News: Advocacy action

October 16, 2024 The Honorable Tammy Baldwin Chair Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. Senate Committee on Appropriations Washington, DC 20510 The Honorable Robert Aderholt Chair Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. House Committee on Appropriations Washington, DC 20515 The Honorable Shelley Capito Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. Senate Committee on Appropriations Washington, DC 20510 The Honorable Rosa DeLauro Ranking Member Subcommittee on Labor, Health and Human Services, Education, and Related Agencies U.S. House Committee on Appropriations Washington, DC 20515 Dear Chairs Baldwin and Aderholt and Ranking Members Capito and DeLauro: As you work toward finalizing Fiscal Year 2025 spending, we, the undersigned, urge you to adopt the Senate’s proposal for funding the National Institute of Allergy and Infectious Diseases (NIAID). This funding is critical to ensuring that the nation can respond to public health challenges of today and disease threats of tomorrow. NIAID plays an essential role in addressing long-standing domestic and global health challenges like influenza, asthma, cancer, HIV/AIDS, Sepsis, valley fever, deadly allergic reactions, long COVID, autoimmune diseases, tuberculosis, malaria, neglected diseases, and so much more. With a unique mandate to better understand, treat, and prevent infectious, immunologic, and allergic diseases, NIAID is forging paths to discovery to improve health and save lives. NIAID’s cutting-edge research and network of scientists are eliminating some of the world’s most serious health threats, as well as addressing risks to national security and public health, including antimicrobial resistance (AMR). Because of this work, NIAID is the world’s leader in the global health research and development ecosystem. NIH and NIAID contributed to four-fifths of all U.S. government-supported global health technologies currently in the final stages of the R&D pipeline before they can reach the market and save lives. Thanks to longterm and sustained support from Congress for NIAID over the years, the U.S. has made groundbreaking progress in the fight against diseases at home and abroad. These achievements include but are not limited to: NIAID-funded research spurred the development of the first vaccine for respiratory syncytial virus (RSV). The vaccine will help to prevent an estimated 160,000 hospitalizations and 10,000 deaths of older adults in the United States and is projected to save up to $4 billion in healthcare costs. Decades of NIAID investment helped facilitate public-private partnerships that led to the transformative development of Teplizumab, the first FDA-approved drug for delaying Type 1 diabetes (T1D) onset. The drug can help delay the onset of T1D by two years following a single treatment, which could benefit nearly 200,000 U.S. children. NIAID-funded research led to the development of antiretroviral agents that suppress HIV to undetectable levels in the body—keeping people with HIV healthy and preventing HIV transmission. Further, Protease inhibitors used in HIV treatment contributed to the development of direct-acting antivirals that cure hepatitis C. NIAID-funded research enabled development of mRNA vaccines in the first 100 days of the COVID-19 pandemic, which saved millions of lives worldwide and allowed the global economy to recover. NIAID scientists developed new technologies to identify geographic hot spots for Aedes mosquitoes—a type of mosquito that can spread diseases such as dengue, Zika, and chikungunya. The tool is poised to deliver targeted interventions to fight dengue and other diseases in the U.S. and communities across the globe. Asthma affects one in 13 Americans, including 20 million adults and over 5 million children. A clinical trial funded through NIAID found that the monoclonal antibody mepolizumab reduced asthma attacks by 27% in children and adolescents with severe asthma. An estimated 50 million Americans suffer from one or more autoimmune diseases, including 1.3 million adults with rheumatoid arthritis (RA). NIAID researchers discovered a new species of bacteria in the gut that may trigger RA, offering new avenues for treatment and prevention. Tuberculosis (TB), particularly in its drug-resistant forms, is not only a lethal threat globally (killing 410,000 per year), but remains a threat to the American people. NIAID has provided significant funding for noncommercial translational research – ranging from early discovery-based efforts to late-stage preclinical development – to develop novel anti-TB medicines. This is of fundamental importance, as research in potentially promising compounds has often been challenged by the inability to attract predictable, long-term funding that NIAID has been able to provide. These investments have led to continued breakthroughs in developing new TB treatments. NIAID-supported research is a bridge from the bench to the bedside, bringing together the full spectrum of the biomedical research and healthcare communities in addressing antimicrobial resistance. Each year, drug-resistant infections impact more than 3 million Americans, killing at least 50,000 people in the U.S. It is projected that AMR could become the leading cause of death globally by 2050 and cost the global economy $100 trillion. NIAID is instrumental in the development and training of the next generation of biomedical researchers and sustaining the current biomedical workforce. Further investments in biomedical workforce development at NIAID will yield far-reaching dividends for global health, global health security, and scientific diplomacy. We urge you and your colleagues to work towards finalizing FY 2025 funding bills to avoid longterm continuing resolutions or a government shutdown and to ensure strong funding for the life-saving work of NIAID so that American ingenuity can continue to forge a healthier, safer, and more equitable world for all. Sincerely, American Society for Microbiology American Society for Virology American Society of Tropical Medicine and Hygiene AVAC Drugs for Neglected Diseases initiative Elizabeth Glaser Pediatric AIDS Foundation Global Health Council Global Health Technologies Coalition HIV Medicine Association HIV+Hepatitis Policy Institute IAVI Immune Deficiency Foundation Infectious Diseases Society of America Research!America TB Alliance Texas Biomedical Research Institute Treatment Action Group

The Honorable Shalanda Young September 17, 2024DirectorOffice of Management and Budget725 17th Street NWWashington, DC 20503 Dear Director Young: As members of the Global Health Technologies Coalition (GHTC)—a group of 50 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people—we write to highlight the critical role of US programs that support global health research and development (R&D) and encourage your continued support for this important work in the fiscal year 2026 (FY26) budget request.   In addition to building the ecosystem that helps to ensure Americans’ health and security, investing in global health innovation also yields significant domestic economic benefits, including remarkable job creation, economic advantages, and a flourishing technology sector propelled by US dollars and expertise. After analyzing the data, GHTC and our partners at Policy Cures Research released a report quantifying the return on investment (ROI) of US funding for global health R&D over the past 16-plus years. Highlights of this ROI analysis include:More than 600,000 new jobs in the United States.A direct influx of more than $104 billion into the economy.A separate and additional $102 billion into the economy from basic-science-related global health research.And finally, an estimated $251 billion that will be infused into the economy from future innovations underpinned by the past 16 years of investment and invention.  Broadly, the US government agency network that supports global health R&D and the above ROI includes the Department of State; the US Agency for International Development (USAID); the Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Advanced Research Projects Agency for Health, and the Biomedical Advanced Research and Development Authority (BARDA); and the Department of Defense (DoD).  In this letter, we aim to provide an overview of the global health R&D ecosystem within the US government, detailing how this crucial work is accomplished and highlighting the unique roles of each component in the global health R&D chain. Thanks to these distinctions and effective interagency collaboration, the United States remains the world leader in global health R&D, a position we can maintain by sustaining and building on our investments during an era marked by pandemics and competing geopolitical models for development support.The US global health R&D apparatus Our historical investments and enduring legacy as a champion of global health diplomacy underscore the essential nature of US funding for the development and deployment of new vaccines, drugs, devices, diagnostics, and other health technologies. This support is crucial for addressing the world’s greatest health challenges—achieving an AIDS-free generation; ending malaria, tuberculosis, neglected tropical diseases, and preventable maternal and child deaths; making progress against antimicrobial resistance (AMR); and preventing future outbreaks of emerging infectious diseases.  As outlined in our ROI report, since 1999, US support has led to the development of 67 approved global health technologies (excluding COVID-19-related technologies), representing just over a quarter of all approved global health technologies created worldwide during this period. Figure 1 highlights how these technologies have received support from multiple corners of the US government to reach approval, a notoriously difficult task. Looking ahead, there are 579 technologies in late-stage development worldwide, with the US government supporting 261 (45 percent) of them through US interagency collaborations, as shown in Figure 1. The United States’ track record of successfully developing lifesaving drugs, vaccines, microbicides, diagnostics, and vector control products is a testament to the efficacy and collaboration of the US government’s network of global health R&D agencies. In the Appendix of this letter, we will delve into each agency’s contribution to global health R&D, providing detailed examples and descriptions. Here is a quick guide:USAID supports the development, introduction, and scale-up of urgently needed drugs, vaccines, diagnostics, and other technologies to address the unmet health needs of people in the world’s poorest places. The agency specializes in late-stage clinical research and implementation research and is the only US agency with a mandate to focus on global health and development.NIH advances basic, applied, and clinical research across a range of global health areas and products. NIH excels at basic and early-stage biomedical research, unlocking scientific discoveries that can later be translated into lifesaving global health technologies by the private sector, nonprofits, and other US agencies.CDC focuses on the R&D of new diagnostic, prevention, and surveillance technologies for global health security at home and abroad. CDC also evaluates the effectiveness of tools, especially diagnostics, that are already in use to determine future R&D needs. DoD supports R&D for infectious diseases, AMR, and other health conditions that pose a risk to US national security and service members stationed abroad. Additionally, because DoD focuses on producing health tools for austere settings like the battlefield, the tools it advances are often well-suited for use in low-resource communities worldwide.BARDA works with industry and other partners to bridge the “valley of death” between basic research and product development, where R&D efforts without a market most often fail. BARDA’s mandate is to protect Americans against threats to public health, including emerging infectious diseases, pandemic influenza, and AMR—though the technologies it supports often have wider global health applicability. This network is especially critical when considering the inevitability of future pandemics. In the recent past, the successful R&D of medical countermeasures to fight novel pathogens and outbreaks was built on preexisting research and technological advancements supported by past investments in global health R&D at USAID, NIH, CDC, DoD, and BARDA. This has been true for every new strain of influenza; coronaviruses like SARS, MERS, and the virus that causes COVID-19; and deadly hemorrhagic fevers like Ebola and Marburg. Without investment today, we will be ill-prepared for tomorrow. Why these investments matterOur recent experience with COVID-19 has underscored two central truths for future global health R&D investments. First, R&D must account for the needs of all settings, including those with inconsistent or limited access to electricity, sanitation, health care expertise and workforce, and refrigeration. The inequitable distribution of tools designed for diverse settings to prevent and treat COVID-19 has inflicted deep cuts in the global economy and health systems. Second, the unprecedented pace of scientific progress for COVID-19 R&D demonstrates how quickly science can advance toward eradicating poverty-related and neglected diseases with greater and more focused investment. In the United States, focused investment enabled progress toward at least 98 health innovations, including diagnostics, therapeutics, vaccines, and medical devices. COVID-19 showed us that protecting the well-being of Americans requires a globally focused, whole-of-government approach. Purposeful and coordinated investment in global health R&D is critical to both combating health threats abroad and promoting global health equity and security. Health crises abroad often quickly escalate into health crises at home, as evidenced by the rise and spread of dengue cases in the Americas (3,290 cases this year in the United States), the global mpox outbreak, the proliferation of H5N1 across US dairy farms, drug-resistant infections in conflict zones, and the still-recent Zika and Ebola epidemics. Furthermore, as the planet warms and climate change restructures habitable environments for disease vectors like mosquitoes—as seen through last year’s locally transmitted cases of malaria in Maryland, Florida, and Texas—global health threats are spreading.  The global health community is urging funding increases for core global health programs in FY26—both to protect progress made against historic public health challenges worldwide and to treat and mitigate emerging health threats. So much has been done globally to achieve our ambitious goals for disease eradication, but new geopolitical and environmental challenges have also emerged, and the disease landscape has changed. With that in mind, the United States must double down on its global health investments and maintain its international leadership as a bastion for global health innovation. GHTC’s minimum and recommended funding levels for FY26 are as follows:       (IN MILLIONS)FY24  OmnibusFY25 President’s Budget RequestHouse FY25Senate FY25FY25 RECOMMENDEDFY26 RECOMMENDEDUSAID       NEW: GLOBAL HEALTH R&D FUND (SIGHT FUND)N/AN/AN/AN/AN/A$250HIV/AIDS  $330$330$330$330$350$350MALARIA  $795$795$800$795$925$925MATERNAL AND CHILD HEALTH $915$940$915$940$1,150$1,180NEGLECTED TROPICAL DISEASES $114.5$114.5$114.5$114.5$125$125NUTRITION $165$160$172.5$165$300$300TUBERCULOSIS $394.5$394.5$394.5$394.5$1,000$1,000GLOBAL HEALTH SECURITY  $700$900???$730$1,000$900STATE DEPT.      PEPFAR $4,395$4,395$4,395$4,395$5,140$5,145GLOBAL FUND  $1,650$1,190$1,250$1,200$2,000asking the U.S. to contribute the full 1/3 of the next replenishmentCDC       CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES $760.27$780.77$780.77$805$900$900GLOBAL HEALTH CENTER$692.8$692.8$563.9$697.6$1,002.3$1002.3OF WHICH GLOBAL PUBLIC HEALTH PROTECTION $293.2$293.2$293.2$296.7$456.4$456.4   FY24  Omnibus  FY25 President’s Budget Request   House FY25  Senate FY25  FY25  RECOMMENDED  FY26 RECOMMENDEDOF WHICH GLOBAL TUBERCULOSIS $11.7$11.7$11.7$11.7$21$21*OF WHICH PARASITIC DISEASES AND MALARIA $29$29$29$30$40 $40NIH       NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES$6,562.28$6,581**$6,631$6,692.3$7,840.25$7,840.25OFFICE OF AIDS RESEARCH  ----$3,953$3,953FOGARTY INTERNATIONAL CENTER $95.16$95.16$95.16$95.16$116.1$116.1BARDA $1,015$970$1,100$1,070--NEW: EMERGING INFECT. DISEASES LINE$10-  $10$775$775AMR IN ALL ACCOUNTS--  $500$500ARPA-H$1,500$1,500$500$1,500Robust funding for global health R&DRobust funding for global health R&D DOD --  Robust agency-wide funding for global health R&D Robust agency-wide funding for global health R&D               Notes:  *CDC’s Division of Parasitic Diseases and Malaria has shifted under the National Center for Emerging and Zoonotic Infectious Diseases from Global Health Center, but the budget line has not yet changed. ** This is the sum allocation for the proposed National Institute of Infectious Diseases and National Institute on the Immune System and Arthritis. These are the two institutes that House Republicans proposed creating by splitting NIAID.Fiscal year 2024 (FY24)Fiscal year 2025 (FY25)Fiscal year 2026 (FY26)President’s Emergency Plan for AIDS Relief (PEPFAR)The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund)Supporting Innovative Global Health Technologies (SIGHT)Centers for Disease Control and Prevention (CDC)Biomedical Advanced Research and Development Authority (BARDA)Advanced Research Projects for Health (ARPA-H)Research and development (R&D)Department of Defense (DOD) Beyond the legacy funding lines GHTC advocates for across the US government, we have been fierce advocates for a new global health R&D budget line and program area at USAID that would act as a disease-agnostic, flexible, and catalytic fund to infuse new funding into R&D efforts to close the biggest gaps in our global health toolkit and save more lives more quickly. A bipartisan bill known as the Supporting Innovative Global Health Technologies (SIGHT) Act, which would lay the foundation for the creation of such a fund, was introduced in the House of Representatives in November 2023. The SIGHT Fund idea has also received support from the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies through its recent fiscal year 2025 bill report that would require USAID to submit a feasibility report to Congress on implementation of the SIGHT Fund.Global health research that improves the lives of people around the world while at the same time supporting US interests, creating jobs, and spurring economic growth at home is a win-win investment. We stand ready to work with you to advance US leadership in global health and global health innovation, and we ask that support for global health R&D not come at the expense of other humanitarian assistance and development accounts. The administration must make forward-thinking choices to respond to the current health threat landscape and draw on the painful lessons learned from past emergencies to ensure that we are primed and ready for the next outbreak—while also committing to continue progress against the full range of global health challenges.  Signed,    APPENDIX USAID For decades, the US Agency for International Development (USAID) has supported the development, introduction, and scale-up of affordable health products that save lives and lower health treatment costs in low- and middle-income countries. Through partnerships with nonprofit and private-sector organizations, USAID has fostered impressive innovations for critical health technologies. As seen in the budget chart, the Global Health Technology Coalition’s (GHTC’s) global health research and development (R&D) advocacy for USAID touches on each of their core Global Health Bureau (GHB) accounts. Below are some examples of how each account has contributed to the global health toolbox: HIV/AIDS: Supporting research to develop safe, effective, accessible, and acceptable tools for use in low-resource settings, including investigational HIV vaccines and microbicides and a microbicide vaginal ring to prevent HIV infection in women. Malaria: Supporting the development of vaccines, antimalarials, insecticides, and novel vector control tools, including a promising single-dose drug for preventing relapse of Plasmodium vivax malaria, which today includes a crucially important pediatric formulation, and the child-friendly malaria drug Coartem® Dispersible. Since 2009, more than 475 million courses of this medicine have been distributed in more than 50 countries, saving an estimated one million child lives. Maternal and child health: Developing interventions to help women and children during childbirth in low-resource settings that may not have consistent access to electricity, refrigeration, trained health care workers, or other resources, such as oxygen therapies. Neglected tropical diseases (NTDs): Supporting the development of drugs and diagnostics, including point-of-care diagnostic tests for schistosomiasis, improved drugs for treating onchocerciasis (or river blindness), and tools to fight dengue and other mosquito-borne diseases that have been deployed from Indonesia to the Florida Keys with promising results. Nutrition: Innovating solutions to tackle malnutrition—which contributes to more than 40 percent of preventable childhood deaths and a myriad of other health effects—through evidence-based food technology solutions such as micronutrient supplements; fortified foods; and biofortified, nutrient-rich staple food crops. Tuberculosis (TB): Playing a key role in the global effort to fight TB by supporting research to develop innovative, new drug regimens and diagnostics for drug-susceptible and drug-resistant TB, including the world’s first child-friendly TB medicines; an all-oral, six-month regimen for the treatment of drug-resistant TB; and a new, all-oral treatment regimen, studied through the Centers for Disease Control and Prevention’s (CDC’s) Tuberculosis Trials Consortium (TBTC) and the National Institutes of Health–sponsored AIDS Clinical Trials Group, which reduces the time it takes to treat drug-susceptible TB from six months to four.  Emerging infectious disease (EID) work done without sustainable funding: Sourcing and scaling up breakthrough innovations to combat EIDs, including COVID-19, Ebola, and Zika. USAID’s Fighting Ebola Grand Challenge—led by the Center for Innovation and Impact—identified 1,500 innovative technologies to advance the fight against Ebola and advanced 14. One of these technologies is a low-cost, battery-powered tool used during both the Ebola and COVID-19 responses that manages the flow rate of IV treatments with a simple gravity system, replacing the need for expensive, difficult-to-use infusion pumps.  In March 2020, USAID issued a request for information for proposals for low-cost, scalable innovations that could support the international COVID-19 response. It received hundreds of proposals, but without dedicated funding to advance and scale them, USAID made limited investments despite the enormous scale of global need. This and other gaps in dedicated funding to combat the EIDs of yesterday, today, and tomorrow led GHTC to home in on the idea of creating a new catalytic fund at USAID for disease-agnostic global health R&D. Through an analysis of USAID’s annual reports on health-related R&D, we found USAID’s spending on global health R&D has stagnated, shrinking as a proportion of total global health spending. Now at less than 2 percent of overall US global health investments through USAID and the Department of State, funding used for global health R&D has been far outstripped by the need for new tools amid growing antimicrobial resistance (AMR), shifting disease burdens, and emerging disease threats. This shrinking spending is a symptom of limited resources and the disease-specific, siloed nature of funding at GHB, which requires program leads to not only decide between prioritizing immediate impact over innovation and long-term progress but also limits them from funding multipurpose products that extend across multiple disease areas or from pivoting as health emergencies arise.  For these reasons, for fiscal year 2026 (FY26), GHTC proposes the creation of a new USAID Supporting Innovative Global Health Technologies (SIGHT) Fund with an initial appropriation of $250 million. The SIGHT Fund would be a new and complementary source of flexible funding for global health R&D that would: Increase the net proportion of spending on R&D within the GHB without siphoning off funds from disease-specific program offices.Provide more flexibility and predictability for USAID program managers who make R&D investment decisions and shift the risk burden of these investments away from programs already stretched thin, allowing them to make bolder, more forward-thinking R&D investment decisions.Enable greater investments in cross-disease health tools, which currently struggle to find support in the disease-specific funding structure of GHB, as well as innovations to address other challenges, such as AMR, which lack a dedicated program office.Institutionalize innovation as a core USAID global health priority by creating healthy competition for R&D funding, prompting disease-specific program offices to more frequently and critically reflect on gaps and the innovations needed to fill those gaps to achieve US global health goals. In parallel, the bipartisan SIGHT Act (H.R.6424) has been introduced in the House of Representatives and exploratory SIGHT Fund language has been introduced into the Senate’s fiscal year 2025 Labor, Health and Human Services, Education, and Related Agencies appropriations bill, which indicates that authorizers and appropriators alike are interested in the role that the SIGHT Fund could play in changing the global health technologies landscape.In addition to standing up this new R&D funding mechanism and maintaining support for existing bilateral health programs advancing health innovations, in FY26, USAID should continue to partner with global institutions supporting health innovation for pandemic preparedness such as the Coalition for Epidemic Preparedness Innovations and the World Bank's Pandemic Fund. As USAID works to implement its global health R&D strategy, it should continue to delineate bilateral investments in global health R&D and investments through outside partners. Furthermore, to improve transparency, the congressionally directed annual reports on this strategy should continue to include specific funding amounts dedicated to research and product development by each program; specific information about health product development goals and timelines; details about USAID’s investments in drugs, vaccines, diagnostics, and devices; details about collaborations with other federal agencies and private-sector partners; and an assessment of any critical gaps in product development for global health and recommendations for filling such gaps. This report is critical to providing insight and transparency into how USAID thinks strategically about R&D investments. In recent years, however, these reports have not consistently been made public—a trend that should be corrected to enable transparency and foster open collaborations among global health R&D stakeholders.To be clear, a core tenet of this proposal is that the SIGHT Fund supplements, rather than supplants, existing funding and partnership models for global health innovation across GHB. As health challenges persist in multiple arenas, GHTC strongly recommends funding the Global Health Programs account at or above the minimum funding levels noted in the table above, urging USAID to invest in R&D for new global health innovations in each of the disease and condition areas within the account and support the creation of a new SIGHT Fund to center innovation as a core global health priority and enable progress toward desperately needed global health tools.  HHSInstitutions within the Department of Health and Human Services (HHS)—including CDC, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA)—make major contributions to the development of new global health technologies.CDCCDC leads global disease surveillance, capacity-building, and the development of new tools and technologies critical to global health—such as diagnostics to identify global threats like Ebola and even the bubonic plague. The thread connecting all of CDC’s international activities is the agency’s scientific and technical leadership, which makes CDC an integral part of the global health R&D ecosystem. Recently, the CDC released its Global Health Strategic Framework (GHSF), which provides the public and appropriators with better insight into how CDC “builds, executes, and evaluates its work at the country level and through global programs that the agency implements across countries and regions.” CDC sees the framework as the new standard for how it carries out global health security by aligning country needs to one of the CDC’s “core capabilities,” which include data and surveillance; laboratory; workforce and institutions; prevention and response; innovation and research; and policy, communications and diplomacy.GHTC’s advocacy focuses on CDC’s Global Health Center (GHC) and National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). GHC provides expertise on immunizations, disease eradication, and public health capacity-building around the globe through its Divisions of Global HIV & TB, Global Public Health Protection, and Global Immunization. Among the far-reaching and high-impact work of GHC, one main priority is to “research, develop, and evaluate new tools and approaches to combat global health threats.” As a global hub for infectious disease research, GHC is uniquely equipped to develop and validate tools for disease surveillance and diagnosis. For example, CDC has developed an HIV rapid test that can diagnose HIV in minutes and distinguish recent from long-standing HIV infections. This test, now commercialized by two manufacturers, is being integrated into routine HIV testing services in 17 US President’s Emergency Plan for AIDS Relief (PEPFAR)-supported countries to establish a real-time HIV surveillance and response system. To that point, GHC operates in some countries where USAID does not have a presence, extending the reach of US global health programming and providing critical scientific and technical support to other agencies and interagency global health initiatives, such as PEPFAR and USAID’s NTD Program.Funded under GHC but sitting in NCEZID, the Division of Parasitic Diseases and Malaria (DPDM) works to protect Americans and those living abroad from malaria and other parasitic diseases that can cause blindness, malnutrition, and disfigurement. DPDM provides parasitic lab capabilities and scientific expertise for the United States and the world. DPDM laboratories have led to the development and implementation of a multiplex-based serologic test that allows for the detection of antibodies and numerous antigens from a single fingerstick blood sample. This multiplex serological assay facilitates integrated surveillance for parasitic and other infectious diseases and can also be used to evaluate vaccine coverage in a population. Additional funding requested in FY26 for DPDM is essential for course-correcting a long-stagnated budget and resourcing the division to manage a growing domestic and global workload supporting innovation. Not to mention, due to last year’s domestic malaria outbreak and other parasitic disease outbreaks in the United States, there has been a necessary focus on laboratory readiness and integrating genome sequencing techniques to support case investigations. This focus requires increased operational costs that must be covered in future appropriations.Beyond DPDM, NCEZID provides advanced laboratory services and molecular detection techniques that enable researchers to understand and monitor infectious diseases, identify new infectious diseases of unknown origin, and develop new diagnostic tests and other tools to combat global health challenges. For example, NCEZID developed Trioplex, a diagnostic that can differentiate between Zika, dengue, and chikungunya viruses, and supports early-stage R&D of vaccines for infectious diseases such as Nipah, dengue, Lassa fever, and Rift Valley fever, as well as CDC’s development of a new, rapid, and cost-effective test to detect the invasive malaria vector Anopheles stephensi.Additionally, the NCEZID Office of Advanced Molecular Detection uses DNA sequencing and advanced computing technologies to study infectious diseases, revealing insights about their basic biology that are critical to developing diagnostics, drugs, and vaccines. The office plays a leading role in the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria to prevent, detect, and control outbreaks of antibiotic-resistant pathogens—including drug-resistant TB—that pose a growing threat to public health. Lastly, TBTC, a collaboration between CDC and international partners, conducts research to improve TB diagnosis, management, and prevention. Even though TBTC is operated by the Division of Tuberculosis Elimination within the National Center for HIV, Viral Hepatitis, STD, and TB Prevention, a domestic CDC office, it relies on CDC’s global activities and international presence to be successful. Over 20 years, TBTC trials with more than 16,000 participants have led to new TB technologies and improved treatment guidelines, halving the duration of prevention and treatment regimens. Ongoing and planned TBTC studies will further optimize TB prevention regimens, extend their benefits to children, and help accelerate the development of the next generation of TB drugs and even shorter treatment regimens for TB. Funding for TB R&D in CDC’s domestic and global accounts and at other US agencies, including NIH, USAID, BARDA, and the Advanced Research Projects Agency for Health (ARPA-H), should be increased to reach the United States’ fair share funding target as identified at the 2023 United Nations High-Level Meeting on TB, which would amount to just 0.15 percent of US gross domestic expenditure on R&D.Investments in CDC’s global activities have a direct impact on American global health security. As health systems around the world are stretched to their limit, years of hard-won progress against persistent global health threats like HIV/AIDS, malaria, TB, and NTDs are at risk. Robust funding for all of CDC’s global health functions is essential to mitigate this damage and ultimately ensure that Americans are protected from a range of enduring and emerging health threats.NIHNIH excels at basic and early-stage biomedical research, unlocking scientific discoveries that can later be translated into lifesaving global health technologies by the private sector, nonprofits, and other US agencies. While NIH primarily facilitates basic research on global health challenges through intramural programs and external grants to universities, nonprofits, and other organizations across the United States, its ongoing investments in clinical trials for HIV/AIDS—and, increasingly, trials for malaria and TB products—also makes it one of the biggest global funders of clinical development in each of these disease areas. Maintaining the integrity of NIH's 27 institutes and centers is crucial to retaining talent, increasing momentum and trust with trial sites, and ensuring the success of ongoing, lifesaving research.Current and past NIH investments allow for nimble responses. Previous research on SARS-CoV-2 and MERS-CoV, funded by NIH, provided a foundation for quickly addressing COVID-19. Within two weeks of identifying the virus, NIH scientists understood how it enters cells; within two months, NIH developed the first COVID-19 vaccine for human trials; and within five months, the agency created a research plan and distributed more than 310 grants averaging $1.5 million each. NIH also launched two public-private partnerships—the ACTIV and Rapid Acceleration of Diagnostics initiatives—to advance COVID-19 therapeutics and diagnostics, initially funded by discretionary resources and later supported by COVID-19 relief bills. However, these emergency packages of funding hamper NIH’s capacity to continue research on the virus that causes COVID-19 and other viruses with pandemic potential. Preparation for health threats on the horizon begins with sustained funding for the health threats of today.For decades, NIH has been a driver of innovation for a range of enduring global health threats, with several institutes and centers serving as hubs for different elements of R&D. The Fogarty International Center (FIC) plays an important role in accelerating science, partnerships, and technical assistance to advance new technologies for some of the world’s most pressing health challenges. With less than one-fifth of one percent of the total NIH budget, the center delivers significant scientific returns for global and American health, forging international partnerships to facilitate truly global research. Many FIC-trained scientists now hold high-ranking academic and government positions around the world and have made critical contributions to long-standing global public health challenges, such as HIV/AIDS and emerging threats like COVID-19, Zika, and Ebola.  Ultimately, FIC investments abroad improve public health in the United States. FIC’s investments in scientific capacity globally improve our ability to detect emerging and novel disease threats sooner. The center also creates a platform for partnerships between scientists in the United States and around the world. When FIC investments lead to new tools or interventions designed for low-resource settings, these innovations can be deployed back in the United States, where they can drive down costs and improve access to health care in rural settings—an exchange known as reciprocal innovation. Progressively increasing FIC’s base budget would allow it to pursue a wider range of research priorities with extramural partners. GHTC calls for an additional $20 million to be appropriated to support sustainable growth and long-term planning in pursuit of FIC’s mission of building research capacity in partner countries.  For over six decades, most NIH funding for neglected disease R&D has flowed through the National Institute of Allergy and Infectious Diseases (NIAID), which conducts research across a range of global infectious disease threats, including HIV/AIDS, malaria, TB, NTDs, influenza, Zika, Ebola, and COVID-19. NIAID scientists, in partnership with Moderna, developed the first COVID-19 vaccine, mRNA-1273, and advanced the vaccine to human clinical trials just 65 days after the genome of the virus was shared—far quicker than any previous vaccine development timeline. Beyond COVID-19, NIAID has recently contributed to several major global health innovations:NIAID supported, through a public-private partnership, the development of an innovative, automated diagnostic for TB—the Cepheid Xpert® MTB/RIF test—which is simple to use and provides results in less than two hours. In comparison, older diagnostic methods can take several weeks. NIAID supported clinical research demonstrating that a combination of two newer drugs, bedaquiline and delamanid, could be safely taken together to treat drug-resistant TB in HIV-positive and HIV-negative individuals. NIAID supported preclinical research that contributed to the development of pretomanid, a new drug recently approved by the US Food and Drug Administration for use as part of a combination therapy for highly drug-resistant forms of TB. NIAID developed an Ebola treatment, mAb114, which was found to dramatically improve the survival rate of infected patients in a clinical trial carried out amid a recent outbreak in the Democratic Republic of the Congo. The technology underpinning this treatment has also been used in research on therapeutics for COVID-19—illustrating how continued investment in a range of global health challenges helps prime our research infrastructure and scientific knowledge base for emerging threats. NIAID established the Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern as part of the Antiviral Program for Pandemics. These centers will work with industry to study viral families with high pandemic potential, develop new drugs that target those viral families, and prepare them for use during future pandemics. NIAID and the National Institute of Child Health and Human Development have demonstrated scientific leadership to accelerate the research, development, and implementation of multipurpose prevention technologies for sexual health that are effective, affordable, acceptable, and easy to deliver. The Office of AIDS Research (OAR) has led NIH’s groundbreaking work in HIV/AIDS R&D since 1988. NIH researchers first identified the HIV virus as the cause of AIDS, developed the first blood test for HIV/AIDS, and created strategies to prevent mother-to-child transmission of the disease. One study estimated that 14.4 million life-years have been gained since 1995 through the use of HIV/AIDS therapies developed through NIH-funded research. Furthermore, the HIV Prevention Trials Network, a worldwide collaborative clinical trials network funded by NIH, is dedicated to the discovery and development of game-changing breakthroughs, including recently FDA-approved long-acting injectable cabotegravir. Today, as we seek to accelerate progress toward the end of HIV/AIDS in the United States in this decade and stem the tide of HIV/AIDS globally, continued investment in NIH’s HIV research will pay dividends by increasing the effectiveness of our prevention and treatment tools—the need for which has increased exponentially as COVID-19 has derailed global goals to end the HIV epidemic. This request is based upon the most recent analysis of need as part of OAR’s congressionally mandated fiscal year 2025 Professional Judgment Budget.GHTC supports strong, steady increases to NIH funding to enable continued progress toward vital R&D targets and vigilance in the global fights against TB, malaria, HIV, and NTDs. From any increase in overall NIH funding, there should be proportionate increases for FIC, NIAID, and OAR. ARPA-HARPA-H is designed to stimulate groundbreaking advancements in biomedical research and health care. Modeled after the Defense Advanced Research Projects Agency, ARPA-H aims to fund high-risk, high-reward projects that could lead to transformative innovations in treating diseases such as cancer, infectious diseases, and neurological disorders. By promoting collaboration across different fields and supporting innovative approaches, ARPA-H intends to speed up the development of new treatments, diagnostics, and technologies. The ultimate objective is to bridge the gap between scientific discoveries and practical applications, thereby improving health outcomes and advancing medical science.GHTC supports robust appropriations for ARPA-H given the agency’s potential to reduce health disparities and inequities in the United States and around the world—as referenced in HHS’s announcement of the establishment of the ARPA-H Health Equity, Dissemination, and Implementation Office. We encourage the administration to ensure that ARPA-H programs have global relevance, especially in areas most likely to be neglected by the market, and produce technologies that can operate in many settings, especially settings with limited resources. We also encourage ARPA-H to ensure that researchers from around the globe are able to compete for research projects to ensure that the best ideas are funded, regardless of where they originate.BARDABARDA, within the Office of the Assistant Secretary for Preparedness and Response in HHS, supports the advanced development of vaccines, drugs, and other medical countermeasures (MCMs) to protect Americans against threats to public health, including EIDs, AMR, and pandemic influenza. BARDA works with industry to bridge the “valley of death” between basic research and product development—so-called because many potential medical innovations stall after public funding for basic research drops off but before other public, private, or nonprofit R&D funders pick up later-stage product development efforts. Through unique contracting and incentive mechanisms, BARDA’s partnerships ensure promising research is translated into urgently needed medical products by creating commercial incentives for private-sector partners to invest in R&D.GHTC’s advocacy for BARDA revolves around two key priorities: to bolster EID and AMR R&D. Over the past decade—and to an unprecedented extent since the emergence of COVID-19—BARDA has played a critical role in advancing the development of MCMs for a range of health threats, including EIDs, but funding for the agency through base appropriations has not reflected this growing mandate. The Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 specifically authorized BARDA to implement “strategic initiatives” to develop MCMs against EIDs, pandemic influenza, and AMR. BARDA, however, was established in response to the anthrax attacks, and this historical legacy has bent the agency toward developing MCMs for man-made threats over naturally occurring and infectious disease threats. EIDs: Through emergency supplemental appropriations, BARDA has made a significant impact during global health emergencies. Between 2015 and 2017, BARDA helped advance at least three Ebola vaccine candidates, at least six diagnostics for Zika, and at least five Zika vaccine candidates, with 11 FDA-approved products for filoviruses like Ebola and Zika. BARDA has also worked on a broad-spectrum antiviral called galidesivir, which has the potential to treat a variety of pathogens, including Ebola, Marburg, yellow fever, and Zika, and was tested in clinical trials against COVID-19. In response to COVID-19, BARDA has supported at least 127 products, including vaccines, diagnostics, therapeutics, and devices, and devices through $25 billion in emergency supplemental funding appropriated through COVID-19 relief bills, which is more than 43 times its base fiscal year 2020 appropriation. As we have all now seen firsthand, the delay between the emergence of a health threat and the development of appropriate tools to combat it costs lives and disrupts the most fundamental functioning of our global society. We cannot let this cycle repeat itself. To fully engage BARDA’s capacity to develop tools for naturally occurring EIDs—including Disease X, pandemic influenza, pan-coronaviruses, and antimicrobial-resistant pathogens—the agency needs significant increases to its base funding for these critical challenges. The administration should propose to Congress a new annual appropriation of $775 million to grow and sustain BARDA’s work on EIDs. Creating a robust, protected funding line for this work would bolster BARDA’s capacity to support the development of MCMs for the full range of priority infectious disease threats identified by health experts as most likely to cause the next pandemic or have an impact on US health security. AMR: BARDA should also prioritize funding for tools to combat AMR. Research published in The Lancet in January 2022 estimated that in 2019, more than 1.27 million deaths could be attributed to AMR. This number is only expected to grow without greater investment in R&D and prevention. BARDA has already made significant contributions to the global effort to curb AMR, including through the founding of the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), as directed by the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria. Since 2017, CARB-X has supported 93 R&D projects in 12 countries. Of these, 18 projects have already advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Indeed, BARDA is a leader across three critical stages of R&D to combat AMR spread across three programs: preclinical research supported by CARB-X, clinical research funded through the Broad Spectrum Antimicrobials Program, and post-approval funding from the Project BioShield Special Reserve Fund.  Welcoming the renewed commitment to CARB-X of up to $300 million over ten years, GHTC recommends no less than $500 million in funding for BARDA’s work on AMR in FY26, including additional funding for CARB-X to ensure that it has adequate resources to launch new funding rounds and replenish a clinical pipeline that the World Health Organization (WHO) recently described as “insufficient” to tackle the challenge of the increasing emergence and spread of AMR. Strong funding should also be provided for late-stage AMR candidates. Both additional funding to CARB-X and strong funding for late-stage AMR candidates would be in line with US support for the 2022 G7 Health Ministers’ Communiqué on AMR.Future AMR work: To continue this progress across all BARDA programs engaged in AMR, GHTC urges that BARDA’s AMR work continue to support highly innovative new classes; new mechanisms of action; and nontraditional alternatives, including support for pediatric indications, multidrug-resistant sexually transmitted infections, and CDC’s full list of antimicrobial-resistant threats as detailed in its Antibiotic Resistance Threats in the United States, 2019 report. The latter includes drug-resistant TB, the leading cause of death globally from AMR. Progress against TB is at great risk as drug resistance grows, potentially faster than new treatments are developed. BARDA currently conducts no research on drug-resistant TB despite its repeated identification as a global health security threat by experts and as a “leading health security threat” to the United States in congressional testimony provided by CDC. Resourcing all these elements of AMR work is critical to preventing a post-antibiotic era that would threaten global health security and reverse antibiotic-dependent medical advances. DoDDoD responds to infectious diseases many Americans may never see up close—such as malaria, leishmaniasis, and cholera—but which military service personnel stationed in low- and middle-income countries are exposed to alongside local communities. The Walter Reed Army Institute of Research (WRAIR) and the Naval Medical Research Center (NMRC) contribute significantly to this mission.For instance, because service members deployed by the US military comprise most of the healthy adults traveling each year to malaria-affected regions on behalf of the US government, the US military has historically taken the primary role in the development of antimalarial drugs and an important role in malaria vaccine development. Nearly all the most effective and widely used antimalarials were developed in part by US military researchers, a remarkable accomplishment. With malaria medicines increasingly facing drug resistance, however, there is an ongoing need for medicines to evolve and for the development of an adult vaccine and single-dose preventive therapies to adequately protect deployed service members, for whom taking prophylactic drugs at regular intervals is difficult. Not to mention the prevalence of other similar pathogens like dengue reveals the need for strong investment in multiplex diagnostics—giving our service members quick diagnoses and, thus, quicker treatments.While focused on protecting and treating the US armed forces, the global health efforts of DoD and its partners include substantial R&D and infrastructure- and capacity-building programs that also benefit countries with limited health care resources and improve our diplomatic relationships with other nations. For example, a new single-dose treatment approved in 2018 for a strain of malaria that sickens around 8 million people annually—including US service members—stems from research conducted at DoD and military research centers. The world’s first malaria vaccine (RTS,S/AS01), whose development traces back to the work of WRAIR and GSK in the 1980s, has now reached more than 1 million children across three pilot countries.We strongly encourage funding for DoD’s malaria drug and vaccine development programs to continue despite recent cuts at DoD to significantly reduce and eventually eliminate malaria drug and research funding—a shortsighted move that would risk the loss of world-leading infectious disease researchers, the US government’s only bench-to-bedside malaria research capabilities, premier malaria research labs, and an insectary utilized by researchers worldwide. GHTC urges the administration to make malaria R&D for vaccines, easier-to-administer treatments, vector control, diagnostics, and other related technologies a continued DoD priority and to ensure that WRAIR and NMRC are funded for this work at no less than fiscal year 2018 levels.Malaria is not the only infectious disease threat our military faces. For instance, the DoD has historically funded leishmaniasis research. Leishmaniasis, like malaria, is a parasitic disease and is spread through the bites of small sandflies. DoD has also invested in another critical infectious disease with implications for both US military readiness and global health: HIV/AIDS. For decades, DoD has sponsored important HIV research. The US Military HIV Research Program led the first HIV vaccine clinical trial that showed a reduction in the risk of HIV infection in humans. This research holds promise for ending the HIV/AIDS epidemic at home and abroad.DoD also supports research on global health security threats. WRAIR led the first clinical trials for a Marburg vaccine developed by NIH. Marburg—a deadly cousin of Ebola—is on WHO’s list of top emerging diseases likely to cause major epidemics. Throughout the COVID-19 pandemic, as part of Operation Warp Speed (now the Countermeasures Acceleration Group), DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense and WRAIR were instrumental in advancing research on vaccine candidates. DoD’s infectious disease research must be robust. If cuts to the infectious disease research programs continue, the core capabilities of DoD’s infectious disease research labs will be weakened, and researchers will be lost. When COVID-19 emerged, DoD leveraged these labs and researchers to address the pandemic by developing a safe and effective vaccine. In the future, these labs will be needed as a warm base to quickly pivot to whatever new threats soldiers may face, but this adaptability requires consistent funding.Congress should also retain tuberculosis in their list of diseases covered by the Congressionally Directed Medical Research Program’s Peer Reviewed Medical Research Program. TB has resumed its status as the largest infectious disease killer globally after surpassing COVID-19 in 2023 and remains a significant concern for DoD because of its potential impact on our armed forces. Each year, more than 10 million people continue to fall ill with TB and an estimated 1.3 million died in 2022 from the infectious disease. Currently, 30 countries are classified as having a high TB burden by WHO based on the number of incident cases of TB and the severity of the disease (incident per capita). These countries include many in which the United States has a large military presence. Furthermore, an estimated 410,000 people developed multidrug-resistant TB in 2022, posing a growing risk to our current methods of treatment and containment.As you consider funding for DoD, we strongly recommend that you consider increases for these accounts within DoD, as well as for the Congressionally Directed Medical Research Programs, and protect agency-wide funding for global health R&D. It is critical to support infectious disease research at WRAIR, NMRC, and the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, including their work on chemoprophylaxis, disease surveillance technologies, novel vaccines, and other countermeasures for diseases of military and global health importance.

CALL TO ACTION The Future of Global Health Diplomacy in a Changing World The Power of Cohesiveness in the G7 & G20 The H20 Summit attendees and the organizers - G20&G7 Health and Development Partnership (G20&G7 HDP) - congratulate the Governments of Brazil and Italy for their inclusive approach to the health track of the 2024 G20 and G7 programs and for taking stock of existing G20 and G7 legacy health Initiatives that have been established since 2017 with health having been integrated into the G20 process. It is imperative that we maintain the continuity of these initiatives to keep health at the highest levels of policymaking to ensure our common goals are met in the long-term and aligned with the UN SDG 2030 commitments. At a time of significant economic and fiscal challenges for Governments worldwide, the G20&G7 HDP recognizes the trend in many countries to freeze and reduce investments in Global and Public Health since the COVID-19 pandemic. Therefore, it is essential to foster a wider and more integrated dialogue across many sectors of society, encouraging the creation of new partnerships at international, national, and local levels. We support the focus of the G20 this year on the social determinants of health in addressing the growing disease burden and acknowledging the climate and health nexus by building further evidence of the impacts of climate change on health. This societal approach is crucial for overcoming the global and public health challenges we face today triggered by leading infections including TB, Malaria, dengue, and HIV/AIDS, and the growing burden of noncommunicable diseases. We support the coordination of the G20 and the G20 Joint Finance and Health Taskforce (JFHTF) to enhance global and multisectoral coordination promoting initiatives to assess social, economic, and health vulnerabilities as well as response financing mechanisms while exploring innovative paths for resource mobilizations in the health sector. We support the G7 Apulia Leaders Communique that calls on strengthening the global health architecture (GHA) via a stronger pandemic preparedness and response agenda and the better integration of the One Health Approach to contain the rising level of antimicrobial resistance, representing a key global public health threat worldwide to our ecosystems. We also welcome the G7 initiative created between DFIs to build institutional capacity to ensure financing to procure, produce, and deliver for Medical Countermeasures (MCMs) in low and low-middle-income countries (MCMs). We generally welcome the G7 call on better alignment across the global health financing ecosystem in support of country-led priorities toward achieving Universal Health Coverage. While the increasing frequency of UN High-Level Meetings in global health is a positive development, with the focus in 2023 on TB, 2024 on AMR, and 2025 on NCDs, the G20&G7 HDP recognizes that the plethora of declarations from these high-level meetings is driven mainly by Ministries of Foreign Affairs. There is a need for the global health community to create a more structured dialogue with foreign ministries, in a similar way to the inclusion of finance ministries regularly in the health ecosystem. Global health governance and public policy The G20&G7 HDP therefore welcomes that a number of G20 countries have appointed global health ambassadors. Yet the G20&G7 HDP believes that for other G20+ countries appointing global health envoys or ambassadors within foreign ministries can enhance the impact of the development of clear and impactful negotiations, declarations on a multilateral level, and create a bridge between relevant ministries that make up the global health ecosystem and its challenges. Those countries that have appointed global health ambassadors, and in the case of AMR, AMR Envoys, contribute significantly to the shaping of the final drafts of heads of Government and ministerial declarations. The G20&G7 HDP strongly believes that addressing the triple planetary challenges—climate change, pollution, and biodiversity loss—requires stronger cooperation between national ministries, including health, finance, environment, and agriculture. This collaboration should be institutionalized within the “One Health” spectrum. Where Governments are adopting this cross-departmental approach, outputs are improved. If many of the health challenges facing the world today are to be addressed, and multilateral declarations fully implemented, then engaging with a wider range of cross-sectoral stakeholders both in the evolution of public policy and in the delivery of impactful initiatives is necessary and the health community needs to step out of its comfort zone and build innovative new partnerships. The G20 and G7 Presidencies offer a unique forum to provide visions, guidelines, and recommendations. However, it is essential to strategically involve and integrate non-state actors, the private sector, parliaments, influencers, patient organizations, and academia in the delivery and accountability of actionable health policies. Evidence-based policy-making We are at a golden moment for progress in science. However, bridging the gap between science and policymakers and promoting evidence-based policymaking is crucial. Evidence-based data is the foundation of all health policies, including those addressing non-communicable and infectious diseases. Strengthening health systems and achieving Universal Health Coverage requires a data-driven approach to create accountability among communities, policymakers, relevant stakeholders, and multilateral fora. Building on the momentum created through the WHO’s 2nd NCD Financing Dialogue this year and the upcoming UN High-Level Meeting on NCDs in 2025, we encourage the Presidencies to prioritize sustainable investment in healthcare infrastructure and systems to address NCDs by driving domestic resource mobilization, implementing underutilized fiscal policies, and leveraging financing. To facilitate communication between governments and investors, we propose developing a taxonomy for health that integrates within existing G20/G7 climate change taxonomy frameworks, enabled by the 2025 Presidencies of the G20 in South Africa and G7 in Canada. Regarding the 2024 UN High-Level Meeting on AMR, this is an opportunity to promote measures that bridge the gap between science and policy makers. Collection of Data on AMR needs to be improved so policy makers better understand the health burden and economic cost of AMR and Leaders can more effectively communicate its impact to the broader community. The G20&G7HDP believes that an Independent Panel on Evidence for Action against Antimicrobial Resistance established with the support of the Quadripartite organizations following appropriate consultation with all Member States on its composition, mandate, scope, and deliverables will provide Member States with regular guidance on the science, data, and evidence across all sectors related to antimicrobial resistance. Integrated accountability mechanisms within the G20 and G7 through the Legislators' framework In the international health space Parliaments are largely overlooked, yet they are the bridge between the public and their government. The G20&G7 HDP has now created with the Commonwealth and Francophone Parliamentary Associations, representing around 150 Parliaments together with the European Parliament a new structured dialogue on AMR, to hold governments not only into account on progress in tackling AMR but also bring a broader understanding of why AMR is an ecosystem challenge beyond health. This model will be used in 2025 to encourage Parliaments to look at the challenge of NCDs in preparation for the 2025 UN High-Level Meeting on NCDs. Future cross-sectoral partnerships The experience of many LMICs during the COVID pandemic has led many countries and regions to consider the benefits of local research and product development through new partnerships. This trend presents complex challenges, including around strengthening global supply chains. However, the G20&G7 HDP sees merit in building on sustainable voluntary initiatives and collaborations that aim to strengthen national, regional and global capacities and capabilities for Pandemic prevention, preparedness and response, including for existing G7/20 workstreams to accelerate research and development, enhance equitable access to medical countermeasures, and support sustainable local and regional manufacturing. The role of Multilateral Development Banks (MDBs) and Development Finance Institutes can and must play a more central role in promoting domestic initiatives to tackle both climate change and the growing disease burden. Through support for innovative financing initiatives in collaboration with other initiatives including the Japan G7 Impact Investment Initiative launched in 2023, MDBs can create an environment that will attract domestic public finance, private sector funding, and philanthropic support via blended finance initiatives. Given the challenges of climate change, sovereign indebtedness, and increasing global insecurity the G20&G7 HDP believes that countries, regional organizations, and the G20 and G7 must keep public and global health at the center of the political agenda as both and benefit for society and a valuable investment that delivers significant long term socioeconomic returns. Women’s, Maternal, and Child Health must be a permanent fixture of the G20 and G7 agendas. We must recognize that women and girls often are agents of change in society, and we need to leverage their role in program design and implementation to address specific healthcare system challenges that cover wellness, prevention, diagnosis, time to treatment, delivery pathways, and access to care across the life course. The G20&G7 Health and Development Partnership therefore calls on G20 and G7 countries to: 1. Recognize and address the disconnect between the excellent evidence-driven outputs of our health scientists and clinicians and our political leaders who shape the public policies that impact the social determinants of health. 2. Recognize that the threats of infectious diseases and non-communicable disease are heavily impacted by the social determinants of health. Therefore, this requires member states to invest in significantly improved dialogue and communication with local communities and citizens on the steps that must be taken to reduce and prevent the risks of infection, build trust, and promote behavioral change in addition to public health prevention, prioritizing sustainable investment in healthcare infrastructure and systems by driving domestic resource mobilization, implementing underutilized fiscal policies, and leveraging financing and intervention mechanisms that will help manage and prevent NCDs, including but not limited to cardiovascular disease, diabetes, and preventable cancers, including cervical cancers, as well as infectious diseases predominantly affecting LMICs such as AIDs, Tuberculosis, Malaria, and Neglected Tropical Diseases. 3. Take urgent action to build resilient and effective cross-government, cross-departmental One Health teams to ensure that national governments are equipped to comprehensively address the triple planetary challenges—climate change, pollution, and biodiversity loss—institutionalizing stronger cooperation between national ministries of health, finance, environment, and agriculture 4. Recognize that health burdens for women are systematically underestimated, with datasets that exclude or undervalue important conditions, we encourage the Presidencies to Systematically collect and analyze, ethnicity and gender-specific data to have a more accurate representation of women’s health burden and the impact of different interventions. 5. Recognize “women's health is wealth” and promote innovative financing mechanisms specifically focused on investing in women’s health at all stages of their lifecycle, including pregnancy & lactation, ensuring a wholeof-society approach. 6. Adopt the practice of an increasing number of G20+ countries of appointing global health ambassadors and AMR envoys to work with multilateral organizations such as the WHO, and the UN on promoting deeper international cooperation and sharing of practical best practices in addressing the global disease burden. 7. Recognize the central role of the WHO in global health, and in keeping with the recommendations of the Member States Working Group on Sustainable Financing adopted by the World Health Assembly, support the resource replenishment approach and the successful implementation of the WHO formal Investment Round to ensure increased, sustainable and predictable funding for the critical work of the WHO. 8. Convene a meeting of MDBs to establish a joint roadmap to fund initiatives on health - starting with new funding, incentive and lending structures to address the growing threat of AMR - developing a common taxonomy on sustainable financing for health that will help attract further investments. 9. Urge all green financing initiatives to contain a clear and meaningful public health dimension and utilize lessons learned and best practices on impact investments in global health. 10. Welcome the structured dialogue that has been created by the G20&G7HDP between the Francophone and Commonwealth Parliamentary Associations together with the European Parliament to strengthen parliamentary engagement and oversight of the outcomes of the G20 and G7 health track and the implementation of conclusions at a country level. 11. Support the establishment of the UN Independent Panel on Evidence for Action on AMR to gather and analyze data on AMR so that key decision-makers can make informed decisions based on common metrics and evidence. 12. Support the establishment of an ongoing AMR Ministerial Meeting, of which will be held in Jeddah in 2024, as a biannual meeting of ministers of Health, Agriculture, Environment and Finance to assess progress on tackling AMR and promoting the sustainable finance required to ensure access, equity, innovation, and improving antibiotic stewardship 13. Ensure that the declarations drawn up for the health track of the G20, G7, and the UN High-Level meetings are practical and actionable, joined up. Signatories Further Signatories Prof Agnes BUZYN (former French minister of Solidarity and Health) Hon. Laurent Wehrli, Chair of the Parliamentary Network to Fight HIV/AIDS, Tuberculosis and Malaria, Chair of the Education, Culture and Education Commission, Parliamentary Assembly of the Francophonie (APF), Member of the National Council of Switzerland Hon. Dr Christopher Kalila, Member of Parliament Zambia, Former Executive Committee member of the Commonwealth Parliamentary Association. Roberto Duran-Fernandez Professor at the School of Government and Public Transformation, Tecnologico de Monterrey Brian Li Han Wong- Independent Consultant Dr Kate Isoken Obayagbona (MD, MPH) Dr Emma Berntman, Senior Engagement Specialist, FAIR David Holland Senior Business Development Manager (Global) Solidsoft Mae Peri Kass, University of Virginia, Stanford University, Morgan Stanley Investment Bank

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