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Info Source Bulletin Number 29

AstraZeneca Canada Inc. v. Health Canada, Minister of Health and Attorney General of Canada

Indexed as: AstraZeneca Canada Inc. v. Canada (Minister of Health)
2005 FC 645
2005 FC 646
2005 FC 647

File No.:	T-1633-01; T-1997-01; T-754-02
Reference:	2005 FC 645; 2005 FC 646; 2005 FC 647
Date of decision:	May 9, 2005
Before:	Phelan J.
Sections of ATIA / PA:	*Ss. 6, 7, 20(1)(a), (b), (c), (d), 25, 29, 73 Access to Information Act* (ATIA)**

Abstract

Irrelevancy of records not a ground for exemption under the ATIA
Jurisdiction of Minister to reverse initial decision not to disclose in two circumstances only
Information about regulatory process not third party information
Manner in which publicly available information is presented does not make that information confidential

Issues

Whether the decision to release records is a nullity because it was allegedly not made by the Minister's delegate under the ATIA?
Whether the Minister was authorized to disclose information allegedly not relevant to the request and whether he was authorized to reverse his initial decision not to disclose the information?
Whether the disputed records are exempt under any of paras. 20(1)(a), (b), (c) or (d) of the ATIA?

Facts

The third party, AstraZeneca Canada Inc. (AstraZeneca) filed three applications for judicial review under s. 44 of the ATIA against a decision of the Minister of Health to disclose certain information related to its supplementary new drug submission Losec.^[9] The records sought are the Comprehensive Summary and the Product Monograph.

AstraZeneca argues:

--That the decision of the Minister to release the records is a nullity because it was made by the Assistant Coordinator who lacked the authority to make decisions to release and in reality was made by an officer of the Proprietary and Scientific Information Assessment (PSIA) Division of Health Canada who provided recommendations with respect to the disclosure of the records;

--That the information, which it acknowledges is in the public domain, is nevertheless confidential because the way in which it compiled the information is confidential, that its reliance on public information is not public knowledge and that disclosure of the information will show how it obtained regulatory approval and will therefore advantage competitors who would then be able to secure their own approvals more rapidly;

--That the information at issue is exempt from disclosure because it is irrelevant or because the Minister could not reverse its initial decision and decide to release information which the Minister previously held to be exempt from disclosure.

Decision

The applications for judicial review were dismissed.

Reasons

Issue 1 – Decision of ATIP Coordinator

In this case the best evidence was that of the Assistant Coordinator who relied upon her usual and ordinary course practice in securing the Coordinator's decision. The Assistant Coordinator confirmed that she would have received an oral decision from the Coordinator. 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 was sufficient, on a balance of probabilities test, to establish that the Coordinator made the decision to release the records.

There is nothing in the ATIA to prevent the decision-maker from obtaining input and recommendations from the staff. Common sense dictates that the decision-maker would be guided by officials with more direct knowledge of the issues so long as the decision-maker makes the ultimate decision: Cyanamid Canada Inc. v. Canada (Minister of Health and Welfare) (1992), 45C.P.R. (3d) 390 (F.C.A.).

The Court concluded that the ultimate decision was made by the person with legal authority to do so and that there was nothing improper in acting upon recommendations from PSIA and other officials.

Issue 2 – Disclosure of irrelevant information

For the reasons expressed in 2005 FC 189, AstraZeneca's objection on the grounds of irrelevancy as well as its objection based on the Minister's lack of authority to reverse its initial decision not to disclose were not sustained.

Issue 3 – S. 20(1) exemptions

Taking publicly available information and "repackaging" it does not cloak the otherwise publicly available information with confidentiality. The regulatory process is not a basis for a confidentiality claim nor is the nature of the relationship between the third party and the regulator, one which creates a requirement for an expectation of confidentiality. Information is kept confidential during the drug approval process not because the system relies on confidentiality for government to operate but because of the harm which may ensue from the premature release of the information.

Knowledge about the regulatory process and how an applicant was able to secure government approval is not the third party's information. Further, the FCA rejected the "head start" argument in Cyanamid, supra.

The information about dates, page numbers and batch numbers is not technical, scientific financial or commercial information. It is purely administrative information.

Information which is common knowledge or in the public domain by virtue of being released in the Product Monograph is not confidential.

Reviewers' comments are not exempt from disclosure unless they disclose the actual confidential information.

Information about the names of companies and what they do is readily observable. To perform certain of their activities, Health Canada issues licences and licence information is available on Health Canada's website.

AstraZeneca failed to establish that the practice in the United States and the information publicly available in that country with respect to its drug is significantly different from the information at issue here.

The mere assertion of a trade secret is not sufficient to conclude that a trade secret exists.

Comments

The third party is appealing.