Law Commons^™

Intellectual Property And “The Lost Year” Of Covid-19 Deaths, Madhavi Sunder, Haochen Sun

Georgetown Law Faculty Publications and Other Works

Protecting intellectual property (IP) is a question of life and death. COVID-19 vaccines, partially incentivized by IP, are estimated to have saved nearly 20 million lives worldwide during the first year of their availability in 2021. However, most of the benefits of this life-saving technology went to high- and upper-middle-income countries. Despite 10 billion vaccines being produced by the end of 2021, only 4 percent of people in low-income countries were fully vaccinated. Paradoxically, IP may also be partly responsible for hundreds of thousands of lives lost in 2021, due to an insufficient supply of vaccines and inequitable access during …

The Federal Global Migration And Quarantine Network: A Report From The National Academies Of Sciences, Engineering, And Medicine, Lawrence O. Gostin, Georges C. Benjamin, Tequam Worku

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic thrust the US Centers for Disease Control and Prevention (CDC) Division of Global Migration and Quarantine (DGMQ) into the epicenter of the national response. DGMQ is charged with preventing the importation of infectious diseases at land and sea borders and the spread of those diseases within the US. For more than 50 years, the agency’s comprehensive quarantine system, its regulatory powers, and scientific guidance has placed DGMQ at the forefront of emergency response. CDC requested the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess the performance of the DGMQ during the COVID-19 pandemic, covering 5 …

A New Architecture For Global Health Emergency Preparedness And Response—The Imperative Of Equity, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Even before COVID-19 emerged in Wuhan, China, in December 2019, the prevailing global narrative was inequity—in health, income, race, and socioeconomic status. COVID-19 amplified all these inequities. Early in the pandemic, low-income countries were left without key medical resources, such as diagnostic tests, personal protective equipment, and ventilators. By 2021, inequitable vaccine distribution captured global attention and outrage. This year, high-income countries have bought the lion’s share of Paxlovid, a highly effective antiviral treatment. Vaccine inequities remain with only 16% of people in low-income countries having received at least 1 vaccine dose vs 80% of people across high-income countries. This …

Financing The Future Of Who, Lawrence O. Gostin, Kevin A. Klock, Helen Clark, Fatimatou Zahra Diop, Dayanath Jayasuriya, Jemilah Mahmood, Attiya Waris

Georgetown Law Faculty Publications and Other Works

WHO's resources have consistently lagged behind its constitutional mandate. There is a deep misalignment between what governments and the public expect WHO to do and what the organisation is resourced to do. WHO is challenged by low levels of political will to increase its financing, strained government treasuries, and a battle over control of priorities. WHO's Executive Board has charged the Working Group on Sustainable Financing with identifying a viable plan for sustainable financing before the World Health Assembly in May. There is no time to lose. WHO's resourcing strategy must match its mission with assured financial support from member …

Life After The Covid-19 Pandemic, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

After 2 years of a seemingly relentless pandemic that has upended work, education, and social interactions, the questions many are asking are when will we get back to normal and what will life be like after the COVID-19 pandemic? In truth, science cannot fully predict what SARS-CoV-2 variants will arise and the trajectory of the pandemic. Yet, history and informed scientific observations provide a guide to how—and when—society will return to pre-pandemic patterns of behavior. There will not be a single moment when social life suddenly goes back to normal. Instead, gradually, over time, most people will view COVID-19 as …

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 …

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.

Developing An Innovative Pandemic Treaty To Advance Global Health Security, Lawrence O. Gostin, Benjamin Mason Meier, Barbara Stocking

Georgetown Law Faculty Publications and Other Works

Recognizing marked limitations of global health law in the COVID-19 pandemic, a rising number of states are supporting the development of a new pandemic treaty. This prospective treaty has the potential to clarify state obligations for pandemic preparedness and response and strengthen World Health Organization authorities to promote global health security. Examining the essential scope and content of a pandemic treaty, this column analyzes the policymaking processes and substantive authorities necessary to meet this historic moment.

National Focal Points And Implementation Of The International Health Regulations, Kumanan Wilson, Sam F. Halabi, Helge Hollmeyer, Lawrence O. Gostin, David P. Fidler, Corinne Packer, Lindsay Wilson, Ronald Labonté

Georgetown Law Faculty Publications and Other Works

As the COVID-19 pandemic continues, the World Health Organization (WHO), the International Health Regulations (IHR) and countries’ adherence to IHR guidance are coming under scrutiny and review. The IHR constitute a legal and governance framework that guides countries in responding to serious disease events while avoiding unnecessary interference with international trade and traffic. The IHR require States Parties to designate or establish national IHR focal points to facilitate information sharing about disease events with WHO, which makes these focal points critical in the effective implementation of the IHR within and between countries. On behalf of the State Party concerned, national …

Sharing Technology And Vaccine Doses To Address Global Vaccine Inequity And End The Covid-19 Pandemic, Matthew M. Kavanagh, Lawrence O. Gostin, Madhavi Sunder

Georgetown Law Faculty Publications and Other Works

Although COVID-19 cases are declining rapidly in the US, they have reached record highs in low- and middle-income countries (LMICs). The nucleus of the pandemic has shifted decidedly to the global south. The South-East Asia region and Latin America now represent 75% of global weekly deaths. On June 22, the Latin America region reported more than 1 million weekly new cases and 30 000 new deaths. Latin America has the highest deaths per capita, where deaths in countries such as Brazil, Argentina, Mexico, and Peru have reached 177 to 564 per hundred thousand. The Africa region has had increasing numbers …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Lockdowns, Quarantines, And Travel Restrictions, During Covid And Beyond: What’S The Law, And How Should We Decide?, Lawrence O. Gostin, Meryl Chertoff

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic ushered in vast deprivations of liberty previously unthinkable: lockdowns, business closures, travel restrictions, and quarantines. Even witnessing China’s January 2020 lockdown of 11 million people in Wuhan, it seemed wholly implausible that London, Rome, or New York would shut down. But they did, and much more. At the initial height of the pandemic in April 2020, more than 3.9 billion people, about half the world's population, were under stay-at-home orders. That same month, 43 US states were under stay-at-home orders.

What are the scientific, public health, and ethical justifications for various forms of liberty deprivations? Are they …

The Coronavirus Pandemic 1 Year On—What Went Wrong?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

January 30, 2021, marked the first anniversary of the declaration by the World Health Organization (WHO) of COVID-19 as a public health emergency of international concern (PHEIC). Thus far, the world has been no match for SARS-CoV-2, with more than 100 million cases and 2.5 million deaths. The US has been among the world’s poorest performers in addressing the pandemic, with more than 500 000 deaths.

Vaccines offer the best chance of returning to normal, but circulating variants pose a major obstacle, particularly the emergence of variants that are more transmissible and are developing partial resistance to vaccines against …

The Battle For Covid-19 Vaccines Highlights The Need For A New Global Governance Mechanism, Anna Mia Ekström, Camilla Berggren, Göran Tomson, Lawrence O. Gostin, Peter Friberg, Ole Petter Ottersen

Georgetown Law Faculty Publications and Other Works

To the Editor—Although the rapid development of several vaccines against COVID-19 is an unparalleled scientific accomplishment, one made possible through the collaboration of researchers, industry and funding bodies, the absence of a system that secures equitable access to vaccines has uncovered deep fissures in the global governance systems for health, as noted in a recent Nature Medicine Editorial.

For example, advance purchase agreements for vaccines against COVID-19 have favored affluent countries, allowing them to secure 150–500% of their predicted needs, while many citizens of low-and middle-income countries (LMICs) will remain unvaccinated until 2024.

Additionally, the power of patent-holders and …

Equitable Allocation Of Covid-19 Vaccines: An Analysis Of The Initial Allocation Plans Of Cdc's Jurisdictions With Implications For Disparate Impact Monitoring, Harald Schmidt, Rebecca Weintraub, Michelle A. Williams, Alison Buttenheim, Emily Sadecki, Helen Wu, Lawrence O. Gostin, Angela A. Shen

Georgetown Law Faculty Publications and Other Works

Major global and national vaccine allocation guidelines urge planners to allocate vaccines in ways that recognize, and ideally reduce, existing societal inequities within countries. However, allocation plans of the US will be determined individually by each of the CDC’s 64 jurisdictions (states, the District of Columbia, five cities, and territories). We analyzed whether jurisdictions have incorporated novel approaches to reduce inequity, based on plans published by the CDC in early November 2020 (63 summaries [98% of all jurisdictions] and 47 full guidance documents [73% of all, including all 50 states]).

Eighteen states adopted a novel proposal to use a disadvantage …

Science, Leadership, And Public Trust In The Covid-19 Pandemic, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Adherence to science in health messaging and public policies helped determine which countries have performed well in containing COVID-19. In the United States, President Trump has interfered with and undermined the work of scientific agencies such as the Centers for Disease Control and Prevention and the Food and Drug Administration, generating public distrust in science and amplifying fears about a future vaccine’s safety and effectiveness. He has also announced that the United States will not join a global partnership that aims to support the development of a vaccine and share access to it.

Science does not always tell us what …

Facilitating Access To A Covid-19 Vaccine Through Global Health Law, Lawrence O. Gostin, Safura Abdool Karim, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

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 …

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 …

Digital Smartphone Tracking For Covid-19: Public Health And Civil Liberties In Tension, I. Glenn Cohen, Lawrence O. Gostin, Daniel J. Weitzner

Georgetown Law Faculty Publications and Other Works

This Viewpoint compares manual and digital strategies for coronavirus disease 2019 (COVID-19) contact tracing, describes how countries in Asia and Europe have used smartphone tracking, and discusses privacy and discrimination concerns and strategies for balancing public health and civil liberties in the US.

Postscript: Covid-19 And The Legal Determinants Of Health, John Coggon, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

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.

Has Global Health Law Risen To Meet The Covid-19 Challenge? Revisiting The International Health Regulations To Prepare For Future Threats, Lawrence O. Gostin, Roojin Habibi, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

Global health law is essential in responding to the infectious disease threats of a globalizing world, where no single country, or border, can wall off disease. Yet, the Coronavirus Disease (COVID-19) pandemic has tested the essential legal foundations of the global health system. Within weeks, the SARS-CoV-2 coronavirus has circumnavigated the globe, bringing the world to a halt and exposing the fragility of the international legal order. Reflecting on how global health law will emerge in the aftermath of the COVID-19 pandemic, it will be crucial to examine the lessons learned in the COVID-19 response and the reforms required to …

The World Health Organization In Global Health Law, Benjamin Mason Meier, Allyn Taylor, Mark Eccleston-Turner, Roojin Habibi, Sharifah Sekalala, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The World Health Organization (WHO) has sought to bring the world together to respond to a shared threat. This column seeks to examine the central importance of WHO in developing and implementing global health law. Recognizing that global health law requires global governance, the column begins by situating WHO’s role at the forefront of global health governance. WHO’s leadership in global governance for health is supported by an expansive mandate to serve as a forum for the codification of international law, which WHO has exercised sporadically through the evolving development of the International Health Regulations (IHR). Yet, where the IHR …

How Well Does Societal Mobility Restriction Help Control The Covid-19 Pandemic? Evidence From Real-Time Evaluation, Juhwan Oh, Hwa-Young Lee, Khuong Quynh Long, Jeffrey F. Markuns, Chris Bullen, Osvaldo Enrique Artaza Barrios, Seung-Sik Hwang, Young Sahng Seo, Judith Mccool, S. Patrick Kachur, Chang-Chung Chan, Soonman Kwon, Naoki Kondo, Hoang Van Minh, J. Robin Moon, Mikael Rostila, Ole F. Norheim, Myoungsoon You, Mellissa Withers, Mu Lil, Eun-Jeung Lee, Caroline Benski, Soo Kyung Park, Eun-Woo Nam, Katie Gottschalk, Matthew M. Kavanagh, Jong-Koo Lee, Martin Mckee, S. V. Subramanian, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

One of the most widely implemented policy response to the novel coronavirus (SARS-CoV-2) pandemic has been the imposition of restrictions on mobility (1). These restrictions have included both incentives, encouraging working from home, supported by a wide range of online activities such as meetings, lessons, and shopping, and sanctions, such as stay at home orders, restrictions on travel, and closure of shops, offices, and public transport (2-5). The measures constitute a major component of efforts to control the COVID-19 pandemic. Compared to previous epidemic responses, they are unprecedented in both scale and scope (6).

The rationale underpinning these public health …

Wealthy Countries Should Share Vaccine Doses Before It Is Too Late: The Greater Good Depends On Ending The Pandemic Everywhere, Lawrence O. Gostin, Eric A. Friedman, Suerie Moon

Georgetown Law Faculty Publications and Other Works

The world is on the brink of failing a critical test, which is whether the international community is willing or able to end a global pandemic without leaving anyone behind. Wealthy countries have bought up vast vaccine supplies, leaving poorer ones with extreme scarcity. An international initiative known as the COVID-19 Global Vaccine Access Facility (COVAX) aims to distribute vaccines widely and equitably, but is not only short of funds. Even if it reaches its 2021 target, COVAX will reach only a small portion of lower-income countries’ populations this year.

Along with moral demands of equitable global distribution, wealthy countries …