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July 4, 2006 Dr. Manmohan Singh Honorable Prime Minister of India The Prime Minister's Office South Block, Raisina Hill, New Delhi, India 110 011 Fax: 23019545 / 23016857 Dear Prime Minister, The global HIV/AIDS Community is thankful to India for the health and hope that the Indian generic pharmaceutical industry gives to those people living with HIV/AIDS around the world. We would like to express our concern that some law and policy changes in India may have adverse effects on the global availability of affordable quality essential HIV/AIDS medicines and new inventions such as women-controlled prevention methods (microbicides). Through this letter, we would like to communicate our concern particularly about the amendments in the Indian Drugs and Cosmetic Act. The implementation of data exclusivity provisions as an amendment to the Drug and Cosmetic Act would seriously affect India's ability to provide drugs to millions of people around the world living with diseases such as HIV/AIDS, hypertension, diabetes, asthma, and many more. There are actions that can be taken that will allow for maximum availability of generic drugs while being TRIPS compliant Without Indian generic drugs, millions of people in developing countries will die as a result of lack of access to affordable medicines. Data exclusivity provisions, if added to the Drugs and Cosmetic Act, will prevent generic companies from using data on existing drugs to gain regulatory approval for generic versions. Generic companies would be forced to repeat time-consuming and expensive studies to receive regulatory approval. Essential medications would be prohibitively expensive without the competition from generic companies and generic drugs would take years to bring to market under data exclusivity laws. Repeating clinical trials would force drug companies to perform unethical studies that withhold medicines known to be effective from the control group. The people of India and the developing world would be denied access to the newest treatments available to those who can afford brand name drugs. Current Trade-Related aspects of Intellectual Property rights (TRIPs) regulations do not include data exclusivity clauses. India is not obligated to impose data exclusivity laws. Article 39.3 simply requires that members protect "undisclosed test or other data against unfair commercial use." The World Health Organization's Commission on Intellectual Property Rights, Innovation, and Public Health recently reinforced the view that TRIPS does not require data exclusivity: "Article 39.3, unlike the case of patents, does not require the provision of specific forms of rights. It does not create property rights, nor a right to prevent others from relying on the data for marketing approval of the same product by a third party or from using the data except when unfair (dishonest) commercial practices are involved." All WTO members also agreed in the Doha Declaration of 2001, "that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health we affirm 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." As a member of the WTO, India has an obligation to protect the rights of the citizens of the world in the face of the HIV/AIDS pandemic. On behalf of the millions of people around the world currently taking generic drugs made in India, we sincerely thank you. And we urge you to keep these life-saving medicines available and affordable to all those in need for the future by not adopting a new amendment that includes data exclusivity provisions in the Drugs and Cosmetic Act. We would welcome an opportunity to meet with you in person to share our concerns and suggestions. Sincerely, CC: Dr. Manmohan Singh Prime Minister of India Room No. 152, South Block, New Delhi Tel: 91-11-23018939, Fax: 91-11-23019545, Email: pmosb@pmo.nic.in Sri Kamal Nath Minster of Commerce & Industry Room No. 45, Udyog Bhavan, New Delhi Tel: 91-11-23063664, Fax: 91-11-23061796, Email: cim@nic.in Sri Ramvilas Paswan Minister of Chemicals and Fertilizers Shastri Bhawan, Dr. Rajendra Prasad Road, New Delhi Tel: 91-11-23386519, Fax: 91-11-23384020, Email: psmin.cpc@sb.nic.in Dr Anbumani Ramadoss Minster of Health and Family Welfare Nirman Bhavan, Maulana Azad Road, New Delhi Tel: 91-11-23061751, Fax: 91-11-23792341, Email: hfm@alpha.nic.in Mrs. Sonia Gandhi President, Indian National Congress Party 10, Janpath, New Delhi Tel: 91-11-23014161, Fax: 91-11-23017047, Email: not available Ms. Sujatha Rao Director General, National AIDS Control Organization (NACO) Chandralok Building, 9th floor, 36 Janpath, New Delhi Fax: 91-11-23731746, Email: asdg@nacoindia.org Dr. Kevin DeCock Director of HIV/AIDS, World Health Organization (WHO) 20, Avenue appia ch-1211 Geneva 27, Switzerland Email: hiv-aids@who.int Latest News Links:Govt accepts UNAIDS' report of 5.7 m HIV/AIDS casesIndian boy kills self on hearing parents have HIV Local Action in Washington DC:Join us NOW to protect the access to affordable medicine around the worldYour fax, letter, phone call or email can make a great difference! Join us in delivering the petition at Indian Embassy in Washington DC When: 2 PM, Saturday, July 8, 2006 Where: Indian Embassy, 2107 Massachusetts Avenue {Red line metro Dupont Circle} This petition supports the efforts of various global and Indian organizations working to protect production of affordable medicines. The organizations include Global AIDS Alliance, Health Gap, Students Global AIDS Campaign, Association for India's Development -CP, American Medical Students Association, People's Health Movement, Lawyers Collective, Indian Network of Positive People, Doctors without Borders, Drug Action Forum, Karnataka, Center for Trade and Development, India's Centre for Human Rights and Law, All India Drugs Action Network, International Peoples Health Council, Diverse women for Diversity, Society for Conflict Analyses and resolution, Alliance for Development, Centre for Research and Advocacy. Privacy PolicyEmail addresses are required to verify the authenticity of the petition. 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