ACCESS TO INFORMATION
Judicial review of Minister’s decision to disclose information concerning applicant’s supplementary new drug submission (SNDS) for “Losec” tablets used as dyspepsia treatment—Applicant argues: (1) decision nullity as made without authority; (2) information exempt from disclosure under Access to Information Act, s. 20(1)(b) or (c) or because irrelevant or previously severed—“Losec” is brand name for omeprazole magnesium which blocks gastric acid secretion, gives relief from upper abdominal discomfort—Records sought: two parts of SNDS (1) Comprehensive Summary (methodologies, results, conclusions, evaluations of each evaluation study) and (2) Product Monograph (concise summary of data in NDS which, in final version, is released to any health care provider upon request)—Applicant submits information is unique compilation, should be maintained as confidential—Also that information reveals how regulatory approval obtained, would be advantage to competitor—As to nullity argument, suggests no evidence Coordinator made release decision—In reality, decision made by officer in Proprietary and Scientific Information Assessment (PSIA) section of Health Canada—Coordinator had power delegated from Minister to make release decision; Assistant Coordinator lacked authority to decide to release records—Impugned letter decision signed by Assistant Coordinator—Applicant submitting this official lacked both delegated power, scientific background to assess records at issue—PSIA staffers do have relevant scientific backgrounds—PSIA reviewed records, recommended disclosure of some—Assistant Coordinator reviewed recommendation, concurred, forwarded documenta-tion to Coordinator for release approval—Coordinator made first disclosure decision, subject to third party representations —Applicant was notified, made representations following which second decision was made, this one signed by Assistant Coordinator—Coordinator has retired and no evidence from this official was filed—Assistant lacked recollection of particular decision, but in accordance with usual practice would have received oral decision from Coordinator—That evidence is sufficient, on balance of probabilities, to establish release decision made by Coordinator—Nothing in Act prevented decision maker from obtaining recommendations from staff—Given technical, detailed analysis involved in access requests, to prevent this would shut down operation of Act—Cyanamid Canada Inc. v. Canada (Minister of Health and Welfare) (1992), 45 C.P.R. (3d) 390 (F.C.A.) held common sense dictates decision maker would be guided by officials having direct knowledge of issues so long as decision maker takes ultimate decision—Impugned decision not nullity —Applicant admits much of information on clinical trials is in public domain but submitting way information compiled is confidential—But third party cannot repackage publicly available information, thereby creating confidentiality cloak— Regulatory process not basis for confidentiality claim any more than is nature of relationship between applicant, regulator—No evidence this type of information kept confidential following product approval—No comparative evidence from countries having similar regimes—Information as to dates, page numbers purely administrative, not technical, scientific, financial or commercial information—Applicant not establishing material harm if information disclosed—“Losec” important product to applicant, but no “materiality” harm threshold established—Harm alleged speculative, not of nature Act designed to protect—Knowledge of regulatory process, how applicant managed to secure approval is not third party’s information—Suggestion would permit competitor to more easily secure approval disregards facts each applicant, drug different, dealt with by regulator according to specific case—“Head start” argument rejected in Cyanamid case— While applicant submitting disclosure causing adverse publicity, information discloses nothing about actual clinical test results—Potential public relations problems at best speculative—Nor had applicant satisfied Court selected information from reviewer’s comments confidential or, if disclosed, will cause material harm—As to irrelevancy, unsevered documents, Court in AstraZeneca Canada Inc. v. Canada (Health), 2005 FC 189, (AstraZeneca No. 1) distinguished Cistel Technology Inc. v. Canada (Correction Service), 2002 FCT 253, referred to Canadian Tobacco Manufacturers’ Council v. M.N.R., 2003 FC 1037; relevancy objection herein rejected for same reasons—As for argument Minister may not change mind regarding disclosure; Matol Botanical International Inc. v. Canada (Minister of National Health and Welfare) (1994), 84 F.T.R. 168, distinguishable—Facts herein similar to those in AstraZeneca No. 1, objection to unsevering denied for reasons given in Supplemental Reasons—Application dismissed—Access to Information Act, R.S.C., 1985, c. A‑1, s. 20(1)(b),(c).
AstraZeneca Canada Inc. v. Canada (Minister of Health) (T‑1633‑01, 2005 FC 645, Phelan J., order dated 9/5/05, 14 pp.)