News: Announcement

As the G20 Health Working Group meets next week to consider political commitments to better prepare for future health threats and advance health equity, GHTC urges them to prioritize the following actions to bolster global research and development (R&D) capabilities:Support the creation of a new pandemic global medical countermeasures platform: The COVID-19 pandemic has made clear that the world needs a global, end-to-end coordination platform to facilitate the rapid development, manufacturing, and equitable delivery of medical countermeasures during health crises. G20 nations should commit to supporting and financing a new platform that builds on lessons learned from the Access to Tools Accelerator and prioritizes accountability, transparency, agility, and inclusivity in its approach.Fully fund the World Bank Pandemic Fund. To date, the fund has secured just US$1.6 billion in pledges against its $10.5 annual target. G20 leaders should also ensure the fund invests in projects to strengthen laboratory, clinical research, and regulatory capacity to advance the development of and access to health technologies, work that is complementary to that of other international health initiatives. Increase investment in R&D for poverty-related and neglected diseases (PRNDs). The pandemic has diverted critical resources and attention away from battles against longstanding global health challenges like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. To reinvigorate these fights, G20 nations should boost funding and incentives for PRND R&D and support product development partnerships, which are uniquely equipped to advance technologies that are affordable, accessible, and adapted to the communities who need them. Center the needs of women, children, and other vulnerable populations in R&D. This includes enacting policies to improve collection and analysis of sex- and gender-disaggregated data and to ensure adequate representation of women, pregnant and lactating individuals, and other underrepresented populations in clinical trials. G20 nations should also work with the World Health Organization to develop target product profiles to advance therapeutic formulations for children, pregnant individuals, and other at-risk populations. Reprioritize R&D to combat antimicrobial resistance (AMR). The G20 has demonstrated past leadership on AMR research through its support of the Global AMR R&D Hub. G20 nations should build on this by continuing to support hub operations and increasing investments and incentives for R&D for new and improved antimicrobials, point-of-care diagnostic devices, vaccines, and other technologies required to stay ahead of this rising threat.Integrate R&D into pandemic prevention, preparedness, and response mechanisms. As negotiations continue on the pandemic accord and reforms to the International Health Regulations (IHR), G20 nations should push for the accord to embrace a holistic approach to supporting end-to-end product development and for the IHR to include new amendments to promote R&D coordination and genetic sequence sharing and new indicators to assess R&D capabilities at the country level.It is our hope that the commitments of this year’s G20 will chart a new path toward realizing a more resilient, fit-for-purpose, and equitable R&D ecosystem.

At next month’s G7 Health Ministers meeting, G7 leaders will be considering political commitments that could impact the health and well-being of millions of people around the world. As G7 nations consider reforms to realize a more fit-for-purpose global health architecture, GHTC urges them to prioritize the following actions to strengthen research and development (R&D):Advance the “100 Days Mission PLUS,” which aims to reduce the impact of future pandemics by developing and making medical countermeasures available within 100 days. To achieve this, G7 nations should strongly invest in the Coalition for Epidemic Preparedness Innovations, FIND, public health institutes, and regional manufacturing hubs, as well as scope and develop an international clinical trials network for coordinated testing and enhanced global regulatory collaboration.Fully fund the World Bank’s Pandemic Fund. To date, the fund has secured just US$1.6 billion in pledges against its $10.5 annual target. G7 leaders should also ensure the fund invests in projects to strengthen laboratory, clinical research, and regulatory capacity to advance the development of and access to health technologies, work that is complementary to that of other international health initiatives.Increase investment in R&D for poverty-related and neglected diseases (PRNDs). The pandemic has diverted critical resources and attention away from battles against long-standing global health challenges like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. To reinvigorate these fights, G7 nations should boost funding and incentives for PRND R&D and support product development partnerships, which are uniquely equipped to advance technologies that are affordable, accessible, and adapted to the communities who need them. Center the needs of women, children, and other vulnerable populations in R&D. This includes expanding the activities of the G7 Gender Equality Advisory Council, as well as enacting policies to improve the collection and analysis of sex- and gender-disaggregated data and ensuring adequate representation of women, pregnant or lactating individuals, and other underrepresented populations in clinical trials. G7 nations should also work with the World Health Organization to develop target product profiles to advance therapeutic formulations for children, pregnant individuals, and other at-risk populations.Re-prioritize R&D to combat antimicrobial resistance (AMR). G7 countries have demonstrated past leadership on AMR research through support of the Global AMR R&D Hub. G7 nations should build on this by continuing to support hub operations and increasing investments and incentives for R&D for new and improved antimicrobials, point-of-care diagnostic devices, vaccines, and other technologies required to stay ahead of this rising threat. Integrate R&D into pandemic prevention, preparedness, and response mechanisms. As negotiations continue on the pandemic accord and reforms to the International Health Regulations, G7 nations should push for the accord to embrace a holistic approach to supporting end-to-end product development and for the International Health Regulations to include new amendments to promote R&D coordination and genetic sequence sharing and new indicators to assess R&D capabilities at the country level.GHTC hopes that commitments made at this year’s G7 will take us one step closer to realizing a more resilient and equitable R&D ecosystem capable of delivering the tools needed to confront long-standing and emerging health threats.

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.