Update: The Quebec Court of Appeal reversed the Quebec Superior Court’s decision in part on February 18, 2022, declaring further provisions invalid.
The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on December 23, 2021 in a statement from the Minister of Health. We have prepared an unofficial consolidated version of the Patented Medicines Regulations incorporating the amendments to date.
The amendments, once in force, will add new price regulatory factors, revise the list of reference countries, and modify reporting requirements for particular categories of drugs (see our previous articles “Final amendments to Patented Medicines Pricing Regulations; in force July 1, 2020” and “Getting Ready for the New Patented Medicines Pricing Regime”).
The provisions relating to confidential third-party rebates will not come into force at the same time as the other provisions. The delayed coming into force follows decisions of the Federal Court finding the provisions invalid and the Quebec Superior Court finding the provisions unconstitutional. Appeals are pending in both cases.
The PMPRB Guidelines, released in October 2020, intended to
operationalize the amendments, were similarly scheduled to take effect on January 1, 2022 but are now also delayed. The PMPRB has updated its website to indicate that the new Guidelines will be in place as of the coming-into-force of the amended Regulations. Innovative Medicines Canada and a number of pharmaceutical companies have commenced an application for judicial review in relation to the Guidelines. On December 17, the Board indicated it decided not to proceed with changes proposed on July 15, 2021.
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.
Related Publications & Articles
-
Minister of Health announces new bilateral agreements with provinces for rare disease drugs
Canada’s first-ever National Strategy for Drugs for Rare Diseases includes up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements.Read More -
Government of Canada announces first pharmacare agreements
The Minister of Health recently announced the first of these bilateral agreements with Manitoba ($219 million over four years), British Columbia ($670 million over four years) and Prince Edward Island...Read More -
PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and utilization
On March 6, 2025, the Patented Medicine Prices Review Board announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting ...Read More