News: Advocacy action

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! 

With G7 and G20 nations set to convene later this year under the respective presidencies of Italy and Brazil, GHTC is calling upon policymakers to robustly fund R&D partnerships for pandemic preparedness, establish a global medical countermeasures platform, support investments to strengthen local R&D capacity globally, advance R&D for key priorities like antimicrobial resistance and climate resiliency, and improve equitable access through regulatory strengthening and prioritizing the R&D needs of underserved populations. G7/G20 2024 Priorities This year’s G7 Italian and Brazilian G20 presidencies will largely continue to focus on priorities that have emerged post-COVID, including pandemic preparedness, prevention, and response and building a more fit for purpose global health architecture; strengthening local capacity, especially manufacturing; and placing a bigger emphasis on climate and health. Although the initial response to the pandemic ignited a surge in political will across all spectrums to accelerate R&D and to do so in more geographically diverse areas, challenges persist in achieving equity and access. The momentum and investment in the necessary global architecture reform and capacity building efforts are already starting to wane. At the same time, antimicrobial resistance (AMR) has been dubbed as the “silent pandemic,” creating an urgent need for R&D and the deployment of safe and innovative new antibiotics. The following are Global Health Technologies’ (GHTC) recommendations to the G7 and G20 to address these concerns.  1. Financing pandemic prevention, preparedness, and response (PPPR)Fully and sustainably finance public-private R&D and access partnerships for strategic health products crucial during a future health emergency or pandemic, including committing $80 million to FIND’s 100 Day Mission (100 DM) framework for diagnostics and $1.5 billion to fulfill the remaining financing needs for Coalition for Epidemic Preparedness’s (CEPI) 100DM strategy for vaccines, and supporting Unitaid, and others for therapeutics including oxygen therapy.Agree on a plan to fully and sustainably finance the Pandemic Fund to enable it to reach its financing target of $10.5 billion per year in response to the high need and demand for support of pandemic preparedness and prevention efforts in low- and middle-income countries (LMICs), beginning with increased support for a robust resource mobilization effort for the Pandemic Fund, to be concluded in Q4 of 2024.Develop and endorse a global pandemic response financing playbook for medical countermeasures (MCMs) access that is rapid, flexible and reflects a network of partnerships.2. Equity in healthInvest and support national and regional regulatory bodies, ensuring that quality-assured and safe products are able to reach those who need them most, especially in LMICs. Ensure that the specific end-to-end R&D needs of women, children, and other vulnerable populations are addressed, including through: Specifying target product profiles for health technologies that address the needs of vulnerable populations and investing in therapeutic formulations for children and pregnant people.Providing technical support to countries to facilitate equitable distribution and uptake of new tools through institutions such as the World Health Organization (WHO). Engaging with primary healthcare providers, communities, and civil society in the design and delivery of health technologies to ensure the interventions meet the needs and priorities of local populations 3. Increase access to medical countermeasuresEstablish and adopt an equitable end-to-end MCM platform guided by human rights principles, focusing on the needs of all, particularly those in LMICs, through sustainable financing, addressing R&D needs, and implementing mechanisms for equitable access. Facilitate collaboration with stakeholders, including the Medicines Patent Pool, to expedite licensing and technology transfer. Prioritize a patient- and human-centered approach with meaningful LMIC and regional body representation in governance. Commit to the development of a shared access framework for public R&D spending during inter-pandemic periods, in consultation with LMICs, industry, and relevant stakeholders, to include consistent clauses within funding agreements to ensure equitable, affordable access to products for LMICs at every stage of R&D. Support the coordination of vaccine manufacturing networks to service clinical trials and routine supplies in inter-pandemic and pandemic periods.Facilitate agreement between key stakeholders, countries and funders on how sustainable stockpiles of (experimental) vaccines, therapeutics, and diagnostics can be created to enable a rapid response to new outbreaks. 4. Strengthen local capacityStrengthen local capacity through support for R&D hubs, distributed manufacturing, and clinical trial infrastructure in LMICs. Support regionally-led plans for economically viable vaccine, diagnostics, therapeutics manufacturing.Manufacturing investments must be coupled with commitments by private-sector companies and governments to step up support for technology transfer, technical assistance to local manufacturers for quality systems, regulatory authorization, market entry, and workforce development so that new manufacturing capacities have the equipment, expertise, know-how, and power to produce and deliver new innovations safely and rapidly at scale.Support preferential procurement policies for regionally manufactured products from global procurers such as Gavi, Global Fund, UNICEF, and Unitaid. Promote knowledge sharing with collaborative tracking and monitoring, and enhance accountability through transparency and robust enforcement mechanisms for traceability of countermeasures.Commit to develop globally accessible online prototype libraries of diagnostics, therapeutics, and vaccines for priority viral and bacterial families, and for disease X, in coordination with the WHO’s updated priority viral family list.Accelerate clinical trials for determining product safety and effectiveness and systematically include community engagement plans in clinical study protocols.  Establish reference standards for diagnostics early in disease outbreaks and clinical trials.5. Climate and antimicrobial resistanceJoin up efforts to strengthen climate and pandemic resilience and improve health outcomes in an agenda for action and investment. Support the adoption of data-driven strategies to prevent and treat climate-sensitive (e.g. vector-borne) disease as part of measures aimed to adapt to climate change, and ensure that health tools are always available to all populations affected by climate change. Invest in R&D that integrates scientific disciplines to enhance the development of intelligently designed, quality-assured, novel and improved antimicrobials, alternative biologics, diagnostics, vaccines, and other health technologies to address drug-resistant bacterial, viral, parasitic, and fungal microorganisms. There are few new antimicrobials in clinical development and declining private investment, and we must take urgent action to support the limited pipeline for antimicrobials and new therapeutics.Increase investment into push and pull incentives with public health–driven selection criteria and strong stewardship and access requirements, in particular contributing to existing global efforts such as the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, and the Global Antibiotic Research & Development Partnership, or GARDP, at the earliest opportunity and within reasonable and feasible timelines.Provide ongoing support to the Global AMR R&D Hub in its work providing countries and investors with the latest AMR R&D landscape that helps address market gaps. The Hub should also pave the way for efficient deployment of tailor-made incentives for R&D and facilitate global discussion on priorities and opportunities for increasing investments in R&D.