PEPFAR Implementation: Progress and Promise


Institute of Medicine   

National Research Council


Public Briefing

March 30, 2007


Opening Statement


Jaime Sepulveda, M.D., Dr.Sc.



Presidential Chair and visiting professor, Global Health Sciences and School of Nursing, University of California, San Francisco


Chair, Committee for the Evaluation of the President's Emergency Plan for AIDS Relief (PEPFAR) Implementation


Only a quarter of a century after first reported, HIV/AIDS has become one of the largest global health scourges of all times. This preventable viral disease caused the death of almost 3 million people last year alone, while over 4 million others became infected. The majority of this disease burden occurs in the developing world, with Sub-Saharan Africa carrying the largest burden.  As a result, life expectancy in that region has decreased, causing enormous human suffering and long-lasting demographic, social and economic consequences.


The very rapid scientific discoveries on the etiology and modes of transmission, and later the development of effective treatment against HIV/AIDS are a tribute to human ingenuity. Our collective social response, however, has taken longer to get organized. Although still far from adequate, the global response to the epidemic is finally growing, and progress is evident on a number of fronts.  Hope has been restored based on a broad awakening of international commitment and strong evidence that the technical challenges can be met on a large scale. 


A major factor in the increasing global response is the President’s Emergency Plan for AIDS Relief, or PEPFAR.  This plan derives from a novel legislation passed by the U.S. Congress in 2003, which also mandated an evaluation of progress on this initiative.  It has been the challenge and privilege of our Institute of Medicine to be charged with the conduct of this independent evaluation.


The emergency plan set ambitious goals.  It seeks to support the prevention of seven million HIV infections, the treatment of two million people with AIDS, and the care of ten million orphans and others affected by this epidemic.  PEPFAR has focused on 15 countries, which collectively represent around 50 percent of the HIV infections worldwide (12 countries in Africa, plus Vietnam, Haiti, and Guyana).


Although the Leadership Act passed in May 2003, funds were not appropriated until January 2004, and the majority of the first year’s funding was not fully obligated until September 2004. When the committee completed its analysis in the fall of 2006, the initiative had been in full operation for only about two years.  Therefore this report is a study of the implementation of the program, not an assessment of its ultimate impact on prevention, treatment, and care.  Still, the committee was able to reach a number of conclusions about PEPFAR's progress to date and hit could advance more effectively.


Based on data provided by PEPFAR and on discussions with a wide range of people involved in implementing programs in the focus countries, the committee concludes that PEPFAR has made a good start toward meeting those targets and establishing the program to make further progress.


The committee’s recommendations for improvement are premised on the assumption that Congress will reauthorize the U.S. Global AIDS Initiative, and are directed toward helping PEPFAR continue the transition from emergency response to sustainability, and thus to make further progress toward both its five-year performance targets and the ultimate goal of the Leadership Act. None of the issues raised by the committee or its recommendations for enabling PEPFAR to progress more effectively should be construed as a lack of support for the U.S. Global AIDS Initiative or its authorizing legislation.


The initiative has supported the expansion of HIV/AIDS prevention, treatment, and care services in the focus countries, and it has done so in a short period of time and in the face of a number of obstacles.


The first three years of PEPFAR have been characterized by a sense of urgency and by rapid implementation of programs. That is understandable; each year that passes, several million more people become infected with HIV and several million more die from AIDS around the world. But because the fight against AIDS will be a protracted one, it is also important to build toward a sustainable program.


Sustainability is an increasingly important consideration, and thus a key recommendation of the report is that PEPFAR should continue to transition from its focus on emergency relief to an emphasis on the long-term strategic planning and capacity building that are necessary for a sustainable, long-term response.


To help support this transition from emergency relief to sustainability, the report identifies a number of opportunities for improving PEPFAR. One area of emphasis is what the global AIDS policy community refers to as harmonization.


The need for harmonization has a number of specific policy implications. The committee found, for example, that congressional budget allocations have limited PEPFAR's ability to tailor its activities to the local epidemic in each country and to harmonize with each country’s national plan. Therefore the report recommends that Congress replace budget allocations with other mechanisms that take into account the needs of individual countries and that allow spending to be directly linked with the efforts necessary to respond to those needs.


A second harmonization-related recommendation deals with how PEPFAR qualifies antiretroviral medications for use in the program. Most other donors and most of the PEPFAR focus countries rely on the World Health Organization (WHO) prequalification process as the accepted global standard for assuring the quality of generic medications, but PEPFAR requires that the medications it provide be approved by the U.S. Food and Drug Administration. This creates complications for countries obtaining antiretroviral medications through PEPFAR, and so the report recommends that the U.S. Global AIDS Coordinator should study WHO prequalification and support transitioning to it as rapidly as feasible.


The report describes a variety of other actions that are necessary for developing a sustainable response to the AIDS pandemic. For example, the ultimate success of the program will depend upon effective prevention. To that end, the report recommends accumulating better data on the precise nature of the epidemic in each country and then using that data to determine the most appropriate interventions and to target the interventions to the people who are most at risk.


The commitment of the U.S. Global AIDS Initiative to work toward reducing stigma and discrimination against people living with HIV/AIDS requires that marginalized and difficult-to-reach groups receive prevention, treatment, and care services. These groups include sex workers, prisoners, those who use injecting drugs, and men who have sex with men--groups that not only are characterized by their high-risk behavior, but also tend to be stigmatized and subject to discrimination.


The report recommends that PEPFAR increase its focus on the factors that put women and girls at greater risk of HIV/AIDS and to support improvements in their legal, economic, educational, and social status.


One of the greatest challenges facing the countries hit hardest by AIDS is a shortage of health care workers. Thus far, PEPFAR’s response to this problem has focused on training existing clinicians and other health care workers to deal with HIV and AIDS, but this approach is insufficient. Programs of all varieties-- particularly those providing antiretroviral therapy--are exceeding their capacity, have long waiting lists, and have insufficient numbers of staff. Thus, the report recommends that the U.S. Global AIDS Initiative should increase its support for expanding work force capacity in a manner consistent with country plans.


Because PEPFAR both is disease-specific and works in parallel with rather than through host governments, these challenges are especially compelling, requiring PEPFAR to be particularly vigilant to ensure that its implementation does not have unintended negative consequences for overall public health in the focus countries.


Although PEPFAR has supported a substantial expansion of prevention, treatment, and care services in the focus countries, further expansion is needed, as is better integration of programs according to a community-based, family-centered model of care.


Finally, the report emphasizes the importance of increasing our knowledge and understanding about what works against the pandemic. To this end, PEPFAR should continue to emphasize evidence-based approaches, learning from experience, and adaptation to new developments, as well as conducting operations research and program evaluations.


Overall, the committee concludes that PEPFAR has made a promising start, but there is an enduring need for U.S. leadership in the effort to respond to the HIV/AIDS pandemic.


This concludes my opening remarks. I and my colleagues would be happy to take your questions now. Please go to one of the microphones to ask your question or use the e-mail form on the National Academies Web site. And please identify yourself by name and affiliation before asking your question.