The amended Patented Medicines Regulations came into force on 1 July 2022 in substantially revised form. The new basket of countries for Patented Medicine Prices Review Board (PMPRB) reporting remain, but the more controversial amendments were dropped (for further details, see "Slam dunk! New basket of countries for PMPRB reporting remain, controversial amendments to Patented Medicines Regulations dropped").
The Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 5 published on 6 July 2022.(1)
These Regulations repeal the provisions of the previously published amendments that would have:
- provided additional price regulatory factors and reporting requirements relating to the new factors of pharmacoeconomic value and market size; and
- allowed the PMPRB to collect price and revenue information net of third-party rebates.
On 30 June 2022, the PMPRB announced a Notice and Comment - PMPRB Price Review Approach During the Interim Period following the publication of Amendments to the Patented Medicines Regulation. The comment period expires on 18 July 2022.
The PMPRB is proposing to adopt a "status quo" approach during the interim period between the coming into force of the amended Patented Medicines Regulations and the final publication of the corresponding revised guidelines. Under this approach, an existing patented medicine will not trigger an investigation provided that:
- its national average transaction price (N-ATP) remains at or below its most recent non-excessive average price (NEAP) established under the existing guidelines; and
- its list price does not increase during the interim period.
In cases where the N-ATP of an existing patented medicine is above the NEAP, the PMPRB will only open an investigation if this results in excess revenues greater than C$50,000, as is currently the case.
The PMPRB will not conduct a price review of any new patented medicines or open any investigations in respect of them until the new guidelines come into effect.
Consultations on the new guidelines are expected to begin in September 2022 with a view to final guidelines in place by the end of 2022.
The revised guidelines are still awaited, as is more information regarding the promised consultation on the price tests to be applied during the interim period when neither the old nor the new guidelines are in effect.
For further information on this topic please contact Daphne Lainson or Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.
Endnotes
(1) A copy of the Regulations is available to view online.