India has rejected the demand of the four European nations EFTA bloc for inclusion of a ‘data exclusivity’ provision in proposed free trade agreements.
- India has stated that it always protects the interests of the domestic generic drugs industry.
- Data exclusivity provides protection to the technical data generated by innovator companies to prove the usefulness of their products.
- In the pharmaceutical sector, drug companies generate data through expensive global clinical trials to prove the efficacy and safety of their new medicine.
- The period of eight years from the initial authorisation of a medicine during which the marketing-authorisation holder benefits from the exclusive rights to the results of preclinical tests and clinical trials on the medicine. After this period, the marketing authorisation holder is obliged to release this information to companies wishing to develop generic versions of the medicine.
- By gaining exclusive rights over this data, innovator companies can prevent their competitors from obtaining marketing licence for low-cost versions during the tenure of this exclusivity.
- Data exclusivity is beyond the provisions of Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement under the WTO (World Trade Organisation).
European Free Trade Association (EFTA)
- The European Free Trade Association (EFTA) members are Iceland, Liechtenstein, Norway, and Switzerland.
- The bloc is negotiating a trade agreement with India.
