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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 823 Introduced in Senate (IS)]

110th CONGRESS
  1st Session
                                 S. 823

To amend the Public Health Service Act with respect to facilitating the 
development of microbicides for preventing transmission of HIV/AIDS and 
                other diseases, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             March 8, 2007

Mr. Obama (for himself, Ms. Snowe, Mr. Durbin, Mr. Dodd, Mrs. Clinton, 
Mrs. Boxer, Mr. Schumer, and Mr. Kerry) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
To amend the Public Health Service Act with respect to facilitating the 
development of microbicides for preventing transmission of HIV/AIDS and 
                other diseases, 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 ``Microbicide Development Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Women and girls are the new face of HIV/AIDS, and are 
        increasingly affected by the disease in every region of the 
        world. As of 2006, nearly half of the 37,200,000 adults living 
        with HIV and AIDS worldwide were women. In sub-Saharan Africa, 
        that proportion was 59 percent.
            (2) Because of their social and biological vulnerabilities, 
        young women are particularly at risk of HIV infection. In sub-
        Saharan Africa, the prevalence of HIV/AIDS is three times 
        higher among women ages 15 to 24 than it is among men in that 
        same age group.
            (3) Women infected with HIV can transmit the infection to 
        their infants during pregnancy, labor, delivery, or breast-
        feeding. The most effective way to interrupt mother-to-child 
        transmission is to ensure that mothers are not infected in the 
        first place.
            (4) Many women who become infected with HIV have just one 
        sexual partner--their husband. Marriage is not necessarily 
        effective protection against HIV, because to protect themselves 
        from HIV, women have to rely on their male partners to be 
        faithful or to use condoms. Many women, especially in the 
        developing world, are unable to insist on mutual monogamy or 
        negotiate condom use, particularly in long-term relationships.
            (5) Scientists are working on a promising new prevention 
        tool that could slow down the spread of the HIV/AIDS epidemic--
        microbicides. Formulated as gels, creams, tablets or rings, 
        microbicides are being designed to stop the transmission of the 
        pathogens that cause AIDS and other sexually transmitted 
        infections (referred to in this section as ``STIs''). 
        Microbicides could allow a woman to protect herself from 
        disease.
            (6) Couples need a method of HIV protection that will allow 
        them to conceive a child and start a family. No existing HIV 
        prevention method also allows conception. Some microbicides in 
        development may allow women to become pregnant while at the 
        same time protecting them from infection.
            (7) According to UNICEF, worldwide, the lack of HIV/AIDS 
        prevention and treatment has left over 15,000,000 children as 
        orphans. Of these, more than 12,000,000 live in sub-Saharan 
        Africa. The number of AIDS orphans in sub-Saharan Africa alone 
        is expected to grow to nearly 16,000,000 by 2010.
            (8) HIV prevention tools like microbicides could also be 
        valuable for women in the United States, who account for an 
        increasing proportion of new HIV and AIDS cases among 
        Americans. Minority women in the United States are particularly 
        affected. Both African-American and Latina women account for a 
        disproportionate number of new AIDS cases, and HIV/AIDS was the 
        leading cause of death in 2002 for African-American women ages 
        25 to 34.
            (9) With nearly 20,000,000 new cases of sexually 
        transmitted infections occurring every year, the United States 
        has the highest STI rates of any industrialized nation. Like 
        HIV, STIs pose significant health threats and costs, with young 
        people and women bearing a disproportionate burden. Nearly half 
        of new STI cases each year occur in people under 25 years of 
        age with women both more vulnerable to infection and more 
        likely to experience serious and lasting health consequences 
        when they do become infected. Some microbicides could help 
        prevent STIs.
            (10) HIV/AIDS threatens national and global security. 
        Beyond its burdens on individuals, families, and communities, 
        the pandemic reduces economic growth, decimates health budgets, 
        undermines civil society, and burdens the armed forces of many 
        nations, including the United States military.
            (11) The microbicide field has gained considerable 
        scientific momentum. Several first-generation products are in 
        large-scale human trials to measure effectiveness, and new 
        products based on recent advances in HIV treatment are well 
        into safety trials.
            (12) Microbicides are a public health good with potential 
        for large social benefits but limited economic incentives for 
        private investment, so that public funding is required to fill 
        the gap. As is the case for vaccines and other public goods, 
        microbicide development must depend heavily on government 
        leadership and investment.
            (13) The Federal Government needs to make a strong 
        commitment to microbicide research and development. Three 
        agencies, the National Institutes of Health, Centers for 
        Disease Control and Prevention, and United States Agency for 
        International Development, have played important roles in the 
        progress to date, and each makes a valuable and unique 
        contribution. As the primary federal agency for conducting and 
        supporting medical research and the largest single Federal 
        Government contributor to microbicide research, the National 
        Institutes of Health supports the Microbicide Trials Network as 
        well as other important research activities. The United States 
        Agency for International Development sustains strong 
        partnerships with public and private organizations working on 
        microbicide research, including trials in developing countries 
        where its experience is extensive, and is well positioned to 
        facilitate introduction of microbicides once available. The 
        Centers for Disease Control and Prevention has a long history 
        of conducting field trials in developing countries, but the 
        extent of its current engagement remains quite limited.
            (14) According to the National Institutes of Health's 
        strategic plan, microbicides may provide ``one of the most 
        promising primary preventative interventions that could be 
        safe, effective, readily available, affordable, and widely 
        acceptable.'' In a recent report to Congress, the United States 
        Agency for International Development states that ``the US 
        government is firmly committed to accelerating the development 
        of safe and effective microbicides to prevent HIV.'' In 
        addition, the President's Emergency Plan for AIDS Relief 
        recognizes the urgency of developing safe and effective 
        microbicides.
            (15) The National Institutes of Health, United States 
        Agency for International Development, and the Centers for 
        Disease Control and Prevention have expanded their microbicide 
        portfolios, but overall Federal leadership and coordination is 
        required to eliminate costly inefficiencies and unproductive 
        duplication of effort.
            (16) HIV prevention options available as of 2006 are 
        insufficient in general. Most critically, they fail to 
        recognize women's particular needs and vulnerabilities. If 
        women are to have a genuine opportunity to protect themselves, 
        their best option is the rapid development of new HIV-
        prevention technologies like microbicides, which women can 
        initiate.

   TITLE I--MICROBICIDE RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH

SEC. 101. OFFICE OF AIDS RESEARCH; PROGRAM REGARDING MICROBICIDES FOR 
              PREVENTING TRANSMISSION OF HIV/AIDS AND OTHER DISEASES.

    Subpart I of part D of title XXIII of the Public Health Service Act 
(42 U.S.C. 300cc-40 et seq.) is amended by inserting after section 2351 
the following:

``SEC. 2351A. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
              OTHER DISEASES.

    ``(a) Federal Strategic Plan.--
            ``(1) In general.--The Director of the Office of AIDS 
        Research shall--
                    ``(A) expedite the implementation of Federal 
                strategic plans for the conduct and support of 
                microbicide research and development; and
                    ``(B) annually review and, as appropriate, revise 
                such plan, to prioritize funding and activities in 
                terms of their scientific urgency.
            ``(2) Coordination.--In implementing, reviewing, and 
        prioritizing elements of the plan described under paragraph 
        (1), the Director of the Office of AIDS Research shall 
        coordinate with--
                    ``(A) other Federal agencies, including the 
                Director of the Centers for Disease Control and 
                Prevention and the Administrator of the United States 
                Agency for International Development, involved in 
                microbicide research;
                    ``(B) the microbicide research and development 
                community; and
                    ``(C) health advocates.
    ``(b) Expansion and Coordination of Activities.--The Director of 
the Office of AIDS Research, acting in coordination with relevant 
institutes and offices, shall expand, intensify, and coordinate the 
activities of all appropriate institutes and components of the National 
Institutes of Health with respect to research and development of 
microbicides to prevent the transmission of the human immunodeficiency 
virus (`HIV') and other sexually transmitted infections.
    ``(c) Microbicide Development Branch.--In carrying out subsection 
(b), the Director of the National Institute of Allergy and Infectious 
Diseases shall establish within the Division of AIDS in the Institute, 
a clearly defined organizational branch charged with carrying out 
microbicide research and development. In establishing such branch, the 
Director shall ensure that there are a sufficient number of employees 
dedicated to carrying out its mission.
    ``(d) Microbicide Clinical Trials.--In carrying out subsection (c), 
the Director of the National Institute of Allergy and Infectious 
Diseases shall assign priority to ensuring adequate funding and support 
for the Microbicide Trials Network and other programs for supporting 
microbicides clinical trials, with particular emphasis on 
implementation of trials leading to product licensure.
    ``(e) Reports to Congress.--
            ``(1) In general.--Not later than 6 months after the date 
        of enactment of the Microbicide Development Act, and annually 
        thereafter, the Director of the Office of AIDS Research shall 
        submit to the appropriate committees of Congress a report that 
        describes the strategies being implemented by the Federal 
        Government regarding microbicide research and development.
            ``(2) Contents of reports.--Each report submitted under 
        paragraph (1) shall include--
                    ``(A) a description of activities with respect to 
                microbicide research and development conducted and 
                supported by the Federal Government;
                    ``(B) a summary and analysis of the expenditures 
                made by the Director of the Office of AIDS Research 
                during the preceding year for activities with respect 
                to microbicide-specific research and development, 
                including basic research, preclinical product 
                development, clinical trials, and behavioral science; 
                and
                    ``(C) a description and evaluation of the progress 
                made, during the preceding year, toward the development 
                of effective microbicides.
            ``(3) Appropriate committees of congress defined.--In this 
        subsection, the term `appropriate committees of Congress' means 
        the Committee on Health, Education, Labor, and Pensions and the 
        Committee on Appropriations of the Senate and the Committee on 
        Energy and Commerce and the Committee on Appropriations of the 
        House of Representatives.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each fiscal year to 
carry out this section.''.

 TITLE II--MICROBICIDE RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND 
                               PREVENTION

SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
              OTHER DISEASES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended--
            (1) by transferring section 317R so as to appear after 
        section 317Q; and
            (2) by inserting after section 317R (as so transferred) the 
        following:

``SEC. 371S. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
              OTHER DISEASES.

    ``(a) Development and Implementation of the Centers for Disease 
Control and Prevention's Microbicide Agenda.--The Director of the 
Centers for Disease Control and Prevention shall fully implement such 
Centers' microbicide agenda to support microbicide research and 
development. Such an agenda shall include--
            ``(1) conducting laboratory research in preparation for, 
        and support of, clinical microbicide trials; and
            ``(2) conducting behavioral research in preparation for, 
        and support of, clinical microbicide trials.
    ``(b) Personnel.--The Centers for Disease Control and Prevention 
shall ensure that there are sufficient numbers of dedicated employees 
for carrying out the microbicide agenda under subsection (a).
    ``(c) Report to Congress.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Microbicide Development Act, and annually 
        thereafter, the Director of the Centers for Disease Control and 
        Prevention shall submit to the appropriate committees of 
        Congress, a report on the strategies being implemented by the 
        Centers for Disease Control and Prevention with respect to 
        microbicide research and development. Such report shall be 
        submitted alone or as part of the overall Federal strategic 
        plan on microbicides compiled annually by the National 
        Institutes of Health Office of AIDS Research as required under 
        section 2351A.
            ``(2) Contents of report.--Such report shall include--
                    ``(A) a description of activities with respect to 
                microbicides conducted or supported by the Director of 
                the Centers for Disease Control and Prevention;
                    ``(B) a summary and analysis of the expenditures 
                made by such Director during the preceding year, for 
                activities with respect to microbicide-specific 
                research and development, including the number of 
                employees of such Centers involved in such activities; 
                and
                    ``(C) a description and evaluation of the progress 
                made, during the preceding year, toward the development 
                of effective microbicides.
            ``(3) Appropriate committees of congress defined.--For the 
        purposes of this subsection, the term `appropriate committees 
        of Congress' means the Committee on Health, Education, Labor, 
        and Pensions and the Committee on Appropriations of the Senate 
        and the Committee on Energy and Commerce and the Committee on 
        Appropriations of the House of Representatives.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary for each fiscal year to 
carry out this section.''.

 TITLE III--MICROBICIDE RESEARCH AND DEVELOPMENT AT THE UNITED STATES 
                  AGENCY FOR INTERNATIONAL DEVELOPMENT

SEC. 301. MICROBICIDES FOR PREVENTING TRANSMISSION OF HIV/AIDS AND 
              OTHER DISEASES.

    Section 104A of the Foreign Assistance Act of 1961 (22 U.S.C. 
2151b-2) is amended by adding at the end the following new subsection:
    ``(h) Microbicides for Preventing Transmission of HIV/AIDS and 
Other Diseases.--
            ``(1) Development and implementation of the microbicide 
        agenda.--The head of the Office of HIV/AIDS of the United 
        States Agency for International Development, in conjunction 
        with other offices of such Agency, shall develop and implement 
        a program to support the development of microbicides for the 
        prevention of the transmission of HIV/AIDS and other diseases, 
        and facilitate wide-scale availability of such products after 
        such development.
            ``(2) Staffing.--The head of the Office of HIV/AIDS shall 
        ensure that the Agency has a sufficient number of dedicated 
        employees to carry out the microbicide agenda.
            ``(3) Reports to congress.--
                    ``(A) In general.--Not later than 1 year after the 
                date of enactment of the Microbicide Development Act, 
                and annually thereafter, the Administrator of the 
                Agency shall submit to the appropriate committees of 
                Congress a report on the activities of the 
                Administrator to carry out the microbicide agenda and 
                on any other activities carried out by the 
                Administrator related to microbicide research and 
                development.
                    ``(B) Contents of report.--Each report submitted 
                under subparagraph (A) shall include--
                            ``(i) a description of activities with 
                        respect to microbicides conducted or supported 
                        by the Administrator;
                            ``(ii) a summary and analysis of the 
                        expenditures made by the Administrator during 
                        the preceding year for activities with respect 
                        to microbicide-specific research and 
                        development, including the number of employees 
                        of the Agency who are involved in such 
                        activities; and
                            ``(iii) a description and evaluation of the 
                        progress made during the preceding year toward 
                        the development of effective microbicides, 
                        including activities in support of eventual 
                        product access.
                    ``(C) Consultation.--The Administrator shall 
                consult with the Director of the Office of AIDS 
                Research of the National Institutes of Health in 
                preparing a report required by subparagraph (A).
                    ``(D) Appropriate committees of congress defined.--
                In this paragraph, the term `appropriate committees of 
                Congress' means the Committee on Foreign Relations and 
                the Committee on Appropriations of the Senate and the 
                Committee on Foreign Affairs and the Committee on 
                Appropriations of the House of Representatives.
            ``(4) Authorization of appropriations.--There are 
        authorized to be appropriated such sums as may be necessary for 
        each fiscal year to carry out this subsection.''.

                  TITLE IV--ADVANCE MARKET COMMITMENTS

SEC. 401. REPORT ON ADVANCE MARKET COMMITMENTS AS INCENTIVES FOR 
              MICROBICIDE DEVELOPMENT.

    (a) Report.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of State shall submit to the 
appropriate committees of Congress a report on the feasibility and 
impediments to the Government of the United States entering into 
advanced market commitments of microbicides to prevent HIV infection as 
a means of creating incentives for the private sector to invest in 
research, development, and manufacturing of microbicides.
    (b) Appropriate Committees of Congress Defined.--In this section, 
the term ``appropriate committees of Congress'' means the Committee on 
Health, Education, Labor, and Pensions and the Committee on Foreign 
Relations of the Senate, and the Committee on Energy and Commerce and 
the Committee on Foreign Affairs of the House of Representatives.
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