Health Law and Policy Commons^™

Structured To Fail: Lessons From The Trump Administration’S Faulty Pandemic Planning And Response, Alejandro E. Camacho, Robert L. Glicksman

Michigan Journal of Environmental & Administrative Law

The Trump Administration’s response to the COVID-19 pandemic is a stark reminder that poorly designed government can be a matter of life and death. This article explains how the Administration’s careless and delayed response to the crisis was made immeasurably worse by its confused and confusing reallocation of authority to perform or supervise tasks essential to reducing the virus’s ravages.

After exploring the rationale for and impact of prior federal reorganizations responding to public health crises, the article shows how a combination of unnecessary and unhelpful overlapping authority and a thoughtless mix of centralized and decentralized authority contributed to the …

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs

Faculty Scholarship

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …

Handbook For Sdg-Aligned Food Companies: Four Pillar Framework Standards, Nora Mardirossian, GaëLle Espinosa, Rico RincóN, Diana Marcela, Erin O’Dwyer, Abrania Marrero, Regan Plekenpol, Claudia P. Baethgen, Urvi Agarwal, Lisa E. Sachs, Jeffrey D. Sachs

Columbia Center on Sustainable Investment Staff Publications

The world food system is in crisis. Outright hunger, unhealthy diets and malnutrition occur parallel to food losses and waste. Farming families in poor countries suffer from extreme poverty. And food production is environmentally unsustainable and increasingly vulnerable to extreme weather events caused by climate change. A historic change of direction is needed to bring about a new era of food system sustainability. Our work aims to help companies, investors and other stakeholders move towards a more sustainable food system that is aligned with the Sustainable Development Goals.

Transforming the world food system to achieve sustainability in all its dimensions …

Covid-19 Protocols For Ncaa Football And The Nfl: Does Collective Bargaining Produce Safer Conditions For Players?, Michael H. Leroy

Utah Law Review

My study surveyed all NCAA football programs in Power 5 conferences during the 2020 season to compare their COVID-19 safety protocols to those in the NFL-NFLPA labor agreement. College protocols lacked input from a players association. In contrast, the NFL and their players collectively bargained a seventy-two-page agreement for COVID- 19 protocols. Policies from nineteen college football programs fell far short of NFL-NFLPA standards, scoring ten to thirty points out of the forty-five safety points in the NFL labor agreement. College policies were strongest for symptom checking and cardiac evaluations. However, most college policies failed to identify players with individual …

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 …

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 …

The Patient Assistance Problem, Daniel O’Brien Lichtenauer

Journal of Law and Policy

Implemented in January 2006 as a voluntary enrollment supplement to standard Medicare plans, Medicare Part D coverage subsidizes the cost of prescription drugs for participants. However, significant gaps in coverage exist for those suffering from rare diseases that require costly drugs. Pharmaceutical companies seek to remove the powerful market force of patient price sensitivity by directly sponsoring or substantially funding “patient assistance programs” that help cover out-of-pocket costs. While pharmaceutical donors insist that their goal is strictly altruistic, the reality is that many of these programs offer a financial windfall for drug makers because they help funnel patients towards new …

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. …

J Mich Dent Assoc December 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:

• Two cover stories presenting perspectives from both ends of the practice life continuum: “Starting Your Practice Life” and “Preparing for Retirement”.
• A feature article, “What Happened in Vegas Became ADA Policy”.
• A feature article, “An Oversight Corrected: 2020 MDA Life Members Recognized”.
• The 2021 Author/Title Index to the Journal of the Michigan Dental Association. …

Beyond Data Ownership, Ignacio Cofone

Cardozo Law Review

Proposals for data ownership are widely misunderstood, aim at the wrong goal, and would be self-defeating if implemented. This Article, first, shows that data ownership proposals do not argue for the bundle of ownership rights that exists over property at common law. Instead, these proposals focus on transferring rights over personal information solely through consent.

Second, this Article shows the flaws of a property approach to personal information. Such an approach magnifies well-known problems of consent in privacy law: asymmetric information, asymmetric bargaining power, and leaving out inferred data. It also creates a fatal problem: moral hazard where corporations lack …

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 …

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 …

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 …

What The Pandemic Taught Us: The Health Care System We Have Is Not The System We Hoped We Had, William M. Sage

Faculty Scholarship

The United States spends nearly twice as much per capita on medical care as any other country. The United States has the world’s most advanced biomedical technologies, sophisticated hospitals, and skilled health professionals. The United States has a national public health body, the Centers for Disease Control and Prevention (CDC), that is generally considered the world’s leader in infectious disease detection and response. Nonetheless, the United States suffered among the world’s worst COVID-19 disease burdens and outcomes, inflicting largely avoidable harm on patients, health professionals, and the broader community.

Why this happened is clearly important. But that it happened is …

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 …

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

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 …