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GHTC submitted written testimony to the Senate Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations subcommittee urging them to sustain and protect global health R&D funding at USAID in the FY24 budget.Global Health Technologies Coalition (GHTC) Outside Witness Testimony for the RecordSubcommittee on Labor, Health and Human Services, Education and Related AgenciesTestimony Submission by Jamie Bay Nishi, Executive Director, GHTC I am providing testimony on fiscal year 2024 (FY24) appropriations for the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA) on behalf of the Global Health Technologies Coalition (GHTC), a group of 45 nonprofit organizations, universities, and aligned businesses advancing the development of new drugs, vaccines, diagnostics, and other tools for global health and global health security.  I am testifying today because we still do not have the technologies that we need to achieve a future where pandemics are prevented, and health is within reach for everyone. In 2019, at least 1.27 million people were killed by antibacterial resistance. In 2021, 1.6 million people were killed by tuberculosis, 1.5 million people were newly diagnosed with HIV, and 247 million people were infected by malaria. Today, more than 1 billion people worldwide are still affected by neglected tropical diseases (NTDs). Unfortunately, it is women and children who are often the most vulnerable. And as we look toward the future, we cannot afford to sit idle and wait for future pandemic threats with the potential to match or exceed the disruption of COVID-19.To develop the technologies that we need to defeat these diseases and to prevent future pandemics, the US government needs to sustainably increase its investments in global health research programs. Public funding is critical for this sector because companies have little commercial incentive to invest in health areas that impact people in poverty. As the world’s leader in biomedical research, the United States has both a responsibility and an opportunity: with relatively small public investments, we have the power to save and improve millions of lives.Three agencies that support global health research are NIH, CDC, and BARDA, and we thank the Committee for its past support of these agencies. Still, there is a large hill ahead of us. To continue our progress toward developing lifesaving tools, we respectfully request:Increased funding for NIH, including an additional US$21 million for the Fogarty International Center (FIC) to a total of $116.1 million and the National Institute of Allergy and Infectious Diseases.Increased funding for CDC to maintain its capabilities in global health and global health security research, especially for the Global Health Center (GHC) and the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID). An additional $775 million in new funding for the Pandemic Preparedness and Biodefense program under the Administration for Strategic Preparedness and Response for BARDA ($400 million in the President’s Budget Request).In addition to funding, we urge the Committee to request that leaders in the Department of Health and Human Services coordinate across the department’s agencies and with the State Department to ensure that US investments in global health research are efficient, coordinated, and streamlined. NIH is a global leader in biomedical research. Within NIH, Fogarty accelerates science through international partnerships, technical assistance, and researcher trainings. The agency delivers significant scientific results and foreign goodwill with less than one-quarter of one percent of the total NIH budget. Many FIC-trained scientists have led their countries’ responses to COVID-19, Zika, and Ebola, as well as to long-standing challenges such as HIV/AIDS. Fogarty is positioned to expand its role in pandemic preparedness and global health research capacity-building. With additional funding, the center could improve global disease surveillance, coordination, and training of scientists in fields that strengthen pandemic preparedness, such as disease transmission modeling. We urge appropriators to increase FIC’s relatively modest budget by $21 million in FY24. Also within NIH, the National Institute of Allergy and Infectious Diseases is the single largest funder of research on neglected and emerging infectious diseases in the world. As it undergoes a historic leadership change, we urge Congress to include report language that emphasizes the importance of the institute’s support for global health research. CDC tracks the spread of diseases and supports the development of new global health technologies, including diagnostics and vaccines. This research happens across several centers including GHC and NCEZID. CDC has recently appointed a new deputy director for global health who will connect and oversee global health programs across the agency. CDC’s GHC leads CDC’s global health security efforts; provides technical support to the President’s Emergency Plan for AIDS Relief, the President’s Malaria Initiative, and the US Agency for International Development’s NTDs Program; and develops and validates tools such as insecticides to prevent malaria. GHC also hosts a gold-standard parasitic diseases laboratory that serves as a reference for scientists around the world. GHC needs additional funding to maintain and expand its laboratory services, expand its public health workforce, and improve its global health security efforts. Also at CDC, NCEZID develops diagnostics for global health threats and is an international reference hub for identifying and tracking known and unknown viral and bacterial diseases. The center has a leading role in the National Strategy for Combating Antibiotic-Resistant Bacteria to prevent, detect, and control outbreaks of antibiotic-resistant pathogens. BARDA sponsors the late-stage development of vaccines, drugs, diagnostics, and other medical devices for naturally occurring biothreats that lack a commercial market—including emerging infectious diseases, pandemic influenza, and antimicrobial resistance. To date, however, BARDA’s work in advancing tools for emerging infectious diseases has mostly been funded through emergency supplemental appropriations. This pattern produces a delayed response with every new outbreak of emerging or reemerging diseases like Ebola, Zika, and COVID-19. We urge Congress to break this cycle by creating a new, dedicated funding line of at least $775 million to support BARDA’s efforts against emerging infectious diseases. Such funding will enable the agency to prepare for—rather than react to—future pandemic threats.  Global health research and development is unique as a foreign policy goal in that it also supports researchers in the United States. From 2007 to 2020, more than $18 billion in federal funding went to US-based institutions for research on neglected diseases, supporting estimated hundreds of thousands of jobs and generating billions more in economic growth. In addition, many of the tools and technologies developed from this funding benefit people living in the United States either directly or indirectly by strengthening national health security and global prosperity.  As we emerge from a global pandemic subdued by publicly supported science, it is clearer than ever what we can achieve with sustained funding and attention. With increased public funding for global health research, we can achieve a world that is healthier and safer for everyone.

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 US Food and Drug administration (FDA) last week approved the first-ever vaccine for respiratory syncytial virus (RSV). GSK’s Arexvy vaccine is a single shot intended for use in adults aged 60 and older and could be available as soon as fall of this year, as long as the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices provides further approval. RSV, which has an annual global death toll of 160,000 people, has challenged vaccine researchers for six decades. Building on those years of efforts, GSK’s Arexvy showed strong results in an ongoing trial of nearly 25,000 adults. Further FDA approvals for RSVP vaccines developed by Pfizer, Moderna, and Bavarian Nordic could follow soon, with the decision on Pfizer’s candidate expected as soon as this month.Last week at the 2nd Global Forum on Childhood Pneumonia in Madrid, Spain, the Bill & Melinda Gates Foundation announced a nearly US$200 million commitment, to be awarded over the next year and a half, to support the development and delivery of affordable vaccines for some of the leading causes of childhood mortality, including pneumonia, meningitis, neonatal sepsis, and RSV. This includes supporting a more affordable next-generation pneumococcal conjugate vaccine, Pneumosil, developed by the Serum Institute of India and PATH and advancing a Group B streptococcus vaccine entering phase III trials later this year. The foundation is partnering with the companies developing these vaccines to ensure they are available and affordable to Gavi and low- and middle-income countries, therefore narrowing the gap between the rollout of vaccines in high-income and Gavi-supported countries.A new gold-standard clinical trial in Kenya showed that a single dose of the human papillomavirus (HPV) vaccine may be as effective as two or three doses over at least three years. Deploying a single-dose strategy could dramatically lower the rates of cervical cancer and other associated diseases, as well as extend vaccine supplies, lower costs, and simplify distribution, especially in low- and middle-income countries. At least 24 countries have already shifted to a one-dose approach, and this trial could make it a more widely adopted strategy, which the World Health Organization estimates could prevent 60 million cervical cancer cases and 45 million deaths worldwide over the next 100 years.

This year’s World Health Assembly represents a pivotal moment to advance policy reforms to deliver a more fit-for-purpose, equitable research and development (R&D) ecosystem. As member states consider agenda items before this year’s assembly, the Global Health Technologies Coalition urges policymakers to prioritize the following actions to accelerate global health innovation capacity:Speed implementation of the clinical trials resolution and build upon it to address gaps in accountability, equity, and data sharing. Last year’s resolution established an important framework to strengthen clinical trial capacity in low- and middle-income countries (LMICs) and improve global coordination and standardization, but the World Health Organization (WHO) and member states must act with greater urgency to develop and enact implementation plans. Additionally, countries should go beyond what is in the resolution to establish stronger mandates for trial registration and reporting, given that only half of all trial results are published. Member states must come together to address inadequacies in clinical trials data, push for more disaggregated data by sex and gender, and improve global data sharing through participation in the International Clinical Trials Registry Platform and the Global Accelerator for Paediatric Formulations. WHO should work with member states to develop updated guidance for best practices in clinical trials that address the safe inclusion of pregnant and lactating individuals in research.Adopt a more expansive diagnostics resolution that addresses all health areas and establishes stronger mechanisms to streamline regulatory pathways and improve alignment. Medicine cannot respond effectively without diagnostics, yet 47 percent of the global population has little to no access to essential diagnostic tools. While the draft diagnostics resolution before this year’s assembly is a welcome show of political commitment to strengthen the development and production of, as well as access to, diagnostics, it does not go far enough. Before adopting it, member states should pursue changes in four key areas:Expand focus on local production to go beyond pandemic preparedness to address all health areas.Add provisions to support collaborative regulatory registration and streamline the WHO prequalification program.Establish a WHO special advisor role for diagnostics coordination and an International Diagnostics Alliance to better align global efforts.Reaffirm the essential role of civil society in informing diagnostic design and development priorities.Advance a pandemic instrument that furthers inclusive innovation and strengthens end-to-end product development. The Intergovernmental Negotiating Body’s zero draft of the pandemic accord included vital provisions to bolster global R&D capacity, yet notable gaps remain. As negotiations move forward, member states should push for additional provisions that highlight the need to incentivize continuous research on medical countermeasures for diseases predominantly impacting LMICs without market incentives; strengthen the capacity of regional regulatory bodies; and improve inclusion of underrepresented populations, including women, children, and pregnant individuals, in clinical trials. WHO and member states should also push for the establishment of meaningful and substantive mechanisms for civil society to continue to inform ongoing negotiations.It is time to end the cycle of panic, neglect, and apathy. To deliver better health for all, WHO member states must take collective action now to establish more inclusive, globally distributed R&D systems and approaches.

Stakeholder Listening Session for the G7 Health Ministers' MeetingThank you for the opportunity to share the Global Health Technologies Coalition’s (GHTC’s) priorities for the upcoming Health Ministers’ meeting in Nagasaki, Japan. As the United States, other G7 countries, and additional stakeholders consider reforms to realize a more fit-for-purpose global health architecture, GHTC urges them to prioritize the following actions to strengthen research and development (R&D):To help advance the “100 Days Mission PLUS,” invest in the Coalition for Epidemic Preparedness Innovations, FIND, public health institutes, and regional manufacturing hubs, as well as scope and develop an international clinical trials network with other G7 partners for coordinated testing and enhanced global regulatory collaboration.To advance the regionally distributed development of and access to medical countermeasures, provide additional funding to the World Bank’s Pandemic Fund. To date, the fund has secured just US$1.6 billion in pledges against its $10.5 annual target.Increase investment in R&D for poverty-related and neglected diseases (PRNDs), with a specific focus on the needs of women, children, and other vulnerable populations.Work with partners to increase investments and incentives for R&D for new and improved antimicrobials, point-of-care diagnostic devices, vaccines, and other technologies required to stay ahead of the rising threat of antimicrobial resistance.Ensure that R&D is integrated into new and existing pandemic prevention, preparedness, and response mechanisms. As negotiations for the Pandemic Accord continue, the United States should push for the framework to embrace a holistic approach to supporting end-to-end product development.