Date: 20050509
Docket: T-1633-01
Citation: 2005 FC 645
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 matter is the first of three decisions related to the others being T-1997-01 and T-754-02) which were heard together. These Reasons should also be read in conjunction with the Reasons in the other two cases, although in each case the facts are slightly different, many of the same principles are common to all three.
[2] These cases also are similar to this Court's decision in AstraZeneca Canada Inc. v. Health Canada, The Minister of Health and The Attorney General of Canada, [2005] FC 189 ("AstraZeneca # 1"). The same reasoning, which is relevant, has been applied in these three cases.
[3] This particular case relates to a decision by the Respondent (Minister) to disclose certain information related to AstraZeneca's supplementary new drug submission for LOSEC tablets (omeprozole magnesium) for the treatment of dyspepsia. AstraZeneca seeks to have this Court review the Minister's decision to disclose this information.
[4] In seeking a review by this Court, AstraZeneca has raised two principal issues:
1) that the decision by the Minister is a nullity because it was made by a person who lacked the authority to make that decision (this is an issue common to all three cases with slight variations in the facts for each);
2) that the information requested is exempt from disclosure pursuant to paragraphs 20(1)(b) and/or (c) of the Access to Information Act (Act) or alternatively because it is either irrelevant to the request or had previously been severed.
BACKGROUND
[5] LOSEC is a brand name with omeprazole magnesium as the active ingredient. The drug is a proton pump inhibitor which binds to the proton pumps of cells found in the stomach, blocking gastric acid secretion and, thereby, reducing the amount of acid in the stomach. Among other conditions, LOSEC is used for dyspepsia, a general term used to describe non-specific upper abdominal pain, such as painful, difficult or disturbed digestion.
[6] The general regime for drug submissions is described in AstraZeneca # 1. In this instance the critical steps for LOSEC were:
- On June 13, 1989, AstraPharma (AstraZeneca's former name) was granted a Notice of Compliance (NOC) for the drug LOSEC for the dosage form of 20 mg capsules.
- AstraPharma subsequently filed a supplemental new drug submission (S/NDS) for the dosage forms of 10 mg and 20 mg delayed release tablets and was granted NOC's on February 21, 1997 and January 12, 1996, respectively.
- AstraPharma also filed a S/NDS for the new indication of dyspepsia for the drug LOSEC, which S/NDS was granted an NOC on December 2, 1999.
- On or about January 19, 2000, AstraPharma submitted an S/NDS for an administrative company name change to AstraZeneca; this resulted in the re-issue of the NOC on February 3, 2000 for LOSEC 10 mg and 20 mg delayed release tablets.
[7] On May 7, 2001, Health Canada's Access to Information Coordinator received a request for access to
all releasable information on Losec and the claim for Dyspepsia which was filed as a supplemental New Drug Submission, including the Comprehensive Summary, correspondence and reviewer's comments.
[8] The records sought are two parts of the NDS, the Comprehensive Summary which contains descriptions of the methodologies, results, conclusions and evaluations of each study used to evaluate the drug and the Product Monograph (PM) which is a concise summary of the data in an NDS and, in its final version, is released to any health care provider who requests it.
[9] In addition to AstraZeneca's allegation that the process of reaching the decision to release the records is contrary to the Act, with respect to the actual documents, AstraZeneca essentially argues that the information is a unique compilation and should be maintained as confidential; that despite the fact that the substance of the records in dispute is in the public domain, the form of records used is confidential; and that its reliance on public information is not public knowledge and must remain confidential. Further, AstraZeneca contends that the information discloses how it obtained its regulatory approval and therefore a competitor will be advantaged by gaining knowledge of the regulatory process and would be able to secure their own approvals more rapidly.
POINTS IN ISSUE
Decision is a Nullity
[10] The basis of AstraZeneca's claim, that the decision to release documents is a nullity, is that there was no evidence that the Coordinator made the decision to release; that the Assistant Coordinator made the decision and, in reality an officer in the Proprietary and Scientific Information Assessment (PSIA) section of Health Canada made the real decision by virtue of PSIA's control of the process.
[11] The Coordinator had power delegated from the Minister to make a decision to release records. The Assistant Coordinator had more limited powers to issue notices to third parties of an intention to disclose and notices of decisions to disclose but did not possess the authority to decide to release records. PSIA had no specific authorizations under the Act.
[12] The decision under review, a letter dated August 23, 2001, was signed by the Assistant Coordinator. AstraZeneca complains that not only did she lack delegated authority to make a disclosure decision but she lacked any scientific background to assess the records in issue in order to make a disclosure decision.
[13] It was standard practice, on requests of this nature, that the request was sent to PSIA which was charged with document retrieval and assessment for disclosure. PSIA personnel have extensive and relevant scientific backgrounds. (AstraZeneca complains that PSIA personnel have no experience working for drug companies).
[14] The evidence establishes that PSIA reviewed the relevant records and made a recommendation that some of the records be disclosed, subject to third party confirmation. The Assistant Coordinator reviewed the recommendation, concurred and forwarded the documentation to the Coordinator for his approval to release subject to third party representations.
[15] There is little doubt that the Coordinator made the first decision to disclose, subject to third party representations. A notice to AstraZeneca was issued requiring its representations on the intended disclosures.
[16] Following receipt of AstraZeneca's representation, a second decision to disclose was made following receipt of PSIA's recommendations on AstraZeneca's representations. It is this second decision, signed by the Assistant Coordinator which is alleged to be without legal basis.
[17] The parties were given an opportunity to file further and better evidence and submissions on this issue particularly as there was no evidence from the Coordinator confirming that it was he who had made this ultimate decision.
[18] The Coordinator had retired by the time this case was proceeding and, even with this further opportunity, no evidence from the Coordinator was filed. The best evidence is that of the Assistant Coordinator who had no independent recollection of this particular decision but relied upon her usual and ordinary course practice in securing the Coordinator's decision. She confirms that she would have received an oral decision from the Coordinator.
[19] While a document signed by the Coordinator might have put this issue to rest, there is no legal requirement for this type of evidence. The Assistant Coordinator's evidence is sufficient, on a balance of probabilities test, to establish that the Coordinator made the decision to release the documents.
[20] The Respondent met the "best efforts" requirement in Prothonotary Aronovitch's order to permit evidence from the Coordinator and no further steps to compel evidence from him was sought.
[21] AstraZeneca also challenges the decision to disclose on the basis that, in reality, officials of PSIA made the disclosure decision because neither the Coordinator nor the Assistant Coordiantor possessed the technical expertise to assess the claims for exemption under the Act.
[22] There is nothing in the Act which prevents the decision-maker from obtaining input and recommendations from staff. Given the technical and detailed analysis involved in many access requests, to limit such input and recommendation process would effectively shut down the operation of the Act.
[23] In Cyanamid Canada Inc. v. Canada (Minister of Health and Welfare) (1992), 45 C.P.R.(3d) 390 (F.C.A.) the Court of Appeal confirmed the Trial Division's conclusion that common sense dictates that the decision-maker (in that instance, the Minister) would be guided by officials with more direct knowledge of the issues so long as the decision-maker makes the ultimate decision.
[24] The Court concludes that, in this case, the ultimate decision was made by the person with legal authority to do so and that there was nothing improper in delegating aspects of the process to PSIA or in acting upon recommendations and advice from PSIA and other officials.
[25] Therefore the decision is not a nullity.
Documents Exemption
[26] There are eleven 11 documents, consisting of approximately 275 pages, at issue and over which AstraZeneca claims exemptions. There are 4 broad categories of documents.
- Category 1; the specific selection and interpretation of the clinical trials that make up the comprehensive summary of the dyspepsia S/NDS, including data such as dates and page numbers.
- Category 2; unpublished data from clinical trials that make up the comprehensive summary of the dyspepsia S/NDS including adverse event data, and batch numbers for the drug products used;
- Category 3; information that reveals the changes and proposed changes made to the draft versions of the PM during the review process, including reviewers' comments; and
- Unsevered/Irrelevant: information which the Minister originally severed and which is not relevant to the request for information pertaining to the dyspepsia S/NDS.
CATEGORY 1 DOCUMENTS
[27] AstraZeneca claims that specific selection and interpretation of clinical trials (the results of which are public) is exempt under both paragraphs 20(1)(b) and (c). More particularly AstraZeneca relies on the claim that the regulatory approval process is confidential, that no one knows exactly how AstraZeneca used publicly available information in their submissions and that competitors will be assisted in their own regulatory processes by knowing how AstraZeneca secured its approval.
[28] In order for this information to fall within paragraph 20(1)(b), it must be information that "is not available from sources otherwise accessible by the public or could not be obtained by observation or independent study by a member of the public acting on his own". (See Air Atonabee Ltd. v Canada (Minister of Transport) 27 C.P.R. (3d) 181 and Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) [2000] F.C.J. No. 1281.
[29] Astrazeneca accepts that much of the information is in the public domain. What it says is confidential is the way in which it compiled the information.
[30] By taking publicly available information and "repackaging it", a third party cannot create a confidentiality cloak. To push the position to its further limits, if a party were to rely upon the front page of the Globe and Mail or La Presse, all of that information would be enshrouded in confidentiality.
[31] The regulatory process is not a basis for a confidentiality claim nor is the nature of the relationship between an applicant and the regulator, one which creates a requirement for and expectation of confidentiality. Information is kept confidential during the approval process because of the harm which may occur to an applicant by the premature release of information about its product - not because the system relies on confidentiality in order to operate for the government.
[32] AstraZeneca has provided no objective evidence that this type of information is, after product approval, kept confidential. There is no comparative evidence, for example from other countries with similar regimes and products, either as to the nature of the confidentiality claimed there or of the harm which is alleged to occur from disclosure.
[33] The information about dates and page numbers is not technical, scientific, financial or commercial information. It is purely administrative.
[34] AstraZeneca has failed to establish that it would suffer material harm if this information were made available. While LOSEC is an important product for AstraZeneca, there is no "materiality" threshold of harm established.
[35] In addition, the harm alleged is speculative and not of the nature which the Act was designed to protect. Firstly, knowledge about the regulatory process and how an applicant was able to secure government approval is not the third party's information. Secondly the harm alleged, that another person would secure regulatory approval more readily, fails to address the fact that each applicant and each drug is different and handled by the regulators according to its specifics. AstraZeneca provided no compelling evidence of how this harm could realistically be realized. Further, the Federal Court of Appeal rejected this "head start" argument in Cyanimid v. Canada (1992), 45 C.P.R. 380 at 403.
CATEGORY 2 DOCUMENTS
[36] AstraZeneca alleges, on the same basis as for Category 1 documents, that the information would also raise issues of adverse publicity because the information is incomplete.
[37] Much of the information under this category has been exempted (except for that which is in the public domain (except References 7 and 10)) or is purely administrative, (such as batch numbers). The information discloses nothing about the actual results of the clinical tests.
[38] For the reasons given in regard to Category 1 and based on the legal principles in AstraZeneca #1, AstraZeneca has not established that the information is exempt from disclosure. The potential problems with public relations is at best speculative (see Air Atonabee, supra).
CATEGORY 3 DOCUMENTS
[39] There are two types of information at issue. The first is that information shown on various draft PM's which was reflected in the final PM (information which did not make it into the final PM was exempted) and the second is certain reviewer's comments.
[40] The basis for exemption is the same as Categories 1 and 2. The information from the draft PM's is now in the public domain. There is insufficient evidence that this information is still confidential (if it ever was) or that any harm will be occasioned by its disclosure.
[41] As discussed in AstraZeneca #1, where the reviewer's comments does not disclose the actual confidential information, that information (subject to other applicable exemptions) may be disclosed. Reviewer's are no, per se, exempt from disclosure.
[42] AstraZeneca has not satisfied the Court that the selected information from the reviewer's comments are either confidential information or if disclosed such information will cause material harm.
IRRELEVANT/UNSEVERED DOCUMENTS
[43] This Court, in AstraZeneca #1, distinguished the decision of Cistel Technology Inc. v. Canada (Correction Services), [2002] F.C.T. 253 and referred to Canadian Tobacco Manufacturers' Council v. Canada (Minister of National Revenue), [2003] F.C. 1037.
[44] For the same reasons the Court concludes that AstraZeneca's objection on the grounds of relevancy cannot be sustained.
[45] AstraZeneca contends that the Minister, once he makes the decision to disclose, cannot change his mind and decide to release information previously held to be exempt from disclosure.
[46] The facts in this case are not similar to those in Matol Botanical International Inc. v. Canada (Minister of National Health and Welfare) (1998), 84 F.T.R. 168 (F.C.T.D.) nor did AstraZeneca rely on that authority.
[47] The circumstances of this case are similar to that in AstraZeneca #1 and for the reasons given in the Supplemental Reasons, the objection to unsevering is dismissed.
CONCLUSION
[48] For these reasons, this application to review the Minister's decision to disclose will be dismissed with costs.
(s) "Michael L. Phelan"
Judge
FEDERAL COURT OF CANADA
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1633-01
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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