• The Medicines for Europe trade agenda works to promote access for patients to high quality medicines around the world.
  • The EU and Canada Comprehensive Economic and Trade Agreement (CETA) can be an opportunity for medicine manufacturers in the two regions.
  • 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.

Medicines for Europe welcomes the approval by the European Parliament of the EU 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 60000 new export-related jobs in the generic and biosimilar medicines sector while boosting our capacity to supply cost-competitive medicines in Europe and abroad. Medicines for Europe calls on the European Commission to rapidly seize this historic opportunity to increase manufacturing growth and employment in the pharmaceutical sector by introducing the SPC manufacturing waiver foreseen by the CETA.

“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.