Health Canada refused Canada RNA Biochemical Inc’ s application and reassessment for BOLUOKE.

An application for a product licence must include information regarding each medicinal ingredient and the recommended conditions of use. It also requires evidence demonstrating the safety and efficacy of the NHP when it is used in accordance with such conditions. Health Canada’s Guidance sets out the minimum criteria for evidence required for applications relating to NHPs like BOLUOKE that make “modern health claims”.

Lumbrokinase is an enzyme complex derived from earthworms that can enhance the breakdown of blood clots, i.e. it has “fibrinolytic” properties. C-RNA sought to label BOLUOKE for its ability to “reduce blood viscosity” and “improve circulation”. As evidence of safety and efficacy, C-RNA filed information on the longstanding use of earthworms in Traditional Chinese Medicine, research and clinical studies, and the approval and safety record of BOLUOKE in other countries. BOLUOKE was considered to be a high level of risk product under Health Canada’s Guidance. Health Canada found C-RNA’s evidence did not satisfy concerns relating to a potential risk of internal bleeding because it did not adequately demonstrate safety in healthy populations – a particular concern in the non-prescription context of NHPs. Health Canada refused C‑RNA’s application and upheld that refusal on a reassessment.

C-RNA argued Health Canada misinterpreted the NHP Regulations by introducing terms and requirements not found in the regulations, namely: the need to demonstrate safety in a “healthy population”, reference to “over-the-counter” and “self-care” as the model for use of NHPs, and a requirement that the “benefits” of BOLUOKE outweigh its “risks”. However, McHaffie J. of the Federal Court, applying the reasonableness standard of review, rejected all of these arguments.

C-RNA also argued Health Canada acted unreasonably in its assessment of BOLUOKE by treating it as a “high risk” product, applying too high a standard for evidence of safety, refusing to license BOLUOKE when licences had been issued for other oral fibrinolytic enzyme products, failing to accept the potential for mitigation of safety risks, and ignoring evidence favouring a finding that BOLUOKE is safe. Justice McHaffie again rejected all of these arguments, holding that the refusal of C-RNA’s application was reasonable, noting it is not the Court’s function to stand as a scientific review panel to second-guess the decision.

Finally, C-RNA argued that the refusal was procedurally unfair, relying on numerous aspects of the review. While McHaffie J. acknowledged the process was lengthy and the reconsideration did not follow a standard form, he was satisfied that the process was fair having regard to the circumstances. C-RNA may appeal as of right.

Source: Smart & Biggar LLP and Smart & Biggar IP Agency Co