On 1 April 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 2 December 2017 (for further details please see "Canada releases proposed amendments to patented medicines pricing regulations");
- the expected impact of the anticipated amendments; 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".
Notably, the amendments are expected to come into force 12 months after they are published in the Canada Gazette.
For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
