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Isabel Raasch
Supreme Court of Canada Limits Health Canada's ability to Disclose Commercially Sensitive Information
By: Anastasia Semenova, Wendy Wagner and John Norman
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 not permitted.
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.
The decision may be found: http://scc.lexum.org/en/2012/2012scc3/2012scc3.html
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