[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 569 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                 S. 569

   To accelerate efforts to develop vaccines for diseases primarily 
         affecting developing countries and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 13, 2007

   Mr. Lugar introduced the following bill; which was read twice and 
             referred to the Committee on Foreign Relations

_______________________________________________________________________

                                 A BILL


 
   To accelerate efforts to develop vaccines for diseases primarily 
         affecting developing countries and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Vaccines for the Future Act of 
2007''.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) AIDS.--The term ``AIDS'' has the meaning given the term 
        in section 104A(g) of the Foreign Assistance Act of 1961 (22 
        U.S.C. 2151b-2).
            (2) Appropriate congressional committees.--The term 
        ``appropriate congressional committees'' means the Committee on 
        Appropriations and the Committee on Foreign Relations of the 
        Senate and the Committee on Appropriations and the Committee on 
        Foreign Affairs of the House of Representatives.
            (3) Developing country.--The term ``developing country'' 
        means a country that the World Bank determines to be a country 
        with a lower middle income or less.
            (4) HIV/AIDS.--The term ``HIV/AIDS'' has the meaning given 
        the term in section 104A(g) of the Foreign Assistance Act of 
        1961 (22 U.S.C. 2151b-2).
            (5) GAVI alliance.--The term ``GAVI Alliance'' means the 
        public-private partnership launched in 2000 for the purpose of 
        saving the lives of children and protecting the health of all 
        people through the widespread use of vaccines.
            (6) Neglected disease.--The term ``neglected disease'' 
        means--
                    (A) HIV/AIDS;
                    (B) malaria;
                    (C) tuberculosis; or
                    (D) any infectious disease that, according to the 
                World Health Organization, afflicts over 1,000,000 
                people and causes more than 250,000 deaths each year in 
                developing countries.
            (7) World bank.--The term ``World Bank'' means the 
        International Bank for Reconstruction and Development.

SEC. 3. FINDINGS.

    Congress makes the following findings:
            (1) Immunization is an inexpensive and effective public 
        health intervention that has had a profound life-saving impact 
        around the world.
            (2) During the 20th century, global immunization efforts 
        have successfully led to the eradication of smallpox and the 
        elimination of polio from the Western Hemisphere, Europe, and 
        most of Asia. Vaccines for diseases such as measles and tetanus 
        have dramatically reduced childhood mortality worldwide, and 
        vaccines for diseases such as influenza, pneumonia, and 
        hepatitis help prevent sickness and death of adults as well as 
        children.
            (3) According to the World Health Organization, combined, 
        AIDS, tuberculosis, and malaria kill more than 5,000,000 people 
        a year, most of whom are in the developing world, yet there are 
        no vaccines for these diseases.
            (4) Other, less well-known neglected diseases, such as 
        pneumococcal disease, lymphatic filariasis, leptospirosis, 
        leprosy, and onchocerciasis, result in severe health 
        consequences for individuals afflicted with them, such as 
        anemia, blindness, malnutrition and impaired childhood growth 
        and development. In addition, these diseases result in lost 
        productivity in developing countries costing in the billions of 
        dollars.
            (5) Infants, children, and adolescents are among the 
        populations hardest hit by AIDS, malaria, and many other 
        neglected diseases. Nearly 11,000,000 children under age 5 die 
        each year due to these diseases, primarily in developing 
        countries. Existing and future vaccines that target children 
        could prevent more than 2,500,000 of these illnesses and 
        deaths.
            (6) The devastating impact of neglected diseases in 
        developing countries threatens the political and economic 
        stability of these countries and constitutes a threat to United 
        States economic and security interests.
            (7) Of more than $100,000,000,000 spent on health research 
        and development across the world, only $6,000,000,000 is spent 
        each year on diseases that are specific to developing 
        countries, most of which is from public and philanthropic 
        sources.
            (8) Despite the devastating impact these and other diseases 
        have on developing countries, it is estimated that only 10 
        percent of the world's research and development on health is 
        targeted on diseases affecting 90 percent of the world's 
        population.
            (9) Because the developing country market is small and 
        unpredictable, there is an insufficient private sector 
        investment in research for vaccines for neglected diseases that 
        disproportionately affect populations in developing countries.
            (10) Creating a broad range of economic incentives to 
        increase private sector research on neglected diseases is 
        critical to the development of vaccines for neglected diseases.
            (11) In recognition of the need for more economic 
        incentives to encourage private sector investment in vaccines 
        for neglected diseases, an international group of health, 
        technical, and economic experts has developed a framework for 
        an advance market commitment pilot program for pneumococcal 
        vaccines. Pneumococcal disease, a cause of pneumonia and 
        meningitis, kills 1,600,000 people every year, an estimated 
        1,000,000 of whom are children under age 5. This pilot program 
        will seek to stimulate investments to develop and produce 
        pneumococcal vaccines that could prevent between 500,000 and 
        700,000 deaths by the year 2020.
            (12) On February 9, 2007, 5 countries, Britain, Canada, 
        Italy, Norway, and Russia, together with the Bill and Melinda 
        Gates Foundation, pledged, under a plan called an Advance 
        Market Commitment, to purchase pneumococcal vaccines now under 
        development. Together, these countries and the Bill and Melinda 
        Gates Foundation have committed $1,500,000,000 for this 
        program. Experts believe that this initiative could accelerate 
        by a decade the widespread use of such a vaccine in the 
        developing world and could prevent the deaths of an estimated 
        5,400,000 children by 2030.

SEC. 4. SENSE OF CONGRESS ON SUPPORT FOR NEGLECTED DISEASES.

    It is the sense of Congress that--
            (1) the President should continue to encourage efforts to 
        support the Global HIV Vaccine Enterprise, a virtual consortium 
        of scientists and organizations committed to accelerating the 
        development of an effective HIV vaccine;
            (2) the United States should work with the Global Fund to 
        Fight AIDS, Tuberculosis and Malaria, the Joint United Nations 
        Programme on HIV/AIDS (``UNAIDS''), the World Health 
        Organization, the International AIDS Vaccine Initiative, the 
        GAVI Alliance, and the World Bank to ensure that all countries 
        heavily affected by the HIV/AIDS pandemic have national AIDS 
        vaccine plans;
            (3) the United States should support and encourage the 
        carrying out of the agreements of the Group of 8 made at the 
        2005 Summit at Gleneagles, Scotland, to increase direct 
        investment and create market incentives, including through 
        public-private partnerships and advance market commitments, to 
        complement public research in the development of vaccines, 
        microbicides, and drugs for HIV/AIDS, malaria, tuberculosis, 
        and other neglected diseases;
            (4) the United States should support the development of 
        effective vaccines for infants, children, and adolescents as 
        early as is medically and ethically appropriate, in order to 
        avoid significant delays in the availability of pediatric 
        vaccines at the cost of thousands of lives;
            (5) the United States should continue supporting the work 
        of the GAVI Alliance and the Global Fund for Children's 
        Vaccines as appropriate and effective vehicles to purchase and 
        distribute vaccines for neglected diseases at an affordable 
        price once such vaccines are discovered in order to distribute 
        them to the developing world;
            (6) the United States should work with others in the 
        international community to address the multiple obstacles to 
        the development of vaccines for neglected diseases including 
        scientific barriers, insufficient economic incentives, 
        protracted regulatory procedures, lack of delivery systems for 
        products once developed, liability risks, and intellectual 
        property rights; and
            (7) the United States should contribute to the pilot 
        Advance Market Commitment for pneumococcal vaccines launched in 
        Rome on February 9, 2007, which could prevent some 500,000 to 
        700,000 child deaths by the year 2020 and an estimated 
        5,400,000 child deaths by 2030.

SEC. 5. PUBLIC-PRIVATE PARTNERSHIPS.

    (a) Findings.--Congress makes the following findings:
            (1) Partnerships between governments and the private sector 
        (including foundations, universities, corporations, community-
        based organizations, and other nongovernmental organizations) 
        are playing a critical role in the area of global health, 
        particularly in the fight against neglected diseases, including 
        HIV/AIDS, tuberculosis, and malaria.
            (2) These public-private partnerships improve the delivery 
        of health services in developing countries and accelerate 
        research and development of vaccines and other preventive 
        medical technologies essential to combating infectious diseases 
        that disproportionately kill people in developing countries.
            (3) These public-private partnerships maximize the unique 
        capabilities of each sector while combining financial and other 
        resources, scientific knowledge, and expertise toward common 
        goals which cannot be achieved by either sector alone.
            (4) Public-private partnerships such as the International 
        AIDS Vaccine Initiative, PATH's Malaria Vaccine Initiative, and 
        the Global TB Drug Facility are playing cutting edge roles in 
        the efforts to develop vaccines for these diseases.
            (5) Public-private partnerships serve as incentives to the 
        research and development of vaccines for neglected diseases by 
        providing biotechnology companies, which often have no 
        experience in developing countries, with technical assistance 
        and on the ground support for clinical trials of the vaccine 
        through the various stages of development.
            (6) Sustaining existing public-private partnerships and 
        building new ones where needed are essential to the success of 
        the efforts by the United States and others in the 
        international community to find a cure for these and other 
        neglected diseases.
    (b) Sense of Congress.--It is the sense of Congress that--
            (1) the sustainment and promotion of public-private 
        partnerships must be a central element of the strategy pursued 
        by the United States to create effective incentives for the 
        development of vaccines and other preventive medical 
        technologies for neglected diseases debilitating the developing 
        world; and
            (2) the United States Government should take steps to 
        address the obstacles to the development of these technologies 
        by increasing investment in research and development and 
        establishing market and other incentives.

SEC. 6. COMPREHENSIVE STRATEGY FOR ACCELERATING THE DEVELOPMENT OF 
              VACCINES FOR NEGLECTED DISEASES.

    (a) Requirement for Strategy.--The President shall establish a 
comprehensive strategy to accelerate efforts to develop vaccines and 
microbicides for neglected diseases such as HIV/AIDS, malaria, and 
tuberculosis. Such strategy shall--
            (1) expand public-private partnerships and seek to leverage 
        resources from other countries and the private sector;
            (2) include the negotiation of advance market commitments 
        and other initiatives to create economic incentives for the 
        research, development, and manufacturing of vaccines and 
        microbicides for HIV/AIDS, tuberculosis, malaria, and other 
        neglected diseases;
            (3) address intellectual property issues surrounding the 
        development of vaccines and microbicides for neglected 
        diseases;
            (4) maximize United States capabilities to support clinical 
        trials of vaccines and microbicides in developing countries;
            (5) address the issue of regulatory approval of such 
        vaccines and microbicides, whether through the Commissioner of 
        the Food and Drug Administration, or the World Health 
        Organization, or another entity; and
            (6) expand the purchase and delivery of existing vaccines.
    (b) Report.--Not later than 180 days after the date of enactment of 
this Act, the President shall submit to the appropriate congressional 
committees a report setting forth the strategy described in subsection 
(a) and the steps to implement such strategy.

SEC. 7. ADVANCE MARKET COMMITMENTS.

    (a) Purpose.--The purpose of this section is to improve global 
health by creating a competitive market for future vaccines through 
advance market commitments.
    (b) Authority to Negotiate.--
            (1) In general.--The Secretary of the Treasury shall enter 
        into negotiations with the appropriate officials of the World 
        Bank, the International Development Association, and the GAVI 
        Alliance, the member nations of such entities, and other 
        interested parties for the purpose of establishing advance 
        market commitments to purchase vaccines and microbicides to 
        combat neglected diseases.
            (2) Report.--Not later than 180 days after the date of the 
        enactment of this Act, the Secretary shall submit to the 
        appropriate congressional committees a report on the status of 
        the negotiations to create advance market commitments under 
        this section. This report may be submitted as part of the 
        report submitted under section 6(b).
    (c) Requirements.--The Secretary of the Treasury shall work with 
the entities referred to in subsection (b) to ensure that there is an 
international framework for the establishment and implementation of 
advance market commitments and that such commitments include--
            (1) legally binding contracts for product purchase that 
        include a fair market price for a guaranteed number of 
        treatments to ensure that the market incentive is sufficient;
            (2) clearly defined and transparent rules of competition 
        for qualified developers and suppliers of the product;
            (3) clearly defined requirements for eligible vaccines to 
        ensure that they are safe and effective;
            (4) dispute settlement mechanisms; and
            (5) 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.
    (d) Authorization of Appropriations.--
            (1) In general.--There are authorized to be appropriated 
        such sums as may be necessary for each of fiscal years 2009 
        through 2014 to fund an advance market commitment pilot program 
        for pneumococcal vaccines.
            (2) Availability.--Amounts appropriated pursuant to this 
        subsection shall remain available until expended without fiscal 
        year limitation.
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