The Federal Court has invalidated Health Canada's decision to disclose records pertaining to a veterinary pharmaceutical product, Fortekor Flavour Tabs (Fortekor), pursuant to the Access to Information Act (the Act). Health Canada defended its decision on the basis that the information contained in the records was "part of public domain information". On judicial review, the Court agreed with the applicant, Elanco Canada Limited (Elanco), that Health Canada's argument was based on unsubstantiated information, relating to different medications, with different compounds, in different jurisdictions.
Through the veterinary drug submission process, Elanco provided Health Canada with information about Fortekor. The active ingredient in Fortekor, Benazepril hydrochloride (Benazepril), is bitter-tasting and unpleasant for animals to consume. Elanco claims that the palatability and taste-masking of Benazepril is the essential selling feature of Fortekor.
Health Canada received an ATI request for information on Fortekor. It determined that Elanco's drug submissions for Fortekor were responsive. Elanco opposed the disclosure of certain information in these records on the basis that they were protected by the exceptions to disclosure in subsection 20(1) of the Act. Health Canada took the position that the information Elanco sought to protect was already in the public domain, and therefore not subject to the disclosure exemption.
Trade secrets & confidential information: "public domain" information is more than a simple word or phrase match
Under the trade secrets and confidential information exemptions (paragraphs 20(1)(a) and (b)), the Court accepted Elanco's evidence that it took the necessary steps to protect the information in the records through confidentiality agreements, and that the record contained confidential financial, commercial, scientific, or technical information. The Court also accepted Elanco's evidence that the public-domain information cited by Health Canada was not the same as the information that Elanco sought to keep confidential.
The Court further found that Health Canada inappropriately relied on foreign information, that was not for the same medication as Fortekor, to argue that the information for Fortekor was "part of the public domain". The Court held that the simple fact that a word or a phrase can be located in public domain information does not equate to Elanco's information being in the public domain.
Competitive position of a third party: threshold is reasonable expectation of probable harm
Elanco also argued that disclosure of the information would prejudice its competitive position (paragraph 20(1)(c)). The Court found that in order to qualify for this exception, Elanco had to demonstrate a reasonable expectation of probable harm. The Court accepted that Elanco had become an industry leader with Fortekor because of its investment in research and development, and that the disclosure of the record to Elanco's competitors would result in financial hardship to Elanco.
Effect of disclosure on contracts
Finally, under the contract or negotiation exemption (paragraph 20(1)(d)), the Court found that proof of harm was not necessary. The Court was satisfied that Elanco had produced the necessary evidence demonstrating that a disclosure of the record could result in serious commercial consequences and financial harm.
This case turned largely on the evidence. The Court was compelled to find in Elanco's favour based on first-hand evidence of an employee, which it preferred to Health Canada's "unsupported blanket assertions" and alleged public-domain information relating to different medications with different compounds in different jurisdictions—which the Court found not to be reliable.
The Court therefore allowed the application with costs in favour of Elanco.
The case is: Elanco Canada Limited v Canada (Health), 2019 FC 1455
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