On July 8, 2017, the Prime Minister of Canada and the President of the European Commission issued a joint statement setting September 21, 2017 as the new provisional application date for the Comprehensive Economic and Trade Agreement (CETA).

CETA was expected to be provisionally applied by July 1, 2017. According to a CBC article, implementation had been delayed as a result of concerns raised by the European pharmaceutical industry regarding changes to Canada’s pharmaceutical patent linkage system. The article reports that the European pharmaceutical industry does not want the European Union to implement CETA until Canada publishes and consults on regulatory changes promised to generic manufacturers. Of particular concern are the proposed regulations to end dual-track litigation. In addition, concerns have been raised about the lack of transparency in Canada’s confidential industry consultations regarding the amendments to the patent linkage system and patent term adjustment.

As previously reported in the E-TIPS® Newsletter, the legislation to implement CETA, Bill C-30, was passed on May 16, 2017. Bill C-30 introduces a number of changes to the patent linkage system, including patent term extension of up to two years for regulatory delays and a right of appeal for innovators under the Patented Medicines (Notice of Compliance) Regulations.

Summary by: Michelle Noonan


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