I 113th CONGRESS 1st Session H. R. 1515 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.

1. Short title This Act may be cited as the 21st Century Global Health Technology Act . 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. 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. 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. . 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.