NGO Letter to Tobias on Generic medicines and U.S.-initiated conference on Fixed-Dose Combinations

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.

29 March 2004

Ambassador Randall Tobias
Global AIDS Coordinator
U.S. Department of State
SA-29, 2nd Floor
2201 C Street, NW
Washington, DC 20522-2920

Re: Generic medicines and U.S.-initiated conference on Fixed-Dose

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 ³Conference on Fixed-Dose Combination (FDC) Drug Products: Scientific and Technical Issues related to Safety, Quality, and Effectiveness,² 29-30 March 2004 in Gaborone, Botswana. This meeting needlessly casts doubt upon the clinically proven quality of generic AIDS medicines, and disregards the WHO¹s 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 President¹s Emergency Plan for AIDS Relief (PEPFAR), and the WHO¹s ³3 by 5² 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 WHO¹s standards for prequalification are supported by UNICEF, the World Bank, the Global Fund to Fight AIDS. TB, and Malaria, Columbia University¹s 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 create expensive new barriers that benefit US drug companies, your office should accept the WHO¹s 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 WHO¹s prequalification project that would impose new barriers to generics entering the global market.


International organizations

International Association of Physicians in AIDS Care (IAPAC), Int¹l

Partners In Health, Int¹l

Oxfam International

International Council of AIDS Service Organizations (ICASO), Int¹l

International Planned Parenthood Federation, Western Hemisphere Region, Int¹l

CAFOD International ¬ Catholic Agency for Overseas Development, Int¹l

AIDSETI – AIDS empowerment & Treatment International, Int¹l

Ecumenical HIV Initiative in Africa, World Council of Churches, Int¹l

European AIDS Treatment Group (EATG), Int¹l

Health Action International, Int¹l

Health Alliance International, Int¹l

ILGA – International Lesbian and Gay Association, Int¹l

International Community of Women (ICW) living with HIV/AIDS, Int¹l

People’s Health Movement Global Secretariat, Int¹l

Red Centroamericana de Personas que Viven con VIH/SIDA (REDCA+), Int¹l

Third World Network, Int¹l – Malaysia

African Jesuit AIDS Network, Int¹l

Artists for a New South Africa, Int¹l/USA-CA

Asociación para la Salud Integral y Ciudadanía de América Latina (ASICAL), Int¹l

COLEGA, La Federación Española COLEGAS de Lesbianas, Gays, Bisexuales y Transexuales, Int¹l

Comite Latinoamericano y del Caribe para Defensa de los Derechos de la Mujer (CLADEM), Int¹l

International Health and Development Associates, Int¹l

International Peoples Health Council, Int¹l

INTERSECT Worldwide, Int¹l

JACANA Real World Development, Int¹l

Joint Mongolian-German Reproductive Health Project, Deutsche Gesellschaft für Technische Zusammenarbeit (GTZ), Int¹l

Kenya AIDS Intervention Prevention Project Group (KAIPPG) Int¹l

Latin American and Caribbean Women¹s Health Network, (LACWHN), Int¹l

Movimiento Latinoamericano y del Caribe de Mujeres Positivas (MLCM+), Int¹l

Pastoral de la Esperanza Iglesia Catolica CentroAmericana, Int¹l

People¹s Health Movement East Africa, Int¹l

Red de Salud de las Mujeres Latinoamericanas y del Caribe (RSMLAC), Int¹l

The River Fund, Int¹l

Ukimwi Orphans Assistance, Int¹l

Voluntary Services Overseas (VSO), Int¹l

WE-ACT – Women’s Equity in Access to Care & Treatment, Int¹l

US National 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


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


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


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

Foreign Country 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 à Vida, Brazil

Médecins Sans Frontières, Project of Access to ARV therapy, Kenya

Médecins Sans Frontières, Spain

Médecins Sans Frontières, Benin

Royal Tropical Institute, Holland

Treatment Action Movement, Nigeria

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 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


Alnæmissamtökin á Íslandi, The AIDS Organization of Iceland, Iceland



Asian-Pacific Resource & Research Centre for Women (ARROW), Malaysia

Asoc. Gente Positiva (GP), Guatemala

Asociación ACCRAD, Argentina

Association is sid’accueil 14, France

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 (ABRAÇO), 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, Int¹l/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, 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

Citizen¹s Health Initiative, Malaysia

Coalicion ONGSIDA y de la Licda, Dominican Republic

Comité Ciudadano Anti-Sida de Castilla-La Mancha, Spain

Comité Ciudadano Anti-Sida de Burgos (CCASB), 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


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

d’Unis-Cité, France

Ecumenical Pharmaceutical Network, Kenya

EDU-PRO Foundation, Albania

Egyptian Initiative for Personal Rights, Egypt

Family Aids Caring Trust, Zimbabwe

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

Groupe de Recherche sur les Femmes et les Lois, Senegal

Grupo Argentino Uso Racional de Medicamentos (GAPURMED), Argentina

Grupo de apoyo de personas viviendo con VIH-SIDA (FUNDASIDA), El Salvador

Grupo De Mujeres De La Argentina

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 Education and Research Association (HERA), Macedonia.

Health Issues Centre, Australia

Helpless Rehabilitation Society (HRS), Nepal

HIV i-Base, UK

Human Genome Analysis, Wellcome Trust Sanger Institute, UK

Imbiza Intersect Coalition, South Africa

Interact Worldwide, Int¹l ¬ 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


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

National Forum of People Living with HIV/AIDS Networks and Organisations, Uganda

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, Int¹l – Brazil

Organización de Apoyo a una Sexualidad Integral frente al SIDA (OASIS), Guatemala

Organization for Social Development of Unemployed, Bangladesh

Pan-African Organisation in Sweden

People Living With HIV/AIDS New South Wales, Australia

People and Planet, UK

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 Vacunaciòn 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

Red Nacional de Educación Salud Sexual y Desarollo para Jóvenes, Peru

REDBOL, 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


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

The Ark Foundation, Ghana

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

Unión Afirmativa de Venezuela

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, The 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

God¹s Love We Deliver, NY

HIV Law Project, Inc, NY

Housing Works, NY

International AIDS Empowerment, T

xLiberty 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 College of Medicine Public Health Club, PA

Philadelphia International Action Center, PA

Philadelphia NORML, PA

Planet Poz, NM

Positive Health Clinic, PA

Prevention Point Philadelphia, PA

Princeton Student Global AIDS Campaign, NJ

Priority Africa Network (PAN), CA

Queers For Racial & Economic Justice, NY

Rescue Childhood, PA


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

Dying for Drugs: How CAFTA Will Undermine Access to Essential Medicines

If adopted, the proposed U.S.-Central America Free Trade Agreement (CAFTA) will cost lives.

The intellectual property, and to a lesser extent the investment, provisions of the draft agreement throw up a number of road blocks to the introduction of generic medicines.

By Robert Weissman
Essential Action

March 5, 2004

If adopted, the proposed U.S.-Central America Free Trade Agreement (CAFTA) will cost lives.

The intellectual property, and to a lesser extent the investment, provisions of the draft agreement throw up a number of road blocks to the introduction of generic medicines.

As elaborated below, these include provisions to establish a system of monopoly protections for pharmaceuticals that runs parallel to the patent system – so that even government efforts to authorize generic production while products are on patent (compulsory licensing) will be thwarted – and provisions to extend patent terms.

The most extreme of the CAFTA provisions appears to establish an effective bar to compulsory licensing of pharmaceuticals in Central American countries.

If CAFTA is adopted, these measures will have a major, harmful impact on healthcare in Central America, and perhaps even in the United States.

This analysis proceeds by briefly discussing the following topics:

• The benefits of generic competition and compulsory licensing;
• How CAFTA’s data exclusivity protections can work as back-door barriers to compulsory licensing;
• A draconian CAFTA data exclusivity provision that may function as a de facto prohibition of compulsory licensing;
• CAFTA provisions requiring patent extensions;
• CAFTA provisions requiring overprotection of patents; and
• A conclusion that CAFTA runs afoul of the Doha Declaration on the TRIPS Agreement and Public Health, and should be rejected.

1. The Benefits of Generic Competition and Compulsory Licensing

It is beyond dispute that the introduction of generic competition lowers price dramatically and enables broadened access to needed medicine. The purpose of patent monopolies is to enable patent holders to collect supracompetitive profits. There is an extensive literature on the price reductions that follow from generic competition in the United States and industrialized countries. And, now several years into the international campaign for access to essential medicines, generic competition has brought down the price of lifesaving antiretrovirals used to treat people with HIV/AIDS by more than 98 percent.

Under the rules of the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), countries are required to provide 20-year patent protections for all products, including pharmaceuticals. This global standard has forced many developing countries that previously did not offer patent protection for pharmaceuticals, or offered only limited protection, to adopt U.S.-style patent rules covering medicines.

Although it imposed on countries the requirement to adopt 20-year patents for drugs, the TRIPS Agreement also contained certain safeguards. Most important among them is the right to undertake compulsory licensing.

Compulsory licensing enables a government to authorize a third party — whether a company, government agency or other party — to use a patent held by another. Honduras, for example, could issue a license to generic company Z for an HIV/AIDS drug manufactured by brand-name company X. Generic firm Z would then manufacture or import the drug for sale in Honduras under a generic name, and pay a reasonable royalty to brand-name company X on each sale.

Compulsory licensing can lower prices to consumers by creating competition in the market for the patented good. The key benefit of compulsory licensing is that it creates competition for a pharmaceutical product while it is still covered by patent. Just as the prices of drugs may decline dramatically when patent protection runs out, compulsory licensing can introduce these price reductions while a drug remains on patent. And, even when compulsory licenses are not issued, the mere prospect that they might be issued may lead patent holders to lower prices to avert the possibility of a compulsory license.

Trade agreement rules that delay in the introduction of generic competition delay the attainment of these gains in lowered prices and expanded access — with deadly effect in the case of life-saving medicines such as antiretrovirals, and diminished quality of life for other medicines with useful if not life-saving effects.

2. Data Exclusivity Protections: Back-Door Barriers to Compulsory Licensing

The most worrisome measures in the U.S.-Central America Free Trade Agreement (FTA) involve requirements that countries establish special monopoly protections for pharmaceutical regulatory data. The impact of these measures will be, at least, to greatly delay countries from undertaking compulsory licensing. The impact will be harshest in the Central American parties to the agreement, but effects may be felt in the United States as well, including during times of gravest national emergency.

As a condition of selling pharmaceuticals, countries require pharmaceutical sellers to submit data showing their drugs are safe and effective. This data is commonly referred to as registration data, or marketing approval data.

Generating the data, based on animal and human testing can be relatively expensive, costing in some cases tens of millions of dollars.

To gain regulatory approval to sell generic versions of drugs already approved for market, generic companies generally do not repeat these studies, which are very time consuming and, from the perspective of the relatively low-capitalized generic industry, costly. Instead, they typically show their product is chemically equivalent and bioequivalent (meaning it will work the same in the body as the brand-name drug). Then the generic companies simply rely on the drug regulatory agency’s approval of the patented product to earn approval for the generic version of the product.

If the generics are not able to rely on approvals granted based on the brand-name data, in many cases they simply will not enter the market. This is especially true in smaller size markets, as in Central America, where prospective revenues are limited. Yet CAFTA includes a number of provisions providing an array of special monopoly protections for regulatory data.

The meaning of these provisions is that generics will effectively be barred from entering the market — even if patent terms have expired, and even if countries have issued compulsory licenses that would otherwise them to sell on the market while a product is on patent — until the monopolies on use of the data expire.

These CAFTA provisions go far, far beyond the requirements of TRIPS.

Under the TRIPS Agreement, countries must protect “undisclosed” pharmaceutical test data from “unfair commercial use” (TRIPS Article 39.3). The meaning of this vague language is uncertain and subject to debate. There is a strong argument that this TRIPS provision is intended only to cover the misappropriation of test data — along the lines of literal theft of the data from files kept by drug regulatory agencies. Whatever else it means, the extremely vague language of the TRIPS provision makes clear that:

1. Countries have considerable discretion in determining what is “unfair.”

2. Multiple approaches to provide reasonable protection will satisfy the provision’s mandate.

3. There is no requirement that countries exclude other parties from using the data or relying on approvals based on the data, and no requirement that any exclusivities granted extend for a particular period of time.

4. Protections for pharmaceutical test data need only be granted for new chemical entities.

These flexibilities in the TRIPS Agreement would be completely overridden by the CAFTA provisions.

Under CAFTA:

• Countries would be required to provide five years of data protection from the moment a product was given regulatory approval in their country. (Article 15.10.1(a).) This amounts to an effective five-year bar on compulsory licensing from the time of marketing approval.

• CAFTA members must grant five years data exclusivity protections to brand-name companies if their product has received marketing approval anywhere in the world – even if the brand-name company has not introduced the product in their country! (Article 15.10.1(b).) In other words, if Pfizer puts a new product on the market in the United States, but does not introduce it in Honduras, Honduras is effectively denied the right to authorize generic versions of the product for five years.

• Pharmaceutical companies could maneuver in this system to extend the period of monopoly control over the data to 10 years. Under CAFTA, countries must grant a fresh period of five years data protection from the moment a product receives marketing approval in their country — even if they have already granted up to five years protection while the product had been approved elsewhere but not put on the market in their country. (Article 15.10.1(b).) Thus, if Pfizer waits five years after introducing its new product in the United States before introducing it in Honduras, Honduras must provide for data exclusivity both during the five year period when the product was not on sale in the country, and for the five-year period after Honduras has granted marketing approval. This outcome would be required even as the United States, which benefited from the initial product introduction, is only required to grant five years of data protection.

• Regulatory data monopolies must be granted for the marketing approval data submitted for all “new pharmaceutical products.” (Article 15.10.1(a).) Under TRIPS, the requirement of data protection applies only to data submitted for new chemical entities. Under CAFTA, data protection must be granted for any new product containing a chemical entity not previously approved in the country – even if it is not actually new. ((Article 15.10.1(c).)

3. A De Facto Prohibition of Compulsory Licensing

CAFTA’s farthest reaching data monopoly protection would have an even more devastating impact. It would effectively make compulsory licensing impossible in Central American countries.

Notwithstanding the provisions discussed in section two above, CAFTA’s Article 15.10.3, appears to prohibit any generic firm from relying on the data submitted by a patent holder at any point during the term of the patent unless the generic firm has the permission of the patent holder.

The actual text of the provision reads:

Where a Party permits, as a condition of the marketing of a pharmaceutical product, persons, other than the person originally submitting safety or efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval in the Party or in another territory, that Party:

(a) shall implement measures in its marketing approval process to prevent such other persons from marketing a product covered by a patent claiming the product or its approved use during the term of that patent, unless by consent or acquiescence of the patent owner; and

(b) if the Party permits a third person to request marketing approval of a product during the term of a patent identified as claiming the product or its approved use, it shall provide that the patent owner be informed of such request and the identity of any such other person.

If in fact this language means what it says, then generic firms cannot rely on marketing approval data for a product for the entire term of the product’s patent, even if a compulsory license is issued. Because of the cost, and the small size of the markets in Central America, generic firms will probably never be able or willing to re-perform safety and efficacy tests to obtain marketing approval in Central American countries. Thus, even if they were issued a compulsory license, they could not enter the market. In other words, this provision appears to be an effective bar to compulsory licensing.

Because this provision appears so draconian, Essential Action has asked the U.S. Trade Representative to clarify if the language should properly be interpreted to mean something other than what it appears. In an informal meeting, a USTR representative agreed that the Essential Action interpretation of the language appeared to be correct, but promised to contact us later with clarification.

This devastating data monopoly protection might also have severe effects in the United States.

In 2001, amidst the anthrax scare, the Department of Health and Human Services (HHS) considered issuing a compulsory license on ciprofloxacin, used to treat anthrax. (The U.S. government maintains very aggressive authority to undertake compulsory licensing for its own use.) The government ultimately did not issue the compulsory license, but the threat helped encourage the patent holder, Bayer, to lower its price.

Suppose the scenario were repeated, and HHS decided that it did want to issue a compulsory license, either because Bayer would not lower its prices sufficiently, or because it could not make an adequate supply available fast enough. If the CAFTA provision were in effect, a generic licensee would not be able to rely on Bayer’s safety and efficacy data, or the fact that it had received regulatory approval. The generic firm would have to repeat the already completed test. Given the size of the likely purchase from HHS, this would probably be a worthwhile investment. But redoing the tests would likely take years – far too long a delay in the case of urgent circumstance.

Perhaps in such a circumstance the U.S. government would simply ignore its obligations under international trade agreements – but surely that is no rationale for entering into such provisions in the first place.

4. Extending the Life of a Patent

TRIPS obligates member countries to grant 20-year patents. Patent terms seek to create a balance between providing incentives for inventors and the public interest in maintaining and promoting competition. The 20-year term manifested such a balance taking into account the known delays in the process of getting a drug to market.

Adding additional time to the patent term after a balance has been struck improperly and dangerously tips the patent system in the direction of patent holders. It discriminates against generic entry, and requires consumers for a longer period of time to buy the patented product from the patent owner, or not at all.

Two key provisions in CAFTA would require countries to extend the life of a patent.

• Patent extensions must be provided to offset delays in the grant of a patent (Article 15.9.6). Whatever the reason for delays in granting a patent, it is clear that consumers are not responsible for them — yet it is consumers who pay the price under this provision.

• Patent extensions must be provided to offset delays in marketing approval for pharmaceuticals (Article 15.10.2). Thus, if regulatory complications result in a delay in the grant of marketing approval, the patent monopoly must be extended. Again, whatever the reason for delays in marketing approval, it is clear that consumers are an innocent party — yet are the ones stuck with the bill under this provision.

5. Overprotection of patents

Other provisions of CAFTA’s intellectual property and investment chapters will unjustifiably deepen monopoly protections for patents.

• The agreement creates an incentive for brand-name drug companies to submit bad patent applications. Article 15.9.8 requires countries to permit patent applicants to amend their patent application. This gives patent applicants an incentive to submit inadequate applications– providing inadequate disclosure of how to make and use the subject invention — or overly broad patents. With this rule, if a patent officer concludes that a patent application is inadequate, the applicant can simply amend it by providing the information initially withheld.

• The agreement biases the judicial system by mandating a presumption in courts that challenged patents are valid. Such a rule obviously makes challenged patents more likely to be upheld, and provides a disincentive for generic firms or others to challenge bad patents. Even in the United States, with a massive bureaucracy devoted to patent examination, federal government agencies acknowledge that bad patents are routinely granted. In many poorer countries, there is little or no serious patent examination — making the mandatory presumption in favor of patent validity all the more misguided.

• CAFTA investment rules will inhibit compulsory licensing. The investment chapter specifies that compulsory licensing done in compliance with TRIPS and/or CAFTA’s intellectual property rules does not violate the investment chapter’s limitation on expropriation (Article 10.7.5) or performance requirements (Article 10.9.3). However, even with these savings provisions, the agreement’s investment chapter rules are so severe that they are likely to chill countries’ willingness to undertake compulsory licensing. The investment agreements are enforced through special rules that investors sue national governments directly, often for huge sums of compensation. If a CAFTA country were to issue a compulsory license, but do so in a manner that was not compatible with the TRIPS Agreement or CAFTA’s intellectual property rules, it would be subject to suit under CAFTA’s investment rules. Even the fear of such a suit, which could require a government to pay heavy compensation to a patent holder, will work to deter countries from issuing compulsory licenses.

6. Conclusion: Reject CAFTA

By design, intellectual property rules in trade agreements are highly technical and confusing.

But the rules embodied in such agreements determine the shape of markets for medicines: which players will be able to compete, when, and on what terms.

Because of the critical importance of medicines in saving lives and maintaining quality of life, these market-determining decisions have life-and-death consequences.

CAFTA contains an array of provisions designed to entrench the power of brand-name pharmaceutical companies, and to delay the entry of generic competition. It will deprive governments of key tools they need to lower prices. It will effectively strip them of the ability to issue compulsory licenses for many years, and quite possibly at all. It will deny them the bargaining power they maintain by virtue of their ability to threaten to issue compulsory licenses.

CAFTA therefore runs afoul of the historic 2001 Doha Declaration on the TRIPS Agreement and Public Health, in which all WTO members “affirm[ed] that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all” and “in this connection … reaffirm[ed] the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.” It runs afoul of the Doha Declaration because it denies countries the right to use the flexibilities intended to promote the goals of protecting public health and promoting access to medicines for all.

The Doha Declaration was the product of the international community at its best, recognizing an overriding commitment to healthcare that cannot be subordinated to commercial considerations.

CAFTA, by contrast, uniformly favors the interests of multinational drug companies over those of patients. It must be rejected.