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 …

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 …

Injustice Is An Underlying Condition, Yael Cannon

Georgetown Law Faculty Publications and Other Works

Race, poverty, and zip code serve as critical determinants of a person's health. Research showed the links between these factors and poor health and mortality before COVID-19, and they have only been amplified during this pandemic.

People of color experience higher rates of asthma, heart disease, diabetes, and other chronic conditions. People of color who live in poverty are even more likely to suffer from poor health; they face a “double burden” of health disparities associated with both racial and socioeconomic marginalization. Neighborhoods with concentrated poverty and with residents who are primarily people of color have even faced a life …

A Global Health Action Agenda For The Biden Administration, Lawrence O. Gostin, Donna E. Shalala, Margaret A. Hamburg, Barry R. Bloom, Jeffrey P. Koplan, Barbara K. Rimer, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Joe Biden will assume the US presidency at a time of unprecedented global health crises, with the COVID-19 pandemic and major setbacks in reducing poverty, hunger, and disease. The COVID-19 pandemic offers rare opportunities for the US President-elect to spearhead long-overdue structural changes and revitalise global health leadership. Building trust among global partners will be challenging, given the USA's withdrawal from, and disruption of, international cooperation under the presidency of Donald Trump. The USA will have to lead in a different, more collaborative way. Here, we offer a Global Action Agenda for the Biden Administration.

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 …

The Great Coronavirus Pandemic Of 2020—7 Critical Lessons, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The world is experiencing a once-in-a-lifetime pandemic, causing untold human suffering and death, unraveling of social relationships, and robbing individuals of livelihoods and countries of prosperity. The coronavirus pandemic has strained health systems, revealed unconscionable inequalities, and upended international institutions. Here are 7 critical lessons.

An Interprofessional Approach To Teaching Advocacy Skills: Lessons From An Academic Medical-Legal Partnership, Vicki W. Girard, Eileen S. Moore, Lisa P. Kessler, Deborah F. Perry, Yael Cannon

Georgetown Law Faculty Publications and Other Works

Medical students and educators recognize that preparing the next generation of health leaders to address seemingly intractable problems like health disparities should include advocacy training. Opportunities to acquire the knowledge and skills needed to effectively advocate at the policy level to promote systems-, community-, and population-level solutions are a critical component of such training. But formal advocacy training programs that develop and measure such skills are scarce. Even less common are interprofessional advocacy training programs that include legal and policy experts to help medical students learn such skills.

This 2016–2017 pilot study started with a legislative advocacy training program for …

Health Policy In The Supreme Court And A New Conservative Majority, Lawrence O. Gostin, Wendy E. Parmet, Sara Rosenbaum

Georgetown Law Faculty Publications and Other Works

This Viewpoint looks at the range of medical and public health issues that could be adversely affected by appointment of Justice Amy Coney Barrett to the US Supreme Court, including weakening or elimination of the Affordable Care Act, Medicaid work requirements that could reduce eligibility, and reduced reproductive rights and governmental public health emergency powers.

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 …

(Not The) Same Old Story: Invisible Reasons For Rejecting Invisible Wounds, Jessica Lynn Wherry

Georgetown Law Faculty Publications and Other Works

Thousands of former military servicemembers have been discharged with other-than-honorable discharges due to misconduct that can be traced to a mental health condition. These veterans may request a post-discharge change to their discharge characterization—known as a “discharge upgrade.” Discharge review boards consider discharge upgrade requests and typically (90-99% of the time) deny the requests. In the past few years, the Department of Defense has issued new policy guidance partly in response to the low grant rate and to specifically address the growing understanding of the relationship between misconduct and mental health conditions for military servicemembers. The policy guidance requires the …

Kicked Out, Kicked Again: The Discharge Review Boards’ Illiberal Application Of Liberal Consideration For Veterans With Post-Traumatic Stress Disorder, Jessica Lynn Wherry

Georgetown Law Faculty Publications and Other Works

In recent years, the Department of Defense (DoD) has responded to the growing awareness of mental health issues for military servicemembers during and after service. This Article focuses on veterans who have already been discharged from service, and specifically those who have been discharged under other-than-honorable conditions for misconduct that is likely the result of a mental health condition, including post-traumatic stress disorder (PTSD), traumatic brain injury, sexual assault, or sexual harassment. Thousands of former servicemembers have been kicked out of the military for misconduct rather than treated for mental health conditions they experienced due to their military service. When …

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 …

The Shibboleth Of Human Rights In Public Health, Lawrence O. Gostin, Tamira Daniely, Hanna E. Huffstetler, Caitlin R. Williams, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

Human rights discourse has greatly influenced advocacy for justice in public health. Yet, beyond rhetorical claims, how can we employ human rights to achieve the aspiration of health with justice? Without human rights education to support public health practice, human rights have become a shibboleth of public health—raised frequently to signal devotion to justice, but employed rarely in policy, programming, or practice. As advocates respond to the public health injustices of populist nationalism during an unprecedented pandemic, human rights education must be an essential foundation to hold governments accountable for implementing rights to safeguard public health.

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 …

The International Health Regulations (2005), The Threat Of Populism And The Covid-19 Pandemic, Kumanan Wilson, Sam F. Halabi, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The global response to the COVID-19 pandemic has laid bare weaknesses and major challenges in the international approach to managing public health emergencies. Populist sentiment is spreading globally as democratic nations are increasing their support for or electing governments that are perceived to represent “traditional” native interests. Measures need to be taken to proactively address populist sentiment when reviewing the IHR (2005) effectiveness in the COVID-19 pandemic. We discuss how populism can impact the IHR (2005) and conversely how the IHR (2005) may be able to address populist concerns if the global community commits to helping states address public health …

Health Justice Is Racial Justice: A Legal Action Agenda For Health Disparities, Sheila Foster, Yael Cannon, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Acknowledging the urgency of both health and racial justice in this moment, Sheila Foster, Yael Cannon, and M. Gregg Bloche set forth a legal agenda to fight the health effects of racism in housing, policing, the environment, and other areas.

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 …

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.

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.

The Legal Determinants Of Health: How Can We Achieve Universal Health Coverage And What Does It Mean?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

How can we keep people – wherever they live – healthy and safe? Among all global health initiatives, Universal Health Coverage (UHC) has garnered most political attention. But can UHC (as important as it is) actually achieve the two fundamental aspirations of the right to health: keeping people healthy and safe, while leaving no one behind? There is a universal longing for health and security, but also a deep-seated belief in fairness and equity. Can UHC achieve both health and equity, or what I have called, “global health with justice.”?

What makes a population healthy and safe? Certainly, universal and …

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 …