Federal Court of Canada Considers the Confidentiality of a New Drug Submission

In Merck Frosst Canada & Co v The Minister of Health Canada [2004 FC 956], the Federal Court of Canada recently considered the accessibility of information contained in a New Drug Submission under the Access to Information Act ("AIA"), the primary legislation by which the public can seek disclosure of information held by the federal government. The New Drug Submission in question had been filed by Merck Frosst Canada & Co (Merck) in connection with its asthma drug, SINGULAIR. Following SINGULAIR's approval and availability on the market, Health Canada received a request by one of Merck's competitors under the AIA for access to the records related to Merck's New Drug Submission, including the Notice of Compliance, the Comprehensive Summary (a key part of a New Drug Submission), the notes made by Health Canada's reviewers and the correspondence between Health Canada and Merck Frosst. Health Canada notified Merck that it intended to disclose and in fact had disclosed some of the requested records; however, it first sought Merck's view whether some of the remaining information was third-party information which was exempt from disclosure. Subsections 20 (1)(a) to (d) of the AIA specify four circumstances under which third-party information may be exempt from disclosure. The primary provision under consideration was subsection 20(1)(b) which exempts information which is confidential information and which is of a financial, commercial, scientific or technical nature and is supplied to a government institution by a third party - a third party which has consistently treated the information in a confidential manner. Merck and the Minister were unable to reach an agreement on disclosure and, following the Minister's formal decision to provide the requester with access to some of the requested information, Merck brought an application for judicial review of the decision in the Federal Court, Trial Division. The Court held that the Notice of Compliance was not confidential and, therefore, Health Canada was entitled to release it to the requester. However, the Court found that each of the Comprehensive Summary, the reviewers' notes and the correspondence between the parties was confidential, and therefore all were exempt from disclosure. The fact that the some of the information appeared to be in the public domain was not determinative. The issue as framed by the Court was not whether there was information in the public domain concerning SINGULAIR, but whether the information as presented in the New Drug Submission was in the public domain. Since the information in the records as presented was not in the public domain, confidentiality had not been lost. Although the Court acknowledged that some of the information at issue was not exempt from disclosure, it held that there could not be a reasonable severance of the non-exempt material from the exempt material. Segments of sentences were all that would remain following the severance of non-exempt material from the exempt material, and while the remaining segments were incomprehensible to the Court, the information might be understood by the requestor. For the full text of the decision, visit: http://decisions.fct-cf.gc.ca/fct/2004/2004fc959.shtml. Summary by: Lenni Carreiro