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The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

All Faculty Scholarship

Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

The Problem With Relying On Profit-Driven Models To Produce Pandemic Drugs, Ana Santos Rutschman

All Faculty Scholarship

The longstanding problems of relying on a market response to a pandemic are becoming readily apparent in the United States, which has quickly become the epicenter of the COVID-19 outbreak. The problems are particularly pronounced in pharmaceutical markets, where we are pinning our hopes for both cures and vaccines. In previous work we have shown how characteristics of healthcare markets in the United States create a divergence between the private incentives of for-profit companies and public health needs, leading to sub-optimal health outcomes in what is a uniquely market-driven healthcare system. In this Essay, written as the COVID-19 pandemic unfolds, …

The Reemergence Of Vaccine Nationalism, Ana Santos Rutschman

All Faculty Scholarship

This short essay explores the reemergence of vaccine nationalism during the COVID-19 pandemic. The essay traces the pre-COVID origins of vaccine nationalism and explains how it can have detrimental effects on equitable access to newly developed vaccines.

Substance Use Disorder, Discrimination, And The Cares Act: Using Disability Law To Strengthen New Protections, Kelly K. Dineen, Elizabeth Pendo

All Faculty Scholarship

The COVID-19 pandemic is having devastating consequences for people with substance use disorders (SUD). SUD is a chronic health condition—like people with other chronic health conditions, people with SUD experience periods of remission and periods of exacerbation and relapse. Unlike people with most other chronic conditions, people with SUD who experience a relapse may face criminal charges and incarceration. They are chronically disadvantaged by pervasive social stigma, discrimination, and structural inequities. People with SUD are also at higher risk for both contracting the SARS-CoV-19 virus and experiencing poorer outcomes. Meanwhile, there are early indications that pandemic conditions have led to …

Employee Testing, Tracing, And Disclosure As A Response To The Coronavirus Pandemic, Matthew T. Bodie, Michael Mcmahon

All Faculty Scholarship

As the COVID-19 pandemic continues to devastate the United States, the federal government has largely failed to implement a national program to prevent and contain the virus. As a result, many employers have undertaken their own workplace coronavirus mitigation efforts. This essay examines, in three parts, the legal framework surrounding employer systems of workplace testing, tracing, and disclosure. It first examines the legal issues surrounding employer-mandated COVID-19 testing and temperature checks, especially issues arising under the Americans with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA). Regarding employer contact tracing efforts, the essay next reviews the multitude …

Comments On The Preliminary Framework For Equitable Allocation Of Covid-19 Vaccine, Ana Santos Rutschman, Julia Barnes-Weise, Robert Gatter, Timothy L. Wiemken

All Faculty Scholarship

On September 1, 2020 the National Academies released a draft framework for Equitable Allocation of a COVID-19 Vaccine. In this response, we analyze the proposed framework and highlight several areas.

Among the proposed changes, we highlight the need for the following interventions. The final framework for distribution of COVID-19 vaccines should give a higher priority to populations made most vulnerable by the social determinants of health. It should incorporate more geography-based approaches in at least some of the four proposed phases of vaccine distribution. It should address the possibility of a vaccine being made available through an emergency use authorization …

Reviving Focused Scrutiny In The Constitutional Review Of Public Health Measures, Robert Gatter

All Faculty Scholarship

This article re-examines the "focused scrutiny" standard proposed by Prof. Scott Burris in 1989 and argues for its application particularly during an infectious disease emergency such as the COVID-19 pandemic. Focused scrutiny seeks to tie judicial review of the constitutionality of public health measures closely to the facts of the particular disease and to evidence of the efficacy of each governmental action to prevent the spread of that disease, even when courts adopt rational basis testing.

Protecting The Rights Of People With Disabilities, Elizabeth Pendo

All Faculty Scholarship

One in four Americans — a diverse group of 61 million people — experience some form of disability (Okoro, 2018). On average, people with disabilities experience significant disparities in education, employment, poverty, access to health care, food security, housing, transportation, and exposure to crime and domestic violence (Pendo & Iezzoni, 2019). Intersections with demographic characteristics such as race, ethnicity, gender, and LGBT status, may intensify certain inequities. For example, women with disability experience greater disparities in income, education, and employment (Nosek, 2016), and members of under-served racial and ethnic groups with disabilities experience greater disparities in health status and access …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

All Faculty Scholarship

Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

Center For Progressive Reform Report: Protecting Workers In A Pandemic--What The Federal Government Should Be Doing, Thomas Mcgarity, Michael C. Duff, Sidney A. Shapiro

All Faculty Scholarship

The "re-opening" of the American economy while the coronavirus that causes COVID-19 is still circulating puts workers at heightened risk of contracting the deadly virus. In some blue-collar industries, the risk is particularly acute because of the inherent nature of the work itself and of the workplaces in which it is conducted. And the risk, for a variety of reasons, falls disproportionately on people of color and low-income workers. With governors stay-at-home orders and other pandemic safety restrictions, Center for Progressive Reform Member Scholars Thomas McGarity, Michael Duff, and Sidney Shapiro examine the federal government's many missed opportunities to stem …

Smoke Screens: An Initial Analysis Of The Coronavirus Lawsuits In The United States Against China And The World Health Organization, Ana Santos Rutschman, Robert Gatter

All Faculty Scholarship

In this short essay we provide a preliminary analysis of the lawsuits filed by Missouri against China, and New York against the World Health Organization over the COVID-19 pandemic. We also situate the lawsuits against the expanding coronavirus-related misinformation “epidemic.”

Coronavirus, Civil Libertities, And The Courts: The Case Against Suspending Judicial Review, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Introduction: For obvious reasons, local and state orders designed to help “flatten the curve” of novel coronavirus infections (and conserve health care capacity to treat coronavirus disease) have provoked a series of constitutional objections — and a growing number of lawsuits attempting to have those orders modified or overturned. Like the coronavirus crisis itself, much of that litigation remains ongoing as we write this Essay. But even in these early days, the emerging body of case law has rather elegantly teed up what we have previously described as “the central (and long-running) normative debate over emergency powers: Should constitutional constraints …

Regulating Cleanups Of Homeless Encampments, Stephen J. Schnably

Articles

No abstract provided.

Religious Liberty In A Pandemic, Caroline Mala Corbin

Articles

The coronavirus pandemic caused an unprecedented shutdown of the United States. The stay-at-home orders issued by most states typically banned large gatherings of any kind, including religious services. Churches sued, arguing that these bans violated their religious liberty rights by treating worship services more strictly than analogous activities that were not banned, such as shopping at a liquor store or superstore. This Essay examines these claims, concluding that the constitutionality of the bans turns on the science of how the pathogen spreads, and that the best available scientific evidence supports the mass gathering bans.

The Incentives Of Private Prisons, John F. Pfaff

Faculty Scholarship

No abstract provided.

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 …

Criminal (Dis)Appearance, Pamela R. Metzger, Janet C. Hoeffel

Faculty Journal Articles and Book Chapters

Across the United States, thousands of newly arrested people disappear. They languish behind bars for days, weeks, or even months without ever seeing a judge or an attorney. Yet, the Supreme Court requires more constitutional process for the seizure “of a refrigerator, the temporary suspension of a public school student, or the suspension of a driver’s license,” than it does for a person who has just been arrested. A new arrestee has no clearly established constitutional right to a prompt initial appearance procedure. As a result, there is no constitutional doctrine that guarantees her the right to appear promptly before …

Covid-19 And Prisoners’ Rights, Gregory Bernstein, Stephanie Guzman, Maggie Hadley, Rosalyn M. Huff, Alison Hung, Anita N.H. Yandle, Alexis Hoag, Bernard E. Harcourt

Faculty Scholarship

As COVID-19 continues to spread rapidly across the country, the crowded and unsanitary conditions in prisons, jails, juvenile detention, and immigration detention centers leave incarcerated individuals especially vulnerable. This chapter will discuss potential avenues for detained persons and their lawyers seeking to use the legal system to obtain relief, including potential release, during this extraordinary, unprecedented crisis.

Linked Fate: Justice And The Criminal Legal System During The Covid-19 Pandemic, Susan P. Sturm, Faiz Pirani, Hyun Kim, Natalie Behr, Zachary D. Hardwick

Faculty Scholarship

The concept of “linked fate” has taken on new meaning in the face of the COVID-19 pandemic. People all over the world – from every walk of life, spanning class, race, gender, and nationality – face a potentially deadly threat requiring cooperation and sacrifice. The plight of the most vulnerable among us affects the capacity of the larger community to cope with, recover, and learn from COVID-19’s devastating impact. COVID-19 makes visible and urgent the need to embrace our linked fate, “develop a sense of commonality and shared circumstances,” and unstick dysfunctional and inequitable political and legal systems.

Nowhere is …

Executive Overreach And Underreach In The Pandemic, Kim Lane Scheppele, David E. Pozen

Faculty Scholarship

The pandemic that convulsed the globe in 2020 was long foretold but still surprising to many. Within a few months of its appearance, COVID-19 became one of the leading causes of death worldwide. Governments struggled at first to comprehend what was happening – and then reacted in very different ways. Most political leaders followed the advice of epidemiologists. Many declared states of emergency. A few pursued autocratic agendas. And some did almost nothing.

During emergencies, constitutional scholars normally worry about executive aggrandizement at the expense of human rights and democratic values. Emergencies often require national executives to act quickly and …

Executive Underreach, In Pandemics And Otherwise, David E. Pozen, Kim Lane Scheppele

Faculty Scholarship

Legal scholars are familiar with the problem of executive overreach, especially in emergencies. But sometimes, instead of being too audacious or extreme, a national executive's attempts to address a true threat prove far too limited and insubstantial. In this Essay, we seek to define and clarify the phenomenon of executive underreach, with special reference to the COVID-19 crisis; to outline ways in which such underreach may compromise constitutional governance and the international legal order; and to suggest a partial remedy.

Privacy And Pandemics, Clarisa Long

Faculty Scholarship

The beginning of 2020 marked an unexpected turn for the world, the global pandemic of COVID-19 has affected every aspect of life. It has also created an unprecedented opportunity for governments to justify the expansion of their surveillance and collection of data. The foregoing essay, which was first published in Faculty Publications at Scholarship Archive of the Columbia Law School focuses on two types of data collection – governmental mass collection of nonanonymized location data and state-collected nonanonymized data on people's health and immunity status. Several countries have applied one or both practices and it is relevant to look into …

Public Health Law Tools: A Brief Guide, Kristen Underhill

Faculty Scholarship

The COVID-19 pandemic offers a threat with few precedents in modern times and tests the tools of modern surveillance and public health law. The goal of this chapter is to provide a brief overview of the types of measures that state and federal governments can invoke to treat and prevent the spread of infectious disease. The following sections will provide an orientation to domestic public health law followed by the types of measures available to state and federal public health authorities.

Although this chapter does not consider international institutions, treaties, or norms that affect public health, these are also essential …

The Bad, The Ugly, And The Horrible: What I Learned About Humanity By Doing Prison Research, Adelina Iftene

Dalhousie Law Journal

Every Canadian academic conducting research with humans must submit an ethics application with their university’s Research Ethics Board. One of the key questions in that application inquired into the level of vulnerability of the interviewees. Filling in that question, I had to check nearly every box: the interviewees were incarcerated, old, under-educated, poor, Indigenous or other racial minorities, and likely had mental and physical disabilities. However, it was not until I met John that I understood what all those boxes actually meant. They were signalling that I was entering a universe of extreme marginalization—the universe of the forgotten. I learned …

Going Rogue: Mobile Research Applications And The Right To Privacy, Stacey A. Tovino

Notre Dame Law Review

This Article investigates whether nonsectoral state laws may serve as a viable source of privacy and security standards for mobile health research participants and other health data subjects until new federal laws are created or enforced. In particular, this Article (1) catalogues and analyzes the nonsectoral data privacy, security, and breach notification statutes of all fifty states and the District of Columbia; (2) applies these statutes to mobile-app-mediated health research conducted by independent scientists, citizen scientists, and patient researchers; and (3) proposes substantive amendments to state law that could help protect the privacy and security of all health data subjects, …

Condominium Government And The Right To Live In The City, Douglas C. Harris

All Faculty Publications

Condominium is an architecture of land ownership that produces separate, privately owned units within multi-unit developments. Condominium also constructs a form of private, democratic government, described as a fourth order of government, that acts beneath federal and provincial governments, and alongside municipal government, to govern owners and their property. This article considers a conflict between residential-unit owners and a commercial-unit owner within a condominium development in Vancouver’s Downtown Eastside. Drawing from material produced in litigation, the article situates the dispute within its property and urban contexts to argue that condominium government requires attention, and not just for its impact on …

Hb 217 - Needle Exchange Program, Alexandra L. Armbruster, J. Bryan Watford

Georgia State University Law Review

The Act authorizes certain nonprofit organizations and hospitals to operate clean needle exchange programs. These programs allow individuals who inject drugs to exchange their needles for clean, unused needles. The purpose of these programs is to prevent the spread of HIV, Hepatitis C, and other infectious diseases associated with the repeated use and sharing of needles. The Act further authorizes the Department of Public Health to regulate the registration of organizations that will participate in these programs and protects employees of those organizations from being charged with crimes or offenses associated with selling, lending, giving, or exchanging needles.

Agricultural Exceptionalism And Industrial Animal Food Production: Exploring The Human Rights Nexus, Charlotte E. Blattner, Odile Ammann

Journal of Food Law & Policy

The host of negative effects of animal agriculture on the immediate environment, workers, and local communities are well-documented, yet little is known about the global repercussions of animal agriculture, especially on human rights guarantees. This contribution attempts to begin filling this soaring gap. It examines the nexus between industrial animal agriculture (with a focus on concentrated animal feeding operations (CAFOs)) on the one hand, and specific international human rights violations on the other hand. Our emphasis is on the role of government in producing these violations, rather than on the agribusiness itself. Laws originally designed to govern small family farms—so-called …

Living Links Connecting The United Nations Sustainable Development Goals: Small-Scale Farmers And Agricultural Biodiversity, Susan H. Bragdon

San Diego International Law Journal

The 17 Sustainable Development Goals (SDGs) and Agenda 2030 adopted by the global community in September 2015 are applicable to all countries with the commitment “that no one is left behind.” As an agenda for “people, planet, prosperity, peace and partnership”, Agenda 2030 provides a vision for people and planet-centered, human rights-based, and gender-sensitive sustainable development. It promises “more peaceful and inclusive societies” which are free from fear and violence.

Small scale farmers and agricultural biodiversity are critical to the achievement of aspects of most of the SDGs. In addition to being essential for the resilience and stability of agricultural …