Update: 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 July 1, 2022, which as announced on April 14, 2022, will be released in a substantially amended form.
As we previously reported (see our June PMPRB update), the coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) is scheduled for January 1, 2022. It is possible that this date will be further extended.
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, are similarly scheduled to take effect on January 1, 2022. 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.