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Last year the Federal Court (trial division) restricted disclosure under the Access to Information Act[1] of confidential information submitted by a pharmaceutical company in connection with a New Drug Submission.  Merck Frosst Canada & Co. v. Canada (Minister of Health), 2004 FC 959 established that as long as information was not public in the same form as it appeared in the records sought under the Act, the confidentiality of the information had not been lost and the records would be exempt from disclosure.[2] Earlier this summer, the Federal Court of Appeal, in Canada (Ministre de Santé) c. Merck Frosst Canada & Co., 2005 CAF 215 (in French only), reversed the trial decision and returned the matter back to the Federal Court (trial division) for reconsideration.

In Merck Frosst, a third party requested the release of documents relating to the review of a New Drug Submission made by Merck Frosst.  In order to be exempt from disclosure under paragraph 20(1)(b) of the Act, a party must show, among other things, that the information had retained its confidentiality.[3] At the trial level, the Court determined that as long as the information was not public in the same form as it appeared in the records held by Health Canada, the confidentiality of the information was maintained.  However, the Federal Court of Appeal found that it was not appropriate to draw this conclusion.  Once information is in the public domain, it is no longer confidential notwithstanding that the form in which the information appears is different from the form of the information in the Health Canada records.  What is important is whether the information contained within a record is confidential or not.

The Court of Appeal also overturned the findings of the trial judge on the status of reviewer's notes and correspondence between Merck Frosst and Health Canada.  The Court of Appeal stated that the simple fact that the notes were created as result of the submission that had been made by Merck Frosst did not mean the information was exempt from disclosure under the Act.  The Court of Appeal observed that the notes contained certain information that had not been supplied by Merck Frosst and that the judge could not, on the basis of section 20(1)(b) of the Act, exclude the documents from disclosure.

The Court accepted the idea that the judge who had rendered the initial decision might have had another section of the Act in mind - section 20(1)(c) which does not require the confidentiality of the information to be established in order to exempt the documents from disclosure under the Act [4] - and  determined that the matter should be referred back to another judge of the trial division for reconsideration.

Practically speaking, if information is publicly available, a party will not be able to resist disclosure under the Act on the basis that the information is not in the same form in the public domain.  As always, vigilance is critical to ensure that confidential information is carefully protected by the company seeking to avoid disclosure of sensitive information under the Act and is not inadvertently disclosed to the public.

More recently, the Federal Court (trial division) has confirmed the principles applicable when a request is made for documents relating to new drug submission information.  In Astrazeneca Canada Inc. v. Canada (Minister of Health), 2005 FC 189, the Federal Court confirmed the guiding principle that establishing that commercial harm will flow in the event the information is publicly disclosed is a heavy burden and one which requires the party claiming injury to provide the Court with credible evidence establishing that harm is reasonably likely to occur.  In the words of the trial judge "the Court requires specific evidence that those outcomes are reasonably probable."  This is often the most difficult aspect for a pharmaceutical company to establish.  The trial judge in Astrazeneca further noted that evidence of how past documents were used, expert evidence on the sensitivity of the information or on the treatment of similar evidence in similar situations could be accepted as a basis for the expectation that the harm could reasonably be expected to result in the event the documents were disclosed.

At time of writing, a date for the re-hearing of the application had not been set by the Court.

The purpose of this document is to provide information as to developments in the law. It does not contain a full analysis of the law nor does it constitute an opinion of Ogilvy Renault LLP or any member of the firm on the points of law discussed.

[1]. Access to Information Act, R.S.C. 1985, c. A-1.

[2]. For an outline of the decision please see our October 2004 newsletter:  Federal Court Strengthens the Confidentiality of Information Held by Health Canada.

[3]. Section 20(1)(b) of the Act excludes from disclosure:

financial, commercial, scientific or technical information that is confidential information supplied to a government institution by a third party and is treated consistently in a confidential manner by the third party.

[4]. Section 20(1)(c) of the Act excludes from disclosure:

information the disclosure of which could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of, a third party.

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