In September, 2024, the UN General Assembly assigned the Quadripartite Joint Secretariat on Antimicrobial Resistance (AMR) the task of establishing an Independent Panel for Evidence for Action against AMR (IPEA). To promote stakeholder views and input around the constitution and functioning of this Panel, which could feed into the Quadripartite Joint Secretariat's consultation process, we independently commissioned seven papers to examine the lessons that could be learned from other high-level scientific panels. We then convened 85 stakeholders, primed with the background papers. The Workshop, held in Lagos, Nigeria in April, 2025, drew representation from around the world, particularly low-income or middle-income countries and Africa, and all One Health sectors. Stakeholder input and preferences on IPEA's structure and governance, science and content, and goals and outputs were collated in small-group roundtable discussions and plenary polling. The stakeholders pushed for a scientifically independent panel that is relevant to and respected by national governments. They also felt that the Panel-rather than third parties-should set its own agenda and establish its ways of working in detail, using open and transparent protocols. In this light, and to ensure that the evidence is presented clearly and forcefully to decision makers, effective communication will have to be a strength of this proposed Panel, along with the ability to parse and synthesise many evidence types from a range of sources. Stakeholder attendees were urged to contribute the Workshop's outputs, shared in plenaries and documented in this Personal View, to the Quadripartite Joint Secretariat's formal consultation.
Introduction:To incentivize drug and vaccine development for neglected tropical diseases (NTDs), US Congress created the Priority Review Voucher (PRV) program in 2007. Sponsors that obtain Food and Drug Administration (FDA) approval for an eligible product receive a voucher redeemable to accelerate review of another product. Methods:We reviewed the program's public health impact by examining all 14 vouchers awarded for NTD products between 2007 and 2024, including the timing of FDA approval relative to World Health Organization (WHO) Prequalification, Essential Medicines List inclusion, first use in endemic countries, and voucher disposition. Results:Eight (57%) achieved WHO Prequalification, and 8 (57%) were listed in the Essential Medicines list. FDA approval occurred a median of 8.7 years after first regulatory approval or use in an endemic country and a median of 5.2 years after WHO Essential Medicines list inclusion. Conclusion:Our findings suggest that the PRV program has primarily rewarded regulatory filings for long-established therapies rather than stimulating innovation or improving access. We propose reforms linking voucher eligibility to equitable pricing and endemic country registration.
Funding: This work is supported by the Social Sciences & Humanities Research Council [#895-2022-1015] and the Wellcome Trust [222422/Z/21/Z]. This work was also supported, in part, by a Novo Nordisk Foundation Grant for a scientifically independent International-Collaborative Bioscience Innovation & Law Programme (Inter-CeBIL) programme (#NNF23SA0087056 & #NNF17SA0027784).
This essay celebrates the BU Health Law Program upon its 70th anniversary, offering reflections on the founders of the program, Fran Miller, George Annas, and Wendy Mariner ("FGW," endearingly), and their contributions to the field.Current faculty offer reflections, including: Several speak to scholarly research, including Elizabeth McCuskey on health care finance, Aziza Ahmed on human rights, Dionne Lomax on antitrust, Christopher Robertson on trust, and Kathy Zeiler on the marketplace. Other contributors speak to the student experience, with Dianne McCarthy on mentorship, Laura Stephens on demanding excellence, Michael Ulrich on teaching, and Larry Vernaglia on merging law and public health. On FGW's broader impacts, Nicole Huberfeld speaks to the translation of research to reach new audiences, and Kevin Outterson writes about FGW's pivotal roles in establishing the health law field and the institutions that now define it.Together these pieces testify to the astounding contributions of these scholar-teacher-leaders across many domains and dimensions of health law. While their contributions are countless and immeasurable, these reflections offer a start.
Background:Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the United States, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically affected immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the United States and their implications for accessibility and patient care. Methods:A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the University of Utah Drug Information Service. Results:While prices for most neglected tropical diseases were stable, albendazole prices decreased by 78% while mebendazole prices rose by 60%. Miltefosine remained expensive at $48 000 per treatment course. There are limited manufacturers of neglected tropical disease treatments in the United States, increasing vulnerability to shortages. Conclusions:Addressing pricing irregularities and supply vulnerabilities requires legislative and policy interventions to enhance generic competition, expand public manufacturing, and strengthen supply chains. Such measures are critical to ensuring affordable and accessible treatment options for neglected tropical diseases in the United States.
New evidence suggests that mass drug administration of azithromycin (MDAA) can significantly reduce childhood mortality in high-burden, low-resource settings, yet the World Health Organization's (WHO) 2020 guidelines take a cautious approach due to concerns about antimicrobial resistance (AMR).While the WHO guidelines cite ethical principles, they insufficiently address key considerations, such as intergenerational justice, equitable burden sharing, and the structural determinants of health that shape infectious disease vulnerability.Global AMR policy often prioritizes conservation over access in ways that disproportionately burden low-income countries, despite high-income countries also bearing significant responsibility for the emergence and spread of AMR.A balanced ethical framework is needed: one that explicitly integrates contextual values, including justice across generations, historical inequities, and community input under uncertainty.Revised WHO guidelines that expand eligibility for MDAA based on context-specific criteria, establish thresholds for mortality and resistance monitoring, and encourage global investment in sustainable health systems and antibiotic access, may better align with the WHO's own principles on equity, human rights, and social determinants of health in the development of guidelines.
Background:Antimicrobial resistance (AMR) poses an important global health challenge, including insufficient investment in research and development. This study quantifies the required "fair share" contributions from the G7+EU27 countries for an effective set of pull incentives for antibacterial research and development. Methods:Fair share targets within the G7+EU27 were calculated from GDP data and revenue targets from the literature, adjusted for inflation. Cefiderocol and ceftazidime-avibactam were selected as representative of key antibacterials. Revenues and volumes from IQVIA MIDAS data on these drugs were used to assess alignment with fair share targets. The study period was January 2015-December 2024. Findings:The G7+EU27 low-end, mid-range, and high-end annual revenue targets are US$258, US$363, and US$562 million in global revenues (USD 2024), respectively, consistently over ten years. An antibiotic meeting the mid-range target would be 230th in a global rank of drugs by revenues. While the UK and Italy are on track to meet annual mid-range targets going forward, other G7 countries are not, and only Italy has met cumulative mid-range targets for both drugs. Interpretation:Collectively, the G7+EU27 has not met cumulative mid-range targets. The UK meets mid-range annual targets going forward due to its antimicrobial subscription program. Italy meets mid-range targets due to higher use and may continue to meet them due to an "orphan" reimbursement fund for antibiotics. German, French, and Japanese antibacterial pull incentives have not met the mid-range targets. No G7 member meets high-end targets at current unit prices or volumes. A revenue guarantee pull incentive designed to top-up market revenues could support innovation and accelerate access without relying on higher prices or volumes. Progress in the UK and Italy demonstrates that meeting fair share targets are achievable within different national contexts. Funding:MG was supported by a post-doctoral fellowship at Boston University. ASK's work was funded by Arnold Ventures and International Collaborative Bioscience Innovation & Law Programme (Novo Nordisk Foundation grant number NNF23SA0087056). While KO is Executive Director of CARB-X, this work was not funded under any CARB-X grant.
Policy Points Antimicrobial resistance (AMR) is a pressing global health crisis driven by complex collective action challenges, requiring locally tailored and context-sensitive solutions. Drawing insights from environmental governance where collective action problems are familiar, we propose nine adaptable strategies for AMR governance, offering policymakers and scholars a flexible policy toolkit for addressing AMR. These strategies integrate the roles of state, market, and community actors to advance sustainable and equitable collective action across diverse global contexts. CONTEXT:Antimicrobial resistance (AMR) is a pressing global health crisis rooted in complex collective action problems. Despite the urgency, policy responses have not kept pace with the escalating threat of drug resistance. By recognizing the similarities between AMR governance and other shared-resource challenges in environmental governance, this article examines potential strategies for AMR governance. METHODS:An analysis of 12 environmental governance frameworks identified three main approaches to collective action: market-driven, state-led, and community-centered strategies. From these strategies, we purposively selected three case studies to illustrate how each approach could inform AMR policy, focusing on: (1) market-based mechanisms in climate governance, (2) state-led initiatives in water management, and (3) community-led efforts in biodiversity conservation. FINDINGS:We propose nine policy options for AMR governance, drawing inspiration from established strategies in environmental governance. These include Pigouvian taxes, cap-and-trade systems, enhanced public-private partnerships with performance metrics and technology transfer, and access-and-benefit sharing agreements. Framed as adaptable strategies, we emphasize the importance of tailoring each option or a blend of options to the economic, political, and health care contexts unique to AMR challenges worldwide. CONCLUSIONS:Although environmental governance has not fully resolved the global issues it addresses, its lessons offer valuable guidance for designing adaptive, equitable, and collaborative AMR governance frameworks. Our analysis highlights the importance of a balanced approach, combining state, market, and community engagement to achieve sustainable AMR solutions. Recognizing the limits of environmental governance, we emphasize that effective AMR strategies should integrate ongoing evaluation, international collaboration, and inclusive stakeholder engagement to foster global commitment and meaningful action.
The Antimicrobial Resistance - Genomes, Big Data and Emerging Technologies Conference explored key topics including measuring the burden of AMR, global public health pathogen genomics infrastructure and surveillance, translation and implementation of genomics for AMR control, use of techniques such as wastewater surveillance, mathematical and statistical modelling, and Artificial Intelligence (AI) to aid understanding of AMR. This report describes research presented during plenary sessions and discussions, keynote presentations and posters.
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Antimicrobial resistance (AMR) causes over 1.27 million deaths annually, making it one of today's most urgent health threats. Given its urgency, there are often calls for large-scale global initiatives to address AMR. However, theories of collective action have yet to be applied to the problem in a systematic and holistic manner. Fuller engagement with collective action theory is necessary to avoid three risks, namely: mischaracterizing the kinds of challenges that AMR presents; over-simplifying the problem by reducing it to a single type of collective action problem while ignoring others; and overstating the ability of collective action theory to formulate effective solutions. This article relies on the work of Elinor Ostrom to develop an analytical framework for collective action problems around public and common goods. When analyzed through this framework, we find that AMR poses at least nine distinct collective action problems. This more granular framing of AMR provides, in our view, a better basis to develop policy solutions to address this multifaceted challenge. We conclude with proposals for future research.
Policy declarations from the G7 and other high-level meetings call for increased incentives for antimicrobial research and development (R&D). Governments fund push incentives like CARB-X and GARDP, and G7 countries are now designing pull incentives-financial rewards given to manufacturers post-market authorization that are intended to encourage the creation and introduction of novel antimicrobials. Germany has declared previously at the G7 that it has developed a pull incentive that will increase revenues from sales of important new antimicrobials, principally by exempting them from some aspects of health technology benefit assessments and reference pricing, which should result in higher prices. This policy move is the latest in a series of reforms that aim to improve the marketability of antimicrobials in Germany. This paper examines Germany's reforms and contributes to the ongoing debate about the merits of its approach in light of R&D and access issues impacting the country, particularly in comparison to pull incentives such as revenue guarantees or subscriptions that delink revenue from sales volume. We find that in order for Germany to produce the same impact on antimicrobial revenues as a delinked pull incentive, it either needs to increase the volume of antimicrobials used or increase prices for these drugs by as much as 3.3-times current values.
In June, 2023, the Council of the EU published a recommendation that the European Commission should contribute to the design and governance of an EU cross-country pull incentive to stimulate antimicrobial innovation and access. In this Personal View, we discuss six key considerations to support the implementation of the new pull incentive—ie, the size of the potential pull incentive and possible contributions of the member states, design of the incentive model, interplay of the new pull incentive with the proposed revisions of the EU pharmaceutical legislation, roles and responsibilities of both the EU and member states, balance between pull and push incentives, and global cooperation and responsibility. As the involvement of the member states with the EU pull incentive will be voluntary, member states should have confidence that the processes used to identify eligible antimicrobials, negotiate terms and conditions, and oversee access agreements are transparent, inclusive, and methodologically robust.
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In the wake of COVID-19, the World Health Organization established an Intergovernmental Negotiating Body to negotiate a new instrument for pandemic prevention, preparedness, and response. This special issue of the Journal of Law, Medicine & Ethics brings together multidisciplinary scholarship to address the question of whether antimicrobial resistance should be included in this new instrument. Drawing from disciplines including law, anthropology, history, public health, public policy, economics, and veterinary medicine, this special issue explores the inclusion of AMR within the Pandemic Instrument from three perspectives: first, through the lens of global AMR governance, second, from the perspective of technical governance challenges and opportunities affecting the global ability to address AMR and future pandemics, and third, from the perspective of pandemic instrument mechanisms for strengthening global AMR governance. Each paper makes a concrete recommendation with respect to the importance of including AMR within the scope of the pandemic instrument.