II 113th CONGRESS 2d Session S. 2407 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.

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. (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. 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. 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. 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.