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
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