[Ip-health] AMC language in PEPFAR

[James Love]

AMC language in S.2731

SEC. 206. FACILITATING VACCINE DEVELOPMENT.

      (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 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 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.


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James Love, Knowledge Ecology International (KEI)
http://www.keionline.org, mailto:james.love@keionline.org
voice +1.202.332.2670, fax +1.202.332.2673, US mobile +1.202.361.3040, Geneva mobile +41.76.413.6584

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