The Glivec case from Novartis
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Open letter to Novartis  (26.04.07)
Last update: April 26th 2007

(N.B.: The organizations and personalities willing to endorse this open letter can do so by writing an e-mail to Julien Reinhard: reinhard@ladb.ch. Please indicate in every case: the name of the organization + the name of the person in charge + the function of this person.)


Dear Mr. Vasella,

Alerted by Indian patients with cancer, health organizations and public interest groups, we are writing to you to express our concerns regarding the legal proceedings that Novartis has started in May 2006 in order to challenge the rejection of its patent application for imatinib mesylate (Glivec®/Gleevec®) as well as the compliance of the Indian Patents Act with the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). We are joining the Indian organizations in their demand that Novartis withdraws these cases.

In particular, we are extremely concerned with Novartis’s challenge of Section 3(d) of the Indian Patents Act, which Novartis claims is not compliant with the TRIPS Agreement.

Section 3(d), which prevents the grant of patents for new forms or new uses of known substances, is one of the recognized flexibilities of the TRIPS Agreement that countries are utterly free to adopt in their legislation. The importance of these flexibilities has been highlighted by the United Kingdom Commission on Intellectual Property Rights in its 2002 report[1] as well as by the World Health Organization Commission on Intellectual Property Rights, Innovation and Health in its 2006 report[2].

Such a challenge is in contradiction with the spirit and the letter of the Doha Declaration on the TRIPS Agreement and Public Health. The Declaration states that the TRIPS 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"[3]. With this challenge, Novartis is seeking to limit the ability of the Indian Government to take measures to protect the public health of its population and to have a patent system adapted to the Indian socio-economic context.

We are very concerned that the changes sought by Novartis in the Indian Patents Act could negatively affect access to essential generic medicines (in particular HIV/AIDS medicines) not only in India but also in all the developing countries that import Indian generic medicines.

Novartis sells Glivec®/Gleevec®, a life-saving medicine at prohibitive prices in India (Rs. 1.44 million, or US$ 26'000, per patient per year) and in other developing countries. This price is well above the financial capacity of the majority of patients in developing countries. Novartis recognizes that only a small number of patients in India are paying for the medicine.

Access to health care and medicines in developing countries depends on different factors and requires solutions at various levels. However, it is everyone's duty to remove barriers within its own abilities.

We are shocked that five years after the end of the trial brought by Novartis and other pharmaceutical companies against the South African government, Novartis is trying again to restrict the flexibility given to a country to adapt the TRIPS Agreement to its public health needs.

The undersigned organizations demand that Novartis withdraws the cases against the Indian Patents Act and the decision of the Indian Patent Office on Glivec®/Gleevec®.

Sincerely yours,

Julien Reinhard
Campaign Director
Berne Declaration

This letter was initially endorsed by the following organizations and persons:

Organizations
  • Aids-Hilfe Bern, Kurt Pärli, Chairman & Mrs Béatrice Aebersold Krähenbühl, Director
  • Aids-Hilfe beider Basel, Stefan Moser, Director
  • Association of European Cancer Leagues (ECL), Bruno Meili, President
  • Berne Declaration, Julien Reinhard, Campaign Director
  • Bethleem Mission Immensee, Stefan Siebenhaar, Campaign Director
  • CO-OPERAID, Dr. Rao Satapati, Director
  • Groupe sida Genève, David Perrot, Director
  • Médecins Sans Frontières - Suisse, Christian Captier, General Director
  • medicuba, Dr. med. Christian Jordi, President
  • MIVA Schweiz, Marco Medici, Director
  • Pharmaciens Sans Frontières - Suisse, M.-J. Barbalat, President
  • SID'Action (Lausanne), Patricia Grigolin, Director
  • SolidarMed Suisse, Dr. med. Pepo Frick, Vice-President
  • Swiss Aids Care International, Susann Mäusli, Director
  • Swiss Cancer League, Prof. Dr med. Thomas Cerny, President
  • Swiss Aids Federation, Franz Walter, Director
  • terre des hommes schweiz, Michael Herzka, Director
  • terre des hommes suisse, Jean-Luc Pittet, Secretary General

In a private capacity
  • Ruth Dreifuss, Chairperson from the Commission on Intellectual Property Rights, Innovation and Public Health, appointed by the World Health Organization
  • Dr Claudia Kessler Bodiang, member of aidsfocus.ch
  • Thomas Schwarz, Co-Director of Medicus Mundi Suisse
  • Helena Zweifel, Coordinator of aidsfocus.ch


The following organizations and personalities have endorsed the letter after the 10 October 2006 (Status on 26 April 2007):

Organizations
  • Oxfam International, Céline Charvériat, Director Trade Campaign
  • Health Action International - Europe, Tim Reed, Director
  • Foundation For Consumers (Thailand), Dr. Jiraporn Limpananont, Director
  • Difäm - Gesundheit in der Einen Welt (Germany) Dr. Rainward Bastian, Director
  • Healthy Skepticism (Australia), Dr Peter Mansfield, Director
  • BUKO Pharma-Kampagne (Germany), Jörg Schaaber, Director
  • EKPIZO (Consumers Association the Quality of Life) (Greece), Eleni Alevritou, President
  • Zürcher Aids-Hilfe (Switzerland), Reto Jeger, Director
  • Diverse Women For Diversity (India), Dr Mira Shiva
  • International Peoples Health Council (South Asia), Dr Mira Shiva
  • Health & Development Foundation (Thailand), Sumlee Jaidee, Director
  • Geneva Infant Feeding Association - GIFA (Member of IBFAN) (Switzerland), Daphne Lachavanne, President
  • Consumers' Association of Penang (CAP) (Malaysia), S.M. Mohamed Idris, President
  • Abhaya ActionAid Karnataka Projects (India), Dr. P. Manish Kumar, Central Coordinator
  • AIDS-Hilfe Zug (Switzerland), Ambord Patrick, Director
  • Books for Change Bangalore (India), Shoba Ramachandran, Publisher and Chief Editor
  • Health Action International - Asia-Pacific, Dr K Balasubramaniam, Co-ordinator and Advisor
  • Saheli Women's Resource Centre New Dehli (India), Ms. Vineeta
  • Act Up-Paris (France), Khalil Elouardighi, chargé des questions internationales
  • Association de Lutte Contre le Sida (ALCS) (Morocco), Othoman Mellouk, chargé des questions internationales
  • G.A.T. - Grupo Português de Activistas sobre Tratamentos de VIH/SIDA (Portugal), Wim Vandevelde, President
  • Positive-Generation (Cameroon), Fogué Foguito
  • HOPE (Humanitarian Organization for People Empowerment) (Cameroon), James Clovis Kayo
  • AIDS ACCESS Foundation (Thailand), Nimit Tienudom , Director
  • medico international schweiz, Lis Füglister & Anita Escher, Directors
  • AGIHAS (PWA - People Living with HIV) Support group (Latvia)
  • Sidaction (France), Eric Fleutelot, Head of International Programs
  • FrontAIDs Sankt-Petersburg (Russia), Alexander Rumiantsev
  • EMPOWER (India), A. Sankar, Executive Director
  • Network of Zimbabwe Positive Women, Martha Tholanah
  • National Working Group on Patent Laws (India), B.K. Keayla, Convenor
  • medico international (Germany), Thomas Gebauer, Director
  • Treatment Action Campaign (South Africa), Mr. Zackie Achmat, Chairperson, and Régis Mtutu, International campaigns Coordinator
  • European AIDS Treatment Group (EATG) (Brussels, Belgium), Wim Vandevelde, Director
  • Friends of Treatment Action Campaign UK (United Kingdom) Andrew Feinstein, Chairperson
  • SAfAIDS - Southern Africa HIV and AIDS Information Dissemination Service (Zimbabwe), Dominica Mudota, Programme Officer- Advocacy and Gender
  • Positive Womens Network (South Africa) ,Prudence Mabele
  • Aktionsbündnis gegen AIDS, Deutschland / Action against AIDS Germany, Katja Roll, Political Coordination & External Relations
  • Grupo Argentino Para el Uso Racional del Medicamento - Gapurmed, DRa Mabel Valsecia, Presidente, y Dr Luis Castiglioni, Vicepresidente
  • AIS Nicaragua, Benito Marchand
  • Salud y Fármacos (USA), Antonio Ugalde y Núria Homedes, editores
  • Fundación Misión Salud (Colombia), Germán Holguín Zamorano, Director General
  • Centrale Sanitaire Suisse Romande (Switzerland), Françoise Schnorf, présidente
  • Réseau Accès aux Médicaments Essentiels - RAME (Burkina Faso), Simon Kabore, Coordonnateur
  • The Church of Scotland HIV/AIDS Project, Nigel Pounde, HIV/AIDS Project Co-ordinator
  • Zimbabwe Diaspora Civic Society Organisations Forum (Johannesburg, South Africa), Nora C Tapiwa, Acting Coordinator
  • Focus on the Global South (Thailand, India, Philippines), Dr Walden Bello, Executive Director
  • Jagori Women's Resource Centre, New Delhi (India), Kalyani Menon-Sen, Coordinator
  • SWISSAID (Switzerland), Caroline Morel, directrice
  • One World Action (United Kingdom), Andy Rutherford, Head of International Partnerships
  • Red Argentina de Personas Viviendo con VIH/Sida - RedAr+ , Eduardo E. Busto, Secretario General
  • Health GAP (USA), Asia Russell, Director, International Policy
  • Keralahealth.org (India), Dr Manoj Kumar, Chairman-Global network
  • Research Foundation for Science Technology & Ecology (India), Dr Vandana Shiva
  • NAVDANY (India), Dr Vandana Shiva
  • Initiative for Health, Society and Equity (India), Dr. Mira Shiva
  • PEACE (Rajahmundry, Andhra Pradesh, India), P.Vijay Prasad, Member of Executive Committee
  • Hilfswerk der Evangelischen Kirchen Schweiz - HEKS (Switzerland), Franz Schüle, Zentralsekretär
  • IT for Change (India), Piyoo Kochar, Manager Programs
  • International Physicians for the Prevention of Nuclear War (IPPNW) - German section (Germany), Dr. Angelika Claußen, Chairperson

In a private capacity
  • Jean Ziegler, United Nations Special Rapporteur on the Right to Food
  • Dr Andrew Herxheimer, Emeritus Fellow of the UK Cochrane Centre (United Kingdom)
  • Joel Lexchin MD, Professor, School of Health Policy and Management, York University, Toronto (Canada)
  • Dr Gopal Dabade, Co-convener, All India Drug Action Network (AIDAN), President, Drug Action Forum - Karnataka (DAF-K) (India)
  • Dr. Markus Fritz, Geschäftsleiter, Schweizerische Medikamenten-Informationsstelle SMI (Switzerland)
  • Staffan Svensson, MD PhD, Dept of Clinical Pharmacology, Sahlgren's Univ Hospital, Gothenburg (Sweden)
  • Annemarie Jurg (The Netherlands)
  • Kanda Naknoi, Assistant professor of economics, Purdue University (USA)
  • Dr. N. Devadasan, Director, Institute of Public Health, Bangalore (India)
  • Jon Jureidini PhD, Head, Department of Psychological Medicine, Children’s Youth and Women’s Health Service, Associate Professor, Department of Psychiatry, University of Adelaide, Senior Research Fellow, Department of Philosophy, Flinders University of South Australia (Australia)
  • Joana Ramos, Cancer Resources & Advocacy, Seattle (USA)
  • Sunita Sheel, Health Researcher, Pune (India)
  • Tendayi Westerhof, Public Personalities Against Aids Trust (Zimbabwe)
  • Roberto López Linares, Coordinador de la Oficina de Coordinación Acción Internacional para la Salud América latina - AIS LAC (Perú)
  • Germán Rojas Caro, Oficina de Coordinación de AIS LAC (Perú)
  • Laura Trujillo Salinas, Profesor titular de Farmacología, Escuela Superior de Medicina del I.P.N. Cd. de México
  • Mendene Marie (Cameroon)
  • Alain Van Belleghem, réalisateur (Belgium)
  • Pedro J. Rivarola, Chairman & CEO MaxCord (USA)
  • Florencia Luna, Director of Bioethics Program FLACSO (Facultad Latinoamericana de Ciencias Sociales) (Argentina)
[1]Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy. London: CIPR, September 2002 (www.iprcommission.org)
[2]Report of the Commission on Intellectual Property Rights, Innovation and Health. Public Health, Innovation and Intellectual Property Rights,Geneva: April 2006 (www.who.int/intellectualproperty/documents/thereport/en/index.html). See also: Carlos CORREA. Integrating Public Health Concerns into Patent Legislation in Developing Countries. Geneva: South Centre, 2000 // UNCTAD-ICTSD. Ressource Book on TRIPS and Development. Cambridge University Press, 2005 // Sisule MUSUNGU (South Centre) and Cecilia Oh (World Health Organization). The Use of Flexibilities in TRIPS by Developing Countries: Can they Promote Access to Medicines? Study 4C for the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva: August 2005.
[3]Declaration on the TRIPS agreement and public health adopted on 14 November 2001 (WT/MIN(01)/DEC/2)



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