What is the President's Emergency Plan for AIDS Relief?

12.07

The President’s Emergency Plan for AIDS Relief (PEPFAR) was announced by President Bush in his 2003 State of the Union Address as a five-year, $15 billion initiative to combat global HIV/AIDS, with the goals of reaching 2 million people with life-saving antiretroviral drugs (ARVs), preventing 7 million new infections and providing care to 10 million people affected by the disease. The majority of PEPFAR financing is focused in 15 of the hardest-hit countries¹ in Africa, the Caribbean and Asia.

President Bush recently proposed a five-year $30 bill ion extension of
PEPFAR
Annual appropriations to PEPFAR have increased significantly from $2.3 billion in FY2004 to $4.6 billion in FY2007. The proposed $30 billion will scale up from the FY2008 Request of $5.4 billion with a likely scale-up of an additional $200 million each year to 2013. If Congress appropriates the full amount outlined in the President’s plan, U.S. spending to fight global HIV/AIDS will reach a total of $48.3 billion over 10 years. The additional funding will allow the initiative to deliver increased results, reaching a total of 2.5 million people with ARVs, preventing a total of 12 million new infections and providing care to more than 12 million people, including five million orphans.

Slower scale up of funding and results from FY2009-FY2013
As the chart below demonstrates, under the President’s proposal, the scale up in both funding provided and results delivered will be slower during PEPFAR’s second five years than in its first.

• For example, a total of 2 million people are expected to be put on treatment by the close of 2008, but just 500,000 more will be added over the initiative’s next five years. The slower scale-up in treatment results, in particular, can be attributed to the significant cost of maintaining existing people on treatment and higher anticipated costs as some patients are forced to switch to more expensive second-line treatments.
• The scale-up in financing will also be slower during the initiative’s second five years, growing by an average of $200 million per year, compared with an estimated average of $600 million during the initiative’s first five years.

Origins of PEPFAR
For several years preceding President Bush’s 2003 State of the Union Address, bipartisan leaders in Congress—including Senators Frist and Kerry and Representatives Leach and Lee—had been considering legislation on global HIV/AIDS as well. After the President’s announcement, Congress passed the “United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003” (PL108-25) in May 2003, which authorized the framework under which PEPFAR would operate: the law provided for expansion and better coordination of U.S. bilateral and multilateral efforts on AIDS, tuberculosis, malaria and AIDS-related research with a focus on 15 countries. The law authorized spending $15 billion over five years for HIV/AIDS, TB, malaria and research and created the Office of the Global AIDS Coordinator (OGAC) to manage and coordinate all HIV/AIDS programs in developing countries. The law also mandated that the executive branch develop a five-year strategy to combat HIV/AIDS.

PEPFAR includes funding for more than just the 15 focus countries
Though many believe PEPFAR refers only to the 15 focus countries, it actually includes all U.S. global HIV/AIDS and TB efforts through both bilateral and multilateral mechanisms. Prior to the announcement of the President’s Malaria Initiative (PMI) in 2005, bilateral malaria programs were also included under PEPFAR. While most PEPFAR funding is directed through bilateral programs in the 15 focus countries, the initiative maintained existing bilateral HIV/AIDS and TB programs in 108 other countries, as well as research efforts. PEPFAR also includes the U.S. Government’s annual contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria, which operates in a total of 136 countries.

Is PEPFAR making a difference?
To date, U.S. bilateral programs have:

• Supported ARV treatment for 1.4 million people
• Provided 6.7 million people with care, including more than 2.7 million orphans and vulnerable children
• Provided 30 million people with voluntary counseling and testing (VCT) for HIV
• Provided services to prevent mother-to-child transmission of HIV during ten million pregnancies.

The Global Fund
The U.S. was a leader in the establishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria and has provided just under 30% of its resources to date. The Fund is set up to enable donors to pool their resources and allows recipient countries to submit applications tailored to their needs. To date, the Fund has committed $9.8 billion to more than 520 programs in 136 countries. Of this total, $4.7 billion has been disbursed. Some accomplishments of the Fund to date include:

• Supported ARV treatment for 1.4 million people
• Provided 3.3 million patients with treatment for TB
• Delivered more than 46 million insecticide-treated bed nets

Once overlap is accounted for, the U.S. is supporting a total of 1.58 million patients on treatment through PEPFAR and the Global Fund combined.

Organization
PEPFAR is centrally managed by the Department of State in the Office of the Global AIDS Coordinator (OGAC). The Global AIDS Coordinator, appointed by the President and confirmed by the Senate, carries the rank of Ambassador and reports directly to the Secretary of State; currently, Ambassador Mark Dybul is serving as the Global AIDS Coordinator, a post he has held since August, 2006.

As mandated by Congress, OGAC performs three roles in the implementation of PEPFAR:

1. Provides funding and direct oversight for programs in the 15 focus countries and monitors progress toward targets
2. Provides funding and general oversight to existing bilateral HIV/AIDS programs in 108 other countries. Direct oversight of these programs largely remains with implementing agencies, primarily the U.S. Agency for International Development (USAID) and the Centers for Disease Control (CDC)
3. Manages and disburses the U.S Government’s annual contribution to the Global Fund.

While the legislation authorizes assistance and appropriations for TB and malaria programs, the Global AIDS Coordinator does not directly manage TB and malaria programs or research (with the exception of programs to address TB/HIV coinfection), but works with other U.S. Government agencies to ensure coordinated programming efforts in countries with bilateral AIDS programs.

In all countries, OGAC relies on U.S. Embassies and key implementing agencies including USAID and CDC, as well as the Departments of Defense and Labor and the Peace Corps, to implement PEPFAR programs. In this way, OGAC serves as a central manager and coordinator for cross-agency collaboration, reducing duplication and capitalizing on each institution’s specialized expertise. Agencies collaborate with country leadership to develop “Country Operational Plans” which prioritize program activities. In focus countries, PEPFAR is administered by the U.S. ambassador who reports directly to the Global AIDS Coordinator.

Funding
When announced by the administration in 2003, the original plan for funding was to begin with $2 billion in FY2004 and scale-up by approximately $500 million per year to reach $4 billion by FY2008. The vast majority of these annual increases would be directed to the “Global AIDS Initiative” line item in the budget, where most funds for bilateral programs in the 15 focus countries would be channeled. Over time, due to widespread bipartisan support in Congress for both the expansion of the 15 country program and the Global Fund, funding levels have grown more quickly:

* Bilateral malaria funding was included in PEPFAR funding totals until the advent of the President's Malaria Initiative (PMI) in July 2005. All bilateral malaria funding is now counted as part of PMI and these funds are no longer included in PEPFAR funding totals.

The original authorizing law requires PEPFAR to divide its spending in the following way:

• 55% for the treatment of individuals with HIV/AIDS
• 15% for the care of individuals with HIV/AIDS
• 20% for HIV/AIDS prevention
• 10% for helping orphans and vulnerable children

Frequently Asked Questions
PEPFAR was born out of both a presidential commitment and an act of Congress. Through a combination of administration policy and the legislative process, certain provisions were included within the global HIV/AIDS legislation, some of which are controversial and frequently misunderstood.

1. How much does the U.S. spend on abstinence?
In total, the U.S. spends 20% of PEPFAR funds on prevention, and within prevention spending, PEPFAR’s prevention activities are divided equally between two types of interventions: prevention of nonsexual transmission (blood safety activities, prevention of mother-to-child transmissions, etc.) and prevention of sexual transmission (abstinence, being faithful, and condom use – commonly referred to as the A-B-C approach).

Much attention has focused on the earmark for abstinence until marriage programs. An amendment to the 2003 legislation cosponsored by Congressmen Pitts and Hyde required that 33% of prevention funding be directed to abstinence until marriage activities. OGAC’s guidance to the field directed country teams was to spend half of
prevention funds on sexual transmission prevention and two-thirds of those funds on abstinence/faithfulness (A and B) activities. (Roughly, this meant that 33% of all prevention funds would be directed to A and B combined). At the same time, OGAC permitted certain teams, especially those with relatively small budgets, to seek waivers from this policy to help them respond to local prevention needs. In FY2006,
OGAC planned to spend 7% of total PEPFAR funds (32% of total prevention funds) on abstinence and being faithful (A and B) activities combined. The Pitts/Hyde amendment is frequently confused in media accounts, which sometimes portray the earmark as a requirement that 33% of all PEPFAR spending go to abstinence programs, or even one-third of prevention going to abstinence. Neither is true. To date, no more than 10% of total PEPFAR funding has gone to abstinence and being faithful (A and B) activities, and no more than 7% has been spent on these activities since FY2005.

2. Which drugs may be purchased using PEPFAR funding?
The large scale-up of treatment was one of the most notable elements of the PEPFAR initiative. At the same time, however, PEPFAR guidelines stipulated that all drugs purchased must be “approved by a stringent regulatory authority or otherwise demonstrate quality, safety and efficacy at the lowest possible cost.” In practical terms, this required Food and Drug Administration (FDA) approval, but the FDA had not previously reviewed any of the commonly used generic anti-retroviral medications. During its first two years, PEPFAR was therefore prevented from purchasing generic anti-retroviral drugs, which were, on average, simpler for the patient to take and three times less expensive than branded medicine. In May 2004, the FDA announced an expedited review and inspection process for generic drugs, which allows approved generics to be purchased by PEPFAR. To date, the FDA has reviewed and tentatively approved 34 generic antiretroviral drugs. Of these, eight are suitable for pediatric use and eight are combination doses containing two or more drugs in a single tablet. Early data suggest that generics will account for 70 percent of AIDS drugs in three key countries, a sevenfold increase in one year.2 PEPFAR expects that moving to FDA-approved generics will save between 5% and 90% depending on the drug.3

3. What is the U.S. policy on prostitution in relation to HIV/AIDS programs?
The U.S. AIDS law states, “No funds made available to carry out this Act, or any amendment made by this Act, may be used to provide assistance to any group or organization that does not have a policy explicitly opposing prostitution and sex trafficking.” In May 2006, two U.S. District Courts ruled that this restriction violated the First Amendment and could not be applied to U.S.-based organizations. Foreign-based organizations wishing to receive PEPFAR funding, whether directly or indirectly, must still comply. While PEPFAR maintains there is no evidence of the restriction preventing organizations from working with prostitutes, some partners claim that such a strict anti-prostitution policy makes it difficult to establish the trust necessary to work with this marginalized population.

4. What is the role of faith-based organizations within PEPFAR?
PEPFAR has made reaching out to faith-based and community-based organizations a priority because of their role in providing many of the health services in focus countries. In FY2005, faith-based organizations comprised 7% of prime partners and 23% of sub-partners. On World AIDS Day (December 1) 2005, President Bush announced the “New Partners Initiative,” a program to provide $200 million for HIV prevention and care grants to focus country organizations with little or no experience working with the U.S. government. The U.S. will offer technical and capacity-building assistance to participants to help them compete for these new partner grants. Critics of NPI and PEPFAR’s prioritization of faith-based organizations more generally, worry that ideologically aligned organizations without the experience or capacity to implement HIV/AIDS programs will be relied upon to deliver these complicated interventions.