PRESIDENT'S EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR)

Health GAP Report: Between the Lines
GAO Report on PEPFAR Prevention Programs: U.S. Abstinence/Being Faithful-Only Programs Produce Stigma and Death

On April 4, 2006, the U.S. Government Accountability Office released a stinging indictment of U.S. prevention policies that prioritize sexual abstinence and being faithful to an HIV-negative partner over scientifically proven methods of reducing the tide of infections.  Although the GAO Report on PEPFAR Prevention Programs documented the negative consequences of rigid guidelines requiring that 1/3 of the overall prevention budget (and 2/3 of the behavioral prevention budget) must be spent on abstinence/being faithful (A/B-only) programming, it failed to highlight the negative consequences of that ideologically narrow focus on the lives of people living with HIV and their sexual partners in terms of stigmatization and lost opportunities for risk reduction.

Download PDF of the entire report

The President's Emergency Plan for AIDS Relief (PEPFAR) contains policies on prevention driven by ideological motivations which completely ignore scientifically proven methods. The Bush administration has tied PEPFAR funding to strict requirements such as mandating that 33% of prevention funds be spent on abstinence-until-marriage programs, limiting condom distribution to narrowly-defined "high risk" groups, and demanding grantees to explicitly condemn sex workers. These approaches all run counter to the establishment and continuation of comprehensive prevention programs which have demonstrated effectiveness in slowing the spread of HIV.

The harmful effects of Bush's PEPFAR prevention policies have most recently taken shape in Uganda where comprehensive prevention efforts were credited with dramatically reducing the HIV prevalence over the past decade. Pressures of PEPFAR funding requirements have caused a notable shift in the prevention approaches of the Ugandan government however as President Museveni and other leaders have strongly endorsed abstinence-only programs and increased anti-condom rhetoric over the past year. Some 32 million quality-approved condoms remain impounded in government warehouses while the U.S. government ramps up financing for abstinence-only approaches to HIV prevention. According to Ugandan AIDS activists, the government's actions will undermine community efforts to reduce HIV prevalence and HIV transmission. These trends away from scientifically sound, evidence-based prevention strategies are occurring in Uganda and in other countries hard-hit by the AIDS epidemic, such as Nigeria, South Africa, and Zambia.

• NOVEMBER PEPFAR WATCH BRIEFING SERIES: Issue papers address topics, related concerns and recommendations. PEPFAR WATCH is a joint project of Health GAP and Center for Health and Gender Equity (CHANGE):
• Supply Chain Management System (SCMS)
• AIDS Drugs procurement policies
• Sex worker policies and restrictions

THE CONDOM CRISIS IN UGANDA
AND PEPFAR's ABSTINENCE-ONLY HIV PREVENTION STRATEGIES

• RELEASE THE CONDOMS, FUND EFFECTIVE PREVENTION STRATEGIES, SAVE LIVES NOW! Community letter from individuals and organizations in and outside of Uganda demanding action on part of the Ugandan government to support comprehensive prevention programs, end abstinence-only programs, and immediately take steps to distribute quality assured condoms in public facilities. Send a letter to MOH Jim Muhwezi

• Read advisory, speakers
• Read Transcript | Download doc

• ACTION ALERT : Tell the Ugandan Government to Stop the Attack on Condoms. Take action to stand in solidarity with Ugandan activists and demand the release of millions of condoms by the government of Uganda. Send letter to Uganda Minister of Health and Minister of Foreign Affairs

• August 30, 2005 (Manhattan) A coalition of AIDS activists held a demonstration in midtown Manhattan outside of the Ugandan Permanent Mission to the United Nations today to bring attention to that nation's severe condom shortage which is putting people at dangerous risk of HIV infection. The crisis has developed over the past ten months as the government of Uganda has stopped its robust program of public sector condom distribution. These condoms previously accounted for 80% of condoms available in the country.
  • Press Release | PDF
  • View photos
  • Letter delivered to the Uganda Mission to the UN | download doc

• August 11, 2005 Letter from Health GAP, CHANGE, TAC, GMHC, Advocates for Youth, and CHAMP, calling upon Peter Piot to mobilize mass-awareness of the Ugandan condom crisis and its implications, and to urgently mobilize resources as necessary to get quality-assured condoms available to the public as well as to rebuild national trust in the Engabu brand and/or quality assured condoms distributed by the government. Read Letter | Download Word doc

• CHANGE press statement
• Fact Sheet: download doc | PDF
• Timeline: download doc | PDF
• Press clippings: read | download doc

• May 17, 2005 (Geneva) Health GAP warns the new U.S. policy requiring funding to recipients to sign a "loyalty oath" against sex workers threathens the independence of the Global Fund as well as HIV prevention best practices. Health GAP Press Release | Civil Society Letter to Bush calling for repeal of funding restrictions | Health GAP questions for US officials | Download Word doc

U.S. PROCUREMENT POLICIES AND THE EFFORT TO SHUT OUT GENERIC DRUGS AND FIXED-DOSE COMBINATIONS (FDCS)

• January 26, 2005 (New York) The announcement that Aspen Pharmacare of South Africa has received approval for co-packaged Lamivudine/Zidovudine and Nevirapine through the FDA fast-track marketing approval process represents a glimmer of progress in what still remains an unnecessary, duplicative, costly, delayed, and ultimately flawed U.S. review process.
  • Aspen's FDA Approval Weak Evidence of the Effectiveness of the FDA Expedited Approval Process Statement | Download Word doc
  • Statement of the Ecumenical Pharmaceutical Network (EPN), , comprised of Christian Health Associations and hospitals, non-profit drug supply organisations and church related development agencies, from 22 countries, on the President's Emergency Plan for AIDS Relief (PEPFAR) Press Statment| Download Word doc

U.S. Global AIDS Initiative (GAI) officials have been using several misleading arguments in order to justify its lack of support for permitting low cost, WHO pre-qualified generic medicines of assured quality to be used in the Presidential Emergency Plan for AIDS Relief (PEPFAR) and other U.S.-funded AIDS projects. These misleading claims include:

MYTH: The WHO is not a regulatory body, so it is not qualified to identify quality-approved manufacturers. Randall Tobias, in testimony before the House Appropriation Committee's Foreign Operations Subcommittee, said: "The problem is there is no process, no principles, no standards in place today, from a regulatory point of view, to make" the assurance that a product is quality assured.

FACT: There are process, principles, and standards that guide WHO pre-qualification. They are clear and transparent (see, for example, http://mednet3.who.int/prequal/default.shtml, the website of the Pre-qualification Project).

According to the WHO, the data that generic companies seeking pre-qualification must submit are, in essence, the same as the criteria that the FDA requires from companies seeking FDA approval for their multi-source (generic) drugs. This includes in vivo bioequivalence studies that show generic companies are producing medicines that are bioequivalent to proprietary medicines. Multi-country site assessment teams are dispatched to inspect product manufacturing sites, and to verify company compliance with Good Manufacturing Practice (GMP) standards. WHO standards for GMP are the only globally accepted standards for generic medicines.

MYTH: The U.S. can't endorse the WHO pre qualification process because the U.S. can't get access to the information in the product dossiers that generic companies submit to the WHO. The U.S. can't be expected to take WHO's word that the generic companies' data are acceptable—but they can't evaluate the information themselves.

FACT: U.S. officials could engage with the pre-qualification project and sign confidentiality agreements that would permit them to have access to all the data prepared by generic companies. Administration officials have refused to take that step. If they got involved, then the U.S. would have to concede that the pre-qualification project is sufficiently rigorous. Instead they are using this non-issue to justify what is an ideologically motivated position—one which allows them to continue gunning for the purchase of overpriced, brand-name medicines.

• Bilateral Financing for ARV Treatment Programs: Promises, Pitfalls, and the Need for Change, Sharonann Lynch, Realising the Right to Health, Mumbai, India, 19 March 2005. Download Slide presentation

• January 26, 2005 (New York) The announcement that Aspen Pharmacare of South Africa has received approval for co-packaged Lamivudine/Zidovudine and Nevirapine through the FDA fast-track marketing approval process represents a glimmer of progress in what still remains an unnecessary, duplicative, costly, delayed, and ultimately flawed U.S. review process.
  • Aspen's FDA Approval Weak Evidence of the Effectiveness of the FDA Expedited Approval Process Statement | Download Word doc
  • Statement of the Ecumenical Pharmaceutical Network (EPN), , comprised of Christian Health Associations and hospitals, non-profit drug supply organisations and church related development agencies, from 22 countries, on the President's Emergency Plan for AIDS Relief (PEPFAR) Press Statment| Download Word doc

• October 6, 2004 (Moshi) Health GAP Presentation: "PEPFAR: Promises, Pitfalls, and the Need for Change," October 6, 2004. Download Power Point

• September 21, 2004 (New York) Health GAP statement issued following President George Bush's address to the United Nations. Health GAP Media Statement

• July 13, 2004 (Bangkok) The non-partisan U.S. Congressional agency charged with maintaining the accountability of government programs delivered a simple message to President George Bush this week: the President's Emergency Plan for AIDS Relief (PEPFAR) is not delivering on its promises. Health GAP Press Release

• April 6, 2004 (Manhattan) Health GAP response to Clinton Foundation, GFATM, UNICEF, and World Bank announcement of support for WHO prequalified generic ARVs in face of Bush anti-generics PEPFAR policy. Health GAP Press Release

• (March 29, 2004) Carrying a banner reading "Bush and Pharma block generic AIDS drugs while millions die." Eight AIDS activists are arrested for blocking traffic in front of the offices of PhRMA, the U.S. drug company lobby at during a demonstration demanding President Bush permit the procurement of generics pre-qualified by WHO in the PEPFAR. Activists, dressed as Bush, laid 50 "money bags" bags of money at the entrance of PRHMA. Read press release

• (March 26, 2004) The Bush Administration faces mounting criticism from the domestic and international community for blocking generic AIDS drugs in its federally funded programs in poor countries. U.S. European Agency for the Evaluation of Medicinal Products (EMEA), the largest drug regulatory authority in the European Union, decides not to send any representative to the Botswana meeting on FDCs, despite previous involvement in planning; Read press release | Download press release | Download Note to Editors

• March 26, 2004 (Manhattan) Health GAP note to editors with background information and links to mounting proof against Bush administration's false claims against quality, safety, and efficacy of WHO prequalified generics and 3 in one pills, or FDCs. Health GAP Note to Editors

• New barriers to accessing medicines: US attacks on WHO Prequalifcation of fixed-dose combinationa ARV, and drug registration catch 22's, Brook Baker, at Centre for the AIDS Programme of Research in South Africa, March 26, 2004. Download Slide presentation

• (March 25, 2004) Transcript of the journalist teleconference hosted by Health GAP and Doctors Without Borders/Médecins Sans Frontières (MSF): "Ignoring Lives To Protect Pharma Profit?: Bush Plan to Block Use of Affordable, Effective, Quality Generic AIDS Medicines," March 25, 2004. Read Online | Download transcript

• (March 22, 2004) Health GAP Briefing Paper: "U.S. Emergency Plan for AIDS Relief (PEPFAR): Facts and Critical Issues" Download PDF

• (February 24, 2004) Health GAP briefing paper on U.S. guidelines for procurement by Brook Baker Download doc

• (December 18, 2003) Health GAP's comments submitted to the International Subcommittee of the President's Advisory Council on HIV/AIDS (PACHA) on critical aspects of PEPFAR. Download PDF | Also download comments from MSF and Center for Health and Gender Equity (CHANGE)

• Health GAP's critique of the behind the scenes machinations of the Bush Administration: U.S.'s Misguided and Bad-Faith Attack on the WHO's 3-by-5 Plan, Brook Baker, December 8, 2003 Read Online | Download doc

• Media clipping on U.S. procurement policies as of March 30, 2004
  Download Doc

• 385 U.S. and international organizations call upon U.S. "to ensure that programs use the most affordable medicines available, and accept the current drug quality standards of World Health Organization's drug prequalification program," in a letter to Randall Tobias, 26 March 2004
  Read Online | Download letter

• Doctors Without Borders/Médecins Sans Frontières (MSF) Fact Sheet on FDCs: "Two Pills a Day Saving Lives: Fixed-Dose Combinations (FDCs) of Antiretroviral Drugs."
  Download PDF

CONGRESS ON PEPFAR PROCUREMENT POLICIES
• (March 26, 2004) Representative Henry Waxman (D-CA) on Bush Administration on technical aspects and support for the WHO Prequalification Project and use of generic versions of AIDS drugs. Download Rep. Waxman's letter to President Bush
• (March 26, 2004) Senator John McCain (R-AZ) and Sen. Kennedy (D-MA) letter to President Bush regarding the U.S. Global AIDS plan and the upcoming U.S.-initiated Botswana meeting, calling for the Bush administration to reconsider its policy prohibiting federal fund from purchasing generic medications. Download Senators' letter to President Bush

WORLD HEALTH ORGANIZATION (WHO)
• WHO SPOKESPEOPLE
  • On prequalification and technical issues: Daniela Bagozzi of Essential Drug and Medicines (EDM) division of WHO. TEL +41 22 791 4544, Email: bagozzid@who.int
  • On clinical issues and FDCs: Marco Vitoria, Medical Officer HIV, WHO. TEL +41 22 791 1949,, Email: vitoriam@who.int
  • On WHO's 3x5 initiative: Samantha Bolton, communications for the HIV Department of WHO. TEL +41 22 781 1970, MOB +41 79 239 2366
  • On WHO's 3x5 initiative: Samantha Bolton, communications for the HIV Department of WHO. TEL +41 22 781 1970, MOB +41 79 239 2366
• WHO MATERIALS
  • Web site of WHO pre qualification program
    http://mednet3.who.int/prequal/default.shtml
  • Fact Sheet: "PREQUALIFICATION PROJECT: Ensuring the Quality, Safety and Efficacy of HIV/AIDS Medicines and Diagnostics"
    Download PDF
  • Brochure: "Prequalifying Priority Medicines"
    Download PDF
  • Requirements specified for generic medicines: "Guide on Requirements for Documentation of Quality For Pharmaceutical Products Related to HIV and AIDS"
    Download PDF
  • Fixed dose combinations for HIV/AIDS, Tuberculosis, and Malaria: Current status and future challenges from clinical, regulatory, intellectual property, and production perspectives," Geneva, 16-18 December 2003.
    Download PDF

U.S. OFFICE OF GLOBAL AIDS INITIATIVE
• Comments by Ambassador Randall Tobias, Bush's Global AIDS Coordinator, on the quality of generic AIDS medicines, compiled March 26, 2004. Download Word Doc
• US Global AIDS Initiative Strategy document: www.state.gov/s/gac/
• US website about the Botswana meeting http://www.globalhealth.gov/fdc.shtml

• Read advisory, speakers
• Read Transcript | Download doc

• Bilateral Financing for ARV Treatment Programs: Promises, Pitfalls, and the Need for Change, Sharonann Lynch, Realising the Right to Health, Mumbai, India, 19 March 2005. Download Slide presentation

• Health GAP Briefing Paper: U.S. Emergency Plan for AIDS Relief (PEPFAR): Facts and Critical Issues Download PDF

• The Less They Know the Better: Abstinence-Only HIV/AIDS Programs in Uganda Human Rights Watch Report, March 2005 Download PDF