AVERT.ORG |
AVERT is an international AIDS charity |
What is the President's Emergency Plan for AIDS Relief?The President's Emergency Plan for AIDS Relief, often known as PEPFAR, is a U.S. five year $15 billion global initiative to combat the HIV/AIDS epidemic. When did PEPFAR start?In his State of the Union Address in January 2003, President Bush made a commitment to substantially increase US support to addressing the global HIV/AIDS epidemic.1 "I ask the Congress to commit $15 billion over the next five years, to turn the tide against AIDS in the most afflicted nations of Africa and the Caribbean" - President Bush. In May 2003, the US Congress approved, and President Bush signed into law, the "United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003" (PL108-25).2 This legislation approved expenditure of up to $15 billion over 5 years and it provides the legal and policy framework for the expenditure. Is this the total U.S. Government expenditure on HIV/AIDS?The sum of $15 billion is the proposed expenditure of the U.S. Government on HIV/AIDS outside of the U.S. over the next five years. This is in addition to domestic HIV/AIDS expenditure for which $17.5 billion was requested for fiscal year (FY) 2005. Will the money being spent by the U.S. Government to help with the Asian Tsumani relief effort, affect the money being provided for PEPFAR?Mark Grossman, the Under Secretary of State for Political Affairs, has stated that the money being provided by the U.S. Government for the Asian Tsumani relief effort, will not affect the $15 billion being provided for PEPFAR.3 What does the Leadership Against HIV/AIDS Act of 2003 say generally about President Bush's AIDS Plan?Congress has stated in the legislation that there should be a: "particular focus on the needs of families with children (including the prevention of mother to child transmission), women, young people, and children (such as unaccompanied minor children and orphans)" How is the money to be divided between different areas of work?Congress required that the PEPFAR money should be divided in the following way:
So PEPFAR has a very strong emphasis on the provision of treatment and care for people with AIDS, with only a fifth of the money being for HIV prevention work. And in FY 2006 through 2008, forty one per cent of the total money is to be spent on the purchase and distribution of antiretroviral drugs. In order that the legislation was passed there had to be considerable cooperation between people of differing political, religious and ideological views, which resulted in many people being dissatisfied with the outcome. Some people were dismayed by the requirement that a third of prevention resources had to be spent on programs promoting sexual abstinence before marriage, However, other people were equally dismayed that two thirds of prevention funds would be used for activities other than abstinence promotion, including condom dissemination.4 Who is in charge of PEPFAR?Ambassador Randall Tobias has been appointed as the U.S. Global AIDS Coordinator and is responsible for coordinating all U.S. Government HIV/AIDS activities. He is based in the Department of State and is directly responsible to the Secretary of State. Is the $15 billion all "new" money?Prior to the start of PEPFAR the U.S. Government was already spending significant sums on combating HIV/AIDS outside of the U.S, with most of this expenditure being through bilateral agreements (agreements between the US and one other country) and most of these agreements will continue. Of the total of $15 billion, $9 billion is extra funding, $5 billion is to continue these existing bilateral agreements (i.e. existing commitments) and $1 billion is money that is proposed should be provided to the Global Fund to Fight AIDS, Tuberculosis and Malaria. Will $15 billion definitely be provided?No, because although Congress has approved $15 billion, the actual amount to be provided each year will depend on how much Congress annually appropriates (approves for spending) for PEPFAR. How much money did President Bush request for PEPFAR in FY 2004 and how much was received?5President Bush requested $1,900 million for combating global HIV/AIDS, TB and Malaria, suggesting that the $3,000 million was an average and that the annual expenditure could be increased over the five year period. Congress insisted on increasing President Bush's figure by $500 million, and in January 2004 appropriated $2.4 billion for HIV/AIDS, TB and Malaria for the FY 2004, which ended on September 30th 2004. Of this total $1,258 million was for existing bilateral programs. In addition there was $488 million for the U.S. Global Coordinator's Office, $149 million for the Mother to Child Prevention Initiative, and $547 million for the Global Fund to Fight AIDS, Tuberculosis and Malaria. Of the overall total, $850 million was "new" money. What is the Mother to Child Prevention Initiative?This is a President Bush AIDS initiative, started in 2002, to reduce Mother to Child Transmission of HIV (MTCT) in 14 specific countries.6 These fourteen countries are the same countries listed below which are to be the main beneficiaries of the new PEPFAR initiative. The initiative committed $500 million over five years, and had the aim of reaching one million women with HIV testing and counselling and providing ARV prophylaxis to 80 per cent of HIV positive delivering women by the end of the initiative. Between October 1 2002 and March 31 2004 the U.S. Government provided $143 for the initiative. From FY 2005 both the funding and activity for the Mother to Child Initiative are to be included in PEPFAR. Which countries are going to benefit from PEPFAR?The Leadership Against HIV/AIDS Act of 2003 refers to funding relating to combating HIV/AIDS focusing on fourteen specific countries designated by the President, the fourteen countries being: Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia. These countries are usually now referred to as the "focus" countries. However, the Act of 2003 also says that the President may designate any other country in which the United States was implementing HIV/AIDS Programs in 2003. Why are there now fifteen focus countries?When Congress appropriated the funding for FY 2004, they required that a 15th focus country should be added, and that it should be outside of Africa and the Caribbean.7 Vietnam was added as an additional focus country in June 2004. When reference is made to PEPFAR does this just mean the fifteen focus countries?The acronym PEPFAR, or the full name, the "President's Emergency AIDS Plan", are often used confusingly as though they refer solely to the focus countries. However PEPFAR and the President's Emergency AIDS Plan refer to all the countries worldwide, and all associated HIV/AIDS expenditure and activities, that the U.S. government provides outside of the U.S. An example of non-focus country PEPFAR expenditure is the funding that is being provided for HIV/AIDS work in India. What are the goals of PEPFAR?President Bush talked about the goals when he made the first announcement of PEPFAR. "This comprehensive plan will prevent 7 million new 'AIDS' infections, treat at least 2 million people with life-extending drugs, and provide humane care for millions of people suffering from AIDS, and for children orphaned by AIDS." Following on from this, Congress specified, in the Leadership Against HIV/AIDS Act of 2003, that the aims for the provision of antiretroviral treatment should be that:
There was also in the Act the renewal of commitments on the prevention of mother to child transmission (PMTCT). At the United Nations Special Session on HIV/AIDS in June 2001, the United States committed to the specific goals with respect to the prevention of mother to child transmission, including the goals of reducing the proportion of infants infected with HIV by 20 percent by the year 2005, and by 50 percent by the year 2010, as specified in the Declaration of Commitment on HIV/AIDS adopted by the United Nations General Assembly at the Special Session. The Leadership Against HIV/AIDS Act of 2003 reaffirmed this commitment, by specifying that PEPFAR should provide for meeting or exceeding the goal of reducing the proportion by 20% by 2005, and by 50% by 2010. What progress is being made towards these goals?By July 2004 PEPFAR was supporting ART for at least 24,900 HIV infected men, women and children in nine countries. Of this number, the Emergency AIDS Plan was directly funding ART for approximately 18,800 HIV infected individuals at the point of service delivery. An additional 6,100 people were receiving indirect treatment support through U.S. Government contributions to national, regional or local activities. These numbers are considerably smaller than the targets set by Congress in the 2003 Act, but as Ambassador Tobias explains in his report on "Current Activities to Expand Treatment", the first money was not received from Congress until January 23, 2004, eight months after enactment, and full implementation of the program did not start until June 2004.8 It is planned that numerous additional sites in all 15 focus countries will soon be providing ART with the goal of reaching at least 200,000 people by June 2005. In January 2005 it was announced that PEPFAR provided ARV therapy to 155,000 people in the focus countries and an additional 17,000 in other countries by the end of September 2004.9 With regard to the targets on PMTCT, by March 2004, 34,000 women had been directly provided with ARV therapy to prevent infection of their unborn child, and as a result 4,800 infant infections had been averted.10 The explanation for this small number in terms of infections prevented, is that there has been a need to develop capacity in order to effectively scale up programs, with there being considerable limitations in respect both of human resources and sites able to provide PMTCT services. What are the treatment targets and numbers achieved by PEPFAR for individual focus countries?The table below gives the treatment targets by country for June 2005 and FY 2008, as well as giving the number provided with treatment by July 200411 and September 200412.
* Vietnam was designated a focus country on 23rd June 2004 and was not included in the reporting period to the end of September 2004. These numbers refer only to people receiving antiretroviral treatment supported by PEPFAR (for data on the total number of people receiving treatment from all sources, see our drug access table). How has this increase been achieved so quickly?There would seem to be several reasons for this rapid increase. Firstly, the early PEPFAR figures were provisional. Secondly, a large number of grants and a great deal of money have been provided very rapidly to organisations in certain focus countries, with priority for grants being given to organisations which were able very quickly to scale up the provision of treatment. Thirdly, 130,000 people are on treatment as a result of funding from the Global Fund, and the US Government has provided a third of all money for the fund. So the Global AIDS Coordinator has decided that when giving totals for people provided with treatment by PEPFAR, there should be included in the totals a third of all the people provided with treatment by the Global Fund, currently 43,000. Finally, in some countries such as Botwana, a small contribution to clinic costs by PEPFAR funds is resulting in all of the people attending certain clinics being credited to PEPFAR.13 PEPFAR, the Global Fund, and indeed WHO do seem to be attaching great importance to the number of people receiving ARVs, and who is credited with achieving this. It is indeed excellent news that in countries such as Kenya and Zambia, an increasing number of people are receiving treatment. However, there also needs to be great importance paid to the quality of treatment, because if insufficient attention is given to such matters as adherence then not only will people die despite receiving treatment, but also a great deal of money will be wasted. This sudden but very welcome increase in numbers, without further clarification, may also obscure some of the real difficulties which exist with the scaling up of treatment. What are some of the critical issues in the scaling up of treatment?A number of major difficulties have been identified as hampering the efforts to expand ARV treatment in the focus countries.14 These difficulties include:
What is the PEPFAR strategy document?In February 2004 the President's Emergency Plan for AIDS Relief, U.S. Five-Year Global HIV/AIDS Strategy was published (the Strategy Plan).15 Required by the Act of 2003, this document is the central policy document that interprets the provisions of the 2003 Act, and as Ambassador Tobias says at the start of the 100 page document, "The plan reflects our current best thinking about what needs to be done and what we believe it is possible to do." The document has major sections on critical interventions on prevention, treatment and care in the focus countries. It also discusses centrally managed interventions that will be needed such as an effective and accountable supply chain, and a strong research program to provide the necessary evidence base for the programs. Which U.S. Government Agencies are involved in distributing the money?The expenditure of money is coordinated by Ambassador Tobias' office, but is distributed through a number of government agencies which include the U.S. Agency for International Development (USAID), the U.S. Department of Health and Human Services Health (HHS), the U.S. Department of Defense, the Department of Labor, the Peace Corps and the Census Bureau.16 Within HHS a number of different agencies are involved including the Centre for Disease Control and Prevention (CDC), the Health Resource and Services Administration (HRSA), and the National Institute of Health (NIH). HHS manages the central funding for providing care and anti-retroviral therapy for HIV positive people, and prevention activities through safe blood programs. USAID manages the central funding for orphans and vulnerable children, for behaviour change through abstinence and being faithful, and for the Supply Chain Management System (SCMS) contract.17, 18 What is the Supply Chain Management System (SCMS) contract?HIV/AIDS programs require a large number of products, and as the Strategy Plan explains effective supply management is critical to the delivery of these products. Any interruption to the supply of antiretroviral drugs can be literally life threatening, but there is also a need to avoid waste, and to address such issues as drug diversion and counterfeiting. President Bush's AIDS Plan has the objective of providing an uninterrupted supply of high-quality, low cost products that flow through an accountable system, and in order to achieve this USAID is proposing to issue a contract to establish and operate: "a safe, secure, reliable, and sustainable Supply Chain Management System (SCMS) to procure and distribute pharmaceuticals and other commodities needed to provide care and treatment of people with HIV/AIDS and related infections."19 The SCMS is designed to provide a one-stop shopping point for HIV/AIDS supplies and supply-related services for use by all HIV/AIDS programs funded by President Bush's AIDS Plan. What is the value of the Supply Chain Management System (SCMS) contract?The minimum value of this contract will be $2,500,000 with further funding possibly being provided later. Some commentators have referred to this as being a $7 billion contract. However although products to the value of several billion dollars may be procured through this contract, the company or consortium awarded the contract will not receive a percentage of the value of the pharmaceuticals and medical supplies procured.20 What products can be purchased with PEPFAR money?A very large amount of PEPFAR money (probably several billion dollars) is going to be spent on the purchase of HIV antiretroviral drugs, and there are also going to be significant purchases of a wide range of other supplies. These other supplies include such diverse items as soap and non-sterile gloves (for home care kits), laboratory equipment for CD4 counts, other laboratory supplies such as fridges, and breast-milk substitutes (for the prevention of mother-to-child transmission).21 The strategy document specifies that all products purchased with Emergency AIDS Plan money must be "of the highest quality", and that "products will be procured from reliable manufacturers to ensure product safety and efficacy". But how is safety and efficacy to be confirmed? Safety and efficacy for all pharmaceuticals purchased with PEPFAR money, was subsequently explained as meaning that the drugs had to be approved by the US FDA or a regulatory agency in Canada, Japan or Western Europe.22 It would not be sufficient for drugs to have been pre-qualified by the World Health Organisation. How does this policy affect the purchase of generic drugs?The strategy document says that drugs purchased with PEPFAR money can be "bioequivalent versions of branded ARV and other medications", suggesting that generics could be purchased. However, the requirement for approval by the US FDA or a similar regulatory body, excludes the purchase of most generics as most generic antiretrovirals are currently only prequalified by WHO. So the US Global AIDS Corordinator would appear to be saying that generic drugs can be purchased with PEPFAR funds as long as the "safety and efficacy of the drugs can be assured", but safety and efficacy is then defined in such a way that most generic drugs are currently excluded.23 The policy totally excludes the purchase of Fixed Dose Combinations (FDCs), none of which are approved by the FDA. AVERT.org has more about low cost treatment and FDCs, as well as a page discussing the issues surrounding TRIPS, AIDS and generic drugs. In May 2004 the FDA announced an accelerated review process for FDCs as well as for new co-packaging of existing therapies, and it was agreed by Ambassador Tobias that drugs approved through this process could then be purchased with President Bush's Emergency AIDS money "where international patent agreements permit them to be purchased".24 But although FDA approval can be provided in as little as six weeks after submission of an application, the first drugs received "tentative" FDA approval through this route only in December 2004.25 How important is the exclusion of FDCs from PEPFAR purchasing?Potentially very important because of the beneficial affect FDCs have on adherence.26, 27 FDCs are not only very important for developing countries but could also be very useful for some people in more developed countries such as the USA and UK. If there really are issues about the quality of these products, then it would be extremely helpful if more effort, and money was spent on solving the quality problems, and if people could work together to reconcile their differing views of the value of different regulatory processes. Is it proposed that a very significant amount of PEPFAR money be spent on "abstinence until marriage" and other HIV prevention work?HIV prevention money only accounts for 20% of total PEPFAR expenditure, although Congress has specified that at least a third (of the 20%) of this money should be spent on abstinence until marriage programs. The grants provided through the USAID managed Abstinence and Healthy Choices for Youth Program have been the focus of considerable discussion, particularly with regard to the effectiveness of this approach at the apparent expense of other initiatives such as the distribution of condoms. More information about these grants is provided later on this page and in a page on PEPFAR funding. Are there other controversial areas?Another controversial area has been the circumventing of the Global Fund to Fight AIDS, Tuberculosis and Malaria, by directing the bulk of resources to a separate initiative. However, the U.S. Government is still the largest contributor to the Global Fund. The controversial areas of PEPFAR have at times overshadowed what has already been achieved, which is the channeling of hundreds of millions of newly appropriated funds to treatment programs for tens of thousands of AIDS patients in Africa and the Caribbean.28 How did the Global AIDS Coordinator plan the implementation of PEPFAR?It was clear from the very specific targets in the legislation that there was a need for the implementation of PEPFAR to take place as rapidly as possible. So planning proceeded along two "pathways" at the same time.
How were the five year focus country plans developed?The U.S. Global AIDS Coordinator asked the USAID Chief Of Mission in each country to undertake a strategic planning process to develop a five year plan for strengthening the quality, availability, and sustainability of treatment, prevention and care services.29 The planning process was to include all relevant U.S. Government (USG) entities, as well as the "host-country" government, the NGO sector, people living with AIDS, other bilateral and multilateral donors, and additional stakeholders. These five year plans had to be submitted to the Global AIDS Coordinator for review, and final approval had to be given by the Coordinator to "ensure consistency with congressional intent, administration policy, and program objectives". Funding levels for the focus countries was to be allocated on the basis of the five year strategic plans. By May 31 2004, 14 countries had had their first year plans totalling $589 approved. How was money to be distributed as quickly as possible?Three funding "tracks" were set up, known as Track 1, Track 1.5, and Track 2. With Track 1, and Track 1.5, the emphasis was on providing funding to organisations that were already doing work in certain areas, and who, with the provision of extra money, could significantly scale up their work. Track 1 initially provided funding to organisations, such as U.S. based NGOs, that could respond quickly in more than one country. Track 1 is also how money is provided for the very large centrally organised contracts, such as the Supply Chain Management Contract. Track 1.5 provided rapid funding to programs run by organisations in individual countries, but the organisations could still be either national or international organisations Track 2 initially provided funding for the first year of each focus country's five year plan. Track 2 funding will also presumably provide funding for the subsequent years of these five year plans. As with the other tracks, grants are being given to a wide range of organisations. Although initially considerable funding was provided through Track 1.5, to get as much activity started as quickly as possible, it would seem that increasingly money is going to be provided through Track 2 for funding of individual country plans, and Track 1 funding for those contracts that are centrally organised. When was the first "new" money given out? What was it given for?The first "new" money of $350 million was made available by Congress in February 2004, and within a few months $114 million had been made available through Track 1 and $232 through Track 2.30 Through Track 1 grants were provided for four main areas of activity.
Who was it given to?Some examples of Track 1 grants awarded on February 23rd 2004 are the awards given to:31
who between them will receive $16.7 million for HIV prevention with young people; and:
who between them received $92 million per year for five years to provide ART in multiple countries in Africa and the Caribbean. Some examples of Track 1.5 grants awarded at the same time are:
AVERT.org has an additional page with more examples and further details of PEPFAR funding. When was the second amount of "new" money given out?The second distribution of "new" money was $550 million made available by Congress in June 2004. This money was distributed as Track 2 funding for each countries first annual operational plan. Who has received Track 2 grants?It is difficult to determine who has received Track 2 grants because much of this money is being allocated at individual country level. Some information is however available through the US Embassies and the USAID Missions of the individual focus countries. Do we at least know how much Track 2 money is provided for each country?The Global AID Coordinator has given the following figures for the funding for each focus country in FY 2004, as well as figures for FY 2005.32
Has all the FY 2004 money been spent?All the "new" money for FY 2004 has been allocated to organisations for specific work, but what is uncertain is how long it is going to take organisations to effectively spend this money. And whether with substantially increased funding available for FY 2005, Ambassador Tobias is going to be able to distribute, and organisations are going to be able to spend, significantly larger sums. What is the budget for PEPFAR in FY 2005 and FY 2006?In FY 2005 President Bush requested $2.8 billion to combat global HIV/AIDS, TB and Malaria33 and Congress increased this to an approved $2.9 billion34. President Bush is reportedly going to ask Congress for $3.2 billion for FY 2006.35 Examples of funding provided by PEPFARAVERT.org has an additional page with more examples and further details of PEPFAR funding. Author Annabel Kanabus.
Last updated February 11, 2005 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||