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Health Canada (Re), 2023 OIC 41

Date: 2023-11-22
OIC file number: 5822-01137
Institution file numbers: A-2020-001455/UM

Summary

The complainant alleged that Health Canada had improperly withheld information under paragraph 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 was in response to an access request for records regarding an Abbreviated New Drug Submission (ANDS) for the medicinal ingredient “tacrolimus”. The complaint falls within paragraph 30(1)(a) of the Act.

The scope of the complaint was limited to the dates on which specific correspondence was exchanged between a third party and Health Canada, which were withheld under paragraphs 20(1)(b) and 20(1)(c) concurrently.

Health Canada and the third party did not show that all of the requirements of paragraphs 20(1)(b) and 20(1)(c) were met.

The Information Commissioner ordered Health Canada to disclose the dates within the records. Health Canada gave notice that it would implement the order.

The complaint is well founded.

Complaint

[1]     The complainant alleged that Health Canada had improperly withheld information under paragraph 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 was in response to an access request for records regarding an Abbreviated New Drug Submission (ANDS) for the medicinal ingredient “tacrolimus”. The complaint falls within paragraph 30(1)(a) of the Act.

[2]     Specifically, the scope of the complaint is limited to the application of paragraphs 20(1)(b) and (c) to withhold the date on which a screening acceptance letter was sent by Health Canada in respect of an ANDS as well as the date the ANDS was submitted by the third party drug manufacturer (the third party) to Health Canada.

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]     The Office of the Information Commissioner (OIC) sought representations from both the third party and Health Canada pursuant to section 35 of the Act. Both parties maintain that the dates in the correspondence were properly withheld under paragraphs 20(1)(b) and (c).

[5]     The OIC also notified the third party pursuant to subsection 36.3(1) of my intention to order Health Canada to disclose the information at issue. In response, the third party re-iterated its representations made during the course of the investigation and continued to object to the disclosure of the information at issue.

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

[6]     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).

[7]     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.

[8]     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.

[9]     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.

Does the information meet the requirements of the exemption?

[10]     This exemption was applied concurrently with paragraph 20(1)(c) to redact the date on which a screening acceptance letter was sent by Health Canada in respect of an ANDS, and the date the ANDS was submitted to Health Canada.

[11]     With respect to the first criteria for the exemption to apply, the third party argues that the dates at issue consist of commercial information because they provide insight into the third party’s internal processes. Health Canada agreed to protect the dates as commercial information since this submission was under review, and this aligns with the standard within the program area.

[12]     In the decision Merck Frosst Canada Ltd. v. Canada (Health), 2012 SCC 3 (Merck Frosst), the Supreme Court of Canada agreed with the well-established jurisprudence of the Federal Court that the terms “financial, commercial, scientific or technical” should be given their ordinary dictionary meanings. The Supreme Court of Canada further recognized that administrative details such as page and volume numbering, dates, and location of information within the records do not constitute financial, commercial, scientific or technical information.

[13]     According to dictionary definitions:

  • the word “commercial” means “concerned with or engaged in commerce”, “making or intended to make a profit”;

[14]     Upon considering the records and representations received, I remain unconvinced that the dates at issue are “commercial” information, within the ordinary meaning of that term. Furthermore, neither party has demonstrated how the length of time between the two dates would reveal the third party’s commercial information when, instead, it appears to simply provide insight into the timeframe of the regulatory process.

[15]     Consequently, I am of the view that the dates on which a screening acceptance letter was sent by Health Canada and the date the ANDS was submitted to Health Canada, do not meet the criteria for the exemption under paragraph 20(1)(b).

[16]     Based on the representations received, I conclude that paragraph 20(1)(b) does not apply to the information at issue.

[17]     Since the information does not meet the requirements of this exemption, the OIC 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

[18]     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.

[19]     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.

[20]     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.

[21]     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?

[22]     This exemption was applied concurrently with paragraph 20(1)(b) to redact the date an ANDS was submitted to Health Canada and the date on which the screening acceptance letter regarding this ANDS was sent by Health Canada.

[23]     The third party, in their representations, claim that disclosure of the dates at issue will give insight into their internal processes and strategies before obtaining a Notice of Compliance. Competitors may then use this information to counter their commercial strategies and try to launch a product or obtain a marketing authorization prior to the third party.

[24]     Health Canada explains that, while their intentions are not always clear, pharmaceutical companies commonly request information about their competitors with the implied intention of using the information for their own competitive advantage. The frequency in which Health Canada receives these requests makes the likelihood of harm reasonable.

[25]     The case law under the Act makes clear that a party resisting disclosure based on paragraph 20(1)(c) bears the onus of establishing that there is a reasonable expectation of a probable harm described in paragraph 20(1)(c) occurring if the information is disclosed. (see: Merck Frosst, paras. 195, 219; Canada Packers Inc. v. Canada (Minister of Agriculture), [1989]     1 F.C. 47 (C.A.) at para. 22). This requires that a party opposing disclosure demonstrate that the harm is well beyond the merely possible or speculative (Merck Frosst, paras. 197, 206).

[26]     While both Health Canada and the third party assert that pharmaceutical competitors could use the dates within the record for their own competitive advantage, thereby causing financial and competitive prejudice to the third party, neither has provided a coherent explanation or convincing evidence showing how this information, which relates to one specific ANDS, could reasonably be expected to result in such probable harm. As observed by the court in AstraZeneca, each drug submission has its own time lines and its own issues, and, in the present instance, neither party has been able to show how the timing of this ANDS could provide insight into the third party’s general approval process in a meaningful way. The evidence presented is too speculative in nature to meet the requirements of paragraph 20(1)(c).

[27]     In support of my finding, I note that in Merck Frosst at paragraph 217, the Supreme Court indicated that “disclosure of general information such as dates, numbering and location of information within records or the manner of its presentation generally does not give rise to the necessary reasonable expectation of harm or competitive prejudice.”

[28]     The case law also makes clear that a third party cannot claim that information about how the regulatory process operates is information about it and its product, either under a class or harm’s test (AstraZeneca, para. 95). The case law further clarifies that knowledge about how the regulatory process works is the type of information that the Act is intended to provide (Merck Frosst, para. 218 and AstraZeneca, para. 94).

[29]     Based on the above, I conclude that paragraph 20(1)(c) does not apply to the information at issue.

Result

[30]     The complaint is well founded.

Order

Under subsection 36.1(1) of the Act, I order the Minister of Health to disclose the dates within the records.

On September 19, 2023, I issued my initial report to the Minister of Health setting out my intended order.

On October 31, 2023, Health Canada’s Executive Director of Access to Information and Privacy gave notice that they would be implementing my order.

The third party has been provided with this report.

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, 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. If no one applies for a review by these deadlines, this order takes effect on the 46th business day after the date of this report.

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