Catalyst Pharmaceuticals, Inc. v. Canada (Attorney General), 2021 FC 505
Justice St-Louis - 2021-05-31
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The Applicants, Catalyst and KYE seek judicial review of the August 10, 2020 decision of the Minister of Health to issue Médunik a Notice of Compliance with respect to Médunik’s New Drug Submission for its amifampridine product, RUZURGI. ... As to the merits, and for reasons set out below, I will grant the Application, quash the Minister’s Decision, and return it to the Minister for redetermination. ... The Court cannot conduct a reasonableness review and find the decision reasonable in the absence of reasons, and when the record contains no indication of the actual process or interpretation applied by the decision-maker. There is simply no clear trace of any of FIRDAPSE’s data protection documentation in the RUZURGI process. The evidence in the record indicates that the decision-maker had incorrect information (as of July 31 and August 5, 2020), i.e., that no drug had been approved at the time Health Canada was approving the RUZURGI NDS, that FIRDAPSE’s status as an innovating drug was not actually listed on the Register of Innovative Drugs before August 10, 2020, and that it was listed on August 13, 2020.
Decision relates to:
- T-984-20 - CATALYST PHARMACEUTICALS INC. ET AL v. AGC ET AL