Case information

Administrative law – Boards and tribunals – Permits and licences – Prerogative writs – Mandamus – Applicant seeking licence from Health Canada to market its product useful in the cessation of smoking – Minister refusing to issue licence after reconsideration process – When is it appropriate for court to exercise its discretion to grant mandamus in face of serious misconduct by government bodies? – Is there a “presumption” that government bodies will act fairly and without bias on a redetermination of same matter? – What is required to demonstrate institutional or systemic bias? – Is the doctrine of functus officio necessarily “limited” in cases involving health and safety or is “door always open” for a government authority to issue further decisions? – Is there a distinction in law where first decision was to deny the license instead of granting it?

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, the Winning Combination Inc. (“TWC”), brought an application for judicial review of a series of related decisions of Health Canada with respect to the licencing of its smoking cessation product, Resolve. Health Canada initially accepted that Resolve met the definition of a “natural health product” as set out in the governing regulations and its Dictionary of Natural Products. A complaint from a competitor, however, triggered a further assessment. Health Canada’s first decision, dated July 19, 2007, refused TWC’s Product Licence Application (“PLA”) based on safety and efficacy concerns. Health Canada’s second decision dated August 21, 2007 refused TWC’s PLA on the ground that Resolve was a drug and not a natural health product. In an ongoing reconsideration process over the course of several years, TWC filed evidence to support the safety, efficacy and classification of its product. Health Canada eventually conceded the safety issue but maintained that the evidence did not support efficacy or the classification of Resolve as a natural health product. TWC sought judicial review of all decisions issued by Health Canada relating to the Resolve PLA, in which it alleged that the process had been tainted by, inter alia, a reasonable apprehension of bias and procedural unfairness.