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 1 July 2022. The news was announced on 23 December 2021 in a statement from the minister of health. An unofficial consolidated version of the Patented Medicines Regulations incorporating the amendments to date can be found here.
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 (for further details, see "Canada releases final amendments to patented medicines pricing regulations" and "Countdown begins: getting ready for 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. An appeal is pending in the Federal Court case, while the Quebec Court of Appeal reversed the Quebec Superior Court's decision in part on 18 February 2022, declaring further provisions invalid
The PMPRB Guidelines, released in October 2020, intended to operationalise the amendments, were similarly scheduled to take effect on 1 January 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 17 December 2021 the Board indicated it decided not to proceed with changes proposed on 15 July 2021.
For further information on this topic please contact Daphne Lainson at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.