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17 July 2019
Healthcare & Life Sciences Canada
On 12 June 2019 Justice Gleeson dismissed Alexion's application for judicial review of a panel of the Patented Medicines Price Review Board's (PMPRB's) decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million).(1)
The PMPRB found that the guidelines were appropriate in assessing increases, but not appropriate in assessing the appropriate benchmark (instead, the lowest international price comparison test was applied) (for further details please see "Patented Medicine Prices Review Board Update"). The PMPRB rejected Alexion's argument that the guidelines were not appropriate regarding permitted increases, as the fluctuations in the exchange rates and the appreciation of the Canadian dollar resulted in the Canadian price appearing higher than the international comparators, while the Canadian price remained unchanged and, in fact, decreased based on changes in the consumer price index.
The Federal Court reviewed the PMPRB's decision on a reasonableness standard and dismissed the application on the grounds that the PMPRB had:
Alexion has appealed.(2)
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (khlee@smart-biggar.ca). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
Endnotes
(1) Alexion Pharmaceuticals Inc v Canada (Attorney General), 2019 FC 734.
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