Canada: Supreme Court Of Canada Considers Application Of Access To Information Act To New Drug Submissions

Last Updated: April 20 2012
Article by Julian Worsley

In Merck Frosst Canada Ltd. v. Canada (Health), 2012 SCC 3, the Supreme Court of Canada considered Merck Frosst Canada Ltd.'s ("Merck's") appeal concerning two requests made under the Access to Information Act (the "ATI Act"). The requests were with respect to information submitted by Merck to Health Canada in the course of seeking approval to market Merck's Singulair products.

Merck applied to obtain approval to market the asthma medication Singulair by filing a new drug submission ("NDS") with Health Canada in 1997. In 1999, Merck applied, with a supplementary NDS ("SNDS"), for approval of Singulair in a 4 mg dose. Both the NDS and SNDS required Merck to submit a great deal of information, including, for example, chemistry and manufacturing information, clinical studies, and investigational studies. In due course, Health Canada received access to information requests relating to both Merck's NDS and SNDS. Collectively, Health Canada identified approximately 800 pages of the NDS and SNDS that fell within the scope of the requests. Health Canada agreed to redact significant portions of both the NDS and SNDS but Merck brought this challenge in Federal Court in respect of a variety of information that Health Canada intended to disclose to the requester.

By way of background, the ATI Act provides a right of access to information in records under the control of a government institution. Under s.4 of the ATI Act, persons and corporations present in Canada can, on request, access any record under the control of a government institution. However, this right of access is qualified in, for example, subsection 20(1) of the ATI Act, which sets out exemptions relating to third party information. A third party is defined, in section 3 of the ATI Act, as a person, group of persons or organization other than the requester or a government institution. Subsection 20(1) provides that the government institution has an obligation to refuse to disclose certain categories of third party information, including:

  1. trade secrets of a third party; [and]
  2. 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;...

While the Supreme Court addressed a variety of issues in its decision, this article focuses on the Court's interpretation of the exemptions from disclosure under paragraphs 20(1)(a) and (b) of the ATI Act. As discussed below, the Supreme Court shed some light on the interpretation of these provisions.


The ATI Act does not define the term "trade secrets." Merck sought an expansive interpretation of the term "trade secrets" in the ATI Act in view of the use of that term in, for example, the Security of Information Act. However, as noted by the Supreme Court the Security of Information Act resulted from amendments to the Official Secrets Act in the wake of the September 11, 2001 attacks, and the purposes of the ATI Act and the Security of Information are significantly different.

The Supreme Court considered the meaning of the term "trade secrets" in paragraph 20(1)(a) and held that the reference to "confidential information" in paragraph 20(1) (b) suggests that the concept of "trade secrets" was meant to be a narrower concept that the general class of confidential financial, commercial, scientific or technical information set out in paragraph 20(1)(b). As held by the Supreme Court, there are four criteria that must be met by a trade secret: (1) the information must be secret in an absolute or relative sense (it is known only by one or a relatively small number of persons); (2) the possessor of the information must demonstrate that he has acted with the intention to treat the information as secret; (3) the information must be capable of industrial or commercial application; and (4) the possessor must have an interest (e.g. an economic interest) worthy of legal protection. As such, a "trade secret" for the purposes of paragraph 20(1)(a) of the ATI Act should be understood as being a plan or process, tool, mechanism or compound which possess each of the four foregoing characteristics.

Merck had asserted that over 150 pages in the NDS and 9 pages in the SNDS fell within the scope of a trade secret. However, as stated by the Supreme Court, the difficulty in this case was not about the definition of "trade secrets", but that Merck's evidence was not responsive to the records as currently redacted by Health Canada. As a result, Merck's appeal on this issue was dismissed.


The Supreme Court accepted three propositions that are well-established in the Federal Court's jurisprudence concerning paragraph 20(1)(b). First, the terms "financial, commercial, scientific or technical" must be given their ordinary dictionary meanings. Second, the case law holds that in order to constitute this type of information, the information need not have an inherent value, such as a client list might have, for example. The value ultimately depends on the use that may be made of the information, its market value will depend on the marketplace, who may want it and for what purpose, and the value may fluctuate widely over time. Third, administrative details, such as page and volume numbering, dates and location of information within the records are not scientific, technical, financial or commercial information.

As set out by the Supreme Court, Health Canada had filed a new affidavit to which was attached a more heavily redacted version of the documents that it proposed to release to the requester. However, Merck did not respond specifically to the new edited versions of the documents. In the result, Merck's appeal under paragraph 20(1)(b) was dismissed.

Ultimately, the Supreme Court held that Merck had not shown that any of the pages in issue, as redacted, contained any information exempted under paragraph 20(1)(a) or (b).
However, as stated by the Supreme Court several times in its decision, the application of each of the above principles turns on the evidence in a particular case.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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