Date: 20050509
Docket: T-754-02
Citation: 2005 FC 647
BETWEEN:
ASTRAZENECA CANADA INC.
Applicant
and
HEALTH CANADA, THE MINISTER OF HEALTH
and THE ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR ORDER
PHELAN J.
INTRODUCTION
[1] This is the last of three Access to Information cases which were heard together. All relate to information concerning AstraZeneca Canada Inc.'s (AstraZeneca) drug LOSEC (capsules and tablets). In this case, the request was for information limited to "chemistry and manufacturing information in relation to the active ingredient omeprazole (LOSEC) and a current product monograph.
[2] AstraZeneca raises the same issues as were dealt with in AstraZeneca Canada Inc. v. Health Canada, The Minister of Health and The Attorney General of Canada files [2005] FC 245 (T-1633-01) and [2005] FC 646 (T-1997-01) (reasons which are being released together). The issues raised are:
- the decision is a nullity because of the failure to make a proper decision;
- the disputed records are exempt from disclosure pursuant to paragraphs 20(1)(a), (b) and (c) of the Access to Information Act (the Act);
- the Minister does not have jurisdiction to disclose information that is irrelevant;
- the Minister does not have jurisdiction to disclose information which had been previously considered to be exempt from disclosure.
[3] Some of the facts in this case are different from its two companion cases, in particular the more extensive reference to United States experience.
BACKGROUND
[4] The details of AstraZeneca's approvals for the drug LOSEC in capsule and tablet form was described in [2005] FC 645 (T-1633-01) and [2005] FC 646 (T-1997-01). At the time of the subject access request, AstraZeneca marketed in Canada the proton pump inhibtor in capsules and tablets under the brand name LOSEC. In the United States, AstraZeneca markets a similar drug, in a dosage form of 10 mg, 20 mg and 40 mg, capsules with omeprazole as the active ingredient, under the brand name Prilosec.
[5] The Product Monograph (PM) for LOSEC capsules, prepared June 13, 1989 and revised October 17, 2000, was partially disclosed to an access requester on or about February 28, 2001.
[6] In the United States, the Food and Drug Administration (FDA) approved LOSEC (subsequently called Prilosec) for certain gastric problems as early as 1988.
[7] The U.S. "Summary Basis of Approval" (SBA) for the LOSEC capsules included the Approval Letter, Medical Officers' Review, Chemistry Review, Pharmacology Review, Biopharmaceutics Review and Statistics Review. The published SBA is a selection of the Reviewers' Reports, similar to the Canadian reviewers' comments and reports related to a new drug approval.
[8] These American documents, which contain equivalent information to the Canadian reviewers' comments made on the chemistry and manufacturing information, are published by the FDA after approval is given to market a drug in the USA.
[9] By letter dated September 17, 2001, Health Canada's Access Co-Ordinator received an access request for a wide sweep of documents related to LOSEC. The scope of the request was subsequently narrowed to the chemistry and manufacturing information in relation to LOSEC and its latest product monograph.
[10] The access request was then processed in the same way as the other access requests related to LOSEC. The matter was referred to PSIA; AstraZeneca received notice of intended disclosure; made representations opposing; PSIA and access personnel reviewed the representations; a letter decision confirming disclosure was issued. AstraZeneca then filed for review by this Court.
[11] AstraZeneca has categorized the documents in issue under 10 headings as follows:
AstraZeneca's Categories of Information
1. Category 1 consists of references to submissions or products, other than omeprazole, e.g. omeprazole magnesium, which did not form part of the basis for regulatory approval of omeprazole capsules. As the request pertains to various records relating to "Omeprazole (Losec)", category 1 information is irrelevant to the request made and, consequently, ought not to be disclosed.
2. Category 3 comprises references to: (I) the quantitative composition of omeprazole capsules, (ii) product manufacturing processes and process validation studies, (iii) specifications and test methods for drug products and substances including references to the type of method and relevant validation of the method, (iv) excipient standards, (v) drug substance synthesis, and/or (vi) any information, including, but not limited to, results from the testing of specific batches.
3. Category 4 comprises references to AstraZeneca's regulatory submission and marketing strategies that indicate the manner in which AstraZeneca was able to obtain regulatory approval and market its products. Category 4 information includes descriptions of data submitted for review, whereby submission of such data was not a specified requirement of TPD policies/guidelines current at the time this data was submitted.
4. Category 5 consists of information pertaining to unpublished: (I) analytical experiments, procedures, their design and results thereof, (ii) comparisons of manufacturing processes, and/or (iii) any other scientific information provided to Health Canada that is neither published nor available to the public.
5. Category 6 consists of references to third parties and any reference to AstraZeneca where the same would reveal the involvement of such companies with activities related to omeprazole. Any information that allows one to infer characteristics of the third parties is also included in this category. The category 6 information remaining in the disputed record consists of references to the commercial activities of AstraZeneca.
6. Category 8 consists of references to impurities and degradation products (including information that directly or indirectly reveals the same). Items to be severed include, but are not limited to, methods for testing, identification codes, chemical structures, quantified levels, and the allowed or expected limits of impurity and degradation products.
7. Category 9 consists of information relating to stability studies including, but not limited to, test methods and validation, limits, results and conclusions.
8. Category 10 consists of information relating to non-marketed package formats.
The parties advised the Court that Categories 2 and 7 are no longer in dispute.
ANALYSIS
Preliminary Issues
[12] AstraZeneca has raised three preliminary issues: that the decision is a nullity; that the Minister lacks the authority to disclose information originally found to be exempt ("unsevering"); that the Minister has no authority to disclose irrelevant information.
[13] AstraZeneca argues that the decision is a nullity because the Access Co-ordinator, the Minister,s delegate for the purpose of this type of decision, did not make the decision under review.
[14] While there is no written record that the Access Co-ordiantor made that decision, the circumstantial evidence of past practice within the access unit and the direct, albeit hearsay evidence, testimony is that the Co-ordinator made the decision. There is no contrary evidence. For the same reasons given in the related decisions, [2005] FC 645 (T-1633-01) and [2005] FC 646 (T-1997-01), this objection is dismissed.
[15] AstraZeneca's objection that the decision is a pro forma decision made, in reality, by officials of the PSIA is, for the same reasons as previously held, dismissed. Therefore the decision is a valid decision.
[16] With respect to the issue of unsevering, this Court has held in the Supplemental Reasons in AstraZeneca Canada Inc. v. Health Canada, The Minister of Health and The Attorney General of Canada, [2005] FC 648 (T-720-02), that the Minister has that authority in the context of a Court review.
[17] Similarly this Court, for reasons given in [2005] FC 648 (T-720-02), has held that the objection to irrelevancy, even if AstraZeneca had established irrelevancy, cannot be sustained.
DOCUMENTS EXEMPTION
[18] AstraZeneca relies on many of the same general arguments which were raised in the companion decisions. The argument is that the documents, being a unique compilation of information, is confidential - even though that information (in different forms) is either in the public domain, or, is generally understood knowledge in the pharmaceutical industry. AstraZeneca also argues that it will suffer harm from disclosure because a competitor will have a better understanding of the regulatory process and therefore will be able to enter the market with their own drugs more rapidly. For the reasons given in [2005] FC 645 (T-1633-01) and [2005] FC 648 (T-720-02), these two general arguments cannot be accepted.
[19] In this case, (unlike the two related cases), there is evidence of the practice of another jurisdiction performing essentially the same function as Health Canada. AstraZeneca has failed to establish that the regimes in the U.S. and the information available is significantly different to the information in issue in this case. Nor has AstraZeneca established that the release of that type of information has caused the type of harm alleged or material harm to either AstraZeneca or other drug manufacturers.
[20] The decisions in Canada Packers Inc. v. Canada (Minister of Agriculture) [1988] 1 F.C. 483; Piller Sausages & Delicatessens Ltd. v. Canada (Minister of Agriculture) [1988] 1 F.C. 446 and Burns Foods Ltd. v. Canada [1982] F.C.J. No. 1026 are particularly apt to this situation. The availability of this information in the United States suggests that it is not the type of information covered by paragraph 20(1)(b). The absence of evidence of material harm from such disclosure in the United States suggests that similar harm will not occur in Canada.
[21] AstraZeneca has also raised paragraph 20(1)(a) - trade secrets - as a basis for non-disclosure. The term "trade secret" has been narrowly defined by Strayer J. (as he then was) in Société Gamma Inc. v. Canada (Department of Secretary of State) [1994] F.C.J. No. 589. AstraZeneca has provided neither sufficient facts nor arguments to establish that any of the information falls within this term.
[22] AstraZeneca's mere assertion of a trade secret is not sufficient for the Court to conclude that a trade secret exists. (See SNC Lavalin v. Canada (Minister for International Cooperation) [2003] 4 F.C. 900.
[23] The following paragraphs contain the Court's comments on the specific category of documents over which AstraZeneca has made its claim.
[24] Category 1: AstraZeneca contends that the information to be disclosed is irrelevant. The Court has dealt with that issue. In this instance the alleged irrelevancy turns on whether omeprazole magnesium is part of the compared omeprazole.
[25] Category 3: While AstraZeneca claims that the information is a trade secret without establishing that to be so, Health Canada has exempted information about specific steps in AstraZeneca's processes. The balance of the information is available from the Product Monograph, observation and deduction. The general claim of harm flowing from knowledge of the regulatory process has been dismissed.
[26] Category 4: For reasons previously given, AstraZeneca has not established that the release of this information on its regulatory submissions is a valid basis for exemption.
[27] Category 5: The methods and types of studies (specific actual results are severed) are known through the Product Monograph, other public documents and Health Canada's Guidelines.
[28] Category 6: The issue of personnel and licensed establishments was dealt with in [2005] FC 646 (T-1997-01) Category 6 and is not exempt. The information is available from other sources or otherwise ascertainable. (See Information Commissioner v. ACOA (1996), 109 F.T.C. 110).
[29] Category 8: The information regarding the codes used in the studies without the "key" discloses nothing of value. AstraZeneca has not established that with the deletions proposed by Health Canada, the information to be disclosed is either confidential or will cause harm.
[30] Category 9: For the same reasons as regards Category 8, there is no basis to exempt this information where the sensitive information has already been exempted.
[31] Category 10: The bulk of the information at issue is referred in the Product Monograph or is otherwise publicly known. For the one item not publicly known, AstraZeneca could establish no material harm from its disclosure.
CONCLUSION
[32] For all these reasons this application will be dismissed with costs.
(s) "Michael L. Phelan"
Judge
FEDERAL COURT OF CANADA
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-754-02
STYLE OF CAUSE: ASTRAZENECA CANADA INC. v. HEALTH CANADA, THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: November 15, 2004
REASONS FOR ORDER: Phelan J.
DATED: May 9, 2005
APPEARANCES:
J. Sheldon Hamilton
Denise L. Lacombe FOR THE APPLICANT
Sadian Campbell
Derek Edwards FOR THE RESPONDENTS
SOLICITORS OF RECORD:
Smart & Biggar
Toronto, Ontario FOR THE APPLICANT
Mr. John H. Sims
Deputy Attorney General of Canada
Ottawa, Ontario FOR THE RESPONDENT
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