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Quebec Court finds price and revenue calculation provisions of amended PMPRB Regulations unconstitutional

Authored byNancy Pei and Daphne Lainson

Update: The Quebec Court of Appeal reversed the decision in part on February 18, 2022. 

On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act and the Regulations, including the amended Regulations, coming into force on January 1, 2021: Merck, Janssen, Servier, Boehringer Ingelheim, Bayer, Theratechnologies, Avir Pharma c. Procureur Général du Canada et Procureur Général Du Québec. The Court declared the amendments (new section 4(4)) that would have required price and revenue reporting to take into account confidential rebates provided to provincial payers invalid, with immediate effect. However, the Court held that the PMPRB provisions of the Patent Act and the Regulations, including the remaining provisions of the amended Regulations, were valid. As reported previously, the Federal Court ruled in June that the same price and revenue reporting provisions were invalid as being ultra vires the Patent Act; appeals are pending.  Further, Innovative Medicines Canada and a number of pharmaceutical companies have recently challenged the validity of the new Guidelines in the Federal Court.

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.

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