Federal Court Of Appeal Affirms Validity Of PMPRB New List Of Comparator Countries

On December 5, 2022, the Federal Court of Appeal of Canada (FCA) issued its decision in Innovative Medicines Canada v Canada (Attorney General), 2022 FCA 210, where it affirmed the validity of the government’s new list of comparator countries, which the Patented Medicine Prices Review Board (the Board) is to consider in determining whether the price of a patented drug is “excessive”.

Innovative Medicines Canada and several Canadian innovative pharmaceutical companies brought a judicial review application in Federal Court challenging portions of a regulation amending the Patented Medicine Regulations, claiming the amendments went beyond the scope of the Patent Act.

The amendments in the regulation, among other things, (1) supply new factors for the Board to consider; (2) specify a new way for the Board to calculate the price of medicines (discounts and rebates are relevant); and (3) change the list of comparator countries for which pricing information must be filed.

The Federal Court found the new price calculation contemplated in item (2) to be invalid as it is outside the Patent Act, as previously reported by the E-TIPS® Newsletter here.  The Federal Court found the remaining two sections to be reasonable and valid. This decision was the subject of the appeal.

After the hearing in the FCA, the Governor in Council repealed items (1) and (2) (S.O.R./2022-162). Thus, the FCA agreed with the parties that the challenges to items (1) and (2) were moot. 

With respect to item (3), the FCA agreed with the Federal Court, concluding that the amendment changing the list of comparator countries was reasonably enacted under the regulation-making power in subsection 101(1) of the Patent Act, and was consistent with the purpose of the amendments, namely, to modernize the tools the Board uses to police the excessive pricing of patented medicines.

Thus, the appeal was dismissed with costs.

Summary By: Michelle Noonan