Many countries, including the European Union, want India to go beyond data protection to data exclusivity
Indian on Wednesday firmly stated that it would not share any test data of drugs or data exclusivity with multinational companies or developed nations, setting at rest speculation about India granting of various concessions in the drugs and pharma domain under the garb of free trade agreements (FTAs).
Making a presentation before the Consultative Committee of Parliament, Union Commerce and Industry Minister Anand Sharma said the provision for data exclusivity, as sought to be incorporated by many countries, would not be part of FTAs that India was pursuing with various countries.
Rejecting the demand for data exclusivity, the Minister told the Parliamentary Committee that such exclusivity would prevent genuine and competing version of a drug from entering the market even when there was no patent as the patent had expired. Data exclusivity provided protection to the test data generated by pharma companies producing generic drugs.
“India does not provide data exclusivity for pharmaceuticals and agro-chemicals which is in the paramount interest of our generic pharmaceutical industry as grant of data exclusivity would have considerable impact in delaying the entry into the market of cheaper generic drugs,'' Mr. Sharma said in an official release.
He said Trade Related Aspects of Intellectual Property Rights (TRIPS) provided for data protection and it should be complied with. Article 39.3 of TRIPS provided for protection of undisclosed test data submitted for obtaining marketing approvals for pharmaceuticals and agricultural chemical products.
Many countries, including the European Union, with which India is in the final stages of FTA, want India to go beyond data protection to data exclusivity.
Mr. Sharma said a large section of the pharmaceutical industry in India was producing generic drugs and any data exclusivity provision at this stage would have a considerable impact on it.
He also spoke against the seizure of Indian generic medicines by the EU in the Netherlands.
“These detentions of Indian generics by Europe were deemed to be TRIPS violative by us and India submitted its request to the Dispute Settlement body of the World Trade Organization. India and Brazil have jointly held two rounds of consultation with the EU in July and September last year.
As a result of our persistent efforts, during the recent India-EU summit, the EU informed that the Commission has intensified its efforts on finalisation of the proposal for revision of Regulation 1383 and hopefully they should be able to complete their international processes shortly,'' he added.