Former Union Minister and senior BJP leader Dr Murli Manohar Joshi has urged the Prime Minister Dr Manmohan Singh to look into the matter of data protection urgently so that the Trade Related Aspects of Intellectual Property Rights (TRIPS) measures are not pushed by the ministries concerned for legislation.
In a letter to Prime Minister, dated June 16, Dr Joshi said during the Uruguay Round of GATT negotiations the question of data protection or data exclusivity was specially discussed. The demand of USA and other developed countries for data exclusivity was rejected and only specific provision was incorporated in section 7 of the TRIPS Agreement for Protection of un-disclosed information.
He said the demand for data exclusivity has been raised at bilateral level with our government by the MNCs and the US government. It is understood that the concerned ministries have been deliberating on this issue for the last 3 to 4 years and now they are at the verge of conceding to the bilateral demand of data exclusivity instead of implementing data protection as stipulated in the TRIPS Agreement.
?The WTO agreement on TRIPS stipulates implementation of eight types of Intellectual Property Rights (IPR). One of the IPR topics deals with the ?Protection of Undisclosed Information?. While we have enacted or amended laws relating to other IPRs we have not legislated on protection of Undisclosed Information. This topic of IPR is supposed to be covered by suitable amendments to our Drugs and Cosmetics Act 1950. Providing of data exclusivity has serious implications for the role of domestic enterprises in 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 the data submitted by the first enterprise, who had generated the data and submitted the same for taking marketing approval. Even if the domestic enterprise has been granted compulsory licence to use the patented subject matter they would be prevented from taking marketing approval during period the data exclusivity is in operation. Thus, stipulation of TRIPS Agreement would be rendered unimplementable and competitive environment, which could be created would also be lost,? the letter said.
Dr Joshi pointed out that the World Health Organisation (WHO) had thoroughly examined this issue in a document prepared by them. He said the WHO, in conclusion, has recommended that the developing countries would be well advised to keep the two systems of IPR and drug regulation separate, and to reject any and all efforts to make connections between them. He further said that the data exclusivity issue and its serious implications were also brought to the notice of the Department Related Parliamentary Standing Committee on Commerce in a meeting held recently. ?In my opinion the views of the WHO deserve an indepth consideration. I urge with you to kindly look into the matter urgently so that this kind of TRIPS plus measures is not pushed by the ministries concerned for legislation,? he added.