The extent to which EU competition law applies in the healthcare context remains a contested question. The contemporaneous publication of the European Commission’s Evaluation of State Subsidy rules for health and social services of general economic interest (SGEI) in December 2022, and of the Court of Justice of the European Union’s April 2023 judgment in Casa Regina Apostolorum regarding state support to hospitals in Italy, underscore uncertainty and appear to indicate an impasse. These publications unfold against the backdrop of two tensions: between state and market, and between the EU and national levels. Hospitals illustrate these tensions well due to the expansion of competition mechanisms into the hospital sector (notably expanding private provider delivery of public hospital services, often supported by “patient choice” policies), and of hospitals remaining typically local or regional in character rather than supranational. This article provides a timely and original analysis of the Casa Regina Apostolorum judgment in light of Commission policy regarding SGEI and hospitals and how EU Member States engage with this. It offers insights into the potential legacy of Casa Regina Apostolorum, and indicates where future legal challenges may focus.

The “EU Vaccines Strategy” launched by the European Commission in June 2020 aimed to ensure vaccine safety, equitable access, affordability, swift distribution, and global solidarity for COVID-19 vaccines. This study critiques the Commission’s centralized procurement approach, focusing on Advance Purchase Agreements (APAs) through a literature review, policy analysis, and a case study of the EU-AstraZeneca’s APA. It identifies critical challenges, including transparency deficits, accountability gaps, and anticompetitive practices by vaccine producers that undermine equitable access. Drawing on these insights, the study proposes the FACER Framework — Fairness, Accountability, Competition Law, Ethics of Innovation, and Resilience — a novel model integrating the Treaty on the European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU) oversight with ethical principles. By embedding legal and moral accountability, FACER offers EU policymakers a robust tool to enhance vaccine strategy and equity in future health crises.

People with HIV (PWH) often encounter health-harming legal needs that impede their access to care, including structural issues such as racism, discrimination, unstable housing, and stigma. Medical-Legal Partnerships (MLPs) have emerged as a promising strategy to address these challenges within HIV care settings. This study aimed to identify the characteristics and strategies of MLPs that are most effective in improving HIV care continuum outcomes. A mixed-methods analysis was conducted utilizing data from a cross-sectional survey of 60 providers in MLPs. Categorical features of MLPs, such as the personnel responsible for screening for health-harming legal needs (HHLN), the organizational structure (community-based vs. institutional), and the delivery of legal services, were examined. A multiple, variable linear regression analysis was conducted to explore the association between these variables and outcomes. Community health organizations were found to be associated with a greater number of patients achieving suppressed HIV viral load. Additionally, a higher number of on-site services were positively correlated with a greater percentage of PWH achieving decreased viral load and completing follow-up appointments. Findings underscore the significance of comprehensive care approaches within MLPs for enhancing positive patient outcomes in HIV care settings.

Current legislation guiding withdrawal of life-sustaining treatment and organ donation after circulatory death (DCD) leaves regulatory gaps that are not optimal for honoring the wishes of patient-donors. We describe these gaps, their consequences, and the need for revision to prevent harm to all parties.

The objective of this paper is to devise a set of principles and practices that can break with the temporalities of current pharmaceutical markets, and on this basis sketch a social contract for a new (temporal) political economy of pharmaceuticals. Pharmaceutical futures are, in my analysis, doubly predetermined by standard arguments around pharmaceutical patenting and pricing: they are narrated as a consequence of “past” investments to be recouped, but they are also predetermined on a particular “future perfect,” where past investment successes and promises to maintain the status quo determine the course of action of future investors. This double colonization of the future, in my analysis, eliminates any scope for meaningful change. Making this often implicit temporality of pharmaceutical markets explicit may allow to better take into account multiple temporalities in regulating this space. Chiefly among them are patients’ temporalities, which typically get overridden by the peculiar timelines of patent-based markets. The mRNA vaccine market serves as an illustration of the theoretical arguments raised, and I discuss four strategies that could lead toward a new temporal political economy of pharmaceutical markets: temporally sensitive policymaking; decolonizing the future through narrower patents; delinking patents from their asset condition; and pharmaceutical commons.

Pronatalist policies are on the rise in many countries. These have stemmed from several motivators, including economic concerns, nationalism, and promotion of traditional family values. As global fertility rates have fallen, many countries have instilled pronatalist policies to encourage people to have more children. In other countries, including the United States, religious traditionalism and nationalist forces have fueled pronatalist policies as a counter to improved female empowerment and global immigration. No matter the stated motivation, government-sanctioned pronatalism overtly leads to reproductive coercion or covertly results in limited reproductive autonomy as collateral damage. Herein, we review global examples of prior and current pronatalist policies, outlining the motivators for their promotion within each case. We demonstrate how these policies are not only ineffective, but are dangerous to the health and well-being of women and other populations and are in direct conflict with modern reproductive goals, reproductive justice, and decades of efforts towards achieving gender parity.

After dispensing major precedents affecting the public’s health in each of its prior three terms, the 2024-2025 term of the US Supreme Court was arguably less impactful amid several unanimous decisions preserving existing jurisprudence (at least in part). However, this is an understatement. While the Court issued key decisions arguably favorable to communal health this prior year it also denied minors access to medical procedures sought by their doctors, diminished diversity, equity, and inclusion (DEI) initiatives in employment, allowed states to deny health providers access to Medicaid because they also provided abortions, disallowed rural hospitals from collecting specific costs for treating low-income patients, and provided a “script” of sorts for executive control of federal health advisory committees.

Hot tap water is the most common source of scald injuries, representing a quarter of all scald injuries requiring hospitalization in the United States. Children and older adults are at increased risk of scald burns. Evidence suggests that poor knowledge of burn risks and treatment among parents and the public may contribute to the burden of scald injuries in children. Medical and injury surveillance categorizes most scald burns as unintentional injuries. However, scald burns can also lead to investigation by the justice system if the injury is suspected to result from abuse or neglect. The Department of Justice recommends assessing criminal intent in childhood scald burns based on traditional indicators derived from medical research: burn uniformity, areas of sparing, burn locations, family history, and speed of medical care. In this study, we present an overview of the existing literature on intentional scald burns in children caused by hot tap water in order to improve their identification and prevention. This systematic review aims to answer two questions: (1) What are the indicators of intentional scald burns in children according to the literature and (2) Is the body of evidence for common indicators of intentional scald burns subject to bias?

We report on an experience with impostor research participants, people who misrepresent themselves, and identify characteristics that can be used by investigators to screen out such participants. We compare the responses of impostor and valid participants, showing that impostors meaningfully change qualitative study findings with implications for policy interventions or follow-on research informed by the study. It is important for investigators to be alert to the potential for impostor participants and plan their research accordingly.

Dr. Tom Beauchamp wrote multiple seminal articles that influenced bioethics, research ethics, and animal ethics. But his influence extends beyond his academic scholarship. Here we honor Dr. Beauchamp’s contributions as a scholar, mentor, and teacher.

This paper examines in what way providers of specialized Large Language Models (LLM) pre-trained and/or fine-tuned on medical data, conduct risk management, define, estimate, mitigate and monitor safety risks under the EU Medical Device Regulation (MDR). Using the example of an Artificial Intelligence (AI)-based medical device for lung cancer detection, we review the current risk management process in the MDR entailing a “forward-walking” approach for providers articulating the medical device’s clear intended use, and moving on sequentially along the definition, mitigation, and monitoring of risks. We note that the forward-walking approach clashes with the MDR requirement for articulating an intended use, as well as circumvents providers reasoning around the risks of specialised LLMs. The forward-walking approach inadvertently introduces different intended users, new hazards for risk control and use cases, producing unclear and incomplete risk management for the safety of LLMs. Our contribution is that the MDR risk management framework requires a backward-walking logic. This concept, similar to the notion of “backward-reasoning” in computer science, entails sub-goals for providers to examine a system’s intended user(s), risks of new hazards and different use cases and then reason around the task-specific options, inherent risks at scale and trade-offs for risk management.

In “Everything is Tuberculosis,” author John Green assesses the intricacies of the communicable condition, TB, as a source of significant morbidity and mortality globally over centuries. Despite available vaccines, treatments, and protocols, tens of millions are infected and over a million persons will die from TB in 2025 alone. In searching for answers to mitigate this global scourge, however, Green looks past a key factor — specifically the role of law — as a primary tool for prevention and control.

The Global Health Security Agenda (GHSA) provides a foundation in global health law to support legal preparedness across nations. This column examines the legal authorities necessary to meet the objectives of the GHSA Legal Preparedness Action Package and advance national law reforms to prevent, detect, and respond to public health emergencies.

Recent literature describes the controversy relating to brain death/death by neurological criteria (DNC), which some have referred to as “widely accepted, but not universally supported.” This article provides an overview of differences in state laws relating to DNC and describes recent proposals to reform the definition of brain death. In 2023, the American Academy of Neurology (AAN) issued clinical guidelines stating that clinicians may declare a patient DNC despite evidence of neuroendocrine function — a position that directly conflicts with state law requirements for determining death. This article offers a critical analysis of AAN guidelines, an update on proposals to reform the Uniform Determination of Death Act, and explains why policy discussions should include how DNC exams occur in practice. Research suggests there are flaws with current clinical testing methods, which contributes to two separate problems: (1) false positives from insufficient testing, and (2) inadvertent misdiagnosis from unintentional errors. Together, this has produced confusion and reduced public trust in the concept of brain death. This article provides recommendations to clarify and retain the current legal standard for brain death, explains the ethical importance of accurate standards for determining DNC, and offers practical solutions to reduce errors.

As surrogacy grows, many states and countries are enacting or considering relevant regulations, while others oppose it. Ethical, legal and policy questions arise: how to balance the rights of various kinds of parents (e.g., heterosexual and same-sex couples and single individuals) against the rights and well-being of surrogates. Concerns include risks of exploitation, autonomy, benefits of enabling prospective parents to create loving families, and mitigating possible harms through regulations. Though a few instances of abuse have been reported in developing countries, these do not appear to have occurred in developed countries, where robust regulations exist. The limited data available on surrogates in general (i.e., including traditional and non-commercial surrogacy) do not suggest exploitation or trafficking. In 2021, New York State enacted robust regulations allowing commercial surrogacy. Subsequent competing bills have sought to loosen or enhance certain restrictions. These regulations may be a model for commercial surrogacy regulations elsewhere, but certain ethical, legal and policy questions remain (e.g., where to draw the line to prevent trafficking). Additional data and exploration of these challenges are crucial