Pangaea Express: Quebec Court of Appeal Case
The Quebec Court of Appeal has confirmed that not only is it unconstitutional for the PMPRB to compel companies to provide information from 3rd party agreements, but also that the pharmacoeconomic factors (health technology assessments, market size, and GDP) were unconstitutional. The new basket of countries, PMPRB11, was upheld by this Court as constitutional.
The original case challenged the “constitutionality of the legislative framework of the Patented Medicines Prices Review Board (PMPRB): the provisions of the Patent Act that establish the PMPRB and its mandate, the Patented Medicines Regulations and the 2019 amendments to those Regulations (the 2019 Amendments)”.(1) The Quebec Superior Court ruling of December 18, 2020, ruled disclosure of confidential rebates as invalid but upheld the economic factors and the change to the 11 comparator countries. However, the Quebec Court of Appeal went further to find the economic factors and the requirement to report rebates "went beyond controlling excessive prices of patented medicines to impose significant price reductions that have nothing to do with the monopoly conferred by patents.” (1)
We now have the Federal Court of Appeal decision in the Alexion case for Soliris (July 2021) that found the Board went beyond the limits of its power to find excessive pricing and instead moved towards price control, and the Quebec Court of Appeal decision ruling the new pharmacoeconomic factors in the amended Regulations also go beyond that of controlling excessive prices, as “These new factors will lead to a significant drop in the prices of patented drugs in Canada… these significant price reductions will result from the application of arbitrary price reductions.” (2) It will be interesting to see the results of the Federal Court of Appeal case that is to be heard February 28, 2022.
Given that we are now 4 months away from the implementation of the Regulations and PMPRB Guidelines and it is not likely there will be another COVID related delay, what exactly will we see implemented come July 1, 2022 remains a question. Will the Federal Court of Appeal also rule the new economic factors as unconstitutional? And how might these decisions affect the amended Regulations from 2019?
Any appeal to the Quebec Court of Appeal decision, must be sought within 60 days from the date of the judgment (i.e., by April 19, 2022).
CanLII (Google Translation) https://www.canlii.org/fr/qc/qcca/doc/2022/2022qcca240/2022qcca240.html