On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ entreaty regarding the validity of the amended handbasket of comparator countries successful the Patented Medicines Regulations: Innovative Medicines Canada v Canada (Attorney General), 2022 FCA 210 (Appeal Decision).
Background
The Patented Medicines Regulations acceptable retired reporting requirements for patentees to the Patented Medicine Prices Review Board (PMPRB). Proposed amendments were archetypal published connected August 21, 2019 which, broadly, would person introduced:
- New terms regulatory factors based connected pharmacoeconomic value, marketplace size and GDP/GDP per capita successful Canada, and related reporting obligations (pharmacoeconomic factors);
- Expanded reporting of terms and gross accusation to see confidential third-party rebates (rebate reporting);
- An amended handbasket of overseas notation countries for reporting purposes (amended basket); and
- Reduced reporting obligations for patented veterinary, over-the-counter (apart from non-prescription docket D drugs specified arsenic vaccines and insulin) and generic medicines.
Court challenges to the validity of amendments (1)-(3) rapidly followed.
The Federal Court held amendments to rebate reporting (2) were invalid, but amendments for pharmacoeconomic factors (1) and the amended handbasket (3) were valid. The Appeal Decision is discussed below.
Ultimately, the Governor successful Council proceeded with amendments (3) and (4) only, and the amendments came into unit connected July 1, 2022. Draft amended Guidelines are presently nether consideration. (Update: The Guidelines volition not beryllium implemented connected January 1, 2023 arsenic antecedently planned.)
Amendment astatine issue
For context, s. 85(1) of the Patent Act sets retired 5 factors for the Board to see successful assessing whether pricing is excessive, and includes:
“(c) the prices astatine which the medicine and different medicines successful the aforesaid therapeutic people person been sold successful countries different than Canada”.
Subsection 101(1)(a) of the Patent Act gives the Governor successful Council the powerfulness to marque regulations:
“(a) specifying the accusation and documents that shall beryllium provided to the Board …”
The Patented Medicines Regulations necessitate patentees to study applicable pricing accusation regarding the medicine sold successful a handbasket of countries different than Canada. Before the amendment, the handbasket of 7 countries was: France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States. The amended handbasket of eleven countries is: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden and the United Kingdom (bolded countries are the aforesaid successful some baskets). The United States and Switzerland are nary longer included.
Appeal Decision
The FCA lone addressed IMC’s entreaty connected the amended handbasket (3), and decided that the determination to enact the amendment changing the database of comparator countries was based connected a tenable mentation of the regulation-making powerfulness successful subsection 101(1) of the Patent Act. The FCA did not judge the submission that the amendments were made for an improper purpose, namely, “the simplification of the terms of medicines mostly successful bid to present wellness attraction savings and to pave the mode for nationalist pharmacare.”
The FCA agreed with the Federal Court that the amendment simply related to a alteration successful postulation of information, the filing of which is “benign.” The intent for which the Board uses the filed accusation nevertheless whitethorn beryllium the taxable of consequent challenge: “[i]f the Board aboriginal uses that comparative accusation to acceptable oregon power prices - alternatively than constabulary excessive pricing - an aggrieved enactment tin found connected judicial reappraisal that the Board has exceeded its jurisdiction.”
Any further entreaty would necessitate permission from the Supreme Court of Canada.
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