[2016] 4 F.C.R. D-2
Food and Drugs
Judicial review in particular of decisions by respondent Health Canada (respondent) respecting applicant’s product RESOLVE, smoking cessation aid, wherein respondent, in notices of rejection (NOR), refusing (1) applicant’s product license application (PLA) based on safety, efficacy concerns pursuant to Natural Health Products Regulations, SOR/2003-196 (NHP Regulations), ss. 7(a),(d) (first decision); (2) applicant’s PLA on grounds RESOLVE not natural health product, subject to regulation under Food and Drug Regulations, C.R.C., c. 870 (second decision) — National Health Products Directorate (NHPD), division of respondent, upholding decisions on reconsideration — Main issues: determining statutory interpretation of NHP Regulations regarding efficacy; whether respondent failing to comply with relevant legislation, regulations, policies, standard operating procedures during PLA consideration, reconsideration process — Applicant arguing, inter alia, standard demanded by NHPD regarding efficacy exceeding reasonable interpretation of NHP Regulations, which do not require any substantive proof for efficacy — Claiming RESOLVE “may” help with smoking cessation, not that it “will”; therefore, any substantive test for efficacy having to be modest — Respondents submitting that applicant afforded procedural fairness beyond what required by law — NHPD both unreasonable in reconsideration decisions, procedurally unfair in dealings with applicant — Clear that applicant not receiving prior notice from NHPD about either efficacy or safety concerns under PLA process — No opportunity for applicant to respond to efficacy concerns before NOR issued; constituting deviation from standard procedures — Extremely high standard of proof of efficacy in form of unimpeachable human clinical studies, as demanded herein by respondent, previously rejected by Court as minimum mandatory requirement for drug submissions — Furthermore, no evidence submitted that respondent ever using standard in any other PLA, giving rise to issues of procedural fairness, apprehension of bias, legal errors in interpretation, reasonableness — Appropriate standard for efficacy under PLA regime not yet authoritatively determined — Lack of established standard, application of strict test to applicant’s PLA, lending credence to argument that respondent applying any standard that would deny applicant’s PLA — Use of term “information” in NHP Regulations, s. 5(g) requiring applicant to provide some meaningful, acceptable documentation that “supports” efficacy of product — If not so provided, application not complete, NHPD then having to notify applicant of deficiency, allow reasonable time for response — Here, applicant never notified that its efficacy information deficient before first decision rendered — Under s. 5(g), applicant required to provide “information” that reasonably supports some degree of efficacy in terms of product claims set out in PLA — Test applied by respondent in present case incorrect as matter of statutory interpretation, unreasonable in full context of manner in which efficacy dealt with — On plain reading of NHP Regulations in full context thereof, applicant satisfying efficacy requirement; decision rejecting PLA on basis thereon unreasonable, contrary to legal requirements — Reconsideration process regarding efficacy not curing first decision — Withholding PLA licence for RESOLVE not justified on basis of evidence herein, conditions for mandamus satisfied in present case — NORs, reconsideration decisions quashed, order for mandamus issued.
Winning Combination Inc. v. Canada (Health) (T-1381-07, 2016 FC 381, Russell, J., judgment dated April 6, 2016, 69 pp.)