Health Canada (Re), 2024 OIC 01

Date: 2024-01-24
OIC file number: 5819-03081
Institution file numbers: A-2014-00280 (EDIMS) A-2014-01444 (FLOW)

Summary

The complainant alleged that Health Canada had improperly withheld information under subsection 19(1) (personal information), paragraphs 20(1)(b) (confidential third-party financial, commercial, scientific or technical information), 20(1)(c) (financial impact on a third party) and 21(1)(a) (advice or recommendations) and section 23 (solicitor-client privilege) of the Access to Information Act in response to an access request for records related to Dukoral, excluding product monographs. The complaint falls within paragraph 30(1)(a) of the Act.

During the investigation, the complainant decided it was no longer necessary for the Office of the Information Commissioner (OIC) to investigate the application of subsection 19(1) to withhold information, or any information about the production process or composition of Dukoral.

The institution and the third party did not demonstrate that all of the information withheld under paragraphs 20(1)(b) or 20(1)(c) met the requirements of these exemptions.

Certain information also did not meet the requirements of paragraph 21(1)(a), including factual information contained in emails.

The institution showed that the information withheld under section 23 met all the requirements of this exemption.

The Information Commissioner ordered that Health Canada disclose specific information withheld under paragraphs 21(1)(a), 20(1)(b) and 20(1)(c).

Health Canada gave notice that it would be implementing the order.

The complaint is well founded.

Complaint

[1] The complainant alleges that Health Canada had improperly withheld information under subsection 19(1) (personal information), paragraphs 20(1)(b) (confidential third-party financial, commercial, scientific or technical information), 20(1)(c) (financial impact on a third party) and 21(1)(a) (advice or recommendations) and section 23 (solicitor-client privilege) of the Access to Information Act in response to an access request for records related to Dukoral, excluding product monographs.

[2] During the investigation, the complainant decided it was no longer necessary for the Office of the Information Commissioner (OIC) to investigate the application of subsection 19(1) to withhold information or any information about the production process or composition of Dukoral.

Investigation

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

[4] During the investigation, the OIC came to the preliminary view that exemptions were not properly applied to withhold the information at issue. As such, the OIC sought representations from Health Canada and the Valneva.

[5] Valneva agreed to the additional disclosure of dates throughout the document. It also agreed to the disclosure of draft carton labels and package inserts, lists of publicly available references, company core safety information and parts of Health Canada’s screening and comprehensive review of regulatory submissions. The pages within the scope of the complaint that Valneva agreed could be disclosed in full are pages 82-86, 429, 601-611, 635-638, 796-797, 804-806, 831-850, 958-970, 973-981, 1008-1013, and 1016. Valneva further agreed to the disclosure of portions of pages 45, 53-54, 798, 829-830, and 971.

[6] Also in its representations, Valneva asserted the confidentiality of its submissions. Section 62 to 64 of the Act sets out the OIC’s confidentiality requirements and the circumstances under which I am authorized to disclose information learned in the performance my duties. The following report discloses only such information as is necessary to establish grounds for my finding and order.

[7] Health Canada indicated in its representations that it would consider the release of pages that Valneva provided consent to release, though it maintained that the information originally met the requirements of the claimed exemptions.

[8] As required by section 36.3, the OIC notified Valneva of my intention to order Health Canada to disclose portions of the information at issue. In response, Valneva re-iterated its representations made during the course of the investigation.

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

[9] 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).

[10] 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.

[11] 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.

[12] 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?

[13] Paragraph 20(1)(b) was applied to withhold information including:

Dates
Meeting agendas and specific issues
Teleconference summaries
Executive minutes
Presentation slides
Screening reviews
Health Canada memorandums
Information related to notifiable changes
Composition information (including non-medicinal ingredients))
Certified product information document
Certificate of analysis
Reasons for submission of Drug Notification Form
Submission certification
Periodic Safety Update Reports, appendices and associated records, including Health Canada review

[14] As noted above, information about the production process and the composition of Dukoral is not at issue in this complaint.

[15] I accept that most of the withheld information is financial, commercial, scientific or technical, meeting the first criterion. Administrative details, such as dates or location of information within the records, however, do not meet this criterion (see AstraZeneca Canada Inc. v. Canada (Minister of Health), 2005 FC 189, para. 73 (AstraZeneca)). Valneva agreed in its representations that the dates could be disclosed.

[16] Regarding the second criterion, 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 not be disclosed; and
the relationship between the government and the third party is not contrary to the public interest and will be fostered for public benefit by keeping the information confidential.

[17] Some of the information that was withheld appears to have been publicly available at the time the request was processed. This information includes a list of adverse reactions and a list of published cases. As noted by the Supreme Court of Canada: “the simple reference to a publicly available study or a description of its contents in a submission generally is not confidential information” (Merck Frosst Canada Ltd. v. Canada (Health), 2012 SCC 3, para. 149 (Merck Frosst)). In the present instance, neither Health Canada nor Valneva has established that because of the context in which the information appeared, this type of information could not be considered publicly available. Valneva also agreed that this information could be disclosed. As a result, for some of the information at issue, the first requirement for confidentiality has not been met.

[18] It has also not been demonstrated that all of the information withheld under paragraph 20(1)(b) was provided to Health Canada with a reasonable expectation of confidence that it would not be disclosed. As noted by the Federal Court:

“[p] arties seeking government approvals, just as parties seeking government funds or contracts, cannot expect the same degree of confidentiality as a party who is assisting government. This is particularly the case where the approvals relate to people’s health and physical well being.” (see AstraZeneca, para. 76).

[19] The fact that some of the records were marked confidential also does not necessarily establish that the information originated and was communicated with a reasonable expectation of confidence that it would not be disclosed (see Brookfield Lepage Johnson Controls Facility Management Services) v. Canada (Minister of Public Works and Government Services), 2003 FCT 254, paras. 12-19, affirmed in 2004 FCA 214). As a result, I am not satisfied that the second requirement for confidentiality is met for the information at issue.

[20] With respect to the third requirement for confidentiality, I am not convinced that the information was communicated within the context of a relationship fostered for public benefit by the communication’s confidentiality.

[21] In light of all of the above, I am not satisfied that all three requirements for confidentiality have been met for all of the information at issue.

[22] Turning to the third requirement for paragraph 20(1)(b) to apply, while it appears that Valneva supplied much of the information in question to a government institution pursuant to the Food and Drugs Act, any information created by Health Canada and its representatives does not meet this criterion. This includes reviews by Health Canada, minutes prepared by Health Canada, or comments provided by Health Canada. As stated in AstraZeneca, at para. 74:

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.

[23] Turning to the final criterion paragraph 20(1)(b) to apply, given the purpose of the records submission to Health Canada, the circumstances in which the records were compiled and communicated, and the representations provided by Valneva, I accept that the information at issue was consistently treated as confidential by Valneva, so as to satisfy this requirement.

[24] As outlined above, it has not been shown that all of the information meets the first, second and third criteria for the exemption. Consequently, I conclude that not all of the information meets the requirements of paragraph 20(1)(b).

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

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

[26] 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.

[27] 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.

[28] 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.

[29] 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.

[30] 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?

[31] Paragraph 20(1)(c) was applied to withhold the same information that was withheld under paragraph 20(1)(b), as well as some additional dates, the purpose of a teleconference, and meeting information.

[32] Paragraph 20(1)(c) requires evidence showing how disclosure could result in material financial loss to Valneva and/or harm to Valneva’s competitive position, and how likely that impact would be. Health Canada and/or Valneva must demonstrate a clear and direct connection between the disclosure of specific information and a risk of harm well beyond the merely possible (Merck Frosst, paras. 197, 206).

[33] 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).

[34] I accept Valneva’s assertion that the disclosure of portions of the information at issue, such as manufacturing information or the regulatory strategy, is likely to result in a competitor using the information to its own advantage and thereby causing competitive harm to Valneva. However, neither Valneva nor Health Canada has provided a detailed explanation demonstrating how the rest of the withheld information could reasonably be expected to result in an injury described in paragraph 20(1)(c).

[35] As noted in the analysis of paragraph 20(1)(b), some of the information that was withheld was publicly available at the time the request was processed, suggesting that the likelihood of financial or competitive harm resulting from releasing such information was small (see Merck Frosst, paras. 208-210).

[36] Regarding dates found within the record that relate to drug submissions and their outcomes, Health Canada regularly discloses this type of information on its website. I am unconvinced that disclosing this information in the records could reasonably result in the types of harm envisioned under paragraph 20(1)(c).

[37] I am similarly not satisfied that the information at issue should be withheld on the basis that it could be misconstrued or taken out of context by the public, leading to potential damage to Valneva’s reputation. In Merck Frosst, the Supreme Court of Canada determined that disclosing information that could give an inaccurate perception of a product’s safety could not, 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. The case law also makes clear that knowledge about how the regulatory process works is the type of information that the Act is intended to provide (Merck Frosst, paras. 217, 218 and AstraZeneca, para. 94). There is nothing preventing Health Canada from providing the complainant with additional explanation if it is concerned about information being misunderstood or taken out of context. Health Canada did not address the potential for misconstruction in its representations.

[38] In light of the above, I do not accept that the release of information that is publicly available, that could allegedly be misconstrued, or that provides general information about the regulatory process would cause competitive harm or financial loss.

[39] Consequently, I conclude that not all 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?

[40] Since Health Canada was of the view that the information met the requirements of paragraphs 20(1)(b) and 20(1)(c), it 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.

[41] Health Canada explained that it considered public interest when processing the records, and determined that there was no generalized public interest that would outweigh any impact on the third party.

[42] To the extent that the information does fall within paragraphs 20(1)(b) and/or (c), I conclude that the circumstances set out in subsection 20(6) did not exist when Health Canada responded to the access request. Consequently, there is no need to examine the issue of discretion.

Paragraph 21(1)(a): advice or recommendations

[43] Paragraph 21(1)(a) allows institutions to refuse to disclose advice or recommendations developed by or for a government institution or a minister.

[44] To qualify for exemption under paragraph 21(1)(a), the records that contain the information must have been created less than 20 years before the access request was made.

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

The information is advice or recommendations.
The information was created by or for a government institution or minister.

[46] When these requirements are met, institutions must then reasonably exercise their discretion to decide whether to disclose the information.

[47] However, subsection 21(2) specifically prohibits institutions from using paragraph 21(1)(a) to refuse to disclose the following:

records that contain reasons for or accounts of decisions that affect the rights of a person made by institutions when exercising discretionary powers or carrying out adjudicative functions; and
reports prepared by consultants or advisers who were not officers or employees of an institution or members of a minister’s staff at the time.

Does the information meet the requirements of the exemption?

[48] Paragraph 21(1)(a) was applied on pages 48-50, 71-73, 77-78, 81, 962 and 1425, alongside paragraphs 20(1)(b) and 20(1)(c).

[49] The records in question were created by or for Health Canada and were created less than 20 years before the access request was made.

[50] With regards to pages 48-50, 71-73, 77-78, 81, Health Canada explained which portions of each page contained advice or recommendations since the pages also contained some factual information that would not meet the criteria for paragraph 21(1)(a), as well as some third party information withheld under paragraphs 20(1)(b) and 20(1)(c). Health Canada did not explain which portions of pages 962 or 1425, if any, contain advice or recommendations.

[51] While the words “advice” and “recommendation” are not defined in the Act, the courts have provided guidance as to the meanings of these terms. The Federal Court of Appeal in Canada (Office of the Information Commissioner) v. Canada (Prime Minister), 2019 FCA 95 stated that it would appear that a “recommendation” indicates a suggested course of action, which may or may not be accepted. In contrast, “advice” does not necessarily urge a specific course of action, but may encompass a range of options with pros and cons. Courts have repeatedly held that information of a largely factual or objective nature is outside the scope of the paragraph 21(1)(a) exemption, unless the facts are inextricably linked to the advice and recommendations, or would reveal them. Furthermore, the courts have highlighted the distinction between providing “advice” and “advising” someone of a fact.

[52] Page 962 is a page containing information that appears to consist of factual responses. No representations were received to explain how these responses consisted of advice or recommendations. Page 962 is amongst the pages that Valneva agreed could be disclosed.

[53] Page 1425 is an email sent from a Health Canada employee, providing factual information. The email’s conclusion includes phrasing that further reinforces that the record did not include advice or recommendations.

[54] For pages 962 and 1425, I conclude that the information does not meet the requirements of paragraph 21(1)(a).

[55] For the remaining pages, I conclude that the information meets the requirements of paragraph 21(1)(a).

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

[56] Since Health Canada was of the view that portions of the record met the requirements of paragraph 21(1)(a), it was required to reasonably exercise its discretion to decide whether to disclose that information. In doing so, Health Canada had to consider all the relevant factors for and against disclosure.

[57] Health Canada does not have to provide a detailed analysis of each factor it considered and explain how it weighed one against the other. However, a blanket declaration that it had exercised its discretion and considered all relevant factors is not sufficient.

[58] Health Canada explained how it exercised its discretion not to disclose the information, but also expressed willingness to reconsider the application of paragraph 21(1)(a) on some pages due to the passage of time.

[59] I conclude that Health Canada considered all relevant factors when it decided not to disclose the information. Consequently, the exercise of discretion by Health Canada was reasonable.

Section 23: solicitor-client privilege

[60] Section 23 allows institutions to refuse to disclose information subject to solicitor-client privilege or the professional secrecy of advocates and notaries when the information relates to legal advice given to a client. Section 23 also allows institutions to refuse to disclose information subject to litigation privilege when the information was prepared or gathered for the purpose of litigation.

[61] To claim this exemption with regard to solicitor-client privilege, institutions must show the following:

The information consists of communication between a lawyer or notary and his or her client.
That communication relates directly to the seeking or giving of legal advice, including all the exchanges of information needed to give legal advice.
The parties intend the communication and advice to remain confidential.

[62] When these requirements are met, institutions (as the owner of the privilege) must then reasonably exercise their discretion to decide whether to disclose the information.

Does the information meet the requirements of the exemption?

[63] Section 23 was applied on pages 1422 and 1434 to withhold the majority of two emails.

[64] It is clear that these exchanges existed as part of the continuum of confidential communications between Health Canada and its legal counsel.

[65] Consequently, I conclude that the information meets the requirements of section 23.

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

[66] Since Health Canada was of the view that the information meets the requirements of section 23, it was required to reasonably exercise its discretion to decide whether to disclose the information. In doing so, Health Canada had to consider all the relevant factors for and against disclosure.

[67] In its representations, Health Canada provided an explanation of its exercise of discretion for information withheld under section 23.

[68] I conclude that Health Canada considered all relevant factors when it decided not to disclose the two emails. Consequently, the exercise of discretion by Health Canada was reasonable.

Outcome

[69] The complaint is well founded.

Order

Under subsection 36.1(1) of the Act, I order the Minister of Health to:

Disclose all of the information withheld under paragraphs 20(1)(b) or 20(1)(c) on the following pages: 19, 29, 30, 82-86, 429, 601-611, 635-638, 796-797, 804-806, 831-850, 958-970, 973-981, 1008-1013, 1425;
Disclose the portions of the following pages that Valneva agreed could be released: 45, 53-54, 798, 829-830, 971, 1114;
Disclose dates withheld under paragraphs 20(1)(b) or 20(1)(c) throughout the records;
Disclose the information on page 81 that was already released on page 87;
Disclose all of the information withheld under paragraph 21(1)(a) on pages 962 and 1425.

Initial report and notice from institution

On October 13, 2023 I issued my initial report to the Minister of Health, setting out my order.

On November 11, 2023, Health Canada gave me notice that it would be implementing my order.

I have provided Valneva with this report.

Review by the Federal Court

When a complaint falls within the scope of paragraph 30(1)(a), (b), (c), (d), (d.1) or (e) of the Act, the complainant and institution have the right to apply to the Federal Court for a review. They must apply for this review within 35 business days after the date of this report. When they do not, Valneva 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. If no one applies for a review by these deadlines, this order takes effect on the 46^th business day after the date of this report.