President's Emergency Plan for AIDS Relief

What is PEPFAR?

The President's Emergency Plan for AIDS Relief, also known as PEPFAR, is America's initiative to combat the global HIV/AIDS epidemic.

When did PEPFAR start?

President George W. Bush signs the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003

In his State of the Union Address in January 2003, President George W. Bush made a commitment to substantially increase US support for addressing HIV/AIDS worldwide.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 George W. 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".² This legislation approved expenditure of up to $15 billion over 5 years and it provided the legal and policy framework for the expenditure.
The first "new" money of $350 million was made available by Congress in January 2004.³ Full implementation of PEPFAR began in June 2004.
PEPFAR was reauthorised for a further five years when President Bush signed the “Tom Lantos and Henry J Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008”, in July 2008.⁴ The act authorised up to $48 billion for PEPFAR for fiscal years (FY) 2009-2013. It was named in honour of two late congressmen, one Republican and one Democrat, who authored the original 2003 act.

Is this the total US Government expenditure on HIV/AIDS?

The sum of $48 billion is the proposed expenditure of the US Government for combating HIV/AIDS, malaria and tuberculosis outside of the US over a five-year period. The bulk of this money, $39 billion, is for HIV/AIDS, with $4 billion going towards tuberculosis, and $5 billion for tackling malaria. The act also doubled the US contribution to the Global Fund to Fight AIDS, Tuberculosis and Malaria to $2 billion yearly. This is in addition to domestic HIV/AIDS expenditure for which $18.2 billion was requested for FY 2009.⁵

How is the money to be divided between different areas of work?

Under the original 2003 act Congress required that PEPFAR money should be divided in the following way:⁶

1. 55% for the treatment of individuals with HIV/AIDS
2. 15% for the palliative care of individuals with HIV/AIDS
3. 20% for HIV/AIDS prevention (of which at least 33% is to be spent on abstinence until marriage programmes)
4. 10% for helping orphans and vulnerable children.

The 2008 reauthorisation act does not specify in such detail how the money should be spent, though there are still some guidelines:⁷

1. Over half of the funds are to be spent on treatment programmes, including antiretroviral treatment, care for associated opportunistic infections and nutritional support for people living with HIV/AIDS.
2. In countries with generalised HIV epidemics, at least half of all money directed towards preventing sexual HIV transmission should be for ‘activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction’.  If this is not complied with then the Global AIDS Coordinator must report to Congress within 30 days on the reasons behind the shortfall.
3. The 10% figure directed towards helping orphans has remained.

Who is in charge of PEPFAR?

The US Global AIDS Coordinator is responsible for coordinating all US Government HIV/AIDS activities. He or she is based in the Department of State and is directly responsible to the Secretary of State.
Dr Eric Goosby was appointed US Global AIDS Coordinator in June 2009.⁸ He replaced Dr Mark Dybul, who was asked to step down soon after the inauguration of President Barack Obama.

Was the US involved in tackling HIV/AIDS overseas prior to PEPFAR?

Prior to the implementation of PEPFAR in 2004 the US Government was already spending significant sums on combating HIV/AIDS outside of the US. However, spending has greatly increased under PEPFAR with $6 billion enacted for PEPFAR in FY 2008 compared with $1.5 billion in FY 2003.⁹ Before PEPFAR most expenditure was through bilateral agreements (agreements between the US and one other country). Most of these agreements - including the Mother to Child Prevention Initiative - continued and became part of PEPFAR.

Which countries benefit from PEPFAR?

The Leadership Against HIV/AIDS Act of 2003 refers to funding relating to combating HIV/AIDS focusing on fourteen specific countries, now usually referred to as “focus” countries:
Botswana, Cote d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda and Zambia.
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.¹⁰ Vietnam was added as an additional focus country in June 2004.

“An example of non-focus country PEPFAR expenditure is the substantial funding that is being provided for HIV/AIDS work in India.”

The acronym PEPFAR, or the longer name, the "President's Emergency Plan", are often used confusingly as though they refer solely to the focus countries. However PEPFAR and the President's Emergency Plan refer to all HIV/AIDS expenditure and activities that the US government provides to all countries outside of the US. An example of non-focus country PEPFAR expenditure is the substantial funding that is being provided for HIV/AIDS work in India.
American recognition of the global scale of the epidemic is demonstrated by amendments made to the Foreign Assistance Act of 1961 during PEPFAR's reauthorisation. The amended act specifically names Central Asia, Eastern Europe and Latin America as regions in which ‘the alarming spread of HIV/AIDS … is a major global health, national security, development, and humanitarian crisis’.¹¹ previously, only sub-Saharan Africa, the Caribbean and 'other developing countries' were mentioned.

How much money has been enacted (provided by Congress) for PEPFAR so far?

For FY 2004, President Bush requested $1.9 billion for combating global HIV/AIDS, TB and Malaria, suggesting that the annual expenditure would increase from then onwards in order to meet the overall $15 billion target. Congress increased President Bush's figure by $500 million, and in January 2004 appropriated $2.4 billion for HIV/AIDS, tuberculosis and malaria. Of this total, $850 million was "new" money.¹²
Funding for HIV/AIDS increased steadily to reach $3.3 billion in FY 2006 and $6.0 billion in FY 2008, which brought the total for the first five-year period to $18.8 billion - exceeding the original commitment of $15 billion. $6.6 billion was enacted for PEPFAR in FY 2009. ¹³
In 2009 Obama pledged $48 billion for HIV/AIDS over a five-year period, as part of the Global Health Initiative.¹⁴ The total funding request for FY2010 for global HIV/AIDS was $6.7 billion. ¹⁵ Funding for 2009-2010 was effectively flat-lined in contrast to the much higher previous year-on-year increases in funding, especially from 2006-2009. In effect, 2010 was the first year US funding for PEPFAR did not increase. Obama's proposed 2011 budget includes almost $7 billion for PEPFAR, representing a 2.2% increase.¹⁶ However, according to some AIDS activists this slight increase is actually a 'step backwards' due to inflation and increasing demand for treatment.¹⁷ The flat-lining of the PEPFAR budget means, so far, the proposed $48 billion target is far from being reached.

How is PEPFAR changing?

PEPFAR II is a term sometimes used to refer to PEPFAR after it was renewed in 2008. The distinction arises from various changes that were introduced by the reauthorisation act and changes that have occurred since reauthorisation, which have transformed PEPFAR significantly from what it was in its initial five years. In particular, there are a few key factors that will have a strong influence over the future of PEPFAR.

A new president

In 2009, Barack Obama replaced George Bush as President of the United States. PEPFAR is upheld as one of the most significant accomplishments of Bush’s presidency, and some PEPFAR recipients worried that his departure would mean the end of “the Bush fund”.¹⁸ Although it is certain that PEPFAR will continue under the new president, there has been much speculation about the way in which it will continue.
Many AIDS organisations have welcomed the new administration as an opportunity for change regarding the more controversial aspects of PEPFAR, specifically in terms of prevention. Obama’s election pledge of “best practice, not ideology”, and his decision to overturn the controversial 'global gag rule' have encouraged hopes for positive changes to PEPFAR policy. The 'global gag rule' prevented US funds from going to any organisation that either offered abortions or provided information and counselling on abortions.

“The lack of new funds means clinics are now being forced to stop enrolling patients.”

During the election campaign Obama pledged to increase PEPFAR funding to provide $50 billion to fight global HIV/AIDS by 2013, including an increase of $1 billion in new money each year.¹⁹ The President's Global Health Initiative, announced in May 2009, has been criticised for undermining this commitment by extending the time frame of its delivery to six years rather than five. Furthermore, Obama's first budget proposes just $366 million in new money for PEPFAR in FY 2010.²⁰ It is feared that a lack of political commitment in the enduring economic downturn could jeopardise PEPFAR funding.²¹ Indeed, for the majority of recipient countries PEPFAR funding flatlined in 2009, rather than increasing as was expected at the time of reauthorisation.²² International AIDS activists have expressed concern that shortfalls in funding will have severe health consequences, including significantly reduced numbers of people receiving vital HIV and AIDS treatment.²³
The experiences of many of PEPFAR’s partners indicate that budget uncertainty is already having a detrimental effect. Dr Mugyenyi, Executive Director of the Joint Clinical Research Centre in Uganda, has said that the lack of new funds means clinics are now being forced to stop enrolling patients.²⁴ The importance of fulfilling PEPFAR’s funding commitments is even greater during the global economic crisis. Peter Piot, former Executive Director of UNAIDS, has warned that rising food and energy costs could exacerbate the spread of HIV and AIDS by increasing vulnerability to the disease. Margaret Chan, Director General of the World Health Organization, has emphasised the danger that the economic crisis poses for national health systems, and the limitations this would create for PEPFAR’s progress.²⁵

Partnership Frameworks 

Partnership Frameworks were introduced as part of the 2008 reauthorisation act, establishing new guidelines which redefine the roles of the US government and PEPFAR’s partners. PEPFAR promotes the new Partnership Framework model as part of a necessary transition from an emergency response to an approach that ensures sustainability by “strengthening country capacity, ownership, and leadership”.²⁶
The guidelines focus on several key principles, which had already been raised as suggested improvements in the Institute of Medicine’s report on PEPFAR’s progress.²⁷ A primary emphasis is on increasing 'host country' autonomy in decision making, in order to promote ‘harmonization’ with national AIDS plans. Another focus is on policy reform, particularly in terms of addressing gender issues and expanding human resources.²⁸
PEPFAR has proposed Partnership Frameworks with all 15 focus countries, as well as a number of others.²⁹ As of May 2010, eight Partnership Frameworks had been signed.³⁰ The Partnership Frameworks must be established before any new funding above FY 2008 levels can be allocated.³¹

Governments - changing roles and increasing responsibilities

Historically, PEPFAR has worked largely through well-established American NGOs, utilising their experience and capacity.³² This method was seen as the most efficient for an emergency response. As a result, the proportion of PEPFAR funds allocated to governments during its first five years was relatively small. In 2005 just 13% of the money obligated by PEPFAR went to host country governments.³³
The new Partnership Frameworks emphasise the role of host country governments in ensuring an effective and sustainable response to the epidemic.³⁴ Matias Gomez, Global Fund Fund Portfolio Manager for Latin America and the Caribbean, highlights the positive impact that this change in PEPFAR's focus could have on human resources for health.³⁵ A 2008 study in Zambia showed that perks gained from working on PEPFAR supported programmes (such as higher salaries, paid overtime, and training opportunities) combined with limited incentives to remain in the public sector (particularly the lack of opportunities for career progression) leads to an "internal brain drain" in which government workers leave their jobs to work for PEPFAR implementing organisations, creating critical shortages in the public sector.³⁶ Greater investment and coordination with host country governments could help to address the 'brain drain' effect.
Although it is likely that PEPFAR’s funding channels will change as a result of the new partnership agreements, the guidelines do not indicate whether governments will receive a greater proportion of PEPFAR funds than in the past. Integral to PEPFAR's principle of country ownership is the increased financial accountability of host country governments. One of the goals stated in the guidance on Partnership Frameworks is for host countries to increase their share of financial contributions and to rely more on financing from the Global Fund.³⁷ Although the guidance specifies that increases in host country financial commitments should be relative to the country’s means, there could be repercussions for people on the ground, principally the many NGOs, companies and institutions who rely on PEPFAR funding.

PEPFAR targets and results

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 [sic], 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."

Later it was decided that care should be provided to 10 million people, completing the so-called "2-7-10" goals to be met by 2008.³⁸
The goals set out for PEPFAR's second phase greatly expand the initial five-year targets set in 2003. Objectives to be achieved by 2014 include:³⁹

• Treating at least 4 million people
• Preventing 12 million new HIV infections worldwide
• Providing care for 12 million people living with or affected by HIV/AIDS, including 5 million orphans
• Providing at least 80% of the target population with services including counselling, testing and treatment to prevent mother-to-child transmission of HIV
• Ensuring the proportion of children receiving treatment for HIV/AIDS is relative to the overall infected proportion
• Training at least 140,000 new health care workers

The reauthorisation act of 2008 expanded the range of prevention initiatives that PEPFAR will fund including the diagnosis and treatment of other sexually transmitted infections; engaging vulnerabilities of women and girls; and addressing the stigma and discrimination that can hinder prevention efforts.
The new act also calls for a wider range of initiatives to support communities affected by HIV/AIDS. These include providing nutritional support and counselling, safe drinking water and sanitation, and legal services; a greater integration of HIV/AIDS programmes with those addressing gender-based violence; ‘opt-out’ HIV testing; and a strengthening of national responses to HIV/AIDS and stronger national health systems in general.⁴⁰

What progress is being made towards these goals?

Initially, progress was slow due to an eight month delay between the enactment of PEPFAR and the first money issued by Congress. Full implementation of the programme did not start until June 2004.⁴¹ Consequently, the programme was supporting antiretroviral treatment for 24,900 HIV infected individuals in nine countries by July 2004 - well below the original target set by Congress in the 2003 act.
Once PEPFAR had been fully implemented, rapid results began to be seen with regards to treatment. By the end of September 2005, some 401,000 people were receiving treatment with PEPFAR support in the focus countries, and around 70,000 were benefiting in other countries through US bilateral programmes.⁴² The focus country number rose to 822,000 by the end of September 2006,⁴³ and 1.36 million by the end of September 2007.⁴⁴

“By the end of September 2008 PEPFAR was supporting treatment for over 2.1 million people around the world, exceeding its 2 million target.”

By the end of September 2008 PEPFAR was supporting treatment for over 2.1 million people around the world, exceeding its 2 million target. This includes 2,007,800 people in the programme’s 15 focus countries.  Treatment figures in some countries, however, have fallen short of their intended targets. In Nigeria, for example, 211,500 people were receiving treatment by the end of September 2008 compared to the goal of 350,000. The number on treatment in Ethiopia fell short of the 210,000 target by over 90,000.⁴⁵
With regard to prevention, PEPFAR will measure its achievements in 2010 using US Census Bureau statistical models of country-level prevelance trends.⁴⁶ To date, the only estimates of prevented infections are those averted through the prevention of mother-to-child transmission. It is estimated that almost 240,000 infant infections were averted over PEPFAR’s first five years.⁴⁷
In FY 2004 around 125,500 women were provided with antiretroviral therapy to prevent infection of their unborn children, and as a result an estimated 23,700 infant infections were averted. The figures for FY 2005 were slightly lower and the target of a 20% reduction in infant infections was not met.⁴⁸ Results were much better in FY 2006, with around 285,600 pregnant women receiving the preventive drugs, improving again to 294,000 in 2007.  The proportion of HIV-positive, pregnant women in focus countries receiving antiretroviral drugs rose from 9% in FY 2004 to 21% in FY 2006.⁴⁹
By the end of September 2008, PEPFAR had supported treatment for more than 2.1 million people. Nearly 9.7 million people in PEPFAR’s focus countries had received care (10.1 million, globally) including nearly 4 million orphans and vulnerable children. PEPFAR has also supported 57 million counselling and testing sessions.⁵⁰

What progress is being made towards treatment targets in individual focus countries?

The table below shows the number provided with treatment by July 2004⁵¹, September 2004⁵², September 2005⁵³, September 2006⁵⁴, September 2007⁵⁵ and September 2008.⁵⁶

Country	Provided treatment by July 2004 (direct US support)	Provided treatment by end September 2004	Receiving treatment end September 2005	Receiving treatment end September 2006	Receiving treatment end September 2007	Receiving treatment end September 2008
Botswana		32,900	37,300	67,500	90,500	111,700
Côte d'Ivoire	400	4,500	11,100	27,600	46,000	50,500
Ethiopia		9,500	16,200	40,000	81,800	119,600
Guyana		500	800	1,600	2,100	2,300
Haiti		2,800	4,300	8,000	12,900	17,700
Kenya	2,700	17,100	44,700	97,800	166,400	229,700
Mozambique		5,200	16,200	34,200	78,200	118,000
Namibia	2,500	4,000	14,300	26,300	43,700	56,100
Nigeria	500	13,500	28,500	67,100	126,400	211,500
Rwanda	100	4,300	15,900	30,000	44,400	59,900
South Africa	3,700	12,200	93,000	210,300	329,000	549,700
Tanzania	100	1,500	14,700	44,300	96,700	144,100
Uganda	7,300	33,000	67,500	89,200	106,000	145,000
Vietnam*		0	700	6,600	11,700	24,500
Zambia	1,500	13,600	36,000	71,500	122,700	167,500
Total	18,800	155,000	401,000	822,000	1,358,500	2,007,800

* 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 treatment access table [PDF]).

What do these numbers really mean?

There are a few issues worth bearing in mind when interpreting PEPFAR treatment figures.
In most cases PEPFAR provides only part of the support needed to enable people to access treatment. In particular, many thousands of people are on treatment supported by both PEPFAR and the Global Fund. In FY 2007 the Global Fund supported treatment for around 864,000 people in the fifteen focus countries, and the US government believes that the vast majority of these people also received some support from PEPFAR. Therefore most, if not all, of these people are counted by both organisations.⁵⁷
PEPFAR's numbers include not only those assisted through site-specific support of treatment centres, but also those supported by PEPFAR through contributions to national, regional or local "system strengthening" (including such activities as staff training, laboratory support, logistics, and curriculum development). Of the 1.64 million on treatment in March 2008, some 1.29 million (79%) received direct, site-specific support.⁵⁸
In some countries such as Botswana, a small contribution to clinic costs by PEPFAR funding is resulting in all of the people attending certain clinics being credited to PEPFAR.⁵⁹ Some Botswanan health officials have argued that in fact zero patients in Botswana have been put on treatment because of PEPFAR.⁶⁰ It is unclear exactly how much PEPFAR needs to contribute to someone's treatment in order to include them in its treatment figures.
PEPFAR, the Global Fund, and indeed the WHO do seem to be attaching great importance to the number of people receiving antiretroviral treatment, 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 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 access to antiretroviral treatment in the focus countries.⁶¹ These difficulties include:

1. coordination difficulties amongst both US and non US agencies
2. US government policy constraints
3. shortages of qualified focus country health workers
4. focus country government restraints
5. weak infrastructure, including data collection and reporting systems, and drug supply systems.

PEPFAR policies

Can generic drugs be purchased with PEPFAR money?

PEPFAR money is used to purchase a wide range of supplies. These 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). Several billion dollars of PEPFAR money is spent on the purchase of HIV antiretroviral drugs.
PEPFAR guidance has never directly prohibited the use of PEPFAR money to purchase lower priced generic drugs. However, the purchase of most generic drugs was initially excluded by PEPFAR’s policy that all drugs had to be approved by the US Food and Drug Administration (FDA) or a regulatory agency in Canada, Japan or Western Europe.⁶² Most generic antiretrovirals were only pre-qualified by the World Health Organisation (WHO), which was not sufficient under PEPFAR regulations despite being a widely trusted system among other donors and national governments. Furthermore, the policy totally excluded the purchase of Fixed Dose Combinations (FDCs), none of which were approved by the FDA.⁶³

2004 demonstration against US policies on generic AIDS drugs.

In May 2004 the FDA announced an accelerated review process for FDCs and generic drugs, and it was agreed that drugs approved through this process could then be purchased with PEPFAR money "where international patent agreements permit them to be purchased’.⁶⁴ 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 2004.⁶⁵
By August 2005, nine generic drugs had won FDA approval. However none could be distributed by PEPFAR because several African countries refused to trust the FDA, and insisted the drugs be approved by the WHO before allowing them to be imported. To solve this unforeseen problem, FDA officials agreed to share with the WHO its files about the drugs, so that the WHO could quickly add them to its list of approved medicines.⁶⁶ PEPFAR eventually began distributing generics towards the end of 2005, by which time 15 such drugs had been approved by the FDA, including two FDCs.⁶⁷
By December 2007 the FDA had approved 57 generic antiretroviral drugs, including eight FDCs and 14 paediatric formulations.⁶⁸ In FY 2006 generics accounted for only 27% of spending on drug procurement in focus countries,⁶⁹ but in FY 2007 some 73% of all antiretroviral drugs delivered by PEPFAR were generics.⁷⁰ Critics say that unnecessary bureaucracy has slowed the transition to using generics.⁷¹
A complete list of all PEPFAR approved antiretroviral drugs can be found on the U.S Food and Drug Administration website.

How important is it that generics and FDCs are made available through PEPFAR?

The inclusion of FDCs is potentially very important because of the beneficial effect FDCs have on adherence.^{72 73} 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.
Generic copies of AIDS drugs are usually cheaper than brand-name versions, so potentially enable more people to receive treatment. Purchasing generics in FY 2007 saved PEPFAR partners an estimated $64 million.⁷⁴

Is it proposed that a very significant amount of PEPFAR money be spent on promoting "abstinence until marriage"?

The 2008 act states that in countries with generalised HIV epidemics, at least half of all money directed towards preventing sexual HIV transmission should be for activities promoting abstinence, monogamy and partner reduction. Failing this the Global AIDS Coordinator is required to report to Congress within 30 days justifying the shortfall. It is not yet clear what possible steps would follow the coordinator's report.
Unlike in the 2003 act, the proportion of funds designated for prevention efforts as a whole is not stated.

What was the allocation for abstinence programmes under the first PEPFAR act?

In the original PEPFAR legislation HIV prevention was allocated 20% of total expenditure, and Congress specified that at least a third of this money should be spent on abstinence until marriage programmes. In late 2005, PEPFAR introduced a new rule that at least two-thirds of all funds for preventing sexual transmission of HIV should be spent on promoting abstinence and being faithful (known as "AB" strategies). The remaining one third of money for preventing sexual transmission was supposed to be spent on "condoms and related activities".
These spending requirements were the focus of considerable discussion; many people questioned the effectiveness of promoting abstinence at the apparent expense of other initiatives such as the distribution of condoms.

What condom programmes does PEPFAR fund?

The original PEPFAR five-year strategy document mentioned condom provision and promotion only for those who practice high-risk behaviours. Those who practice high-risk behaviours include "prostitutes, sexually active discordant couples [in which one partner is known to have HIV], substance abusers, and others". Condoms were not mentioned as a strategy for helping young people in general.⁷⁵ This approach differed significantly from previous US policy and the policies of other donors including the Global Fund and the European Union.
It is unclear whether this policy will be retained over PEPFAR's second five-year term.

What are the effects of these prevention policies?

There have been some reports of organisations refusing US funding because they believe condoms should be promoted beyond "high risk" groups. Such groups fear that PEPFAR's approach will lead to re-stigmatisation of condoms, and will promote the notion that condoms don't work as a form of HIV prevention.⁷⁶ However Dr Mark Dybul, the previous Global AIDS Coordinator, has claimed that,

"It is impossible for a site to be told to stop distributing condoms, or to close because of condom distribution... it would be directly contravening the stated policy of the U.S. government to say that because someone distributes condoms, they cannot receive resources from the U.S. government."

Dr Dybul has also insisted that,

"The notion that there's an excessive focus on abstinence is just untrue... The policy both in the guidance we issue and in the programs we support is fully ABC - abstain, be faithful, and correct and consistent use of condoms."⁷⁷

In April 2006, the Government Accountability Office (GAO) released the results of an extensive investigation of PEPFAR's policies for preventing sexual HIV transmission. Seventeen of the twenty country teams interviewed by the GAO said that fulfilling the spending requirements set by PEPFAR presented "challenges to their ability to respond to local prevention needs." Some said that they had had to scale down efforts to prevent mother-to-child transmission or to improve blood safety in order to try to meet the one-third AB requirement, and many said that not enough emphasis was being placed on condoms. In one country, the budget for outreach work with high-risk groups such as sex workers, sexually active youth and discordant couples was cut from $8 million to $4 million in order to meet AB requirements.⁷⁸
Moreover the official funding rules may not be the only constraints on the type of work that is carried out. According to one of PEPFAR's implementing partners in Nairobi:

"There are perceived restrictions in PEPFAR about what you can discuss with whom, so everyone is being very cautious... People are afraid to discuss family planning, condoms, abortion - so many groups don't address them at all."⁷⁹

This opinion is echoed by Canon Gideon, an HIV-positive Anglican minister from Uganda:

"The policy is making people fearful to talk comprehensively about HIV, because they think if they do, they will miss funding. Although they know the right things to say, they don't say them, because they fear that if you talk about condoms and other safe practices, you might not get access to this money."⁸⁰

A study of the impacts of PEPFAR in Zambia found that several PEPFAR funded organisations had not only stopped promoting condoms, but had eliminated any reference to condoms in their programmes out of fear that they would lose their funding. The programme implementers believed that these measures were required by PEPFAR.⁸¹
Such reports have led many to criticise PEPFAR for disproportionately funding abstinence and fidelity programmes. Critics have included the HIV Medicine Association (HIVMA) and the Infectious Diseases Society of America (IDSA);⁸² prominent American HIV prevention experts;^83 84 and non-governmental organisations such as ActionAid International, CARE and the Elizabeth Glaser Pediatric AIDS Foundation.^85 86
In a statement widely viewed as a criticism of PEPFAR policy, the European Union has said it is "profoundly concerned about the resurgence of partial or incomplete messages on HIV prevention which are not grounded in evidence and have limited effectiveness."⁸⁷

Other funding restrictions

PEPFAR sets other funding restrictions that are not necessarily based on evidence of what is most effective in combatting HIV/AIDS.
Needle exchange programmes
The First Annual Report states that, "Emergency Plan funds will not support needle or syringe exchange".⁸⁸ Many people have objected to this because needle exchange programmes have been proven to help reduce the spread of blood-borne HIV by providing injecting drug users with sterile syringes, without encouraging drug use. In some areas, this may be part of a wider harm reduction strategy, whereby users are given a safe, monitored place to inject and/or pure uncontaminated drugs to reduce the risk of overdose. However, the US government is opposed to such measures as it believes they make drug use seem more acceptable, and facilitate continued drug use.
Sex workers
The "Leadership" act of 2003 states that, "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."⁸⁹ This condition (sometimes called the "Prostitution Loyalty Oath") led to Brazil refusing $40 million of PEPFAR funds in May 2005. The director of Brazil's HIV/AIDS programme explained, "Brazil has taken this decision in order to preserve its autonomy on issues related to HIV/AIDS as well as ethical and human rights principles".The Brazilian government and many organisations believed that adopting the PEPFAR condition would be a serious barrier to helping sex workers protect themselves and their clients from HIV.⁹⁰

“Numerous non-governmental organisations and public health experts believe that the anti-prostitution clause is harmful and should be removed.”

In January 2006, the BBC World Service Trust abandoned a USAID-funded, multi-million-dollar AIDS awareness campaign in Tanzania because it refused to comply with this anti-prostitution clause. The Trust said it did not want to inhibit its ability to make television and radio programmes that discuss sex workers in a non-judgmental way.⁹¹ As a result Tanzania was left without any mass media programme to combat HIV.
Numerous non-governmental organisations and public health experts believe that the anti-prostitution clause is harmful and should be removed.^{92 93} Some have tried to challenge its legality under the First Amendment of the US constitution, which guarantees the right to free speech. In May 2006, two American judges ruled in two separate cases that the clause did indeed violate the First Amendment and so could not be applied to the US-based organisations that brought the cases, though all overseas groups wishing to receive US Government funding, whether directly or indirectly, would still have to comply.⁹⁴ In February 2007 a higher court overturned one of these rulings.⁹⁵ It is therefore likely that the clause will continue to be imposed unless and until it is repealed by new legislation.
Safe abortion services
The 'Global Gag Rule', also known as the 'Mexico City Policy', denied US international family planning funding to foreign non-governmental organisations that provide safe abortion services, counselling, referral, or information about safe abortion, advocate for changes in abortion law in their own country, conduct research on the effects of unsafe abortion, or otherwise work on safe abortion issues.
In August 2003, President Bush released an Executive Order specifically exempting HIV/AIDS funds from restrictions under the Global Gag Rule. However, the restriction appeared twice in Kenya's $193 million Request for Application (RFA) for HIV/AIDS prevention, treatment and care, released by USAID in November 2005.⁹⁶ The inclusion seems to have been due to administrative error, and the document was later retracted. Nevertheless, there remained confusion about how the Global Gag Rule related to HIV/AIDS funding, and some organisations may have been denied funds as a result. Moreover, the policy was a significant obstacle to the integration of HIV prevention with reproductive health services.
President Obama rescinded the Global Gag Rule very soon after assuming office in January 2009, hopefully ending any doubts or confusion over whether organisations with particular abortion policies could receive PEPFAR funding.
In pursuit of rapid results, PEPFAR is in some cases taking over established projects that already had sufficient (though perhaps less generous) funding from other donors. In order to qualify for US support, the organisations running such projects are compelled to sign documents setting out what activities they may and may not perform. Successful programmes may be terminated if they do not comply with PEPFAR conditions. Organisations that have previously relied on large amounts of US money may have great difficulty securing alternative funding should they refuse to comply with the new "morality clauses".

Are there any 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. Nevertheless, the US Government is still the greatest sponsor of the Global Fund. Under the 2008 PEPFAR reauthorisation act, America doubled its yearly contribution to $2 billion.
The controversial areas of PEPFAR have at times overshadowed what has already been achieved, which is the channelling of hundreds of millions of newly appropriated funds to treatment programmes for tens of thousands of AIDS patients around the world.⁹⁷

"Since I started medication and I realized that I'm strong, I can do other things, my feelings are coming back. That's why I went back to school. What I was planning, I can now do it. So when you talk of PEPFAR, that's my life, because without it, I could have not lived."John Robert Ongole, the first recipient of PEPFAR-supported antiretroviral treatment.⁹⁸

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