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Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

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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 …

Property And Intellectual Property In Vaccine Markets, Ana Santos Rutschman

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As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that [h]appy families are all alike; every unhappy family is unhappy in its own way.¹ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy's principle² in the field of biopharmaceutical innovation.

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

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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

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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 …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

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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, …

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

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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

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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.

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

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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 …

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

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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 …

Mapping Misinformation In The Coronavirus Outbreak, Ana Santos Rutschman

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The coronavirus outbreak has sent ripples of fear and confusion across the world. These sentiments—and our collective responses to the outbreak—are made worse by rampant misinformation surrounding the new strain of the virus, COVID-2019. In this post, I survey some of the most pervasive areas of tentacular coronavirus-related misinformation that has proliferated online -- as well as the responses of social media companies like YouTube, Facebook, Pinterest and TikTok that may ultimately prove inadequate given the magnitude of the problem.

The Reemergence Of Vaccine Nationalism, Ana Santos Rutschman

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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.

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

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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 …

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

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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 …

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

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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 …

The Case For Face Shields: Improving The Covid-19 Public Health Policy Toolkit, Timothy L. Wiemken, Ana Santos Rutschman, Robert Gatter

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As the United States battles the later stages of the first wave of COVID-19 and faces the prospect of future waves, it is time to consider the practical utility of face shields as an alternative or complement to face masks in the policy guidance. Without face shields specifically noted in national guidance, many areas may be reluctant to allow their use as an alternative to cloth face masks, even with sufficient modification.

In this piece, we discuss the benefits of face shields as a substitute to face masks in the context of public health policy. We further discuss the implications …

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

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As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

Protecting The Rights Of People With Disabilities, Elizabeth Pendo

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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 …

Vaccine Hesitancy: Experimentalism As Regulatory Opportunity, Ana Santos Rutschman, Timothy L. Wiemken

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This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost …

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

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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, …

PortugalʼS Response To Covid-19, Ana Santos Rutschman

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This essay for the Regulatory Review's special series on Comparing Nations’ Responses to COVID-19 examines the early response to the pandemic in Portugal. The essay focuses on measures adopted in connection with the declarations of state of emergency and state of calamity, as well as the treatment of migrant populations throughout the pandemic.

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

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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.

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

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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

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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 …