Health / Medical Law & Bioethics

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 endeavours 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?

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.

Introduction: 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.

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.

Abstract: The response to COVID-19 has been mired in political debates. In a moment of scarcity, especially with regard to medical equipment and capacity, the question of who deserves the few available resources becomes front and center. It is in this context that abortion access has been injected into the political and medical response to COVID-19. There are three main sites of the ongoing abortion debate in the COVID-19 context. First, in the application of the Hyde Amendment to the CARES Act, second, in the attempt by state legislators to classify abortion as an elective procedure that cannot be performed during a time of PPE and personnel shortages, and, finally, a move by state attorney generals (AGs) to seek greater access abortion via telehealth through changing the FDA rules on a necessary abortifacient. This essay describes the current status of the terrain and the potential long-term implications on abortion access and care.

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 U.S. 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, we address an important question: When new waves of the current pandemic emerge or another novel pandemic emerges, how can the U.S. be better prepared and also ensure a rapid response that reduces rather than exacerbates social and health inequities? We argue for a health equity framework to pandemic preparedness, grounded in meaningful community engagement 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.

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.

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.

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.

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.

Abstract: European Union and the United States have experienced some of the most sever 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.

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.

Abstract: The coronavirus pandemic has forced us to reckon with the possibility of having to ration life-saving medical treatments. In response, many health systems have employed protocols that explicitly de-prioritize people for these treatments based on pre-existing disabilities. This Essay argues that such protocols violate the Americans with Disabilities Act, the Rehabilitation Act, and the Affordable Care Act. Such explicit discrimination on its face violates these statutes. Nor can medical providers simply define disabled patients as being "unqualified" because of disabilities that do not affect the ability to ameliorate the condition for which treatment is sought. A proper interpretation of the law may permit medical providers to use disability as a basis for a rationing decision where an individual's underlying disability will kill the individual in the immediate term regardless of the treatment. However, as this Essay demonstrates, those circumstances will be narrow. Further, the law requires that such imminent-death determinations will be made based on the best available objective evidence, free from both bias against people with disabilities and devaluation of their lives.

Note: see review of this article by Trudo Lemmens, 'Addressing the Tension between Discrimination Law and Pandemic Clinical Triage Protocols' (2020) Jotwell: The Journal of Things We Like (Lots) (published 31 July 2020)

Abstract: This briefing paper provides an account of ventilator availability and procurement in the UK, a summary of government action, and a discussion of other issues associated with ventilator use.

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 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.

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.

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.

Introduction: 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.1 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.2 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.

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.

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.

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.

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.

Abstract: Most commentators claim that age is a determinant of deaths from Co-Vid 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.

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?

Abstract : A COVID-19 has spread across our country and the globe, patients are seeking medical care from behind the safety of a screen, through telehealth. The volume of telehealth visits has skyrocketed since March 2020, exposing a substantial hole in this manner of care: the ability to monitor patients remotely. Recent innovations in wearable devices provide promising benefit to fill this hole and should be assimilated into patient care. Utilizing wearable devices in remote patient care can be a catalyst towards the ultimate triple aim of health care: to increase patient access, reduce overall costs, and increase the quality care. Despite these benefits, changing the standard of care in medicine can be an arduous task. Additionally, wearable devices still face regulatory challenges in gaining classification as a medical device, practitioners face barriers to reimbursement, and there is much uncertainty regarding the ability to protect patient privacy when using wearable devices. Despite these barriers, COVID-19 has disrupted modern day medicine in ways that the population could not have imagined even six-months ago. Addressing these issues will be key in enabling effective care through remote treatment methods and telemedicine.

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.

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.

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.

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.

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?

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. 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.

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.

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.

Introduction: 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.

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.

Extract: 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.

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.

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.

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.

Extract: 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Introduction: 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 care systems have been stretched to breaking point. Unprecedented work is going on around the world to discover effective treatments and vaccines. In their absence, we are reliant upon traditional public health measures that aim to both prevent transmission (through the use of isolation, quarantine, physical distancing, restrictions on movement, shutting of borders, etc.) and detect infected individuals and those possibly exposed to infection (through testing and contact tracing, etc.). The implementation of such actions, particularly physical distancing, has caused massive disruption to social life and economic activity, resulting in significant costs to physical and mental health, increased unemployment and the exacerbation of existing inequalities. The impact of the pandemic and our response will be with us for decades to come.

Introduction: 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.'

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.

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.

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.

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.

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.

Introduction: 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.

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.

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.

Abstract: 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.

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?

This historical retrospective will provide a timeline summary of events to help the reader orient themselves to many aspects of the crisis previously unknown and will discuss the significance of the March 24, 2020 COVID19 Alert No. 2 that had a dramatic impact upon cause of death reporting numbers. Supportive data comparisons suggest the existing COVID-19 fatality data, which has been so influential upon public policy, may be substantially compromised regarding accuracy and integrity, and illegal under existing federal laws. If the fatality data being presented by the CDC is illegally inflated, then all public health policies based upon them would be immediately null and void.

Abstract: For decades, the Department of Justice 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. While 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 - careful examination of the settlements touted in those DOJ press releases calls into question whether DOJ's settlement practices - which almost uniformly lack any admission of responsibility by defendants - are conveying the message DOJ seeks to impart or having the impact it hopes to achieve.

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.

Summary: 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.

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.

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.

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.

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.

Extract: 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.

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.

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.

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.

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.

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.

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.

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.

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.

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 CDC 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 Article 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 Article 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.

_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

Extract from Introduction: 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.

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.

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.

Note: this article is a response to the article by Solnica, Barski and Jotkowitz listed below.

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.

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.

Introduction: This column explores the global health law reforms necessary to progressively realize universal access to a future COVID-19 vaccine. We begin by explaining the importance of global health law in the distribution of essential vaccines as a determinant of public health. The column then turns to examine the human rights foundations of global health law, conceptualizing vaccination access as a universal human right. We find that it will be crucial to develop legal commitments to ensure vaccine access prior to a scientific breakthrough, analyzing the legal barriers that impede global access and the global health law reforms necessary to facilitate global solidarity.

Abstract: In a 2019 report by Woolf and Schoomaker, average life expectancy in the U.S. was revealed to be in decline from 2014-2017, a trend which the COVID-19 pandemic is anticipated to exacerbate in 2020. As we assess in this commentary, concerted actions to address these declines are highly warranted. Among many potential solutions, "legal determinants of health," namely how law can address underlying causes of premature mortality, provide clear options for policymakers seeking to reverse these trends for the next decade. Cost-effective, evidence-based laws can safeguard the public's health, reduce disparities, and extend life expectancy across socio-economic groups, especially in disproportionately impacted U.S. regions. These benefits are often achievable without substantial public sector funding increases.
Yet, public health laws are underutilized. Variations in legal innovations lead to uneven applications of evidence-based laws and geographic disparities in key health indicators. Federal inaction lends to legal inconsistencies in socially controversial spheres, including firearms, reproductive health, and commercial taxation and regulation. Federal and state authorities increasingly preempt lower level public health laws, impeding grassroots initiatives in food and nutrition, environment, or consumer litigation.
Declinations in U.S. life expectancy requires a resetting of national health priorities especially against the backdrop of the greatest public health infectious disease threat of the 21st century. Evidence-based, cost-effective laws can reverse ongoing declines in health and longevity, and help improve social determinants.

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.1 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?

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?

Note: this article was written in 2019, before the coronavirus pandemic.

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.

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.

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; and 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.

This article begins what will need to be a much longer and deeper discussion--if the future develops along certain paths. It proceeds in six parts. The first five of those parts argue that immunity certificates come with major problems. I start by reviewing some of the scientific questions of immunity to COVID-19 and, second, look at antibody tests. The third and fourth parts discuss some of the practical problems they raise, first in issuing COVID-19 immunity certificates and then in how such certificates might be used. (Although not scientifically or ethically exciting, and hence thus far rarely discussed, these may turn out to be the biggest barriers to the implementation of such immunity certificates anytime soon.) Only then, in the fifth and sixth parts, I begin to consider the ethical and social issues stemming from immunity certificates and possible legal barriers to their adoption and use. The last part shifts gears. Although I believe such certificates should not be implemented now, I end with seven suggestions for decision-makers considering them in a less uncertain future.

Abstract: The very first shock of COVID-19 might be over, but the crisis continues. We have already learned much about what the European Union can and cannot do to help its Member States and peoples manage the crisis--and what it might be able to do better.

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: 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.

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.

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 responsible response and an unjust and discriminatory response.

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.

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.

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.

Note: the Harvard Roadmap for Pandemic Resilience discussed in this article is here.

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.

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.

Recently in the United Kingdom, our doctors' trade union The British Medical Association (BMA) and The National Institute for Health and Care Excellence (NICE), the latter established ostensibly to provide: "national guidance and advice to improve health and social care," seem to be in danger of forgetting their values as well as ours, and their mission, their very raisons d'etre.

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., 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.

Abstract: The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, we illustrate how this divergence of private incentives from public health needs widens in contexts of pandemic preparedness and pandemic response. The Essay begins by explaining why the design of pharmaceutical markets in the United States yields suboptimal and sometimes even negative health outcomes. The Essay then follows the trajectory of the drug remdesivir as a case study that illustrates the consequences of relying on profit-driven pharmaceutical research and development (R&D) models for pandemic preparedness and response. We conclude that, contrary to what many commentators suggest, government policy responses to pandemic threats that rely primarily on increasing private market incentives within our existing pharmaceutical markets are unlikely to yield pandemic treatments that meet public healthcare needs. Policy interventions should instead be designed in ways that narrow the divergence of private interests from public health needs, especially in pandemic contexts. Achieving this will likely require greater public-sector involvement in pharmaceutical R&D.

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.

Note: see review of this article by Trudo Lemmens, 'Addressing the Tension between Discrimination Law and Pandemic Clinical Triage Protocols' (2020) Jotwell: The Journal of Things We Like (Lots) (published 31 July 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.

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.

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.

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.'

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.

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.

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

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.

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.

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.

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.

Abstract: The COVID-19 pandemic is the first modern public health crisis with the potential to overwhelm the public health care system. Health care is a shared society resource, and thus the ethical principles guiding its rationing require health care services, drugs, and equipment to be applied where they are most effective, which gives priority to patients most likely to benefit from treatment. Health care providers--primarily physicians--will make these rationing decisions, and providers deserve considerable latitude for good-faith decisions guided by settled ethical frameworks. Those disadvantaged by these decisions are likely to second-guess those who make them. Providers have a responsibility to make these decisions fairly, both procedurally and substantively, and, like all professionals, they should be held accountable for them. The legal standard of care requires health care professionals to exercise the skill and knowledge normally possessed by providers in good standing in the same field or class of practice in similar communities acting in the same or similar circumstances. But practicing medicine in crisis conditions, like those created by COVID-19, is not the same as or similar to practicing in non-crisis conditions. Thus, the standard of care, properly applied, expects less of health care professionals making decisions under the stress of COVID-19's triage conditions. Because many health care providers do not perceive this to be true, and for pragmatic and normative reasons, policymakers should articulate clearer rules that limit the liability for health care providers' rationing decisions, as well as other acts and omissions, occurring in crisis conditions. Clarified limitations on liability should not create absolute immunities, however. Health care providers should be accountable when practicing in crisis conditions for their acts, omissions, and decisions--including rationing decisions--that are criminal, reckless, willful or wanton, grossly negligent, or unlawfully discriminatory, or that are intentional violations of settled ethical norms.

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.

Extract from Introduction: On 28 February 2020 the WHO issued a report on China's efforts to control the Coronavirus outbreak, dictating a comprehensive government-led 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.

Article 49-3 is a nasty part of the Vth Republic's Constitution, introduced to transcend the 'instability' of governments under the IVth Republic. However, it was conceived for rare situations in which a government could not muster a majority in the National Assembly to act on problems of national significance in emergency circumstances....

As at 2 June, France had over 28,900 deaths attributed to COVID-19, in the 'top' league (apart from the populous US) with its neighbours UK, Italy, Spain and Belgium. Of this total, an estimated 37% occurred in 'medical-social' institutions, overwhelmingly aged care facilities. The debilitated hospital system has had to cope with the rest. T

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.

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.

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.

Abstract: 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.

Introduction: 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

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.

Abstract: Front-line healthcare personnel, particularly anesthetists and others 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 intubation of COVID-19 patients. Although several international bodies have issued recommendations for a very high-level PPE to be used when intubation procedures are undertaken, the current PPE guidelines in Australia are more relaxed, and hospital authorities relying on them might not comply with legal obligations to their employee healthcare workers. Failure to provide high level PPE in many hospitals is of concern for large number of healthcare workers; this article examines the scientific literature on the topic and provides a legal perspective on hospital authorities' possible liability in negligence.

Note: the articles in this special issue are being progressively added to the journal's website. We have listed them in the relevant place in this bibliography.

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.

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.

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 patient, 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.

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.

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.

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'.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic presents substantial challenges to global health and social care systems. Mental health services have faced restrictions in service delivery, risking the deterioration of already vulnerable individuals. Mental health staff have been working with new risks, in unfamiliar ways, for which they often feel inexperienced and untrained, for example accessing and using personal protective equipment (PPE).

Prisons face unique additional hazards to both prisoners and staff. Public Health England's recent report describes limited and variable COVID-19 testing, concerns about an outbreak in prisons and the unsuccessful follow-through of the early release strategy which, according to modelling, would considerably reduce deaths from COVID-19. The report also highlights the longer-term challenges. Whilst recognising these additional difficulties, we argue that there is precedent and evidence from which we can learn. We propose ways to optimise the support to staff and prisoners.

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.

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.

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.

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.

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.

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.

Abstract: The COVID-19 pandemic currently wracking the world represents a crucial test for our ethical toolkit. Governments, institutions and individuals are suddenly called upon to make life and death decisions for which they typically ill-prepared. Vocabulary which has suddenly become so familiar--"flatten the curve"; "social distancing"; "R0"--was unknown to most of us a bare few weeks ago. Even for experts, every option continues to have huge uncertainties associated with it. When experts are divided and unsure, how are the rest of us responsibly to decide how to act and who to trust?

In this paper, we focus on the responsibilities, in particular, of people like ourselves and (we assume) many readers of this journal: people with a genuine claim to expertise in some area, but none in epidemiology. They may be experts in ethics or in law or in some other branch of the sciences or of medicine. These kinds of expertise are (we believe) every bit as valuable as expertise in epidemiology, but they usually leave us ill-equipped to assess claims in that discipline. What is our role and what our responsibilities in the face of our epistemic limitations? How do our responsibilities differ from those of other non-epidemiologists (politicians and businesspeople, for example) who decisions shape responses to the pandemic?

Extract: 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.

Extract from Introduction: 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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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 if the recent four JPA procurement actions facilitated equitable access to medical supplies and services. Secondly, it will ask if 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. This article has been published in a revised form in the European Journal of Risk Regulation [https://doi.org/10.1017/err.2020.91]. This version is free to view and download for private research and study only. Not for re-distribution or re-use.

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.

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.

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.

Abstract: At some health establishments, doctors and nurses employed there are refusing to treat COVID-19 patients - even when they have been provided with the necessary personal protective equipment. 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 (SA), the SA Nursing Council and some of the provisions of the SA 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.

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.

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.

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.

See section entitled 'Medicolegal implications' - paragraphs 23-31

Extract (para [23]): 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

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.

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.

Introduction: American history can serve as a map for how we survive COVID-19. How did past generations of Americans survive plagues and pandemics, most of which have been viral? What map have our fathers and mothers handed to us? Like a quest in which we need a magic ring for survival, I think there are three necessary steps we must take on this journey.

Abstract: China's transformation from developing economy to powerhouse status ranks among the most dramatic stories of the 21st century, with the Belt and Road Initiative its latest chapter. But serious concerns over the government's treatment of the Uighurs and human rights, and the devastating outbreak of Covid-19, threaten to derail the country's ambitious project.

Abstract: More than a third of the world population is currently under some form of partial or total lockdown to limit morbidity and mortality due to covid-19. Whereas these measures are working, they are exerting an unprecedented negative socio-economic impact on the general wellbeing, and thus may not be sustained for long. Alternative control measures that limit the spread of the virus and yet facilitate socioeconomic progression and wellbeing are urgent. In this article, we make suggestions based on the disease transmission characteristics, the World Health Organization recommendation, and current practices across the globe. The suggestions focus on the prevention of transmission and acquisition by; (1) ensuring all put on some form of protective barriers to prevent further spread and acquisition while in public or risky spaces, (2) proactively preventing contamination of surfaces at individual and group/community level, (3) disinfecting frequently all surfaces prone to contamination in public and private spaces (4) ensuring that all gathering, work, schools and other public places have COVID-19 prevention protocols in place and are followed, (5) developing an efficient surveillance system that ensures early detection and isolation of COVID-19 cases, (6) strengthening health facilities at all levels of the healthcare system to ably screen, test, isolate, and manage COVID-19 before complications set in, (7) Stepping up health education and awareness at population level on prevention measures for COVID-19 using all possible platforms, (8) Designing special prevention measures for congested neighborhoods and slum dwellings, care homes, and other institutionalized dwellings to prevent a surge in infection and catastrophes, and finally (9) strengthening national, regional and global collaboration to prevent cross-border transmission. A combination of several of the measures above should help ease lockdown and moreover sustain the gains in the absence of the vaccine - thus, ease the consequences of strict social distancing, travel bans and lockdown across settings.

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.

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.

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.

Abstract: In the first two months of the COVID-19 pandemic, the Republic of Korea (South Korea) had the second highest number of cases globally yet was able to dramatically lower the incidence of new cases and sustain a low mortality rate, making it a promising example of strong national response. We describe the main strategies undertaken and selected facilitators and challenges in order to identify transferable lessons for other countries working to control the spread and impact of COVID-19. Identified strategies included early recognition of the threat and rapid activation of national response protocols led by national leadership; rapid establishment of diagnostic capacity; scale-up of measures for preventing community transmission; and redesigning the triage and treatment systems, mobilizing the necessary resources for clinical care. Facilitators included existing hospital capacity, the epidemiology of the COVID-19 outbreak, and strong national leadership despite political changes and population sensitization due to the 2015 Middle East respiratory syndrome-related coronavirus (MERS-CoV) epidemic. Challenges included sustaining adequate human resources and supplies in high-caseload areas. Key recommendations include (1) recognize the problem, (2) establish diagnostic capacity, (3) implement aggressive measures to prevent community transmission, (4) redesign and reallocate clinical resources for the new environment, and (5) work to limit economic impact through and while prioritizing controlling the spread and impact of COVID-19. South Korea's strategies to prevent, detect, and respond to the pandemic represent applicable knowledge that can be adopted by other countries and the global community facing the enormous COVID-19 challenges ahead.

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.

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.

Abstract: In the context of responses to the Covid-19 pandemic, the paper examines the African regional regime for public health crises and disasters. Using the combined analytic lenses of Capability Approach, Institutional Theory, Constructivism, New Regionalism Approach and Actor Network Theory, it focuses on the opportunities offered by, and limitations of, the African Union legal order.

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.

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.

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.

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.

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.

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.

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.

Abstract: Law can serve as both an enabler and a barrier to global health, equity, and justice. 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 nationalism 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.

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, one proposal that some governments have suggested, including Chile, Germany, Italy, the UK, and the USA, 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.

Abstract: 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Abstract: COVID-19 has led 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 creates a risk that the safeguards in place to assure that vaccines are safe and effective will be ignored. The U.S. 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 from 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, undersharing, and responding to misinformation - and suggests how to handle them.

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. 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. 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.

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.

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). Specifically, it discusses what appears to be a hiatus between the nature of transnational and European regulatory frameworks governing the complex process leading to the marketing authorisation of new vaccines, which are largely inspired by market-oriented logics, and the guidelines, decisions and policies adopted by Public Health institutions to face emergent health threats, including PEDs. Vaccines being the universally recognised prime method of prevention, immunization campaigns and vaccine 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 recent PED outbreaks, to conclude that the COVID-19 pandemic calls for a paradigm shift in vaccine R&D, which should become integral to public health preparedness.

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.

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.

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.

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.

Introduction: 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.

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.

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.

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.

Abstract: This piece 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 piece reflects on the longer term need for suitable procurement rules to face impending challenges, such as Brexit and, more importantly, climate change.

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.

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.

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.

Introduction: 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.

Extract from Introduction: 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. 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. Following criticism, NICE explicitly clarified that frailty scores should not be used to inform decisions in patients younger than 65 yr, or with a stable learning disability.... The current practice guidelines issued by NICE are neither utilitarian nor egalitarian. They differentiate between people on the basis of probability of survival (as predicted, supposedly, by frailty), but not length or quality of life (Table 1). This will maximise the numbers of lives saved, but not give everyone an equal chance, nor will it maximise the good of the outcome in terms of years of life saved, adjusted for their quality.

Note: the Guidelines referred to in this article are the National Institute for Health and Care Excellence, 'COVID19 Rapid Guideline: Critical Care in Adults' (NICE, 20 March 2020).

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.

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.

Abstract: Describes the EU and international legal landscape concerning global research activities associated with epidemic and pandemic threats to public health, including on the use of genetic material and new virus data. Discusses the aims of the European Commission's Decision 1082/2013 to improve international cooperation on vaccine-preventable diseases and the World Health Organization's influenza preparedness strategy.

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.

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.

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.

Abstract: 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.

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.

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.

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.

Abstract: During its most recent Term, the U.S. Supreme decided an unusually large number of cases of interest to health care and mental health professionals on topics that included abortion, capital punishment, contraception, DACA, HIV prevention, the insanity defense, jury verdicts, Obama Care, police-official immunity, and sex. The degree of interest among health professionals in these issues was evidenced by the large number if amicus curiae briefs filed this Term by health-related organizations. The Court also decided a variety of other issues of general interest and importance, including asylum and immigration, elections, international child custody, gun laws, presidential subpoenas, religious schools, and robocalls. The work of the Court was interrupted by COVID, and near the end of the Term, the Court held some oral arguments by telephone. The Court decided 60 cases, including 53 'signed' merits opinions after oral argument, an unusually low number of cases. Chief Justice Roberts was the 'median' justice--in the majority in 12 of the 13 5-4 decisions. The Court will undoubtedly open with only eight justices. On September 18, 2020, Justice Ruth Bader Ginsburg passed away at age 87. She had served on the Court since 1993. She was a gifted lawyer and justice. She also became a cultural icon--'the Notorious RBG.' Her death in the middle of a presidential campaign set off a major political struggle. The cases already selected for the October 2020 Term (beginning October 5), suggest another extraordinary Term ahead.

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.' 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.

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.

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.

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.'

Note: this special issue contains many relevant articles, but almost all are in Italian only, and we 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.

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.

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.

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.

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.

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. Two recent decisions of tribunals illustrate these concerns.

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.

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.

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.

Abstract: John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses patient safety during the present coronavirus pandemic

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 legislation named 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.

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 etc can be adjudged as negligent actions for which medical practitioners & medical institutions can be liable.

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.

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.

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).

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.

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.

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.

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.

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.

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 (a) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (b) the relevance of saving lives; (c) the flaws of first-come, first-served allocation; (d) the relevance of post-episode survival; (e) the difference between age and other life-expectancy expectancy; and (f) 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 (a) conflicts between maximizing benefits and priority to the worst off; (b) role-based priority; and (c) whether patients' existing lifesaving resources should be subject to redistribution.

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.

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.

Abstract: In a crisis like the Covid-19 pandemic, the role of judges is first and foremost to adjudicate urgent requests for temporary restraining orders and preliminary injunctions. This means that judges hearing challenges to bans on gatherings, orders to close gun shops, orders to halt abortion care, and detention of civil immigration detainees in crowded and unsanitary conditions are issuing orders based on the parties' pleadings alone. There is no time--yet--for the discovery, expert testimony, or amicus briefs from professional groups that typically inform assessments of science by judges. This essay examines the role public health science is likely to play in the coming months as judges field challenges to mandatory orders adopted as part of the community mitigation the Covid-19 pandemic. It identifies voluntary guidelines from international and federal health agencies as a resource judges rely on heavily in reviewing emergency communicable disease control orders and argues that transparency of and accountability for guidelines should therefore be held to a higher bar than their voluntary status might otherwise suggest.

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 [1]. Even more worrisome, various news articles have begun to shed light on the healthcare inequities that have become increasingly more transparent during this crisis [2-4]. 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 [5]. 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 [6-8]. 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 [9]. 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 [10]. 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 [10]. 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 [11]. 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 [12]. 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.

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.'

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.

Abstract: Reports on allegations that the Chinese authorities perceived a risk to public order when doctors first raised concerns about the coronavirus outbreak, and tried to silence them. Examines the cases of Dr Ai Fen and Dr Li Wenliang. Discusses whether China missed opportunities to limit the spread of disease because of preoccupation with administrative secrecy.

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.