HealthLawProf Blog

Comments on the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine

Ana Santos Rutschman (Saint Louis University), Robert Gatter (Saint Louis University), Timothy L. Wiemken (Saint Louis University), Julia Barnes-Weise, Comments on the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, St. Louis U. Legal Stud. Research Paper No. 2020-25:

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.

COVID-19 And The Duty of A State to Protect the Public’s Health and Security During A Pandemic - A European Convention on Human Rights Perspective

Sascha Dov Bachmann (Canberra Law School), Joachim Sanden (Leuphana University), COVID-19 And The Duty of A State to Protect the Public’s Health and Security During A Pandemic - A European Convention on Human Rights Perspective, Indonesian J. Int’l & Comp. L. (2020):

This article discusses the consequences of the broader concept of health as a security concept under the applicable law of the European Convention on Human Rights (ECHR) in the case of serious threats of to public health. Based on judgments by the European Court of Human Rights, a positive obligation of the Member States to act proactively towards health protection can be extracted from Article 5 (1) ECHR (liberty and security). The authors explore the scope of this provision in times of a public health emergency like a pandemic, a prolonged natural hazard or bio-terrorism to protect a citizen´s health and life. This article has particular relevance before the present global Coronavirus (COVID-19) pandemic. It argues in favour of a government’s right and duty to keep its citizens safe from harm by providing an ECHR perspective on governmental duties to act in a proactive way when dealing with public health emergencies while at the same time balancing its human rights obligations.

Privacy in Pandemic: Law, Technology, and Public Health in the COVID-19 Crisis

Tiffany C. Li (Yale Law School), Privacy in Pandemic: Law, Technology, and Public Health in the COVID-19 Crisis, 52 (3) Loyola U. Chic. L. J. (2021, Forthcoming):

The COVID-19 pandemic has caused millions of deaths and disastrous consequences around the world, with lasting repercussions for every field of law, including privacy and technology. The unique characteristics of this pandemic have precipitated an increase in use of new technologies, including remote communications platforms, healthcare robots, and medical AI. Public and private actors are using new technologies, like heat sensing, and technologically-influenced programs, like contact tracing, alike in response, leading to a rise in government and corporate surveillance in sectors like healthcare, employment, education, and commerce. Advocates have raised the alarm for privacy and civil liberties violations, but the emergency nature of the pandemic has drowned out many concerns. This Article is the first comprehensive account of privacy impacts related to technology and public health responses to the COVID-19 crisis. Many have written on the general need for better health privacy protections, education privacy protections, consumer privacy protections, and protections against government and corporate surveillance. However, this Article is the first comprehensive article to examine these problems of privacy and technology specifically in light of the pandemic, arguing that the lens of the pandemic exposes the need for both widescale and small-scale reform of privacy law. This Article approaches these problems with a focus on technical realities and social salience, and with a critical awareness of digital and political inequities, crafting normative recommendations with these concepts in mind. Understanding privacy in this time of pandemic is critical for law and policymaking in the near future and for the long-term goals of creating a future society that protects both civil liberties and public health. It is also important to create a contemporary scholarly understanding of privacy in pandemic at this moment in time, as a matter of historical record. By examining privacy in pandemic, in the midst of pandemic, this Article seeks to create a holistic scholarly foundation for future work on privacy, technology, public health, and legal responses to global crises.

Vaccine Trials: A Review of needed Ethical Reconsideration and the Law

Chinomnso Okebie (University of Essex), Elina Konstantinidou (Anglia Ruskin University), Vaccine Trials: A Review of needed Ethical Reconsideration and the Law, MSU J. Med & L. (2021, Forthcoming):

Communicable diseases is as old as mankind. With recent advances in medical sciences and increased human activities, recent years have seen even more resilient infectious diseases. While sciences have made numerous advances in the fight and eradication of such diseases strong contentions still exists on ethics and processes. With innovations around vaccines, the importance of humans and the key stakeholders need to be emphasized. This paper looks at the various theories and ethical implications of vaccine trials and testings and how this might be impacting innovation and the law. It further highlights the importance of proper ethical processes to vaccine trials and how such would not only enhance the process but provide workable methods for future pandemics. It critically analyses some important theoretical frameworks related to vaccine trials and how these tie to protecting not just the human rights of volunteers but future patients and other stakeholders.

Reinventing the Wheel … and Rolling Over Fundamental Freedoms? The COVID-19 Epidemic in France and the ‘State of Health Emergency'

Sébastien Platon (University of Bordeaux), Reinventing the Wheel … and Rolling Over Fundamental Freedoms? The COVID-19 Epidemic in France and the ‘State of Health Emergency' The Theory and Practice of Legislation

In order to cope with the COVID-19 crisis, the French Parliament has adopted an Act creating a new emergency powers regime, dubbed state of health emergency, which is currently in force. The present paper aims at analysing and providing a critical appraisal of this regime. In particular, it will be demonstrated that this regime is rather imbalanced in that it confers important powers to the executive with limited checks and balances. It will also be contended that the creation of a new regime was not necessary, and that it would have been wiser to amend the existing state of emergency.

COVID-19 and Federalism in India: Capturing the Effects of Voluntary, State and Central Responses on Mobility

Himangshu Kumar, Manikantha Nataraj, Srikanta Kundu, COVID-19 and Federalism in India: Capturing the Effects of Voluntary, State and Central Responses on Mobility, SSRN:

In response to rapidly rising COVID-19 cases, nations resorted to two channels to reduce population mobility and ensure social distancing. These channels were government-ordered containment and closure measures; and voluntary reductions in mobility due to rising public awareness. Initially, India’s state governments enacted varying social distancing policies until the Central government overrode states to impose a nationwide lockdown on 24th March. This paper examines the relative impact of state and central level policies on changes in mobility. This is analysed using event study difference-in-differences (DID) and panel GLS regressions of state-level data on closure orders and mobility changes. The first policy enacted by each state was ineffective on average, but some states managed to reduce mobility by imposing further restrictions. In contrast, the national lockdown had a much larger and persistent effect for almost all states. Further, rising awareness about COVID-19 did not lead to any independent changes in mobility.

The Politics of a Pandemic

Helen Eenmaa (University of Tartu), Mika Kerttunen (Tallinn University), Eneken Tikk (Tallinn University), The Politics of a Pandemic, SSRN:

The lessons learned from COVID-19 are not only about virology. The pandemic has intensified the dilemma between human and material values in national politics and reiterated the bitter contestation over the world order.

A Trillion Dollar Question: Who Should Pay for COVID-19?

Sebastian Guidi (Yale Law School), Nahuel Maisley (University of Buenos Aires), A Trillion Dollar Question: Who Should Pay for COVID-19? NYU L. Rev. (2021, Forthcoming)

Who should bear the costs of the COVID-19 pandemic? While multilateral institutions are beginning to consider how to distribute them, President Trump and others have suggested suing China for damages. This “lawsuit-approach” draws on a deep-seated conception of international law: states have a sovereign “right to be left alone;” the only limit to this right is a correlative duty to avoid harming others. Those harmed can, then, sue for damages. In this view, who should pay for the costs of the pandemic (and how much) is not a normative question about justice, but rather one about factual causes and actuarial calculations. In this Article, we explore this lawsuit-approach; not for its legal viability, but for its conceptual implications. We exhaustively and critically assess the doctrinal discussion on China’s international liability for the pandemic, while also pointing at deep theoretical implications that this novel crisis has for international law more broadly. Specifically, we make three novel claims. The first is that the arguments of the lawsuit-approach (based on the International Health Regulations and on the no-harm principle), when meticulously analyzed under existing international norms, run into unexpected obstacles. On top of the jurisdictional and evidentiary hurdles noted by many, we argue that the lawsuit-approach faces difficulties stemming from the lack of deep normative agreement, in international law, on how to deal with unprecedented challenges such as COVID-19.

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The Case for Face Shields: Improving the COVID-19 Public Health Policy Toolkit

Timothy L. Wiemken (Saint Louis University), Ana Santos Rutschman (Saint Louis University), Robert Gatter (Saint Louis University), The Case for Face Shields: Improving the COVID-19 Public Health Policy Toolkit, St. Louis Legal Studies Research Paper No. 2020-26:

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.

Health Justice Strategies to Eradicate Lead Poisoning: an Urgent Call to Action to Safeguard Future Generations

Emily A. Benfer (Wake Forest University), Emily Coffey, Allyson E. Gold (University of Alabama), Mona Hanna-Attisha (Michigan State University), Bruce P. Lanphear (University of British Columbia), Helen Y. Li, Ruth Ann Norton, David Rosner (Columbia University), Kate Walz, Health Justice Strategies to Eradicate Lead Poisoning: an Urgent Call to Action to Safeguard Future Generations, 19 (2) Yale J. Health Pol’y, Law, & Ethics (2020):

Despite over a century of evidence that lead is a neurotoxin that causes irreparable harm, today, lead continues to pervade children’s environments and remains a constant threat to health and wellbeing. One in three homes across the United States housing children under the age of six has significant lead-based paint hazards that place occupants at risk of permanent neurological harm and lifelong poor health risks. During the COVID-19 pandemic, the potential for lead exposure and lead poisoning increased due to a reduction in well child visits, strained public health departments, the move to remote learning and strategies to contain the COVID-19 pandemic that required shelter in place. As the United States works to contain the virus, it must also prioritize the control of lead hazards to prevent permanent harm to children. Federal, state, and local governments must use a range of primary prevention strategies in order to fully eradicate the risks and protect children from lead poisoning. This Article provides a comprehensive examination of best practices for addressing lead poisoning and proposes urgent reform measures at the local and state levels. Successful interventions ultimately prioritize health justice strategies and rely on community ownership and cross-sector participation; dedicate significant resources and funding to completely eliminate lead in the environment; and prioritize primary prevention practices that identify lead-based paint hazards before children are exposed.

Partisanship And Mobility During The COVID-19 Pandemic

Shikhar P Acharya (Loras College), Biniv K Maskay (Loras College), Partisanship And Mobility During The COVID-19 Pandemic, SSRN:

States and local governments have resorted to "social distancing" measures to control the spread of COVID-19 given the absence of pharmaceutical interventions. As communities practice social distancing, either voluntarily or to follow the directives issued by the local and state governments, the mobility of individuals in the community has been reduced remarkably. This paper studies if a county's political affiliation affects its mobility, a proxy for measuring the effectiveness of social distancing. Using the county-level voting record from the 2016 Presidential Election to determine whether a county is "democratic-leaning" or "republican-leaning," this paper finds that mobility, in the areas of retail and recreation, groceries and pharmacies, parks, transit stations, and workplace, are reduced more for "democratic-leaning" counties than for "republican-leaning" counties. On the other hand, residential mobility has increased more for "democratic-leaning" countries than for "republican-leaning" counties.

Patterns of Policy Responses to the COVID-19 Pandemic in Federal vs. Unitary European Democracies

Tim Buthe (TUM), Joan Barceló (Washington University), Cindy Cheng (TUM), Paula Ganga (Columbia University), Luca Messerschmidt (TUM), Allison Spencer Hartnett (University of Oxford), Robert Kubinec (University of Virginia), Patterns of Policy Responses to the COVID-19 Pandemic in Federal vs. Unitary European Democracies, SSRN:

Do countries with federal political structures develop more or less effective policies compared to those with unitary political structures? We seek to resolve this long-standing theoretical debate by arguing that the extent to which federalist countries reap the benefits or suffer the costs of giving sub-national units greater autonomy depends on whether a given policy is itself more optimally implemented homogenously or heterogeneously across different regions. Using both statistical and qualitative case study methods, we analyse national and sub-national policy responses to COVID-19 in 2 federal (Germany and Switzerland) and 2 unitary countries (France and Italy). We find that overall, federal countries are more likely to possess heterogeneity in their policy responses than unitary countries. We find mixed evidence as to whether federal or unitary countries' policies are more responsive to the severity of the COVID-19 crisis at the sub-national level.

Pregnancy's Risks and the Health Exception in Abortion Jurisprudence

Elyssa Spitzer (Harvard University), Pregnancy's Risks and the Health Exception in Abortion Jurisprudence, Georgetown J. Gender & L. (2021, Forthcoming):

Current abortion jurisprudence provides logically sufficient grounds for universal access. Under the health exception, abortion-regulating legislation must explicitly permit abortion access when a pregnancy threatens a pregnant person’s health. This article argues that, given the universal risks of pregnancy and birth, the reasoning of the health exception supports abortion access for all pregnancies, pre-and post-viability. Though the Court has presumed risks in pregnancy to be rarities, contemporary medical research into pregnancy and birth make clear how sweepingly common, unpredictable, severe, and multiple health risks remain. Since 1999, maternal mortality and morbidity rates – both persistently worse for people of color – have been increasing. Combing the legal standard and medical research, this article demonstrates that according to the logic of the health exception, abortion should be permitted in all circumstances, as each pregnancy and birth poses a threat to the pregnant person’s health. This logical consequence has implications for abortion access. If the health exception were given the effect this article argues both jurisprudence and medical research mandate, abortion should be available whenever sought, viability-defining legislation notwithstanding.

States As Activists

Isaac Buck (University of Tennessee), States As Activists, 39 L. Legal Med. 121 (2019):

Empowered to play a larger role in the delivery and administration of health care, a number of states are attempting to solve the pharmaceutical pricing crisis in creative and varied ways. This essay summarizes three particular states’ more activist approaches, including states that have sought to empower their Medicaid programs to limit coverage of certain drugs based on price, attempted to use leverage to impose cost-efficiency requirements, and, in the most dramatic example, relied on new usage of “gouging” laws to bring down the costs of prescription drugs. Although all three approaches have met substantial resistance, they illustrate a new era of state experimentation in an effort to bring down the cost of prescription drugs.

Election Regulation during the COVID-19 Pandemic

Ilya Shapiro (Cato Institute), James T. Knight II, Election Regulation during the COVID-19 Pandemic, CATO Institute, Legal Pol’y Bulletin No. 5 (2020):

The ongoing pandemic has necessitated dramatic changes to nearly every aspect of American life. The ways we work, shop, eat, and socialize have been radically restructured to protect our own health and that of our communities. This November, that radical restructuring will extend to the way we vote. Changes to our voting systems to safeguard public health, such as by allowing mail‐​in voting, are sorely needed, particularly if fears of another COVID-19 wave in the fall come true. At the same time, hastily switching from in‐​person voting to more‐​anonymized systems with which the states lack experience creates the potential for chaos, errors, and decreased electoral legitimacy in the eyes of voters. With little more than two months until the election, states must finalize decisions on what they are doing and communicate those plans to their citizens and the country as a whole.

The Blacker the Berry, Kill the Fruit: Why Being Pregnant and Black is the United States’ Genocide

Rubila Smith, The Blacker the Berry, Kill the Fruit: Why Being Pregnant and Black is the United States’ Genocide, Southern U. L. Center, J. Race, Gender & Poverty (2021, Forthcoming):

The United States of America presents, through the Center for Disease Control and Prevention, alarming data regarding maternal mortality and the disparities amongst black women. Whether the cause is socioeconomic, inadequate access to healthcare, or some sort of genetic difficulty that affects one group more than another, the disparities are present and require immediate correction. However, the United States has failed to address the issues of maternal mortality, especially when black women are steadily suffering from the lack of attention and care. This article shows the troubling disparities, heartbreaking data, and unreal numbers, as well as the attempts across the country to rectify this issue. It concludes that a federal change must take place, and the United States as a whole must be held responsible for the brazen disregard of the inadequate healthcare of black women. Nevertheless, this article shows why healthcare reform, specifically geared to address racial disparities, is necessary to combat maternal mortality.

Regulating Opioid Supply Through Insurance Coverage

Chris Auld (University of Victoria), Jill R. Horwitz (UCLA School of Law), Ben Lukenchuk, Lynn McClelland (University of California), Regulating Opioid Supply Through Insurance Coverage, 39 (9) Health Affairs (2020):

Responding to an opioid crisis in Canada, policy makers have implemented supply-side interventions seldom used in the US, regulating insurance reimbursement to discourage the prescribing of specified opioids. Using national databases of all opioids dispensed through provincial pharmaceutical programs and of opioid hospitalizations from January 2006 through March 2017, we found that requiring physicians to obtain prior authorization for patients to receive reimbursement for OxyContin prescriptions substantially reduced OxyContin fills, particularly among opioid-naive patients; it also reduced overall opioid prescriptions, suggesting limited substitution. “Grandfathering” OxyNeo (an abuse-resistant OxyContin variant), allowing previous OxyContin patients to obtain OxyNeo, increased OxyNeo fills but had no detectable effect on total opioid prescriptions, which points to substantial opioid substitution among chronic users of prescription opioids. We found no effects of regulatory changes on opioid-related hospitalizations. These results suggest that restrictions on pharmaceutical formularies can reduce fills of targeted opioids with the additional benefit of altering treatment of opioid-naive and other patients differently. Canadian policy makers may wish to extend such regulations to more provincial formularies and private insurers, and policy makers in the US and elsewhere could fruitfully follow suit.

A Stronger Claim to Data Protection During Pandemics? Leveraging the American Convention on Human Rights Against Governmental Inaction: A Brazilian Case-Study

Nicolo Zingales, A Stronger Claim to Data Protection During Pandemics? Leveraging the American Convention on Human Rights Against Governmental Inaction: A Brazilian Case-Study, Revista de Direitos Fundamentais & Justiça (2020 Forthcoming)

This article presents a case-study to illustrate the crucial importance of an effective data protection law in the fight against pandemics, and critically assess the extent to which the absence of such framework may amount to a violation of the American Convention of Human Rights. The analysis focuses on Brazil as an emblematic example, as the country has been facing the pandemic without being able to rely on a comprehensive and properly supervised data protection law, while also failing to adopt data-driven responses which could have helped to raise awareness and prevent the spread of the virus. Although the relationship between the adopted policies and the unwavering rise of contagions and deaths is one of correlation, and not necessarily causation, it is argued that an examination of the facts through the lenses of the Convention and its case-law could give sufficient grounding to a claim of responsibility for failure to ensure sufficient protection to the right to privacy, life and integrity. To substantiate such claim, the article begins by describing the Brazilian government´s approach towards the health risks raised by the pandemic (Section 2), and highlighting the privacy and data protection questions raised by technological solutions that are dependent on the collection and use of personal data (Section 3). It follows with an overview of the troubled process of entry into force of a general data protection law in the country, and of a Supreme Court ruling that invalidated the government´s attempt to make use of personal data in order to gather evidence for the adoption of economic measures (Section 4). Finally, having explained the nature of the positive obligations assumed by States that are parties to the Convention, the article examines whether the Brazilian data protection framework has proven fit for purpose during the pandemic (Section 5), and concludes with lessons learned from this case-study (Section 6).

Health Equity Through Housing: A Blueprint for Systematic Legal Action

Scott Burris (Temple University), Katrina Korfmacher (University of Rochester), Katie Moran-McCabe (Temple University), Nadya Prood (Temple University), Kim Blankenship, Angus Corbett, Bethany Saxon (Temple University), Health Equity Through Housing: A Blueprint for Systematic Legal Action, Temple U. Legal Studies Research Paper No. 2020-28

This is the sixth and final report in a series of reports exploring the role of law in housing equity and innovative uses of law to improve health equity through housing. The reports are based on extensive literature scans and semi-structured interviews with people who are taking action in housing policy and practice. The full series includes: Report I: A Vision of Health Equity in Housing; Report II: Legal Levers for Health Equity in Housing: A Systems Approach; Report III: Health Equity in Housing: Evidence and Evidence Gaps; Report IV: Creative People and Places Building Health Equity in Housing; Report V: Governing Health Equity in Housing; and Report VI: Health Equity through Housing: A Blueprint for Systematic Legal Action. This report offers guidance for action based on our research. We propose one overarching recommendation, the adoption of a systematic policy experimentation approach to achieving health equity in housing. We explore this approach through a case study of lead poisoning prevention efforts in Rochester, NY. We then present six areas of housing law that are ideal for experimentation. They range in topics, including strengthening fair housing enforcement to reduce discrimination, and supporting residential stability. The report also contains an appendix with additional ideas for experiments that emerged through our research and interviews.

Americans Outside the Welfare State

Andrew Hammond (University of Florida), Americans Outside the Welfare State, Mich. L. Rev. (2021, Forthcoming):

Federal law excludes millions of American citizens from crucial public benefits simply because they live in the overseas territories. If the Social Security Administration determines an individual has a disability, that person can move to another state and continue to receive benefits. But if that person moves to, say, Guam or the U.S. Virgin Islands, that person loses their right to federal aid. Similarly with SNAP (food stamps), federal spending rises with increased demand—whether because of a recession, a pandemic, or a natural disaster. But unlike the rest of the United States, Puerto Rico, the Northern Mariana Islands, and American Samoa receive a limited amount of federal food assistance, regardless of need. That’s why, after Hurricane Maria decimated Puerto Rico, over a million residents lost food assistance. And with Medicaid, federal law caps medical assistance for each of these five territories, a limit that does not exist for the fifty states or the District of Columbia.

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