Notes and references
1. Study of microbicide gel shows reduced risk of HIV and herpes infection in women [press release]. Durban, South Africa: University of KwaZulu-Natal; July 20, 2010.
2. Grant RM, Lama JR, Anderson PL, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. The New England Journal of Medicine. 2010; 363:2587–2599.
3. Nandi A. The Importance of the Global Health Sector in California: An Evaluation of the Economic Impact [PDF]. San Francisco: UC Global Health Institute; 2009.
4. The United States Government Global Health Initiative Strategy [PDF]. The United States Government. 2009. Accessed April 27, 2011.
5. Hormats RD. The Role of Innovation in Addressing Global Health. Remarks from the Under Secretary for Economic, Energy and Agricultural Affairs, March 17, 2011; Washington, DC. Accessed April 27, 2011.
6. Fact Sheet: U.S. Global Development Policy. Washington, DC: The White House Office of the Press Secretary; September 22, 2010.
7. Remarks by the President in the State of the Union Address [press release]. Washington, DC: The White House Office of the Press Secretary; January 25, 2011.
8. Among its priorities, the Quadrennial Diplomacy and Development Review aims to bolster the position of development as a core pillar of US foreign policy, as well as strengthen the US Agency for International Development’s role as the United States’ lead international development agency.
9. US National Institutes of Health (NIH) Research Portfolio Online Reporting Tools are available online. Accessed April 27, 2011.
10. The Foreign Assistance Dashboard is available online. Accessed April 27, 2011.
11. Report to Congress: Health-Related Research and Development Activities at USAID is available online. Accessed April 27, 2011.
12. In 2008, the World Health Organization (WHO) found that only about 20 percent of countries—all of them industrialized—have fully operational regulatory systems for medicines. Among the remaining 80 percent of countries, approximately one-half have varying regulatory capacities and approximately one-third have very limited or no regulation for medicine. According to WHO, more than two thirds of people worldwide live in countries with “marginal or inadequate” systems for ensuring drug quality, safety, and effectiveness.
13. A country’s inability to effectively regulate and monitor health tools can result in harmful consequences. In a March 2010 letter, the South African HIV Clinicians Society called on the country’s drug registration body, the Medicines Control Council (MCC), to fast track the approval of certain antiretroviral drugs for HIV/AIDS. According to the letter, the single greatest obstacle to obtaining affordable access to medicines appears to be the regulatory registration process, as some applications have been before the MCC for years. This delay in reviewing and approving HIV/AIDS drugs means that millions of people living with the disease in South Africa do not have access to these lifesaving therapies.
14. US Food and Drug Administration information on the US President’s Emergency Plan for AIDS Relief is available online. Accessed April 27, 2011.
15. US Food and Drug Administration (FDA). President’s Emergency Plan for AIDS Relief: Approved and Tentatively Approved Antiretrovirals in Association with the President’s Emergency Plan. Washington, DC. Accessed April 26, 2011.
16. The review group was created under legislation sponsored by former senator Sam Brownback (R-KS), which passed as an amendment to the US Department of Agriculture fiscal year 2010 appropriations bill.
17. Several speakers at the hearing (see summary available on Global Health Technologies Coalition website) proposed that the FDA strengthen its engagement with groups and entities such as product development partnerships (PDPs) to develop the tools to prevent, diagnose, and treat diseases of the developing world. It is crucial for the FDA to engage with nontraditional product sponsors, including PDPs, at several stages of development so that the agency can serve as a mentor to these groups on regulatory issues. Speakers called on the FDA to bolster its relationships with global regulatory stakeholders, such as the World Health Organization, national regulatory authorities, and regional regulatory networks.
18. NIH and FDA announce collaborative initiative to fast-track innovations to the public [press release]. Washington, DC: National Institutes of Health and US Food and Drug Administration; February 24, 2010.
19. US Food and Drug Administration (FDA). FDA’s International Posts: Improving the Safety of Imported Food and Medical Products [PDF]. FDA Consumer Health Information; March 2010.
20. US Food and Drug Administration (FDA). Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st Century [PDF]. Draft. US Food and Drug Administration: Washington, DC; September 29, 2010.
21. Global partners join forces to speed development of new TB drug combinations [press release]. Washington, DC: Global Alliance for TB Drug Development; March 18, 2010.
22. Senate Bill S.3606, 111th Congress [PDF], is available online. Accessed April 28, 2011.
23. Product development partnerships (PDPs) are nonprofit organizations with a mandate to research, develop, and support accessibility of new health tools that target diseases disproportionately affecting developing countries. PDPs advance global health goals by accelerating the development of products that may not otherwise be created.
24. US Department of Health & Human Services website. Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Programs. Accessed April 26, 2011.
25. World's poorest children among first to receive new life-saving pneumococcal vaccines [press release]. Geneva: GAVI Alliance; March 23, 2010.
26. In addition to Nicaragua, 18 countries are expected to launch the pneumococcal vaccine over the next few years with support from the GAVI Alliance. GAVI’s challenge to secure the additional financing needed to meet the demand from more than 40 countries for the pneumococcal vaccine over the next four years should be noted. Globally, an additional $3.7 billion will be needed to meet this demand.
27. US National Institutes of Health (NIH) first to share patents with medicines patent pool [press release]. Geneva: UNITAID; September 30, 2010.
28. The Pool for Open Innovation is administered by the group BIO Ventures for Global Health.
29. The Creating Hope Act [PDF] of 2011 would add Chagas disease to the list of eligible diseases and would also allow for multiple sales and transfers of a voucher once it is awarded. Allowing multiple sales and transfers would make the priority review voucher a more attractive option to private industry.
30. HR 5116, 111th Congress, is available online. Accessed April 28, 2011.
31. Saving lives at birth [press release]. Washington, DC: March 9, 2011.
32. USAID announces development innovation ventures program [press release]. Washington, DC: USAID; October 8, 2010.
33. Under the proposed program, patent holders who make their technologies available for humanitarian purposes would be eligible for a voucher for accelerated reexamination of a patent.
34. Public comments on the US Patent and Trademark Office’s proposed mechanism are available online. Accessed April 27, 2011.
35. The Global Health Technologies Coalition has developed a set of criteria (PDF available on the GHTC website) that the US Government and other partners can use to develop a rigorous evaluation framework.
36. In 2010, the Results for Development Institute (R4D) released its first policy assessment on accelerating research and development for global health diseases. “Prizes for Global Health Technologies” is a resource for US policymakers and other partners who are evaluating incentives and innovative financing. The report is the first in a series of policy evaluations to speed research in diseases primarily affecting low-income and developing nations.