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GHTC statement for WHA HHS Stakeholder Listening Session on clinical trials resolution implementation

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PATH/Matthew Dakin
May 3, 2023

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 coordination

Last 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
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GHTC statement for HHS Stakeholder Listening Session for the G7 Health Ministers’ Meeting

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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.
PATH/Georgina Goodwin
May 3, 2023

GHTC statement for WHA HHS Stakeholder Listening Session on diagnostics resolution

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GHTC Statement for HHS Stakeholder Listening Session in preparation for the 76th World Health Assembly – Strengthening Diagnostics CapacityThe COVID-19 pandemic has highlighted the centrality of access to diagnostics as a key component of detecting and controlling emerging infectious diseases. Simply put, medicine cannot respond effectively without diagnostics. Yet a recent study from The Lancet highlighted that 47 percent of the global population has little to no access to these critical health tools. The United States must continue to show strong leadership and work with the World Health Organization (WHO) and other member states to address the diagnostics gap.The WHO resolution is a good first step in acknowledging and addressing the gap in political prioritization, and we urge the United States to consider the following:We urge the United States to push for a special advisor to serve as a senior central point of contact at WHO for diagnostics to ensure internal alignment and push for greater strategic prioritization through a potential “International Diagnostics Alliance.”Additional provisions should be added to the resolution to strengthen regulatory mechanisms like collaborative registration, which help expedite access to new diagnostics, especially in lower- and middle-income countries (LMICs).The resolution recognizes the importance of strengthening local production capacity of diagnostics in LMICs as a critical enabler of universal health coverage. However, strengthening local production should not be limited to pandemic preparedness. We, therefore, call on the United States to support investment in the production of diagnostics for all health areas, in particular recognizing that significant gaps remain for poverty-related and neglected diseases.Diagnostic procurement also remains significantly underfunded, and improved coordination across stakeholders—including donors and global, regional, and national procurement mechanisms—is needed to fill gaps and ensure all populations have access to critical diagnostics.Lastly, the resolution should reaffirm the essential role played by civil society in defining, developing, and deploying better diagnostics.