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.

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