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The Global Health Technologies Coalition, FIND, Medicines for Malaria Venture, IAVI, PATH, and TB Alliance welcome the establishment of the G20 Global Coalition for Local and Regional Production, Innovation and Equitable Access.We are particularly supportive of the focus on innovation to develop the missing health tools needed by some of the world’s most neglected communities—including those facing historically neglected diseases, such as leishmaniasis, Chagas disease, and dengue, as well as more common poverty-related diseases such as HIV, tuberculosis, and malaria.We are encouraged by the Coalition’s focus on strengthening local and regional production to promote more equitable access to safe, affordable, quality, and effective health products and technologies. Shifting the center of gravity of innovation, manufacturing, and production to countries and regions that carry the greatest burden of disease will help reduce disparities and build resilience into health systems. Current outbreaks like mpox highlight the need for manufacturing capacity in all regions. G20 countries are uniquely situated to mobilize the necessary scientific and financial resources to make this Coalition a success and build upon knowledge, as well as match capabilities and needs across G20 countries and other invited countries and partners.We commend Brazil for its leadership, and we urge leaders to ensure civil society and community voices have a seat at the table. Our organizations stand ready to support the Coalition.

Page 1 of 4 Dear Leaders Schumer and McConnell, Speaker Johnson, and Leader Jeffries, On behalf of the undersigned organizations, we write to urge you to include a comprehensive reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA) in a legislative package before the end of the 118th Congressional Session. The Senate and House health committees have each passed reauthorization bills that make critical improvements to our nation’s health security programs, originally authorized in PAHPA. These programs at the Department of Health and Human Services, such as the Assistant Secretary for Preparedness and Response (now the Administration for Strategic Preparedness and Response) and the Biomedical Advanced Research and Development Authority (BARDA), will be called upon to prevent, prepare for, and respond to any national health security threats. These threats—whether they emerge from advances in biotechnology and artificial intelligence, naturally occurring outbreaks, major storms, deliberate attacks, or accidents—require an agile, authorized, responsive government infrastructure. The PAHPA framework, which was originally authorized 17 years ago, expired on September 30, 2023, requiring stopgap, temporary extensions in prior continuing resolutions. However, we urge you to pass a comprehensive PAHPA reauthorization package, one that includes key new provisions that strengthen US preparedness and response capabilities, before the end of the year. The last three PAHPA reauthorization packages shared major recurring themes: they all adjusted to the changing threat landscape, focused on challenges identified since the prior bill, and strengthened our nation’s health security with each reauthorization. A new reauthorization bill would continue to do that by strengthening existing programs and continuing to adapt and improve America’s health security infrastructure for new and future challenges. Failing to reauthorize PAHPA now would have serious effects on our country’s economic wellbeing, national security, and health given the rapidly changing threat landscape. For example, Congress would leave critical preparedness programs—like the Strategic National Stockpile, medical supply chain resilience, and hospital preparedness programs—without clear direction and oversight. November 13, 2024 The Honorable Charles Schumer Majority Leader US Senate S-221 Capitol Building Washington, DC 20510 The Honorable Mike Johnson Speaker of the House US House of Representatives H-232 Capitol Building Washington, DC 20515 The Honorable Mitch McConnell Minority Leader US Senate S-230 Capitol Building Washington, DC 20510 The Honorable Hakeem Jeffries Minority Leader US House of Representatives H-204 Capitol Building Washington, DC 20515 Page 2 of 4 We are hopeful that PAHPA will remain a strong bipartisan legislative framework, as it has always been. We stand ready to assist you however we can to help get this important law reauthorized this year. Thank you for your attention to this critical matter; please contact Joel Straus at joel.straus@jhu.edu with any questions. Sincerely (in alphabetical order), 1Day Sooner Acadian Companies Adjuvant Capital, LP AdvaMed Aequor Inc. American Academy of Pediatrics American Ambulance Association American Clinical Laboratory Association American College of Emergency Physicians American College of Physicians American College of Surgeons American Lung Association American Medical Manufacturers Association (AMMA) American Public Health Association American Society for Microbiology Antheia, Inc. Arizona Bioindustry Association, Inc. (AZBio) Association of American Medical Colleges Association of Maternal & Child Health Programs Association of Public Health Laboratories Asthma and Allergy Foundation of America ATCC Atea Pharmaceuticals, Inc. Bavarian Nordic Big Cities Health Coalition BIO Biocom California BioCT BioForward Wisconsin BioNJ BioUtah BluZoneBio LLC Bugworks California Life Sciences Cencora (formerly AmerisourceBergen) Civitas Networks for Health Codagenix Colorado BioScience Association Council of State and Territorial Epidemiologists Council of State Bioscience Associations Dentec Safety Specialists Elusys Therapeutics, Inc. Emergent BioSolutions Federation of American Hospitals FluGen Inc. Genentech, a member of the Roche Group Georgetown University Georgia Bio Gerontological Society of America Global Health Investment Corporation (GHIC) Global Health Technologies Coalition GSK Page 3 of 4 Hamilton Grace LLC Harvard Kennedy School, Belfer Center for Science and International Affairs Health Industry Distributors Association Health Supply US Healthcare Distribution Alliance Healthcare Information and Management Systems Society (HIMSS) Helix, Inc. High Alert Institute, Inc. HIV Medicine Association IAVI Illinois Biotechnology Innovation Organization, iBIO Indiana Life Sciences Association Infectious Diseases Society of America Institute for Progress Johns Hopkins Center for Health Security Life Science Tennessee Life Sciences Pennsylvania Maryland Tech Council Mass General Brigham Massachusetts Biotechnology Council (MassBio) Maxter Healthcare Inc Medical Alley Medical Countermeasures Coalition Michigan Biosciences Industry Association (MichBio) Missouri Biotechnology Association Montana BioScience Alliance Mount Sinai Health System NC Life Sciences Organization Neuroene Therapeutics New Mexico Biotechnology & Biomedical Association New Orleans BioInnovation Center NewYorkBIO Ohio Life Sciences Oregon Bioscience Association Premier Inc. Public Health Accreditation Board READDI, Inc. Recce Pharmaceuticals Ltd Research!America Roche Diagnostics SAB Biotherapeutics, Inc. Sanofi Scbio Scorpius Biomanufacturing Shionogi Inc. SIGA Technologies, Inc. SoCalBio Society for Public Health Education South Dakota Biotech Association SPOC Proteomics, Inc. Texas Healthcare & Bioscience Institute Tonix Pharmaceuticals, Inc Trinity Health TrippBio, Inc. Trust for America’s Health United Safety Technology Inc. University of Nebraska System Valneva USA Vaxxas Inc VIDA

The mission of the Global Health Technologies Coalition (GHTC) is to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. The next Administration and Congress will have the opportunity to catalyze a new era of biomedical innovation through investing in the United States’ global health research and development (R&D) apparatus, which is underpinned by the lifesaving work happening at the US Agency for International Development, National Institutes of Health, Biomedical Advanced Research and Development Authority, Centers for Disease Control and Prevention, and many other government entities. This new era could tackle legacy issues of malaria, tuberculosis, and HIV/AIDS; shift the balance in the fight against antimicrobial resistance; and prepare us for new and emerging health threats at home and abroad. At this crucial pivot point, GHTC stands ready to work with decision-makers of both parties to ensure US support for global health R&D remains integral to US foreign and domestic policy. GHTC is committed to ensuring that the gains we have already made on neglected and emerging health challenges are not only sustained but also strengthened to combat a more troubling and evolving health landscape. We know strong support for global health R&D is central to our country’s national security, diplomatic efforts, and economic interests. But above all, US support to create the next generation of global health technologies saves lives and bolsters the health and well-being of everyone everywhere.  GHTC will continue to work with our more than 45 member organizations to articulate these needs to the new slate of political leaders and reinvigorate the United States’ role as a global health leader.

The Global Health Technologies Coalition (GHTC) welcomes yesterday’s G20 Health Ministers’ Declaration, as well as their Declaration on Climate Change, Health and Equity, and on One Health, which elevates the importance of investments in new tools and technologies to fight infectious diseases—work that can be broadly beneficial in confronting a wide range of health threats.It was encouraging to see G20 leaders offer such strong support to the Pandemic Fund, the intergovernmental negotiating body process on a pandemic accord, and the International Health Regulations amendments made earlier this year.   GHTC strongly supports the establishment of a Coalition for Local and Regional Production, Innovation and Equitable Access centered on voluntary cooperation to promote access to vaccines, therapeutics, diagnostics, and other health technologies for neglected and infectious diseases. We are pleased to see that the health ministerial declaration explicitly highlights the need for this coalition to promote synergies with existing and potential future initiatives and to work with a wide range of stakeholders. We appreciate that there are specific callouts supporting the efforts of several of our members and partners, including the Coalition for Epidemic Preparedness Innovations; Gavi, the Vaccine Alliance, and its African Vaccine Manufacturing Accelerator initiative; the Regionalized Vaccine Manufacturing Collaborative; the Pandemic Fund; PATH; Drugs for Neglected Diseases initiative; Stop TB; Global Fund; UNITAID; and Medicines Patent Pool.   While the creation of the coalition is an encouraging step forward, we urge G20 nations to consider additional ways to strengthen local research capacity, including through support for research and development (R&D) hubs, distributed manufacturing, and clinical trial infrastructure in low- and middle-income countries. We also would have liked to see a stronger emphasis on equity throughout the health ministerial declaration—not just in some sections—emphasizing the urgency to address the specific needs of women, children, and other underserved populations.   Beyond placing a strong focus on local production, the Brazilian G20 presidency also elevated the linkages between climate, health, and antimicrobial resistance (AMR) this year. It was encouraging to see the health equity and climate change declaration call on G20 nations to encourage and promote health R&D and stronger, more transparent partnerships between the public and the private sectors, as well as academia, affected communities, and the scientific community.   We also welcome the continued support highlighted in the health equity and climate change declaration for initiatives such as the Global AMR R&D Hub, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, the Global Antibiotic Research and Development Partnership, and the International Centre for Antimicrobial Resistance Solutions. Furthermore, we appreciate the declaration’s continued support for regional organizations that guide research, development, and strategies to accelerate new AMR health technologies and alternatives to the use of antimicrobials, promote equitable access and global stewardship, and maximize public investment returns. We are pleased that the declaration also emphasizes the importance of promoting equitable access to new tools, including through programs like the World Health Organization AWaRe classification of antibiotics.   We applaud G20 leaders for underscoring the linkages between AMR and the ongoing malaria, tuberculosis, and HIV/AIDS epidemics, stressing the need to break down silos. However, it is disappointing to see no commitments or robust support for the financing of AMR, whether through push-pull incentive models or other specific initiatives.   As always, we urge G20 members to work with civil society to push for the successful implementation of these key principles, pledges, and initiatives, and we hope that all relevant stakeholders will work diligently toward increasing access to health technologies.

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