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    NGO Letter to the Office of the Global AIDS Initiative: 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

    March 26, 2004



    Ambassador Randall Tobias
    Global AIDS Coordinator
    U.S. Department of State
    Washington, D.C.

    Dear Ambassador Randall Tobias,

    We, the undersigned organizations, are writing to express our serious concerns about efforts by the Bush administration and by your office to block the use of affordable generic HIV/AIDS medicines in U.S.-financed programs in poor countries. In order to mount a rapid and successful response to the growing AIDS pandemic, we call upon you 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.

    We are particularly concerned about the U.S.-initiated "Conference on Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical Issues related to Safety, Quality, and Effectiveness," 29-30 March 2004 in Gaborone, Botswana. This meeting needlessly casts doubt upon the clinically proven quality of generic AIDS medicines, and disregards the WHO's internationally recognized Drug Prequalification Program. The meeting is intended to justify the use of expensive, more complex branded treatment regimens, and will be used by the US as the minimum basis to justify its efforts to use bilateral assistance programs to lock generics out of developing countries. Of particular concern is your attempt to discredit the use of urgently needed fixed- dose combinations (FDCs) of antiretroviral AIDS medications.

    Single-pill combinations promote adherence, decrease the risk of resistance, and facilitate stock and procurement management, and are widely recognized as a core element in efforts to scale up ARV treatment in developing countries. FDCs are strongly preferred over blister packs and other multi-pill regimens. In addition to ease of use and other advantages, FDCs, which are taken in the form of one pill twice a day, are also by far the least expensive option: today, triple FDCs from generic manufacturers are available for less than $140 per person per year. The same combination from brand-name companies costs a minimum of $562 per person per year and must be taken in the form of six pills a day. Forcing people with HIV/AIDS to accept higher pill burdens, wasting limited taxpayer resources on brand name products, and, most importantly, using scarce resources to treat one person when the same amount of money could treat four is unacceptable.

    If the ambitious goals of the President's Emergency Plan for AIDS Relief (PEPFAR), and the WHO's "3 by 5" initiative are to be met, triple combination FDCs pre-qualified by WHO must be made widely available. FDCs are recommended in WHO treatment guidelines, and several generic FDCs have been certified by WHO as meeting stringent international standards for drug quality, safety and efficacy through its Prequalification Project. The WHO's standards for prequalification are supported by UNICEF, the World Bank, the Global Fund to Fight AIDS. TB, and Malaria, Columbia University's MTCT-Plus program, many national governments in developing countries, international humanitarian organizations such as Médecins Sans Frontières (MSF), and other programs with experience treating people living with HIV. Clinicians in resource poor settings are already using triple combination generics with tens of thousands of patients, with efficacy and adherence rates equal-to-or-better than treatment success and adherence rates in the United States.

    Rather than disregarding the drug procurement policies of developing nations to creating expensive new barriers that benefit US drug companies, your office should accept the WHO's internationally recognized drug quality standards and promote access to affordable medications. We object to any and all efforts by the Bush Administration and your office to block the use of WHO prequalified generic medications, and any efforts to discredit the standards of WHO's prequalification project that would impose new barriers to generics entering the global market.

    Signed,

    International organizations, multi-country
    International Association of Physicians in AIDS Care (IAPAC), Int'l
    Partners In Health, Int'l
    Oxfam International
    International Council of AIDS Service Organizations (ICASO), Int'l
    International Planned Parenthood Federation, Western Hemisphere Region, Int'l
    CAFOD International Ð Catholic Agency for Overseas Development, Int'l
    AIDSETI- AIDS empowerment & Treatment International, Int'l
    Ecumenical HIV Initiative in Africa, World Council of Churches, Int'l
    European AIDS Treatment Group (EATG), Int'l
    Health Action International, Int'l
    ILGA - International Lesbian and Gay Association, Int'l
    International Community of Women (ICW) living with HIV/AIDS, Int'l
    People's Health Movement Global Secretariat, Int'l
    Red Centroamericana de Personas que Viven con VIH/SIDA (REDCA+), Int'l
    Third World Network, Int'l - Malaysia
    African Jesuit AIDS Network, Int'l
    Asociacióón para la Salud Integral y Ciudadanía de América Latina (ASICAL), Int'l
    COLEGA, La Federación Española COLEGAS de Lesbianas, Gays, Bisexuales y Transexuales, Int'l
    Comite Latinoamericano y del Caribe para Defensa de los Derechos de la Mujer (CLADEM), Int'l
    International Health and Development Associates, Int'l
    International Peoples Health Council, Int'l
    INTERSECT Worldwide, Int'l
    Joint Mongolian-German Reproductive Health Project, Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ), Int'l
    Kenya AIDS Intervention Prevention Project Group (KAIPPG) Int'l
    Latin American and Caribbean Women's Health Network, (LACWHN), Int'l
    Movimiento Latinoamericano y del Caribe de Mujeres Positivas (MLCM+), Int'l
    Pastoral de la Esperanza Iglesia Catolica CentroAmericana, Int'l
    People's Health Movement East Africa, Int'l
    Red de Salud de las Mujeres Latinoamericanas y del Caribe (RSMLAC), Int'l
    The River Fund, Int'l
    Ukimwi Orphans Assistance, Int'l
    Voluntary Services Overseas (VSO), Int'l
    WE-ACT - Women's Equity in Access to Care & Treatment, Int'l

    Nationwide US Organizations
    Episcopal Church USA
    Presbyterian Church, USA
    Unitarian Universalist Association of Congregations, USA
    Amnesty International, USA
    American Foundation for AIDS Research (AmFAR), USA
    National Gay and Lesbian Task Force, USA
    ActionAid International USA
    Africa Action, USA
    AIDS Treatment News, USA
    AIDS Vaccine Advocacy Coalition (AVAC), USA
    American Jewish World Service, USA
    American Medical Students Association (AMSA), USA
    Center for Health and Gender Equity (CHANGE), USA
    CHAMP, USA
    Church Women United, USA
    Commission on Social Action of Reform Judaism, USA
    Consumer Project on Technology, USA
    Essential Action, USA
    Gay Men's Health Crisis (GMHC), USA
    Global AIDS Alliance, USA
    Global Exchange, USA
    Health GAP (Global Access Project), USA
    Jubilee USA Network, USA
    Maryknoll Office for Global Concerns, USA
    National Minority AIDS Council (NMAC), USA
    Our Bodies Ourselves, USA
    Physicians for Human Rights, USA
    POZ Magazine, USA
    Project INFORM, USA
    Reformed Church in America Mission Services program in Africa, USA
    Student Global AIDS Campaign, USA
    TII CANN - Title II Community AIDS National Network, USA
    Treatment Action Group, USA
    Washington Office on Africa, USA
    Women's International League for Peace and Freedom, United States Section
    50 Years Is Enough: U.S. Network for Global Economic Justice, USA
    Adrian Dominican Sisters, USA
    Africa Faith and Justice Network, USA
    AIDS Treatment Data Network, USA
    The Praxis Project, USA
    AIDS.ORG, USA
    Corporate Responsibility Program, Province of St. Joseph of the Capuchin Order, USA
    Health Professional Student AIDS Advocacy Network, USA
    Institute for Agriculture and Trade Policy, USA
    Keep A Child Alive, USA
    Maryknoll AIDS Task Force, USA
    Medical Mission Sisters' Alliance for Justice, USA
    Missionary Oblates, Justice/Peace & Integrity of Creation, USA
    National Association for Victims of Transfusion-Acquired AIDS (NAVTA), USA
    Operation USA
    Share International USA
    South Africa Development Fund, USA
    Universities Allied for Essential Medicines, USA

    International Organizations
    Act Up-Paris, France
    Agua Buena Human Rights Association, Costa Rica
    AIDES, France
    Bread for the World, Germany
    Deutsche AIDS-Hilfe, Germany
    Grupo de Incentivo ˆ Vida, Brazil
    Royal Tropical Institute, Amsterdam
    Action for Southern Africa (ACTSA), UK
    Advancement of Rural People And Nature (ARPAN), India
    African Research Institute, LaTrobe University, Australia
    African Services Committee, Ethiopia
    Agency for Cooperation and Research in Development (ACORD), UK
    AGIHAS PLWHA Support group, Latvia
    AIDS ACCESS Foundation, Thailand
    AIDS Council of New South Wales (ACON), Australia
    AIDS Law Unit, Legal Assistance Centre, Namibia
    AIDS Task Force (HIV/AIDS Division of Africa Japan Forum), Japan
    AKINA MAMA, Sweden
    Aln¾missamtökin ‡ êslandi, The AIDS Organization of Iceland, Iceland
    AMAS/AFAS, Mali
    APPRENDE, Peru
    Artists for a New South Africa, Int'l/USA-CA
    Asian-Pacific Resource & Research Centre for Women (ARROW), Malaysia
    Asoc. Gente Positiva (GP), Guatemala
    Asociación ACCRAD, Argentina
    Asociacion Amigos de Ayacucho, Spain
    Asociación Atlacatl Vivo Positivo, El Salvador
    Asociacion Comunitaria Anti SIDA, Spain
    Asociación Coordinadora de Sectores de Lucha Contra el SIDA (ACSLCS), Guatemala
    Asociación Costarricense De Personas Viviendo Con VIH/SIDA, Costa Rica
    Asociación de Mujeres Contra la Violencia Intrafamiliar, México
    Asociación por la Vida (ASOVIDA), Venezuela
    Associação Brasileira Interdisciplinar de AIDS (ABIA), Brazil
    Associação de apoio a pessoas com VIH/SIDA (ABRA‚O), Portugal
    Associação Justiça, Paz e Democracia (AJPD), Angola
    Association Bondeko, France
    Association de Lutte Contre le SIDA (ACLS), Morocco
    Association Kénédougou Solidarité, Mali
    ATTAC Japan, Japan
    Australasian Society for HIV Medicine, Int'l/Australia
    Australian Federation of AIDS Organisations, Australia
    Australian People for Health, Education and Development Abroad (international humanitarian agency of the Australian Council of Trade Unions), Australia
    Australian Red Cross, (Lao PDR Office), Australia
    AVERT - Averting HIV and AIDS Worldwide, UK
    Begin (learning & living with HIV), UK
    BolivaGAY.com, Bolivia
    British Columbia Persons With AIDS Society (BCPWA), Canada
    Campagne pour les Droits de l'Homme au Congo (CDHC) , Congo
    Campaign for Improved Access to Treatment for AIDS in resource poor countries (ImpAcTAIDS), Scotland
    Canadian African Partnership on AIDS (CAP-AIDS), Canada
    Canadian HIV/AIDS Legal Network, Canada
    Canadian Union of Public Employees (CUPE), Canada
    CARE Raks Thai Foundation, Thailand
    Casa del Paso del Peregrino, Argentina
    CASI - Comité d'Action Sociale et Internationale of the Université de Montréal, Canada
    Catholics for AIDS Prevention & Support (CAPS), UK
    Center for Health and Gender Equity (CHANGE), PERU
    Center for Information and Advisory Services in Health, Nicaragua
    Centers of Excellence- Substance Abuse & HIV/AIDS, India
    Centre for International Health (CIH) of the Macfarlane Burnet institute for Medical Research and Public Health, Australia
    Centro Regional de Farmacovigilancia, Argentina
    Cheshire Homes, South Africa
    ChildrenFIRST, South Africa
    Children's Rights Centre, South Africa
    Christian Health Association of Nigeria (CHAN), Nigeria
    Christian Medical Association of India
    CICOP Argentina
    CIIEMAD/ National Poytechnic Institute, Mexico
    Citizen's Health Initiative, Malaysia
    Coalicion ONGSIDA y de la Licda, Dominican Republic
    Comité Ciudadano Anti-Sida de Castilla-La Mancha, Spain
    Comite Dominicano de los Derechos Humanos CDH, Dominican Republic
    Comité Orgullo México
    Committee of Arab and African Families United to Survive AIDS, France
    Community Health Cell, India
    Consultants for Health and Development, The Netherlands
    Consumer Education Trust (CONSENT), Uganda
    Coordinadora de Animación Socio Cultural (CASCO), Dominican Republic
    COPROMOR, Burundi
    Dame Una Mano, Chile
    Departamento Acceso a Tratamiento Via Medidas Cautelares (DATVMC), Dominican Republic
    Department of Pharmacology, School of Medicine, National University of La Plata, Argentina
    Difaem - German Institute for Medical Mission. Germany
    Discipline of Clinical Pharmacology, Faculty of Health, University of Newcastle, Australia
    Ecumenical Pharmaceutical Network, Kenya
    EDU-PRO Foundation, Albania
    Egyptian Initiative for Personal Rights, Egypt
    Farmacéuticos Mundi (ONL), Spain
    Farmacia Siglo XXI Foundation, Spain
    Farmamundi Extremadura, Spain
    Five Loaves of Bread Christian Community for Homosexuals, Hungary
    Foundation For Social Concerns Inc., West Indies
    Foundation for Studies and Research on Women (FEIM), Argentina
    Freedom Foundation-India
    Fundación CIPRESS (Centro de Investigación y Promoción de la Salud y la Sexualidad), Chile
    Fundación Henry Ardila, Colombia
    Fundación Nimehuatzin, Nicaragua
    Fundación para el Desarrollo Humano y Social de la Región del Pueblo Mam (FUNDAMAM), Guatemala
    Fundacion para la Prevencion del VIH/SIDA (PRESIDA), Nicaragua
    Fundacion PRESIDA, Nicaragua
    Fundación Proyecto Gente, Columbia
    Fundacion Schorer, The Netherlands
    Génesis Panama+
    Ghana AIDS Treatment Access Group (GATAG), Ghana
    Gram Bharati Samiti, India
    Green Scenery, Sierra Leone
    Grupo Argentino Uso Racional de Medicamentos (GAPURMED), Argentina
    Grupo de apoyo de personas viviendo con VIH-SIDA (FUNDASIDA), El Salvador
    Grupo Desde el pié, Argentina
    Grupo Desida Por La Vida, Argentina
    Grupo Português de Activistas sobre Tratamentos de VIH/SIDA (GAT), Portugal
    GTP+ grupo de Trabalhos em Prevenção Posithivo, Brazil
    Health Alliance International, Int'l Ð USA/WA
    Health Issues Centre, Australia
    Helpless Rehabilitation Society, Nepal
    HIV i-Base, UK
    Human Genome Analysis, Wellcome Trust Sanger Institute, UK
    Imbiza Intersect Coalition, South Africa
    Interact Worldwide, Int'l Ð UK
    Interchurch Organisation for Development Cooperation (ICCO), The Netherlands
    International Cooperation Area, Foundation Institut Catala de Farmacologia, Spain
    International Family Health, UK
    International Gender Equality Network (IGEN), Hungary
    Ipas Mexico A.C., Mexico
    Irish Missionary Union, Ireland
    Jamaica-Japan Network, Japan
    Jana Arogya Andolana (PHM - Karnataka), India
    Kenya AIDS Intervention Prevention Project Group (KAIPPG), Kenya
    Kenya Treatment Access Movement, Kenya
    KwaZulu Natal Intersect Coalition, South Africa
    l'Association des Femmes Avocates au Congo ( AFEAC), Congo
    LGBT Organization of Venezuela
    Liga Colombiana De Lucha Contra el SIDA, Columbia
    Living Hope Organization, Nigeria
    LOCOST (Low Cost Standard Therapeutics), India
    Massive Effort Campaign, Switzerland
    McGill International Health Initiative, Canada
    MCS-Consult, Utrecht, The Netherlands
    MICHOACANOS POR LA SALUD Y CONTRA EL SIDA, Mexico
    Misiones Diocesanas Vascas, Spain
    Mulher e Saúde-Centro de Referência de Educação em Saúde da Mulher, Brazil
    Myanmar Buddhist Association of South Africa (MBASA), South Africa
    National Association of People Living With HIV/AIDS (NAPWA), Australia
    Nazareth Hospital-Holy Family Center, Kenya
    Network Earth Village Japan, Japan
    Network of People Living with HIV/AIDS in Nigeria (NEPWHAN), Nigeria
    Network of Sex Work Projects, Int'l - Brazil
    Organización de Apoyo a una Sexualidad Integral frente al SIDA (OASIS), Guatemala
    Organization for Social Development of Unemployed
    Pan-African Organisation In Sweden
    People Living With HIV/AIDS New South Wales, Australia
    People's Health Coalition for Equitable Society, South Korea
    Point of View, India
    Positive Life Association of Nigeria (PLAN), Nigeria
    Positive Living, Malaysia
    Positive Movement, Belarus
    Positive Women Victoria, inc., Australia
    Prodemur significa Promoción de la Mujer Rural, Argentina
    Programa de Prevención y Atención a las personas afectadas por ell VIH-SIDA en Asturias (PAVSA), Spain
    Programa de Soporte a la Autoayuda de Personas Viviendo con VIH ( PROSA), Peru
    Progressive Organization of Gays in the Philippines (PROGAY Philippines)
    Proyecto de Vacunaci˜n y Desarrollo Comunal de Nicaragua (PROVADENIC), Nicaragua
    Public Personalities Against Aids Trust, Zimbabwe
    Radio Rhino International Africa, Germany
    Reach Out Mbuya HIV/AIDS Initiative, Uganda
    Red Argentina de Género, Ciencia y Tecnología (RAGCyT), Argentina
    Red Colombiana de Mujeres por los Derechos Sexualers y Reproductivos, Colombia
    Red Hispana de Derechos Humanos en vih - sida y minorías sexuales, Columbia
    REDBOL, Bolivia
    REDVIHDA, Bolivia
    Regional AIDS Initiative of Southern Africa (RAISA) initiative of VSO, Zimbabwe
    Regional Committee for the Promotion of Community Health, Nicaragua
    Reproductive Health Matters, UK
    Reseau des associations des PVVIH, Togo
    Réseau du Burundi des PVVIH (RBP+), Burundi
    RESULTS, Canada
    RNP+ Núcleo RJ, Brazil
    Salud Integral para la Mujer, A.C. (SIPAM), Mexico
    SAPES Trust, Zimbabwe
    Sección Sindical de la Confederación General del Trabajo del Ministerio de Fomento, Spain
    Sida Info Service, France
    SIDACTION - Ensemble Contre le SIDA, France
    Social Welfare Association for Men (SWAM), India
    Sociedad Wills Wilde, Venezuela
    Society for Women and AIDS in Africa - Cameroun (SWAA), Cameroon
    Solidarité Sida, France
    Southern African AIDS Information Dissemination (SAfAIDS), Zimbabwe
    Spanish National Community Advisory Board (CACSIDA), Spain
    Spiritia Foundation (Indonesian Peer Support Network for PLHAs), Indonesia
    St. Joseph's Matale Youth Organization, Uganda
    Synthesis, Greece
    Tanzania Network Of Organization Of People Living With HIV/AIDS (TANOPHA), Tanzania
    Targeted AIDS Interventions, South Africa
    Tertulia Feminist Magazine, Guatemala
    Thandanani Childrens Foundation, South Africa
    TREE, Training & Resources in Early Education, South Africa
    Trócaire, Ireland
    Tuyakula Group, Namibia
    Uganda Coalition for Access to Essential Medicines, Uganda
    UK Coalition of People Living with HIV and AIDS (UKC), UK
    United Nations Association Of Uganda
    University of Manitoba Medical Students' AIDS Outreach, Canada
    University of Toronto International Health Program, Canada
    Vanguardia Mexicana de Personas Afectadas por el VIH/SIDA (VANMPAVIH), Mexico
    Vida Positiva Quilpue, Chile
    VIH/SIDA de la Iglesia Catolica de Honduras
    Waverley Care Trust, Scotland
    Wemos Foundation, Netherlands
    Western Cape Intersect Coalition, South Africa
    Wits Pediatric HIV Working Group, South Africa
    Women on Waves, The Netherlands
    Women's Dignity Project, Tanzania
    WTO Watch Qld, Australia
    Xtending Hope Partnership, St. Francis Xavier University, Canada
    Youth (OSDUY), Bangladesh
    YWCA of Albania

    US Local and Regional Organizations:
    ACT UP Cleveland, OH
    ACT UP East Bay, CA
    ACT UP New York, NY
    ACT UP Philadelphia, PA
    ActionAIDS Philadelphia, PA
    Africa Bridge, OR
    African Services Committee, NY
    AIDS Action Baltimore, MD
    AIDS Foundation of Chicago, IL
    AIDS Policy Project, PA
    AIDS Survival Project, GA
    Balm in Gilead, NY
    Blood:Water Mission, TN
    Brown University Center for AIDS Research, RI
    Catholic Mission Office, Diocese of St. Cloud, MN
    Citizens for Consumer Justice, PA
    COLOURS Organization, PA
    Concerned Medical and Health Care Professionals, MD
    Drexel University (Public Health Interest Group) PHIG, PA
    George Washington University Student Global AIDS Campaign. DC
    God's Love We Deliver, NY
    HIV Law Project, Inc, NY
    Housing Works, NY
    International AIDS Empowerment, TX
    Liberty Research Group, NY
    Loyola AIDS Awareness Coalition, MD
    Lutheran Campus Ministry at the University of Arizona, AZ
    Migration & Refugee Services, Diocese of Trenton, NJ
    NCATA (NW Coalition for AIDS Treatment in Africa), WA
    New Mexico POZ Coalition, NM
    New York AIDS Coalition, NY
    Office of Religion, Catholic Diocese of Scranton, PA
    PA Civil Rights Initiative, PA
    Pacientes de SIDA pro Politica Sana, PR
    Pediatric HIV/AIDS program at The Children's Hospital of Philadelphia, PA
    Pennsylvania Lesbian and Gay Task Force (PLGTF), PA
    Philadelphia International Action Center, PA
    Philadelphia NORML, PA
    Planet Poz, NM
    Positive Health Clinic, PA
    Prevention Point Philadelphia, PA
    Priority Africa Network (PAN), CA
    Queers For Racial & Economic Justice, NY
    Rescue Childhood, PA
    RESULTS Seattle, WA
    Rochester Area Task Force on AIDS, NY
    Rochester Global AIDS Project, NY
    Sisters Mobilized for AIDS Research and Treatment (SMART University), NY
    Sisters of St. Joseph of Carondelet, St. Louis Province, MO
    Starfish Project, New York Presbyterian Hospital, NY
    Survive AIDS, CA
    The Washington State Africa Network, WA
    Universities Allied for Essential Medicines, University of Minnesota, MN
    Village Care of New York AIDS Day Treatment Program, NY
    Vukani Mawethu Choir, CA
    Washington Biotechnology Action Council, WA
    Women's Environment and Development Organization (WEDO),NY
    Yale AIDS Network, CT
    Youth-Health Empowerment Project (Y-HEP), PA


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