KEY TAKEAWAYS

India’s Commerce Secretary said EFTA wanted data exclusivity to be included in the proposed FTA, but India has rejected the demand
If India agreed, entry of yet-to-be approved generics and biosimilars would be significantly delayed as only the owner or generator of nonclinical and clinical trial data can use it to seek marketing authorization while other applicants are barred
It would have also lowered incentive for innovator companies to enter into voluntary licensing agreements with Indian companies.
Compulsory licensing, currently permitted in India, would also be impacted as the European Union’s experience during COVID-19 has shown
Indian laws and regulation are already in line with TRIPS provisions and data exclusivity is a TRIPS-plus requirement, MSF has pointed out

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

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