ADMINISTRATIVE LAW REPORTS Fifth Series/Cinqui`Eme S´Erie Recueil De Jurisprudence En Droit Administratif
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ADMINISTRATIVE LAW REPORTS Fifth Series/Cinqui`eme s´erie Recueil de jurisprudence en droit administratif VOLUME 53 (Cited 53 Admin. L.R. (5th)) EDITORS-IN-CHIEF/REDACTEURS´ EN CHEF David Phillip Jones, Q.C., Anne S. de Villars, Q.C., C. ARB., B.A.(HONS.) (MCGILL),C. ARB., B.SC. (HONS.) (SOUTHAMPTON), B.C.L., M.A.(OXON.) LL.B.(ALBERTA) de Villars Jones Barristers and Solicitors Edmonton, Alberta QUEBEC EDITOR/REDACTEUR´ POUR LE QUEBEC´ Denis Lemieux, LL.L., D. EN D. Facult´e de droit, Universit´e Laval Qu´ebec, Qu´ebec ASSOCIATE EDITOR/REDACTEUR´ ADJOINT Andrew J. Roman, B.A.(MCGILL), LL.B.(OSGOODE HALL) Miller, Thomson Toronto, Ontario ADMINISTRATIVE LAW REPORTS, a national series of topical law re- Recueil de jurisprudence en droit administratif, une s´erie nationale de ports, is published 12 times per year. Subscription rate $421.00 per bound recueils de jurisprudence sp´ecialis´ee, est publi´e 12 fois par ann´ee. volume including parts. 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ISSN 0824-2615 ISBN 978-0-7798-2458-8 Printed in Canada by Thomson Reuters CARSWELL, A DIVISION OF THOMSON REUTERS CANADA LIMITED One Corporate Plaza Customer Relations 2075 Kennedy Road Toronto 1-416-609-3800 Toronto, Ontario Elsewhere in Canada/U.S. 1-800-387-5164 M1T 3V4 Fax 1-416-298-5082 www.carswell.com Contact www.carswell.com/contact ASSISTANT EDITORS/REDACTEURS´ ASSISTANTS David N. Jardine, Philip Bryden, B.A.(DALHOUSIE), LL.B.(ALBERTA), LL.M.(BRITISH CO- B.A.(JURIS.), B.C.L.(OXON), LUMBIA) LL.M.(HARVARD) Shores Belzil Dean, Faculty of Law, Edmonton, Alberta University of Alberta Edmonton, Alberta Karen M. Munro, William W. Shores, Q.C., B.SC. (H. EC.), LL.B.(ALBERTA),B.A.(HONS.), M.P.M., LL.B.(ALBERTA) LL.M.(OSGOODE HALL) Shores Belzil Alberta Justice, Civil Law Branch Edmonton, Alberta Edmonton, Alberta Kathy Cherniowsky, Glenn D. Tait, B.COMM., LL.B., LL.M. B. COMM. (ALBERTA), Edmonton, Alberta LL.B.(QUEEN’S), LL.M.(TORONTO) McLennan Ross Yellowknife, Northwest Territories Dawn M. Knowles, B. ADMIN. (REGINA), LL.B.(ALBERTA) de Villars Jones Edmonton, Alberta CARSWELL EDITORIAL STAFF/REDACTION´ DE CARSWELL Cheryl L. McPherson, B.A.(HONS.) Director, Primary Content Operations Sarah Bourne, B.A., LL.B. Product Development Manager Nicole Ross, B.A., LL.B. Heather Stone, B.A., LL.B. (Acting) Supervisor, Legal Writing Lead Legal Writer Peggy Gibbons, B.A.(HONS.), LL.B. Peter Bondy, B.A.(HONS.), LL.B. Senior Legal Writer Senior Legal Writer Amanda Stewart, B.A.(HONS.), LL.B. Stephanie Hanna, B.A., M.A., LL.B. Senior Legal Writer Senior Legal Writer Mark Koskie, B.A.(HONS.), M.A., LL.B. Martin-Fran¸cois Parent, LL.B., LL.M, Legal Writer DEA (PARIS II) Bilingual Legal Writer Rachel Bernstein, B.A.(HONS.), J.D. Andrew Pignataro, B.A.(HONS.) Legal Writer Content Editor Celgene Inc. v. Canada (Minister of Health) 177 [Indexed as: Celgene Inc. v. Canada (Minister of Health)] The Minister of Health, Appellant and Celgene Inc., Respondent and Canadian Generic Pharmaceutical Association, Intervener Federal Court of Appeal Docket: A-75-12 2013 FCA 43 Johanne Gauthier, K. Sharlow, M. Nadon JJ.A. Heard: November 27, 2012 Judgment: February 15, 2013 Commercial law –––– Trade and commerce — Consumer protection — Public health legislation — Pure food and drugs — Regulation of new drugs –––– Thalidomide was previously approved by Health Canada in 1960 and 1961, but approval was withdrawn for safety reasons in 1962 — In 2009, corpo- rate respondent C Inc. sought approval for drug Thalomid with medicinal ingre- dient thalidomide — Regulations under Food and Drugs Act required that manu- facturers submit evidence of efficacy in seeking notice of compliance (“NOC”) — NOC was issued, but appellant Minister of Health refused to regis- ter C Inc.’s drug on register of innovative drugs, on basis that medicinal ingredi- ent thalidomide was not innovative — Minister advised C Inc. that Thalomid would not be eligible for data protection because thalidomide had been previ- ously approved by minister — C Inc. brought successful application for judicial review — Application judge held that prior approvals in this case should not stand in way of data protection for later approved product and that drug was innovative drug and eligible for listing on register — Minister appealed — Ap- peal allowed — Parliament had power to extend data protection to other “new drugs” as defined in regulations, which also required filing of similarly substan- tial confidential data — It was clear from definition adopted that legislator chose not to do so — Despite exceptional history of thalidomide, there was no cogent legal basis to create exception.