[Ip-health] Anand Sharma: No data sharing on drugs of pharma cos in FTAs
krista.cox at keionline.org
Tue Mar 29 15:33:59 PDT 2011
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
“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,”
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
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
* 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
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