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Federal Court blocks Health Canada from disclosing veterinary drug submission records pursuant to ATI request

On January 17, 2020, the Federal Court issued a public version of reasons that granted a judicial review application of Elanco Canada: Elanco Canada Limited v Canada (Health), 2019 FC 1455. Elanco sought an Order prohibiting Health Canada from disclosing information about FORTEKOR, a veterinary drug, pursuant to a request under the Access to Information Act (the ATIA). Generally, the Court agreed with Elanco that the records should not be disclosed as the information relied upon by Health Canada was not in the public domain: it related to different pharmaceutical formulations in different regulatory jurisdictions.

The Records at Issue

FORTEKOR is used to slow the progression of chronic heart failure in dogs and to treat chronic kidney disease in cats. However, the native form of its active pharmaceutical ingredient is bitter tasting and unpleasant for animals to consume. According to Elanco, the essential selling features of FORTEKOR are its palatability and taste-masking, which have been achieved through extensive investment in research and development.

The present judicial review is of a decision by Health Canada to release records to an unknown third party pursuant to an Access to Information (ATI) request. The records relate to Elanco’s submissions to Health Canada for approval of FORTEKOR Flavour Tabs. Elanco opposed disclosure of certain information contained in these records. To be withheld from disclosure, Elanco needed to establish, on a balance of probabilities, that the information fell under one or more of the exemptions listed in subsection 20(1) of the ATIA.

Trade Secrets

At issue was whether the information Elanco sought to protect under the trade secret exemption (ATIA, subsection 20(1)(a)) was in the public domain. Health Canada relied upon foreign and patent information in support of its position that Elanco’s information was already in the public domain. However, the Court preferred Elanco’s first-hand evidence which demonstrated that the information relied upon by Health Canada was not the same as the information in the requested records.

Confidential Information

Health Canada again argued that certain information Elanco sought to protect under the confidential information exemption (ATIA, subsection 20(1)(b)) was in the public domain, relying on information from other jurisdictions. However, the Court held that Health Canada did not offer any evidence to confirm that the information from these foreign jurisdictions was comparable and applicable to the present drug. In particular, the Court stated that “more than a simple word match” is required to rely upon information to support a position that the requested information is the same and therefore should be disclosed.

Health Canada also argued that confidentiality agreements between Elanco and its suppliers cannot supersede the right of access under the ATIA. However, the Court held that this was irreconcilable with the fact that the ATIA specifically protects confidential information provided the evidence meets the criteria outlined in subsection 20(1)(b).

Competitive Position

Health Canada argued harm must be demonstrated to qualify for an exemption under subsection 20(1)(c) of the ATIA. However, the Court affirmed that a third party relying on this exemption is only required to establish there is a reasonable expectation of probable harm; it does not need to establish harm or prejudice will in fact result from the disclosure. The Court held that Elanco provided sufficient affidavit evidence to establish a reasonable expectation of harm if this information was disclosed. In particular, the Court accepted the evidence of Elanco that it is an industry leader for this drug, that their investment in research and development is the reason and that to allow the information to be released to a competitor would result in financial harm to Elanco. Expert evidence was not required.

Contractual or Other Negotiations

While evidence about the effect on actual contractual negotiations is required, the Court held that to qualify for an exemption under subsection 20(1)(d) of the ATIA “proof” of harm is not necessary. Elanco filed evidence that its supplier information is protected by contractual agreements and confidentiality provisions that prohibit it from disclosing the existence and details of its relationship with these suppliers. The Court was satisfied that Elanco had produced all evidence that was possible to produce in the circumstances and held this information is entitled to protection under subsection 20(1)(d).

Summary

While Elanco provided first-hand evidence from an employee, the Court held that Health Canada made “unsupported blanket assertions” and relied upon public domain information that related to different medications with different compounds in different jurisdictions, which was unsubstantiated and not reliable. In view of its assessment of the evidence offered by the parties, the Court allowed the judicial review and declared Health Canada’s decision to disclose the requested records invalid. The Minister has appealed.