In Canada (Minister of Health) v. Merck Frosst Canada Ltd. (2009 FCA 166), the Federal Court of Appeal (“FCA”) reversed the Federal Court (“FC”) and held the Minister of Health (“MOH”) could disclose pharmaceutical regulatory approval records to a competitor access requestor under section 4(1) of the Access to Information Act (“the Act”) without notice since none of the narrow exceptions listed in sections 20(1)(a)-(c) of the Act applied.

An access requestor requested records from the Minister of Health (“MOH”) regarding Merck Frosst Canada’s (“Merck Frosst”) New Drug Submission (“NDS”) for Singulair, a drug used in the treatment of asthma. After considering the section 20(1) exceptions, the MOH disclosed sections of the records to the requesting party without notice to Merck Frosst. The FC had held the MOH could not disclose information to an access requestor unless Merck Frosst was given notice to object since the records contained trade secrets, confidential technical information, or materials that could affect the financial or competitive position of a party.

However, the FCA found the FC’s approach was clearly contradicted by case law stressing that based on the Act’s goal of providing “a right of access to information in records under the control of a government institution,” the section 20(1) exceptions “must be limited and specific”. In addition, the FCA noted the Act gives the head of the government institution discretion as to whether notice should be given to a third party before disclosure of information.

Under the section 20(1)(a)-(c) exceptions, access to records can be denied if they contain trade secrets, confidential technical information, or information that could reasonably be expected to result in material financial or competitive prejudice. The FC ordered records containing information regarding the manufacture, analysis, control and specifications of the active substance be removed based on trade secret status, but not did provide any specific legal or evidentiary analysis. The FCA held that based on precedent a trade secret is something technical in nature that is guarded very closely and of such peculiar value to the owner that harm would be presumed by mere disclosure. There must be objective evidence presented to satisfy this test, which requires a high threshold to meet. Merck Frosst’s submissions relied on general, unsupported statements claiming the records constituted trade secrets. Similarly, the confidential information exception can only be satisfied if the responding parties provide actual direct evidence of the confidential nature of the information at issue. As Merck Frosst did not meet the burden of providing objective and specific evidence to conclude that the information were either trade secrets or confidential information, the records were not subject to the section 20(1) exemptions.