Trade Sector Updates – Falling Exports, TIES, MEIS, Foreign Trade Policy, etc.

India Rejected Demand for Data Exclusivity in Drug Development in EFTA


From UPSC perspective, the following things are important :

Prelims level: European Free Trade Association (EFTA) Bloc

Mains level: Issues with FTA


  • India has firmly rejected the demand from four European nations in the EFTA bloc for the inclusion of a ‘data exclusivity’ provision in proposed free trade agreements, citing its commitment to protecting the interests of the domestic generic drugs industry.

About the European Free Trade Association (EFTA) Bloc

Member Iceland, Liechtenstein, Norway, Switzerland
Formation Established in 1960 by seven European countries as an alternative trade bloc to the EU
Trade Relations Free trade agreements among themselves and with other regions
Activities Participate in European Single Market through the EEA Agreement
Institutions EFTA Court, EFTA Surveillance Authority, EFTA Secretariat
Relationship with EU Not part of the EU,

But have close economic ties and trade agreements with EU countries

Debate over Data Exclusivity

  • Pharmaceutical Sector Implications: Data exclusivity provides innovator companies with exclusive rights over the technical data generated through expensive global clinical trials, preventing competitors from obtaining marketing licenses for low-cost versions during the exclusivity period.
  • Influence of Swiss Pharma Firms: Switzerland, home to major pharmaceutical firms like Novartis and Roche, has been advocating for data exclusivity, but India remains steadfast in its stance against it.

Protection of Generic Industry

  • Significance of Generic Industry: Barthwal highlighted the significant contribution of the generic drug industry to India’s exports and emphasized the government’s commitment to protecting its interests.
  • Export Growth: India emphasized that the generic drug industry’s growth aligns with its objective of promoting exports, showcasing its importance to the national economy.

Negotiations and Progress

  • Trade and Economic Partnership Agreement (TEPA): India and EFTA have been negotiating the TEPA since January 2008 to enhance economic ties, with talks covering various chapters, including intellectual property rights.
  • Advanced Stage of Talks: Negotiations are at an advanced stage, with both parties discussing trade in goods, rules of origin, intellectual property rights, and other key areas.


  • India’s firm stance against the inclusion of data exclusivity provisions in FTAs reflects its commitment to safeguarding the interests of its generic drug industry.
  • As negotiations with EFTA progress, India remains focused on promoting fair and equitable trade relations while upholding its principles of protecting domestic industries.

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