Law Commons^™

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

The Us Supreme Court’S Rulings On Large Business And Health Care Worker Vaccine Mandates: Ramifications For The Covid-19 Response And The Future Of Federal Public Health Protection, Lawrence O. Gostin, Wendy E. Parmet, Sara Rosenbaum

Georgetown Law Faculty Publications and Other Works

On January 13, 2022, the Supreme Court issued 2 landmark rulings on the federal government’s power to mandate COVID-19 vaccinations. The Court curtailed the government’s ability to respond to the pandemic and may have also severely limited the authority of federal agencies to issue health and safety regulations.

In National Federation of Independent Business v Department of Labor, the Court blocked an Occupational Safety and Health Administration (OSHA) emergency temporary standard (ETS) requiring vaccination, subject to religious or disability accommodations, or weekly testing and masking in businesses with 100 or more employees. In Biden v Missouri, the Court …

The First 2 Years Of Covid-19: Lessons To Improve Preparedness For The Next Pandemic, Jennifer B. Nuzzo, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On December 31, 2019, the World Health Organization (WHO) Country Office in China reported novel “viral pneumonias of unknown cause” in Wuhan, but China did not confirm case clusters until January 3, 2020. Two years later, more than 285 million cases and 5.4 million deaths have been reported. As of December 2021, more than 800 000 COVID-19 deaths have occurred in the US, surpassing the 675 446 total deaths that occurred during the great influenza pandemic of 1918. The COVID-19 pandemic reduced global economic growth by an estimated 3.2% in 2020, with trade declining by 5.3%; an estimated 75 million …

Worth A Shot: Encouraging Vaccine Uptake Through "Empathy", Jody L. Madeira

Articles by Maurer Faculty

Pro- and anti-vaccine organizations and individuals have frequently invoked empathy as a strategy for increasing uptake of COVID-19 precautions, including vaccinations. On one hand, vaccine supporters deployed empathy to defuse conflict, prioritize safeguarding the collective welfare, and avoid government mandates. On the other hand, vaccine opponents used empathy to emphasize the alleged individual effects of pandemic precautions, mobilize public voices, and stress the importance of medical freedom in policy-making contexts.

This Article first defines empathy and reviews empathy scholarship, paying particular attention to its relationship with narrative and the contexts where empathy can be difficult or dangerous. It then applies …

No Future But A Shared Future, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to …

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

Pediatric Covid-19 Vaccines: What Parents, Practitioners, And Policy Makers Need To Know, William J. Moss, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The US Food and Drug Administration (FDA) granted Emergency Use Authorization for Pfizer-BioNTech’s mRNA COVID-19 vaccine (BNT162b2) for children 5 to 11 years of age on October 29, 2021. The Centers for Disease Control and Prevention recommended use of the vaccine among children in this age group on November 2, 2021. Approximately 28 million children are now eligible for vaccination, with only those younger than 5 years remaining excluded from vaccine eligibility. The benefits of pediatric COVID-19 vaccines are clear. Vaccinations protect children, decrease spread to families and communities, and ensure educational continuity. What do parents, practitioners, and policy makers …

Twenty Years After The Anthrax Terrorist Attacks Of 2001: Lessons Learned And Unlearned For The Covid-19 Response, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The 20th anniversary of the terrorist attacks on September 11, 2001, resulted in deep national reflection. Less remembered are the events that began to unfold 7 days later as anonymous letters laced with deadly anthrax (Bacillus anthracis) spores began arriving at postal facilities, media companies, and congressional offices. The first death from inhaled anthrax exposure occurred on October 5, with an additional 4 deaths and 17 infections over the ensuing months.

The anthrax attacks exposed a health system ill-equipped to respond to acute emergencies. This article explores the lessons learned, and unlearned, from the anthrax attacks, through to …

Covid-19 Vaccine Mandates—A Wider Freedom, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

President Biden has required COVID-19 vaccinations across much of the US workforce, reaching nearly 100 million workers. Opponents call it unconstitutional, a violation of personal freedom, and even “un-American.” The truth is that vaccine mandates are lawful and deeply entrenched in US history and values. They constitute a “wider freedom” so that everyone in society can feel safer where they work, learn, worship, and live.

An International Agreement On Pandemic Prevention And Preparedness, Lawrence O. Gostin, Sam F. Halabi, Kevin A. Klock

Georgetown Law Faculty Publications and Other Works

During late 2021, national delegations are, or have, met at the United Nations General Assembly, the G20, and, most importantly, the Special Session of the World Health Assembly in November to determine whether the world needs a new international agreement to address pandemic prevention, preparedness, and response. The current international agreement, the International Health Regulations (2005), failed to work effectively – SARS-CoV-2 was not detected sufficiently early, relevant information was not shared efficiently, and the global response has not been coordinated. Even the most basic investigations were inadequate such as to discover the origins of SARS-CoV-2. Current proposals focus on …

Systemic Racism, The Government’S Pandemic Response, And Racial Inequities In Covid-19, Ruqaiijah Yearby, Seema Mohapatra

All Faculty Scholarship

During the COVID-19 pandemic, the federal and state governments have ignored racial and ethnic minorities’ unequal access to employment and health care that results in racial inequities in COVID-19 infections and deaths. In addition, they have enacted laws that further exacerbate these inequities. Consequently, many racial and ethnic minorities are employed in low-wage essential jobs that lack paid sick leave and health insurance. This lack of benefits causes them to go to work even when they are sick and prevents them from receiving appropriate medical treatment. As a result, racial and ethnic minorities have disproportionately been infected and died from …

Post-Pandemic Privacy Law, Tiffany C. Li

Law Faculty Scholarship

COVD-19, the global pandemic that began in 2019, altered how we live our lives in just about every way imaginable. Some of those changes were obvious-for example, those who were fortunate enough to be able to work from home began working online-while other changes were more subtle. The latter category included unprecedented levels of data collection by governments and organizations purporting to collect information that would help stop the pandemic's spread. Given the deadly nature of COVID-19, few would question any public health efforts, no matter their impact on privacy. However, the lack of attention to privacy issues during the …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Second Thoughts On Fda's Covid-Era Mental Health App Policy, Michael Mattioli

Articles by Maurer Faculty

As the coronavirus pandemic swept across the globe in April 2020, the US Food and Drug Administration (FDA) made an unusual decision. The agency announced that it would relax its enforcement of compliance rules for “digital therapeutics”—smartphone apps designed to address mental health disorders. The measure was a response to widely reported upticks in symptoms of anxiety, depression, and substance abuse brought on by the pandemic. As an added benefit, the agency explained, digital therapeutics could promote social distancing by removing patients’ need to visit health care providers.

This essay explores the possible lasting effects of the FDA’s temporary suspension …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

Introduction A Bold Agenda For The Next Steps In Health Reform, Lindsay Wiley

Articles in Law Reviews & Other Academic Journals

Introduction: In the aftermath of the largely failed Clinton-era health reform push and the build-up to Obamaera reforms, experts worried that another failed effort could cast a ten-year shadow. The tenth anniversary of the Affordable Care Act offered an opportunity for participants in the 2019 Next Steps in Health Reform conference to reflect. If the ACA proves resilient, what paths will it have paved for the next decade of reforms?

Health Priorities For Sustainable Development, Lisa E. Sachs, Jeffrey D. Sachs

Columbia Center on Sustainable Investment Staff Publications

The right to health has been repeatedly recognized as one of the core human rights, essential for human functioning, human dignity, economic well-being and development. But the right to health continues to elude hundreds of millions and with Covid-19, perhaps billions of people. Poverty remains the most critical obstacle to the realization of the right to health in developing countries. Achieving universal health coverage, before the additional costs of Covid-19, would require roughly $50 billion per year, approximately 0.1 percent of the GDP of the high-income OECD countries. Yet despite this broad understanding of the vicious cycle of poverty and …

Mid-Atlantic Ethics Committee Newsletter, Fall 2020

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Medicaid's Vital Role In Addressing Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

Faculty Scholarship

Medicaid plays an essential role in helping states respond to crises. Medicaid guarantees federal matching funds to states, which helps with unanticipated costs associated with public health emergencies, like COVID-19, and increases in enrollment that inevitably occur during times of economic downturn. Medicaid’s joint federal/state structure, called cooperative federalism, gives states significant flexibility within federal rules that allows states to streamline eligibility and expand benefits, which is especially important during emergencies. Federal emergency declarations give the secretary of Health and Human Services temporary authority to exercise regulatory flexibility to ensure that sufficient health care is available to meet the needs …

Expanding Access To Patents For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases …

Upholding Tribal Sovereignty And Promoting Tribal Public Health Capacity During The Covid-19 Pandemic, Heather Tanana, Aila Hoss

Utah Law Faculty Scholarship

Tribes are sovereign nations with authorities and responsibilities over their land and people. This inherent sovereign authority includes the right to promote and protect the health and welfare of their communities. The COVID-19 pandemic has brought national attention to the health inequities experienced by American Indian and Alaska Native communities. The sovereign legal authority for Tribes to respond to this pandemic has received less attention. This Chapter describes some, but not all, of the urgent legal issues impacting Tribal response to the COVID-19 pandemic. It describes and identifies gaps in federal Indian health policies and highlights how Tribes have exercised …

Busting Myths And Dispelling Doubts About Covid-19, Mark Findlay

Research Collection Yong Pung How School Of Law

The Centre for AI and Data Governance (CAIDG) at Singapore Management University (SMU) has embarked over past months on a programme of research designed to confront concerns about the pandemic and its control. Our interest is primarily directed to the ways in which AI-assisted technologies and mass data sharing have become a feature of pandemic control strategies. We want to know what impact these developments are having on community confidence and health safety. In developing this work, we have come across many myths that need busting.

Hearing On The Foreign Sovereign Immunities Act, Coronavirus, And Addressing China’S Culpability Before The Senate Committee On The Judiciary, Russell A. Miller

Scholarly Articles

There are a number of theories about the Chinese government’s acts or omissions concerning the emergence and world-wide spread of the coronavirus that may be the proximate cause of actionable transboundary harm. All of these theories start with the incontestable fact that the coronavirus outbreak originated in China. One theory is concerned with the conduct of the Chinese government after the health crisis emerged. This “ex post” theory alleges a broad range of acts and omissions that helped transform a local outbreak into a global pandemic. There is room for this theory under the Transboundary Harm Principle. But the “ex …

Law School News: Will Sheehan '20 Selected For Prestigious Immigration Fellowship 06-17-2020, Michael M. Bowden

Life of the Law School (1993- )

No abstract provided.

Emergency Parole Release For Older Parole-Eligible Doc Inmates, David I. Bruck

Scholarly Articles

Professor Bruck writes to Secretary Moran and Chairwoman Bennett to urge them to protect elderly Virginia prison inmates from the risk of death from COVID-19 by granting immediate parole release to as many over-60 parole-eligible prisoners as possible, upon a showing that they are at low risk to re-offend, and have a supportive home to go to once released.

Rwu Law News: The Newsletter Of Roger Williams University School Of Law 06-2020, Roger Williams University School Of Law, Michael M. Bowden, Katie Mulvaney

Life of the Law School (1993- )

No abstract provided.

Imagining Global Health With Justice: Transformative Ideas For Health And Wellbeing While Leaving No One Behind, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

The disproportionate impact of COVID-19 on communities of color in the United States and immense vulnerabilities in lower-income countries has revealed a global health reality that is often overshadowed by decades of progress in overall global health, with new lows in child and maternal deaths every year, more people with HIV receiving access to lifesaving anti-retroviral therapy, and rising life expectancies. That reality is one of vast national and global inequalities, with the lived experiences of members of marginalized populations far removed from laudatory health headlines.

Here, we propose an ambitious agenda to bridge the gap between progress in global …

Who Gets The Ventilator? Disability Discrimination In Covid-19 Medical-Rationing Protocols, Samuel Bagenstos

Articles

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 …

State Prosecutors At The Center Of Mass Imprisonment And Criminal Justice Reform, Nora V. Demleitner

Scholarly Articles

State prosecutors around the country have played a crucial role in mass imprisonment. Little supervision and virtually unsurpassed decision making power have provided them with unrivaled influence over the size, growth, and composition of our criminal justice system. They decide which cases to prosecute, whether to divert a case, whether to offer a plea, and what sentence to recommend. Their impact does not stop at sentencing. They weigh in on alternative dockets, supervision violations, parole release, and even clemency requests. But they are also part of a larger system that constrains them. Funding, judicial limits on their power, and legislative …

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

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.