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.

Medical-legal partnerships (MLPs) attempt to integrate the social determinants of health into health care delivery to eliminate health inequities. Yet, MLPs have not fully adapted to identify and address structural racism, one of the root causes of health inequities. This article provides a health justice perspective on the role of MLPs to challenge legal regimes to address structural racism and reimagine systems rooted in joy, safety, and collective liberation.