CUSMA vs Food and Drug Regulations: Federal law predominates

Justice Stratas, writing a unanimous decision for the Federal Court of Appeal in Janssen v Attorney General of Canada, 2024 FCA 66, dismissed Janssen’s appeal of 2023 FC 7 where the Federal Court dismissed Janssen’s application for judicial review of the Minister’s decision that SPRAVATO was not an “innovative drug” under C.08.004.1(1) of the Food and Drug Regulations.

In the underlying decision Justice Manson found the Minister’s decision was reviewable on a reasonableness standard. Janssen argued that the Canadian-United States-Mexico Agreement Implementation Act [CUSMA Implementation Act] requires that federal legislation is interpreted consistently with CUSMA which defines “new pharmaceutical product” at Article 20.49. Janssen argued Article 20.49 sufficiently changed the meaning of “innovative drug” under subsection C.08.004.1(1) to render enantiomers of previously approved drugs within its ambit. Justice Manson found that OSIP reasonably interpreted “innovative drug” and “while the context provided by CUSMA is important, in the end, it is the Regulations as implemented by the Governor in Council that govern.”

The Federal Court of Appeal found Justice Manson’s conclusion that CUSMA does not displace the Federal Court of Appeal’s previous interpretation of C.08.004.1(1) definition of “innovative drug” reasonable. Justice Stratas reiterated that “while international treaties can form part of the context relevant to the adoption of legislation, they do not amend legislation.” Further the CUSMA Implementation Act provides CUSMA is to be used to interpret legislation, not amend it. The Federal Court of Appeal added that any vires challenge to the unconformity of subsection C.08.004.1(1) and CUSMA could not be inserted into this proceeding at this late appeal stage and must be brought in a new proceeding.

The full decision can be read here.