Apotex Inc. v. Canada ( Attorney General )
T-1877-91
19/1/93
46 pp.
Application for mandamus directing Minister to review new drug submissions in respect of Apo-A and Apo-B to determine whether adequately establish safety and effectiveness for use in Canada "without regard to a condition precedent to such review that the reference product tested in the comparative availability study be purchased in Canada or that there be certification from the manufacturer of the Canadian reference product that it is identical to the non-Canadian product"-Also seeking order directing respondent upon completion of review of submissions to issue notices of compliance if review satisfactory, and if unsatisfactory to respond to submission with details of deficiencies disclosed-Apotex manufacturer and distributor of generic pharmaceutical products-New drug submissions concerning drugs for which Health Protection Branch (HPB) approval of original brand for sale in Canada and FDA approval in U.S.A. already obtained-Apotex's submissions including bioavailability study comparing new product with reference product not obtained in Canada i.e. with U.S. originator-HPB advising submission inadequate because bioavailability study incomplete-Basic issues: (1) scope of discretion vested in Minister in regard to evidence to be considered in new drug submission; and (2) appropriate standard for intervention of Court through judicial review in relation to discretion-Evidence establishing HPB refusing to accept evidence of equivalency of U.S. and Canadian originator products-Policy requiring bioavailability study to establish safety and effectiveness of new generic drugs be done with reference to product already on Canadian market not established until year after Apotex's submission for Apo[ib]-A-Even thereafter policy not applied consistently-Refusal to consider full submission for Apo[ib]-A because of such policy unfair administration of regulatory authority and unlawful fettering of discretion-Apotex entitled to have bioavailability study reviewed-Director's discretion requiring special expertise in applied and basic sciences-Judgment affecting not only rights of applicant, but health of others-Discretion of this sort warranting judicial deference recognizing special expertise and responsibilities of Minister and advisers-In judicial review of specialized tribunals whose decisions, based upon particular expertise and experience final and not subject to appeal or review, court will only intervene if interpretation of legislation patently unreasonable-Same test applies herein-No basis for Court to determine HPB requirement of satisfactory study comparing two drugs patently unreasonable or beyond Director's discretion-No basis for mandamus in relation to new drug submission in relation to Apo[ib]-A-No costs awarded-HPB at times dissembling, if not actually misleading-Notice of compliance issued for Apo[ib]-B after hearing-Application as relates to Apo[ib]-B moot-Just as change in circumstances following trial and decision but before appeal heard may render moot issues raised on appeal so may change in circumstances following hearing, but before decision-Circumstances outlined by Sopinka J. in Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 342 warranting exercise of Court's discretion to decide moot issue absent-Food and Drugs Act, R.S.C., 1985, c. F[ib]-27, s. 30(1)-Food and Drug Regulations, C.R.C., c. 870, C.08.001, C.08.002, C.08.004 (as am. by SOR/85-143, s. 3; 88-257, s. 1).