On February 3, 2012, the Supreme Court of Canada released a
decision that limits Health Canada's ability to disclose an
innovator's commercially sensitive pharmaceutical product
information to competitors. The appeal from the Federal Court of
Appeal's decision in Minister of Health v. Merck Frosst
Canada Ltd. was heard on November 12, 2010. The Court accepted
BIOTECanada's (Intervener) key arguments in limiting disclosure
of commercially sensitive information. BIOTECanada was represented
by Gowlings' Tony Creber, John Norman, Wendy Wagner, Henry
Brown and Anastasia Semenova. Although the decision is a win for
innovators in general, the appeal was dismissed based on the facts
of the case.
What the Decision Means
The decision provides fundamental procedural safeguards for
innovators who must rely on the Minister to exempt from disclosure
the highly sensitive and confidential information that must be
submitted as part of the regulatory approval process. The decision
makes the Canadian regulatory system, with respect to new drug
submissions, more consistent with international agreements, such as
TRIPS and NAFTA, as well as the legislation of other jurisdictions.
The decision is particularly significant for the Subsequent Entry
Biologics (SEB) sector, where information related to even very
minor details in the manufacturing process can be of crucial value
to a competitor in attempting to replicate the final product.
Details about the Decision
The Court held that while the Minister of Health is not
automatically required to give notice to the owner of confidential
information before disclosing the information under the access to
information regime, the threshold that will trigger the obligation
to do so is fairly low. In other words, the Minister cannot
disclose pharmaceutical data without notice unless the evidence
supports the conclusion that there is no reason to believe that the
record might contain exempted material.
The Supreme Court held that the institution must give notice if
it is in doubt about whether the information is exempt. In giving
notice, the institution cannot simply shift the responsibility to
review the records onto the third party, but must make a serious
attempt to apply the exemptions by reviewing each individual record
to determine which portions may be exempted. It is also prudent for
a third party, who is generally in a better position to identify
information that falls within one of the s. 20(1) exemptions, to be
as helpful as it can be in identifying precisely why disclosure is
The Supreme Court also held the court below erred by narrowly
interpreting the meaning of "trade secret" and
"confidential information" in s. 20(1) of the Act and by
requiring an unduly onerous standard of proof to establish the
exemption. The Court noted the applicable standard of proof is the
civil standard of the balance of probabilities.
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