On June 1, 2024, the World Health Assembly reached consensus on a package of amendments to the 2005 International Health Regulations (IHR). These amendments follow nearly two decades of implementation and an intensive multilateral process prompted by the global struggle against COVID-19. This article critically examines whether the amended IHR reflect lessons learned from the pandemic, potentially ushering in a new era for global health law in pandemic preparedness and response, or if they deflect attention from the need for deeper structural reforms. While the IHR remain the only near-universal legal framework for preventing and addressing the international spread of disease, these amendments emphasize equity and solidarity, and potentially shift the IHR from a technical instrument to one focusing on inherently political issues. This analysis examines key IHR amendments and their implications for the future of global health law, particularly in the context of equity, financing, and implementation.

Artificial Intelligence (AI) has the potential to revolutionize public health surveillance by analyzing large datasets to detect outbreaks. However, privacy, consent, and governance issues persist. While the International Health Regulations do not explicitly mention the use of AI in infectious disease surveillance, transparent processes, accountability, and public trust are key for responsibly integrating AI in pandemic preparedness.

Colonialism has produced the global health system, and decoloniality must inform global health law. This article considers the foundational impact of colonialism on the global health system and advocates for adopting decoloniality as a crucial framework to reshape global health law. Through a historical lens, it examines how European colonialism established power dynamics and structures that continue to influence contemporary global health governance. This article calls for overcoming enduring challenges by emphasizing the urgency of dismantling outdated and unjust systems that perpetuate health inequities and hinder effective interventions. It argues for a paradigm shift toward epistemically inclusive, ethical, and equitable practices, emphasizing the active participation of marginalized communities in health policymaking. By addressing the root causes of health disparities and decoupling health systems from racial capitalism, a decolonial approach promises a more just and effective future for global health law.

International law and global governance regimes for environmental health challenges have been slow to reflect the intertwined relationship between the environment and human health. Historical legacies have caused artificial fragmentation between the two that has resulted in distinct fields of international law and institutions for the environment and health. However, new global paradigms for thinking about environmental health have emerged to foster synthesis under global health law, including One Health and Planetary Health approaches, as well as through international human rights law like the recognition of the right to a clean, safe, and healthy environment. Guided by equity, new international law and global governance reforms, including the proposed Pandemic Agreement and Plastics Treaty, are opportunities to synthesize the intersecting dimensions of the environment and global health. However, future paths towards cohesion must explicitly incorporate human rights in environmental health governance, including the rights of Indigenous Peoples, while actively addressing inequities in global health law, between and within countries, and across generations.

The field of global health law encompasses both “hard” law treaties and “soft” law policies that shape global health norms. Transitioning from “international health law” to “global health law and policy,” global health policymakers have increasingly looked to soft law instruments to address public health needs in a rapidly globalizing world – within the World Health Organization and across global health governance. Yet, as policymakers have expanded the landscape of soft law policy instruments to advance global health across state and non-state actors, the COVID-19 response revealed the limitations of this soft law approach to global health threats, with states now seeking hard law reforms to strengthen global health governance. As hard and soft law can provide complementary approaches to preventing disease and promoting health, future research must conceptualize how these normative frameworks interact in advancing global health.

In the decade since the first edition of Global Health Law was published, the world has moved incrementally towards global health with justice, at least by one basic metric: life expectancy has edged up globally, with more rapid gains in low- than high-income countries. But to look around the world, global health with justice still seems a distant dream. Health gaps between people in rich and poor countries remain shocking and unconscionable—as do health inequities within countries. The pandemic also gave salience to profound health injustices—from injustices in access to lifesaving vaccines to gaping disparities in morbidity and mortality based on income, race, and national origin. So did the Trump administration’s decision to pause, and then slash, foreign assistance, bringing an end to lifesaving programs around the world. Guided by the overarching theme of justice, these reflections canvass the history of global health law as a field and discuss developments and challenges in the field across four core themes: multilateralism; equitable distribution of the benefits of scientific advancement; global health law for the poly-crises; and human rights and equity.

The field of global health law has evolved over the past decade to describe new legal and policy instruments that apply to a changing set of public health threats, non-state actors, and regulatory norms that structure the global response to public health challenges. This special issue—bringing together the O’Neill Institute for National & Global Health Law and the Global Health Law Consortium—examines the expansive evolution of the field of global health law and its continuing development to face new health threats.

Scientific advances to fight infectious diseases have been remarkable. International law and global governance have sought, and often failed, to keep pace, secure equity, and stop outbreaks. We trace the law and governance model emerging from early failure in the AIDS response and identify four elements: use of law by national governments to compel sharing; decentralized generic manufacturing; mechanisms for voluntary sharing of patents and technology transfer; international funding. In combination, these created a remarkable new ecosystem. We find that when COVID-19 hit and mRNA vaccines were rapidly developed, global North governments opposed mobilizing this synergistic model. Instead, equity efforts focused on financing purchase of vaccines from originator companies with little use of law. Amidst monopolies and scarcity of doses, vaccine nationalism fatally undermined this effort. Whether more synergistic law and governance emerges from rapidly changing global health law will likely dictate the efficacy of future global infectious disease response.

The tenth anniversary of the publication of Lawrence Gostin’s seminal treatise Global Health Law affords us the opportunity to reflect on his enduring legacy as a preeminent scholar, and one of the field’s founding thought leaders.

Law can function and act on norms, through legislation, regulation, treaties and the like. Law can also be a key accompaniment to activism. The career of Larry Gostin represents both aspects of the law in achieving social change.

Over the last three years, Larry Gostin, I, and many others have urged world leaders to open their minds toward specific subsets of reform in the interest of pandemic response, including mechanisms for transparency, accountability, and, crucially, financial buy-in. With negotiations for a new pandemic accord still incomplete, our focus must remain on reaching global agreement, and keeping at top of mind the immense stakes if that is not possible.

Communities and individuals globally continue to suffer the violent impacts of colonialism and racism, in a global system of governance that remains rooted in unequal and hierarchical power imbalances. The interpersonal, societal, and structural violence that persists around the world exists in violation of human rights, and is evidence of a persistent lack of political will to effectively invest in human rights, including the right to health, as a true priority.

The demand on States and non-State actors to fulfil the human right to health is imperative. Attacks on civilians during times of conflict and catastrophe, as seen in the latest escalation and display of imperial aggression by Israel in the occupied Palestinian territory, demonstrate the consistent uneven application of human rights and commitment to fulfilling them.

Protecting human rights, and specifically the realization of the right to health, is fundamental as it has significant consequences for the realisation of other human rights. Eliminating discrimination requires paying sufficient attention to groups of individuals that suffer historical or persistent prejudice. Fulfilling a commitment to health equity and justice demands creating opportunity and conducive conditions for the dignity for all people.

Retracted research publications reached an all-time high in 2023, and COVID-19 publications may have higher retraction rates than other publications. To better understand the impact of COVID-19 on the research literature, we analyzed 244 retracted publications related to COVID-19 in the PubMed database and the reasons for their retraction. Peer-review manipulation (18.4%) and error (20.9%) were the most common reasons for retraction, with time to retraction occurring far more quickly than in the past (13.2 mos, compared with 32.9 mos in a 2012 study). Publications focused on controversial topics were retracted rapidly (mean time to retraction 10.8 mos) but continued to receive media attention, suggesting that retraction alone may be insufficient to prevent the spread of scientific misinformation. More than half of the retractions resulted from problems that could have been detected prior to publication, including compromise of the peer review process, plagiarism, authorship issues, lack of ethics approvals, or journal errors, suggesting that more robust screening and peer review by journals can help to mitigate the recent rise in retractions.

Systematic reviewers are ideally placed to detect untrustworthy studies and decrease their use in decision making. The systematic review process already requires rigorous evaluation of an entire body of evidence related to a particular question. Excluding untrustworthy studies from systematic reviews can reduce their subsequent impact on evidence used for decisions and raise awareness of the problem among universities, journal editors, research funders and other stakeholders who can take appropriate action to eliminate them from the scientific literature.

This paper reflects on the availability of a key document in the research integrity landscape: Reports of institutional and university misconduct investigations. It reviews how universities have typically responded to calls for disclosure, offers suggestions to mitigate concerns, and argues that the failure to release such reports creates a critical evidence gap. It closes with a call for disclosure of such reports as a default.

This study characterizes 2008-2022 FDA advisory committee discussions of new supplemental indication applications that were not approved by FDA. Discussion themes included contextual concerns unique to already-approved drugs, including insights from prior experience and concerns about off-label use, and efficacy and safety concerns also observed for new drugs. These findings highlight advisory committees’ role in transparency of regulatory decision-making, specifically for drugs already authorized for use.

Genome editing, prominently led by the revolutionary CRISPR-Cas9 technology, is a powerful tool with significant applications in diverse fields, particularly in medicine and agriculture. It empowers scientists with the ability to effect precise genetic modifications, thereby potentially paving the way for advanced treatments for genetic disorders such as Huntington’s disease, hemophilia, and cystic fibrosis. Yet, the significant capabilities of this technology also brings to the fore a myriad of intricate bioethical, legal, and regulatory dilemmas. In light of these complexities, this article endeavors to conduct a comprehensive scoping review of the existing literature on the most significant ethical implications emanating from genome editing. In conducting this review, we utilized the power of software tools like EndNote and Rayyan to aid in the systematic and thorough review of the literature. EndNote, a reference management software, was instrumental in organizing and managing the references and bibliographies, while Rayyan, a web application designed for managing and screening records for systematic and scoping reviews, proved crucial in the import and management of text records for the review.The review identified as main aspects of ethical, bioethical and medico-legal interest the exacerbation of social inequalities, safety concerns such as off-target mutations and immunological risks, ecological and evolutionary implications, and challenges to human dignity. It highlights the necessity for equitable access, rigorous regulation, and public engagement to address these issues responsibly.The ultimate objective of this article is to underscore the importance of an informed and inclusive dialogue regarding genome editing. Such dialogue is pivotal for fostering responsible innovation in this rapidly advancing field, ensuring that scientific progress aligns with ethical considerations. By presenting a comprehensive examination of the ethical implications of genome editing, we aim to contribute to this ongoing dialogue and promote a balanced and nuanced understanding of this impactful technology.

Two key strategies that brand-name pharmaceutical manufacturers employ to limit generic competition are patent thickets and product hops. The former strategy entails obtaining numerous patents on peripheral features of products (not just the active ingredients), and the latter involves shifting active ingredients into reformulations with new patent protection that can extend periods of market exclusivity. These strategies have become particularly problematic for drug-device combinations like inhalers and glucagon-like peptide-1 receptor agonists, which contain pharmaceutical compounds that are sold together with their delivery devices. The Senate Judiciary Committee moved three bipartisan bills out of committee during the last legislative session aimed at facilitating more timely generic competition. Although these bills offer a valuable step forward, more is needed to limit the sort of patent gamesmanship that has become pervasive in the US pharmaceutical industry. Such reforms should include routine reexamination by the US Patent and Trademark Office of patents submitted for listing with the Food and Drug Administration (FDA), a greater role for the FDA in reviewing such listings, limits on the number of patents that brand-name firms can assert when suing for infringement following patent challenges, stronger incentives for patent challenges, and more flexibility for the FDA to approve complex generic drugs.

I will describe how a fraudulent paper developed and offer insights into the institutional changes that are needed. I was a co-author on a paper described as a “clusterfake” due to at least two frauds allegedly occurring in the same paper. I will use my knowledge of behavioral ethics and my experience as a co-author on a fraudulent paper to explore changes that are needed to improve research integrity.