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Info Source Bulletin Number 28

Merck Frosst Canada & Co. v. Minister of Health

Indexed as: Merck Frosst Ltd. v. Canada (Minister of Health)

File No.:	T-90-01
Reference:	2004 FC 959
Date of decision:	July 6, 2004
Before:	Harrington J.
Sections of ATIA / PA:	Ss. 20(1)(b), (c), (d), 25, 27, 44, 74 Access to Information Act (ATIA)

Abstract

Records related to review of new drug submission
Records consisting of third party confidential information with exception of Notice of Compliance
Jurisdiction of Court under a s. 44 application

Issues

Whether the requested information is exempt from disclosure pursuant to para. 20(1)(b)
Whether some information may be severed pursuant to s. 25 of the ATIA
Whether the Court can review the head of a government institution's decision to release information without giving a s. 27 notice to the third party

Facts

This is an application for judicial review under s. 44 of the ATIA following Health Canada's decision to disclose records which the applicants claim should be exempt from disclosure on the basis of paras. 20(1)(b), (c) and (d) of the Act.

Health Canada received a request under the ATIA for access to records related to the review of Merck Frosst's New Drug Submission in connection with its newly approved and marketed asthma drug known as Singulair. The requested records consist of the Notice of Compliance, the Comprehensive Summary, the reviewers' notes and the correspondence between Health Canada and Merck Frosst regarding the review of the New Drug Submission.

The requested documents represent a total of 549 pages. Health Canada determined that 15 pages, including the Notice of Compliance, contained no confidential information (with the exception of one portion of one of these pages). Health Canada released those pages to the requester without consulting Merck Frosst.

In its review of the remaining 534 pages, Health Canada determined that there was confidential information in 32, and that there might also be other information of a confidential nature. The Department then informed the applicant about the request for information and invited it to send their written representations with respect to the reasons why the records should not be disclosed. The applicant did not convince the respondent that subs. 20(1) applied in order to allow the non-disclosure of the records. Following the Minister's decision to provide the requester with access to some of the requested information, Merck Frosst applied for a judicial review of the decision under s. 44 of the ATIA.

The applicant objected to the disclosure of any of the requested information except the Notice of Compliance.

Decision

The application for judicial review is allowed with costs. It is declared that with the exception of the Notice of Compliance, the Minister of Health's decision to provide the requester access to any part of the record it sought was invalid. The Minister was ordered not to disclose any other part of the requested record as the record in its entirety is exempt from disclosure pursuant to subs. 20(1) of the ATIA.

Reasons

Issue 1 - Whether the requested information is exempt from disclosure pursuant to para. 20(1)(b)

In the first part of his analysis, Justice Harrington looked at the issue of whether the requested information consisted of third party information. He determined that all the information requested, including the notes of reviewers either in the employ of Health Canada or retained as outside experts, was third party information.

In the second part of his analysis, the judge looked at whether the requested information was confidential. With respect to the Notice of Compliance, he decided that Health Canada was entitled to release the document to the requester without consulting Merck Frosst. In the Court's view, the Notice of Compliance is not a confidential document because everyone, competitor or not, is entitled to know whether a drug which is on the market has been approved.

Justice Harrington decided that the Comprehensive Summary is entirely exempt from disclosure because "in pith and substance" it is third party confidential information. Also, with respect to the Comprehensive Summary, the reviewers' notes and the correspondence, the Court ruled that the contents, purpose and circumstances under which the documents were compiled and communicated show that they are confidential.

Finally, the Court held that while some of the information appears to be in the public domain, the question is not really whether or not there is information in the public concerning Singulair, the question is whether the information as presented in the New Drug Submission is in the public domain. Justice Harrington decided that since the information in the records as presented was not in the public domain, confidentiality had not been lost.

Issue 2 - Whether some information may be severed pursuant to s. 25 of the ATIA

Although Justice Harrington acknowledged that some of the requested information was non confidential information, he decided that there could not be a reasonable severance of the non-exempt material from the exempt material. All that would remain would be portions of sentences which are incomprehensible.

Issue 3 - Whether the Court can review the head of a government institution's decision to release information without giving a s. 27 notice to the third party

Merck Frosst requested that Health Canada's decision to disclose 15 pages without giving a s. 27 notice be also reviewed by the Court. Health Canada objected to this decision being reviewed on the ground that a s. 44 application is triggered by notice given by the head of a government institution to a third party. The judge did not agree with Health Canada and held that the Department should not have disclosed part of the requested records without first giving a s. 27 notice to Merck Frosst. In Justice Harrington's view, s. 44 cannot be ousted because a notice which was not given should have been given.

Comments

The decision was reversed by the Federal Court of Appeal: 2005 FCA 215.