UPDATE: See our article here highlighting changes relative to the June 2020 draft Guidelines.
This morning, the PMPRB released the final Guidelines operationalizing the amended Patented Medicines Regulations (Amended Regulations). The Guidelines describe the price review methodology that will be applied to medicines beginning January 1, 2021, when the Amended Regulations come into force (see our article here).
The PMPRB has also released its October 2020 NEWSletter, which includes an overview of final changes as well as next steps, outreach, and engagement opportunities.
Notably, since the publication of the revised draft Guidelines in June 2020, the Federal Court has invalidated the price calculation provision of the Amended Regulations (see our article here). The decision has been appealed. A separate challenge to the constitutionality of the PMPRB provisions of the Patent Act and the Patented Medicines Regulations is ongoing.
Smart & Biggar will publish a more detailed review of the final Guidelines next week.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.