June 25, 2019
The Federal Court has dismissed Alexion’s request to review the PMPRB’s decision that SOLIRIS’ price was excessive. In the case of Alexion vs the Attorney General of Canada, the Feds allowed the PMPRB to use the lowest international price comparison (LIPC) test, a test that is not in the PMPRB Guidelines, to consider the appropriate pricing of this drug. The Federal Court Decision stated that a [PMPRB] panel is required to consider drug pricing on a case-by-case basis and, as written under Section 96 (4) of the Patent Act, guidelines are not binding on the Board or any patentee. According to a summary by Torys.com, the Federal Court deemed this LIPC test was consistent with the Patent Act and not unreasonable.(1)
Alexion had originally priced SOLIRIS according to the median international price comparison (MIPC) test. While the actual price of SOLIRIS did not increase, fluctuations in exchange rates rendered the drug price excessive and as currency exchange fluctuations are the responsibility of the patentee, the Federal Court held that Alexion should have amended its Canadian pricing accordingly. The Federal Court also agreed with the PMPRB’s dismissal of any rebates from provincial product listing agreements. Provinces that receive rebates from patentees are not the “customers” of the patentee and as such the rebate should not be used to determine the average transaction price.(1)
Even with the amended “Regulations” coming tomorrow in Canada Gazette II, what does it matter when the PMPRB can consider the price of any drug, on a case-by-base basis, and deem it to be unreasonable. What do Guidelines even matter when the Feds can go outside of their boundaries if it seems “reasonable”.