Ensuring US support for global health innovation during political transition

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 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.