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Joshi cautions against conceding data exclusivity to MNCs

Written by: Staff

New Delhi, June 17 (UNI) Senior BJP leader and former Human Resource Development Minister Murli Manohar Joshi has cautioned Prime Minister Manmohan Singh against conceding the bilateral demand of data exclusivity of the multi-national corporations instead of implementing data protection as stipulated in the TRIPS Agreement, which would endanger the very existence of domestic pharmaceutical units in the country.

In his letter addressed to Dr Manmohan Singh yesterday, Dr Joshi said the demand for data exclusivity was raised at bilateral level with India by the MNCs and US Government. ''I understand that the concerned Ministries are deliberating on the issue for the last three four years and are on the verge of conceding bilateral demand of data exclusivity instead of implementing data protection as stipulated in the TRIPS. The Government should heed the advice of the WHO which had asked the developing countries to reject all efforts to link the IPR regime with the Drug Regulatory System.'' The WHO, in its March 2006 report, had concluded that the developing countries would be well advised to keep the Intellectual Property and Drug Regulatory systems separate and reject all efforts to link the two systems. The two systems, the WHO argued, had different objectives and were administered separately and functioned independently. The efforts to integrate the two system through data exclusivity would have negative implications for access to medicines.

Dr Joshi said the data exclusivity issue were brought to the notice of the Parliamentary Standing Committee of the Commerce Ministry and he had recorded his views of the World Health Organisation which deserved an 'in-depth consideration'. ''I urge you to kindly have this matter looked into urgently so that this kind of TRIPS plus measure is not pushed by the Ministries concerned for legislation.'' He said providing data exclusivity has serious implications for the role of domestic enterprises int the fields of pharmaceutical and agro-chemical products. If data exclusivity is conceded domestic enterprises would be prevented from taking marketing approval on the basis of data submitted by the first enterprise who had generated the data and submitted it for taking marketing approval. Even if the domestic units were granted compulsory licence to use patented subject matters, they would be prevented from taking marketing approval during period of data exclusivity in operation. ''Thus stipulation of TRIPS Agreement would be rendered unimplementable and competitive environment which could be created would also be lost,'' Dr Joshi said.


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