News

Executive Director of the Global Health Technologies Coalition (GHTC) Dr. Kristie Mikus issued the following statement following the Senate Committee on Appropriations’ passage of the fiscal year 2025 (FY25) State, Foreign Operations, and Related Programs (SFOPS) bill:GHTC applauds the work of Senators Chris Coons (D-DE) and Lindsey Graham (R-SC), Chair and Ranking Member of the Senate Appropriations SFOPS Subcommittee, and Senators Patty Murray (D-WA) and Susan Collins (R-ME), Chair and Ranking Member of the full Senate Committee on Appropriations, for ensuring critical funding for US global health programs under increased fiscal pressure.  We especially thank Senate appropriators for including language in the Senate’s FY25 SFOPS appropriations report recognizing the importance of funding for global health research and development (R&D) and directing the US Agency for International Development (USAID) to examine the feasibility of creating a new dedicated global health R&D budget line.  This language is an important step toward realizing a GHTC-led proposal to create a Supporting Innovative Global Health Technologies (SIGHT) Fund—a flexible, disease-agnostic fund to be housed at USAID that would infuse new funding into R&D efforts to close the biggest gaps in our global health toolkit.R&D partnerships led by USAID have been instrumental in saving and improving millions of lives around the world while at the same time protecting the health of Americans and stimulating jobs here in the United States. US investments in global health R&D have infused $104 billion into the US economy and created more than 600,000 US jobs since 2007.  Appropriating dedicated global health R&D funds at USAID, to be implemented via a program like the SIGHT Fund, would intensify this tremendous impact and offer significant advantages over funding R&D solely through health-area-specific funding streams. It would ensure a strategic focus on innovation by reducing the trade-off between funding the implementation of existing tools and developing new and improved ones, as well as preserve the effectiveness of ongoing programs, enhance accountability, encourage risk-taking and partnerships, and strengthen the global health infrastructure for future challenges.    As the SIGHT Act (H.R. 6424)—legislation that would authorize the creation of a new global health R&D budget line—works its way through Congress in parallel, we are encouraged to see the Senate FY25 SFOPS report lay the groundwork for the incoming president to request—and Congress to appropriate—disease-agnostic funds specifically for global health R&D that are distinct from and do not compete directly with funding for program implementation or any other purpose.  GHTC calls on appropriators and authorizers in the House and Senate to build on this momentum and support USAID's global health R&D mandate by advancing the SIGHT Fund's mission in this and the next Congress. By committing to dedicated R&D funding, Congress can empower USAID to make groundbreaking advances in global health that could save millions of lives and improve health outcomes worldwide.   

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. The Africa Centres for Disease Control and Prevention (Africa CDC) is expected to declare its first-ever “public health emergency of continental security” as the mpox outbreak in sub-Saharan Africa continues to grow—with 14,000 cases and 511 deaths reported so far—and spread to countries that had never previously identified cases. The decision, a direct response to the global inequity faced by Africa during the COVID-19 pandemic, aims to mobilize international support and vaccine donations. Africa CDC has said that the need for vaccines greatly exceeds what is available and what many African countries can afford, with a costly price tag for the currently available vaccine. The United States has pledged almost $424 million to the Democratic Republic of Congo, where the outbreak started, as well as $10 million for the mpox response and 5,000 mpox vaccine doses. Japan, the European Union, and vaccine manufacturers are also preparing vaccine donations. World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus announced last week that he will convene an emergency panel of experts to advise him on whether to declare the outbreak a global health emergency, which would garner even more attention and international support.Phylex Biosciences recently published the preliminary findings from an immunogenicity study conducted in collaboration with scientists from the US Centers for Disease Control and Prevention that showed promising results for a new mRNA nanoparticle vaccine against Nipah virus, a serious zoonotic disease that has an estimated case fatality rate between 40 and 75 percent. There is no preventive vaccine available for Nipah. The study found that the vaccine elicited a robust neutralizing response and confirmed the advantages of using mRNA and a nanoparticle, which allow, respectively, for quicker manufacturing and development timelines and efficacy after one dose. The company will next pursue clinical development for the vaccine candidate.Last week, WHO called for greater coordination on policies to strengthen the antibacterial pipeline as the global challenge of drug resistance, which disproportionately impacts low- and middle-income countries (LMICs), continues to rise. WHO highlighted the insufficient number of antibiotic candidates and limited innovative products in the fragile R&D antibacterial pipeline, as well as the lack of products in clinical development that address the evolving mechanisms of drug resistance, use oral formulations, and are formulated for infants and newborns, pointing to persistent R&D challenges like the dominance of small, resource-limited biotechnology companies in the sector. At the highest level, WHO called for greater global coordination and cooperation to improve data collection and sharing and ensure that efforts to boost R&D address the needs of underserved populations and LMICs. Specifically, WHO called on governments to provide adequate resources and incentives to boost the antibiotic R&D pipeline by addressing the needs of the small companies that dominate the sector and strengthening the capacity of the scientific communities and drug developers in LMICs.

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

GHTC responded to a request for information (RFI) from Representatives Larry Bucshon (IN-08) and Diana DeGette (CO-01) on what Congress can do to bring about a next generation of treatments through the Next-Generation Cures Bill with the below response, urging decision-makers to be bold in the legislation and expand the aperture of innovation to include global health technologies for low-resource settings.To the attention of:Representatives Larry Bucshon and Diana DeGetteWe write to you today representing 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. Thank you for the opportunity to contribute GHTC’s thoughts and perspectives to the Next-Generation Cures Bill. The 21st Century Cures Act’s legacy and the ideas-turned-legislation from the Cures 2.0 bill have accelerated the global health research and development (R&D) community’s success and provided the United States and the world with critical biomedical innovations. According to a recent report published by GHTC and our partners at Policy Cures Research, US investments in global health R&D have a remarkable return on investment and, over the past 16 years, have generated $104 billion in the economy and added more than 600,000 jobs to the US workforce. We strongly urge you and your fellow members of Congress to ensure that any legislation that tackles biomedical research should include reference to and encourage funding for global health R&D to mitigate health threats of the past, present, and future.Today, we recommend the following key priority areas for consideration for the Next-Generation Cures Act and offer ourselves as a resource as you develop this future landmark legislation:1. Strengthening ARPA-H’s mandate for global health.The Advanced Research Projects Agency for Health (ARPA-H) is a crowning achievement of the push for Cures 2.0 and one that GHTC is a vocal supporter of. GHTC would like to see the Office of International Affairs at ARPA-H empowered to address global health challenges like neglected diseases, emerging infectious diseases, antimicrobial resistance (AMR), and other health threats using the same novel approach ARPA-H is known for. High-risk, high-reward or fail-fast innovation in global health R&D is necessary to create new technologies for low-resourced communities worldwide. Innovation for low-resourced communities in global health could provide benefits for low-resourced settings in the United States. 2. Including PASTEUR (Sec. 105 of Cures 2.0) into the Next-Generation Cures Act.The Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act would create a program in the Department of Health and Human Services to incentivize the development of new drugs to address AMR through a subscription-based payment model.Since this was a past priority of Cures 2.0, it should be included in the Next-Generation Cures Act. 3. Including other bills with no clear paths to passage into the legislation.The bipartisan Supporting Innovative Global Health Technologies (SIGHT) Act is a piece of legislation that could use a powerful vehicle like the Next-Generation Cures Act to get it across the finish line. The SIGHT Act would create a distinct program and budget line for health R&D at the US Agency for International Development, establish a new leadership role and advisory council to guide investments, grant the agency authority to provide research awards, and mandate annual reporting on health R&D investments and results. This bill would transform our global health toolbox of the future and is worth considering for Next-Generation Cures.4. Prioritize transparency and authorize loan authorities at BARDA.The Biomedical Advanced Research and Development Authority (BARDA) is a critical federal agency for biomedical innovation, and greater transparency will assist innovators in understanding what has already been developed and what is still needed. Previously, BARDA has responded to requests to publicly report on its investments, providing valuable information to innovators and stakeholders that engage with the agency and invest in medical countermeasure development. This reporting should be used for all BARDA investments, including chemical, biological, radiological, and nuclear; emerging infectious disease; and AMR countermeasures. This transparency is important for oversight, reduces duplication, and promotes collaboration and coordination with other federal agencies and external partners engaged in global health security research. Additionally, BARDA needs a mechanism to support the finance of large-scale projects that could better prepare the United States and the world for future biological threats. With loan authorities, BARDA would be capable of supporting projects like innovative biomanufacturing facilities, such as microneedle patch vaccines.5. Prioritize deliverability and applicability of all global health technologies for use in low-resource settings.The deliverability and administration of new medical countermeasures are often blocked by the constraints of low-resource settings in the United States and abroad, where there is limited or inconsistent access to refrigeration, sanitation, electricity, highly trained health care workers, laboratories, and/or other resources. These constraints impeded the global deliverability of first-generation COVID-19 vaccines and therapeutics. Operation Warp Speed was successful at quickly developing safe and effective vaccines, but its leadership told GHTC that deliverability for low-resource settings was not being considered in vaccine portfolio decisions. We should learn from our past mistakes and, across the innovation ecosystem, ensure technologies that can be used for global health challenges are designed for low-resource settings.6. Encourage growth and strengthening of global health innovation at CDC.The Centers for Disease Control and Prevention (CDC), through their work in the National Center for Emerging and Zoonotic Infectious Diseases and the Global Health Center, are on the front lines of the next pandemic. By strengthening their mandates for innovation and R&D, the Next-Generation Cures Bill would be an investment in our global health security because of the important work these institutes conduct in surveillance, diagnostics, and delivery. Investments in strengthening the coordination that the Global Health Center conducts are integral to our pandemic preparedness.Investing and bolstering our global health R&D ecosystem across the US government leads to lives saved, jobs created, and economies strengthened. The global health security of the United States depends on other countries' capacity to fight against endemic diseases and quickly respond to outbreaks. The technologies we pioneer and fund with US dollars fortify our global defenses in preparation for those threats of yesterday, today, and tomorrow. By being bold in the Next-Generation Cures Bill and expanding the aperture of innovation to include global health technologies for low-resource settings, we can fight the world’s most pressing health challenges, maintain US leadership in global health diplomacy, and keep our country safe.Sincerely,Alex LongPolicy and Advocacy OfficerGlobal Health Technologies Coalition (GHTC)