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Health Canada (Re), 2022 OIC 52

Date: 2022-12-15
OIC file number: 5821-05041
Institution file number: A-2021-000118

Summary

The complainant alleged that Health Canada had improperly withheld information under paragraphs 20(1)(b) (confidential third-party financial, commercial, scientific or technical information) and 20(1)(c) (financial impact on a third party) of the Access to Information Act. This wasin response to an access request for two versions of a non-clinical overview of the Novavax SARS CoV-2 rS vaccine. This complaint falls within paragraph 30(1)(a) of the Act.

Paragraph 20(1)(b) was applied to withhold two versions of a non-clinical overview of Novavax’s COVID-19 Vaccine which had been supplied to Heath Canada for the purpose of seeking Canadian marketing authorization.

The OIC is satisfied that the information qualifies for exemption as it is confidential third-party financial, commercial, scientific or technical information. Furthermore, the OIC concludes that the circumstances set out in subsections 20(5) and 20(6), which would require Health Canada to reasonably exercise its discretion to decide whether to release the information, did not exist when Health Canada responded to the access request.

The complaint is not well founded.

Complaint

[1]     The complainant alleged that Health Canada had improperly withheld information under paragraphs 20(1)(b) (confidential third-party financial, commercial, scientific or technical information) and 20(1)(c) (financial impact on a third party) of the Access to Information Act. This wasin response to an access request for two versions of a non-clinical overview of the Novavax SARS CoV-2 rS vaccine. This complaint falls within paragraph 30(1)(a) of the Act.

Investigation

[2]      When an institution withholds information related to a third party, the third party and/or the institution bears the burden of showing that refusing to grant access is justified.

[3]      During the course of the investigation, the Office of the Information Commissioner (OIC) sought representations from Novavax pursuant to paragraph 35(2)(c) of the Act. Novavax maintained that the entirety of the information at issue is exempt from disclosure pursuant to paragraphs 20(1)(b) and (c) of the Act and provided detailed representations in support of this position.

Paragraph 20(1)(b): confidential third‐party financial, commercial, scientific or technical information

[4]      Paragraph 20(1)(b) requires institutions to refuse to release confidential financial, commercial, scientific or technical information provided to a government institution by a third party (that is, a private company or individual, but not the person who made the access request).

[5]      To claim this exemption, institutions must show the following:

  • The information is financial, commercial, scientific or technical.
  • The information is confidential.
  • The third party supplied the information to a government institution.
  • The third party has consistently treated the information as confidential.

[6]     When these requirements are met, and the third party to whom the information relates consents to its disclosure, subsection 20(5) requires institutions to reasonably exercise their discretion to decide whether to release the information.

[7]     In addition, when the requirements are met, subsection 20(6) requires institutions to reasonably exercise their discretion to decide whether to release the information for public health or public safety reasons, or to protect the environment, when both of the following circumstances exist:

  • disclosure of the information would be in the public interest; and
  • the public interest in disclosure clearly outweighs any financial impact on the third party, any prejudice to the security of the third party’s structures, networks or systems, or competitive position, or any interference with its contractual or other negotiations.

[8]     However, subsections 20(2) and 20(4) specifically prohibit institutions from using paragraph 20(1)(b) to refuse to release information that contains the results of product or environmental testing carried out by or on behalf of a government institution, unless the testing was done for a fee for an individual or organization other than a government institution.

Does the information meet the requirement of the exemption?

[9]      Paragraph 20(1)(b) was applied to withhold two versions of a non-clinical overview of Novavax’s COVID-19 Vaccine which had been supplied to Heath Canada for the purpose of seeking Canadian marketing authorization.

[10]    Regarding the first requirement, in the decision Merck Frosst Canada Ltd. v Canada (Health),2012 SCC3, the Supreme Court of Canada stated that the terms “financial, commercial, scientific or technical” should be given their ordinary dictionary meanings. The OIC accepts that the information at issue consists of scientific or technical information.

[11]    Regarding the second requirement, in order for paragraph 20(1)(b) to be applied, the record must be confidential. In Air Atonabee Limited v. Canada(1989), 27 F.T.R. 194 (F.C.T.D), the Federal Court outlined three specific sub-criteria, each of which must be met, for the information to be considered confidential:

  • the information is not otherwise available from public sources;
  • the information originates and is communicated in a reasonable expectation of confidence that it will be not disclosed; and
  • the relationship between the government the third party is not contrary to the public interest and will be fostered for public benefit by keeping the information confidential.

[12]    The information in question was not publicly available at the time Heath Canada responded to this access request, however, some articles citing information in Novavax’s non-clinical overview appear to have been made public since then. As noted in the Information Commissioner’s guidance, when investigating a complaint from someone who was refused access to a record under the Act, the OIC reviews the institution’s decision to apply any exemptions to withhold information at the time the decision was made. (Change of circumstances, including the passage of time (oic-ci.gc.ca)).

[13]    In addition, Novavax asserts that materials filed in a new drug submission are considered proprietary confidential information particularly where the drug is not yet approved. In light of the above, the OIC accepts that the information, at the time the request was processed, would have been pending approval for use in Canada, and been communicated to Health Canada with a reasonable expectation of confidence that it would not be disclosed.

[14]    Turning to the third criterion of confidentiality, the OIC accepts that maintaining the information’s confidentiality would foster a relationship between Health Canada and Novavax for public benefit.

[15]    Regarding the third requirement of paragraph 20(1)(b), the OIC accepts that the records in question were supplied to Health Canada by Novavax.

[16]    As for the final requirement, given the purpose of the records submission to Health Canada and the circumstances in which the records were compiled and communicated, the OIC accepts that the information at issue was consistently treated as confidential by Novavax, so as to satisfy this requirement.

[17]    In light of the above, the OIC accepts that, at the time the request was processed, the information at issue qualified for exemption under paragraph 20(1)(b).

[18]    Since the OIC is of the view that paragraph 20(1)(b) applied, there is no need to examine the application of paragraph 20(1)(c) to withhold the same information.

Did the institution reasonably exercise its discretion to decide whether to release the information?

[19]    Since the information met the requirements of paragraph 20(1)(b), Health Canada was required to reasonably exercise its discretion to decide whether to disclose the information when the third party to whom it relates consents to its disclosure, as per subsection 20(5).

[20]    Health Canada was also required to reasonably exercise its discretion to decide whether to disclose the information for public health or public safety reasons, or to protect the environment, when the two circumstances described in subsection 20(6) existed when it responded to the access request.

[21]    The OIC concludes that the circumstances set out in subsections 20(5) and 20(6) did not exist when Health Canada responded to the access request. Novavax did not consent to the release of any of the information at issue. In addition, the Novavax vaccine had not yet received approval for use in Canada; therefore, the public interest to disclose the information did not clearly outweigh in importance any financial loss or gain to Novavax, any prejudice to the security of its structures, networks or systems, any prejudice to its competitive position or any interference with its contractual or other negotiations.

[22]    Consequently, there is no need to further examine the issue of discretion.

Result

[23]    The complaint is not well founded.

When a complaint falls within the scope of paragraph 30(1)(a), (b), (c), (d), (d.1) or (e) of the Act, the complainant has the right to apply to the Federal Court for a review. The complainant must apply for this review within 35 business days after the date of this report. When they do not, third parties may apply for a review within the next 10 business days. The person who applies for a review must serve a copy of the application for review to the relevant parties, as per section 43.

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