Health Law and Policy Commons^™

Charging Abortion, Milan Markovic

Faculty Scholarship

As long as Roe v. Wade remained good law, prosecutors could largely avoid the question of abortion. The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization has now placed prosecutors at the forefront of the abortion wars. Some chief prosecutors in antiabortion states have pledged to not enforce antiabortion laws, whereas others are targeting even out-of-state providers. This post-Dobbs reality, wherein the ability to obtain an abortion depends not only on the politics of one’s state but also the policies of one’s local district attorney, has received minimal scrutiny from legal scholars.

Prosecutors have broad charging discretion, …

Historic Tensions Involving International Intellectual Property Protection Of Medical Technology With Disastrous Public Health Consequences, Srividhya Ragavan, Swaraj Paul Barooah

Faculty Scholarship

Historic tensions have pervaded the alliance of intellectual property's ill-fated accord with trade. The intersections of the alliance have impacted access to medical technologies resulting in plaguing public health with disastrous consequences in select parts of the globe, the first of which was perhaps most notably seen during the HIV-AIDS crisis at the turn of the century. At this time, WTO’s sacrosanct norms from the accord between trade and intellectual property rights essentially force African countries to choose between international trade sanctions, and saving thousands of lives by allowing exceptions to patent rights. While much has been written about global …

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, …

The Health Care Industry Is Ready For A Revolution: Its Privacy Laws Are Not, Erin Rutherford

Student Scholarship

This paper highlights the costs and benefits associated with the gathering, storing, analyzing, and digitizing of health information; examines current privacy laws and their inadequacies in the new and constantly changing digital health world; and then provides a proposal framework to balance encouraging innovation while protecting individual autonomy. The article specifically proceeds as follows. This paper first discusses of the evolution of the health industry, from paper records to the wide array of sources generating health information today. Next, it considers the benefits to the ever-increasing amount of health information, which, while considerable can often be in tension with privacy …

Pro-Choice Plans, Brendan S. Maher

Faculty Scholarship

After Dobbs v. Jackson Women’s Health Organization, the United States Constitution may no longer protect abortion, but a surprising federal statute does. That statute is called the Employee Retirement Income Security Act of 1974 (“ERISA”), and it has long been one of the most powerful preemptive statutes in the entire United States Code. ERISA regulates “employee benefit plans,” which are the vehicle by which approximately 155 million people receive their health insurance. Plans are thus a major private payer for health benefits—and therefore abortions. While many post-Dobbs anti-abortion laws directly bar abortion by making either the receipt or provision of …

A Response To Rules Of Medical Necessity, Brendan S. Maher

Faculty Scholarship

Professors Monahan and Schwarcz’s recent Article in the Iowa Law Review, Rules of Medical Necessity, is a must-read for multiple audiences. In this short Response, I informally describe health insurance, and—using that perspective—describe and comment on why Rules of Medical Necessity is a piece of work that not only deserves attention from experts in the field, but is also one that casual readers should choose first when attempting to understand how health insurance works in theory and practice.

Deferring Intellectual Property Rights In Pandemic Times, Peter K. Yu

Faculty Scholarship

This Article examines an unprecedented proposal that India and South Africa submitted to the World Trade Organization (WTO) in October 2020, which called for a waiver of more than 30 provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights to help combat COVID-19. It begins by recounting the proposal's strengths and weaknesses. The Article then identifies the challenges surrounding the negotiation and implementation of the proposed waiver. It shows why these two sets of challenges were neither separate nor sequential, but deeply entangled at the time of the international negotiations.

To respond to these challenges and the negotiation …

Optimizing Disaster Preparedness Planning For Minority Older Adults: One Size Does Not Fit All, Omolola E. Adepoju, Luz E. Herrera, Minji Chae, Daikwon Han

Faculty Scholarship

By 2050, one in five Americans will be 65 years and older. The growing proportion of older adults in the U.S. population has implications for many aspects of health including disaster preparedness. This study assessed correlates of disaster preparedness among community-dwelling minority older adults and explored unique differences for African American and Hispanic older adults. An electronic survey was disseminated to older minority adults 55+, between November 2020 and January 2021 (n = 522). An empirical framework was used to contextualize 12 disaster-related activities into survival and planning actions. Multivariate logistic regression models were stratified by race/ethnicity to examine the …

Designing For Justice: Pandemic Lessons For Criminal Courts, Cynthia Alkon

Faculty Scholarship

March 2020 brought an unprecedented crisis to the United States: COVID-19. In a two-week period, criminal courts across the country closed. But, that is where the uniformity ended. Criminal courts did not have a clear process to decide how to conduct necessary business. As a result, criminal courts across the country took different approaches to deciding how to continue necessary operations and in doing so many did not consider the impact on justice of the operational changes that were made to manage the COVID-19 crisis. One key problem was that many courts did not use inclusive processes and include all …

A Copernican View Of Health Care Antitrust, William M. Sage, Peter J. Hammer

Faculty Scholarship

Sage and Hammer use the analogy of Copernican astronomy to suggest that understanding the dramatic change wrought by managed care requires a conceptual reorientation regarding the meaning of competition in health care and its appropriate legal and regulatory oversight. Both share the belief that misperceiving the world limits potential for technical and social progress.

Data Privacy In The Time Of Plague, Cason Schmit, Brian N. Larson, Hye-Chung Kum

Faculty Scholarship

Data privacy is a life-or-death matter for public health. Beginning in late fall 2019, two series of events unfolded, one everyone talked about and one hardly anyone noticed: The greatest world-health crisis in at least 100 years, the COVID-19 pandemic; and the development of the Personal Data Protection Act Committee by the Uniform Law Commissioners (ULC) in the United States. By July 2021, each of these stories had reached a turning point. In the developed, Western world, most people who wanted to receive the vaccine against COVID- 19 could do so. Meanwhile, the ULC adopted the Uniform Personal Data Protection …

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Student Scholarship

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to(1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory licensing …

Immigration Detention And Illusory Alternatives To Habeas, Fatma Marouf

Faculty Scholarship

The Supreme Court has never directly addressed whether, or under what circumstances, a writ of habeas corpus may be used to challenge the conditions of detention, as opposed to the fact or duration of detention. Consequently, a circuit split exists on habeas jurisdiction over conditions claims. The COVID-19 pandemic brought this issue into the spotlight as detained individuals fearing infection, serious illness, and death requested release through habeas petitions around the country. One of the factors that courts considered in deciding whether to exercise habeas jurisdiction was whether alternative remedies exist, through a civil rights or tort-based action. This Article …

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 …

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 …

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 …

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 …

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 …

Trademarks And The Covid-19 Pandemic: An Empirical Analysis Of Trademark Applications Including The Terms "Covid," "Coronavirus," "Quarantine," "Social Distancing," "Six Feet Apart," And "Shelter In Place", Irene Calboli

Faculty Scholarship

True to its nature as a (hopefully) once in a lifetime event, the COVID-19 pandemic has led to a tsunami of trademark applications. These include the terms “COVID,” “Coronavirus,” and other medical and pandemic-management related terms. This unprecedented number of applications has been highlighted by several commentators in general terms in the past months. This Article examines these applications in detail. Notably, the Article presents the first and most complete survey of the applications filed between the onset of the pandemic and the end of 2020, which include the following terms: “COVID,” “Coronavirus,” “Quarantine,” “Social Distancing,” “Six Feet Apart,” and …

Trade Marking ‘Covid’ And ‘Coronavirus’ In The Usa: An Empirical Review, Irene Calboli

Faculty Scholarship

Famous and sensational events often lead to several entities filing trade mark applications that include terms related to these events. The most recent example of this phenomenon is the COVID-19 pandemic, which has led to large numbers of (largely controversial) filings worldwide.

In this article, I review the applications including the terms ‘COVID’ and ‘Coronavirus’ filed with the United States Patent and Trademark Office (USPTO) in 2020 based on the data available and recorded by the end of January 2021. These data offer significant information related to the type of products for which the applications were filed, the type of …

The Private Option, Brendan S. Maher

Faculty Scholarship

Health care reform is once again in the air. Virtually all Democrats favor some meaningful expansion of public insurance, whether through single payer or the creation of a “public option” that would allow consumers dissatisfied with the private market to buy into a public program. Republicans, not surprisingly, have pushed back, not only against single payer, but also against the public option, saying it will drive private payors to extinction. All the political jousting implicates a larger and serious policy question; namely, what should be the role of private payors in the nation’s health care system?

Arguments to date on …

The Impact Of Covid-19 On Immigration Detention, Fatma Marouf

Faculty Scholarship

COVID-19 has spread quickly through immigration detention facilities in the United States. As of December 2, 2020, there have been over 7,500 confirmed COVID-19 cases among detained noncitizens. This Article examines why COVID-19 spread rapidly in immigration detention facilities, how it has transformed detention and deportation proceedings, and what can be done to improve the situation for detained noncitizens. Part I identifies key factors that contributed to the rapid spread of COVID-19 in immigration detention. While these factors are not an exhaustive list, they highlight important weaknesses in the immigration detention system. Part II then examines how the pandemic changed …

Adding Principle To Pragmatism: The Transformative Potential Of "Medicare-For-All" In Post-Pandemic Health Reform, William M. Sage

Faculty Scholarship

“Medicare-for-All” should be more than a badge of political identity or opposition. This Article examines the concept’s potential to catalyze policy innovation in the U.S. health care system. After suggesting that the half century of existing Medicare has been as much “Gilded Age” as “Golden Age,” the Article arrays the operational possibilities for a Medicare-for-All initiative. It revisits America’s recent history of pragmatic rather than principled health policy, and identifies professional and political barriers to more sweeping reform. It focuses on four aspects of health policy that have become apparent: simultaneous inefficiency and injustice in medical care, neglect of the …

Giving Pharmacists Provider Rights, Tanya E. Karwaki

Texas A&M Law Review

Changes to our health care system, robotics and health care mergers among them, are forcing pharmacists into expanded provider roles, yet federal policymakers are failing to act on these changes. State lawmakers are acting but not swiftly enough. A federal response, including recognizing pharmacists as health care providers and making them eligible for independent Medicare reimbursement, will be necessary to enable pharmacists to fill their role in our health care system. Policymakers have an opportunity now to respond proactively to a changing climate in health care by clarifying the boundaries on pharmacists’ services, particularly those boundaries regarding direct patient care …

A Unified Theory Of Data, William Magnuson

Faculty Scholarship

How does the proliferation of data in our modern economy affect our legal system? Scholars that have addressed the question have nearly universally agreed that the dramatic increases in the amount of data available to companies, as well as the new uses to which that data is being put, raise fundamental problems for our regulatory structures. But just what those problems might be remains an area of deep disagreement. Some argue that the problem with data is that current uses lead to discriminatory results that harm minority groups. Some argue that the problem with data is that it impinges on …

Ethical Challenges In The Middle Tier Of Covid-19 Vaccine Allocation: Guidance For Organizational Decision-Making, Nancy Berlinger, Matthew Wynia, Tia Powell, Aimee Milliken, Parinda Khatri, Fatma Marouf, Keisha Ray, Johanna Crane

Faculty Scholarship

This supplement to The Hastings Center’s “Ethical Framework” aims to help structure time-sensitive discussion of significant, foreseeable ethical concerns in responding to Covid-19 and to support collaboration across institutions throughout pandemic response and recovery. It is designed for use by county health systems and by hospitals, community health centers, and other health care organizations responsible for patient care or preventive health, including vaccine education, vaccine distribution, and vaccination. This document aims to support formal and informal convening and policy work within the same geographic region, such as a municipality, county, metropolitan area, state, or multistate area, led by public health …

Caps On Capsules: Prescription For Lower Drug Prices In The United States, Christine Chasse

Student Scholarship

The United States is the foremost innovator of pharmaceutical therapies in the world. That innovation, however, comes at a price—literally. Americans pay more for their medications than any other country. In a country without universal healthcare, the topics of economics, human rights, and healthcare intersect at the crossroads of pharmaceutical pricing. In contrast to most other countries, the United States has no regulations on pharmaceutical price control. One major argument against government regulation is its inherent opposition to the free market system: the heart of the American economy. Further still is the argument that profit restriction would create a chilling …

Following The Money: The Aca’S Fiscal-Political Economy And Lessons For Future Health Care Reform, William M. Sage, Timothy M. Westmoreland

Faculty Scholarship

It is no exaggeration to say that American health policy is frequently subordinated to budgetary policies and procedures. The Affordable Care Act (ACA) was undeniably ambitious, reaching health care services and underlying health as well as health insurance. Yet fiscal politics determined the ACA’s design and guided its implementation, as well as sometimes assisting and sometimes constraining efforts to repeal or replace it. In particular, the ACA’s vulnerability to litigation has been the price its drafters paid in exchange for fiscal-political acceptability. Future health care reformers should consider whether the nation is well served by perpetuating such an artificial relationship …

Trade Mark Licensing And Covid-19: Why Fashion Companies Have A Duty To Comply With Their Legal Obligations, Irene Calboli

Faculty Scholarship

For the past several months, Covid-19 has dominated the intellectual property (IP) debate. Most discussions have focused on the implications of patent protection on access to treatments against the virus and a hopefully soon to be found vaccine. In these remarks, I would like to focus on another Covid-19 crisis making headlines across the world and partially related to IP: millions of workers in the garment industry in developing countries have been fired or furloughed as fashion companies have cancelled orders due to plunging sales since the pandemic’s beginning. Famous Western groups such as Inditex (Zara), C&A, Target, and Marks …

Reconsidering The Rationale For The Duration Of Data Exclusivity, Jonathan Kimball, Srividhya Ragavan, Sophia Vegas

Faculty Scholarship

The paper’s focus is the singular one question of whether the 12-years of exclusivity that was needed in 2008 remains justified in 2019 given that technological advancement reduces the cost and the time for drug discovery? Basically, new and emerging technologies are deployed every day to enhance efficiencies and reduce the time it takes to bring a drug to the market. The paper asserts that as new technologies are adopted and advances in scientific understanding are leveraged, it results in shorter drug development timelines. This factum, the paper asserts should have a bearing to reduce the period of exclusivity granted …