On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments which were released in draft on December 2, 2017 (see our article here), their expected impact, and the consultation process, including the results of an independent assessment which concluded that “there is no good economic or conceptual reason not to proceed with the proposed regulatory changes.” Of particular note, the amendments are expected to be published in Part II of the Canada Gazette in the Spring 2019 session, and are expected to come into force 12 months thereafter.
