On November 7, 2023, Health Canada released its annual report on the Access to Information Act and Privacy Act, reporting on the requests for access to information that it handled between 2022-2023. A copy of the report can be found here.
Health Canada receives and reviews submissions seeking approval to market drugs, foods, and other products (e.g., through the Food and Drug Regulations, Natural Health Products Regulations, Cannabis Regulations). It regularly receives requests pursuant to the Access to Information Act seeking information from those submissions that belongs to a third party (Health Canada being the first party, and the requestor being the second party).
Pursuant to section 27 of the Access to Information Act, Health Canada will make every reasonable effort to notify the third party (i.e., the party whose information is being sought) of a request if it intends to disclose a record that contains or that it has reason to believe might contain information falling within a category listed in section 20.
Pursuant to section 20 of the Access to Information Act, Health Canada shall refuse to disclose any record requested that contains, among other things:
- trade secrets of a third party;
- financial, commercial, scientific or technical information that is confidential information supplied to a government institution by a third party and is treated consistently in a confidential manner by the third party;
- information the disclosure of which could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of, a third party; or
- information the disclosure of which could reasonably be expected to interfere with contractual or other negotiations of a third party.
The third party will have an opportunity to make representations explaining why the record or portions of the record fall into these categories and should not be disclosed. Notably, pursuant to section 25 of the Access to Information Act, Health Canada will work with the third party to determine whether any portion of the record can be severed and disclosed, even if the document contains trade secrets or otherwise exempt information.
Section 44 of the Access to Information Act allows the third party to apply to the Federal Court to challenge Health Canada’s decision to disclose a record or part of a record. The requestor will be informed of the court challenge.
In its 2022-2023 Annual ATIP Report, Health Canada summarized 12 judicial review matters handled during the reporting period, 11 of which were commenced by third parties to challenge disclosure of their records as described above. We provide an up to date summary of these third party reviews:
- Provital Health v. Canada (Minister of Health) [T-190-19], Preventous Collaborative Health v. Canada (Minister of Health) [T-189-19], Copeman Healthcare v. Canada (Minister of Health) [T-191-19]: Three private medical clinics applied in January 2019 to challenge Health Canada’s disclosure of part of their audit reports to a requestor. Health Canada obtained the audit reports from Alberta Health, which did not request that the audit reports be kept confidential. The audit reports included the annual enrollment and membership fees charged by the Applicants. These matters are ongoing. The Federal Court of Appeal (2022 FCA 153) determined as part of these proceedings that applicants under section 44 of the Access to Information Act are not entitled to the Health Canada’s “record” leading to its decision, which they would be in a traditional judicial review under section 18.1 of the Federal Courts Act and section 317 of the Federal Courts Rules.
- Jamp Pharma Corporation v Minister of Health et al [T-625-23]: JAMP applied on March 30, 2023 to challenge Health Canada’s disclosure of records relating to JAMP’s drug product, which JAMP considered confidential. The matter was discontinued on June 30, 2023.
- Elanco Canada Limited v. Canada (Minister of Health) [T-2092-17, A-468-19]: Elanco applied on December 22, 2017 to challenge Health Canada’s disclosure of records relating to Fortekor Flavour Tabs, which Elanco considered to be confidential. The Federal Court agreed with Elanco and set aside Health Canada’s decision (2019 FC 1455). Health Canada appealed, and the Federal Court of Appeal reversed and remitted the matter, finding the judgment was worded too broadly (2021 FCA 191). The matter is ongoing in the Federal Court.
- Bayer Inc. v. Minister of Health and Attorney General of Canada [T-1902-21]: Bayer applied on December 15, 2021 to challenge Health Canada’s disclosure of records, which Bayer considered confidential and alleged the disclosure could harm its competitive decision. The matter is ongoing.
- Apotex Inc. v. Minister of Health and Attorney General of Canada [T-1875-21, T-1980-21, T-132-22, T-595-22]: On December 9, 2021, December 29, 2021, January 25, 2022, and March 17, 2022, Apotex applied to challenge Health Canada’s decisions to disclose records and documents relating to Apotex’s drug products. Apotex opposed each of the disclosures on the basis that certain records were confidential, that certain records were not responsive to the requests, that Health Canada lacked procedural fairness, that Health Canada’s decision was devoid of reasons and/or that Health Canada’s delay was prejudicial. The matter in Court File No. T-132-22 is ongoing, and the others were discontinued in November and December 2022.
- Apotex Inc. v. Minister of Health and Attorney General of Canada [T-1311-19]: Apotex applied in August 2019 to challenge Health Canada’s decision to disclose records related to Apotex’s drug submission that had been withdrawn from assessment. As the submission was withdrawn, the matter concerned whether the records were already public. The matter was discontinued on August 22, 2023.
- Actial Farmaceutical S.R.L. v. Minister of Health [T-6-20, A-196-22]: On January 3, 2020, Actial applied to challengeHealth Canada’s decision to partially disclose records relating to the natural health product VSL#3. Health Canada had originally sent a notice of the request and its decision on the request to Ferring Inc., the original licensee for this product who had transferred the license to Actial. The Federal Court dismissed the review, finding that Actial did not have standing to bring the application because it was not the entity who received Health Canada’s decision, and finding that Actial had not established the records were exempt from disclosure (2022 FC 971). Actial appealed, and the Federal Court of Appeal upheld that the records were not exempt from disclosure; the Court of Appeal declined to review the standing issue as a result (2023 FCA 216).