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The Global Health Technologies Coalition (GHTC) today released recommendations to Congress and the Obama Administration to ensure that the United States maximizes its investment in global health and continues as a leader in global health research and development. The recommendations are contained in GHTC’s first annual policy report, Innovation in Action: Policies to Promote Development and Delivery of Global Health Tools.

The report makes recommendations in public financing, regulatory pathways, and incentives and innovative financing, including the recommendations below.

Public financing

Include research and product innovation as a key component of the overall US global health strategy, including the president’s new Global Health Initiative. A commitment to global health research and product innovation should be included as a priority in all US global health efforts and should be seen as complementary to existing programs.

Increase US funding for and coordination of global health research to develop new tools. Policymakers should ensure that funding for global health research and development meets the needs of US agencies to carry out product development. Sufficient funding is needed for agencies such as the US Centers for Disease Control and Prevention, US Food and Drug Administration (FDA), Department of Defense, National Institutes of Health, and US Agency for International Development (USAID).

Bolster documentation of US investments in global health research and development. US contributions to global health research and development are significant, but it has historically been challenging to determine the full breadth of this investment. Congress should commission a Congressional Research Service report to examine US government funding for global health research and development. The Administration should request that USAID develop a six-year strategy for research and development, to begin when the agency’s current strategy expires, and that USAID produce annual reports on the progress of this strategy.

Regulatory systems

Ensure timely implementation of recommendations from new FDA review groups. Congress should ensure that new, congressionally authorized groups—mandated to review and make recommendations on review processes for products addressing rare and neglected diseases—are convened in a timely manner. In addition, Congress should allocate sufficient resources to the FDA to ensure that recommendations are submitted and implemented in a swift timeframe.

Pursue stronger partnerships between the United States and global regulatory stakeholders. The United States should increasingly collaborate with the World Health Organization and national regulatory authorities to accelerate access to global health products. Congress should allocate adequate financial and political support to the FDA and USAID so that they can offer regulatory assistance, where appropriate.

Strengthen the FDA’s engagement with other agencies and product developers. The FDA should increase its collaboration with other US government agencies that conduct research and development of global health tools. An initial step in this direction would be to include the FDA in existing and future interagency global health committees.

Expand membership in FDA advisory committees to include developing-country representatives. Advisory committees within the FDA provide important expertise and guidance to agency centers on scientific decisions, as well as on safety and efficacy evaluations of new products. These committees could benefit from developing-country perspectives when reviewing products intended for the developing world.

Incentives and innovative financing mechanisms

Form a cross-agency working group to explore US participation in a portfolio of incentives and innovative financing mechanisms. This group should consider adopting a set of criteria to use when evaluating the role of the United States in supporting specific mechanisms. These criteria should be applied to the evaluation of multiple mechanisms with the goal of supporting one or two new mechanisms in 2011.

Ensure that a vigorous assessment is conducted of each incentive mechanism in which the United States invests. During and following implementation of an incentive mechanism or innovative financing strategy, US policymakers should ensure that a robust assessment takes place to monitor effectiveness and impact of the mechanism.

Support US involvement with the Leading Group on Innovative Financing for Development and other international groups working on financing for health. US involvement should eventually lead to the nation’s participation in future innovative financing mechanisms, such as an advance market commitment (AMC). As directed by the Lantos-Hyde Act, the US government should consider participating in future negotiations for AMCs and other financing mechanisms for new vaccines.

About the GHTC

Housed at PATH and funded by the Bill & Melinda Gates Foundation, the Global Health Technologies Coalition includes more than 30 organizations advocating for research and development of tools to prevent, diagnose, and treat global diseases so health solutions are available when populations need them.

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