On August 9, 2019, Health Canada issued a press release announcing that the highly-anticipated amendments to the Patented Medicines Regulations (the “Regulations”) will be officially published on August 21, 2019. The amendments to the Regulations are expected to be effective as of July 1, 2020.
Also on August 9, 2019, the Patented Medicines Price Review Board (the “PMPRB” or the “Board”) announced that the Board plans to publish draft Guidelines this fall, which will be subject to a consultation process. The draft Guidelines will play an important role in highlighting how the Board plans to interpret and implement the amended Regulations. The Patent Act empowers the PMPRB to issue guidelines with respect to any matter within its jurisdiction. While not legally binding on the Board or pharmaceutical patentees, in practice the Guidelines constitute the instrumental document by which the Board makes its determinations regarding pricing.