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With the G7 Leaders Summit currently underway in Italy, ARMoR in collaboration with the Global Antibiotic Research and Development Partnership and the AMR Funding Circle, have put together a series of policy recommendations aimed at driving further action from leaders on the crucial topic of antimicrobial R&D and access. Our recommendations have been published as part of the Think7's "One World, One Health. A Strategic Vision for a Resilient Global Health System" and the full brief is linked above.
G7 Summits have suggested collective approaches to address AMR since 2014, but thus far members have not fully introduced new policies and practices that would meet the ambitions of their own commitments. It is our hope that this years G7 and G20 Summits, as well as the UNGA High Level Meeting in September, will see more granular and concrete action proposed and taken forward. Further details on our specific recommendations can be found below.
Proposal 1: Strengthen global antimicrobial R&D and access infrastructure through increased push funding, government support and other relevant investments.
Proposal 1.1: R&D infrastructure. The G7, building on prior commitments, and in
coordination with the G20 and LMICs, should fully finance and support existing R&D infrastructure, including the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP), and make additional investments to address gaps and unmet needs. Investing in and expanding R&D infrastructure to create more inclusive and comprehensive systems is vital to ensure the prioritisation of the highest unmet needs globally, including the specific needs of vulnerable populations, such as children of all ages.
Ideally, push funding should be explicitly linked to access commitments, such as licensing to third parties, and a commitment to registration in high-burden countries, to ensure that public funds are used to meet public health needs. Global priorities, as well as target product profiles, for the development of new antimicrobials and combinations should continue to be set through existing processes convened by the WHO and play a key role in directing funding and support. One means to strengthen the capacity of the WHO and relevant R&D actors to set priorities is through improved global surveillance programs. Thus, the G7 should increase investments in the WHO Global Antimicrobial Resistance and Use Surveillance System.
Proposal 1.2: Infrastructure to assure timely registration, manufacturing and procurement. Markets for antimicrobials are typically small, fragmented and unpredictable, with weak supply chains. Registration of new antimicrobials can take years and, in many countries, including G7 members, it may not happen at all. Additionally, many antimicrobials may be unaffordable and shortages are an increasingly urgent problem. Consequently, timely supply of affordable antimicrobials is a frequent and recurring issue.
To overcome these chronic problems, the G7 should support and provide full funding for innovative mechanisms, institutions and models aimed at ensuring adequate manufacturing, supply, timely registration and procurement. Such measures include regional pooled procurement, not-for-profit partnerships such as GARDP, global or regional stockpiling, expansion of the WHO Prequalification Programme, improved regulatory harmonisation through G7 Members or regional regulatory processes, and support and investments in decentralised manufacturing. Support should also be given to the SECURE project, a collaborative initiative established by WHO and GARDP to expand access to essential antibiotics in participating countries.
Additionally, the G7 should urge antimicrobial developers to ensure timely supply and robust availability worldwide, including prompt registration in high-burden countries and licensing of new and existing antimicrobials to entities such as GARDP or commercial partners to ensure adequate manufacturing and distribution of such treatments.
Proposal 1.3: Infrastructure to ensure timely and appropriate access to antimicrobials where needed. Even when antimicrobials are available where needed, there is often insufficient diagnostic capabilities and evidence of their real-world effectiveness to guide use and facilitate access. The G7 should continue to invest in entities and work with collaborators, including clinical trial networks and not-for-profit partnerships such as GARDP, to generate appropriate evidence to guide use in all relevant populations during clinical development and following regulatory approval. Furthermore, the G7 should invest in appropriate entities and partnerships, including FIND, to develop and roll-out diagnostic tests, while taking steps to reduce the cost and increase availability of existing diagnostic tests.
Proposal 2: Commit to a coordinated approach to financing and supporting pull incentive schemes, considering global needs for R&D and access.
Building on commitments from previous Leaders Summits, and in line with current, national-level efforts of G7 Members, the G7 should establish a common framework and approach for national level pull incentives that can be introduced by each G7 government, with flexibility to account for the diverse national processes and health systems of its members.
Such a pull incentive should be designed to encourage private investment in the development of treatments that meet global priorities as defined through the WHO Priority Pathogen List and national priority lists. Additionally, it should promote equity, by encouraging companies to account for the needs of all populations in its approach to R&D and access. As with push funding, it is also crucial that any pull incentive should include obligations that can strengthen global access and stewardship, including licensing to third parties and/or a commitment to registration in high-burden countries.
To provide the required financing for both proposals in a timely manner, G7 Members should commit to a meeting of finance ministers following the conclusion of the UNGA HLM on AMR in October 2024.