Balancing Interests In Drug Submissions To Health Canada: Confidentiality Versus Disclosure

When an innovator pharmaceutical company files a New Drug Submission (NDS) or a Supplementary New Drug Submission (SNDS) with Health Canada, it may be forgiven for thinking that its submission will be held in confidence. Innovator submissions typically contain valuable and commercially sensitive information, such as manufacturing processes, and competitors may request disclosure of the submission pursuant to the Access to Information Act (the Act). This article explores recent law that describes what may happen after such a request is made.

The general rule under the Act is that the government must disclose information, such as information in a submission, to the requesting party. However, there are exemptions that protect confidential information submitted by a party. These exemptions are found under section 20(1) of the Act. Recently, the Supreme Court of Canada (SCC), in Merck Frosst Canada Ltd. v. Canada (Health), 2012 SCC 3, ruled on the scope of the exemptions under the Act.

In Merck, one of Merck's competitors made a request under the Act for disclosure of Merck's NDS and SNDS relating to the drug SingulairR. Health Canada refused to disclose some documents while disclosing others without providing notice to Merck, and requested that Merck make submissions as to why the remaining set of documents should not be disclosed to the requesting party. Merck took the position that none of the documents, including those already provided to their competitor, should be disclosed, as they are exempted under the Act. This led Merck to bring a judicial review of Health Canada's decision, which Merck eventually appealed up to the SCC.

The SCC first considered the circumstances under which notice of an intention to disclose information must be provided to the party that submitted the information. In this regard, the SCC interpreted section 27 of the Act, and held that the government may disclose information without providing notice only in clear cases where, after reviewing all of the evidence, it concludes that there is no reason to believe that the information to be disclosed falls under one of the section 20 exemptions. Such a high threshold should help to ensure that, as a standard practice, confidential information is not disclosed without providing notice to the originator of that information.

The SCC then dealt with the exemptions under section 20(1) of the Act which outline the types of information that cannot be disclosed to a requesting...