Case information

Administrative law — Judicial review — Standard of review — Procedural fairness — Permits and licences — How should courts interpret and apply Canada’s NHP regime — To what extent can the government read in additional licensing requirements — What is the legal status of Ministerial guidelines in Canada — To what extent are the regulations applicable to NHPs legally and operationally discrete — What procedural fairness guarantees are afforded to Canadian businesses navigating the NHP Regulations — What is the standard of review applicable to judicial review decisions in Canada — What is the role of an appellate court when considering an appeal from an application for judicial review — Is there an obligation to show a palpable and overriding error or is the role of the appellate courts in Canada to step into the shoes of the court which heard the judicial review.

Case summaries are prepared by the Office of the Registrar of the Supreme Court of Canada (Law Branch). Please note that summaries are not provided to the Judges of the Court. They are placed on the Court file and website for information purposes only.

The applicant sought a natural health product (NHP) licence for oral lumbrokinase capsules, branded Boluoke. The product has a single medicinal ingredient, lumbrokinase, which is an enzyme derived from earthworms. Lumbrokinase has “fibrinolytic” properties, which means that it enhances the breakdown of blood clots or prevents them from forming. In its application, the applicant emphasized Boluoke’s fibrinolytic properties and its ability to reduce blood viscosity and improve circulation. Health Canada rejected the application, in part finding that the applicant’s evidence was insufficient to support the safe use of this product in the target subpopulation. Health Canada’s notice of refusal emphasized that the risk of internal bleeding could not be properly monitored in circumstances where the product was sold over the counter. The applicant requested a reconsideration, which was unsuccessful. An application to the Federal Court for judicial review was dismissed, as was an appeal to the Federal Court of Appeal.