News: Announcement

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on June 28, 2023 on the zero draft of the Intergovernmental Negotiating Body's zero draft of a pandemic accord.The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, particularly leadership from the Departments of Health & Human Services and State, for providing this consultative opportunity to comment on the ongoing Intergovernmental Negotiating Body process and highlight that our focus remains the innovation of and equitable access to health tools, thereby strengthening the world’s capacities for preventing, preparing for, responding to, and recovering from pandemics.We call on the United States to consider explicit language in the draft that highlights the need for interconnectedness between health system strengthening and pandemic preparedness and includes provisions that underscore the need to focus on sustainability and dual use when it comes to research and development. We note that Article 9 currently does not cover incentivizing continuous research to develop vaccines, diagnostics, therapeutics, and other health technologies for diseases that cause outbreaks primarily in lower- and middle-income countries but are not profitable for manufacturers to produce, such as those for cholera, Ebola/Marburg fever, and other neglected tropical diseases. Continuous research can accelerate the development of medical countermeasures for novel pathogens, as was the case when research on an mRNA vaccine for HIV helped to speed up the development of the COVID-19 vaccine. A provision should be added for supporting such research.Article 9 also outlines important principles of an effective and equitable system for developing the research base needed to accelerate the production of pandemic countermeasures; however, the latest draft does not currently include provisions for accountability of these principles. As an example, there should 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 child-bearing age. GHTC would also appreciate more clarity on whether the newly proposed medical countermeasures platform could eventually fit into this space.We also urge the United States to support provisions strengthening the capacity of regional regulatory bodies, like the newly formed African Medicines Agency. Investing in the regulatory capacity, and not just harmonization, of these regional bodies will help fill gaps for countries with lower regulatory maturity levels. There is a need to include text that establishes national and regional policies or protocols for the regulation of products during health emergencies. Currently, the draft only highlights general regulatory harmonization and focuses on the licensing of pandemic products without taking into account broader elements of the regulatory ecosystem.

GHTC submitted the following intervention at a US Department of Health and Human Services (HHS) listening session held on June 20, 2023 on the amendment process for the International Health Regulations (IHR).The Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, particularly leadership from the Departments of Health & Human Services and State, for providing this consultative opportunity to comment on the ongoing International Health Regulations (IHR) amendment process. GHTC supports the ongoing negotiations of the Working Group on Amendments to the International Health Regulations (WGIHR) as it continues to advance discussions of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies.  These negotiations must be inclusive and transparent and must find ways to meaningfully engage a broad spectrum of stakeholders to ensure a successful outcome. We would encourage the United States to use its voice as a member state to ensure that non-state actors can engage in these processes and have the opportunity to provide their technical expertise.We also wish to stress the importance of embedding research as a core pillar of health preparedness and that capacity-building assessments must reflect the essential role that research and development plays in responding to pandemics. While some progress was made in the latest version of the Joint External Evaluation (JEE), including adding a specific indicator to measure research and development with a particular focus on implementation research, the United States should push the World Health Organization (WHO) and other member states to also consider further revisions or expansion of the JEE to better reflect a range of health preparedness requirements, including the ability to develop and manufacture medical countermeasures, as well as regulatory indicators that assess capacity to rapidly approve new health technologies. Meaningful end-to-end development of medical countermeasures only happens when research, manufacturing, and regulatory capacities can come together.The United States must also underscore its commitment to the Global Health Security Agenda (GHSA) and work with partners to ensure that the framework can continue to play an important role in IHR implementation. GHSA has offered a unique and valued platform to drive country ownership, multisectoral cooperation, and innovation for health security, and a new framework that is built with the changing global health architecture in mind, including a stronger focus on research coordination, as well as clinical trial, regulatory, and manufacturing capacities in lower- and middle-income countries, should be a key focus for the working group.While not every country needs a full suite of capabilities for the end-to-end development of vaccines, diagnostics, therapeutics, and other technologies, like personal protective equipment and oxygen therapies, through manufacturing, every country should have a plan and pathway to gain access to these tools at an affordable price when needed.

The Global Health Technologies Coalition (GHTC) welcomes commitments by G7 nations to advancing health research and development (R&D) included in the G7 Hiroshima Leaders’ Communiqué. R&D has long been the bedrock of progress in global health—from driving the near eradication of polio to dramatically extending the lives of those living with HIV/AIDS to changing the course of the COVID-19 pandemic. Yet sustained commitment is needed to deliver next generation innovations for enduring and emerging threats that are affordable and accessible to all people worldwide.That is why we are pleased to see G7 leaders reiterate support for strengthening the R&D of medical countermeasures (MCMs)—in line with the 100 Days Mission to reduce the impact of future pandemics by developing MCMs within 100 days—and commit to enhancing equitable access to MCMs by supporting diversified manufacturing and the launch of a new MCM delivery partnership. We also welcome their acknowledgement of the need to increase contributions to the World Bank Pandemic Fund and advance a new surge financing framework for future pandemics, both of which are urgently needed to unlock resources to strengthen R&D capacities in low- and middle-income countries and advance a sustainable end-to-end MCM R&D ecosystem. Given the setbacks in global health caused by the COVID-19 pandemic and the rising threat of antimicrobial resistance, we are also encouraged to see leaders commit to spearheading research to tackle enduring challenges like HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases and implementing push and pull incentives to accelerate the R&D of antimicrobials.While we applaud G7 leaders for this timely recognition of the critical role of R&D in driving global health progress and preventing pandemics, we now call on them to match this rhetoric with tangible policies and financial pledges to translate these commitments into reality.

The Global Health Technologies Coalition (GHTC) is greatly encouraged that yesterday’s G7 Nagasaki Health Ministers’ Communiqué contains strong support for investing in research and development (R&D) initiatives to strengthen pandemic preparedness, combat antimicrobial resistance, and address long-standing global health challenges.The COVID-19 pandemic underscored how vital the R&D of medical countermeasures (MCMs) is to addressing pandemic threats but also revealed systematic gaps in our ability to provide equitable access to the resulting tools. Thus, we applaud the G7’s support for developing an end-to-end MCM ecosystem and delivery partnership to coordinate the rapid development of and facilitate equitable, timely, and affordable global access to health tools during emergencies. We are also pleased to see the ministers voice continued commitment to the 100 Days Mission to reduce the impact of future pandemics by developing MCMs within 100 days and their recognition of the need to support regional bodies and low- and middle-income countries (LMICs) in strengthening R&D, clinical trial, and production capabilities. Additionally, we welcome the commitment to addressing the financing gaps of the World Bank Pandemic Fund, which has secured just US$1.6 billion in pledges against its $10.5 billion annual target, as it could prove a powerful new financial instrument to strengthen R&D and regulatory capacities in LMICs. Finally, we were encouraged to see leaders reaffirm the G7’s target of supporting at least 100 LMICs in implementing the core capacities required in the International Health Regulations for another five years until 2027, as committed in 2022, and underscore the need to strengthen existing institutions for capacity-building, including the Global Health Security Agenda.Given the COVID-19 pandemic has diverted critical resources and attention away from battles against other long-standing global health challenges, GHTC welcomes the G7’s support for investing in the development and adoption of innovative technologies for HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as R&D for new antimicrobials, including contributing to existing global pooled efforts, such as the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, the Global Antibiotic Research and Development Partnership, and SECURE. However, we are disappointed G7 leaders failed to acknowledge the importance of strengthening the end-to-end ecosystem for poverty-related and neglected diseases and recognize more explicit linkages for dual-use capacity-building for both pandemic preparedness and ongoing health threats. Through yesterday’s communiqué, the G7 Health Ministers are sending an important signal that R&D continues to be critical for driving solutions to enduring and emerging threats. We now look to G7 nations to match this rhetoric with tangible policies and financial commitments to truly deliver a more resilient and equitable R&D ecosystem.