As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices Review Board (PMPRB) reporting remain, but the more controversial amendments were dropped.
The Regulations Amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 5 will be published on July 6, 2022. A copy of the Regulations is available to view online. We will update this article once the official consolidated Patented Medicines Regulations incorporating the amendments are available.
These Regulations repeal the provisions of the previously published amendments that (1) would have provided additional price regulatory factors and reporting requirements related to the new factors of pharmacoeconomic value and market size, and (2) would have allowed the PMPRB to collect price and revenue information net of third party rebates.
Friday, the PMPRB announced a Notice and Comment - PMPRB Price Review Approach During the Interim Period following the publication of Amendments to the Patented Medicines Regulations. The comment period expires on July 18, 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: 1) 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; 2) 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 $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 with a view to final Guidelines in place by the end of 2022.
We still await revised Guidelines, and 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.