Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications

The contentious issue of data exclusivity has came to the fore once again after recent speculation that India could succumb to a demand made by the European Free Trade Association (EFTA), comprising Switzerland, Norway, Iceland and Liechtenstein, to accept data exclusivity norms in a Free Trade Agreement (FTA) under negotiation.

Given that only the owner or generator of non-clinical and clinical trial data can use such data to seek marketing authorization while other applicants are barred from relying on these in support of their own applications during the data exclusivity period, it is