[2016] 2 F.C.R. D-3
Health
Judicial review of decision by respondent to impose import ban preventing importation of drug products into Canada from two of Apotex Inc’s (Apotex) manufacturing facilities in India (Apotex Pharmachem India Pvt Ltd. (APIPL), Apotex Research Private Limited (ARPL)), related issuance by respondent Minister of Health of establishment letters (letters) purporting to amend applicant Apotex Inc.’s establishment licences (ELs), prohibiting import of all products, apart from those deemed medically necessary — To fabricate, distribute or import into Canada for sale any drug, manufacturer having to hold EL — ELs granted if facilities complying with Good Manufacturing Practices (GMP), meeting requirements of Food and Drugs Regulations, C.R.C., c. 870, (Regulations) Part C, Division 2 — APIPL found non-compliant with U.S. GMP requirements by U.S. Food and Drug Administration (FDA) — FDA finding APIPL’s corrective, preventative actions insufficient to prevent recurrence of GMP deviations — Respondent receiving “new information” from FDA, instructing Canada Border Services Agency to restrict importation of drug products from APIPL, ARPL — Respondent also issuing public statement with respect to import ban — Main issues whether respondent acted in accordance with duty of procedural fairness, whether respondent acted beyond or not in accordance with regulatory powers, whether Regulations unconstitutional under Canadian Bill of Rights, s. 2(e) — Regulatory regime, present circumstances suggesting procedural fairness should have been afforded prior to implementation of import ban — Respondent failing to provide notice, denying Apotex opportunity to be heard before unilaterally imposing ban — Evidence demonstrating respondent acting for improper purpose — Issue whether import ban implemented based on legitimate concern for protecting Canadians’ health, safety, not to silence criticism in media or Parliament — Facts suggesting ban motivated by desire to ease pressure triggered from media, House of Commons — Such purpose falling outside respondent’s delegated authority from enabling legislation — Respondent’s actions therefore ultra vires — Regulations, s. C.01A.008(4) authorizing respondent to add new terms, conditions to previously issued ELs — However, procedural rights provided to EL holders throughout Regulations, Division 1A in similar circumstances (like notice, reasons for imposing new terms and conditions) should also be afforded when terms, conditions added to existing ELs — While basic procedural fairness should have been provided when Health Canada imposed new terms, conditions on applicant’s ELs, this is not synonymous with imposing right to hearing — Protections afforded by Canadian Bill of Rights, s. 2(e) operative only in application of law to individual rights, obligations in proceeding before court, tribunal or similar body — Finally, decision to implement import ban neither reasonable nor correct, quashed, respondent’s public statements ordered retracted.
Apotex Inc. v. Canada (Health) (T-2223-14, 2015 FC 1161, Manson J., judgment dated October 14, 2015, 76 pp.)