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      Global drug firms now want backdoor patent for generics


      Even as India is contemplating changes in the Drugs and Cosmetics Act, multinationals are lobbying hard for a new clause in the statute that could lead to a steep rise in medicine prices, experts say.Global pharmaceutical firms want the government - which proposes changes in the law in the upcoming parliament session - to insert a data exclusivity clause to protect their clinical trial data from infringement by domestic firms.

      Quoting the agreement on Trade Related Intellectual Property Rights (TRIPS), the drug firms argue that clinical data is a matter of intellectual property and must accordingly be given legal protection.

      "Data exclusivity will prevent drug companies from utilising an original, or an innovator's, clinical trial data for a specific period. So generic drugs cannot be manufactured on the basis of such data," an expert says.

      In most countries, especially in the developing world, drug controllers depend on clinical trial data - often prepared by big drug companies - as the basis to approve generic drugs that can be produced by domestic companies.

      The data, which must be published by drug companies, is often used to develop and produce new pharmaceutical products after it is free from patent protection, since the cost of conducting original tests are high and time consuming.

      "What these multinational firms have been trying to get is further protection beyond the patent period of a drug," says Mr Biswajit Dhar, head of the Centre for World Trade Organisation (WTO) Studies at the Indian Institute of Foreign Trade.

      "Under the name of `data exclusivity' these companies are trying to acquire market exclusivity," Mr Dhar told IANS.

      "Providing data exclusivity to multinationals will definitely affect the prices of medicines, including essential medicines," says Mr N S Gopalakrishnan, director of the School of Legal Studies, Cochin University of Science and Technology.

      Mr Gopalakrishnan says he has submitted a report to the commerce ministry, asking it to reject the demand for data exclusivity and provide trade secret protection for drugs and cosmetics.

      Both experts say that the TRIPS agreement does not mandate the creation of any exclusive rights on the data and the obligation is just to protect the data submitted for approval from unfair competition during the tenure of patent.

      "Their argument that TRIPS obliges member countries of the WTO to provide data exclusivity is absolutely baseless," Mr Gopalakrishnan says.

      But the experts admitted that amendments are needed in the Drugs and Cosmetics Act since Indian law does not explicitly provide data protection.

      October 16, 2005


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