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PATH/Matthew Dakin
May 2, 2024

GHTC provides recommendations for World Health Assembly at HHS stakeholder listening session

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on May 2, 2024, on agenda items that will be tackled during this year’s World Health Assembly.

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Thank you for the opportunity to provide feedback on agenda items that will be tackled during this year’s World Health Assembly. GHTC urges US policymakers to prioritize the following actions to strengthen research and development (R&D) to address these urgent health challenges: On antimicrobial resistance (AMR), it is vital to bolster investments and incentives for R&D for new antimicrobials and other tools to fight AMR and to improve global surveillance and laboratory capacity. Innovations should be developed with the goal of promoting broad accessibility, including for vulnerable populations and those in low-resource settings. The United States should work with member states to support the resolution tabled under this agenda item and call for the creation of a global AMR laboratory network to strengthen diagnostic capacity. In advance of this year’s United Nations High-Level Meeting on AMR, we also urge the United States to push the relevant United Nations agencies to hold an open, inclusive consultative process to define global AMR priorities. On maternal and child health, we welcome the draft resolution and its proposed language calling for increased R&D of health tools to address the specific medical needs of women and children, which are often neglected. We urge the United States to support the ongoing work of the Global Accelerator for Paediatric Formulations Network, or GAP-f, including prioritizing R&D for priority products on the World Health Organization’s (WHO’s) Paediatric Antiretroviral Drug Optimization list. For pregnant women, we need to speed up and scale up access to preventive tools and treatments and include pregnant and lactating women in research and clinical trials to improve data quality and availability of therapeutic options. On tuberculosis (TB) and neglected tropical diseases (NTDs), we urge the United States to work with member states to substantially increase investments in R&D. To meet the goals of the Global Strategy for Tuberculosis Research and Innovation, member states must increase domestic investments in TB R&D in line with fair share targets and supercharge research efforts to develop novel vaccines, point-of-care diagnostics, and improved therapies while also ensuring tools are appropriate for all populations, including pregnant people and children. In implementing research efforts to support the NTD roadmap, member states and WHO should position impacted countries to lead in R&D priority-setting, promote South-South collaboration models, and consider the growing impact of climate change. For both TB and NTD innovations, the United States should work with WHO’s divisions on Science and Access to Medicines and Health Products, as well as member states to consider ways to better align the prequalification and regulatory approval processes to accelerate access to vaccines, diagnostics, and therapeutics.  

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PATH/Matthew Dakin
May 2, 2024

GHTC provides recommendations for World Health Assembly at HHS stakeholder listening session

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on May 2, 2024, on agenda items that will be tackled during this year’s World Health Assembly.

Read time:
Thank you for the opportunity to provide feedback on agenda items that will be tackled during this year’s World Health Assembly. GHTC urges US policymakers to prioritize the following actions to strengthen research and development (R&D) to address these urgent health challenges: On antimicrobial resistance (AMR), it is vital to bolster investments and incentives for R&D for new antimicrobials and other tools to fight AMR and to improve global surveillance and laboratory capacity. Innovations should be developed with the goal of promoting broad accessibility, including for vulnerable populations and those in low-resource settings. The United States should work with member states to support the resolution tabled under this agenda item and call for the creation of a global AMR laboratory network to strengthen diagnostic capacity. In advance of this year’s United Nations High-Level Meeting on AMR, we also urge the United States to push the relevant United Nations agencies to hold an open, inclusive consultative process to define global AMR priorities. On maternal and child health, we welcome the draft resolution and its proposed language calling for increased R&D of health tools to address the specific medical needs of women and children, which are often neglected. We urge the United States to support the ongoing work of the Global Accelerator for Paediatric Formulations Network, or GAP-f, including prioritizing R&D for priority products on the World Health Organization’s (WHO’s) Paediatric Antiretroviral Drug Optimization list. For pregnant women, we need to speed up and scale up access to preventive tools and treatments and include pregnant and lactating women in research and clinical trials to improve data quality and availability of therapeutic options. On tuberculosis (TB) and neglected tropical diseases (NTDs), we urge the United States to work with member states to substantially increase investments in R&D. To meet the goals of the Global Strategy for Tuberculosis Research and Innovation, member states must increase domestic investments in TB R&D in line with fair share targets and supercharge research efforts to develop novel vaccines, point-of-care diagnostics, and improved therapies while also ensuring tools are appropriate for all populations, including pregnant people and children. In implementing research efforts to support the NTD roadmap, member states and WHO should position impacted countries to lead in R&D priority-setting, promote South-South collaboration models, and consider the growing impact of climate change. For both TB and NTD innovations, the United States should work with WHO’s divisions on Science and Access to Medicines and Health Products, as well as member states to consider ways to better align the prequalification and regulatory approval processes to accelerate access to vaccines, diagnostics, and therapeutics.  
PATH/Christopher Nelson
April 30, 2024

GHTC sends FY25 letters to congressional appropriators

GHTC sends letters to the relevant appropriations subcommittees in the House and Senate asking them to sustain and protect global health R&D funding in the fiscal year 2025 budget.

Read time: 45 minutes
GHTC sent letters to House and Senate appropriations subcommittees: the Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS); the Subcommittee on State, Foreign Operations, and Related Programs (SFOPS); and the Subcommittee on Defense, urging these subcommittees to sustain and protect global health research and development funding in the fiscal year 2025 (FY25) budget.
PATH/Christopher Nelson
April 18, 2024

GHTC provides recommendations for G20 Health Ministers' Meeting at HHS stakeholder listening session

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on April 18 ahead of the G20 Health Ministers' Meeting in Rio de Janeiro.

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GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on April 18 ahead of the G20 Health Ministers' Meeting in Rio de Janeiro.Thank you for the opportunity to share our coalition’s priorities for the upcoming G20 Health Ministers’ meeting in Rio de Janeiro. As the United States and others consider reforms to realize a more fit-for-purpose global health architecture, the Global Health Technologies Coalition urges them to prioritize the following actions to strengthen research and development (R&D): 1. We urge the G20 countries to invest $80 million in FIND's 100 Days Mission for diagnostic and $1.5 billion to fulfill the Coalition for Epidemic Preparedness Innovations' 100 Days Mission strategy for vaccines, as well as to support Unitaid and others for therapeutics. Additionally, we appreciate US leadership in catalyzing investment in the Pandemic Fund, and we urge the US government to work with G20 countries to fully finance the institution annually at $10.5 billion, focusing on low- and middle-income countries, and to develop a global pandemic response financing playbook for flexible access to medical countermeasures. 2. We urge the United States to support national and regional regulatory bodies ensuring safe product distribution in low- and middle-income countries, invest in tailored health technologies for vulnerable populations, provide technical support for equitable distribution through organizations like the World Health Organization, and engage local communities in designing and delivering health technologies. 3. We advocate for the establishment of an inclusive medical countermeasures platform guided by human rights principles, prioritizing low- and middle-income countries through sustainable financing and equitable access.  4. To strengthen local capacity, we urge the United States to support R&D hubs, endorse regionally led manufacturing plans, and secure commitments from private sector and government for technology transfer and regulatory support.  5. To tackle climate and antimicrobial resistance (AMR), we urge the United States to invest in interdisciplinary R&D for novel antimicrobials, increase funding for push and pull incentives like the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator and the Global Antibiotic Research and Development Partnership, and facilitate global discussions on R&D priorities through the Global AMR R&D Hub. 
PATH
April 11, 2024

GHTC provides recommendations for pandemic accord at HHS stakeholder listening session

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on April 11 on the Intergovernmental Negotiating Body's pandemic accord process.

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GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on April 11 on the Intergovernmental Negotiating Body's pandemic accord process.Thank you for the opportunity to provide feedback on the pandemic accord process. I represent the Global Health Technologies Coalition, an R&D-focused advocacy coalition of more than 45 members. Given the late stage of negotiations, we want to highlight potential areas that can be enhanced in the current draft and offer small tweaks and some specific changes that we would like to see reflected in the final agreement.  Firstly, we call on the United States to consider explicit language underscoring the importance of gender equity and broader inclusion across all stages of research and development (R&D) to ensure effective pandemic prevention, preparedness, and response. While there is a strong focus on gender equity in certain parts of the current draft, we believe that this language should be reflected consistently and explicitly across all sections of the text, not just those specifically focused on equity and inclusion.  We note that in Article 9, language on equitable representation in clinical trials has been removed; GHTC recommends reinstating this language, as well as reinstating detailed language on enhancing clinical trials capacity, including for health research workforce. There should also be an explicit reference to the inclusion of underserved populations in all their diversity in clinical trials, including children and people who are pregnant or of childbearing age.  In Article 10, we urge the United States to push to expand provisions to incentivize continuous research for epidemic-prone diseases. Furthermore, we call on the United States to continue to stress the importance of equitable access to medical countermeasures and call for transparency provisions that focus on compelling the publication of license agreements to be included, particularly in Article 11.  Finally, we call on the United States to support provisions that underscore the importance of regulatory capacity, not just harmonization. Text should be added that establishes regional protocols for the regulation of products during health emergencies. The current draft only focuses on licensing of pandemic products without considering broader elements of the regulatory ecosystem. In addition, we emphasize the need for greater coordination between regulatory authorities and ethics committees for clinical trials and highlight the pivotal role of the World Health Organization in coordinating research efforts and defining research priorities.  Thank you for your consideration, and good luck in the final stretch of negotiations! 
US Department of State
March 29, 2024

GHTC welcomes WHO move to parallel processes for product review pathways and use recommendations for health products

GHTC welcomes the World Health Organization's (WHO's) newly announced plans to parallel the processes of prequalification and/or Emergency Use Listing assessments and recommendations on product use to expedite access to health products.

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GHTC welcomes the recent announcement by the World Health Organization (WHO) that it will apply parallel, rather than sequential, processes in developing guidelines recommending the use of novel health products and certifying their safety and efficacy via prequalification (PQ) and/or Emergency Use Listing (EUL). Many of our members and partners have highlighted how the prior procedure, which required guidelines to be in place as a prerequisite to EUL or PQ, was a major bottleneck for innovative products—adding significantly to approval timelines and delaying access to critical new health technologies in low- and middle-income countries.We believe that this new parallel process, which was first trialed during the pandemic for COVID-19 products, could significantly improve and accelerate access to vital innovative health technologies in countries that rely on WHO recommendations for the use of these products. We urge WHO to provide additional details on the implementation of this new process and encourage the PQ program to provide a platform for continued feedback and input from key stakeholders, including product developers, national regulators, procurers, and civil society.We believe that WHO’s PQ program continues to be an essential link in the regulatory ecosystem, and we hope this is just one of several steps WHO will take to reduce bottlenecks and improve the program’s efficiency and impact.