Breakthroughs Blog: Medicines

The US Agency for International Development (USAID) released a new report on its global health research and development (R&D) programs for fiscal year 2022 that includes unprecedented insight into the product development programs the agency supported—and highlights the need for additional, dedicated resources for global health research.Why it matters: The report gives insight into an agency that is a key sponsor of global health product development.Due to a lack of commercial incentive for industry investment, most global health research is supported by public funders, most notably the US government.Several US agencies support global health research, but USAID is the only agency with a mandate to improve global health and development. The agency excels at pushing products through the end of the research pipeline and advancing tools to suit the needs of people in low-resource settings.What’s new: This report includes an unprecedented 13-page appendix detailing USAID’s individual product-level investments. By our count, USAID supported at least 59 products in 2021 covering multiple health areas and product types.By the numbers: In 2021, USAID spent US$165 million in baseline funding and $50 million in COVID-19 supplemental funding on health product development and research to assess the best way to implement new products and practices.Research spending from baseline funds increased slightly over the prior year (+$4 million) — but continued to decline as a proportion of total global health spending. In 2021, proportionate spending on research dropped slightly to 5.1 percent, continuing a years-long pattern. If the trend continues, GHTC estimates that proportionate spending on R&D will drop to 4.2 percent by 2026 unless Congress passes a policy like the Supporting Innovative Global Health Technologies (SIGHT) Fund to direct more dedicated funding to R&D.Our take: GHTC applauds the release of the report and the additional detail provided by USAID. We call policymakers’ attention to the continued need for additional, dedicated resources for global health research at USAID that this report exposes.

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.A recent study found that an inexpensive, widely available antibiotic could sharply reduce the number of pregnant individuals in low- and middle-income countries who develop sepsis in childbirth, which is among the three leading causes of maternal deaths globally. The study, conducted in seven countries mostly in sub-Saharan Africa and Asia, showed that a single dose of the drug azithromycin during labor cut the risk of the mother developing sepsis by around 35 percent. Azithromycin is a generic drug, it has a long half-life, and it does not require refrigeration, making it an inexpensive and easy-to-deliver tool that could be widely adopted even in low-resource settings.Following the recent discovery of an outbreak of H5N1 on a Spanish mink farm, scientists have identified that the strain of the virus behind the outbreak contains a mutation that could make the virus more adaptable to mammals. While experts have stressed that there is no need panic, the outbreak is a reminder of the importance of disease surveillance and preparedness measures, especially as a new variant of H5N1 has spread among bird populations and spilled over into humans in recent years. Scientists have not detected any transmission of this latest strain among humans, although the mutation could increase the potential risk.Fungal pathogens are a growing threat to global public health, according to experts and the World Health Organization (WHO), which published a list of priority fungal pathogens last year. Resistance is exacerbating the threat. For example, Candida auris, Aspergillus fumigatus, and Cryptococcus neoformans, which WHO ranks among the four highest priority threats, have all shown resistance to current tools. There are also no vaccines for the top four critical infections identified. As aging populations and the climate crisis contribute to growing antimicrobial resistance, there is a strong need for improving surveillance capacity and investing in developing diagnostics, medicines, and other interventions for fungal infections, which currently account for less than 1.5 percent of all infectious disease research spending, according to WHO.

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.Last week, CEPI announced a partnership with Dutch biotechnology company, 20Med, to support the development of technology that could eliminate the need for frozen storage of mRNA vaccines. The initial investment of up to US$850,000 will go toward a proof-of-concept of the company’s bio-responsive polymeric nanoparticle platform technology. If effective, the technology could help make major strides in access to mRNA vaccines, which transformed the global response to COVID-19 and have the potential to address a number of other diseases but require cold storage, which creates access challenges to these products, especially in low resource settings.A recent study in The Lancet found that an experimental vaccine against Marburg virus was safe and produced an immune response in a small, first-in-human phase 1 clinical trial. The candidate, cAd3-Marburg, was developed at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center and uses a vaccine platform called cAd3, which previously demonstrated a good safety profile in investigational vaccines developed for Ebola virus and Sudan virus by the center. Further trials of the vaccine candidate are planned in Ghana, Kenya, Uganda, and the United States, which could propel the candidate as a viable tool in the response to outbreaks of Marburg virus.2022 saw a handful of milestones in the fight against neglected tropical diseases (NTDs) with Togo becoming the first country to eliminate four of the diseases and Malawi eliminating trachoma, among other achievements. However, to address the major challenges that remain, funding for the research and development (R&D) of improved treatments and diagnostics will be crucial. New medicines to treat NTDS are urgently needed as current treatments medicines are often ineffective, intolerable, or entirely absent. While promising innovations for treatments against sleeping sickness and visceral leishmaniasis, among others, are in the pipeline, collaboration and partnerships will be necessary to catalyze further innovation and development.

2022 G-FINDER report highlights the inadequacy of global health R&D funding: GHTC offers key takeaways for the global health communityThe release of the 2022 G-FINDER report sheds light on current funding trends in global health research and development (R&D). Despite hard-won advocacy victories by GHTC and the global health advocacy community, neglected diseases are living up to their moniker from a funding standpoint, as global investment in HIV/AIDS, tuberculosis (TB), malaria, and neglected tropical diseases (NTDs) remains far below levels required to overcome these persistent and devastating health threats. The new report highlights several new and ongoing funding trends. GHTC has identified three findings of particular importance to the global health research community.Funding for NTDs dropped precipitously; funding shortfalls for HIV/AIDS, malaria, and TB persist.Funding for NTDs included within the G-FINDER scope decreased by 10 percent in 2021, falling to their lowest total since 2009. NTDs impact more than a billion people each year, disproportionately afflicting women and children. The reduction in funding is particularly alarming given that many of the targets set in the WHO roadmap on NTDs (2012-2020) have not been met. Outside of NTDs, funding for malaria saw a substantial 5.7 percent dip, HIV/AIDS investment experienced a modest uptick of 2.7 percent, and TB funding remained virtually flat, dipping less than a tenth of a percent. While these three diseases receive more resources than NTDs, their funding levels are significantly below that which is needed to overcome these health crises and reach global health and development targets, like the Sustainable Development Goals.Funding for Product Development Partnerships (PDPs) declined for the fourth consecutive year.PDPs are the leading engines of medical innovation for diseases that lack sufficient commercial market incentives. Thus, it is distressing to see that neglected disease R&D funding for PDPs fell by 18 percent in 2021, continuing a multiyear backslide. Current PDP funding sits 40 percent below its peak, which was 13 G-FINDER cycles ago. The most recent dip was driven by reduced investment from large donors like the Bill & Melinda Gates Foundation, the UK Foreign, Commonwealth & Development Office, and the US Agency for International Development (USAID). These findings also highlight the need to further diversify funding sources for PDPs, as well as global health R&D more broadly. Specifically on the US government funding front, PDP funding was not the only area in which USAID funding declined. Neglected disease R&D funding from the agency reached a record low, further highlighting the need for additional mechanisms within USAID to facilitate supporting medical innovations for unmet needs. During the virtual launch event for the report, keynote speaker Dr. Peter Hotez noted the vital role that US agencies like USAID and the US National Institutes for Health play in the global health R&D ecosystem.Funding for platform technologies and non-disease-specific investment is on the rise. For the seventh consecutive year, funding for non-disease specific (NDS) R&D increased, rising by 5.6 percent. Specifically, investment in platform technologies grew for the fourth consecutive year and now accounts for 22 percent of NDS funding. Much of the past year’s growth was buoyed by an increase in drug-related platform technologies, which historically received the smallest share of funding. This trend dovetails with a larger shift of investments toward drugs, as overall drug R&D funding eclipsed vaccine R&D funding for the first time in 2021.Overall, the global health advocacy community has made incredible strides in protecting and growing funding for global health innovation. This past year in the United States, GHTC helped support the passage of a global health research-friendly fiscal year 2023 omnibus package, which included significant funding increases across nearly every line relevant to global health R&D, as well as complimentary directives that will support global health R&D across several agencies. However, the challenges of competing global interests and tough funding environments are formidable, as shown by the G-FINDER report. This coming year presents a number of strong opportunities to elevate attention and support for resources for global health innovation, including United Nations High-Level Meetings on TB and universal health coverage. We urge leaders around the world to step up and invest in lifesaving global health R&D, and our advocacy community partners to continue to hold the world accountable for ensuring health and health equity for all.