The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred, once again, until 1 July 2022.
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 "Final amendments to Patented Medicines Pricing Regulations; in force July 1, 2020" and "Getting Ready for the New Patented Medicines Pricing Regime").
The coming into effect of the PMPRB guidelines, released in October 2020, intended to operationalise the amendments, has similarly been delayed. 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.