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 party. Exempted information falls into one of three categories:
- Trade secrets;
- Financial, commercial, scientific or technical information that is confidential; and
- Information, the disclosure of which, could reasonably be expected to result in material financial loss or gain, or prejudice the competitive position of the information provider.
After notice of intended disclosure is provided, the originator of the information must, if it seeks to prevent disclosure, prove on a balance of probabilities that the information falls into one of the above categories. The SCC in Merck provided the following guidelines concerning these categories.
1. Trade Secrets
The SCC's interpretation of the scope of the first category, namely trade secrets, is broader than that of the lower appellate court, essentially holding that in the context of the Act, a trade secret is a plan or process, tool, mechanism or compound which is intended to remain confidential by the party disclosing this information.
2. Confidential Financial, Commercial, Scientific or Technical Information
With respect to the second exemption category, the SCC held that it does not encompass the formatting and structure of any information or submission provided to Health Canada. Furthermore, where the submission relies on publicly available materials, such as scientific articles and studies in the public domain, then such materials are not exempted from disclosure since they are not confidential. Having said this, the SCC left the door open to situations where it is not the existence of public studies and articles that is argued as being confidential, but rather the reliance on or evaluation of these studies and articles by an innovator that is confidential. Such a determination will depend entirely on the facts of a particular case.
3. Material Financial Loss or Gain or Prejudice to Competitive Position
Finally, with respect to the third exemption, the SCC held that the party seeking to prevent disclosure of this category by Health Canada must establish a "reasonable expectation of probable harm." As a result, the possibility of harm is not sufficient to invoke this exemption. However, the SCC also noted that a party need not show on a balance of probabilities that harm will in fact occur as a result of disclosure. The appropriate standard is somewhere in between, and each case will turn on the evidence presented.
In summary, the SCC expanded the circumstances under which notice of intended disclosure must be given, and also clarified how the Act's exemptions will apply to commercially sensitive information. However, it should not be forgotten that the SCC dismissed Merck's appeal and did not overturn the Minister's unilateral decision to disclose Merck's information. Innovators will need to be wary about what they disclose to the Minister and, perhaps more importantly, how they respond to any notice of intended disclosure provided by the Minister.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.