Update on amended Patented Medicines Regulations

Smart & Biggar

Federal Court decision appealed

Both the applicants and the respondent have appealed the June 29, 2020 decision striking subsection 3(4) of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (Amended Regulations) (see our article here). On September 10, 2020, Innovative Medicines Canada and the company applicants appealed Manson J.’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed (A-215-20 Notice of Cross-Appeal).

Constitutional challenge scheduled to start Sept 28, 2020

The constitutional challenge to the Amended Regulations proceeding in the Quebec Superior Court has been scheduled to begin on September 28, 2020 (see our review of the challenge here).

PMPRB Guidelines to provide special consideration for COVID-19 drugs

On September 17, 2020, the Patented Medicine Prices Review Board (PMPRB) advised that the upcoming final PMPRB Guidelines will afford special consideration to drugs appearing on the List of Drugs for Exceptional Importation and Sale and on the list(s) published by Health Canada pursuant to the September 16, 2020 Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (see article here). Absent a pre-existing complaint, medicines appearing on these lists will only be subject to review or investigation by PMPRB Staff if a pricing complaint is received from the federal Minister of Health or any of her provincial or territorial counterparts. Upon expiry/repeal of the Interim Orders or removal from the applicable list, absent a pre-existing complaint, price reviews will be based on prevailing international and domestic list prices, and not on introductory discounted prices in Canada.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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