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Federal Court of Appeal upholds Minister of Health’s refusal to grant NHP licence for BOLUOKE

Update: The Supreme Court of Canada dismissed C-RNA’s leave to appeal (Docket No. 39994).

As previously reported, McHaffie J. of the Federal Court dismissed an application for judicial review brought by Canada RNA Biochemical (C-RNA), concluding that the Minister of Health (Minister) was reasonable in refusing to grant a Natural Health Product (NHP) licence to C-RNA for its oral lumbrokinase capsules (BOLUOKE): Canada RNA Biochemical Inc v Canada (Health), 2020 FC 668. Lumbrokinase is an enzyme derived from earthworms that is alleged to have “fibrinolytic properties” by enhancing breakdown and preventing formation of blood clots.

On November 2, 2021, the Federal Court of Appeal (FCA) dismissed C-RNA’s appeal to set aside the Federal Court’s decision, finding that C-RNA did not demonstrate any reviewable error in either the Minister’s decision to refuse the NHP licence or the Federal Court’s reasoning: Canada RNA Biochemical Inc v Canada (Health), 2021 FCA 213.

On the appeal, C-RNA advanced a number of arguments, each of which was dismissed by the FCA.

1. Drug vs. NHP: As a preliminary matter, C-RNA argued that the Minister was “confused” about which regulatory regime governs the BOLUOKE application, i.e., whether it was to be considered a drug under the Food and Drugs Regulations, or an NHP under the Natural Health Products Regulations (NHP Regulations). 

In rejecting this argument, the FCA stated that the two regulatory regimes not only make explicit “legislative demarcations” between a prescription drug and an NHP, which is a naturally-occurring substance sold without a prescription, but are also “legally and operationally discrete.” Accordingly, it found that BOLUOKE “falls squarely” under the NHP regulations as a non-prescription product derived from animals.

2. Onus to prove safety and efficacy: C-RNA contended that the Minister bears the onus to prove a substance is not safe or efficacious in a NHP licence application. The FCA disagreed. It stated that ss. 5 and 7 of the NHP Regulations place the burden on the applicant to provide evidence demonstrating the safety and efficacy of its product to the Minister’s satisfaction, which C-RNA had not done in this case.

3. Standard of review: The FCA further rejected C-RNA’s arguments that the Federal Court erred in its standard of review analysis. It agreed with the Federal Court's reasoning that many of C-RNA’s challenges to procedural fairness were in fact substantive in nature and therefore, correctly assessed on a reasonableness standard. Although the Federal Court rendered its decision after the Supreme Court of Canada’s decision in Vavilov (Canada (Minister of Citizenship and Immigration) v. Vavilov, 2019 SCC 65), the FCA held that the Federal Court did not err in not considering the Vavilov framework in its analysis, as C-RNA had neither suggested nor demonstrated that applying Vavilov would arrive at a different outcome.

4. Breaches of procedural fairness: Finally, the FCA held that the Minister did not breach its duty of procedural fairness in consulting an external hematologist, as the Minister gave C-RNA proper notice and provided C-RNA with the opportunity to respond. The FCA also found no evidence that the Minister had led C-RNA astray by recommending but later rejecting the option to have BOLUOKE approved under a “professional use” designation.

C-RNA would need leave from the Supreme Court of Canada to appeal this decision.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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