India has recently rejected the demand for ‘data exclusivity’ in the proposed Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA) bloc
- The TEPA, negotiated since 2008, seeks to enhance economic ties between India and EFTA.
About the recent decision:
- India’s refusal is aimed at preventing EFTA innovator companies from blocking Indian generic companies from obtaining marketing licenses for low-cost versions of drugs during the exclusivity period.
- It aims to protect the interests of the domestic generic drugs industry.
About the Data exclusivity:
- The Data exclusivity is an intellectual property protection that provides protection to the technical data generated by innovator companies to prove the usefulness of their products.
- It extends beyond TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement provisions.
It is specifically designed for pharmaceutical clinical trial data, preventing generic firms from using this data to gain marketing approval for a fixed period, and thus prolonging the monopoly of original drug manufacturers
Ref: Source
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