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The health ministers of G20 nations concluded their annual meeting last weekend with the adoption of an “outcome document” that includes welcome commitments to advance the research and development (R&D) of health products. While normally such a ministerial-level meeting would end with the release of a formal consensus communique, broader geopolitics derailed this process, with Russia and China opposing the inclusion of language condemning the Russian war of aggression against Ukraine. Below we break down what R&D commitments are included in the outcome document, why it matters, and where conversations are expected to go from here. What’s in the declaration? At the highest level, G20 nations made commitments to strengthen the global health architecture and “build more resilient, equitable, sustainable and inclusive health systems equipped to address ongoing global health challenges and future public health emergencies with equitable access to safe, effective, quality-assured and affordable vaccines, therapeutics, diagnostics, and other medical countermeasures.” They also reaffirmed their commitment to ending the epidemics of AIDS, tuberculosis, and malaria; achieving polio eradication; advancing universal health coverage (UHC) and the Sustainable Development Goals (SDGs); and tackling antimicrobial resistance (AMR). On the latter issue of AMR, the ministers vowed to strengthen R&D for AMR and further the development of novel antimicrobials. They welcomed the work of various international initiatives and GHTC members including the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and the Global Antibiotic Research and Development Partnership (GARDP) and voiced continued support for the Global AMR R&D Hub, which was established under the German G20 presidency to promote AMR R&D coordination. On the broader issue of R&D for pandemic prevention, preparedness, and response (PPPR), G20 leaders agreed to support a World Health Organization (WHO)-led consultative process to develop an interim (and potentially later permanent) medical countermeasures (MCMs) mechanism to coordinate the end-to-end R&D, manufacturing, procurement, and equitable delivery of MCMs during health emergencies. They advised that such a mechanism should consider a “network of networks” approach, building off existing international and regional partnerships, and should be coherent with the outcomes of ongoing efforts to amend the International Health Regulations (IHR) and advance a binding pandemic instrument. Additionally, the ministers underscored the need to strengthen local and regional R&D networks and manufacturing capabilities, especially in low- and middle-income countries, as well as voiced support for what many call the “100 Days Mission” to develop and make available safe and effective vaccines, therapeutics, and diagnostics within 100 days of the identification of a pandemic or epidemic threat. They also noted the importance of public-private R&D partnerships—calling out the contributions of GHTC members the Coalition for Epidemic Preparedness Innovations (CEPI), Medicines Patent Pool (MPP), and FIND—and technology transfer and knowledge sharing “on voluntary and mutually agreed terms.”Why it matters?  G20 nations currently conduct and fund the majority of the world’s health R&D. Thus, it is great to see G20 leaders reaffirm the importance of R&D to achieving UHC, SDGs, and PPPR and demonstrate political will to accelerate R&D efforts. However, the outcome document is short on specifics as to how G20 countries intend to operationalize their many promises, and it disappointingly includes no new funding targets or commitments.  Additionally, going into this year’s G20 cycle, many observers and health advocates also expected that the G20 under the Indian presidency would play a more active role in envisioning and detailing a specific proposal for the creation of an end-to-end MCMs mechanism or platform to succeed and build upon the Access to COVID-19 Tools Accelerator. Instead, the G20 simply promised to support a WHO-led consultative process to design an interim mechanism and punted it to the International Negotiating Body (INB) process for a pandemic instrument to determine the prospects for a permanent MCMs platform. What’s next? With G20 nations offering few specifics on a vision to reimagine the global health architecture and advance an MCMs platform, the focal point for change is now squarely within the separate but interrelated processes now underway to amend the IHR, advance a pandemic accord that will create a more comprehensive framework for how countries will prevent and respond to outbreaks, and design an interim MCMs platform. While these processes have been ongoing, the deliberations have been stymied as countries struggle to reach consensus around thorny R&D topics like access and benefit sharing, with some pushing for more aggressive legally binding commitments for transparency, conditions on public R&D funding, patent waivers, and new supply chain mechanisms for ensuring low- and middle-income countries access to medical countermeasures. Questions remain on the full scope of some of the processes, and how they will delineate which issues will be tackled where and with the target date of May 2024 for the adoption of an instrument rapidly approaching and the INB and IHR processes largely behind schedule, it remains to be seen what tangible changes for R&D can be realized. While it is impossible to know what exactly what the future of these negotiations hold, GHTC promises to continue to watch, weigh in, and report back in the months ahead as these interrelated processes unfold. Stay tuned! 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. As COVID-19 infections and hospitalizations rise across the United States, last week Moderna reported initial data that showed the efficacy of their updated COVID-19 vaccine, which was originally aimed at protecting against the XBB.1.5 subvariant, against the increasingly dominant Eris (EG.5) and Fornax (FL 1.5.1) subvariants. The updated vaccine is expected to be available in the fall, pending approvals from US Food and Drug Administration (FDA) and other national regulators. Novavax, as well as Pfizer and partner BioNTech, are also advancing updated shots.The United Kingdom’s Fleming Fund last week announced that it will provide up to $267.5 million for strengthening antimicrobial resistance (AMR) surveillance capacity in low- and middle-income countries in Africa and Asia, where the threat and burden of AMR is the highest. Specifically, the funding will go to upgrading laboratories, introducing new genome sequencing technology, and supporting training sessions. This announcement, which came ahead of this past weekend’s G20 Health Minister’s Meeting, where AMR was an important topic, marks a significant investment in a data-driven approach to fighting the rising threat of AMR.A new antibiotic combination drug that could significantly improve the treatment of complicated urinary tract infections and potentially serious infectious caused by highly resistant bacteria is now on track to receive a final review by FDA. Cefepime-taniborbactam, developed by Venatorx Pharmaceuticals and the Global Antibiotic Research & Development Partnership (GARDP), could be approved as early as next February. If successful, the treatment would be the first new treatment in GARDP’s clinical development portfolio to gain regulatory approval and would be a boon to global equitable access to new antibiotic treatments due to GARDP’s exclusive rights to distribute and sub-distribute the treatment in 64 low- and middle-income countries.

In recognition of World Mosquito Day on August 20, 2023, GHTC is testing our readers’ knowledge of mosquito-borne diseases and ongoing efforts to develop treatments, vaccines, vector-control innovations, and other tools to outsmart the world's deadliest animal. Test your knowledge by taking the quiz below!

GHTC responded to Senator Ben Cardin's (D-MD) request for information (RFI) on strengthening global health systems through local partnerships post-pandemic by emphasizing the need to invest in innovative product development and the broader innovation ecosystem, as well as strengthening research and manufacturing capacities, especially in low- and middle-income countries.To the attention of:Senator Benjamin L. CardinCOVID-19 cast the importance of a strong, unified, and fully financed global health architecture into sharp relief. However, while the pandemic dominated headlines, progress toward the Sustainable Development Goals and other health priorities has stalled, underscoring the need to reaffirm the importance of investments in ongoing epidemics, including in tuberculosis, malaria, HIV, neglected tropical diseases, and other neglected infectious diseases. To regain our global footing on these diseases, known and unknown, investments by the government in Health Systems Strengthening (HSS) must include catalyzing product development for new drugs, vaccines, diagnostics, vector control products, and other health tools, as well as strengthening research and manufacturing capacities and ensuring more direct investment in existing innovation ecosystems, especially in low- and middle- income countries (LMICs).According to the same Lancet Commission on Investing in Health paper cited in the RFI, even if our current health technologies were scaled widely, the world could still not achieve our Sustainable Development Goals for health. True HSS must address future supply chain issues and dependence on a handful of stakeholders for vital health products, and global and regional leaders must make a concerted effort to strengthen local production and technical capacities to enhance regional manufacturing capabilities. Investments should be made in regional hubs that can serve multiple countries, especially during major outbreaks, but also for ongoing health threats from poverty-related and neglected diseases.The US Agency for International Development (USAID) is a leader in global health and development, making them uniquely poised to not only conduct HSS but also to invest in the research and development of technologies for global health on a disease-agnostic level. Congress should seek to invest in USAID’s mandate to both bolster the human and infrastructural resources of health systems and vest those systems with the capacity to innovate and build next-generation technologies that are fit for use in LMICs.Sincerely,Alex Long