Health Law and Policy Commons^™

Fraud Law And Misinfodemics, Wes Henricksen

Utah Law Review

During the COVID-19 pandemic, many on whom the public depended for truthful information purposefully or recklessly spread misinformation that put thousands at risk. The term “misinfodemic,” coined in 2019, describes such events where misinformation facilitates the spread of a disease or causes some other health-related outcome. Though the term was only recently defined, the recent misinfodemic was not a new or novel phenomenon. False information is spread to the public all the time. This often results in harm to public health. False claims are communicated by corporations seeking to mislead the public to make more money, by politicians to gain …

High Time For A Change: How The Relationship Between Signatory Countries And The United Nations Conventions Governing Narcotic Drugs Must Adapt To Foster A Global Shift In Cannabis Law, Alexander Clementi

Brooklyn Journal of International Law

Since the early 1970’s, the inclusion of cannabis and its byproducts in the United Nations Single Convention on Narcotic Drugs has mandated a strict prohibition on cultivation and use of the substance, which has led to a largely global practice of criminalization and imprisonment of anyone found to be in its possession. Yet recently, mostly in response to growing public health concerns, countries like Uruguay, Portugal, The Netherlands, Canada, and the United States have enacted laws which seek to decriminalize or even legalize cannabis use and possession. Yet, cannabis remains classified as a Schedule IV narcotic under the Single Convention, …

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

Federalized Corporate Governance: The Dream Of William O. Douglas As Sarbanes-Oxley Turns 20, Joan Macleod Heminway

Brooklyn Journal of Corporate, Financial & Commercial Law

The federalization of U.S. corporate governance has been a topic of conversation among policymakers from the very beginning of federal securities law in the New Deal era. Among the early proponents of a federalized system of corporate governance oversight was William O. Douglas—perhaps best known as the longest-serving U.S. Supreme Court justice, but who also was a former commissioner and chair of the U.S. Securities and Exchange Commission. Reflecting on Douglas’s federal corporate governance ideas, Professor Roberta Karmel wrote a law review article for the Delaware Journal of Corporate Law, published in 2005, commenting on the extent and nature of …

Public-Private Litigation For Health, Liza S. Vertinsky, Reuben A. Guttman

Utah Law Review

Public health litigation can be a powerful mechanism for addressing public health harms where alternative interventions have failed. It can draw public attention to corporate misconduct and create a public record of the actions taken and the harms done. In an ideal world, it could achieve compensation for past harms and incentivize deterrence of future misconduct. But the full public health potential of these lawsuits is rarely achieved, even when the suits are brought on behalf of federal, state, and local governments with the ostensible goal of protecting the health of the citizens. The increasing involvement of private attorneys in …

Are Vaccine Lotteries Worth The Money?, Christopher Robertson, K. Aleks Schaefer, Daniel Scheitrum

Faculty Scholarship

This research evaluates the effects of the twelve statewide vaccine lottery schemes that were announced as of June 7, 2021 on state vaccination rates. We construct a dataset that matches information on the timing and location of these lotteries with daily, county-level data from the U.S. Centers for Disease Control (CDC) on the cumulative number of people who have received at least one dose of an emergency-authorized Covid-19 vaccine. We find that 10 of the 12 statewide lotteries studied (i.e., all but Arkansas and California) generated a positive, statistically significant, and economically meaningful impact on vaccine uptake after thirty days. …

Health Reform Reconstruction, Lindsay F. Wiley, Elizabeth Mccuskey, Matthew B. Lawrence, Erin C. Fuse Brown

Faculty Scholarship

This Article connects the failed, inequitable U.S. coronavirus pandemic response to conceptual and structural constraints that have held back U.S health reform for decades and calls for reconstruction. For more than a half-century, a cramped "iron triangle" ethos has constrained health reform conceptually. Reforms aimed to balance individual interests in cost, quality, and access to health care, while marginalizing equity, solidarity, and public health. In the iron triangle era, reforms unquestioningly accommodated four legally and logistically entrenched fixtures - individualism, fiscal fragmentation, privatization, and federalism - that distort and diffuse any reach toward social justice. The profound racial disparities and …

Direct-To-Consumer Genetic Testing, Ellen W. Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals’ responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such …

No Future But A Shared Future, Lawrence O. Gostin, Kevin A. Klock, Sam F. Halabi, Katie Gottschalk, Katherine Ginsbach

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic revealed the fractured and inadequate state of national and global health law and institutions, revealing deeply embedded inequalities. In response to a World Health Assembly resolution proposing a special session to consider the benefits of developing a WHO convention or other international instrument on pandemic preparedness and response, the O’Neill Institute for National and Global Health Law and the Foundation for the National Institutes of Health (FNIH) convened 30 of the world’s leading authorities on global health law, financing, biomedical science, implementation, and emergency response along with leaders from prominent international organizations deeply engaged in responding to …

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

Toward A More Strategic National Stockpile, Troy Rule

Texas A&M Law Review

The COVID–19 pandemic exposed major deficiencies in the United States’ approach to stockpiling for emergencies. States, cities, and hospitals across the country had meager inventories of critical medical items on hand when the pandemic first reached U.S. soil, and the federal government’s Strategic National Stockpile proved far too small to serve the country’s needs in the first several months of the crisis. As nationwide shortages spread, many state governments were compelled to bid against each other to procure scarce medical supplies—a distribution approach that disadvantaged low-income and minority communities and left countless healthcare professionals and staff ill-equipped to protect themselves …

Title 42, Asylum, And Politicising Public Health, Michael Ulrich, Sondra S. Crosby

Faculty Scholarship

President Biden has continued the controversial immigration policy of the Trump era known as Title 42, which has caused harm and suffering to scores of asylum seekers under the guise of public health.1 The Centers for Disease Control and Prevention (CDC) ordered the policy in March 2020 with the stated purpose of limiting the spread of the coronavirus into the U.S.; though, CDC and public health officials have admitted this policy has no scientific basis and there is no evidence it has protected the public.2,3 Instead, the impetus behind the policy appears to be a desire to keep out or …

Managing Covid-19: Legal And Institutional Issues, Yon-Shik Lee

Minnesota Journal of Law, Science & Technology

No abstract provided.

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

Articles

Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …

Pediatric Covid-19 Vaccines: What Parents, Practitioners, And Policy Makers Need To Know, William J. Moss, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The US Food and Drug Administration (FDA) granted Emergency Use Authorization for Pfizer-BioNTech’s mRNA COVID-19 vaccine (BNT162b2) for children 5 to 11 years of age on October 29, 2021. The Centers for Disease Control and Prevention recommended use of the vaccine among children in this age group on November 2, 2021. Approximately 28 million children are now eligible for vaccination, with only those younger than 5 years remaining excluded from vaccine eligibility. The benefits of pediatric COVID-19 vaccines are clear. Vaccinations protect children, decrease spread to families and communities, and ensure educational continuity. What do parents, practitioners, and policy makers …

The Right To Abortion Access And Reproductive Healthcare, Cardozo Public Interest Law Student Association, If/When/How: Lawyering For Reproductive Justice Cardozo Chapter, Cardozo Women's Law Initiative, Cardozo Students For Human Rights

2021–2022 Flyers

No abstract provided.

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

Problematic Interactions Between Ai And Health Privacy, Nicholson Price

Utah Law Review

The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set of entities, the process of data collection while following privacy rules, and the use of …

Coronavirus, Compulsory Licensing, And Collaboration: Analyzing The 2020 Global Vaccine Response With 20/20 Hindsight, Arjun Padmanabhan

Student Scholarship

In December 2019, COVID-19, a novel strain of the SARS-2 Virus, appeared in Wuhan, China. Within a year, over ninety million people had been infected, and two million had died. Amid all the death and desolation, humanity's ingenuity and willpower emerged in history's greatest vaccine race. The global community sought to find novel ways to protect innovation and intellectual property while still collaborating to roll out a vaccine in record time. Despite the presence of compulsory licensing provisions like 28 U.S.C. § 1498 and the Bayh-Dole Act in the U.S., and the TRIPS Agreement at the international level, the journey …

J Mich Dent Assoc November 2021

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• Cover stories with a “Focus on Advocacy: Helping Dentistry Succeed”, including “MDA Dental PAC: What It Is and Why It Matters “, “2021 Advocacy Success — and More to Come “, and “Dental Programs Maintained in 2021-22 State Budget”.
• A feature article on “The Anishinaabe Dental Outreach Program”.
• A feature article, “How Your Website and …

Waive Ip Rights & Save Lives, Srividhya Ragavan

Faculty Scholarship

In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries. The waiver was proposed as a tool to kick-start prevention, containment and treatment of COVID-19. While there is an imminent need to meet a growing supply-demand gap for all medical products, COVID-19 related products are urgently required in poorer nations to contain the pandemic. The waiver has an additional role to play in the larger trade schema. In enabling vaccination of populations across the globe, the waiver would be critical …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Preface, Tammy M. Frisby, Leslie P. Francis

Utah Law Review

When the Utah Law Review editors selected the topic for this symposium issue in early February 2020, we did not anticipate—nor would we have wished for—how exceptionally timely the topic would become over the next year-and-a-half. By the time we were extending invitations to participate in the fall 2020 symposium event, most teaching and learning at the law school, including the annual Lee E. Teitelbaum law review symposium, had moved online. As in so many aspects of life during the pandemic, our conversations turned to COVID-19. The extent and forms of regulation of medical research in the U.S. are sources …

Certificates Of Confidentiality: Mind The Gap, Leslie E. Wolf, Laura M. Beskow

Utah Law Review

Certificates of Confidentiality (“Certificates”) are a federal mechanism designed to protect sensitive, identifiable research data from compelled disclosure in any legal proceeding. The 21st Century Cures Act revised the authorizing statute to address criticisms raised about the Certificates’ coverage and protections. Despite many changes that expanded the scope and reinforced the protection of Certificates, questions remain concerning the robustness of the protection Certificates afford. Here, we briefly review the legal evolution of Certificates and then examine the gaps in protections that remain and their implications. We conclude with recommendations for areas of clarification and future research.

Proceedings Of The 2020 Lee E. Teitelbaum Utah Law Review Symposium, Utah Law Review

Utah Law Review

In the autumn of 2020, the Utah Law Review, in cooperation with the S.J. Quinney College of Law Center for Law and Biomedical Sciences, convened a twoday virtual symposium exploring “The Law and Ethics of Medical Research.” On November 13th, leading scholars from across the country joined us for a panel discussion titled “Sharing Medical Research Data: Privacy and Confidentiality.” On November 20th, a second set of distinguished scholars and practitioners gathered virtually for three more panel discussions: “Clinical Trials—Legal and Ethical Issues in the Age of COVID-19,” “Intellectual Property and Medical Research,” and “Medical Research as a Public Health …

Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines, Kevin Outterson

Faculty Scholarship

Antibacterial medicines should be foundational for modern medicine—a key part of the infrastructure of contemporary practice. Recently, however, antibacterials have struggled commercially. Even with “push” incentives (grants paid before regulatory approval), antibacterials have failed on the market because revenues are tied to volume sold. There are policy initiatives under way in the United States and United Kingdom that explore paying for exceptional antibacterials with “pull” incentives (paid after regulatory approval) by delinking the payments from volume via other payment formats such as market entry rewards and subscriptions. This article discusses these initiatives but also proposes an expected net present value …

Supported Decisions As The Patient’S Own?, Leslie Francis

Utah Law Faculty Scholarship

This brief commentary addresses what I regard as the thorniest challenge to supported decision making: how to determine if a supported decision really is the decision of the supported person, rather than an insidious form of concealed paternalism or conflicts of interest. The risk that apparent supported decision-making really becomes the decision of the supporter looms as capacities wane. Peterson, Karlawash and Largent (PK&L), who offer a defense of supported decision making in health care for people with dynamic and diminishing capacity, are alert to these problems but skirt their implications. The authors’ model for supported decisionmaking is incomplete; at …

The Ratio Method: Addressing Complex Tort Liability In The Fourth Industrial Revolution, Harrison C. Margolin, Grant H. Frazier

St. Mary's Law Journal

Emerging technologies of the Fourth Industrial Revolution show fundamental promise for improving productivity and quality of life, though their misuse may also cause significant social disruption. For example, while artificial intelligence will be used to accelerate society’s processes, it may also displace millions of workers and arm cybercriminals with increasingly powerful hacking capabilities. Similarly, human gene editing shows promise for curing numerous diseases, but also raises significant concerns about adverse health consequences related to the corruption of human and pathogenic genomes.

In most instances, only specialists understand the growing intricacies of these novel technologies. As the complexity and speed of …