CETA has potential to strengthen European manufacturing base of the generic, biosimilar sectors

Trade group Medicines for Europe says it welcomes the approval by the European Parliament of the European Union and Canada Comprehensive Economic and Trade Agreement (CETA) that can be an opportunity for medicine manufacturers in the two regions.

The Medicines for Europe trade agenda works to promote access for patients to high quality medicines around the world. The CETA has the potential to strengthen the European manufacturing base of the generic, biosimilar and value added medicines industries, which are investing in existing and new manufacturing plants across Europe.

The CETA includes a Supplementary Protection Certificate (SPC) protection in Canada, which extends market exclusivity for originator industries for regulatory marketing approval delays. It also provides for an SPC manufacturing waiver, which the European Commission is planning to implement in the context of its Single Market Strategy. Once introduced, the SPC manufacturing waiver will create over 60,000 new export-related jobs in the generic and biosimilar medicines sector while boosting its capacity to supply cost-competitive medicines in Europe and abroad.