Data Exclusivity

• India has rejected the demand of the European Free Trade Association (EFTA) for ‘data exclusivity’ provisions in the free trade agreement that both sides are negotiating.
• India and EFTA have been negotiating the Trade and Economic Partnership Agreement since January 2008.

WHAT IS DATA EXCLUSIVITY?

• Data Exclusivity is a form of intellectual property protection that applies specifically to data from pharmaceutical clinical trials.
• It means that generic drug manufacturer cannot apply for regulatory approval for equivalent drugs relying on the originator’s data for a specified number of years.
• It is not mandatory under Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement (WTO) and Indian laws do not provide for it.
• Impact
  • Data exclusivity provisions will bar generic drug producers from using data of preclinical tests and clinical trials of former patent holders.
  • If generic medicine makers wish to introduce their version of an off-patent drug then they will have to either generate their own clinical data or wait for the exclusivity period to end.

ABOUT EFTA

• It is an intergovernmental organisation established in 1960 by the Stockholm Convention.
• EFTA’s members — Iceland, Liechtenstein, Norway, and Switzerland — are countries that have opted out of the European Union.
• The members of this organization are all open, competitive economies committed to the progressive liberalisation of trade in the multinational arena as well as in free trade agreements.
• In contrast to the European Union (EU), it is not a customs union.