Digital Commons Network^™

Eliding Consent In The Case Of Pandemic Countermeasures Authorized Only For Emergency Use, Lars Noah

UF Law Faculty Publications

Four months after the first vaccines against Covid-19 became available to the public, and just as some universities announced plans to require inoculations, the Boston Globe quoted me as (alone) suggesting that mandates would conflict with federal law. When Congress created a special mechanism for the emergency use of still investigational products, it directed providers to reveal, among other things, that individuals remained free to decline such an intervention; only after full FDA approval of a medical countermeasure would this disclosure obligation become inapplicable. I have watched with dismay over the last three years as nearly everyone—including Executive branch officials, …

Does Federal Preemption Inoculate Us Against The Alarming Prospect Of State Vaccine Bans?, Lars Noah

UF Law Faculty Publications

With growing resistance to vaccinations-premised, for instance, on misplaced fears of side effects or religious objections-it takes little effort to imagine that a state might act to prohibit some or all uses of a particular vaccine licensed by the federal government. Indeed, one year ago, legislators in a couple of states toyed with the idea of banning the primary vaccines against Covid-19, and, twenty years ago, half a dozen states effectively barred certain uses of one flu vaccine formulation. Although federal law should preempt at least some of these types of state restrictions, the Supremacy Clause of the U.S. Constitution …

Rethinking Health Law Architecture, Ani B. Satz

Faculty Articles

Neither the individualistic regulatory health paradigm nor the vulnerable populations approach of public health can provide the legal structure necessary to address the most pressing problems in health care today. These approaches fail to address conflicts between individuals and populations as well as challenges to qualifying for care and are in inherent conflict with each other, sometimes within the same statute. As health concerns become more global, it is necessary to move past a vulnerable populations approach to a broader population approach that respects individual choice but does not sacrifice community health for liberty interests.

Effective Public Health Communication In A Post-Covid-19 America: Lessons From Behavioral Science, Molly J. Walker Wilson

Lewis & Clark Law Review

As we emerge from the worst of the COVID-19 pandemic, Americans are still reeling from the loss of life, the financial fallout, and the deep divide that continues to characterize our social and political institutions. Public health experts who were tasked with communicating facts and advice to the American public faced a daunting challenge, particularly because three distinct groups of Americans received messages differently. One group of Americans was receptive to scientific findings and amenable to taking recommended precautions. A second group was skeptical about the safety and efficacy of available vaccines, and genuinely confused or suspicious about the source …

Sharing Pathogen Sequence Data For Global Scientific Research Under The Nagoya Protocol To The Convention On Biological Diversity, Jerome H. Reichman, Carolina Dos S. Ribeiro, George B. Haringhuizen, Paul F. Uhlir

Faculty Scholarship

The Nagoya Protocol to the Convention on Biological Diversity (CBD) has threatened to impede access to genetic resources and related data for cross-border scientific research. In principle, every use of genetic resources would require a set of contracts under the CBD, in a “bilateral” regime. The related transaction costs could overwhelm many transnational research undertakings, affecting even public health responses to outbreaks and epidemics. However, the Nagoya Protocol also offers a unique opportunity to resolve this dilemma, despite struggles to define the meaning and coverage of “digital sequence information.” The coverage of genetic sequence data under the CBD remains controversial …

Addressing Ip And Technology Challenges To Pandemic Protection: A Need For Global Coordination To Promote National Security, Cynthia M. Ho

Faculty Publications & Other Works

This Artie!£ argues that effective national security mandates protection against the spread of infectious diseases, which requires addressing intellectual property (IP) and technology obstacles. Without modification, IP laws can bar the manufacture of needed treatments by anyone besides the IP owner and its licensees. Although there was some recognition during the COVID-19 pandemic that existing IP laws should be modified, there was strong resistance not only by IP-owning companies, but also by individual countries that impeded the ability to manufac­ture needed vaccines during the height of the pandemic. Many global leaders have recognized that future pandemics are inevitabw and that …

Pandemics Of Limitation Of Rights, Rinat Kitai-Sangero

Touro Law Review

This Article discusses the limitation of rights due to pandemics. It analyzes from a constitutional standpoint the holding of the German Federal Constitutional Court (Das BUNDESVERFASSUNGSGERICHT) from April 2022 as a symptom of moral panic disguised through an analytical process. Though it focuses on this case, it sheds light on the moral panic that characterized many countries’ approaches during the COVID-19 pandemic. On April 27, 2022, the German Federal Constitutional Court held that a provision to provide proof of vaccination against COVID-19, recovery from COVID-19, or a medical exemption to COVID-19 vaccination as a condition of employment in the health …

Challenging The Criminalization Of Undocumented Drivers Through A Health-Justice Framework, Jason A. Cade

Scholarly Works

States increasingly use driver’s license laws to further policy objectives unrelated to road safety. This symposium contribution employs a health justice lens to focus on one manifestation of this trend—state schemes that prohibit noncitizen residents from accessing driver’s licenses and then impose criminal sanctions for driving without authorization. Status-based no-license laws not only facilitate legally questionable enforcement of local immigration priorities but also impose structural inequities with long-term health consequences for immigrants and their family members, including US citizen children. Safe, reliable transportation is a significant social determinant of health for individuals, families, and communities. Applying a health justice lens …

Black Liberty In Emergency, Norrinda Brown

Northwestern University Law Review

COVID-19 pandemic orders were weaponized by state and local governments in Black neighborhoods, often through violent acts of the police. This revealed an intersection of three centuries-old patterns— criminalizing Black movement, quarantining racial minorities in public health crises, and segregation. The geographic borders of the most restrictive pandemic order enforcement were nearly identical to the borders of highly segregated, historically Black neighborhoods.

The right to free movement is fundamental and, as a rule, cannot be impeded by the state. But the jurisprudence around state power in public health emergencies, deriving from the 1905 case Jacobson v. Massachusetts, has practically resulted …

Intellectual Property And “The Lost Year” Of Covid-19 Deaths, Madhavi Sunder, Haochen Sun

Georgetown Law Faculty Publications and Other Works

Protecting intellectual property (IP) is a question of life and death. COVID-19 vaccines, partially incentivized by IP, are estimated to have saved nearly 20 million lives worldwide during the first year of their availability in 2021. However, most of the benefits of this life-saving technology went to high- and upper-middle-income countries. Despite 10 billion vaccines being produced by the end of 2021, only 4 percent of people in low-income countries were fully vaccinated. Paradoxically, IP may also be partly responsible for hundreds of thousands of lives lost in 2021, due to an insufficient supply of vaccines and inequitable access during …

The Low-Hanging Fruit: Health, Rights, And The Commission, Bright Nkrumah

Washington and Lee Journal of Civil Rights and Social Justice

The year 2022 marked the 35th anniversary of the African Commission on Human and Peoples’ Rights. As it is a custom in many communities, when one reaches this milestone, it is an opportune time to introspect and reflect on the successes and challenges encountered in one’s journey. It is this template that the paper adopts to measure the prospects and setbacks of the African Commission in the advancement of the right to health. The Article argues that while the body remains the poster child of the continent’s human rights architecture, its inability to clearly articulate how states ought to advance …

Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu

Faculty Scholarship

This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …

J Mich Dent Assoc October 2023

The Journal of the Michigan Dental Association

The October 2023 issue of the Journal of the Michigan Dental Association provides: A message from the chair of the Michigan Dental Association political action committee with a listing of donors and a report on MDA advocacy during 2023, which are this month’s cover stories. Also included is a Q&A feature on dealing with dental benefits companies. This month’s clinical article is a discussion of the management of a failing implant using guided bone regeneration and esthetic crown lengthening. Other features include a listing of 2023 MDA life members and a President’s Message on the dental workforce crisis in Michigan. …

The Code Of Life And Death, Braden R. Leach

Notre Dame Journal on Emerging Technologies

Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet. The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences. Unsurprisingly, voluntary guidance has not …

Federalism, Leadership, And Covid-19: Evolving Lessons For The Public’S Health, Nicole Huberfeld

Faculty Scholarship

The COVID-19 pandemic has had an enduring effect across the entire spectrum of law and policy, in areas ranging from health equity and racial justice, to constitutional law, the law of prisons, federal benefit programs, election law and much more. This collection provides a critical reflection on what changes the pandemic has already introduced, and what its legacy may be. Chapters evaluate how healthcare and government institutions have succeeded and failed during this global 'stress test,' and explore how the US and the world will move forward to ensure we are better prepared for future pandemics. This timely volume identifies …

The Global Health And Care Worker Compact: Evidence Base And Policy Considerations, Eric A. Friedman, Robert Bickford, Charles Bjork, James Campbell, Giorgio Cometto, Alexandra Finch, Catherine Kane, Sarah A. Wetter, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Background During the COVID-19 pandemic, and recognising the sacrifice of health and care workers alongside discrimination, violence, poor working conditions and other violations of their rights, health and safety, in 2021 the World Health Assembly requested WHO to develop a global health and care worker compact, building on existing normative documentation, to provide guidance to ‘protect health and care workers and safeguard their rights’.

Methods A review of existing international law and other normative documents was conducted. We manually searched five main sets of international instruments: (1) International Labour Organization conventions and recommendations; (2) WHO documents; (3) United Nations (UN) …

Dying In Isolation: Public Health Implications Of Transportation And Burial Of Human Remains During A Pandemic A Fifty State Survey, Christopher Ogolla

Faculty Scholarship

No abstract provided.

The Hipaa Privacy Rule At Age 25: Privacy For Equitable Ai, Barbara J. Evans

UF Law Faculty Publications

This Article argues that unconsented access to data is not ethically problematic in and of itself. What has made it problematic is the weak framework of alternative protections that the Privacy Rule prescribes when data are used without individual consent. This Article proposes specific measures to strengthen those protections so that the pursuit of greater health care equity need not imply a loss of meaningful privacy standards.

Part I describes two competing visions of how to protect data privacy, examining the roots of ongoing discontent with the Privacy Rule and tracing policymakers’ original rationale for fashioning a major federal privacy …

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

A Pandemics Treaty: A Boon For Africa, Kafumu Kalyalya

Southern African Journal of Policy and Development

This article illustrates the weaknesses of the current global health framework. It highlights two pillars a new treaty regime ought to be built upon. The analysis seeks to establish how these pillars could have helped Africa during the pandemic and can indeed help Africa in future pandemics. The analysis suggests the need for a unified global health regime or pandemics’ treaty that promotes a level legal and political playing field regarding future pandemics. The treaty could focus on coordination of research and development; build a stronger global framework that reinforces legal obligations and norms; provide for universal access to medicines, …

Advancing Equity In The Pandemic Treaty, Lawrence O. Gostin, Kevin A. Klock, Katherine Ginsbach, Sam F. Halabi, Taylor Hall-Debnam, Janelle Lewis, Vanessa S. Perlman, Katie Robinson

Georgetown Law Faculty Publications and Other Works

There is a broad consensus around equity’s importance. Even countries that hoarded supplies during the acute phase of COVID-19 seem to understand that the international community must find a means to ensure fairer allocation of medical resources when the next health crisis hits. But there has been little agreement about the concrete steps needed to operationalize fairer access and benefit sharing. That is, what are the workable mechanisms that could reduce the divide between richer and poorer populations? The World Health Assembly, the governing body of the World Health Organization, has appointed an Intergovernmental Negotiating Body to develop a pandemic …

Disaster Risk In The Carceral State, Saptarishi Bandopadhyay, Joshua R. Coene

Journal Articles

The overlap between prisoner vulnerability and disasters in the United States is undeniable. During 2020 and 2021, the United States endured a series of natural hazards such as wildfires, floods, and hurricanes, many of which exposed the country’s 2.1 million inmates to additional risks and compounded the danger posed by COVID-19. Yet policymakers and scholars are only beginning to appreciate the centrality and magnitude of disaster risk management for the millions of people currently held in penal institutions around the country. Unsurprisingly, the production of “lessons learned” documents that follow in the aftermath of disasters overlook how prisoner vulnerability is …

Pooling Patents For Pandemic Progress: Mrna Vaccines And The Broader Context Of Modernatx Inc V. Pfizer Inc., Francis Brefo

DePaul Journal of Art, Technology & Intellectual Property Law

No abstract provided.

A Thousand Views Of The Cathedral: The Law, Politics, And Statistics Of Pandemic Dashboards, Jeff Lingwall, Tj Bliss

Health Matrix: The Journal of Law-Medicine

This Article explores the law, politics, and statistics of communicating data through the thousands of state, county, school district, and higher-education dashboards created in response to the COVID-19 global pandemic. Using a nationally distributed questionnaire and series of interviews with dashboard managers and stakeholders, we offer a wide-ranging view of data visualization practice in response to COVID-19. We pair this evidence with a survey of almost 3,000 entities responsible for public health communication, which resulted in collection of over 1,100 COVID-19 dashboards from a spectrum of government actors and private parties. We evaluate how legal issues were perceived and acted …

Evidence For Community Face Masking To Limit The Spread Of Sars-Cov-2: A Critical Review, Ian T. Liu, Vinay Prasad, Jonathan D. Darrow

Health Matrix: The Journal of Law-Medicine

The use of facemasks in community settings has become an accepted public policy response to decrease disease transmission during the COVID-19 pandemic. Yet evidence of facemask efficacy is based primarily on observational studies that are subject to confounding and on mechanistic studies that rely on surrogate endpoints (such as droplet dispersion) as proxies for disease transmission. The available clinical evidence of facemask efficacy is of low quality and the best available clinical evidence has mostly failed to show efficacy, with fourteen of sixteen identified randomized controlled trials comparing face masks to no mask controls failing to find statistically significant benefit …

Compassion Fatigue In An Infodemic: A Physician’S Duty To Treat In The Age Of Misinformation, Alessandra Perez

University of Miami International and Comparative Law Review

This Note considers how misinformation has exacerbated the COVID-19 pandemic and the inevitable burden it has placed on the healthcare industry. It explores the intersection between a doctor’s oath of ethics and their right to refuse care by uncovering the obligations that guide their decisions. Justice dictates that physicians provide care to all who seek it, and it is unconstitutional for a physician to refuse to treat patients based on race, ethnicity, gender, religion, or sexual orientation. Even if a patient’s request is antithetical to a physician’s personal beliefs, the unwavering duty to treat generally mandates that physicians treat any …

The Inherent Monetary Incentive Of Intellectual Property Rights And The Failure Of Intellectual Property Waivers To Recognize This Motive, Ellaheh D. Sims

Barry Law Review

No abstract provided.

Independent Freestanding Emergency Centers: The Face Of An Alternative Model To Healthcare In Rural America, Alisha Patel

Belmont Health Law Journal

This Note will attempt to provide a background of rural healthcare disparities and the issues facing these regions. This Note will also explore the history of IFECs in the United States to better understand the context of the issues and reasons as to why emergency regulations such as EMTALA do not already extend to IFECs. Part 1 of this Note will examine the origin of IFECs and their role in the healthcare landscape today. Part II will discuss EMTALA and the challenges associated with IFECs during a public health emergency. Lastly, Part III of this Note will highlight the advantages …

Taking Care Of Business: An Empirical Examination Of The Top S&P 500 Companies And Their Role As Public Health Regulators During The Covid-19 Pandemic, Megan M. O’Malley

University of Miami Business Law Review

Data from the top 15 constituents by weight on the S&P 500 is assembled to identify trends among the policies these companies implemented in the United States during the COVID-19 pandemic. Some policies were fairly consistent across the board, especially in regard to remote work opportunities and health and safety measures for essential and/or in-person employees. Other policies, including vaccination requirements and vaccine incentives, varied across and within industries. Some companies that were examined went beyond the relevant federal, state, or local requirements in effect at the time, while other companies pushed back against public health guidance.

Center For Health & Homeland Security Newsletter, Spring 2023

Newsletter

No abstract provided.