[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 2407 Introduced in Senate (IS)]

113th CONGRESS
  2d Session
                                S. 2407

 To amend the Foreign Assistance Act of 1961 by authorizing the United 
States Agency for International Development to continue supporting the 
    development of technologies for global health under the Health 
             Technologies Program, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 22, 2014

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

_______________________________________________________________________

                                 A BILL


 
 To amend the Foreign Assistance Act of 1961 by authorizing the United 
States Agency for International Development to continue supporting the 
    development of technologies for global health under the Health 
             Technologies Program, 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.
            (2) Research and innovation can help to break the cycle of 
        aid dependency by providing sustainable solutions to long-term 
        problems.
            (3) Research and development for global health is crucial 
        for meeting new and emerging challenges, creating efficiencies, 
        strengthening health systems, shifting tasks, strengthening 
        workforces, and increasing access to health services for the 
        most vulnerable people.
            (4) Advances in health and medical technologies have been 
        the major drivers behind massive improvements in health 
        worldwide during the past century, resulting in an average 
        increase in life expectancy of 21 years in low- and middle-
        income countries between 1960 and 2002.
            (5) New health technologies have a high return on 
        investment. For example, a new meningitis A vaccine developed 
        in collaboration with the United States Agency for 
        International Development (referred to in this section as 
        ``USAID''), the Centers for Disease Control and Prevention, the 
        National Institutes of Health, and the Food and Drug 
        Administration, will save an estimated $570,000,000 in costs 
        that would otherwise be incurred for emergency vaccination 
        campaigns during the next decade, freeing much needed resources 
        for use elsewhere in overstretched health systems.
            (6) USAID, the Centers for Disease Control and Prevention, 
        the National Institutes of Health, the Food and Drug 
        Administration, and the Department of Defense provide 
        significant contributions each year to global health research 
        and development. The United States Government is supporting the 
        development of 200 of the 365 products in the global pipeline 
        of products for neglected and poverty-related diseases.
            (7) This commitment from the United States Government 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 of these 
        new global health products in the last decade, including--
                    (A) 6 drugs for malaria;
                    (B) 2 vaccines for pneumonia;
                    (C) 6 diagnostics for tuberculosis; and
                    (D) 2 drugs for leishmaniasis.
            (8) Although investments from the United States Government 
        have enabled tremendous progress in the introduction of new 
        technologies for global health, gaps still exist in bringing 
        certain technologies through the development process and 
        rapidly scaling them up in the field.
            (9) Better coordination is needed between Federal 
        agencies--
                    (A) to align research strategies;
                    (B) to identify and address gaps in product 
                development activity; and
                    (C) to move products efficiently along the 
                research-to-introduction continuum.
            (10) Infectious diseases disproportionately impact 
        populations in low-income nations across Latin America, sub-
        Saharan Africa, and Asia. Poor and vulnerable communities in 
        the United States are also at 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 communities with high poverty 
        rates in States along the United States border with Mexico.
            (11) In collaboration with the World Health Organization 
        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.
            (12) Because of its presence in the field, USAID is 
        uniquely placed--
                    (A) to assess local health conditions;
                    (B) to partner with public and private stakeholders 
                to ensure the development and timely introduction and 
                scale-up of tools that are culturally acceptable;
                    (C) to address serious and all-too-common health 
                problems; and
                    (D) to contribute to the strengthening of health 
                systems.
            (13) In a recent report to Congress, USAID asserts that--
                    (A) health research is ``integral'' to its 
                ``ability to achieve its health and development 
                objectives worldwide''; and
                    (B) 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''.
            (14)(A) In ``Report to Congress: Health-Related Research 
        and Development Activities at USAID (HRRD), May 2011'', USAID 
        analyzed its activities from 2006 through 2010 and set forth a 
        5-year health research strategy for the next 5 years.
            (B) The new strategy is--
                    (i) an important source of information on USAID's 
                programs for global health product development; and
                    (ii) an effective tool for measuring expected 
                results from 2011 through 2015.
            (C) The strategy does not articulate USAID's investments 
        and programming for research and development in several 
        critical areas, including--
                    (i) new tools to diagnose, prevent, and treat 
                neglected tropical diseases;
                    (ii) research addressing the leading causes of 
                death and illness of women, newborns, and children; and
                    (iii) new tuberculosis vaccines.
            (15) USAID has established a variety of instruments to 
        promote innovation and global health, such as--
                    (A) Grand Challenges for Development;
                    (B) the Innovation Fund for the Americas;
                    (C) Higher Education Solutions Network (HESN);
                    (D) university Development Labs; and
                    (E) Research and Innovation Fellowships.
            (16) 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 (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.
            (17) The United States should invest in affordable, 
        appropriate health technologies, including--
                    (A) medical devices for maternal, newborn, and 
                child care;
                    (B) new vaccines;
                    (C) new vaccine technologies and delivery tools;
                    (D) safe injection devices;
                    (E) diagnostic tests for infectious diseases;
                    (F) new tools for water, sanitation, and nutrition;
                    (G) multipurpose prevention technologies;
                    (H) information systems and mobile health and 
                information systems; and
                    (I) innovative disease prevention strategies.
            (18) United States investments in the health technologies 
        set forth in paragraph (17) would--
                    (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) result in significant cost savings for 
                development assistance funds.
            (19) In circumstances where markets fail, public-private 
        partnerships are an effective way to develop, introduce and 
        scale up new health technologies.
            (20)(A) Product development partnerships (referred to in 
        this paragraph as ``PDPs'') are a model of public-private 
        partnership that is successfully accelerating research to 
        benefit the developing world.
            (B) PDPs are non-profit, nongovernmental entities that work 
        to accelerate the development of new tools to fight diseases in 
        resource-poor settings.
            (C) PDPs typically 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.
            (D) USAID has played a significant role in advancing the 
        PDP model through its financial support.
            (E) Between 2004 and 2013, the achievements of PDPs have 
        become increasingly successful at advancing new products 
        through the development pipeline towards registration, product 
        introduction, and use.
            (21) 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.
            (22)(A) A Center for Accelerating Innovation and Impact 
        (referred to in this paragraph as the ``Center'') 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.
            (B) For diseases and conditions in which 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.
            (C) The Center also catalyzes partnerships with the public 
        and private sectors to develop and rapidly deploy new products.
            (23) Since 1982, USAID has carried out a program to support 
        the development of health technologies through which USAID--
                    (A) has maximized the limited resources available 
                for global health;
                    (B) has ensured that products and medicines 
                developed for use in low-resource settings have reached 
                the people that need such products and medicines;
                    (C) has invented, designed, developed, or co-
                developed 85 health technologies; and
                    (D) has collaborated with more than 100 private-
                sector organizations, which have matched the funds 
                received from USAID by a 2:1 ratio.
            (24) The research and development activities of USAID are 
        complementary to the work of other Federal agencies.

SEC. 3. PURPOSES.

    The purposes of this Act are--
            (1) to acknowledge the role of the United States Agency for 
        International Development (referred to in this section as 
        ``USAID'') in product development, introduction, and scale-up 
        of new global health tools; and
            (2) to establish the Technologies for Health Program within 
        USAID to support the development of technologies for global 
        health that will--
                    (A) improve global health;
                    (B) reduce maternal, newborn, and child mortality 
                rates;
                    (C) improve health and nutrition;
                    (D) reverse the incidence of HIV/AIDS, malaria, 
                tuberculosis, and other infectious diseases;
                    (E) reduce the burden of chronic diseases;
                    (F) overcome technical, supply, and policy hurdles 
                to product introduction and scale-up; and
                    (G) support research and development that is 
                consistent with a global development strategy and other 
                related strategies developed by USAID.

SEC. 4. ESTABLISHMENT OF HEALTH TECHNOLOGIES PROGRAM.

    (a) In General.--Section 107 of the Foreign Assistance Act of 1961 
(22 U.S.C. 2151e) is amended by adding at the end the following:
    ``(c) Technologies for Health.--
            ``(1) Establishment.--There is established, within the 
        Health and Infectious Diseases and Nutrition Section of the 
        Global Health Bureau of the United States Agency for 
        International Development (referred to in this subsection as 
        `USAID'), the Technologies for Health Program (referred to in 
        this subsection as the `Program').
            ``(2) Functions.--The Program shall develop, advance, and 
        introduce affordable, available, and appropriate and primarily 
        late-stage technologies specifically designed--
                    ``(A) to improve the health and nutrition of 
                populations in developing countries;
                    ``(B) to reduce maternal, newborn, and child 
                mortality in such countries; and
                    ``(C) to improve the diagnosis, prevention, and 
                reduction of disease, especially HIV/AIDS, malaria, 
                tuberculosis, and other infectious diseases, in such 
                countries.
            ``(3) Agreement.--The Program shall be carried out under a 
        cooperative agreement between USAID and 1 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.
    ``(d) Action Plans.--The Administrator of USAID shall--
            ``(1) 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;
            ``(2) establish metrics to measure progress in implementing 
        the action plans; and
            ``(3) consider all options in implementing the action 
        plans, including the use of public-private partnerships.
    ``(e) Priority Global Health Interventions.--The Center for 
Accelerating Innovation and Impact of USAID shall continue its work to 
speed the development, introduction, and scale-up of priority global 
health interventions.''.
    (b) Savings Provision.--Section 107(c) of the Foreign Assistance 
Act of 1961, as added by subsection (a)--
            (1) authorizes the United States Agency for International 
        Development (referred to in this subsection and section 5 as 
        ``USAID'') to continue the health technologies research and 
        development activities carried out by USAID before the date of 
        the enactment of this Act; and
            (2) does not establish a new program for such purposes.

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

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, and annually thereafter for the following 4 
years, the Administrator of the United States Agency for International 
Development, after consultation with the Centers for Disease Control 
and Prevention, the Department of Defense, the Food and Drug 
Administration, and the National Institutes of Health, shall submit a 
separate report to Congress on the research and development activities 
carried out by USAID.
    (b) Matters To Be Included.--Each report submitted under subsection 
(a) shall include--
            (1) updates on the implementation of USAID's strategy for 
        using research funds to stimulate the development and 
        introduction of products in each of its global health and 
        development programs;
            (2) a description of USAID's collaborations and 
        coordination with other Federal departments and agencies in 
        support of translational and applied global health research and 
        development;
            (3) a description of USAID's collaborations and 
        coordination with partner governments, bilateral and 
        multilateral donors, and other relevant governmental entities 
        in support of translational and applied global health research 
        and development;
            (4) a description of USAID investments in science, 
        technology, and innovation;
            (5) an explanation of how technologies and research 
        products developed by USAID complement work being done by other 
        Federal departments and agencies; and
            (6) a list of technologies and research products that have 
        been introduced into field trials or use.
    (c) Consultation.--The Administrator of USAID shall annually 
consult 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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