Search the GHTC website
June 28, 2023

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.