GHTC statement for HHS Stakeholder Listening Session for the G7 Health Ministers’ Meeting

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.

GHTC Statement for HHS Stakeholder Listening Session in preparation for the 76th World Health Assembly – Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordinationLast year’s clinical trial resolution was a major milestone for building greater clinical trial capacity in low- and middle-income countries (LMICs), and we appreciate the United States’ leadership in pushing for strong language for facilitating greater clinical trial coordination. However, implementation is still slow and ongoing, and there are several areas where the resolution could have gone further to address the public health needs of LMICs and support the needs of vulnerable populations.We therefore urge the United States to consider the following as member states continue to implement the agreed-upon recommendations and commitments made at the World Health Assembly last year:The resolution should have included stronger mandates for trial registration. Despite the World Health Organization’s (WHO’s) recommendations that all trials are registered, around half of all trial results are never published.The resolution underscores the need to better ensure clinical trials are targeted at treatments for diseases of global, regional, and national importance, but it does not outline what these are or how they can be identified. This should be addressed as the implementation framework is developed.We call on the United States to elevate the Global Health Security Agenda as a platform where LMICs can highlight bottlenecks, share best practices, and align around clinical trial and research and development capacity assessment needs.We would welcome a continued push by the United States for WHO and member states to address the inadequate reporting of data disaggregated by sex and gender relating to WHO’s priority pathogens, such as those for neglected tropical diseases and in WHO’s R&D Blueprint, as well as for new antibiotics for highly resistant pathogens.To fill gender equity gaps in research and better meet the health needs of these neglected populations, we encourage the United States to align with other member states to ensure WHO’s guidance on best practices for clinical trials is specifically focused on protecting persons of childbearing potential through and not from research, including during pregnancy and lactation. Lastly, we urge the United States to support the Global Accelerator for Paediatric Formulations and the WHO International Clinical Trial Registry Platform through data sharing and technical support.