This contribution marks a dual milestone at the intersection of public health law and JLME: my 50th publication of a substantive manuscript in the 50th anniversary of the Journal in 2022. In recognition of these coinciding landmarks, this installment of the Public Health Law column for JLME features observations and reflections of the field based largely on prior publications.

Gene therapies to treat sickle cell disease are in development and are expected to have high costs. The large eligible population size — by far, the largest for a gene therapy — poses daunting budget challenges and threatens to exacerbate health disparities for Black patients, who make up the vast majority of American sickle cell patients.

Physicians’ fear of criminal prosecution for prescribing opioid analgesics is a major reason why many chronic pain patients are having an increasingly difficult time obtaining medically appropriate pain relief. In Ruan v. United States, 142 S. Ct. 2370 (2022), the Supreme Court unanimously vacated two federal convictions under the Controlled Substances Act. The Court held that the government must prove that the defendant knowingly or intentionally acted in an unauthorized manner.

Law journals permit submission of scholarly manuscripts to multiple journals concurrently, but biomedical journals strictly forbid submission of manuscripts to more than one journal at a time. Law journals may then compete for the publication of manuscripts. This article examines whether the single-submission requirement of biomedical journals may constitute restraint of trade in violation of Section 1 of the Sherman Antitrust Act.

The COVID-19 Law Lab platform enables quantitative representation of epidemic law and policies in a given country for multiple years, enabling governments and researchers to compare countries, and learn about the impacts and drivers of policy choices. The Law Lab initiative is designed to address the urgent need for quality legal information to support the study of how law and policy can be used to effectively manage this, and future, pandemic(s).

Written in response to what he recognizes as the problematic philosophical underpinnings of “orthodox research ethics,” Alex John London’s For the Common Good reimagines what is called for in any effort to create a better system of oversight and regulation in biomedical research. London weaves a common thread — justice — through this historical and critical account of the practice of research ethics and its organization of stakeholders, institutions and regulations. By introducing the idea of “a common good” London reframes the narrative and responsibilities of the research ethics field to demonstrate that scientific research and regard for the rights and welfare of individuals are not mutually exclusive. This impressive monograph encourages its readers to push past the limitations of traditional research ethics to consider the context in which the discipline is embedded. That is, rather than settling for analysis at the level of researchers and research participants alone, London encourages us to expand our inquiry to encompass a wider array of stakeholders who co-labor in the social undertaking of biomedical knowledge production. London accomplishes the difficult task of upstream analysis — turning his attention to the conditions and assumptions which create ethical dilemmas rather than applying a retrospective ethical salve to injuries near-guaranteed by a broken system. As opposed to the limited domain of orthodox research ethics (researchers, participants, and the institutional bodies which regulate interaction between the two) London also considers the role and contributions of affected communities, pharmaceutical firms, philanthropic organizations, and journal editors among others.

The Global Health Security Agenda (GHSA) is a multilateral, multisectoral partnership comprised of more than 70 countries, international organizations, foundations, and businesses to strengthen global health security.

Amid undulating conceptions of the role and prowess of federalism emerges its central constitutional role: protecting American liberties against unwarranted governmental intrusions. To the extent that federalism is used as a guise for withdrawing fundamental rights to abortion by the U.S. Supreme Court in Dobbs v. Jackson Women’s Health Organization, individual rights are sacrificed in contravention of constitutional structural norms.

New research and a government investigation have shed light on an anticompetitive practice called “Product Hopping” and specifically how it was employed in the case of the multiple sclerosis treatment glatiramer acetate beginning in 2014, which cost payers billions of dollars. We examine this case as well as a separate, impending instance of product hopping.

The “right to repair” movement highlights opportunities to reduce health care costs and promote public health resilience through increased competition in the way in which medical devices are serviced and updated over their lifespan. We review legislative and legal facets of third-party repair of medical devices, and conclude with specific recommendations to help this market function more efficiently to the benefit of patients and health care systems.

As Member States of the World Health Organization (WHO) meet in an International Negotiating Body (INB) to negotiate a legally binding agreement on pandemic prevention, preparedness, and response for submission to the 77th World Health Assembly in May 2024, this column reflects on creative but pragmatic and complementary means that could be employed in the short timeframe allotted for this important global health law negotiation.