Digital Commons Network^™

The Right To Mental Health In Yemen, Waleed Alhariri, Amanda Mcnally, Sarah Knuckey

Faculty Scholarship

Mental health issues are all too common consequences of conflict and atrocity crimes, often causing upwards of one-quarter of the post-conflict, post-atrocity population to suffer from physical and mental sequelae that linger long after weapons have been silenced. After more than six years of ongoing conflict, Yemen’s already weak health care system is on the brink of collapse, and population resilience has been severely stressed by indiscriminate attacks, airstrikes, torture, food insecurity, unemployment, cholera, and now the COVID-19 pandemic. This paper examines Yemen’s responsibilities regarding the right to mental health and details the few actions the government has taken to …

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

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

Faculty Scholarship

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

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

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

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

Is There A Cure For Vaccine Nationalism?, Ana Santos Rutschman

All Faculty Scholarship

“[V]accine nationalism . . . should serve as a reality check for the status of global health cooperation in the twenty-first century.”

Gaps In Worker Protections That Increase Essential Workers’ Exposure To Covid-19, Ruqaiijah Yearby

All Faculty Scholarship

States and localities designated more than 55 million Americans as essential workers. Essential workers not only comprise those employed by the health care and food and agriculture industry, but also include teachers, grocery store workers, transit and airline workers, mail and delivery workers, energy sector and utility workers, and domestic workers (Petition for Emergency, 2020). Racial and ethnic minorities are disproportionately employed as essential workers, with Black Americans the most likely to be essential workers (Petition for Emergency, 2020). Essential workers have been left vulnerable to workplace COVID-19 infections and deaths in large part due to the federal and state …

Paying Americans To Take The Vaccine - Would It Help Or Backfire?, Christopher Robertson, Daniel Scheitrum, K. Aleks Schaefer, Trey Malone, Brandon R. Mcfadden, Kent D. Messer, Paul J. Ferraro

Faculty Scholarship

This research investigates the extent to which financial incentives (conditional cash transfers) would induce Americans to opt for vaccination against COVID-19. We performed a randomized survey experiment with a representative sample of 1,000 American adults in December 2020. Respondents were asked whether they would opt for vaccination under one of three incentive conditions ($1,000, $1,500, or $2,000 financial incentive) or a no-incentive condition. We find that—without coupled financial incentives—only 58% of survey respondents would elect for vaccination. A coupled financial incentive yields an 8-percentage-point increase in vaccine uptake relative to this baseline. The size of the cash transfer does not …

Health Information Beyond Pandemic Emergencies: Privacy For Social Justice, Leslie Francis

American University Law Review

The COVID-19 pandemic has forcefully revealed the critical importance of timely information to identify emerging infections, discern patterns of disease, and stop disease spread. Information about individuals both as patients, and as ordinary people in the world is necessary for each of these tasks. Yet the implications for information use and efforts to achieve social justice are significant.

This Article first surveys information needs as revealed by the pandemic. It then articulates different normative approaches to privacy and confidentiality to develop two implications for privacy and justice: that information gleaned in clinical care and information possessed by public health should …

National Legal Paradigms For Public Health Emergency Responses, James G. Hodge Jr.

American University Law Review

The COVID-19 pandemic has exposed significant weaknesses of the U.S. federalist system in controlling major infectious disease threats. At the root of American failures to adequately respond is a battle over public health primacy in emergency preparedness and response. Which level of government—federal or state—should actually “call the shots” to quell national emergencies? Constitutional principles of cooperative federalism suggest both levels of government are responsible. Yet real-time applications of these principles, coupled with dubious national leadership, contributed to horrific public health outcomes across America. No one seeks a repeat performance of U.S. COVID-19 response efforts to forthcoming major health threats. …

Disease And Data In Society: How The Pandemic Expanded Data Collection And Surveillance Systems, Alan Butler, Enid Zhou

American University Law Review

The COVID-19 pandemic1 is a global tragedy of historic proportions, and its impacts on our families, communities, and social structures will be felt for many years to come. From the significant to the mundane, COVID-19 has changed many aspects of daily life. One of the less obvious but more long-lasting changes may well be the expansion of data collection and surveillance systems adopted both in response to, and as a result of, the pandemic.

Post-Pandemic Privacy Law, Tiffany C. Li

American University Law Review

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

Tracing The Invisible: Information Fiduciaries And The Pandemic, Anne L. Washington, Lauren Rhue

American University Law Review

Predictive data technology designed to contain the COVID-19 pandemic was not as successful as promised. Data-centric solutions to providing testing and tracing did little to limit the virus’s spread in part because they served only the most visible parts of society. This Article argues for more robust solutions to protect individuals’ privacy—whether those individuals are currently visible or invisible to pandemic technology—if pandemic technology is to provide the universal coverage necessary for a public health emergency, such as the COVID- 19 pandemic. First, we contend that current pandemic data technology operates under rigid technical and social assumptions that thwart participation …

Antibiotic Development Incentives That Reflect Societal Value Of Antibiotics, Helen Boucher, Thomas M. File, Vance Fowler, Amanda Jezek, John Rex, Kevin Outterson

Faculty Scholarship

TO THE EDITOR—Rome and Kesselheim [1] claimed that rewarding developers of novel antibiotics with transferable exclusivity vouchers is an expensive approach to promoting antibiotic development. This analysis is incomplete as it focuses only on the cost of bringing new antibiotics to market without acknowledging their societal value. The authors also did not suggest an alternative approach. With patients running out of treatment options for resistant infections, failing to strengthen the antibiotic pipeline is not a reasonable option.

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

All Faculty Scholarship

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

Protecting The Rights And Wellbeing Of People With Disabilities During The Covid-19 Pandemic, Elizabeth Pendo

All Faculty Scholarship

The COVID-19 pandemic has exposed and exacerbated significant inequities experienced by people with disabilities. It has also emphasized the value of legal protections against discrimination based on disability. The Americans with Disabilities Act was enacted 30 years ago to eliminate discrimination against people with disabilities and ensure equal opportunity across major areas of American life (ADA, 2008). Together with an earlier law, the Rehabilitation Act of 1973 Rehabilitation Act, 2012), this landmark civil rights law impacts a broad range of issues raised by the COVID-19 pandemic and protects a large and growing number of Americans. This Chapter focuses on application …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

All Faculty Scholarship

Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Lessons Learned: Strengthening Medicaid To Address Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

All Faculty Scholarship

COVID-19 has disproportionately harmed low-income people, especially Black and Latino populations, seniors, and people with disabilities. Medicaid plays an essential role in providing coverage and access to care for these populations. As COVID-19 disrupted employment, earnings, and insurance coverage, Medicaid enrollment increased, in part because Congress offered states increased Medicaid funding in return for maintaining eligibility and enrollment for the duration of the public health emergency (PHE). At the same time, many states expanded eligibility and streamlined enrollment to assure that people could secure and keep coverage. Such policies resulted in more than 5.3 million more Americans having Medicaid coverage …

Covid-19 Employee Health Checks, Remote Work, And Disability Law, Elizabeth Pendo

All Faculty Scholarship

The Americans with Disabilities Act (ADA) prohibits discrimination against people with disabilities, about 61 million individuals in the U.S. The law’s protections in the workplace are especially important during COVID-19, which has worsened pre-existing disparities experienced by people with disabilities. The ADA also applies to new strategies to reduce the risk of COVID-19 infection in the workplace. This Chapter will focus on two strategies that impact individuals with and without disabilities – employee health screening, testing and vaccination policies, and new or expanded remote work programs.

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

All Faculty Scholarship

Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

All Faculty Scholarship

We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

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 "People's Total War On Covid-19": Urban Pandemic Management Through (Non-)Law In Wuhan, China, Philipp Renninger

Washington International Law Journal

Although COVID-19 was first detected in the People’s Republic of China, the pandemic now appears contained there. Western and Chinese media attribute this apparent success to the central level of the Chinese state and the Communist Party. However, this article reveals that local entities provided critical contributions to China’s COVID-19 management, particularly in the pandemic’s first epicenter: Wuhan city in Hubei province. Chinese cities like Wuhan can fight public health emergencies through legal and nonlegal instruments. Although Wuhan had prepared for possible pandemics, its existing plans, institutions, and warning systems initially failed against COVID-19. The city did not contain the …

An Australian Conundrum: Genomic Technology, Data, And The Covidsafe App, David Morrison, Patrick T. Quirk

Pace International Law Review

This paper examines the difficulties that have arisen in Australia in the use of its contact-tracing app. We examine the privacy implications around the use of the app, the wider economic imperative, and the balancing of those concerns against the health threat of the COVID-19 pandemic. We posit that default options are superior in times of emergency and rather than begging for the adoption of lifesaving technology, we suggest that the evidence gathered by behavioral economists provides an apposite and powerful alternative worthy of consideration.

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 …

Forced Business Closures: Executive Orders By The Governor Closing Private Businesses, Baylee A. Culverhouse, Alexa R. Martin

Georgia State University Law Review

Governor Brian Kemp (R) issued Executive Orders in response to the COVID-19 pandemic that required businesses to close in an effort to limit the spread of the virus. Business owners often challenged those forced business closures as unconstitutional or as exceeding the State’s police power, and those challenges were met with varying degrees of success.

Bioethics: Ethical Considerations Of Ventilator Triage During A Pandemic, Susannah J. Gleason, William J. Keegan

Georgia State University Law Review

In the midst of the COVID-19 pandemic, hospitals across the country faced unprecedented volumes of patients seeking treatment related to the respiratory complications of the virus. As a result, states were forced to reassess existing scarce resource allocation guidelines to appropriately accommodate the high demand. This Peach Sheet analyzes the ethical considerations implicated in enacting and following these guidelines when treating patients, specifically in the context of ventilator triage in response to the COVID-19 pandemic.

Public Health State Of Emergency: Executive Order By The Governor Declaring A Public Health State Of Emergency, Rebecca Hu, Ellen Y. Min

Georgia State University Law Review

The Executive Order primarily functions to enumerate the Governor’s emergency powers during a Public Health State of Emergency. The Executive Order allows for the Governor to assist health and emergency management officials by deploying available resources for the mitigation and treatment of COVID-19 within Georgia.