[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1515 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 1515

 To amend the Foreign Assistance Act of 1961 to codify the cooperative 
 agreement, known as the Health Technologies program, under which the 
    United States Agency for International Development supports the 
 development of technologies for global health, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 11, 2013

 Mr. Sires (for himself and Mr. Diaz-Balart) introduced the following 
      bill; which was referred to the Committee on Foreign Affairs

_______________________________________________________________________

                                 A BILL


 
 To amend the Foreign Assistance Act of 1961 to codify the cooperative 
 agreement, known as the Health Technologies program, under which the 
    United States Agency for International Development supports the 
 development of technologies for global health, 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 ``21st Century Global Health 
Technology Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Research and development is a critical component of 
        United States leadership in global health. Research and 
        innovation can help to break the cycle of aid dependency by 
        providing sustainable solutions to long-term problems. Research 
        and development for global health is crucial for meeting new 
        and emerging challenges, creating efficiencies, strengthening 
        health systems, shifting tasks and strengthening workforces, 
        and increasing access to health services for the most 
        vulnerable. Research suggests that advances in health and 
        medical technologies have been the major drivers behind massive 
        improvements in health worldwide over the past century, 
        resulting in an average increase in life expectancies of 21 
        years in low- and middle-income countries between 1960 and 
        2002. Additionally, new health technologies have a high return 
        on investment. For example, it is estimated that a new 
        meningitis A vaccine developed in collaboration with the United 
        States Agency for International Development (USAID), the 
        Centers for Disease Control and Prevention (CDC), the National 
        Institutes of Health (NIH), and the Food and Drug 
        Administration (FDA), will save $570,000,000 over the next 
        decade in costs that would otherwise be incurred for emergency 
        vaccination campaigns, freeing much needed resources for use 
        elsewhere in overstretched health systems.
            (2) Five Federal agencies--NIH, USAID, the Department of 
        Defense, CDC, and FDA--provide significant contributions each 
        year to global health research and development. The United 
        States Government is supporting the development of 200--55 
        percent--of the 365 products in the global pipeline of products 
        for neglected and poverty-related diseases.
            (3) This commitment from the United States Government and 
        its Federal agencies has led to a remarkable increase in global 
        health products. Forty-five new health tools were registered 
        between 2000 and 2010, and the United States Government was 
        involved in 24, or 53 percent, of these new global health 
        products in the last decade including 6 drugs for malaria, 2 
        vaccines for pneumonia, 6 diagnostics for tuberculosis, and 2 
        drugs for leishmaniasis.
            (4) United States investments have enabled tremendous 
        progress in the introduction of new technologies for global 
        health; however, gaps exist in bringing certain technologies 
        through the development process and rapidly scaling them up in 
        the field. Better coordination is needed between Federal 
        agencies to align research strategies, identify and address 
        gaps in product development activity and move products 
        efficiently along the research-to-introduction continuum.
            (5) Infectious diseases disproportionately impact 
        populations in low-income nations across Latin America, sub-
        Saharan Africa, and Asia. However, even in the United States, 
        poor and vulnerable communities are at much greater risk for 
        contracting diseases usually considered to be diseases of the 
        developing world. For example, cases of Chagas disease, which 
        is found throughout Latin America, and dengue fever, endemic to 
        Mexico and Central America, have been detected in southern 
        States along the United States border with Mexico, in 
        communities where poverty rates are high.
            (6) In collaboration with the World Health Organization 
        (WHO) and its member states, the United States is a leading 
        participant in discussions to improve coordination and 
        financing of global health research and development. This 
        process will establish mechanisms to map research needs, 
        identify resource gaps, and set priorities to ensure that the 
        most crucial global health products are developed and delivered 
        for maximum global health impact.
            (7) Because of its presence in the field, USAID is uniquely 
        placed to assess local health conditions, then partner with 
        public and private stakeholders to ensure the development and 
        timely introduction and scale-up of tools that are culturally 
        acceptable, address serious and all-too-common health problems, 
        and contribute to the strengthening of health systems. In a 
        recent report to Congress, USAID calls health research 
        ``integral'' to its ``ability to achieve its health and 
        development objectives worldwide'' and states that innovation 
        through research allows the agency ``to develop and introduce 
        affordable health products and practices and contribute to 
        policies appropriate for addressing health-related concerns in 
        the developing world''. The elevation of the Office of Science 
        and Technology would assist USAID in achieving its global 
        health and development goals. In 2011, USAID outlined a 5-year 
        health research strategy: ``Report to Congress: Health-Related 
        Research and Development Activities at USAID (HRRD), May 
        2011'', with a timeline through 2010. This strategy is an 
        important source of information on USAID's programs for global 
        health product development and is an effective tool for 
        measuring expected results from 2011 through 2015. The strategy 
        does not articulate USAID's investments and programming for 
        research and development in several critical areas such as--
                    (A) new tools to diagnose, prevent and treat 
                neglected tropical diseases;
                    (B) biomedical products, technologies and devices 
                for conditions and diseases impacting maternal health, 
                newborns, and children, including research for vaccines 
                for the leading causes of death in children; and
                    (C) new tuberculosis vaccines.
            (8) Congress notes the interrelated initiatives that USAID 
        has taken to advance science, technology, and innovation for 
        development, including the Grand Development Challenges, the 
        Innovation Fund, Higher Education Science Network, the 
        Development Lab, and the Innovation Fellowship.
            (9) Research and development at USAID--
                    (A) facilitates public-private collaboration in the 
                development of global health technologies;
                    (B) leverages public and private sector support for 
                early stage research and development of health 
                technologies to encourage private sector investment in 
                late-stage technology development and product 
                introduction in developing countries;
                    (C) benefits the United States economy by investing 
                in the growing United States global health technology 
                sector, which--
                            (i) provides skilled jobs for American 
                        workers for example, 64 cents of every United 
                        States dollar invested in global health 
                        research benefits United States-based 
                        researchers;
                            (ii) creates opportunities for United 
                        States businesses in the development and 
                        production of new technologies; and
                            (iii) enhances United States 
                        competitiveness in the increasingly 
                        technological and knowledge-based global 
                        economy; and
                    (D) enhances United States national security by--
                            (i) reducing the risk of pandemic disease; 
                        and
                            (ii) contributing to economic development 
                        and stability in developing countries.
            (10) Investments by the United States in affordable, 
        appropriate health technologies, such as medical devices for 
        maternal, newborn, and child care; new vaccines; new vaccine 
        technologies and delivery tools; safe injection devices; 
        diagnostic tests for infectious diseases; new tools for water, 
        sanitation, and nutrition; multipurpose prevention 
        technologies; information systems and mobile health and 
        information systems; and innovative disease prevention 
        strategies--
                    (A) reduce the risk of disease transmission;
                    (B) accelerate access to life-saving global health 
                interventions for the world's poor;
                    (C) reduce the burden on local health systems; and
                    (D) have been found by the United States Government 
                and WHO to result in significant cost savings for 
                development assistance funds.
            (11) Where markets fail, public-private partnerships are an 
        effective way to develop, introduce and scale up new health 
        technologies. Product development partnerships (PDPs) are one 
        model of public private partnership that is successfully 
        accelerating research to benefit the developing world. PDPs are 
        non-profit, nongovernmental entities that work to accelerate 
        the development of new tools to fight diseases in resource-poor 
        settings. Typically, PDPs manage resources and partnerships 
        from across public, private, and philanthropic sectors to drive 
        the development of a full pipeline of potential new products 
        that could save and improve lives in the developing world. 
        USAID has played a significant role in advancing the PDP model 
        through its financial support. Over the past decade, the 
        achievements of PDPs have become increasingly successful at 
        advancing new products through the development pipeline towards 
        registration, product introduction, and use.
            (12) USAID supports research and introduction activities 
        along a research-to-use continuum including--
                    (A) evidence reviews and health assessments in 
                developing countries; and
                    (B) the development, testing, adaptation, and 
                introduction of appropriate products and interventions 
                within the context of strengthening health systems.
            (13) A Center for Accelerating Innovation and Impact has 
        been established at USAID to address technical, supply and 
        policy barriers in the development, introduction and scale-up 
        of new products and technologies for global health. For 
        diseases and conditions where market forces have proven 
        insufficient to generate and rapidly deliver new technologies, 
        the Center promotes and reinforces solutions to overcome 
        obstacles such as regulatory inefficiencies in developing 
        countries, limited user demand, gaps in market data and supply 
        chain hurdles. The Center also catalyzes partnerships with the 
        public and private sectors to develop and rapidly deploy new 
        products.
            (14) Through a cooperative agreement, known as the Health 
        Technologies program, USAID supports the development of 
        technologies that--
                    (A) maximize the limited resources available for 
                global health; and
                    (B) ensure that products and medicines developed 
                for use in low-resource settings reach the people that 
                need such products and medicines.
        Through the Health Technologies program, 85 technologies have 
        been invented, designed, developed or co-developed and more 
        than 100 private-sector collaborators have been involved in the 
        Health Technologies program, matching USAID dollars at least 
        two to one. Over its 25-year history, more than 95 private-
        sector collaborators have been involved in the Health 
        Technologies program, matching USAID dollars two to one.
            (15) USAID's research and development is complementary to 
        the work of other agencies.

SEC. 3. PURPOSES.

    The purpose of this Act is to acknowledge USAID's role in product 
development, introduction and scale-up of new global health tools and 
authorize USAID's Health Technologies program, in effect as of the date 
of the enactment of this Act, under which the United States Agency for 
International Development supports the development of technologies for 
global health to--
            (1) improve global health;
            (2) reduce maternal, newborn, and child mortality rates;
            (3) reverse the incidence of HIV/AIDS, malaria, 
        tuberculosis, and other infectious diseases;
            (4) reduce the burden of chronic diseases;
            (5) overcome technical, supply and policy hurdles to 
        product introduction and scale-up; and
            (6) support research and development that is consistent 
        with a global development strategy and other related strategies 
        developed by USAID.

SEC. 4. CODIFICATION OF HEALTH TECHNOLOGIES PROGRAM.

    Section 107 of the Foreign Assistance Act of 1961 (22 U.S.C. 2151e) 
is amended by adding at the end the following:
    ``(c) Health Technologies Program.--(1) There is established in the 
United States Agency for International Development (USAID) a health 
technologies program (referred to in this subsection as the `program').
    ``(2) The program shall develop, advance, and introduce affordable, 
available, and appropriate and primarily late-stage technologies 
specifically designed to--
            ``(A) improve the health and nutrition of populations in 
        developing countries;
            ``(B) reduce maternal, newborn, and child mortality in such 
        countries; and
            ``(C) improve the diagnosis, prevention, and reduction of 
        disease, especially HIV/AIDS, malaria, tuberculosis, and other 
        infectious diseases, in such countries.
    ``(3) The program shall be carried out under a cooperative 
agreement between USAID and one or more institutions with a successful 
record of--
            ``(A) advancing the technologies described in paragraph 
        (2); and
            ``(B) integrating practical field experience into the 
        research and development process in order to introduce the most 
        appropriate technologies.
    ``(4) The provisions of this subsection codify the cooperative 
agreement, known as the Health Technologies program, in effect as of 
the date of the enactment of this subsection, under which USAID 
supports the development of technologies for global health. The 
provisions of this subsection do not establish a new cooperative 
agreement or program for such purposes.
    ``(d) Action Plans.--The Administrator of the United States Agency 
for International Development (USAID) shall establish and implement 
action plans to incorporate global health research and product 
development within each of the global health and development programs, 
with support from coordinating agencies, and shall establish metrics to 
measure progress. In implementing the action plans, the Administrator 
shall consider all options, including the use of public private 
partnerships.
    ``(e) Priority Global Health Interventions.--The Center for 
Accelerating Innovation and Impact of the United States Agency for 
International Development shall continue its work to speed the 
development, introduction, and scale-up of priority global health 
interventions.''.

SEC. 5. REPORT ON RESEARCH AND DEVELOPMENT ACTIVITIES AT USAID.

    (a) In General.--The Administrator of the United States Agency for 
International Development (referred to in this section as ``USAID'') 
shall submit to Congress an annual report on research and development 
activities at USAID.
    (b) Matters To Be Included.--The report required by subsection (b) 
shall describe--
            (1) updates on the implementation of its strategy for using 
        research funds to stimulate the development and introduction of 
        products in each of its global health and development programs;
            (2) USAID's collaborations and coordination with other 
        Federal departments and agencies in support of translational 
        and applied global health research and development;
            (3) its investments for the fiscal year in science, 
        technology, and innovation;
            (4) how these technologies and research products complement 
        the work being done by other Federal departments and agencies, 
        if applicable; and
            (5) technologies and research products that have been 
        introduced into field trials or use.
    (c) Consultation.--The Administrator of USAID shall consult on an 
annual basis with the heads of other Federal departments and agencies 
to improve alignment of USAID's health-related research strategy with 
other similar agency strategies, with the intent of working towards a 
whole-of-government strategy for global health research and 
development.
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