A decision released by the Federal Court of Appeal in
Minister of Health v. Merck Frosst Canada Ltd. represents
a blow to innovative drug manufacturers under Canada's access
to information regime. The decision was released in English last
week, following an earlier publication in French issued last
The Federal Court of Appeal's decision concerns two separate
third party requests filed with the Minister of Health for the
release of information contained in drug submissions on file with
the Minister relating to Merck's drug product Singulair. In
response to these requests, the Minister disclosed certain
information without prior notification to Merck and further advised
of his intention to release other information, despite receiving
representations from Merck that the information was exempt from
release under section 20 of the Access to Information
Act1 (Act). Merck challenged the Minister's
decisions through two judicial review applications (heard by the
same judge). Though Merck was successful in the court at first
instance, both decisions were reversed on appeal.
The Court of Appeal concluded that the application judge had
erred in law in holding that prior notice must always be given
before release of third party information. The Court also rejected
Merck's arguments regarding the application of the exemptions
to disclosure set out in section 20 of the Act. As regards section
20(1)(a), the Court ascribed a very narrow meaning to the term
"trade secret" and found that Merck had failed to
establish that the information proposed to be disclosed (which
included summaries of research data, and technical details about
the manufacture, analysis, control and specifications of the active
substance and the final product) constituted trade secrets. While
the Court accepted that much of the information proposed to be
disclosed constituted scientific or technical information belonging
to Merck, it found that section 20(1)(b) of the Act was not engaged
because there was no direct and objective evidence regarding the
information's confidentiality or its treatment by Merck.
Finally, as regards section 20(1)(c) of the Act, the Court the
found that Merck had presented statements that were vague,
speculative and "silent" as to specifically how and why
disclosure of the disputed information would harm Merck.
The decision of the Court of Appeal appears to be based, at
least in part, on the Court's uncertainty about the state of
the arguments and the documents being considered for release.
Merck's arguments referred to an earlier version of the
documents, which contained additional information that had
subsequently been redacted. These arguments could not be reconciled
with the documents that the Minister was proposing to release.
The decision underscores, however, the importance of, and
confirms the challenges in, establishing that information contained
in a drug submission constitutes a trade secret or confidential
information. This decision also means that it is insufficient for
drug innovators to simply mark a drug submission or other
information submitted to the government as "Confidential"
and expect to receive prior notice of any proposed disclosure. The
decision highlights the need to present direct and objective
evidence of confidentiality, at the very least, in response to any
proposed disclosure and possibly even at the time of submitting the
information to the government.
Merck has obtained leave to appeal to the Supreme Court of
Canada and a hearing has been tentatively scheduled for later in
2010. In the meantime, companies affected by this decision may wish
to adopt a more aggressive approach in protecting their
confidential information. They will be eagerly awaiting
clarification of this area of the law by the country's highest
1. Section 20 of the Act creates certain exceptions to
the release of information, including trade secrets of a third
party (section 20(1)(a));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 (section 20(1)(b)); and
information whose disclosure 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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