News: Announcement

The Biden administration’s fiscal year 2024 (FY24) budget request is a mixed bag for global health research. The request includes a few bright spots, especially for global health security, but overall fails to address the significant gaps and recent setbacks for global health.For the State Department and the US Agency for International Development (USAID), the request includes increases to global health security—including to the Coalition for Epidemic Preparedness Innovations—but otherwise proposes cuts to bilateral HIV, tuberculosis, and malaria programs.These proposed cuts to the President’s Emergency Plan for AIDS Relief, and tuberculosis and malaria programs at USAID are especially disappointing at a time when these programs face lingering setbacks from COVID-19.GHTC was especially disappointed that the request did not include additive funding under USAID for a new global health research and development line, a proposal supported by more than 100 global health organizations and former senior USAID officials.In the Department of Health and Human Services, GHTC was disappointed that the budget proposes flat funding to the National Institute of Allergy and Infectious Diseases and the Fogarty International Center.The Fogarty International Center trains infectious disease researchers, invests in health systems, and improves pandemic preparedness around the world. It is a best buy for global health.GHTC applauds the proposed increases to the US Centers for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases and Global Health Center, including to Global Public Health Protection and the Division for Parasitic Diseases and Malaria.These centers track infectious diseases globally, support the development of new technologies, and provide technical expertise to many partners in the United States and globally.In addition to an increase for the Biomedical Advanced Research and Development Authority (BARDA), GHTC applauds the Biden administration for including a longstanding priority for our community: proposing a new line of funding at US$400 million for emerging infectious diseases (titled Pandemic Preparedness and Biodefense) under the Administration for Strategic Preparedness and Response.Nearly all BARDA’s support for emerging infectious disease (EID) medical countermeasures to date has been funded through emergency supplemental appropriations. This new line will enable the agency to be proactive, rather than reactive, to future pandemic threats.Beyond EIDs, however, GHTC is disappointed that the request deprioritizes antimicrobial resistance research, proposing $155 million in support for the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, and the advanced development of new antimicrobial therapeutics at BARDA—$30 million less than for fiscal year 2023, despite a topline increase.GHTC urges Congress to build upon the Biden administration’s request and to pass a spending package for FY24 that recognizes how far we are from achieving our goals for global health research and development. Achieving these research milestones is critical for achieving our national and global health objectives.

GHTC Statement on the WHO Clinical Trials ResolutionLast year’s clinical trial resolution was a major milestone for building greater clinical trial capacity in low- and middle-income countries. However, creating a framework for standardization and implementation is still slow and ongoing. There are numerous areas where the current framework could be improved. Member states have highlighted that there continues to be inadequate reporting of data disaggregated by sex and gender relating to the World Health Organization's (WHO’s) priority pathogens, such as those for neglected tropical diseases and in WHO’s R&D Blueprint, as well as for new antibiotics for highly-resistant pathogens. Actions are needed to fill these gaps in the global evidence base, as well as for strengthening inclusiveness. Greater coordination is also needed to ensure efficacy and alignment with other clinical trial capacity-strengthening mechanisms, including the Global Health Security Agenda, and investments driven through international financial institutions, including the new Pandemic Fund. There is also a need for domestic resource mobilization, and other sustainable financing mechanisms should also support capacity-building initiatives. We, therefore, urge members and WHO to consider the following recommendations to build upon the work started last year:Improve international collaboration and coordination among member states on key research priorities and multiregional clinical trials, where appropriate. At present, effective coordination mechanisms are lacking for clinical trials, and funding for clinical trials across all WHO regions and disease areas is insufficient. Furthermore, improved coordination around global research agendas could enable more timely capacity-building of clinical trial sites.Support new trial modalities such as decentralized and paperless clinical trials that incorporate patient perspectives, mobile technologies and telemedicine, and increased use of adaptive, multicountry platform trials.Invest in building regulatory capacity in low- and middle-income countries (LMICs), including further building off of progress to date across the African Medicines Regulatory Harmonization programme and supporting the launch of the African Medicines Agency. Continued investment in regulatory strengthening will be critical to expanding clinical trial capacity in LMICs. Increase investment in workforce capacity and research institute infrastructure in LMICs. Additional investment is critical to sustainably build the capacity of LMICs to execute their own research agendas.Address gaps in data on specific population groups and disease targets and gender biases in data. Biases may result in these groups being precluded from the development of, and access to, needed interventions. This includes, but is not restricted to, pediatric data and data from pregnant and breastfeeding people.Support the Global Accelerator for Paediatric Formulations and the WHO International Clinical Trial Registry Platform through data sharing and technical support, as these platforms will be crucial for providing and streamlining the clinical evidence base necessary for policymakers to understand the current clinical trial landscape and its current gaps. There is also an urgent need to overcome the challenges in clinical trials for children and support platforms such as the Global Accelerator for Paediatric Formulations to strengthen partnerships to overcome these barriers.

GHTC Statement on the WHO Diagnostics ResolutionThe COVID-19 pandemic has highlighted the centrality of access to diagnostics as a key component of detecting and controlling emerging infectious diseases. Early issues in developing accurate tests hampered the understanding of, and response to, the initial stages of the COVID-19 outbreak. This is the case for a broader range of health areas, including poverty-related neglected diseases.Simply put, medicine cannot respond effectively without diagnostics. Yet despite diagnostics being an integral pillar to quality health care, a recent study from The Lancet highlighted that 47 percent of the global population has little to no access to diagnostics.This resolution on diagnostics is a good first step in acknowledging and addressing the gap in political prioritization, and we urge the World Health Organization (WHO) and member states to consider the following: Push for a special advisor to serve as a senior central point of contact at WHO for diagnostics to ensure internal alignment and push for greater strategic prioritization through a potential “International Diagnostics Alliance.” Likewise, the resolution should reaffirm the essential role played by civil society in defining, developing, and deploying better diagnostics. Include provisions in the resolution to build, strengthen, and enforce national and regional regulatory frameworks covering the market for diagnostics and the registration, accreditation, and oversight of laboratories. Coordinate national regulations concerning medical devices, and streamline and improve the WHO prequalification process to ensure greater access to diagnostics in lower- and middle-income countries. Mechanisms like collaborative registration should be strengthened to expedite the registration of new diagnostics in countries.Promote local and regional research and development, manufacturing, and distribution capacities for diagnostics. Prioritize investment in the procurement of diagnostics for all health areas, in particular recognizing that significant gaps remain for poverty-related and neglected diseases. Funding for diagnostic procurement remains significantly underfunded, and improved coordination across stakeholders—including donors and procurement mechanisms—is needed to fill gaps and ensure populations, particularly those in low- and middle-income countries, have access to critical diagnostics. 

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.