[2017] 4 F.C.R. D-6
Food and Drugs
Appeal from Federal Court (F.C.) decision (2016 FC 381) setting aside Minister of Health decision, subsequent variations, reconsiderations under Natural Health Products Regulations, SOR/2003-196 (Regulations) refusing licence for Resolve, product assisting in cessation from smoking — Health Canada, Natural Health Products Directorate initially concluding that Resolve falling within definition of a natural health product (NHP) as defined under Regulations, Schedule 1 — Respondent purchasing rights to Resolve, selling product in Canada in 2006 — Pfizer Canada Inc. (Pfizer) alleging health and safety concerns related to Resolve in complaint to Health Canada — Health Canada requesting stop of sale, advertising of Resolve — Natural Health Products Directorate (NHPD) issuing Notice of Refusal, expressing concerns over, inter alia, active ingredient’s potential effects on health — Respondent seeking reconsideration, requesting that new process be conducted by different officials than those involved in original licence assessment — NHPD maintaining that Resolve not meeting definition of NHP — F.C. finding, inter alia, that Health Canada concluding, on basis of its own criteria, that Resolve properly classified as NHP; that standards upon which Resolve evaluated as NHP were asserted, then changed during reconsideration process; that NHPD’s reading of Regulations incorrect, unreasonable; reasonable apprehension of bias arising from consideration of safety of Resolve — Relying on new evidence to support award of mandamus compelling Minister to issue natural product licence to respondent — Main issue whether F.C. erring in law in issuing mandamus, usurping duty vested in Minister under Regulations — F.C. erring in granting mandamus — F.C.’s findings of individual bias having solid foundation; however, of entirely different order to extrapolate those findings to entire department of government — F.C. erring in placing evidentiary onus on Health Canada to affirmatively prove that it could conduct fair, objective redetermination — Predicating its decision to grant mandamus on inference that could not be sustained on evidence — Classification of substance as NHP or drug elastic concept — Parameters of Schedule 1, definition of natural health product can be matter of legitimate scientific debate — Evidence on appeal appearing to be debate on scientific question, undermining basis on which F.C. determined that respondent had clear right to licence on record before it — F.C. erring insofar as it relied on new evidence to answer question of classification — Doctrine of functus officio limited in context of Minister’s mandate to ensure safety of licenced products — Nothing in regulatory scheme supporting position that Minister may not revisit all licensing requirements — Principles of functus officio having limited application in context of regulatory approval of products where use may have deleterious impacts on health of consumer — Reading limitation on scope of reconsideration into Regulations, s. 10 to only matters put in issue by respondent inconsistent with governing principle of statutory interpretation — However, power to reconsider all issues not unlimited — Matter remitted to Minister for redetermination — Appeal allowed in part.
Canada (Health) v. The Winning Combination Inc. (A-117-16, 2017 FCA 101, Rennie J.A., judgment dated May 15, 2017, 33 pp.)