HealthLawProf Blog

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

Ana Santos Rutschman (Saint Louis University), Julia Barnes-Weise, The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal, Bill of Health (2021):

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal – that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

Repairing Medical Equipment in Times of Pandemic

Ofer Tur-Sinai (Ono Academic College), Leah Chan Grinvald (Suffolk University), Repairing Medical Equipment in Times of Pandemic, Seton Hall L. Rev. (2021):

The COVID-19 pandemic that has gripped the world since early 2020 has underscored the need for an effective right to repair medical equipment. As healthcare systems have been pushed to the limit, keeping critical medical equipment (such as ventilators) in working order has become a matter of life and death. Unfortunately, the ability of hospitals and other health care providers to service and fix their medical equipment is often hindered by the tight control that original equipment manufacturers keep over repair of their products. On top of direct contractual restrictions on repair, one of the major difficulties encountered by hospital-based and third-party service providers is the lack of access to service manuals, service keys, schematics, replacement parts, and repair tools. The ability to block access to these critical items is abetted, in large part, by intellectual property laws.In August 2020, a new federal legislation was introduced to address this problem—the Critical Medical Infrastructure Right-to-Repair Act of 2020 (the “Act”). The Act is designed to facilitate repair of critical medical infrastructure during the current COVID-19 pandemic, and to do so, it addresses various relevant intellectual property issues. This Article provides a critical analysis of the Act and examines the extent to which it could serve its prescribed goal. We also investigate the role that courts could play, alongside such legislation, by using policy levers that already exist in intellectual property law to provide relief to hospital-based and independent service technicians and mandate manufacturers to cooperate with them in certain circumstances.

Children and Disasters: The Essential Role of Children's Rights Law

Jonathan Todres (Georgia State University), Children and Disasters: The Essential Role of Children's Rights Law, 2 Yearbook Int’l Disaster L. 177 (2021):

Although children constitute approximately one-third of the world’s population, they remain marginalized when it comes to law and policy discourses and actions. Disasters do not change this dynamic. Despite being the face of media portrayals in the aftermath of disasters, children often are relegated to the margins and not adequately accounted for in disaster response initiatives. Moreover, children continue to receive insufficient attention in research on disasters and their impact, even though in disaster settings, they are among the most vulnerable and hard-hit populations.This chapter discusses the various ways disasters affect children and the international law frameworks relevant to children and disasters (notably IDRL and children’s rights law). It then examines how the international community and national governments must reframe their approach to children in the context of disasters so that they are no longer overlooked, urging a mainstreaming of both children’s views and children’s rights in the prevention of and responses to disasters.

Violation of Drug Manufacturing and Quality Control Regulations in the USA

Viktor Shestak, Liana Khalikova, Violation of Drug Manufacturing and Quality Control Regulations in the USA, SSRN:

The article examines the violations of the rules of organization of production and quality control of medicines in the United States of America. The author presents an analysis of the requirements of the Food and Drug Administration. The paper considers statistical data relating to the most common claims made against pharmaceutical companies. Specific cases of fraud in the health care industry are cited. The relevance of the problem of fabrication of medical products is disclosed. On the basis of the study the need for an effective mechanism of production of medicines is substantiated.

COVID-19 and Sites of Confinement: Public Health, Disposable Lives and Legal Accountability in Immigration Detention and Aged Care

Sara Dehm (University of Technology Sydney), Claire Bernadette Loughnan (University of Melbourne), Linda Steele (University of Technology Sydney), COVID-19 and Sites of Confinement: Public Health, Disposable Lives and Legal Accountability in Immigration Detention and Aged Care, 44(1) UNSW L. J. 59 (2021):

The global COVID-19 pandemic starkly revealed the underlying structural harms and produced vulnerabilities for people living in closed congregate settings like immigration detention centres (‘IDCs’) and residential aged care facilities (‘RACFs’). This article compares the Australian legal regimes that regulate IDCs and RACFs, conceptualising both as authorising and enabling sites of control, confinement and social isolation. We argue that specific COVID-19 measures have intensified a logic of social exclusion and disposability towards people in IDCs and RACFs. Through comparing recent COVID-19 litigation, the article explores the possibilities and limitations of engaging legal strategies to achieve social reform and legal accountability within both sites of confinement. Ultimately, we suggest that such COVID-19 litigation has the greatest possibility of advancing social justice when it is embedded in a broader politics of de-incarceration and abolition oriented towards political inclusion, public health and building more equitable and just communities.

Disease and Data in Society: How the Pandemic Expanded Data Collection and Surveillance Systems

Alan Butler, Enid Zhou, Disease and Data in Society: How the Pandemic Expanded Data Collection and Surveillance Systems, 70(5) Am. U. L. Rev. (Forthcoming, 2021):

The COVID-19 pandemic 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 is the expansion of data collection and surveillance systems adopted both in response to, and as a result of, the pandemic. As the United States brings the pandemic under control and shifts back to some form of normalcy, it is important to critically evaluate the data collection and surveillance systems that have become more widespread during the pandemic. Academics, historians, and journalists alike are contributing to a growing body of work that is examining the privacy impact of the technological and social changes caused by the pandemic. This Article contributes to the existing literature on privacy during the pandemic by highlighting important trends and recommending policy responses. This Article focuses in particular on two categories of surveillance and personal data collection systems that have been deployed and adapted because of the pandemic by non-government actors. The first category includes systems that collect and monitor health and health-related data in response to the spread of COVID-19. The second category includes systems of surveillance and data collection that have expanded as a result of the shift to remote work, school, and life. The main focus of this Article is on consumer, healthcare, workplace, and educational surveillance systems rather than the types of surveillance systems typically associated with law enforcement investigations. This Article aims to provide recommendations on how to protect privacy while responding to the pandemic and what lawmakers should do once the pandemic abates.

COVID-19: Isolating the Problems in Privacy Protection for Individuals with Substance Use Disorder

Kimberly Johnson (The University of Chicago), COVID-19: Isolating the Problems in Privacy Protection for Individuals with Substance Use Disorder, U. Chic. Legal Forum (Forthcoming):

The COVID-19 pandemic has introduced social distancing orders, as well as exacerbated housing instability and unemployment, all of which interfere with substance use disorder (“SUD”) treatment. Treatment access concerns are accompanied by concerns regarding privacy, stigmatization, and discrimination with treatment. The pandemic has galvanized discussion over SUD privacy law. In March 2020, Congress passed the CARES Act, which, inter alia, amended the privacy framework for SUD treatment records. This Comment evaluates the extent to which the CARES Act privacy modifications sustainably balance individual privacy expectations with strong public interests in obtaining SUD records and integrating care. It suggests that heightened antidiscrimination law is better situated to reduce barriers to treatment and avoid widespread treatment discontinuity in a future public health crisis.

The U.S. Posture on Global Access to Medication & the Case for Change

Michael Palmedo (American University), Srividhya Ragavan (Texas A&M University), The U.S. Posture on Global Access to Medication & the Case for Change, SSRN:

The TRIPS Waiver sought by India and South Africa features as the hot button issue of 2021. This paper enables that discussion by empirically showcasing the traditional role of the United States Trade Representative (USTR) on the question of pharmaceutical patents. The USTR is authorized by statute to identify and pursue countries perceived as denying adequate and effective protection of intellectual property (IP) rights and/or fair and equitable market access to U.S. industries or entities that rely on IP protection. The paper examines whether the allegations of poorer nations that repeatedly, the changes sought by the US have often deterred other member nations from using negotiated trade flexibilities. In doing so, this paper highlights that, it is a fact that the USTR has historically exerted pressure - often, unilaterally - on other countries in a manner that violates the spirit of the multilateral dispute settlement mechanism of the World Trade Organization. The paper showcases the number of times the USTR has tended to focus its allegations of violations on pharmaceuticals, seemingly only based on the rhetoric from PhRMA. In fact, once a country is an identified violator, the USTR has tended towards applying direct and indirect pressure through trade negotiations and preference systems in order to win policy changes favoring the U.S. intellectual property owners. The unfortunate reality, this paper concludes , is that traditionally many such changes sought by the USTR lack due consideration of local realities, and has not truly allowed allies to use negotiated TRIPS- flexibilities meant to provide access to medications in the targeted nations. 

COVID-19 Employee Health Checks, Remote Work, and Disability Law

Elizabeth Pendo  (Saint Louis University), COVID-19 Employee Health Checks, Remote Work, and Disability Law,Work Law Under COVID-19 (2021)

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.

Ability Apartheid and Paid Leave

Ryan H. Nelson(Harvard Law School), Ability Apartheid and Paid Leave, 120 Mich. L. Rev. (Forthcoming, 2022):

Paul David Harpur's book, Ableism at Work: Disablement and Hierarchies of Impairment, justifies the public’s renewed focus on uprooting systemic discrimination by arguing that employment laws marginalize workers with psychosocial disabilities. As such, Harpur’s work would have been a welcome addition to the 2020s even if we had not been living through this once-in-a-century (we hope) pandemic. COVID-19 renders Harpur’s book all the more urgent. The widespread effects of the pandemic (including death, sickness, social disruption) prefigure an imminent mental health surge that mental health professionals are calling “another second wave.” Moreover, pervasive unemployment has afforded employers significant leeway in deciding which workers to retain and under what conditions. Combined, these phenomena portend a serious problem for workers with a psychosocial disability: an increase in mental impairments coupled with the incentives for employers to marginalize workers with such impairments.

COVID-19 and Sites of Confinement: Public Health, Disposable Lives and Legal Accountability in Immigration Detention and Aged Care

Sara Dehm (University of Technology Sydney), Claire Bernadette Loughnan (University of Melbourne), Linda Steele  (University of Technology Sydney), COVID-19 and Sites of Confinement: Public Health, Disposable Lives and Legal Accountability in Immigration Detention and Aged Care, 44(1) UNSW L. J. 59 (2021):

The global COVID-19 pandemic starkly revealed the underlying structural harms and produced vulnerabilities for people living in closed congregate settings like immigration detention centres (‘IDCs’) and residential aged care facilities (‘RACFs’). This article compares the Australian legal regimes that regulate IDCs and RACFs, conceptualising both as authorising and enabling sites of control, confinement and social isolation. We argue that specific COVID-19 measures have intensified a logic of social exclusion and disposability towards people in IDCs and RACFs. Through comparing recent COVID-19 litigation, the article explores the possibilities and limitations of engaging legal strategies to achieve social reform and legal accountability within both sites of confinement. Ultimately, we suggest that such COVID-19 litigation has the greatest possibility of advancing social justice when it is embedded in a broader politics of de-incarceration and abolition oriented towards political inclusion, public health and building more equitable and just communities.

COVID-19: Isolating the Problems in Privacy Protection for Individuals with Substance Use Disorder

Kimberly Johnson  (The University of Chicago), COVID-19: Isolating the Problems in Privacy Protection for Individuals with Substance Use Disorder, U. Chic. Legal Forum (Forthcoming):

The COVID-19 pandemic has introduced social distancing orders, as well as exacerbated housing instability and unemployment, all of which interfere with substance use disorder (“SUD”) treatment. Treatment access concerns are accompanied by concerns regarding privacy, stigmatization, and discrimination with treatment. The pandemic has galvanized discussion over SUD privacy law. In March 2020, Congress passed the CARES Act, which, inter alia, amended the privacy framework for SUD treatment records. This Comment evaluates the extent to which the CARES Act privacy modifications sustainably balance individual privacy expectations with strong public interests in obtaining SUD records and integrating care. It suggests that heightened antidiscrimination law is better situated to reduce barriers to treatment and avoid widespread treatment discontinuity in a future public health crisis.

Legal Strategies for Promoting Mental Health and Wellbeing in Relation to the COVID-19 Pandemic

Jill Krueger, Legal Strategies for Promoting Mental Health and Wellbeing in Relation to the COVID-19 Pandemic, COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future. Boston: Public Health Law Watch (2021):

The loss of life, severe illnesses, uncertainty, loneliness, and exhaustion related to COVID-19, together with the social and economic impacts of community mitigation measures, have taken a toll on mental health throughout the population. Many elderly, African-Americans, Latinos, Native Americans, Asian Americans, health care providers, public health professionals, essential workers, unemployed people, children, young adults, educators, parents, women, caregivers, LQBTQ people, prisoners, and people who live alone have experienced heightened stress, anxiety, depression, burnout, and isolation. Beyond treating individuals experiencing mental illness, law and policy can support mental health and wellbeing in four primary ways: (1) strengthen the social and economic safety net, (2) improve access to mental health care, (3) support mental health knowledge and skills, and (4) prevent self-harm and violence. Bolstering the ability to meet basic needs such as housing, food, childcare, and safer employment or unemployment benefits will reduce stress and improve health outcomes. Substantial, sustained investment in community mental health will expand access to treatment, increase use of public and private insurance, and overcome provider shortages, especially in rural communities and communities of color. Every educational setting must prioritize social and emotional wellbeing of students, educators, employees, and parents. Strengthening interventions including Psychological First Aid, the Crisis Counseling Program, suicide prevention, and violence prevention will support connectedness, nurture coping skills, and increase safety. Legal action to reverse structural racism and support mental health in communities of color is essential. Strategies to support posttraumatic growth should be at the forefront of pandemic response, recovery, and restructuring. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

Access to Treatment for Individuals with Opioid Use Disorder

Corey S. Davis, Amy Judd Lieberman, Access to Treatment for Individuals with Opioid Use Disorder, COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future. Boston: Public Health Law Watch (2021):

Highly effective medications to treat opioid use disorder (OUD) have existed for decades. Despite their proven efficacy, federal and state laws severely limit access to these medications, limitations that disproportionately impact those who are made particularly vulnerable by factors including economic injustice and structural racism. In response to the COVID-19 epidemic, the U.S. Drug Enforcement Administration (DEA) and other federal agencies have taken steps to temporarily remove some legal and regulatory barriers to these medications. Most of these changes are set to expire with the COVID-19 public health emergency declaration, although the epidemic of opioid-related harm will not end when the novel coronavirus is controlled. Indeed, data from many states show a sharp increase in opioid-related harm since the beginning of the COVID-19 pandemic. This Chapter highlights the positive impact of OUD treatment, recent changes to increase access to that treatment, and recommendations for permanently reducing legislative and regulatory barriers to effective, evidence-based interventions for OUD. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

Implementation and Enforcement of Quality and Safety in Long-Term Care

Tara Sklar (University of Arizona), Implementation and Enforcement of Quality and Safety in Long-Term Care, COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future. Boston: Public Health Law Watch (2021):

To understand how long-term care facilities, which less than 1% of the U.S. population lives in, became the source of more than 35% of COVID-19 deaths, you have to look beyond the vulnerability of the residents and examine how these facilities manage their employees and are regulated. Throughout the pandemic, grim reports consistently identified inadequate staffing, lack of effective infectious disease control and prevention, and poor emergency planning, as all factors that contributed to the death toll among residents and workers. In an effort to curb infection rates, federal emergency laws were passed, including the first universal paid sick leave law, and billions of federal government dollars were distributed to these facilities. In addition, the CDC Advisory Committee on Immunization Practices recommended targeting the limited vaccine doses to long-term care facilities first, in Phase 1a, which most states followed. However, these federal efforts failed to reach many of the intended constituents due to inequities around race, age, gender, socio-economic, and citizenship status. This Chapter provides recommendations on how to improve upon implementation of these federal efforts so that they are optimally and universally applied for a more resilient and equitable long-term care system. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association.

Disparities in Health Care: The Pandemic’s Lessons for Health Lawyers

Danielle Pelfrey Duryea (Boston University), Nicole Huberfeld (Boston University), Ruqaiijah Yearby (Saint Louis University), Disparities in Health Care: The Pandemic’s Lessons for Health Lawyers, Am. Health L. Assoc. Health L. Watch (2021):

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 of forces and systems shaping the conditions of daily life.” Although it may seem obvious that differential access to high-quality care results in differential health outcomes, less obvious are the ways that multiple factors—including facially neutral laws and organizational practices—interact over time to produce population-level disparities in care and outcomes.