Pangaea Express: Impact of the recent Federal Court decision on PMPRB Guidelines
On July 8, the PMPRB updated its website to include its views on the recent Federal Court decision pertaining to the amendments to the Patented Medicines Regulations and their impact on the Guidelines.
Back on June 29, the Federal Court of Canada issued its ruling in the case of Innovative Medicines Canada v. Canada (Attorney General). IMC along with 16 individual companies challenged the legal aspect of the amendments to the Patented Medicines Regulations taking issue with 3 aspects of the Amendments:
- The new price regulatory factors – pharmacoeconomic, market size and GDP
- The new basket of comparator countries
- The reporting of discounts and rebates provided to third parties
The Court upheld the excessive pricing factors and the new Schedule of comparator countries but agreed that the requirement to report rebates and discounts provided by patentees to third party insurers are outside the scope of the Patent Act as they are unrelated to the “price” at which patented medicines are “sold”. In the analysis, Justice Manson reasoned, “patentees generally do not sell medicines to public drug plans or private insurers, and these entities do not purchase or take title of medicines from patentees”.
The PMPRB has stated in their notice July 8 that “upon coming into force of the Amended Regulations in January 2021, subsection 4(4) of the Patented Medicines Regulations in their current form will remain in effect.” The PMPRB further states that they do “not believe any substantive changes to the June 2020 Draft Guidelines are required as a result” of this decision. They do acknowledge that stakeholders may want to include their views of this Court decision in their written submissions and will therefore extend the consultative period until August 4, 2020.
Of course, this may not be the final verdict given the appeal process. As explained by Torys LLP, appeals to the ruling must be filed within 30 days. However, given the fact that July and August are not counted within these 30 days, both parties have until the end of September to appeal. (1)
Torys also reminds its readers of the 2nd court case against the PMPRB issued by 6 industry players that will be held before the Quebec Superior Court in September 2020.
So the Regulations that come into force Jan. 1, 2021 will not include the amendments relating to rebates and discounts but what happens if there are new rulings after the appeal? What may come from the 2nd case before the Quebec Superior Court? Do we really know how the amended Patented Medicines Regulations will look in its final form? Is it possible we may see another revision to the PMPRB Guidelines?