A recent Federal Court decision—holding that Health Canada denied The Winning Combination Inc. (TWC) procedural fairness in TWC's application for a Natural Health Product licence—highlights the requirements of administrative fairness that Health Canada must consider in the context of marketing approvals.
Until 2007, Resolve, a smoking cessation aid, was marketed by TWC as a natural way to reduce smoking. The lozenge was made with an undisclosed active ingredient then listed on Health Canada’s Dictionary of Natural Products' list of natural substances.
Resolve had filed, but not yet received, a Natural Health Product (NHP) licence, and was operating under the Natural Health Products (Unprocessed Product Licence Applications) Regulations—temporary regulations that allowed lower-risk NHPs meeting safety and efficacy requirements to be legally sold and labelled with exemption numbers while awaiting full review.
Health Canada's Natural Health Product Directorate (NHPD) rejected TWC’s NHP licence application twice. The first time, the NHPD determined that TWC had submitted insufficient evidence to support the safety and efficacy of Resolve, alleging that it contained a substance acquired from passionflower that was harmful. Following this decision, TWC filed a request for reconsideration.
The second time, the NHPD refused TWC's NHP licence application on the basis that Resolve’s active ingredient was allegedly not naturally occurring and was a drug under the Food and Drug Regulations (rather than an NHP under the Natural Health Product Regulations). As a result of the reclassification, Resolve was determined to be an unlicensed drug and effectively prohibited from sale in Canada.
TWC filed an application to the Federal Court for judicial review of the decisions made by Health Canada. The Court quashed both of Health Canada’s refusals, and all of the subsequent decisions. 1 The Court held that Health Canada had denied TWC procedural fairness on the basis that information was deliberately withheld from TWC, targets were moved, standards were changed and biased personnel prevented any true independent assessment.
The Minister was ordered to grant TWC a licence for Resolve within 30 days because Health Canada had conceded that the product was safe for its prescribed uses, information submitted by TWC supported efficacy and evidence showed that the active ingredient is naturally occurring. Subject to an appeal, this decision can be leveraged by future applicants where Health Canada or another government body does not appear to meet requirements of administrative fairness and reasonableness.
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1 The Winning Combination Inc. v. Minister of Health et al. 2016 FC 381. Health Canada has appealed the Federal Court’s decision.
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