Health Affairs

In 2003 the United States created the President's Emergency Plan for AIDS Relief (PEPFAR), a major program of assistance to foreign countries affected by HIV/AIDS. The program has since pumped tens of billions of dollars into low- and middle-income countries to help them put millions of people on anti-HIV drugs; provide additional medical and supportive care for millions of others, including orphans and vulnerable children; and put in place an array of programs aimed at preventing the spread of HIV.

The law authorizing PEPFAR will be considered for reauthorization in 2013. Although it is likely that the program will be extended, Congress will probably debate a number of issues, including the amount of funding to be devoted to the program, given constraints on federal spending. A central concern is that spending on PEPFAR might be curbed at the same time that important gains could be made by increasing resources to stop the spread of HIV.

This brief describes the context in which PEPFAR was crafted, how the program has evolved, issues under debate, and policy considerations for the future.

PEPFAR is a broad-based program of US assistance to a select number of countries affected by HIV/AIDS. Today, it provides funding and program support in more than 30 countries. PEPFAR pays for antiretroviral drugs for an estimated 4 million people; other medical care for people with HIV; testing, counseling, and prevention services; care for children who have lost one or both parents to HIV/AIDS and other children made vulnerable by the epidemic; and technical assistance to strengthen health systems in countries hard hit by the epidemic (Exhibit 1).

Exhibit 1
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PEPFAR programs are carried out largely through an array of "implementing partners," including foreign governments and their health agencies, international and domestic nongovernmental organizations, and private sector firms.

DESTABILIZING IMPACT: Before the creation of PEPFAR in 2003, skyrocketing rates of HIV infection threatened to destabilize sub-Saharan Africa and trigger broader epidemics of HIV/AIDS in countries ranging from Haiti to Vietnam. In Botswana and Swaziland, nearly 4 of every 10 adults ages 15 to 49 were living with HIV, while in South Africa, more than 1 in 4 adults were infected. More than half of all Africans living with HIV were women.

Although the majority of HIV-infected people in developed countries were surviving through drug therapy, the high cost of the drugs put them out of reach of poor countries. As a result, the disease was killing an entire generation of working-age adults in many nations, leaving behind about 12 million children who had lost one or both parents in sub-Saharan Africa alone. Life expectancy plummeted in the hardest-hit countries. The World Bank reported in 2002 that AIDS related complications were killing teachers in some parts of Africa faster than replacements could be trained.

In the late 1990s and early 2000s, pressure had begun to build on pharmaceutical companies to make HIV drugs more readily available and affordable. There were also rising demands that large industrialized nations take a vastly expanded role in fighting HIV/AIDS. In 2002 the multilateral Global Fund to Fight AIDS, Tuberculosis, and Malaria was created to channel support from international donors to AIDS-affected countries, and the United States became the fund's largest single country donor.

In addition to its contribution to the Global Fund, the United States had been supporting relatively small programs of "bilateral aid" or direct assistance to AIDS-affected countries. These have been delivered by several different agencies without a central coordinating body and with no unified, overall strategy.

Beginning in 2002 President George W. Bush began to take a great personal interest in the issue of global HIV/AIDS, supported by evangelical and conservative groups and encouraged by passionate aides. He first directed a broad expansion of a program to halt the transmission of HIV from pregnant or breastfeeding mothers to children. Then, at his State of the Union address in 2003, Bush proposed the creation of the emergency relief program that would focus on getting life-saving treatment to people in 15 priority countries.

PASSAGE INTO LAW: In May 2003 Congress enacted Bush's proposal into law, authorizing $15 billion over a five-year period to create PEPFAR and to support the Global Fund. More than half (55 percent) of the funding was to be spent on treatment with the class of effective HIV-fighting drugs known as antiretrovirals. The law established three targets: preventing 7 million new infections; treating 2 million people living with HIV and AIDS; and caring for 10 million people living with or affected by HIV and AIDS, including orphans and vulnerable children.

PEPFAR was created with several characteristics that distinguished it from other development assistance programs. The Office of the US Global AIDS Coordinator used a military "central command" model to coordinate efforts across various federal agencies, such as the US Agency for International Development and the Centers for Disease Control and Prevention. At the country level, the US ambassador was charged with coordination.

Designed to be results driven, PEPFAR required data to prove that it was working. Thus, reporting requirements were established that far exceeded the norm at the time. PEPFAR was premised on a partnership approach in which the United States would play a supporting role to host governments, with shared responsibility for success.

CONTROVERSY FROM START: PEPFAR was not without controversy or pitfalls. In creating PEPFAR, Congress set specific budget allocations for prevention initiatives that directed a third of prevention funding into programs that promoted abstinence before marriage, despite the lack of evidence about its effectiveness and the inherent difficulties in implementing such a policy.

Subsequently, under pressure from conservative lawmakers, the Bush administration prohibited federal agencies from directing any PEPFAR funding to organizations that represented or assisted sex workers or refused to sign a pledge indicating that they would not promote prostitution. (That requirement has since been rescinded.)

Moreover, in the early years of PEPFAR, policy required use of Food and Drug Administration (FDA)-approved antiretroviral drugs only. These were typically brand-name drugs, which were 10 to 40 times more costly than generic antiretrovirals that were beginning to come on the market, often in foreign countries. Eventually, the FDA developed a policy to rapidly approve generic drugs, and treatment costs fell. In Mozambique, for example, annual antiretroviral drug treatment costs dropped from $265 to $145 per person.

More broadly, concerns have been voiced that PEPFAR and other "vertical" health programs--those aimed at one condition or disease--siphon resources away from "horizontal" programs--those designed to strengthen countries' health systems--to address health needs for the broad population. However, some evidence suggests that PEPFAR support has had both vertical and horizontal effects, namely treating HIV and strengthening health systems generally.

For example, Margaret E. Kruk of Columbia University and her coauthors looked at how 257 PEPFAR-supported HIV programs in eight sub-Saharan African countries affected other maternal health programs. Writing in the July 2012 issue of Health Affairs, they report that PEPFAR-funded infrastructure investments, such as on-site laboratories at health clinics, were associated with more deliveries by women not infected with HIV from 2007 to 2011.

CONSIDERABLE SUCCESS: Controversy notwithstanding, the program reported that its first five years resulted in considerable success from many perspectives. PEPFAR officials have estimated that the program has averted an estimated 240,000 infant HIV infections and more than 600,000 adult deaths in Africa. They also estimate that it provided care to more than 10 million people, including 4 million orphans and vulnerable children. In addition, it also reached an estimated 58 million people through community prevention programs, supplied more than 2.2 billion condoms, and tested nearly 16 million pregnant women to prevent mother-to-child HIV transmission. The Institute of Medicine is now conducting an independent review of PEPFAR's accomplisments, which, in effect, will serve as an audit of these reported results.

In 2008 Congress reauthorized the program for another five years, under what is known as the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDs, Tuberculosis, and Malaria Reauthorization Act. This law authorized up to $48 billion, of which approximately $39 billion was designated for PEPFAR and the balance for the Global Fund. The 2008 law also expanded PEPFAR's reach to include Central Asia, Eastern Europe, and Latin America. The Lantos-Hyde Act set new prevention and treatment targets for PEPFAR to be achieved by 2014: more than 2 million people were to be placed on treatment; care was to be provided to 12 million people, including 5 million orphans and vulnerable children; and 12 million new infections were to be prevented.

The law required 50 percent of funding to be spent on antiretroviral drug treatment and other treatment services for HIV-infected people, and had targets for training 140,000 new health workers. It also added new language to strengthen monitoring and impact evaluation of PEPFAR's programs.

In addition, the reauthorized statute removed the requirement that one-third of all prevention funds be spent on abstinence programs. But it required a report to Congress if prevention programs in high-prevalence countries failed to spend at least half of prevention monies on such activities as promoting abstinence before marriage, monogamy, fidelity, and reduction in the number of sexual partners.

In the years since its creation, PEPFAR, together with the Global Fund, has helped to slow the spread of the pandemic and lay the groundwork for ending it. In addition to providing treatment, care, and prevention initiatives, aspects of the program have also sought to address underlying social determinants of the epidemic, which include gender inequality, poverty, and stigma related to the disease and discrimination against people living with HIV and AIDS, particularly men who have sex with men, sex workers, and injection drug users.

PEPFAR's support, as well as that of the Global Fund, has produced broad socioeconomic benefits in affected countries. Many people on the verge of dying have regained their health and even returned to work. One study found, for example, that a group of South African men and women placed on antiretroviral treatment experienced nearly complete recovery of employment four years after beginning therapy. Another found that children living in households with infected adults on treatment are more likely to attend school than those in households with untreated adults.

Going forward, PEPFAR faces several key challenges, as follows:

• Improving program efficiencies. Constrained resources demand strengthened efforts to reduce costs, improve efficiency, and increase the impact of global HIV programs. Writing in the July 2012 issue of Health Affairs, Charles B. Holmes, chief medical officer and director of the Office of Research and Science in the Office of the US Global AIDS Coordinator at the State Department, and coauthors describe results of PEPFAR's Impact and Efficiency and Acceleration Plan. This initiative is working to improve the collection and use of economic and financial data, increase the efficiency of HIV/AIDS program implementation, and encourage collaboration with governments and organizations to maximize the impact of resources.
  
  Eric Goosby, US Global AIDS Coordinator at the State Department, observes that PEPFAR will need to continue expanding and sharing its understanding of what works and focus on evidence-based "combination prevention" strategies, such as providing antiretroviral treatments for people living with HIV; preventing mother-to-child transmission; and encouraging voluntary male circumcision, while also employing conventional prevention methods, such as using condoms and counseling people to be monogamous or to reduce the number of sexual partners.
  
  Writing in the July 2012 issue of Health Affairs, Goosby identifies several other strategies, including making "smart investments" that focus on proven interventions and tapping into private-sector expertise to improve supply chain, marketing, and distribution networks.
  
  
• Building the health workforce. Writing in the July 2012 issue of Health Affairs, Michael H. Merson, director of Duke University's Global Health Institute, and coauthors describe various PEPFAR capacity-building efforts that seek to strengthen in-country leadership and the Medical Education Partnership Initiative and the Nursing Education Partnership Initiative, which seek to increase the number of local health workers, improve local medical and nursing education, and strengthen local research capacity. Goosby also notes that in 2011, PEPFAR and other US government agencies supported the launch of the African Society for Laboratory Medicine--a pan-African organization dedicated to improving laboratory medical practices, science, systems, and networks.
  
  
• Promoting sustainability. Under PEPFAR's Partnership Framework, explicit commitments have been sought and obtained from host governments to work toward sustainable, "country-owned" programs of HIV/AIDS services integrated into national health systems. Over time, the objective is to diminish or withdraw US funding and turn most, if not all, responsibility for battling HIV/AIDS--both in terms of paying for health services and providing them--over to the affected countries.
  
  Many countries are still not in a position to implement or fund programs on their own and need continued assistance. The development dilemma is how to move countries away from PEPFAR assistance without sacrificing the progress made during the past nine years. One suggestion has been to redirect some or all US support to the Global Fund over time. The Global Fund would then, as it does now, channel support to country-led programs to fight HIV/AIDS, malaria, and tuberculosis until countries are in a better position to handle these health concerns themselves.
  
  
• Treatment as prevention. Going forward, PEPFAR and other global HIV/AIDS programs may face tensions over maintaining treatment for the millions who are already on it, while at the same time expanding treatment to millions more far earlier in the infection and disease process. Thanks to substantial progress in science, dramatic opportunities appear to have opened up to make great strides in preventing HIV and further reducing the burden of HIV/AIDS. Interim results of a key clinical trial reported in 2011 showed that, when one member of a couple was infected with HIV and the other wasn't, having the infected person go on antiretroviral drugs much earlier than was previously thought necessary virtually halted sexual transmission of the virus to the noninfected person. New trials will now test whether earlier use of antiretroviral drugs can halt transmission of the virus more broadly.

In addition, other trials continue to test the merits of "preexposure prophylaxis," or giving antiretroviral drugs to noninfected people to prevent them from acquiring the virus. And another intervention, voluntary medical circumcision of adult males, has been shown to reduce the chance of HIV transmission by about half.

These findings have led to new combination prevention strategies, through which broadening the use of antiretroviral drugs and male circumcision are added to conventional prevention methods, such as using condoms and counseling people to be monogamous or to reduce the number of sexual partners. Ultimately, the costs of administering drugs much more widely will be large, and will have to be weighed against ethical imperatives to support those already on treatment as well as the benefits of further reducing transmission of HIV.

In a speech in November 2011, Secretary of State Hillary Rodham Clinton called on the United States and other international partners to harness this new potential to prevent tens of millions of HIV infections and create an "AIDS-free generation" within a decade. To work toward that goal, on World AIDS Day in December 2011, President Barack Obama announced increased targets for PEPFAR for 2013, calling for a total of 6 million people to be on antiretroviral therapy; 4.75 million voluntary male circumcisions to be carried out; and treatment to be provided to 1.5 million HIV-infected pregnant women to prevent mother-to-child transmission of HIV. These are ambitious targets that will require considerable new resources.

PEPFAR faces reauthorization at a time when fiscal concerns that have already put pressure on its budget are likely to be heightened. With measureable improvement in battling the AIDS pandemic, the sense of crisis among many US policy makers has diminished, and some lawmakers now question whether PEPFAR needs to be maintained.

Others argue that the crisis is far from over, and that the numbers of new infections will continue to outpace the numbers of people receiving antiretroviral medications and other needed assistance unless funding is boosted. There is also the moral question of whether the United States could walk away from funding treatments to people with HIV and AIDS who currently are supported by PEPFAR funds.

Although it seems likely that the program will be reauthorized, given its longstanding bipartisan support, what is far less certain is the amount of funding that Congress will authorize and eventually appropriate. The outcome is likely to hinge, in part, on the political composition of Congress and on who occupies the White House in 2013.

Bristol, Nellie, "Slow Going for the Global Health Initiative," Health Affairs 30 no. 6 (2011): 1007-9.

Goosby, Eric, "The President's Emergency Plan for AIDS Relief: Marshalling All Tools at Our Disposal toward an AIDS-Free Generation," Health Affairs 31, no. 7 (2012): 1593-8.

Government Accountability Office, "President's Emergency Plan for Aids Relief: Agencies Can Enhance Evaluation Quality, Planning, and Dissemination," GAO-12-673, May 2012.

Holmes, Charles B., John M. Blandford, Nalinee Sangrujee, Scott R. Stewart, Amy DuBois, Tyler R. Smith, et al., "PEPFAR's Past and Future Efforts to Cut Costs, Improve Efficiency, and Increase the Impact of Global HIV Programs," Health Affairs 31, no. 7 (2012): 1553-60.

Institute of Medicine, "Strategic Approach to the Evaluation of Programs Implemented under the Tom Lantos and Henry J. Hyde U.S. Global Leadership against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008," July 7, 2010.

Kaiser Family Foundation, "The U.S. President's Emergency Plan for AIDS Relief (PEPFAR)," November 2009.

Kendall, Alexandra E., "U.S. Response to the Global Threat of HIV/AIDS: Basic Facts," Congressional Research Service, June 15, 2012.

Kruk, Margaret E., Aleksandra Jakubowski, Miriam Rabkin, Batya Elul, Michael Friedman, and Wafaa El-Sadr, "PEPFAR Programs Linked to More Deliveries in Health Facilities by African Women Who Are Not Infected with HIV," Health Affairs 31, no. 7 (2012): 1478-88.

Merson, Michael H., James W. Curran, Caroline Hope Griffith, and Braveen Ragunanthan, "The President's Emergency Plan for AIDS Relief: From Successes of the Emergency Response to Challenges of Sustainable Action," Health Affairs 31, no. 7 (2012): 1380-8.

PEPFAR, "The U.S. President's Emergency Plan for AIDS Relief: Eighth Annual Report to Congress," 2012.

Written by
Mary Mulhern Kincaid
President
Iris Group

Editorial review by
Michael H. Merson
Director
Duke Global Health Institute
Duke University

Ted Agres
Senior Editor
Health Affairs

Susan Dentzer
Editor-in-Chief
Health Affairs

Health Policy Briefs are produced under a partnership of Health Affairs and the Robert Wood Johnson Foundation.

Cite as:
"Assistance for Global HIV/AIDS," Health Affairs, July 13, 2011.

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