§7624 — Title 22 Foreign Relations and Intercourse | U.S. Code

Summary

USAID’s leader can work with public and private partners and with other international agencies to help governments in developing countries. The help must build their ability to gather evidence to decide about new vaccines (including possible HIV/AIDS, tuberculosis, and malaria vaccines if those are shown to be safe and effective), to review and run clinical trials better, and to make sure vaccine supply and delivery systems work. The United States must take part in talks to set up advance market commitments to buy future vaccines for HIV/AIDS, tuberculosis, malaria, and related diseases. The Treasury Secretary must negotiate with the World Bank, the GAVI Alliance, their member countries, and others. The Secretary must check that proposed programs have binding purchase contracts at fair prices for up to a set number of treatments; clear rules for suppliers; clear safety, effectiveness, and delivery standards; dispute resolution; and flexibility to update contracts with new information while keeping the purchase promise. No later than 1 year after July 30, 2008, the Secretary must report to Congress on these talks, and the President must have a study group write a full plan to speed vaccine development. That plan must include ways to create economic incentives for vaccine research and manufacturing, expand public‑private partnerships and shared funding, and strengthen U.S. support for clinical trials and delivery in developing countries so vaccines reach people faster.

Title 22, §7624

Foreign Relations and Intercourse — Source: USLM XML via OLRC

(a)The Administrator of the United States Agency for International Development, utilizing public-private partners, as appropriate, and working in coordination with other international development agencies, 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 HIV/AIDS, tuberculosis, and malaria vaccines, if such vaccines are determined to be safe and effective;

(2)review protocols for clinical trials and impact studies and improve the implementation of clinical trials; and

(3)ensure adequate supply chain and delivery systems.

(b)(1)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)The Secretary of the Treasury shall enter into negotiations with the appropriate officials of the International Bank of Reconstruction and Development (World Bank) and the GAVI 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)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 maximum 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 adjusted in accord with new information related to projected market size and other factors while still maintaining the purchase commitment at a fair price.

(4)Not later than 1 year after July 30, 2008—

(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 subsection; and

(B)the President shall produce a comprehensive report, written by a study group of qualified professionals from relevant Federal agencies and initiatives, nongovernmental organizations, and industry representatives, that sets forth a coordinated strategy to accelerate development of vaccines for infectious diseases, such as HIV/AIDS, malaria, and tuberculosis, which includes—

(i)initiatives to create economic incentives for the research, development, and manufacturing of vaccines for HIV/AIDS, tuberculosis, malaria, and other infectious diseases;

(ii)an expansion of public-private partnerships and the leveraging of resources from other countries and the private sector; and

(iii)efforts to maximize United States capabilities to support clinical trials of vaccines in developing countries and to address the challenges of delivering vaccines in developing countries to minimize delays in access once vaccines are available.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was enacted as part of the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, and not as part of the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 which comprises this chapter.

§7624 Facilitating Vaccine Development

Summary

Title 22, §7624

Notes & Related Subsidiaries

Editorial Notes

Citations & Metadata