Pangaea Express: Supreme Court of Canada Dismisses Appeal in SOLIRIS case
On March 24, 2022, the Supreme Court of Canada dismissed the application by the Attorney General of Canada in its appeal to the Federal Court Decision in the SOLIRIS case.
Back in July of 2021, the Federal Court of Appeal ruled against the PMPRB’s decision in the Alexion case for SOLIRIS. The PMPRB had determined SOLIRIS to be priced excessively and ordered Alexion to forfeit excess revenues earned between 2009 – 2017. This original ruling was based on the lowest international price, which was a departure from the Guidelines that identify the highest international price as the key comparator. The Federal Court of Appeal found the PMPRB had overstepped their jurisdiction of ensuring the price of patented medications were not excessive and determined the PMPRB’s statements “smack as price control, not policing for excessiveness.”
This Supreme Court decision means the matter will go back to the PMPRB for redetermination, to examine the evidence, interpret the legislation and ensure a reasoned explanation for its outcome.
Now that both the Federal Court of Appeal (pricing of SOLIRIS) and the Quebec Court of Appeal (constitutionality of the amended Regulations) rulings both found that the PMPRB went beyond their mandate of controlling excessive prices to one of price control, the key question is whether will we see further changes prior to the implementation of the Regulations July 1, 2022. If no changes are made to the Regulations and Guidelines, is it reasonable to predict many potential court cases may arise arguing the legality of the new economic factors and transparency of rebates?