Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until July 1, 2022.

These amendments form the basis for new PMPRB Guidelines. The PMPRB has updated its website to indicate that the new Guidelines will be in place as of the coming-into-force of the amendments. As we reported earlier this week, the PMPRB has decided not to proceed with changes to these Guidelines that had been proposed July 15, 2021.

The amendments

The amendments to the Regulations contain a number of changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the Board, such as pharmacoeconomic value; a requirement to include “adjustments” when computing average transaction prices reported to the PMPRB; and a revised basket of international comparator countries for reference pricing that omitted the United States and Switzerland.

Delayed coming-into-force

As we reported, the amendments to the Regulations were introduced in August 2019. Most recently, they had been scheduled to come into force on January 1, 2022. In addition, the coming-into-force date of the amendment regarding average transaction prices had been delayed to an unspecified future date, after it was held to be invalid by two separate courts.[1]

A December 23, 2021 statement from the Minister of Health indicates that the purpose of the most recent six-month delay until July 1, 2022 is to provide “additional time for impacted stakeholders, including industry, governments, and other parties within the drug reimbursement and distribution system to continue to focus their efforts on responding to the unprecedented challenges presented by the COVID-19 pandemic.”

[1] Innovative Medicines Canada v Canada (Attorney General), 2020 FC 725; Merck Canada inc. c Procureur général du Canada, 2020 QCCS 4541.