12 2 STA T . 2 94 4 PUBLIC LA W 11 0– 29 3—J UL Y 30 , 200 8(B)byinsert in go r ‘ ‘or se c tion 903 o f t h e F oreign S er v ice A ct of 1 9 8 0( 2 2 U. S. C . 4 083) ’ ’ a fter ‘‘Co d e’’. SEC.206 . FA C IL I T ATI NGV ACCINE D EVEL OPM ENT. (a) TECHNI C AL A S SIS T ANCE FORD E V ELO P IN G CO U NTRIES. — The Ad m inistrator of the United States Agency for I nternationa l Develo p ment ,u tili z ing public - private partners, as appropriate, and w or k ing in coordination with other international development agen- cies, is authorized to strengthen the capacity of developing countries’ governmental institutions to— (1) collect evidence for informed decision-making and introduction of new vaccines, including potential H I V/ AIDS, tuberculosis, and malaria vaccines, if such vaccines are deter- mined to be safe and effective
(2) review protocols for clinical trials and impact studies and improve the implementation of clinical trials; and (3) ensure ade q uate supply chain and delivery systems. (b) A D VANCED M AR K ET CO M MITMENTS.— (1) P URPOSE.—The purpose of this subsection is to improve global health by requiring the United States to participate in negotiations for advance market commitments for the development of future vaccines, including potential vaccines for HIV/AIDS, tuberculosis, and malaria. (2) N EGOTIATION RE Q UIREMENT.—The Secretary of the Treasury shall enter into negotiations with the appropriate officials of the International Bank of R econstruction and Development ( W orld Bank) and the G AVI Alliance, the member nations of such entities, and other interested parties to establish advanced market commitments to purchase vaccines to combat HIV/AIDS, tuberculosis, malaria, and other related infectious diseases. (3) REQUIREMENTS.—In negotiating the United States participation in programs for advanced market commitments, the Secretary of the Treasury shall take into account whether programs for advance market commitments include— (A) legally binding contracts for product purchase that include a fair market price for up to a ma x imum number of treatments, creating a strong market incentive; (B) clearly defined and transparent rules of program participation for qualified developers and suppliers of the product; (C) clearly defined requirements for eligible vaccines to ensure that they are safe and effective and can be delivered in developing country contexts; (D) dispute settlement mechanisms; and ( E ) sufficient flexibility to enable the contracts to be ad j usted in accord with new information related to pro- jected market size and other factors while still maintaining the purchase commitment at a fair price. (4) REPORT.—Not later than 1 year after the date of the enactment of this Act— (A) the Secretary of the Treasury shall submit a report to the appropriate congressional committees on the status of the United States negotiations to participate in programs for the advanced market commitments under this sub- section; and Deadlin e .2 2 USC76 2 4 .
�
