ALLcrimesfood&drugstaxestelecomcommercehealthconservationtransportationagricultureveteransbrowse all titles »
0

22 U.S.C. § 7624Facilitating vaccine development

submitted 18 years ago by Pub. L. 110-293 to r/title-22-FOREIGN-RELATIONS-AND-INTERCOURSE · 504 words · no verdicts yet

in plain englishAI-generated · not legal advice

USAID can help developing countries build the skills to test and roll out new vaccines, including for HIV/AIDS, tuberculosis, and malaria. The Treasury Department must also negotiate deals with the World Bank and other groups to guarantee future vaccine purchases. Both agencies must report to Congress on their progress.

(a) Technical assistance for developing countries. USAID's Administrator, using public-private partnerships where useful and coordinating with other international development agencies, is authorized to help developing-country governments (1) gather evidence to make good decisions about rolling out new vaccines — including possible HIV/AIDS, tuberculosis, or malaria vaccines, once those vaccines are proven safe and effective; (2) review clinical trial and impact-study protocols and run better clinical trials; and (3) build reliable supply chains and delivery systems for vaccines. (b) Advance market commitments. (1) Purpose: this subsection aims to improve global health by requiring the US to help negotiate "advance market commitments" — advance promises to buy future vaccines, including possible vaccines for HIV/AIDS, tuberculosis, and malaria. (2) Negotiation requirement: the Treasury Secretary must negotiate with the World Bank, the GAVI Alliance, their member countries, and other interested parties to set up these commitments to purchase vaccines against HIV/AIDS, tuberculosis, malaria, and related infectious diseases. (3) Requirements to consider: in these negotiations, the Treasury Secretary must weigh whether the commitment programs include (A) legally binding contracts to buy a set number of treatments at a fair price, to create a real market incentive; (B) clear, transparent rules for which developers and suppliers can take part; (C) clear requirements that eligible vaccines are safe, effective, and deliverable in developing countries; (D) ways to settle disputes; and (E) enough flexibility to adjust contracts as market conditions change, while still honoring the purchase commitment at a fair price. (4) Report: within one year of July 30, 2008, (A) the Treasury Secretary must report to Congress on the status of these negotiations, and (B) the President must produce a comprehensive report — written by a study group of qualified people from relevant federal agencies, nongovernmental groups, and industry — laying out a coordinated strategy to speed up vaccine development for infectious diseases like HIV/AIDS, malaria, and tuberculosis. That strategy must include (i) ways to create economic incentives for researching, developing, and manufacturing such vaccines; (ii) expanding public-private partnerships and pooling resources from other countries and the private sector; and (iii) efforts to maximize US ability to support vaccine clinical trials in developing countries and speed up access once vaccines exist.
the actual law source: uscode.house.gov ↗public domain
(a) Technical assistance for developing countries

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) Advanced market commitments
(1) Purpose

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) Negotiation requirement

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) 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 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) Report

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.

Source credit: (Pub. L. 110–293, title II, § 206, July 30, 2008, 122 Stat. 2944.)

history & why it existsrecord from the source credit
  • 2008Enacted · Pub. L. 110-293 · 122 Stat. 2944

A history note hasn’t been published yet. The record shows enactment by Pub. L. 110-293 on 2008-07-30.

all 0 arguments · sorted by: best

0/280

no arguments yet — make the first case