Health Canada (Re), 2026 OIC 43

Date: 2026-05-08
OIC file number: 5824-02216
Access request number: A-2024-000366

Summary

The complainant alleged that Health Canada had improperly withheld information under paragraph 20(1)(a) (third-party trade secrets), paragraph 20(1)(b) (confidential third-party financial, commercial, scientific or technical information) and paragraph 20(1)(c) (financial impact on a third party) of the Access to Information Act in response to an access request for records related to the Issue Analysis Summary that was addressed in Inquiry of Ministry Q-2670. This allegation falls under paragraph 30(1)(a).

Neither Health Canada nor the third party established that the requirements of the exemptions were met for certain information.

The Information Commissioner ordered Health Canada to disclose specific information, including administrative details, information supplied by the government and any other information that is not financial, commercial, scientific or technical. Health Canada gave notice to the Commissioner that it would comply with the order. The complaint is well founded.

Complaint

[1]The complainant alleged that Health Canada had improperly withheld information under paragraph 20(1)(a) (third-party trade secrets), paragraph 20(1)(b) (confidential third-party financial, commercial, scientific or technical information) and paragraph 20(1)(c) (financial impact on a third party) of the Access to Information Act in response to an access request for records related to the Issue Analysis Summary that was addressed in Inquiry of Ministry Q-2670. This allegation falls under paragraph 30(1)(a).

Investigation

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

[3]The OIC sought representations from Pfizer Canada Inc. (Pfizer) pursuant to paragraph 35(2)(c) of the Act.

[4]Pfizer asserted that the withheld information should not be released.

[5]Health Canada conceded that certain information withheld under paragraphs 20(1)(a), 20(1)(b) and 20(1)(c) would not meet the requirements for exemption.

[6]Since no representations were received on the conceded information, the OIC notified Pfizer pursuant to subsection 36.3(1) of my intention to order Health Canada to disclose this information with other information that did not meet the requirements for exemption. Pfizer provided additional representations, which I have considered.

[7]I have also considered the representations received from Health Canada and the complainant in coming to my conclusions.

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

[8]Paragraph 20(1)(b) requires institutions to refuse to disclose 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).

[9]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.

[10]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 disclose the information.

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

Does the information meet the requirements of the exemption?

[12]Health Canada applied paragraph 20(1)(b) concurrently with paragraphs 20(1)(a) and 20(1)(c) to partially withhold information on pages 1-5. The information that is the subject of this complaint consists of Chemistry and Manufacturing (C&M) information and references to a specific sequence.

[13]Paragraph 20(1)(b) requires representations from the parties resisting disclosure that demonstrate all four requirements of the exemption are met for the specific information being withheld.

Is the information financial, commercial, scientific and/or technical?

[14]In the decision Merck Frosst Canada Ltd. v. Canada (Health), 2012 SCC 3 (Merck), the Supreme Court of Canada stated that that the terms “financial, commercial, scientific or technical” should be given their ordinary dictionary meanings.

[15]I accept that most of the withheld information is scientific and technical, meeting the first requirement. The following information, however, does not meet this requirement:

Withheld information on pages 1-2 the headings under “Event” and “Issue”; and
Administrative details on pages 2-3 (see AstraZeneca Canada Inc. v. Canada (Minister of Health), 2005 FC 189, para. 73).

[16]Pfizer did not provide any representations explaining how this information is financial, commercial, scientific or technical. Health Canada agreed that this information does not meet the requirements of paragraph 20(1)(b).

[17]I conclude that the withheld information meets the first requirement of paragraph 20(1)(b), apart from the information described above.

Is the information confidential?

[18]In order for paragraph 20(1)(b) to apply, the information must be objectively confidential. In Air Atonabee Ltd. v. Canada (Minister of Transport), 1989 CanLII 10334 (FC) (Air Atonabee), 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 with a reasonable expectation of confidence that it will not be disclosed; and
the relationship between the government and third party is not contrary to the public interest and will be fostered for public benefit by keeping the information confidential.

Is the information publicly available?

[19]I am satisfied that the information was not publicly available and that disclosure of any withheld information would reveal more than what is public.

[20]The complainant provided representations claiming that all of the information withheld under paragraph 20(1)(b) should be disclosed by virtue of being public.

[21]Having performed a thorough search of publicly available information, including sources pointed to by the complainant, I find that no further severance would have been reasonable without revealing more than what is publicly known. I do not find that the information that remains at issue is publicly available.

[22]Considering the foregoing, I conclude that the information meets the first condition for confidentiality.

Was the information communicated with a reasonable expectation of confidentiality?

[23]Regarding the second condition for confidentiality, for information to be confidential by an objective standard, there must also be a reasonable expectation of confidence that the information will not be disclosed. Whether or not that reasonable expectation of confidence exists will depend on the facts, including the substance and purpose of the information and how it came to be under the government institution’s control.

[24]Pfizer stated that the information was communicated for the purpose of obtaining marketing approval in circumstances which give rise to a reasonable expectation of confidentiality. The weight given to this statement depends on the specific information at issue.

[25]I accept that much of the information is proprietary information and that Pfizer had a reasonable expectation that it would be held in confidence by Health Canada.

[26]Health Canada noted that typically no information regarding a plasmid would have been released or acknowledged. Given that such information is highly sensitive commercial information, revealing aspects of the third party’s proprietary product and processes, the OIC is satisfied that there was reasonable expectation of confidentiality on the part of the third party.

[27]Although the complainant claimed that confidentiality of any third-party information transformed into government analysis is significantly reduced, I do not find that the C&M information withheld in the records is in the form of government analysis.

[28]I conclude that that the information meets the second condition for confidentiality.

Was the relationship fostered for public benefit by maintaining confidentiality?

[29]Regarding the third condition for confidentiality, although the complainant claimed that information provided in support of regulatory authorization affecting public health carries a diminished expectation of confidentiality, I do not find that the information that remains at issue is directly related to the safety of the product. I am satisfied that the information was communicated within the context of a relationship between the third party and Health Canada that would be fostered for public benefit by the communication’s confidentiality. In Air Atonabee Ltd, the Federal Court found that the third party would be encouraged to be open and frank with inspectors if its understanding about the restricted purposes and circulation of its communications is recognized and respected.

[30]I conclude that the information at issue meets the third condition for confidentiality.

Was the information supplied by a third party to a government institution?

[31]While I accept that Pfizer supplied some of the information in question to a government institution, any information created by Health Canada and its representatives does not meet this requirement, such as:

Withheld information on pages 1-2 under the headings “Event”, “Knowledge at time of event” and “Issue”;
Portions of the last sentence withheld under the heading “Background and Issue Analysis” on page 2 excluding references to a specific promoter that was used;
Withheld information between the headings “Background and Issue Analysis” and “Appendix 1” except for the second sentence on the third line of the section; and
Administrative details on pages 2-3.

[32]As stated in AstraZeneca Canada Inc. v. Canada (Minister of Health), 2005 FC 189, at para. 74:

[33]Information which reflects government officials' viewpoints, opinions or comments is not information supplied by third parties. AstraZeneca does not have some proprietary right to knowing how the government dealt with its NDS. Only to the extent that those opinions or comments disclose the actual information supplied by the third party, the information must then be assessed against the other criterion in the Act.

[34]I find that the above-mentioned information consists of the views of Health Canada, and therefore I am not convinced that it was supplied by Pfizer.

[35]During the investigation, Health Canada agreed that much of this information would not meet the third requirement for exemption under paragraph 20(1)(b), however, maintained the application of exemption to withhold the following information:

The first sentence withheld under “Background and Issue Analysis”; and
The third sentence withheld between “Background and Issue Analysis” and “Appendix 1”.

[36]Health Canada explained that while these statements reflect in part the views of the regulator, it reflects information that was provided by Pfizer in its submission to Health Canada. Pfizer indicated that the first sentence withheld under “Background and Issue Analysis” constitutes scientific and technical information that was supplied by Pfizer to Health Canada in confidence as part of its regulatory submissions and subsequent scientific dialogue. Pfizer did not provide any additional representations explaining how the remaining information was provided by the third party.

[37]I accept that portions of the first sentence withheld under “Background and Issue Analysis” contains C&M information that was provided by Pfizer and meets the third requirement of the exemption. I also accept that severance would not be reasonable to disclose snippets of the sentence that carry no real meaning on their own.

[38]I conclude that much of the information was supplied by the third party, but certain information within the records withheld under paragraph 20(1)(b) which was created by Health Canada does not meet the third requirement of the exemption.

Has the third party consistently treated the information as confidential?

[39]As for the final requirement, I accept that the information at issue was consistently treated as confidential by Pfizer, so as to satisfy this requirement.

[40]In light of all of my analysis above, I conclude that the following information meets the requirements of paragraph 20(1)(b):

Plasmid names;
The content of Table 1;
Sequence locations;
The first paragraph withheld on page 2;
The first sentence withheld under “Background and Issue Analysis” on page 2;
Portions of the last sentence withheld under “Background and Issue Analysis” on page 2;
Portions of the third sentence withheld between “Background and Issue Analysis” and “Appendix 1”; and
The content of Appendix 1 and Appendix 2, apart from administrative details.

[41]Since this information meets the requirements for exemption under paragraph 20(1)(b), it is not necessary to analyze whether other exemptions apply to the same information.

[42]Since some information does not meet the requirements of this exemption, I examined whether Health Canada had properly applied paragraph 20(1)(a) and 20(1)(c) to withhold the same information.

Paragraph 20(1)(a): third-party trade secrets

[43]Paragraph 20(1)(a) requires institutions to refuse to disclose trade secrets that belong to a third party (that is, a private company or individual, but not the person who made the access request).

[44]To claim this exemption, institutions must show that the information is a trade secret—that is, a plan or process, tool, mechanism or compound that possesses all four of the following characteristics:

The information is secret—that is, only one or a relatively small number of people know it.
The third party intended to treat the information as secret.
The information has industrial or commercial application.
The third party has an interest worthy of legal protection (that is, an economic interest).

[45]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 disclose the information.

Does the information meet the requirements of the exemption?

[46]Health Canada initially applied paragraph 20(1)(a) concurrently with paragraphs 20(1)(b) and 20(1)(c) to withhold information described above.

[47]The information that remains at issue under paragraph 20(1)(a) is what I have not already found to meet the requirements of paragraph 20(1)(b).

[48]Paragraph 20(1)(a) requires representations from the parties resisting disclosure that demonstrate all four requirements of the exemption are met for the specific information being withheld.

Is the information secret in an absolute or relative sense?

[49]The information that remains at issue under paragraph 20(1)(a) is information originating from Health Canada, rather than Pfizer.

[50]Neither Health Canada nor Pfizer provided representations explaining how this specific information meets the requirements of paragraph 20(1)(a). Rather, most of the explanations seem to apply to the C&M information only.

[51]Regarding information withheld between “Background and Issue Analysis” and “Appendix 1” on page 2, Pfizer explained in its representations to the OIC that “the company position and future plans are confidential”. However, this information seems to consist of views of Health Canada, rather than Pfizer, and without any evidence that this information is secret in an absolute or relative sense, I cannot find that this information meets the first requirement of the exemption under paragraph 20(1)(a).

[52]Without any concrete evidence specifying the number of people that have access to the information, I cannot assume that the information is only known by a relatively small number of persons.

[53]Therefore, I must conclude that the information is not secret in an absolute or relative sense.

[54]Given that the first requirement of this exemption is not met, I conclude that the information does not meet the requirements of paragraph 20(1)(a).

Paragraph 20(1)(c): financial impact on a third party

[55]Paragraph 20(1)(c) requires institutions to refuse to disclose information that, if disclosed, could reasonably be expected to have a material financial impact on a third party (that is, a private company or individual, but not the person who made the access request) or harm its competitive position.

[56]To claim this exemption with regard to financial impact on a third party, institutions must show the following:

Disclosing the information could result in material financial loss or gain to the third party.
There is a reasonable expectation that this harm could occur—that is, the expectation is well beyond a mere possibility.

[57]To claim this exemption with regard to competitive position, institutions must show the following:

Disclosing the information could injure the competitive position of the third party.
There is a reasonable expectation that this prejudice could occur—that is, the expectation is well beyond a mere possibility.

[58]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 disclose the information.

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

Does the information meet the requirements of the exemption?

[60]Health Canada applied paragraph 20(1)(c) concurrently with paragraphs 20(1)(a) and 20(1)(b) to withhold the information described above.

[61]Paragraph 20(1)(c) requires evidence showing the financial impact disclosing the information could have on Pfizer or the harm that disclosure could cause to its competitive position, and how likely that impact would be. The parties must demonstrate a clear and direct connection between the disclosure of specific information and a risk of harm well beyond the merely possible (see: Merck supra, at paras. 197, 206).

[62]The case law under the Act makes clear that a party resisting disclosure based on paragraph 20(1)(c) bears the onus of establishing in more than just a general way that there is a reasonable expectation of a probable harm described in paragraph 20(1)(c) occurring if the information is disclosed (see: Les Viandes du Breton Inc. v. Canada (Department of Agriculture), 2000 CanLII 16764 (FC), at para 12). This requires that a party opposing disclosure demonstrate that the harm is reasonably probable and must be assessed based on facts and on the specific records at issue in an access request (see: Samsung Electronics Canada Inc. v. Canada (Health), 2020 FC 1103, at para 113).

[63]As noted in the analysis of paragraph 20(1)(b), some information was withheld that is publicly available, suggesting that the likelihood of financial or competitive harm resulting from releasing the information is small (see Merck, paras. 208‐210).

[64]During the investigation, Health Canada acknowledged that administrative details and reference to the presence of a specific sequence would not meet the requirements for exemption under paragraph 20(1)(c).

[65]Health Canada did not provide a detailed explanation demonstrating that the redacted information could reasonably be expected to result in any injury described in paragraph 20(1)(c), beyond simply stating that the interpretation of the information relating to the disclosure of the sequence is subjective.

[66]Pfizer explained in its representations that disclosing these statements could mislead stakeholders and the public, casting doubt on the scientific integrity of Pfizer’s design and manufacturing process for its products, especially when Health Canada ultimately approved Pfizer’s COVID-19 variant vaccines.

[67]I am not convinced that the information, if disclosed, could be misconstrued or taken out of context by the public, leading to potential damage to their reputation. In Merck, paras. 208-210, the Supreme Court of Canada determined that disclosing information that could give an inaccurate perception of a product’s safety cannot, except in an unusual case, give rise to the necessary reasonable expectation of harm. A refusal to disclose for fear of public misunderstanding would undermine the fundamental purpose of the Act.

[68]Consequently, I conclude that none of the information meets the requirements of paragraph 20(1)(c).

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

[69]Since some of the information meets the requirements of paragraph 20(1)(b), Health Canada was 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.

[70]Health Canada indicated that it considered the balance of potential harm to Pfizer’s competitive position against the interest of the public, namely, in the interest of public health, and determined that the benefit to disclosure greatly outweighs any potential harm. Health Canada found no safety risk related to the withheld information and determined that further disclosure of the section 20(1) exempt information would not provide benefit to public interest that would outweigh the potential harm to the third party.

[71]I conclude that the circumstances set out in subsection 20(6) did not exist when Health Canada responded to the access request. There is no need to examine the issue of discretion.

Outcome

[72]The complaint is well founded.

Orders

I order the Minister of Health to disclose the following information on pages 1-3:

Withheld information on pages 1-2 under the headings “Event”, “Knowledge at time of event” and “Issue”;
Portions of the last sentence withheld under the heading “Background and Issue Analysis” on page 2 excluding references to a specific promoter that was used;
Withheld information between the headings “Background and Issue Analysis” and “Appendix 1” excluding references a plasmid’s role in the third sentence; and
Administrative details on pages 2-3 next to Figure A1-1 and A1-2.

Initial report and notice from institution

On March 31, 2026, I issued my initial report to the Minister setting out my orders.

On April 30, 2026, Health Canada gave me notice that Health Canada would be complying with my orders.

Review by Federal Court

When an allegation in a complaint falls under 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. When the Information Commissioner makes an order(s), the institution also has the right to apply for a review. The complainant and/or institution must apply for a 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. Whoever applies for a review must serve a copy of the application for review to the relevant parties, as per section 43. If no one applies for a review by these deadlines, the order(s) takes effect on the 46th business day after the date of this report.

Other recipients of final report

As required by subsection 37(2), this report was provided to Pfizer.