On 23 October 2020 the Patented Medicine Prices Review Board (PMPRB) released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force (for further details please see "Amended Patented Medicines Regulations will come into force on 1 January 2021").
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 amended regulations' price calculation provision (for further details please see "Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations"). 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.
For further information on this topic please contact Abigail Smith or Nancy Pei at Smart & Biggar's Toronto office by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). Alternatively, please contact Daphne Lainson at Smart & Biggar's Ottawa office by telephone (+1 613 232 2486) or email ([email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
