Law Commons^™

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

The Stellenbosch Consensus On The International Legal Obligation To Collaborate And Assist In Addressing Pandemics: Clarifying Article 44 Of The International Health Regulations, Margherita Cinà, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Roojin Habibi, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to potential global health emergencies such as the ongoing covid-19 pandemic. While Article 44 of this binding legal instrument requires countries to collaborate and assist each other in meeting their respective obligations, recent events demonstrate that the precise nature and scope of these legal obligations are ill-understood. A shared understanding of the level and type of collaboration legally required by the IHR is a necessary step in ensuring these obligations can be acted upon …

The Stellenbosch Consensus On Legal National Responses To Public Health Risks: Clarifying Article 43 Of The International Health Regulations, Roojin Habibi, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Margherita Cinà, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to global health emergencies such as the ongoing COVID-19 pandemic. Countries are permitted to exercise their sovereignty in taking additional health measures to respond to such emergencies if these measures adhere to Article 43 of this legally binding instrument. Overbroad measures taken during recent public health emergencies of international concern, however, reveal that the provision remains inadequately understood. A shared understanding of the measures legally permitted by Article 43 is a necessary step in …

Reforming And Strengthening The Centers For Disease Control And Prevention: Five Key Reforms To Renew The Agency’S Stature And Effectiveness, Lawrence O. Gostin, Sandro Galea

Georgetown Law Faculty Publications and Other Works

The US Centers for Disease Control and Prevention (CDC) is the world’s leading public health agency, so admired that whole regions and countries have borrowed its name—in Africa, Europe, even China. In past epidemics, CDC’s expertise was transformative, such as in AIDS, Ebola, Zika, and Influenza H1N1. If there ever were a moment for the CDC to show leadership domestically and globally, it was the COVID-19 pandemic. Yet, the CDC’s stature was diminished—not enhanced—in an administration that not only eschewed science and politically pressured the CDC, but also gave notice of withdrawal from the World Health Organization (WHO), where CDC …

Tuberculosis, Human Rights, And Law Reform: Addressing The Lack Of Progress In The Global Tuberculosis Response, Matthew M. Kavanagh, Lawrence O. Gostin, John Stephens

Georgetown Law Faculty Publications and Other Works

In 2018, the United Nations General Assembly convened the first-ever high-level meeting (HLM) on tuberculosis (TB). Since that time news on the world’s most lethal infectious disease is not good—the 2019 WHO TB report shows 1.2 million people died from TB, a number that has fallen just 11% since 2015, less than one-third of the way towards the End TB Strategy milestone of a 35% reduction (to about 850 million deaths) by 2020. The same number of people, 10.0 million, are estimated to have fallen ill with TB in 2018 as in 2017. The stubborn persistence of TB is attributable …

A Global Survey Of Potential Acceptance Of A Covid-19 Vaccine, Jeffrey V. Lazarus, Scott C. Ratzan, Adam Palayew, Lawrence O. Gostin, Heidi J. Larson, Kenneth Rabin, Spencer Kimball, Ayman El-Mohandes

Georgetown Law Faculty Publications and Other Works

Several coronavirus disease 2019 (COVID-19) vaccines are currently in human trials. In June 2020, we surveyed 13,426 people in 19 countries to determine potential acceptance rates and factors influencing acceptance of a COVID-19 vaccine. Of these, 71.5% of participants reported that they would be very or somewhat likely to take a COVID-19 vaccine, and 61.4% reported that they would accept their employer’s recommendation to do so. Differences in acceptance rates ranged from almost 90% (in China) to less than 55% (in Russia). Respondents reporting higher levels of trust in information from government sources were more likely to accept a vaccine …

Is It Lawful And Ethical To Prioritize Racial Minorities For Covid-19 Vaccines?, Harald Schmidt, Lawrence O. Gostin, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in …

The Value Proposition Of The Global Health Security Index, Sanjana J. Ravi, Kelsey Lane Warmbrod, Lucia Mullen, Diane Meyer, Elizabeth Cameron, Jessica Bell, Priya Bapat, Michael Paterra, Catherine Machalaba, Indira Nath, Lawrence O. Gostin, Wilmot James, Dylan George, Simo Nikkari, Ernesto Gozzer, Oyewale Tomori, Issa Makumbi, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

Infectious disease outbreaks pose major threats to human health and security. Countries with robust capacities for preventing, detecting and responding to outbreaks can avert many of the social, political, economic and health system costs of such crises. The Global Health Security Index (GHS Index)—the first comprehensive assessment and benchmarking of health security and related capabilities across 195 countries—recently found that no country is sufficiently prepared for epidemics or pandemics. The GHS Index can help health security stakeholders identify areas of weakness, as well as opportunities to collaborate across sectors, collectively strengthen health systems and achieve shared public health goals. Some …

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 …

Universal Masking In The United States: The Role Of Mandates, Health Education, And The Cdc, Lawrence O. Gostin, I. Glenn Cohen, Jeffrey P. Koplan

Georgetown Law Faculty Publications and Other Works

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 …

An Analysis Of International Health Regulations Emergency Committees And Public Health Emergency Of International Concern Designations, Lucia Mullen, Christina Potter, Lawrence O. Gostin, Anita Cicero, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

Nine public health events have been assessed for the potential declaration of a Public Health Emergency of International Concern (PHEIC). According to the World Health Organization (WHO) International Health Regulations (IHR), a PHEIC is defined as an extraordinary event that constitutes a public health risk to other states through international spread and requires a coordinated international response. The WHO Director-General convenes Emergency Committees (ECs) to provide their advice on whether an event constitutes a PHEIC. The EC rationales have been continuously criticised for being non-transparent and contradictory to the IHR. This first comprehensive analysis of EC rationale provides recommendations to …

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 …

Access To Lifesaving Medical Resources For African Countries: Covid-19 Testing And Response, Ethics, And Politics, Matthew M. Kavanagh, Ngozi A. Erondu, Oyewale Tomori, Victor J. Dzau, Emelda A. Okiro, Allan Maleche, Ifeyinwa C. Aniebo, Umunya Rugege, Charles B. Holmes, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

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 …

When Does A Major Outbreak Become A Public Health Emergency Of International Concern?, David N. Durrheim, Lawrence O. Gostin, Keymanthri Moodley

Georgetown Law Faculty Publications and Other Works

The process of determining whether a Public Health Emergencies of International Concern (PHEIC) exists and should be declared has drawn increasing criticism over the past few years with allegations that it is more political than technical. Delaying declaration, where appropriate, means that the opportunity of garnering international solidarity and necessary resources in the early phases of epidemics, when public health measures may be more effective, is lost. A reform agenda aimed at enhancing WHO/Emergency Committee transparency and objectivity for the PHEIC declaration process is required.

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 …

Using Covid-19 To Strengthen The Who: Promoting Health And Science Above Politics, Lawrence O. Gostin, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

On April 14, 2020, President Trump announced the suspension of funding for the World Health Organization (WHO) to investigate WHO’s handling of the COVID-19 pandemic—citing WHO’s “disastrous decision” to oppose a travel ban on China, and for being slow and “China-centric.” Certainly, China failed in its international duty to respond rapidly and transparently to the novel coronavirus, and it suppressed truthful information, propelling a localized outbreak into a pandemic now in over 210 countries. Yet close examination of WHO’s COVID-19 response reveals that the Organization acted in line with its authority under the International Health Regulations, and using the available …

The Lancet–O’Neill Institute/Georgetown University Commission On Global Health And Law: The Power Of Law To Advance The Right To Health, Jenny Kaldor, Lawrence O. Gostin, John T. Monahan, Katie Gottschalk

Georgetown Law Faculty Publications and Other Works

The Lancet–O’Neill Institute/Georgetown University Commission on Global Health and Law published its report on the Legal Determinants of Health in 2019. The term ‘legal determinants of health’ draws attention to the power of law to influence upstream social and economic influences on population health. In this article, we introduce the Commission, including its background and rationale, set out its methodology, summarize its key findings and recommendations and reflect on its impact since publication. We also look to the future, making suggestions as to how the global health community can make the best use of the Commission’s momentum in relation …

Regulating Medicines In A Globalized World With Increased Recognition And Reliance Among Regulators: A National Academies Report, Lawrence O. Gostin, Alastair J. Wood, Patricia A. Cuff

Georgetown Law Faculty Publications and Other Works

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains. Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously. The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, …

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 …

Introduction: Global Health And Human Rights, Lawrence O. Gostin, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

This introduction highlights the foundational importance of human rights for global health and provides an academic framework for this book by laying out the role of human rights under international law as a basis for public health. Part I seeks to define the evolving conceptualization of health, examining both the shifting focus from medicine to public health and the shifting response from international health to global health. Framing global health as a human rights imperative, Part II examines the establishment of human rights under international law, the implementation of these rights in public policy, and the development of rights for …

Rationing Safe And Effective Covid-19 Vaccines: Allocating To States Proportionate To Population May Undermine Commitments To Mitigating Health Disparities, Harald Schmidt, Parag A. Pathak, Michelle A. Williams, Tayfun Sönmez, M. Utku Ünver, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A central goal in the National Academies of Science, Engineering and Medicine’s (NASEM) framework for equitable COVID-19 vaccine allocation is to mitigate existing inequities, particularly those affecting economically worse-off racial and ethnic minorities. The Advisory Committee on Immunization Practice (ACIP) likewise notes that equity demands to “reduce, rather than increase, health disparities in each phase of vaccine distribution”. A crucial question in this regard is how vaccines should be distributed to states. The default is to allocate proportionate to population size. However, this approach risks increasing scarcity for worse-off populations in states where they represent above-average shares. To avoid lower …

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 …