Info Source Bulletin Number 30

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Janssen-Ortho Inc. v. Minister of Health

Indexed as: Janssen-Ortho Inc. v. Canada (Minister of Health)

File Nos.:	T-2201-00
References:	2005 FC 1633
Date of decisions:	July 14, 2005
Before:	Simpson J.
Sections of ATIA / PA:	Ss. 19(1), 19(2), 20(1)(b), 20(1)(c), 25 and 44 Access to Information Act (ATIA); s. 3(i) Privacy Act (PA)

Abstract

• S. 44 ATIA judicial review against decision to disclose third party's records regarding a medication withdrawn from the Canadian market following a number of adverse drug reaction reports
• Names of third party's employees personal information
• Third party's references to published studies it considers reliable protected under para. 20(1)(b)
• Lack of evidence regarding confidentiality of adverse reaction reports
• Whether passage of time may result in loss of confidentiality and commercial nature of information to be determined on a case-by-case basis
• Para. 20(1)(c) harm contemplates harm to third party, not to the "public interest"
• "Material financial loss" not covering litigation costs and damage awards

Issues

(1)     Should the information contained in the third party's records be exempted from release pursuant to subs. 19(1) ATIA as constituting personal information of the employees of Janssen-Ortho Inc.?

(2)     Should the records that Health Canada seeks to disclose be exempted from release pursuant to para. 20(1)(b) ATIA?

(3)     Should the records that Health Canada seeks to disclose be exempted from release pursuant to para. 20(1)(c) ATIA?

Facts

Health Canada received a request for access which related, in part, to the discussions held in 1999 and 2000 between Health Canada and Janssen-Ortho Inc. (JOI) about the safety of Prepulsid, a medication used to treat gastrointestinal disorders, and about its withdrawal from the Canadian market. The request encompassed "briefing notes, media lines, testing, [… the department's actions in assessing prepulsid, including their knowledge of its adverse effects, other countries' actions, their review of the drug's approval and use for a decade, and consumer, users' feedback and exchanges with Janssen‑Ortho Inc., on its use, and withdrawal". After consultations with JOI, Health Canada reduced the number of records to be disclosed, but nonetheless was prepared to disclose the balance of the records on the basis that they did not qualify for exemption under the Act. JOI filed an application under s. 44 ATIA challenging the proposed disclosure by Health Canada. The records at issue were divided into the following categories: personal information; research reports (an "Appraisal Report" and a "Summary"); suspect adverse reaction reports and miscellaneous items including presentation slides and correspondence.

Decision

The application for judicial review was allowed in accordance with the reasons for judgment.

Reasons

Under s. 44 ATIA, the Federal Court is required to conduct a de novo review of the records Health Canada proposes to disclose. Exceptions to the right of access should be limited and specific and the burden of persuasion rests upon the party resisting disclosure, i.e. JOI. The standard of proof to be applied in reviewing exemptions under subs. 20(1) of the Act is that of a balance of probabilities.

Issue 1

Under subs. 19(1) ATIA, subject to subs. 19(2), the head of a government institution shall refuse to disclose any record requested under this Act that contains personal information as defined in s. 3 of the Privacy Act. No employee of JOI consented to the release of his/her name and it was not suggested that the disclosure was in accordance with s. 8 of the Privacy Act. Citing para. 3(i) of the Privacy Act, Simpson J. held that the disclosure of the JOI employees' names would reveal information about them (such as the fact that the employees attended meetings, wrote letters and authored studies regarding the drug's safety) which is not in the public domain as the public is unaware of their involvement or their opinions, suggestions and conclusions.

Issue 2

The Court adopted the approach articulated in Air Atonabee v. Minister of Transport (1989) 27 C.P.R. (3d) 180 (F.C.T.D.) regarding para. 20(1)(b) ATIA, which protects on a mandatory basis 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 is confidential if it meets the following criteria:

(a) it is not available from sources otherwise accessible by the public or that could not be obtained by observation or independent study by a member of the public acting on his or her own initiative;

(b) it originates and is communicated in a reasonable expectation of confidence that it will not be disclosed; and

(c) it is communicated, whether required by law or supplied gratuitously, in a relationship between government and the party supplying it that is either a fiduciary relationship or one that is not contrary to the public interest, and which relationship will be fostered for public benefit by confidential communication.

Issue 3

Paragraph 20(1)(c) ATIA protects on a mandatory basis 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. Both of these circumstances require a reasonable expectation of probable harm, not speculation nor mere possibility of harm.

Simpson J. applied the principles respecting the interpretation of paras. 20(1)(b) and (c) to the various categories of records.

With respect to the Appraisal Report, Simpson J. observed that the fact that the Report was a summary of other exempt documents did not automatically entitle it to an exemption under the ATIA. However, although the information in dispute was largely a description of the findings in published studies which would normally be disclosed, Simpson J. applied para. 20(1)(b) ATIA on the ground that the fact that JOI considered the findings to be accurate and trustworthy has not been publicized and would only become known through disclosure. As a result, JOI's references to published studies which JOI considered reliable were exempted from disclosure. Similarly, JOI's response report to a document prepared by Health Canada (the "Summary") constituted confidential commercial information and was to be exempted in its entirety.

Adverse drug reactions reports were to be disclosed as there was no indication that they were treated confidentially by Health Canada or JOI, thus precluding the application of para. 20(1)(b) ATIA. The documents were not marked "confidential" and there was no evidence that they were submitted in confidence to Health Canada. Moreover, there was no evidence to indicate reasonable expectation of probable harm under para. 20(1)(c) ATIA. The Court noted that the harm envisaged in para. 20(1)(c) is not a "public interest" harm but rather harm to a third party and that "material financial loss" was not intended to cover litigation costs and damage awards.

With respect to the issue of confidentiality under para. 20(1)(b), Simpson J. noted that the passage of time could affect the confidentiality of information, but that loss of confidentiality would depend on the circumstances of each case. With respect to the presentation slides, Simpson J. held that the passage of time was not relevant to the issue of confidentiality on the grounds that related litigation and drug developments were ongoing. Simpson J. rejected Health Canada's submission that since the drug had not been on the market for almost five years, the information contained in the slides could no longer be considered commercial. It was held that the passage of time had not affected the commercial nature of the information contained in the slides. In contrast, it was held that while a draft of a letter to doctors which JOI had provided to Health Canada remained confidential, it could not be protected under para. 20(1)(b) on the ground that the letter could no longer be considered commercial due to the passage of time and the specific and limited nature of the information it contained. Other categories of correspondence were protected in whole or in part.

With respect to s. 25 ATIA, Simpson J. held that the disclosure of sentences expressing courteous sentiments or conveying good wishes and gratitude did not amount to reasonable severance.

Comments

The decision has not been appealed.

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