Recommendations Discussed in This Chapter

Recommendation 5-1: The U.S. Global AIDS Coordinator should ensure that adequate medications are available to place 2 million people on sustained antiretroviral therapy to achieve PEPFAR’s stated 5-year treatment target. To achieve this target, the Coordinator should also ensure that adequate linkages are established among prevention, treatment, and care programs and rapidly expand the availability of antiretroviral therapy to both children and adults.

Recommendation 5-2: To support countries’ ownership of their responses to their HIV/AIDS epidemics, the U.S. Global AIDS Initiative should maintain its commitment to harmonization and participate fully in the development of harmonized procedures. To this end, the U.S. Global AIDS Coordinator should work to support World Health Organization (WHO) prequalification as the accepted global standard for assuring the quality of generic medications. Specifically, the Coordinator should provide an analysis of WHO prequalification that determines whether it can adequately assure the quality of generic antiretroviral medications for purchase under PEPFAR. If the analysis shows that WHO prequalification needs strengthening to provide a sufficient guarantee of quality for PEPFAR, the U.S. Global AIDS Initiative should work with other donors to support strengthening of the process, and work to transition from U.S. Food and Drug Administration approval to WHO prequalification as rapidly as feasible.