohammadi, Akram and Bizhan Hajiazizi, ‘The Legal Aspects of the COVID-19 Vaccine Produced Based on Genetic Modification (Approach of the Legal Systems of the United States of America, the European Union and Iran)’ (2022) 0 Public Law Studies Quarterly (advance article, published online 18 June 2022
Abstract: The spread of COVID-19 disease has now become the biggest health crisis worldwide. Biotechnology research companies have begun a new era in overcoming the disease by using genetic modification techniques. The findings of the present study, which was performed by descriptive-analytical method, indicate that the COVID-19 vaccine based on genetic modification technology faces two main challenges: First, the relatively strict approach regulation to genetically modified organisms that exists to protect the environment and human health, and compliance with these requirements may make the vaccine production process a lengthy evaluation process. Second, companies active in this field seek legal protection for their intellectual achievements: Critics of intellectual property protection, however, believe that this type of protection of the COVID vaccine could potentially affect accessibility and cost-effectiveness. In the legal system of the European Union and the America, special legal actions are prescribed to exit the above challenges. However, due to the emergency situation caused by the spread of the disease in the Iranian legal system, we still face Legal vacuum.

Ahmed, Aziza, ‘How the COVID-19 Response Is Altering the Legal and Regulatory Landscape on Abortion’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa012

Ahuja, Anvita, Jasmeen Kaur and Prateek Rastogi, ‘Covid-19 Vaccination Hesitancy: Causes, Legislation and Ethics’ (2021) 21(1) Journal of Punjab Academy of Forensic Medicine & Toxicology 226–230

Aidonojie, Paul Atagamen et al, ‘Legal Issues Concerning Compulsory COVID-19 Vaccination: Nigeria as a Case Study’ (2024) 3(2) Golden Ratio of Law and Social Policy Review 74–83
Abstract: It is no news that COVID-19 has rendered severe havoc in the global environment. Although, various medical scientists and scholars were able to find a possible curtailment (Through vaccination) of the deadly COVID-19, however, there seems to be fear of the negative medical outcome of being vaccinated with the COVID-19 vaccine, given several claims of the potential danger. Furthermore, it suffices to state that Nigeria has also had its fair share of the COVID-19 pandemic. In this regard, to curtail the spread of COVID-19 in Nigeria, the Nigerian government sorts to make vaccination compulsory, despite the legal and medical rights of its citizens as enshrined in the constitution and judicial precedent. It is in this regard, that this study sort to adopt a hybrid method of study concerning the legal issues of compulsory vaccination in Nigeria. Concerning this, 310 questionnaires were sent to respondents residing in Nigeria. The study therefore found that there were incidences of COVID-19 in Nigeria and there are laws concerning the control of infectious disease in Nigeria. However, the study further found that it is a legal misnomer to compel an individual forcefully against his/her wishes to be vaccinated. Therefore, the study concludes and recommends that for effective vaccination against COVID-19, the Nigerian government needs to avoid forceful vaccination, but rather a wide sensitization concerning the vaccine’s potency as against the negative claim concerning the COVID-19 vaccine.

Aini, MH and G Widjaja, ‘Mandatory Coronavirus Disease-19 (Covid-19) Vaccination in Indonesia: Legal Aspect’ (2021) 24(Special Issue 1) Journal of Legal, Ethical and Regulatory Issues 1–15
Abstract: COVID-19 pandemic has spread globally and has reached a dangerous point. COVID-19 pandemic has even been declared a national health emergency in Indonesia. Various efforts have been made to overcome the Covid-19 pandemic, one of which is vaccination. The COVID-19 vaccination aims to establish herd immunity. Herd immunity requires about 70% of the population to be vaccinated. However, the vaccination raises pros and cons in the community. There are even groups of people who refuse to be vaccinated. This community group feels that mandatory vaccination violates human rights and doubts about the quality of the vaccine. The Government has taken a policy to mandate vaccination with administrative and criminal sanctions that are different from the approach of WHO and other countries. This research is a normative study with a conceptual and a normative approach analysis. Data uses secondary data from the literature, both legal and non-legal materials related to covid vaccination. The results show that vaccination is a very important policy in COVID-19 countermeasures. Mandatory vaccination must be carried out to protect all citizens according to the Indonesian constitution. Vaccination is also part of human rights that must be accommodated and implemented. However, in its implementation, there are problems with doubts and rejection of the vaccine. This obligation causes the restriction of several human rights. However, refusal to vaccinate can violate human rights because it can harm other people and the nation. Therefore, the provision of both administrative and criminal sanctions should be the ultimum remedium. A persuasive and promotive approach and socialization should be the initial approach. However, the regulation of vaccination obligations has shortcomings ranging from the potential for errors in law-making procedures to the absence of an umbrella act. Umbrella act specifically for COVID-19 is a must-have due to an abnormal situation. And the obligation to vaccinate citizens also has implications for the state to be obliged to carry out vaccinations. The Government is obliged to run a vaccination program by ensuring the availability, access, acceptance, and quality of COVID-19 vaccinations.

Akbar, Dwiky Maulana, Nouratama Anugerah Nandiyani and Muhammad Hafidz Rafiansyah, ‘Legal Protection of Citizens’ Health Rights Countries Affected on Medical Waste Disposal COVID-19’ (2022) 10(2) Jurnal Independent 1–12
Abstract: Every citizen has the right to health and a good environment. The increasing medical waste during the pandemic becomes the government’s responsibility in such waste management. However, in practice, medical waste handling cannot be properly resolved. It is detrimental to residents, especially those who live around medical waste disposal. The government has the authority and responsibility to protect, respect, and provide benefits to its citizens. This study was conducted by analyzing the legal norms in the applicable laws and regulations, which was related to the existence of the legal issues that will be examined in the study. From this study, it can be concluded that the government contributes to medical waste management and the right to a good and healthy environment according to the constitution’s mandate.

Akrami, Forouzan, ‘Health Law and the COVID-19 Related Stigma and Discrimination’ (2022) Journal of Law Research (advance article, published online 5 July 2022)
Abstract: The realization of the right to health and the provision of public access to health care are essential to the enjoyment of other human rights. Because health enables people to have an equal fair opportunity to achieve their goals and pursue their life plans. Stigma and discrimination have been prohibited as one of the key barriers to access health care, and a factor in increasing inequality in health outcomes. One of the adverse consequences of the COVID-19 pandemic is its association with social stigma and discrimination. In this study, the concept of stigma is described and the causes of COVID-19 stigma are analyzed, and also the strategies to deal with it are discussed. In answer to the question of the causes of the COVID-19 stigma, it can be said that the stigma is caused due to the defensive mechanism and cognitive adaptation that humans adopt in order to avoid social contact and interactions with the carrier of this infectious pathogen. Fear of violation of privacy and disclosure of information on the one hand, and stigma caused by the disease on the other hand, due to the feeling of worthlessness and isolation in the labeled person can avoid him from referring to care and treatment services; This matter not only can increase the risk of complications and death in the patients, but also do not receiving medical care by the patient or discrimination in providing health care to him can cause the spread of infection in society and endanger public health.

Al-Azri, Nasser Hammad, ‘Healthcare Workers’ Legal Liability and Immunity during the COVID-19 Pandemic’ [2020] Disaster Medicine and Public Health Preparedness (advance article, published 19 November 2020)
Abstract: The COVID-19 pandemic is the most unprecedented crisis facing modern healthcare governance in a century. Many healthcare activities are attracting scrutiny from ethical and legal perspectives. Therefore, healthcare professionals are concerned about legal ambiguity regarding legal liability and immunity in their areas of practice. Law is a key response activity that promotes a sense of safety and security among healthcare workers. This article describes why it is important formally to address issues of altered operations in healthcare practice during emergencies. Furthermore, this article provides suggestions regarding solutions to the issue of legal liability during disasters. Implementing ethical and legal clarity during disaster response is a necessity for a strong healthcare system at every level from international to local in order to achieve a stable healthcare workforce operating for the public good within a safe and secure working environment.

Alabdulla, Majid, Shuja Reagu and Bushra Elhusein, ‘Impact of the COVID-19 Pandemic on Mental Health Law in the State of Qatar’ (2021) 79(November–December) International Journal of Law & Psychiatry Article 101748
Abstract: COVID-19 has significantly impacted mental health care systems worldwide. Qatar has started implementing a dedicated Mental Health Legislation. Qatar faced challenges in honoring the law while upholding best practice. This review examines these challenges and the impact on mental health care.

Alberti, Philip M, Paula M Lantz and Consuelo H Wilkins, ‘Equitable Pandemic Preparedness and Rapid Response: Lessons from COVID-19 for Pandemic Health Equity’ (2020) 45(6) Journal of Health Politics, Policy and Law 921–935
Abstract: The novel coronavirus pandemic has set in high relief the entrenched health, social, racial, political, and economic inequities within American society as the incidence of severe morbidity and mortality from the disease caused by the virus appears to be much greater in black and other racial/ethnic minority populations, within homeless and incarcerated populations, and in lower-income communities in general. The reality is that the United States is ill equipped to realize health equity in prevention and control efforts for any type of health outcome, including an infectious disease pandemic. In this article, the authors address an important question: When new waves of the current pandemic emerge, or another novel pandemic emerges, how can the United States be better prepared and also ensure a rapid response that reduces rather than exacerbates social and health inequities? The authors argue for a health equity framework to pandemic preparedness that is grounded in meaningful community engagement and that, while recognizing the fundamental causes of social and health inequity, has a clear focus on upstream and midstream preparedness and downstream rapid response efforts that put social and health equity at the forefront.

Alexe, Ioana et al, ‘Legal Provisions Tendencies of Malpractice and Medical Liability Regarding the Covid-19 Pandemic’ (2021)(3) 29 Romanian Society of Legal Medicine 299–304
Abstract: COVID-19 continues to be both a major medical problem and a real ethical and forensic issue, profoundly affecting both patients and health services around the world. This pandemic has produced major changes in the provision of healthcare, especially in patients with chronic conditions. The consequence has been the deviation in some medical situations from the medical guidelines and protocols in force with forensic risks for clinicians. When the criteria of professional competence are met, the civil liability ensures a protection of the health workers. Disputes can arise when there are doubts about how the medical activity was performed in safe conditions for patients, when local care decisions were made or when there are no nationally validated guidelines. In conclusion, clarifying legal concepts on the public health crisis, developing a legislative framework and appropriate means to combat it, are important desideratum on more judicious management of a crisis situation.

Alfandre, David et al, ‘Between Usual and Crisis Phases of a Public Health Emergency: The Mediating Role of Contingency Measures’ (2021) 21(8) The American Journal of Bioethics 4–16
Abstract: Much of the sustained attention on pandemic preparedness has focused on the ethical justification for plans for the ‘crisis’ phase of a surge when, despite augmentation efforts, the demand for life-saving resources outstrips supply. The ethical frameworks that should guide planning and implementation of the ‘contingency’ phase of a public health emergency are less well described. The contingency phase is when strategies to augment staff, space, and supplies are systematically deployed to forestall critical resource scarcity, reduce disproportionate harm to patients and health care providers, and provide patient care that remains functionally equivalent to conventional practice. We describe an ethical framework to inform planning and implementation for COVID-19 contingency surge responses and apply this framework to 3 use cases. Examining the unique ethical challenges of this mediating phase will facilitate proactive ethics conversations about healthcare operations during the contingency phase and ideally lead to ethically stronger health care practices.

Ali, Younis Salahuddin, ‘The Civil Liability from Medical Negligence of Doctors Treating Complications of Coronavirus in the English Law / A Comparative Study with the Iraqi Civil Law’ (2023) 6(1) International Journal of Law and Society 1-9
Abstract: The Author has tried hard in this study to make a logic comparison between two different legal systems. That is to say the English common law, considered the leading system among other Anglo-American ones. And the Iraqi civil law highly affected and influenced by both the Islamic jurisprudence and the Egyptian civil law. It is worth-bearing in mind that the English common law includes many types of torts and the civil liability arising from them, including the tort of negligence in general. The general principles applied to which, can also be applied to medical negligence in particular. After the wide-spread dissemination of the coronavirus the British national health services organ (NHS) has given the cases of the doctor’s treating the complications of this pandemic an ultimate importance. And the English courts based the civil liability arising from the medical negligence on three basic elements: the duty of care taken by doctors, the breach of this duty, and the damage suffered by patients. As well as the causation or the causal link between the tort of negligence and the damage or injury. Whereas the Iraqi civil law No. (40) of 1951 deals with the problems related to the civil liability arising from medical negligence of treating patients from coronavirus pandemic, by resorting to the general rules of the civil liability from the illegal act, which is based upon three basic elements: the trespass or transgression committed by the wrongdoer, the damage suffered by the victim and the causal link between them. As opposite to the Egyptian civil law No. (131) of 1948, which considers the first element of this liability as the fault rather than the trespass or transgression. After discussing the attitudes adopted by both the English and Iraqi laws, the author recommends that the Iraqi legislator should adopt the attitude taken by the English law, and let the Act of God deny both the fault element and the causation element of the civil liability arising from medical negligence. And also let the plea volenti non fit injuria deny both the fault element and the causation element of the civil liability of the defendant doctor arising from medical negligence.

Allan-Blitz, Lao-Tzu, ‘Is It Ethical to Mandate SARS-CoV-2 Vaccinations among Incarcerated Persons?’ (2021) American Journal of Bioethics (advance article, published online 1 October 2021)

Almarayeh, Taha, ‘Developing Countries vs COVID-19. A Commentary from MENA Countries’ (SSRN Scholarly Paper No ID 3570073, 6 April 2020)
Abstract: Motivated by the rapid spread of novel coronavirus COVID-19 outbreak in the world. This article aims to provide a swift perspective to readers regarding the coronavirus outbreak in MANA countries. Unfortunately, the most identified cases in MANA states are mainly obtained through people who have returned from endemic areas such as Europe, the United States, and China. Like any other developing country, MANA countries generally have a poor healthcare infrastructure with a fragile economic development that may lead to massive harmful effects. Finally, to control the COVID-19 outbreak in MANA, We need a galvanizing concerted global effort towards international infectious disease in such a setting.

Amarillo, Claudia Rivera, ‘Feminism on Lockdown’ (2020) 52(3) NACLA Report on the Americas 274–281
Abstract: In the Southern Cone, feminist movements leading the ‘green tide’ and setting the tone for struggles for legal abortion across latin america are finding new ways to support the right to choose despite the pandemic.

Anderson, Evan, ‘Assuring Essential Medical Supplies During a Pandemic: Using Federal Law to Measure Need, Stimulate Production, and Coordinate Distribution’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Law Health Watch, 2020) 170–176
Abstract: The global COVID-19 pandemic has temporarily increased demand for basic medical equipment and supplies, and disrupted global supply chains. Governments at all levels and the private sector have found themselves scrambling — and often competing — for the supplies they need. Federal law anticipates that emergencies can generate this kind of sudden demand for medical equipment. Federal agencies not only have ample legal authority to respond to shortages, but also the duty and the authority to prepare for emergencies by planning, supply-chain monitoring, investment and partnership with the private sector, and stockpiling. Perhaps the most important federal law for preventing and ameliorating shortages, and the primary focus of this Chapter, is the federal Defense Production Act (DPA). The DPA provides a menu of powers to stimulate production, strengthen supply chains, coordinate expertise, and resolve market failures. Although the shortfall in personal protective equipment and other basic medical equipment was anticipated by planners and demonstrated in simulation exercises, federal action to address the problem in the face of the pandemic have landed somewhere between failing and making matters worse. This Chapter recommends an independent commission be established to investigate and draw lessons from the federal public health response, but in the meantime points to two core, fixable problems related to law and administration: (1) the failure of Congress and successive administrations to provide sufficient resources to staff and maintain a vigorous infrastructure to prepare for surges in demand, and (2) the failure of the current administration to use its legal authority to lead, manage, rationalize and stimulate production and distribution of needed equipment.

Aneja, Kashish et al, ‘COVID-19 Law Lab: Building Strong Legal Evidence’ (2022) 50(2) Journal of Law, Medicine & Ethics 385–389
Abstract: The COVID-19 Law Lab platform enables quantitative representation of epidemic law and policies in a given country for multiple years, enabling governments and researchers to compare countries, and learn about the impacts and drivers of policy choices. The Law Lab initiative is designed to address the urgent need for quality legal information to support the study of how law and policy can be used to effectively manage this, and future, pandemic(s).

Annas, George J and Sondra S Crosby, ‘Standard Racism: Trying to Use “Crisis Standards of Care” in the COVID-19 Pandemic’ (2021) 21(8) The American Journal of Bioethics 1–3
Introduction: Lowering the standard of care in a pandemic is a recipe for inferior care and discrimination. Wealthy white patients will continue to get ‘standard of care’ medicine, while the poor and racial minorities (especially black and brown people) will get what is openly described as substandard care rationalized by the assertion that substandard care is all that we can deliver to them in a crisis. (IOM 2009) Paul Farmer’s experience in responding to the Ebola outbreak in West Africa is a shocking, if extreme, example of how dangerous to patients this practice is. White patients were treated with the US standard of care, including transfer to the US for treatment, black (local) patients were often given little no medical care at all (on the premise that it was too dangerous for caregivers to touch them or to place IVs to hydrate them). The standard of care for the local population, in Farmer’s words, ‘in many cases didn’t resemble care at all.’ (Farmer 2020) As COVID-19 has taught us, structural racism in healthcare is not just a problem in West Africa, and does not just manifest itself in a pandemic.

Armstrong, Pat, Hugh Armstrong and Ivy Bourgeault, ‘Privatization and COVID-19: A Deadly Combination for Nursing Homes’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 447
Abstract: In this chapter, we make visible the different forms of privatization of nursing homes to help understand how it has made residents and workers so highly susceptible to the deadliest aspects of the COVID-19 pandemic. Privatization includes the move to private (often for-profit) delivery of services, managerial practices, and responsibilization of individuals and their families. All these forms are evident in nursing homes, exacerbated by austerity measures. The conditions of work in nursing homes intensified with increasing privatization, decreased staffing, and increased resident acuity before the pandemic, but deteriorated dramatically when it began to hit home after home. The extent to which this deterioration can be directly linked to privatization is difficult to determine, but there are clear indications that privatization set the stage. Bold responses are needed to correct this course, not just during the current emergency, but going forward, to ensure that the many deaths in this sector have come with important lessons learned.

Artono, Harry, ‘Legal Protection of Patients and Health Workers Rights in the Covid-19 Pandemic’ (Proceedings of the 4th International Conference on Indonesian Legal Studies, ICILS 2021, June 8-9 2021, Semarang, Indonesia, 2022)
Abstract: Until now, the Covid-19 pandemic has become a serious threat on a global scale, including in Indonesia and seriously threatens public health, so that all parties are trying to eradicate Covid-19. The right to health services for patients is one of the constitutional rights mandated in Article 28H of the 1945 Constitution of the Republic of Indonesia, and parties who have the capacity and ability to carry out health services are health workers. However, until now, legal protection for the rights of patients and health workers has not been maximally implemented, especially in the aspect of fulfilling medical facilities, infrastructure and equipment that not yet to be distributed fairly and equitably, so that legal protection of health and safety must be guaranteed. This journal research method is juridical-normative legal research with secondary data which includes primary legal materials: UUD NRI 1945; UU Number 36 of 2009 concerning Health; and Presidential Decree Number 12 of 2020; secondary legal materials: books, journals, and scientific research on health law; Tertiary legal materials: Big Indonesian Dictionary (KBBI) and Black’s Law Dictionary.

Aslim, Erkmen Giray and Murat C Mungan, ‘Access to Substance Use Disorder Treatment During COVID-19: Implications from Reduced Local Jail Populations’ (George Mason Law & Economics Research Paper No 20–27, 23 September 2020)
Abstract: Many states have responded to the spread of COVID-19 by implementing policies which have led to a dramatic reduction in jail populations. We consider benefits associated with providing the population of individuals who would, but for these policies, be incarcerated with substance use disorder (SUD) treatment. We discuss problems that may prevent this population from receiving SUD treatment as well as policies which may mitigate these problems.

Aubrecht, Paul et al, ‘Centralized and Decentralized Responses to COVID-19 in Federal Systems: US and EU Comparisons’ (SSRN Scholarly Paper No ID 3584182, 24 April 2020)
Abstract: European Union and the United States have experienced some of the most severe outbreaks of COVID-19. Paper investigates the EU and US divisions of power and suggest that due to the relative advantages and disadvantages of centralized federal responses and decentralized state responses, actions seeking to limit the impact of Covid-19 on society need to reflect a ‘smart mix’ of both centralized and decentralized responses to the pandemic. Centralized procurement and distribution of necessary medical goods can solve problems related to harmful competition between states to procure these goods and allows states to exercise buying power. Centralized responses to procurement and distribution may solve a problem of moral hazard which leads to the hoarding of necessary medical goods, which represents a cross border externality when other states within the federal system face a shortage of necessary medical goods. This also applies to the procurement of medical goods related to testing for CV. However, paper argues the use of these goods and implementation of testing programs may be best done through a decentralized process because localized authorities have an information advantage over centralized authorities. Decentralized responses may also be necessary to gather information about which form of public health intervention works best, given that there is uncertainty as to which approach is most efficient. States must weigh not only the benefits of implementing public health interventions, but also the costs of these interventions on society.

Augsberg, Steffen, ‘Immunity and Vaccination Certificates in the Covid-19 Crisis: Ethical and Legal Problems of a Possible Need for Differentiation’ in Andreas Reis, Martina Schmidhuber and Andreas Frewer (eds), Pandemics and Ethics: Development – Problems – Solutions (Springer, 2023) 137–147
Abstract: After about one year of ‘corona crisis’, it had become clear that even very strict and comprehensive hygiene protection measures in themselves are not enough to return to at least tolerable (proto-)normality. The hopes associated with the different Covid-19 vaccines derived their special meaning from this insight. While we know now (and could and probably should have known much earlier) that the vaccinations do not significantly reduce infectivity, under the given circumstances to assume so was not unreasonable. Furthermore, because with the vaccinations, at least severe or even fatal courses of the disease can be avoided with high probability, they help to counteract an overload of the health system and the resulting, society-wide problematic ‘domino effect’. As far as this is the central, if not the decisive justification for the far-reaching and serious infection protection-based restrictions on freedom (cf. German Ethics Council 2020a, 2021), it must be considered whether and to what extent these—especially in view of already existing and future ‘collateral damage’ (cf. Nicola et al. 2020)—can still be maintained. The general argument of epidemic control is not enough for this. In order to avoid a ‘operation successful, patient dead!’ scenario, a consistent approach is required which reflects and monitors the legitimately pursued goals as well as both the intended and unintended consequences on a continuous basis. To completely eradicate Sars-CoV-2 is neither a realistic nor situation-appropriate purpose in this sense: Whoever demands this underestimates the expected practical difficulties, both with regard to the unavoidable and desirable international contacts in open societies and with regard to the possible pathogen reservoir in the animal kingdom. At the same time and above all, such an absolutization of infection protection would only be possible at the expense of numerous additional, massive impairments of freedom and health. In the end, this would result in authoritarian biopolitical scheme that could only achieve its goal of saving lives (or more precisely: life years) at the expense of endangering and sacrificing essential rights up to and including life. This is neither ethically nor legally acceptable. Therefore, the restrictions applicable to the general population are to be lifted step by step to the extent that the (primary) goal of preventing severe and fatal Covid-19 courses is achieved (cf. German Ethics Council 2021).

Auriemma, Catherine L et al, ‘Eliminating Categorical Exclusion Criteria in Crisis Standards of Care Frameworks’ (2020) 20(7) The American Journal of Bioethics 28–36
Abstract: During public health crises including the COVID-19 pandemic, resource scarcity and contagion risks may require health systems to shift—to some degree—from a usual clinical ethic, focused on the well-being of individual patients, to a public health ethic, focused on population health. Many triage policies exist that fall under the legal protections afforded by ‘crisis standards of care,’ but they have key differences. We critically appraise one of the most fundamental differences among policies, namely the use of criteria to categorically exclude certain patients from eligibility for otherwise standard medical services. We examine these categorical exclusion criteria from ethical, legal, disability, and implementation perspectives. Focusing our analysis on the most common type of exclusion criteria, which are disease-specific, we conclude that optimal policies for critical care resource allocation and the use of cardiopulmonary resuscitation (CPR) should not use categorical exclusions. We argue that the avoidance of categorical exclusions is often practically feasible, consistent with public health norms, and mitigates discrimination against persons with disabilities.

Ayers, Samantha R, ‘Vaccinations and Fundamental Rights: The Need for Federal Vaccination Legislation’ (2021) 52(2) University of Toledo Law Review 261–287
Extract from Introduction: This note focuses on the interaction between fundamental rights and the consequences of parental refusal to vaccinate their minor children. Whereas parents have the right to raise their children,10 and a right to religious freedom, those rights are restricted by a governmental interest in protecting public health, child welfare, and promoting uniformity among the several states in the country. The note aims to explore different rights afforded to citizens by the Constitution and explain situations in which it is necessary, and constitutional, for the government to regulate behaviors and limit rights of the people, to protect the country as a whole. Section I of this note explores fundamental rights that have been granted to individuals by the Supreme Court of the United States through their interpretations of the Constitution and the Equal Protection and Due Process Clauses. Through those fundamental rights, individuals have been protected heavily from governmental intrusion into their lives. The rights granted, however, are not unqualified, and are subject to government regulation in some circumstances.
Section II of this note outlines when states are able to regulate the scope of fundamental rights. Specifically, this section discusses governmental regulation in cases of possible medical abuse or neglect, which makes it possible for the refusal to vaccinate a child to be considered medical neglect, although it has not yet been held to do so.
Section III of this note explains specific instances and reasons that the state has to intervene with, and overcome, individuals’ fundamental rights. The section aims to explain when the government is able to infringe upon an individual’s ability to choose whether to vaccinate, although it could interfere with fundamental rights that have been recognized and protected under the Constitution. Courts have continuously upheld the rights of the state governments to override parental decisions when it comes to public health and safety concerns during an outbreak.
Section IV of this note discusses the main reason a why many parents refuse to vaccinate their children: religious beliefs. It goes on to explore multiple instances in which the court has determined that although individuals have religious freedoms, the government is able to regulate their conduct when it comes to furthering important interests.
Section V provides an argument describing why there should be federal legislation regarding childhood vaccinations to promote uniformity among the states regarding the issue, as well as to promote protections of public safety and child welfare. It also proposes a possible federal law, allowing for only a medical exemption to mandatory vaccinations for minor children. There is also discussion and explanation of why federal legislation would survive multiple levels of Supreme Court review.

Aziz, Norazlina Abdul et al, ‘Legal Concerns of COVID-19 Vaccine in Malaysia and the United States of America: A Comparative Study’ (2022) 7(SI7 Special Issue) Environment-Behaviour Proceedings Journal (advance article, published online 31 August 2022)
Abstract: This study explored and compared the COVID-19 vaccines related issues in Malaysia and the United States of America to identify the adequacy of the current legal framework in ensuring effective administration of vaccines in Malaysia. It aims to consolidate the best practice adopted by these jurisdictions. This study adopts a qualitative method utilising the doctrinal study and semi-structured interview relating to the legal framework governing the role of the Drug Control Authority. The data were then triangulated and analysed using content and thematic analysis. The findings of this study may assist in identifying the loopholes within the administrative control on the vaccination program adopted by Malaysia.

Bagenstos, Samuel R, ‘Who Gets the Ventilator? Disability Discrimination in COVID-19 Medical-Rationing Protocols’ (2020) 130 Yale Law Journal Forum 1–25
Abstract: The coronavirus pandemic has forced us to take the threat of rationing life-saving treatments seriously. Many health systems employ protocols that explicitly deprioritize people for these treatments based on pre-existing disabilities. This argues that such protocols violate the Americans with Disabilities Act, the Rehabilitation Act, and the Affordable Care Act.

Baharuddin, Ahmad Syukran et al, ‘Offense of Spreading Infectious Disease and Methods of Proof Through Forensic Science’ (2020) 3(1) INSLA E-Proceedings 340–350
Abstract: Since 1988, a specific Act has been enacted concerning the prevention and control of infectious diseases. This Act is known as the Prevention and Control of Infectious Diseases Act 1988. The preamble to this Act states that it was enacted to amend and consolidate laws relating to the prevention and control of infectious diseases and to provide for other matters relating thereto. In this Act, there are several types of actions that if committed can be convicted as an offense under this Act, among them include acting in a manner that can spread infectious diseases. This study discusses matters related to offense causing the spread of infectious diseases from the view of civil and Syariah law. It also covers scientific methods to prove such offense. This qualitative study has collected relevant data through primary and secondary documents and subsequently analysed it using the document analysis method. The result of this study found that the act of exposing others to the risk of infection is an offense and it is forbidden in Islam. Several scientific methods can be used in convicting this offense; among them are medical reports, travel records, physical examinations, CCTV footage, and biological examinations. This study suggests that the aspect of proof for such cases should be emphasized because such studies have not yet been conducted by previous researchers

Bainbridge, Jessica, ‘The Vaccine Mandate’s Luck Runs Out in Judicial Lottery’ (2022) 83 Ohio State Law Journal Sixth Circuit Review Article 005
Abstract: The vaccine mandate’s long journey through the judiciary has exposed a system where important legal conclusions are left to the luck of the draw. After the Fifth Circuit issued a nationwide stay, an actual lottery sent the vaccine mandate to the Sixth Circuit where the favorable composition of a three-judge panel resulted in the mandate’s reinstatement. Although the Sixth Circuit’s reinstatement appeared to be a monumental win for those urging for mass vaccinations in order to combat the pandemic, this win was short-lived when the conservative majority of the Supreme Court pronounced the mandate dead on arrival. The Department of Labor’s Occupational Safety and Health Administration (‘OSHA’) issued the mandate in the form of an Emergency Temporary Standard (‘ETS’) in November of 2021.4 The ETS, which was estimated to affect over 84 million workers, was issued in order for the agency to fulfill its statutory directive in response to ‘the “extraordinary and exigent circumstances” presented by [the] unprecedented pandemic.’ It directed large employers to have most of their employees either get vaccinated or wear facemasks indoors and test for COVID-19 on a weekly basis. In contrast with the Sixth Circuit’s decision, which adheres to precedent and clearly explains the law, the Supreme Court’s ruling on the mandate relies on twisted logic to establish what they think the law ought to be rather than what the law is, or at least has been.

Bapat, Shreya, ‘A New Paradigm to Health Laws in Times of COVID-19’ (2021) 24 Supremo Amicus Journal (unpaginated)
Jurisdiction: India
Abstract: Begun in 2019, the COVID-19 outbreak has given a new outlook to everything from our lifestyle to laws. This article highlights the position of Right to Health laws in our constitution with help of relevant case laws and draws attention towards the significance of the ‘Rule of Law’ in law-making process during a time crisis. No revisions have been made to the Epidemic Diseases Act of 1897, invoked by several State Governments to combat the spread of virus, ever since it was enacted. Moreover, Data from the Government shows a little over 1% of total GDP is spent over public healthcare over last 10 years. Intending to create awareness among readers regarding the complexities faced in these difficult times in the healthcare sector, the author derives a need for new set of Public Health Laws and their quick implementation by the state. Overall, we conclude the one of its kind COVID-19 pandemic has provided us with an opportunity and wide scope to improve our pre-existing policies and health laws.

Bard, Jennifer, ‘The President’s Remedy: Taking Another Look at Off-Label Prescribing in the Context of President Trump’s Relentless Promotion of Hydroxychloroquine’ (SSRN Scholarly Paper No ID 3680199, 21 August 2020)
Abstract: In the spring of 2020 the world watched as the President of the United States became ‘Salesman-in-Chief’ for a long outdated FDA approved malaria drug, which he called HYDROXYCHLOROQUINE, as a miracle cure for Covid-19. Although not approved by the FDA for use outside of a hospital, the effects of the President’s advocacy became visible almost immediately. Prescriptions for the drug increased to a point that it became difficult to obtain for patients who depended on hydroxychloroquine for its other FDA approved uses, Lupus and rheumatoid arthritis. But the prescriptions weren’t for Covid-19 patients. They came from a wide range of health professionals stockpiling the drug for themselves, their family, and the worried well. This was all legal because once a drug is approved by the FDA for any use, it can, through a backdoor process called ‘off-label’ use, be prescribed for any purpose. ‘Off-label prescribing’ has become so integrated into contemporary medical practice that by some estimates up to 80% of oncology drugs and a substantial percentage of psychiatric drugs are prescribed off-label. Increasingly, researchers around the world have found that contrary to the beliefs of the doctors who prescribe off-label, the results for patients are often poor. Yet the practice is so powerful that it has evaded all attempts to implement commonsense measures such as like mandatory tracking of off-label prescribing. Moreover, in no state must a doctor specifically inform a patient when they prescribe off-label. In light of events like the President induced run on hydroxychloroquine, now is the time to revisit the continued existence of a practice more suited to a time when doctors made house-calls by horse and buggy than today’s world where genomics and AI have revolutionized medical practice and drug development. It may be several years before we know how much death or cardiac damage was caused by the unnecessary use of hydroxychloroquine for treating Covid-19, but this very public display of how off-label prescribing can be abused needs to be a catalyst for getting the states and the FDA working together to develop a patient centered approach that creates a framework for assuring that everyone who is prescribed a drug can rely that it has been proven safe and effective.

Barkane, Irena et al, ‘The Legal Implications of COVID-19 Vaccination Certificates: Implementation Experiences from Nordic and Baltic Region’ in New Legal Reality: Challenges and Perspectives. II (University of Latvia Press, 2022) 209–223
Abstract: EU Digital green certificates were initially envisaged as a joint EU initiative to facilitate free movement during the pandemic. However, many countries rapidly extended their use in different contexts at the national level, raising serious ethical and legal concerns and questions, in particular, on how to strike a right balance between the interests of the individual and the interests of society. The paper aims to explore the legal implications of using vaccination certificates at the national level, in particular by exploring and comparing practices in selected Nordic and Baltic countries. The article emphasises that, despite COVID-19 crises, the governments should protect fundamental rights and values and when deciding on new restrictions carefully assess their necessity and proportionality. National responses call for a new regulatory framework to ensure responsible use of digital technologies in public interests.

Barranco, Rosario and Francesco Ventura, ‘COVID-19 and Infection in Health-Care Workers: An Emerging Problem’ (2020) 88(2) Medico-Legal Journal 65–66
Abstract: The 2019 coronavirus infection (called SARS-CoV-2) began in Wuhan, spread rapidly throughout the world. In many countries the exponential growth of Covid-19 cases is overwhelming health care systems with overcrowding of hospitals and overflowing Intensive Care Units. While people must stay at home to reduce the spread of this virus health-care workers do the exact opposite. In some countries doctors are working with insufficient protection and are constantly at risk of contracting Covid-19. Health-care workers should be constantly monitored because if they are infected they may spread the virus to colleagues, hospitalized patients and even family members. Increased rates of infection in health-care workers could cause the health-care system to collapse and a further worsening of the pandemic; if there are too few doctors it will be even more difficult to manage.

Barranco, Rosario and Francesco Ventura, ‘The Role of Forensic Pathologists in Coronavirus Disease 2019 Infection: The Importance of an Interdisciplinary Research’ (2020) 60(3) Medicine, Science and the Law 237–238
Abstract: Discusses the risks faced by forensic pathologists when performing post-mortem examinations involving confirmed or possible cases of coronavirus infection, the importance of following recommended procedures, the medico-legal implications, and the need for interdisciplinary research.

Bartenschlager, Christina C et al, ‘The AI Ethics of Digital COVID-19 Diagnosis and Their Legal, Medical, Technological, and Operational Managerial Implications’ (2024) 152 Artificial Intelligence in Medicine Article 102873
Abstract: The COVID-19 pandemic has given rise to a broad range of research from fields alongside and beyond the core concerns of infectiology, epidemiology, and immunology. One significant subset of this work centers on machine learning-based approaches to supporting medical decision-making around COVID-19 diagnosis. To date, various challenges, including IT issues, have meant that, notwithstanding this strand of research on digital diagnosis of COVID-19, the actual use of these methods in medical facilities remains incipient at best, despite their potential to relieve pressure on scarce medical resources, prevent instances of infection, and help manage the difficulties and unpredictabilities surrounding the emergence of new mutations. The reasons behind this research-application gap are manifold and may imply an interdisciplinary dimension. We argue that the discipline of AI ethics can provide a framework for interdisciplinary discussion and create a roadmap for the application of digital COVID-19 diagnosis, taking into account all disciplinary stakeholders involved. This article proposes such an ethical framework for the practical use of digital COVID-19 diagnosis, considering legal, medical, operational managerial, and technological aspects of the issue in accordance with our diverse research backgrounds and noting the potential of the approach we set out here to guide future research.

Bartlett, Oliver, ‘COVID-19, European Health Union, and the CJEU: Lessons from the Case Law on Banking Union’ (2020) 11(4) European Journal of Risk Regulation 781–789
Abstract: The Court of Justice of the European Union (CJEU) has given a number of pivotal judgments in cases that dealt with the intersection of health policy and EU law, and in so doing has played a key role in the emergence of EU health law as a distinct field. EU health law has developed to a point that scholars have called for the creation of a distinct European Health Union, to consolidate common European rules and standards that will contribute to improving the health of all Europeans. As the implications of the COVID-19 pandemic for European cooperation on health issues become clearer, the calls for a European Health Union have been reinforced. In light of such a seismic shift in how the world perceives the health, economic and social risks inherent in an uncontrolled global infectious disease outbreak, there will probably never be a better stimulus for EU Member States to develop the tools for enhanced formal cooperation on health issues.

Bates, Elizabeth Stubbins, ‘Article 2 ECHR’s Positive Obligations: How Can Human Rights Law Inform the Protection of Health Care Personnel and Vulnerable Patients in the COVID-19 Pandemic?’ in Barrie Sander and Jason Rudall (eds), Opinio Juris Symposium on COVID-19 and International Law (2020)
Abstract: Introduction: This post analyses the case law of the European Court of Human Rights (ECtHR) on states’ positive operational obligations to protect life under Article 2 of the ECHR, and offers concrete arguments for the protection of health care personnel and vulnerable patients through this human rights lens.

Beazley, Ashlee, ‘Contagion, Containment, Consent: Infectious Disease Pandemics and the Ethics, Rights, and Legality of State-Enforced Vaccination’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa021
Abstract: In the face of a pandemic, and in response to a contagion such as SARS-COV-2, can the law allow a state to enforce, or compel, its citizens to undergo mandatory vaccination? Using arguments drawn from ethics, human rights and principles of international law, this piece will attempt to address some of the complexities inherent in such questions. It will argue, further, that present circumstances demand that such questions are asked now, before human rights and civil liberties are (inadvertently) compromised. The answer is not a simple one: the ethical dilemma surrounding the curtailment of consent demands a delicate balance be struck between this, and the wider common good. While human rights prove a natural qualification to the broadening of the latter, even these have their own limitations. And it is on this heavily nuanced fence that the legality of state-enforced vaccination appears to sit. While a state’s own legal and factual nuances will prove determinative, any human rights qualifications must nevertheless remain within the appropriate boundaries—e.g. the Siracusa Principles. Further, in the face of an ongoing (and ever-evolving) pandemic, it is pertinent decisions on matters such as compulsory vaccination are taken now, before they must be made in haste.

Ben Amar, Wiem et al, ‘Criminal Medical Liability in the Context of Covid-19 Pandemic’ (2020) 98(5) La Tunisie Medicale 334–342
Abstract: The COVID-19 infection causes to medical community many difficulties worldwide. In addition to its therapeutic problems, it can generate situations with high medico-legal risk to doctor who can see his criminal medical liability engaged. In fact, in Tunisia, this new infection imposes many specific legal obligations. Some of these obligations have recently been introduced, therefore still little or not known by doctors, despite the need for them to comply with. In this paper, we propose to analyse the circumstances of medical practice in Covid-19 pandemic period , which risk to engage the doctor’s criminal medical liability, and to set out the sanctions incurred, in order to protect health professionals against the specific legal risk of this emerging disease.

Benavides, Ximena, ‘Inequitable by Design: The Law and Politics of Global COVID-19 Vaccine Access - And a Way Out’ (2023) 56(2) University of Michigan Journal of Law Reform (forthcoming)
Abstract: COVID-19 vaccine access has been highly inequitable worldwide, with coverage depending largely on a country’s wealth. By the end of 2021, 64.1% of people living in high-income countries had received at least one dose of the vaccine, compared to only 5.4% of those in low-income countries. Similarly, only high- and upper-middle-income countries had received the most effective vaccines. The uneven distribution of these lifesaving vaccines is complex due to the convergence of several factors, but it suggests that the expanding and ossifying extraordinary market and political power of a few vaccine manufacturers founded on intellectual property and complementary policies are decisive factors in shaping our healthcare systems and securing equitable access to vaccines. This Article analyzes the power dynamics of vaccine manufacturing and distribution of U.S. pharmaceutical companies in the context of global COVID 19 vaccination. Drawing on the health-justice and law-and-political-economy scholarship of the last decade, this Article demonstrates how a ‘patent culture’ shaped by intellectual property law fundamentally neglects health-equity principles as it politicizes healthcare access. These contemporary frameworks suggest that the global COVID-19 vaccine-access problem is the result of avoidable policy choices of big manufacturers and affluent governments. Despite a long history of inequities in access to healthcare, policy choices—as predicted by Hart’s inverse equity theory—have favored a purposely inequitable-by-design vaccination program driven by the wealth and power of those allowed to control vaccine production and supply globally. Finally, the Article proposes ways to challenge the normalized and institutionalized patent culture that has commodified access to lifesaving conditions beyond national borders. As it examines national and international legal strategies to address the vaccine-access problem, the Article suggests equity-based principles of public value, transparency, and inclusivity to guide healthcare governance and future reformation of the vaccine-access landscape. An interdisciplinary analysis of the first year of the global vaccine rollout provides an account critical to future policies aiming to address the structural conditions needed to attain equitable health outcomes, even after the pandemic.

Benbow, David I, ‘The Dizziness of Freedom: Understanding and Responding to Vaccine Anxieties’ (2021) 49(4) Journal of Law, Medicine & Ethics 580–595
Abstract: The rise in vaccine hesitancy in high-income countries has led some to recommend that certain vaccinations be made compulsory in states where they are currently voluntary. In contrast, I contend that legal coercion is generally inappropriate to address the complex social and psychological phenomenon of vaccine anxieties.

Benfer, Emily A et al, ‘Health Justice Strategies to Combat the Pandemic: Eliminating Discrimination, Poverty, and Health Inequity During and After COVID-19’ (SSRN Scholarly Paper No ID 3636975, 1 June 2020)
Abstract: Past infectious disease epidemics in the United States and governmental responses to them made it highly predictable that people living in poverty, people of color, and people with disabilities would bear the brunt of the coronavirus pandemic due to discrimination that limits equal access to resources, such as health care, housing, and employment. The COVID-19 pandemic magnified and accelerated the impact of longstanding discrimination and health inequity among historically marginalized groups and low-income populations. Black and Latinx populations have a higher COVID-19 contraction and mortality rate, higher rates of unemployment, less access to health care, and are at higher risk of eviction during the pandemic, among other significant inequities. Without robust and swift government interventions, the impacts of the pandemic will be wide and deep. This article analyzes mechanisms of discrimination and barriers to health in the pandemic setting using the health justice framework to address discrimination and poverty. The health justice framework offers four overarching principles to prevent and eliminate health disparities during and after the COVID-19 pandemic. First, legal and policy responses must address the impacts of discrimination and poverty on the social determinants of health, which in turn threaten to exacerbate the health, financial, and social impacts of a public health emergency on low-income communities, communities of color, and other marginalized communities. Second, interventions mandating healthy behaviors—such as staying at home from work when sick, mask wearing, and minimizing close contacts outside the home—must be accompanied by legal protections, accommodations, and social supports to enable those behaviors while minimizing economic, social, and cultural harms. Third, because emergencies typically exacerbate long-standing and interconnected crises in low-income communities and communities of color, legal and policy responses must address root problems in addition to immediate needs. Fourth, historically marginalized communities must be engaged as leaders in the development of any interventions and the attainment of health justice. To demonstrate the application of the health justice framework and principles, this article focuses upon three pillars that support resilience and equip marginalized communities to withstand the immediate and long-term impacts of the pandemic: health care, housing, and employment. This article explains how health care discrimination is a social determinant of health, how lack of access to health care operated as a barrier to health justice during the COVID-19 pandemic, and applies the health justice framework to address health inequity. Then this article explains how housing and eviction are social determinants of health, how housing discrimination is a barrier to health justice during the COVID-19 pandemic, and suggests way to achieve health justice in housing. Finally, this article discusses how poverty and employment inequity are social determinants of health, how structural discrimination is an accelerator of employment inequity during the COVID-19 pandemic, and suggests how health justice principles can help achieve equity in employment. Ultimately, the framework can be adopted across numerous social determinants of health and structures to ensure the elimination of discrimination, poverty, and poor health among marginalized people during and after the pandemic.

Berlin, Joey, ‘Pandemic Poses Legal Pitfalls: TMA Seeks Better Liability Shields’ (2020) 116(8) Texas Medicine 38–40
Abstract: Under Texas law, physicians treating COVID-19 patients in a volunteer capacity have potential defenses against lawsuits that might arise from that care. But for non-volunteer physicians on the COVID battlefield - often working in harrowing, overloaded settings, high on patient count and low on equipment - the same liability shields don’t exist. And with a resurgence in COVID-19 cases and hospitalizations taking hold in June, the Texas Medical Association continued its pandemic-long push to extend liability protections to all frontline physicians, volunteer or not.

Berlinger, Nancy et al, ‘Ethical Challenges in the Middle Tier of Covid-19 Vaccine Allocation: Guidance for Organizational Decision-Making’ (The Hastings Center Supplement to Ethical Framework for Health Care Institutions Responding to Novel Coronavirus SARS-CoV-2 (Covid-19), with Guidelines for Institutional Ethics Services Responding to Covid-19: Managing Uncertainty, Safeguarding Communities, Guiding Practice, 1 January 2021)
Abstract: This supplement to The Hastings Center’s ‘Ethical Framework’ aims to help structure time-sensitive discussion of significant, foreseeable ethical concerns in responding to Covid-19 and to support collaboration across institutions throughout pandemic response and recovery. It is designed for use by county health systems and by hospitals, community health centers, and other health care organizations responsible for patient care or preventive health, including vaccine education, vaccine distribution, and vaccination. This document aims to support formal and informal convening and policy work within the same geographic region, such as a municipality, county, metropolitan area, state, or multistate area, led by public health authorities, health care institutions, or other groups involved in vaccine allocation. The document’s scope is limited to the ethics of vaccine distribution within the United States; it does not address the ethics of international cooperation and sharing vaccines versus focusing solely on ensuring vaccine access in one’s own nation (‘vaccine nationalism’).The focus of this document is the middle tier of vaccine allocation and the ethical challenges arising in the U.S. in the first half of 2021. This focus reflects general consensus and ongoing implementation concerning highest-priority vaccination of two populations: frontline health care workers and residents of long-term care facilities (the groups constituting “Phase 1ain recommendations from the Advisory Committee on Immunization Practices [ACIP]). The ethical justification for prioritizing these populations was their high risk of contracting the virus, of passing it to others at high risk of severe disease, and, in the case of long-term care residents, of dying of severe Covid-19. Additional justifications include the relatively small size of these initial cohorts, the relative ease of locating them and providing the vaccine, and the value of public trust created by witnessing health professionals receiving the vaccine. There is also broad consensus that vaccine allocation to the general public—people without major risk factors and who can reasonably protect themselves through masking and physical distancing—should occur only after the vaccination of groups at high risk of infection or at high risk of severe illness or death if infected. This document therefore does not address the final stages of vaccine distribution to lower-risk members of the public.

Bhasin, Asees, ‘The Telehealth “Revolution” & How It Fails to Transform Care for Undocumented Immigrants’ (2022) 24(1) North Carolina Journal of Law & Technology 1–48
Abstract: The outbreak of Covid-19 led to the rapid adoption and expansion of telehealth services. Upon understanding its potential for underserved populations, people began referring to this method of health care delivery as ‘revolutionary.’ This reputation stuck, even though it quickly became obvious that telehealth utilization was more common among White, educated, and relatively richer individuals. Meanwhile, advocates of telehealth equity found that the benefits of telehealth did not adequately trickle down to lower-income and rural communities, as well as communities of color. Undocumented immigrants as a group were often ignored during considerations of these disparities. This Article is among the first, even within inter-disciplinary scholarship, to center undocumented immigrants and their (in)ability to access telehealth services. It begins with a discussion of federal and state immigration policies that govern health care access for immigrants and goes on to analyze their health care needs and enhanced vulnerability during the pandemic. It then discusses four themes along which undocumented status makes telehealth services harder to access, namely insurance and affordability, fears of privacy breaches and surveillance, access to technology and digital skills, and limited English language proficiency. This Article concludes by making certain recommendations for changes to state and federal immigration policies that may help undocumented immigrants realize the novel and innovative ways to access health care which were promised by the telehealth revolution.

Bhuiyan, ASM Anwarullah, ‘Seeking an Ethical Theory for the COVID-19 Pandemic Outbreak with Special Reference to Bangladesh’s Law and Policy’ [2020] Developing World Bioethics (advance article, published 6 September 2020)
Abstract: Globally, a traditional management model has generally been used to manage disaster situations, including in Bangladesh. In Bangladesh, the government mostly uses the preparedness policy for pandemic outbreak case management. With regard to the limitations arising from the pandemic outbreak the current research will investigate the following questions: when facing a devastating situation, what exactly is the nature of the pandemic outbreak management model incorporated at the governmental level? Keeping these questions in mind, the intention of the existing model is to provide smooth and appropriate assistance to recover from a pandemic outbreak, and to implement effective governance of the situation. This research will identify deficiencies in the current epidemic management policy in Bangladesh, and will assist in forming a new model and developing a systematic procedure for managing future pandemic outbreak situations. The main deficiency in Bangladesh’s pandemic management is that the policy paper has failed to identify all hazardous events that may occur in a pandemic outbreak. In most cases, it has underestimated the issues of bioethical responsibility toward the different stakeholders affected during the devastating situation of a pandemic outbreak. The policy does not emphasize the bioethical model; therefore, it fails to encourage support for either public protection or an ethically friendly management system. The model proposed in this article demonstrates an appropriate way to reduce or, if possible, avoid potential damages and losses from a pandemic outbreak. The model aims to prioritize the problems that need assistance to recover from the outbreak.

Bílková, Veronika, ‘Age-Based Triage and Human Rights’ (2023) 41(1) Netherlands Quarterly of Human Rights 13–34
Abstract: The article provides the first comprehensive assessment of age-based triage from the perspective of human rights. Triage, that is the sorting of patients into categories of priority of treatment, has been known for decades. It has however got larger prominence during the Covid-19 crisis. The crisis has exposed healthcare systems in many countries to a critical shortage of resources, forcing them to consider resorting to triage. The absence of legal rules has been compensated by non-binding triage guidelines, adopted by professional medical and ethical associations. This article analyses 11 guidelines, showing that none of them is truly age neutral. Some use allocation criteria that entail disparate treatment of older persons, consisting of their de-prioritization or exclusion from access to life-saving treatment on account of their age. Others rely on allocation criteria whose application has disparate effects on older persons. The article argues that whereas the latter approach could be compatible with human rights standards, the former entails violations of the principle of non-discrimination and of several other human rights (the right to life, the prohibition of inhuman and degrading treatment, the right to private life, and the right to health).

Billauer, Barbara Pfeffer, ‘Ageism and COVID-19: First They Lock the Oldsters Up, Then They Refuse The Ventilators. What’s Next?’ (SSRN Scholarly Paper No ID 3647209, 9 July 2020)
Abstract: Most commentators claim that age is a determinant of deaths from COVID-19. This paper suggests flaws in this analysis. While co-morbidities associated with age may be contributory, there is no data showing that oldsters are more vulnerable to death from CoVid 19 than they are for dying generally. In fact, it appears that the aged population is less likely to die from CoVid than from Influenza and that the healthy oldster may be able to survive CoVid better than the healthy youngster. I further claim that CoVid policies targeting the elderly have unnecessarily contributed to their deaths. Thus rationing policies depriving the elderly of respirators and imposing restrictive lockdowns themselves contributed to the very assumptions on which these policy decisions were based.

Billauer, Barbara Pfeffer, ‘On the Proposal Not to Vaccinate the Aged for COVID-19’ (SSRN Scholarly Paper No ID 3694407, 17 September 2020)
Abstract: Public Health Practice champions the objective of saving lives when allocating scarce resources. Bioethical precepts advocate equal respect for individuals. Anti-discrimination laws forbid making decisions on the basis of class or stereotypes. What happens when academics propose vaccine- allocation plans (in an article in The Conversation) which trespass on all three- promising that their plain will stop the epidemic? Insidious schemes which seem to promise nirvana while violating human and civil rights need to be examined very carefully. In this case, a careful examination discloses the proposed plan is inherently flawed, not just from a legal and ethical perspective, but from a public health perspective as well.

Bilotta, Clio et al, ‘The Medico-Legal Implications in Medical Malpractice Claims during Covid-19 Pandemic: Increase or Trend Reversal?’ (2020) 88(1 (Supp)) Medico-Legal Journal 35–37
Abstract: The Covid-19 pandemic caused a marked increase in admissions to intensive care units. The critically ill patients’ condition from the infection resulted in their deaths. The healthcare facilities have got into trouble because of the pandemic. In fact, they had to create additional beds in a very short time and to protect health workers with personal protective equipment. Healthcare professionals fear that there will be an increase in complaints and medico-legal malpractice claims and hence they have urged politicians to discuss this. The Italian Parliament recently debated the topic of medical liability and passed the Decree-Law no. 18 of 17 March 2020 (DL – so called Cura Italia) by which they want to extend the concept of ‘gross negligence’ to healthcare facilities. Several Extended Care Units have suffered from outbreaks of Covid-19, so the Prosecutor’s Office of several cities initiated investigations against them. This situation has reached Sicily, where the Prosecutor’s Office of Palermo has opened an inquiry against an Extended Care Unit. Simultaneously, the Covid-19 pandemic may change patients’ attitudes towards healthcare professionals, who are risking their lives daily. So the Italian medico-legal community is debating these questions, with one last pending question remaining: is the number of medico-legal claims likely to increase or trend down?

Baltutite, Iolanta and Olesya Kazachenok, ‘Legal Regulation of Digital Transformation of Technologies in Healthcare in Russia and Abroad Under the Influence of the COVID-19 Pandemic’ (II International Scientific and Practical Conference " COVID-19: Implementation of the Sustainable Development Goals (RTCOV ), 2021) 178–183
Abstract: Currently, in the context of the COVID-19 pandemic and periodically introduced lockdowns for the Russian healthcare system, an important goal is to create conditions for the provision of medical care to all citizens, despite the territorial location and the possibility of physical visits to a hospital or polyclinic. In modern conditions of digitalization of life, an effective way to solve this problem is the development of information tools in the field of healthcare through the creation of a unified medical information space. The progressive development of technologies (medical and infocommunication) launches the process of digital transformation and the development of telemedicine. With all the above, it is fair to note that there is currently no formulated idea of what telemedicine includes, and there are also no fully formed norms for telemedicine services. A number of problems specific to telemedicine, but requiring solutions, for example, the question of who and what responsibility should be borne for the consultation provided, the problem of proper protection of personal data and compliance with medical secrecy, need to be resolved in the near future, which will make it more accessible and widespread to provide remote medical care using digital technologies.

Bismark, Marie, Ron Paterson and Owen Bradfield, ‘Patient Rights and Practitioner Responsibilities During a Pandemic’ in Belinda Bennett and Ian Freckelton (eds), Pandemics, Public Health Emergencies and Government Powers: Perspectives on Australian Law (Federation Press, 2021)

Blaney, Jane E, ‘Hidden in Plain Sight: How COVID-19 Revealed the Need to Incorporate Wearable Devices Into Patient Care’ (2020) 13(3) Journal of Health & Life Sciences Law 41–69

Blore, Ken and Felicity Nagorcka, ‘Human Rights and Trust in the Time of COVID-19: Lockdowns, Prison Conditions and Vaccine Mandates’ [2024] (110) AIAL Forum 21-49
Abstract: On the eve of the COVID-19 pandemic, Queensland joined the Australian Capital Territory and Victoria in enacting human rights legislation. The response to the pandemic required incursions on fundamental rights and freedoms which tested the human rights frameworks in each of these jurisdictions. Under that framework, whenever an act, decision or statutory provision limits a human right, generally that limit must be justified according to a test of proportionality. In this way, the legislation aims to embed a "culture of justification". This article follows how this culture of justification played out in the ACT, Victoria and Queensland for lockdowns, vaccine mandates and the heightened risks of transmission in a prison setting. It explores what these examples reveal about how human rights legislation interacts with trust in government institutions, and seeks to answer the following question: does a human rights framework help to build trust in government or might it, conversely, encourage scepticism about government decision-making?

Bodenschatz, Anja et al, ‘Triage or Randomization: Who Receives a Chance of Survival in the COVID-19 Pandemic Crisis?’ (SSRN Scholarly Paper No ID 3725507, 5 November 2020)
Abstract: The COVID-19 pandemic has proven to be exceptionally challenging for health care worldwide. Media and politicians currently pay attention to the ethical dilemma of distributing a prospective and potentially scarce COVID-19 vaccine. Meanwhile, physicians in intensive care units that are running out of equipment and qualified staff face vital ethical dilemmas already today. The specific course of the COVID-19 virus leads to situations in which physicians are aware that they make a pivotal decision over the life or death of one patient, for the direct benefit or disadvantage of others. Until now, these decisions are left to the individual physician without legal backing. While guidelines by professional medical associations provide orientation, the law often stands idly by. The guidelines themselves are ethically and legally controversial. We draw on literature in the behavioral sciences to outline which pitfalls the current juridical situation may entail. We argue that polity has to decide whether there are criteria for duly justified cases in which the medical system has to prioritize patients, and the procedure to do so, to overcome the intolerable present legal situation. This will provide due justification and relief for physicians. We show how informative research on ethical dilemmas in autonomous driving can inform policymakers which triage criteria may find acceptance in society if dilemmatic resource shortages occur. If policymakers refuse to lay down criteria for triage, by which they would deliberately impose harm on some in order to avoid greater harm for others, every patient must be given an equal chance of treatment, irrespectively of age or condition. We argue that this would imply that ventilators and other vital medical resources have to be allocated randomly. Furthermore, we provide empirical evidence for the acceptance of randomization in emergencies during the COVID-19 pandemic. Polity has to provide legal certainty for physicians, who face ethical dilemmas induced by resource shortages. It has to define legally binding triage criteria, or else deliberately refuse to do so and rely on a random allocation of scarce resources among the needy, to explicitly exclude any kind of discrimination.

von Bogdandy, Armin and Pedro Villarreal, ‘The Role of International Law in Vaccinating Against COVID-19: Appraising the COVAX Initiative’ (Max Planck Institute for Comparative Public Law & International Law (MPIL) Research Paper No 2020–46, November 2020)
Abstract: Soon there will be vaccines against COVID-19, but they will initially be scarce. Vaccine nationalism, resultantly, looms large. However, for considerations of effectiveness, solidarity as well as of international law, national governments should also cater for the health of other countries’ populations. This article presents the main legal instruments of vaccine nationalism as well as the COVAX Initiative as an instrument for a fairer global distribution. An analysis of the international right to health shows the normative corridor in which COVAX is situated and the promise it holds for some degree of sustainable solidarity.

Bolcato, Matteo et al, ‘Take-Home Messages from the COVID-19 Pandemic: Strengths and Pitfalls of the Italian National Health Service from a Medico-Legal Point of View’ (2021) 9(17) Healthcare 1–13
Abstract: The World Health Organization (WHO) declared the outbreak of the Coronavirus disease-2019 (COVID-19) infection a pandemic on 11 March 2020. As of the end of October 2020, there were 50 million cases of infection and over one million deaths recorded worldwide, over 45,000 of which occurred in Italy. In Italy, the demand for intensive care over the course of this pandemic crisis has been exceptionally high, resulting in a severe imbalance between the demand for and availability of the necessary resources. This paper focuses on elements of preventive medicine and medical treatments in emergency and non-emergency situations which, based on the international scientific literature, may prove to be useful to physicians on a behavioral level and avert professional liability problems. In order to achieve this objective, we have performed a search on MEDLINE to find published articles related to the risks associated with the pandemic that contain useful suggestions and strategies for mitigating risks and protecting the safety of the population. The results have been collocated in line with these specific study areas.

Bollyky, Thomas J, Lawrence O Gostin and Margaret Hamburg, ‘The Equitable Distribution of COVID-19 Therapeutics and Vaccines’ (2020) 323(24) Journal of the American Medical Association 2462–2463
Abstract: Scientists from across the globe are racing to develop effective vaccines and therapeutics for coronavirus disease 2019 (COVID-19). Plans are beginning to emerge for ensuring the equitable worldwide distribution of vaccines and therapeutics resulting from biomedical innovations. Absent broad agreement and buy-in on those plans, governments may prioritize their own populations, resulting in inequitable distribution of medical products both within and among countries. During the 2009 influenza A(H1N1) pandemic, wealthy nations bought virtually all vaccine supplies. Even after the WHO appealed for donations, supplies for low- and middle-income countries (LMICs) were limited. The White House may have already sought exclusive access to a COVID-19 vaccine candidate. European and Asian countries have imposed export controls on personal protective equipment and ventilators, with similar export controls likely to extend to COVID-19 vaccine and therapeutic stocks.The development and widespread distribution of COVID-19 medical treatments are a common global interest. Here we offer a proposal for global cooperation to ensure equitable distribution of vaccines and therapies for COViD -19.

Bonvicini, Barbara et al, ‘Legal Scenarios in the Coronavirus Time: Medico Legal Implications in the Aspects of Governance’ (2021) 48 Legal Medicine Article 101832
Abstract: Along with rising levels of the infection around the world, the state of emergency prompted by the COVID-19 pandemic has also been having a heavy legal impact. The situation is posing important criminal challenges, as well as an ocean of social and public health issues around the world. It has not only directly affected constitutionally-guaranteed rights and individual freedoms, but also brought to the fore certain types of criminal offence that had previously been of little practical importance, such as the crime of ‘maliciously or unintentionally causing an epidemic’. Different countries and states have introduced policies to manage the emergency at different times and in different ways. The measures adopted have been the object of much criticism, also raising questions of constitutional legitimacy in countries like Italy. The present contribution begins with a brief outline of the different international scenarios. Then we examine some of the medicolegal aspects of criminal offences previously envisaged and newly introduced since the arrival of the pandemic. We suggest the need for a sort of ‘code of public health laws for the time of coronavirus’, that could also be applied to other public health emergencies, pandemic or otherwise. The idea is to give operators in the sector and the general population the opportunity to identify clear and simple rules to follow in the current complex global situation. We need a new, appropriate interpretation of the ‘boundaries’ of our individual rights in relation to the need to safeguard the wider community and its more vulnerable members.

Botes, M, ‘Informed Consent during Pandemics: Experimental Medicine, Experienced Consent’ (2021) 14(3) South African Journal of Bioethics & Law 93–96
Abstract: No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits’ end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine’s stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients’ consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient’s explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine’s development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.

Botrugno, Carlo, ‘The Ethical, Legal, and Social Implications of Digital Healthcare Services in the COVID-19 Pandemic’ (2022) 7 The Future of Science and Ethics 69–81
Abstract: Since the beginning of the pandemic, national governments and health authorities have adopted heavy restrictions in order to respond to the COVID-19 health emergency. As a consequence, fundamental rights and individual freedoms were signifcantly constrained. In parallel, multiple attempts were made to shift our lives towards a ‘digital transition’. In such a context, information and communication technologies undertook a fundamental role in reshaping quantity, quality, and meaningfulness of our social and professional relationships. This paper analyses the most relevant ethical, legal and social issues posed by the use of these technologies for managing COVID-19 pandemic by clustering them into three groups: (i) the attempts to digitalise healthcare delivery, (ii) the weight of digital divides in ensuring equitable access to healthcare, and (iii) and the (e)merging logic of healthcare and control, which is legally and socially legitimised on the grounds of public health protection.

Bretthauer, Michael et al, ‘Evidence and Precaution for Legal Health Interventions: Learning From the COVID-19 Pandemic’ (2021) Annals of Internal Medicine (advance article)
Abstract: During the COVID-19 pandemic, far-reaching restrictions on normal life were implemented by laws and regulations to prevent disease transmission and protect people and society. In the absence of evidence for the most appropriate legal mitigation measures, decision makers often cited principles of precaution as the basis for implementing restrictive laws and regulations and unprecedented measures such as lockdowns, curfews, and school closings. To avert harm in crises, many people consider precaution as a morally correct concept for action. Many regard authorities who act with precaution as alert and responsive, fulfilling obligations to take care of people in times of uncertainty. Critics have castigated political leaders who failed to act with caution, particularly when disastrous consequences apparently followed from failure to take strong preventive measures. Soon after the start of the pandemic, investigators initiated a surge of clinical trials for drugs and vaccines, which have been enormously valuable and contributed to evidence-based improvements in clinical care and disease prevention. However, for public health, such mitigation measures as the 3- and 6-foot distancing rules, strategies for school openings, or quarantine duration remain untested in clinical trials. Their comparative benefit–harm ratio is still guided by the precautionary principle rather than by empirical evidence.

Brothers, Kyle B, Aaron J Goldenberg and R Jean Cadigan, ‘“If It’s Ethical During a Pandemic…”: Lessons from COVID-19 for Post-Pandemic Biobanking’ (2021) 21(12) American Journal of Bioethics 34–36

Brown, Christian et al, ‘Isolation of Patients in Psychiatric Hospitals in the Context of the COVID-19 Pandemic: An Ethical, Legal, and Practical Challenge’ (2020) 71(July/August, Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus)) International Journal of Law and Psychiatry Article 101572
Abstract: Psychiatric inpatients are particularly vulnerable to the transmission and effects of COVID-19. As such, healthcare providers should implement measures to prevent its spread within mental health units, including adequate testing, cohorting, and in some cases, the isolation of patients. Respiratory isolation imposes a significant limitation on an individual’s right to liberty, and should be accompanied by appropriate legal safeguards. This paper explores the implications of respiratory isolation in English law, considering the applicability of the common law doctrine of necessity, the Mental Capacity Act 2005, the Mental Health Act 1983, and public health legislation. We then interrogate the practicality of currently available approaches by applying them to a series of hypothetical cases. There are currently no ‘neat’ or practicable solutions to the problem of lawfully isolating patients on mental health units, and we discuss the myriad issues with both mental health and public health law approaches to the problem. We conclude by making some suggestions to policymakers.

Brown, Italo M et al, ‘COVID-19 Disparities and the Black Community: A Health Equity–Informed Rapid Response Is Needed’ (2020) 110(9) American Journal of Public Health 1350–1351

Brown, Rebecca, ‘Quarantine Island: Australia’s Health Policy and Its Construction of International Law’ (2024) 41(1) Australian Year Book of International Law Online 299–343
Abstract: This article explores the development of Australia’s policy approach towards communicable disease, both domestically and internationally. Drawing on archival records, it considers the methods used by federal and state governments to manage disease in Australia over time, analysing the key beliefs and priorities held by successive governments, and how these reflect Australia’s particular character and history. Against these domestic concerns, the article interrogates Australia’s approach to global health governance, with a particular focus on the state’s contributions to the drafting of major international health instruments on communicable disease. This analysis reveals the idiosyncratic nature of Australia’s health policy and the resulting impact on Australia’s contributions to the international legal system. It shows that Australia’s approach has consistently relied on the creation and preservation of an impermeable national border. This policy reflects an institutionalised belief, held continually since the early colonial period, that disease must be fully eradicated, and that this is best effected through taking advantage of the country’s geographic isolation. Domestically, this conception of disease control results in the adoption of strict quarantine requirements, immigration restrictions and broad discretionary powers regarding the entry of people and goods, while in the international context, Australia supports norms that facilitate its reification of its border. Accordingly, the article contextualises Australia’s health policy across four time periods of global health governance: the first sanitary conferences of the 19th and early-20th centuries, the post-World War II creation of the World Health Organization, the International Health Regulations 2005 revision project, and those Regulations’ operation before and during the COVID-19 pandemic. This article’s findings reveal the intrinsic connection between the unique domestic concerns of states and their approaches to international negotiations, which stymies the ability to generate effective cooperation globally. It clarifies this relationship and invites reflection on the resulting obstacles to international law’s progressive development.

Brown, Teneille R, ‘When the Wrong People Are Immune’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa018
Abstract: After a disaster such as the COVID-19 pandemic, there will be an irresistible desire to blame others. Despite documented failures in the federal government’s response to the pandemic, injured individuals will not be able to hold it accountable due to the broad application of governmental immunity. Congress and state governments have provided targeted immunity to various device manufacturers and emergency volunteers. However, the one group with huge targets on their backs are individual physicians, who are often making impossible choices that are reasonable at the time, but might not appear reasonable to a jury after the fact, and with the bias of hindsight. Recognizing that the potential for liability might cause undue psychological stress on health care providers, this essay argues for statutory immunity that protects them from rationing and other health care decisions that are made in good faith, and that are in compliance with documented state, institutional, or professional pandemic-response guidelines.

Buck, Isaac D, ‘When Hospitals Sue Patients’ (2022) 73(2) Hastings Law Journal 191–232
Abstract: Grimly demonstrated by the COVID-19 pandemic, hospitals serve as the central hub of American health care. Increasingly exercising market power, setting clinical standards, and fostering innovation, hospitals’ influence over health care delivery and access is unmatched. They are the behemoth in the delivery chain, exerting unrivaled control. As such, hospitals have naturally become the locus of the worst of the collision between consumerism and universality, between cost and access--a gloomy setting for citizens who simply cannot afford the health care they need to flourish, or to survive. Indeed, the price of American health care--a cost that is increasingly borne by American patients--is unsustainable. Those costs continue to rise thanks to a pernicious mix of increasingly brittle and ineffective insurance plans, a squeeze on public funding, and a lack of price sensitivity among the providers of American health care. Patients are suffering. And hospitals are not getting paid. In a predictable but catastrophic turn, hospitals are suing their former patients for unpaid medical bills. Litigation has replaced systematic financing. The operating room has been swapped for the courtroom. And adversarial proceedings now follow the Hippocratic Oath. Tracking the phenomenon of these lawsuits, this Article lays out the harms that result to the American health care system. When hospitals sue patients, they harm public health and destroy patient trust. And they shatter widely held beliefs, highlighting the inadequacy of policy goals and the inequity of health finance rules. Further, once and for all, they expose the failure of the consumer-based paradigm of American health care, spotlighting the inapplicability of moral hazard and demonstrating the means by which individuals with private insurance and high deductibles--a rapidly growing population in the United States--are inadequately protected against the very actors that undertake to protect their health and wellbeing. This Article makes the moral, legal, and policy-based argument that hospital lawsuits against former patients must be brought to an end. American patients simply cannot afford it.

Budiono, Arief, ‘Legal Protection of Vaccine Administration Health Service to Prevent the Spread of the Coronavirus Disease 2019 in Indonesia’ (2021) 9(E) Open Access Macedonian Journal of Medical Sciences 1050–1054
Abstract: The increase of Coronavirus disease (COVID-19) infections leads countries to implement preventive steps such as wearing masks, social distancing, and vaccine administration. Indonesia started administering mass vaccination in January 2021 using the Sinovac vaccine, but there are still problems such as the emergence of side effects. This research aims to explain the legal protection of COVID-19 vaccine administration and its obstacles. The research results show that the legal protection of COVID-19 vaccine administration includes Law No. 36 of 2009 on Health and Presidential Decree No. 99 of 2020 on Vaccine Procurement and Administration to Overcome the COVID-19 Pandemic. Then, the obstacles in the vaccine administration include the limited stock of vaccines and supporting health equipment such as hazmat suits and injection needles. Thus, the government of Indonesia should implement the Health Protocols during this pandemic, as stipulated in the Decree of the Republic of Indonesia’s Ministry of Health No. Hk.01.07/Menkes/382/2020.

Bueno De Mesquita, Judith and Benjamin Mason Meier, ‘Moving Towards Global Solidarity for Global Health through Multilateral Governance in the Covid-19 Response’ in Carla Ferstman and Andrew Fagan (eds), Covid-19, Law and Human Rights: Essex Dialogues (School of Law and Human Rights Centre, University of Essex, 2020) 31–39
Abstract: Introduction: The rapid spread of, and devastation caused by, Covid-19 worldwide reflects not only its viral properties, but the dichotomy between a globalised world profoundly connected by trade and travel and the absence of global solidarity and coordination in the response to the pandemic. Challenging a rising disengagement from multilateral governance, the UN Secretary General, the World Health Organisation (WHO), and the UN Committee on Economic, Social and Cultural Rights (CESCR) have all called for global solidarity and international assistance and cooperation to be at the heart of the Covid-19 response. In this paper, we explore what this means for global health, giving particular attention to two core components of global health law that provide legally binding obligations regarding Covid-19: the commitments to global governance under the International Health Regulations (IHR) and obligations of international assistance and cooperation towards the realisation of economic, social and cultural rights, including the right to health, under the International Covenant on Economic, Social and Cultural Rights (ICESCR). Situating the global pandemic response in the context of the contemporaneous decline of multilateralism, our article takes a critical look at the international institutions and frameworks and their role during pandemic responses, and the imperative of a more cosmopolitan approach to global governance, embracing solidarity and international cooperation in a way that serves low-income countries and rights holders everywhere.

Burnett, Martha, ‘When Did Saving Lives Become a Decision on Who Gets to Live?’ (2020) 20(5) Without Prejudice 7–8
Abstract: ‘I had the worst day of my whole Nursing career today. We were literally discussing who gets to live and who dies – there are not enough ventilators in our hospital for all who need one. My heart is broken. How did we get here?’

Burström, Bo and Wenjing Tao, ‘Social Determinants of Health and Inequalities in COVID-19’ (2020) 30(4) European Journal of Public Health 617–618
Abstract: The COVID-19 pandemic is affecting populations worldwide. Although everyone is susceptible to the virus, there are numerous accounts of the pandemic having a greater impact on lower socioeconomic groups and minorities.1,2 Also, in Stockholm, Sweden, the infection rate is 3–4 times higher in some socioeconomically disadvantaged residential areas compared to the regional average. Scientific studies of inequalities in Coronavirus disease 2019 (COVID-19) are lacking at present, but it is reasonable to assume that disparities in social determinants of health have contributed to these early observations and result in differential exposure to the virus, differential vulnerability to the infection and differential consequences of the disease.

Bustomi, Yazid, ‘Conflict Between Health Law and Territorial Quarantine Law Regarding the Provision of COVID-19 Vaccine’ (2021) 7(1) Unnes Law Journal: Jurnal Hukum Universitas Negeri Semarang (advance article, published 9 April 2021)
Abstract: In the context of preventing the increasingly widespread Covid-19 which has claimed many lives, the Indonesian government has made various efforts to overcome this and the most recent effort is giving Covid-19 vaccinations to the public. In practice, various conflicts emerge and one of them is the conflict between Law Number 6 of 2018 concerning Health Quarantine which states that vaccines are an obligation and Law Number 36 of 2009 concerning Health which states that vaccines are a right. This type of research is juridical normative using a statutory and conceptual approach. The results of this study indicate that Covid-19 is an emergency so that the principle of non-habet legem necessity applies, which means that in a state of legal emergency it does not apply, so that regulatory conflicts regarding Covid-19 vaccination do not become a problem, because the current government’s efforts are the safety of the people. the highest law in an emergency, this is also in line with the salus populi suprema et lex principle. To ensure the safety of the people, the government is obliged to make efforts to vaccinate Covid-19 to restore the situation to its original state, this is in line with the principle of restutio in integrum. In its enforcement, sanctions are needed to make the community obey. However, several regulations have different norms regarding sanctions for those who do not comply and until now there have been no specific regulations from the center regarding the provision of the Covid-19 vaccine. As a conclusion, currently giving the Covid-19 vaccine is mandatory because it is an emergency, but the government also needs to make special regulations from the center regarding vaccine administration regulations so that there are no disparities between each of the regulations from the vaccine-giving regions.

Cahyani, Prilian and Didik Endro Purwoleksono, ‘Coronavirus Disease (Covid-19) Vaccination Policy as a Right or Obligation: Health Law Perspective’ (2023) 19(Supp 2) Malaysian Journal of Medicine and Health Sciences 18–24
Abstract: The legal issue in this paper is the uncertainty regarding the recognition of the COVID-19 vaccination policy as a citizen’s right or obligation. Vaccination is a medical procedure that provides a vaccine that stimulates the production of immunity in the body as a preventive measure. The vaccination program is an effort to realize the 3 SDGs. In Indonesia, the rules regarding health rights and obligations are regulated in the Health Law, but it is still not explicitly regulated in terms of vaccination, nor is vaccine approval legally regulated. Furthermore, the Outbreak Management Act provides legal consequences for anyone who refuses to be vaccinated because it is considered to hinder the control of the epidemic. This paper analyses the categories of rights and obligations. The implementation of the COVID-19 vaccine policy as a human right has an inherent obligation to humans. Therefore, in practice the implementation of the COVID-19 vaccine policy as a citizen’s right, in the end cannot be implemented, even though it is based on individual beliefs because there are obligations that require someone to fulfill the rights of others including the right to health and criminal sanctions are imposed if not implemented. This research shows that the Covid-19 vaccination policy in Indonesia is not only a human right but also an obligation. So that criminal sanctions arise for people who do not implement them.

Campbell, Meghan, Sandra Fredman and Aaron Reeves, ‘Palliation or Protection: How Should the Right to Equality Inform the Government’s Response to Covid-19?’ (2020) 20(4) International Journal of Discrimination and the Law 183–202
Abstract: This article examines what role equality law can play in addressing the inequalities created and exacerbated by the British government’s response to the Covid-19 pandemic. We argue that while there is great potential in existing legislation, there is a need for both policy-makers and courts to apply a more searching and nuanced understanding of the right to equality if this potential is to be realised. We begin by examining how the burdens of confronting this pandemic as a society fall more heavily on those already at the bottom end of the scale of inequality. We then ask whether and to what extent the current legal structures protecting the right to equality can be mobilised to redress such inequalities, paying particular attention to the Public Sector Equality Duty under the Equality Act 2010 and on the Human Rights Act 1998. Finally, we argue that, to fulfil the requirements of both these legal duties, the courts should subject policies and practices to close scrutiny under the four-dimensional approach. When making and operationalising policies around Covid-19, substantive equality requires account to be taken simultaneously of the four dimensions of inequality to the greatest extent possible.

Campos, Thana C De, ‘The Traditional Definition of Pandemics, Its Moral Conflations, and Its Practical Implications: A Defense of Conceptual Clarity in Global Health Laws and Policies’ (2020) 29(2) Cambridge Quarterly of Healthcare Ethics 205-217
Abstract: This paper argues that the existing definition of pandemics is not nuanced enough, because it is predicated solely on the criterion of spread, rather than on the criteria of spread and severity. This definitional challenge is what I call ‘the conflation problem’: there is a conflation of two different realities of global health, namely global health emergencies (i.e., severe communicable diseases that spread across borders) and nonemergencies (i.e., communicable or noncommunicable diseases that spread across borders and that may be severe). To put this argument forth, this paper begins by discussing the existing and internationally accepted definition of pandemics, its requirements, as well as its strengths (section 1). Section 2 then considers the problem with the standard definition of pandemics (i.e., the conflation problem) and some examples of it. Finally, section 3 evaluates some practical implications of the conflation problem to then explore conceptual clarity as the adequate solution.

Capíková, Silvia, Eduard Burda and Mária Nováková, ‘Measures Introduced in the Slovak Republic in Response to the Public Health Crisis Caused by the COVID-19 Pandemic’ (2021) 14(2) Medicine, Law & Society 321–350
Abstract: The SARS-Cov-2 pandemic outbreak in the Slovak Republic in March 2020 required rapid legal response to protect lives and health of inhabitants and new complex challenges emerged. The objective of this paper is an analysis and critical assessment of measures adopted in the field of health law. As most significant problem fields in Slovakia arose: 1/ Legality and hierarchy of measures limiting everyday life and exercise of citizen rights and freedoms; 2/ the scope, proportionality, extent and duration of measures; 3/ adherence to the measures by the public and law enforcement issues. The pandemic unraveled need to innovate the legal framework of contagious diseases control, for example, constitutional emergency regimen, or powers of the Public Health Authority. Established rule of law framework served to safeguarding against some disproportionate or unwanted effects of anti-pandemic measures, however, future development of more sophisticated legal tools to control the pandemic is needed.

Capps, Benjamin, ‘Where Does Open Science Lead Us During a Pandemic? A Public Good Argument to Prioritize Rights in the Open Commons’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 11–24
Abstract: During the 2020 COVID-19 pandemic, open science has become central to experimental, public health, and clinical responses across the globe. Open science (OS) is described as an open commons, in which a right to science renders all possible scientific data for everyone to access and use. In this common space, capitalist platforms now provide many essential services and are taking the lead in public health activities. These neoliberal businesses, however, have a problematic role in the capture of public goods. This paper argues that the open commons is a community of rights, consisting of people and institutions whose interests mutually support the public good. If OS is a cornerstone of public health, then reaffirming the public good is its overriding purpose, and unethical platforms ought to be excluded from the commons and its benefits.

Caputo, Fiorella et al, ‘Covid-19 Emergency in Prison: Current Management and Forensic Perspectives’ (2020) 88(4) Medico-Legal Journal 185–186
Abstract: The Covid-19 pandemic is currently a major worldwide public health problem. Contagion within prisons and in other custodial settings will need to be addressed promptly, but the management of preventive measures will be difficult due to overcrowding and inmates and officers’ close physical contact. There may also be less access to care than in community settings. Accordingly, prisons are particularly vulnerable to outbreaks of infection, and in addition to the likely greater risks of contagion attention must be paid to the psychological problems that the pandemic can have on the prison population. Riots and episodes of violence have already taken place in various prisons. With the inevitable restrictions on social contact and family meetings, prisoners who already are at increased risk of mental illness and suicide are more susceptible to adverse psychological repercussions. From a forensic point of view, therefore, we stress the need for the development of a strong support network by mental health workers for the prison population.

Cardilli, Riccardo, ‘Covid-19 and Law : the Legal Science of the XXI Century in the Age of the “Great Pandemic”’ (2020) 11(4) dA Derecho Animal : Forum of Animal Law Studies 64–70
Abstract: The real meaning of the words ‘epidemic’ and ‘pandemic’. The pandemic in history: the Antonine plague in the Roman Empire and the epidemic in Athens. The issue of the role of law in managing extraordinary events: the modern perspective and the Roman law perspective in comparison. Carl Schmitt’s theory of ‘Ausnahmezustand’ and the need to overcome this model. The importance of law and legal science in times of emergency.

Carroll, Andrew, ‘Forensic Mental-Health Assessments after Coronavirus Disease 2019: Will Telehealth Lead Us to Trade Psychological Depth for Convenience?’ (2020) 60(3) Medicine, Science and the Law 169–171
Abstract: Courts, tribunals and other decision-making bodies frequently rely on the expert reports of forensic mental-health practitioners (principally psychiatrists and psychologists) to assist with their deliberations in both criminal and civil matters. Less than a year ago, a leading Australian judge asserted that ‘in other than the rarest of circumstances’,1 courts were entitled to expect forensic assessments to be based on direct face-to-face contact between assessor and subject. With the imposition of the restrictions arising from the coronavirus disease 2019 (COVID-19) global pandemic, however, the usage of telehealth in forensic assessment work has shifted from an occasional exigency to a day-to-day necessity. A consideration of the advantages and disadvantages of telehealth, and recent learnings garnered from the necessary constraints of lockdown, suggest that rigid insistence on traditional face-to-face interaction between assessor and subject is no longer tenable. As we anticipate the nature of forensic mental-health assessment work in a financially constrained post-COVID-19 world, it therefore behoves us to reflect on the risks of telehealth becoming the new default mode for forensic mental-health assessments.

Carson, Saphronia and Shannon K Carter, ‘Abortion as a Public Health Risk in Covid-19 Anti-Abortion Legislation’ (2023) Journal of Health Politics, Policy and Law (advance article, published online 23 January 2023)
Abstract: During the early months of the COVID-19 pandemic, twelve states banned or restricted abortion access under elective procedure restrictions. The rationale was preserving hospital capacity and personal protective equipment (PPE), however abortions commonly take place in clinics and use less PPE than childbirth. This paper investigates the discursive construction of abortions, the people who get them, and fetuses in this legislation. The authors collaborated to analyze 13 anti-abortion documents using an iterative process of thematic coding and memo-writing. Twenty-three percent of the legislation listed abortion as banned, whereas the remaining laws implied abortion within the terms ‘elective’ or ‘non-essential.’ Legislation used common anti-abortion tactics, such as trivialization of abortion, risk discourses, and constructions of motherhood and fetal personhood. Discourses delegitimized abortion providers and used quasi-medical justifications for banning abortion. Finally, legislation constructed abortion clinics as sites of contagion and waste, and consequently as risks to public health. Results highlight the vulnerability of abortion and the connection between abortion policy and other conservative policy, and gesture towards a strategic attempt to federally ban abortion. Thus, these findings have several implications for a post-Roe US and for various stakeholders wishing to increase abortion access.

Castelyn, C de V et al, ‘Resource Allocation during COVID-19: A Focus on Vulnerable Populations’ (2020) 13(2) South African Journal of Bioethics and Law 83–86
Abstract: South Africa (SA) is a country of contrasts, with abundant resources, hard-won civil rights and a diverse population. Woven into the fabric of our society is a large divide between its poorest and its wealthiest members. In this article we highlight the vulnerabilities in our society that have been amplified by the COVID-19 crisis. Based on recent projections, it is very likely that the healthcare system will be overwhelmed. We acknowledge the recognition by government and civil society of these vulnerabilities, and note that difficult decisions will need to be made with regard to resource allocation. Our plea, however, is to ensure that human dignity and the principle of distributive justice are maintained, and that when difficult decisions are made, vulnerable people do not suffer disproportionately. Furthermore, it is of great concern that there is no national directive guiding resource allocation, prioritisation and triage decisions in both public and private hospitals. The Health Professions Council of SA should, as a matter of urgency, issue guidance on priority-setting and triage decisions in the context of COVID-19, based on distributive justice principles.

Cattuto, Ciro and Alessandro Spina, ‘The Institutionalisation of Digital Public Health: Lessons Learned from the COVID-19 App’ (2020) 11(2) European Journal of Risk Regulation Special Issue-‘Taming COVID-19 by Regulation’ 228-235
Abstract: Amid the outbreak of the SARS-CoV-2 pandemic, there has been a call to use innovative digital tools for the purpose of protecting public health. There are a number of proposals to embed digital solutions into the regulatory strategies adopted by public authorities to control the spread of the coronavirus more effectively. They range from algorithms to detect population movements by using telecommunications data to the use of artificial intelligence and high-performance computing power to detect patterns in the spread of the virus. However, the use of a mobile phone application for contact tracing is certainly the most popular.

Cave, Emma and Aisling McMahon, ‘Should States Restrict Recipient Choice amongst Relevant and Available COVID-19 Vaccines?’ (2023) 31(2) Medical Law Review 272–292
Abstract: Several COVID-19 vaccinations have been authorised worldwide. Whilst some vaccines are contraindicated for certain age groups or health conditions, there are often multiple clinically suitable authorised vaccine brands available. Few states have allowed recipients to choose amongst them, though there are multiple reasons why choice would be valued. We consider the policy justifications for state controls on recipient choice amongst COVID-19 vaccine brands, focusing on European countries and drawing on the UK context as an example. We contrast justifications for not offering choice at the height of the early pandemic crisis, and as some states seek to de-escalate their response and transition towards living with COVID-19. We argue that in the latter context public expectations of choice between available vaccine brands and platforms may rise, but that several considerations may justify continued restrictions on choice. A key factor which states should continue to take into consideration is the global nature of the pandemic. Insofar as offering recipient choice at a national level might exacerbate global inequity in vaccine distribution, states retain a normative and legal justification for restricting choice amongst available and clinically suitable vaccine brands.

Cederblom, Michael L, ‘Towards Action and In Pursuit of Scofflaws: Shifting the Framework of Pandemic Public Health Punishment from Theory to Pragmatism’ [2022] Lincoln Memorial University Law Review (forthcoming)
Abstract: The COVID-19 pandemic sparked a debate over whether public health interventions like mask mandates should be implemented and whether public health scofflaws should be punished. The result was a split largely across political lines; ‘permissive’ jurisdictions promoted ideas of individual freedom and condemnation of government-imposed punishment while ‘restrictive’ jurisdictions implemented a range of punishments attached to mask mandates. This political battle became one of stagnant theories and essentially fused considerations of public health and legal punishment. Bracketing political concerns, what philosophical theories fueled this divide? While public health generally employs a utilitarian framework limited by deontic constraints, permissive jurisdictions exuded a purer libertarian deontology and restrictive jurisdictions exhibited a retribution-laced utilitarianism. Neither are sufficient to guide public health punishment during a pandemic based on their reliance on too pure a theory. Permissive jurisdictions promoted government inaction which is simply in contravention to public health principles during an emergency, and restrictive jurisdictions used overly harsh punishments that threatens equity. What is needed is pragmatic reconciliation: the decision-making framework guiding public health punishment during a pandemic must recognize the exigency of the crisis and shift the balance of values (like emergency medicine) to prioritize population health and equity. Lawmakers utilizing this more grounded approach which draws on foreign example will deliver a more practical public health response that delivers fairer outcomes, protects individual liberties, and reduces overall suffering.

Chakraborty, Anogh and Shubhayan Chakraborty, ‘Obligations of Medical Professionals During a Pandemic: An Analysis of Law and Ethics’ (2020) 3(2) _Indian Journal of Health & Medical Law_
Abstract: A doctor assumes a certain level of authority in discharging his duties during a situation of crisis which may bring about criminal liabilities. The generic debate that if the medical professionals are legally bound to serve relentlessly, knowing that it may cause significant physical harm or death as a part of the professional commitment to the society, is sought to be debunked in due course. Medical literature comparatively, in different countries have scrutinised what codified and standard professional ethics can a medical professional be a subject to when the number of infected people dramatically rises in calamitous circumstances. As India continues to be dependent on a colonial statute, it lacks provisions governing the action of state authorities and their response mechanisms in times of an epidemic. The paper finally concludes with remarks on the Constitutional elements of the response surrounding the spread of COVID-19, the basic right to health care thereof, and the way forward for the Indian health care framework to combat this emerging crisis.

Chan, Hui Yun, ‘Hospitals’ Liabilities in Times of Pandemic: Recalibrating the Legal Obligation to Provide Personal Protective Equipment to Healthcare Workers’ (2021) 42(2) Liverpool Law Review 185–205
Abstract: The Covid-19 pandemic has precipitated the global race for essential personal protective equipment in delivering critical patient care. This has created a dearth of personal protective equipment availability in some countries, which posed particular harm to frontline healthcare workers’ health and safety, with undesirable consequences to public health. Substantial discussions have been devoted to the imperative of providing adequate personal protective equipment to frontline healthcare workers. The specific legal obligations of hospitals towards healthcare workers in the pandemic context have so far escaped important scrutiny. This paper endeavours to examine this overlooked aspect in the light of legal actions brought by frontline healthcare workers against their employers arising from a shortage of personal protective equipment. By analysing the potential legal liabilities of hospitals, the paper sheds light on the interlinked attributes and factors in understanding hospitals’ obligations towards healthcare workers and how such duty can be justifiably recalibrated in times of pandemic.

Chandler, Jennifer A et al, ‘Weighing Public Health and Mental Health Responses to Non-Compliance with Public Health Directives in the Context of Mental Illness’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 433
Abstract: COVID-19 has highlighted and reinforced the vulnerability of multiple populations, including people who live with mental illness. Challenges are posed by the requirements for physical distancing and self-isolation. Mental illness does not automatically render a person incapable of adopting such measures or their decisions not to do so suspect. People with mental illnesses may decide not to follow public health directives just as other people without mental illness may choose to do, and public health enforcement measures would apply. In some cases, symptoms of mental illness do affect a person’s adherence to public health directives by undermining the abilities to understand, to exercise appropriate judgment, and to evaluate risk. Should a person whose ability to follow directives is compromised by mental illness face the sanctions and enforcement procedures under public health laws, or should a mental health intervention such as involuntary hospitalization be pursued to protect both the person concerned and others, as well as the community in general? In this chapter, we consider the interplay of these two legislative regimes, recognizing that the balance may change with the evolution of the pandemic, shifting information, risk trade-offs, and social attitudes.

Chaufan, Claudia and Faisal Mohamed, ‘How the Politics of Big Pharma Is Undermining COVID-19 Public Health Policy in Canada’ (SSRN Scholarly Paper ID 3875637, 22 April 2021)
Abstract: In December 2020 a former NATO commander in Iraq appointed to lead vaccination logistics in the Public Health Agency of Canada announced that the country would adopt a ‘whole-of-nation’ approach to achieve the goal of vaccinating all Canadians by the summer. Two months away from the summer, four into the announcement, and with 400 million doses procured to vaccinate 38 million people several times over, less than 3% of Canadians have received two doses of the leading, authorized products. A range of explanations have been proffered for the delay, including that the Liberal Trudeau Government is treating Big Pharma unfairly, thus causing unnecessary barriers to vaccine supplies. We argue that the assertion does not stand up to scrutiny. As our analysis will show, Canadian pharmaceutical policy is extremely corporate friendly and has been so for decades. This has led to both a predictably rocky vaccine effort and to the continuing failure by the government to guarantee equitable access to medically necessary drugs, prior to, during, and beyond the COVID-19 pandemic.

Chen, Bo and Donna Marie McNamara, ‘Disability Discrimination, Medical Rationing and COVID-19’ (2020) 12 Asian Bioethics Review 511–518
Abstract: The current public health crisis has exposed deep cracks in social equality and justice for marginalised and vulnerable communities around the world. The reported rise in the number of ‘do not resuscitate’ orders being imposed on people with disabilities has caused particular concerns from a human rights perspective. While the evidence of this is contested, this article will consider the human rights implications at stake and the dangers associated with using ‘quality of life’ measures as determinant of care in medical decision-making and triage assessments.

Chen, Yu-Wei, ‘Risk-Taking or Risk-Negotiating Model of Vaccine Liability? Legal and Policy Considerations for Pandemic Vaccines’ (2022) 9(3) Lincoln Memorial University Law Review 136–177
Abstract: Solving the issue of vaccine liability is as equally important as vaccine equity in ensuring access to vaccines. This paper will unravel how different models of liability arrangements tackle vaccine injury and business risks, focusing on the United States and the European Union models. The analysis will begin with vaccine liability in normal times and investigate how the two models of vaccine liability accommodate a public health emergency. Next, to gain a deeper insight into this topic, this paper will discuss fundamental legislation and judicial decisions that shape the underlying principles and trade-offs for vaccine liability. This issue implicates a broad range of legal and policy considerations; it involves governments, individuals, and manufacturers, so the discovery is essential to our understanding of legal enablers or impediments arising from different models of vaccine liability.

Cheong, Mark Wing Loong, Pascale Allotey and Daniel D Reidpath, ‘Unequal Access to Vaccines Will Exacerbate Other Inequalities’ (2020) 32(6–7) Asia Pacific Journal of Public Health 379–380
Abstract: There is a consensus that a vaccine, and the immunity that it confers, is required for countries to lift their restrictions and restart their economies. This has led to countries competing for supplies of potential COVID-19 vaccines. A corresponding surge of activism has occurred to ensure that vaccines will be equitably distributed. Equal access to a vaccine will be needed to prevent the development of health disparities between the vaccinated and unvaccinated. Unfair access to vaccines will also create inequalities in rights and freedom. There are numerous reports of communities who are perceived to be at higher risk of being infected, being targets of discrimination, and having their rights curtailed. It requires no stretch of the imagination to see how unequal access to a vaccine will result in the rise of a 2-caste system: the clean, who are immune and noncontagious, and the untouchables, who are nonimmune and a feared source of infection.

Chia, T and OI Oyeniran, ‘Human Health versus Human Rights: An Emerging Ethical Dilemma Arising from Coronavirus Disease Pandemic’ (2020) 14(July-September) Ethics, Medicine and Public Health 100511
Abstract: Introduction: The world is contending to contain the outbreak of coronavirus which has now resulted to36,571 mortalities out of the 754,948 confirmed cases in 202 countries, areas or territories as at March 31, 2020. Pandemics are usually characterized by a sense of panic and uncertainties. Even though global preparedness and emergency procedures have been enacted, the uncertainties surrounding this pandemic raise considerable questions to their adherence. Widespread restrictions of varying degrees have been placed on individuals, groups, communities, cities or even whole regions. These restrictions ab initio are in contradiction to civil and human rights. These measures, which are now widely implemented in many regions and countries of the globe, have thrown up fresh ethical questions. Between human health and human rights, which takes primacy?

Childs, Andrew, ‘The Distribution of Fake Australian Vaccine Digital Certificates on an Alt-Tech Platform’ (2023) 26(2) Trends in Organized Crime 136–155
Abstract: This paper provides the first exploration of the online distribution of fake Australian COVID-19 vaccine certificates. Drawing on a collection of 2589 posts between five distributors and their community members on the alt-tech platform Gab, this study gathers key insights into the mechanics of illicit vaccine certificate distribution. The qualitative findings in this research demonstrate the various motivations and binding ideologies that underpinned this illicit distribution (e.g. anti-vaccine and anti-surveillance motivations); the unique cybercultural aspects of this online illicit network (e.g. ‘crowdsourcing’ the creation of fake vaccine passes); and how the online community was used to share information on the risks of engaging in this illicit service, setting the appropriate contexts of using fake vaccine passes, and the evasion of guardians in offline settings. Implications for future research in cybercrime, illicit networks, and organised crime in digital spaces are discussed.

Chin, H Paul and Guillermo Palchik, ‘Telepsychiatry in the Age of COVID: Some Ethical Considerations’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 37–41
Abstract: The COVID-19 pandemic has necessitated a rapid escalation in the use of telepsychiatry. Herein we revisit some of the ethical issues regarding its use, including patient benefice, distributive justice, privacy, and autonomy. Based on these considerations we would hold that telepsychiatry is a vital aspect of providing psychiatric care, and ethically should be offered as a format for treatment, likely beyond the pandemic period. Investigative and advocacy efforts will need to continue to determine its exact role within psychiatric care, and expand its availability for those most in need.

Choer Moraes, Henrique, ‘Too Big to Heal? Macroprudential Policies in Health Governance’ (SSRN Scholarly Paper No ID 3591536, 29 April 2020)
Abstract: Amidst the many consequences it will leave in its wake, COVID-19 might reveal that global health governance should focus on systemic risk management, just as their peers in financial regulation did over a decade ago.

Chohan, Usman W, ‘After the Coronavirus Vaccine’s Discovery: Concerns Regarding a COVID-19 Vaccination’s Distribution’ (CASS Working Papers on Economics and National Affairs No EC021UC, 2020)
Abstract: The fervent global quest for the development of a vaccine against the novel coronavirus (COVID-19) begs the frightening questions: who will go first in receiving it? and will everyone get to receive it at all? This working paper seeks to highlight the risk that mercantilist market-logic approaches to hoard or overprice a future vaccine poses for human lives, and how it might reproduce global inequalities in a fatal manner. It draws upon the literature on socioeconomic disparities in vaccination to argue that the infrastructure for international dissemination of the vaccine must be built in advance and in a manner that forsakes the hostile mercantilism that has accompanied a shifting and combative international order.

Cioffi, Andrea and Raffaella Rinaldi, ‘COVID-19 and Medical Liability: A Delicate Balance’ (2020) 88(4) Medico-Legal Journal 187–188
Abstract: During the Covid-19 pandemic, many countries around the world are considering whether and how to provide liability protection to front-line healthcare staff. The guiding principle of liability protection for physicians and others is to ensure that, in a serious emergency situation, health professionals can devote themselves exclusively to their work and to patient care, without the fear of future claims for unforeseeable, but above all unavoidable, injury, loss and damage caused by their conduct. Great care is needed to balance the interests and rights of all those involved. Liability protection could have risky consequences with the final result that doctors will not be protected, but institutions such as health facilities will be even if they were in fact responsible for foreseeable and avoidable damage.

Clark, Helen and HE Ellen Johnson Sirleaf, ‘COVID-19: Make It the Last Pandemic’ (Independent Panel for Pandemic Preparedness and Response, 10 May 2021)
Abstract: The world is still in the midst of a pandemic that has spread wider and faster than any in human history. The social and economic crisis precipitated by COVID-19 is affecting families, communities and nations across the globe. Seized by the gravity of the crisis, in May 2020 the World Health Assembly requested the Director-General of WHO to initiate an impartial, independent, and comprehensive review of the international health response to COVID-19 and of experiences gained and lessons learned from that, and to make recommendations to improve capacities for the future. The Director-General asked H.E. Ellen Johnson Sirleaf and the Rt Hon. Helen Clark to convene an independent panel for this purpose and to report to the World Health Assembly in May 2021. The Panel has taken a systematic, rigorous and comprehensive approach to its work. It has sought to listen to and learn from a wide range of interlocutors. Since mid-September 2020, the Panel has reviewed extensive literature, conducted original research, heard from experts in 15 round-table discussions and in interviews, received the testimony of people working on the front lines of the pandemic in town-hall-style meetings, and welcomed many submissions from its open invitation to contribute. The Panel has examined the state of pandemic preparedness prior to COVID-19, the circumstances of the identification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the disease it causes, coronavirus disease (COVID-19), and responses globally, regionally and nationally, particularly in the pandemic’s early months. It has also analysed the wide-ranging impact of the pandemic and the ongoing social and economic crisis that it has precipitated. This report presents the Panel’s findings on what happened, the lessons to be learned from that, and our recommendations for strategic action now to end this pandemic and to ensure that any future infectious disease outbreak does not become a catastrophic pandemic.

Clemens, Timo and Helmut Brand, ‘Will COVID-19 Lead to a Major Change of the EU Public Health Mandate? A Renewed Approach to EU’s Role Is Needed’ (2020) 30(4) European Journal of Public Health 624–625
Abstract: These days we see the first assessments on the EU’s role as crisis manager. Commentators differ in their view whether the EU has failed, been late or has finally come to a substantial response.

Close, Eliana et al, ‘Legal Challenges to ICU Triage Decisions in the COVID-19 Pandemic: How Effectively Does the Law Regulate Bedside Rationing Decisions in Australia?’ (2021) 44(1) UNSW Law Journal 9–59
Abstract: The COVID-19 pandemic has raised the difficult question of how to ration scarce intensive care resources when a health system is overwhelmed. Despite substantial ethical scholarship addressing these rationing decisions, little is known about the legal position in Australia. This article considers various legal challenges in response to a clinical scenario denying intensive care admission and a ventilator to a critically ill patient with COVID-19. The article considers key challenges in negligence, criminal law, administrative law, human rights law, and under the parens patriae jurisdiction and guardianship legislation, and how they would apply to this scenario. The article concludes that while there are many obstacles to a successful legal challenge, the law can provide important scrutiny and guidance in the design of decision-making processes and triage policies. To adequately protect individual interests, the article supports calls in the ethical literature to make these policies transparent for public scrutiny.

Close, Eliana et al, ‘Transparent Triage Policies during the COVID-19 Pandemic: A Critical Part of Medico-Legal Risk Management for Clinicians’ (2021) 215(2) Medical Journal of Australia 71-74
Introduction: Clinicians, ethicists and lawyers have long debated the parameters of triage in response to the inevitable disasters that sporadically overwhelm the health care system. Almost universally, they have advocated for open, transparent and consultative triage protocols, guidelines and legislation to combat biases and to support clinicians making unavoidable decisions in the interests of the community as a whole. The coronavirus disease 2019 (COVID-19) pandemic has highlighted the importance of transparent triage. While there is considerable debate about ethical aspects of triage protocols, including concerns that the traditional focus on utilitarianism is discriminatory, largely missing from this discussion in Australia is that triage protocols are also important from a legal perspective — as a mechanism to promote lawful decision-making processes and as a justification or defence to support clinicians’ decisions if a matter is litigated. The purpose of this article is twofold. First, after providing an overview of current COVID-19 triage policies in Australia, we assess their legal status. Second, we argue that beyond ethics, transparent policies are needed so their compliance with law can be tested, and to enable practitioners to better understand their obligations before making sometimes ‘impossible’ decisions.

Coggon, John and Lawrence O Gostin, ‘Postscript: COVID-19 and the Legal Determinants of Health’ [2020] Public Health Ethics (advance article, published 25 May) 1-2
Abstract: This is a short postscript to the Public Health Ethics special issue on the legal determinants of health. We reflect briefly on emerging responses to COVID-19, and raise important questions of ethics and law that must be addressed; including through the lens of legal determinants, and with critical attention to what it means to protect health with justice.

Coghlan, N et al, ‘COVID-19: Legal Implications for Critical Care’ (2020) 75(11) Anaesthesia 1517–1528
Abstract: The COVID-19 pandemic has caused an unprecedented challenge for the provision of critical care. Anticipating an unsustainable burden on the health service, the UK Government introduced numerous legislative measures culminating in the Coronavirus Act, which interfere with existing legislation and rights. However, the existing standards and legal frameworks relevant to critical care clinicians are not extinguished, but anticipated to adapt to a new context. This new context influences the standard of care that can be reasonably provided and yields many human rights considerations, for example, in the use of restraints, or the restrictions placed on patients and visitors under the Infection Prevention and Control guidance. The changing landscape has also highlighted previously unrecognised legal dilemmas. The perceived difficulties in the provision of personal protective equipment for employees pose a legal risk for Trusts and a regulatory risk for clinicians. The spectre of rationing critical care poses a number of legal issues. Notably, the flux between clinical decisions based on best interests towards decisions explicitly based on resource considerations should be underpinned by an authoritative public policy decision to preserve legitimacy and lawfulness. Such a policy should be medically coherent, legally robust and ethically justified. The current crisis poses numerous challenges for clinicians aspiring to remain faithful to medicolegal and human rights principles developed over many decades, especially when such principles could easily be dismissed. However, it is exactly at such times that these principles are needed the most and clinicians play a disproportionate role in safeguarding them for the most vulnerable.

Cohen, I Glenn et al (eds), COVID-19 and the Law: Disruption, Impact and Legacy (Cambridge University Press, 2023) [OPEN ACCESS E-BOOK ON CAMBRIDGE CORE]
Part I: The Health Care System That COVID-19 Encountered
Introduction - Carmel Shachar
  1. COVID-19 and Clinical Ethics: Reflections on New York’s 2020 Spring Surge - Joseph J. Fins
  2. Patients First, Public Health Last - Richard S. Saver
  3. Risk, Responsibility, Resilience, Respect: COVID-19 and the Protection of Health Care Workers - William M. Sage and Victoria L. Tiase
  4. Post-Truth Won’t Set Us Free: Health Law, Patient Autonomy, and the Rise of the Infodemic - Wendy E. Parmet and Jeremy Paul
  5. Structural Factors Related to COVID-19 Disparities - Saida I. Coreas, Erik J. Rodriquez, and Eliseo J. Pérez-Stable
Part II: COVID-19, Disparities, and Vulnerable Populations
Introduction - Asees Bhasin
  1. Tolerating the Harms of Detention, With and Without COVID-19 - Jaimie Meyer, Marisol Orihuela, and Judith Resnik
  2. COVID-19 and Racial Justice in America - Scott J. Schweikart, Fernando De Maio, Mia Keeys, Joaquin Baca, Brian Vandenberg, and Aletha Maybank
  3. Access to Scarce Interventions: Age and Disability - Govind Persad and Jessica L. Roberts
  4. Humane and Resilient Long-Term Care: A Post-COVID-19 Vision - Nina A. Kohn
Part III: Government Response and Reaction to COVID-19
Prologue - Marcella Nunez-Smith
Introduction - Abbe R. Gluck
  1. Federalism, Leadership, and COVID-19: Evolving Lessons for the Public’s Health - Nicole Huberfeld
  2. COVID-19 Reveals the Fiscal Determinants of Health - Matthew B. Lawrence
  3. Legislating a More Responsive Safety Net - Andrew Hammond, Ariel Jurow Kleiman, and Gabriel Scheffler
  4. Eradicating Pandemic Health Inequities: Health Justice in Emergency Preparedness - Ruqaiijah Yearby
  5. The Jacobson Question: Individual Rights, Expertise, and Public Health Necessity - Lindsay F. Wiley
Part IV: Innovation During COVID-19
Introduction - I. Glenn Cohen
  1. Innovation Law and COVID-19: Promoting Incentives and Access for New Health Care Technologies - Rachel E. Sachs et al
  2. Addressing Exclusivity Issues: COVID-19 and Beyond - Michael S. Sinha, Sven J.R. Bostyn, and Timo Minssen
  3. At-Risk Populations & Vaccine Injury Compensation- Katharine Van Tassel and Sharona Hoffman
Part V: Opening New Pathways for Health Care Delivery and Access
Introduction: Katherine L. Kraschel
  1. Telehealth Transformation in COVID-19 - Ryan P. Knox et al
  2. Changes in Methadone Regulation During COVID-19 - Zoe M. Adams et al
  3. Reproductive Justice after the Pandemic: How “Personal Responsibility” Entrenches Disparities and Limits Autonomy - Rachel L. Zacharias et al
  4. Abortion At-Home and At-Law During a Pandemic - Joanna N. Erdman
Part VI: Global Responses to COVID-19
Introduction - Michelle M. Mello
  1. COVID-19 and National Public Health Regimes: Whither the Post-Washington Consensus in Public Health? - Tess Wise et al
  2. Mapping COVID-19 Legal Responses: A Functionalist Analysis - Joelle Grogan and Alicia Ely Yamin
  3. A Tale of Two Crises: COVID-19, Climate Change, and Crisis Response - Daniel Farber
  4. Vaccine Tourism, Federalism, Nationalism - I. Glenn Cohen
    Epilogue: COVID-19 in the Courts - Abbe R. Gluck and Jacob Hutt

Cohen, I Glenn, Andrew M Crespo and Douglas B White, ‘Potential Legal Liability for Withdrawing or Withholding Ventilators During COVID-19: Assessing the Risks and Identifying Needed Reforms’ (2020) 323(19) JAMA 1901–1902
Abstract: This Viewpoint discusses the legal risks to health care workers and hospital systems from withdrawing or withholding ventilation from COVID-19 patients and cites a Maryland statute that offers legal immunity to clinicians making good faith decisions under emergency conditions as an example for other...

Cohen, I Glenn, Lawrence O Gostin and Daniel J Weitzner, ‘Digital Smartphone Tracking for COVID-19: Public Health and Civil Liberties in Tension’ (2020) 323(23) Journal of the American Medical Association (JAMA) 2371–2372
Abstract: This Viewpoint compares manual and digital strategies for coronavirus disease 2019 (COVID-19) contact tracing, describes how countries in Asia and Europe have used smartphone tracking, and discusses privacy and discrimination concerns and strategies for balancing public health and civil liberties in the

Coleman, Doriane Lambelet and Philip M Rosoff, ‘The Enhanced Danger of Physicians’ off-Label Prescribing during a Public Health Emergency’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa031
Abstract: The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of physicians to do what they and their patients think is the best course of action. In this essay we ask whether the special conditions existing in a public healthcare crisis, such as the current pandemic, would justify a relaxing of our argument and permit ongoing unregulated off-label use. We outline at least four areas of concern, all of which can be exacerbated by the widespread distress and despair amongst doctors, patients and other stakeholders. We contend that, if anything, these conditions warrant even more caution and scrutiny of this practice.

Conklin, Michael, ‘Legality of Racial Discrimination in the Distribution of Lifesaving COVID-19 Treatments’ (SSRN Scholarly Paper ID 4027108, 1 February 2022)
Abstract: In 2021 the Federal Drug Administration released a statement advocating for race and ethnicity to be used in rationing lifesaving COVID-19 treatments. By January 2022 three states had implemented policies explicitly prioritizing treatments based on race, which resulted in multiple legal challenges. This Article analyzes the uphill battle such policies would face in an equal protection challenge. It also rebuts the attempt to analogize these policies to the legally acceptable practice of racial preferences in college admissions. Finally, nonlegal, pragmatic consequences are considered, such as how the policy risks disproportionately favoring the wealthy, reduces trust in future government pronouncements regarding COVID-19, perpetuates harmful stereotypes about racial inferiority, breeds racial resentment, and causes unnecessary delays in treatment. The racially disparate outcomes from the COVID-19 pandemic illuminate numerous background factors that disadvantage minority groups. However, the implementation of racial preferences in lifesaving treatments is not the answer. As demonstrated in this Article, such policies spectacularly fail judicial scrutiny. Furthermore, the nonlegal, pragmatic considerations establish that such a policy does far more harm than good. These considerations are of paramount importance not only for the current COVID-19 crisis but also for future pandemics and the rationing of other limited medical resources, such as organ transplants and intensive care unit beds.

Conklin, Michael, ‘Racial Preferences in COVID-19 Vaccination: Legal and Practical Implications’ (SSRN Scholarly Paper ID 3765168, 1 January 2021)
Abstract: The severity of COVID-19 and the limited supply of vaccines poses a pressing question: Who should receive priority for the vaccine? Many experts support the controversial plan to prioritize black and Hispanic people. For justification they point to the highly disparate health outcomes minorities experience from COVID-19 that are rooted in historical racial injustice. However, such racial classifications implicate the Equal Protection Clause of the Fourteenth Amendment.This Article analyzes the potential outcome of such an equal protection challenge. It explains why strict scrutiny would be the controlling legal standard even though the issue has never been adjudicated by the Supreme Court in a health care context. Next, it considers how the existence of alternative vaccine distribution policies violate the narrowly tailored requirement. It considers the analogous case law of affirmative action in college admissions, in which the use of racial preferences is well established. And it considers alternative vaccine distribution plans that do not utilize racial preferences and how even they are susceptible to legal challenges.This Article further addresses pragmatic implications that would tangentially affect the legal determinations. These implications include potential counterproductive results of racial preferences, such as increased skepticism among the most vulnerable that they are being used as guinea pigs, a stigmatizing effect that could be used by white supremacist groups to promote a perceived martyrdom status, and the dangerous conflation of disparate health outcomes with genetic superiority and inferiority. These issues are considered against the backdrop of a changing Supreme Court, which has shown a willingness to diverge from established precedent regarding racial preferences.

Conley, John and Arlene Davis, ‘Can Bioethics Guide Governance in Public Health Emergencies? Lessons from the Pandemic’ 23(4) 701–740
Abstract: The role of scientific experts in making public policy has rarely been as controversial as it has been during the COVID-19 pandemic. From the first public health containment strategies to the development and rollout of the vaccines, governmental authorities have claimed to rely on the ‘science,’ citing an array of scientists and physicians, most of whom were used to working in relative anonymity. Those experts—with Dr. Anthony Fauci as the prime example—have been alternately praised and vilified in a public discourse driven more by politics than science. This Article focuses on the pandemic-related work of bioethicists, another category of once-anonymous experts who were suddenly thrust into the public eye. In early 2020, with COVID-19 cases overwhelming health care systems around the world, a raging debate erupted about the triage of patients and the rationing of care and equipment. Bioethicists were often drawn into this debate, sometimes by making real-time policy recommendations, and in other cases by influencing policy through background work. Both their specific recommendations and their longstanding operating principles came under attack from interested advocates and the general media. This Article tracks the role of bioethics in shaping, first, triage and care-rationing policies and, later, the allocation of initially scarce vaccines. These Authors conclude that, viewed from the perspective of early 2022, bioethics has had little practical impact on the public health response to the COVID-19 pandemic. Early rationing strategies drew heavily on bioethics, but the recommended strategies were rarely—if ever—used. When this bioethics influence was discovered by various public constituencies, the response was overwhelmingly negative—and correct, in these Authors’ view. During the early vaccine rollout, strategies (and results) were tied much more closely to local politics than any principles of bioethics. This Article’s ultimate argument is that policy decisions in public health emergencies should be political, in the sense of made by democratically accountable officials who consult experts only for basic medical information.

Copeland, Katrice Bridges Copeland, ‘Telemedicine Scams’ (2022) 108(1) Iowa Law Review 69–126
Abstract: Telemedicine emerged as a lifeline during the COVID-19 pandemic. Although the technology existed long before the pandemic, its use was limited due to strict government regulations that limited reimbursement for telemedicine visits. In response to the pandemic, the Government waived many of its restrictions for the duration of the Public Health Emergency. These changes fueled the growth of telemedicine. The problem, however, is that telemedicine makes it easier to conduct fraud on a large scale because without in-person visits, medical providers can reach many more beneficiaries in a short period of time. Thus, the size and scale of typical health care fraud schemes, such as sending medically unnecessary durable medical equipment, is magnified. This type of fraud has been on the rise since 2016, and, with the relaxed rules for telemedicine reimbursement during the pandemic, there is a serious concern that there will be a sharp increase in telemedicine fraud. This Article examines the fraudulent practices in the telemedicine industry and the conditions that permit them to flourish. This Article critically assesses the changes to telemedicine coverage and their relationship to fraud. It examines the fraudulent practices through the lens of the fraud triangle to determine why telemedicine fraud occurs. After assessing the causes of telemedicine fraud, this Article argues that there is no need for additional criminal statutes to address telemedicine fraud. As the typical telemedicine scam involves the payment of kickbacks and billing for medically unnecessary treatment and services, the existing fraud laws such as the Anti-Kickback statute and the False Claims Act are sufficiently capacious to address the criminality involved in these cases. This Article also argues that in lieu of additional criminal statutes, the Government should focus on additional measures to prevent or detect telemedicine fraud because preventative measures are the best way to safeguard the integrity of federal health care programs.

Cordasco, Fabrizio et al, ‘The Silent Deaths of the Elderly in Long-Term Care Facilities during the Covid-19 Pandemic: The Role of Forensic Pathology’ (2020) 88(2) Medico-Legal Journal 66–68
Abstract: The Covid-19 pandemic is currently a major global public health problem. We know that the elderly and people with chronic diseases contract the infection more easily and they develop clinically more serious and often lethal forms. To date, the reasons for this have been generically attributed to old age and underlying diseases. Most Covid-19 deaths occurred in long-term care facilities because the residents are elderly people with chronic illness living in close contact. Therefore, facilities have become epidemic outbreaks. Forensic knowledge is very limited because an autopsy is rarely performed. Post-mortem investigations can help increase knowledge about Covid-19 and identify any undiagnosed pathologies in life. Therefore, forensic investigations play a role in protecting a frail population. Autopsies should be encouraged on elderly people who died of Covid-19.

Costa, Eva Dias and Micaela Pinho, ‘Does Implicit Healthcare Rationing Impose an Unfair Legal Burden on Doctors? A Study of Portuguese Jurisprudence’ (2020) 20(1) Medical Law International 31–57
Abstract: Healthcare rationing is inevitable, never more so than during the COVID-19 pandemic. In Portugal, rationing is largely implicit and relies too much on bedside decisions, made in stressful circumstances, involving ethical dilemmas and being prone to error. This study uses a qualitative approach by exploring the public records of Portuguese courts for malpractice suits between the years of 2008 and 2019 to ascertain whether the damage suffered by patients in these cases could in any part be attributed to a lack of resources. During this research, we found that a large number of lawsuits against doctors and hospitals might have in fact been the unfortunate result of the constraints of implicit prioritization. We concluded that lawyers and judges must be made aware of the impact of implicit rationing decisions on healthcare professionals, who are judged against a professional standard and an inverse onus rule that places on them a heavy burden of proof.

Coste, Joonu-Noel Andrews, ‘COVID-19, Health Justice, and the Privilege of Space: A New Critical Intersectional Framework for Creating a Prescription for Equal Well-Being and Applied to Addressing Health of Children Residing in Psychiatric Institutions’ (2021) 43(3) Campbell Law Review 309–374
Abstract: Our nation - founded on life, liberty, and the pursuit of happiness--is a year into the COVID-19 pandemic. The pandemic has revealed the gap between what we are as a society and that which we long to be. A new critical intersectional legal framework, guided by Dr. Martin Luther King Jr.’s vision of The Beloved Community, will allow legal scholars and policymakers to reframe health equality and health justice toward a more perfect union. By combining the philosophical rigor of dialectical thinking, critical theory, and intersectional analysis, analysts can meet this moment and create new legal frameworks to correct social injustice. Analysts can build a just society based on equality to address the disproportionate sickness, disability, and death of America’s historically oppressed peoples. With the goal of addressing oppression across multiple axes of identity at once, and in the spirit of Dr. King ’s appropriation of eclectic theologies and philosophies, this Article proposes a new Critical Intersectional Legal Analysis that develops critical social theory by bringing an intersectional analysis to the principles of dialectical thought and indeterminacy. This Article ’s framework will analyze power structures as they exist and work together through the power of the state to class, race, and disable people moment to moment. Finally, this Article’s framework is reconstructive through self-reflexive application of theory through praxis. This Article will apply that new framework to a specific condition of oppression - the privilege of space as it relates to the risks of viral transmission, infection, and disease during the current coronavirus pandemic for children in psychiatric institutional settings in North Carolina and the Southeast.

Cotrim-Junior, Dorival Fagundes, Lucas Manoel da Silva Cabral and João Paulo Almeida Brito, ‘Additional Compensation for Health Care Professionals in COVID-19 Pandemic: An Essay in the Light of Health Law’ (2022) 20(01) Revista Brasileira de Medicina do Trabalho / Brazilian Journal of Occupational Medicine 154–160
Abstract: This theoretical-critical assay is intended to perform a detailed reflection on the mandatory payment of an additional compensation to health care professionals during the pandemic caused by COVID-19. For this consideration, academic and opinion articles, as well as national and state legislative proposals, were searched in dialogue with Regulatory Standard 15, which provides for unhealthy activities and operations. After reflection, the position taken is that payment is due for the duration of the pandemic, to all health care professionals working in the frontline against COVID-19.

Coughlin, Christine Nero and Nancy MP King, ‘The Stories We Tell: Narrative, Policymaking, and the Right to Try’ [2020] Wake Forest Journal of Law and Policy (forthcoming)
Abstract: Personal stories that demonstrate public health problems can be a persuasive tool to obtain public support for a legislative, regulatory, or other legally oriented solution. Personal stories associate an identified life—a specific, inherently sympathetic person who needs help now—with a problem that can be solved by public action. This association enables us to draw parallels between ourselves and the identified life—the story’s protagonist. These parallels also motivate us to act on behalf of the identified life. The more emotionally charged the story, the more likely we are to credit the narrative as an accurate and representative portrayal of the problem. But public health focuses on the health of whole populations. Public health policies protect and promote the health of statistical lives, which are both numerous and invisible, and thus lack the immediate appeal of identified lives. For these reasons, personal narratives, while a powerful motivating force, can limit appreciation of the complexity of the public health issue and proposed policy to which they draw attention and sympathy. The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 and its forty-one state law counterparts offer a stark example of how tragic personal stories—rather than sound data and normative justification—created laws that are at best misleading and inefficient, and at worst, dangerous to public health. This essay examines the history of investigational drugs and expanded access through some of the stories that influenced FDA policy and practice. It then turns its focus to the right to try movement and explores some of the many personal stories that were used to propel the development of right to try laws by focusing exclusively on autonomy and access. Our focus then shifts to those whose personal stories—equally compelling—are not being told in the right to try discussions. These untold stories include narratives that highlight the need for careful science and the duties of researchers; stories that illustrate systematic disadvantage and structural injustice and can help demonstrate the need for a health care system that is meaningfully available to all from the outset; stories about unidentified statistical lives; stories from those who have come to regret the exercise of their right to try; and stories by and about those who have struggled between the do-everything mindset and the desire for a good death. We discuss the concept of identified lives and why the public supports ‘rescuing’ individuals it deems attractive and deserving, and we address the problems associated with elevating these identified lives over other untold stories and statistical unidentified lives in the context of right to try laws. This essay concludes that personal narrative has a place in public health policy generally, and in the question of access to investigational drugs specifically. Personal stories, used judiciously, can be a powerful tool for advocating for needed change. However, in the context of access to investigational drugs, crafting policy with a sole focus on the primacy of personal choice and autonomy fails to incorporate the public policy mandate to base available choices on at least a minimal amount of safety data and a high degree of information transparency. Where research directed to improving human health is at issue, contributing to generalizable knowledge—the principal purpose of research—should not be minimized because patients with life-threatening illnesses believe that they have nothing to lose by trying. While personal narratives can and should be considered, they should be combined with acknowledgment of the complexities of the investigational drug and clinical trial processes, and with awareness of the perennial and inevitable tension between providing access and collecting data supporting safety and efficacy. Even in the most tragic of circumstances, health care policy in this area deserves to be made collectively, based on careful science, good research, and a fair allocation of resources.

Cousins, Emily, Kay de Vries and Karen Harrison Dening, ‘Ethical Care during COVID-19 for Care Home Residents with Dementia’ (2021) 28(1) Nursing Ethics 46–57
Abstract: The COVID-19 pandemic has had a devastating impact on care homes in the United Kingdom, particularly for those residents living with dementia. The impetus for this article comes from a recent review conducted by the authors. That review, a qualitative media analysis of news and academic articles published during the first few months of the outbreak, identified ethical care as a key theme warranting further investigation within the context of the crisis. To explore ethical care further, a set of salient ethical values for delivering care to care home residents living with dementia during the pandemic was derived from a synthesis of relevant ethical standards, codes and philosophical approaches. The ethical values identified were caring, non-maleficence, beneficence, procedural justice, dignity in death and dying, well-being, safety, and personhood. Using these ethical values as a framework, alongside examples from contemporaneous media and academic sources, this article discusses the delivery of ethical care to care home residents with dementia within the context of COVID-19. The analysis identifies positive examples of ethical values displayed by care home staff, care sector organisations, healthcare professionals and third sector advocacy organisations. However, concerns relating to the death rates, dignity, safety, well-being and personhood – of residents and staff – are also evident. These shortcomings are attributable to negligent government strategy, which resulted in delayed guidance, lack of resources and Personal Protective Equipment, unclear data, and inconsistent testing. Consequently, this review demonstrates the ways in which care homes are underfunded, under resourced and undervalued.

Cox, Caitríona L, ‘“Healthcare Heroes”: Problems with Media Focus on Heroism from Healthcare Workers during the COVID-19 Pandemic’ (2020) 46(8) Journal of Medical Ethics 510–513
Abstract: During the COVID-19 pandemic, the media have repeatedly praised healthcare workers for their ‘heroic’ work. Although this gratitude is undoubtedly appreciated by many, we must be cautious about overuse of the term ‘hero’ in such discussions. The challenges currently faced by healthcare workers are substantially greater than those encountered in their normal work, and it is understandable that the language of heroism has been evoked to praise them for their actions. Yet such language can have potentially negative consequences. Here, I examine what heroism is and why it is being applied to the healthcare workers currently, before outlining some of the problems associated with the heroism narrative currently being employed by the media. Healthcare workers have a clear and limited duty to treat during the COVID-19 pandemic, which can be grounded in a broad social contract and is strongly associated with certain reciprocal duties that society has towards healthcare workers. I argue that the heroism narrative can be damaging, as it stifles meaningful discussion about what the limits of this duty to treat are. It fails to acknowledge the importance of reciprocity, and through its implication that all healthcare workers have to be heroic, it can have negative psychological effects on workers themselves. I conclude that rather than invoking the language of heroism to praise healthcare workers, we should examine, as a society, what duties healthcare workers have to work in this pandemic, and how we can support them in fulfilling these.

Craig, Robin Kundis, ‘The Regulatory Shifting Baseline Syndrome: Vaccines, Generational Amnesia, and the Shifting Perception of Risk in Public Law Regimes’ (SSRN Scholarly Paper ID 4028027, 6 February 2022)
Abstract: Vaccination mandates have been controversial since long before COVID-19, but the current COVID controversies obscure a more pervasive problem for U.S. public health laws and vaccine-preventable diseases than the intense politicization surrounding the pandemic. Until the late 20th century, for most people the risk of various dread diseases was sufficiently high that they embraced new vaccines. The intentional result of federal and state vaccination policies was that fewer people got these diseases. The perverse result was that perceptions of disease risk shifted, making the vaccines themselves seem like the far riskier option to many people and pressures to eliminate or mitigate vaccination mandates increased. Perhaps most importantly, in the early 21st century, state legislatures increasingly enacted exemptions from school vaccination requirements, setting the stage for measles resurgences in 2015 and 2019. Focusing primarily on measles vaccination, this Article argues that, while not the only factor, a regulatory shifting baseline syndrome fueled the pre-COVID-19 resistance to childhood vaccination. In 1995, Dr. Daniel Pauly described the ‘shifting baseline syndrome’ and its problems for fisheries management. Pauly posited that each generation forgets what the ocean and its fisheries used to be and that this generational amnesia allows successive generations to accept the current impoverished state of marine fisheries as normal. The generational forgetting of prior fisheries, in other words, makes opaque what the goals of fisheries regulation should be, or even could be. This Article brings the shifting baseline concept into public law, identifying for the first time a regulatory shifting baseline syndrome that can undermine the law’s ability to protect society at large. This syndrome arises when a public legal regime, like a school vaccination mandate, so successfully eliminates a societal problem, like dread diseases, that citizens, politicians, and lawmakers forget that the regime is in fact still working to keep that problem at bay. This generational amnesia, in turn, can lead to changes in law and policy allow the prior problem to re-emerge in society, as occurred with measles outbreaks. While COVID-19 vaccination mandates are almost uniquely politicized and too new to reflect and regulatory shifting baseline syndrome, decisions are nevertheless being made in the COVID-19 context that may give the regulatory shifting baseline syndrome more room to operate, potentially threatening public health gains made with respect to a plethora of other vaccine-preventable diseases in the United States.

Crompton, Darryl, ‘President Biden’s Executive Order 13995 on COVID-19 and Health Equity: Seeking Justice in a Public Health Crisis’ (2022) 16(1) Journal of Health and Life Sciences Law 8–15 download PDF print replica of entire issue here]
Abstract: This article explores several health policy issues related to the President’s COVID-19 Executive Order, including health equity and justice, structural racism, health disparities, vaccine access, and vaccine acceptance in communities of color. This article also proposes several health equity policy considerations to local governments intended to supplement the Task Force recommendations. Health care attorneys can play a key role in achieving health equity by engaging with local officials and communities of color to adopt these local government health equity policy considerations.

Culotta, Emma, ‘Understanding the Distributive Equity Framework for Allocating Scarce Medical Resources in Times of Crisis’ (2022) 100(4) Texas Law Review 803–837
Abstract: The goal of this Note is to examine the moral and legal questions raised by scarcity of life-saving medical resources from a distributive justice perspective. This Note argues that the traditional antidiscrimination framework cannot resolve questions of resource allocation because antidiscrimination laws focus on eliminating barriers to access without addressing issues of substantive equity. Because a solution requires prioritizing across similarly legitimate claims to healthcare to ensure equitable access to health for all, resource allocation is a substantive concern better suited for analysis under a distributive equity framework. This Note identifies the proper space-or good-of distribution as the basic human capability of health and the appropriate metric for distribution within that space as a structured balance of utilitarian and prioritarian principles called the Principle of Proportionate Priority (PPP), a new principle of distributive justice developed by Professor Talha Syed of Berkeley Law. This Note contributes to its relevant field of scholarship by applying this novel principle in the context of medical-resource allocation and proposing it as a useful tool for states to improve resource-allocation protocols like the Crisis Standards of Care developed in response to COVID-19. Under the proper distributive equity framework, the Principle of Proportionate Priority appropriately affords priority as a matter of degree based on how much worse off a patient is relative to others and how much they stand to benefit from treatment. In practical terms, this means a patient’s claim for priority is strongest when they have both the greatest need, because of their young age or poor lifetime levels of health, and the greatest potential for benefit, because of their chance of survival or the effectiveness of treatment. This comparative priority approach is preferable to a strictly utilitarian principle that ignores the plight of the worst off or a strictly need-based prioritarian principle that disregards the importance of efficiently stewarding resources, particularly in times of scarcity. When developing protocols for the allocation of scarce medical resources, states can fairly consider the rationing factors of age, severity of condition, probability of survival, and life expectancy after treatment to determine whether a patient suffers from greater need or stands to reap greater benefits from treatment.

Czarnecki, Łukasz and Monika Skowrońska, ‘The Unlawful and Unequal Wearing of Masks: The Case of Poland during COVID-19’ in Noriko Suzuki et al (eds), Public Behavioural Responses to Policy Making during the Pandemic: Comparative Perspectives on Mask-Wearing Policies (Routledge, 2022)

da Costa, Karen and Shlomit Zuckerman, ‘Human Rights and Ethics in the Management of the Covid-19 Pandemic: The Experiences of Brazil and Israel’ in Dónal O’Mathúna and Veselin Mitrović (eds), Disaster Construction and Reconstruction: Lessons from Covid-19 for Ethics, Politics and Law (Institute of Social Sciences, 2024)
Abstract: This paper examines Brazil and Israel’s responses to the COVID-19 pandemic, focusing on human rights and ethical issues. Through documental analysis, utilizing primary sources such as official reports and regulations, as well as secondary sources, especially academic literature, the research explores how these nations addressed the pandemic with respect to human rights and ethical conduct. In Brazil, a convergence of health emergencies and governance crises contributed to a heightened death toll, emphasizing the need to learn from past mistakes, enhance healthcare systems, and eliminate discriminatory policies against vulnerable groups. The shift in rhetoric under President Lula’s new government since January 2023 reflects a more human rights-friendly approach, prioritizing dialogue and incorporating lessons from the pandemic. In contrast, Israel faces a trajectory marked by a right-wing government’s proposed judicial reform, challenging democratic principles and sparking a constitutional crisis. Public protests, especially from healthcare professionals, criticize the reform for potentially undermining human rights, notably the right to health, through unchecked decisions that neglect health implications, disproportionately affecting vulnerable groups. Beyond these cases, the paper underscores the global impact of COVID-19, emphasizing the interconnectedness of humanity. While countries experienced the disease differently, the collective response necessitates global cooperation for effective pandemic management. The study concludes that despite diverse individual experiences, global collaboration is vital for addressing future pandemics, offering valuable insights into the intricate relationship between pandemic management, human rights, and ethical considerations, with implications for future public health crises.

Dahlen, Hannah G, Bashi Kumar-Hazard and Mary Chiarella, ‘How COVID-19 Highlights an Ongoing Pandemic of Neglect and Oppression When It Comes to Women’s Reproductive Rights’ (2020) 27(4) Journal of law and Medicine 812
Abstract: The coronavirus disease-19 (COVID-19) pandemic has exposed an underlying pandemic of neglect affecting women’s reproductive rights, particularly in the provision of abortion services and maternity care. The systemic neglect in the Australian context has resulted in a rise in demand for the services provided by privately practising midwives (PPMs) that is not matched by systemic support for, nor recognition of, women choosing to birth at home. As a result, PPMs are unable to meet the rise in demand, which in itself reflects decades of limited State support for the choice to birth at home and opposition by incumbent stakeholders in the provision of maternity care to healthy women with low-risk pregnancies. We discuss the historical backdrop to these currently erupting issues, along with the real reasons for the opposition to PPMs in Australia. Finally, we offer solutions to this ongoing issue.

Dash, Lipsa and Sambhabi Patnaik, ‘Artificial Intelligence in Covid-19: Application and Legal Conundrums’ in Sachi Nandan Mohanty et al (eds), Applications of Artificial Intelligence in COVID-19 (Springer, 2021) 581–595
Abstract: The current healthcare system needs strong support from new technology support systems like Artificial Intelligence (AI), Internet of Things (IoT), machine learning devices to help diagnose, analyze, assist, and prevent new diseases that are spreading in our world. The current international crisis that the world is suffering and witnessing is a virus contaminating and the spread which initiated as an epidemic but later declared by WHO to be a pandemic Covid-19. Corona virus has triggered a global challenge and has crossed boundaries in dismantling mental and physical health of people. AI technologies have seen to be introduced to help management of patients real time monitoring of its outbreaks and helping update the patients data, improve treatment outcome by prioritizing patients, diagnosis and recording of minute fluctuations in patients, assisting medical practitioners and giving productive solutions. The researchers will show the paradigm shift in the number of patents filed every year in the field of AI specific to healthcare sector from diagnosis to recovery of patients. The chapter includes how all the above applications lead to legal conundrums and the imminent need of bringing amendments to existing legislations or drafting new policies and encouraging government to bring up initiatives for innovations and research and development on the same. The Constitution of India has incorporated provisions which guarantees everyone the ‘right for the highest attainable standard of physical and mental health’. With the growth in usage of AI-induced systems in the healthcare sector, it has invited some unwanted issues. Protection of sensitive personal information and the impact assessment is however a major concern and is dealt by different International and national legislations and bills. AIs will soon lead the national security of India and economy. An analysis on the existing data, application of AI in healthcare and the legal implications shows the expected outcome in a few years. The consequence mainly technical and legal is discussed by the researchers.

Davies, Rheian et al, ‘Mental Health: Focus’ (September) Legal Action 22–27
Abstract: Reflects on how the coronavirus pandemic has affected the rights of individuals detained under the Mental Health Act 1983. Summarises key reforms affecting issues including the performance of remote assessments in England, hospital managers’ hearings, independent scrutiny on wards, and data collection. Reviews concerns over the limited Parliamentary scrutiny of COVID-19 legislation, and assesses levels of compliance with ECHR arts 5 and 6.

Davis, Corey S and Amy Judd Lieberman, ‘Access to Treatment for Individuals with Opioid Use Disorder’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Law Health Watch, 2020) 133–137
Abstract: The United States is currently facing two severe public health emergencies: COVID-19 and the continuing epidemic of preventable opioid-related harm. While these epidemics share some similarities, there is one key difference: while there are currently no approved pharmaceutical treatments for the novel coronavirus, highly effective medications to treat opioid use disorder (OUD) have existed for decades. Despite their proven efficacy, access to these medications has long been limited by federal and state laws, limitations that disproportionately impact those who are made particularly vulnerable by structural factors including economic injustice and structural racism. In response to the COVID-19 epidemic, the U.S. Drug Enforcement Administration and other federal agencies have taken steps to temporarily remove some legal and regulatory barriers to these medications. These changes are not comprehensive, and most are tied to the COVID-19 public health emergency declaration. The epidemic of opioid-related harm will not end when the new coronavirus is controlled or the related emergency declaration expires. Indeed, it seems likely that steps taken to attempt to control the virus’ spread may result in an even more unhealthy risk environment for people with OUD, with a resulting increase in treatment need. This Chapter briefly highlights the potential positive impact of increased access to OUD treatment, current changes to increase access to that treatment, and recommendations for making those changes permanent.

Dawson, Angus and Marcel Verweij, ‘Law, Ethics, and Politics in the Face of a Global Pandemic’ (2020) 13(1) Public Health Ethics 1–3
Abstract: We are in the midst of a global pandemic caused by the novel SARS-CoV-2 virus. Millions of people have been infected, hundreds of thousands have died and health

De Gama, Rafia, ‘COVID-19, Clinical Trials Regulations: Making Sure Africa Is Not an Unregulated Testing Ground’ (Afronomicslaw COVID-19 Symposium on International Economic Law in the Global South (May 2020), Symposium II: Intellectual Property, Technology and Agriculture)
Abstract: Recently, there has been discussion in the media, about vaccine trials for COVID-19 that may take place on the African continent. This discussion had been in the offing, mainly because Africa has sometimes been left out of vaccine trials. The discussions stirred more controversy when two top French scientists suggested that clinical trials should take place in Africa. Since the interview, The World Health Organisation (WHO) Director General (DG) Dr. Tedros Adhanom Ghebreyesus addressed the utterances to state categorically that this problematic colonial mindset was unacceptable. At the same time, the Democratic Republic of Congo has agreed to be one of the countries to test a COVID-19 vaccine, further ‘muddying the waters.

Delfino, Rebecca A, ‘A New Prescription for the Opioid Epidemic: 360-Degree Accountability for Pharmaceutical Companies and Their Executives’ (2022) 73(2) Hastings Law Journal 301–369
Abstract: We can no longer ignore this--A national crisis resulting in more than half-a-million American deaths, costing hundreds of millions of dollars in losses to the economy, ravaging the health care system, and devastating state and local communities. This narrative describes the COVID-19 pandemic and something else: the epidemic of opioid addiction and abuse. In the last twenty years, the opioid epidemic claimed the lives of more than 700,000 people at the cost of more than 500 billion dollars to the economy. The COVID-19 pandemic has made the opioid epidemic worse, causing a staggering increase in opioid-related overdose deaths. Even now, on average, 140 people die every day from an opioid overdose, making it a leading cause of injury-related death in the United States. And 70 percent of those deaths involve a prescription opioid. There is a growing sense that those responsible for the opioid epidemic, specifically drug companies and their executives, have escaped responsibility for their dangerous and deceptive practices in manufacturing and marketing opioids. Although they have confronted civil lawsuits, the pharmaceutical industry has faced virtually no criminal scrutiny; only a couple of companies and executives have ever been criminally charged for the devastation that opioids have caused. This raises questions: Given the increasing number of opioid overdose deaths nationally, why are charges and convictions of drug companies and their executives so rare? And why haven’t existing legal mechanisms worked to punish the improper manufacturing and marketing practices and curb the epidemic? Their misconduct continues because no single federal law exists to prosecute pharmaceutical companies and their executives for causing the epidemic. And the laws that govern the industry are ineffective; they fail to criminalize the type of conduct that caused the epidemic, contain elements that are prohibitively difficult to prove, or impose minimal penalties that fail to deter bad actors. Thus, the drug industry has persisted in dubious practices unfettered by civil litigation, government enforcement actions, and fines. This article seeks to examine these issues and others. It is the first in legal scholarship to offer a concrete and omnibus solution grounded in federal law to address the pharmaceutical industry’s misconduct. The article also continues the conversation I began in my article, The Prescription Abuse Prevention Act: A New Federal Statute to Criminalize Overprescribing Opioids, 39 YALE L. & POL’Y REV. (forthcoming, 2021) which offered a proposal for federal criminalization of doctors who overprescribe opioids. The novel 360-degree solution proposed here—the ‘Controlled Substance Manufacturing and Marketing Accountability Act’--will deter and punish those pharmaceutical companies and their executives who provided misleading information to government regulators and used deceptive practices in marketing opioids to the public. It also recognizes that when properly prescribed, these drugs provide essential relief for pain and suffering. Thus, this proposal seeks to address prior misconduct and point the way forward to avoid the next drug epidemic.

DeRosa, Nicholas et al, ‘Pharmacist Allowances for the Dispensing of Emergency or Continuation of Therapy Prescription Refills and the COVID-19 Impact: A Multistate Legal Review’ (2021) 12(3) Pharmacy Practice & Practice-Based Research, Article 17
Abstract: The COVID-19 pandemic has taught Americans many lessons, including what can happen when our healthcare system is strained. During the pandemic, certain healthcare related activities such as seeing or contacting a practitioner to receive a prescription refill may have been a challenge for some patients that could have interfered in the patient’s medication adherence and continuity of care. Given these circumstances, the pandemic also shed light on the necessity for pharmacists to dispense emergency refills, which often is based on variable state pharmacy laws and regulations. State pharmacy laws and regulations vary from allowing pharmacists to dispense as much medication that is required for the patient to receive a new prescription to emergency refills being allowed only in the direst situations to save a patient’s life. State pharmacy laws and regulations vary in the allowable quantities that may be dispensed, the federal schedule of controlled substance medications, and the circumstances they can be dispensed. In many cases, COVID-19 emergency regulations, governor executive orders and board of pharmacy guidance have expanded the authority for a pharmacist to dispense emergency refills. However, these allowances are often finite in nature and would end when the pandemic state of emergency ends. This paper seeks to analyze the laws and regulations in each state pertaining to the ability of a pharmacist to dispense an emergency refill when a patient’s prescription does not have refills and provide a recommendation to optimize the state legal and regulatory landscape to expand current allowances.

DeWitt, Samuel, ‘Reimagining U.S. Drug Policy Post-Pandemic’ (Ohio State Legal Studies Research Paper No 684, 2022)
Abstract: The COVID-19 pandemic caused increased drug use and a widespread decline in mental health throughout American society. Yet, despite the unprecedented pandemic, society as a whole has shown an impressive ability to adapt to new ways of living, suggesting that a dramatically different version of America is not only possible, but achievable. Domestic drug policy, which has needlessly prohibited and criminalized a vast array of drugs since the early 1900s, is an area ripe for a similar dramatic change. This paper explores how the pandemic, combined with concurrent events including a change in Federal Administration and nationwide protests against systemic racism, presents an opportunity for our country to rethink its long-standing drug prohibition on a national scale.

Dhand, Ruby et al, ‘Litigating in the Time of Coronavirus: Mental Health Tribunals’ Response to COVID-19’ (SSRN Scholarly Paper No ID 3749772, 15 December 2020)
Abstract: People with mental health and addiction issues are disproportionately affected by COVID-19 given the elevated risk of contracting COVID-19 within psychiatric facilities. The impact of the pandemic on this extraordinarily vulnerable population includes the potential for large outbreaks and multiple deaths. There is also the increased risk of serious psychological harm, exacerbating preexisting mental health and substance use issues and in turn elevating their risk to themselves and/or others. In Part I of this paper, we analyze the procedural barriers to access to justice that arose as a result of the initial responses to COVID-19 by the Consent and Capacity Board [CCB] and the Ontario Review Board [ORB]. In Part V, we include a brief report on how appeals taken from both tribunals have been handled throughout COVID-19 to date. In Part VI, we analyze the discretionary and systemic barriers experienced by people with mental health and addiction issues appearing before the CCB and ORB during COVID-19. We critique recent mental health law cases during COVID-19 where deprivations of liberty interests and substantive equality have occurred, and access to justice for people with mental health and addictions issues has been denied, suspended or impaired. Through a legal analysis of how the pandemic has impacted this vulnerable community of litigants, we hope this research will result in further advocacy and education to prevent outbreaks and death, improve health care practices, and increase access to justice.

Díez-Picazo, Luis María, ‘The State as Protector/Guarantor of Last Resort: General Conclusions’ (2022) 34(1) European Review of Public Law_
_Abstract: This text reflects the oral conclusions presented at the end of the EGPL reunion in September 2021. Given the broad variety of topics touched by the different speakers, these conclusions deal in particular with two questions: the legal problems posed by the practice of triage (i.e. selecting which patients can be attended when not all of them can be treated) and the ambiguities of the ‘state’ as guarantor of last resort. The conclusions also include a reference to their author’s professional experience during the pandemic.

Diller, Paul A, ‘Municipal Vaccine Passport Regimes in the United States: A European Import Spreads Widely’ (2022) 45(4) Fordham International Law Journal 639–656
Abstract: Approximately two dozen municipalities in the United States adopted ‘vaccine passport’ regimes between August 2021 and January 2022. These regimes required public accommodations such as restaurants, cafes, movie theaters, and gyms to check patrons for proof of vaccination against COVID-19 as a condition of entry. Some of these regimes applied to employees of such establishments as well. Most exempted at least some people, including persons too young to be vaccinated and those with religious or medical reasons for being unvaccinated. While most of these regimes have since been rescinded, most mayors and health officials reserve the authority to reinstate them should they deem conditions to require it. This essay surveys the vaccine passport phenomenon in the United States and categorizes the method by which the various jurisdictions adopted them. The essay shows that the vast majority of cities and counties with vaccine passport regimes adopted them by mayoral or health commissioner order, often premised on the invocation of emergency power, as opposed to by ordinance or administrative rule. The essay concludes by probing the normative implications of such unilateral, emergency local policymaking, as well as its potential implications for policy innovation in other areas.

Diller, Paul A, ‘Training a Public Accommodations Lens on Vaccine Passports’ (2023) 27 Lewis & Clark Law Review (forthcoming)
Abstract: The Covid pandemic and the rise of smartphone technology enabled the use of ‘vaccine passports’—that is, a requirement to show proof of vaccination against Covid—on a scale unmatched before in human history. In the United States, many public accommodations such as restaurants, coffee shops, stadiums, and movie theaters required patrons to show proof of vaccination in order to enter or consume food and drink on the premises. In approximately two dozen local jurisdictions as well as the District of Columbia and Puerto Rico, government mandated that public accommodations do this, with varied carveouts for religious objections and medical or age-based inability to vaccinate. In requiring proof of vaccination, these businesses, entities, and municipalities acted in an area of law with a centuries-old lineage. Legal scholars like Harvard professor Joseph Singer have forcefully argued that businesses and venues open to the public should be required to take all comers under the common law, unless the particular patron would disrupt the business’s operations. This argument reflects a pre-Covid skepticism among left-leaning scholars and policymakers regarding businesses and venues having carte blanche to decide whom to admit and serve. Ironically, this skepticism dissipated among many commentators and policymakers during the Covid emergency, with vaccine passport proponents glibly analogizing them to ‘no shoes, no shirt, no service’ policies. Ironically, the only states that have explicitly protected against vaccine status discrimination through legislation in response to Covid vaccine passports are states generally considered ‘conservative,’ at least these days: Alabama, Florida, Iowa, Montana, North Dakota, South Carolina, and Texas. In addition to the common law, federal and state statutes seek to promote equality of access and individual dignity by limiting public accommodations’ prerogative to exclude certain customers. The most well-known such antidiscrimination law is Title II of the Civil Rights Act of 1964; state and local legislation often go even further both in terms of the venues and services they regulate and the classes of persons they protect from discrimination. This Article analyzes vaccine passports amidst both the common law and statutory tableau, demonstrating that the weaker the evidence of the vaccines’ preventing the spread of Covid, as opposed to protecting against severe disease and death, the weaker the argument for their use under the vision of the common law promoted by Singer. Unfortunately for the opponents of vaccine passports, that vision has achieved limited purchase doctrinally among state courts. Assessing the legality of both voluntary and municipal vaccine passports under antidiscrimination statutes reveals that there are many unanswered questions decades into their existence. Almost sixty years in, the federal courts still haven’t decided if Title II protects against disparate impact discrimination, for instance. Reasoning by analogy from Title VII, the article walks through what a lawsuit based on Title II regarding Covid vaccine passports might look like and why its chances of success would be limited. The Article suggests, however, that some of the municipal vaccine mandates likely violated Title II with respect to religion. The Article also analyzes vaccine passports and medical exemptions thereto under the Americans With Disabilities Act, as well as age-based discrimination under (some) states’ antidiscrimination laws and find that some voluntary practices in this area may have been suspect as well.

Dineen, Kelly K and Elizabeth Pendo, ‘Substance Use Disorder, Discrimination, and The CARES Act: Using Disability Law to Strengthen New Protections’ [2021] (Spring) _Arizona State Law Journal Online_
Abstract: The COVID-19 pandemic is having devastating consequences for people with substance use disorders (SUD). SUD is a chronic health condition—like people with other chronic health conditions, people with SUD experience periods of remission and periods of exacerbation and relapse. Unlike people with most other chronic conditions, people with SUD who experience a relapse may face criminal charges and incarceration. They are chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. People with SUD are also at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions have led to new and increased drug use, and overdose deaths are surging. More than ever, people with SUDs need access to evidence-based treatment and other services without structural barriers and with civil rights protections. To that end, a new provision in the Coronavirus Aid, Relief, and Economic Securities Act (CARES Act) strengthens penalties for the wrongful disclosure of SUD treatment records as well as addresses discrimination in multiple settings based on the misuse of those records. People with SUD reasonably fear negative treatment and discrimination if their condition is exposed. To address this barrier, federal law strictly protects the confidentiality of SUD treatment records. These protections have existed for nearly 50 years; however, the stringent requirements have been blamed for hampered and even deadly treatment decisions by health care providers who do not have access to SUD treatment records. Section 3221 of the CARES Act, effective March 2021, enacts the first major statutory changes to SUD treatment record confidentiality since 1992 and is aimed at improving information sharing among SUD treatment providers and other health care providers. But increased information sharing also creates concerns about information misuse and discrimination, and the possibility of renewed treatment avoidance. To address the tension between the benefits of information sharing and the possible harms of discrimination after disclosure, Section 3221 strengthens the disclosure penalties to align with HIPAA. It also adds an entirely new nondiscrimination provision which prohibits discriminatory use by recipients of disclosed SUD treatment information in areas including health care, employment and receipt of worker’s compensation, rental or sale of housing, access to courts, and social services and benefits funded by federal, state, or local governments. This essay provides the first analysis of the new nondiscrimination protections in Section 3221 of CARES Act for individuals with SUD using the framework of existing protections against disability-based discrimination in the Americans with Disabilities Act, Section 504 of the Rehabilitation Act, Section 1557 of the Patient Protection and Affordable Care Act, and the Fair Housing Act. We propose that as the new protections of Section 3221 are implemented through regulations, guidance, and enforcement, they should be understood within the context of existing disability nondiscrimination laws as well as the specific purpose of Section 3221 to ensure that discrimination against such people does not continue to serve as a barrier to seeking treatment. We offer three insights to achieve this goal. First, the new protections should be understood to include current illegal substance users and should be construed broadly. Second, the scope of entities covered by the new protections should be interpreted consistently with existing definitions in laws that prohibit disability-based discrimination in employment, public programs, services, and activities, health care, and housing. Finally, robust enforcement must be coupled with educational initiatives about the pervasive discrimination faced by people with SUDs, and new and existing nondiscrimination requirements that protect them.

Dishman, Elysa, ‘Calling the Shots: Multistage Challenges to Federal Vaccine Mandates’ (BYU Law Research Paper No 22–17, 19 May 2022)
Abstract: Litigation brought by state attorneys general (AGs) successfully frustrated the Biden administration’s efforts to combat COVID-19 by vaccinating American workers. State challenges to vaccine mandates are consistent with trends in multistate litigation that have occurred in recent presidential administrations. At the same time, these cases reveal emerging new trends that shed light on the future of multistate public law litigation and nationwide injunctions. Challenges to vaccine mandates have raised ongoing criticisms of nationwide injunctions and offer a pathway forward for reform.

Doan, Hai, Jing-Bao Nie and Elizabeth Fenton, ‘The Precautionary Principle in Public Health Emergency Regime: Ethical and Legal Examinations of Vietnamese and Global Response to COVID-19’ [2023] Bioethics (advance article)
Abstract: Responses to the COVID-19 pandemic have been widely criticized for being too delayed and indecisive. As a result, the precautionary principle has been endorsed, applauded, and proposed to guide future responses to global public health emergencies. Drawing from controversial issues in response to COVID-19, especially in Vietnam, this paper critically discusses some key ethical and legal issues of employing the precautionary principle in public health emergencies. Engaging with discussions concerning this principle, especially in environmental law where the precautionary principle first appeared as a guiding principle with objective content(s), this paper formulates the precautionary principle as ‘in dubio pro salus’, which is about advising, justifying and demanding states to proactively prepare for scenarios arising out of any public health emergency. It distinguishes the precautionary principle into moderate and hard versions. A moderate version largely takes a holistic approach and fulfils a series of criteria specified in this paper, while a hard version either permits restrictive measures to be deployed primarily on a hypothetic basis or expresses an instrumental mentality. The hard version should be rejected because of the ethical and legal problems it raises, including risk-risk tradeoffs, internal paradoxes, unjustified causing of fear and unreasonable presupposition. Ultimately, this paper defends the moderate version.

Doerr, Megan and Jennifer K Wagner, ‘Research Ethics in a Pandemic: Considerations for the Use of Research Infrastructure and Resources for Public Health Activities’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa028
Abstract: The number and size of existing research studies with massive databases and biosample repositories that could be leveraged for public health response against SARS-CoV-2 (or other infectious disease pathogens) are unparalleled in history. What risks are posed by coopting research infrastructure—not just data and samples but also participant recruitment and contact networks, communications, and coordination functions—for public health activities? The case of the Seattle Flu Study highlights the general challenges associated with utilizing research infrastructure for public health response, including the legal and ethical considerations for research data use, the return of the results of public health activities relying upon research resources to unwitting research participants, and the possible impacts of public health reporting mandates on future research participation. While research, including public health research, is essential during a pandemic, careful consideration should be given to distinguishing and balancing the ethical mandates of public health activities against the existing ethical responsibilities of biomedical researchers.

Domenici, Irene and Franciska Engeser, ‘The Institutional Tragedy of Pandemic Triage Regulation in Italy and Germany’ (2022) European Journal of Health Law (Advance article, published online 4 March 2022)
Abstract: This article adopts a comparative approach exploring the reactions to the scarcity of resources resulting from the Covid-19 pandemic in Italy and Germany. Both countries showed a fragmented structure including individual hospitals, medical associations and recommendatory interdisciplinary bodies, such as ethics councils. Against this background, the authors use the different constitutional frameworks in which the healthcare systems are embedded to assess the legitimacy of the intervention by non-legislative bodies. It is demonstrated that, in both jurisdictions, a certain level of parliamentary involvement in establishing triage criteria or procedures is constitutionally required, as in situations of extreme scarcity the prioritisation decision cannot be determined by a mere clinical analysis but rather demands a normative choice.

Donati, Alessandra, ‘The Conditional Marketing Authorisation of Covid-19 Vaccines: A Critical Assessment under EU Law’ (2022) European Journal of Health Law (Advance article, published online 4 March 2022)
Abstract: The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission.

Donley, Greer, Beatrice Chen and Sonya Borrero, ‘The Legal and Medical Necessity of Abortion Care Amid the COVID-19 Pandemic’ (2020) 7(1) Journal of Law & the Biosciences Article lsaa013
Abstract: In response to the COVID-19 pandemic, states have ordered the cessation of non-essential healthcare. Unfortunately, many conservative states have sought to capitalize on those orders to halt abortion care. In this short paper, we argue that abortion should not fall under any state’s non-essential healthcare order. Major medical organizations recognize that abortion is essential healthcare that must be provided even in a pandemic, and the law recognizes abortion as a time-sensitive constitutional right. Finally, we examine the constitutional arguments as to why enforcing these orders against abortion providers should not stand constitutional scrutiny. We conclude that no public health purpose can be served by this application because abortion uses less scarce resources and involves fewer contacts with healthcare professionals than prenatal care and delivery assistance, which is continuing to be provided in this public health emergency.

Dooling, Bridget CE and Laura Stanley, ‘Extending Pandemic Flexibilities for Opioid Use Disorder Treatment: Authorities and Methods’ (2021) 106(1) Minnesota Law Review 74–99
Abstract: This essay evaluates two specific flexibilities the government granted during the COVID-19 pandemic that made it easier for patients to access life-saving medications to treat opioid use disorder: buprenorphine and methadone. First, the Drug Enforcement Administration (DEA) allowed practitioners to prescribe buprenorphine using telemedicine without first conducting an in-person medical exam. Second, the Substance Abuse and Mental Health Services Administration (SAMHSA) made it easier for patients to have a take-home supply of methadone, reducing many patients’ need to make a daily trip to an opioid treatment program. While it is still early, there is some evidence that these flexibilities are working well for patients. Patients and practitioners worry that these flexibilities will come to an end after the pandemic, and one of the federal agencies involved has indicated that it lacks the legal authority to extend its flexibility beyond the pandemic. We disagree. At a political level, the White House Office of National Drug Control Policy has indicated that extending pandemic flexibilities for treating opioid use disorder is a priority for the Biden administration, and this essay offers a roadmap for the executive branch to extend these flexibilities using existing authority.

Dorfman, Doron, ‘Can the COVID-19 Interstate Travel Restrictions Help Lift the FDA’s Blood Ban?’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa009
Abstract: Optimism among health law scholars is rare in the time of coronavirus. Yet this piece suggests that the crisis might be helpful in overruling one controversial health law policy that predates the virus: the FDA’s blood donation ban for gay and bisexual men. The blood ban was developed in response to the 1980s HIV-AIDS outbreak. Scholars have criticized this policy for years now as being outdated and unconstitutional. A step in the right direction occurred on April 2, 2020, when the FDA issued new recommendations to blood banks changing the one-year deferral for donations from men who have sex with men to a three-month deferral due to the shortage in the blood supply and after a public outcry on the issue. Yet, the policy is still problematic as it expresses disdain about sex between men. In response to the COVID-19 pandemic, states have issued travel restrictions on travelers from severely impacted states. This piece argues that outside of the dwindling blood supply, experience with stigma as a result of the travel restrictions has the potential to change public perceptions about the ban. Both policies, the blood ban and the COVID-19 interstate travel restrictions, are necessary for the short term, are based on activities connected with a disease, and create stigma with respect to the affected populations. Although no one can imagine the travel restrictions continuing after the pandemic is under control, the FDA’s ban has existed for decades after the end of the AIDS crisis. Drawing parallels between the policies and their stigmatizing effects could help mobilize the public against the blood ban and eventually have it lifted entirely.

Drogin, Eric Y, ‘Forensic Mental Telehealth Assessment (FMTA) in the Context of COVID-19’ (2020) 71(July-August, : Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus)) International Journal of Law and Psychiatry Article 101595
Abstract: Due to the present COVID-19 pandemic, forensic mental telehealth assessment (FMTA) is an increasingly utilized means of conducting court-sanctioned psychiatric and psychological evaluations. FMTA is not a novel development, and studies have been published during the past two decades that opine on the positive and negative implications of conducting testing and interview procedures online, in forensic and traditionally clinical matters alike. The present article examines prospects for eventual legal challenges to FMTA, describes considerations for conducting FMTA in both institutional and residential settings, and concludes that FMTA is now—due to predicted accommodations on the part of courts, attorneys, institutions, and professional guilds—a permanent part of the forensic evaluation landscape, even once the present COVID-19 pandemic has subsided.

Dubey, Uttam, ‘Right to Emergency Medical Services In India’ (SSRN Scholarly Paper No ID 3639124, 30 May 2020)
Abstract: The onslaught of the Novel Corona Virus (COVID-19) pandemic has awakened the individuals and governments globally from the delusion of possessing an efficient public health care system to the worst of the nightmares. The nightmare of people from most advanced countries dying on the streets due to non-availability of beds in hospitals is turning into reality during this pandemic.Although the intellectuals worldwide are busy painting the post-COVID-19 scenario, it is difficult for anyone to paint a conclusive picture of pandemic aftermath. Nonetheless, this pandemic has white-washed the farce created by the States in providing efficient healthcare to its citizens.The situation in India is much grave. Developed countries worldwide became helpless at the peak of the pandemic as the number of patients exceeded the public health care infrastructure. However, in India, the helplessness in providing adequate medical care is imposed on the citizens due to non-cooperation from private hospitals.During the pandemic, the private Hospitals, on the one hand, refused to treat non- COVID 19 patients by mandating a COVID 19 negative certificate and on the other hand did not open up their infrastructure for the COVID-19 patients by citing health concerns of its negative patients. This non-cooperation of private hospitals was precipitated by inaction of the government in enforcing their writ on these hospitals.These dire circumstances compel everyone to ponder upon a pertinent question related to emergency medical care in India. Whether as an Indian citizen, do we have any right to emergency medical care and whether the authorities are doing enough to ensure such right is not violated due to whims of management of private hospitals?The question is as tricky as any question related to rights of Indian citizens enshrined in Constitution of India as it provides a dream of utopian State for its citizens, like the delusion of the efficient public health care system as stated above. However, Indians most often wake to the reality of their rights trampled upon without any redress by institutions created under the Constitution.

Dubov, Alex and Steven Shoptaw, ‘The Value and Ethics of Using Technology to Contain the COVID-19 Epidemic’ (2020) 20(7) The American Journal of Bioethics W7–W11
Abstract: As the world grapples with COVID-19, experts are calling for better identification and isolation of new cases. In this paper, we argue that these tasks can be scaled up with the use of technology. Digital contact tracing can accelerate identifying newly diagnosed patients, instantly informing past contacts about their risk of infection, and supporting social distancing efforts. Geolocation data can be used to enforce quarantine measures. Social media data can be used to predict outbreak clusters and trace the spread of misinformation online. These technology tools have played a role in turning the tide of the epidemic and easing lockdown measures in China, South Korea, and Singapore. There is a growing interest in the US in digital contact-tracing tools that may help rein in contagion and relax lockdown measures. This paper provides an overview of the ways in which technology can support non-pharmaceutical interventions during the COVID-19 epidemic and outlines the ethical challenges associated with these approaches.

Dudzinski, Denise M, Benjamin Y Hoisington and Crystal E Brown, ‘Ethics Lessons From Seattle’s Early Experience With COVID-19’ (2020) 20(7) The American Journal of Bioethics 67–74
Abstract: Ethics consultants and critical care clinicians reflect on Seattle’s early experience as the United States’ first epicenter of COVID-19. We discuss ethically salient issues confronted at UW Medicine’s hospitals and provide lessons for other health care institutions that may soon face what we have faced.

Dugard, Jackie, Mandivavarira Mudarikwa and Nicola Soekoe, ‘COVID-19, International Trade Law, and the Gendered Dimensions of the Global Vaccine Apartheid: A Rights-Based Analysis’ in The Routledge Companion to Gender and COVID-19 (Routledge, 2024)
Abstract: Even as the COVID-19 pandemic retreats into a relatively more manageable phenomenon, the costs of the global failure to overcome ‘vaccine apartheid’—including through expeditiously supporting a waiver proposal at the World Trade Organization (WTO)—are still being counted. This is especially so in the Global South, where inadequate access to COVID-19 vaccines has exacerbated exclusion, marginalization, and invisibility and has resulted in disproportionate burdens and impacts for poor women of color. Providing a gendered analysis of the impacts of vaccine apartheid, this chapter offers some insights into how international human rights can be mobilized in the effort to ensure that trade law is not used to justify the power imbalances and systematic inequalities that COVID-19 has both exposed and entrenched.

Duignan, Kieran and Chloe Bradbury, ‘Covid-19 and Medical Negligence Litigation: Immunity for Healthcare Professionals?’ (2020) 88(1) Medico-Legal Journal 31–34
Abstract: This article considers the recent calls to provide doctors with immunity from medical negligence claims arising out of the Covid-19 pandemic. It provides a critical analysis as to the conditions that would need to be considered for such a policy as well as exploring the wider ramifications.

Dyer, Clare, ‘Covid-19: Doctors’ Call for Legal Protection against Claims of Unlawful Killing Is Rejected’ (2021) 372 BMJ Article164
Abstract: England’s health and social care secretary has rejected a call to bring in emergency legislation to protect doctors from ‘inappropriate’ legal action amid fears that the NHS will be overwhelmed by the covid-19 pandemic.

Dyer, Clare, ‘Covid 19: How to Feel Safe Working on the Front Line: Your Legal and Ethical Questions Answered’ (2021) 372 BMJ Article 179
Abstract: The pandemic has presented doctors with legal and ethical challenges around how to treat patients in overstretched health services. Clare Dyer examines some of the key questions.

Dyer, Clare, ‘Patients Launch Legal Action against AstraZeneca over Its Covid-19 Vaccine’ (2023) 380 BMJ 725
Abstract: Dozens of patients and families are launching legal action against AstraZeneca over a rare side effect of its covid-19 vaccine.

Dzhafer, Nigyar and Jannis V Papathanasiou, ‘Compassionate Drug Use - Time Arising for a New Law in Bulgaria in the Era of COVID-19’ (2020) 62(3) Folia Medica 592–596
Introduction: Despite clinical trials, there are still no approved specific therapies or any vaccine against COVID-19. The only option available is using investigational drugs for compassionate use. The update of the existing regulation regarding compassionate use is to ensure the effective and sustainable development of health policies and technologies over the COVID-19 pandemic and beyond. AIM: The present short communication aimed to highlight the need for early and expanded access to investigational drugs for compassionate use as well as a call for an update of the existing regulation in Bulgaria concerning compassionate use in the era of COVID-19. MATERIALS AND METHODS: In EU and Bulgaria as well, the legal framework for compassionate use was introduced by Article 83 (1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council; in principle, Regulations of the European Parliament and of the Council are mandatory for all Member States. Remdesivir appears to have a favorable clinical and safety profile, as reported in a case involving patients with severe COVID-19 through a compassionate use programme. RESULTS: The overall probability of clinical improvement observed in 36 of 53 COVID-19 patients received intravenous remdesivir as part of a compassionate use programme was 68% (95% CI 40% to 80%). Thirty two patients (60%) demonstrated at least one adverse event, twelve 12 patients (23%) experienced serious adverse events and seven patients (13%) died. CONCLUSION: The global pandemic mandates Bulgarian Drug Agency for a reasonable update of the existing national regulation concerning compassionate use and off-label therapies. In the era of COVID-19, it is important for Bulgarian patients to have early and expanded access to investigational drugs for compassionate use.

Ealy, Henry et al, ‘COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Retrospective’ (2020) 2(4–22) Science, Public Health Policy, and The Law 1–25
Abstract: According to the Centers for Disease Control and Prevention (CDC) on August 23, 2020, ‘For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19 , on average, there were 2.6 additional conditions or causes per death.’[1] For a nation tormented by restrictive public health policies mandated for healthy individuals and small businesses, this is the most important statistical revelation of this crisis. This revelation significantly impacts the published fatalities count due to COVID-19. More importantly, it exposes major problems with the process by which the CDC was able to generate inaccurate data during a crisis. The CDC has advocated for social isolation, social distancing, and personal protective equipment use as primary mitigation strategies in response to the COVID-19 crisis, while simultaneously refusing to acknowledge the promise of inexpensive pharmaceutical and natural treatments. These mitigation strategies were promoted largely in response to projection model fatality forecasts that have proven to be substantially inaccurate. Further investigation into the legality of the methods used to create these strategies raised additional concerns and questions. Why would the CDC decide against using a system of data collection & reporting they authored, and which has been in use nationwide for 17 years without incident, in favor of an untested & unproven system exclusively for COVID-19 without discussion and peer-review? Did the CDC’s decision to abandon a known and proven effective system also breach several federal laws that ensure data accuracy and integrity? Did the CDC knowingly alter rules for reporting cause of death in the presence of comorbidity exclusively for COVID-19? If so, why?

Edge, Peter W, ‘A National Emergency or a Public Health Crisis? Reflecting on the 2020 and 2021 Manx Responses to the Global Pandemic’ (2021) 3(1) Amicus Curiae, Series 2, 56-75
Abstract: The Isle of Man, a self-governing Crown Dependency, developed its own response to the global pandemic, including strict border controls and periods of lockdown. In 2020, this was given legal effect through the declaration of a formal State of Emergency, while, in 2021, similar measures were implemented under public health legislation without a State of Emergency. Framing the 2021 lockdowns as a public health crisis led to a more tightly focused response than the 2020 framing as a national emergency. Within this narrower range, however, the structure of the public health legislation as implemented provided less democratic accountability than the emergency powers legislation and reduced the emphasis given to the rules as laws, leading to a decrease in formality in relation to both creation and publication of these legal rules, and exacerbating a blurring between law and advice. These disadvantages were not, however, intrinsic to the public health legislation itself, and if corrected the public health response is to be preferred.

Edmonds, Sterling et al, ‘Transparency Too Little, Too Late? Why and How Health Canada Should Make Clinical Data and Regulatory Decision-Making Open to Scrutiny in the Face of COVID-19’ (2020) 7(1) Journal of Law and the Biosciences, Article lsaa083
Abstract: Hard-won gains in the transparency of therapeutic product data in recent years have occurred alongside growing reliance by regulators upon expedited review processes. The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality. The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the number and use of expedited review processes for COVID-19 therapies, and at the same time, the proliferation of misinformation about any potential SARS-CoV-2 intervention reveals the limitations of recently implemented transparency measures.

Elberg, Jacob T, ‘Health Care Fraud Means Never Having to Say You’re Sorry’ (2021) 96(2) Washington Law Review 371–423
Jurisdiction: USA
Abstract: For decades, the Department of Justice (DOJ) has issued a steady flood of press releases announcing False Claims Act (FCA) settlements against health care entities and extolling the purportedly sharp message sent to the industry through these settlements about the consequences of engaging in wrongdoing. The FCA is the primary mechanism for government enforcement against health care entities engaged in wrongdoing, and it is expected to be DOJ’s key tool for addressing fraud arising out of government programs in response to the COVID-19 pandemic. DOJ has pointed to three key goals of its enforcement efforts (deterrence, incentivizing cooperation, and building a culture of compliance in the health care industry). However, careful examination of the settlements touted in those DOJ press releases calls into question whether DOJ’s settlement practices are conveying the message DOJ seeks to impart or having the impact it hopes to achieve. Virtually all FCA cases resolve without requiring the defendant to admit wrongdoing, and many defendants issue explicit public denials of wrongdoing when the resolution is announced. The absence of any need to admit wrongdoing has fueled a cost-of-doing-business narrative in which health care entities are required periodically to pay inconsequential settlements to the government regardless of their conduct. DOJ thereby risks both diminishing the general deterrence value of resolutions and lending credence to the vocal skepticism among industry and the defense bar that DOJ could, in fact, prevail at trial. DOJ’s willingness to allow settlements in health care fraud cases without admissions is diametrically contrary to DOJ’s policy in criminal cases, which is against permitting resolutions without defendants’ clear and unequivocal acceptance of responsibility for violating the law. Permitting no-responsibility settlements in the civil FCA context suggests both that DOJ pursues, illegitimately, weak cases it cannot prove at trial, and potentially weakens the general deterrence value of civil FCA claims in general. New defendants may be left with cover that they are not wrongdoers but are merely ensnared in an illegitimate money grab. Even defendants who frankly recognize that they are in violation of the statute may be comforted that they likely face paying little more than restitution, and no significant penalties or social opprobrium. These practices suggest that DOJ rewards willingness to settle, and the monetary recovery it brings, above all other factors. DOJ’s focus on settling and monetary recoveries in turn lends credence to the widespread belief that civil health care fraud settlements simply do not signal wrongdoing. There is no law, policy, or practice that prevents DOJ from requiring admissions in FCA settlements. Yet an in-depth review of nearly 200 FCA resolutions involving health care entities over the past two years reveals that approximately 92% did not include defendants’ clear acceptance of responsibility, and approximately 37% involved defendants actively denying responsibility. The absence of any DOJ policy favoring admissions has important negative consequences, undermining DOJ’s goals of deterrence, incentivizing cooperation, and building a culture of compliance. First, when corporate actors believe DOJ will pursue claims regardless of wrongdoing and the consequences of even a settlement will be relatively painless from a financial and reputational perspective, those actors have reduced incentive to put in place compliance structures dedicated to preventing wrongdoing. Second, and perhaps more importantly, when corporate actors diminish the force of settlements with DOJ by denying responsibility, they undermine the system’s legitimacy vital for DOJ to encourage cooperation and for the government and well-meaning corporate actors to cultivate an industry-wide culture of compliance. This Article examines DOJ policy both from an economic incentive perspective and in light of research surrounding the psychology of legal authority, concluding that under both lenses DOJ undercuts its own goals. With DOJ actively reforming FCA policy and the FCA poised to take center stage in the government’s fight against COVID-19 program abuse, it is beyond time to address this gap in DOJ’s enforcement policy.

Elsayed, Reda Mohammed and Sara Elsayed Kasem, ‘Effect of COVID-19 Pandemic and National Lockdown on the Medicolegal Aspects of Trauma in Sohag Governorate: A Comparative Retrospective Study’ (2022) 20(1) Zagazig Journal of Forensic Medicine 1–12
Abstract: Corona virus (COVID-19) infection, which was first reported in China in 2019, has rapidly spread across the entire world. On 24 March 2020, the Egyptian government started a national lockdown trying to decrease the spread of infection. The aim of the work: To study the medicolegal aspects of trauma cases attended Sohag University Hospitals during the COVID-19 pandemic and national lockdown in comparison with those in the same period in the preceding year 2019. Subjects and methods: The study is a retrospective study included trauma cases attended to Sohag University Hospitals from 1/4/ 2020 to 30/5/ 2020 (COVID group) and those from 1/4/ 2019 to 30/5/ 2019 (Pre-COVID group). Results: The total number of cases was 424 in COVID group and 427 in Pre-COVID group. The majority of trauma was in the age groups (Conclusion: COVID-19 has disrupted social structures worldwide. These disruptions directly and indirectly affected trauma admissions at Sohag University Hospitals. In spite of the total number of trauma cases did not change but there was a change in the causes of injury and outcome of the case in COVID group in comparison with Pre-COVID group.

Elzein, Rola et al, ‘Legal Liability Facing COVID-19 in Dentistry: Between Malpractice and Preventive Recommendations’ (2021) 78 Journal of Forensic and Legal Medicine Article 102123
Abstract: The dental profession is considered at high potential risk of exposure and transmission of SARS-Cov-2. Thus, dentists should implement special safety measures in order to prevent any possible contamination during dental sessions and should be aware of the legal implications of their act in order to avoid malpractice leading them to be a causative agent of transmission of this virus. This paper aimed to provide a global review on COVID-19 preventive recommendations at dental clinics and discussed the legal values of such procedures, the dentist criminal and civil liability arising from transmitting this virus to a patient, the obligation of care under COVID-19 and the possible solution to this dilemma. The review concluded that dentists should follow all modern scientific procedures which are in their interest and in the interest of patients to maintain their safety and advised dentists to document all steps taken during the period of COVID-19 outbreak, because any undocumented action is considered not to have taken place, and they shall be bound by the burden of proof.

Erasmus, N, ‘Age Discrimination in Critical Care Triage in South Africa: The Law and the Allocation of Scarce Health Resources in the COVID-19 Pandemic’ (2020) 110(12) South African Medical Journal 1172–1175
Abstract: No one may be refused emergency medical treatment in South Africa (SA). Yet score-based categorical exclusions used in critical care triage guidelines disproportionately discriminate against older adults, the cognitively and physically impaired, and the disabled. Adults over the age of 60, who make up 9.1% of the SA population, are most likely to present with disabilities and comorbidities at triage. Score-based models, drawn from international precedents, deny these patients admission to an ICU when resources are constrained, such as during influenza and COVID-19 outbreaks. The Critical Care Society of Southern Africa and the South African Medical Association adopted the Clinical Frailty Scale, which progressively withholds admission to ICUs based on age, frailty and comorbidities in a manner that potentially contravenes constitutional and equality prohibitions against unfair discrimination. The legal implications for healthcare providers are extensive, ranging from personal liability to hate speech and crimes against humanity. COVID-19 guidelines and score-based triage protocols must be revised urgently to eliminate unlawful discrimination against legally protected categories of patients in SA, including the disabled and the elderly. That will ensure legal certainty for health practitioners, and secure the full protections of the law to which the health-vulnerable and those of advanced age are constitutionally entitled.

Erwin, Cheryl et al, ‘Rural and Remote Communities: Unique Ethical Issues in the COVID-19 Pandemic’ (2020) 20(7) The American Journal of Bioethics 117–120
Abstract: We expand on the article ‘Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force’ to consider the ways in which rural and remote communities pose unique ethical questions in the current COVID-19 pandemic.

Farrell, Anne-Maree and Patrick Hann, ‘Mental Health and Capacity Laws in Northern Ireland and the COVID-19 Pandemic: Examining Powers, Procedures and Protections under Emergency Legislation’ (2020) 71(July-August: Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus)) International Journal of Law and Psychiatry Article 101602
Abstract: This article examines the changes made to mental health and capacity laws in Northern Ireland through temporary emergency legislation, known as the Coronavirus Act 2020. The purpose of the legislation was to respond to the emergency situation created by the COVID-19 pandemic, in particular the increase pressure placed on health services in the United Kingdom. An overview is provided of the government’s rationale for the changes to Northern Ireland mental health and capacity laws, as well as exploring how they are likely to be operationalised in practice. Consideration is also given as to how such changes may impact upon existing human rights protections for persons assessed as lacking mental capacity. It is argued that it is important that regular parliamentary oversight is maintained in relation to the potential impact and consequences of such changes during the period they are in force. This should be done in order to assess whether they remain a necessary, proportionate and least restrictive response to the challenges faced in managing mental health and capacity issues in Northern Ireland during this public health emergency.

Farringer, Deborah, ‘A Telehealth Explosion: Using Lessons from the Pandemic to Shape the Future of Telehealth Regulation’ (SSRN Scholarly Paper No ID 3681070, 5 August 2020)
Abstract: The coronavirus pandemic has changed the way individuals work and live, with an ever increasing reliance on technology to carry out daily life. Like schools and business, physicians and physician offices around the country not tasked with treating patients suffering from COVID-19 shuttered their doors and turned to technology, through telehealth, to render necessary healthcare services. Telehealth services, generally defined as being able to diagnose and/or treat a patient via technology as opposed to in-person, have been around for some time, but there have been significant barriers that have hindered widespread growth. Despite this, telehealth advocates have been doggedly and slowly pushing for expansion and trying to break through the known obstacles for decades in an effort to hopefully achieve the touted gains from telehealth, such as enhanced health care services to rural and medically underserved populations, more integrated care across platforms to coordinated providers all treating the same episode of care, and greater convenience and efficiency for the patients and providers for some of the more basics health care needs. Now, the global pandemic has pushed telehealth services into the mainstream and, like a set of dominoes, various federal and state restrictions and limitations that have been built up over the years around telehealth were suddenly waived in order to allow patients to continue to seek necessary medical care. Unlike before, however, patients now found themselves able to access such services from their homes or other places of residence. While some of the restrictions previously in place are likely to return, many are speculating that the pandemic has finally been telehealth’s ‘tipping point’ and could usher in more robust and widespread use of telehealth even after the pandemic has passed or at least waned. As telehealth services have become more widely available and proven to be useful, it now seems unlikely there will be a return to the previous status quo for the industry, but this still leaves the industry, regulators, and enforcers to contemplate what the telehealth industry should look like in a post-pandemic environment. This is a unique time to be able to observe the use of telehealth in an unfettered state and, through that lens, provide legislators and policymakers with valuable data to reconsider the delivery of telehealth and its regulatory structure with the goal of enacting practical and workable regulations that advance efficient and effective health care delivery. To this end, Part I of this Article will examine the history of telehealth, from its early origins, and define what telehealth means today in all of its various forms. Part I will further explain the restrictions and regulatory structure, both federal and state, that applied to telehealth prior to the coronavirus pandemic and the then-current enforcement trends. Next, Part II will describe all of the various waivers and regulatory changes that went into effect in response to the coronavirus pandemic and examine how the pandemic has fueled increased telehealth growth. Part II will also analyze trends realized during the pandemic and other usage data to consider the impact and effect of the waivers and loosening of restrictions on telehealth services. This Article will then argue in Part III that legislators and regulators should avoid either a return to status quo or a permanent adoption of all of the waivers in effect and should instead utilize data and evidence gathered during this time period when restrictions were largely lifted to understand the true concerns raised by telehealth usage and consider a revised regime that focuses its attention and efforts on those aspects of the regulatory structure that are most detrimental to the health and safety of patients and consumers. It will further provide some general recommendations for reconsidering the telehealth regulatory regime once the public health emergency has subsided in order to promote the use of telehealth in a way that enhances and enriches the benefits of telehealth, without harming patients and consumers. Finally, Part IV will conclude with some final thoughts regarding the importance of reimaging the telehealth infrastructure for a sustained and successful future.

Fassiaux, Sébastien, ‘Comparative Survey on Vaccination’ (2021) 1(1–3) Legal Policy and Pandemics: The Journal of the Global Pandemic Network 181–196
Abstract: Vaccination is considered the most effective way of ending the COVID-19 pandemic that has been raging since March 2020. As with other issues during the pandemic, vaccination has generated important litigation involving the balancing of fundamental rights. This article surveys four key areas in vaccination litigation around the world from a comparative perspective. First, the article analyzes the issue of compulsory vaccination and links it to the government measures that potentially discriminate citizens based on their vaccination status. The second issue relates to prioritization, which is also subject to extensive litigation because some categories of people believe they should be prioritized for vaccination. The third issue deals with the processing of vaccination data, in particular the extent to which authorities can collect and process citizens’ health data linked to vaccination. Finally, the fourth issue is institutional, as it concerns litigation regarding which level of government is competent to lead vaccination campaigns. Overall, the survey shows the important role that courts have been playing in balancing fundamental rights in the context of ongoing vaccination campaigns worldwide.

Fedeli, Piergiorgio et al, ‘Legal and Ethical Issues Regarding Minors in the Italian Coronavirus Flu Emergency’ (2021) 9 Frontiers in Pediatrics Article 544461
Abstract: On February 21, 2020, Italy became one of the countries hit by an epidemic of the new coronavirus that causes ‘severe acute respiratory syndrome coronavirus 2’ (SARS-CoV-2). Even a month before that, however, the Italian government began issuing a series of decrees and ordinances aimed at the containment of the virus in Italy, the first of them on January 25, 2020. The COVID 19 infection has been faced as an epidemic through measures to enforce a high degree of isolation. These regulations hold for minors, as well, with consequent difficulties for this age group. While at the moment young people appear to be the least vulnerable to the severe complications of COVID 19, the psychological problems that may be brought on by pandemic-related restrictions should be taken into serious consideration.

Fenton, Elizabeth, ‘Priority Is Not a Proportional, Fitting, or Fair Return for Vaccination’ (2024) 24(7) The American Journal of Bioethics 104–106
Abstract: The article focuses on the ethical implications of prioritizing scarce health resources based on vaccination status. Topics include the debate on whether vaccination warrants priority as a reciprocal return for contributing to public health, the disproportionate nature of such prioritization compared to the contribution of vaccination, and the broader implications of using vaccination status alone as a criterion for resource allocation during a pandemic.

Fernandes, Eugene J, ‘Immunizing Canada from Pandemic Populism’ (2021) [ no publication information]
Abstract: In Canada, are individual citizens ends in themselves, or are they ‘simply tools of collective national policy’ as in China? This philosophical question is brought into sharp focus when we analyze the rights and freedoms that unvaccinated Canadians are denied. Contrary to popular belief, vaccine passports do not clearly violate a citizen’s rights because the government does not mandate him to do or not do anything. 1 Instead, the government mandates that businesses ensure that their guests be vaccinated. The Canadian Charter of Rights and Freedoms protects individual rights more than business rights, so this essay will focus on vaccine mandates where a governmental body imposes an obligation to be vaccinated on an individual, in violation of a right. I will argue that the law should not give the vaccinated more rights than the unvaccinated. We otherwise become a segregated and unethical nation with partial and illiberal institutions.

Ferrara, Alessandro, ‘The Ethical Triage Dilemma: Who Should Receive Medical Care First; Is This the Right Question?’ (2023) 36(2) Ratio Juris 178–190
Abstract: In 2020, with the outbreak of the COVID-19 pandemic, academics and scientists began to question the triage criteria for allocating insufficient healthcare resources, trying to ethically justify the answer to the question, Who should receive medical care first? In this article, I will argue that even if we apply triage criteria, we won’t be able to avoid the violation of human dignity or of the right to life and to health care. I will then suggest that, maybe, the real ethical triage dilemma lies not in the question, Who should receive medical care first? but in the question, How are we to decide who should receive medical care first?

Finch, John, ‘Care Homes, COVID-19 and Legal Liability’ (2020) 22(9) Nursing and Residential Care 1–3
Abstract: The UK response to the pandemic has been characterised by a focus on the NHS, to the detriment of the adult social care sector. Official guidance has often been muddled and opaque, and legal action regarding duty of care and equipment provision may be on the horizion. John Finch explains

Fins, Joseph J, ‘Resuscitating Patient Rights during the Pandemic: COVID-19 and the Risk of Resurgent Paternalism’ [2020] Cambridge Quarterly of Healthcare Ethics advance article, published 24 June 2020) 1-7
Abstract: By late March 2020, New York was in crisis mode. Our Emergency Department - like its counterparts across the City - was bulging at its seams. We were overwhelmed by the COVID-19 surge. Patients were arriving in respiratory failure at the cusp of needing to be resuscitated and the sheer volume of critically-ill patients appearing at the same time was as if there had been a major plane crash at LaGuardia Airport. The only difference was that this was a sustained disaster with a steady flow of dying patients arriving at the hospital. And this was a stress test for medical ethics, for distributive justice and the allocation of scarce resources. Simply put, there were more patients to be resuscitated than available personnel, much less equipment.

Firmansyah, Yohanes and St Laksanto Utomo, ‘A Hospital’s Legal Responsibility for Patient Rights During The Covid-19 Pandemic: A Review From The Health Sector’s Law Regulations’ (2021) 2(8) Jurnal Indonesia Sosial Sains 1392–1406
Jurisdiction: Indonesia
Abstract: The hospital’s legal responsibility to fulfill the patient’s rights cannot be separated from the hospital’s obligations to the patient, according to the law. In practice, the growing number of COVID-19 cases in Indonesia has resulted in hospitals being unable to accommodate patients in need of treatment, particularly those with severe and critical conditions who require intensive care units. With bed occupancy rates (BOR) exceeding 85 percent in almost all hospitals, the community must understand that hospitals must prioritize care for patients with moderate, severe, or life-threatening conditions. In any case, the COVID-19 pandemic had an effect on the quality of hospital care provided to patients. The study used normative juridical research methods and empirical evidence to examine hospitals’ legal responsibility for upholding patient rights during the COVID-19 pandemic. The study’s findings indicate that, despite limitations in providing excellent health care to patients, hospitals must uphold patient rights to safety and security during hospitalization. As a result, it is necessary to establish a legal framework that protects the rights of health care workers and hospitals providing services to patients during this pandemic, particularly the protection of work standards, occupational health and safety standards, and labor social security standards. In terms of facilities and infrastructure, the government must assist by increasing the number of emergency hospitals to accommodate the anticipated increase in COVID-19 patients.

Fischman Afori, Orit, Miriam Marcowitz-Bitton and Emily Michiko Morris, ‘A Global Pandemic Remedy to Vaccine Nationalism’ (SSRN Scholarly Paper ID 3829419, 19 April 2021)
Abstract: The COVID-19 pandemic has had devastating effects on our social, economic and political lives. While the race to develop vaccines has yielded results in record time, ensuring widespread, affordable access to these vaccines remains a major challenge. Vaccines are now in a race against new, more virulent variants of COVID-19, and unless everyone can be vaccinated soon, these new variants may lead to many more deaths. Current vaccine supplies fall far short of what is needed, however, and in what has become known as ‘vaccine nationalism,’ wealthier countries have poured billions of dollars into advance purchasing agreements that guarantee themselves preferential access. The distribution inequities resulting from this nationalistic response undermines the interest all countries have in speedy and universal inoculation. At the heart of the problem is the fact that the pharmaceutical industry has taken a market-driven rather than public-health driven approach to vaccine development and distribution. A market-driven approach makes sense to some extent, as the pharmaceutical companies must have some means of recovering their investments in the risky research and development required to create new vaccines. Patent protections and other exclusive rights are widely regarded as necessary incentivizes for investment in pharmaceutical innovation, as they allow supracompetitive pricing. In times of global public health crises, however, the ordinary principles of exclusivity must give way to the pressing need for immediate, affordable, and widely available access. We desperately need other manufacturers to be able to help boost vaccine supplies and lower vaccine prices.Recognizing the need for flexibility in times of emergency and building upon knowledge gained from existing international and domestic compulsory licensing laws, we propose a global, centralized scheme to provide access to vaccines during pandemics. In many ways our proposal mirrors some of the WHO’s COVID-19 vaccine initiatives but consolidates and expands them into a much more efficacious form. Under the proposed model, the World Health Organization’s declaration of a pandemic would trigger a global procurement and distribution scheme for vaccines. The proposed scheme would be mandatory and would require that all countries operate as one buyer vis-à-vis vaccine developers. A single buyer scheme provides a buyer with significant economic leverage, allowing not only to negotiate vaccine pricing and distribution from a better bargaining position, but also to discourage defection. This procurement scheme would be supported by the power to issue global compulsory licenses of patent, trade secret, regulatory data, and other assets necessary for vaccine production, to become effective if and when consensual negotiations with vaccine developers fail. The success of such a global procurement initiative, especially at times of emergency where each country is tempted to defect and take a nationalistic approach, depends on mandatory global participation and a firm commitment to the scheme.

Fleck, Leonard M, ‘Vexing Vaccine Ethics: Denying ICU Care to Vaccine Refusers’ (2024) 24(7) The American Journal of Bioethics 92–94
Abstract: The article focuses on the ethical considerations of denying Intensive Care Unit (ICU) care to vaccine refusers during the COVID-19 pandemic. Topics include the ethical implications of using vaccine status as a criterion for scarce medical resource allocation, exploring values of responsibility, and justice within medical decision-making.

Fletes, Abigail et al, ‘Advancing Syringe Services in the United States: The Untapped Role of the Americans with Disabilities Act’ (2022) Yale Journal of Health Policy, Law, and Ethics (forthcoming)
Abstract: The United States is facing an unprecedented set of public health challenges. Now killing nearly 1000 people daily, the COVID-19 pandemic is also compounding the ongoing crisis of addiction and risky substance use. Disruption in treatment and support services, economic shocks, despair and social isolation wrought by coronavirus have all impeded efforts to bend the overdose curve—now surging again after a momentary deceleration prior to the onset of the pandemic. By the same token, there is evidence that people with substance use disorder are more susceptible to COVID-19 infection and its deadly sequelae. Now more than ever, prevention and supportive services are vital to safeguarding the health of people with substance use disorder. Although access to substance use treatment has received substantial attention and support, harm reduction services are being left behind. These vital programs include syringe service programs (SSPs), naloxone distribution, drug checking, and supervised consumption facilities. Intended to address the needs of highly-stigmatized, criminalized people who use illicit drugs, SSPs have been shown especially effective as platforms for stemming bloodborne infections, preventing overdose, and facilitating access to a broad range of assistance, including COVID-19 testing, substance use treatment, housing, and other essential support.

Font, Joan Costa, Rosella Levaggi and Gilberto Turati, ‘Resilient Managed Competition during Pandemics: Lessons from the Italian Experience during COVID-19’ [2020] Health Economics, Policy and Law (advance online article, published 4 September 2020)
Abstract: In the last decades, several European health systems have abandoned their vertically integrated health care in favour of some form of managed competition (MC), either in a centralised or decentralised format. However, during a pandemic, MC may put health systems under additional strain as they follow some form of organisational self-interest””, and hence face reduced incentives for both provider coordination (e.g., temporary hospital close down, change in the case-mix), and information sharing. We illustrate our argument using evidence for the Covid-19 pandemic outbreak in Italy during March and April 2020, which calls for the development of ‘coordination mechanisms’ at times of a health emergency.

Franc, Aleš and Vladimír Bíba, ‘Ethical and Legal Requirements for Vaccination against COVID-19’ (2022) 71(1) Ceska a Slovenska Farmacie 3–12
Abstract: In the current context, there is an extraordinary interest of states in vaccinating the population to prevent Covid-19. In the Czech Republic, gene mRNA and vector DNA vaccines are approved only with conditional marketing authorization, for which a complete and long-term safety assessment is currently lacking. Vaccines show some potential risks, such as penetration of lipid nanoparticles into surrounding tissues, incorporation of DNA into the host genome, ADE syndrome, development of resistant mutations, myocarditis, pericarditis, and thromboembolic events. Since the level of antibodies after vaccination is soon decreasing, immunity after the disease persists longer, and the disease's fatality rate is very low, especially in adolescents, only voluntary vaccination is ethically acceptable, without any direct or indirect restrictions on the unvaccinated. The conclusion is in line with the principles of medical ethics of nonmaleficence, beneficence, autonomy, and justice.

Franciosi, Laura, ‘Covid-19 and the Italian Legal System’ (2023) 15(1) Journal of Civil Law Studies 365–391
Abstract: COVID-19 hit Italy with particular violence. Then spreading around Europe and worldwide, the virus raised unprecedented issues requiring the implementation of urgent measures to prevent its propagation. This Article focuses on selected topics of the Italian civil law particularly affected by the rise of COVID-19 and tries to provide brief comparative remarks. Namely, after summarizing the most important events that occurred in Italy––originating from the discovery of the first Italian case of COVID-19 in Codogno––it outlines relevant social and legal scenarios. This Article also concentrates on commercial lease contracts, and subsequently addresses the legal implications of vaccination, with reference to the consent of incapacitated persons.

Frankford, David M, ‘Sick at Heart: A Fundamental Reason the United States Was Unprepared for the COVID-19 Emergency’ (2020) 72(5) Rutgers University Law Review (forthcoming)
Abstract: This article explicates a fundamental reason the United States was unprepared for the COVID-19 pandemic, which is that we have systematically institutionalized and created a culture of selfishness in our system for financing and delivering health care. After a brief introduction, the article proceeds in six steps. In Part One, I describe the origins of the novel coronavirus in China, the actions taken there, the fact that while the ban on domestic travel from Wuhan limited the degree of spread within China to cities like Beijing and Shanghai, it failed to prevent the virus’s spread across the world and its march across the United States in the midst of denial, obfuscation, refusals to act and delay. In Part Two, I explicate the various ways in which the United States was unprepared for the pandemic, focusing particularly on the lack of public health infrastructure, including the ability to mobilize supply lines, but also the breakdowns in hospitals and nursing homes and, importantly, the manner in which our continuing lack of a national health care system is part of our lack of preparedness. In Part Three, I describe how some other nations have had much greater success in staunching the outbreak, focusing particularly on Germany, as a liberal democracy in which civil liberty is respected. In Part Four, I take note of some of the complicated social, political and cultural features that steer a pandemic, which is as much a biological as a social and cultural phenomenon: leadership; disparate interests, regional rivalries and political structures; globalization; the role of the 24/7 news cycle; and finally, the importance of communal embrace of public health to minimize the need for coercive measures. In Part Five, I turn to the institutionalization and embodiment in culture of selfishness in our system for financing and delivering health care, giving rise to a fragmented system of payment and delivery, along with massive concentration of economic power and separate, siloed networks, all reflected in and created by legal doctrine that itself is fragmented. Finally, in Part Six, I offer a brief reflection on the possibility of change, given the crisis. This reflection is rather gloomy, as is, frankly, what is written in the entire article.

Freckelton, Ian, ‘COVID-19: Fear, Quackery, False Representations and the Law’ (2020) 43(September-October)) International Journal of Law and Psychiatry: Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus) Article 101611
Abstract: Fear, anxiety and even paranoia can proliferate during a pandemic. Such conditions, even when subclinical, tend to be a product of personal and predispositional factors, as well as shared cultural influences, including religious, literary, film, and gaming, all of which can lead to emotional and less than rational responses. They can render people vulnerable to engage in implausible conspiracy theories about the causes of illness and governmental responses to it. They can also lead people to give credence to simplistic and unscientific misrepresentations about medications and devices which are claimed to prevent, treat or cure disease. In turn such vulnerability creates predatory opportunities for the unscrupulous. This article notes the eruption of quackery during the 1889–1892 Russian Flu and the 1918–1920 Spanish Flu and the emergence during 2020 of spurious claims during the COVID-19 pandemic. It identifies consumer protection strategies and interventions formulated during the 2020 pandemic. Using examples from the United States, Japan, Australia and the United Kingdom, it argues that during a pandemic there is a need for three responses by government to the risks posed by conspiracy theories and false representations: calm, scientifically-based messaging from public health authorities; cease and desist warnings directed toward those making extravagant or inappropriate claims; and the taking of assertive and well publicised legal action against individuals and entities that make false representations during a pandemic in order to protect consumers rendered vulnerable by their emotional responses to the phenomenology of the pandemic.

Freckelton, Ian, ‘COVID-19, Negligence and Occupational Health and Safety: Ethical and Legal Issues for Hospitals and Health Centres’ (2020) 27(3) Journal of Law and Medicine 590–600
Abstract: The international incidence of health workers being infected with COVID-19 is deeply troubling. Until a vaccine is developed, they are the community’s bulwark against the pandemic. It is vital that they be protected to the maximum extent possible. This entails the need for implementation of effective and compassionate protocols to keep their workplace as safe as possible for them, their colleagues and their patients in a context of much as yet not being known about the virus and awareness that some persons infected by it are for a time at least asymptomatic and that others test negative for it when they are prodromal or even already displaying some symptomatology. This has repercussions both for the liability of hospitals and multi-practitioner centres for negligence and also under occupational health and safety legislation. With the commencement of the roll out of biosecurity and disaster/emergency measures by government and escalating levels of anxiety in the general population, it is important to reflect upon the measures that most effectively can be adopted practically and ethically to protect the health and safety of those whose task it is to care for us if we become infected by COVID-19.

Freckelton, Ian, ‘Perils of Precipitate Publication: Fraudulent and Substandard COVID-19 Research’ 27(4) Journal of Law and Medicine 779–789
Abstract: The COVID-19 pandemic has created an environment highly conducive to substandard and fraudulent research. The incentives and temptations for the unethical are substantial. The articles published during 2020 in The Lancet and the New England Journal of Medicine that were based on spurious datasets, allegedly hosted by a cloud-based health care analytics platform, are deeply confronting for research integrity. They illustrate the perils of precipitate publication, inadequate peer-reviewing and co-authorship without proper assumption of responsibility. A period of crisis such as that in existence during the COVID-19 pandemic calls for high-quality research that is robustly evaluated. It is not a time for panic to propel premature publication or for relaxation in scholarly standards. Any other approach will replicate errors of the past and result in illusory research breakthroughs to global detriment.

Freckelton, Ian and Vera Lúcia Raposo, ‘International Access to Public Health Data: An Important Brazilian Precedent’ (2020) 27(4) Journal of Law and Medicine 895–900
Abstract: Accurate, up-to-date data are the bedrock of effective public health responses, including in the context of the suffering caused by COVID-19. Any action to inhibit the compilation of such data has ramifications locally, nationally and internationally, and risks impairing the global capacity to respond to the virus. This article contextualises the decision of the government of President Bolsonaro of Brazil to reduce the accessibility of contemporary data about COVID-19 infections in Brazil within his views about, and responses to, the virus. It identifies the nature of actions taken to suppress such data by the Brazilian Ministry of Health and then scrutinises a decision by De Moraes J of Brazil’s High Court in Sustainability Network v The President of the Republic of Brazil (ADPF 690 MC/DF, 8 June 2020), which quashed the attempted suppression of public health data. The article hails the decision as an important public health law precedent.

Frere, Kelly G and Matthew B Frere, ‘When Seniors Are Forced to Leave a Facility: Options for Care Can Be Limited’ (2020) 56(9) Tennessee Bar Journal 42–43
Abstract: An issue that is increasingly affecting seniors is being discharged or evicted — against their will and when they have nowhere else to go — from a hospital, long-term care facility or in-home care services. Unfortunately, this problem exists with little in the way of solutions. As the family’s lawyer, you need to know what resources are available — and be aware that there are not many.

Friedman, Eric A et al, ‘Global Health in the Age of COVID-19: Responsive Health Systems Through a Right to Health Fund’ (2020) 22(1) Health and Human Rights Journal 199–207
Abstract: We propose that a Right to Health Capacity Fund (R2HCF) be created as a central institution of a reimagined global health architecture developed in the aftermath of the COVID-19 pandemic. Such a fund would help ensure the strong health systems required to prevent disease outbreaks from becoming devastating global pandemics, while ensuring genuinely universal health coverage that would encompass even the most marginalized populations. The R2HCF ’s mission would be to promote inclusive participation, equality, and accountability for advancing the right to health. The fund would focus its resources on civil society organizations, supporting their advocacy and strengthening mechanisms for accountability and participation. We propose an initial annual target of US$500 million for the fund, adjusted based on needs assessments. Such a financing level would be both achievable and transformative, given the limited right to health funding presently and the demonstrated potential of right to health initiatives to strengthen health systems and meet the health needs of marginalized populations—and enable these populations to be treated with dignity. We call for a civil society-led multi-stakeholder process to further conceptualize, and then launch, an R2HCF, helping create a world where, whether during a health emergency or in ordinary times, no one is left behind.

Frith, Lucy et al, ‘Neither “Crisis Light” nor “Business as Usual”: Considering the Distinctive Ethical Issues Raised by the Contingency and Reset Phases of a Pandemic’ (2021) 21(8) The American Journal of Bioethics 34–37
Introduction: We have been researching the distinctive ethical issues raised by what we have called ‘the reset period,’ when non-Covid services resumed alongside the continuing pandemic in the UK. In this commentary, we will first consider the similarities and differences between the reset and contingency phases, as described by Alfandre et al. We will then unpack Alfandre et al.’s position that the contingency phase should be characterized by operating a standard of care that is functionally equivalent to ‘usual’ practice, arguing that in the reset and contingency phases, the standards of ‘usual’ care may be unobtainable and, in these circumstances, we cannot fall back on the primacy of ‘patient centered care.’ Consequently, different ethical principles and balancing strategies are needed when care is neither ‘crisis light’ nor ‘business as usual.’ We will conclude by reflecting on what these should be.

Frosh, Ariane, ‘Reproducing Equality: How Covid-19 Can Strengthen Abortion Rights’ (2020) 168(Special Issue: Law Meets World) UCLA Law Review Discourse 80–101
Abstract: States hostile to reproductive freedom have weaponized the COVID-19 pandemic to ban abortion in the name of public safety. Relying on heightened power the state typically exercises during an emergency, it can capitalize on public panic to achieve its policy goals. By laying bare the racial inequities of our healthcare systems and the opportunistic banning of abortion by an emergency-emboldened state, the COVID-19 pandemic invites a reexamination of the constitutional frameworks that support reproductive freedom. The status quo, rooted in substantive due process and illusory notions of ‘choice,’ reinforces these inequities. The emergency usurpation of abortion rights suggests the need for a broader framework: one rooted in equality and social justice. An equal protection foundation for the right to abortion can help ebb the steady erosion of Roe’s core promise. More holistically, an equal protection approach can remedy the gaps in access to abortion care along racial and class lines by situating future litigation in the human rights framework of the reproductive justice movement.

Frye III, John W, ‘A Minor Question of Vaccine Consent: Not for Ethics Alone to Answer’ (2022) 22(1) American Journal of Bioethics 64–65
Abstract: The article considers that for an adolescent to give valid and sufficient consent to a COVID-19 vaccine, she must possess both capacity and competency, as in the case of 15-year-old Alesha. Topics include how an ethics consultant should assess Alesha’s capacity for vaccination, how an advanced practice registered nurse’s presumed concern about competency should be addressed and the ethics consultant’s need to work with a legal department to help develop guidelines or policy for such situations.

Gable, Lance, ‘Allocation of Scarce Medical Resources and Crisis Standards of Care’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 177–182
Abstract: Potential shortages of medical resources and services related to COVID-19 present government officials and emergency planners with difficult choices. If resources become too scarce, health care professionals and institutions may need to implement triage protocols adopting crisis standards of care. COVID-19 patient surges tested the health care system in March and April 2020, and highlighted the need to prepare to accommodate larger patient capacity in the near future. As a primary consideration, governments and health care institutions should utilize existing powers and resources to avoid shortages and mitigate their severity. If shortages do occur, most states have begun to develop crisis standards of care protocols to assist in making decisions about allocating scarce resources. These protocols attempt to maximize the number of lives saved. Many protocols give priority access to health care and other essential workers. These protocols should be structured to facilitate fair and equitable access, although several have been found to be inconsistent with federal antidiscrimination law. Legal issues that may arise in this context include liability for health care professionals and institutions who decide to not allocate resources to patients who later suffer harm, and civil rights concerns over discrimination arising from the protocols or their implementation. Liability shields have been put in place by many states to protect health care professionals from lawsuits based on allocation decisions. Federal and state officials should support efforts to clarify and incorporate protections into crisis standards of care plans that prioritize antidiscrimination, fairness, and equity in allocation decision making.

Gable, Lance, Natalie Ram and Jeffrey L Ram, ‘Legal and Ethical Implications of Wastewater Monitoring of SARS-CoV-2 for COVID-19 Surveillance’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa039
Abstract: Scientists have observed that molecular markers for COVID-19 can be detected in wastewater of infected communities both during an outbreak and, in some cases, before the first case is confirmed. The Centers for Disease Control and Prevention and other government entities are considering whether to add community surveillance through wastewater monitoring to assist in tracking disease prevalence and guiding public health responses to the COVID-19 pandemic. This scientific breakthrough may lead to many useful potential applications for tracking disease, intensifying testing, initiating social distancing or quarantines, and even lifting restrictions once a cessation of infection is detected and confirmed. Yet, new technologies developed in response to a public health crisis may raise difficult legal and ethical questions about how such technologies may impact both the public health and civil liberties of the population. This paper describes recent scientific evidence regarding COVID-19 detection in wastewater, identifying public health benefits that may result from this breakthrough, as well as the limitations of existing data. The paper then assesses the legal and ethical implications of implementing policy based on positive sewage signals. It concludes that the first step to implementing legal and ethical wastewater monitoring is to develop scientific understanding. Even if reliability and efficacy are established, limits on sample and data collection, use, and sharing must also be considered to prevent undermining privacy and autonomy in order to implement these public health strategies consistent with legal and ethical considerations.

Gandjour, Afschin, ‘Vaccination Mandates, Physically Forced Vaccination, and Rationing in the Intensive Care Unit: Searching for Ethical Coherence in the COVID-19 Pandemic’ (2022) 22(11) The American Journal of Bioethics 11–14
Abstract: For a long time, German politicians agreed that there should be no COVID-19 vaccination mandate. However, sluggish vaccine uptake and rapidly filling intensive care unit (ICU) beds in certain federal states have led to a growing debate over proposals to encourage vaccine uptake including mandates. In parallel, a debate over whether COVID-19 vaccination status should be used for rationing scarce ICU beds has risen but German politicians have almost uniformly rejected this principle so far. Physically forced vaccination appears even less agreeable. The purpose of this editorial is to discuss the ethical coherence of the three positions, that is, support of vaccination mandates for the general population on the one hand and rejection of physically forced vaccination and vaccination status as a triage factor in ICUs on the other.

Gangadarsana, PG, ‘Right to Health: It’s [sic] Implications in India During the Covid Era’ (2021) 24 Supremo Amicus Journal (unpaginated)
Abstract: ‘Right to Health’ is a fundamental human right that is imperative of all other rights. The human right to health is guaranteed internationally and nationally in various International Instruments and National legislations respectively. Ever since the outbreak of novel Corona virus, there prevails an incessant debate of defending the basic right of health to every human-being by various organizations and communities across the globe. The World Health Organization, being the upholder of health right stays as a silent spectator when it comes to balancing the right of health and controlling the spread of Covid, ever since it declared the spread of virus as a ‘Global Pandemic’. In India, COVID-19 is contemplated an eye-opener in the arena of ‘Public health care system’ and ‘Protection of right to health’. This article brings to light, the implications revolving around ‘Human right to Health’ – the framework of laws and the infrastructure of public health system in the post-Covid era in India.

Garner, Craig B, ‘Ignorance Is Not Bliss: The Consequences of How Little We Know about COVID-19’ [2020] (3) _California Lawyers Association Business Law News_
Abstract: An expensive endeavor, hospital disaster preparedness focuses on a rapid response to an unexpected event, designed to protect, stabilize, and bring calm to shaken communities following a disaster’s aftermath. The 2019 novel coronavirus disease (COVID-19) has presented a different type of disaster necessitating just as novel a response. In pandemic’s early days, it moved in slow-motion as the health care community initiated disaster protocol over a period of weeks, not hours. While mobilizing any hospital to battle a pandemic is not easy, legally at least, hospitals benefitted from unprecedented support by practically every federal and state agency, the assistance from which eliminated most barriers overnight so hospitals could establish and maintain momentum in the face of an epic disaster that, over several months, has moved forward, backward, and forward again

Gates, Alexander A, ‘Legal and Ethical Implications of Mandatory COVID-19 Vaccination Programs’ (2022) 25 Quinnipiac Health Law Journal 125
Abstract: This article will explore the legality behind vaccine mandates that inherently infringe on civil liberties and what it means for people in different walks of life. In Part II, this note will illustrate the historical background of vaccines and discuss the characteristics that make vaccines unique in preventing infection from otherwise deadly viruses. In Part III, a constitutional basis for compulsory vaccination will be reviewed using case law. In Part IV, the religious and philosophical exemptions that are inherent objections to vaccines will be discussed. In Part V, the Food, Drug, and Cosmetic Act’s (FDCA) Emergency Use Authorization (EUA) will be explored. In Part VI, this note will determine the legality of vaccine mandates in specific situations. In Part VII, the ethical considerations of mandating a vaccine will be evaluated using different frameworks. Part VIII will conclude with a legal and ethical analysis of vaccine mandates.

Gather, J et al, ‘Under Which Conditions Are Changes in the Treatment of People under Involuntary Commitment Justified during the COVID-19 Pandemic? An Ethical Evaluation of Current Developments in Germany’ (2020) 73(November-December) International Journal of Law & Psychiatry Article 101615
Abstract: The COVID-19 pandemic poses significant challenges in psychiatric hospitals, particularly in the context of the treatment of people under involuntary commitment. The question arises at various points in the procedure for and process of involuntary commitment whether procedural modifications or further restrictive measures are necessary to minimise the spread of COVID-19 and protect all people involved from infection. In the light of current developments in Germany, this article examines under which conditions changes in the treatment of people under involuntary commitment are ethically justified in view of the COVID-19 pandemic. Among others, we discuss ethical arguments for and against involuntary commitments with reference to COVID-19, the use of different coercive interventions, the introduction of video hearings, an increased use of video surveillance and interventions based on the German Infection Protection Act. We argue that strict hygiene concepts, the provision of sufficient personal protective equipment and frequent testing for COVID-19 should be the central strategies to ensure the best possible protection against infection. Any further restrictions of the liberty of people under involuntary commitment require a sound ethical justification based on the criteria of suitability, necessity and proportionality. A strict compliance with these criteria and the continued oversight by external and independent control mechanisms are important to prevent ethically unjustified restrictions and discrimination against people with the diagnosis of a mental disorder during the COVID-19 pandemic.

Germain, Sabrina, ‘The Role of Medical Professionals in Shaping Healthcare Law during Covid-19’ (2021) 3(1) Amicus Curiae, Series 2, 33–55
Abstract: This article explores the changing nature of the allocation of healthcare resources during the Covid-19 crisis and how it may have shaped a new role for medical professionals in healthcare law and policymaking. It contrasts the traditional input of medical professionals in systemic healthcare reforms (1946, 1990 and 2012) with their role in the elaboration of ethical emergency guidance published by the British Medical Association and the Royal College of Physicians in March–April 2020, using a discourse analysis methodology and concepts borrowed from political philosophy.

Germain, Sabrina, ‘Will COVID-19 Mark the End of an Egalitarian National Health Service?’ (2020) 11(2) European Journal of Risk Regulation: Special Issue - ‘Taming COVID-19 by Regulation’ Special Issue-‘Taming COVID-19 by Regulation’ 358-365
Abstract: The paper first unpacks why the allocation of healthcare resources is fundamentally a question of justice in Britain and explains why healthcare law and policy require a philosophical approach in times of crucial change and crisis. Secondly, the paper provides a critical analysis of the current situation for the allocation of healthcare resources and the provision of services to patients directly or indirectly affected by the virus. It concludes that the liberal egalitarian conception of distributive justice at the heart of the NHS that aims to guarantee free and equal access to healthcare is now in jeopardy and is being replaced by a utilitarian approach based on a priority ranking of patients for the provision of services at this critical time.

Germain, Sabrina and Adrienne Yong, ‘COVID-19 Highlighting Inequalities in Access to Healthcare in England: A Case Study of Ethnic Minority and Migrant Women’ (2020) 28(3) Feminist Legal Studies 301–310
Abstract: Our commentary aims to show that the COVID-19 pandemic has amplified existing barriers to healthcare in England for ethnic minority and migrant women. We expose how the pandemic has affected the allocation of healthcare resources leading to the prioritisation of COVID-19 patients and suspending the equal access to healthcare services approach. We argue that we must look beyond this disruption in provision by examining existing barriers to access that have been amplified by the pandemic in order to understand the poorer health outcomes for women in ethnic minority and migrant communities. The reflection focuses on racialised medical perceptions, gendered cultural norms including information barriers and stigma, and specific legal barriers.

Ghitani, Sara A et al, ‘The Ethical and Medico-Legal Challenges of Telemedicine in the Coronavirus Disease 2019 Era: A Comparison between Egypt and India’ (2021) Clinical Ethics (advance article, published online 29 November 2021)
Abstract: In the coronavirus disease 2019 era, doctors have tried to decrease hospital visits and admissions. To this end, telemedicine was implemented in a non-systematic manner according. The objective of this study was to assess the current knowledge and attitudes of physicians in Alexandria, Egypt, and Punjab, India, toward telemedicine and its ethical and medico-legal issues.

Ghosh, Sriparna, Agnitra Roy Choudhury and Alicia Plemmons, ‘Certificate-of-Need Laws and Healthcare Utilization During COVID-19 Pandemic’ (SSRN Scholarly Paper No ID 3663547, 29 July 2020)
Abstract: This paper investigates the impact of state-level Certificate-of-Need (CON) laws on COVID and non-COVID deaths in the United States during the SARS-CoV-2 pandemic. CON laws are legal limitations to the expansion and acquisition of medical services within a state and were not structured in a way to prepare or stockpile medical goods and services to the volume that has been required to meet demand swells during the recent pandemic. Our investigation primarily focuses on mortality caused by COVID and non-COVID related reasons, and in understanding how these laws affect access to healthcare for illnesses that might require similar medical equipment. Our baseline results suggest that mortality rates are higher in states with CON laws relative to that in states without any CON laws. Furthermore, states with high healthcare utilization due to COVID that reformed their CON laws during the pandemic saw a significant reduction in mortality resulting from natural death, Septicemia, Diabetes, Chronic Lower Respiratory Disease, Influenza or Pneumonia, and Alzheimer’s Disease in addition to reduction in COVID deaths.

Gitter, Donna M, ‘First Amendment Challenges to State Vaccine Mandates: Why the U.S. Supreme Court Should Hold That the Free Exercise Clause Does Not Require Religious Exemptions’ (2022) 71(6) American University Law Review 2243–2317
Abstract: The U.S. Supreme Court has never issued a judicial opinion on the merits declaring that the First Amendment Free Exercise Clause permits states to mandate vaccinations without offering religious exemptions. However, in two recent cases, the Court in brief orders declined applications for emergency relief to block state vaccine mandates, and the petitioners have vowed to continue to pursue these cases. This Article explores how the seemingly sudden onset of the coronavirus pandemic, coupled with its protracted duration, has occasioned both emergency and enduring state regulation of religious behavior in a way that exposes deep divides in our society’s views of the proper exercise of the state’s police powers to promote public health and safety, and of the protections afforded by the Free Exercise Clause. Part I of this article considers state vaccination jurisprudence in the United States, beginning with the seminal 1905 case of Jacobson v. Massachusetts, illustrating that federal and state courts have consistently deferred to states’ exercise of their police powers in mandating vaccination, and have held that states need not offer religious exemptions to vaccination. Part II of this article analyzes the two recent cases brought by health care workers who petitioned the Supreme Court for emergency relief from vaccine mandates. This Part focuses on the dissenting Justices’ view that a state must offer a religious exemption to vaccination if it offers a secular one. Part III explores how these dissenting justices developed their interpretation through cases relating to restrictions on religious gatherings, thereby changing Free Exercise jurisprudence significantly during the pandemic era. Finally, Part IV critiques the view that a state violates the Free Exercise Clause where it permits a secular but not a religious exemption to a state vaccine mandate, and explains how the Supreme Court can distinguish the cases concerning pandemic gatherings from cases involving vaccine mandates, so as to uphold state vaccine mandates as constitutional.

Giubilini, Alberto, Julian Savulescu and Dominic Wilkinson, ‘COVID-19 Vaccine: Vaccinate the Young to Protect the Old?’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa050
Abstract: When we have a vaccine against COVID-19, who should be vaccinated first? The question is relevant because, initially, vaccine availability will likely be limited. After healthcare and some other essential workers, it might seem the most obvious candidates are the elderly and other groups that are more vulnerable to the virus. However, we argue that this is not necessarily the case. Protecting the most vulnerable might require prioritizing vaccinating children in order to maximize the benefits of indirect immunity for the elderly and the other vulnerable groups. Whether this will be the best strategy from a public health perspective will depend on characteristics of the vaccine and of the virus, which are currently unknown. Here, we assess this possibility from an ethical point of view, by drawing comparisons and analogies with the case of the flu vaccination and with other examples of health policies and practices. We conclude that there are strong ethical reasons to vaccinate the young to protect the old, provided that the risks imposed on children are reasonable, even if that implies using children as a means to protect the elderly and the vulnerable.

Gleckel, Jareb A and Sheryl Wulkan, ‘Abortion and Telemedicine: Beyond COVID-19 and the Shadow Docket’ [2021] UC Davis Law Review Online (forthcoming)
Abstract: This Article examines the Supreme Court’s recent shadow docket opinion in FDA v. American College of Obstetricians and Gynecologists (ACOG)—not just its present effects, but its bigger-picture implications for the future of abortion jurisprudence. In FDA v. ACOG, the Court, without full briefing or argument, stayed a Maryland court’s injunction against the FDA. In doing so, it allowed the FDA to continue enforcing its ‘in-person requirement,’ forcing women to travel to pick up abortion medication during the COVID-19 pandemic. Parts I and II of this paper review the Court’s abortion jurisprudence and the opinion in FDA v. ACOG. Part II also suggests that FDA v. ACOG is inconsistent with the Court’s contemporaneous ‘shadow docket’ opinions—summary opinions that enjoined states’ restrictions on church gatherings during the pandemic. Part III then explores the impact that FDA v. ACOG could have on abortion jurisprudence in a post-pandemic world. We first speculate about a post-pandemic United States where the Court continues to recognize abortion as a constitutionally-protected right. We argue that, while ‘in-person requirements’ impede women seeking abortions, they also, ironically, make it harder for states to pass laws restricting access to abortion under contemporary case law. We then contemplate a parallel post-pandemic universe in which the Court overturns Roe v. Wade and stops recognizing the right to abortion. If the Court decides that abortion is not a fundamental right, as pro-choice liberals fear, it will be the in-person mifepristone requirements, or lack thereof, that determine the severity of that decision for many women in the United States. In a world without Roe, in-person requirements would maximally restrict women’s access to abortion.

Gold, Allyson E, Alicia Gilbert and Benjamin J McMichael, ‘Socially Distant Healthcare’ (2021) 96 Tulane Law Review (forthcoming)
Abstract: The COVID-19 pandemic has elucidated many problems within the American healthcare system, chief among them the continuing access-to-care issue. Though the Affordable Care Act increased access to health insurance, the current pandemic has demonstrated that health insurance is not enough. Communities need access to healthcare providers. Indeed, many fully insured Americans across the country are experiencing what many have face on a daily basis—the inability to access a healthcare provider. Rural areas and minority communities, in particular, regularly battle an inability to obtain care from healthcare professionals and have done so for many years. Much of the care demanded during the pandemic has been for COVID-19 itself, but the pandemic has also created access-to-care problems because of the quarantines and shut-downs instituted to slow its spread. These measures have prevented millions from receiving necessary care for chronic diseases, simple injuries, and mental health needs, among others. Despite the tragic consequences of the COVID-19 pandemic, one of the bright spots has been state and federal responses designed to increase access to healthcare providers. One of the most important mechanisms that governments have employed to increase access to care has been telehealth. Though telehealth has been possible for decades, the federal government and many state governments maintain salient legal barriers to its use. Congress recently considered Protecting Access to Post-COVID-19 Telehealth Act of 202, which seeks to remove some barriers to accessing telehealth. Against this backdrop of political hunger for continued improvement in telehealth access, this Article explores the policy experimentation catalyzed by the COVID-19 pandemic to make specific policy prescriptions aimed at alleviating both acute and chronic access-to-care issues. It argues that, following the pandemic, federal agencies and states should continue to dismantle barriers to telehealth as an important tool for increasing access-to-healthcare providers among residents of rural areas and minority communities that have historically lacked reliable access to providers. Importantly, governments at both levels should make permanent many of the temporary policies they have instituted to improve access to telehealth and, therefore, healthcare more generally.

Gold, Azgad, ‘Are Healthcare Workers Obligated to Risk Themselves during the COVID-19 Pandemic According to Jewish Law? A Response to Solnica et Al’ (2020) 46(11) Journal of Medical Ethics 736–737
Abstract: Solnica et al argue that ‘Jewish law and modern secular approaches based on professional responsibilities obligate physicians to care for all patients even those with communicable diseases’. The authors base their viewpoint on the opinion of Rabbi Eliezer Waldenberg and apply it to suggest that physicians are obligated to endanger themselves during epidemics, such as COVID-19. It is argued that Solnica et al’s analysis of Rabbi Waldenberg’s text and their conclusion that healthcare workers are obligated to endanger themselves while treating patient who suffer from contagious illness during epidemics according to Jewish law suffer from various shortcomings. Indeed, Jewish law looks favourably on healthcare workers who take a reasonable risk in treating their patients in the context of epidemics. However, it is considered a voluntary supererogatory act—not obligatory. Solnica et al may express a legitimate ethical viewpoint. However, it does not seem to represent the mainstream approach of what Jewish law would demand as obligatory from its practitioners.

Goldberg, Daniel S, ‘The Need for Historical Fluency in Pandemic Law and Policy’ [2024] Journal of the History of Medicine and Allied Sciences (advance article jrae009, published online 30 May 2024)
Abstract: The primary claim of this essay is that historical fluency is required for effective work in crafting legal and policy interventions as a part of public health emergency preparedness and response (PHEPR). At a broad level, public health law is explicitly recognized as a key systems-level component of PHEPR practice.1 This essay therefore focuses on the extent to which historical fluency is necessary or at least useful to all aspects of PHEPR that draw on or deploy legal and policy mechanisms (e.g., design, planning, implementation, dissemination, monitoring and evaluation, etc.). The essay collectively refers to these legal and policy mechanisms as epidemic law and policy response (ELAPR). Part I explains the concept of historical fluency. Part II explores the foundations of public health law both as a way of highlighting key structural features of ELAPR and in supporting the claim that historical fluency is critical for ELAPR. Part III applies the previous arguments to a specific case study to highlight the promise and power of historical fluency – the outbreak of bubonic plague in San Francisco in 1900. Tracking this essay’s pragmatic focus, part IV offers several recommendations for how specifically historical fluency in public health law and ethics can be operationalized in PHEPR practice and policy. Part V summarizes and concludes.

Goldberg, Richard, ‘Vaccine Damage Schemes in the US and UK Reappraised: Making Them Fit for Purpose in the Light of Covid-19’ (2022) 42(4) Legal Studies 576–599
Abstract: Vaccines have continued to play a crucial global role in preventing infectious diseases in the twenty-first century. The Covid-19 pandemic has underlined their importance, with vaccines seen as the best way to protect the public from coronavirus. A longstanding problem of governments has been the extent to which they should assume responsibility for the compensation of those injured by vaccines. This paper reappraises the vaccine damage schemes currently available in the US and UK in the light of the Covid-19 pandemic. It argues that any improvements to both US and UK schemes should be included in a revised national vaccine policy which takes into consideration their respective long-term national vaccine strategies to prepare for future pandemics. It supports the adoption of a UK-wide National Vaccine Injury Compensation Programme, similar to the one in the US, to be administered by the Secretary of State for Health and Social Care. To balance the need for rigorous criteria to determine causation with the need for fairness, the programme should adopt the US practice of allowing negotiated settlements between parties in circumstances where review of the evidence has not concluded that the vaccine(s) caused the alleged injury but there are close calls concerning causation.

Goldenfein, Jake, Ben Green and Salome Viljoen, ‘Privacy Versus Health Is a False Trade-OffJacobin 17 April 2020
Abstract: As tech firms team up with governments to fight the coronavirus pandemic, we’re being asked to accept a trade-off between our digital privacy and our health. It’s a false choice: we can achieve the public health benefits of data without accepting abusive and illicit surveillance.

Goldman, Matthew L et al, ‘Mental Health Policy in the Era of COVID-19’ (2020) 71(11) Psychiatric Services 1158–1162
Abstract: The response to the global COVID-19 pandemic has important ramifications for mental health systems and the patients they serve. This article describes significant changes in mental health policy prompted by the COVID-19 crisis across five major areas: legislation, regulation, financing, accountability, and workforce development. Special considerations for mental health policy are discussed, including social determinants of health, innovative technologies, and research and evaluation. These extraordinary advances provide an unprecedented opportunity to evaluate the effects of mental health policies that may be adopted in the post–COVID-19 era in the United States.

Gostin, Lawrence O, ‘Global Health Security in an Era of Explosive Pandemic Potential’ (2019) 14(1) Asian Journal of WTO & International Health Law and Policy 267–285
Abstract: Pandemics pose a significant risk to security, economic stability, and development. Annualized expected losses from pandemics are estimated at $60 billion per year. Despite the certainty and magnitude of the threat, the global community has significantly underestimated and underinvested in preparing for pandemic threats.We cannot wait or continue with the status quo, in which we pay attention to infectious disease threats only when they are at their peak and then are complacent and remain vulnerable until the next major outbreak. To reinforce and sustain international focus, funding, and action, it is crucial that pandemics rise to the level of ‘high politics,’ becoming standing agenda items for political actors.I make the case for fundamental reform of the international system to safeguard global health security. I propose an action agenda for rapid detection and response to dangerous infectious diseases. If my action plan were adopted, it would safeguard the global population far better against infectious disease threats. It would reap dividends in security, development, and productivity.

Gostin, Lawrence O, ‘Judicial Trends in the Era of COVID-19: Public Health in Peril’ (2023) 113(3) American Journal of Public Health 272–274

Gostin, Lawrence O, I Glenn Cohen and Jeffrey P Koplan, ‘Universal Masking in the United States: The Role of Mandates, Health Education, and the CDC’ (2020) 324(9) JAMA 837–838
Abstract: The Centers for Disease Control and Prevention (CDC) recommends cloth face coverings in public settings to prevent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19). Face coverings decrease the amount of infectious virus exhaled into the environment, reducing the risk an exposed person will become infected. Although many states and localities have ordered mask use, considerable variability and inconsistencies exist. Would a national mandate be an effective COVID-19 prevention strategy, and would it be lawful? Given the patchwork of state pandemic responses, should the CDC have enhanced funding and powers to forge a nationally coordinated response to COVID-19 and to future health emergencies?

Gostin, Lawrence O, Eric Friedman and Sarah Wetter, ‘Responding to COVID‐19: How to Navigate a Public Health Emergency Legally and Ethically’ (SSRN Scholarly Paper No ID 3579094, 26 March 2020)
Abstract: Widespread social separation is rapidly becoming the norm, including closure of schools and universities, tele-commuting to work, bans on large gatherings, and millions of people isolated in their homes or make-shift facilities. Bans on international travel are already pervasive. Domestic travel restrictions are exceedingly rare, but now within the realm of possibility. Officials are even discussing cordon sanitaires (guarded areas where people may not enter or leave), popularly described as ‘lockdowns’ or mass quarantines. When the health system becomes stretched beyond capacity, how can we ethically allocate scarce health goods and services? How can we ensure that marginalized populations can access the care they need? What ethical duties do we owe to vulnerable people separated from their families and communities? And how do we ethically and legally balance public health with civil liberties?

Gostin, Lawrence O, Safura Abdool Karim and Benjamin Mason Meier, ‘Facilitating Access to a COVID-19 Vaccine through Global Health Law’ (2020) 48(3) The Journal of Law, Medicine & Ethics 622–626

Gostin, Lawrence O and Daniel A Salmon, ‘The Dual Epidemics of COVID-19 and Influenza: Vaccine Acceptance, Coverage, and Mandates’ (2020) 324(4) Journal of the American Medical Association (JAMA) 335–336
Abstract: The confluence of coronavirus disease 2019 (COVID-19) and seasonal influenza this fall and winter will result in considerable morbidity and mortality, stressing the health system. With more than 100 000 COVID-19–related deaths already, the US could see a second wave of disease later this year. In 2018-2019 (a ‘moderate’ year for influenza), the US experienced 35.5 million influenza cases, with 490 600 hospitalizations and 34 200 deaths related to influenza.1 An effective COVID-19 vaccine is unlikely until 2021. Even though seasonal influenza vaccines have variable year-to-year effectiveness, they can significantly reduce morbidity and mortality, especially with high coverage.The health system, and wider society, must prepare for the likelihood of co-epidemics of COVID-19 and influenza. What are the most effective strategies for increasing influenza vaccine coverage across the population and particularly in schools, businesses, and hospitals? Should states or businesses require vaccinations? Influenza vaccination, moreover, could offer valuable lessons for ensuring vaccine acceptance and uptake when COVID-19 vaccines become available.

Gostin, Lawrence O, Daniel A Salmon and Heidi J Larson, ‘Mandating COVID-19 VaccinesJournal of the American Medical Association (JAMA) E1-E2 (published online 29 December 2020)
Abstract: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities. Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December 8, 2020 found that when a COVID-19 vaccine is approved and widely available: 34% would get it as soon as possible; 39% would wait; 9% would only get it if required for work/school; 15% would definitely not get it. Black persons, at high risk of infection and hospitalization, are less likely to report vaccine intent with only 20% reporting they would get the vaccine soon and 52% intending to wait. Intent to vaccinate has changed substantially over time and is likely to evolve. In this JAMA Viewpoint, we examine whether vaccine mandates would be lawful and ethical, and whether they could boost vaccine uptake.

Göttert, Elena Ana Francesca, ‘What Is Fair? Ethical Analysis of Triage Criteria and Disability Rights during the COVID-19 Pandemic and the German Legislation’ [2023] Journal of Medical Ethics (advance article)
Abstract: This essay discusses the ethical challenges and dilemmas in allocating scarce medical resources during the COVID-19 pandemic, using the German legislative process as a starting point. It is guided by the right to non-discrimination of people with disability and generally contrasts utilitarian and rights-based principles of allocation. Three approaches that were suggested in the German discussion, are presented, the lottery principle, the first come first served principle and the probability to survive principle. Arguments in favour and against each principle are discussed. The focus is on the utilitarian probability to survive principle, which was adopted in German legislation in 2022, and its discriminatory potential against people with disability. The essay suggests ways to mitigate the concerns of discrimination related to the probability to survive principle. It concludes that resolving the triage dilemma requires a balanced approach between utilitarian and rights-based concerns, which promotes both maximising the number of patients surviving and the right not to be discriminated against and be treated equally. It calls for a further debate on how many ethical values such as equity, fairness and non-discrimination we are willing to sacrifice for a higher number of survivors and when we are willing to sacrifice survivors to secure ethical values.

Gowd, Kiran Kumar, Donthagani Veerababu and Veeraiahgari Revanth Reddy, ‘COVID-19 and the Legislative Response in India: The Need for a Comprehensive Health Care Law’ (2021) Journal of Public Affairs Advance article No e2669, published 21 March 2021
Abstract: The outbreak of the SARS CoV2 virus, commonly referred to as the COVID-19 pandemic, has impacted the social, economic, political, and cultural lives of citizens around the world. The sudden outbreak of the pandemic has exposed the legal preparedness, or lack thereof, of governments to reduce and contain its drastic impact. Strong legislative measures play a crucial role in any epidemic or pandemic situation. In this situation, the Indian Government has requested all state governments to invoke the Epidemic Disease Act (EDA) of 1897 to address the COVID-19 emergency. The Central Government has also used the powers provided in the Disaster Management Act (DMA) of 2005. As the country is facing its first major health emergency since independence, the existing legislative measures to deal with a COVID-19 like situation are lacking and require certain amendments to address such situations in the future. This paper aims to present the current constitutional and legislative response to health emergencies in India and attempts to identify gray areas in the statutory provisions. Based on the analysis, this paper suggests several recommendations for amending current legislation and suggests the promulgation of comprehensive public health law. This paper is largely based on primary sources such as the EDA and the DMA, regulations, guidelines, rules issued by the public authorities and court cases related to health and health emergencies along with secondary resources such as newspaper articles and published papers.

Greely, Henry T, ‘COVID-19 Immunity Certificates: Science, Ethics, Policy, and Law’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa035
Abstract: There is much discussion of adopting COVID-19 immunity certificates to allow those proven to have antibodies to the SARS-CoV-2 virus that causes COVID-19 to resume normal life and help restart the economy. This article points out issues that must be considered before adopting any such program. These issues fall into six categories: the uncertain science of COVID-19 immunity; the questionable quality of COVID-19 antibody tests; practical problems with issuing such certificates; deciding how the certificates might be used; ethical and social issues they would raise, especially fairness and self-infection; and potential legal barriers. It does not ultimately take a position on whether some narrow COVID-19 immunity plans should be adopted, concluding that the answer depends on too many currently unknown conditions. But its seventh part makes recommendations to decision-makers who might consider implementing such programs.

Greer, Scott and Anniek de Ruijter, ‘EU Health Law and Policy in and after the COVID-19 Crisis’ (2020) 30(4) European Journal of Public Health 623–624
Abstract: The very first shock of COVID-19 might beover, but the crisis continues. We have already learned much about what the European Union can and cannot do to help it

Grey, Betsy, ‘Against Immunizing Nursing Homes’ [2021] The University of Chicago Law Review Online (advance article, published 8 July 2021)
Abstract: Nursing homes and other long-term care facilities account for approximately one third of the over 500,000 Covid-19 deaths in the United States. Facing liability from that widespread harm, the facilities have sought immunity protection from tort liability. In particular, they have sought protection under the federal Public Readiness and Emergency Preparedness (PREP) Act, which is designed to extend immunity from liability claims arising from various Covid-19 countermeasures developed and used during the pandemic. Importantly for this essay, the lawsuits filed against nursing homes have centered on their failure to take mitigation measures, rather than on harm from their affirmative use of mitigation measures. Initially, courts held that PREP Act immunity does not apply to these failure-to-act claims. In the waning days of the Trump Administration, however, HHS issued an opinion that (together with other HHS statements) interprets the statute otherwise, broadening immunity even to cover the failure to take mitigation measures. That interpretation has been followed by at least one federal district court. This essay questions the wisdom of HHS’s opinion. It argues that it misreads the words and purpose of the PREP Act’s immunity provisions, and undermines accountability of the nursing home industry, creates the wrong incentives for the industry, and may leave victims without any compensatory remedy. This issue should reach appellate courts soon. If the interpretation continues to be followed by the courts, then the Biden Administration should rescind the opinion so that tort law may continue to protect one of society’s most vulnerable populations.

Griffith, Richard, ‘Using Public Health Law to Contain the Spread of COVID-19’ (2020) 29(5) British Journal of Nursing 326–327
Abstract: Richard Griffith, Senior Lecturer in Health Law at Swansea University, considers what powers are available to ministers, health and local authorities to minimise the spread of the novel coronavirus and the disease it causes [ABSTRACT FROM AUTHOR]

Grobler, C, ‘COVID-19: Mental Health and Clinical Equipoise in the Face of Moral Injury’ (2020) 13(1) South African Journal of Bioethics and Law 21–22
Abstract: The COVID-19 pandemic may result in ‘moral injury’ and mental illness to health care workers (HCWs). Resources may at some point run out and situations may arise where difficult ethical decisions need to be made. Properly preparing staff for the job and the associated challenges reduces the risk of moral injury and mental health problems. Under conditions of information overload and uncertainty-related anxiety such as with the COVID-19 pandemic, doctors may stop acting with clinical equipoise and make cognitive errors. These circumstances require doctors to be the voice of reason and lead by example. Doctors must reason critically, be aware of the biases that may influence thinking processes and critically appraise evidence in deciding how to treat patients. Health care systems must address the stress of HCW’s by continuously monitoring reactions and and creating mechanisms to offer psychosocial support.

Guastella, Virginie et al, ‘Withholding or Withdrawing Life-Sustaining Treatments in the COVID-19 Pandemic: Adherence to Legal Standards’ [2023] BMJ Supportive & Palliative Care (advance article, published online 3 August 2023)
Abstract: In France, when the patient is unable to express his wishes, the decision to withhold or withdraw life-sustaining treatment (WWLST) is made following a collegial procedure described by a law. The aim of our study was to assess how closely this WWLST decision-making procedure in end of life patients was maintained during the COVID-19 pandemic. In France, more than half of WWLST decisions do not comply with the law. The COVID-19 pandemic did not increase this non-compliance rate. Further studies are needed for a better understanding of the mechanisms underlying non-compliance with WWLST decision-making procedure.

Gulati, Gautam and Brendan D Kelly, ‘Domestic Violence against Women and the COVID-19 Pandemic: What Is the Role of Psychiatry?’ (2020) 71(July-August) International Journal of Law and Psychiatry: Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus) Article 101594
Abstract: A heightened risk of domestic violence has been associated with infection-reducing measures undertaken by governments during the COVID-19 pandemic. Psychiatric services can play a key role in addressing this issue by (a) addressing certain risk factors for perpetration of domestic violence through, for example, assertive identification and management of substance misuse; (b) providing support, advocacy and treatment services for victims of domestic violence; and (c) multi-agency working to strengthen medical and social responses to domestic violence. At a time like this, it is important that multi-disciplinary mental health services are strengthened, rather than depleted, in order to address the pressing issues at hand.

Gunder, Jessica R and Lauren Ballenger, ‘COVID-19 Vaccine Scarcity and Prioritization’ (SSRN Scholarly Paper ID 3908231, 19 August 2021)
Abstract: Over the initial months of the vaccine rollout, demand for COVID-19 vaccines exceeded supply. Although the CDC issued data-based guidance for how to prioritize access to the vaccines, it was non-binding, and many state and local governments set different priorities. This Article documents the different prioritizations set by the 64 different local health authorities – or ‘jurisdictions’ – that received COVID-19 vaccines through the CDC’s program. These jurisdictions consisted of all 50 states, the District of Columbia, five large cities (Chicago, Houston, New York City, Philadelphia, and San Antonio), along with American Samoa, Guam, Marshall Islands, Micronesia, Northern Marina Islands, Palau, Puerto Rico, and the United States Virgin Islands. Many of these jurisdictions changed their vaccine prioritizations mid-course. The following tables reflect those changes and show how the COVID-19 vaccine was distributed to individuals aged 16 and older in each jurisdiction.

Gunnarsdóttir, Hrefna D et al, ‘Applying the Proportionality Principle to COVID-19 Antibody Testing’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa058
Abstract: As the COVID-19 pandemic continues to ravage the globe, many nations have started to relax stringent restrictions in an effort to restart the economy. While Member States of the European Union have approached reopening without the use of antibody testing for COVID-19, such testing may be central to a long-term, sustainable strategy for international travel, employment, and the allocation and monitoring of vaccines. As the use of antibody testing to dictate the enjoyment of individual freedom remains highly controversial, we describe its use in the context of three case studies (return to the workplace, travel and vaccination), applying the substantive legal balancing entailed in the proportionality principle. Differential treatment of individuals based on COVID-19 antibody test results can be justified through the proportionality principle, which offers a sound dividing line between a reasonable and legitimate response and an unjust and discriminatory response.

Gur-Arie, Rachel, Zackary Berger and Dorit Rubinstein Reiss, ‘COVID-19 Vaccine Uptake Through the Lived Experiences of Health Care Personnel: Policy and Legal Considerations’ (2021) 5(1) Health Equity 688–696
Purpose: To investigate whether coronavirus disease 2019 (COVID-19) vaccination campaigns targeted at health care personnel (HCP) in the United States have addressed the lived experiences of HCP on the frontlines of the COVID-19 pandemic and to analyze policy and legal considerations for improving COVID-19 vaccine uptake among HCP.
Methods: We conducted a literature and policy review to explore the lived experiences of different occupational groups of HCP on the frontlines of the COVID-19 pandemic—physicians, nurses, trainees, and nonclinical essential workers—in relation to ongoing COVID-19 vaccination campaigns. Finally, we discuss policy and legal considerations to improve the state of HCP COVID-19 vaccine uptake as the pandemic progresses.
Results: COVID-19 vaccination campaigns have not achieved consistent high uptake among HCP for many reasons, including vaccine hesitancy, personal, professional considerations, and equity-rooted challenges.
Conclusion: HCPs lived experiences during the COVID-19 pandemic reveal meaningful impediments to their COVID-19 vaccine uptake. We suggest that health care systems minimize inequity inherent in existing vaccination campaigns by providing financial and social support to HCP to raise HCP COVID-19 vaccine uptake.

Gutiérrez Silva, Rodolfo, ‘Judicial Protection of the Right to Health in the Context of Covid-19 and Populism in Brazil’ (2023) 2023(178) Médecine & Droit 13–19
Abstract: The Covid-19 pandemic has brought new challenges to the health systems of Latin America. However, the institutions and mechanisms created by the Social State of Law were unable to confront these new risks. As a result of that, populist governments have used this crisis as an opportunity to deepen the high levels of inequalities through the appropriation of power, wealth and social welfare. Courts have also reacted in order to guarantee the right to health; however, many challenges remain. There is an inversely proportional relationship between the intensity of the crisis and the level of judicial activism on the part of the Courts. Therefore, the more the scale and intensity of the crisis generated by populist governments in the context of pandemics, uncertainty, and inequality the more reflexive, and strategic courts should be and the more protection, defense and monitoring should be promoted in order to ensure the fulfilment of the right to the highest attainable level of health especially of the most vulnerable. On the other hand, the more compliance through the availability of health goods and services, and the more availability of health workers with better salaries, social security and working conditions the more resilient the State will be to face emergencies, which at the same time will promote fewer restrictions on fundamental rights. Courts play a special role in protecting the right to health, especially in the context of emergencies and crises. States must adopt measures by using the maximum available resources in order to protect the right to the highest attainable standard of health.

Gutorova, Natalia Oleksandrivna, Yuliia Yuriivna Zabuha and Tetiana Oleksandrivna Mykhailichenko, ‘Legal Issues of Epidemic Safety Due to the Pandemic COVID-19 and the War in Ukraine’ in The European Dimension of Modern Legal Science (Baltija Publishing, 2022) 181–205
Abstract: The experience of fighting the COVID-19 pandemic has shown how vital epidemic safety is for each country. Furthermore, it is not just about saving the lives and health of millions of people. The economic crisis engulfed the whole world. At the same time, we had a crisis in the tourism sector, restricting access to proper and quality education and temporarily restricting freedom of movement. The restrictions on human rights and freedoms were significant, and many countries introduced them in violation of the law. With the increase in the number of mental and psychiatric diseases, the following problems of economic character are a partial list of the negative consequences of this pandemic. In order to prevent these consequences or reduce them to a minimum, the state must have a properly developed system of measures to contain the epidemic and pandemic. That is why they especially need proper legal regulation. This study is devoted to issues that arise precisely at the last (third) level of legal regulation of epidemic safety, when, as a result of an epidemic or pandemic, the state must declare a state of emergency. In addition, Ukraine has a large-scale war, started by the Russian Federation on February 24, 2022, and martial law. These, as well as many other factors, indicate an even more significant deterioration in the country is already the somewhat unfavorable epidemic situation, which determines the relevance of the chosen topic.

Guy, Mary, ‘(How) Is COVID-19 Reframing Interaction between the NHS and Private Healthcare?’ (2023) 23(2) Medical Law International 138–158
Abstract: In March 2020 a ‘major deal’ was struck between the National Health Service (NHS) and private healthcare sector to facilitate ‘crisis’ and ‘continuity’ responses to COVID-19. A further deal was struck in January 2022 to support the NHS in tackling the Omicron variant, suggesting that the pandemic was evolving, rather than definitively over. The legal basis for these deals was a Public Policy Exclusion Order, a temporary relaxation mechanism in UK competition law defined by a ‘disruption period’. In a global pandemic, the ‘healthcare disruption period’ might be considered to be of a different scope and nature to short-term disturbances experienced in other sectors, such as groceries. This article examines the Public Policy Exclusion Orders issued in respect of health services in England and Wales, and the Collective Agreements notified under these between March 2020 and March 2021, and again in March 2022. Amid ongoing tensions surrounding ‘NHS privatisation’, this enables a timely analysis of whether the underlying relationship between the NHS and private healthcare may be changing in response to COVID-19, and how considerations of ethical frameworks are also relevant to this aspect of the pandemic response.

Haddow, Kim et al, ‘Preemption, Public Health, and Equity in the Time of COVID-19’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 71–76
Abstract: Preemption is a legal doctrine that allows a higher level of government to limit or eliminate the power of a lower level of government to regulate a specific issue. As governments seek to address the myriad health, social, and economic consequences of COVID-19, an effective response requires coordination between state and local governments. Unfortunately, for many localities, the misuse of state preemption over the last decade has increased state and local government friction and weakened or abolished local governments’ ability to adopt the health- and equity-promoting policies necessary to respond to and recover from this crisis. The broad misuse of preemption has left localities without the legal authority and policy tools needed to respond to the pandemic. Existing state preemption of paid sick leave, municipal broadband, and equitable housing policies, for example, forced local governments to start from behind. Moreover, many state executive orders issued in response to COVID-19 outlawed local efforts to enact stronger policies to protect the health and wellbeing of communities. And, preemption in the time of COVID-19 has exacerbated the health and economic inequities affecting people of color, lowwage workers, and women. Conflict between state and local governments has cost lives, delayed effective responses, and created confusion that continues to undermine public health efforts. The new coronavirus pandemic has made it clear that the overwhelming majority of state preemption occurring today harms public health efforts and worsens health inequities. The crisis also has underscored the need to reform and rebalance the relationship between states and local governments.

Hafrida, Hafrida, Helmi Helmi and Retno Kusniati, ‘Health Workers’ Legal Protection Policy to the Coronavirus Disease 19 (Covid-19) Containment Measures’ (2021) 15(1) Fiat Justisia: Jurnal Ilmu Hukum 51–74
Jurisdiction: Indonesia
Abstract: This research aims to analyze protection policies for health workers amidst COVID-19. Through statute approach and based on the rights theory, this study examines legal development, or legal framework is needed to formulate and to protect health worker. Since the COVID-19 outbreak spreads quickly and massively, Health worker is at the forefront of handling COVID-19, but they are also vulnerable to get infected by the virus. Some cases showed that many health workers tested positive after providing health services. The findings of the research showed that the right of medical workers to get personal protective equipment and safety guarantees were not enough to protect them. On the other hand, the community was still ignoring the risk of this disease and broke the health protocol in the public place. Health workers can perform their job effectively if people are in healthy condition and do not need to go to the hospital. To containment measures of the COVID-19 State has to choose one of the effective ways to protect people and health workers by regulating and giving a penalty to the perpetrators of the COVID-19 protocol.

Haggai, Yoga Khirari, Erikson Aritonang and Pandini Riata M, ‘Legal Protection of Hospital Patients in the Corona Virus Pandemic Period’ (2020) 1(4) Journal La Sociale 18–25
Abstract: This study aims to explain the legal protection for patients during the Covid-19 pandemic and the protection mechanism for patients as consumers. This research used doctrinal research. Basically, health development involves all aspects of life, physical, mental and socio-economic. In the growth of health development so far, there has been a change in orientation, both value ​​and thought, especially regarding effort to solve problem in the health sector which are influenced by politic, economic, socio-cultural, defence and security as well as science and technology. The change of orientation will affect the implementation process of health development. Health development, which is basically the responsibility of the state, becomes very important because the private sector also participates in creating a product in the health sector. This society is generally referred to as consumer. Indonesia and all over the world are currently in a pandemic of the Covid-19 virus, where the virus is spreading so fast. Not yet found anti-virus against this virus, the only way is that everyone is obliged to maintain immunity in the body. But it is very unfair for other patients, currently the focus of medical personnel and hospital is to deal with the Covid-19 outbreak, so that the rights of other patients cannot be fulfilled.

Haider, Kulsum, ‘Mental Health as a Protected Legal Right during Covid-19’ (2022) 3(1) Jus Corpus Law Journal 45–60
Abstract: In proper understanding, health is a state of well-being that includes physical, mental, and social health and not merely the absence of any disease or infirmity. When we talk about legal rights, we tend to protect our health through national and international legislation being part of fundamental, human, and statuary rights. The ongoing pandemic due to COVID-19 (Corona Virus Disease- 2019) has posed several challenges in our country. It has affected people’s physical and mental health with many issues and challenges that the researchers in the paper have discussed through doctrinal work. It is rightly said that good health cannot be without mental health. The strain of COVID-19 has disproportionately affected people with pre-existing mental illnesses and those who have developed later. It has affected the health of people around the world and had an uncontrolled impact on people’s mental health. The research on the mental health aspect due to COVID-19 is lacking for several reasons. The researchers have highlighted those issues and the issues affecting the legal rights of people with mental illness during the COVID-19 pandemic, which can act as a resource for further study. The researcher has recommended making a resource study on mental health issues during the pandemic as there is a lack of study.

Halabi, Sam, Michelle Rourke and Rebecca Katz, ‘The Effect of Proprietary and Attribution Claims on Data Sharing During Infectious Disease Emergencies’ (2021) 23(2) Journal of Health Care Law & Policy 203–226
Abstract: The article examines the effects of proprietary and attribution claims on data sharing during infectious disease emergencies like the COVID-19 pandemic. Also cited are how commercial and scientific proprietary claims have hindered critical data sharing during emergencies, and the administrative, ethical, technological, regulatory and cultural factors affecting data sharing during public health emergencies.

Halabi, Sam et al, ‘No-Fault Vaccine Injury Compensation Systems Adopted Pursuant to the COVID-19 Public Health Emergency Response’ (2022) 37(1) Emory International Law Review 55
Abstract: No-fault vaccine injury compensation systems have developed over the course of the twentieth century, mostly in the richest countries in the world. Acknowledging that severe reactions to vaccines are rare, but can result in serious and sometimes complex injury, these systems provide financial and social support for those suffering these rare side effects. During the COVID-19 pandemic, and the rapid development and deployment of vaccines using novel technologies, these systems have proliferated not only among wealthy countries, where in their modern form they originated and spread, but also low- and middle-income ones. Adopting varying approaches to funding, eligibility, administration, process, and components of compensation and rights of appeal, these new systems offer protections to populations in low- and middle-income countries that until 2020 covered only those in relatively wealthy states, especially Europe and North America. The purpose of this Article is twofold. First, it provides the first comprehensive landscape analysis of no-fault vaccine injury compensation systems since before the COVID-19 pandemic. That analysis identifies twenty-five such systems, almost all of which were established for routine immunizations. Second, it provides an accessible resource for advocates and planners in low- and middle-income countries that may benefit from an analysis of administrative, funding, eligibility, and compensation alternatives that they may consult when considering whether and how to construct their own no-fault vaccine injury compensation systems.

Handfield, Robert B et al, ‘A New Acquisition Model for the next Disaster: Overcoming Disaster Federalism Issues through Effective Utilization of the Strategic National Stockpile’ (2024) 84(1) Public Administration Review 65–85
Abstract: Using primary data collected from interviews with federal and state government officials and secondary data related to PPE distribution and state healthcare statistics, we discovered evidence that the use of the Strategic National Stockpile (SNS) to distribute personal protective equipment to state and local agencies in need during the height of COVID-19 was indeed poorly designed to cope with the COVID-19 emergency, leaving many states with shortages of badly needed medical supplies. As a result, many states struggled to organize an uncoordinated procurement response—which we suggest is due to federalism issues. To overcome federalism challenges and increase future disaster preparedness, we recommend four necessary reforms to the SNS that include (1) the incorporation of uncompensated industry experts into SNS administration, (2) the provision of an emergency production board for times of crisis, (3) elevated political leadership for the SNS, (4) improvement of federal-state supply chain governance.

Hansmann, Lisa and Ganesh Sitaraman, ‘Designing an Interstate Compact for a Pandemic Testing Board’ (Vanderbilt Law Research Paper No 20–41, 2020)
Abstract: Analysts have recently focused their attention on two pathways for the United States to reopen prior to the development of a vaccine for COVID-19. The first is to accept a series of rolling openings and closings: reopening as infection rates decrease, then reclosing as they rise again due to increased interac- tions. This approach is generally thought to be enormously costly economically and socially, as people will be kept in their homes and commerce restrained for considerable amounts of time. The second approach is to massively ramp up the production of testing, either through a universal testing regime (which would require capacity to test all 300+ million Americans every week or two) or a system of testing, tracing, and supported isolation (which would require testing 5 million Americans a day, plus tracing those who were in contact with the infected and isolating them). The testing pathway would enable the United States to reopen without having to close repeatedly and it would, as a result, save billions of dollars.The problem is that we do not have the number of tests necessary to pursue a testing pathway to reopening. Scaling up testing presents a variety of challenges -- including supply of the underlying materials within the supply chain; coordination problems that link supply to demand; and personnel and plans for how to deploy millions of tests per day. One solution to these challenges, which the Harvard Roadmap for Pandemic Resilience has outlined, is to establish a single coordinating body—a Pandemic Testing Board—to be tasked with ensuring the necessary supply of tests, deploying those tests, and facilitating a tracing program. There are two ways to design this body. It could be a federal government institution, part of the Executive Branch. Or it could be built through an interstate compact, with federal appropriations but not federal administration. This paper offers a blueprint for how to design a pandemic testing board via an interstate compact.

Harel, Alon, Alon Klement and Eyal Klement, ‘Regulated Voluntary Exposure to the COVID-19 Virus: Welfare and Ethical Analysis’ (SSRN Scholarly Paper No ID 3697209, 22 September 2020)
Abstract: This Essay examines the societal and ethical implications of a regulated voluntary exposure strategy for addressing the COVID-19 pandemic crisis. Under the proposed strategy the state would allow healthy and young individuals to voluntarily expose themselves to the virus and thus get immunized against future infection. These individuals would be certified as immune, and then be allowed to return to lead normal life without risking others. This strategy would reduce the time for bringing about herd-immunity, and would also reduce overall mortality and demand for the health care system. We show that under certain conditions the voluntary exposure strategy is welfare enhancing and Pareto-superior to any other strategy. We then examine the proposal’s ethical implications and discuss potential concerns relating to the voluntariness of program participants, and to the proposal’s allocative and redistributive implications. We show that objections to the proposal by-and-large rest on ‘the Nirvana fallacy’, which compares a perfect (and, consequently, unrealistic) world in which there is no voluntary exposure with the imperfect world in which voluntary exposure is encouraged.

Harmon, Shawn and David Faour, ‘Immunization Governance Challenges Exposed by Covid-19: Missing Standards in Vacccine Surveillance and Adverse Events Following Immunization (AEFIs)’ (2021) 49(3) Georgia Journal of International & Comparative Law 533–562
Extract from Introduction: We begin by briefly outlining the vaccine development and safety ecosystem in Canada, identifying its key stages and mechanisms. We then explore in more detail two elements of that ecosystem. First, we examine the market authorization stage, focusing on how it was used in response to COVID-19. We argue that the manner in which it has functioned, both generally and throughout the COVID-19 pandemic, exhibits a systemic operational weakness, being a lack of sufficient and appropriate transparency. Second, we explore the post-deployment or clinical surveillance stage, arguing that its mechanisms aimed at identifying and reporting ‘adverse events following immunization’ (AEFIs) are characterized by an improper absence of standards, signifying design shortcomings. These shortcomings have been accentuated by the COVID-19 pandemic, and could, in turn, undermine actions taken in response to the COVID-19 pandemic.

Haron, Hafidz Hakimi, Nadiah Arsat and Muhammad Ashraf Fauzi, ‘Covid-19 Vaccine Hesitancy in Malaysia: Challenges Within the Law and Way Forward’ (2023) 31(1) IIUM Law Journal 261–286
Abstract: For hundreds of years, vaccines have been a critical tool in the prevention of viral diseases. Vaccination programmes have gained prominence as one of the primary strategies for combating the COVID-19 pandemic. Despite this, COVID-19 vaccination programmes have frequently been viewed negatively by many. This is evident by the fact that vaccine hesitancy continues to grow at an unprecedented rate which is much facilitated by the rapid growth of communication and information technology. Despite the fact that vaccines and vaccinations are considered medical products, the difficulties they present are socio-legal in nature. The study examines four major factors that contribute to COVID-19 vaccine hesitancy in Malaysia namely compulsory vaccination and adverse event following vaccination (AEFI), information disclosure, misleading religious beliefs and sentiments, and misinformation and disinformation. It should be noted that, the identification and discussion of the factors mentioned above are vital as the failure of any future vaccination campaigns resulting from vaccine hesitancy would pose a huge threat to achieve the United Nations’ Sustainable Goals (UNSDG), especially in respect of good health and sustainable economic growth. Therefore, for the purpose of this research, the paper adopts qualitative research approach to achieve its objectives. The paper recommends that the Malaysian vaccination legal framework be strengthened.

Harrington, John, Barbara Hughes-Moore and Erin Thomas, ‘Towards a Welsh Health Law: Devolution, Divergence and Values’ (2021) 72(S1: Supplementary Issue on COVID-19) Northern Ireland Legal Quarterly 62–90
Abstract: COVID-19 and Brexit have given political impetus to re-examine Wales’s place within the United Kingdom’s devolution settlement. Health has been a key site for divergence in law and policy as between the administrations in Cardiff and London. In light of these contests, and the longer-running trends in devolution, this article considers whether a distinct ‘Welsh’ health law has now emerged. We examine the constitutional context and the range of sources for this new legal field. We argue that a set of values can be identified through an attentive reading of the legislative output of the Welsh Parliament, through reflection on the policy development of health in Wales, through the devolution process. While accepting that these are varied and heterogeneous, these values are as much an expression of universal ethical goals as they are of any delineable Welsh essence. No mere summation of positive law, these values allow one to define a distinctive realm of Welsh health law, have the potential to act as an interpretative lens for analysing law and policy flowing from Westminster, and could potentially act as a value structure for further Welsh legislation.

Harris, Curtis E, ‘The Conflict of Public Health Law and Civil Liberties Part III: A Myriad of Partially Effective Attempts to Mitigate COVID-19’ [2023] The American Journal of Medicine (advance article, published online 22 September 2023)
Abstract: Over the last three years, various nations have responded in remarkably different ways to the enforcement of various Public Health laws, each thought at the time to be effective measures to prevent the spread of the disease. For example, China made violation of mandatory masking and quarantine rules subject to criminal enforcement, while the Netherlands generally had few restrictions on public gatherings. The policies in the United States were a hodgepodge of rules and laws, based largely on the response of each State to the recommendations of the Center for Disease Control (CDC) and the recommendations of the various State Departments of Public Health. Because of the widely variable attempts in many nations to slow the spread of COVID-19, it is now possible to study which measures were or were not effective.

Harris, John, ‘Why Kill the Cabin Boy?’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 4–10
Abstract: The task of combatting and defeating Covid-19 calls for drastic measures as well as cool heads. It also requires that we keep our nerve and our moral integrity. In the fight for survival, as individuals and as societies, we must not lose our grip on the values and the compassion that make individual and collective survival worth fighting for, or indeed worth having.1

Hartini, Tri, ‘Legal Policy of Protection COVID-19 Patients in Hospitals’ (2022) 2(1) Journal of Human Rights, Culture and Legal System 45–57
Abstract: The government has issued a number of measures in response to Covid-19, but these policies do not ensure patient rights as defined by the constitution. This is a juridical-normative study with a focus on legislation. The results indicated that legal protection for Covid-19 patients at home was accomplished in three ways: first, through civil legal remedies based on civil provisions; second, through criminal legal remedies based on medical practice; and third, through legal administration efforts that can be reported to the Council. Indonesian Medicine and the Honorary Council of Indonesian Medical Disciplines The rules and regulations controlling the protection of the law have an effect on the legal protection of patients; they compel health workers delivering health services to respect applicable laws and regulations.

Häyry, Matti, ‘The COVID-19 Pandemic: A Month of Bioethics in Finland’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 114–122
Abstract: The role of bioethicists amidst crises like the COVID-19 pandemic is not well defined. As professionals in the field, they should respond, but how? The observation of the early days of pandemic confinement in Finland showed that moral philosophers with limited experience in bioethics tended to apply their favorite theories to public decisions, with varying results. Medical ethicists were more likely to lend support to the public authorities by soothing or descriptive accounts of the solutions assumed. These are approaches that Tuija Takala has called the firefighting and window dressing models of bioethics. Human rights lawyers drew attention to the flaws of the government’s regulative thinking. Critical bioethicists offered analyses of the arguments presented and the moral and political theories that could be used as the basis of good and acceptable decisions.

Häyry, Matti, ‘The COVID-19 Pandemic: Healthcare Crisis Leadership as Ethics Communication’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 42–50
Abstract: Governmental reactions to crises like the COVID-19 pandemic can be seen as ethics communication. Governments can contain the disease and thereby mitigate the detrimental public health impact; allow the virus to spread to reach herd immunity; test, track, isolate, and treat; and suppress the disease regionally. An observation of Sweden and Finland showed a difference in feasible ways to communicate the chosen policy to the citizenry. Sweden assumed the herd immunity strategy and backed it up with health utilitarian arguments. This was easy to communicate to the Swedish people, who appreciated the voluntary restrictions approach and trusted their decision makers. Finland chose the contain and mitigate strategy and was towards the end of the observation period apparently hesitating between suppression and the test, track, isolate, and treat approach. Both are difficult to communicate to the general public accurately, truthfully, and acceptably. Apart from health utilitarian argumentation, something like the republican political philosophy or selective truth telling are needed. The application of republicanism to the issue, however, is problematic, and hiding the truth seems to go against the basic tenets of liberal democracy.

Heled, Yaniv, Ana Santos Rutschman and Liza Vertinsky, ‘The Problem with Relying on Profit-Driven Models to Produce Pandemic Drugs’ (2020) 7(1) Journal of Law and the Biosciences, Article lsaa060
Abstract: In this article, we explain why profit-driven models for developing treatments for epidemic pathogens produce sub-optimal and sometimes negative public health outcomes. Using the example of the drug remdesivir, we demonstrate how the divergence of private incentives from public health needs has led to such outcomes during the COVID-19 pandemic. We conclude that policy responses to this and future pandemics ought to be conceived and designed in ways that narrow the divergence of private interests from public health needs, including through greater public-sector involvement in pharmaceutical R&D.

Helland, Sophia S and Edward R Morrison, ‘The Healthcare System and Pandemics: Where Is the Market Failure?’ (2021) 82(5) Ohio State Law Journal 833–844
Abstract: Barak D. Richman and Steven L. Schwarcz argue that healthcare providers played a central—and failing—role in stemming the fallout from the COVID19 pandemic. Analogizing to the financial crisis of 2008, they view our healthcare system as a collection of providers, each maximizing returns to its own stakeholders in a laissez-faire regulatory environment that ignored the essential interconnectedness of providers. Because neither hospitals nor regulators were attuned to this interconnectedness, our healthcare system was unprepared for the pandemic, resulting in a reduced standard of care. Just as Dodd-Frank and related legislation view financial institutions as part of a larger, interconnected system that must be regulated to minimize exposure to and build robustness against shocks, so too must federal regulators approach our healthcare providers as a ‘system’ that can work as a collective to mitigate the fallout from shocks. We believe this narrative overstates the role of healthcare providers in managing pandemics.

Hellman, Deborah and Kate Nicholson, ‘Rationing and Disability in a State of Crisis’ (Virginia Public Law and Legal Theory Research Paper No 2020–33, 2020)
Abstract: The rise in COVID-19 cases is soon to overwhelm health care systems, leading to difficult moral and legal choices about how to ration scarce resources, and, most especially, ventilators. Many states have protocols that address this question. These protocols adopt a fully utilitarian approach, aiming simply to save as many lives as possible. To do so, they prioritize patients who are most likely to benefit from care and set standard benchmarks for how quickly a patient must show improvement to continue ventilation. These protocols and related policies of private health care systems are likely to disadvantage people with disabilities, as a disproportionate number of disabled people have health conditions that will make them less likely to survive or will require them to have more time to show improvement.This (draft) Article examines whether the utilitarian approach, which considers only aggregate harms and benefits, is consistent with The Americans With Disabilities Act, and other discrimination statutes, which pay significant attention to the distribution of harms and benefits. The Article focuses especially on facially-neutral policies that will have the effect of discriminating impermissibly against the disabled. As such, it considers four rationing principles that track those used by states and ultimately argues that none balances equity with utility, as discrimination law demands.

Hemel, Daniel Jacob and Anup Malani, ‘Immunity Passports and Moral Hazard’ (SSRN Scholarly Paper No ID 3596569, 8 May 2020)
Abstract: The idea of using ‘immunity passports’ to restart the economy before the arrival of a SARS-CoV-2 vaccine has attracted increasing attention as the Covid-19 crisis has escalated. Under an ‘immunity passport’ regime, individuals who test positive for SARS-CoV-2 antibodies would receive certificates allowing them to return to work and potentially to participate in a broader range of activities without social distancing. One concern raised by the ‘immunity passport’ proposal is that not-yet-infected individuals would have an incentive to expose themselves to the virus intentionally so that they can develop antibodies and obtain passports. This paper evaluates the moral-hazard risk that an immunity passport regime would generate. We develop a rudimentary rational-actor model of self-infection decisions under an immunity passport regime and then parameterize the model using early data on SARS-CoV-2 infection outcomes. Our topline result is that strategic self-infection would be privately rational for younger adults under a wide range of plausible parameters. This result raises two significant concerns. First, in the process of infecting themselves, younger adults may expose others—including older and/or immunocompromised individuals—to SARS-CoV-2, generating significant negative externalities. Second, even if younger adults can self-infect without exposing others to risk, large numbers of self-infections over a short timeframe after introduction of the immunity passport regime may impose significant congestion externalities on health care infrastructure. We then evaluate several interventions that could mitigate moral hazard under an immunity passport regime, including the extension of unemployment benefits, staggered implementation of passports, and controlled exposure of individuals who seek to self-infect. Our results underscore the importance of careful planning around moral hazard as part of any widescale immunity passport regime.

Henreckson, Josh, ‘Arbitration Order Ruled Invalid in COVID Wrongful Death Case. That Could Be Trouble for Nursing Homes: Legal Experts’ (2024) McKnight’s Long-Term Care News (7 February 2024)
Abstract: An appellate court judge has ruled that a plaintiff who filed a wrongful death case on behalf of her mother was not bound by an arbitration agreement she had signed in her role as power of attorney. The late Friday decision, delivered by Justice Eugene Doherty of the Appellate Court of Illinois Fourth District, partially overruled a lower court that sided with providers and sent a wrongful death case to arbitration instead of through the courts. The ruling could become a cause of concern for state nursing homes.

Hermer, Laura D, ‘COVID-19, Abortion, and Public Health in the Culture Wars’ (2020) 47 Mitchell Hamline Law Review 1–30
Jurisdiction: USA
Abstract: At the start of the COVID-19 pandemic, 36 governors ordered or requested a halt to all elective health care visits, procedures, and tests in March or April 2020 to conserve scarce personal protective equipment (PPE) and testing supplies and to help prevent the spread of the virus. Among those states, at least nine expressly chose to include many or most abortion services within the order’s scope, whether directly or through informal clarification. Civil liberties and women’s health care organizations rapidly filed suit in eight of the states to enjoin the various orders. Over the course of about three weeks, federal district courts in six of the cases granted plaintiffs’ requests for temporary restraining orders. The Sixth, Tenth, and Eleventh Circuits upheld the district courts’ decisions on appeal, but the Fifth and Eighth Circuits reversed. Both of those reversals were ultimately rendered moot when Texas and Arkansas each permitted elective procedures to resume. Three other cases settled. The states that implemented abortion restrictions generally took substantial efforts to protect their populace from COVID-19, except in health care contexts involving abortion. At the same time, the lower-income women and women of color who disproportionately provided essential services during the pandemic and were infected with and suffered more severe cases of Covid-19 also disproportionately need abortion services. While they were making the greatest sacrifices for all of us, they also found their reproductive safety net in grave jeopardy. Documents filed in the litigation over state-level COVID abortion restrictions make it clear that the states that sought to use pandemic PPE shortages to restrict abortions were not concerned about the health or welfare of any of the parties involved, including fetuses. The article examines the arguments that they and their amici made to support their policy choices and details the implications of those policies on the patients seeking abortions, their health care providers, their fetuses, and their loved ones in the context of the pandemic. The evidence demonstrates that the restrictions had nothing to do with protecting anyone’s life or health or conserving scarce PPE. The juxtaposition of these restrictions against our society’s fierce fight against the pandemic makes the disparities in how we treat certain biological problems rather stark. The time is ripe for a re-evaluation of when, if ever, it may be reasonable for a state to restrict the right to an abortion.

Hermer, Laura D, ‘Skirting the Law: Medicaid Block Grants and Per-Capita Caps in a Pandemic’ (2021) St. Louis University Journal of Health Law and Policy (forthcoming)
Abstract: To what extent can an administration abridge Medicaid’s entitlement status by administrative fiat? In the final year of the Trump administration, just before the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) sought to push the outer bounds of this question by announcing the Healthy Adult Opportunity (HAO) initiative. It invited states to submit § 1115 demonstration applications to cover individuals not eligible for Medicaid benefits under the state’ s Medicaid plan—meaning, in many cases, the Affordable Care Act’s (ACA’s) Medicaid expansion population. Spending on those populations would be capped, not by purporting to waive federal law regarding matching payments under Medicaid—which would clearly exceed the government’s authority under § 1115(a)(1)—but rather through application of the demonstration’s budget neutrality limit. ‘Savings’—or the difference between the cap and actual state expenditures under the demonstration—could be used on a variety of otherwise non-matchable state projects. This Article traces some of the history of this maneuver, showing that the HAO misguidedly seeks to ‘return’ Medicaid to a program it has not been for decades. It furthermore argues that the Trump administration’s attempt to cap federal expenditures for certain Medicaid populations in exchange for certain state flexibilities is beyond the administration’s legal authority to grant. As this Article shows, the issue turns on how ‘individuals not eligible for benefits under the state plan’ are defined: Are they expansion populations considered to be ‘receiving medical assistance under a state plan approved under Title XIX,’ at least for the duration of the demonstration, and hence entitled to all the protections given to categorical and optional Medicaid populations covered under a state plan, or are they simply ‘regarded’ as such for the purpose of expenditures only, and not protections and privileges under the Medicaid statute? A careful reading of the statute, relevant regulations, and recent caselaw show that, at least in the case of the ACA’s Medicaid expansion population, the HAO initiative’s structure and suggested flexibilities do not comply with the law.

Hermes, Clint and Nikki Wethington, ‘Balancing Hope and Proof: Investigational Products During the COVID-19 Pandemic’ (2020) 33(2) Health Lawyer 6–12
Abstract: On October 2, 2020, the White House announced that President Trump received an investigational antibody cocktail (REGN-COV2) for COVID-19 made by Regeneron Pharmaceuticals, Inc. REGNCOV2 is still in clinical trials and has not been approved for any use by the Food and Drug Administration (FDA). In addition, because of the declaration of a public health emergency, the FDA may allow unapproved medical products or unapproved uses of approved medical products to be used to diagnose, treat, or prevent COVID-19 under an EUA.[6] In general, EUAs expire at the end of the public health emergency unless they are revoked earlier. Development of a COVID-19 Vaccine In an effort to expedite the availability of a COVID-19 vaccine, the FDA is considering issuing an EUA for potential COVID-19 vaccines currently in development.

Herreros, Benjamin, Pablo Gella and Diego Real de Asua, ‘Triage during the COVID-19 Epidemic in Spain: Better and Worse Ethical Arguments’ (2020) 46(7) Journal of Medical Ethics 455–458
Abstract: The COVID-19 pandemic has generated an imbalance between the clinical needs of the population and the effective availability of advanced life support (ALS) resources. Triage protocols have thus become necessary. Triage decisions in situations of scarce resources were not extraordinary in the pre-COVID-19 era; these protocols abounded in the context of organ transplantation. However, this prior experience was not considered during the COVID-19 outbreak in Spain. Lacking national guidance or public coordination, each hospital has been forced to put forth independent and autonomous triage protocols, most of which were, nonetheless, based on common ethical principles and clinical criteria. However, controversial, non-clinical criteria have also been defended by Spanish scientific societies and public institutions, including setting an age cut-off value for unilaterally withholding ALS, using ‘social utility’ criteria, prioritising healthcare professionals or using ‘first come, first served’ policies. This paper describes the most common triage criteria used in the Spanish context during the COVID-19 epidemic. We will highlight our missed opportunities by comparing these criteria to those used in organ transplantation protocols. The problems posed by subjective, non-clinical criteria will also be discussed. We hope that this critical review might be of use to countries at earlier stages of the epidemic while we learn from our mistakes.

Heywood, Rob, ‘The COVID-19 Care Home Discharge Policies: Public Authority Liability, Justiciability and the Common Law Duty of Care’ [2024] (2) Public Law 270–292
Abstract: During the COVID-19 pandemic, the Department of Health and Social Care implemented policies that sought to discharge patients from hospitals into care homes. These were a contributing factor to the high death rate in the latter. A question that has received little attention concerns the potential for any claim in negligence to be pursued in respect of those policies. This would involve allegations of negligence against defendants who are subject to both statutory duties and powers, and there is now a degree of uncertainty as to how the courts will treat public authority liability in the aftermath of the Supreme Court judgment in Poole. The starting point for any claimants would be establishing that a common law duty of care was owed to them. This paper therefore considers that important question.

Hill, B Jessie, ‘Essentially Elective: The Law and Ideology of Restricting Abortion During the COVID-19 Pandemic’ (Case Legal Studies Research Paper No 2020–7, 2020)
Abstract: During the COVID-19 pandemic, several states adopted orders temporarily suspending elective surgeries and procedures. A subset of those states moved to limit abortions under those orders, provoking emergency litigation to keep abortion clinics open and functioning. No similar lawsuits have been necessary to protect access to other time-sensitive medical procedures. So why was abortion singled out for disparate treatment? This Essay provides an overview of the litigation that ensued in the wake of some states’ attempts to limit abortion access under the authority of executive orders banning non-essential or elective procedures. It argues that abortion was singled out in two ways that reflect deeper ambivalence about the place of abortion within medicine more generally. First, the COVID-19 crisis allowed anti-abortion officials to rely on the narrow meaning of “elective” in the abortion context to argue that abortions are medically unnecessary and can be halted indefinitely during a pandemic. Second, and relatedly, they used the exceptional treatment of abortion and the longstanding ambivalence about the place of abortion within health care to argue that abortion providers’ demands to be treated like every other health care provider under these executive orders was in fact a claim for special treatment. This Essay ends by suggesting that, for long-term protection of abortion rights, abortion must be reframed as a medically necessary and appropriate treatment, and it must be rhetorically re-incorporated into healthcare more generally.

Hodge, James G et al, ‘Legal Challenges Underlying COVID-19 Vaccinations’ (2021) Journal of Law, Medicine, and Ethics (forthcoming)
Abstract: Immunizing hundreds of millions against COVID-19 through the most extensive national vaccine roll-out ever undertaken in the United States has generated significant law and policy challenges. Beyond initial controversies in the development and FDA authorization of the vaccines, multiple issues pervade their real-time allocation and administration. This commentary briefly examines premier law and policy issues shaping the COVID-19 national vaccination campaign.

Hodge, James G et al, ‘Legal “Tug-of-Wars” During the COVID-19 Pandemic: Public Health v. Economic Prosperity’ (SSRN Scholarly Paper No ID 3623516, 9 June 2020)
Abstract: Governmental efforts to re-open businesses, religious entities, schools, and other enterprises following months of social distancing in response to COVID-19 raise significant legal and policy issues on both sides of the ‘tug-of-war’ between protecting the public’s health and rebooting the economy.

Hodge, James G et al, ‘Post-COVID U.S. Legal Reforms Promoting Public Health and Equity’ [2021] Journal of Law, Medicine, and Ethics (advance article, published 6 January 2021)
Abstract: There is no clear silver lining to the COVID-19 pandemic. Yet, arising from the crisis are substantial changes in laws and policies to improve public health responses and advance health equity. Some seismic legal shifts are already underway; others are in conceptual stages. We propose and explore ten major areas of legal and policy reforms precipitated by unprecedented responses and experiences underlying the COVID-19 pandemic. These include (1) constitutional assurances to abate health inequities; (2) extensive reconsideration of national and state emergency public health laws and policies; (3) development of emergency measures to counter-balance economic impacts; (4) tax laws and policies supporting wider provision of health services; (5) unification of data gathering, reporting, and sharing practices; (6) greater access to basic health care services; (7) enhanced reproductive health protections; (8) elimination of structural racial inequities impacting health outcomes; (9) law enforcement approaches promoting social justice; and (10) renewed acclimation of ‘health-in-all-policies.’

Hodge, Jr., James G. et al, ‘Vaccinating Urban Populations in Response to COVID-19: Legal Challenges and Options’ (2021) 49(1) Fordham Urban Law Journal 1–30
Abstract: The real-time development of multiple, efficacious vaccines through federal alliances with U.S.-based pharmaceutical companies via Operation Warp Speed during the COVID-19 pandemic is a shining achievement. The health and safety of U.S. residents rely on a national vaccine campaign led by the Biden Administration seeking to rapidly achieve ‘herd immunity,’ especially among populations in denser, urban environments. Immunizing millions of persons in urban locales is complicated by their vulnerabilities to COVID-19, initial lack of access to vaccines, issues of eligibility, and vaccine hesitancy. This Essay explores these challenges and how they are addressed through legal and policy responses promoting national mass vaccination efforts affecting U.S. urban populations.

Hodge, James G, Hanna Reinke and Claudia M Reeves, ‘Balancing Religious Freedoms and Public Health Protections During the COVID-19 Pandemic’ (SSRN Scholarly Paper No ID 3619427, 4 June 2020)
Abstract: Extraordinary responses to the COVID-19 pandemic are generating substantial debates over the scope and reach of public health powers and religious freedoms. Emergency declarations at every level of government to limit societal impacts of COVID-19 may shift constitutional norms, but do not completely negate rights to free exercise or assemble. Yet, no one has an unmitigated right to harm others in pursuit of their faith. Somewhere between individual religious rights and communal public health objectives lies a legally viable balance. Finding it during the pandemic is controversial. Among the most contentious issues are governments’ temporary orders suspending large religious gatherings to maintain social distances. While many religious leaders have complied, others have vociferously objected. Reaching accord begins with an assessment of legal principles of separation of church and state, especially concerning claims of religious rights to assemble despite unprecedented public health risks.

Hodge, James G, Jr and Jennifer L Piatt, ‘Legal Decision-Making and Crisis Standards of Care: Tiebreaking During the COVID-19 Pandemic and in Other Public Health Emergencies’ (2022) 3(1) JAMA Health Forum e214799
Abstract: Extensive surges of patients coupled with shortages of staff and resources throughout the COVID-19 pandemic have contributed to repeated crises in US hospitals and health care facilities. During the recent wave of infections in mid-July through mid-November 2021, more than 1 million individuals with COVID-19 were admitted to hospitals, 156 382 of whom died of COVID-19 complications. Most of these hospital admissions and patient deaths were preventable through widely available and efficacious SARS-CoV-2 vaccines. Still, nearly 40% of vaccine-eligible people in the US are not fully immunized, suggesting additional patient surges are foreseeable in 2022. Decisive actions among doctors, hospitalists, and health officials aim to allocate available treatments, resources, and personnel to avoid limiting patient access to services. Yet, in select hospitals, regions, and states, scarcities have warranted shifts to crisis standards of care (CSC). Legal invocations of CSC vary. Governors in Alaska, Arizona, Idaho, New Hampshire, and New Mexico have formally invoked CSC. Declarations of emergency in Utah may automatically activate existing facility CSC plans. Kansas and Tennessee expressly allow hospitals to shift to CSC on their own initiative. Georgia, Ohio, Oregon, and other jurisdictions that lack statewide CSC plans rely on regional and/or local activations. No matter how CSC is invoked, its goal remains the same: to “extend care to as many patients as possible and save as many lives as possible”.

Hodge, Samuel D Jr and Jack E Hubbard, ‘COVID-19: The Ethical and Legal Implications of Medical Rationing’ (2020) 56(1) Gonzaga Law Review 159-204
Extract from Introduction: This article explores the medical and legal implications of the coronavirus. The medical section discusses the basics of viruses including immunity and then more specifically the coronavirus and SARS-CoV-2, which causes COVID-19. It also explains the symptoms of COVID-19 and why it is such a fatal disease. Finally, the medical section discusses management of COVID-19, focusing on the critical use of ventilators which are in such short supply. The medical section is followed by a discussion of the legal and ethical implications of a national health emergency with attention devoted to the laws that apply as well as the altered standard of care for medical professionals. The article also addresses the implications involving the rationing of ventilators and the litigation that has arisen over the years involving these life-saving devices.

Hoffman, David A, ‘Increasing Access to Care: Telehealth During COVID-19’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa043
Abstract: The COVID-19 public health emergency has amplified both the potential value and the challenges with health care providers deploying telehealth solutions. As people across the country find ways to stay at home, telehealth preserves an opportunity to obtain necessary healthcare services. Further, telehealth can help individuals avoid COVID-19 infection, free up hospital beds and other resources for those patients most in need and prevent infected individuals from spreading that infection. Federal and state regulators have recognized this potential of telehealth and have quickly changed a variety of laws and regulations to enable health care providers to deploy solutions quickly. These changes can provide lasting benefits for the use of telehealth well after the current crisis. However, to best realize telehealth’s benefits further legal and regulatory action are necessary. Specifically, lawmakers and regulators should focus on six areas: reimbursement, privacy/cybersecurity, liability, licensure, technology access, and AI.

Holcombe, Kate, ‘Ensuring Non-Discrimination in the Context of COVID-19 Triage Protocols’ (2021) 36(5) American University International Law Review 1053-1065
Extract: I would like to focus particularly on the role international law has to play in ensuring that the real or perceived limitations of States’ health care resources are not allocated on the basis of discrimination.... Thankfully, international law provides extensive guidance to States on ensuring non-discrimination that can be applied to the context of COVID-19 triage protocols and related resource rationing.

Holland, Stephen, ‘Liberty, Public Health Ethics, and Policy Responses to COVID-19’ (2021) 14(40) HUMANA.MENTE Journal of Philosophical Studies 23–53
Abstract: This paper presents, defends and applies a conception of public health ethics as focused on liberty-limiting public health action. This approach has been persistently criticised, but the criticism is ambiguous between two challenges: that the focus on liberty makes an objectionable presumption in favour of liberal values and that the focus on liberty fails to address institutionalised social injustice. Part One of the paper addresses both challenges to show they can be met by a nuanced account of a liberty-oriented public health ethics. Part Two establishes that debates about policy responses to the current Covid-19 pandemic illustrate and vindicate this conception of public health ethics as focused on liberty-limiting public health action. The discussion then turns to the methodological question as to how public health policies are to be evaluated, focusing particular on the role of normative theory in such evaluations. The methodology of ‘wide reflective equilibrium’ is described and endorsed; the paper ends with a case study to illustrate this evaluative methodology, focused on the ethics of COVID-19 immunity passports.

Horielova, Veronika and Veronika Horielova, ‘Conceptual Provisions of Law and Morals in a Pandemic Condition’ (2020) 2(22) Актуальні проблеми правознавства / Actual Problems of Law 18–21
Abstract: The article is devoted to the problem of morality and law in a pandemic, because the COVID-19 pandemic has put doctors around the world in front of a tough issue of priority. In this regard, the question of the ethical choice of the doctor and what regulations he should be guided by is relevant. The purpose of the article is to comprehensively assess the rights of the patient and the doctor in a pandemic, justify and identify the moral guidelines of the doctor in a pandemic. The patient’s rights are analyzed in a broad sense: the legal relations in the field of health care are enshrined in the law, and in a narrow sense, as a subjective, real relationship between the doctor (medical institution) and the patient in need of care. It is revealed that the actions of a doctor cannot be prescribed as a certain algorithm, and each action and decision of a doctor in a certain extreme situation is only his independent, moral choice. It has been studied that Ukraine takes responsibility for a sick person, giving him a number of additional rights, but there are certain restrictions in the law that can cause harm. It is proposed at the legislative level to develop ethical guidelines for doctors who must act in a pandemic, which will reduce the morale in which the health worker and the patient find themselves.

Hromovenko, Kostiantyn et al, ‘Legal Responsibility for Vaccination against COVID-19 in Ukraine and Other Countries’ (2021) 10(43) Amazonia Investiga 264–271
Abstract: This article analyzes the liability that may arise in case of refusal to receive a COVID-19 vaccine shot, as well as vaccination-related problems in Ukraine and worldwide. We focused on the international and Ukrainian situation regarding the COVID-19 vaccination process. We also considered the legal framework on this issue. The main task of the study was to determine whether there is a liability, including criminal liability, for refusing to receive the COVID-19 vaccine, the nuances, and the legal basis of this process. The research methodology includes general scientific and special scientific methods, such as systemic, structural, formal-legal, hermeneutic, and methods of analysis and synthesis. We found that COVID-19 vaccination is currently voluntary but not mandatory in Ukraine. At the same time, according to legal documents, vaccination against several diseases such as diphtheria, pertussis, measles, polio, tetanus, and tuberculosis is mandatory. Practically, this means that those who are subject to such preventive vaccinations may be subject to sanctions in the form of dismissal for refusing to vaccinate. Only a few foreign countries currently use mandatory COVID-19 vaccination for the entire adult population. More common is mandatory vaccination of certain categories of workers, including health workers, social workers, essential workers, civil servants, and others who are in close contact with people or whose health and well-being are of particular importance to national security.

Hunt, Paul and Sophie Bradwell-Pollak, ‘Access to Vaccines and New Zealand’s Distinctive Response to COVID-19’ (2022) 24(2) Health and Human Rights Journal 215–218
Abstract: When considering equitable access to vaccines, and New Zealand’s general response to the pandemic, it is important to recognize New Zealand’s foundation document, Te Tiriti o Waitangi, which was agreed in 1840 between the Crown and Māori, the Indigenous peoples of New Zealand. Crucially, article 3 of Te Tiriti sets out a commitment to equity. In this viewpoint, we consider how New Zealand’s vaccine rollout drew, to one degree or another, from the country’s distinctive approach to human rights.

Hurford, James E, ‘The BMA COVID-19 Ethical Guidance: A Legal Analysis’ (2020) 26(2) The New Bioethics 176–189
Abstract: The paper considers the recently published British Medical Association Guidance on ethical issues arising in relation to rationing of treatment during the COVID-19 Pandemic. It considers whether it is lawful to create policies for the rationing and withdrawal of treatment, and goes on to consider how such policies might apply in practice. Legal analysis is undertaken of certain aspects of the Guidance which appear to misunderstand the law in respect of withdrawing treatment.

Hurst, Samia A, ‘Responsibility - Crime, and Punishment: Why We Should Not Allocate Intensive Care Based on Vaccination Status’ (2024) 24(7) The American Journal of Bioethics 109–111
Abstract: The article focuses on the debate surrounding vaccine-sensitive allocation in intensive care during the COVID-19 pandemic. Topics include ethical considerations regarding responsibility for health outcomes due to lifestyle choices, the implications of collective health decisions on individual care access, and the ethical challenges of viewing healthcare as a resource subject to punishment based on personal choices rather than medical need.

Hyera, Mozart, ‘The Dialogue on the Consent to the COVID-19 Vaccination in Tanzania: Legal Perspective’ (SSRN Scholarly Paper ID 3944755, 18 October 2021)
Abstract: It has been over a year and half now ever since the world was struck by the deadly virus, coined as COVID-19. It’s of no dispute the virus took a lot from us worse of all death of our loved ones and brought us a new and ‘unprecedented’ lifestyle. But even after such a disastrous pandemic, the world scientific society did not back down, most states tireless employed their experts to work tirelessly on finding if not a cure then a vaccine that would help reduce or control the rate of deaths that kept on occurring. Fortunately, as of 30th August 2021, the world through World Health Organization approved a total of 7 vaccines to include Janssen (Johnson & Johnson), Moderna mRNA-1273, Pfizer/BioNTech, Oxford/AstraZeneca, CoronaVac, BBIBP-CorV (Vero Cells). Tanzania did not fall short on welcoming the use of vaccine. On July 24th 2021, Tanzania’s Health Minister Dorothy Gwajima received the first consignment of doses donated from the United States3. Led by the President Samia Suluhu Hassan, the state with a population of 62 million has only received 1,058,450 doses of the Johnson & Johnson vaccine. The policy however is as such that the first batch of COVID-19 vaccines will target frontline health care workers given their high exposure to COVID-19, the second being elderly and people with co-morbid conditions who are at high risk of developing severe illness if exposed to the COVID-19 virus.4Even after such a relief, the government insisted that the vaccine is to be taken out of free will and coerced though this has raised eyebrows on the safety of the vaccines administered. That not being enough, the government through the Ministry of Health accompanied with instruction on the preliminaries of the shot, issued an exemption clause, or one would say a warning statement or disclaimer before one opts to administer the vaccine. Though the objectives might be good, questions on the credibility of the vaccines have originated from the ‘escape from liability’ clause to be signed before administering the vaccine. This paper examines the nature of exemption clauses and it legality in relation to the ongoing debate of the statement.

Ignovska, Elena, ‘Human Rights and Bioethics During the Covid-19 Pandemic: The International Legal Match Djokovic v. Australia’ in Čović, Ana and Oliver Nikolić (eds), Pravni i Društveni Aspekti Vakcinacije Tokom Pandemije Kovida 19 / Legal And Social Aspects Of Vaccination During The Covid-19 Pandemic (Institute of Comparative Law, 2022) 71-86 *[OPEN ACCESS BOOK]*
Abstract: The (in)glorious case of Novak Djokovic posed serious questions to the way societies were dealing with the pandemics, the crucial being: could the right to make informed decisions about one’s body and announce them endanger the public health through the spread of the anti-vaccination idea and not the infectious disease per se? Legal and ethical issues at stake are observed through the prism of: private life (related to the bioethical concept of individual autonomy) and public health (related to the bioethical concepts of beneficence and non-maleficence). However, the author concludes that irrelevant of the assessment of these two, if personal views about own choices are expressed publicly and, as a result, a person is refrained from enjoyment of some human rights, then the legal certainty and the freedom of thought and expression are affected too.

Ino, Hiroyasu, Eisuke Nakazawa and Akira Akabayashi, ‘Drug Repurposing for COVID-19: Ethical Considerations and Roadmaps’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 51–58
Abstract: While the world rushed to develop treatments for COVID-19, some turned hopefully to drug repurposing (drug repositioning). However, little study has addressed issues of drug repurposing in emergency situations from a broader perspective, taking into account the social and ethical ramifications. When drug repurposing is employed in emergency situations, the fairness of resource distribution becomes an issue that requires careful ethical consideration.This paper examines the drug repurposing in emergency situations focusing on the fairness using Japanese cases. Ethical issues under these circumstances addressed by the authors include: maintaining the evidence level, integrity of clinical research ethics, and voluntary consent by original indication patients. In order to address these issues, they argue that rapid accumulation of ethically and scientifically valid evidence is required, as is obtaining information on resource quantity.

Irawan, Benny and Rena Yulia, ‘Emerging Challenges to Prisoners Vaccination of Covid-19: Historical, Legal and Humanitarian View’ (2022) 11(4) Journal of Public Health Research (advance article, published online 20 October 2022)
Abstract: This research aims to present a legal history of the prisoners? treatment in global crises along with presenting an overview of prisoners? treatment during Covid-19 in view of International Humanitarian Laws. Using the formative research method with a conceptual approach and statute approach, data was gathered from various legal documents related to prisoners’ health laws linked to legal purpose theories. This study further explains the need to treat old age prisoners on a priority basis and to what extent international health organizations are making efforts to establish criteria to vaccinate this societal segment. The international regulatory framework was deeply analyzed to draw conclusions and recommendations along with WHO efforts. It was revealed that there exist adequate laws regarding priority health treatment of the prisoners in crises times but existed an enormous need to highlight and address the sensitive humanitarian issue. Additionally, WHO and other international organizations have also revised the international laws during Covid-19 to treat the prisoners. However, there is an immense need to devise explicit regulations regarding the accessibility of the vaccine to all the groups of society, including prisoners. The provision of a detailed overview of international laws and treaties regarding prisoners’ priority health treatment is a major advance of this research. Further recommendations for the developed and developing nations and future research directions are suggested.

Iserson, Kenneth V, ‘SARS-CoV-2 (COVID-19) Vaccine Development and Production: An Ethical Way Forward’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 59–68
Abstract: The world awaits a SARS-CoV-2 virus (i.e., COVID-19 disease) vaccine to keep the populace healthy, fully reopen their economies, and return their social and healthcare systems to ‘normal.’ Vaccine safety and efficacy requires meticulous testing and oversight; this paper describes how despite grandiose public statements, the current vaccine development, testing, and production methods may prove to be ethically dubious, medically dangerous, and socially volatile. The basic moral concern is the potential danger to the health of human test subjects and, eventually, many vaccine recipients. This is further complicated by economic and political pressures to reduce government oversight on rushed vaccine testing and production, nationalistic distribution goals, and failure to plan for the widespread immunization needed to produce global herd immunity. As this paper asserts, the public must be better informed to assess promises about the novel vaccines being produced and to tolerate delays and uncertainty.

Iwry, Jonathan, ‘FDA Emergency Use Authorization from 9/11 to COVID-19: Historical Lessons and Ethical Challenges’ (2021) 76(2) Food and Drug Law Journal (forthcoming)
Abstract: Emergency use authorization (EUA) is a power granted by Congress to FDA to expedite the availability and distribution of medical countermeasures during public health emergencies. This article reviews the history of FDA’s EUA authority from its inception in the post-9/11 era to its present-day use in response to COVID-19 in order to better understand and anticipate the limitations, potential, and risks of EUAs. We offer several reflections on the history of EUAs and ethical considerations relevant to their use in connection with COVID-19 (including a potential vaccine) and future emergencies. This history and analysis center around four main themes: (i) the effects that post-9/11 counterterrorist concerns have had on FDA’s ability to deal with naturally-occurring threats to public health and safety; (ii) political interference in efforts to defend the country against those threats; (iii) the question of where the risks posed by emergency countermeasures should fall, including with respect to legal liability for vaccine-related injuries; and (iv) the key ethical and policy issues confronting FDA in public health emergencies.

Jackman, Martha, ‘Fault Lines: COVID-19, the Charter, and Long-Term Care’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 339
Abstract: COVID-19 has underscored the crucial role of the single-payer health care system in ensuring access to care based on need, consistent with the Canadian Charter of Rights and Freedoms (the Charter) and international human rights guarantees. But significant fault lines were exposed when health authorities across the country concentrated their pandemic readiness efforts on maximizing hospitals’ capacity to deal with the anticipated surge of COVID-19 patients, without considering the potentially disastrous consequences for an already struggling long-term care system. COVID-19 laid bare the reality that barriers to care continue to exist as a function of who patients are and where they are being treated. Focussing on COVID-19 hospital transfer decisions and their impact on the life, liberty, and security of the person and the equality rights of long-term care residents, this chapter argues that governments and health care decision makers in Canada must recognize that access to a comprehensive range of care is a fundamental right, and that human rights–based accountability is urgently needed in the battle against COVID-19, and beyond.

Jackson, Jason and Aziza Ahmed, ‘The Public/Private Distinction in Public Health: The Case of COVID-19’ 90(6) Fordham Law Review 2541–2559
Abstract: In this Essay, we argue that the paradigm of the public/private distinction is implicitly operating as a primary frame in the public health response to the pandemic. The public/private distinction is particularly evident in the guidance around masking and other risk-mitigation policies and advice issued by public health agencies. This public health approach reifies the notion of the home as an exceptional private space that exists outside of the possibility of COVID-19 transmission, obscuring the reality of the high risk of transmission in some households.8 We argue that the manifestation of the public/private distinction in the COVID-19 response is deeply raced and classed as it ignores the high risks borne by essential workers, who are disproportionately lower-income workers of color, and their families. The reality is that many essential workers could not follow the primary advice offered over the course of the pandemic to stay at home and thus bore disproportionate risk of contracting COVID-19 in the workplace and exposing family members at home. The rest of this Essay is organized as follows. Part I describes how the primary public health response of stay-at-home orders was organized around a sharp differentiation between risk of transmission in the public sphere versus risk of transmission in the private domain of the home. Part II elaborates the logic and history of the public/private distinction and the role it has played in structuring the governance of modern society. Part III shows how the public/private distinction has shaped the approach to understanding the household in neoclassical political economy and traces the way those ideas have had an imprint on public health law and policy. In Part IV, we move beyond the public/private distinction by turning our attention to commonsense public health policy measures that would contribute to decreased risk of COVID-19 transmission in the home, such as Dr. Collins’s masking advice. Highlighting the simplicity of these responses not only offers pragmatic tips, but also serves to highlight how entrenched the public/private distinction has been in the response. Without this divide, these responses could have—and should have—been prioritized. This Essay then concludes with a brief discussion of the theoretical and policy implications of the preceding analysis.

Jafarova, Lala A, Vugar G Mammadov and Leyli E Mammadov, ‘Azerbaijan’s Healthcare Legislation: Major Developments Amid the COVID-19 Pandemic’ (2021) 28(5) European Journal of Health Law 507–524
Abstract: Significant changes in the field of Azerbaijan’s healthcare legislation came just at the time when the coronavirus (COVID-19) pandemic broke out in the world. The end of 2019 was supposed to lay the groundwork for the introduction of the country’s long-awaited health insurance – a landmark change in terms of national healthcare transformation; although the Law ‘On health insurance’ was adopted in the 1990s, its implementation was per se frozen for many years due to various reasons. Therefore, the pandemic complicated the process even more. It also coincided with significant updates of the Law ‘On human organs and tissues donation and transplantation’, which comes into force in 2022, and legislation related to disability. Thus, this paper focuses on recent changes in healthcare legislation; analyses system of health insurance, updated transplantation and disability laws. It gives an overview of the developments that accompany the process of legislation transformation.

Jain, Dipika et al, Legal Barriers to Abortion Access During the COVID-19 Pandemic in India: One Year at a Glance (March 2020-21) (Centre for Justice, Law and Society, Jindal Global Law School, 2021)
Extract from Executive Summary: India has no comprehensive legislation to deal with pandemic or other health related crisis/disasters. The lack of a legal framework to deal with pandemics, epidemics and public health emergencies in general has farreaching implications for challenges associated with such events, including restrictions on mobility and travel, employment status, provision of essential commodities and many others. The application of broad and general legislations during the pandemic, including the Epidemic Diseases Act, 1897 and the Disaster Management Act, 2005, and Section 144 of the Indian Penal Code, 1860, awarded the governments a wide range of powers, with limited legislative or judicial check upon their exercise. In this background, the situation of abortion services during the pandemic became chaotic and arbitrary, with lockdowns and the fear of COVID-19 have intensifying existing shortfalls in the public health system and exacerbating structural factors that impede access of marginalised groups to SRH services. There exist multiple challenges to access safe abortion services, including both surgical and non-surgical methods, such as disruption in the supply chain for drugs and commodities, redeployment of facilities and staff for COVID-19 care, closure of private facilities, lack of transport, lack of access to legal remedies, and restricted mobility. This report contains an analysis of the various barriers to SRH services, including the overburdened and insufficient health infrastructure in India, the restrictive guidelines around telemedicine, the lack of specialised laws to tackle issues arising from the pandemic and, finally, the failure of the Central and State Government to identify and protect the most marginalised groups who are likely to be the worst affected in a health crisis. The report highlights select instances of legal barriers to safe abortion services including legal reforms introduced during the pandemic as well as the litigation.

Jalali, Mohammad, Adam Landman and William Gordon, ‘Telemedicine, Privacy, and Information Security in the Age of COVID-19’ (SSRN Scholarly Paper No ID 3646320, 8 July 2020)
Abstract: COVID-19 has highlighted the shortcomings of healthcare systems globally as countries struggle to meet the high demand for patient care. The spread of COVID-19 has resulted in unprecedented circumstances that necessitate a shift towards adopting infrastructure to enable care to be provided virtually. This shift is critical to minimize insufficiencies and maximize the quality of care in healthcare systems. While COVID-19 has dramatically accelerated the adoption of technology into care delivery, ongoing work is needed to ensure that our technology infrastructure provides an environment for safe and effective care delivery.Telemedicine usage has substantially increased over the past decade (1), and many hospital systems have robust telemedicine programs. Yet traditional in-person visits remain the cornerstone of clinical care, despite the fact that a significant amount of these visits, including follow-ups, treatment for minor illnesses, and chronic disease management could be substituted by virtual communication. Telemedicine has previously been identified as particularly important during disasters, due to the inaccessibility of traditional care services. This is especially salient for the COVID-19 pandemic where in-person healthcare visits pose a high risk to exposure (2). Additionally, responses to COVID-19, specifically social isolation and the intensified burden on essential workers, are eliciting detrimental psychological effects on large populations, while simultaneously making mental health resources highly inaccessible (3). Overall, with the increased strain and demand on traditional medical resources, telemedicine has emerged as an essential component of clinical care delivery during the COVID-19 pandemic (4) with many healthcare organizations reporting substantial increases in telemedicine use during COVID-19. For example, NYU saw an increase in non-urgent care virtual visits from a pre-COVID-19 average of 95 daily to 4,209 post COVID-19 expansion (4,330% increase) (5).However, as we continue the shift to telemedicine, new issues unravel that need to be addressed, particularly in regard to technology infrastructure. In the US, the Department of Health and Human Services recently lifted many of the restrictions on communication apps, reducing barriers that previously prevented the use of telemedicine services for individuals. That being said, the substantial information security and privacy concerns surrounding telemedicine cannot be overlooked. For example, Zoom, currently one of the most popular video conferencing platforms, has had a 10-fold increase in usage over just a few months including increasing use in healthcare, leading to several important privacy considerations—outsiders joining video conferences, or inadequate encryption of communications (6), leading to the possibility of eavesdropping.State and federal agencies have warned of increased risk of cyberattacks towards healthcare and public health sector and organizations doing research on COVID-19 (7). Ransomware attacks—a type of cybersecurity threat that involves encrypting data and demanding payment in return for unencrypting the data—have continued unabated during the pandemic, with many targeting hospitals specifically. Recent ransomware attacks have included the Illinois Public Health District website and a medical testing facility in the UK (7). Successful cyberattacks negatively impact hospital operations, delay access to clinical services, and lead to significant economic loss (8, 9), all of which would be particularly devastating to organizations already under unprecedented economic and clinical strain during this pandemic.Therefore, while global healthcare systems should allocate significant resources towards improving telemedicine capabilities, improvements must ensure that the technology delivers care that is both safe and effective. Balancing the significant privacy and information security concerns with the enormous potential benefits of virtual care during this pandemic will remain a vital component to our continuously evolving response to COVID-19. Now more than ever, health care workers and organizations need to follow best practices to reduce cyber incidents.

Jeffrey, David Ian, ‘Relational Ethical Approaches to the COVID-19 Pandemic’ (2020) 46(8) Journal of Medical Ethics 495–498
Abstract: Key ethical challenges for healthcare workers arising from the COVID-19 pandemic are identified: isolation and social distancing, duty of care and fair access to treatment. The paper argues for a relational approach to ethics which includes solidarity, relational autonomy, duty, equity, trust and reciprocity as core values. The needs of the poor and socially disadvantaged are highlighted. Relational autonomy and solidarity are explored in relation to isolation and social distancing. Reciprocity is discussed with reference to healthcare workers’ duty of care and its limits. Priority setting and access to treatment raise ethical issues of utility and equity. Difficult ethical dilemmas around triage, do not resuscitate decisions, and withholding and withdrawing treatment are discussed in the light of recently published guidelines. The paper concludes with the hope for a wider discussion of relational ethics and a glimpse of a future after the pandemic has subsided.

Jerry, Robert H, ‘COVID-19: Responsibility and Accountability in a World of Rationing’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa076
Abstract: The COVID-19 pandemic is the first modern public health crisis with the potential to overwhelm the public healthcare system. When rationing of services, drugs, and equipment must occur, healthcare providers have a responsibility to make rationing decisions fairly, both procedurally and substantively. In addition, healthcare providers, like all professionals, are accountable for their decisions. The legal standard of care requires providers to exercise the skill and knowledge normally possessed by providers in good standing in the same field or class of practice acting in the same or similar circumstances. But making rationing decisions in crisis conditions, like those created by COVID-19, is not the same as or similar to decision making in non-crisis conditions. Thus, the standard of care, properly applied, expects less of providers practicing under the stress of COVID-19’s triage conditions. Because many healthcare providers do not perceive this is true, and for pragmatic and normative reasons, policymakers should articulate rules limiting providers’ liability for rationing decisions—as well as other acts and omissions—occurring in and attendant to crisis conditions. These rules should not, however, create absolute immunities. As the COVID-19 pandemic unfolds, more states are embracing this approach.

Jia, Yuxiu et al, ‘Nurses’ Ethical Challenges Caring for People with COVID-19: A Qualitative Study’ (2021) 28(1) Nursing Ethics 33–45
Background: Ethical challenges are common in clinical nursing practice, and an infectious environment could put nurses under ethical challenges more easily, which may cause nurses to submit to negative emotions and psychological pressure, damaging their mental health.
Purpose: To examine the ethical challenges encountered by nurses caring for patients with the novel coronavirus pneumonia (COVID-19) and to provide nurses with suggestions and support regarding promotion of their mental health.
Research design and method: A qualitative study was carried out using a qualitative content analysis. The participants were 18 nurses who agreed to attend an interview and describe their own experiences of providing care to COVID-19 patients in China. They were purposively sampled, and structured, in-depth interviews were performed. Data were iteratively collected and analyzed from February to March 2020.
Ethical considerations: The proposal was approved by the Research Ethics Committee of the Second Hospital of Shandong University, China.
Findings: The findings revealed three main themes and 10 categories. The themes were the following: (1) ethical challenges (people with COVID-19, inequality, professional ethics, and job competency); (2) coping styles (active control and planning, seeking support as well as catharsis, and staying focused); and (3) impacts on career (specialized nursing skills, scientific research ability, and management skills).
Conclusion: Nurses faced ethical challenges on multiple fronts in caring for COVID-19 patients. The results may help nurses with more safety, ethics, and humanistic care in nursing practice.

Jian, Yang et al, ‘Addressing the Vaccine Gap: Goal-Based Governance and Health Silk Road’ (SSRN Scholarly Paper ID 3937053, 28 September 2021)
Abstract: Our previous report Health Silk Road 2020: A Bridge to the Future for Health to All tracked the rapid development of the Health Silk Road. The year 2020 concluded with two Chinese vaccines being tested throughout 15 countries. In this study, we continue to track the H1 2021 development of the Health Silk Road with a focus on vaccine production and distribution of both Chinese vaccines and those manufactured in countries around the world. During this period of explosive vaccine production growth, both actual in 2021 and planned for 2022, there developed a significant gap between the dosages produced, versus those distributed and to which recipients. This is a world full of differences. But the people of all countries have a common expectation, that is, to work together to free the world from the shadow of COVID-19 and return to a normal track: normal social activities, normal economic activities, and normal international travels. In the first half of 2020, when COVID-19 appeared and broke out, some epidemiologists predicted that the epidemic would be effectively controlled in the summer of 2021 and the world would return to normal. However, we have not yet seen any signs of restoring order in the world in the second half of 2021. Indeed, after more than a year of hard work and trials, we have seen that the spread of the virus has been moderated, and the number of the infected patients has declined in some countries, which allows the world to see the dawn of the restoration of normal order. However, in recent months, the epidemic has suddenly spread rapidly again in certain developing countries such as in regions of Southeast Asia, Latin America and Africa. This shows that the effective containing of the virus in some individual countries can only provide an exemplary role, and cannot solve the problem of re-opening the borders between countries, nor can it guarantee the world back to normal order. If other countries lose the guard against COVID-19, the effective governance of individual countries cannot be sustained.

Johnson, Candice C and Mirela A Aldea, ‘Ethical Considerations for Telepsychotherapy and the Management of High-Risk Patients During Coronavirus 2019 (COVID-19): Challenges and Practice Considerations’ (2021) 31(3) Ethics & Behavior 193–204
Abstract: The COVID-19 pandemic has caused a widespread cultural change to the provision of psychotherapy with patients rapidly converted to a virtual format. During this unprecedented time, therapists can benefit from reviewing and implementing best practice guidelines outlined by various professional organizations across the globe. Clinicians should utilize the resources put forth by international professional organizations to ethically adapt these recommendations to their clinical practice. Therapists must develop safety protocols to ethically deliver services to high-risk patients and also recognize the potential for new high-risk subgroups during this pandemic.

Johnson, Stephanie B, ‘Advancing Global Health Equity in the COVID-19 Response: Beyond Solidarity’ (2020) 17 Journal of Bioethical Inquiry 703–707
Abstract: In the coming weeks and months SARS-CoV-2 may ravage countries with weak health systems and populations disproportionately affected by HIV, tuberculosis (TB), and other infectious diseases. Without safeguards and proper attention to global health equity and justice, the effects of this pandemic are likely to exacerbate existing health and socio-economic inequalities. This paper argues that achieving global health equity in the context of COVID-19 will require that notions of reciprocity and relational equity are introduced to the response.

Johnson, Tess, ‘Is Resource Allocation That Is Sensitive to Vaccination Status Coercive? Who Cares?’ (2024) 24(7) The American Journal of Bioethics 106–108
Abstract: The article focuses on the ethical considerations of resource allocation during a pandemic, specifically ventilators and healthcare staff, examining the use of vaccination status as a criterion. Topics include ethical concepts such as responsibility, reciprocity, and justice, notably omitting a discussion on whether such allocation could coerce individuals into vaccination.

Johnston, Carolyn, ‘Telehealth: What Has Been Learned through the Covid-19 Pandemic?’ in Digital Health Technologies: Law, Ethics, and the Doctor-Patient Relationship (Routledge, 2023)

Jones, Evan, ‘COVID-19 Hits the French Health System’ (2020) 85 Journal of Australian Political Economy 94–100
Abstract: On 28 February 2020 the WHO issued a report on China’s efforts to control the Coronavirus outbreak, dictating a comprehensive governmentled response to the threat. On 29 February, the French Prime Minister Edouard Philippe chose to divert priorities from a Ministerial Council dedicated to COVID-19 by utilising article 49-3 of the Constitution to bypass Parliament and authorise a brutal retirement ‘reform’ package, against which vast sections of the country had struck and demonstrated.

Jøranson, Nina et al, ‘Older Patients’ Perspectives on Illness and Healthcare during the Early Phase of the COVID-19 Pandemic’ (2022) 29(4) Nursing Ethics 872–884
Background: Equal access to healthcare is a core principle in Norway’s public healthcare system. The COVID-19 pandemic challenged healthcare systems in the early phase – in particular, related to testing and hospital capacity. There is little knowledge on how older people experienced being infected with an unfamiliar and severe disease, and how they experienced the need for healthcare early in the pandemic.
Findings: The main finding was that the informants experienced vulnerability and arbitrariness. This finding was supported by three sub-themes: experiences with a severe and unfamiliar disease, the strict criteria and the importance of someone advocating needs.
Discussion: Participants described varying access to healthcare. Those who did not meet the national criteria to be tested or hospitalised struggled against the system. Findings reveal arbitrary access to healthcare, in contrast to Norway’s ethical principle of fair and just access to health services. Moreover, to access and receive necessary healthcare, informants were dependent on their next-of-kin’s advocacy.
Conclusion: Even when dealing with an unfamiliar disease, health professionals’ assessments of symptoms must be performed with an ethical obligation to applicate competent appraisal and the exercise of discernment; this is in line with care ethics and ethical standards for nurses. These perspectives are a significant part of caring and the intension of doing good.

Kahn, Robert, ‘Masks, Culture Wars, and Public Health Expertise: Confessions of a Mask “Expert” _University of St Thomas Law Journal (forthcoming)_
Abstract: The arrival of COVID-19 has seen a sea change in how we view masks. As the author of an encyclopedia entry and law review article on anti-mask laws I know this well. Over the past three months, reporters have been asking me about masks, the reluctance of Americans to wear them and the Red vs. Blue culture wars. This paper outlines my experiences and thoughts. After briefly describing the volte face in attitudes towards masks, I take up the argument that, in the coronavirus context, the mask is not a symbol but merely a tool to fight the virus. Then I look at masks and the culture wars, focusing particularly on the argument masking is less common in red states for political reasons. Finally, I look at how to create a culture of masking. Here I look at how public health officials have at times undercut their position by relying too heavily on law enforcement solutions to masking and treating questions, such as whether to protest, as a medical issue rather than a political one. I conclude with plea to treat mask wears as persons, rather than targets of law enforcement, or subjects of medical study.

Kalokairinou, Louiza et al, ‘The Promise of Direct-to-Consumer COVID-19 Testing: Ethical and Regulatory Issues’ (2020) 7(1) Journal of Law and the Biosciences, Article lsaa069
Abstract: Widespread diagnostic and serological (antibody) testing is one key to mitigating the COVID-19 pandemic. While at first, the majority of COVID-19 diagnostic testing in the USA took place in healthcare settings, quickly a direct-to-consumer (DTC) testing market also emerged. In these DTC provision models, the test is initiated by a consumer and the sample collection occurs at home or in a commercial laboratory. Although the provision of DTC tests has potential benefits—such as expanding access to testing and reducing the risk of exposure for consumers and medical personnel—it also raises significant ethical and regulatory concerns. This article reviews these challenges and shows how they parallel and also diverge from prior concerns raised in the DTC health testing arena. The first part of this paper provides an overview of the landscape of diagnostic and serological tests for COVID-19, anticipating how provision models are likely to evolve in the future. The second part discusses five primary issues for DTC COVID-19 tests: test accuracy; potential misinterpretation of results; misleading claims and other misinformation; privacy concerns; and fair allocation of scarce resources. We conclude with recommendations for regulators and companies that aim to ensure ethically marketed DTC COVID-19 tests.

Kaminer, Debbie, ‘Vaccines in the Time of COVID-19: How Government and Businesses Can Help Us Reach Herd Immunity’ (SSRN Scholarly Paper No ID 3712739, 16 October 2020)
Abstract: The COVID-19 pandemic continues to wreak havoc on American society. Public health experts agree that the best way to end it is with the development, distribution and implementation of a safe and effective vaccine program. However, a vaccine will only be successful if the number of Americans inoculated is sufficient to reach herd immunity. Unfortunately, recent polls indicate this may not be achieved because the majority of Americans appear unwilling to be vaccinated against the SARS-CoV-2 coronavirus. Such a failure might be prevented by action of both the government and private entities. This Essay addresses the potential strategies available to government and private businesses to either mandate or encourage people to get vaccinated. First, the Essay examines the broad power state governments have to pass mandatory vaccination laws and how this would apply to a vaccine against the SARS-CoV-2 coronavirus. In doing so, it distinguishes between broad mandatory vaccination policies that apply to all residents of a given location and more targeted policies that condition receipt of a government benefit on vaccination. Next the Essay focuses on how private businesses could mandate vaccination for both employees and customers, highlighting potential legal issues involving medical and religious exemptions. Finally, the Essay discusses how lessons learned from behavioral economics can be used by both government and employers to nudge people to be vaccinated. The Essay concludes by explaining that the best approach for ensuring that a sufficient number of Americans are immunized is a combination of targeted government mandates, employer mandates and nudging by both government and private businesses.

Kamphorst, Bart A, Marcel F Verweij and Josephine AW van Zeben, ‘On the Voluntariness of Public Health Apps: A European Case Study on Digital Contact Tracing’ (2023) 15(1) Law, Innovation and Technology 107–123
Abstract: As evidenced during the COVID-19 pandemic, there is a growing reliance on smartphone apps such as digital contact tracing apps and vaccination passports to respond to and mitigate public health threats. In light of the European Commission’s guidance, Member States typically offer such apps on a voluntary, ‘opt-in’ basis. In this paper, we question the extent to which the individual choice to use these apps – and similar future technologies – is indeed a voluntary one. By explicating ethical and legal considerations governing the choice situations surrounding the use of smartphone apps, specifically those related to the negative consequences that declining the use of these apps may have (e.g. loss of opportunities, social exclusion, stigma), we argue that the projected downsides of refusal may in effect limit the liberty to decline for certain subpopulations. To mitigate these concerns, we recommend three categories of approaches that may be employed by governments to safeguard voluntariness.

Kaneda, Yudai, Mira Namba and Masaki Takebayashi, ‘Navigating Japan’s COVID-19 Vaccination Challenges: A Shift in Legal Classification and the Opt-out System’ [2023] JMA Journal (advance article, published online 27 November 2023)
Abstract: On January 20, 2023, the Japanese government announced easing the legal handling of the novel coronavirus disease 2019 (COVID-19) under its Infectious Diseases Control Act, effective May 8, 2023. While free vaccines will continue in fiscal year 2023, the future of mass vaccinations remains uncertain. The opt-out system, wherein local governments schedule vaccinations on behalf of the residents, may potentially alleviate issues associated with the currently adopted opt-in approach, such as procedural intricacies and scheduling difficulties, thereby facilitating the recovery of vaccination rates and simultaneously addressing vaccine wastage concerns. Given that COVID-19 still presents a substantial risk to specific groups, such as the elderly, recognizing the benefits of the opt-out system and the ethical and geographical challenges it poses is essential. With the collaboration of local governments and healthcare institutions, ongoing surveillance and scientific assessment are indispensable.

Kaplan, Bonnie, ‘Revisting Health Information Technology Ethical, Legal, and Social Issues and Evaluation: Telehealth/Telemedicine and COVID-19’ (2020) 143 International Journal of Medical Informatics Article 104239
Abstract: Background: Information technologies have been vital during the COVID-19 pandemic. Telehealth and telemedicine services, especially, fulfilled their promise by allowing patients to receive advice and care at a distance, making it safer for all concerned. Over the preceding years, professional societies, governments, and scholars examined ethical, legal, and social issues (ELSI) related to telemedicine and telehealth. Primary concerns evident from reviewing this literature have been quality of care, access, consent, and privacy. Objectives: To identify and summarize ethical, legal, and social issues related to information technology in healthcare, as exemplified by telehealth and telemedicine. To expand on prior analyses and address gaps illuminated by the COVID-19 experience. To propose future research directions. Methods: Literature was identified through searches, forward and backward citation chaining, and the author’s knowledge of scholars and works in the area. EU and professional organizations’ guidelines, and nineteen scholarly papers were examined and categories created to identify ethical, legal, and social issues they addressed. A synthesis matrix was developed to categorize issues addressed by each source. Results: A synthesis matrix was developed and issues categorized as: quality of care, consent and autonomy, access to care and technology, legal and regulatory, clinician responsibilities, patient responsibilities, changed relationships, commercialization, policy, information needs, and evaluation, with subcategories that fleshed out each category. The literature primarily addressed quality of care, access, consent, and privacy. Other identified considerations were little discussed. These and newer concerns include: usability, tailoring services to each patient, curriculum and training, implementation, commercialization, and licensing and liability. The need for interoperability, data availability, cybersecurity, and informatics infrastructure also is more apparent. These issues are applicable to other information technologies in healthcare. Conclusions Clinicians and organizations need updated guidelines for ethical use of telemedicine and telehealth care, and decision- and policy-makers need evidence to inform decisions. The variety of newly implemented telemedicine services is an on-going natural experiment presenting an unparalleled opportunity to develop an evidence-based way forward. The paper recommends evaluation using an applied ethics, context-sensitive approach that explores interactions among multiple factors and considerations. It suggests evaluation questions to investigate ethical, social, and legal issues through multi-method, sociotechnical, interpretive and ethnographic, and interactionist evaluation approaches. Such evaluation can help telehealth, and other information technologies, be integrated into healthcare ethically and effectively. Objectives To identify and summarize ethical, legal, and social issues related to information technology in healthcare, as exemplified by telehealth and telemedicine. To expand on prior analyses and address gaps illuminated by the COVID-19 experience. To propose future research directions. Methods Literature was identified through searches, forward and backward citation chaining, and the author’s knowledge of scholars and works in the area. EU and professional organizations’ guidelines, and nineteen scholarly papers were examined and categories created to identify ethical, legal, and social issues they addressed. A synthesis matrix was developed to categorize issues addressed by each source. Results A synthesis matrix was developed and issues categorized as: quality of care, consent and autonomy, access to care and technology, legal and regulatory, clinician responsibilities, patient responsibilities, changed relationships, commercialization, policy, information needs, and evaluation, with subcategories that fleshed out each category. The literature primarily addressed quality of care, access, consent, and privacy. Other identified considerations were little discussed. These and newer concerns include: usability, tailoring services to each patient, curriculum and training, implementation, commercialization, and licensing and liability. The need for interoperability, data availability, cybersecurity, and informatics infrastructure also is more apparent. These issues are applicable to other information technologies in healthcare. Conclusions Clinicians and organizations need updated guidelines for ethical use of telemedicine and telehealth care, and decision- and policy-makers need evidence to inform decisions. The variety of newly implemented telemedicine services is an on-going natural experiment presenting an unparalleled opportunity to develop an evidence-based way forward. The paper recommends evaluation using an applied ethics, context-sensitive approach that explores interactions among multiple factors and considerations. It suggests evaluation questions to investigate ethical, social, and legal issues through multi-method, sociotechnical, interpretive and ethnographic, and interactionist evaluation approaches. Such evaluation can help telehealth, and other information technologies, be integrated into healthcare ethically and effectively.

Karacic, Jasna et al, ‘Failure of Health Diplomacy to Communicate Covid-19: Political, Ethical, Legal and Medical Perspective’ (2021) 9(2) Global Bioethics Enquiry 127–130
Abstract: The COVID-19 pandemic has demonstrated the vital importance of global solidarity to confront common public health warnings. Despite the expectations and responsibility of the World Health Organization (W.H.O.) in supporting countries to respond in a coordinated way and to bring together decisions aimed to jointly address the pandemic, it has an enormous global impact and has led to substantial misunderstanding worldwide.

Kartikawati, Dwi Ratna, ‘Professional Responsibility of Doctors in a Legal Perspective on Fulfilling Patients’ Health Rights during the COVID-19 Pandemic in Indonesia’ (2021) (Special Issue) Jurnal Undang-undang dan Masyarakat 71–83
Abstract: The COVID-19 pandemic began to enter Indonesia in early 2020, in this case the responsibilities and obligations of doctors are one of the concerns during the pandemic. The responsibility of medicine from a legal perspective is very diverse and implemented in various countries. In Indonesia, to realize the responsibilities, obligations and rights of the medical profession, it can be done through the fulfillment of a code of ethics that needs to be developed in various conditions. This study used a qualitative juridical research model with a review of legal texts and other supporting literature. It is hoped that this research can provide an overview of how the medical profession responds to the phenomenon of the COVID-19 pandemic in Indonesia and the future prospects for professional development and a medical code of ethics.

Kathuria, Yatin, ‘A Case for Implementation of Covid-19 Vaccination: A Brief Outline of the Various Associated Legal Aspects in India’ (2021) 25 Supremo Amicus Journal (unpaginated)
Abstract: In analysing and studying the various aspects of vaccination as a process, two questions need to be posed right at the outset. These are respectively what the alternatives to vaccination are? And what is the desired process of vaccination? From the first question asked, the urgency of the vaccination program can be examined, whereas from the second question asked, the various safeguards of any vaccination drive can be outlined. The purpose of the present paper is to attempt a brief answer to the above mentioned questions primarily from a legal perspective. Further, it will also be an additional (secondary) objective of the present paper to put forward brief arguments to support the claim that in the answer to the above questions, the rights-based broader questions of the citizens can be subsumed.

Kavanagh, Matthew M et al, ‘Access to Lifesaving Medical Resources for African Countries: COVID-19 Testing and Response, Ethics, and Politics’ (2020) 395(10238) Lancet (London, England) 1735–1738
Abstract: Coronavirus disease 2019 (COVID-19) has revealed how strikingly unprepared the world is for a pandemic and how easily viruses spread in our interconnected world. A governance crisis is unfolding alongside the pandemic as health officials around the world compete for access to scarce medical supplies. As governments of African countries, and those in low-income and middle-income countries around the world, seek to avoid potentially catastrophic epidemics and learn from what has worked in other countries, testing and other medical resources are of concern. With accelerating spread, funding is urgently needed. Yet even where there is enough money, many African health authorities are unable to obtain the supplies needed as geopolitically powerful countries mobilise economic, political, and strategic power to procure stocks for their populations. We have seen this before. In the AIDS pandemic lifesaving diagnostics and drugs came to many African countries long after they were available in Europe and North America. In 2020, this situation can be avoided. Although health system weakness remains acute in many places, investments by national governments, the African Union, and international initiatives to tackle AIDS, tuberculosis, malaria, polio, and post-Ebola global health security have built important public health capacities. Global leaders have an ethical obligation to avoid needless loss of life due to the foreseeable prospect of slow and inadequate access to supplies in Africa.

Kavanagh, Matthew M and Renu Singh, ‘Democracy, Capacity, and Coercion in Pandemic Response: COVID 19 in Comparative Political Perspective’ (2020) 45(6) Journal of Health Politics, Policy and Law 997–1012
Abstract: article, The COVID-19 pandemic has challenged governments around the world. It has also challenged conventional wisdom and empirical understandings in the comparative politics and policy of health. Three major questions present themselves: First, some of the countries considered to be the most prepared—having the greatest capacity for outbreak response—have failed to respond effectively to the pandemic. How should our understanding of capacity shift in light of COVID-19, and how can we incorporate political capacity into thinking about pandemic preparedness? Second, several of the mechanisms through which democracy has been shown to be beneficial for health have not traveled well to explain the performance of governments in this pandemic. Is there an authoritarian advantage in disease response? Third, after decades in which coercive public health measures have increasingly been considered counterproductive, COVID-19 has inspired widespread embrace of rigid lockdowns, isolation, and quarantine enforced by police. Will these measures prove effective in the long run and reshape public health thinking? This article explores some of these questions with emerging examples, even amid the pandemic when it is too soon to draw conclusions.

Kavanagh, Matthew M and Renu Singh, ‘Vaccine Politics: Law and Inequality in the Pandemic Response to COVID-19’ [2023] Global Policy (advance article, published online 29 March 2023)
Abstract: International mechanisms failed to achieve equitable distribution of COVID-19 vaccines—prolonging and deepening the pandemic. To understand why, we conduct process tracing of the first year of international policymaking on vaccine equity. We find that, in the absence of a single venue for global negotiation, two competing law and policy paradigms emerged. One focused on demand and voluntary action by states and firms, while the alternative focused on opening knowledge and expanding production through national and international law. While these could have been complementary, power inequalities between key actors kept the second paradigm from gaining traction on the global agenda. The failure of the prevailing policy paradigm to secure equity is explained, not by unforeseen technical and financing challenges as some suggest, but by a fundamental misalignment with the political environment. While norm entrepreneurs encouraged sharing, political incentives pushed governments towards securing and hoarding doses. Firms responded to the latter. Mechanisms like COVAX proved incapable of countering these predictable international and domestic political forces. Earlier funding would not likely have changed the behaviour of states or firms in the absence of legal commitment. Barring significant geopolitical changes, a shift to include open/supply-focused policies will be necessary to achieve equity in future pandemics.

Keane, Michael, ‘Hydroxychloroquine, Parachutes And How to Understand “The Evidence”’ (SSRN Scholarly Paper ID 3676982, 19 August 2020)
Abstract: It is deliberately misleading to make general claims that hydroxychloroquine doesn’t work for CoViD -19. It is even more misleading to claim that ‘the evidence’ proves that hydroxychloroquine doesn’t work. To understand this, consider the use of parachutes. Consider someone who claimed that parachutes don’t work to stop death or serious injury when jumping out of a plane. What if they further claimed that ‘the evidence’ proves that parachutes don’t work? Now consider if this same person advocated that because parachutes ‘don’t work’, we should ban their use and demanded that conscientious pilots who give a parachute to someone jumping out of a plane should lose their pilot’s license. Surely, such claims would be considered false and misleading. Two classic parodies, published in the British Medical Journal, showed that the above statements about parachutes are technically true. In 2003, a straight-faced literature search found no high quality, randomized, placebo-controlled trials of parachutes. The fact that people usually get squashed to smithereens when they hit the ground without a parachute was just epidemiological data. There’s no proof the parachute makes any difference. It could be due to confounding factors or bias. Subsequently, in 2018, a group of researchers actually did a randomized, placebo-controlled trial of the use of parachutes when jumping from a plane. There was no difference in death or serious injury in those who wore a parachute and those who didn’t. However, the participants jumped out of a plane 60cm off the ground while it was stationary. So, it would, or course, be misleading to make the claim that the ‘evidence says that parachutes don’t work.’ That is, the general claim that parachutes ‘don’t work’ cannot be derived from studies where they are not used in the situation where they can provide benefit. Of course, everyone is going to survive whether you give them a parachute or not when jumping from 60 cm. It is egregiously misleading, and it would be lethal, to deprive someone of a parachute when jumping from 10,000 feet based on a study that tested a parachute at 60 cm. Now let’s look at hydroxychloroquine. CoViD -19 is a disease with very different stages. And the vast majority of people, especially young people, are not going to die from CoViD -19. The suggestion from a significant amount of epidemiological data is that, if given early in the course of the disease, HCQ might prevent progression to critical illness or death in at-risk population groups. However, the randomized controlled trials (RCTs) performed to test the effect of hydroxychloroquine have been the equivalent of testing the effect of parachutes in the following circumstances: after a 60 cm jump; or pulling the rip-cord 2 feet above the ground after free-falling; or putting the parachute on someone after they hit the ground. Different RCTs on hydroxychloroquine have had variable characteristics including the following: control groups with average ages in the 30s and 40s; a cohort with 99% of patients with mild to moderate disease; a cohort with death rates of 0.4%; a cohort with zero incidence of death or mechanical ventilation; patients already on ventilators or even ECMO; patients having symptoms up to 14 days before being commenced on hydroxychloroquine; patients having symptoms an average of 16 days before commencement of hydroxychloroquine.

Kelly, Brendan D, ‘Emergency Mental Health Legislation in Response to the Covid-19 (Coronavirus) Pandemic in Ireland: Urgency, Necessity and Proportionality’ (2020) 70(May-June) International Journal of Law and Psychiatry Article 101564
Abstract: Many countries have enacted, or are in the process of enacting, emergency mental health legislation in response to the global pandemic of Covid-19 (coronavirus). In Ireland, the Emergency Measures in the Public Interest (Covid-19) Act, 2020 amends the Mental Health Act 2001 to permit the Mental Health Commission to request an independent psychiatric report about an involuntary patient from any consultant psychiatrist who is not treating the patient (and not just those on its designated panel). This independent examination may occur ‘in person’, ‘by other appropriate means’, or even, ‘due to the exigencies of the public health emergency’, not occur at all, once this is explained in the resultant report. The 2020 Act acknowledges that ‘the exigencies of the public health emergency’ might hamper the independent psychiatrist’s work and requires a written report from the patient’s treating psychiatrist ‘no earlier than the day before’ the tribunal, in lieu of the psychiatrist physically attending a tribunal hearing, although, if possible, they will attend (i.e. phone in to) a tribunal held by conference call. The 2020 Act permits the Mental Health Commission to, if necessary, appoint tribunals ‘consisting of one member who shall be a practising barrister or solicitor’. Such a tribunal shall, if possible, consult with a consultant psychiatrist if the reports from the independent psychiatrist and treating psychiatrist conflict or if it is otherwise ‘necessary in the interest of the patient’. A tribunal can extend an involuntary order by a second period of 14 days ‘of its own motion if the tribunal, having due regard to the interest of the patient, is satisfied that it is necessary’. Tribunals for current involuntary patients will be prioritised over retrospective tribunals for discharged patients; a tribunal can direct a witness to provide ‘a written statement’ rather than attending; and the patient can make written representation to the tribunal instead of physically attending a tribunal hearing, although they may attend (i.e. phone in to) a tribunal held by conference call. Psycho-surgery for involuntary patients is banned. While it is clear that revisions are urgent and necessary in light of Covid-19, the proportionality of these changes will depend on how, and the extent to which, they are used in practice. With good communication, efficient team-working and close adherence to professional codes of practice and ethics, it is hoped that these amendments will result in a review system that is as reasonable, robust and reassuring as the current, highly unusual circumstances permit.

Kelly, Brendan D et al, ‘Introduction: Mental Health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus)’ (2020) 73(November-December) International Journal of Law and Psychiatry: Special Issue on Mental Health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus) Article 101632
Abstract: The emergence of the Covid-19 (coronavirus) pandemic in late 2019 and early 2020 presented new and urgent challenges to mental health services and legislators around the world. This special issue of the International Journal of Law and Psychiatry explores mental health law, mental capacity law, and medical and legal ethics in the context of Covid-19. Papers are drawn from India, Australia, the United Kingdom, Ireland, Germany, Portugal and the United States. Together, these articles demonstrate the complexity of psychiatric and legal issues prompted by Covid-19 in terms of providing mental health care, protecting rights, exercising decision-making capacity and a range of other topics. While further work is needed in many of these areas, these papers provide a strong frame-work for addressing key issues and meeting the challenges that Covid-19 and, possibly, other outbreaks are likely to present in the future.

Kelman, Mark, ‘Rationing in the Time of COVID and the Perils of Anti-Subordination Rhetoric’ (2021) 77(2) Washington and Lee Law Review Online 249–269
Abstract: With surges in COVID-19 cases threatening to overload some hospital facilities, we must face the possibility that therapeutic treatments will need to be rationed, at least in some places. I do not propose any particular ideal rationing scheme but caution strongly against adopting a position that Professor Bagenstos advocated this past spring, rejecting rationing on the basis of patient life expectancy simply because life expectancy based rationing might threaten the factual interests of those with disabilities and might conceivably be implemented by those making judgments that were not simply inaccurate but grounded in biased, unacceptably discriminatory intuitions that some decision makers would have about the life expectancy of those with disabilities. My view is that Professor Bagenstos does not make either considered normative or empirical arguments that attending to the factual interests of those with disabilities or protecting against the possibility of discriminatory implementation of a plan should trump all other considerations; instead, he is ‘performing’ his rhetorical commitment to a subordinated community as though that commitment functioned in the same way as a formal, normatively and factually defended side constraint on action would function.

Khan, Mehran Idris et al, ‘Novel Coronavirus and Emerging Mental Health Issues: A Timely Analysis of Potential Consequences and Legal Policies Perspective’ (2021) 14(1) Fudan Journal of the Humanities and Social Sciences 87–105
Abstract: The present outbreak of coronavirus disease 2019 (COVID-19) has swiftly crossed borders, and inflicted the global mental health issues. It is also affecting peoples’ daily behaviours, economics, prevention strategies and decision-making among policymakers, healthcare organisations and medical centres that may unintentionally weaken COVID-19 control strategies and lead to increased morbidity, as well as mental health care needs globally. Ultimately, this outbreak is leading to further health complications worldwide, such as stress, fear of the unknown, anger, anxiety, denial, depression symptoms, and insomnia. Notwithstanding all the resources used to counter the spread of the virus, further universal strategies are desirable to address the associated mental health problems. The present study uses the qualitative means to investigate the potential impact of COVID-19, the consequences and legal aspects, then recommend policy implications, in an attempt to cover any apparent loopholes. It presents a unique analysis of its kind on the policy and legal aspects of the ongoing pandemic, as regards mental health. It concludes that there is an acute need to prioritising the health care and curative issues, strengthen awareness and address the psychological syndromes or similar complications afflicting members of the general public during this pandemic.

Khan, Muhammad Danyal, Muhammad Mumtaz Ali Khan and Imran Alam, ‘Dealing Anti-Vaxxers; Legal Framework to Deal the COVID-19 Immunisation Hesitancy in Pakistan’ (2021) 12 Pakistan Journal of Social Issues 171–180
Abstract: The COVID-19 vaccine has been administered to the majority of population through governmental initiatives. Keeping in view the polio vaccine hesitancy and challenges, the government of Pakistan needs to deal with the COVID-19 immunisation hesitancy. There are numerous reasons for uncertainty about the vaccine that included religious misinterpretations, fake-news, socio-cultural conservative ideas, and lack of understanding about the progress within the therapeutic sciences. Owing to the challenges of vaccinating the entire population effectively, the authorities of Punjab, Pakistan have adopted a new law to conduct the immunisation campaigns in Pakistan. This paper will analyse the efficacy of the new legal framework to deal with the expected issue of vaccine hesitancy in Punjab, Pakistan.

Khanal, Anjita, Sara Franco-Correia and Maria-Pilar Mosteiro-Diaz, ‘Ethical Conflict among Critical Care Nurses during the COVID-19 Pandemic’ (2022) 29(4) Nursing Ethics 819–832
Background: Ethical conflict is a problem with negative consequences, which can compromise the quality and ethical standards of the nursing profession and it is a source of stress for health care practitioners, especially for nurses.
Objectives: The main aim of this study was to analyze Spanish critical care nurses’ level of exposure to ethical conflict and its association with sociodemographic, occupational, and COVID-19 related variables.
Findings: Data indicates a moderate level of exposure to ethical conflicts. The most frequent ethical conflicts were related to situations about ‘treatment and clinical procedures.’ The most intensity of ethical conflicts was related to situations about ‘treatment and clinical procedures’ and ‘dynamics of the service and working environment.’ No statistical significance was identified between the socio-demographic variables and level of exposure to ethical conflicts. However, for critical care nurses working in ICU, nurses with perceived worked stress had a higher level of exposure to ethical conflicts. Likewise, critical care nurses whose family/friends were infected with COVID-19 had a higher level of exposure.
Conclusions: Critical care nurses experience a moderate level of exposure to ethical conflicts which is consistent with the results of previous studies. A deeper understanding of ethical conflicts in conflictive situations allows recognition of the situations that occur in everyday clinical practice, identification of the ethical conflicts, and facilitation of the nurses working in the challenging clinical situation.

Kim, Oliver, ‘Tsunami: Recommitting to Address AAPI Mental Health in a Post-COVID Era’ (2022) 46 Nova Law Review 370-392 (pre-print published on SSRN 18 May 2022)
Abstract: For too many in the Asian American and Pacific Islander (AAPI) community, this past year has been one of particular hardships: a global pandemic that caused suffering at home and abroad, political and social unrest, economic hardship, and an ongoing series of violent attacks on Asian Americans. Some health experts warn that this COVID pandemic will be followed by widespread mental health issues caused by the stressors that the pandemic has caused—social isolation, the economic anxiety, and political and social unrest that have engulfed our collective psyche. But again, for many communities of color, these stressors only brought to light disparities in our healthcare system, particularly our mental health system. As policymakers and stakeholders envision a new system, particularly for mental health, in a post-pandemic world, we should add our voices for a more equitable system by calling out the circumstances facing the Asian American community. This is a pivotal time to not only address the coming ‘second pandemic’ of mental health issues brought about by the COVID pandemic but also to rebuild the healthcare system and address systemic changes that have long needed attention. Like many other communities of color, AAPI communities are no strangers to understanding racism as a public health issue, and the pandemic has exacerbated such underlying tensions, not necessarily generated new ones. Like other communities of color, the history of AAPIs in the United States is complicated, running the gamut as explored below between outright exclusion to elevation as a model minority and a wedge for identity politics. For instance, economic anxieties about China as well as scapegoating of Asian American-owned businesses parallel the nativism that led to events ranging from the passage of the Chinese Exclusion Act to the Vincent Chin murder. In building that more equitable system, this paper will discuss three interconnected—but not necessarily exhaustive— issues to facilitate a more equitable mental health system post-pandemic: Asian cultural attitudes towards mental health, AAPIs’ station as a community of color, and understanding the long-term impact of the COVID pandemic on the community. The paper will then turn to recommendations to not only addressing the mental health needs of the AAPI community in the wake of COVID and the uptick in violence but also bringing greater equity into mental health services for all communities of color. For example, recently Congress passed the Covid-19 Hate Crimes Act, an important part of responding. But some critics argue that the law does not address the underlying causes of anti-Asian sentiment nor the needs of the community.

Kitahara, Kanako et al, ‘An Overview of the Reclassification of COVID-19 of the Infectious Diseases Control Law in Japan’ [2023] Global Health & Medicine (advance article, published online 8 April 2023)
Abstract: Japan’s responses to COVID-19 have been conducted based on the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases (the Infectious Diseases Control Law) and the Act on Special Measures against Novel Influenza, etc. (the Act on Special Measures), as COVID-19 is classified as the category of ‘the Novel Influenza etc.’ under the Infectious Diseases Control Law. The government’s Novel Coronavirus Response Headquarters decided to reclassify COVID-19 as a Category V infectious disease under the Infectious Diseases Control Law in May 2023 since the disease has become less lethal. Accordingly, the countermeasures such as surveillance and medical care are going to be reviewed, and COVID-19 prevention actions will depend on personal choices (Prior to the review in May, mask usage will be changed from 13 March). However, this does not mean that infection control measures are no longer necessary; it is recommended that such measures be taken in certain settings in order to prevent the elderly and those who at a high risk of severe illness from being infected, even after the disease is classified as Category V.

Kitchin, Rob, ‘Civil Liberties or Public Health, or Civil Liberties and Public Health? Using Surveillance Technologies to Tackle the Spread of COVID-19’ [2020] Space and Polity (advance article, published 3 June 2020)
Abstract: To help tackle the spread of COVID-19 a range of surveillance technologies – smartphone apps, facial recognition and thermal cameras, biometric wearables, smart helmets, drones, and predictive analytics – have been rapidly developed and deployed. Used for contact tracing, quarantine enforcement, travel permission, social distancing/movement monitoring, and symptom tracking, their rushed rollout has been justified by the argument that they are vital to suppressing the virus, and civil liberties have to be sacrificed for public health. I challenge these contentions, questioning the technical and practical efficacy of surveillance technologies, and examining their implications for civil liberties, governmentality, surveillance capitalism, and public health.

Knoppers, Bartha Maria et al, ‘Modeling Consent in the Time of COVID-19’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa020
Abstract: Effective responses to the COVID-19 pandemic require novel solutions for research and responsible data sharing. Biobanking presents itself as a key priority in furthering our understanding of COVID-19. In this article, we propose a tripartite approach to consent to create resources for research relating to COVID-19. The approach aims to link three levels of participation: COVID-19 patients, respiratory/infectious disease patients, and longitudinal study participants. We explore the potential approaches that can be taken to consent processes with these three participant groups. We furthermore describe an access model for both single-site and multi-site data and sample storage. Through dealing with these topics at a high level, the model may be adapted to local legal and ethical requirements while still pursuing its ultimate goal: the creation of a research infrastructure that supports transparent, strong, and open science.

Koch, Valerie Gutmann and Susie A Han, ‘COVID in NYC: What New York Did, and Should Have Done’ (2020) 20(7) American Journal of Bioethics 153–155
Abstract: New York is in the unenviable position of being the first and largest COVID-19 hotspot in the United States, forcing city and state leaders to make difficult — if not impossible — policy decisions in order to avoid community spread, reduce the burden on health care institutions and providers, and distribute scarce resources such as tests, personal protective equipment, medical equipment, and staff. In their evaluation of New York’s response to the coronavirus’ assault on the state, Powell and Chuang enumerate three things the state could do better. As the New York State Task Force on Life and the Law’s staff members who oversaw the publication of New York’s Ventilator Allocation Guidelines (2015), we believe their second recommendation, that ‘communities should insist that political representatives demonstrate responsible leadership by implementing, and updating as needed, crisis standards of care in public health disasters,’ is crucial to ensuring public trust and the greatest benefit to as many patients as possible.

Kolber, Adam J, ‘Why We (Probably) Must Deliberately Infect’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa024
Abstract: In the grip of a pandemic of proportions that have not been seen for generations, some have proposed conducting ‘human challenge’ vaccine trials in which healthy volunteers are deliberately infected with the SARS-CoV-2 virus that causes COVID-19. Such trials might substantially speed up the search for a safe and effective vaccine and save many thousands of lives. I argue that such trials are not only permissible, but given reasonable assumptions, they are morally required, subject to some important caveats.

Kolouch, Jan, Tomáš Zahradnický and Adam Kučínský, ‘Cyber Security: Lessons Learned from Cyber-Attacks on Hospitals in the Covid-19 Pandemic’ (2021) 15(2) Masaryk University Journal of Law & Technology 301–341
Abstract: The article deals with the issue of cyber security, specifically the security of medical facilities. The introduction summarizes and briefly analyzes the cyber attacks demonstrated on Czech health care facilities in the period from 12/2019 to 1/2021, together with the procedures adopted by the responsible authorities. The article also newly presents the current regulatory requirements for cyber security of hospitals. In the context of past attacks and based on analyzes of attacks, current legislation and events, the article will provide an opinion on whether the requirements for cyber security of hospitals are set sufficiently or whether this area should be revised. At the same time, measures will be recommended to strengthen the cyber security of hospitals.

Kompas, Tom et al, ‘The Scythe versus the Hammer: Health and Economic Costs of COVID-19 Control in Australia’ (SSRN Scholarly Paper No ID 3608596, 23 May 2020)
Abstract: We evaluate whether a lock-down to control COVID-19 infections is justified by estimating the economic costs for the ‘scythe’, the absence of any government-imposed suppression measures and the ‘hammer’, an early lock-down intended to drastically reduce community transmission. Using a fit-for-purpose compartment model for Australia estimated from actual data, and a value of a statistical life year (VSLY) to measure welfare losses of COVID-19 patients, we find: (1) economic costs of the scythe are several times greater than the hammer; (2) VSLY welfare losses of fatalities equivalent to GDP losses from a lock-down indicate that for the hammer not to be the preferred strategy requires that Australians prefer more than 30,000 deaths to an 8-weeks lock-down; and (3) in a high-income countries, like Australia, the preferred response to COVID-19 from both a public health and and economy perspective is to ‘go hard, go early’.

Kornienko, Alexander and Nikolai Samokhvalov, ‘COVID-19: Legal Regulation of Universal Vaccination’ (2021) 2(3) Legal Issues in the Digital Age 151–167
Abstract: The topic of this article is relevant, first of all, due to the fact that at the moment it is objectively impossible to deny the acquisition of the COVID-19 pandemic and its consequences as a kind of main indicator of socio-economic processes and a mechanism for legitimizing the state system of regulation and management in covid and post-covid conditions. The subject of the article is the legal regulation of mandatory vaccination against COVID-19. The purpose of the study is to identify the problems of legal regulation of the process of mandatory vaccination against COVID-19 through the prism of the human right to health protection and medical care in the system of universal values. This research is based on a combination of groups of general scientific methods (induction, deduction, analysis, synthesis) and special methods of legal science (formal legal, comparative legal and others). The authors carried out a conceptual analysis of the human right to health protection and medical care in the context of domestic law, as well as administrative and legal aspects of mandatory vaccination against COVID-19 based on the analysis of the generalized experience of two macro-regions of Moscow and the Moscow region. According to the results of the study, the authors come to the following key conclusions: firstly, the chief state sanitary doctor of the subject of the Russian Federation has an objective right dictated by the norms of domestic legislation to issue an executive-executive-administrative act on the mandatory vaccination in a pandemic; secondly, the employer is obliged to suspend from work (not to hire)citizens who refused vaccination only if it is a question of works named in the List of works, the performance of which is associated with a high risk of infectious diseases. Such measures cannot be applied to employees performing other types of work; thirdly, failure by an organization/individual entrepreneur to comply with resolution of the chief state sanitary doctor entails appropriate measures of legal responsibility provided for by the norms of the current legislation of the Russian Federation.

Kothari, Radha et al, ‘COVID-19 and Prisons: Providing Mental Health Care for People in Prison, Minimising Moral Injury and Psychological Distress in Mental Health Staff’ (2020) 60(3) Medicine, Science and the Law 165–168

Kramer, Katherine Jennifer, Capricia Bell and Maurice-Andre Recanati, ‘For Those with Inadequate Legal Documents, COVID-19 Vaccination Remains Challenging’ (2021) 5(2) World Journal of Gynecology & Womens Health 609
Abstract: Mass vaccination against COVID-19 is ever urgent as the incidence of infection with the more contagious and severe Delta variant continues to rise. Though the COVID-19 vaccination is recommended for eligible individuals over the age of twelve and has become widely available to all, it remains elusive for poorly document individuals.

Krueger, Jill, ‘Legal Strategies for Promoting Mental Health and Wellbeing in the COVID-19 Pandemic’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 138–142
Abstract: While mental health is often viewed as a matter of individual treatment of mental illness, mental health and well-being may be promoted throughout the population, including through law and policy. The inadequacy of our mental health care system, including limited public and private insurance coverage and provider shortages, has been apparent during the response to COVID-19, though expanded access to tele-mental health has closed the gap somewhat. Inability to meet basic needs contributes to stress, anxiety, and depression, so COVID-19 response measures to ensure access to employment or unemployment benefits, housing, food, childcare, and the like are critical to community mental health. Interventions aimed at mental health, such as Psychological First Aid, the Crisis Counseling Program, suicide prevention, and violence prevention programs can promote feelings of calm and safety, while supporting collaboration, nurturing problem-solving skills, and increasing hope. Longstanding inequities have contributed to higher infection and mortality rates, especially among African Americans, Latinos, and Native Americans, while Asian-Americans have been targeted with harassment and discrimination, making legal action to support mental health in communities of color essential. With schools abruptly shifting to remote learning in spring, school-based mental health services and opportunities for social emotional learning were disrupted. Intentional support for the mental health and wellbeing of students, teachers, school employees, and parents is needed this fall, regardless of educational setting. If the COVID-19 pandemic is viewed as a mass trauma, strategies to support posttraumatic growth ought to be at the forefront of pandemic response, recovery, and restructuring.

Kukura, Elizabeth, ‘Birthing Alone’ (2022) 79(4) Washington and Lee Law Review 1463–1537
Abstract: Throughout the COVID-19 pandemic, hospitals implemented restrictive visitor policies that have prevented many pregnant people from giving birth with their chosen support people. For some, this meant foregoing labor and delivery support by a birth doula, someone who serves in a nonclinical role and provides emotional, physical, and informational support to birthing people. Given that continuous labor support such as the care provided by doulas is associated with fewer cesareans and other interventions, less need for pain medication, and shorter labors, the promotion of doula care is a promising strategy to ease the maternal health crisis and, in particular, shrink the perinatal health equity gap, as reflected in a pregnancy-related mortality rate for Black women that is three to four times higher than for White women. As COVID-19 case rates declined and hospitals relaxed their restrictions, some doulas found themselves subject to new hospital credentialing requirements in order to attend births, even though they serve in nonclinical roles and are hired by the birthing person rather than the hospital. This Article explores the often-contested relationship between doulas and hospitals, and between doulas and hospital-based perinatal care providers, against the historical backdrop of other restrictions on birthing companions since birth shifted from the home to the hospital around the turn of the twentieth century. It details the important role doulas play in promoting good perinatal health outcomes and considers why many hospitals and healthcare providers perceive doulas as a threat rather than as a source of value in the delivery room, which results in strategies to restrict doulas through formal and informal mechanisms. This Article suggests that hostility to doulas and restrictions on birth support reflect central qualities of mainstream perinatal care, such as liability-driven decision-making, nonadherence to evidence-based medicine, medical paternalism, and fear, all of which interfere with efforts to improve health outcomes in the midst of a maternal health crisis that disproportionately burdens communities of color. Ultimately, this Article argues that doula credentialing is a regulatory mismatch that should be abandoned by hospitals as misguided and counterproductive, and instead identifies public and private policy changes, along with related advocacy strategies, that would provide appropriate recognition of doulas within the perinatal healthcare system and serve both patient and provider interests while protecting the autonomy of doulas to operate within their scope of practice. Increased attention to the United States’ maternal health crisis and the opportunity to advance healthcare reforms that incorporate lessons from the pandemic make this a critical time to prevent the widespread adoption of credentialing requirements before they become the default norm, and instead to pursue investment in growing the doula model as an efficient and effective means to improve childbirth experiences and reduce the stark racial inequities in perinatal health outcomes.

Kuppuswamy, Gayathri and Uma Warrier, ‘COVID-19 and Violence against Doctors: Why a Law Is Needed?’ (2021) 10(1) Journal of Family Medicine and Primary Care 35–40
Abstract: Today, when India is reeling under the COVID-19 epidemic, a new epidemic disease (Amendment) Ordinance has been brought out with regard to protection of the health care staff, which is a big welcome step to the medical fraternity. A much-needed step. The assaults on doctors have been happening in hospitals in India for a long time. This review article traces the journey of the Prevention of the Doctors Violence Act and suggests a way forward with regard to violence on the doctors and why there must be a permanent solution for the same. Methodology is based on a detailed study across a range of published literature in journals, articles, and other online sources. An extensive review has been undertaken of these articles based on an explanatory approach. The review provided insight into the current status of violence against doctors. Most of the initiatives on prevention of violence against doctors mentioned in the studies are mainly directed towards patient-doctor relationship, lack of infrastructure, strenuous working environment, and societal obligations. Study findings revealed that there was less emphasis on the current legal measures available and its implementation. This article highlights the critical aspect of protection of the health care workforce and also shares recommendations to enhance the protection of doctors at their workplace by sharing the current state-level legal measures available and advocates the impelling need for central legislation. These recommendations have been suggested as a combined effort of the medical fraternity, media, and the academic community.

Lanphier, Elizabeth and Shannon Fyfe, ‘Pediatric Off-Label Use of Covid-19 Vaccines: Ethical and Legal Considerations’ [2021] Hastings Center Report (advance article, published 8 November 2021)
Abstract: When the U.S. Food and Drug Administration fully approved the Pfizer-BioNTech Covid-19 vaccine for people sixteen and older, questions arose. Parents, pediatricians, and the media wondered whether Covid-19 vaccines could be used off-label—and whether they should be. The American Academy of Pediatrics cautioned against pediatric off-label use of the vaccine, and the vaccine provider agreement from the Centers for Disease Control and Prevention appears to prohibit it. After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of a blanket prohibition on off-label pediatric Covid-19 vaccination, as it limits clinician ability to provide care they may determine to be clinically and ethically appropriate. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.

Lasmadi, Sahuri, ‘The Legal Act on Counterfeiting the Covid-19 Vaccine in Indonesian Health Law’ (2021) 5(2) International Journal of Law Reconstruction 273–291
Abstract: The International Criminal Police Organization has officially issued a global warning to law enforcement officials in 194 member countries to prepare to prevent and deal with various world criminal networks that will seek to utilize the Covid-19 vaccine, both physically. The online form is counterfeiting the Covid-19 vaccine. This study aims to analyze the criminal act of counterfeiting the Covid-19 vaccine from the Health Law in Indonesia. The research method used is the Normative Law research method, which examines library materials or secondary data. Normative legal research is also called doctrinal legal research. The criminal act of counterfeiting the Covid-19 vaccine is generally regulated in Article 386 Paragraph 1 of the Criminal Code relating to acts of fraud and forgery. However, it is specifically regulated in the provisions regarding penalties for distributing fake vaccines in Indonesia as regulated in Articles 196, 197, 198, and 201 Act No. 36 of 2009 concerning health. The ingredients are everyone deliberately and producing and circulating counterfeit vaccine preparations. For the criminal act ofCovid-19 vaccine counterfeiting corporate, the corporation can be subject to additional penalties in the form of revocation of business licenses and revocation of legal entity status.

Law, Richard WM and Kartina A Choong, ‘Covid-19: Refracting Decision-Making through the Prism of Resource Allocation’ (2020) 88(2) Medico-Legal Journal 97–101
Abstract: Medical decision-making has, across the history of the NHS, made a transitional journey from a model characterised by paternalism to one which places emphasis on partnership and patient autonomy. This article assesses the extent to which the circumstances generated by the Covid-19 pandemic affect the mode of critical care decision-making. It observes that clinical judgment influenced by protocols, algorithms and resource constraints do not lend themselves to full identification with either of the two frameworks familiar to the NHS. The unique mode of decision-making engendered can only be understood on its own terms.

Leader, Sheldon, ‘The Reach of Rights in the Crisis’ in Carla Ferstman and Andrew Fagan (eds), Covid-19, Law and Human Rights: Essex Dialogues (School of Law and Human Rights Centre, University of Essex, 2020) 5–9
Introduction: This chapter explores some central challenges to bringing domestic and international human rights principles to bear on the provision of health care in this pandemic. It looks at the ways in which policy aims to balance a variety of competing rights and demands. Some involve competition for access to scarce resources in hospitals, where the competition might be between possessors of the same right to enjoy the highest attainable standard of health: a gain for one might require a loss for another. Other situations involve a competition between a human right that might conflict with institutional demands that do not themselves rank as implementing human rights, but are nevertheless demands that are sometimes considered legitimate and which can exercise considerable downward pressure on the ability to give full effect to the human rights in question. This happens in the present pandemic, for example, when orders, backed by the threat of dismissal, are given by some enterprises to their workforces to return to work despite evidence that this return can jeopardise their health. While the enterprise cannot usually claim to be making a human rights-based demand in an order to return to work, there is here a recognisable competition between the right to health and the demand to stimulate the economy.

Lee, Christopher M et al, ‘Assessment on the Effectiveness of Universal Health Care (UHC) Law in the Philippines during the Covid-19 Pandemic: An Analysis’ (27 January 2023)
Abstract: The Philippines Universal Health Care (UHC) Law are indeed one of the public policies that are considered mandatory towards our health care interventions and primarily concern with the basic healthcare problems like the Covid-19 Pandemic that strikes the Philippines last 2020-2022, and the healthcare services towards Filipinos. It likewise gives us healthcare assistance on both rural and urban facility conveniences. The construction of the research article is to give importance to UHC Law, and how these public policy help us to improve our healthcare systems and services. Because, If we talked about personal health, many people may agree that Health is wealth, and Health must be prioritize among us. Meanwhile, the research limits possible circumstances during the progress of the study article. These may discuss in the latter part of the article. And as for the future and potential researches about UHC Law, many people may agree that searching for different healthcare improvement, services and proposed research suggestions always depends on the economic stability and healthcare progress of one nation. That is why the completeness of the research study may set future guidelines and recommendations.

Lee, Tsung-Ling, ‘COVID-19 Vaccination Certificates and Their Geopolitical Discontents’ (2021) 12(2) European Journal of Risk Regulation 321–331
Abstract: At the international level, proof of vaccination against SARS-CoV-2 offers an enticing promise to the return of normality, particularly for the much-desired reopening of national borders. At the same time, vaccination passports could be a false hope: the requirement of vaccine passports could adversely embed social and economic inequalities that reflect the power dynamics in international relations. Specifically, the ability to secure vaccines relates to the varying market and economic power across countries. This paper focuses on Taiwan as a case study to explore ways in which the use of COVID-19 certifications, if used as a precondition for international travel, would further exacerbate a binary of exclusion and inclusion as a function of geopolitics. With its relative success in containing the COVID-19 pandemic within its borders, Taiwan represents a low priority for vaccine distribution in the COVAX initiative. Furthermore, due to Taiwan’s contentious political status and its exclusion from the World Health Organization regime, if vaccination passports are required as a precondition for international travel, then outbound passengers from Taiwan potentially could be subjected to restriction of movement absent wide availability of vaccines domestically. This paper argues that insofar as sustainable pandemic control requires a global concerted effort, vaccination passports could further polarise a global response. This paper suggests that equitable access to effective vaccines worldwide and governance reform of global health would help to rebuild global solidarity and mitigate the unimaginable human, social and economic suffering arising from the pandemic.

Lee, Tsung-ling, ‘Global Health in a Turbulence Time: A Commentary’ (2020) 15(1) Asian Journal of WTO & International Health Law and Policy 27–60
Abstract: The emergence of the 2019 novel coronavirus—or COVID-19—outbreak has resuscitated global attention on the state of global health governance. Legal scholars and political scientists have long been fascinated by global governance of health, which had galvanized intellectual discourse that began almost two decades ago. Increasingly, global health operates in a complex, multipolar world, which is informed by pluralistic values. The ever-changing configuration of players, interests and values adds complexity to the global health landscape. It is timely to reexamine the landscape of global health, where new transnational challenges—such as galvanizing a global concerted effort towards international infectious disease control, financing global health activities in a sustainable manner, and achieving Universal Health Coverage—also inform new global health configuration. The article takes a historical view and traces the evolving of the global health landscape and examines the various of norms, processes and institutions that form global governance of health. The article also identifies the strengths and weakness of the International Health Regulations—the international legal architecture for international infectious disease control—as the novel coronavirus outbreak unfolds.

Lemmens, Trudo, ‘Addressing the Tension between Discrimination Law and Pandemic Clinical Triage Protocols’ (2020) 2020 Jotwell: The Journal of Things We Like (Lots) 1

Lemmens, Trudo and Roxanne Mykitiuk, ‘Disability Rights Concerns and Clinical Triage Protocol Development During the COVID-19 Pandemic’ (2020) 40(4) Health Law in Canada 103–112
Abstract: In the context of the COVID-19 pandemic a number of jurisdictions and authorities have drafted triage protocols to guide decision making in the face of severe shortage of ventilators and intensive care resources. Several of these have evoked debate about their compatibility with human rights standards, and in particular the rights of people with disabilities. In Canada, the Canadian Medical Association came out with a general Framework for Ethical Decision Making, while Ontario Health produced a draft Clinical Triage Protocol for Major Surge in COVID Pandemic. In this commentary we critically review both documents to determine how their development process and their substantive provisions align with approaches to substantive equality and the promotion of human rights of persons with disabilities. We offer a number of recommendations to ensure that the human rights of persons with disabilities are promoted in COVID-19 triage policies.

Lemos, George Azevedo et al, ‘Human Anatomy Education and Management of Anatomic Specimens during and after COVID-19 Pandemic: Ethical, Legal and Biosafety Aspects’ (2021) 233 Annals of Anatomy / Anatomischer Anzeiger Article 151608
Abstract: COVID-19 is an infection caused by the SARS-CoV-2 virus, initially identified in the city of Wuhan, China, in December 2019. Since then, the virus has spread to the continents, causing a major pandemic. The impacts of this pandemic on the education of human anatomy interfere in at least two aspects: (1) receiving and managing anatomical specimens in anatomy laboratories and (2) adaptations for classes on remote virtual teaching. Therefore, this study reviewed and discussed the legal and bioethical aspects, considering the scenario of a South American Country, aiming to stimulate the debate on these two relevant themes in the international community. Because of the COVID-19 pandemic and the impossibility of mass testing, anatomists and other workers in the field must deal with the risk of receiving bodies infected with SARS-CoV-2. In this situation, additional care measures in biosafety practices are essential to protect the staff. Such measures are: the bodies must be preserved by the perfusion of formaldehyde or other fixative solutions; embalming must be performed in ventilated rooms with a good air exhaust system; to avoid excessive manipulation of bodies and procedures such as pulmonary insufflation or craniotomy; and proper use of personal protective equipment, including lab coat, gloves and masks. As for exposure of body images in online classes, this review showed that there are no legal impediments to this end. However, anatomists must adopt measures aimed at protecting the memory of the deceased, such as using secure digital platforms with restricted access; family authorization/consent and student awareness.

Lersch, Kim M, ‘COVID-19 and Mental Health: An Examination of 911 Calls for Service’ [2020] Policing: A Journal of Policy and Practice Article paaa049 (advance online article, published 5 August 2020)
Abstract: The purpose of this study was to explore the rate and geographic distribution of 911 calls for service related to mental health issues during the Coronavirus Disease 2019 (COVID-19) pandemic in the City of Detroit, MI, USA. The results suggest that the total number of calls for mental health issues was at the lowest level when compared with the same time period for the previous 3 years. Furthermore, as both the daily reported COVID-19 cases and related deaths increased over time, there was a significant decline in both suicide threats and suicides in progress. Significant hot spots were found for the total calls as well as for threats of suicide. These hot spots did not coincide with the spatial distribution of reported cases of COVID-19 by ZIP code. While higher and lower areas of reported cases were found, these differences by ZIP code were not found to be significant. When compared with the previous 3 years of data, the hot spot area was much smaller in 2020, implying that the mental health-related calls for service were more evenly spread throughout the city.

Levy, Neil and Julian Savulescu, ‘Epistemic Responsibility in the Face of a Pandemic’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa033
Abstract: Should non-experts defer to epidemiologists with regard to the response to the coronavirus pandemic? We argue that deference is required with regard to settled science: non-experts (that is, people who may possess expertise of their own but whose expertise is not relevant to a particular question) ought to defer with regard to climate science and the efficacy of vaccines. However, we suggest that this deference is warranted because these questions have been appropriately probed many times by many different kinds of people. While non-experts should defer to epidemiologists with regard to matters within the sphere of epidemiology specifically, responding to the pandemic requires expertise from many fields. We best build a consensus worth deferring to by contributing our expertise now. Ethicists and philosophers are not epistemically arrogant if they question policy responses. Rather, they play a responsible role in building a reliable consensus.

Lexchin, Joel et al, ‘Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19’ (2021) 51(1) International Journal of Health Services 5–13
Abstract: Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials is becoming more available, regulators are still reluctant to provide detailed information about how that information is interpreted. As medicines and vaccines come up for approval for treatment of COVID-19, transparency in how pivotal trials are interpreted will be critical in determining how these treatments should be used.

Li, Yan and Sandro Galea, ‘Racism and the COVID-19 Epidemic: Recommendations for Health Care Workers’ (2020) 110(7) American Journal of Public Health 956–957
Abstract: In the midst of the COVID-19 pandemic, racism and racial discrimination against people of Asian descent may have the following adverse health consequences. First, racism causes mental health problems—such as depression and anxiety—among those targeted. As misinformation about the causes of the virus spread rapidly on social media, people of Chinese or other Asian descent have been increasingly discriminated against and isolated at work, at school, and in other public places. Several countries and many local businesses have decided to ban Chinese nationals from entry, which inevitably increases the stress level of those thus restricted and may have long-term mental health consequences for them.

Liddell, Kathleen et al, ‘Isolating Residents Including Wandering Residents in Care and Group Homes: Medical Ethics and English Law in the Context of Covid-19’ (2021) 74(January-February) International Journal of Law and Psychiatry Article 101649
Abstract: This article investigates the lawfulness of isolating residents of care and group homes during the COVID-19 pandemic. Many residents are mobile, and their freedom to move is a central ethical tenet and human right. It is not however an absolute right and trade-offs between autonomy, liberty and health need to be made since COVID-19 is highly infectious and poses serious risks of critical illness and death. People living in care and group homes may be particularly vulnerable because recommended hygiene practices are difficult for them and many residents are elderly, and/or have co-morbidities. In some circumstances, the trade-offs can be made easily with the agreement of the resident and for short periods of time. However challenging cases arise, in particular for residents and occupants with dementia who ‘wander’, meaning they have a strong need to walk, sometimes due to agitation, as may also be the case for some people with developmental disability (e.g. autism), or as a consequence of mental illness. This article addresses three central questions: (1) in what circumstances is it lawful to isolate residents of social care homes to prevent transmission of COVID-19, in particular where the resident has a strong compulsion to walk and will not, or cannot, remain still and isolated? (2) what types of strategies are lawful to curtail walking and achieve isolation and social distancing? (3) is law reform required to ensure any action to restrict freedoms is lawful and not excessive? These questions emerged during the first wave of the COVID-19 pandemic and are still relevant. Although focussed on COVID-19, the results are also relevant to other future outbreaks of infectious diseases in care and group homes. Likewise, while we concentrate on the law in England and Wales, the analysis and implications have international significance.

Liddell, Kathleen et al, ‘Who Gets the Ventilator? Important Legal Rights’ (2020) 46(7) Journal of Medical Ethics (Forthcoming) 421–426
Abstract: At some point during this pandemic or next, all countries will need to answer hard questions about whether and when scarce ICU resources (such as ventilators, beds and staff) should be either withheld or withdrawn from certain groups of patients solely for the purpose of providing them to others. Attempts to answer these hard questions can be found in ICU triage protocols and ethical guidance documents, many of which embrace the foundational principle of ‘save the most lives’. Unfortunately, this worthwhile goal has generated many suggestions that could violate the law. This article identifies 10 ways in which the withholding or withdrawal of a clinically indicated ventilator might violate a patient’s rights, along with recommendations on how to avoid doing so. While our analysis is based on UK law, its lessons are relevant for other countries with similar legal systems. If the issues we identify are not addressed, doctors may act unlawfully. Worse, patients may die unlawfully.

Lilienthal, Gary I, ‘Anti-Pandemic Legal Rules: Medicalization by the Established Contagion Principles of Fracastoro’ in Gary I Lilienthal (ed), Human Capital and Development: Economic Issues, Problems and Perspectives (Nova Science Publishers, 2021) 257–297
Link to book page on publisher’s website for details and pricing
Abstract: In 2020, Rajasthan acted against more than 1,300 people for violating anti-pandemic rules, relating to COVID-19, suggesting ‘medicalization’ of the government’s response. The objective of this research is to examine critically the genesis of this form of medical regulation. The question is whether the state response to pandemics is medicalized, and if so, how. Argument seeks to demonstrate that early regulatory and legislative responses had derived from fears of ‘otherness’, arising from alchemical medical metaphors, allowing states to confer administrative powers onto medical officials to contain the jurisdiction’s human capital and prevent its decay. Fracastoro’s alchemical formulae for opposing seedlets by antipathetic means were the bases for future legislation. The 542 CE Acts of Justinian established a system by which pandemics could be controlled. Fracastoro demonstrated to the Pope that his alchemical metaphor of contagion could move and herd a Papal conclave. The International Sanitary Conferences confirmed national rules into international medicalization of human capital, using Fracastoro’s principles, becoming the International Health Regulations 2005.

Lima, Taisa Maria Macena De and Maria de Fátima Sá, ‘The Right to Mental Health in Brazil and the Silent Pandemic’ (2020) 2(2) Humanities and Rights Global Network Journal 42–65
Abstract: This text focuses on the psychological repercussions of the Covid-19 pandemic on mental health. Repercussions that tend to endure in the post-pandemic world. The background of this article is the Brazilian law, and it develops in two parts. The first centered on the legislation hierarchically inferior to the Constitution to protect mental health, and the second focused on reaching the silent pandemic, that is, the mental illness resulting from traumas generated by the new coronavirus pandemic.

Lingis, Alphonso, ‘The New Fear of One Another’ (2020) 17 Journal of Bioethical Inquiry 471–472
Abstract: The COVID-19 contagion makes us fear anyone and everyone. Fear those with whom we are quarantined. Fear those confined in institutions. Doctors and nurses, who nonetheless care for us, know the most intense fear.

Liu, Yangzi, Sanjana Salwi and Brian C Drolet, ‘Multivalue Ethical Framework for Fair Global Allocation of a COVID-19 Vaccine’ (2020) 46(8) Journal of Medical Ethics 499–501
Abstract: The urgent drive for vaccine development in the midst of the current COVID-19 pandemic has prompted public and private organisations to invest heavily in research and development of a COVID-19 vaccine. Organisations globally have affirmed the commitment of fair global access, but the means by which a successful vaccine can be mass produced and equitably distributed remains notably unanswered. Barriers for low-income countries include the inability to afford vaccines as well as inadequate resources to vaccinate, barriers that are exacerbated during a pandemic. Fair distribution of a pandemic vaccine is unlikely without a solid ethical framework for allocation. This piece analyses four allocation paradigms: ability to develop or purchase; reciprocity; ability to implement; and distributive justice, and synthesises their ethical considerations to develop an allocation model to fit the COVID-19 pandemic.

Ljungholm, Doina Popescu and Marilena Lavinia Olah, ‘Implementing Digital Vaccine Passports to Control the Spread of COVID-19: Law, Rights, and Ethics’ (2021) 20 Linguistic & Philosophical Investigations 25–34
Abstract: Employing recent research results covering the implementation of digital vaccine passports to control the spread of COVID-19, and building our argument by drawing on data collected from Access Now, Becker, CNN, and Royal Society, we per- formed analyses and made estimates regarding the ethical and legal acceptability of COVID-19 vaccine passports. Descriptive statistics of compiled data from the completed surveys were calculated when appropriate.

London, Alex John, ‘Self-Defeating Codes of Medical Ethics and How to Fix Them: Failures in COVID-19 Response and Beyond’ (2021) 21(1) American Journal of Bioethics 4–13
Abstract: Statements of the core ethical and professional responsibilities of medical professionals are incomplete in ways that threaten fundamental goals of medicine. First, in the absence of explicit guidance for responding to cases in which there is significant uncertainty or disagreement about the relative therapeutic, prophylactic or diagnostic merits of available interventions they perpetuate self-defeating practices. Second, without addressing the role of advertising in shaping patient and community preferences they risk creating moral loopholes that bypass and undermine professional duties of fidelity, honesty and transparency. In both cases, these flaws are exacerbated by an individualism that ignores the critical role of health systems in managing and reducing uncertainty and conflict over best practices, and in communicating with and shaping the expectations of the public. These points are illustrated with examples from the response to COVID-19 and suggestions for reform are proposed.

Loughran, Matthew and Richard Latham, ‘Autonomy, Liberty, and Risk: The Ethical and Legal Challenges of Suspending Leave of Absence for Patients Detained under the Mental Health Act 1983 during the COVID-19 (Coronavirus) Pandemic’ [2022] Medicine, Science and the Law (advance article, published online 12 May 2022)
Jurisdiction: UK
Abstract: During the COVID-19 pandemic, many governments around the world have imposed significant restrictions on freedom of movement to tackle the virus. Mental health units have mirrored this approach, implementing restrictive measures to safeguard the health of patients, staff, and the wider community. This paper explores the relevant legal provisions and ethical principles that guide medical decisions regarding restriction of liberty, before considering the suspension of leave from hospital that occurred in several mental health services in response to the pandemic. It reviews how existing ethical principles within the field of public health may support a better-informed decision-making process, should similar widespread restrictions be imposed again.

Lupușoru, M et al, ‘Legal Challenges of Medical Practice During the Covid-19 Pandemic’ (2021) 29(3) Romanian Journal of Legal Medicine 305–308
Abstract: This article attempts to illustrate the challenges of medical practice during the COVID-19 pandemic. We address and discuss patient and medical worker’s safety, access to healthcare, standard of care and the emerging role of telemedicine, from both, medical and legal perspectives. We conclude that attention should be paid to problems related to allocation of scarce resources, the moral dilemma on who to treat, and pressing legal considerations regarding the medical practice during the pandemic and to burden and stress of the medical workers.

da Luz Scherf, Erick, Marcos Vinicius Viana da Silva and Janaína S. F., ‘The Management (or Lack Thereof) of COVID-19 in Brazil: Implications for Human Rights and Public Health’ (SSRN Scholarly Paper No ID 3609303, 24 May 2020)
Abstract: The objective of this article is to explore how the COVID-19 pandemic has been managed in Brazil, especially through the analysis of the actions and inactions of the Brazilian president Jair Bolsonaro related to the complete denial of the global threat that the new coronavirus represents, seeking to demonstrate its major impacts on human rights and public health in the country. Our main conclusions were that: (i) since the election of Bolsonaro in 2018, Brazilian politics have been entrenched with a neoliberal spirit marked by illiberal notions that have compromised Brazil’s democracy and rights regime; (ii) since 2016, the Brazilian Unified Health System (SUS) has been subjected to a privatizing logic guided by market rules and exploitation of health as a source of profits, which represents a serious threat to the right to health in the country as a result of the first; (iii) by not making sufficient efforts to safeguard the lives of Brazilians or to strengthen public health institutions in the middle of the new coronavirus pandemic, the Brazilian State is violating the rights to life and health by omission; (iv) ultimately, it was demonstrated that Bolsonaro has worked unceasingly to bulldoze anti-COVID-19 efforts in Brazil and how it can be better explained through the concept of necropolitics.

Lynch, Holly Fernandez et al, ‘Ethical Payment to Participants in Human Infection Challenge Studies, with a Focus on SARS-CoV-2: Report and Recommendations’ (SSRN Scholarly Paper No ID 3674548, 14 August 2020)
Abstract: To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, this report offers an expert analysis of ethical approaches to paying research participants in these studies, as well as HICS more broadly. The report first provides an overarching ethical framework for research payment that divides payment into reimbursement, compensation, and incentive, focusing on fairness and promoting adequate recruitment and retention as counterweights to ethical concerns about undue inducement. It then describes variables relevant to applying this framework to any type of study, including the prospect of direct medical benefit, early participant withdrawal, study setting and location, pandemic circumstances, study budget, and participant perspectives. We conclude that there is no need for a unique payment framework specific to HICS or SARS-CoV-2 HICS, but that there may be features of particular relevance to ethical payment for these studies. Participants have varied motivations for enrolling in HICS, including financial considerations, altruism, and other interests, but undue inducement does not seem to be a significant problem based on available evidence. Payment in these studies should reflect the nature of participant confinement, anticipated discomfort from induced infection, risks and uncertainty, participant motivations, and the need to recruit from certain populations, as relevant. Where HICS involve significant risks and highly contingent social value, special review confirming the ethical permissibility of these studies can help promote confidence in the ethical permissibility of offers of payment to participate in them. We do not propose specific payment amounts for potential SARS-CoV-2 HICS, as these will be highly variable based on the relevant factors described in the report. Instead, we note that it is reasonable to start from payments offered in other similar studies, while adopting a systematic approach based on the ethical framework herein, as reflected in a pragmatic payment worksheet describing goals, coverage, factors to consider, and potential benchmarks.

Lynch, Holly Fernandez et al, ‘Regulatory Flexibility for COVID-19 Research’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa057
Abstract: Clinical research is critical to combatting COVID-19, but regulatory requirements for human subjects protection may sometimes pose a challenge in pandemic circumstances. Although regulators have offered some helpful guidance for research during the pandemic, we identify further compliance challenges regarding IRB review and approval, informed consent, emergency research, and research involving incarcerated people. Our proposals for regulatory flexibility in these areas seek to satisfy the goals of protecting participants and promoting the development of high-quality evidence to improve patient care. These recommendations may have relevance beyond the COVID-19 pandemic to enhance the efficiency of research oversight and participant protection more broadly. Clinical research to understand, treat, and prevent COVID-19 is both crucial and highly regulated. Most intervention studies are subject to Food and Drug Administration (FDA) requirements and federally funded research with human subjects must follow requirements imposed by the Common Rule. Strict regulatory compliance may be challenging amidst a public health emergency, but participant protection and high-quality science remain essential.1 In recognition of these considerations, FDA and the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) have issued guidance on conducting research during the COVID-19 pandemic. Although this guidance offers a helpful start, gaps remain and additional regulatory flexibility is warranted in some instances. COVID-19 research has been running at a remarkable pace, challenging the capacity of both investigators and institutional review boards (IRBs). To ensure that this research proceeds efficiently and ethically, we offer suggestions to proactively address regulatory compliance challenges regarding IRB review and approval, informed consent, and inclusion of vulnerable populations.

Lynner, Natalie Banta, ‘Death in a Pandemic: Funeral Practices and Industry Disruption’ (2023) 70(1) UCLA Law Review 154–205
Abstract: The COVID-19 death toll is staggering and has impacted the funeral industry more than any other event in recent memory. Funeral service providers have been on the frontlines of this pandemic doing the work of the dead—transporting, storing, and disposing our dead. They have performed a critical service during uncertain times. Even before the COVID-19 pandemic, the funeral industry was beginning to adapt to the changing personal preferences about death care and increasing concerns about sustainability, technology, and cost. The COVID-19 pandemic has drawn attention to the changing norms and practices in American funerals and succession law and accelerated a shift toward digital funeral practices and digital testamentary instruments to meet the demands of a quarantined public. This Article is the first to provide a comprehensive analysis of the impact of COVID-19 on funeral practices and the funeral industry.

Machado, Marta and Taís Penteado, ‘Covid-19 and Exponential Reproductive Rights-Related Inequalities in Brazil’ in Shreya Atrey and Sandra Fredman (eds), Exponential Inequalities: Equality Law in Times of Crisis (Oxford University Press, 2023) 295
Abstract: The exponentiation of gender inequalities during the pandemic and the centrality of care work and sexual violence in this equation make the Covid-19 crisis a critical juncture that exposes the inextricable relation between sexual and reproductive rights and equality. Aggravating the situation, during the Covid-19 crisis, the Brazilian government accelerated the process of hollowing out the access to contraception and legal abortion services in the public health system. This has taken many forms—the most serious being the issuing of an executive measure imposing new formal barriers to access the right to legal abortion (Ordinance No 2282 of 27 August 27 2020). By using the Reproductive Justice Framework as a critical lens, this chapter unearths the inequality dimensions of reproduction—exponentiated by the combination of the Covid-19 crisis and the government’s attacks on reproductive rights. Grounded in empirical data, it proposes the formulation of legal challenges to the Ordinance through the mobilization of the substantive equality approach. The equality-based argument envisioned in the chapter has as premise the idea that intersectional inequalities are related to social hierarchies and that equality, in turn, would demand the dismantling of such relations. It is argued that restrictions on abortion, when seen in context, emerge as issues that arise from, are permeated by, and perpetuate inequalities and, as such, should be legally treated accordingly.

Maggiolo, Marcello, ‘Coronavirus and Medical Liability: The Italian Perspective’ in Ewoud et al Hondius (ed), Coronavirus and the Law in Europe (Intersentia, 2020)
Abstract: Malpractice cases or public bodies’ liability cases, both originated by Coronavirus, are bound to be discussed in terms of liability for non – pecuniary losses and of medical liability. The essay outlines the Italian scenario and some possible future development of the relevant law.

Makhlouf, Medha D, ‘Health Care Sanctuaries’ (2021) 20(1) Yale Journal of Health Policy, Law and Ethics 1–67
Abstract: It is increasingly common for noncitizens living in the United States to avoid seeing a doctor or enrolling in publicly funded health programs because they fear surveillance by immigration authorities. This is the consequence of a decades-long shift in the locus of immigration enforcement activities from the border to the interior, as well as a recent period of heightened immigration enforcement. These fears persist because the law incompletely constrains immigration surveillance in health care. This Article argues that immigration surveillance in health care is a poor choice of resource allocation for immigration enforcement because it has severe consequences for health and the health care system; additionally, it compromises the legitimacy of the state vis-à-vis its noncitizen residents. The consequences include public health threats, health care system inefficiency, ethical dilemmas, and increased vulnerability in immigrant communities. Laws permitting immigration surveillance in health care also create legitimacy harms by obstructing noncitizens’ access to health care and undermining their privacy and rights to public benefits. The COVID-19 pandemic starkly illustrates these dangers, but they exist even in the absence of a novel disease outbreak. Health care access for noncitizens has largely been left to the vagaries of immigration policy. Immigration surveillance in health care should prompt us to consider the scope and limits of health law and the role of discretion in immigration law. Health care sanctuaries — durable legal protections against immigration surveillance in health care — recover some of the lost equilibrium between immigration enforcement and other goals and values of public policy.

Mandiyanike, David and Onthatile Olerile Moeti, ‘The Implications of COVID-19 Legislation on Chronic Ailments Patients: Perspectives from Botswana’ (2021) Transforming Government: People, Process and Policy (advance article, published 4 February 2021)
Purpose: COVID-19 is one of the greatest public health challenges in the 21st century. The World Health Organisation recommended physical distancing to halt the upward trajectory of the infections. Countries including Botswana imposed lockdown for non-essential workers. This paper aims to argue that lockdown as imposed by the Government of Botswana was a necessary measure given the nature of transmission of COVID-19.
Design/methodology/approach: The paper uses exploratory research to unpack impacts of the novel COVID-19 regulations or be responsive to new concerns by breaking new ground through delving into new problem areas. The paper used a use case to explain a single outcome for a single case. Findings The restriction on the freedom of movement is necessary to protect citizens, particularly, those with chronic illness from contracting the deadly virus. The paper further observes that while the legislative intent of the GOB was to protect those with chronic illnesses from COVID-19, the lockdown resulted in near death experiences for some chronic ailment patients. These experiences result from unfettered discretion of functionaries who were policing and manning the streets and those who are conferred with authority to issue travel permits to seek and obtain medical assistance, lack of public transport and the processes of applications for the permits, which exposed citizens to COVID-19.
Research limitations/implications: The study was desk based. It may have yielded different results. Lockdowns limited mobility for non-essential services. The full impact of the restrictions and the attendant defaulting was yet to be fully realised. Observing the COVID-19 protocols and bureaucratic requirements for obtaining information from the government offices were major challenges. Practical implications Achieving total lockdown as an end in itself may amount to a pyrrhic victory – the authorities may successfully achieve total lockdown but with heavy costs on gains made in combating ailments. Botswana has fought many other pandemics and chronic illnesses still subsist and need to be catered for. For patients, there is not only the complexity of dealing with one chronic condition but also the work of trying to live ‘normal’ lives in the face of co-morbidity, which can be overwhelming. The COVID-19 pandemic adds to the ‘work’ that patients must do to manage and live with such health conditions and the psychological distress.
Social implications: Authorities need to be fully aware of the consequences of their actions. Abrasive actions may lead to a higher constituency of discontent. Botswana has had a good track record of being democratic, and this needs to be strengthened.
Originality/value: The implementation of the COVID-19 regulations particularly the requirement for a travel permit to seek health-care services may hinder access to essential health services and ultimately increase the pressure on emergency services or, at worst, increase mortality. Clear guidelines and sober interpretation of the regulations are necessary. This will also make it easier for the frontline security officers manning the streets to correctly understand the prevailing circumstances. In view of the massive gains garnered in combating chronic illnesses, it is important that such gains are not reversed, while the GOB fights COVID-19. People living with HIV/AIDS, the elderly and people with pre-existing health conditions are known to be at significantly higher risk of developing severe illness when contracting COVID-19. Achieving total lockdown as an end in itself may amount to a pyrrhic victory – the authorities may successfully achieve total lockdown but with heavy costs on gains made in combating other chronic ailments.

Mangiameli, Agata Amato, ‘Law, Philosophy, Medicine: The Ancient Maxim Iatròs Philòsophos Isòtheos and the Current Pandemic’ (2020) 2(2) Humanities and Rights Global Network Journal 7–24
Abstract: The recent health emergency caused by covid-19 has, in its way, highlighted the fundamental interweaving between law, philosophy and medicine, as well as the need to resort the ancient principles – disclosed by philosophical questions – which must represent the basis of both legal and medical issues.

Manian, Maya, ‘Abortion Access in a Post-COVID and Post-Roe World’ in The Routledge Companion to Gender and COVID-19 (Routledge, 2024)
Abstract: This chapter describes the U.S. Supreme Court’s momentous decision to overturn Roe v. Wade and legal and public health consequences of that decision in a post-COVID world. The COVID-19 pandemic provided opportunities to both restrict and expand access to abortion care. During the height of the pandemic, the Supreme Court agreed to hear several cases on abortion rights, ultimately leading to the demise of the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization. This chapter analyzes the Dobbs decision and its impact on state legislatures’ attempts to regulate abortion through criminal, regulatory, and civil penalties during and after the height of the pandemic. This chapter also highlights the public health consequences of overturning Roe during the long tail of the pandemic. The pandemic both exposed and exacerbated health disparities for low income people and people of color. The reversal of Roe v. Wade portends worsening reproductive health disparities among communities already ravaged by the pandemic.

Manullang, Sardjana Orba, ‘Giving COVID-19 Vaccines to Citizens: Understanding Legal Basis’ (2021) 5(3) International journal of health sciences 364–372
Abstract: This paper aims to understand the legal basis for administering the COVID vaccine to Indonesian citizens. In order to complete this understanding, we have collected data on the evidence of the study of publications from several journals that have a high level of investment in the discussion on the legal point of giving vaccines to the public and many journals that raise the issues of this COVID outbreak. So, after we collect the data, we continue with a study involving the coding system, evaluate the data carefully, and then try to interpret it as much as possible to get answers that we consider validity and reliability in answering this legal study issue. After we reviewed our data and continued our discussion, we finally found that the state has a legal umbrella in implementing the COVID-19 vaccination program for all Indonesian citizens with so many legal foundations, so at this moment, the results of our study will be helpful in the development of legal studies discussions and problems with the rising COVID vaccination program in Indonesia future.

Marks, Mason M, ‘Controlled Substance Regulation for the COVID-19 Mental Health Crisis’ (2020) 72(4) Administrative Law Review 649-718
Jurisdiction: USA
Abstract: This Article explores the legal obstacles to administering psilocybin and MDMA to mitigate the COVID-19 mental health crisis.

Marks, Mason, ‘Drug Regulation for the COVID-19 Mental Health Crisis’ (2020) 72 Administrative Law Review (forthcoming)
Abstract: The COVID-19 pandemic is producing widespread loss of life, unemployment, and social isolation that is triggering a mental health crisis. Experts warn there could be record levels of depression, suicide, and substance use disorders. The U.S. healthcare system is not prepared. It lacks the resources to provide prolonged psychotherapy at scale, and existing drug treatments are ineffective for up to sixty percent of people. Fortunately, there is an untapped resource in the form of the experimental drugs psilocybin and MDMA. Clinical trials suggest that they are safe and effective for treating a variety of mental health conditions. Moreover, they act quickly, and their beneficial effects are often sustained.The U.S. Drug Enforcement Administration (DEA) classifies psilocybin and MDMA as schedule 1 controlled substances with a high potential for abuse and no currently accepted medical uses. However, a growing body of research undermines the DEA’s position. This Essay surveys the scientific evidence for the therapeutic use of psilocybin and MDMA. It argues that due to the urgent need for effective mental health treatments, the DEA should re-schedule these drugs and the Food and Drug Administration (FDA) should issue emergency authorizations for their use. To further enhance safety, the FDA should issue Risk Evaluation and Mitigation Strategies (REMS) requiring the drugs to be administered in controlled settings under professional supervision. The Department of Justice, which oversees the DEA, should pledge not to prosecute individuals who use psychedelics in jurisdictions, such as Denver, Oakland, and Santa Cruz, where they have been decriminalized.

Marmo, Rossella et al, ‘The Response of the Italian Healthcare Facilities to the COVID-19 Pandemic: Analysis of National and Regional Legislation’ in John R Littlewood, Robert J Howlett and Lakhmi C Jain (eds), Sustainability in Energy and Buildings 2021 (Springer, forthcoming 2022) 79–88
Abstract: Since January 2020 Italy has been countering the COVID-19 pandemic with several measures, including strategies to improve the National Health System’s preparedness to such a threat. The paper aims to analyse response plans and measures against the COVID-19 pandemic within the Italian healthcare system, at national and regional level. Two objectives have been set: reviewing governmental provisions for territorial and hospital health services rearrangement; reviewing operational responses on the regional scale to address those demands. To collect and review operational responses at the regional level, six Regions have been considered as the field of study, chosen for being a relevant sample of the resident population in North, Middle and South Italy. Comparative analyses have been carried out to outline similarities and differences in managing this difficult healthcare situation. Results show that territorial medicine, particularly epidemiologic service, has been essential in facing the national crisis, but hospitals have been the main actors in addressing COVID-19 needs. Relevant structural, technological and organisational changes were needed to prepare hospitals. The built environment plays a significant role in managing the pandemic response, indeed. Further efforts to develop a novel, resilient and sustainable hospital model are needed. This study contributes to a better understanding of factors influencing current Italian hospitals’ strengths and limitations, shedding light on future design models which can increase resilience in emergency conditions.

Martin‐Howard, Simone and JD Kyle Farmbry, ‘Framing a Needed Discourse on Health Disparities and Social Inequities: Drawing Lessons from a Pandemic’ (2020) 80(5) Public Administration Review 839–844
Abstract: COVID-19 provides numerous opportunities for policymakers to consider matters of social equity in relation to the field of public health. Specifically, by reflecting on health disparities in relation to the disproportionate impact of COVID-19 on minority and historically underserved populations, we can leverage a needed discourse on health outcomes for many communities. Grounded in the social determinants of health conceptual framework, this article explores the application of the disproportionate impact of COVID-19 on vulnerable populations and communities of color for a discussion on strategies for minimizing health disparities.

Martinez, William, ‘How to Get Away with Immunity: FDA’s Emergency Use Authorization Scheme and PREP Act Liability Protection in the Context of COVID-19Loyola Consumer Law Review (forthcoming)
Abstract: The U.S. Food and Drug Administration (FDA) plays a vital role in our country’s response to biological agents that threaten public health and safety. On December 31, 2019, officials in Wuhan, China confirmed dozens of cases of pneumonia caused by an unknown pathogen. Chinese officials later identified that pathogen as severe acute respiratory syndrome coronavirus (SARS-CoV-2), which causes the disease COVID-19. The COVID-19 pandemic has created a perfect storm for unprecedented and litigation-provoking health harms in the United States. As the country’s death toll rises and states seek to reopen, many Americans are assessing their COVID-19-related health status based on the results of diagnostic and antibody tests, which have been cleared through the FDA’s emergency use authorization scheme notwithstanding their concerning inaccuracy rates. This paper argues that the unacceptably high inaccuracy rates of these COVID-19 tests are a direct result of lax FDA regulation and oversight under current federal law. The Public Readiness and Emergency Preparedness Act of 2005 (PREP Act) established a framework that extends blanket immunity from liability to the manufacturers of medical products, including blood assays and serology tests, that are used to diagnose and treat COVID-19. The breadth and scope of the statute’s immunity make it nearly impossible for an injured plaintiff to recover from injuries sustained from their use of or reliance on diagnostic tests. This paper details and critiques PREP Act immunity and proposes several PREP Act reforms aimed at enhancing public health and safety during a infectious disease pandemic. As special interest groups ramp pressure of the federal and state legislatures to enact additional immunity protection as the states reopen, the quality of COVID-19 related care and treatment is likely to continue to worsen unless and until the country implements reforms that authorize meaningful medical device regulation and oversight.

Marzi, Leopold-Michael, ‘Suggestions for an Efficient European Fight Against a Pandemic: Legal Aspects in the Health Care Sector’ (ÖGfE Policy Brief No 15a, 2020)
Abstract: Since the so-called ‘Spanish-flu’, the worst world-wide pandemic in history, which raged in the years 1918- 1920, Europe was untroubled by pandemics. Now, exactly hundred years later, nobody exists who can remember this situation. In fact the European health care systems were unprepared in February 2020 when the coronavirus crisis started in northern regions of Italy and reapidly endangered other countries in Europe. A pandemic ingnores state borders. Because even in the European Single Market health care systems are in the responsibility of the member states, it was soon obvious that the lack of harmonised standards regarding a pandemic would be an enormous obstacle in the fight against it and this situation unveiled a huge gap in the European cooperation. There is an unconditional need for EU-wide standards in the future concerning the storage of always available protective masks, protective clothing, disinfectants etc. in relation to the population. Furthermore it is necessary that the member states coordinate cross-border cooperation in case of emergency in order to prevent the spreading of a pandemic from the very beginning. It will not be sufficient just developing new standards and action plans to combat a pandemic, the new standards also have to be executed effectively, even before the outbreak of a pandemic. Therefore a ‘European Agency for Health Care Safety’ with a stable legal basis, which can only be avieved by adding a new article 168a in the Treaty on the Functioning of the European Union, is essential.

Maysarah, Maysarah, ‘Hospital Responsibilities for the Use of Covid-19 Handling Funds Based on a State Administrative Law Perspective’ (2020) 1(2) International Journal Reglement & Society (IJRS) 44–52
Abstract: Hospitals as a device or component of health have responsibility for the funds for handling Corona Virus Disease (Covid-19) in Indonesia. During this pandemic, hospitals certainly play an important role for public health, especially those with Covid-19. The method used in this research is normative law research which combines the data obtained from library materials and then analyzed qualitatively. From the research results it is known that the Government is taking action quickly, precisely, and accurately in handling the Covid-19 pandemic. The government’s steps in handling the Covid-19 pandemic were carried out by combining the use of statutory authority, policy regulations, actions of government agencies and officials, and bureaucratic support as a policy implementing organ. In handling the Covid-19 pandemic, the President took a policy by establishing a Government Regulation in Lieu of Law (Perppu) Number 1 of 2020 concerning State Financial Policy and Financial System Stability for Handling the Corona Virus Disease (Covid-19) Pandemic and / or in the Context of Facing Dangerous Threats National Economy and / or Financial System Stability on March 31, 2020. That the responsibility of the hospital is to use the funds for handling Covid-19 to provide medical devices related to prevention or treatment of Covid-19 such as PPE, test kits, reagents, ventilators, hand sanitizers and others.

Mažrimaitė, Andra and Vilius Lapis, ‘The Distinctive Nature of COVID-19 Vaccines: Compensation for Potential Damages under the Legal Framework of Lithuanian State in the Context of Global Examples’ (2022) 6(1) Bratislava Law Review 87–106
Abstract: The article analyses legal mechanisms of compensation for damages caused by side effects of COVID-19 vaccines in Lithuania. In particular, draft amendments to the Law on the Rights of Patients and Compensation of the Damage to their Health registered by the Parliament of the Republic of Lithuania in 2021 are evaluated and arguments for the need for further improvement are provided herein. In order to comprehensively assess the nature of the side effects that may be a substantiated cause for damages, pharmaceutical analysis and evaluation of COVID-19 vaccines eligible in Lithuania are analysed. Analysis of the legal framework and proposals are construed mainly in light of the assessment of global examples. Following thorough evaluation of the question at hand, it is the opinion of the authors that the product liability mechanism is not appropriate in the context of the vaccination program applied in Lithuania and ‘a no-fault compensation model’ shall be adopted instead, which would be funded by a separate (non) State institute/fund in Lithuania.

McCuskey, Elizabeth Y, ‘FDA in the Time of COVID-19’ (2020) 45(3) ABA Administrative & Regulatory Law News 7–9
Abstract: Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers’ misinformation about treatments. This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

Mcevoy, Emma and Delia Ferri, ‘The Role of the Joint Procurement Agreement during the COVID-19 Pandemic: Assessing Its Usefulness and Discussing Its Potential to Support a European Health Union’ (2020) 11(4) European Journal of Risk Regulation - Special Issue: Beyond Covid-19: Towards a European Health Union 851–863
Abstract: In 2014, the European Joint Procurement Agreement (JPA) was introduced as an innovative instrument to organise the procurement of vaccines and medications in preparation for pandemics. An overriding purpose of the JPA is to secure equitable and cost-effective access to medical supplies for participating EU Member States during serious health crises. This article aims to understand the current use of the JPA in response to the COVID-19 pandemic. Post-analysis of the recent use of the JPA, the article will discuss how the regional procurement mechanism can be strengthened to support the development of a European Health Union. In particular, the article will firstly question whether the four recent JPA procurement actions facilitated equitable access to medical supplies and services. Secondly, it will ask whether the centralised procurement actions preserved the integrity of the Internal Market. The importance and originality of this study are that it addresses an instrument, the JPA, which has been largely overlooked by legal scholars, and it explores how the provisions for the joint procurement of medical countermeasures as included in Article 5 of Decision 1082/2013/EU on serious cross-border threats to health could be extended to support the functioning of a European Health Union.

McGuire, Amy L et al, ‘Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force’ (2020) 20(7) The American Journal of Bioethics 15–27
Abstract: The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient’s ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.

McQuoid -Mason, DJ, ‘COVID-19 and Its Impact on Informed Consent: What Should Health Professionals Tell Their Patients or Their Proxies?: Research’ (2020) 13(1) South African Journal of Bioethics and Law 7–10
Abstract: Given the increasing number of ethical and legal issues arising from the impact of the COVID-19 epidemic on informed consent by patients, it is necessary for health professionals to explain to patients how the measures taken to combat the spread of the virus impact on their right to give informed consent. Patients need to be reassured that wherever possible, health professionals are ethically bound to obtain informed consent from patients before they subject them to diagnostic testing and treatment, but at the same time, have to comply with the demands of the law. While the South African Constitution, statutory law and the common law all recognise a person’s right to consent before being subjected to treatment or surgical operations, it is necessary to take remedial steps, because of the dangers of spreading the potentially fatal COVID-19 virus, to prevent this. Such steps may involve compelling patients to be screened, tested and treated – sometimes without their consent. Guidance is given to healthcare professionals on how they should counsel their patients, and what they should tell patients about the impact of the COVID-19 regulations on healthcare professionals’ ethical and legal duties regarding the obtaining of informed consent, as well as on whether, if asked, employers can compel their employees to undergo testing without consent, and what to tell patients about this.

McQuoid -Mason, DJ, ‘COVID-19: May Healthcare Practitioners Ethically and Legally Refuse to Work at Hospitals and Health Establishments Where Frontline Employees Are Not Provided with Personal Protective Equipment?: Forum’ (2020) 13(1) South African Journal of Bioethics and Law 11–14
Abstract: The purpose of this article is not to encourage health practitioners to refuse to assist COVID-19 patients if they are not provided with personal protective equipment (PPE) at the workplace. It is to encourage them to advocate for PPE by pointing out that in South Africa (SA), health establishments that fail to provide them with PPE will be held ethically and legally responsible for the deaths of any patients – not health practitioners – if as a last resort such health professionals have to withdraw their services to protect other patients, themselves, their families and their colleagues. The article refers to the World Medical Association, World Health Organization and Health Professions Council of SA guidelines regarding the use of PPE during the COVID-19 epidemic, especially in the case of shortages. All the guidelines state that the safety of healthcare workers is a priority if they are to care for their patients properly. Mitigation measures are suggested, but do not extend to failing to provide PPE to those healthcare workers who deal directly with patients. The law protects all workers, who have a constitutional and statutory right to a working environment that is not harmful and does not threaten their health and safety. The article concludes that as a last resort, if the international and national ethical guidelines and legal rules are not being followed regarding PPE and advocacy attempts to persuade health establishments to provide PPE fail, and healthcare workers are exposed to the COVID-19 virus, they may ethically and legally withhold their services. These points should be made when health practitioners are advocating for PPE.

McQuoid -Mason, DJ, ‘COVID-19: What Should Employers Do If Employed Health Professionals Such as Doctors and Nurses Refuse to Treat COVID-19 Patients despite Being Provided with the Required Personal Protective Equipment?’ (2020) 13(2) South African Journal of Bioethics and Law 87–90
Abstract: At some health establishments doctors and nurses employed there are refusing to treat Covid-19 patients - even though they have been provided with the necessary personal protection equipment (PPE). Such conduct would appear to be in breach of the World Medical Association International Code of Medical Ethics , the International Council of Nurses Code of Ethics for Nurses , the Rules of Conduct of the Health Professions Council of South Africa, the South African Nursing Council, some of the provisions of the South African Constitution and of the relevant labour legislation. Guidance is provided to employers on how to deal with the situation based on ethical and legal considerations.

Medicine and Law (2020) 39(2) - Special Issue: The COVID-19 Pandemic: A Time Capsule of the First 6 Months – An International Perspective
Note: This entire issue has been made available on open access by HEIN Online as one PDF document. It includes a detailed introduction and then separate coverage of the background and current situations in 17 countries: Australia, Azerbaijan, Belgium, Brazil, China, France, Hungary, Hong Kong, Israel, Japan, Netherlands, Peru, Russia, Turkey, Ukraine, UK and USA.

Mehta, Anuj B and Matthew K Wynia, ‘Good Ethics Begin with Good Facts: Vaccination Sensitive Strategies for Scarce Resource Allocation Are Impractical as Well as Unethical’ (2024) 24(7) The American Journal of Bioethics 83–86
Abstract: The article focuses on the impracticality and ethical concerns surrounding vaccination-sensitive strategies for allocating scarce resources like ventilators during the COVID-19 pandemic. Topics include the initial ethical values guiding resource allocation, proposals to prioritize vaccinated individuals, and the challenges of implementing such strategies due to uncertainties in timely access to vaccination status and the causes of patients’ respiratory failure.

Mello, Michelle M et al, ‘Legal Infrastructure for Pandemic Response: Lessons Not Learnt in the US’ (2024) 384 BMJ Article e076269
Abstract: Covid-19 related mortality in the US was higher than in every western European country. Compared with its closest neighbour, Canada, also a federated country with a decentralised health system, the US fared far worse. With over 1.1 million dead at the end of 2023,3 leaders and academics have begun a painful postmortem. What went wrong, and what can be done to make authorities in the US better equipped for the next pandemic?

Mendelson, Danuta et al, ‘Legal Implications of Personal Protective Equipment Use When Treating Patients for COVID-19 (SARS-CoV-2)’ (2020) 27(4) Journal of Law and Medicine 856
Abstract: Front-line health care personnel, including anaesthetists, otolaryngologists, and other health professionals dealing with acute cases of coronavirus, face a high risk of infection and thus mortality. The scientific evidence establishes that to protect them, hospital protocols should require that wearing of the highest levels of personal protective equipment (PPE) be available for doctors and nurses performing aerosol-generating procedures, such as intubation, sputum induction, open suctioning of airways, bronchoscopy, etc. of COVID-19 patients. Although several international bodies have issued recommendations for a very high-level PPE to be used when these procedures are undertaken, the current PPE guidelines in Australia have tended to be more relaxed, and hospital authorities relying on them might not comply with legal obligations to their employee health care workers. Failure to provide high-level PPE in many hospitals is of concern for a large number of health care workers; this article examines the scientific literature on the topic and provides a legal perspective on hospital authorities’ possible liability in negligence.

Merks, Piotr et al, ‘The Legal Extension of the Role of Pharmacists in Light of the COVID-19 Global Pandemic’ (2020) 17(1) Research in Social and Administrative Pharmacy 1807–1812
Abstract: Background The COVID-19 epidemic has affected every area of life. The greatest challenge has been to adapt the functioning of the health service to prevent the spread of the epidemic and to help infected patients. This has required the involvement of not only doctors and nurses, but also pharmacists. In the face of this pandemic, governments in many countries have granted pharmacists greater authority. Objectives The purpose of this paper is to review the legal extension of the role of pharmacists in light of the COVID-19 pandemic. The review considers recent changes in European countries, Canada, and the United States. Methods A literature review was performed to summarise knowledge about the extension of the role of pharmacists during the pandemic period. Key articles were retrieved mainly from PubMed and Google Scholar, using the terms ‘COVID‐19’, ‘2019‐nCoV’, ‘coronavirus’, and ‘pandemic’ in combination with ‘pharmacist’ as keywords for our search. We included scientific publications from February 1, 2019 to May 15, 2020. Results Pharmacists have been given numerous opportunities so that they can actively join in the fight against the virus. Some of the novel legal extensions aimed at aiding overloaded healthcare systems are as follows: authorisation to prepare hand and surface disinfectants, eligibility to renew chronic treatment prescriptions, as well as filling pro auctore and pro familia prescriptions by pharmacists, performing COVID-19, influenza, and Group A Streptococcus screening tests, and vaccine administration. Moreover, many countries have facilitated Internet services, such as virtual medical consultations, e-prescriptions, and home drug delivery – to promote social distancing among patients. To mitigate drug shortages, the following strategies have been implemented: alternative sourcing, strength, generic, or therapeutic substitution, and preparing compounded formulations at the pharmacy. Conclusions Novel legal extensions have allowed exploitation of the full potential ofpharmacists worldwide, aiding the limited resources of overloaded healthcare systems.

Mert, Selda et al, ‘The Effect of Covid-19 on Ethical Sensitivity’ (2021) 28(7/8) Nursing Ethics 1124–1136
Abstract: In the midst of the Covid-19 pandemic, healthcare workers increasingly encounter serious ethical issues that negatively affect their professionalism. Purpose: The study aims to examine the ethical sensitivity levels of physicians and nurses working in surgical units during the Covid-19 pandemic and the associating factors. The study revealed that ethical issues during the Covid-19 pandemic, sociodemographic characteristics, knowledge-skills about Covid-19, and the problems encountered in the work environment during the pandemic affect the ethical sensitivity of healthcare workers in the dimensions of conflict and holistic approach. Therefore, it is recommended that governments and all healthcare workers, and stakeholders in the health system in our country and other countries take action to promote ethical sensitivity in response to the rapidly increasing epidemic by considering the factors that adversely affect ethical sensitivity.

Meybodi, Seyed Mostafa Mirmohamadi and Nasrollah Jafari, ‘Legal Principles and Strategies to Encourage Citizens to Get Vaccinated against COVID-19 Virus’ [2024] Journal of Community Health Research_
_Abstract: Following the outbreak of COVID-19 pandemic, in some countries, mandatory vaccination programs were put to practice. However, there were widespread opposition against vaccination, which is investigated in this research. With the emergence of corona virus in the world and the need to end this dangerous pandemic, various countries, including Iran’s legal system, decided to implement ‘compulsory vaccination’ mechanisms. The findings of this study indicated that the government from the perspective of various schools (even the school of individual originality) was not only allowed to legislate rules to make vaccination obligatory, but also it was expected to enact appropriate laws to create public safety. According to the principles of Islamic jurisprudence and law, including the priority of collective interests over the individual, the rule of no harm, and the authority of the Supreme Leader, the government is not only authorized but also obliged to enact laws for making vaccination obligatory.

Meyers, Peter H, ‘The Trump Administration’s Flawed Decision on Coronavirus Vaccine Injury Compensation: Recommendations for Changes’ (2020) 7(1) Journal of Law and the Biosciences, Article lsaa082
Extract from Introduction: Part II of this Article discusses the importance of preparing for the likelihood that COVID-19 vaccines will, like other vaccines, have adverse effects on some small percentage of the population. Part III describes the limitations and problems with the flawed Countermeasures Injury Compensation Program. Part IV describes the better but still problematic Vaccine Injury Compensation Program. Part V describes the highly successful September 11th Victim Compensation Fund. Part VI contains the proposed provisions for the new compensation fund that should be created to handle injury claims that may be filed in connection with the coronavirus vaccines currently being developed, based on the best features of the Vaccine Injury Compensation Program and the September 11th Victim Compensation Fund.

Miaskowska-Daszkiewicz, Katarzyna, ‘Compulsory Vaccinations against Covid-19 versus the Right to Respect for Private Life’ (2021) 14(2) Medicine, Law & Society . 419-438
Abstract: The development and marketing authorisation of COVID-19 vaccines has given the authorities a much-anticipated instrument to fight a pandemic. At the same time, however, for the extinction of the epidemic to become real, according to epidemiologists’ estimates, the threshold of herd immunity must reach the value of 50-70 percent. To ensure mass vaccination, it should be considered whether a compulsory vaccination against COVID-19 would be an acceptable solution. It is a sensitive issue in the context of the right to self-determination, guaranteed both in Article 8 European Convention on Human Rights, as well as most modern constitutions. The aim of this paper is to investigate whether the compulsory vaccination against COVID-19 could be the next step in the fight against the pandemic. In particular, whether the current approach of the ECHR and national courts to compulsory vaccination can be considered adequate in relation to COVID-19 vaccines with a conditional marketing authorisation.

Michalowski, Sabine, ‘The Use of Age as a Triage Criterion’ in Carla Ferstman and Andrew Fagan (eds), Covid-19, Law and Human Rights: Essex Dialogues (School of Law and Human Rights Centre, University of Essex, 2020) 93–100
Extract from Introduction: This contribution will address some of the ethical and human rights considerations that should inform the discussion of whether age can be regarded as a valid criterion to decide who receives life-saving treatment at a time of acute scarcity of medical resources, using the Covid-19 pandemic as a case study.

de Miguel Beriain, Íñigo and Jon Rueda, ‘Digital Covid Certificates as Immunity Passports: An Analysis of Their Main Ethical, Legal, and Social Issues’ (2022) Journal of Bioethical Inquiry (advance article, published online 19 September 2022)
Abstract: Digital COVID certificates are a novel public health policy to tackle the COVID-19 pandemic. These immunity certificates aim to incentivize vaccination and to deny international travel or access to essential spaces to those who are unable to prove that they are not infectious. In this article, we start by describing immunity certificates and highlighting their differences from vaccination certificates. Then, we focus on the ethical, legal, and social issues involved in their use, namely autonomy and consent, data protection, equity, and international mobility from a global fairness perspective. The main conclusion of our analysis is that digital COVID certificates are only acceptable if they meet certain conditions: that they should not process personal data beyond what is strictly necessary for the aimed goals, that equal access to them should be guaranteed, and that they should not restrict people’s autonomy to access places where contagion is unlikely. We conclude that, if such conditions are guaranteed, digital COVID certificates could contribute to mitigating some of the most severe socioeconomic consequences of the pandemic.

Miller, Tom, ‘Will New Macromedical Regulation Be Prudential?’ (2021) 82(5) Ohio State Law Journal 803–813
Abstract: The COVID-19 pandemic potentially offers many important lessons for health policy makers. However, among the ones more likely to be neglected or downplayed are healthier skepticism about reupholstered regulatory fixes, greater modesty about our underlying political and cultural habits, and realistic prioritization in identifying what is most feasible and necessary rather than desirable but elusive. Three overlapping spheres of regulatory policy history flash yellow caution lights and post speed limit signs—whether involving strained analogies to banking regulation, broader historical traits of regulation within the U.S. political system, or the dense web of chronic, preexisting conditions that frustrates efforts to overhaul regulation of our health care services and operations. All of them should help to curb our enthusiasm, before refocusing on more necessary initial steps.

Mills, Dr Susanna, ‘COVID-19, Public Health Measures, Legal Considerations: A Medical Perspective’ (2020) 25(2) Judicial Review 71–79
Abstract: COVID-19 and the Coronavirus Act 2020 raise a wide range of related legal issues and questions, which are the focus of in-depth study through articles in this journal issue. The salient medicolegal implications are highlighted briefly below.

Milo, Caterina, ‘COVID-19 Vaccination and the Role of Informed Consent: England as a Case Study’ (2023) 30(4) European Journal of Health Law 428–448
Abstract: Informed consent (IC), following the Supreme Court judgment in Montgomery v Lanarkshire Health Board, [2015] UKSC 11, constitutes a key patients’ right. There is a vast literature exploring the significance of this right, while an analysis of the role that this has played in England during the COVID-19 vaccine distribution has been under-explored. Using England as a case study, this paper argues that IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere ‘consent’ has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach, namely in a way that enhances patients’ autonomy and medical partnership, and also to better prepare and respond to future pandemics.

Milošević, Milan et al, ‘Legal Aspects of Recognizing COVID-19 As an Occupational Disease in The Republic of Croatia’ (2022) 29(3) Revija za socijalnu politiku 403–412
Abstract: Occupational diseases are diseases directly induced by work and working conditions. In the Republic of Croatia, according to the procedure set out by law, occupational diseases are reported and recognized by the Croatian Health Insurance Fund and registered and monitored in the Registry of Occupational Diseases kept by the Croatian Institute for Public Health – Department of Occupational Health. Diagnoses are under responsibility of occupational medicine specialists and are carried out according to modern occupational health criteria, which include determining the clinical picture of the disease and the damage caused by the work process. The recognition of COVID-19 as an occupational disease is extremely important for the worker considering the financial and pension benefits according to the applicable laws and regulations. Most workers who have had COVID-19 as a professional disease do not get the disease recognized as an occupational disease while they are sick. The length of the acute disease is shorter than the process of application and evaluation of occupational disease. However, the recognition of COVID-19 as an occupational disease may be important for the future. Should any of the complications (e.g. post COVID-19 syndrome) arise in the future, the worker holds their rights under health insurance. The scientific and healthcare community is still in the process of evaluating and recognizing complications of COVID-19 disease and their long-term impact on health and work ability.

Mirocha, Łukasz, ‘The Possibility of Introducing Conscientious Exemption from Mandatory Vaccination in Poland: A Critical Perspective’ (2021) 28(4) European Journal of Health Law 359–376
Abstract: Considerations comprised in the article concern the problem of mandatory vaccination in Poland. Particular attention is paid to the issue of conscientious exemption from the vaccine obligation. The article presents the problem of social support for vaccination in Poland, the arguments issued by vaccination opponents, the current legal status of vaccination in Poland, and finally – the legal analysis regarding the introduction of a conscientious exemption from mandatory vaccination in Poland. The article focuses on judicial opportunities of introducing conscientious exemption in the field of mandatory vaccination; it presents possibilities and obstacles to establishing institution under discussion. The thesis that public health reasons should prevail over conscientious or moral demands is advocated in the article.

Misheva, Kristina and Marija Ampovska, ‘The Legal Aspects of Telehealth’ (2022) 6 EU and Comparative Law Issues and Challenges Series (ECLIC) 393–409
Abstract: Telehealth seems to be the new normal in this fast-changing environment. According to the European Commission eHealth was among the highest priorities before the COVID -19 pandemic. Transformation of health and care in the digital single market is among the EU`s six political priorities of the Commission 2019-2024 (2018 Communication on Digital Health and Care). The pandemic caused by COVID-19 just accelerates the necessity of the inclusion of digital health into the traditional healthcare systems. Telehealth services are among the biggest eHealth trends in EU. Therefore, one of the challenges is the national, regional and regulatory priorities regarding telehealth. There is lack of telehealth special legislative and governmental policies that needs to stimulate the developing and innovative solutions in medicine through technology and to envisage the upcoming innovation technology. Therefore, the government support and adequate policy making is important to support the development of the telehealth services. One of the main challenges is the electronic transactions of patient data among the telehealth providers and services and the cross-border patient data share. Another issue is the exchange of information among the national health institutions and providers and their interoperability. The Macedonian legislation does not have special legislation (policies, or laws) about telehealth. Telehealth is regulated as a term in the Law on health protection. Additionally, there is a lack of national acts, literature, and research in this subject matter. Thus, this paper will explore the telehealth from two main perspectives: scientific theories and legal practice and the users’ practice. Hence, this paper will analyze the legislation about the telehealth on the EU level and the EU Member States and the Macedonian legislation and the impact on the e-health that was made during COVID-19 pandemic. Furthermore, it will make comparative analyses among different countries into the EU zone compared with the EU aspirant country- the Republic of North Macedonia. A survey conducted among doctors in private and public healthcare institutions in the primary, secondary, and tertiary healthcare levels in the city of Stip and in the city of Skopje will provide data about the challenges, risks, and trends in telehealth before and during COVID -19.

Mishra, Abhisek et al, ‘Covid-19: Catalyst for a Comprehensive Law to Combat Potential Pandemics in India’ (2022) Indian Journal of Medical Ethics (advance article, published online 4 June 2022)
Abstract: Despite the relative decline in communicable diseases, India witnesses hundreds of outbreaks every year. Including the current Covid-19 pandemic, India has suffered through several major pandemics and large-scale epidemics since 1900s. However, the response to most of the epidemics has been inadequate. The Epidemic Diseases Act, enacted in 1897 (EDA 1897), has been in action since and is based on the science and the socio-political environment of the country in the nineteenth century. India has several legal mechanisms to help contain and control the spread of epidemics, but on different platforms. There has been a paradigm shift in the socio-political milieu as well as scientific advancements in the prevention and control of epidemics. The century-old EDA 1897 has not been effective in containing and controlling such epidemics/pandemics, as has been witnessed during the ongoing Covid-19 pandemic. Hence, it needs to be revised to define an appropriate structural scalar chain, provide clear-cut and unambiguous terms/definitions and guidelines, delineate ethics and human rights, determine the duties and responsibilities of the affected population/community, determine the role of the private health sector, and provide for appropriate punitive measures to deter repeated violations.

Mishra, Ankur, ‘COVID-19 in India: Impact on the Sustainable Development of Health Sector’ (SSRN Scholarly Paper ID 3774123, 27 June 2020)
Abstract: India is one of the worst-performing states in terms of achieving its Sustainable Development Goals. The unprecedented COVID-19 pandemic has worsened the situation of healthcare in India. Despite the poor health infrastructure, India has consistently allotted a meagre share of its total spending to healthcare. This paper aims to highlight the shortage of health expenditure in India as compared to other nations and also discusses the impact of poor healthcare in achieving India’s SDG-3 goals. The paper also compares the healthcare models and expenditure employed by the Indian states of Gujarat and Kerala in fighting the COVID-19 pandemic.

Mishra, Priyanka and Amborish Nath, ‘Who Deserves a Ventilator Amidst the Covid-19 Pandemic? Sorting the Moral, Ethical and Legal Dilemma in Indian Scenario’ (2021) 8(4) International Journal of Clinical Case Reports and Reviews (advance article, published 27 September 2021)
Abstract: The novel coronavirus disease (COVID-19) has rampaged into a second wave and shook the health infrastructure of several countries with India being among one of the worst-hit nations. In consideration of the current immense scarcity of ventilators in India, cautious resource allocation is the need of the hour. Hence, the Intensive care units and the ventilator allocation triage need to be formulated by a central public policy. This is due to the clinical implications, subjective judgments, ethical controversy, evidentiary weaknesses, and organizational complexities. This article suggests few approaches to suitably acknowledge everyone’s rights and judiciously allocate the ventilators for maximum benefit. This will ensure that the ‘maximum life years’ are saved and no patient dies unlawfully.

Mišič, Luka and Grega Strban, ‘Regulation of Triage in Times of a Pandemic: Experiences from Slovenia (and Beyond)’ (2021) 14(2) Medicine, Law & Society 189–208
Abstract: The article offers an overview of legal regulations governing (medical) triage in Slovenia and their importance in times of the Covid-19 epidemic. Focusing on the Patients’ Rights, Health Care and Health Insurance, Medical Services, and Health Services Act, it looks at ways in which legal rules and medical standards intertwine when it comes to deciding who should receive particular limited medical treatment first or in what order. It also deals with ways in which professional rules of conduct or medical standards may, on the one hand, exclude the unlawfulness of particular conduct, and how, on the other hand, law may limit the autonomy of medical practitioners. Both the autonomy in their professional conduct as well as healthcare providers’, but especially professional organizations’ law-making autonomy. Even if grounded in the Slovenian legal order, the present article by nature surpasses its domestic boundaries, since the Covid-19 epidemic created similar issues in several if not in all European jurisdictions. Even more so, since the article addresses several general challenges concerning triage in times or moments of crisis, such as state’s positive obligations, recognition of patients’ private autonomy, medical treatment abroad, ethical deliberations concerning a just distribution of scarce medical services, etc.

Mitchell, Kimberly, M Grupac and A Zauskova, ‘Ethical Management and Implementation of COVID-19 Immunity Passports and Vaccination Certificates: Lawfulness, Fairness, and Transparency’ (2021) 20 Linguistic and Philosophical Investigations 45–54
Abstract: This paper analyzes the outcomes of an exploratory review of the current research on the ethical management and implementation of COVID-19 immunity passports and vaccination certificates. The data used for this study was obtained and replicated from previous research conducted by Ada Lovelace Institute, Ipsos,, The Serco Institute, Survation, and Verywell. We performed analyses and made estimates regarding whether COVID-19 immunity passports would risk exacerbating discrimination in law. Data collected from 4,800 respondents are tested against the research model. Descriptive statistics of compiled data from the completed surveys were calculated when appropriate.

Mohapatra, Seema, ‘Passports of Privilege’ (2021) 70(5) American University Law Review 1729–1763
Abstract: All Americans sixteen and older are now eligible to receive a COVID-19 vaccination. However, many will not be able to access such vaccinations due to their work situation, health status, and inaccessible vaccination sites. Some have suggested that the use of vaccine passports, credentials used to gain access to places and countries by showing proof of vaccinations, may encourage people to get vaccinated. The COVID-19 pandemic has laid bare deep inequities in our society, and this Article argues that the use of vaccine passports would further exacerbate such chasms. Part I of this Article describes the differences between immunity passports and vaccine passports and the scientific uncertainty about their use, given the novel nature of this virus. Part II discusses whether the use of vaccine passports are legal in the United States. Part III discusses the ethical problems of immunity serving as a marker for the privilege to re-enter society, and the unwise focus on a technological fix for what is essentially a public health and equity disaster. While vaccine passports arguably may produce greater absolute economic benefits in the short term, a more equitable approach would be to address the social determinants of health and thereby spur far greater distributional economic benefits in the long term.

Monrad, Joshua Teperowski, ‘Ethical Considerations for Epidemic Vaccine Trials’ (2020) 46(7) Journal of Medical Ethics 465–469
Abstract: Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines.

De Montalvo Jääskeläinen, Federico, ‘Ethical and Legal Requirements for Biomedical Research Involving Health Data in the Context of the Covid-19 Pandemic: Is Informed Consent Still Playing the Leading Role?’ [2021] (Special Issue 2) BioLaw Journal – Rivista di BioDiritto 157–167
Abstract: The current pandemic could have accelerated a change of the traditional paradigm about the secondary use of health data. The traditional one has been based on the faculty of the individuals about accepting or not that use of their health data through the main role of informed consent. The new paradigm considers the current value of that secondary use for the improvement of the health of community and its individuals, through the possibilities offered by Big Data and AI. Therefore, the need of a balance between individual rights and the common good is indispensable. Pseudonymization could be the way to find this balance.

Monteverde, Settimio, ‘Who Is Essential in Care? Reflections from the Pandemic’s Backstage’ (2022) 29(5) Nursing Ethics 1096–1106
Abstract: Since the beginning of the pandemic spread of the Coronavirus, societies have been reminded that the impact of Covid-19 and public health measures of infection containment reflect known gradients of inequality. Measures focusing only the (acknowledged) frontstage of the pandemic and neglecting its (unacknowledged) backstage—understood as those framework conditions indispensable for societies to thrive—have worsened the impact of social determinants of health on the most vulnerable, as shown by the deleterious effects of prolonged social isolation of residents of nursing homes. To reflect this phenomenon ethically, a framework is proposed which is inspired by the feminist philosopher Margret Little. At its core stands the assumption that caring for people and moral ends allows us to identify what is morally salient. This epistemological stance allows a critical look at the alleged dilemmas invoked to enforce brute, long-lasting policies of closing nursing homes in many places—especially in the light of their dubious effectiveness in preventing viral spread and the severe physical and psychological consequences for those affected. If moral salience is only fully perceived through the closeness of the caring relationship, the human suffering resulting from these policies reveals the utter inadequacy of the dilemma rhetoric used to justify them. This insight is illustrated by the personal experience of the author: He describes his role as an essential care partner of his mother living in a nursing home and forced into the role of a ‘visitor’ who witnessed a constant deterioration of care. Based on an epistemological understanding of caring for making reliable moral judgments, potentially exclusionary effects of distinguishing essential from non-essential groups in care will be addressed together with the need to overcome strict boundaries between front- and backstage. Such efforts will strengthen the moral community of persons needing care, professional care givers and essential care partners.

Morvillo, Marta, ‘I Just Can’t Get Enough (of Experts): The Numbers of COVID-19 and the Need for a European Approach to Testing’ (2020) 11(2) European Journal of Risk Regulation Special Issue-‘Taming COVID-19 by Regulation’ 366-374
Abstract: This article offers a reflection on the testing strategies deployed in the generation of epidemiological data in the European Union (EU). I will argue that, while in the early days of the pandemic, Member States proceeded to testing in a rather scattered way, the shortage of resources seems to have acted as a driver of coordination, which is now increasingly being discussed at EU level. I will examine the legal and institutional framework supporting such embryonic coordination efforts and offer a preliminary assessment of their implications for a European approach to epidemiological knowledge-making.

Mosley, Mark, ‘Conquering COVID-19 with Technology and the Law’ (2020) 42(8A) Emergency Medicine News

Moustis, Matthew, ‘COVID-19 & The Illinois Health Care Right of Conscience Act: A Legal Analysis’ (2022) 43(1) Northern Illinois University Law Review 1–28
Abstract: During the COVID-19 pandemic, many people who refused to be vaccinated because of their religious or moral beliefs tried to use the Illinois Health Care Right of Conscience Act to block their employers’ vaccination requirements. In response, some elected officials argued that the Act was being misinterpreted. They believed it was intended only to protect health care providers who refused to provide certain services to patients, not to allow people to avoid measures taken to ensure public health during a pandemic. Their interpretations were incorrect. The Illinois Health Care Right of Conscience Act was properly construed as a right to refuse COVID-19 vaccines on religious or moral grounds. And it was properly construed as applying to anyone, not solely to health care providers. Contrary interpretations are inconsistent with the public policy, the statutory language, and the interpretive caselaw. Furthermore, the latest amendment was not a legislative clarification but a substantive change to the law.

Myers, William M and Davia C Downey, ‘Face Mask Mandates: Unilateral Authority and Gubernatorial Leadership in US States’ (2023) 45(3) Law & Policy 353–372
Abstract: During the first year of the COVID-19 pandemic in the United States, the coordination and cooperation between the federal government and the states failed. American governors were thus tasked with making critical public health policy choices—under extreme uncertainty—with varying institutional capacities, partisan pressures, and state demographic differences. Yet most of the nation’s governors chose to impose a face covering or mask mandate to limit the spread of cases. We collected each governor’s executive order that mandated the conditions under which their residents would be required to wear a mask and employed a sentiment analysis program to extract key qualities of crisis leadership communication. Our analyses provide insights into the institutional and partisan factors that determined a face mask mandate as well as the institutional, demographic, and leadership communication qualities that affected the total number of cases per capita in the states. Our findings have important implications for post-pandemic policy recommendations with respect to the effectiveness of policies that seek to lower the transmission of viruses in public spaces and the characteristics of impactful public health messaging by government leaders.

Mukhlis, Muchammad Fauzan and Faridatul Fauziah, ‘The Risk of Pregnancy and Labour during the Covid19 Pandemic Relationship to Children’s Health Insurance Related To Law No 35 of 2014 Concerning Child Protection and Law No 36 of 2009 about Health’ (2021) 4(4) Budapest International Research and Critics Institute (BIRCI-Journal): Humanities and Social Sciences 11264–11274
Jurisdiction: Indonesia
Abstract: Pregnancy and childbirth are happy moments for every mother-to-be in the world. However, pregnancy and childbirth during a pandemic have risks for transmission to both the mother and the fetus. Thus, giving attention to children is given since the child is conceived, during the delivery process and after delivery. During the COVID-19 pandemic, mothers can check their pregnancy 6 times during pregnancy. Preparing to give birth during the COVID-19 pandemic needs to be considered. The choice of place to give birth, be it at home, clinic, or hospital, taking into account the risks and benefits. After the baby is born it is important to continue to do consultations, including undergoing routine immunizations. Every mother should be more active in asking about safe ways to make appointments for consultations and immunizations in the midst of a pandemic. Given the bad impact, the government pays special attention to child protection by issuing Law Number 35 of 2014 concerning Child Protection in Article 1 it is stated that children are given special protection, namely a form of protection received by children in certain situations and conditions to get guarantees. a sense of security against threats that endanger themselves and their lives in their growth and development. Law Number 36 of 2009 concerning Health states that maternal health efforts must be aimed at maintaining maternal health so that they are able to give birth to a healthy and quality generation and reduce maternal mortality. Therefore, the role and alertness of the government and health workers as the front line in handling Covid-19 can provide peace to pregnant women through pregnancy and childbirth in the midst of a pandemic. Pregnant women need to pay more attention to complying with health protocols even though they have made an agreement to consult with health workers when preparing for pregnancy and childbirth during the COVID-19 pandemic.

Muller, Lynn S, ‘Changing Legal Landscape Observations Post-COVID-19’ (2021) 26(6) Professional Case Management 309–312

Mykhalovskiy, Eric et al, ‘Human Rights, Public Health and COVID-19 in Canada’ (2020) 111(6) Canadian Journal of Public Health 975–979
Abstract: Faced with the extraordinary global public health crisis of COVID-19, governments across Canada must decide, often with limited and imperfect evidence, how to implement measures to reduce its spread. Drawing on a health and human rights framework, this commentary explores several features of the Canadian response to date that raise human rights concerns. Our discussion focuses on criminal law, fines, data collection, and so-called snitch lines. We argue that the approach of governmental and public health authorities must be grounded in the best available scientific evidence and align with human rights standards. Our aim is to encourage dialogue within the public health community in Canada about the importance of human rights-based responses to COVID-19.

Narattharaksa, Teeradej and Kanida Nikky Narattharaksa, ‘A Study on Government Laws and Regulations That Do Not Facilitate Public Access to Drugs and Vaccines during Public Health Emergency’ (SSRN Scholarly Paper No 4438714, 5 May 2023)
Jurisdiction: Thailand
Abstract: The world is currently facing public health problems due to emerging diseases. Current laws, rules, and regulations of the State may, partially or totally, not be conducive to dealing with public health emergencies and for many agencies from the public sector, private sector, and civil society to fulfill their obligations, including public access to drugs and vaccines in a public health emergency. To achieve prevention, supervision, and response to current and future emerging problems the State should operate nationwide with good public governance. State agencies should cooperate and coordinate to improve efficiency in their operations and public service provisions. This principle also applies to a local administrative organization.

Nasfa, Aminath and Mohammad Rauf, ‘Knowledge, Attitudes and Practice of Healthcare Law and Ethics Among Nurses: A Case Study of Indira Gandhi Memorial Hospital of Maldives in the Prospective of Covid-19 Pandemic’ in Mohammad, Rauf, Covid-19 Emerging Socio-Economic and Legal Trends in Maldives (Mahi Publication, 2021) (2021) 164–184
Abstract: Nurses must be well aware of healthcare ethics and law to prevent both nurses and patients from negative impacts. For ideal nursing practice, it requires not only practical efficacy but also it requires ethical standards. The Nurses that are most exposed to face the legal issues mainly are nurses that employed at emergency department, intensive care unit and at community field, where decision about the patients’ health are taken by the patient themselves or spouse or guardian. Therefore, nurses are must have more critical thinking and wisdoms to handle the issues which demands exceptional judicial knowledge. During Covid-19 pandemic, large number of nurses are working at front line and face lot of challenges to deliver quality care due to lack of resources. As a result, emotional trauma among nurses more common and end up with suicide. One of the issues faced is problem of equity and fairness in how patients are treated and this issue has become big challenge to accept justification for such decisions. In addition, this may imply a change from a person-centered to a population-based nursing approach. This is because protecting the general welfare often necessitates limiting people's rights and desires. It could be argued that there is an ethical obligation to devote scarce resources where they can be most beneficial, saving the most lives.

Nasrun, Mastika et al, ‘Legal Challenges of the Covid-19 Vaccination Program: A Comparative Discourse between Malaysia and Australia’ (2021) 6(10) Malaysian Journal of Social Sciences and Humanities (MJSSH) 319–333
Abstract: During the spread of the COVID-19 pandemic, many health-related industries were alarmed and pressured to innovate solutional vaccines to reduce the effect of the COVID-19 pandemic. Extra effort and lab activities had taken place in several jurisdictions to respond to the increased demand for the COVID-19 vaccine. With these attempts, various vaccines were created and entered the market. All countries designed their own COVID-19 programme in the route to combat the viruses. These countries showed their willingness to invest to secure access to vaccines. In parallel to this development, the vaccination program is bombarded with several issues such as safety assurance, equal access to the vaccine, and protests by the anti-vaccine group. The inability to address these issues will jeopardise the success of building herd immunity which is the core in eradicating COVID-19 cases. Thus, this study explored and analysed the issues and challenges to have an effective vaccination program in a battle against the spread of the COVID-19 virus. It is a comparative study between Malaysia and Australia that includes safety measures, anti-vaccine groups and access to vaccines. This study adopts a qualitative method utilising the doctrinal study on the legal framework that describes the scope and limitation of power accorded to the Drug Control Authority of the selected jurisdictions. The research activities also include semi-structured interviews with relevant authorities using online interviews. The data are analysed using content and thematic analysis. Findings to this study may assist in identifying the loopholes within the administrative control on the vaccination program adopted by Malaysia.

Neri, Rocco, ‘The Pandemic Law: Lights and Shadows’ [2022] (2) Democracy and Law 130–143

Nickerson, Jason W and Matthew Herder, ‘COVID-19 Vaccines as Global Public Goods’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 591
Abstract: There is growing awareness that the only end to the COVID-19 pandemic, without causing an unacceptably large number of deaths, will be with one or more vaccines mass-produced and readily available to meet the world’s needs. A flurry of research and development activities are underway; however, the way the vaccine research and development system is currently constructed is not optimized to develop, manufacture, and equitably distribute vaccines on a global scale. In this chapter, we propose that resolving the tension between these realities requires a different approach to health innovation, one that operationalizes the concept of global public goods throughout the phases of vaccine development, manufacturing, and distribution. We argue that such an approach is not only the morally correct thing to do, given the scale of needs and the risk that the public has accepted by financing the development of various experimental vaccines, but it is also the only possible way of ensuring sufficient global manufacturing capacity and equitable distribution of any vaccines that prove effective against COVID-19. We detail what adopting a global public goods approach to vaccine production would require in Canada, in an effort to encourage other jurisdictions to follow the same approach.

Nielsen, Alyssa, ‘Utilitarian Triage in Disasters’ (2021) 46(1) BYU Law Review 217–248
Abstract: In the article, the author discusses the need to provide medical professionals and hospitals with legal immunity in cases where utilitarian triage is necessary to effectively respond to medical emergencies like the COVID-19 pandemic. Also cited is the proposal that U.S. state legislators should eliminate all factors other than the patients’ existing medical statuses when enacting laws that provide immunity to medical professionals against lawsuits regarding their triage decisions.

Njiri, Kenneth, ‘Mental Health and Covid-19: The Right to Mental Health during the COVID-19 Pandemic’ (SSRN Scholarly Paper No ID 3598916, 12 May 2020)
Abstract: The covid-19 pandemic has disrupted the lives of people in the world. Kenya has not been left alone. As a result, jobs have been lost. Families are apart. There is panic and worry in the world. As a result, the mental health of persons is at risk. In my paper, I argue that there is need for the government of Kenya to safeguard the mental health of its citizens. Further, a multi-sectoral approach should be adopted in ensuring the mental wellness of the people.

Nikitin, Yurii et al, ‘Constitutional Right to Health Protection and Medical Care in Ukraine in the Context of the Pandemic COVID-19’ (2020) 13(4) Journal of Politics and Law 99–109
Abstract: The content of the right to health protection and medical care according to Ukrainian legislation is analyzed in the article as well as peculiarities of its realisation in the context of the pandemic COVID-19. It examines also the correlation between the notion ‘health protection’ and ‘medical care’. On the basis of this correlation, the conclusion is made that the right to health protection is broader and includes, but is not limited to, the right to medical care. Some international standards in the sphere of health protection, which constitute the basis of Ukrainian legislation in this area, are analyzed. The conclusion is made that Ukraine should take into account such standards while limiting human rights, in particular, the right to health protection and medical care in the context of the pandemic COVID-19. It is mentioned that the significant problem remains the legal regulation of quality control of medical care, the creation of organizational technologies with a clear division of control functions between the various actors in the health care system, which is extremely important in terms of the pandemic. The attention is also paid to the personal data protection issue in the sphere of health care. The conclusion is drawn that there should be mechanisms for reporting and protecting against abuse while collecting personal data, and people should be able to challenge any COVID-19-related measures for the collection, aggregation, storage and further use of their data.

Nioi, Matteo et al, ‘Fear of the COVID-19 and Medical Liability. Insights from a Series of 130 Consecutives Medico-Legal Claims Evaluated in a Single Institution during SARS-CoV-2-Related Pandemic’ (2021) Journal of Anesthesia, Intensive Care, Emergency and Pain Medicine (pre-print, published online 26 May 2021)
Objectives: The aim of the current work was to evaluate the frequency and the type of cases of medical liability from a single center in the first ten months of the pandemic as well as to identify critical issues associated with the organization of public health during the coronavirus disease 2019 pandemic.
Methods: We compared 130 cases evaluated for medical liability from March 2020 to January 2021 and compared with 159 cases from March 2019 to January 2020. The cases were divided in four pre-established groups: surgical error, diagnostic/therapeutic errors and nosocomial diseases, delays, and problems related to assistance.
Results: Analysis showed a significant increase in cases due to delay in treat-ment/hospitalization and shortages in health care of non-autonomous patients [χ2 (1, N = 289) = 5.6746, p = 0.02]. Conclusions: The work showed an increase in medical/legal cases regarding non-COVID-19 emergencies in which the outcome is related to the time of treatment and/or arrival at the hospital. There was also a rise in complaints of deficits in supervision and care for non-autonomous patients. Despite the persistence of preventive measures for the current pandemic, measures should be taken to improve health care in these categories of patients.

Noah, Lars, ‘Eliding Consent in the Case of Pandemic Countermeasures Authorized Only for Emergency Use’ (2024) 58(1) Indiana Law Review (forthcoming)
Abstract: Four months after the first vaccines against Covid-19 became available to the public, and just as some universities announced plans to require inoculations, the Boston Globe quoted me as (alone) suggesting that mandates would conflict with federal law. When Congress created a special mechanism for the emergency use of still investigational products, it directed providers to reveal, among other things, that individuals remained free to decline such an intervention; only after full FDA approval of a medical countermeasure would this disclosure obligation become inapplicable. I have watched with dismay over the last three years as nearly everyone—including Executive branch officials, federal and state judges, and various academic commentators—cavalierly dismissed an entirely valid statutory objection. This paper probes what accounts for the universal rejection of an argument that, on further reflection, continues to strike me as far from frivolous.

Norman, Ishmael, Emmanuel Kpeglo and Raymond Agalga, ‘Cross-Sectional and Medico-Legal Investigations of Covid-19 Response, Ghana’ (2020) 2(6) European Journal of Medical and Health Sciences 587
Abstract: From the 12th of March 2020, Ghana took bold steps against Covid-19, aimed at controlling the spread among the population, protecting against community infections, treating those with the disease and ensuring public trust in the healthcare delivery system. This cross-sectional survey, assessed the effectiveness of Ghana’s risk communication, legal framework and response approaches to the Covid-19 Pandemic. The first part was a Cross-Sectional approach. The authors used data collected on-line via a self-reported questionnaire between 16th March and 16th April from [127] participants. Differences in mean scores and other factors associated with awareness; as a function of risk communication; to Covid-19, knowledge of safety protocols, and practices towards the disease, were conducted using univariate and multivariate data analytical methods. The second approach was a literature review of Ghana’s legal framework existing prior to the outbreak of Covid-19 and those enacted by Parliament during the emergency period towards the management of the pandemic. A content analyses of the legal framework, to assess official compliance with the framework in relation to the aim of this study was conducted. The majority of the study participants were knowledgeable about how Covid-19 was transmitted. An independent samples t-test was performed to determine if a difference existed between the mean scores of COVID-19 knowledges for males and females. The outcome variable was found to be normally distributed and equal variances are assumed based upon results of Levene’s test (F (125) = 0.097, p-value = 0.756). There was no significant difference in knowledge scores (with minimum = 1, and maximum = 3) for males (mean = 1.61, standard deviation = 0.665) and females (mean = 1.56, standard deviation = 0.698; t- value t (125) =0.374, p-value = 0.709, two-tailed). The magnitude of the difference in the means (mean difference = 0.054, 95% confidence interval: -0.234, 0.343) and the effect size was very small (Cohen d = 0.08). The independent samples t-test was also performed to test the hypothesis that males and females were associated with statistically significant different COVID-19 awareness mean scores. The test showed no significant difference in the awareness scores for males and females. The results from the content analyses of the legal framework show there was lax adherence of government to the legal framework for Pandemic response on these dimensions: Planning and Coordination; Surveillance, Situation monitoring and Assessment; Prevention, Containment and Management; Communications; and Social Mitigation. It further shows that neither the existing legislation nor the Executive Instruments, E. I. 63 - 66, and 164 directed at Covid-19 administrative and epidemiologic controls, have helped to stop the spread of Covid-19, considering the uptick of new infections of Covid-19. Covid-19 has exposed the lack of effective risk communication modalities in Ghana and the government’s lack of adherence to the legal framework on disasters and emergencies in general, a vacuum which is filled by social media.

Nugraha, Ignatius Yordan, Juncal Montero Regules and Merel Vrancken, ‘Vavřička and Others v. The Czech Republic’ (2022) 116(3) American Journal of International Law 579–585
Abstract: In Vavřička and Others v. the Czech Republic, the Grand Chamber of the European Court of Human Rights (ECtHR or Court) addressed whether compulsory childhood vaccination is in line with the European Convention on Human Rights (ECHR). Provided all necessary precautions are taken, states may require childhood vaccination in the interest of ‘social solidarity.’ While concerned with mandatory vaccination of children for diseases such as measles and tetanus, the judgment was issued in the context of the COVID-19 pandemic (ongoing at the time of writing), for which it has obvious implications. We argue that the Court’s deference to European consensus is warranted for public health decision making, and Vavřička demonstrates that the Court would most likely accept mandatory vaccinations for COVID-19 as being in line with the ECHR. At the same time, the judgment still has some pitfalls—most notably, that the Court failed meaningfully to engage with the concepts of ‘best interests of the child’ and ‘social solidarity’ on which its decision relied.

Nugraheni, Destri Budi et al, ‘Problem Identification of Islamic Law Implementation in COVID-19 Mortuary Practice in Indonesia from the Perspective of Forensic Pathologists’ (2023) 17(2) Indian Journal of Forensic Medicine & Toxicology 25–31
Abstract: Indonesia consists of many different ethnic groups and religions. Islam is the major religion in Indonesia, thus also rendering Islamic tradition as being significant in Indonesia. This is also the case with Islamic law. In March 11, 2020, COVID-19 was declared as pandemic by WHO. Since then, there were reported cases of forceful seizure of deceased bodies by the deceased’s family in Indonesia. The aim of this research is to understand the problems related with Islamic law implementation in COVID-19 mortuary practice in Indonesia from the perspective of forensic pathologists. This study also aims to analyze whether the solutions given are in accordance with Islamic law. The sampling method used was convenience sampling. The respondents were forensic pathologists from different areas in Indonesia. 19 out of 20 respondents reported problems and solutions. The solutions were in accordance to Islamic law. Problem that is present in mortuary practice in the context of muslim COVID-19 patients are related to the bathing and shrouding process. There is distrust on whether proper care had been carried out. The situation happened due to the community’s lack of comprehensive understanding of proper Islamic mortuary practice in COVID-19 pandemic context.

Nwokeke, Chidera, ‘A Perusal on COVID-19 and Rights of Patients’ (SSRN Scholarly Paper No ID 3579257, 18 April 2020)
Abstract: A perusal on Covid-19 and the rights of patients in Nigeria. This article examines the position of our laws with regards to patients’ rights and its enforceability in our Courts and the remedies available to a patient.

Oguamanam, Chidi, ‘COVID-19 and Africa: Does One Size Fit All in Public Health Intervention?’ in Colleen M et al Flood (ed), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 543
Abstract: Taking into account the socio-economic, cultural, and political dynamics of Africa, and drawing from a universe of publicly available information, this chapter explores Africa’s experiences with selected aspects of COVID-19 public health and associated response measures. It aims, in part, to identify facets of the contextual dynamics of the continent that warrant creative and fit- for-context public health responses outside of a one-size-fits-all milieu. Also, the chapter identifies and reflects on some real and potential lessons and opportunities from the COVID-19 experience on the African continent that could reposition the continent and enhance its resilience in the face of the first global pandemic in a globalized and technology-driven world order.

Oh, Juhwan et al, ‘Announcement of Launching the JGHS Commission on COVID-19 Response’ (2020) 2(1) Journal of Global Health Science e20
Abstract: Global Health Science, Article e20 Extract: JGHS recognizes that the underlying causes of the spread and impact of the pandemic, the response and the impact of the response is too wide-ranging to expect the bio-medical scientific community alone to design and evaluate comprehensive and effective system level responses to this and any future pandemic. In addition, JGHS believes that an effective response requires a profound understanding from all regions of the globe. This philosophy, set out in the inaugural issue of JGHS has inspired the launch of the JGHS Commission on COVID-19 Response.

O’Leary, Diarmuid, ‘Curtailing Covid Casualties, From Hospital Room to Courtroom: An Analysis of Ireland’s Deficient Liability Regime During Public Health Emergencies’ (2021) 28(4) European Journal of Health Law 377–392
Abstract: This article considers the liability of healthcare professionals during public health crises in Ireland. It argues that Covid-19 has shown that Irish law lacks protective measures for healthcare practitioners who elect to value high-capacity care over best possible treatment to smaller numbers of patients. Such a prohibition, it is contended, has the potential to be fatal to the management of public health emergencies and can lead to defensive clinical practices which serve to slow or halt progress in the provision of emergency healthcare. As such, a broad, accessible and clearly-defined immunity regime limited to periods of crisis is recommended in order to allow for the protection of the practitioner and the provision of healthcare to the masses.

Oliva, A et al, ‘Future Medico-Legal Implications on Obstetrics and Gynaecology Practice in the SARS-CoV-2 Pandemic’ (2021) 33(4) Italian Journal of Gynaecology and Obstetrics 263–274
Abstract: Since February 2020, the Italian National Healthcare System had to mitigate the possibility of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) transmission to vulnerable patients. Healthcare professionals rapidly reviewed their workflow to maintain a safe and high standard treatment, but weak scientific evidences and organizational limits resulted in the adoption of heterogeneous measures. Adherence to screening protocols and follow-up programs pregnant women and oncological patients has not been always guaranteed this scenario could evolve in an enormous number of medico-legal actions. This context, showing the weakness of the Italian law No. 24/2017, imposes an urgent reorganization of the legal framework to homogenize the judgements to ‘protect’ healthcare professionals involved in this epochal emergency.

Oliva, Jennifer D, ‘Policing Opioid Use Disorder in a Pandemic’ [2020] University of Chicago Law Review Online (forthcoming)
Abstract: This essay examines the federal government’s pandemic-provoked waiver of long-standing legal and regulatory barriers to evidence-based opioid use disorder (OUD) treatment aimed at enhancing access to OUD care while mitigating the risk of exposure to COVID-19. OUD is a highly stigmatized, chronic neurological disease with a poorly understood etiology. The prevailing approach in the United States, however, has been to criminalize individuals with OUD. This is because U.S. drug policy has been long dominated by the antiquated view that OUD is a deviant moral failing that deserves prosecution instead of a complex health care condition that demands evidence-based treatment. The persistence of such anti-scientific theories about OUD motivated the federal government’s creation of a surveille-and-supervise regulatory regime that isolates OUD treatment from the traditional health care delivery system and prioritizes the policing of individuals with OUD over the provision of expansive access to care. Unlike prior U.S. drug crises, which were attributed to the alleged immoral nature of targeted racial and ethnic minority groups, the country’s current drug use and overdose dilemma has been characterized as a predominantly rural and suburban white American problem instigated by clinical overprescribing and the aggressive and fraudulent marketing of opioid analgesics. This popular narrative, which shifts blame for use disorder from the white ‘victim,’ to unscrupulous prescribers and Big Pharma, changed the substance use disorder solutions rhetoric from policing and punishment to public health interventions. Consequently, federal health officials were more amenable to policies aimed at enhancing assess to OUD treatment as the novel coronavirus began to sweep over the United States in early months of 2020. In fact, they quickly waived several of the rigid federal legal requirements that attend to OUD treatment—and have long-obstructed access to OUD therapeutics—at the inception of the COVID-19 national health emergency. The federal government’s decision to waive certain access to treatment barriers for individuals with OUD was a long overdue positive development. There is no question that the federal agencies that oversee the draconian U.S. OUD therapeutic regulatory regime ought to make those waivers permanent post-pandemic. This essay argues, however, that the benefits of the OUD-related COVID-19 waivers have disproportionately inured to individuals who use buprenorphine and are overwhelmingly white at the expense of individuals who use methadone and are overwhelmingly persons of color. This is particularly tragic given that it was considerably easier to obtain a prescription for officed-based buprenorphine than access methadone administration treatment under the drug control regulatory regime pre-pandemic. The essay concludes by advancing a series of additional reforms beyond the current COVID-19 waivers that the federal government should adopt to ensure more equitably enhance access to OUD treatment.

de Oliveira Andrade, Adriano et al, ‘On the Use of Telemedicine in the Context of COVID-19: Legal Aspects and a Systematic Review of Technology’ [2021] Research on Biomedical Engineering (advance online article, published 13 March 2021)
Purposes: The aim of this study was to carry out a systematic review of telemedicine technology and to discuss the role of legislation in the application of telemedicine technology within the scope of COVID-19.
Conclusion: Telemedicine allows for care in remote areas and at a lower cost to the patient and, in the current situation, it can reduce the number of contagions as well as the occupation of beds in health facilities. elemedicine may suffer from limitations, mainly due to current legislation, but in this pandemic era of COVID-19, several countries around the world have made their laws more flexible to allow more widespread use of telemedicine.

Omelchuk, Oleh M et al, ‘Legal Aspects of Mass Vaccination during the COVID-19 Pandemic on the Example of Ukraine’ (2021) 40(3) Medicine and Law 411–424
Abstract: This article considers the issue of mass vaccination during the COVID-19 pandemic, which is one of the main issues of medical law in terms of the concept of natural law. This topic is acquiring special relevance. The purpose of the article is to study respect for human rights in the mass vaccination against COVID-19, in terms of the balance between the patient’s right to make medical decisions and the interests of society. For the purposes of this work, which is closely related to the observance of human rights, a method such as the human rights-based approach (HRBA) has been used. Based on the PANEL principles, along with an active campaign to support vaccination, the state needs to develop an effective mechanism to influence those who do not want to be vaccinated, using existing mechanisms. There are three such mechanisms the establishment of a penalty for refusing vaccination;the introduction of certain restrictions for unvaccinated citizens;the establishment of certain benefits for medical care for people who have been vaccinated in time.

Omelchuk, Oleh M, Inna V Shevchuk and Anna V Danilova, ‘The Impact of Covid-19 Pandemic on Improving the Legal Regulation Of Protection of Human Right to Health’ (2020) 73(12 cz 2) Wiadomosci Lekarskie 2768–2772
Objective: Theoretical and methodological substantiation of the impact of COVID-19 on the implementation of state policy on the protection of human right to health in terms of improving the legal framework in the field of demographic security.
Materials and methods: The main research materials are the norms of the International Covenant on Economic, Social and Cultural Rights, the Conventions for the Protection of Human Rights and Fundamental Freedoms and the legal framework of the countries that have adopted temporary quarantine measures. This research is based on empiricaland analytical data from WHO, Bloomberg’s financial information provider. During the research, the following methods have been used: statistical, system-structural analysis, content-analysis, comparison, grouping and forecasting.
Conclusions: Under the conditions of pandemic, attention should be paid to strengthening both administrative and criminal liability for violating quarantine, which will serve as a prerequisite for improving the legal mechanism of combating threats to the country’s demographic security. The protection of the right to health requires the state to create conditions to prevent the risk of occupational diseases among health care workers and others involved in the response to COVID-19.

Ó Néill, Clayton et al, ‘COVID-19 Vaccination In The UK And Ireland: Ethics In Practice’ (Edinburgh School of Law Research Paper No 2021/16, 15 July 2021)
Abstract: This working paper examines questions of values in relation to the COVID-19 vaccination programmes in the United Kingdom and Ireland. We first present a brief overview of developments in relation to COVID-19 vaccine development and rollout on a global basis. We then proceed with an examination of key ethical, policy and legal developments in these areas in the United Kingdom and Ireland, followed by the identification of commonalities and differences as between the two countries. In the final section, we consider the broader issue of values raised by the COVID-19 vaccination programmes in the UK and Ireland.

O’Neill, J, ‘A Lesson from MMR: Is Choice of Vaccine the Missing Link in Promoting Vaccine Confidence through Informed Consent?’ (2023) 33(4) Ethics & Behavior 272–285
Abstract: A recent study suggests that vaccine hesitancy amongst key demographics – including females, younger individuals, and certain ethnic groups – could undermine the pursuit of herd immunity against COVID-19 in the United Kingdom. At the same time, the UK Joint Committee on Vaccination and Immunization (JVCI) indicated that it will not facilitate the choice between available COVID-19 vaccines. This paper reflects upon lessons from the introduction of the UK’s combined Measles, Mumps and Rubella (MMR) vaccine strategy of the 1980s when Member of Parliament Miss Julie Kirkbride argued that had parents been allowed to choose between vaccine variants, then the crisis of low herd immunity – and subsequent outbreaks – could have been avoided. This paper explores this argument, as applied to the COVID-19 vaccination strategy, by considering how three key elements of informed consent – disclosure of risk, benefit, and reasonable alternatives – may be employed to tackle vaccine hesitancy and build vaccine confidence.

O’Neil, Meghan M, ‘What Happens When a Pandemic Intersects an Epidemic?’ (SSRN Scholarly Paper No ID 3587094, 23 April 2020)
Abstract: Persons experiencing addiction may be at very high risk of infectious disease like COVID-19 due to high rates of smoking, recent imprisonment, conditions like HIV/AIDS, and high-risk behaviors (Ezzati et al. 2002; Farhoudian, et. al. 2020). During the COVID-19 pandemic, most courts have shuttered, and treatment center admissions have halted, yet the opioid crisis rages on. America’s opioid epidemic may have just become more lethal and socially costly.

Onyediri, Jason, ‘Social Insurance for the Socially Distant: Reforming the Countermeasures Injury Compensation Program’ (2022) 101(1) Texas Law Review 237–271
Abstract: The various COVID-19 vaccines have done immeasurable good for society. The vaccines have slowed the spread of the virus, reduced hospitalization rates, and prevented deaths. Of course, the vaccines are not perfect. Of the hundreds of millions of people who have been vaccinated, some, albeit relatively few, have suffered serious adverse side effects from vaccination. How these individuals are compensated has significant implications for the nation’s vaccination efforts and public health. Pursuant to the Public Readiness and Emergency Preparedness Act (PREP Act), broad liability protections are afforded to manufacturers and administrators of COVID-19 vaccines. Thus, those that allege harm from vaccines cannot bring suit to recover damages for their injuries. At present, the Countermeasure Injury Compensation Program (CICP) is the exclusive mechanism by which individuals injured by COVID-19 vaccines can seek compensation. However, the CICP was not designed with COVID-19 in mind. The program is woefully deficient, particularly when compared to its sister federal vaccine injury program, the Vaccine Injury Compensation Program (VICP). Moreover, other social insurance programs employ successful design principles that are lacking in the CICP. This Note argues that the CICP is best conceptualized as social insurance and draws from successful social insurance programs to suggest reforms to the CICP. Others have critiqued the CICP, compared it to the VICP, and proposed reforms. However, this Note is unique in developing its reform suggestions by viewing the CICP through the lens of social insurance. In doing so, this Note seeks to inform the current federal vaccine injury compensation reform discourse by extracting valuable design principles from social insurance programs.

Opolska, Zuzanna, ‘How Has Norway Beaten the COVID-19 Pandemic?’ (2021) 7(1) Journal of Health Inequalities 7–11
Abstract: Norway is seen as a model in the fight against COVID-19. In 15 months, just 789 people died from the coronavirus. Frode Forland from the Institute of Public Health tells us how Norway managed to overcome the pandemic.

Orie, Erimma Gloria, ‘Climate Change, Sustainable Health and COVID-19 Pandemic in Nigeria: The Legal Issues in Perspective’ (2023) 19(1) Medical Sciences Forum 7
Abstract: The paper examined legal impediments to sustainable health in Nigeria due to the impact of climate change (CC) exacerbated by coronavirus (COVID-19). COVID-19 has presented the world with a crisis greatly accentuated by the urgency with which we need to fight the CC debacle, making the need for sustainable development (SD) more obviously acute than ever and requiring a response rooted in the principles of SD. On 29 September 2020, a total of 1 million COVID-19 deaths had occurred worldwide, while in Africa, there were about 35,954 cumulative fatalities. In Nigeria, the situation was similar. This paper found that despite the ravaging COVID-19 pandemic, health is still a low priority in Nigeria; 4.526 percent of the country’s budget was appropriated to the health sector in 2021 and 4.3 percent in 2022, contrary to the 2001 Abuja Declaration by African leaders and the 15 percent value stipulated by the WHO. The challenge is that Nigeria’s efforts in attaining sustainable health and eradication of COVID-19 are arbitrary and have been hampered by the absence of tested laws on CC andCOVID-19, thereby resulting in avoidable fatalities. Using analytical research methodology and drawing from global best practices to achieve sustainable health, this paper recommended the incorporation of legal and institutional frameworks to combat COVID-19 pandemic in Nigeria.

Oseni, Alexandra Adetutu, ‘Examining Implementation of Policy Effects on Coronavirus (Covid-19) in United State of America’ (2020) 96 Journal of Law, Policy and Globalization 123–129
Abstract: This particular study examines public policy implementation theories on the various interventions to combat the Coronavirus (COVID-19) pandemic. As underscored in the literature COVID-19 is perceived to be a respiratory disease caused by a novel Coronavirus. The virus was first noticed in Wuhan in China. This global killer-COVID-19 has caused many countries, including the United States of America, to get on rigorous policies measures to help contain the spread. Some of the perceived preventive measures taken by the United States of America include travel restrictions, official and self quarantines, postponements of events facility closures and curfews. All these are possible immediate solution proposed by healthcare experts and professionals to flatten the COVID-19 curve. As a result of adding to public policy literature and to also assist policymaker to understand the implication of their choice of intervention procedures, the study uses the two main approaches of policy or program implementation-top-down and bottom-up to all governors, decision makers on possible ways to approach pandemic issues. In the face of this COVID-19 pandemic, the study recommended that all preventive care, possible treatment tools (or medication), screening and if possible vaccination must be either free or demanded at a subsidized rate in order make eradication possible

O’Shea, Bill et al, ‘Flattening the Curve: Why the Law Should Allow for Compulsory Testing in a Pandemic’ (2020) 94(10) Law Institute Journal 18–21
Abstract: In Victoria, the Public Health and Wellbeing Act 2008 (PHW Act) is the key legislation that aims to protect the community from public health emergencies. It does not, however, adequately address the unprecedented challenges presented by the COVID-19 pandemic. Responding effectively to COVID-19 requires testing and detaining large numbers of people in a short time frame. The PHW Act should be amended to strengthen the requirement for testing and allow longer compulsory detention.

Otlowski, Margaret and Ian Freckelton, ‘Health Research and COVID-19’ in Belinda Bennett and Ian Freckelton (eds), Pandemics, Public Health Emergencies and Government Powers: Perspectives on Australian Law (Federation Press, 2021)

Ouliaris, Calina, Linda Sheahan and Duncan George, ‘Preventing Prejudice by Preserving the Spirit of Mental Health Legislation during the COVID-19 National Emergency’ (2020) 28(5) Australasian Psychiatry 500–503
Abstract: The COVID-19 national emergency activates legislative powers that allow a proportional infringement upon individual liberties. We canvas the complex legal landscape governing mental health consumers in this climate, highlight ethical considerations in application of the law and offer a simple algorithm to navigate this space. In times of emergency, it is crucial that we uphold the safeguards embodied within mental health legislation to prevent prejudicial treatment of mental health consumers.

Palmieri, Sofia and Tom Goffin, ‘De Jure and De Facto: An Overview on the Italian Measures on Compulsory Vaccination’ (2022) European Journal of Health Law (Advance article, published online 4 March 2022)
Abstract: The outbreak of the Covid-19 pandemic has forced States to take restrictive measures to contain the growing number of infections. Among these measures, after the approval of vaccines by the EMA, the possibility of introducing a compulsory vaccination has become a plausible and attractive prospect. In Italy, Covid-19 compulsory vaccination is implemented by a succession of Decrees concerning specific categories of workers and, only recently, a section of the population with the recent Decree of 7 January, 2022, no. 1. However, if we look back at the most critical restrictions implemented in the country, we realise that a de facto obligation was already in place before establishing a de jure obligation. The following article traces the most important profiles of the vaccination obligation implemented de jure and de facto by the Italian government.

Panagopoulou, Fereniki, ‘Mandatory Vaccination during the Period of a Pandemic: Legal and Ethical Considerations in Europe’ (2021) 10(4) BioTech Article 29
Abstract: The present study explores the pressing matter of mandatory vaccination in Europe from an ethical-constitutional perspective. To start with, it considers the bases of the concerns that have been raised to date, as well as those of the documented opposition. This is followed by an analysis of the applicable European legal framework and a discussion on mandatory vaccination in the workplace, education and the leisure industry, before outlining the conclusions reached. The position taken by this paper is that as long as certain conditions are met, mandatory vaccination does not violate fundamental rights. On the contrary, provided that the principle of proportionality is satisfied, mandatory vaccination as a form of medical intervention constitutes a manifestation of the obligation on the part of the state to protect the fundamental rights to life and health.

Paradise, Jordan and Elise Fester, ‘FDA Publicity and Enforcement in the COVID-19 Era’ (2020) 60(1) Washburn Law Journal 77–106
Abstract: Global public health emergencies such as the current COVID-19 pandemic provide urgent context to the scope of the FDA’s legal authority, including enforcement actions and widespread public health warnings issued through adverse publicity power to counter fraudulent and dangerous product promotion... In order to further study how the FDA is pursuing its public health mission in the COVID era, this Article both qualitatively and quantitatively explores recent FDA activity, through the mechanisms of publicity and warning letters, against allegedly violative medical products promoted or advertised for use as a treatment or prevention for COVID-19.

Park, Jin K and Ben Davies, ‘Rationing, Responsibility, and Vaccination during COVID-19: A Conceptual Map’ (2024) 24(7) The American Journal of Bioethics 66–79
Abstract: Throughout the COVID-19 pandemic, shortages of scarce healthcare resources consistently presented significant moral and practical challenges. While the importance of vaccines as a key pharmaceutical intervention to stem pandemic scarcity was widely publicized, a sizable proportion of the population chose not to vaccinate. In response, some have defended the use of vaccination status as a criterion for the allocation of scarce medical resources. In this paper, we critically interpret this burgeoning literature, and describe a framework for thinking about vaccine-sensitive resource allocation using the values of responsibility, reciprocity, and justice. Although our aim here is not to defend a single view of vaccine-sensitive resource allocation, we believe that attending critically with the diversity of arguments in favor (and against) vaccine-sensitivity reveals a number of questions that a vaccine-sensitive approach to allocation should answer in future pandemics.

Parsons, Jordan A and Harleen Kaur Johal, ‘Best Interests versus Resource Allocation: Could COVID-19 Cloud Decision-Making for the Cognitively Impaired?’ (2020) 46(7) Journal of Medical Ethics 447–450
Abstract: The COVID-19 pandemic is putting the NHS under unprecedented pressure, requiring clinicians to make uncomfortable decisions they would not ordinarily face. These decisions revolve primarily around intensive care and whether a patient should undergo invasive ventilation. Certain vulnerable populations have featured in the media as falling victim to an increasingly utilitarian response to the pandemic—primarily those of advanced years or with serious existing health conditions. Another vulnerable population potentially at risk is those who lack the capacity to make their own care decisions. Owing to the pandemic, there are increased practical and normative challenges to following the requirements of the Mental Capacity Act 2005. Both capacity assessments and best interests decisions may prove more difficult in the current situation. This may create a more paternalistic situation in decisions about the care of the cognitively impaired which is at risk of taking on a utilitarian focus. We look to these issues and consider whether there is a risk of patients who lack capacity to make their own care decisions being short-changed.

Parveen, Md Zafar Mahfooz Nomani Rehana, ‘Legal Dimensions of Public Health with Special Reference to COVID-19 Pandemic in India’ (2020) 11(7) Systematic Reviews in Pharmacy 131–134
Abstract: The public health laws are passing through a process churning in the COVID-19 pandemic in India. The effectiveness of quarantine law under 160 years old Indian Penal Code, 1860, and 123 years old Epidemic Diseases Act, 1897 proved short-lived euphoria in controlling horrendous COVID-19 pandemic. The nation-wide Lockdowns on the ground of Sections 6, 10, 38, and 72 of the Disaster Management Act, 2005, provided significant assistance in dealing with formidable challenges of COVID-19. The execution of these laws revealed the safety and security of public health professionals and the delivery system to high vulnerability. Therefore, the President of India promulgated the Epidemic Diseases (Amendment) Ordinance, 2020 declaring ‘act of violence’ cognizable and non-bailable with high deterrent value. The paper explores the range of normative choices in refurbishing the public health laws beyond the command and control approach evidenced in Epidemic Diseases (Amendment) Ordinance, 2020, to therapeutic perception public health and equity in India.

Pashkov, Vitalii, ‘The Legal Nature of Managed Entry Agreements (MEAs) in the Coronavirus Response System’ in Roman Maydanyk, André den Exter and Iryna Izarova (eds), Ukrainian Healthcare Law in the Context of European and International Law (Springer, 2022) 261–276
Abstract: This article elaborates on the admission procedure for vaccines against COVID-19 in various European countries and the United States. Neither the EU countries nor the United States has applied for a full license to manufacture or issue a coronavirus vaccine registration certificate. At best, it is an emergency use authorization or conditional marketing authorization. A particular focus will be on the Legal Nature of Managed Entry Agreements (MEAs) in the Coronavirus Response System. The use of MEAs allows not only to legalize emergency use authorization or conditional marketing authorization as a way to combat coronavirus infection, but also others, including for treating, preventing, or diagnosing seriously debilitating or life-threatening diseases. That includes orphan medicines. However, Ukraine and Russia have followed the path of simplifying the registration and full admission of vaccines for further use. Russia registered vaccines against COVID-19 of its own development, however, in Ukraine, there is a situation when it fully legalizes vaccines against COVID-19 earlier than the countries of this vaccine’s origin. This is due to ignoring the regulations and the experience of using MEAs both by Ukraine and Russia.

Pathberiya, Niroshan, ‘An Analysis of the Legal Ramifications of Mandatory Vaccination in the Light of Rights to Life and Health: The Case of Sri Lanka’ in Čović, Ana and Oliver Nikolić (eds), Pravni i Društveni Aspekti Vakcinacije Tokom Pandemije Kovida 19 / Legal And Social Aspects Of Vaccination During The Covid-19 Pandemic (Institute of Comparative Law, 2022) 117–127 *[OPEN ACCESS BOOK]*
Abstract: The consistency of the decision of making Covid-19 vaccination mandatory with the rights to life and health of the citizens has initiated a heated debate in Sri Lanka. The enjoyment of the rights to physical and mental health includes the citizens’ right not to be exposed to situations or substances that pose or appear to pose threats to their life and health. However, the counter-premise that mandatory vaccination guarantees a person’s immunity against the virus, uplifting his as well as others’ physical fitness and mental confidence, is an equally valid argument. In Sri Lanka, during a fast-spreading pandemic, decisions to ensure and safeguard individual rights and liberties of all persons in all situations, while maintaining public health and its standards, is a challenge; adoption of and providing for one view might require limiting or rejecting others. In the absence of solid medical evidence of the effects and after-effects of vaccination, as well as its capability to prevent the spread of the Covid-19 virus – at least beyond reasonable doubt – whether treating vaccinated and non-vaccinated differently can be construed as a violation of individual rights to life, personal health and equality is a matter that requires a thorough consideration of facts. Hence, this paper, referring to international conventions and treaties on human rights and health, investigates and analyses the legal ramifications of the mandatory Covid-19 vaccination in Sri Lanka. The study recommends maintaining the status quo in general, and application of mandatory vaccination policies to settings and persons that require immunity against the virus – such as health personnel – immediately, and holding its application as a method of preventing the spread, until research and medical evidence affirm the capabilities and side effects of the vaccination, with solutions. This approach minimizes unnecessary conflicts between individual rights and interests, and the state’s responsibilities during the pandemic.

Paton, Alexis, ‘Fairness, Ethnicity, and COVID-19 Ethics’ (2020) 17(4) Journal of Bioethical Inquiry 595–600
Abstract: Recent weeks have seen an increased focus on the ethical response to the COVID-19 pandemic. Ethics guidance has proliferated across Britain, with ethicists and those with a keen interest in ethics in their professions working to produce advice and support for the National Health Service. The guiding principles of the pandemic have emerged, in one form or another, to favour fairness, especially with regard to allocating resources and prioritizing care. However, fairness is not equivalent to equity when it comes to healthcare, and the focus on fairness means that existing guidance inadvertently discriminates against people from ethnic minority backgrounds. Drawing on early criticisms of existing clinical guidance (for example, the frailty decision tool) and ethical guidance in Britain, this essay will discuss the importance of including sociology, specifically the relationship between ethnicity and health, in any ethical and clinical guidance for care during the pandemic in the United Kingdom. To do otherwise, I will argue, would be actively choosing to allow a proportion of the British population to die for no other reason than their ethnic background. Finally, I will end by arguing why sociology must be a key component in any guidance, outlining how sociology was incorporated into the cross-college guidance produced by the Royal College of Physicians.

Perlstein, Olivia C, ‘Covid Research Inequalities: Highlighting the Need for Increased Minority Participation in Clinical Trials’ (2021) 52(2) Seton Hall Law Review 545–571
Abstract: Although minority communities are disproportionately affected by COVID-19, both treatment and vaccine clinical trials have failed to enroll sufficiently diverse participants. While the National Institutes of Health (NIH) has issued regulations requiring minorities to be represented in Phase III clinical trials receiving NIH funding, the U.S. Food and Drug Administration (FDA), which oversees clinical trials of drugs and medical devices, has merely issued non-binding guidance encouraging diversity in clinical trial participants. These efforts have been largely unsuccessful. This Comment will argue that to reduce racial disparities in clinical trials effectively, the FDA must promulgate binding regulations requiring drug developers to increase diversity of clinical trial participants, especially when the disease that the drug or intervention targets disproportionately affects minority populations.

Perrone, Giulio et al, ‘Telemedicine during Covid-19 Pandemic: Advantage or Critical Issue?’ (2020) 88(2) Medico-Legal Journal 76–77
Abstract: Telemedicine offers a support to traditional medicine, delivering clinical services when distance is a critical factor. Although this tool does not replace a medical examination, during Covid-19 pandemic, it reduces the spread of infection and avoids the need for a patient’s visit. It is useful in the management of chronic disorders or for patients undergoing palliative treatment. The University Hospital of Palermo has applied this in cases of chronic illness caring for patients who cannot stop their treatment, such as Department of Onco-Haematology, Internal Medicine, Dermatology, etc. The Department of Legal Medicine of Palermo, in particular, is also using telemedicine to manage medico-legal sudden natural death investigations and dealing with the Public Prosecutor’s office of Palermo. Even after the Covid-19 emergency, telemedicine will be essential to streamline outpatient visits, while at the same time limiting costs, with significant benefits for the Italian National Public Health Service budget. In conclusion, telemedicine can offer a valuable support to the doctor’s activity by streamlining and facilitating their work. In this sense, the Covid-19 pandemic represents a positive input for the acceleration and enhancement of these tools.

Persad, Govind and Emily A Largent, ‘Fairly Incorporating Vaccination Status into Scarce Resource Allocation Frameworks’ (2024) 24(7) The American Journal of Bioethics 80–83

Perry, Frederick V and Miriam Weismann, ‘Rationing Healthcare During a Pandemic: Shielding Healthcare Providers from Tort Liability in Uncharted Legal Territory’ (2022) 30(2) University of Miami Business Law Review 142–187
Abstract: As the coronavirus pandemic intensified, many communities in the U.S. experienced shortages of ventilators, ICU beds, and other medical supplies and treatment. There was no single national response providing guidance on the allocation of scarce healthcare resources. There has been no consistent state response either. Instead, various governmental and nongovernmental state actors in several but not all states formulated ‘triage protocols,’ known as Crisis Standards of Care, to prioritize patient access to care where population demand exceeded supply. One intended purpose of the protocols was to immunize or shield healthcare providers from tort liability based on injuries resulting from a medical decision rationing access to care. Research shows that various state protocols have been implemented to this end by either executive order issued by the governor; state legislation; or action by individual hospital ethics boards. This paper examines a legal question of first impression: Whether the right to institute suit for pandemic related healthcare injuries can be constitutionally eliminated using state triage protocol immunity provisions passed by executive order or state statute during the pandemic. The paper concludes that healthcare providers may still be subject to some legal liability depending upon each state’s unique constitutional grant of powers to the executive and legislative branches and the dictates of the Fourteenth Amendment.

Perry, Ronen and Tal Zarsky, ‘Tragic Allocation Challenges in the COVID-19 Era’ (2021) Florida State University Law Review (forthcoming)
Abstract: Human society is facing its worst nightmare—a global pandemic caused by a highly infectious, resilient, and enigmatic virus. Questions that have occupied moral philosophers for ages transform into urgent practical predicaments for doctors, ethicists, and healthcare policymakers facing impossible situations. Societies, grown accustomed to the notion of plentifulness, are forced to grapple with the prospect of scarcity, particularly that of life-saving resources, such as ventilators, ICU beds, health human resources, medication, and vaccines. Leading health ethicists and other professionals have already penned articles addressing the reemerging dilemmas regarding the allocation of scarce life-saving resources. Although several papers discussing these matters have been published in the most prominent medical journals, they lacked a broader interdisciplinary perspective. In this Article, we illuminate the difficult questions ahead from a somewhat different angle – that of legal experience and scholarship. After reviewing previously proposed recommendations, the Article calls on the policy and health community to reconsider some of them, while accounting for existing legal literature and critical thinking about allocation methods and benefiting from their accumulated wisdom. Part I presents the primary medical allocation principles, explains their limits, and outlines possible solutions, such as the use of ‘non-conventional’ methods for the allocation of scarce life-saving resources among equally situated candidates. Part II closely examines and challenges the recent recommendations to opt for allocation via lotteries when patients are relatively equal, explaining why applying queues is often preferable from a fairness perspective. Part III compares the two methods (lotteries and queues) from an efficiency perspective. Part IV addresses key exceptions to the application of non-conventional allocation models - consent, merit, and skill - and argues that these exceptions should be applied carefully and narrowly. Part V examines the feasibility, utility, and fairness of reallocating scarce life-saving resources after their initial allocation. It focuses on ‘sharing’ ventilators and medical staff among patients in critical condition over time. In doing so, it frames the policy discussion regarding these matters within the broader legal and policy debates on reallocating resources (‘time-sharing’) and explains how relying on this paradigm can prove fruitful to the analysis.

Persad, Govind, ‘Allocating Medicine Fairly in an Unfair Pandemic’ (University of Denver Legal Studies Research Paper No 20–26, 2020)
Abstract: America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. In this Essay, I focus on the pressing question of how the allocation of scarce treatments for COVID-19 should respond to these racial disparities. Many policymakers and popular commentators have recognized that the inevitable initial scarcity of COVID-19 vaccines presents questions about racial disparity. Novel treatments like remdesivir, convalescent plasma, and monoclonal antibodies raise similar questions, as do emergency interventions such as ventilators and ICU beds. Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that such a prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. In Part I, I provide a brief overview of current and proposed COVID-19 treatments and identify documented or likely scarcities and disparities in access. In Part II, I argue that randomly allocating COVID-19 treatments, as some propose, will not effectively address disparities: it both permits unnecessary deaths and concentrates those deaths among people who are more exposed to infection. In Part III, I explain why using individual-level racial classifications in allocation is precluded by current Supreme Court precedent. Addressing disparities will require policies that avoid such classifications, though they may consider race at an aggregate rather than individual level. I also argue that policies prioritizing members of Native American tribes can succeed legally even where policies based on race would not. In Part IV, I propose two complementary strategies to narrow racial disparities. One would prioritize individuals who live in disadvantaged geographic areas or work in occupations hard-hit by COVID-19, potentially alongside aggregate metrics like neighborhood segregation. These approaches, like the policies school districts adopted after the Supreme Court rejected individualized racial classifications in school assignment policies, would narrow disparities without classifying individuals by race. The other approach would address stark racial disparities in mortality among younger patients by avoiding policies that prioritize all patients over a certain age without regard to risk.

Persad, Govind, ‘Considering Vaccination Status’ (2023) 74(2) Hastings Law Journal 399–432
Abstract: This Article examines whether policies--sometimes termed ‘vaccine mandates’ or ‘vaccine requirements’--that consider vaccination status as a condition of employment, receipt of goods and services, or educational or other activity for participation are legally permitted, and whether such policies may even sometimes be legally required. It does so with particular reference to COVID-19 vaccines. Part I explains the legality of private actors, such as employers or private universities, considering vaccination status, and concludes that such consideration is almost always legally permissible unless foreclosed by specific state legislation. Part II examines the consideration of vaccination status by state or federal policy. It concludes that such consideration is similarly allowed at the state level unless expressly foreclosed, and is allowed at the federal level if appropriately supported by federal regulatory authority. Part III examines what may be a future front in these debates: whether policies considering vaccination status may be required rather than merely permitted, just as some courts have found that mask requirements may be federally required in certain circumstances.

Persad, Govind, ‘Why Disability Law Permits Evidence-Based Triage in a Pandemic’ (2020) 130 Yale Law Journal Forum 26
Abstract: This paper explains why the two core goals of policies proposed or adopted in response to the COVID-19 pandemic that allocate scarce medical resources by using medical evidence—saving more lives and saving more years of life—are compatible with disability law. Disability law, properly understood, permits considering medical evidence about patients’ probability of surviving treatment and the quantity of scarce treatments they will likely use. It also permits prioritizing health workers, and considering patients’ post-treatment life expectancy. All of these factors, when assessed based on medical evidence and not inaccurate stereotypes, are legal to consider even if they disadvantage some patients with specific disabilities. It then discusses why triage policies that use medical evidence to save more lives and years of life, which I call ‘evidence-based triage,’ are ethically preferable for people with and without disabilities. In doing so, I explain why recent critiques err by treating people with disabilities as a monolith, overlooking the political disadvantages of less-visible victims, and treating the social origins of scarcity as a justification for sacrificing vulnerable lives. Evidence-based triage should be recognized as similar to other responses to COVID-19, like physical distancing and postponing some medical procedures, that may burden people with specific disabilities but are nevertheless justified because they save more patients with and without disabilities.

Pervou, Ioanna and Panagiotis Mpogiatzidis, ‘Restrictive Human Rights Measures against the Spread of COVID-19: An Interdisciplinary Approach between Law and Health-Care Management’ (2023) International Journal of Human Rights in Healthcare (advance article, published online 7 April 2023)
Abstract: The purpose of this paper is to demonstrate the close relationship between the disciplines of law and health-care studies. This interrelation has become particularly evident during the spread of the COVID-19 pandemic, when restrictive human rights provisions have been initiated by many states for the sake of public health. Research focuses on the notional proximity of the principle of proportionality and its health-care correlative: effectiveness. It also goes through the influence of acceptance rates for the application of restrictive measures.

Pesapane, Filippo et al, ‘Legal and Regulatory Framework for AI Solutions in Healthcare in EU, US, China, and Russia: New Scenarios after a Pandemic’ (2021) 1(4) Radiation 261–276
Abstract: The COVID-19 crisis has exposed some of the most pressing challenges affecting healthcare and highlighted the benefits that robust integration of digital and AI technologies in the healthcare setting may bring. Although medical solutions based on AI are growing rapidly, regulatory issues and policy initiatives including ownership and control of data, data sharing, privacy protection, telemedicine, and accountability need to be carefully and continually addressed as AI research requires robust and ethical guidelines, demanding an update of the legal and regulatory framework all over the world. Several recently proposed regulatory frameworks provide a solid foundation but do not address a number of issues that may prevent algorithms from being fully trusted. A global effort is needed for an open, mature conversation about the best possible way to guard against and mitigate possible harms to realize the potential of AI across health systems in a respectful and ethical way. This conversation must include national and international policymakers, physicians, digital health and machine learning leaders from industry and academia. If this is done properly and in a timely fashion, the potential of AI in healthcare will be realized.

Pestoff, Victor and Yayoi Saito, ‘COVID-19, Co-Production and Governance of Japanese Healthcare Providers’ (2021) 10(2) Journal of Entrepreneurial and Organizational Diversity 54–70
Abstract: The COVID-19 pandemic underlines the importance of citizen support for and compliance with public health goals. This paper explores the contribution of governance to the staff’s work environment, and patient participation in public financed healthcare services. More staff control over their daily work-life tasks will promote greater work satisfaction; in turn, more satisfied staff will provide better quality services than dissatisfied staff. Therefore, it considers three models for governing public financed services: a democratic, multi-stakeholder model, a stewardship model, and a more traditional ‘command and control’ model. The paper investigates whether a participatory governance model allows the staff greater autonomy and promotes a multi-stakeholder dialogue that facilitates greater user/citizen participation. It also asks how public financed service providers can develop institutions that facilitate, foster and institutionalize user/citizen participation. Furthermore, the paper presents a case study from the Minami Medical Co-op in Nagoya, Japan and concludes that participatory governance can serve as a ‘best practice’ for other public and private healthcare providers.

Petroia, Andrei and Elena Zubcova, ‘Financing of the Anti-COVID-19 Immunization Process in the Republic of Moldova’ (SSRN Scholarly Paper ID 3779843, 5 February 2021)
Abstract: The immunization is a multidimensional process, with an integrated approach to the health system, and provides quality, safe immunization services, provided to the population fairly at all levels of health care.The Government of the Republic of Moldova fully finances the procurement of vaccines and consumables, as well as the services provided under the National Immunization Program, and their implementation is carried out with the involvement of the health system, central authorities and local public administration with the involvement of society as a whole and of each individual.The Republic of Moldova and most countries of the world use vaccination programs as a platform for safety and security of individual and public health. The objectives of national immunization programs are to eliminate or reduce morbidity, disability and mortality. At the same time, the well-being of the community can be measured by the degree of preparedness and ability to cope with major public health emergencies, including those caused by vaccine-preventable infectious diseases.

Phelan, Alexandra L, ‘COVID-19 Immunity Passports and Vaccination Certificates: Scientific, Equitable, and Legal Challenges’ (2020) 395(10237) The Lancet 1595–1598
Abstract: Many governments are looking for paths out of restrictive physical distancing measures imposed to control the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With a potential vaccine against coronavirus disease 2019 (COVID-19) many months away,1 one proposal that some governments have suggested, including Chile, Germany, Italy, the UK, and the USA,2 is the use of immunity passports—ie, digital or physical documents that certify an individual has been infected and is purportedly immune to SARS-CoV-2.

Phelan, Alexandra L et al, ‘Legal Agreements: Barriers and Enablers to Global Equitable COVID-19 Vaccine Access’ (2020) 396(10254) The Lancet 800–802
Abstract: Law can serve as both an enabler and a barrier to global health, equity, and justice.1 The impact of legal determinants of health on the COVID-19 pandemic is evident where law is being used as a mechanism to enable or prevent global equitable access to COVID-19 vaccines. Barriers to equitable access are partly driven by vaccine nationalism2 with governments seeking to use law to secure priority access to future vaccines through Advance Purchase Agreements (APAs) with vaccine manufacturers. These bilateral legal agreements can be in a nation’s interest, but given the uncertain success of individual COVID-19 vaccine candidates and the global spread of SARS-CoV-2, APAs are a gamble and erode collaboration between countries.

Phelan, Alexandra L, Rebecca Katz and Lawrence O Gostin, ‘The Novel Coronavirus Originating in Wuhan, China: Challenges for Global Health Governance’ (2020) 323(8) Journal of the American Medical Association (JAMA) 709–710
In this Viewpoint, Gostin and colleagues review the emerging novel coronavirus (2019-nCoV) outbreak, discuss the public health benefits and risks of the Chinese government’s large city quarantines, and call for WHO leadership to coordinate a global coordinated response that could contain this and prevent similar future outbreaks.

Philpott, Jane, ‘A View from the Front Lines of a COVID-19 Outbreak’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 463
Abstract: This chapter offers a narrative of a COVID-19 outbreak at Participation House Markham. It is a not-for-profit group home for adults with disabilities, established in 1972 by the Cerebral Palsy Parent Council of Toronto. With this outbreak, 95% of the home’s residents were infected. Six of them died. Fifty-seven workers were infected. The story illustrates themes discussed elsewhere in this book, but focuses particularly on the role of the labour force in a care home. It notes the pre-pandemic vulnerability of any congregate setting without a full staffing complement. In any group home or long-term care facility, an infectious outbreak exacerbates workforce challenges, as workers may be exposed to the virus; become ill; or become restricted to a single place of employment. By describing the clinical cases of three residents in one group home, this chapter demonstrates why the shortage of nurses, personal support workers, kitchen staff, and others, would trigger a crisis in this institution or others like it. The chapter includes policy recommendations that are amplified elsewhere in this section. These could contribute to a national review of how to provide residential care for people living with disabilities in a manner that is safe, healthy, and dignified.

Platt, Elizabeth et al, ‘Trends in US State Public Health Emergency Laws, 2021–2022’ (2023) 113(3) American Journal of Public Health 288–296
Abstract: State laws setting the scope and limits of emergency authority are crucial to effective public health response. These laws are changing in ways that threaten to reduce response capacity. Tracking changes in health law infrastructure is important for evaluating changes in health authority and ensuring that stakeholders recognize these changes. The COVID-19 pandemic called for quick, decisive action to limit infections, and when the next outbreak hits, new laws limiting health authority will make such action even more difficult.

Platt, Claire, ‘Public Legitimacy of Vaccine Passports: Ethical and Regulatory Issues Raised by COVID-19 Immunity Certificates’ (2021) 20 Linguistic and Philosophical Investigations 135–144
Abstract: Employing recent research results covering ethical and regulatory issues raised by COVID-19 immunity certificates, and building my argument by drawing on data collected from Ada Lovelace Institute, CSA Canada, and Institute for Government, I performed analyses and made estimates regarding the freedoms COVID-19 immunity passports confer. Descriptive statistics of compiled data from the completed surveys were calculated when appropriate.

Plaza, Cecilia, ‘In It for the Long Haul: The American Legal System’s Failure to Protect Patients with Persistent COVID-19 Symptoms from Gender Discrimination in Healthcare’ (2022) 18 Journal of Health & Biomedical Law 33–71
Abstract: The rising incidence of chronic illness due to long COVID will contribute to rising healthcare costs and disability. As our healthcare system becomes more strained, lack of resources will continue to drive up costs for all Americans. Additionally, an increase in disability among American workers diminishes productivity, increases corporate costs, and weakens the American economy. Effective legal redress for gender discrimination in healthcare will likely decrease the long-term costs of chronic illness triggered by the COVID-19 virus by decreasing misdiagnosis of long COVID, particularly among women patients, which provides those disabled by long COVID with access to SSDI and ADA protections. Prompt legal reform is necessary to effectively deal with the fallout of this pandemic.

Pollard Sacks, Deana, ‘Judicial Protection of Medical Liberty’ (SSRN Scholarly Paper ID 3801253, 25 February 2021)
Abstract: The article discusses the history of vaccine jurisprudence in the courts and in particular the lower courts’ failure to engage meaningful constitutional review of state vaccination mandates. The lack of separation of powers in conjunction with the National Childhood Vaccine Injury Act and the Supreme Court’s interpretation of the Act has resulted in unfettered discretion among legislators to mandate vaccines in order for the public to obtain necessary and very valuable services. Since late 2020, the Supreme Court has indicated that the judiciary may take a more active role in reviewing COVID-19 mandates and this may signal that the judiciary will also review vaccine mandates generally with more care. The balance of powers relative to vaccination law and policy that has been lost over a century of poor jurisprudence in the lower courts may be restored to protect individual liberties adequately.

Poole, Danielle N et al, ‘Responding to the COVID-19 Pandemic in Complex Humanitarian Crises’ (2020) 19(1) International Journal for Equity in Health Article 41
Abstract: Over 168 million people across 50 countries are estimated to need humanitarian assistance in 2020. Response to epidemics in complex humanitarian crises—such as the recent cholera epidemic in Yemen and the Ebola epidemic in the Democratic Republic of Congo—is a global health challenge of increasing scale. The thousands of Yemeni and Congolese who have died in these years-long epidemics demonstrate the difficulty of combatting even well-known pathogens in humanitarian settings. The novel severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) may represent a still greater threat to those in complex humanitarian crises, which lack the infrastructure, support, and health systems to mount a comprehensive response. Poor governance, public distrust, and political violence may further undermine interventions in these settings.

Powell, Tia and Elizabeth Chuang, ‘COVID in NYC: What We Could Do Better’ (2020) 20(7) The American Journal of Bioethics 62–66
Abstract: New York City hospitals expanded resources to an unprecedented extent in response to the COVID pandemic. Thousands of beds, ICU beds, staff members, and ventilators were rapidly incorporated into hospital systems. Nonetheless, this historic public health disaster still created scarcities and the need for formal crisis standards of care. These were not available to NY clinicians because of the state’s failure to implement, with or without revision, long-standing guidance documents intended for just such a pandemic. The authors argue that public health plans for disasters should be well-funded and based on available research and expertise. Communities should insist that political representatives demonstrate responsible leadership by implementing and updating as needed, crisis standards of care. Finally, surge requirements should address the needs of both those expected to survive and those who will not, by expanding palliative care and other resources for the dying.

Pranka, Darius, ‘Criminal Liability Nuances of Medical Negligence During the COVID-19 Pandemic’ (2022) 15(1) Baltic Journal of Law & Politics 117–140
Abstract: Under normal circumstances, the medical negligence of doctors in most European (continental) states is assessed within the limits of criminal liability under the criminal laws of each state, without exception in the case of COVID-19 or another pandemic. The author raises the question of whether doctors, in the performance of their duties and in the provision of treatment services during the COVID-19 pandemic, deserve any relief from their liability due to errors or negligence in the performance of their duties that have resulted in the consequences of damage to health or life loss of patients. The article provides an analysis of the special laws created for such situations and adopted in Poland and Italy while presenting the shortcomings and advantages of such legal regulation and distinguishing the discussion issues raised by legal scholars and practitioners of the abovementioned states. The author criticises the attempt to adopt a similar legal act in Lithuania and at the same time proposes to discuss the possibility of changing the existing legal regulation and setting limits on the criminal liability of doctors during the COVID-19 pandemic.

Prieto Carrero, José Luis et al, ‘The Management of the Deceased from the COVID-19 Pandemic and Its Organizational Challenges from the Medico-Legal Services Perspective’ [2021] Spanish Journal of Legal Medicine (advance article, published online 27 October 2021)
Abstract: The new coronavirus disease (COVID-19), which emerged at the end of 2019 in the Chinese city of Wuhan, was declared as a pandemic by the World Health Organization on 11 March 2020. In the most affected countries and regions, in parallel to the high number of patients and the consequent saturation of the health services, the unusually high number of deaths adds a very sensitive burden to authorities regarding the management of corpses. The purpose of this article is to identify the particular challenges of an appropriate management and coordination of the institutions involved and to propose recommendations for action for the proper and dignified management of the deceased and the protection of the rights of their families to a respectful treatment, to know the fate and whereabouts of their loved ones and to honor them according to their beliefs and customs. The important role that medical-legal services may play for this is highlighted.

Puaschunder, Julia M and Dirk Beerbaum, ‘Healthcare Inequality in the Digital 21st Century: The Case for a Mandate for Equal Access to Quality Medicine for All’ in _Proceedings of the Unequal World Conference of the United Nations, United Nations, New York, 28-29 September 28-29 2020_
Abstract: The currently ongoing COVID-19 crisis challenges health around the world. Public and private sector healthcare provision differs between countries. On an interconnected globe with a highly mobile 21st century population and a most contagious virus, healthcare appears as internationally-interdependent as never before in the history of humankind. More than ever before pandemic precaution requires globally-carried solutions and risks management based on internationally-harmonized action. The endeavor of a commonly healthy world is challenged in light of the nowadays unprecedentedly-blatant healthcare inequality around the world. Based on macroeconomic modelling, our empirical research brought forward four indices shedding light on health inequality in the 21st digital century. International data on digitalization, economic prosperity, healthcare standards and innovation market financialization revealed that Europe and North America feature excellent starting positions on economic productivity and relatively low levels of corruption. Internet connectivity and high Gross Domestic Product are likely to lead on AI-driven big data insights for pandemic prevention, of which Europe, Asia and North America have optimal global healthcare leadership potential. Europe benefits from highest standards on public preventive medical care, while the United States has the most prosperous market financialization to advance medical innovations. Oceania performs well on general healthcare but has comparatively less international medical market power. Asia and the Gulf region are in the middle ranges of healthcare provision and market innovation financing but are critical on corruption, which also appears to hinder access to quality healthcare in South America. Africa ranks low on healthcare and raising funds for medical purposes in corruption-prone territories. The currently ongoing COVID-19 crisis has created awareness for the global interconnectivity of healthcare but also heighted attention to the drastic medical standard differences around the world, which unprecedentedly leverages the sustainable development mandate to grant equal access to healthcare.

Puaschunder, Julia and Martin Gelter, ‘The Law, Economics, and Governance of Generation Covid-19 Long-Haul’ 19(1) Indiana Health Law Review 47–125
Abstract: The SARS-CoV-2 novel coronavirus is an external shock to all societies with lasting impacts that have changed individual, political, and corporate decisions profoundly. Increasing evidence reveals that an estimated 10-50% of those previously infected with COVID-19 face a longer-term or long-term health impact and/or chronic debilitation that in many cases comes and goes in waves. This phenomenon has already been referred to as a pandemic within the pandemic. The broad-based and long-term impact of COVID Long Haulers have also holds the potential to change our world and modern society, lasting through the following three outlined speculative trends: (1) The coronavirus crisis has widened novel and already existing inequalities, of which the rather surprising finance performance versus real economy liquidity constraint gap led to unequal emotional and sociopsychological crisis fallout propensities. Corporate governance and political economy power dynamics may shift in the eye of Long Haulers’ relation to work and a healthy, productive environment. Employers will likely face pressure to create a safe and secure working environment but also have rising tort liability risks that may be mitigated by hiring health consulting agents. Proactive care for maintaining a healthy workforce and the overall long-term well-being of employees, including preventive care in teams, will become an essential corporate feature to attract qualified labor, whose bargaining power increased in the eye of labor shortages in direct contact industries and positions. (2) Long Haulers may initiate an artificial intelligence revolution of self-monitoring and constant health status tracking, but also democratization of healthcare information. Artificial intelligence, robotics, and big data offer essential complements to fill in for long-haul attention and productivity deficits that may occur in waves. Long Haulers have already found themselves in online self-help groups – such as Survivor Corps – for quick and unbureaucratic information exchange about an emerging group phenomenon. Social online media platforms served as an easy remedy during a time when a surge of severe COVID cases precluded COVID hospitalization. Nowadays, COVID long-haul patients have become – more than ever before – citizen scientists that bundle decentralized information on their health status and potential remedies in order to inform the medical profession about newly emerging trends. The rise in medical self-help and mutual support will have profound implications for the regulation of the medical profession and will likely stretch the medical remedy spectrum and boost alternative medicine. In the online exchange of sensitive information about one’s health status, citizen scientists are also particularly vulnerable in terms of their privacy, potentially even more susceptible to online marketing campaigns under medically impaired conditions, but also because of their sensitive information having been publicly disclosed online over time. (3) As historical precedents show, Generation COVID Long-Haul partially being recognized as a disability may result in increased pressures to reform social, healthcare, and retirement systems. Given waves of debilitation, the analysis of macroeconomic aggregates will have to change in order to reflect a more diversified and temporal view of social preferences. Future economic policy research may take inspiration from the legal concept of disparate impact. Behavioral insights on how to navigate the world with attention deficits and uncertainty may focus on developing an idea of the economic benefits of rest by incorporating preferences for minimalism in a turbulent world longing for recovery

Puluhulawa, Jufryanto et al, ‘Rejection of the Implementation of the Covid-19 Protocol on Patients Who Died: A Discourse between Human Rights and Health Law in Indonesia’ (2022) 4(2) American Journal of Multidisciplinary Research & Development 53–59
Abstract: The refusal to implement the handling of corpses using the COVID-19 health protocol still occurs in Indonesia in general and in Gorontalo Province in particular, even though there are legal regulations that regulate and even strengthen the fatwa of the Indonesian Ulema Council. The research approach method used is a case approach, a conceptual approach and statute approach. In the author’s conclusion, there is a guarantee of human rights to the bodies of Covid-19 patients. Even though there are special medical procedures that are applied, in essence, there is a legal guarantee that all procedures carried out continue to pay attention to religious law so as not to injure the rights of the corpse. Therefore, the refusal to handle the bodies of Covid-19 patients using the Covid-19 funeral health protocol is certainly something that must be intervened so that their dignity is then returned following existing regulatory provisions. From the perspective of human rights law, the actions of the patient’s family who refuse their relatives who died due to Covid-19 indications being buried using the Covid19 health protocol endanger others and increase the potential for the spread of the Covid-19 virus so that it will cause harm to the wider community. The implication is that human rights violations occur. Meanwhile, if examined from the perspective of health law, there are criminal sanctions that are ready to ensnare parties who are not cooperative and do not want to submit to the applicable rules.

Puri, Sandeep, Eli Perencevich and Michael Weiner, ‘Index-Based Policy to Guide Mask-Wearing for SARS-CoV-2 and Other Pandemics’ (2022) University of Dayton Law Review (forthcoming)
Abstract: As the world experiences yet another surge in cases of COVID-19, many organizations and jurisdictions have reinstated or expanded mandates to protect workers, children, older people, and the public at large. Mandates to wear face masks in indoor public areas are often met with confusion, fear, anger, disagreement, and lack of knowledge about risks and benefits of action and inaction. To move towards an evidence-based approach, we propose that when five criteria collectively signal that a communicable disease poses greater harm to society than that of a benchmark, such as that of the average seasonal influenza during years 2010 to 2019, then the local, state, and federal government should introduce an indoor mask-wearing mandate, subject to certain exceptions. We suggest the following five measures and corresponding metrics comprising composite criteria for the requirement to wear a mask: contagiousness (R0), vulnerability of communities to infection (rate of growth in the percentage of the national population that is infected), harm caused by the disease (cumulative deaths per week), severity of harm (infection fatality rate), and direction of harm (percentage change in cumulative deaths per week). Each criterion would be scored. An aggregate score would then signal when the social health risk exceeds that of seasonal influenza as a point of reference, based on methodology. Although additional details would require clarification, attention to validity and timeliness of measurement, and development of appropriate scoring thresholds, the criteria provide a foundation for action that goes beyond rhetoric, politics, impulsiveness, and guesswork. Pursuing measurement of these factors would yield an improvement over the current approach.

Purser, Kelly et al, ‘End of Life Decision-Making, Advance Care Planning and Estate Planning During a Pandemic’ in Belinda Bennett and Ian Freckelton (eds), Pandemics, Public Health Emergencies and Government Powers: Perspectives on Australian Law (Federation Press, 2021)

Radanović, Nina Mišić, ‘Violations of the Right to Health Due to Limited Access to Protection of Health during the COVID-19 Pandemic in the Republic of Croatia and Possible Legal Implications’ (2021) 14(2) Medicine, Law & Society 271–300
Abstract: The battle against the COVID-19 pandemic is still the most important problem and a great challenge for the overburdened health system in the Republic of Croatia. This paper examines the research into how violations of humans’ right to health occurred due to the inaccessibility to health protection for uninfected persons during the COVID-19 pandemic. The research implemented showed that a system of anti-epidemic measures which completely suspended or significantly reduced the possibility to access primary and hospital health care, stopped preventive programs of cancer detection. Much medical research has already revealed the possible harmful effects to people’s health in the increase in cases of the contraction of and death from cancer and other serious illnesses, particularly in relation to certain vulnerable groups for example, women and oncology patients. The author concludes that the right to access protection of health during the COVID-19 pandemic in the Republic of Croatia was significantly limited and analyzes possible legal consequences which could occur due to the suspension or limitation to the right to access health care as a violation of the right to health.

Rakhmadhani, Irzal et al, ‘COVID-19 Vaccine Hesitancy on Society and Related Legal Regulations’ (2021) 583 Advances in Social Science, Education and Humanities Research 281–285
Abstract: In order to overcome the COVID-19 pandemic, all countries throughout the world are prioritizing COVID-19 vaccination. Vaccination is the key to achieving herd immunity in society and reducing COVID-19-related morbidity and mortality. However, the COVID-19 vaccination process in Indonesia is running slowly due to public refusal of vaccines. The Indonesian government has issued various legal actions related to COVID-19 vaccines in society. However, this legal action has caused public controversy, especially in the aspect of providing sanctions for those who refuse the vaccination. The purpose of this study is to look into the reasons for COVID-19 vaccine hesitancy in society, as well as the impact of legal acts that regulate vaccination in increasing vaccination coverage. These research methods are scoping review and normative juridical with statute approach and conceptual approach. Some of the causes of vaccination rejection in society are hesitations of safety, effectiveness, side effects after vaccination, distrust of vaccinations in general, and religious factors. The legal regulations have helped increase community vaccination participation. Presidential Regulation No. 14 of 2021 has regulated mandatory vaccination for those who have met the criteria for COVID-19 vaccination. The Minister of Public Health’s Decree No. HK.01.07/MENKES/4638/2021 regarding Technical Guidelines for Vaccination Implementation in the Context of Overcoming the COVID-19 Pandemic establishes the conditions for vaccine recipients to ensure recipients’ safety by looking to the individual health status of COVID-19 vaccine recipients. Effective communication strategies and behavioral change interventions for vaccine recipients are needed to reduce public refusal.

Rakhmadhani, Irzal et al, ‘COVID-19 Vaccination Services: Legal Issues and Protection for Health Workers’ (2021) 583 Advances in Social Science, Education and Humanities Research 110–114
Jurisdiction: Indonesia
Abstract: COVID-19 cases are on the rise, and strict health protocols haven’t been able to keep up. COVID-19 vaccinations are required to slow the transmission of the virus in the community; lessen pain and death caused by the disease; accelerate herd immunity, and protect the community from COVID-19 during the recovery of social and economic activities. However, COVID-19 vaccination is still experiencing various obstacles due to public rejection of vaccination which leads to potential legal problems between health workers and certain community groups. The purpose of this article is to investigate potential legal issues as well as the protection of health workers involved in the COVID-19 vaccination service at Health Service Facilities. The method that is used in this scientific journal is normative juridical. The public’s refusal of COVID-19 vaccination raises various problems, and they lead to public misunderstandings including accusations of vaccination conspiracy by health workers. According to a review of the literature, health workers in COVID-19 vaccination in Indonesia are legally protected if the services are provided in accordance with established procedures. RI Law No. 29 of 2004 concerning Medical Practice, Presidential Regulation No. 14 of 2021, Regulation of the Health Minister of Republic Indonesia No. 269 and 290, and Decree of the Minister for Public Health HK.01.07/Menkes/413/2020 concerning Guidelines for Prevention and Control Coronavirus Disease 2019 all contain aspects of legal protection for health workers.

Ram, Natalie, Lance Gable and Jeffrey Ram, ‘The Future of Wastewater Monitoring for the Public Health’ (2022) 56 University of Richmond Law Review (forthcoming)
Abstract: The COVID-19 pandemic has invited dramatic investment in and expansion of wastewater surveillance. This surveillance may enable early detection of an increasing presence of COVID-19 in the community. But the same technology may simultaneously or soon be turned to other uses, including for drug interdiction, community wellness, or environmental monitoring. All of these uses raise urgent legal and ethical questions. But the legal literature, to date, has almost uniformly failed to even consider the ramifications of wastewater-based epidemiology. Indeed, we are aware of only two articles discussing wastewater surveillance in the legal literature—one of which is our own prior work. In prior work, we have raised questions about the legal and ethical dimensions of wastewater surveillance in response to the COVID-19 pandemic. But that work arrived in the earliest days of the pandemic, when research efforts were not yet well established or as broadly implemented, and when legal and ethical consideration was focused almost exclusively on the drastic public health emergency at issue. This Article thus expands the extant literature by considering the legal and ethical dimensions of wastewater surveillance more thoroughly and more broadly. It arrives at an auspicious time, as the United States moves into a vaccine-mediated phase in which COVID-19 is less likely to give rise to broad stay-at-home orders and more likely to trigger narrower, more targeted interventions. It seeks to offer guidance for the legal and ethical use of wastewater surveillance along two dimensions. The first considers the circumstances under which wastewater monitoring should be deployed for detecting and responding to COVID-19 specifically. The second zooms out, to consider whether and how this surveillance infrastructure, largely created in response to the COVID-19 pandemic, might be deployed for other uses, and examines the legal and ethical difficulties that may attend these broader uses. This Article proceeds in three parts. Part I reviews the state of the science for wastewater-based epidemiology, focusing specifically on how this technique has been deployed to monitor for or detect the virus that causes COVID-19. One of the authors is a research scientist currently working to establish and oversee wastewater-based epidemiological efforts related to COVID-19 monitoring in the City of Detroit, Michigan, and Part I draws on that expertise. Part II then moves from what is possible to what is legal and ethical. If wastewater-based epidemiology is to be deployed now and in the future for detecting and responding to COVID-19, what parameters should guide the collection of wastewater signals, and how should that data be used by policymakers and others to enact further public health protections? Finally, Part III broadens its scope beyond COVID-19. Wastewater surveillance for COVID-19 sentinel surveillance can be well justified, provided guidelines are established ex ante for public health response to monitoring results. Other uses of wastewater surveillance infrastructure, however, may raise substantial privacy concerns, particularly if this infrastructure becomes denser and correspondingly more granular in the data it discloses. Such uses may, in turn, undermine both the legal soundness of and public trust in wastewater monitoring writ large.

Ranjith, PV and Aparna J Varma, ‘Safety of Healthcare Workers in India’ (SSRN Scholarly Paper No ID 3629428, 20 May 2020)
Abstract: Health is one of our fundamental human rights and the role of workers in the healthcare system is inseparable. Health workers being the front line staff have more complicated situations to deal with especially in the wake of a pandemic like COVID- 19. WHO cautions that they are exposed to hazards that put them at risk of infection. Nevertheless, we are witnessing the relentless efforts put forth by health workers to reinstall the health care system in their respective countries. Amidst all this tension, another concern that derails the COVID-19 battle is the attacks happening against COVID-19 warriors around different parts of the country. This paper is a subjective personal introspection of the authors on the safety of health workers in India. The main objective of the study is to find out the different problems of safety faced by healthcare workers in India and measures to control them.

Ranson, David, ‘COVID-19 and Forensic Medical Practice’ (2020) 24(4) Journal of Law and Medicine 807
Abstract: The COVID-19 pandemic has affected the community in multiple ways. These include direct health impacts on those infected and indirect health impacts on others who may, through fear of infection, not avail themselves of available ‘face-to-face’ health care services. The impact of COVID-19 on the legal system and the related medico-legal services it relies upon has received less attention but the ongoing social restrictions put in place because of the pandemic have the capacity to disrupt a range of legal processes. The impact of the pandemic has the capacity to interfere with both forensic medical and legal processes both in the short term and the long term. It may take some time for the potential harms to be realised but as the pandemic gradually comes under control from a public health perspective the interference to criminal and civil justice will start to become more visible.

Raposo, Vera Lúcia, ‘Pigs Don’t Fly and You Cannot Expect Absolutely Safe COVID-19 Vaccines (But You Should Expect a Fair Compensation)’ (2021) 28(2) European Journal of Health Law 165–183
Abstract: This paper focuses on the COVID-19 vaccines authorised for use in the European Union, and explores the mechanisms in place to control vaccine safety and to compensate injured patients, mainly in the context of European law. Based on these considerations, the paper concludes that the refusal by some potential vaccinees to take the vaccine based on safety concerns is ungrounded and an indication of unrealistic expectations, but that in order to build public trust proper compensation mechanisms should be in place.

Raunig, Brooke L, Aaron S Kesselheim and Jonathan J Darrow, ‘Drug Shortages and the Defense Production Act’ (2020) 110(10) American Journal of Public Health 1504–1505
Abstract: Amid the COVID-19 pandemic, US hospitals have faced shortages of critical drugs, including sedatives and neuromuscular blocking agents needed to intubate patients and maintain ventilatory support, opioids for pain control and sedation, antibiotics to address secondary bacterial infections, and bronchodilators to open airways.1 In response to limited supplies of ventilators and personal protective equipment, the Trump administration invoked the Defense Production Act (DPA), but shortages of personal protective equipment remain. Although the DPA—if applied more broadly—could be effective in helping to address remaining shortages of personal protective equipment, using the DPA to address drug shortages is more challenging, and additional government interventions to support the drug supply chain are needed.

Rebouché, Rachel, ‘Abortion Opportunism’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa029
Abstract: Eleven states have tried to suspend abortion care in response to COVID-19. State officials claim that they will preserve medical supplies, hospital space, and health care capacity by classifying abortion as an elective, non-essential surgery that must be delayed. Advocacy groups representing abortion providers sued in several states to enjoin these bans. What has emerged is a fight that ignores medical evidence and threatens to exacerbate the current public health emergency. The Executive Order issued in Texas offers an apt example. Though abortion may be available in Texas for the time being, opinions from the U.S. Court of Appeals for the Fifth Circuit provide a troubling roadmap for suspending constitutional rights as a health emergency measure.

Rebouché, Rachel, ‘Assuring Access to Abortion’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 117–122
Abstract: Over the spring of 2020, numerous states announced measures suspending abortions in response to COVID-19. Banning abortion during the pandemic is counterproductive. Impeding access to abortion will not help preserve healthcare resources. Moreover, prohibiting access to abortion care exacerbates the strain on the healthcare system. People who lack access to abortions will travel to neighboring states, induce their own abortions, or carry pregnancies to term, which will require prenatal care and assistance in childbirth. Perhaps more importantly, the people hit hardest by suspending abortion care are those for whom the pandemic already has had devastating effects. Lifting restrictions on medication abortion and expanding telehealth abortion services will conserve healthcare resources and improve public health. Recognizing the advantages of telemedicine, some states, as well as the federal government, have relaxed restrictions on remote diagnosis and treatment. However, many of those same states have carved out exceptions for abortion in their telemedicine policies. In addition, people seeking medication abortions still face unnecessary restrictions on access, none of which are applied to comparable office-based procedures. Policymakers can eliminate barriers to safe abortion services now and in the future. ‘No-touch’ terminations, in which all medical supervision happens over the telephone or online, can better accomplish the goals that the present abortion suspensions cannot. Telehealth for medical abortion can ease the burdens on pregnant people, healthcare workers, and health systems in light of the unprecedented challenges presented by COVID-19.

Redhead, Caroline AB et al, ‘Relationships, Rights, and Responsibilities: (Re)Viewing the NHS Constitution for the Post-Pandemic “New Normal”’ (2023) 31(1) Medical Law Review 83–108
Abstract: Action needs to be taken to map out the fairest way to meet the needs of all NHS stakeholders in the post-pandemic ‘new normal’. In this article, we review the NHS Constitution, looking at it from a relational perspective and suggesting that it offers a useful starting point for such a project, but that new ways of thinking are required to accommodate the significant changes the pandemic has made to the fabric of the NHS. These new ways of thinking should encompass concepts of solidarity, care, and (reciprocal) responsibility, grounded in an acceptance of the importance of relationships in society. To this end, we explore and emphasise the importance of our interconnections as NHS stakeholders and ‘re-view’ the NHS Constitution from a relational perspective, concentrating on the rights and responsibilities it describes for patients and the public as NHS stakeholders. We argue that the NHS Constitution, of which most stakeholders are probably unaware, can be used as a tool to engage us, and to catalyse conversation about how our responsibilities as NHS stakeholders should change in the post-pandemic ‘new normal’.

Reis-Dennis, Samuel, ‘Understanding Autonomy: An Urgent Intervention’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa037
Abstract: In this paper, I argue that the principle of respect for autonomy can serve as the basis for laws that significantly limit conduct, including orders mandating isolation and quarantine. This thesis is fundamentally at odds with an overwhelming consensus in contemporary bioethics that the principle of respect for autonomy, while important in everyday clinical encounters, must be ‘curtailed’, ‘constrained’, or ‘overridden’ by other principles in times of crisis. I contend that bioethicists have embraced an indefensibly ‘thin’ notion of autonomy that uproots the concept from its foundations in Kantian ethics. According to this thin conception, respect for autonomy, if unconditioned by competing principles (beneficence, justice, non-maleficence) would give competent adults the right to do anything they desired to do so long as they satisfied certain baseline psychological conditions. I argue that the dominant ‘principlist’ model of bioethical reasoning depends on this thin view of autonomy and show how it deprives us of powerful analytical tools that would help us to think seriously about the foundations of human rights, justice, and law. Then, I offer a brief sketch of a ‘thick’, historically grounded notion of autonomy and show what we could gain by taking it seriously.

Reiss, Dorit Rubinstein, ‘Institutionalizing the Centers for Disease Control and Prevention’s Independence’ (SSRN Scholarly Paper No ID 3682044, 27 August 2020)
Abstract: The United States response to the COVID-19 pandemic was sub-optimal. One problem in it was the politicization of the public health response. One aspect of that politicization was aggressive political intervention in CDC efforts to provide guidance and help pandemic response. The concern was strong enough that four previous CDC Director, in an unusual step, published an op-ed calling out political intervention in CDC. This article proposes two changes to strengthen the CDC’s institutional independence: codifying the CDC’s role in preventing diseases and reducing harms in a statute, and restructuring the agency to be led by a multi-member Board appointed for long times and with removal protections (along the lines of the Board of the Federal Reserve System). These changes can send a strong message that expert advice in public health should be science-based and less, rather than more, political. It can also protect CDC’s long-standing independence, while preserving some political control.

Reiss, Dorit Rubinstein, ‘The COVID-19 Vaccine Dilemma’ (2020) 6(2) Administrative Law Review, ALR Accord 49–83
Abstract: COVID-19 continues to lead to large numbers of deaths, harms, and financial costs. Without an effective vaccine, those will continue. The pressure to find a vaccine is high; and that pressure places a risk on the safeguards in place to assure that vaccines are safe and effective will be ignored. The United States has an extensive apparatus to oversee vaccine safety before and after licensing, including multiple federal committees and several monitoring systems, and that apparatus gave us, in 2020, an extraordinarily safe vaccine supply. This Article explains the different pressures that push for and against using the same apparatus for COVID-19 vaccines, including the extensive harms from the disease on one side and the need for a vaccine that is, in fact, safe and effective on the other. It examines the options for speeding up the process without sacrificing too much oversight. It examines which ‘shortcuts’ are reasonable, which may be challenging, and which are bad ideas. Finally, it addresses three messaging challenges—overselling, under-sharing, and responding to misinformation—and suggests how to handle them.

Reiss, Dorit Rubinstein and Arthur L Caplan, ‘Considerations in Mandating a New Covid-19 Vaccine in the USA for Children and Adults’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa025
Abstract: As cases of COVID-19 spread globally and across the United States, reaching over 140,000 United States cases by March 30, 2020 (a number that is almost certainly an under-estimate, given the lack of testing across states), scientists and companies throughout the world are searching for a response, a treatment or vaccine.1 Multiple companies are currently working on developing vaccines for the disease.2 A vaccine will, by the most optimistic estimates, not be available for at least 12-18 months; but while there is no certainty, there are good chances one or more of variable efficacy will, eventually, be available.3 When it is, one potential question states will have to address is whether the vaccine should be mandated for school children and anyone else. This article examines this question; the answer, naturally, is ―it depends,‖ but this article offers guidance about the ethical and legal considerations for making the decision. The article will address this in three parts: the ethical considerations that affect whether a COVID-19 vaccine mandate is appropriate; potential legal constraints; and practical and political considerations.

Reiss, Dorit Rubinstein and John DiPaolo, ‘COVID-19 Vaccine Mandates for University Students’ (SSRN Scholarly Paper ID 3874159, 25 June 2021)
Abstract: Universities and colleges (‘universities’) preparing to reopen after COVID-19 understandably seek to increase safety on campus and reduce the risk of a COVID-19 outbreak. One approach universities and colleges are considering is requiring vaccines from students. This article addresses the legal framework behind university vaccine mandates for students. It sets out the general constitutional framework and explains why universities are constitutionally permitted to impose reasonable vaccine mandates. It addresses whether universities need to offer a religious exemption, explaining that under current Supreme Court jurisprudence universities are likely not required to offer a religious exemption, but that may change, and public universities in states with a Religious Freedom Restoration Act may have to offer a religious exemption. The article discusses how federal disability law will require accommodations under a vaccine mandate in certain cases. The article asks whether the emergency use authorization (EUA) status of current COVID-19 vaccines is a barrier to requiring vaccines from students, and concludes that it is probably not a limit. Acknowledging the complexity of the issue, instead of offering a prescription for all universities, the article offers a matrix of strategies to consider for increasing vaccine rates including vaccine mandates, along with considerations for each option.

Rhodes, Rosamond, ‘Justice Pluralism during the COVID-19 Pandemic’ (2024) 24(7) The American Journal of Bioethics 89–91

Richards, Adair D, ‘Ethical Guidelines for Deliberately Infecting Volunteers with COVID-19’ (2020) 46(8) Journal of Medical Ethics 502–504
Abstract: Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made.

Richman, Barak D and Steven L Schwarcz, ‘Macromedical Regulation’ (2021) 82(5) Ohio State Law Journal 727–777
Abstract: The COVID-19 pandemic has dramatically shown that a localized disease can be transmitted to the broader population, nationally and worldwide. This Article analyzes how to design regulation to help control that transmission. To that end, we first observe that existing healthcare regulation focuses almost exclusively on regulating individual components of the medical and healthcare industry, while lacking a capacity to address how those components work together as a system—a system that pandemics can destabilize. Indeed, one factor that contributed to COVID-19’s spread was the inability of U.S. healthcare regulation to operate on a societal level, to protect certain components from the deficiencies of others. We contend that healthcare regulation must also include what we call ‘macromedical’ regulation: regulation that focuses on protecting the stability of the healthcare sector as a system of interconnected parts. We find some useful analogies in the Dodd-Frank Act and other post-crisis financial regulation, particularly in macroprudential regulation designed to protect the financial system as a system.

Rifai, Eddy et al, ‘Legal Protection of Health Workers Who Experience Violence from Patients and Their Families in the Time of the Covid-19 Pandemic’ (2022) 5(1) Nurani Hukum: Journal of Legal Studies 12–22
Jurisdiction: Indonesia
Abstract: Along with the number of deaths among health workers during the COVID-19 pandemic, violence against health workers also often occurs. This shows that there is a need for an analysis related to legal protection for health workers. The problems that will be discussed in this research are: What are the legal provisions related to protection for health workers during the COVID-19 pandemic? And what about legal protection for health workers who experience violence The research method uses a normative juridical approach with qualitative analysis. The results of the study indicate that legal protection is an effort to maintain the rights of individuals or groups that can be fulfilled from strong or powerful parties such as the government or businessmen and other parties for the creation of security and public order. Legal protection for health workers is regulated in Article 57 of Law no. 36 of 2014 concerning Health Workers. Meanwhile, health workers who have been attacked have been protected and regulated in Articles 170 and 351 of the Criminal Code.

Rizzi, Marco, ‘Health Professionals’ Standard of Care and Breach of Duty in Western Australia: A Requiem for the “Peer Professional” Test at a Time of Uncertainty’ (2020) 26(2) _Torts Law Journal_
Abstract: In late September 2019, the Court of Appeal of Western Australia, comprising Quinlan CJ, Murphy and Pritchard JJA, handed down a significant judgment that sheds a measure of light over some intricate aspects of medical liability in WA. The Civil Liability Act 2002 (WA) (‘CLA’) is unique in its provision of a special standard of care for health professionals under s 5PB. Other civil liability statutes include special provisions for the liability of ‘professionals’ in general, and these provisions normally take the form of the so-called ‘peer professional opinion’ defence. The decision in Child and Adolescent Health Service v Mabior (‘Child’) gave the WA Court of Appeal the opportunity to clarify the nature of s 5PB as a special standard of care (as opposed to a defence). The Court also made some important points regarding the method of identification of relevant experts for the purpose of establishing complex scientific facts, which is a different exercise from the identification of the health professional’s peers for the purpose of establishing standard of care and breach of duty. While this decision systematises a rather oddly worded portion of the CLA, it arguably does so at the expense of its intended scope of application. Indeed, the restrictive approach adopted by the court may well have deprived s 5PB of any practical relevance. This is not an insignificant development. Indeed, the COVID-19 pandemic is putting healthcare systems under increasing amounts of pressure, and patients are bound to be cared for in accordance to practices that, by the very nature of the rapidly evolving current circumstances, cannot be well-established.

Rizzi, Marco, ‘Rethinking Vaccine Development as an Integral Part of Preparedness in the European Health Union’ (2020) 11(4) European Journal of Risk Regulation 821–830
Abstract: This opinion piece puts forward a critique of the policy and regulatory frameworks governing vaccines, understood as tools to confront pandemic and epidemic diseases (PEDs). Vaccines being the universally recognised prime method of prevention, immunisation campaigns and vaccine research and development (R&D) could reasonably be expected to feature prominently in any policy and/or strategic document addressing emerging health threats. Yet, vaccination occupies a relatively subsidiary role, with a prevalent focus on risk management mechanisms. This piece outlines the main characteristics of preparedness frameworks and looks at vaccine development in the course of PED outbreaks in the recent past, concluding that the COVID-19 pandemic calls for a paradigm shift in vaccine R&D, which should become integral to public health preparedness.

Rizzi, Marco, ‘The Road to a Vaccine for COVID-19: Regulatory and Policy Infrastructure, Incentives and Obstacles’ (2020) 4(2) European Pharmaceutical Law Review 98–103
Abstract: A brief commentary on the rush to a vaccine for COVID-19, with a focus on regulatory requirements under ‘normal’ circumstances vs during a pandemic, and some lessons from past outbreaks.

Robert, René et al, ‘Ethical Dilemmas Due to the COVID-19 Pandemic’ (2020) 10(1) Annals of Intensive Care 84
Abstract: The devastating pandemic that has stricken the worldwide population induced an unprecedented influx of patients in ICUs, raising ethical concerns not only surrounding triage and withdrawal of life support decisions, but also regarding family visits and quality of end-of-life support. These ingredients are liable to shake up our ethical principles, sharpen our ethical dilemmas, and lead to situations of major caregiver sufferings. Proposals have been made to rationalize triage policies in conjunction with ethical justifications. However, whatever the angle of approach, imbalance between utilitarian and individual ethics leads to unsolvable discomforts that caregivers will need to overcome. With this in mind, we aimed to point out some critical ethical choices with which ICU caregivers have been confronted during the Covid-19 pandemic and to underline their limits. The formalized strategies integrating the relevant tools of ethical reflection were disseminated without deviating from usual practices, leaving to intensivists the ultimate choice of decision.

Robertson, Christopher T, ‘What the Harm Principle Says About Vaccination and Healthcare Rationing’ (2022) Journal of Law and Biosciences (forthcoming)
Abstract: Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales – a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated by the discrete decision of some to decline a free, safe, and highly effective vaccine, where the facts are clear. In such a future case, if healthcare must be denied to some patients, rationers who ignore vaccination status will become complicit in externalizing the consequences of refusing vaccination onto those who did not refuse. I argue that giving the unvaccinated person healthcare resources that would have otherwise gone to other patients is to wrongfully setback the interests, or harm, those patients. The article considers rejoinders around the voluntariness of the vaccination choice, which impinges both access and information, and how to scale this criterion proportionally with other rationing criteria that serve utility. Ultimately, the article speculates on why there will be some cognitive dissonance under this approach, while upholding a more general solidarity with and concern for all those seeking healthcare.

Romanczuk-Gracka, Marta, ‘Conflicts of Doctor’s Duties in the Case of an Extreme Shortage of Intensive Care Beds and the Good Samaritan Clause from the Perspective of Criminal Law’ (2021) 26(6) Bialystok Legal Studies / Bialostockie Studia Prawnicze 163–184
Jurisdiction: Poland
Abstract: The Covid-19 pandemic has exposed many weaknesses of healthcare systems. An example of a crisis situation is the case of a doctor who has to make a decision about qualifying a patient with COVID-19 for an intensive care bed when there are not enough such beds and when, out of the many obligations to save lives, he can choose and fulfi l only one. The aim of this paper is to analyse the criteria of establishing the priority in access to intensive care, to settle the conflict of obligations in regard to criminal liability, with respect to Art. 26 § 5 of the Polish penal code regarding the doctor’s decision to provide, or to not provide, healthcare services including intensive care given the extreme shortage of the beds, to determine the scope of legal safety guarantees laid down in the good Samaritan clause and the relationship between the conflict of duties and the clause. The work is theoretical with the use of a formal-dogmatic and functional analysis of Polish criminal law.

Romanis, Elizabeth Chloe and Jordan A Parsons, ‘Legal and Policy Responses to the Delivery of Abortion Care during COVID-19’ (2020) 151(3) International Journal of Gynecology & Obstetrics 479–486
Abstract: Access to abortion care has long been a global challenge, even in jurisdictions where abortion is legal. The COVID-19 pandemic has exacerbated barriers to access, thereby preventing many women from terminating unwanted pregnancies for an extended period. In this paper, we outline existing and COVID-specific barriers to abortion care and consider potential solutions, including the use of telemedicine, to overcome barriers to access during the pandemic and beyond. We explore the responses of governments throughout the world to the challenge of abortion access during the pandemic, which are an eclectic mix of progressive, neutral, and regressive policies. Finally, we call on all governments to recognize abortion as essential healthcare and act to ensure that the law does not continue to interfere with providers’ ability to adapt to circumstances and to guarantee safe and appropriate care not only during the pandemic, but permanently.

Romanis, Elizabeth Chloe, Jordan Parsons and Nathan Hodson, ‘COVID-19 and Reproductive Justice in Great Britain and the United States: Ensuring Access to Abortion Care during a Global Pandemic’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa027
Abstract: In this paper we consider the impact that the COVID-19 pandemic is having on access to abortion care in Great Britain (England, Wales, and Scotland) and the United States. The pandemic has exacerbated problems in access to abortion services because social distancing or lockdown measures, increasing caring responsibilities, and the need to self-isolate are making clinics much more difficult to access; and this is when clinics are able to stay open which many are not. In response we argue there is a need to facilitate telemedical early medical abortion in order to ensure access to essential healthcare for people in need of terminations. There are substantial legal barriers to the establishment of telemedical abortion services in parts of Great Britain and parts of the United States. We argue that during a pandemic any restriction on telemedicine for basic healthcare is an unjustifiable human rights violation and, in the United States, is unconstitutional.

Roncati, Luca and Monica Roncati, ‘COVID-19 “Green Pass”: A Lesson on the Proportionality Principle from Galicia’ (2021) 28(5) European Journal of Health Law 525–532
Abstract: Coronavirus Disease 2019 (COVID-19) is the most dramatic pandemic of the new millennium, and extraordinary measures concerning with health, law and policy are required around the world. One of these is without doubts the ‘green pass’, officially known in the European Union (EU) as EU Digital COVID Certificate (EUDCC). Initially conceived as a tool for overcoming the lockdown restrictions, it has unexpectedly turned into a means of discrimination between pass holders and non-holders, thus increasing social tension at the expense of solidarity and brotherhood. Here, we analyze in depth the dark sides of the ‘green pass’ in the light of the European and international legislation and of the ongoing pandemic scenario.

Rondon, Gabriela, Debora Diniz and Juliano Zaiden Benvindo, ‘Speaking Truth to Power: Legal Scholars as Survivors and Witnesses of the Covid-19 Maternal Mortality in Brazil’ (2022) 20(3) International Journal of Constitutional Law 1360–1369
Abstract: The Covid-19 health emergency has placed special demands on legal scholars, particularly on those based in the Global South. Brazil has been one of the epicenters of the pandemic, with over 680,000 deaths as of August 2022. Our narrative emerges from the duality of our positions amid a national tragedy—we are at the same time survivors of the collective threat of a would-be autocrat and a Covid-19-denialist government, and witnesses to how our preexisting privileges put us in a position of readiness ‘to speak truth to power.’ Speaking truth to power means not only to exercise an independent spirit of analysis and judgment with respect to power, but also to interpellate power openly about its wrongdoings. We understand that our responsibility as legal scholars is to embrace the urgency of the moment—to expand our research agendas beyond our previous academic trajectories and work to mitigate situations of rights violations. It also means that our work as legal scholars has had to transcend the traditional academic spaces. We have positioned ourselves as advocates and litigators for those most affected by the pandemic, in particular vulnerable women. In this article, we share one of our key initiatives during the pandemic—a constitutional lawsuit to demand the right of pregnant and postpartum people to access Covid-19 vaccines.

Rosenbaum, Sara and Morgan Handley, ‘Caring for the Uninsured in a Pandemic Era’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 110–116
Abstract: On the eve of the COVID-19 pandemic, millions of Americans were uninsured despite a booming economy and a decade of health reform. The pandemic and its associated job losses have significantly increased the number of uninsured Americans – predominantly low-income, working-age adults and their families. Underlying drivers are the pandemic-triggered economic crisis, the inherent limits of the Affordable Care Act (ACA), the 2012 United States Supreme Court’s ruling on the constitutionality of its nationwide Medicaid expansion, and policies pursued by the Trump administration and certain states that further restrict the ACA’s reach. Especially serious during a public health emergency, the uninsured are significantly less likely to receive necessary care and are more likely to forgo care because of cost. Health care safety net providers established and operated under federal, state, and local law offer vital care for the uninsured and medically underserved rural and urban populations and communities. Federal COVID-19 legislation enacted to date appropriates funding to directly support health care providers, but the administration’s implementation approach may be limiting the effectiveness of this funding for the highest-need populations and communities. Beyond reforms aimed at improving how federally appropriated emergency health care funding is spent, states should use Medicaid to foster greater safety net provider stability and should pursue policies that promote accountability by tax-exempt hospitals with charity care obligations.

Rosmelani, Arlinda, Endang Sutrisno and Sanusi Sanusi, ‘Implementation of Hospital Policies in Legal Accountability of the Doctor in Responsibility of Services (Dpjp) During the Covid 19 Pandemic’ (2023) 7(2) Hermeneutika: Jurnal Ilmu Hukum [pagination unknown]
Abstract: Basically, everyone has the right to receive health services and the state is responsible for providing proper health service facilities and public service facilities. The hospital as a business entity organization in the health sector has an important role in realizing public health. During the Covid 19 pandemic, the hospital’s policy to regulate doctors in charge of services was regulated in the Decree of the Hospital Director and the Handbook of Doctors in Charge of Hospital Services. This becomes the regulation that forms the basis of the Doctor in Charge of Service in the implementation of medical care, and the Director’s decree and this guidebook are the main reference for the Hospital. Juridical Consequences due to negligence of the Doctor in Charge of Service, i.e. in civil, criminal law and administration by the Hospital. In an effort to discipline doctors in charge of services who commit negligence in carrying out their duties, it is carried out by the Hospital Ethics Committee through a professional discipline committee, namely the Medical Committee.

Roth, Lauren, ‘Sanitation: Judicially-Mandated Individualism in Public Health Law’ (SSRN Scholarly Paper No 4166201, 18 July 2022)
Abstract: On April 18, 2022, in Health Freedom Defense Fund, Inc. v. Biden, United States District Judge Kathryn Kimball Mizelle vacated the mask mandate issued by the Centers for Disease Control and Prevention. Following a framework laid out in other decisions restricting CDC actions in response to COVID-19, the court found that the agency lacked statutory authority to protect the public from the virus by requiring mask wearing during travel and at transit hubs because Congress did not intend such a broad grant of power. Countering decades of public health jurisprudence, the federal district court failed to defer to experts and prioritized individual liberties over population health. What makes this case different from other recent federal cases restricting the authority of administrative agencies is its redefinition of the term ‘sanitation’ away from the meaning it has long held under federal and state jurisprudence and in the public health field. While not binding on the states, this decision creates a path for state courts to follow when restricting actions taken by public health agencies, allowing judicially-mandated individualism to spread and courts to gain power as they narrow the boundaries of administrative discretion.

Rothstein, Mark A, ‘The Coronavirus Pandemic: Public Health and American Values’ (2020) 48(2) The Journal of Law, Medicine & Ethics 354–359
Abstract: In 2004, the year after the SARS epidemic in Asia and Canada, I wrote an article in which I considered whether the United States would be able to replicate the large-scale quarantine and isolation strategies effectively implemented by the countries hardest-hit by SARS. I called it ‘Are Traditional Public Health Strategies Consistent with Contemporary American Values?’. Although I cautioned against overreliance on social distancing measures, I questioned whether there would be adequate levels of compliance with quarantine in a society grounded on libertarianism, as distinguished from the more collective or communitarian societies of Canada, China, Hong Kong, Singapore, Taiwan, and Vietnam. More generally, I wondered whether the United States had the social solidarity to respond to a major public health threat. Now, 16 years later, we face a challenge much greater than SARS, and it seems appropriate to reexamine American values during the coronavirus pandemic and beyond.

Ruck Keene, Alex, ‘Capacity in the Time of Coronavirus’ (2020) 70(May-June) International Journal of Law and Psychiatry: Capacity in the Time of Coronavirus’ (2020) 70 (May/June) International Journal of Law and Psychiatry: Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus), Article 101560
Abstract: In the course of a few short weeks, many of the established legal frameworks relating to decision-making in England & Wales in respect of those with impaired decision-making capacity have been ripped up, or apparently rendered all but unusable. Although the Mental Capacity Act 2005 itself has not been amended, the impact of other legislation (especially the Coronavirus Act 2020) means that duties towards those with impaired decision-making capacity have been radically changed. This article reflects the experience of a practising barrister in England & Wales grappling with the impact of COVID-19 upon the Mental Capacity Act 2005 across a range of fields in the weeks after the world appeared to change in mid-March 2020.

de Ruijter, A et al, ‘EU Solidarity and Policy in Fighting Infectious Diseases: State of Play, Obstacles, Citizen Preferences and Ways Forward’ (Amsterdam Centre for European Studies Research Paper No 2020/06, 4 April 2020)
Abstract: In this paper we confront the role the EU traditionally plays in the domain of health with the urgent need for collective action triggered by the corona virus pandemic. In the face of such a crisis, we argue that the joint procurement, stockpiling and allocation of medical countermeasures is a key component of true European solidarity, besides maintaining the integrity of the Single Market. We present the first results of a survey experiment taken before the current crisis on citizens’ attitudes towards centralizing at the EU level of policies to combat infectious diseases, which indicates considerable support. We conclude that a more robust policy framework with substantial centralization of procurement, stockpiling and allocation is warranted.

Rusdianto, Rusdianto and Diva Pitaloka, ‘Legal Formulation of Imposing Administrative Sanction for Anti-Covid-19 Vaccinations Movement’ (2022) 8(1) Unnes Law Journal: Jurnal Hukum Universitas Negeri Semarang 21–38
Jurisdiction: Indonesia
Abstract: In order to accelerate the handling Covid-19, the Government has issued a policy that impose administrative sanction for those refusing Covid-19 vaccination. This journal underlines and focuses the administrative sanction for those who refuse to take the vaccinations. Those sanctions could be social security termination, and/or administrative service moratorium. While it is assumed that this policy is urgently needed in addressing the pandemic issue, it also leads to other issues. The first is that whether those administrative sanctions are compliant with law principles and human rights protection. Another is whether there are legal implications for those who refuse to take vaccinations. Method adopted in this research is normative law research method based on facts, issues, regulations, analysis, and conclusion (FIRAK). This journal points out two results. Firstly, the right to obtain health service is a part of human rights. In order to fulfill that right and to achieve a greater good, the Government is responsible to create a clean and healthy environment. Thus, providing Covid-19 vaccinations and imposing administrative sanction comply with law principles and human rights protection. The latter, legal implication from such policy is that the vaccination is mandatory. Thus, those refusing it would be imposed administrative sanctions. It is expected that this policy would become a legal formulation in addressing and handling the Covid-19 pandemic.

Ruslina, Elli and Rita Sekarsari, ‘Legal Protection of Medical Staff in Hospitals during The Covid-19 Pandemic Era’ (2020) 1(1) International Journal of Latin Notary 29–35
Abstract: This research begins with the COVID-19 pandemic which requires serious control because it has had a dangerous impact on society, especially health workers in hospitals. The research focus is aimed at the legal protection of health workers in hospitals and the state’s responsibility for health workers. The research method used is library research, which is a method used by studying literature such as books, legislation and articles, journals related to the subject matter. Primary data used in field research, through interviews with related parties, namely hospitals and health workers. The focus of the discussion is to emphasize more on laws and regulations related to Social Distancing / Physical Distancing policies as regulations for legal protection of health workers as the frontline and state responsibility for health workers. The results showed that various laws and regulations as a policy for handling Covid-19 cannot be realized concretely in the field because they are related to different bureaucracy and implementation. The role of the state in the responsibility for health workers is not The responsibility of the state in this case is that the Government and Administrators of Health Service Facilities are obliged to ensure the sustainability of the availability of standardized Personal Protective Equipment (PPE) for health workers who work in health service facilities.

Sachs, Rachel, ‘Encouraging Interagency Collaboration: Learning from COVID-19’ (2021) Journal of Law & Innovation (forthcoming)
Jurisdiction: USA
Abstract: In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the COVID-19 context, however, failures of federal interagency coordination may have had much more severe negative consequences for the spread of the pandemic in the United States. This Article first spotlights two examples of healthcare innovation for COVID-19 – diagnostic tests and vaccines – and details both the ways in which agency failures of collaboration created serious problems for our COVID-19 response and the ways in which interagency collaborations have successfully driven innovation and access to these new technologies. The Article goes on to consider what lessons can be learned from the successes and failures of these innovative efforts about best – and worst – practices in interagency collaboration going forward.

Sage, William M, ‘What the Pandemic Taught Us: The Health Care System We Have Is Not the System We Hoped We Had’ (2021) 82(5) Ohio State Law Journal 857–868
Abstract: The United States spends nearly twice as much per capita on medical care as any other country. The United States has the world’s most advanced biomedical technologies, sophisticated hospitals, and skilled health professionals. The United States has a national public health body, the Centers for Disease Control and Prevention (CDC), that is generally considered the world’s leader in infectious disease detection and response. Nonetheless, the United States suffered among the world’s worst COVID-19 disease burdens and outcomes, inflicting largely avoidable harm on patients, health professionals, and the broader community. Why this happened is clearly important. But that it happened is itself significant. Criticisms of the U.S. health care system abound, but often have a Lake Wobegon character: The ‘health care system’ may be bad, but my personal doctor is good. A silver lining of the pandemic experience is the possibility that Americans will finally recognize that, whether or not one’s own doctor is in fact good, American health care is unreliable, wasteful, and unjust. Should this occur, the path forward should combine several issues of law and policy to which I have devoted much of my scholarly career. These include improving corporate governance, rethinking professional ethics and selfregulation, remaking health care delivery, and broadening competition policy— with the common objective of enhancing collective goals and obligations in U.S. health policy.

Saletti-Cuesta, Lorena and Lila Aizenberg, ‘Approaches To Gender-Based Violence And Legal Abortion in Health Services During COVID-19 Lockdown’ (2021) 17 Salud Colectiva / Collective Health Article e3678
Jurisdiction: Argentina
Abstract: This study is interested in analyzing how health services address gender-based violence and legal abortion in a context of mandatory preventive social isolation. Between May and June 2020, 27 telephone interviews were conducted with healthcare professionals and key informants from Córdoba and Resistencia. Changes in detection, methods, and demand were identified, related to the reorganization of the healthcare system, modifications in the care relationship, and the resources needed to respond to demand. The pandemic has deepened barriers to women’s access to health services and has added new ones. Networks among healthcare professionals, feminist healthcare practices, and innovative approaches were identified as facilitators of access, which have been central in mitigating the effects of the pandemic and guaranteeing rights.

Saman, Faizal, ‘Debatable of Indonesian Citizens’ Rights and Obligations Regarding the Covid-19 Vaccination Policy’ (2022) 4(2) Estudiante Law Journal 309–321
Abstract: The purpose of this study is to examine the rights and obligations of Indonesian citizens regarding vaccination. This research uses a type of normative legal research with a statute approach. Collect data by grouping and reviewing regulations, library materials, books, and other sources related to problems in this study. The results showed that polemics that led to pros and cons related to vaccination were caused by several factors such as vaccines being new, the safety of vaccines that cannot be passed, and the sanctions imposed on those who refuse vaccines. The pro-life community considers vaccination to be an obligation and the contras think that the imposition of vaccination is in line with the right to health. There are several variables for the reason for the vaccination policy to be implemented, namely the state in a state of emergency, namely in a pandemic crisis, and subsequently related to the human obligation to respect the human rights of others (the right to the health of others). Thus, the problem of legal certainty from the implementation of vaccination is an obligation of Indonesian citizens.

Sanchez-Graells, Albert, ‘COVID-19 PPE Extremely Urgent Procurement in England. A Cautionary Tale for an Overheating Public Governance’ (SSRN Scholarly Paper No ID 3711526, 14 October 2020)
Abstract: In this short paper, I reflect on the case study of the procurement of personal protective equipment (PPE) for the English NHS during the first wave of the COVID-19 pandemic. I put forward two main claims. My first claim is that the UK Government not only was particularly ill-positioned to deal with the pandemic as a result of years of austerity and the institutional unsettling resulting from the continuous reform of the NHS, its internal market and its supply chain—but also due to the imminence of Brexit and its political ramifications. My second contribution is that, in its desperate reaction to the PPE fiasco, the UK Government misused and abused the disapplication of the standard procurement rules on the basis of the ‘extremely urgent need’ exemption. This resulted in the opaque award of large numbers of high value contracts to companies that would not survive basic screening under normal conditions. Overall, my goal is to lay bare the more general problems in the UK Government’s approach to the governance of public procurement and its increasing insularity as a result of Brexit, with the hope that this will show a path for change that could avert even more significant fiascos in the face of the massive challenges that climate change will bring.

Sanchez-Graells, Albert, ‘Procurement and Commissioning during COVID-19: Reflections and (Early) Lessons’ (2020) 71(3) Northern Ireland Legal Quarterly 523–530
Abstract: This commentary reflects on some common themes that are starting to emerge in the early analysis of the healthcare procurement and commissioning response to the COVID-19 pandemic. Although it largely results from the observation of the situation in the English NHS, the most salient issues are common to procurement in other EU healthcare systems, as well as more broadly across areas of the public sector that have strongly relied on the extremely urgent procurement exception in the aftermath of the first wave of the pandemic. Given the disfunction and abuse of ‘unregulated procurement’ in the context of COVID-19, the commentary reflects on the longer term need for suitable procurement rules to face impending challenges, such as Brexit and, more importantly, climate change.

Santos Rutschman, Ana et al, ‘Comments on the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine’ (Saint Louis University Legal Studies Research Paper No 2020–25, 2020)
Abstract: On September 1, 2020 the National Academies released a draft framework for Equitable Allocation of a COVID-19 Vaccine. In this response, we analyze the proposed framework and highlight several areas. Among the proposed changes, we highlight the need for the following interventions. The final framework for distribution of COVID-19 vaccines should give a higher priority to populations made most vulnerable by the social determinants of health. It should incorporate more geography-based approaches in at least some of the four proposed phases of vaccine distribution. It should address the possibility of a vaccine being made available through an emergency use authorization (EUA), which we argue should not serve as a basis for widespread distribution of COVID-19 vaccines, and which may not be appropriate at all for the regulatory review of new vaccines. Moreover, it should address potential adjustments to the allocative framework once additional data pertaining to multiple vaccines becomes available, especially by discussing whether steps should be taken to prevent the administration of different vaccines to the same individual. Finally, it should provide guidance on allocation of vaccine in the case of a surplus, and specifically the Committee should specify whether unused doses of vaccine would automatically be allocated to next-level priority populations, and whether that would take place in the same geographical area.

Santos Rutschman, Ana, ‘The Mosaic of Coronavirus Vaccine Development: Systemic Failures in Vaccine Innovation’ _Journal of International Affairs (forthcoming)_
Abstract: Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

Santos Rutschman, Ana, ‘The Reemergence of Vaccine Nationalism’ (Saint Louis University Legal Studies Research Paper No 2020–16, 2020)
Abstract: This short essay explores the reemergence of vaccine nationalism during the COVID-19 pandemic. The essay traces the pre-COVID origins of vaccine nationalism and explains how it can have detrimental effects on equitable access to newly developed vaccines.

Santos Rutschman, Ana, ‘Vaccine Hesitancy Across Time: Legal and Policy Interventions from the Dawn of the Anti-Vaccination Movement to the Era of Social Media’ (2022) 23(3) North Carolina Journal of Law and Technology 840-881
Abstract: This symposium article explores the intertwined topics of hesitancy and trust towards vaccines. It traces the evolution of anti-vaccine sentiments, their consolidation into organized movements, and their recent evolution as vaccine misinformation and disinformation circulates with unprecedented ease through digital channels. The Article then examines selected legal and policy interventions that have been used to counter vaccine hesitancy—sometimes through top-down or mandatory frameworks, other times through voluntary ones. In particular, the Article examines vaccination mandates, as well as rules imposing or promoting vaccination; mechanisms designed to increase the flow of information about vaccines; and nudges to vaccination, such as lotteries and other prize-like mechanisms.

Satyarthi, Archisha, ‘Neo-Colonialism and the Right to Health: The Covid-19 Pandemic and Access to Vaccines by the Global South’ (SSRN Scholarly Paper No 4663114, 11 December 2023)
Abstract: A study reveals the stark gap between the vaccine programs in different countries. And while vaccine doses remain relatively scarce globally, concerns around waning immunity have prompted many countries, including United States, to start administering additional doses, whereas many of the countries in the Global South are not expected to have substantial doses of COVID vaccine delivered as late as 2024 and rely on a global vaccine sharing agreement/program called COVAX - initiated by World Health Organization (WHO), which was originally aimed at providing 2 billion doses by the end of 2021, but has repeatedly lowered expectations due to production issues, export bans and vaccine hoarding by wealthy nations while depriving poor countries of any substantial access. They prioritize bilateral deals and go around COVAX to jump in front of the queue in order to secure large doses (as much as one billion) of COVID vaccines. Further, the European Union authorised its member states to put limitations on the exportation of vaccines. Moreover, the failure of COVAX can be mainly attributed to the insufficiency of contributions, funds and donations made by the wealthy countries and faces a funding gap of about 7.2 billion to realize its goal but amidst the pandemic brought world economic crisis, filling this gap can be challenging. Additionally, the hoarding of vaccines by rich countries has only multiplied the problem by driving up the prices and making the sufficient procurement of vaccine hellacious for many of the Global South nations.In late February 2021, Ghana became the first country to receive vaccine doses under the COVAX scheme. Yet, the late ‘timing and the relatively modest supply—enough for just 1% of Ghana’s population—point to major challenges’ moving forward. Indeed, by April 2021, COVAX ‘distributed 43 million doses of vaccine to 119 countries—covering just 0.5 percent of their combined population of more than four billion.’ This delayed access and inequity is further exacerbated by driving monopoly over the prices by giant pharmaceuticals. These vaccine monopolies make cost of vaccinating the world against COVID at least 5 times more expensive than it could be. Where 81% of the population in high and upper-middle income countries have received at least one dose of the vaccine, a mere 18% of the population has been vaccinated in the low-income countries. Africa has the lowest vaccination rate of any continent, with only 22.9 percent of the population receiving at least one vaccination. To boot and highlight the irregularity further, South Africa was only able to procure AstraZeneca vaccine for its population at a brazen cost of $5.25 per dose, which is more than double of $2.16 per dose at which the European Union obtained many millions of the said vaccine. This is compounded by Moderna’s earlier indication that it did not plan to distribute its vaccine in South Africa. One of the most expensive vaccines- a single dose of Moderna costs between $32 to $37 with an efficacy of 95% and while Moderna has pledged to not enforce its patent during the pandemic; however, to put simply, it does not own all the patents in its vaccine and therefore cannot make any credible commitments binding other patent holders. The past seems to be the present-day reality of the lives of Black and other people of colour in the shape and size of their exploitation. From the unethical clinical trial conducted by Pfizer in Nigeria during the meningitis outbreak of 1996, where eleven children died and many others were left suffering from brain damage, paralysis and slurred speech, after two hundred children were given an experimental antibiotic - to the - trials conducted in Uganda to test the efficacy and side effects of vaccine designed for HIV Subtype B – a subtype of HIV that is dominantly prevalent in Europe and Americas as opposed to Subtype D, which is the chief form prevalent in Africa. It underscores elements of medical colonialism and the absurdity of such research where Uganda is viewed as a playground to test the safety of a vaccine made to attack HIV subtype that is not dominant in the very region. It also highlights the preference of vaccine developers to focus on catering healthcare products for dominant variant in high- income countries of the Global North. Much on these racialized lines, when in April 2020, two French doctors publicly discussed about potentially utilizing African subjects in experimental trials conducted to test tuberculosis vaccine for the novel coronavirus i.e., COVID-19, it generated much backlash on social media and opened many wounds for the Black, Indigenous and other people of colour being treated as ‘disposable’. The controversial utterances were widely condemned and the Director-General of World Health Organisation (WHO) dispraised their racist remarks as ‘hangover from “colonial mentality”’ and said that‘Africa won’t be a testing ground for any vaccine’. Note worthy to mention that colonialist patterns that focuses on Euro-Western world superiority have shaped language and the consequent response around the current pandemic affecting Global South nations by using labelling such as the ‘Wuhan Virus’ or the ‘Chinese Virus’, Chinese and other East Asian populations worldwide are being scapegoated and facing discrimination. Therefore, unveiling the layers of racial valuation is crucial to identify its remnants in contemporary practices and laws that discreetly and in covert ways facilitate racial subordination globally, which has widened the pre-existing inequities resulting from histories of slavery, redlining, racism and the predatory nature of capitalism that underpin the design of global and public health systems.

Saver, Richard S, ‘Physicians’ Elusive Public Health Duties’ (2021) 99(4) North Carolina Law Review 923–984
Abstract: Law, consistent with bioethics and medical norms, directs physicians to ‘put patients first.’ To what extent do physicians have broader responsibilities for community health, beyond and even counter to those owed to their patients? More salient in the era of COVID-19, the question of physicians’ obligations to safeguard the health of non-patients continually vexes courts, policy makers, and scholars. This Article reveals how physicians’ public health duties are confoundingly elusive. Elusive in the sense that while at times affirming physicians’ special capacity and obligations to improve the health of the community, law more often obscures physicians’ public health duties with limited, ad hoc recognition and insufficient theorization. These public health duties are also elusive in actual application. Physicians can point to individual patient obligations as reasons to evade compliance with certain public health laws or to discount public health considerations in clinical decision-making. The strong patient-primacy directive has underappreciated costs. It frequently overrides physicians’ more elusive public health duties in ways that facilitate externalization of health risks to the general public. This Article analyzes the COVID-19 pandemic, antibiotic resistance, infectious disease reporting, the opioid crisis, and gun violence as disturbing examples. It further identifies important justifications, including, most importantly, role indispensability for amplifying physicians’ public health responsibilities.

Savulescu, Julian et al, ‘An Ethical Algorithm for Rationing Life-Sustaining Treatment during the COVID-19 Pandemic’ (2020) 125(3) BJA: British Journal of Anaesthesia 253–258
Abstract: The burning ethical question raised by the coronavirus disease 2019 (COVID-19) pandemic is how to deal fairly and ethically with a large number of patients simultaneously becoming critically unwell. Across the world, in both developed and developing countries, health systems are grappling with the possibility or the reality that the demand for intensive medical care will outstrip availability. There is a need for ethical guidelines on how to allocate treatment, but such guidelines are potentially highly controversial. In this commentary, we set out a simple algorithm, including what we take to be the essential ethical principles that ought to guide resource allocation in any country or setting and optional elements that will vary between countries depending on the weight placed on different ethical values.

Savulescu, Julian, James Cameron and Dominic Wilkinson, ‘Equality or Utility? Ethics and Law of Rationing Ventilators’ (2020) 125(1) British Journal of Anaesthesia 10–15
Abstract: It is predicted that there will be a severe shortage of ventilators in coming weeks for the respiratory support of patients severely affected by coronavirus disease 2019 (COVID-19). The National Institute for Health and Care Excellence (NICE) has recently issued guidelines that set out decision-making procedures for allocation of intensive care and ventilation.1 These essentially state that factors that affect the probability of survival, such as frailty in older patients, are relevant, but it eschews consideration of factors, such as age, length of life, quality of life, and disability.

Scendoni, Roberto et al, ‘Legal and Ethical Issues Around Covid-19 Vaccination Consent in Italian Children from 12 Years Of Age’ (2021) 24(Special Issue 1) Business Ethics (in press)
Abstract: In Europe, there are currently two vaccines against COVID-19 recommended by the European Medicines Agency (EMA) for children aged 12 and older: Spikevax (Moderna) and Comirnaty (Pfizer-BioNTech). At the moment, about half of European countries have decided to age 12 as the minimum age for vaccination against COVID-19. In addition to Italy, France, Spain, Austria, Slovenia, Hungary, Czechia, Slovakia, Denmark, Switzerland, Romania, Bulgaria, Lithuania, Latvia and Estonia. Others (Germany, UK, Netherlands, Belgium, Sweden, Finland) recommend vaccination only for children in textual conditions facing COVID-19 or living with frail people. The Italian Medicines Agency (AIFA) has approved the extension of the therapeutic indications for Comirnaty on May 31 and for Spikevax on July 29, 2021. The various scientific societies in Italy (SIPPS, SIP) agreed in favor of vaccinating children from 12 years old. However the problem of informed consent to COVID-19 vaccination in minors is absolutely emerging, in Italy as well as in other countries (Heuerman, 2021). According to national and international conventions, he should be informed, listened to and must participate in the co-decision process regarding medical treatment. Achieving a ‘triple’ medical-parent-child therapeutic alliance is the main goal at this time of the pandemic, but this is not always possible (Morgan, 2021). The main key legal and ethical issues on the matter are represented below.

Scharloth, Joachim, ‘Between “Mouth-Nose-Protection” and “Muzzle”: Mask Wearing in German Public Debate’ in Noriko Suzuki et al (eds), Public Behavioural Responses to Policy Making during the Pandemic: Comparative Perspectives on Mask-Wearing Policies (Routledge, 2022)

Schmit, Cason D et al, ‘Telehealth in the COVID-19 Pandemic’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 123–132
Abstract: The COVID-19 pandemic highlights the value of telehealth as a public health measure by permitting health care at a distance, keeping providers and patients safe while enabling health care in strained health systems. This Chapter explores how states have acted through legislative, regulatory, and executive actions to leverage telehealth in the COVID-19 response. Congress passed three new pieces of federal telehealth legislation in response to COVID-19: The Coronavirus Aid, Relief, and Economic Security (CARES) Act, the Telehealth Services During Certain Emergency Periods Act, and the Families First Coronavirus Response Act. These new federal laws provide additional funding and regulatory flexibility for telehealth under the Medicare and TRICARE programs. Additionally, 27 states have new telehealth authorities in response to COVID-19. These new state authorities generally expand telehealth by removing regulatory barriers, authorizing more telehealth providers or telehealth modalities, and expanding telehealth coverage. This Chapter includes a number of recommendations for policymakers including addressing inequities, eliminating telehealth barriers (e.g., location requirements), authorizing additional providers and telehealth modalities, and expanding telehealth coverage.

Schuklenk, Udo, ‘What Healthcare Professionals Owe Us: Why Their Duty to Treat during a Pandemic Is Contingent on Personal Protective Equipment (PPE)’ (2020) 46(7) Journal of Medical Ethics 432–435
Abstract: Healthcare professionals’ capacity to protect themselves, while caring for infected patients during an infectious disease pandemic, depends on their ability to practise universal precautions. In turn, universal precautions rely on the availability of personal protective equipment (PPE). During the SARS-CoV2 outbreak many healthcare workers across the globe have been reluctant to provide patient care because crucial PPE components are in short supply. The lack of such equipment during the pandemic was not a result of careful resource allocation decisions in the global north, where the short supply could be explained through their high cost. Instead, they were the result of democratically elected governments prioritising low tax regimes over an adequate resourcing of their healthcare delivery systems. Such decisions were made despite global health experts warning about the high probability of pandemics like SARS-CoV2 occurring during our lifetimes. Avoidable allocation decisions by democratically elected political leaders resulted in a lack of sufficient PPE for healthcare professionals. After discussing and discounting various ethical arguments in support of a professional obligation to treat, even without or with suboptimal PPE, I conclude that these policy decisions were sufficiently grave that they provide a sound ethical rationale to justify healthcare workers’ refusal to provide care to infected patients.

Seitz, Claudia, ‘Genetic Material and Sequence Data to Protect Global Health in the Light of Pandemic Outbreaks : Mapping the Legal Landscape under European and International Law’ (2020) 27(3) European Journal of Health Law 232–241
Abstract: The current pandemic outbreak of corona virus SARS-CoV-2 shows the need for comprehensive European cooperation in drug development and the importance of genetic material and sequence data in research concerning this unknown disease. As corona virus SARS-CoV-2 is spreading across Europe and worldwide, national authorities and the European Union (EU) institutions do their utmost to address the pandemic and accelerate innovation to protect global health. In order to be prepared and to be able to respond immediately to serious epidemic and pandemic diseases, the EU has already adopted the Decision No (EU) 1082/2013 on serious cross-border threats to health. The World Health Organization (WHO) has established a global system to collect genetic material and information to protect a global influenza pandemic outbreak. The article describes the current legal landscape under EU and international law.

Seraj, Shaikh S et al, ‘Covid-19: Exploring Medico-Legal Perceptions amongst Orthopaedic Surgeons and Lawyers’ (2023) Medico-Legal Journal (advance article, published online 25 January 2023
Abstract: British national guidelines and laws published by the British Orthopaedic Association and the new Coronovirus Act 2020 favoured treatment of trauma and orthopaedic conditions with non-operative alternatives. Feedback from lawyers reassures trauma and orthopaedic clinicians that negligence claims should not rise due to the updated national guidelines.

Shaibu, Sheila et al, ‘Duty Versus Distributive Justice During the COVID-19 Pandemic’ (2021) 28(6) Nursing Ethics 1073–1080
Abstract: The COVID-19 pandemic exposed vulnerabilities in inadequately prioritized healthcare systems in low- and middle-income countries such as Kenya. In this prolonged pandemic, nurses and midwives working at the frontline face multiple ethical problems, including their obligation to care for their patients and the risk for infection with severe acute respiratory syndrome coronavirus 2. Despite the frequency of emergencies in Africa, there is a paucity of literature on ethical issues during epidemics. Furthermore, nursing regulatory bodies in African countries such as Kenya have primarily adopted a Western code of ethics that may not reflect the realities of the healthcare systems and cultural context in which nurses and midwives care for patients. In this article, we discuss the tension between nurses’ and midwives’ duty of care and resource allocation in the context of the COVID-19 pandemic. There is an urgent need to clarify nurses’ and midwives’ rights and responsibilities, especially in the current political setting, limited resources, and ambiguous professional codes of ethics that guide their practice.

Shamuel, Natalia, ‘Telehealth Fraud and Abuse Before and “After” the Pandemic: Are Things Going to Get Better?’ (2023) 24(2) DePaul Journal of Health Care Law Article 3
Abstract: Telehealth and telemedicine have become increasingly useful to both patients and health care providers. The ease and comfort of attending a doctor’s appointment in the comfort of one’s own home made telehealth and telemedicine convenient, safe, and effective options for seeing a doctor during the height of the COVID-19 pandemic. However, with increased usage of telehealth and telemedicine came increased health care fraud and abuse. With increased health care fraud and abuse came increased regulations, both on the federal and state levels. This Note provides a brief analysis of health care fraud and abuse in the telehealth and telemedicine space. It also provides insight on state and federal telehealth and telemedicine regulations implemented both before and during the COVID-19 pandemic. In this Note, I analyze and discuss how the COVID-19 pandemic influenced health care fraud and abuse and how Congress and other regulators are responding.

Sharma, Arti and JK Mittal, ‘Covid-19: A Study of Its Impact with Special Reference to Medico- Legal Rights of Senior Citizens’ (2021) 18(4) PalArch’s Journal of Archaeology of Egypt / Egyptology 1414–1423
Abstract: The Research topic under the captioned title is of essence. The Epidemic in the form of Covid-19 escaping from Chinese Laboratory in Vuyan engulfed most parts of the globe. The Medical Experts consider among others the older people vulnerable to the virus. The Covid-19 virus has proved itself to survive in all the temperatures casing doubt to natural emergence on one side and obligation of China as a State under International Law responsible for Un-natural use of Lab & Resources in germinating the virus, its escape causing loss of life irrespective of territorial areas and/or race or religion. The Expert opinion world over is consensus on threat to senior citizens, in the process, curtailing their freedom by confining them within four walls of residential enclosures. Not only the right to freedom and other rights of Senior citizens is under challenge but even right to medical care and due cremation in case of death is on denial mode. In Socio-Theological Society like India these rights are indispensable. The senior citizens have Constitutional protection generally among others in Articles 21 of the Constitution of India read specifically with other Article 41 of the constitution requires the state to give public assistance to elderly people. Besides, the statutory protection in State Legislations like Maintenance and Welfare of Parents and Senior Citizens, Act 2007. The Covid-19 has put senior citizens to risk and aggravated their health hazards including the right to live. The Country responsible seems unconcerned, behaving like rouge, while the country of residence has no cure known for the epidemic. Senior citizen is on test to survive or suffer even in presence of national laws and global conventions/declarations. Accordingly, the Research topic is deliberated by adopting doctrinal methodology and using both the primary and secondary source of data for analysis and in arriving at conclusions and suggestions.

Sharma, Deepansh and Shivanshi Kaushik, ‘Public Health Legislation during COVID-19 in India: A Brief Analysis’ (2023) 3(1) International Journal of Law, Justice and Jurisprudence 15–18
Abstract: The study’s goal is to look into how COVID-19 has affected the nation’s ‘Public Health Legislation’ and ‘Medical and Legal Framework.’ The current research is unique in that it provides a medico-legal perspective on the subject, analyzing in depth how the aforementioned problem disrupted the country in both disciplines and had a negative effect on the economy. A doctrinal methodology has been used in the present research with qualitative analysis and a descriptive research strategy followed by the use of both primary and secondary sources of data collection. This research looks at the influence of the current COVID-19 on all such policies, laws and frameworks, starting with India’s historical journey through the Plague, cholera, malaria, and other similar diseases, and ending with how they led to the creation of a legal framework. While the study’s primary emphasis has been on Public Health Legislation and how it has evolved in response to pandemics, it has also briefly discussed how COVID-19 has affected other areas of law, particularly in the areas where quarantine has temporarily altered duties.

Sheahan, Linda and Scott Lamont, ‘Understanding Ethical and Legal Obligations in a Pandemic: A Taxonomy of “Duty” for Health Practitioners’ (2020) 17(4) Journal of Bioethical Inquiry 697–701
Abstract: From the ethics perspective, ‘duty of care’ is a difficult and contested term, fraught with misconceptions and apparent misappropriations. However, it is a term that clinicians use frequently as they navigate COVID-19, somehow core to their understanding of themselves and their obligations, but with uncertainty as to how to translate or operationalize this in the context of a pandemic. This paper explores the ‘duty of care’ from a legal perspective, distinguishes it from broader notions of duty on professional and personal levels, and proposes a working taxonomy for practitioners to better understand the concept of ‘duty’ in their response to COVID-19.

Sheikh, Asim A, ‘COVID-19: A Brave New Medico-Legal World?’ (2020) 26(1) Medico-Legal Journal of Ireland 2
Abstract: Reflects on the medico-legal issues raised by the coronavirus pandemic. Notes provisions of the Irish Health (Preservation and Protection and Other Emergency Measures in the Public Interest) Act 2020 restricting individual freedoms and protecting the especially vulnerable.

Siddique, Fahad Bin, ‘Protecting Human Rights in Bangladesh: Difficulties During the Period of the Covid-19 Pandemic’ in Ana Čović and Oliver Nikolić (eds), Pravni i Društveni Aspekti Vakcinacije Tokom Pandemije Kovida 19 / Legal And Social Aspects Of Vaccination During The Covid-19 Pandemic (Institute of Comparative Law, 2022) 145–167 *[OPEN ACCESS BOOK]*
Abstract: When the Covid-19 outbreak started, Bangladesh, as a developing nation, did not have adequate resources to fight against it compared to other developed nations. To the government of Bangladesh, the primary challenge was to protect the citizens’ health and ensure their safety from the outbreak with limited resources. Moreover, this public health-related challenge motivated them to announce lockdown in the name of general holiday for several times. However, with these restrictions, the people of Bangladesh are deprived of several fundamental rights according to the constitution of Bangladesh, as well as a number of human rights norms. It is pretty fascinating that, for the first time in history, the people of Bangladesh were deprived of their rights, including freedom of movement, assembly, etc, without the declaration of emergency in accordance with the constitution. Even the Supreme Court was on vacation for several days, which generated a vacuum condition in the justice system for the people who were deprived of their fundamental rights. This paper aims to analyse the conditions of human rights in Bangladesh during the Covid-19 pandemic and how the pandemic-related laws and law enforcement agencies of Bangladesh regulated citizens. On the other hand, in terms of participation, Bangladesh’s Covid-19 vaccination drive has been quite successful in the South Asian region despite the government keeping it optional for everyone. This paper has aimed to scrutinise the social hesitancy regarding the ongoing vaccination drive. Furthermore, this paper will take a hypothetical view and further examine if the government made it compulsory, then how it will deal with the supreme law of Bangladesh.

Sifris, Ronli and Karinne Ludlow, ‘The Impact of COVID-19 on Fertility Treatment in Australia’ (2021) Journal of Law and Medicine (forthcoming)
Abstract: On 25 March 2020, as part of the Australian response to the coronavirus pandemic, all non-essential elective surgery was indefinitely suspended. This had immediate impact on the provision of fertility treatment because the vast majority of fertility treatments were classified as non-essential. The suspension ended on 27 April 2020, although other restrictions continued. Between June and August 2020, we conducted semi-structured interviews to determine the impact of these initial regulatory responses to the pandemic on the provision of fertility treatment in Australia during two key periods: the suspension of non-essential surgery and the reopening. Changes to the practice of fertility treatment demonstrate the importance of planning for prioritisation and other matters to be addressed in preparation for possible future pandemics.

Sikorski, Sebastian, ‘Telemedicine During the Epidemic’ in Irena Lipowicz, Grażyna Szpor and Aleksandra Syrt (eds), Instruments of Public Law: Digital Transformation during the Pandemic (Routledge, 2022)

Silva, Evelin Carine Alves et al, ‘The Choice of Sophie: An Ethical and Legal Approach in Pandemic Times’ (2021) 8 Revista Culturas Jurídicas (advance article)
Abstract: The expression ‘Sophie’s choice’ defines the imposition of making a decision under pressure and enormous sacrifice. The COVID-19 pandemic caused a worldwide crisis, characterized by the scarcity of resources, making Sophie’s choice present in the reality of public and private hospitals. Given this scenario, the purpose of this article is to address and analyze ethical and legal aspects of Sophie’s choice in times of Pandemic. Ethics must be based on the principle that to deny human rights is to destroy our humanity. In analysis of the applicable international human rights diplomas, there is no legal justification for adopting a priority medical care scheme in the context of a pandemic that takes into account the possibilities of post-treatment life. We conclude that the establishment of objective criteria for ‘Sophie’s choice’ in the context of the pandemic COVID-19 violates both ethical precepts and general human rights principles.

Silva, Michael Da, ‘COVID-19 and Health-Related Authority Allocation Puzzles’ (2021) 30(1) Cambridge Quarterly of Healthcare Ethics 25–36
Abstract: COVID-19-related controversies concerning the allocation of scarce resources, travel restrictions, and physical distancing norms each raise a foundational question: How should authority, and thus responsibility, over healthcare and public health law and policy be allocated? Each controversy raises principles that support claims by traditional wielders of authority in ‘federal’ countries, like federal and state governments, and less traditional entities, like cities and sub-state nations. No existing principle divides ‘healthcare and public law and policy’ into units that can be allocated in intuitively compelling ways. This leads to puzzles concerning (a) the principles for justifiably allocating ‘powers’ in these domains and (b) whether and how they change during ‘emergencies.’ This work motivates the puzzles, explains why resolving them should be part of long-term responses to COVID-19, and outlines some initial COVID-19-related findings that shed light on justifiable authority allocation, emergencies, emergency powers, and the relationships between them.

Simamora, Anggiat P and Ramsul Nababan, ‘Legal Analysis of Covid-19 Vaccination Obligations and Sanctions: Interest Theory Perspective’ (2021) 4(2) ENDLESS: International Journal of Future Studies 170–179
Abstract: This paper will answer two questions related to whether there is a need for sanctions for those who refuse to be vaccinated, what sanctions are appropriate from the perspective of interest theory, and what is the legal basis for imposing sanctions for those who refuse to be vaccinated in Indonesia. This study uses a sociolegal approach from the perspective of interest theory, it is found that sanctions can not only be given but must be given to those who refuse to be vaccinated. According to this perspective, the appropriate sanction is not fines or imprisonment, but deprivation of the right to socialize. The legal basis for imposing sanctions for those who refuse to be vaccinated is Article 5 of Law 4/1984 and PerPres12/2021. The sanctions referred to are administrative in nature in the form of termination of social security or social assistance, postponement or termination of government administration services, and fines. These sanctions do not contribute to stopping the spread of the Covid-19 virus, so it is recommended that amendments to these provisions are necessary.

Simpson, Alexander IF et al, ‘Management of COVID-19 Response in a Secure Forensic Mental Health Setting’ (2020) 65(10) The Canadian Journal of Psychiatry 695–700
Objectives: The coronavirus disease 2019 (COVID-19) pandemic presents major challenges to places of detention, including secure forensic hospitals. International guidance presents a range of approaches to assist in decreasing the risk of COVID-19 outbreaks as well as responses to manage outbreaks of infection should they occur. Methods: We conducted a literature search on pandemic or outbreak management in forensic mental health settings, including gray literature sources, from 2000 to April 2020. We describe the evolution of a COVID-19 outbreak in our own facility, and the design, and staffing of a forensic isolation unit. Results: We found a range of useful guidance but no published experience of implementing these approaches. We experienced outbreaks of COVID-19 on two secure forensic units with 13 patients and 10 staff becoming positive. One patient died. The outbreaks lasted for 41 days on each unit from declaration to resolution. We describe the approaches taken to reduction of infection risk, social distancing and changes to the care delivery model. Conclusions: Forensic secure settings present major challenges as some proposals for pandemic management such as decarceration or early release are not possible, and facilities may present challenges to achieve sustained social distancing. Assertive testing, cohorting, and isolation units are appropriate responses to these challenges.

Sinha, Michael S, ‘COVID-19: State and Local Responses to PPE Shortages’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 152–157
Abstract: In mid-March, healthcare workers on social media and elsewhere sounded the alarm: #GetMePPE. This public plea was in response to shortages of personal protective equipment (PPE) at many hospitals, coinciding with surges in hospital emergency department and intensive care unit capacity due to COVID-19. Within days, the Strategic National Stockpile of PPE was depleted; states, localities, and hospitals had to act urgently to procure PPE and reuse or extend the use of existing PPE. A true cottage industry emerged, consisting of a network of designers, makers, engineers, and healthcare workers focused on designing and producing high-quality PPE to address urgent needs. Devices such as face shields were designed to protect healthcare workers from mucous membrane exposure. As N95 respirator masks became scarce, techniques for sterilization were developed, as were methods for ensuring a qualitative fit after multiple rounds of sterilization. Alternatives to N95 masks, known as powered air purifying respirators (PAPRs), were developed from scratch. Finally, ventilators and ventilator parts were produced in an effort to maximize resources during peak waves of COVID-19. The FDA released a series of guidance documents, accompanied by permissive emergency use authorizations (EUAs), to address the manufacture and use of PPE in healthcare settings. This article reviews actions taken by the FDA in response to the PPE shortage, evaluates the impact of local manufacturing of PPE in one U.S. state (Massachusetts), and offers solutions for federal and state policymakers to ensure robust state and community-level responses to shortages in the future.

Situmeang, Ampuan et al, ‘Navigating the Pandemic: Social-Legal Approaches for Establishing a Specialized Infectious Disease Hospital’ (2024) 7(1) Nurani Hukum_
_Abstract: In accordance with Government Regulation "Perpres No. 52 of 2020," the construction of a Special Infection Hospital (Rumah Sakit Khusus Infeksi/RSKI) was completed, and the BMN administration was transferred to the Ministry of Defense. Currently, the RSKI functions as an emergency clinic dedicated to treating COVID-19 patients explicitly. Once the pandemic is declared over, the RSKI will serve as a medical clinic for maintenance purposes. This study aims to examine and analyze the establishment of the RSKI from legal perspectives. It also to identify challenges or obstacles encountered by the Batam City Government pursuant to the construction of the RSKI for the purpose of treating and reducing the Covid-19 patients. Hence, this study utilized socio-legal research by collecting primary data through in-depth interviews with stakeholders, The secondary data was also used and collected through library research. Both data were analyzed by using qualitative approaches. It was found that the establishment of the RSKI was based on Law Number 44 of 2009 on Hospital. However, the Batam City Government remained to face challenges in handling the Covid-19 pandemic because of a lack of people’s awareness on health protocols, consequently many of them rejected the Covid-19 vaccines. Furthermore, Batam City was pointed as the entry point of the repatriation of Indonesian migrant workers from Malaysia and Singapore. The RSKI had fewer adequate facilities to provide effective treatments to the Covid-19 patients.

Sklar, Tara, ‘Implementation and Enforcement of Quality and Safety in Long Term Care’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 143–147
Abstract: Long before the new coronavirus struck, nursing homes and other long-term care facilities have had declining quality care that coincides with inadequate staffing and rampant infections. These prepandemic conditions increased the vulnerability of these facilities to an infectious disease outbreak. As the elderly death toll rises into the tens of thousands, an overdue national discussion on how to prioritize long-term care in the US has emerged, revealing an opportunity to better link quality care metrics with sufficient reimbursement and meaningful regulatory oversight. However, the opposite approach has also surfaced, which would allow the status quo to continue and may erode the minimum standards of care that currently exist. This concerning trend is on the rise with efforts to relax the Centers for Medicare and Medicaid Services (CMS) regulatory authority over nursing homes by waiving requirements and reducing enforcement penalties. In addition, states are passing measures to limit liability exposure for nursing homes during COVID-19 and similar protections are under consideration at the federal level, even as infection rates climb and there is no evidence of frivolous lawsuits. While political will is uncertain, public outcry is ready for legislative reform that will lead to better later-in-life care. The stakes have never been higher — act now and pass laws that connect funding with regulation to support quality care in nursing homes during and after the COVID-19 pandemic — or continue to condone practices that allow infection to spread and take many lives before their time.

Smith, Maxwell J and Ross EG Upshur, ‘Learning Lessons from COVID-19 Requires Recognizing Moral Failures’ (2020) 17(4) Journal of Bioethical Inquiry 563–566
Abstract: The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a ‘wake-up call’—an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19). It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the ‘wake-up call’ we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn.

Smith, Steven R, ‘Supreme Court 2019–2020: Insanity, Discrimination, and DACA—And a Pandemic’ (2020) 46(4) Journal of Health Service Psychology 181–199
Abstract: The 2019–2020 Supreme Court session was an extraordinary session. One major ruling involved insanity defense and whether the two prongs of cognitive capacity and moral capacity were required. Sexual identity was ruled to be covered by the Civil Rights Act in relation to employment. Unanimous criminal jury decisions were ruled a required condition for conviction. The rescindment of DACA was overturned on procedural grounds. Other decisions related to conditions of abortion, habitual residence in international custody cases, police immunity from civil liability, guns, HIV, and capital punishment. Thirty-five percent of cases were unanimous (down from the recent average), and 22% were decided by a 5–4 vote (slightly above the recent average).

Smorto, Guido, ‘The Right to Health and Resource Allocation. Who Gets What and Why in the COVID-19 Pandemic’ in Giuseppina Campisi, Arabella Mocciaro Li Destri and Carlo Amenta (eds), COVID-19 and Communities: The University of Palermo’s Voices and Analyses During the Pandemic (Springer, 2022) 131–141
Abstract: The COVID-19 outbreak has led to a worldwide, substantial increase in the demand for pharmaceuticals, hospital beds, ventilators, and medical supplies. When needs suddenly exceed demand worldwide, resources may quickly become scarce with potential demand, so that strict rationing is the only viable response. Against this backdrop, this chapter scrutinizes the rationales for the prioritization of scarce resources. It questions the essential role and reaches the market concerning resources essential to delivering health care, especially in severe shortages, such as during a global pandemic.

Solaiman, Barry, ‘COVID-19 and the Shift Towards Telemedicine: Developing a Regulatory Foundation in a Post-Pandemic World’ (2020) 2(December) _The Qatar Business Law Review_
Abstract: This article argues that regulations ought to be developed in Qatar for telemedicine. There has been a significant rise in remote consultations between doctors and patients following the COVID—19 pandemic. Around the world, healthcare leaders have sought to stem the spread of the virus while maintaining safe access to doctors. Most countries, including Qatar, have yet to develop bespoke regulations and licensing requirements. This article recommends that a telemedicine practising licence and regulations should be developed.An analysis of other jurisdictions highlights four key areas where regulations would most benefit practice. They include the standard of care required in remote consultations, information requirements for both doctors and patients, an assessment of the appropriateness of telemedicine for a given consultation, and standards on data processing and security. Regulating these areas will provide greater certainty to all parties while developing a foundation for telemedicine’s continued use.

Šolc, M, ‘The Pandemic and the Law: Challenges of Covid-19 to the Ethical and Legal Paradigm of Health Care’ (2021) 12 Czech Yearbook of Public and Private International Law 371–380
Abstract: Since the Covid-19 pandemic started in early 2020, countries across all the continents have faced a dilemma between the protection of several conflicting fundamental rights guaranteed by international law. On the one hand, the life and health of people have been seriously endangered by the new virus. On the other hand, many epidemiological measures have interfered with some other fundamental rights. Therefore, careful balancing has been necessary to find proportionality between the protection of competing rights. Nevertheless, the proportionality of interferences with human rights is arguably dependent on the epidemiological situation in each country, i.e., on the nature and intensity of threat to human life and health. This might bring us to a broader question of what ethical theories provide the basis for containment measures and whether the contemporary ethical paradigm has passed the test of the current crisis. The paper analyses the possible changes in the role of utilitarianism as one of the leading theories in medical ethics during the pandemic. Furthermore, it asks whether it is reasonable to strive for the generally valid set of legal and ethical rules applicable regardless of the wider circumstances.

Solimini, Renata et al, ‘Ethical and Legal Challenges of Telemedicine in the Era of the COVID-19 Pandemic’ (2021) 57(12) Medicina 1314
Abstract: Telemedicine or telehealth services has been increasingly practiced in the recent years. During the COVID-19 pandemic, telemedicine turned into and indispensable service in order to avoid contagion between healthcare professionals and patients, involving a growing number of medical disciplines. Nevertheless, at present, several ethical and legal issues related to the practice of these services still remain unsolved and need adequate regulation. This narrative review will give a synthesis of the main ethical and legal issues of telemedicine practice during the COVID-19 pandemic.

Solnica, Amy, Leonid Barski and Alan Jotkowitz, ‘Allocation of Scarce Resources during the COVID-19 Pandemic: A Jewish Ethical Perspective’ (2020) 46(7) Journal of Medical Ethics 444–446
Abstract: The novel COVID-19 pandemic has placed medical triage decision-making in the spotlight. As life-saving ventilators become scarce, clinicians are being forced to allocate scarce resources in even the wealthiest countries. The pervasiveness of air travel and high rate of transmission has caused this pandemic to spread swiftly throughout the world. Ethical triage decisions are commonly based on the utilitarian approach of maximising total benefits and life expectancy. We present triage guidelines from Italy, USA and the UK as well as the Jewish ethical prospective on medical triage. The Jewish tradition also recognises the utilitarian approach but there is disagreement between the rabbis whether human discretion has any role in the allocation of scarce resources and triage decision-making.

Solnica, Amy, Leonid Barski and Alan Jotkowitz, ‘The Healthcare Worker at Risk during the COVID-19 Pandemic: A Jewish Ethical Perspective’ (2020) 46(7) Journal of Medical Ethics 441–443
Abstract: The current COVID-19 pandemic has raised many questions and dilemmas for modern day ethicists and healthcare providers. Are physicians, nurses and other healthcare workers morally obligated to put themselves in harm’s way and treat patients during a pandemic, occurring a great risk to themselves, their families and potentially to other patients? The issue was relevant during the 1918 influenza epidemic and more recently severe acute respiratory syndrome epidemic in 2003. Since the risk to the healthcare workers was great, there was tension between the ethical duty and responsibility to treat and the risk to one’s own life. This tension was further noted during the 2014 Ebola outbreak in West Africa that left hundreds of healthcare workers dead. The AMA Code of Ethics states that physicians are to ‘provide urgent medical care during disasters…even in the face of greater than usual risk to physicians’ own safety, health or life.’1 Classic Jewish sources have dealt with this question as well. There is an obligation ‘to not stand by idly when your friends life is in danger’; however, the question arises as to whether there are limits to this obligation? Is one required to risk one’s own life to save another’s? There is a consensus that one is not required but the question open to debate is whether it is praiseworthy to do so. However, regarding healthcare workers, there is agreement for ethical, professional and societal reasons that they are required to put themselves in harm’s way to care for their patients.

Solomon, Mildred, Matthew Wynia and Lawrence O Gostin, ‘COVID-19 Crisis Triage: Optimizing Health Outcomes and Disability Rights’ (2020) 2020(3) New England Journal of Medicine e27
Abstract: On March 28, 2020, the Office of Civil Rights at the Department of Health and Human Services (HHS) opened investigations into recently released critical care crisis triage protocols. Disability rights advocates are urging Congress to prohibit crisis triage based on ‘anticipated or demonstrated resource-intensity needs, the relative survival probabilities of patients deemed likely to benefit from medical treatment, and assessments of pre- or post-treatment quality of life.’

Solomon, Mildred Z, Matthew Wynia and Lawrence O Gostin, ‘Scarcity in the COVID-19 Pandemic’ (2020) 50(2) Hastings Center Report 3–3
Abstract: As we write, U.S. cities and states with extensive community transmission of COVID-19 are in harm’s way—not only because of the disease itself but also because of prior and current failures to act. During the 2009 influenza pandemic, public health agencies and hospitals developed but never adequately implemented preparedness plans. Focused on efficiency in a competitive market, health systems had few incentives to maintain stockpiles of essential medical equipment. Just-in-time economic models resulted in storage of only those supplies needed then. At the same time, global purchasing in search of lower prices reduced the number of U.S. suppliers, with hospitals dependent on foreign companies. There is still a possibility that the pandemic will be manageably bad rather than unmanageably catastrophic in this country. Immediate, powerful, and sustained federal action could make the difference.

Sommaggio, Paolo and Samuela Marchiori, ‘Tragic Choices in the Time of Pandemics’ (2020) 20(1S) BioLaw Journal / Rivista di BioDiritto 453–458
Note: this special issue contains many relevant articles, but almost all are in Italian only, and have only included those in English in this bibliography. Link to the entire journal issue.
Extract from Introduction: At the time of writing, with the total number of positive cases well within the 5-digit territory, the CoViD -19 emergency has been putting the Italian health system to a severe test. Data recovered from the first two weeks of the COVID19 outbreak show that about 1 in 10 of infected patients require intensive treatment in the form of ventilatory support, due to interstitial pneumonia characterised by severe hypoxemia, which is potentially reversible, but can result in a long, acute phase, and has led to abnormal exploitation of intensive care units, whose maximum capacity has been severely challenged. It is in this context that the Italian Society of Anesthesia, Analgesia, Resuscitation, and Intensive Care (SIAARTI), noticing a massive imbalance between the availability of intensive resources and the actual clinical needs of the population, introduced the Recommendations of clinical ethics for admission to intensive care treatments and their suspension, in exceptional conditions of imbalance between needs and available resources (March 6), which have since been heavily criticised on multiple fronts.

Spece, Roy G, ‘COVID-19 Control: Disrupting Doctor-Patient Relationships’ (Arizona Legal Studies Discussion Paper No 20–39, 2020)
Abstract: The full-armamentarium of public health countermeasures came into play when COVID-19 emerged; a few examples are quarantine, closures, and social distancing. These countermeasures are intended to protect population health, but trench on many important rights protected by ethical precepts and tort, constitutional, or other law. The measure studied here, orders to delay ‘elective’ medical procedures to preserve resources, have been virtually ignored. Yet, they are uniquely broad, risky, and disrupt information gathering and therapeutic trust engendered by doctor-patient relationships. Although medicine (speaking for the few) and public health (speaking for the few) traditionally have clashed, it is shown that medical and public health law and ethics combine to require strict (constitutional) or stringent (medical and public health ethics) scrutiny of delay actions. Delay also can be shoddily promulgated or implemented, thus creating tort liability. A ‘new public health’ and ethical models (medicine) and frameworks (public health) combine to require that countermeasure be shown necessary, effective, and the least intrusive way to further vital governmental goals. Delay trenches on several fundamental or special liberties, and these rights have been analyzed by scholars addressing other countermeasures. This article explores another seldom-discussed topic: the fundamental right to purchase care (or insurance for it) available in the open market. Although delay regimes can be beneficial if properly promulgated and implemented, it is unlikely that the current actions can meet ethical standards or withstand constitutional strict or even certain intermediate scrutiny because they cannot be shown to work or to be the least restrictive alternative.

Spillane, Alison et al, ‘Early Abortion Care during the COVID-19 Public Health Emergency in Ireland: Implications for Law, Policy, and Service Delivery’ [2021] International Journal of Gynecology & Obstetrics (Advance article, published 24 April 2021)
Abstract: Early abortion care became available in Ireland in January 2019. Service delivery involves two consultations with a medical practitioner, separated by a mandatory 3-day waiting period. The Model of Care for termination of pregnancy initially required in-person visits. The onset of the COVID-19 pandemic necessitated significant reductions in in-person interactions in healthcare. A revised Model of Care for termination of pregnancy, issued for the duration of the pandemic, permits delivery of early abortion care by remote consultation. Significantly, this was introduced without amending the 2018 abortion law. The pandemic precipitated a rapid development in the delivery of abortion care that was not anticipated at the time of abortion law reform only 18 months earlier. We outline the work undertaken to maintain access to abortion care in early pregnancy through the lens of a single community-level provider and explore what these developments may mean for abortion law, policy, and service delivery.

Spivakovsky, Claire and Linda Roslyn Steele, ‘Disability Law in a Pandemic: The Temporal Folds of Medico-Legal Violence’ (2021) Social & Legal Studies (advance article, published 10 June 2021)
Abstract: Disabled people are subject to disability laws – such as guardianship, mental health and mental capacity legislation – which only apply to them, and which enable legal violence on the basis of disability (‘disability-specific lawful violence’). While public health laws during the COVID-19 pandemic enabled coercive interventions in the general population, disabled people have additionally been subject to the continued, and at times intensified, operation of disability laws and their lawful violence. In this article we engage with scholarship on law, temporality and disability to explore the amplification of disability-specific lawful violence during the pandemic. We show how this amplification has been made possible through the folding of longstanding assumptions about disabled people – as at risk of police contact; as vulnerable, unhealthy and contaminating – into the immediate crisis of the pandemic; ignoring structural drivers of oppression, and responsibilising disabled people for their circumstances and the violence they experience.

Sprengholz, Philipp, Luca Henkel and Cornelia Betsch, ‘Payments and Freedoms: Effects of Monetary and Legal Incentives on COVID-19 Vaccination Intentions in Germany’ (published online 4 June 2021)
Abstract: Monetary and legal incentives have been proposed to promote COVID-19 vaccination uptake. To evaluate the suitability of incentives, an experiment with German participants examined the effects of payments (varied within subjects: 0 to 10,000 EUR) and freedoms (varied between subjects: vaccination leading vs. not leading to the same benefits as a negative test result) on the vaccination intentions of previously unvaccinated individuals (n = 782). While no effect could be found for freedoms, the share of participants willing to be vaccinated increased with the payment amount. However, a significant change required large rewards of 3,250 EUR or more. While monetary incentives could increase vaccination uptake by a few percentage points, the high costs of implementation challenge the efficiency of the measure and call for alternatives. As experimental data suggest that considering vaccination as safe, necessary, and prosocial increases an individual’s likelihood of wanting to get vaccinated without payment, educational campaigns should emphasize these features when promoting vaccination against COVID-19.

Stavert, Jill and Colin McKay, ‘Scottish Mental Health and Capacity Law: The Normal, Pandemic and “New Normal”’ (2020) 71(July-August) International Journal of Law and Psychiatry Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus), Article 101593
Abstract: A state’s real commitment to its international human rights obligations is never more challenged than when it faces emergency situations. Addressing actual and potential resourcing pressures arising from the COVID-19 pandemic has resulted in, amongst other things, modifications to Scottish mental health and capacity law and the issuing of new guidance relating to associated practice. Whether these emergency or ordinary measures are invoked during the crisis there are potential implications for the rights of persons with mental illness, learning disability and dementia notably those relating to individual autonomy and dignity. This article will consider areas of particular concern but how strict adherence to the legal, ethical and human rights framework in Scotland will help to reduce the risk of adverse consequences.

Stein, C and A Dhai, ‘Consent in Health Research with Incapacitated Adults in a Time of Pandemic : The National Health Research Ethics Council Needs to Urgently Reassess Its Guidelines: Research’ (2020) 13(1) South African Journal of Bioethics and Law 29–33
Abstract: In most instances, health research involves patients who are capable of giving informed consent, a statutory and ethical requirement. A smaller subset of patients lacking this capacity owing to their condition present an ethical problem, particularly because both the Bill of Rights of the Constitution of South Africa, and the National Health Act, require adult participant consent, without exception. Local research ethics guidelines, as a way of facilitating such research, suggest the use of a strategy combining proxy and delayed consent. Under conditions of a pandemic, research involving possibly large numbers of critically ill, incapacitated adults is likely. However, with lockdown restrictions, proxy decision-makers will not be available much of the time. Currently, local guidelines do not address the problem of what ought to be done in situations where incapacitated research participants die before being able to provide delayed consent for use of their research data. Under such circumstances, retention and use of such data is ethically justifiable based on the resultant public health benefits. The National Health Research Ethics Council needs to urgently reassess its consent guidelines in this respect.

Stewart, Ashleigh, Reece Cossar and Mark Stoové, ‘The Response to COVID-19 in Prisons Must Consider the Broader Mental Health Impacts for People in Prison’ (2020) 54(12) Australian & New Zealand Journal of Psychiatry 1227–1228
Introduction: Prisons are an integral part of the global public health response to coronavirus disease 2019 (COVID-19). In light of typically over-crowded physical environments, prisons operating beyond their capacity and restrictions on freedom of movement, the introduction of COVID-19 in prisons and other custodial settings could be devastating. Effective COVID-19 infection control strategies in custodial settings have seen an emergent emphasis on physical distancing and quarantining (World Health Organization [WHO], 2020). These strategies are crucial to slow COVID-19 transmission; however, they also pose significant risk for people with mental illness in these settings. Rates of severe mental illness and mental health morbidity and mortality are substantially higher among people in prison compared to general populations. Therefore, the response to COVID-19 requires consideration of associated mental health implications to minimise adverse consequences for people in prison.

Stewart, Cameron and Christopher Rudge, ‘Challenging Pandemic Law: From Vaccine Mandates to Judicial Review of Vaccine Approvals’ (2024) 31(2) Journal of Law and Medicine 225–243
Abstract: Over recent years, dozens of legal challenges have been instituted in response to government action during the COVID-19 pandemic. While public health orders have been challenged on several grounds, few cases have succeeded. Fewer cases still have called into question decisions made by the Therapeutic Goods Administration (TGA) to approve the COVID-19 vaccines. This section provides a brief update on one recent, partially successful COVID-19 health directions case before examining two applications in the Federal Court of Australia seeking judicial review of the TGA's approval of the COVID-19 vaccines. The section argues that, while both TGA applications were dismissed for lack of standing, they illustrate how and why third parties will ordinarily not be entitled to challenge administrative decisions about therapeutic goods.

Stewart, Cameron, Scott Brunero and Scott Lamont, ‘COVID-19: Restrictive Practices and the Law during a Global Pandemic – an Australian Perspective’ (2020) 29(5) International Journal of Mental Health Nursing 753–755
Abstract: The COVID-19 pandemic has created a heightened state of anxiety and fear in many communities (Usher, Durkin, & Bhullar, 2020), particularly within vulnerable populations (such as the elderly, people with disability and people with mental illness; prisoners and asylum seekers). These vulnerable populations are already sensitive to the use of restrictive practices, namely, the use of interventions that restrict the rights or freedom of movement of patients via restraint (chemical, mechanical, social or physical) and seclusion. These concerns are exacerbated in a time of pandemic (World Health Organization, 2020). The laws in all Australian jurisdictions require consideration of the principle that the freedom of people in care is restricted as little as possible. It is therefore essential that restrictive practices are undertaken lawfully and with careful consideration (Chandler, White, & Wilmott, 2016). Two recent decisions of tribunals illustrate these concerns.

Stobbs, Nigel, Belinda Bennett and Ian Freckelton, ‘Compassion, the Vulnerable and COVID-19’ (2020) 27(4) Journal of Law and Medicine 865–876
Abstract: Levels of personal anxiety are inevitably escalating in response to the COVID-19 pandemic, including individual fear of infection, grief at the loss of loved ones and reactive depression related to loss of employment and livelihood. This article considers the importance of compassion in a range of contemporary and emerging contexts during a time of pandemic. These include: exposure of medical and care professionals to the acute demands of overstretched institutions resulting in adverse mental health outcomes and compassion fatigue; attitudes towards the burgeoning cohort of welfare recipients; and particularly vulnerable groups such as the elderly, and those who are homeless. The article considers how we ought to conceive of compassion in these contexts and makes some suggestions for building future compassion interventions and training.

Subarna, Farzana Yasmin, ‘State Obligation for Ensuring Right to Health during COVID-19 Pandemic in Bangladesh: A Critical Analysis on Private Medical Perspective’ (SSRN Scholarly Paper No 4152342, 13 April 2021)
Abstract: COVID-19 shows its unrestrained and devastating power in the present world. The Developed countries like the UK, The USA, Spain, Italy, and other EU countries with their well-equipped in medical sector and infrastructure become stressed and suffered from huge date rates. Lack of proper knowledge about the COVID-19, poor management system, huge unaware people, and scarcity of well medical equipment triggered the transmission rate in Bangladesh. Only the government hospitals do not manage the COVID-19 test and treatment for the huge affected people. At the beginning of the COVID- 19 transmission in Bangladesh the government hospitals could not properly ready to cope with this pandemic situation and the majority of private hospitals and nursing homes deny providing treatment to the COVID-19 patients for fear. With the COVID-19 patients, non-COVID patients are also ignored from getting basic medical care during this pandemic. Very few private medical and healthcare centers started COVID-19 testing and proving treatment to the affected patients with an allegation of poor service, high treatment and testing costs, and certificate scams. This paper focused on the government’s obligation in private healthcare negligence and mismanagement to ensure the right to health during this pandemic.

Suhartono, Suhartono, ‘Legal Certainty and Benefits in Emergency Use Authorization of Sinovac Vaccines as Halal Products During the Covid-19 Pandemic Outbreak in Indonesia’ (2022) 5(1) The 5nd International Conference And Call Paper 198–207
Abstract: The World Health Organization (WHO) has declared COVID-19 as a Global Pandemic and the Government has declared a public health emergency of Corona Virus Disease 2019 (COVID-19) in Indonesia through Presidential Decree Number 11 of 2020 concerning the Determination of the Public Health Emergency of Corona Virus Disease 2019 (COVID-19).So that countermeasures must be carried out in accordance with the provisions of the legislation. Therefore, it is necessary to conduct an effective intervention to break the chain of disease transmission, namely through vaccination efforts. On January 11, 2021, BPOM gave approval for the Use of Sinovac Vaccine in Emergency Use Authorization.” The research used is empirical juridical research, which examines the applicable legal provisions and what happens in reality in society. Concluded the emergency use of Sinovac Vaccine as a Halal product has legal certainty and benefits.”

Tahiri, Ryan, ‘Legal and Ethical Implications of U.S. and Canadian Vaccine Contracts: The Impact of Vaccine Nationalism on the Global Pandemic Response’ (2021) 53(1) University of Miami Inter-American Law Review 231–266
Abstract: This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These ‘pre-purchases,’ many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations have the opportunity to purchase vaccine doses at reduced costs for their respective populations. This initiative offers a realistic solution to shortening the timeline of the COVID-19 pandemic and bringing the global population closer to herd immunity.

Tamarana, Lavanya, ‘Medico-Legal Issues amidst the Pandemic’ (2021) 2(1) Jus Corpus Law Journal 653–664
Abstract: On March 11, 2020, the World Health Organization (WHO) declared the Coronavirus disease-2019 (COVID-19) infection a pandemic. We’ve all heard of curfews, lockdowns, red zones, social separation, quarantine, Standard Operating Procedures (SOPs) and penal actions for violation, implemented by the central and state government, which led to ethical and legal aspects. This paper mainly focuses on the issues like medical ethics and the physician-patient relationship, while others including medical responsibility and malpractice arose during the pandemic. Furthermore, medico-legal issues are appearing in respect to the workplace hazards of COVID-19 infection. The covid-19 pandemic infection’s effects on the severely sick individuals led to their deaths and because of the life duration of the COVID -19 virus in different body samples after death, conducting autopsies for COVID-19 patients is a controversial topic. And this paper further discusses the healthcare law in India which includes acts, rules, guidelines, protocols and regulations that are implemented during pandemic and also from the past.

Tanana, Heather, ‘Learning from the Past and the Pandemic to Address Mental Health in Tribal Communities’ (University of Utah College of Law Research Paper No 381, 2 September 2020)
Abstract: When COVID-19 hit, it devastated Tribal communities. Based on past federal policies, American Indians and Alaska Natives suffer various health and socioeconomic disparities that make them not only more vulnerable to contracting COVID-19, but also more susceptible to negative outcomes once infected. Much attention has focused on COVID-19 infection rates and related deaths in Indian country. However, the pandemic’s reach has gone beyond physical impacts on the body. COVID-19 has also affected the mental health of Tribal members and their access to mental health services. This Article dives into the effects of the coronavirus pandemic on the mental health and general well-being of Tribal communities. A brief history of federal and Tribal relations is provided, followed by a summary of the current state of mental health in Indian country. The impacts of COVID-19 on Tribal communities is discussed as well as the rise of telehealth to provide much needed mental health services during the pandemic. The article concludes by providing recommendations to continue the progress made to fill the historic gap in mental health services in Indian country post-pandemic.

Taschner, Dana and Ashley Atwood, ‘COVID-19: Legal Framework for Vaccine Distributions and Mandates’ (2021) 24(1) Science and Technology Law Review 65–96
Abstract: The COVID-19 pandemic has created heightened turmoil for at-risk populations, solidified laws allowing the use of mask mandates, raised legal issues surrounding vaccine mandates, and presented the new issue of a vaccine passport. As a nation, we have failed to implement vaccination schemes that properly protect vulnerable populations. Specifically, the homeless population has been overlooked, creating an additional layer of hardship, and contributing to greater community spread. This article contemplates the various methods by which an equitable vaccination scheme could have been achieved and the division of powers that created complications. Additionally, the legality of vaccine mandates is discussed, and shows how our case law lays a foundation that would make a vaccine mandate legal. There are a multitude of vaccines already required for entry into school and other events. While the relatively low fatality rate of COVID-19 has been the source of backlash, this article shows how sufficient risk to an individual is not synonymous to sufficient risk to the community. Finally, the novel implications of vaccine passports are presented, and possible treatments of this issue in court are contemplated.

Teo, Wendy, Lawrence H Brenner and B Sonny Bal, ‘Medicolegal Sidebar: Legal Immunity for Healthcare Workers During COVID-19’ (2020) 478(10) Clinical Orthopaedics and Related Research 2218–2220
Introduction: As the United states confronts the spread of coronavirus disease 2019 (COVID-19), heathcare providers find themselves working in unfamiliar environments. Some providers have traveled to other states to serve in the front lines of hospitals stretched to capacity, while others are working within specialities outside their normal scope of practice. Lawsuits arising from deliverering care to patients with COVID-19 under difficult cicumstances are a concern, and efforts are underway, both at the state and federal level, to shield healthcare providers from litigation over medical treatment during the COVID-19 health emergency. While protecting hard-working frontline healthcare professionals from the risk and distraction of lawsuits during COVID-19 seems logical, the subject of legislating immunity from civil and, in some cases, criminal lawsuits is not straightforward.

Terry, Nicolas, ‘COVID-19 and Healthcare Lessons Already Learned’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa016
Abstract: COVID-19 has exposed deep-rooted flaws in our health system regarding healthcare financing and delivery. This essay uses COVID-19 as a frame to reflect on the growth in our uninsured population, the flaws inherent in healthcare federalism, how ‘Trumpcare’ has made things worse, the magnified importance of Medicaid, and the problems inherent in relying primarily on private actors.

Testoni, Ines, ‘The COVID-19 Pandemic Between Bio-Ethics, Bio-Law and Bio-Politics: A Case Study on The Italian Experience of The DuPre Commission’ (2022) 13(2) Ethics in Progress 90–106
Abstract: The aim of this qualitative study was to consider the question of whether the Italian political management of the pandemic respected the European bio-ethical and bio-juridical approaches in light of the principles of autonomy, dignity, integrity and vulnerability. As no specific consolidated literature exists on the subject, the Italian situation was taken into consideration, specifically the work of a spontaneous commission (DuPre) that collected the reflections of academics and researchers interested in discussing political decisions for the management of the emergency, which was the coronavirus disease (COVID-19) pandemic. The analysis took into account the contributions of scholars during two conferences (without proceedings), which were transcribed and examined. From the texts processed with a thematic analysis, three main themes emerged: ‘pandemic as a state of exception, sovereignty and crisis of democracy’, ‘the value of doubt and refutation’ and ‘elimination of informed consent between persuasion and blackmail’. In this paper, the final bio-political considerations on the European approach and the management of the COVID-19 pandemic in Italy are presented.

Thomas, Bryan et al, ‘Vaccine Ins and Outs: An Exploration of the Legal Issues Raised by Vaccine Passports’ (C.D. Howe Institute working paper, 13 July 2021)
Jurisdiction: Canada
Abstract: In this report five leading experts in health law and medicine at the University of Ottawa examine vaccine passports in the context of Charter rights, privacy rights, and implementation. The paper first explores whether a vaccine passport regime would infringe Charter rights, including mobility rights, rights to liberty and security of the person, freedom of religion and conscience, and rights to equality and non-discrimination. Broadly speaking, the authors conclude that a well-designed vaccine passport regime, backed by an equitable vaccine distribution scheme, will likely withstand a Charter challenge. The paper then turns to an in-depth discussion of privacy issues, first exploring key aspects of privacy compliance in the design of vaccine passports before turning to an analysis of their use conditions. Again, the paper’s broad contention is that privacy issues raised by vaccine passports can be adequately addressed through careful design and regulation. The authors then discuss potential avenues for the implementation of vaccine passports, within the framework of Canadian federalism and its fragmented jurisdiction over healthcare and public health. As part of this discussion, we suggest some broad principles for the design of a vaccine passport regime, arguing that passport gating should be limited to non-essential services, and that wherever feasible, the unvaccinated should be accommodated with rapid testing.

Thome, Johannes et al, ‘The Impact of the COVID-19 Outbreak on the Medico-Legal and Human Rights of Psychiatric Patients’ (2020) 63(1) European Psychiatry e50
Abstract: The COVID-19 pandemic has raised significant concerns for population mental health and the effective provision of mental health services in the light of increased demands and barriers to service delivery [1]. Particular attention is being directed toward the possible neuropsychiatric sequelae of both COVID-19 and of the stringent societal mitigation steps deployed by national governments, concerns that are informed by historical increases in the incidence of psychotic disorders following influenza pandemics [2]. However, so far there has been scant attention paid to other important areas of psychiatry during COVID-19, including medico-legal aspects and human rights. In this paper, we discuss the legal implications for psychiatry of the COVID-19 pandemic and report a novel situation in which psychiatric patients may experience diminution of their statutory protections. We believe that this represents a paradigm shift in psychiatric care and that the consideration of the fundamental rights of psychiatric patients as ‘less important’ than infection control measures compel mental health professionals to ‘advocate for … patients and their caregivers’ in this time of crisis [1].

Thomson, Michael, ‘Law as a Determinant of Health: COVID-19 and Gender’ in The Routledge Companion to Gender and COVID-19 (Routledge, 2024)
Abstract: COVID-19 has impacted disproportionately along familiar fault lines of systemic inequality and disadvantage. It has highlighted once more how health inequalities are driven by social inequalities, and the pressing need to address these if health equity and social justice are to be improved. This chapter explores the role of law in this context. It assesses moves to explicitly articulate law within the social determinants of health framework and questions the place of addressing inequalities in these accounts. It is argued that in demonstrating the connection between social and health inequalities so profoundly and urgently, the pandemic is a provocation to look again at how law and legal systems might help in delivering greater health justice. Focusing on the gendered impacts of COVID-19, the pandemic illustrates the necessity of a public health law that foregrounds law’s role in improving fairness in social arrangements and the distribution of resources.

Tickell, Andrew and Alison Britton, ‘Towards an “All Hazards” Approach at Last? Scottish Public Health Law Before, During and After Covid-19’ [2024] (January) Public Law 19-29
Abstract: This article critically examines the state of Scottish public health law before, during and after the COVID-19 pandemic through the lens of the World Health Organization’s "all hazards" approach. With reference to the evolving framework of public health powers applying in Scotland from the spring of 2020 to the concluding phase of the pandemic in 2022, we explore why the key Scots public health statute in place at the start of the pandemic—the Public Health Etc (Scotland) Act 2008 —proved maladapted to dealing with COVID-19. Key regulatory assumptions underpinning Scotland’s evolving public health law are identified, including the impact of attempted ECHR compliance on the design of devolved public health powers. The concluding section discusses the new framework adopted by the Scottish Parliament in the Coronavirus (Recovery and Reform) (Scotland) Act 2022, considering whether its reforms are likely to future-proof the Scots statute book against new and emerging public health threats any more successfully than the 2008 Act. We suggest that it will—but at the price of permanently extending Scottish ministers’ powers and re-centring public health powers on the Scottish Government, rather than health boards. This article contributes not only to the evaluation of regulatory preparedness for pandemic illness under devolution—which seems likely to inform both UK and Scottish COVID-19 Inquiries—but also to the limited literature on public health powers available to public authorities in Scotland,1 contextualised against wider issues of concern for public law, including democratic accountability mechanisms and their interactions with emergency powers and fundamental rights.

Tillman, L Christine, ‘The Louisiana Health Emergency Powers Act: What Would the Louisiana Supreme Court Say?’ (2022) 49 Southern University Law Review (forthcoming)
Abstract: This Article explores the background of the Louisiana Health Emergency Powers Act (‘LHEPA’), including proclamations that have summoned its current applicability, historical development, and, most importantly, Lejeune v. Steck, the only reported case to date involving the LHEPA. The Author extracts legislative purpose, relevant points, and conclusions, and develops three issues presented in the form of challenges. A simulation of the Louisiana Supreme Court’s responses to these challenges exposes the inherent fallacies of the LHEPA and the Lejeune decision. Approximately eleven years after the LHEPA was adopted, the Louisiana Fifth Circuit Court of Appeal handed down the Lejeune decision, sending shockwaves throughout the legal community. The Lejeune decision established that during a state of public-health emergency, the LHEPA’s scope relative to which health-care providers are afforded liability protections is essentially unlimited, encompassing all health-care providers, and gross negligence is the prevailing standard rather than the longstanding general negligence standard set forth in the Louisiana Medical Malpractice Act.The Author explores how the LHEPA leads to absurd consequences because of its unlimited reach and how courts should limit its application. A declared state of public-health emergency is the only prerequisite for a health-care provider to be shielded from liability for causing injury or death to another person, e.g., the provider does not have be in the course and scope of employment or even providing health care. The LHEPA could be applied if a health-care provider ‘accidently’ and ‘negligently’ caused a fatality while operating a motor vehicle during a state of public-health emergency. The Lejeune decision also allows the LHEPA to reach beyond the boundaries of the statute’s very function and legal designation as a statutory immunity. The Author opines that allowing an affirmative defense that has not been pled or proven to lower the standard from negligence to gross negligence is legal error—applying incorrect principles of law that are inherently prejudicial by casting a more onerous standard than the law requires. The Author concludes by encouraging lawyers to continually challenge the LHEPA until new precedents ensue.

Tingle, John, ‘Patient Safety and Litigation in the NHS Post-COVID-19.’ (2020) 29(7) British Journal of Nursing 444–445
Abstract: John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses patient safety during the present coronavirus pandemic

Tiwari, Ruchi, ‘An Empirical Research Study on COVID-19: A Cause for Replace Decrepit Epidemic Law’ (2020) 40(71) Studies in Indian Place Names 1534–1542
Abstract: Freshly, India has invoked various provisions of the Epidemic Diseases Act of 1897 to control communicable disease which is more or less turned into the most critical one globally. Coming up of COVID-19 has opened the debate for the new legislation or to clear the pending bill The Public Health (Prevention, Control and Management of Epidemics, Bio-Terrorism and Disasters) Bill, 2017 or to come up with special legislationnamed The Epidemic Bill, 2020. Here, the public health should be the concern in present condition of the society. Objective To respond to Epidemic situation for dissemination of lessons learnt from present crisis across the country that has begun with the strong need of legislation which can repeal the Epidemic Act,1897.

Tobun, Tomilola, ‘Medical Malpractice in Public Health Emergencies: A Review of Medical Response to COVID-19 in Nigeria’ (SSRN Scholarly Paper No ID 3608656, 23 May 2020)
Abstract: The Article establishes that in a pandemic situation, there is a duty to prevent the transmission of disease & an established duty of care to all other patients. The upsurge in demand for health services in a pandemic situation should not excuse or justify the breach of this duty of care which can result in any harm or injury being done to a patient.In a pandemic situation, the rejection of patients by hospitals, the failure to pay special attention to patients even in isolation centres e.t.c can be adjudged as negligent actions for which medical practitioners & medical institutions can be liable.

Tolchin, Benjamin et al, ‘Developing a Triage Protocol for the COVID-19 Pandemic: Allocating Scarce Medical Resources in a Public Health Emergency’ (2020) 31(4) Journal of Clinical Ethics 303–317
Abstract: The coronavirus disease-2019 (COVID-19) has caused shortages of life-sustaining medical resources, and future waves of the virus may cause further scarcity. The Yale New Haven Health System developed a triage protocol to allocate scarce medical resources during the COVID-19 pandemic, with the primary goal of saving the most lives possible, and a secondary goal of making triage assessments and decisions consistent, transparent, and fair. We outline the process of developing the triage protocol, summarize the protocol itself, and discuss the major ethical challenges encountered, along with our answers to these challenges. These challenges include (1) the role of age and chronic comorbidities; (2) evaluating children and pregnant patients; (3) racial, ethnic, and socioeconomic disparities in health; (4) prioritization of healthcare workers; and (5) balancing clinical judgment versus protocolized assessments. We conclude with a review of the limitations of our protocol and the lessons learned. We hope that a robust public discussion of such protocols and the ethical challenges that they raise will result in the fairest possible processes, less need for triage, and more lives saved during future waves of the COVID-19 pandemic and similar public health emergencies.

Tomić-Petrović, Nataša M, ‘Right to Health in the Times of Pandemic (The Case of Serbia)’ (2021) 84(1) Curentul Juridic 37–41
Abstract: Health is the most beautiful gift that nature gives us, and viruses are the most serious threat to humanity. Since ancient times many infections have tormented the people in our area. It is believed that the first quarantine in history was introduced in the Balkans, in the 14th century during the fight against the black plague. During the Great War in 1914, Serbia faced an epidemic of typhus, and in 1972, the epidemic of smallpox in Serbia ended, and our anti-epidemic struggle was assessed by international institutions as successful. In the Republic of Serbia, amendments to the Law on Protection of the Population from Infectious Diseases were adopted in 2015. The Law on Health Care of Serbia, as the basic law in the legal system of Serbia, regulated the entire system of health care. The Institute for Public Health, established for the territory of the Republic of Serbia, coordinates the implementation of epidemiological monitoring on the territory of the Republic and issues expert instructions for epidemiological monitoring for infectious diseases and special health issues. The year is 2020, the viral epidemic is conquering Serbia as well. Along with the relevant national regulations, the paper presents the chronology of infectious diseases in the world and in our country until today’s pandemic, which changed our lives. The race for development, production and application of the Covid 19 vaccine around the world continues with increasing of research in centers around the world

Tomori, Cecília et al, ‘Your Health Is in Your Hands? US CDC COVID-19 Mask Guidance Reveals the Moral Foundations of Public Health’ (2021) 38 EClinicalMedicine Article 101071
Abstract: In the second year of the COVID-19 pandemic, US public health policy remains at a crossroads. The US Centers for Disease Control and Prevention’s (CDC’s) May 28, 2021 guidance, which lifted masking recommendations for vaccinated people in most situations, exemplifies a troubling shift — away from public health objectives that center equity and toward a model of individual personal responsibility for health. CDC Director Rochelle Walensky emphasized that ‘your health is in your hands,’ undermining the idea that fighting COVID is a ‘public’ health responsibility that requires the support of institutions and communities. The social impacts of this scientific guidance, combined with the emergence of new variants, have exposed the fallacy of this approach, with most local mask restrictions lifted and infections rising dramatically among disadvantaged populations. Rapidly rising cases prompted the CDC on July 27th to recommend resuming indoor masking even for vaccinated people in ‘areas of substantial or high transmission,’ but US policy continues to frame the pandemic largely as a matter of individual responsibility to the detriment of public health. As public health professionals and advocates, we call for a renewed commitment to core public health principles of collective responsibility, health equity, and human rights.

Tongue, Zoe L, ‘Telemedical and Self-Managed Abortion: A Human Rights Imperative?’ (2022) 30(2) European Journal of Health Law 158–181
Abstract: Early into the COVID-19 pandemic, abortion rights advocates highlighted the importance of maintaining access to abortion through telemedicine. It was argued that telemedical and self-managed abortion was, in the pandemic context, a human rights imperative. This article argues that providing for telemedical and self-managed abortion remains a human rights imperative beyond the duration of the pandemic. Telemedical and self-managed abortion is safe and effective, supports the pregnant person’s preferences and reproductive autonomy, and minimises many of the physical and structural barriers faced by pregnant people in accessing abortion services. International and European human rights standards access to abortion require states to take positive measures to guarantee access to abortion, and this article argues that such measures include telemedical and self-managed abortion.

Toomey, James, ‘Too Important for the Bureaucrats: Rethinking Risk and Regulatory Presumptions in Times of Crisis’ (2021) 47(2–3) American Journal of Law & Medicine 249–263 [ pre-print available on SSRN]
Abstract: The posture of American regulation of medicine is negative—we assume that a new drug is unsafe and ineffective until it is proven safe and effective. This regulatory posture is a heuristic normative principle, a specific instance of the so-called precautionary principle in public health law. It is defensible, if debatable, in many ordinary circumstances. But like many normative heuristics, this negative posture may compel suboptimal decision-making in emergencies, where context-specific decisions must be made and a range of unique values may apply. This Article considers the challenge of emergency normative decision-making—a fundamental challenge of democratic legal design—in the context of authorization of new drugs or vaccines in public health emergencies. I conclude, for the same reasons of political theory that apply in the analogous context of emergency military decision-making, that the President ought to have the authority to deviate from the normative heuristics of our drug law in emergencies. This is so for two reasons. First, because emergency decision-making must happen quickly and decisively, it is best situated in one person. Second, normative decisions are political decisions, and in democracies we make political decisions through electoral processes. If we are to situate emergency decision-making in one person, it ought to be the most broadly democratically responsive federal official—the President. Because, however (and unlike the military context), the President’s constitutional authority in public health emergencies is debatable, and the current emergency provisions in our drug laws are inadequate, the federal drug laws should be amended to grant the President clear statutory authority to deviate from the ordinary process of premarket approval where necessary to combat public health emergencies. In short, just as we recognize that war is too important to be left to the generals, notwithstanding their military expertise, we ought to recognize that balancing risk and reward in public health emergencies is too important to be left to the scientists, and value Presidential control over the Food and Drug Administration just as we value civilian control of the Pentagon.

Torrie, Carmen et al, ‘Social Justice in Pandemic Immunization Policy: We’re All in This Together’ (2021) 28(6) Nursing Ethics 924–934
Abstract: Policy decisions regarding immunization during a pandemic are informed by the ethical understandings of policy makers. With the possibility that a vaccine might soon be available to mitigate the deadly COVID-19 pandemic, policy makers can consider learnings from past pandemic immunization campaigns. This critical analysis of three policy decisions made in Alberta, Canada, during the 2009 H1N1 influenza pandemic demonstrates the predominance of distributive justice principles and the problems that this created for vulnerable groups. Vulnerable groups identified in Alberta include rural and First Nations populations. We propose a social justice approach as a viable alternative to inform pandemic immunization policy and invite debate.

Townsend, BA, M Mars and RE Scott, ‘The HPCSA’s Telemedicine Guidance during COVID-19: A Review’ (2020) 13(2) South African Journal of Bioethics and Law 97–102
Abstract: The confluence of COVID-19 and raised interest in the application of ‘e-health’ (electronic- health) or ‘d-health’ (digital health) innovations has occurred throughout the world. Leadership in many countries has risen to the crisis by rapidly developing, refining, or retooling e-health solutions as well as existing legislation and guidelines to permit their swift implementation. Anticipation globally is that these events will stimulate sustained change in the interest in and use of e-health (e.g., telehealth, telemedicine, m-health, e-learning, and health informatics). In South Africa the existing stance of the Health Professions Council of South Africa hampered this response, initially even in the face of the pandemic. This paper briefly reviews recent events in South Africa, relevant World Medical Association statements, and international COVID-19 related response. It concludes the HPCSA must acknowledge global experience, and provide South Africa with clear, evidence-based, and clinically practicable guidelines that promote and sustain use of telemedicine broadly, now and post-COVID-19.

Tremblay-Huet, Sabrina et al, ‘The Impact of the COVID-19 Pandemic on Medical Assistance in Dying in Canada and the Relationship of Public Health Laws to Private Understandings of the Legal Order’ (2020) (1) Journal of Law and the Biosciences Article 1-17
Abstract: Drawing on interviews we conducted with fifteen MAiD providers from across Canada, we examine how physicians and nurse practitioners reconcile respect for the new, changing rules brought upon by the COVID-19 pandemic, along with their existing legal obligations and ethical commitments as health care professionals and MAiD providers. Our respondents reported situations where they did not follow or did not insist on others following the applicable public health rules. We identify a variety of techniques that they deployed either to minimize, rationalize, justify or excuse deviations from the relevant public health rules. They implicitly invoked the exceptionality and emotionality of the MAiD context, especially in the time of COVID, when offering their accounts and explanations. What respondents relate about their experiences providing MAiD during the COVID pandemic offers occasion to reflect on the role actors themselves play in giving meaning (if not coherence) to the potentially conflicting normative expectations to which they are subject.

Tsiakiri, Lydia and Andreas Albertsen, ‘The Ethics of Using Vaccination Status as a Rationing Criterion: Luck Egalitarianism and Discrimination’ (2024) 24(7) The American Journal of Bioethics 86–88
Abstract: In “Rationing, Responsibility, and Vaccination during COVID-19: A Conceptual Map,” Park and Davies interestingly lay out the discussion of employing vaccination status as a rationing criterion in times of emergency (Park and Davies Citation2024). In what follows, we first address whether rationing based on vaccination status should be understood as directly and/or indirectly discriminatory. Then, we consider some further luck egalitarian perspectives for the policies’ potential implementation.

Tsuji, Yuichiro, ‘COVID-19 Vaccination in Japan: Remedies for Injured Patients’ (2021) 16(1) Health Law & Policy Brief 40–54
Abstract: This article examines COVID-19 vaccination in Japan and possible compensation rights for those who experience adverse reactions. In Japan, the Constitution and the Local Autonomy Act place regular vaccination of citizens as a municipal task. If a disaster occurs that is beyond the jurisdiction of the municipality, the prefectural government, which is positioned above the municipality, responds. The central government is constitutionally responsible for coordinating prefectures in the event of a disaster that exceeds their capacity to handle. Japanese constitutional jurisprudence holds that social restrictions inherent to property rights do not necessitate compensation, but it is possible that compensation would be necessary if society’s evaluation of compensation for property rights changes significantly. A lower court decided that compensation under the property rights provision could be applied if the vaccination caused serious damage to the health or life of citizens. The Supreme Court of Japan has recognized the government’s liability, judging that negligence exists in the system of vaccination itself in the obligation of doctors to question patients during vaccination when serious damage to health or life occurs due to vaccination. This decision would also apply to adverse reactions caused by COVID-19. The debate on whether compensation is necessary or unnecessary gives a scathing assessment of the negligence of the political branches. Even if compensation based on property rights is not necessary, provisions based on social rights can be used to require the government to take steps in parliament and governance to help the socioeconomically vulnerable. Constitutional scholars should be careful when they argue that compensation for property rights is unnecessary, as citizens may misunderstand that socioeconomic support based on social rights is also unnecessary.

Tullio, Valeria et al, ‘Psychological Support and Psychotherapy via Digital Devices in COVID-19 Emergency Time: Some Critical Issues’ (2020) 88(2) Medico-Legal Journal 73–76
Abstract: The COVID-19 pandemic and the resulting fear, quarantine and lockdown measures implemented in Italy and other countries to contain the risk of contagion have seriously impacted the mental health of a large number of people. The need to offer psychological and psychotherapeutic support to these people, while respecting the government’s pressing calls to ‘stay home’, have led many psychologists and psychotherapists, both in the public and private sectors, to provide their professional services via teleconference, telephone, smartphone, etc. The aim of this work is to highlight some critical issues related to the sudden switch from the traditional method of providing psychological services to the digital one in Italy.

Tumelty, Mary-Elizabeth et al, ‘COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland’ (2022) 29(2) European Journal of Health Law 240–259
Abstract: Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.

Udayanganie, UaT, ‘Dilemma of Mandatory Vaccination for COVID 19: Analysis of Constitutional and Legal Issues under the Sri Lankan Law’ (Proceedings of the Annual Research Symposium, Faculty of Law, University of Colombo, 23rd November 2021 (2021) 216
Abstract: Sri Lankan authorities have suggested that the vaccination card for COVID-19 be made mandatory for citizens above the age of 30 years old, whenever they visit public places from Sept. 15, 2021 onwards. Such policies appear to be effective in convincing some non- vaccinated individuals to get their dosage to ensure community safety. Even so, this raises many complex issues regarding the interplay of competing rights. The key issue is where to draw the line between government’s duty to protect the health and community protection and the individual autonomy, bodily integrity and human dignity, particularly when a worldwide pandemic causes millions of deaths and economic devastation. Another crucial point that need to be considered in the current vaccination debate in Sri Lanka is that Covid-19 poses a major public health risk not just to people who are non-vaccinated by choice, but to those who cannot yet get vaccinated, such as children due to irregular and inconsistent supply of vaccines, issues in the process of vaccination prioritization and people who did get vaccinated but develop breakthrough infections. First part of this paper presents a constitutional and legal analysis of the possibility of the country making the vaccination against COVID-19 mandatory. Second part of the paper seeks to reflect debates in other jurisdictions as well where mandatory vaccination is being recommended to tackle the COVID-19 pandemic. Finally, the paper suggests the proportionality approach in designing and implementing such a law or policy and substantiates the argument that a mandatory vaccination would be legal if the government has designed and implemented rational criteria within the explicit parameters that a mandatory vaccination is required and proportionate in the interest of public health and safety and for the protection of the rights and freedoms of the community. The research employs a doctrinal black letter approach by referring to relevant primary and secondary sources.

Underhill, Kristen and Olatunde CA Johnson, ‘Vaccination Equity by Design’ (2021) 131 Yale Law Journal Forum 53–88
Abstract: This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

Utami, Mieke Aprilia, ‘Legal Protection of Patients During Pandemic COVID-19’ (2022) 1(1) Journal of Law Article 9
Abstract: This legal research aims to determine the implementation of legal protection for health services during the outbreak of the Corona Virus Disease (Covid-19) pandemic which spreads to all countries in the world without exception in Indonesia, including to various regions, one of which is in the Blora Regency, where patients, especially non-Covid-19 patients, need health service providers, both in health centers and in hospitals. This legal research uses empirical legal research that is descriptive in nature to review the implementation of applicable laws and regulations and compare it with the reality in the field. The research sources take primary data based on facts in the field and secondary data based on applicable laws and regulations Based on the results of research that has been done, it shows that during the Covid-19 pandemic the implementation of health services for non-Covid 19 patients in Blora Regency, several things were in accordance with health protocol standards and legal protection that patients received in the form of legal protection. both preventively and repressively based on Law Number 36 of 2009 concerning Health.

van Aardt, Willem, ‘Covid-19 Vaccine Mandates, International Human Rights Law and the Voluntary Consent Criterion’ (2023) Regional Law Review 81–96
Abstract: International human rights standards and bioethical norms with regard to informed consent for all medical interventions logically apply to COVID-19 vaccines. This invasive medical procedure carries both known and unknown risks. Over the past two years, COVID-19 vaccine mandates significantly infringed on the individual’s right to medical self-determination, violating Article 7 of the International Covenant on Civil and Political Rights, and Article 5 of the Oviedo Convention. The COVID-19 era practices to ostracize, spurn, pressure, mandate, pay, fraudulently induce, and shame people into getting vaccinated against their will violated key Bioethical standards and long-established International Human Rights Law norms jus cogens and obligations erga omnes. Voluntariness, like so many other notions, is not an over-simplified yes-or-no concept but a matter of degree and understanding all the relevant facts in casu. Coercion itself encompasses a broad range of permutations, from applying physical force at one end to applying subtle emotional pressure on the other. Any kind of pressure put on an individual impedes and therefore nullifies the voluntariness of his or her decision, irrespective of the degree. When Government and Corporate COVID-19 biomedical medical paternalists pressured citizens to take the COVID-19 vaccines through threats of punishment if they did not and promises of reward if they did, it failed voluntariness on all counts.

van Aardt, Willem, ‘State of Emergency in South Africa, Mandatory Covid-19 Vaccination and International Human Rights Law’ in Ana Čović and Oliver Nikolić (eds), Pravni i Društveni Aspekti Vakcinacije Tokom Pandemije Kovida 19 / Legal And Social Aspects Of Vaccination During The Covid-19 Pandemic (Institute of Comparative Law, 2022) 205–225 *[OPEN ACCESS BOOK]*
Abstract: Recent events across the globe have again brought the world’s attention to the complex interrelationship between States of Emergency and the protection of fundamental human rights. South Africa was the first African country to declare a national state of emergency. As part of its emergency response to the Covid-19 pandemic, South Africa’s Health Minister in April 2021 announced the launch of its mass vaccination campaign against Covid-19. Derogation provisions in the International Covenant on Civil and Political Rights allow for States Parties to lawfully suspend human rights guarantees to respond to an emergency ‘that threatens the life of the nation’ To decide on both the presence of such an emergency and the nature and scope of derogations necessary to avert it, authorities have a wide margin of appreciation. Derogation from rights recognized under international human rights law to respond to ‘a threat to the life of the nation’ is, however, not exercised in a legal vacuum. It is authorized by law, and as such, it is subject to several legal principles and standards. An emergency that threatens the life of the nation must imperil fundamental elements of statehood or the survival of the population. No State party has the right to violate citizens’ right to life and the right to be free from torture, cruel, inhumane, or degrading treatment, and the right to be free from medical experimentation without free consent. These jus cogens norms are not derogable under any circumstances, even for the stated purpose of safeguarding the life of the nation during a public health emergency.

Van Tassel, Katharine A and Sharona Hoffman, 'Vulnerable Populations and Vaccine Injury Compensation: The Need for Legal Reform' (Case Legal Studies Research Paper No 2021–9, 2021)
Abstract: This chapter argues that the potential for vaccine-related harms raises acute concerns for vulnerable populations. These harms have a disparate impact on low-income people, who are disproportionately non-White, and who have limited financial resources to obtain medical care, weather job losses, and pursue injury compensation. When a vaccine is given as a countermeasure during a declared public health emergency (PHE), the problem is acute because of the limited availability of injury compensation.

Venkatapuram, Sridhar, ‘How Should We Allocate Health and Social Resources During a Pandemic?’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 313
Abstract: In this chapter, I argue that the particular use and applications of two scientific ideas profoundly affected national pandemic responses, including the allocation of resources, with significant harmful implications for social and health equity. First, the familiar ‘contain and control’ approach to infectious diseases was applied maximally by countries (through national lockdowns) and was without precedent. Second, the epidemic forecasting models and modelling that were so influential early on were mono-dimensional; they modelled scenarios of how human bodies will likely spread infections, and of the biological impacts (infected, recovered, or dead) over time. These models erased acute and endemic vulnerabilities, and were not capable of identifying the impacts of policies to reduce virus transmissions on other health and well-being issues, or on other important social domains (for example, the economy).

Vermeersch, Pieter and Emmanuel André, ‘How the European In Vitro Diagnostic Regulation Could Negatively Impact the European Response to the next Pandemic: An Urgent Call for Action before May 2022’ (2021) Clinical Microbiology and Infection (advance article, published 9 May 2021)
Abstract: The Corona Virus Disease 2019 (COVID-19) pandemic has demonstrated that the ability for laboratories to quickly set up and implement labdeveloped tests (LDTs) is essential to respond to an emerging health crisis. The Regulation on in vitro diagnostic medical devices (IVDR) could, however, profoundly impact our ability to respond to a future pandemic since the IVDR could significant restrict the use of LDTs. We address using the example of the current pandemic a number of LDT implementing issues problems which should be addressed. We conclude that the COVID-19 pandemic illustrates that commercial tests cannot cover all patient needs under any given circumstance and that sufficient degrees of freedom for laboratories to ensure their expertise to develop and implement LDTs ultimately benefit European citizens.

Versveld, Bernadette and Jodi Hardy, ‘COVID-19: Ensure Opportunistic Product Offerings Are Legally Compliant’ (2020) 20(5) Without Prejudice 6
Abstract: Demand for new products to combat COVID-19 infections presents an opportunity for businesses under strain, but they should be aware of advertising, medical and intellectual property restrictions.

Vicary, Sarah et al, ‘“It’s about How Much We Can Do, and Not How Little We Can Get Away with”: Coronavirus-Related Legislative Changes for Social Care in the United Kingdom’ (2020) 72(September-October 2020) International Journal of Law and Psychiatry Article 101601
Abstract: The coronavirus pandemic, referred to here as Covid-19, has brought into sharp focus the increasing divergence of devolved legislation and its implementation in the United Kingdom. One such instance is the emergency health and social care legislation and guidance introduced by the United Kingdom Central Government and the devolved Governments of Wales, Scotland and Northern Ireland in response to this pandemic. We provide a summary, comparison and discussion of these proposed and actual changes with a particular focus on the impact on adult social care and safeguarding of the rights of citizens. To begin, a summary and comparison of the relevant changes, or potential changes, to mental health, mental capacity and adult social care law across the four jurisdictions is provided. Next, we critique the suggested and actual changes and in so doing consider the immediate and longer term implications for adult social care, including mental health and mental capacity, at the time of publication.several core themes emerged: concerns around process and scrutiny; concerns about possible changes to the workforce and last, the possible threat on the ability to safeguard human rights. It has been shown that, ordinarily, legislative provisions across the jurisdictions of the UK are different, save for Wales (which shares most of its mental health law provisions with England). Such divergence is also mirrored in the way in which the suggested emergency changes could be implemented. Aside from this, there is also a wider concern about a lack of parity of esteem between social care and health care, a concern which is common to all. What is interesting is that the introduction of CVA 2020 forced a comparison to be made between the four UK nations which also shines a spotlight on how citizens can anticipate receipt of services.

Vidua, Raghvendra Kumar et al, ‘Dead Body Management amidst Global Pandemic of COVID-19’ (2020) 88(2) Medico-Legal Journal 80–83
Abstract: COVID-19 has reached almost all the nations in the world. More and more people are dying from it and in some countries, even the army has been called upon to help dispose of the dead as there is a shortage of coffins, and undertakers are overwhelmed. Therefore, it is essential to have measures in place to contain the spread of infection while handling dead bodies. In view of this, different guidelines and protocols have been proposed bearing in mind the limited information we have about the virus. This review article sets them out for better reference.

Viero, A et al, ‘Violence against Women in the Covid-19 Pandemic: A Review of the Literature and a Call for Shared Strategies to Tackle Health and Social Emergencies’ (2021) 319 Forensic Science International (advance article) Article 1106502
Abstract: The aim of this article was to conduct a rapid critical review of the literature about the relationship between violence against women (VAW) and the current COVID-19 pandemic. After the screening process, a total of 42 articles were considered. Our review confirmed that the ‘stay at home’ policies to contrast the pandemic have increased the problem of VAW, creating a ‘shadow pandemic within the pandemic’, as it was called by the United Nations. However, rigorous studies estimating the relationship between VAW and COVID-19 pandemic are scarce; most of the articles are commentaries, letters, editorials, and most of the published data derives from social media, internet, anecdotal evidence and helplines reports. Health care systems should promote further investigations into the relation between VAW and COVID-19, to identify creative solutions to provide clinical care and forensic services for victims of VAW.

Vinceti, Silvio Roberto, ‘COVID-19 Compulsory Vaccination and the European Court of Human Rights’ (2021) 92(Supplement 6) Acta Biomedica Atenei Parmensis e2021472
Abstract: Between August and September 2021, the European Court of Human Rights rejected three requests for interim measures against France and Greece’s compulsory vaccination statutes against COVID-19. Due to the procedural nature of the interim measures, however, the status of vaccine mandates against SARS-CoV-2 under the European Convention of Human Rights has not been addressed. The paper argues that COVID-19 compulsory vaccination is consistent with both the text and the original understanding of Article 8 of the Convention. Moreover, considering pertinent case law on medical mandatory treatments, COVID-19 vaccine mandates should also square with the European Court of Human Right’s ‘living instrument’ doctrine. For this reason, it is expected that the European Court of Human rights will uphold COVID-19 vaccination programs. At the same time, it would be beneficial if more Council of Europe member states triggered Article 15 derogation mechanism in order to make an even stronger case for fast-track developed vaccines and contrast vaccine hesitancy.

Vinceti, Silvio Roberto and Tommaso Filippini, ‘Revising the Legislation of Ethics Committees to Ease Biomedical Research in Humans across the World: Lessons from the COVID-19 Emergency’ (2022) 93(2) Acta Bio-Medica: Atenei Parmensis Article e2021579
Abstract: As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications’ review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience.

Vokinger, Kerstin Noelle et al, ‘Digital Health and the COVID-19 Epidemic: An Assessment Framework for Apps from an Epidemiological and Legal Perspective’ (2020) 150(1920) Swiss Medical Weekly Article w20282
Abstract: Building on an existing trustworthiness checklist for digital health applications, the authors searched the literature and developed a framework to guide the assessment of smartphone and web-based applications that aim to contribute to controlling the current epidemic or mitigating its effects.

Von Batten, Karl, ‘The Effects of Multiple Delayed National Regulatory Actions on the Number of COVID-19 Infections in the European Union and the United Kingdom’ (SSRN Scholarly Paper No ID 3625365, 10 June 2020)
Abstract: There is a noticeable difference in the amount of time it took European Union (EU) member states and the United Kingdom (UK) to enact nationwide stay-at-home orders and mandatory face mask provisions in response to the COVID-19 pandemic. Some EU member states enacted nationwide stay-at-home orders and mandatory face mask provisions shortly after the first confirmed case of COVID-19 infection within their respective jurisdiction. In contrast, other EU member states and the UK took much longer to initiate similar regulatory measures. This study’s findings indicate that there is a statistically significant difference in the number of COVID-19 infections between these two groups of countries, with a higher number of COVID-19 infections in the group of countries that took longer to enact nationwide stay-at-home orders and mandatory face mask provisions. This study’s findings also show a moderate positive correlation between the number of confirmed COVID-19 infections and the lag time between the first confirmed COVID-19 infections and the issuance of nationwide stay-at-home orders and mandatory face mask provisions, respectively. The results also show a very strong positive correlation between the number of confirmed COVID-19 infections and the number of COVID-19 infection tests. A Stepwise multiple regression analysis was performed, in place of Poisson regression, due to a failure to fit. The regression results indicate that confirmed COVID-19 infections increased by 0.0454 infections each test performed, decreased by -60,017 because of mandatory face mask provisions, and increased by 1,141 each day of lag time between the first confirmed COVID-19 infections and the issuance of mandatory nationwide face mask provisions.

Vural, Ipek Eren, Matthew Herder and Janice E Graham, ‘From Sandbox to Pandemic: Agile Reform of Canadian Drug Regulation’ [2021] Health Policy (Article pre-proof, published 15 May 2021)
Abstract: Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new ‘agile’ licensing framework known as the ‘Advanced Therapeutic Pathway’ (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada’s COVID- 19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement.

Wahid, Braira, ‘Forensic Casework Analysis and Legal Challenges during the Coronavirus Disease 2019 Global Pandemic: An Update from Pakistan’ [2020] Medicine, Science and the Law (advance article, published 9 August 2020)

Wałachowska, Monika and Michał P Ziemiak, ‘Impact of the COVID19 Pandemic on Patient Rights and Contract Law: Selected Problems’ in Frydrych-Depka, Anna, Maciej Serowaniec and Zbigniew Witkowski (eds), Pandemic Poland: Impacts of Covid-19 on Polish Law (Vandenhoeck & Ruprecht, 2021) 213

Wallace, Johnna, ‘Vaccines, Public Health, and the Law’ (2021) 40(2) IEEE Technology and Society Magazine 35–39
Abstract: The COVID-19 pandemic has loomed over the world for the better part of a year now; yet, many still cannot shake the disbelief that it is here. Nonetheless, countries around the world continue to be ravaged by death, and the healthcare workers battle on. As vaccine distribution makes its way to the mainstream, I cannot help but wonder, will people even take the vaccine? In an already divided country, where many are refusing to wear masks due to disbelief, violation of liberty, or mere quarantine fatigue, what will become of those that disobey if vaccination orders become mandatory? Public health emergencies may seem novel, but that is not the case. Even with modern technology and the most brilliant minds, certain diseases continue to baffle the scientific community [1, pp. 611–612]. Furthermore, new ones appear and seem to render the world at the same mercy as the diseases of centuries before [1, pp. 618–619]. On the other hand, the evolution of vaccination has been successful on many fronts as well. Vaccines for polio, measles, rubella, mumps, and varicella are just a few of the vaccines that have been used successfully for several decades [2, S5, S6].

Wang, Yuming et al, ‘Contingency Measures During the COVID-19 Pandemic in China: An Analysis Based on a New Ethical Framework’ (2021) 21(8) The American Journal of Bioethics 28–30
Extract from Introduction: As the first country hit by the COVID-19 outbreak, China adopted many measures for hospital surge capacity planning, including Fangcang shelter hospitals, designated hospitals, and internet hospitals, along with emerging technologies, such as artificial intelligence, big data analysis, cloud computing, and 5G (Sun et al. 2021). However, no organizations or scholars have proposed an ethical framework to guide contingency practices in China. In this commentary, we chose two contingency measures (telehealth and designated hospitals) which have been widely used in China during the COVID-19 pandemic, and analyze two examples based on the application of the ethical framework provided by Alfandre et al. (2021). We aim to illustrate how the contingency measures during the COVID-19 pandemic mediated the tensions between the values of both patient-centered care and public health in China, and wish to verify the applicability of the ethical framework through the analysis of the healthcare practices across cultures.

Wasserman, David, Govind Persad and Joseph Millum, ‘Setting Priorities Fairly in Response to COVID-19: Identifying Overlapping Consensus and Reasonable Disagreement’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa044
Abstract: Proposals for allocating scarce lifesaving resources in the face of the COVID-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution.

Webb, Julia M, ‘HIPAA & Telehealth during COVID-19: A Legal Review’ (SSRN Scholarly Paper No 4235321, 3 March 2022)
Abstract: Patient privacy has always been important, but the shift in virtual healthcare during the COVID-19 pandemic brought about different challenges. This brief legal analysis focuses on the nationwide efforts to increase access to care in the pandemic while still protecting privacy.

Webster, Paul, ‘Virtual Health Care in the Era of COVID-19’ (2020) 395(10231) Lancet 1180–1181

Weinstock, Daniel and Vardit Ravitsky, ‘Should Immunity Licences Be an Ingredient in Our Policy Response to COVID-19?’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 277
Abstract: According to their advocates, immunity licences in the post-confinement phase of the COVID-19 pandemic should be granted to those who have been exposed to the virus and as a result have (presumably) developed immunity. This would allow them to go back to work, engage in leisure activities, and travel. Those who are in favour of such licences argue that the ability of some to return to work would be of benefit to all. Opponents of the proposal point to their lack of scientific basis, to the perverse incentives that their introduction might generate, and to the risk that they might exacerbate existing inequalities. But should we consider them as wrong per se, that is, independent of the negative consequences that they might produce in present circumstances, consequences that might be neutralized by scientific advances and by an appropriate regulatory apparatus? They would still be morally deficient because they violate the principle of ‘least infringement’ relative to the value of equality. Reorganizing the spaces in which we work and play, and create is one way in which the task of emerging from confinement safely could be accomplished in a more egalitarian manner.

Wiemken, Timothy L, Ana Santos Rutschman and Robert Gatter, ‘The Case for Face Shields: Improving the COVID-19 Public Health Policy Toolkit’ (Saint Louis U. Legal Studies Research Paper No 2020–26, 2 September 2020)
Abstract: As the United States battles the later stages of the first wave of COVID-19 and faces the prospect of future waves, it is time to consider the practical utility of face shields as an alternative or complement to face masks in the policy guidance. Without face shields specifically noted in national guidance, many areas may be reluctant to allow their use as an alternative to cloth face masks, even with sufficient modification.In this piece, we discuss the benefits of face shields as a substitute to face masks in the context of public health policy. We further discuss the implications and opportunity costs of creating policy guidance with only a small subset of scientific data, much of which is limited. We conclude by arguing that existing federal guidance should be expanded to include face shields as a policy option.

Wijaya, Hanna and Imam Haryanto, ‘Law Enforcement against Medical Waste Management Negligence Covid-19 Sample Examination by Start-Up Companies’ (2021) 4(4) Budapest International Research and Critics Institute (BIRCI-Journal): Humanities and Social Sciences 13630–13640
Abstract: The world is being shocked by the COVID-19 disease, which has quickly evolved into a pandemic. rRT-PCR is used to examine this disease. This attracts a large number of Start-Up companies to the health industry, resulting in a significant increase in medical waste. As an outcome, medical waste that is not appropriately managed in accordance with SOP accumulates. There are quite a few people who carelessly discard medical waste. This journal is a juridical-normative study. If not correctly managed, the outcomes of this investigation in the form of medical waste can pollute the environment and endanger surrounding populations. The study’s conclusion is that medical waste must be carefully managed in compliance with SOP. Individuals who fail to properly handle medical waste will face criminal consequences under the criminal code of law.

Wiley, Lindsay F, ‘The 2023 US Supreme Court Term: Implications for Public Health’ (2023) 113(3) American Journal of Public Health 269–271

Wiley, Lindsay F, ‘Public Health Law and Science in the Community Mitigation Strategy for COVID-19’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa019
Abstract: The Bay Area Orders, which broke the floodgates on mandatory sheltering-in-place as a strategy for mitigating the spread of Covid-19 in the USA, originated in post-9/11 public health preparedness plans and long-standing relationships between public health scientists and lawyers.1 The powerful combination of public health science and law has prompted more than its fair share of legal and ethical controversy. From compulsory vaccination orders to sanitary cordons, from ‘Big Gulp bans’ to prohibitions on the sale of tobacco products at pharmacies, public health laws have often put judges in the position of assessing the reasonableness of restrictions on individual and economic liberty. The standards of review judges have developed to guide this task, require political leaders to articulate not only the purpose of their actions but also the fit between their ends and the means they have adopted. Assessing the means-ends fit usually boils down to a discussion of scientific evidence and guidelines.

Wiley, Lindsay F et al, ‘Health Reform Reconstruction’ (2021) 55(2) U.C. Davis Law Review 657–742
Abstract: This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades and calls for reconstruction. For more than a halfcentury, a cramped ‘iron triangle’ ethos has constrained health reform conceptually. Reforms aimed to balance individual interests in cost, quality, and access to health care, while marginalizing equity, solidarity, and public health. In the iron triangle era, reforms unquestioningly accommodated four legally and logistically entrenched fixtures -- individualism, fiscal fragmentation, privatization, and federalism -- that distort and diffuse any reach toward social justice. The profound racial disparities and public health failures of the U.S. pandemic response have agonizingly manifested the limitations of pre-2020 health reform and demand a reconstruction. Health reform reconstruction begins with a new conceptual framework that aims to realize health justice. Health justice requires commitments to anti-racism, equitable distribution of the burdens and benefits of public investments in health care and public health (for which health care access, quality, and cost are useful, but not exhaustive, metrics), and community empowerment. These commitments put health justice on a collision course with the fixtures of individualism, fiscal fragmentation, privatization, and federalism. Thus, incremental reforms must be measured by the extent to which they confront these fixtures. This Article describes how health reform reconstruction can chart the path for legal change and proposes ‘confrontational incrementalism’ as a method for recognizing the necessity of reconstructive reform, along with its near impossibility.

Wiley, Lindsay F and Samuel R Bagenstos, ‘The Personal Responsibility Pandemic: Centering Solidarity in Public Health and Employment Law’ [2020] Arizona State Law Journal (forthcoming)
Abstract: The personal responsibility ethos that has driven the US response to the coronavirus pandemic has been ineffective, atomizing, and unjust. Restrictions on public services and private activities have disproportionately burdened people living in low-income households, people with disabilities, people of color, and women. At the same time, the severe illnesses and deaths that have continued to occur in spite of public health responses have been disproportionately concentrated among people of color, disabled people, and low-wage workers. This paper argues that fundamentally individualistic employment and antidiscrimination laws have undermined—rather than supported—disempowered workers’ ability to protect themselves and others. The law has failed to protect people who live and work in congregate institutions (including nursing homes, prisons, jails, detention facilities, factories, and warehouses . . . and, perhaps soon, schools) and thus has failed to protect the broader communities with which these institutions are interconnected. Together, public health and employment laws have put the onus on individuals to adopt protective behaviors without providing them with the supports, accommodations, and protections they need to do so. We identify three key areas for reform to ensure more effective and just pandemic response—for this pandemic and the next one—built on a core commitment to social solidarity in public health law and employment and antidiscrimination law. First, public health law should prioritize supports that create the conditions required mitigate the spread of infection over punitive measures targeting individuals. Second, employment law should protect workers from infection, including through workplace safety, privacy, and antidiscrimination protections that enable them to adopt protective health behaviors. Third, for individuals for whom returning to work would be especially unsafe—whether because their employers maintain particularly dangerous conditions or because of their own, or their family members’, underlying health conditions—employment law should remove any obligation to return to work while the special dangers associated with the pandemic persist. In addition to making concrete proposals for reform, our argument contributes to the academic literature in both public health and employment law. First, we show that a broad vision of public health law that encompasses action on the social determinants of health in ‘non-health’ sectors such as employment and antidiscrimination law is not only tenable, but essential. The US experience with the coronavirus pandemic puts the final nail in the coffin of the ‘old’ public health, which its cramped focus on microbial and behavioral interventions. Second, we bring to the foreground an additional justification for employment and antidiscrimination law—to promote solidarity by ensuring that the burdens and benefits of measures that serve the public as a whole are shared equitably. Social solidarity may offer a useful way of understanding the application of these bodies of law in other health-related contexts as well, such as genetic discrimination and workplace injuries. Third, we show that the attribution of fault and responsibility is a persistent obsession of employment and antidiscrimination law. These points should be of broad interest to employment and public health law scholars alike.

Wilkinson, Dominic JC, ‘Frailty Triage: Is Rationing Intensive Medical Treatment on the Grounds of Frailty Ethical?’ (2021) 21(11) American Journal of Bioethics 48–63
Abstract: In early 2020, a number of countries developed and published intensive care triage guidelines for the pandemic. Several of those guidelines, especially in the UK, encouraged the explicit assessment of clinical frailty as part of triage. Frailty is relevant to resource allocation in at least three separate ways, through its impact on probability of survival, longevity and quality of life (though not a fourth—length of intensive care stay). I review and reject claims that frailty-based triage would represent unjust discrimination on the grounds of age or disability. I outline three important steps to improve the ethical incorporation of frailty into triage. Triage criteria (ie frailty) should be assessed consistently in all patients referred to the intensive care unit. Guidelines must make explicit the ethical basis for the triage decision. This can then be applied, using the concept of triage equivalence, to other (non-frail) patients referred to intensive care.

Williams, Christina M, ‘Policy and Law Changes to Address Healthcare Inequities for Minority Populations during COVID-19’ (2020) 1(3) Journal of Allergy and Infectious Diseases 49–52
Introduction: While other countries have begun to see a flattening of the Severe Acute Respiratory Syndrome – Coronavirus-2 (SARS-CoV-2) curve, the United States continues to see a rise in cases, with approximately 7.4 million confirmed cases to date. Even more worrisome, various news articles have begun to shed light on the healthcare inequities that have become increasingly more transparent during this crisis. The current literature shows that during this coronavirus disease-2019 (COVID-19) pandemic, viral transmission has disproportionately affected Black, American Indian/ Alaska Native, Latinx, Asian-American, and the Pacific Islander communities. More specifically, in states such as Chicago and Louisiana, African Americans experience at least a 50% higher total death count as compared to their White counterparts. In states such as New York, the deaths per 100,000 for African Americans has been around double that of Whites since the beginning of the crisis. A recent study from the New England Journal of Medicine has shown that 76.9% of patients hospitalized with COVID-19 and 70.6% of those who died were Black, despite the fact that only 31% of the Ochsner Health Population in the state is African American. Healthcare in Alabama has highlighted similar glaring issues. An increasing number of White Americans are being infected with COVID-19, but African Americans continue to represent a higher percentage of total COVID-19-associated deaths. Interestingly, fewer African Americans have been infected with COVID-19 in Alabama, but a higher mortality rate exists even for African Americans who were found to have no other underlying medical conditions. Based on the COVID Racial Data Tracker, which measures data from the District of Columbia and 41 states, the Latinx community has been disproportionately testing positive as well. In 30 states, the rates have been around double that of non-minority populations, and over four times the rate in eight alternate states. The American Indian community, specifically the Navajo Nation, has accounted for 60% of cases in New Mexico, while only comprising 9% of the total population. The pandemic has brought healthcare inequities that have existed for decades to the forefront of policy conversations—there are steps that can be taken in both the short and long-term to address the needs of these vulnerable populations.

Wilson, Kay, ‘The COVID-19 Pandemic and the Human Rights of Persons with Mental and Cognitive Impairments Subject to Coercive Powers in Australia’ (2020) 73(November-December) International Journal of Law and Psychiatry: Special Issue on Mental health, Mental Capacity, Ethics and the Law in the Context of Covid-19 (Coronavirus) Articlw 101605
Abstract: The purpose of this paper is to explore the effect of the COVID-19 pandemic on the human rights of persons with mental and cognitive impairments subject to coercive powers in Australia. It sets out the relevant human rights in the Convention on the Rights of Persons with Disabilities which have been engaged by the COVID-19 pandemic and the government’s response to it. It examines the effect of emergency legislation on the relaxation of human rights safeguards in mental health laws, with a focus on mental health tribunals (although it is limited by a lack of published decisions and gaps in publicly available information). However, some of the issues created for persons with disabilities during the COVID-19 pandemic are evident in some decisions published by the New South Wales Guardianship Tribunal. The paper critically analyses two guardianship decisions UZX [2020] NSWCATGD 3 (3 April, 2020) and GZK [2020] NSWCATGD 5 (23 April, 2020) and some emergency South Australian legislation COVID-19 Emergency Response Act, 2020 (SA) Schedule 1 to demonstrate the ways in which the human rights of persons with mental and cognitive impairments can be more at risk than those of the general population, even when the general population is itself in ‘lockdown.’

Witt, John, ‘American Contagions: Unexpected Pasts, Unwieldy Presents, and Contested Futures’ (2022) 18(2) University of St. Thomas Law Journal 510–524
Abstract: With this article, I aim to trace three different features of the law of pandemics. First, I will describe an unexpected history of epidemics in the United States, one that I think will be surprising to many Americans and that looks different than one might have imagined. Second, I will turn to our unwieldy present, with its cacophony of different points of view and perspectives and account for some of the controversies that have arisen in the law of pandemics in the last year or so. Third, I will do what historians should never do: I will make a couple predictions about our contested future—or at least try to shine a light on some of the directions we might be headed.

Wolf, Susan M and James G Hodge, ‘Designing COVID-19 Vaccine Mandates in Colleges and Universities: A Roadmap to the 10 Key Questions’ (2022) Journal of Law & the Biosciences (forthcoming)
Abstract: COVID-19 transmission among students, faculty, and staff at U.S. institutions of higher education (IHEs) is a pressing concern, especially with the dominance of the highly contagious Delta variant and emergence of the Omicron variant. To protect their populations and surrounding communities, IHE administrators are increasingly considering COVID-19 vaccine requirements. Roughly one-quarter of the nearly 4,000 college and university campuses across the U.S. have announced COVID-19 vaccine mandates for students or employees. Deciding to require vaccination is only the first of multiple decisions, as IHEs face complex issues of how to design and refine their mandates, including whether to require boosters. Mandates vary significantly in stringency, implementation, impact on members of the college or university community, and net benefit to the institution. This essay examines 10 key questions that IHEs face in designing or refining a COVID-19 vaccination mandate. Showing that these 10 questions were carefully considered may be crucial if the institution’s mandate is challenged. Ultimately, how an IHE designs its mandate may make the difference between meaningful risk mitigation that advances institutional goals and benefits students, faculty, and staff versus a public health failure that erodes trust, raises equity concerns, threatens to undermine preexisting vaccination requirements, and divides the campus.

Wong, Patrick et al, ‘COVID-19 Pandemic: Ethical and Legal Aspects of Inadequate Quantity and Quality of Personal Protective Equipment for Resuscitation’ (2021) 74(1) Korean Journal of Anesthesiology 73–75
Extract: The legal duty to ensure that ‘safety is reasonably practicable’ is open to interpretation. If employers breach their duty of providing adequate PPE (in appropriate quantity and quality), they may be liable to prosecution depending on local regulations. Furthermore, negative publicity and legal risk may ensue. On the other hand, disadvantages of non-disclosure include the inability to conduct investigations and provide treatment (e.g., counselling and isolation), risk of further transmission, and potential harm (e.g., COVID-19). To balance this, ‘disclosure should be the norm, even when the probability of harm is extremely low’.

Wynne, Keona Jeane, Mila Petrova and Rachel Coghlan, ‘Dying Individuals and Suffering Populations: Applying a Population-Level Bioethics Lens to Palliative Care in Humanitarian Contexts: Before, during and after the COVID-19 Pandemic’ (2020) 46(8) Journal of Medical Ethics 514–525
Abstract: Background Humanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care—a specialty focusing on supporting people with serious or terminal illness or those nearing death. In the COVID-19 pandemic, palliative care has received unprecedented levels of societal attention. Unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations. Yet global guidance was available. In 2018, the WHO released a guide on ‘Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises’—the first guidance on the topic by an international body. Aims This paper argues that while a landmark document, the WHO guide took a narrowly clinical bioethics perspective and missed crucial moral dilemmas. We argue for adding a population-level bioethics lens, which draws forth complex moral dilemmas arising from the fact that groups having differential innate and acquired resources in the context of social and historical determinants of health. We discuss dilemmas concerning: limitations of material and human resources; patient prioritisation; euthanasia; and legacy inequalities, discrimination and power imbalances. Implications In parts of the world where opportunity for preparation still exists, and as countries emerge from COVID-19, planners must consider care for the dying. Immediate steps to support better resolutions to ethical dilemmas of the provision of palliative care in humanitarian and emergency contexts will require honest debate; concerted research effort; and international, national and local ethical guidance.

Xia, Yuhan, ‘Legal Obligation to Vaccinate Against COVID-19’ (8th International Conference on Humanities and Social Science Research (ICHSSR 2022), 2022) 2561–2565
Abstract: In the context of the current COVID-19 pandemic, vaccine development and vaccination have become a top priority for all countries. Is it necessary for China to increase the vaccination rate of the COVID-19 vaccine through legal means so as to effectively control the rebound and outbreak of COVID-19 and maintain public order and security? This paper discusses the theoretical origin of vaccination obligation from the perspectives of deontology, utilitarianism, and moral utilitarianism, and clarifies the legal basis of vaccination obligation. Considering the needs of collective needs and the principle of fairness, this paper analyzed and determined the necessity of incorporating the COVID-19 vaccine into the scope of legal regulation and clarified the legal significance of COVID-19 vaccine vaccination. The paper finds that whether on the theoretical basis of deontology, utilitarianism, or moral utilitarianism, citizens all have the obligation to get vaccinated in the immunization program. At the same time, the COVID-19 vaccine has already met the substantive requirements of an ‘immunization planning vaccine’ as stipulated in the Basic Medical and Health Law and the Vaccine Administration Law. Therefore, citizens’ vaccination obligations can be included in the scope of legal regulation.

Xue, Qiwei Claire and Lisa Larrimore Ouellette, ‘Innovation Policy and the Market for Vaccines’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa026
Abstract: Vaccines play a crucial role in improving global public health, with the ability to stem the spread of infectious diseases and the potential to eradicate them completely. Compared with pharmaceuticals that treat disease, however, preventative vaccines have received less attention from both biomedical researchers and innovation scholars. This neglect has substantial human and financial costs, as vividly illustrated by the COVID-19 pandemic. In this article, we argue that the large number of ``missing’’ vaccines is likely due to more than lack of scientific opportunities. Two key aspects of vaccines help account for their anemic development pipeline: (1) they are preventatives rather than treatments; and (2) they are generally durable goods with long-term effects rather than products purchased repeatedly. We explain how both aspects make vaccines less profitable than repeat-purchase treatments, even given comparable IP protection. We conclude by arguing that innovation policy should address these market distortions by experimenting with larger government-set rewards for vaccine production and use. Most modestly, policymakers should increase direct funding—including no grants and public-private partnerships—and insurance-based market subsidies for vaccine development. We also make the case for a large cash prize for any new vaccine made available at low or zero cost.

Yakovi Gan-Or, Nofar, ‘Going Solo: The Law and Ethics of Childbirth during the COVID-19 Pandemic’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa079
Abstract: The COVID-19 pandemic has had devastating effects on women’s reproductive lives. Women’s access to both abortion and contraceptive care has been restricted in many states across the U.S. Yet, the coronavirus has put a strain on another aspect of women’s reproductive rights: childbirth. In New York, for example, several hospitals instituted bans on all visitors in order to protect obstetric health care providers, as well as patients and newborn babies, from the risks posed by the virus. The policies were met with anger and confusion among expectant parents. An executive order issued in response to such criticism, overruling these policies, was described by some health professionals as unethical and ill-informed. Against this background this Essay maps the ethical and legal issues raised by childbirth visitation bans. It argues that the benefits of such visitation bans should be weighed against the implications they may have on laboring women’s emotional and physical well-being, considering the challenges they already face during facility-based childbirth. It then considers several national and international legal frameworks through which women’s birthing rights may be affirmed, also pointing out where they fall short. Lastly, this Essay makes recommendations for how such rights may be better addressed by different legal actors, including scholars, courts, and legislators.

Yan, Sophia, ‘Wuhan’s Whistleblowers’ (2020) 74(3) IBA Global Insight 13–17
Abstract: Before COVID-19 became a pandemic, the Chinese authorities suppressed information received from experts including whistleblower doctors in Wuhan, the epicentre of the outbreak. The move has proved devastating.

Zahari, Hariz Sufi Bin et al, ‘The Feasibility of Mandatory Vaccination Program Under the Malaysian Legal Framework for Education Sector’ (2021) 6(10) Malaysian Journal of Social Sciences and Humanities (MJSSH) 343–357
Abstract: The spread of the COVID-19 virus has been halted partially due to the vaccination program around the globe. However, such initiation has been actively under attack by a portion of society that believes vaccination is not the way out of the pandemic. A similar notion of anti-vaccine has slipped through Malaysia, particularly in the education sector, as they refuse to be vaccinated. This has been contributed by the lack of legal provision that regulates vaccination in Malaysia. Based on the literature and scientific data on the effectiveness of vaccination programs in curbing the spread of COVID-19, this paper aimed to weigh the legal argument on the possibility of imposing mandatory COVID-19 vaccination in Malaysia’s education sector to eradicate this deadly disease virus permanently. This paper embarked on a comparative, doctrinal analysis methodology where secondary data were collected and analysed. Literature from primary and secondary sources such as the laws, guidelines, textbooks, journal articles, government reports, newspaper articles, and online sources from multiple jurisdictions was analysed. The outcome of such analysis is laid down in a narrative design in highlighting the importance of mandatory vaccination within the education sector. This paper proposed hard and soft approaches on imposing mandatory vaccination programs within the education sectors in Malaysia is highly recommended, considering that the benefits of vaccination outweigh the risk of eradicating COVID-19 in Malaysia.

Zainuddin, Zainuddin et al, ‘Muslims Resistance to Health Protocols in COVID-19 Funeral: A Study of Islamic Law’ (2022) 6(2) Samarah: Jurnal Hukum Keluarga dan Hukum Islam 757–774
Abstract: Some Muslims have stood up against health protocols for burying COVID-19 corpses. This research aimed to investigate the initial occurrence of this resistance in society, the contributing factors to the resistance, and the implications of the resistance. To date, most studies on resistance focused on social perspectives, but this research probed into the discourse of resistance during COVID-19 from the perspective of legal transformation, especially in Islamic law or fiqh. This study employed a qualitative approach supported by data obtained from printed and electronic media, and informants. The analysis revealed that public resistance to the burial which complied to health protocols was not only embodied in rhetorics or values but made apparent in their attitude. This study concludes that public resistance sucessfully reformed the law by bringing about the new fiqh regarding the burial practice. Since the community might not readily understand and accept this neq fiqh, we advised the government and related institutions to take intensive approaches to introduce this transformation to public.

Zettler, Patricia J, Micah L Berman and Efthimios Parasidis, ‘Drug and Vaccine Development and Access’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 163–169
Abstract: This Chapter explains how drugs and vaccines for COVID-19 can reach the market in the United States. As is always true, drug and vaccine manufacturers may seek U.S. Food and Drug Administration (FDA) approval of their products via traditional approval mechanisms and drug manufacturers may offer pre-approval access under the expanded access or right to try pathways. In a public health emergency like COVID-19, an additional mechanism is also available: the Emergency Use Authorization (EUA) pathway. This Chapter (1) assesses how FDA has used its EUA authorities for COVID-19 drugs thus far, (2) considers how FDA has balanced the need for robust evidence of safety and effectiveness for COVID-19 pharmaceuticals against the urgent need to speed patients’ access amid the clinical and political realities of the pandemic, and (3) highlights considerations specific to vaccines should FDA be faced with a request to issue an EUA for a COVID-19 vaccine. The Chapter concludes with recommendations for policymakers and regulators at the federal and state levels. The recommendations aim to improve public understanding of the regulatory process for COVID-19 drugs and vaccines, protect scientific decision making from undue political pressure, and ensure that manufacturers develop robust evidence of safety and effectiveness—and ultimately safe and effective COVID-19 countermeasures.

Zhang, Baobao et al, ‘Building Robust and Ethical Vaccination Verification Systems’ (SSRN Scholarly Paper ID 3782749, 26 January 2021)
Abstract: The rapid development of an effective COVID-19 vaccine provides hope that the pandemic might be brought to an end, but as societies roll out vaccines and begin to open up, policymakers face difficult questions about how to best verify individuals’ vaccine records. Building vaccine record verification (VRV) systems that are robust and ethical will be vital to reopening businesses, educational institutions, and travel. Historically, such systems have been the domain of governments and have relied on paper records, but, now, a variety of non-profit groups, corporations, and academic researchers are developing digital verification systems. These digital vaccine passports include the CommonPass app developed by the World Economic Forum to verify COVID-19 test results and vaccine status, as well as similar systems several major tech companies are actively exploring.VRV systems present both opportunities and risks in tackling the COVID-19 pandemic. They offer hope of more accurate verification of vaccine status, but they also run the risk of both exacerbating existing health and economic inequalities and introducing significant security and privacy vulnerabilities. To mitigate those risks, we propose a series of principles that ought to guide the deployment of VRV systems by public health authorities, policymakers, health care providers, and software developers. In particular, we argue that VRV systems ought to align with vaccine prioritization decisions; uphold fairness and equity; and be built on trustworthy technology.

Zheng, Long, Taoying Li and Qiang Chen, ‘Lessons from China’s Experience: Legal Analysis of Health Risks and Medical Obstacles of Personnel in COVID-19 Control Areas’ (2023) 16 Risk Management and Healthcare Policy 735–745
Abstract: Individuals in controlled areas often face restrictions on their personal freedom, and if they are unable to receive medical treatment when needed, it can significantly increase their health risks. However, current epidemic prevention and control policies do not provide clear guidelines on how to ensure individuals in controlled areas to seek medical attention when faced with health problems. By implementing specific measures that local governments must take in order to protect the health of those in controlled areas, the risks to their health can be greatly reduced.

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