I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘21st Century Global 

5 Health Technology Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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1 (1) Research and development is a critical com2 ponent of United States leadership in global health. 

3 Research and innovation can help to break the cycle 

4 of aid dependency by providing sustainable solutions 

5 to long-term problems. Research and development 

6 for global health is crucial for meeting new and 

7 emerging challenges, creating efficiencies, strength8 ening health systems, shifting tasks and strength9 ening workforces, and increasing access to health 

10 services for the most vulnerable. Research suggests 

11 that advances in health and medical technologies 

12 have been the major drivers behind massive improve13 ments in health worldwide over the past century, re14 sulting in an average increase in life expectancies of 

15 21 years in low- and middle-income countries be16 tween 1960 and 2002. Additionally, new health tech17 nologies have a high return on investment. For ex18 ample, it is estimated that a new meningitis A vac19 cine developed in collaboration with the United 

20 States Agency for International Development 

21 (USAID), the Centers for Disease Control and Pre22 vention (CDC), the National Institutes of Health 

23 (NIH), and the Food and Drug Administration 

24 (FDA), will save $570,000,000 over the next decade 

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1 gency vaccination campaigns, freeing much needed 

2 resources for use elsewhere in overstretched health 

3 systems. 

4 (2) Five Federal agencies—NIH, USAID, the 

5 Department of Defense, CDC, and FDA—provide 

6 significant contributions each year to global health 

7 research and development. The United States Gov8 ernment is supporting the development of 200—55 

9 percent—of the 365 products in the global pipeline 

10 of products for neglected and poverty-related dis11 eases. 

12 (3) This commitment from the United States 

13 Government and its Federal agencies has led to a re14 markable increase in global health products. Forty15 five new health tools were registered between 2000 

16 and 2010, and the United States Government was 

17 involved in 24, or 53 percent, of these new global 

18 health products in the last decade including 6 drugs 

19 for malaria, 2 vaccines for pneumonia, 6 diagnostics 

20 for tuberculosis, and 2 drugs for leishmaniasis. 

21 (4) United States investments have enabled tre22 mendous progress in the introduction of new tech23 nologies for global health; however, gaps exist in 

24 bringing certain technologies through the develop25 ment process and rapidly scaling them up in the 


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1 field. Better coordination is needed between Federal 

2 agencies to align research strategies, identify and 

3 address gaps in product development activity and 

4 move products efficiently along the research-to-intro5 duction continuum. 

6 (5) Infectious diseases disproportionately im7 pact populations in low-income nations across Latin 

8 America, sub-Saharan Africa, and Asia. However, 

9 even in the United States, poor and vulnerable com10 munities are at much greater risk for contracting 

11 diseases usually considered to be diseases of the de12 veloping world. For example, cases of Chagas dis13 ease, which is found throughout Latin America, and 

14 dengue fever, endemic to Mexico and Central Amer15 ica, have been detected in southern States along the 

16 United States border with Mexico, in communities 

17 where poverty rates are high. 

18 (6) In collaboration with the World Health Or19 ganization (WHO) and its member states, the 

20 United States is a leading participant in discussions 

21 to improve coordination and financing of global 

22 health research and development. This process will 

23 establish mechanisms to map research needs, iden24 tify resource gaps, and set priorities to ensure that 


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1 the most crucial global health products are developed 

2 and delivered for maximum global health impact. 

3 (7) Because of its presence in the field, USAID 

4 is uniquely placed to assess local health conditions, 

5 then partner with public and private stakeholders to 

6 ensure the development and timely introduction and 

7 scale-up of tools that are culturally acceptable, ad8 dress serious and all-too-common health problems, 

9 and contribute to the strengthening of health sys10 tems. In a recent report to Congress, USAID calls 

11 health research ‘‘integral’’ to its ‘‘ability to achieve 

12 its health and development objectives worldwide’’ 

13 and states that innovation through research allows 

14 the agency ‘‘to develop and introduce affordable 

15 health products and practices and contribute to poli16 cies appropriate for addressing health-related con17 cerns in the developing world’’. The elevation of the 

18 Office of Science and Technology would assist 

19 USAID in achieving its global health and develop20 ment goals. In 2011, USAID outlined a 5-year 

21 health research strategy: ‘‘Report to Congress: 

22 Health-Related Research and Development Activities 

23 at USAID (HRRD), May 2011’’, with a timeline 

24 through 2010. This strategy is an important source 

25 of information on USAID’s programs for global 


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1 health product development and is an effective tool 

2 for measuring expected results from 2011 through 

3 2015. The strategy does not articulate USAID’s in4 vestments and programming for research and devel5 opment in several critical areas such as— 

6 (A) new tools to diagnose, prevent and 

7 treat neglected tropical diseases; 

8 (B) biomedical products, technologies and 

9 devices for conditions and diseases impacting 

10 maternal health, newborns, and children, in11 cluding research for vaccines for the leading 

12 causes of death in children; and 

13 (C) new tuberculosis vaccines. 

14 (8) Congress notes the interrelated initiatives 

15 that USAID has taken to advance science, tech16 nology, and innovation for development, including 

17 the Grand Development Challenges, the Innovation 

18 Fund, Higher Education Science Network, the De19 velopment Lab, and the Innovation Fellowship. 

20 (9) Research and development at USAID— 

21 (A) facilitates public-private collaboration 

22 in the development of global health tech23 nologies; 

24 (B) leverages public and private sector 

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1 ment of health technologies to encourage pri2 vate sector investment in late-stage technology 

3 development and product introduction in devel4 oping countries; 

5 (C) benefits the United States economy by 

6 investing in the growing United States global 

7 health technology sector, which— 

8 (i) provides skilled jobs for American 

9 workers for example, 64 cents of every 

10 United States dollar invested in global 

11 health research benefits United States12 based researchers; 

13 (ii) creates opportunities for United 

14 States businesses in the development and 

15 production of new technologies; and 

16 (iii) enhances United States competi17 tiveness in the increasingly technological 

18 and knowledge-based global economy; and 

19 (D) enhances United States national secu20 rity by— 

21 (i) reducing the risk of pandemic dis22 ease; and 

23 (ii) contributing to economic develop24 ment and stability in developing countries. 


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1 (10) Investments by the United States in af2 fordable, appropriate health technologies, such as 

3 medical devices for maternal, newborn, and child 

4 care; new vaccines; new vaccine technologies and de5 livery tools; safe injection devices; diagnostic tests 

6 for infectious diseases; new tools for water, sanita7 tion, and nutrition; multipurpose prevention tech8 nologies; information systems and mobile health and 

9 information systems; and innovative disease preven10 tion strategies— 

11 (A) reduce the risk of disease transmission; 

12 (B) accelerate access to life-saving global 

13 health interventions for the world’s poor; 

14 (C) reduce the burden on local health sys15 tems; and 

16 (D) have been found by the United States 

17 Government and WHO to result in significant 

18 cost savings for development assistance funds. 

19 (11) Where markets fail, public-private partner20 ships are an effective way to develop, introduce and 

21 scale up new health technologies. Product develop22 ment partnerships (PDPs) are one model of public 

23 private partnership that is successfully accelerating 

24 research to benefit the developing world. PDPs are 

25 non-profit, nongovernmental entities that work to 


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1 accelerate the development of new tools to fight dis2 eases in resource-poor settings. Typically, PDPs 

3 manage resources and partnerships from across pub4 lic, private, and philanthropic sectors to drive the 

5 development of a full pipeline of potential new prod6 ucts that could save and improve lives in the devel7 oping world. USAID has played a significant role in 

8 advancing the PDP model through its financial sup9 port. Over the past decade, the achievements of 

10 PDPs have become increasingly successful at ad11 vancing new products through the development pipe12 line towards registration, product introduction, and 

13 use. 

14 (12) USAID supports research and introduction 

15 activities along a research-to-use continuum includ16 ing— 

17 (A) evidence reviews and health assess18 ments in developing countries; and 

19 (B) the development, testing, adaptation, 

20 and introduction of appropriate products and 

21 interventions within the context of strength22 ening health systems. 

23 (13) A Center for Accelerating Innovation and 

24 Impact has been established at USAID to address 

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1 ment, introduction and scale-up of new products and 

2 technologies for global health. For diseases and con3 ditions where market forces have proven insufficient 

4 to generate and rapidly deliver new technologies, the 

5 Center promotes and reinforces solutions to over6 come obstacles such as regulatory inefficiencies in 

7 developing countries, limited user demand, gaps in 

8 market data and supply chain hurdles. The Center 

9 also catalyzes partnerships with the public and pri10 vate sectors to develop and rapidly deploy new prod11 ucts. 

12 (14) Through a cooperative agreement, known 

13 as the Health Technologies program, USAID sup14 ports the development of technologies that— 

15 (A) maximize the limited resources avail16 able for global health; and 

17 (B) ensure that products and medicines 

18 developed for use in low-resource settings reach 

19 the people that need such products and medi20 cines. 

21 Through the Health Technologies program, 85 tech22 nologies have been invented, designed, developed or 

23 co-developed and more than 100 private-sector col24 laborators have been involved in the Health Tech25 nologies program, matching USAID dollars at least 


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1 two to one. Over its 25-year history, more than 95 

2 private-sector collaborators have been involved in the 

3 Health Technologies program, matching USAID dol4 lars two to one. 

5 (15) USAID’s research and development is 

6 complementary to the work of other agencies. 

7 SEC. 3. PURPOSES. 

8 The purpose of this Act is to acknowledge USAID’s 

9 role in product development, introduction and scale-up of 

10 new global health tools and authorize USAID’s Health 

11 Technologies program, in effect as of the date of the en12 actment of this Act, under which the United States Agen13 cy for International Development supports the develop14 ment of technologies for global health to— 

15 (1) improve global health; 

16 (2) reduce maternal, newborn, and child mor17 tality rates; 

18 (3) reverse the incidence of HIV/AIDS, malaria, 

19 tuberculosis, and other infectious diseases; 

20 (4) reduce the burden of chronic diseases; 

21 (5) overcome technical, supply and policy hur22 dles to product introduction and scale-up; and 

23 (6) support research and development that is 

24 consistent with a global development strategy and 

25 other related strategies developed by USAID. 


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1 SEC. 4. CODIFICATION OF HEALTH TECHNOLOGIES PRO2 GRAM. 

3 Section 107 of the Foreign Assistance Act of 1961 

4 (22 U.S.C. 2151e) is amended by adding at the end the 

5 following: 

6 ‘‘(c) HEALTH TECHNOLOGIES PROGRAM.—(1) There 

7 is established in the United States Agency for Inter8 national Development (USAID) a health technologies pro9 gram (referred to in this subsection as the ‘program’). 

10 ‘‘(2) The program shall develop, advance, and intro11 duce affordable, available, and appropriate and primarily 

12 late-stage technologies specifically designed to— 

13 ‘‘(A) improve the health and nutrition of popu14 lations in developing countries; 

15 ‘‘(B) reduce maternal, newborn, and child mor16 tality in such countries; and 

17 ‘‘(C) improve the diagnosis, prevention, and re18 duction of disease, especially HIV/AIDS, malaria, 

19 tuberculosis, and other infectious diseases, in such 

20 countries. 

21 ‘‘(3) The program shall be carried out under a coop22 erative agreement between USAID and one or more insti23 tutions with a successful record of— 

24 ‘‘(A) advancing the technologies described in 

25 paragraph (2); and 


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1 ‘‘(B) integrating practical field experience into 

2 the research and development process in order to in3 troduce the most appropriate technologies. 

4 ‘‘(4) The provisions of this subsection codify the coop5 erative agreement, known as the Health Technologies pro6 gram, in effect as of the date of the enactment of this 

7 subsection, under which USAID supports the development 

8 of technologies for global health. The provisions of this 

9 subsection do not establish a new cooperative agreement 

10 or program for such purposes. 

11 ‘‘(d) ACTION PLANS.—The Administrator of the 

12 United States Agency for International Development 

13 (USAID) shall establish and implement action plans to in14 corporate global health research and product development 

15 within each of the global health and development pro16 grams, with support from coordinating agencies, and shall 

17 establish metrics to measure progress. In implementing 

18 the action plans, the Administrator shall consider all op19 tions, including the use of public private partnerships. 

20 ‘‘(e) PRIORITY GLOBAL HEALTH INTERVENTIONS.— 

21 The Center for Accelerating Innovation and Impact of the 

22 United States Agency for International Development shall 

23 continue its work to speed the development, introduction, 

24 and scale-up of priority global health interventions.’’. 


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1 SEC. 5. REPORT ON RESEARCH AND DEVELOPMENT AC2 TIVITIES AT USAID. 

3 (a) IN GENERAL.—The Administrator of the United 

4 States Agency for International Development (referred to 

5 in this section as ‘‘USAID’’) shall submit to Congress an 

6 annual report on research and development activities at 

7 USAID. 

8 (b) MATTERS TO BE INCLUDED.—The report re9 quired by subsection (b) shall describe— 

10 (1) updates on the implementation of its strat11 egy for using research funds to stimulate the devel12 opment and introduction of products in each of its 

13 global health and development programs; 

14 (2) USAID’s collaborations and coordination 

15 with other Federal departments and agencies in sup16 port of translational and applied global health re17 search and development; 

18 (3) its investments for the fiscal year in science, 

19 technology, and innovation; 

20 (4) how these technologies and research prod21 ucts complement the work being done by other Fed22 eral departments and agencies, if applicable; and 

23 (5) technologies and research products that 

24 have been introduced into field trials or use. 

25 (c) CONSULTATION.—The Administrator of USAID 

26 shall consult on an annual basis with the heads of other 


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1 Federal departments and agencies to improve alignment 

2 of USAID’s health-related research strategy with other 

3 similar agency strategies, with the intent of working to4 wards a whole-of-government strategy for global health re5 search and development. 

Æ 


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