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The global rollout of COVID-19 vaccines is underway, and with it the inevitable occurrence of severe side effects that accompany, rarely, even the safest and most effective vaccines. Governments have invested billions of dollars in supporting research, development, logistics, and supply chains, as well as supporting the creation of networks of healthcare providers to deliver vaccines to recipients all over the world. The European Commission and several international organizations have established the COVAX Facility to pool resources in promising vaccine candidates and to subsidize their procurement by low- and middle-income countries. Yet up-front investment in vaccine development and delivery solves only half the problem with respect to vaccine access. Risks of legal liabilities, particularly product liability for severe side effects, will serve as an important, if not decisive, factor in how vaccine manufacturers participate in the response with Emergency Use Authorized and recently-licensed COVID-19 vaccines. If manufacturers do not receive sufficient assurance against legal liability, especially product liability, they will not ship vaccines. There is limited experience with developing coronavirus vaccines, and severe side effects following immunization are inevitable, as evidenced from Phase III trials and strongly suggested by early administration of Emergency Use Authorized vaccines. Therefore, there is a critical need to balance the risk calculations of manufacturers with justice for immunization recipients who become seriously ill or die in order to contribute to herd immunity in the community. This Article outlines the components of a global no-fault liability, indemnification, and compensation system that includes leveraging current no-fault systems in thirty-nine countries, a World Health Organization insurance mechanism, and a combination of insurance and compensation fund construction based on claims-processing precedents from the Deepwater Horizon Oil Spill and Boeing 737 Max crashes—both of which had tens of thousands of claims originating from dozens of countries and processed in at least six languages. The proposed system will be essential for vaccine manufacturer response and to address vaccine hesitancy and injury in populations across the globe.

This Article critically examines calls by scholars, legislators, and regulators advocating the imposition of fiduciary duties upon a broad range of actors including judges, jurors, agencies, parents, friends, and even entire countries. The Article examines the physician-patient relationship—an archetypal and frequently cited relationship in which fiduciary duties, administered by courts, are asserted to work well. It argues that some of the most significant problems fiduciary duties are used to address like asymmetry of information, conflicts of interest, and professional conduct have not only been handled badly by courts, but have actually found more effective resolution through legislative fact-finding, acknowledgment of the complexity of medical practice, and ultimately regulatory solutions aimed at sources of conflicts of interest and specific circumstances in which claims for medical malpractice arise. Behind many of these initiatives are physicians themselves—who experience the sources of potential conflicts and endeavor to create self-regulatory and legislative solutions to them. In contrast, court-administered fiduciary duties are often marginalized as judicially manageable claims related to the duties of loyalty and the duty of care converge, litigants focus on settlement, and the high expectations held for fiduciaries are rarely enforced. The Article concludes that not only may imposing more fiduciary duties on more relationships not generate the benefits many scholars suggest, but that doing so will stymie more targeted and effective solutions to problems that occur in trust relationships.

The article focuses on the importance of expanding and coordinating global regulatory capacity to better prepare for future pandemics. Topics include the need for equitable access to essential medical products; the challenges posed by the concentration of regulatory capacity in high-income countries; and the benefits of decentralizing regulatory review to accelerate access to diagnostics, therapeutics and vaccines.

As the coronavirus disease 2019 (COVID-19) pandemic continues, the World Health Organization (WHO), the International Health Regulations (IHR) and countries' adherence to IHR guidance are coming under scrutiny and review. [...]

(1) Background: This study addresses two weaknesses in current international efforts to prevent and prepare for the next pandemic: the lack of robust evidence supporting global policy measures and the corresponding extent to which those measures advance equity. (2) Methods: Using UNICEF's publicly available but underused COVID-19 Market Dashboard database, we conducted a cross-sectional analysis of vaccine deliveries as of mid-2022 and vaccine procurement strategies used by African low- and lower middle-income countries (LMICs) over the course of the COVID-19 pandemic. (3) Results: Pooled procurement of the kind typified by COVAX (a clearinghouse for high-income-country contributions of vaccines and financing toward the end of equitable LMIC procurement) crowded out alternative strategies that must be supported in future: regional procurement, donation, and bilateral procurement (binding agreement between two parties: one seller (i.e., a national government or a vaccine manufacturer) and one recipient (i.e., national government)), which showed a significant relationship with technology transfer and advancing local production capacity. (4) Conclusions: Expanding the scope of vaccine procurement alternatives to COVAX such as regional pooled procurement and bilateral procurement can stratify risk of supply agreements not materializing in actual supply. Sharing the technology necessary to produce vaccines with LMICs can mitigate obstacles to bilateral procurement. A pooled purchase alliance to procure vaccine doses on behalf of participating countries within a given region can benefit LMICs by accounting for infrastructure limitations that these countries share. Finally, donations bolster global redistributed supply essential to LMICs. [ABSTRACT FROM AUTHOR]

Table of Contents Introduction I. The Drug Repurposing "Problem" II. Drug Development Processes, Incentives, and Players A. The Conventional Pharmaceutical Model: Small Molecules, Specific Targets, Widespread Disease B. Origins and [...], The pharmaceutical industry is in a state of fundamental transition. New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is "drug repurposing"--finding new ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This Article examines the system that surrounds drug repurposing, including serendipitous discovery, the application of "big data" methods to prioritize promising repurposing candidates, the unorthodoxly regulated off-label prescription practices of providers, and related prohibitions on pharmaceutical firms' off-label marketing. The Article argues that there is a complex ecosystem in place and that additional or disruptive IP or market exclusivity incentives may harm as much as help in promoting repurposing activity. To illustrate this threat, the Article traces the trajectory of metformin, a common diabetes drug that shows promise for conditions ranging from polycystic ovary syndrome to breast cancer. From the initial reasons for Bristol-Myers Squibb to refuse to invest in promising alternative uses, to the institutions, researchers, and regulators who identified possibilities for metformin treatment, this Article aims to map the role of intellectual property protection, market exclusivity, and search for capital that led to metformin's ascent as a repurposed drug. The Article contributes a concrete understanding to an important problem in pharmaceutical law and policy, one for which scholars have quickly suggested more powerful patent and market exclusivity protection when doing so may undermine the very processes now leading to effective alternative uses for existing drugs.

This article highlights and evaluates the role of CEPI and its contribution to global equitable access to COVID-19 vaccines through its established partnerships for vaccine development. The article adds to the understanding of how and when such partnerships can work for public health, especially under emergency citations. [ABSTRACT FROM AUTHOR]