Health GAP (Global Access Project)
NOTE FOR EDITORS
www.healthgap.org
March 26, 2004
I would like to draw your attention to resources and contact information provided below for expert information on prequalified generic AIDS drugs in the developing world.
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 positionÑone which allows them to continue gunning for the purchase of overpriced, brand-name medicines.
Transcript of the journalist teleconference hosted by Doctors Without Borders/Médecins Sans Frontière (MSF) and Health GAP from Thursday, March 25, 2004: Download transcript
ADDITIONAL RESOURCES FOR JOURNALISTS
CONGRESS
Note: Senator Kerry's responded to a Global AIDS candidates questionnaire about access to medicines with: "I would adopt a policy consistent with international trade rules that purchases lowest-cost, quality medicines, including those presented in fixed-dose combinationsÐwhether brand-name or generic, through transparent open competitive bids." He also writes that as President "I intend to ensure that all relevant agreements negotiated under my tenure will increase access by developing countries to generic, affordable drugs." Download Answers to Questionnaire|Senator Kerrys' AIDS platform
NON-GOVERNMENTAL ORGANIZATIONS (NGOS)
Sharonann Lynch: TEL (646) 645-5225, Email: salynch@healthgap.org or Asia Russell: TEL (267) 475-2645, Email: asia@healthgap.org
Comments prepared for the teleconference: "Ignoring Lives To Protect Pharma Profit?: Bush Plan to Block Use of Affordable, Effective, Quality Generic AIDS Medicines," March 25, 2004:
Download PDF | Also download comments from MSF and Center for Health and Gender Equity (CHANGE)
Health GAP Briefing Paper: "U.S. Emergency Plan for AIDS Relief (PEPFAR): Facts and Critical Issues":
Download PDF
Health GAP briefing paper on U.S. guidelines for procurement:
Download doc
Spokespeople, Njogu Morgan and Nathan Geffen, South Africa. TEL: +27-21-788-3507, Email: njogu@tac.org.za
EXPERTS AND NON-GOVERNMENTAL ORGANIZATIONS (NGOS) ON AIDS TREATMENT IN SUB-SAHARAN AFRICA
Doctors Without Borders/Médecins Sans Frontière (MSF) Fact Sheet on FDCs: "Two Pills a Day Saving Lives: Fixed-Dose Combinations (FDCs) of Antiretroviral Drugs."
http://www.accessmed-msf.org/documents/factsheetfdc.pdf
WORLD HEALTH ORGANIZATION (WHO)
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"
http://mednet3.who.int/prequal/documents/Prequal-one-pager.pdf
Brochure: "Prequalifying Priority Medicines":
http://mednet3.who.int/prequal/documents/prequal_brochure.pdf
Requirements specified for generic medicines: "Guide on Requirements for Documentation of Quality For Pharmaceutical Products Related to HIV and AIDS":
http://mednet3.who.int/prequal/hiv/generic_hiv.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.
U.S. OFFICE OF GLOBAL AIDS INITIATIVE
Comments by Ambassador Randall Tobias, Bush's Global AIDS Coordinator, on the quality of generic AIDS medicines: Download Word Doc
US Global AIDS Initiative Strategy document:
http://www.state.gov/s/gac/
US website about the Botswana meeting:
http://www.globalhealth.gov/fdc.shtml
For more information, contact: TEL +1 646 645 5225 Sharonann Lynch, TEL +1 267 475 2645 Asia Russell
Health GAP (Global Access Project) is dedicated to eliminating barriers to global access to affordable life-sustaining medicines for people living with HIV/AIDS. Health GAP believes that the human right to life and to health must prevail over the pharmaceutical industry's excessive profits and expanding patent rights. For more information visit www.healthgap.org
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