Indian Express
No data sharing on drugs of pharma cos in FTAs: Sharma
ENS Economic Bureau, India
30 March 2011
India today ruled out sharing test data of drugs, or data exclusivity, of Indian pharma firms with developed countries and multi-national companies, and stressed that the provision will not form part of any free trade agreements pursued by the country.
India said it will not provide data exclusivity because it “will prevent genuine and competing version of a drug from entering the market even when there is no patent as the patent has expired”. Data exclusivity provides 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,” commerce and industry minister Anand Sharma said at a meeting of consultative committee of Parliament.
He said that Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for data protection and it should be complied with.
Article 39.3 of the TRIPS provides for protection of undisclosed test data submitted for obtaining marketing approvals for pharmaceuticals and agricultural chemical products.
However, developed nations including the European Union want countries to go beyond data protection to data exclusivity.
“A large proportion of the Indian Pharmaceutical industry is producing generic drugs. Extending data exclusivity at this stage would have a considerable impact on the Indian industry especially in the short run,” Sharma said.
In fact, data exclusivity provisions will impact access to medicines, which is a major social cost for a country with a large population living below the poverty line.
The 27-nation bloc EU is pressing hard to include data exclusivity in the proposed Bilateral Trade and Investment Agreement (BTIA). India and EU are negotiating a comprehensive free trade agreement that will include trade in goods, services and investments. However, the negotiations have been hampered by stalemate in issues like data exclusivity, child labour and environment.
On the EU drug seizure issue, Sharma said that European Union (EU) will soon amend its rule to stop re-occurrence of drug seizure by some EU member nations.
Tough stance
* Data exclusivity provides protection to the test data generated by pharma companies producing generic drugs
* Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for data protection, says commerce and industry minister Anand Sharma
* However, developed nations including the European Union want countries to go beyond data protection to data exclusivity