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 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 …

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 …

Caps On Capsules: Prescription For Lower Drug Prices In The United States, Christine Chasse

Student Scholarship

The United States is the foremost innovator of pharmaceutical therapies in the world. That innovation, however, comes at a price—literally. Americans pay more for their medications than any other country. In a country without universal healthcare, the topics of economics, human rights, and healthcare intersect at the crossroads of pharmaceutical pricing. In contrast to most other countries, the United States has no regulations on pharmaceutical price control. One major argument against government regulation is its inherent opposition to the free market system: the heart of the American economy. Further still is the argument that profit restriction would create a chilling …

Feminist Perspectives On Disaster, Pandemics, And Intimate Partner Violence, Margaret Drew

Faculty Publications

The COVID-19 pandemic brought international awareness to the likelihood of increased abuse of those in abusive intimate partner relationships because of the forced confinement with their abusers (Bettinger-Lopez and Bro, A double pandemic: domestic violence in the age of COVID 19, Council on Foreign Relations. https://www.cfr.org/in-brief/double-pandemic-domestic-violence-age-covid-19, 2020). While this awareness was much discussed, assistance to survivors of abuse was limited because survivors often could not reach out for help, nor could advocates wishing to offer assistance safely reach in to advise them (Taub, A new Covid-19 crisis: domestic abuse rises worldwide. https://www.nytimes.com/2020/04/06/world/coronavirus-domestic-violence.html, 2020). The ever-present influence of the …

Cost, Coverage, And The Underuse Of Medications Among People With Cf, Semret Seyoum, Marsha Regenstein, Lea Nolan

Health Policy and Management Issue Briefs

No abstract provided.

Following The Money: The Aca’S Fiscal-Political Economy And Lessons For Future Health Care Reform, William M. Sage, Timothy M. Westmoreland

Faculty Scholarship

It is no exaggeration to say that American health policy is frequently subordinated to budgetary policies and procedures. The Affordable Care Act (ACA) was undeniably ambitious, reaching health care services and underlying health as well as health insurance. Yet fiscal politics determined the ACA’s design and guided its implementation, as well as sometimes assisting and sometimes constraining efforts to repeal or replace it. In particular, the ACA’s vulnerability to litigation has been the price its drafters paid in exchange for fiscal-political acceptability. Future health care reformers should consider whether the nation is well served by perpetuating such an artificial relationship …

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Christopher Robertson, Jonathan Darrow, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

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.

Laboratories Of Exclusion: Medicaid, Federalism & Immigrants, Medha D. Makhlouf

Faculty Scholarly Works

Medicaid’s cooperative federalism structure gives states significant discretion to include or exclude various categories of immigrants. This has created extreme geographic variability in immigrants’ access to health coverage. This Article describes federalism’s role in influencing state policies on immigrant eligibility for Medicaid and its implications for national health policy. Although there are disagreements over the extent to which public funds should be used to subsidize immigrant health coverage, this Article reveals that decentralized policymaking on immigrant access to Medicaid has weakened national health policy. It has failed to incentivize the type of state policy experimentation and replication that justifies federalism …

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 …

My Covid Pause, Jennifer Nedelsky

Articles & Book Chapters

No abstract provided.

Taxes As Pandemic Controls, Ashley C. Craig, James R. Hines Jr.

Articles

Tax policy can play important roles in limiting the spread of communicable disease and in managing the economic fallout of a pandemic. Taxes on business activities that bring workers or customers into close contact with each other offer efficient alternatives to broad regulatory measures, such as shutdowns, that have been effective but enormously costly. Corrective taxation also helps raise the revenue required to cover elevated government expenditure during a pandemic. Moreover, the restricted consumer choice that accompanies a pandemic reduces the welfare cost of raising tax revenue from higher-income taxpayers, making it a good time for deficit closure. Current U.S. …

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 …

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.

The Contested Boundaries Of Emerging International Migration Law In The Post-Pandemic, Ian M. Kysel, Chantal Thomas

Cornell Law Faculty Publications

One measure of how and whether the COVID-19 pandemic reshapes the emerging field of international migration law will be the extent to which transnational civil society and activist movements can counteract the intensification of state border controls that the pandemic has triggered. Before the pandemic, transnational efforts to establish a new normative framework for migration seemed to be accelerating. These efforts included new, if nonbinding, global compacts on refugees and migration, and new, if modest, efforts at facilitating global cooperation, alongside innovative approaches to scholarly engagement. Such developments arguably contributed to an emerging framework for protecting migrants under international law. …

Video; Health Law & Ethics 2020, Kathy Cerminara, Jonathan Kroner Law Office, Mcdermott Will & Emery Llp, Lubell & Rosen, Gerald M. Morris

NSU Law Seminar Series

This program will focus on the current climate of health law and the necessary steps used through federal practice to adjust to the ever-changing atmosphere of new legislation. Attendees will learn about the various paths within the practice, about emerging new laws, outreach and training, and how to become involved in the federal practice of health law. The presenters will explain what you need to get started, what different types of experiences and exposure might be helpful in entering the field and instruct you on maintaining ethics by knowing and following the Federal Rules of Civil Procedure and Model Rules …

FacebookʼS Latest Attempt To Address Vaccine Misinformation — And Why ItʼS Not Enough, Ana Santos Rutschman

All Faculty Scholarship

On October 13, 2020 Facebook announced the adoption of a series of measures to promote vaccine trust “while prohibiting ads with misinformation that could harm public health efforts.” In the post written by Kang-Xing Jin (head of health) and Rob Leathern (director of product management), the company explained that the new measures were designed with an emphasis on encouraging widespread use of this yearʼs flu vaccine, as well as in anticipation of potential COVID-19 vaccines becoming available in the near future.

The changes focus mainly on the establishment of a multiprong informational campaign about the seasonal flu vaccine, which includes …

The Role Of The Opioid Crisis In Elder Abuse, Kimberly I. Snow Mhsa, Jennifer Pratt, Stuart Bratesman Mpp

Disability & Aging

As the opioid crisis has deepened over the past twenty years, its effect on individuals and families, including older adults, has grown. To find out how the opioid crisis might be impacting elder abuse, neglect, and exploitation in Maine, we conducted a mixed methods analysis of 2015-2018 Maine Adult Protective Services (APS) investigations to determine: 1) Did opioid-related investigations increase over time? 2) Do investigations involving opioid misuse or abuse differ from investigations that don’t involve opioids? 3) What themes or features of cases involving opioid misuse or abuse by clients and/or perpetrators emerge from the data?

Key Findings: The …

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

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 …

Good Health And Good Privacy Go Hand-In-Hand (Originally Published By Jnslp), Jennifer Daskal

Joint PIJIP/TLS Research Paper Series

No abstract provided.

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 …

Public Policy Origins Of U.S. Data, Bert Chapman

Libraries Faculty and Staff Presentations

Provides detailed introduction and overview of public policy origins of U.S. data. Shows how congressional legislation and Office of Management and Budget documents influence compilation and dissemination of U.S. Government data. Stresses how Indiana General Assembly requirements influence compilation of Indiana state agency data and Indiana local government agency data. Places emphasis on roles played in data compilation and dissemination by public policy research institutions/think tanks. Concludes by stressing limitations of data collection by governmental and non-governmental entities.

Reimagining Disability: The Screening Of Donor Gametes And Embryos In Ivf, Isabel Karpin, Roxanne Mykitiuk

Articles & Book Chapters

In this article,we examine how disability is figured in the imaginaries that are given shape by the reproductive projects and parental desires facilitated by the bio-medical techniques and practices of assisted reproductive technologies (ARTs) that involve selection and screening for disability. We investigate how some users of ARTs understand and deploy these imaginaries in ways that are both concordant with and resistant to the understanding of disability embedded within the broader sociotechnical and social imaginaries. It is through users’ deliberations, choices, responses, and expectations that we come to understand how these imaginaries are perpetuated and resisted, and how maintaining them …

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?