This symposium Article describes how prison abolitionist arguments also support the hypothesis that a defining goal of health law should be the abolition of hospitals. Like prison abolitionism, the hospital abolition hypothesis can provide a constructive way to shift the focus of legal analysis from substantive dimensions (in health law — cost, quality, access, and equity) to the dimension of power.

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.

It was a great privilege to know Professor Charity Scott. I first met her when I was finishing Emory University’s joint law and public health program in the early 2000s, through the Office of General Counsel at the U.S. Centers for Disease Control (CDC), in the early days of CDC’s Public Health Law Program, now the Office of Public Health Law Services. In those days, introductions were generous and frequent for excited students beginning their careers, but meeting Professor Scott made an impression on me. She was the first and only female health law professor in the field that I had the opportunity to know in the early years of my career.

This is how Georgia State University College of Law Professor Charity Scott introduced the concept of mindfulness to numerous law students and lawyers. Aware that her skeptical, mind-driven audience needed a clear definition for a practice that seemed curious, at best, and esoteric, at worst, she immediately gave us the very lawyerly task of “pars[ing] each of these phrases to understand their importance and relevance to the legal profession”2 and applying them to our own experience of studying or practicing law. Using scientific evidence, she described the benefits of mindfulness and then invited us to try it and decide for ourselves. Charity was a superb teacher, who knew how to impart knowledge skillfully, and a brilliant lawyer, who could present and defend her case exceptionally well. In fact, “Charity Scott owned the subject matter so deeply that she was able to engage lawyers who otherwise would never have given the concept of mindfulness any credence in a million years. In a way that’s hard to describe, she didn’t brook any resistance on the topic and, as a result, was able to move the needle on well-being for lawyers at a time when, as far as I can tell, she was the only one doing the lifting,” reflects Lynn Garson, health care attorney and mental health advocate. But I believe Charity Scott’s true mastery and impact came from her embodiment of mindfulness itself. In her presence, mindfulness ceased to be a mere concept, but instead became her way of being that illuminated her words and actions, nourished her relationships, and changed lives.

Charity Scott was a professor of health law at Georgia State University College of Law, the founding director of the College of Law’s Center for Law, Health, and Society, and co-founder of the Health Law Partnership (HeLP) at Georgia State. She is an iconic figure in her adopted hometown of Atlanta and certainly one of the most important scholars in the history of the health law field, justly celebrated for her teaching, her innovation, her commitment to interdisciplinary work, and for her compassion and love for others. She was also a dear friend of mine. In this short essay I will reflect on my friendship with Charity and her involvement with the American Society of Law, Medicine & Ethics, the publisher of this journal.

As the federal government continues to expand upon and improve its data sharing policies over the past 20 years, complex challenges remain. Our interviews with U.S. academic genetic researchers (n=23) found that the burden, translation, industry limitations, and consent structure of data sharing remain major governance challenges.

May 11, 2023, marked the end of the federal COVID-19 Public Health Emergency (PHE). During the PHE, regulatory flexibilities allowed telehealth to more effectively connect physicians providing care and patients seeking it. This paper discusses the implications of the end of the PHE on telehealth coverage, payment, reimbursement, and licensure, and exposes inconsistencies and inequities in extant state regulations.

The end of the federal COVID-19 public health emergency (PHE) on May 11, 2023, marked a pivotal shift in the landscape of telehealth regulation in the US. Kwan, Jolin, and Shachar analyze the implications of this transition by exposing inconsistencies in access to care. We agree that we now face a “convoluted patchwork of permanent and temporary changes to telehealth law and policy.”1

In an effort to respond to the large surge in COVID-19 cases in Arizona that began between May and July 2020, the Arizona State University (ASU) Student Outbreak Response Team (SORT) formed a remote, volunteer-based case investigation team that worked in partnership with a local public health department through delegated public health authority.

Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents.

The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this “biosimilar gap” has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5

Contemporary understanding of the mechanisms of disease increasingly points to examples of “genetic diseases” with an infectious component and of “infectious diseases” with a genetic component. Such blurred boundaries generate ethical, legal, and social issues and highlight historical contexts that must be examined when incorporating host genomic information into the prevention, outbreak control, and treatment of infectious diseases.

Over the past two decades there has been a rapid expansion in our understanding of how human genetic variability impacts susceptibility and severity of disease. Through applications of genome-wide association studies, genome and exome sequencing, researchers have made thousands of discoveries of genetic variants that impact risk of common and rare disorders affecting millions of people. Although these techniques have been primarily applied to highly prevalent chronic disorders such as diabetes1 and cardiovascular disease2, infectious diseases have proven to not be immune to genome-wide association, with studies of Tuberculosis3, HIV4 and SARS-CoV25, to name but a few, identifying host susceptibility loci across the genome. Unlike non-communicable diseases, infectious diseases have the unique element of impacting not only the affected the host, but those who may be most vulnerable to acquiring the infection. Thus, genetic variants that impact one individual’s susceptibility to and severity of an infection may also have broader implications to public health, as was brought into keen focus during the COVID-19 pandemic. Therefore, as we begin to apply the knowledge gained from genomic studies in the clinic or into policy, there are unique ethical, legal, and social implications (ELSI) at the intersection of infectious diseases and human genomics. In this issue of the Journal of Law, Medicine and Ethics, Jose et al attempt to address this need by proposing a research agenda for ELSI studies at what they term the “blurred boundaries” of infectious and genetic diseases.6

When skeletal dysplasias are suspected in the prenatal period, investigation, counseling, and management become especially challenging. By better understanding the complex forces at play and parental values, prenatal health care providers may improve the ways in which they counsel patients to improve the decision-making process under conditions of significant uncertainty, including in cases of prenatally suspected skeletal dysplasia.

Vaccines are not the only public health tool, but they are critical in routine and emergency settings. Achieving optimal vaccination rates requires timely access to vaccines. However, we have persistently failed to secure, distribute, and administer vaccines in a timely, effective, and equitable manner despite an enduring rhetoric of global health equity.

The Covid-19 pandemic elevated global attention to the complex problem of allocating and disseminating newly approved vaccines. Following early calls for vaccine equity,1 global health leaders made progress but struggled to fully realize distribution goals.2 With respect to vaccination rates, low and middle income countries have not achieved full parity with high income countries.3 In this issue, Harmon, Kholina, and Graham follow longstanding critiques of market-based vaccine procurement to propose “legal and practical solutions for realizing a new access to vaccines environment”4 that will, they suggest, further the goal of global health justice.

In a “mixed bag” 2023-2024 session, the U.S. Supreme Court issued a series of decisions both favorable and antithetical to public health and safety. Taking on tough constitutional issues implicating gun control, misinformation, and homelessness, the Court also avoided substantive reviews in favor of procedural dismissals in key cases involving reproductive rights and government censorship.

This article analyzes trends in drug shortages in the US and Germany, the largest pharmaceutical market in Europe, between 2016 and 2023. It assesses the commonalities and differences between the countries in terms of active substances in shortage, time duration in shortage, and cyclic trends.

The 2024 U.S. election will shape the future of global health policy, with crucial implications for continuing U.S. leadership in global health. The United States has long played a critical role in global health governance, through multilateral institutions under the United Nations (UN) and bilateral assistance to advance U.S. priorities. However, political shifts have challenged U.S. engagement in global health, with the politicization of global health policy threatening global governance under the World Health Organization (WHO) and dividing global health support across political parties. This political polarization in global health proved catastrophic in the COVID-19 pandemic response and influential in the 2020 Presidential Elections. With the United States again seeking to advance global health policy, the 2024 Elections present a clear contrast in global health visions across U.S. political parties – with sweeping impacts on global governance, health funding, sexual and reproductive health, corporate regulations, tax equity, humanitarian challenges, and climate change. The future of U.S. leadership in global health hangs in the balance of this election, raising an imperative for candidates to highlight their global health positions and for voters to consider the global health implications.

This column describes the history, mission, and work of Saint Louis University School of Law’s service-learning course Health Law, Policy and Advocacy: Grassroots Advocacy. Grassroots Advocacy allows law students to work with advocacy organizations on state and federal health policy initiatives, engaging in legislative and administrative advocacy and public education. The course uses community collaboration, community-led advocacy, and collaborative learning to train the next generation of health policy advocates for Missouri and the nation.