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Europe "Must Adopt the CETA Manufacturing Waiver "


February 22, 2017

  The generics and biosimilars industry association Medicines for Europe has welcomed the approval by the European Parliament of the EU and Canada Comprehensive Economic and Trade Agreement (CETA), stating "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. Once introduced, states Medicines for Europe, the SPC manufacturing waiver will create over 60000 new export-related jobs in the generic and biosimilar medicines sector while boosting capacity to supply cost-competitive medicines in Europe and abroad.    “Generic and biosimilar medicines will represent 80% of the volume of medicines by 2020. If Europe wants to keep a strong pharmaceutical manufacturing sector, it needs to adopt the SPC manufacturing waiver now”, commented Adrian van den Hoven, Medicines for Europe Director General.