GHTC applauds Senate appropriators for exploring feasibility of establishing dedicated global health R&D funding line at USAID

GHTC responded to a request for information (RFI) on House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA)'s recently published framework that lays out the current challenges facing the National Institutes of Health (NIH) and makes recommendations for reform with the letter below, raising concerns that some of the recommendations could limit important and lifesaving work and urging that any reforms included in legislation to be thoroughly vetted to protect that work.Dear Chair McMorris Rodgers, As members of the global health advocacy community, thank you for your interest in optimizing the National Institutes of Health (NIH) and for the opportunity to provide input on the  Reforming the National Institutes of Health Framework for Discussion.We are pleased to share thoughts below on several specific proposals. However, given the significance of NIH to the health, security, and well-being of the American people and populations across the globe, it is critical to engage in a process that permits interactive discussion with and between different parties who can shed light on the day-to-day implications of these potential changes. Through this process, we can work together to identify opportunities to strengthen NIH in support of the goals and objectives of members of Congress from both sides of the aisle.    For this reason, we are deeply concerned that changes outlined in the framework have been incorporated into the Fiscal Year 2025 House Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill even before the deadline for comments on the proposal. Our concern is not that the calls for reform and increased transparency are without merit but rather that any reform included in legislation be thoroughly vetted to ensure that the important and lifesaving work of NIH is allowed to thrive.In the spirit of such a process, the following text provides specific input from the global health research community and advocates on several proposals included in the framework. The community’s apprehension centers on bifurcating the National Institute of Allergy and Infectious Diseases (NIAID); collapsing several institutes and centers, including the Fogarty International Center, into a single institute; and incorporating the Advanced Research Projects Agency for Health (ARPA-H) into an NIH institute. These actions will impose barriers, both administrative and scientific, for global health research and development that will affect NIH’s reputation as the global leader in biomedical sciences, a legacy that enhances the United States’ image on the international stage as a champion of global health innovation and a steward of global health diplomacy. NIAID is the world leader in global health research and development because its basic research expands our fundamental knowledge of antimicrobial resistance, HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases. As COVID-19 variants continue to arise, the complex interactions between immunity and infectious threats have reached the public’s attention as never before. Antimicrobial resistance is another example of how the intertwined nature of infectious diseases and immunity requires constant collaboration between professionals from these fields. We are concerned that NIAID will not cleanly split in two as the LHHS report and House Committee on Energy & Commerce’s proposed framework posit. Rather, the split will disrupt the research helping us defeat the most deadly infectious disease threats—past, present, and future—at home and abroad. We are also concerned that grouping the Fogarty International Center (FIC) with topically unrelated and domestic-facing institutes into the Institute on Health Sciences Research would minimize the key role FIC plays in maintaining the United States’ global health security leadership role and advancing medical progress that benefits the American people and populations across the globe. FIC is a lesser-known but hugely consequential branch of NIH responsible for training a vast network of approximately 8,500 professionals from 132 countries in public health threat response. These trainees have gone on to hold high-ranking academic and government positions and have moved the needle on neglected and emerging infectious diseases, such as HIV/AIDS, COVID-19, Zika, and Ebola.  Rather than embedding FIC in another institute, we believe an important opportunity exists to strengthen this center to play an even more impactful role in advancing the health and security of Americans. We would welcome the opportunity to discuss options such as expanding FIC’s role to encompass strengthening clinical trial capacity and strategic partnerships in countries where capacity gaps pose risks and create tragic missed opportunities for faster medical progress. Finally, we believe that maintaining ARPA-H’s independent status is important for preserving its unique approach to high-risk, high-reward innovation as initially envisioned by Congress, which does not duplicate NIH’s critical role in basic and translational research.  The agency, authorized in 2022, has not been in place long enough to evaluate federal investment in this new model. Its efforts to reverse blindness, dramatically increase the precision of tumor removal, and overcome challenges with broad significance should be given the time they need to succeed or fail. Had Congress abandoned the Defense Advanced Research Projects Agency in its first years of operation, GPS could be a matter of science fiction, not everyday use. ARPA-H has the potential to bring new scientific thought and processes to a field marked by tradition—minimizing its role risks the United States falling behind our geopolitical rivals in health innovation during an age of rapidly evolving technologies. We believe it is in the nation’s interests to put ARPA-H’s muscle toward addressing health threats within and (currently) outside our borders. Again, Chair McMorris Rodgers, we share your commitment to strengthening NIH and believe that thoughtful, bipartisan reforms, supported by thorough discussion and vetting, are key to achieving this goal. We write to advocate for robust funding and a structural, operational, and policy infrastructure that best supports fast-paced scientific, medical, and public health progress. NIH is an asset that serves US interests and contributes in profoundly important ways to the health and well-being of all around the world. We urge that congressional efforts to optimize NIH take place on a bipartisan and bicameral basis and that only changes that have been carefully vetted through a thorough, interactive, and cross-sector process are considered. Thank you for your consideration,Alex LongUS Policy & Advocacy OfficerGlobal Health Technologies Coalition (GHTC)E: along@ghtcoalition.org 

Antimicrobial resistance (AMR) poses a significant global health threat; it is associated with nearly 5 million deaths each year across the world, according to the World Health Organization (WHO). Growing resistance to antibiotics, antivirals, antifungals, antiparasitics, and other antimicrobial drugs disproportionately affects low- and middle-income countries (LMICs), which bear the significant burden of AMR-associated deaths.AMR is intricately linked to global health security due to its potential to undermine the effectiveness of essential medicines. Addressing AMR, through a One Health approach, research and development (R&D), and global coordination is critical for achieving universal health coverage and maintaining the security of health care systems worldwide. The Political Declaration of the United Nations High-Level Meeting on AMR is an opportunity to drive a robust political agenda to combat this silent pandemic.   While the current text highlights many key priorities, implementation and follow-up will be vital in ensuring the success of this multilateral moment. As the Global Health Technologies Coalition, a coalition of 50 nonprofit organizations, academic institutions, and aligned businesses working to save and improve lives by encouraging the R&D of essential health technologies, we urge leaders to take the following actions: 1. Establish an Independent Panel on Evidence for Action against Antimicrobial Resistance by the end of 2025, through the support of the Quadripartite organizations1, to monitor progress, identify gaps, and provide Member States with regular guidance and updates on the science, data, and evidence across all sectors related to combatting AMR. The process for creating the panel must be inclusive and transparent. Few details are articulated in the current text regarding the governance structure.  Its leadership must be representative of different communities and stakeholders, especially those from underserved populations.  Key metrics, including on R&D, must be developed to adequately measure progress.  Countries should facilitate and support greater evidence generation for unmet needs, such as through coordination with the Global AMR R&D Hub, which provides an evidence base to enhance AMR R&D activities and policies across the One Health spectrum. 2. Ensure equitable access to antimicrobials, vaccines, and diagnostics, especially in LMICs, in line with the WHO Model List of Essential Medicines and the Global Essential Veterinary Medicines List , taking into account national contexts and treatment needs.  Countries should explicitly support key mechanisms to ensure equitable access to antimicrobials, including the SECURE initiative for antibiotic access. Research funders should ensure underserved populations, including children and pregnant women, are included in research efforts, so that they can benefit from new technologies. Increase transparency of AMR R&D to fast-track progress and ensure equitable access and maximal return on public investment in scientific progress. Update country-aligned lists for medicines.  3. Mobilize sufficient, sustainable, and predictable funding to advance the development of new health technologies and strengthen the research ecosystem to fight AMR.  Addressing AMR globally will require robust financing well beyond what is currently available within existing funding mechanisms. Financing commitments and responsibilities should reflect countries’ available resources and capacity, and funding mechanisms should be harmonized with existing programs for health and pandemic preparedness and response to reduce fragmentation and administrative burdens on LMICs. Robust funding should include support for nonprofit partnerships, such as the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, the Global Antibiotic Research & Development Partnership, and other product development partnerships that play a critical role in supporting the discovery, development, registration, and introduction of new antimicrobials to all populations in need.  The political declaration must emphasize the need for increased financing and support from large pharmaceutical companies beyond their investment in the AMR Action Fund. Acknowledge the importance of global collaboration in the field of antimicrobial R&D and ensure that there are explicit platforms for the coordination of basic and clinical research, as well as product development and manufacturing. 4. Reach the target of 100 percent of countries having basic water, sanitation, and hygiene (WASH) services in all health care facilities and 90 percent of countries meeting all WHO’s minimum requirements for infection prevention and control (IPC) programs at the national level by 2030. Countries must strengthen health systems as part of universal health coverage through fully funded comprehensive primary and secondary prevention strategies, such as IPC; stewardship programs; WASH; vaccination; early diagnosis and prompt treatment; and environmental management of air, water, soil, food, and vectors for better human, animal, and environmental health. Member states must ensure that IPC and WASH indicators are included in AMR assessments, evidence generation, and monitoring, guiding investments into AMR interventions. 1 Quadripartite includes the Food and Agriculture Organization of the United Nations, the UN Environment Programme, WHO, and the World Organization for Animal Health.