ARCHIVED - Info Source Bulletin Number 29

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AstraZeneca Canada Inc. v. Health Canada, Minister of Health and Attorney General of Canada

Indexed as: AstraZeneca Canada Inc. v. Canada (Minister of Health)

File No.:	T-720-02[1]
Reference:	2005 FC 189
Date of decision:	February 8, 2005
Before:	Phelan J.
Sections of ATIA / PA:	Ss. 4, 6, 7, 20(1)(a), (b), (c), (d), 25, 27, 28(1)(b), 73 Access to Information Act (ATIA)

Abstract

• Decision to release properly made by ATIP Coordinator
• Third party cannot invoke irrelevancy of records as exemption from disclosure
• Information common or known in a particular industry not constituting a trade secret
• Expectation of confidentiality less where third party seeking government approval than when third party assisting government in carrying out its mandate
• Information about how regulatory approval process works is not information about a third party
• Third party's reliance on studies in the public domain not confidential information
• Meaning of "other negotiations" in para. 20(1)(d)

Issues

1. Whether the decision to release records is a nullity because it was allegedly not made by the Minister's delegate under the ATIA?
2. Whether the Minister has the jurisdiction to disclose information which is not relevant to the request for access?
3. Whether the disputed records are exempt under any of paras. 20(1)(a), (b), (c) or (d) of the ATIA?

Facts

This is an application by AstraZeneca Canada Inc. (AstraZeneca) made pursuant to s. 44 ATIA against a decision of the Minister of Health to release certain records related to AstraZeneca's New Drug Submission (NDS) for Nexium, an antacid pill, to the requester, a pharmaceutical consulting organization.

AstraZeneca raised two preliminary jurisdictional objections.

With respect to the access request process, AstraZeneca submits that the decision to release was not made by the Minister's appropriate delegate, the ATIP Coordinator, but was actually taken by the officials of the Proprietary and Scientific Assessment Information (PSIA) Division of Health Canada to whom the request was first forwarded for purposes of record retrieval and recommendations. The facts show that the documents were reviewed by the Assistant Coordinator who recommended non-disclosure with respect to certain information. The Assistant Coordinator discussed the access request with the Coordinator who agreed with the recommendations. The Coordinator's acceptance has been described as an oral decision. There was no internal document recoding that decision. The Assistant Coordinator thereupon signed the para. 28(1)(b) ATIA notice to AstraZeneca advising it of the decision to release. The Assistant Coordinator held delegated authority to sign notice of decision documents but did not have authority to make the decision.

AstraZeneca's second objection is to the effect that the Minister intended to disclose information irrelevant to the request for access.

With respect to s. 20(1), AstraZeneca claims that some of the document are trade secrets, particularly the manufacturing procedures and process validation. AstraZeneca claims para. 20(1)(b) for all the records. It argues, essentially, that the manner in which it organized the information within the NDS to obtain regulatory approval rendered the information confidential. With respect to para. 20(1)(c), AstraZeneca relies particularly on the claim that its competitors can use the information to accelerate their own regulatory submissions. Finally, AstraZeneca claims that disclosure of some of the information would interfere with negotiations with provincial authorities for the listing of Nexium on provincial formularies.

Decision

The application for judicial review is dismissed

Reasons

Issue 1 – Decision of ATIP Coordinator

The ATIA does not require the Coordinator to personally review each document and reach a conclusion on its disclosure. Such an interpretation would paralyse the operation of the ATIA. The evidence indicates that the ATIP Coordinator, in a brief discussion, accepted the recommendation of the Assistant Coordinator and therefore made the decision to disclose. In addition, the fact that the decision to disclose was significantly influenced by the recommendations of the PSIA does not impugn the decision. The ATIA could not operate, particularly in scientific and technical fields, unless those administering the Act on behalf of a particular department were able to obtain expert advice and recommendation. The Court added that, while the creation of a decision document is not required under the ATIA, such a procedure would eliminate any issue of improper delegation of decision making.

Issue 2 – Disclosure of Irrelevant Information

Neither s. 6 nor s. 7 of the ATIA import a relevancy test. To read in such a requirement would run counter to the purpose of the ATIA as set out in subs. 2(1) and to the basic right of access found in s. 4 and would add a further exemption not spelled out in the legislation. The only grounds upon which the third party can rely are those in s. 20 of the ATIA. The Court held that this was not a case where the documents were so clearly not a "record requested under the Act".

Issue 3 – S. 20(1) exemptions

Paragraph 20(1)(a)

AstraZeneca did not establish that some of the information disclosed a trade secret as that term has been defined in Société Gamma v. Canada (Secretary of State) (1994), 79 F.T.R. 42 (F.C.T.D.). Information common or known in a particular industry will not constitute a trade secret.

Paragraph 20(1)(b)

The Court, in Air Atonabee,^[2] and subsequent cases, has recognized that communications between third parties and government can be treated as confidential where the third party has treated them as confidential and to do so is in the public interest, and that confidentiality would foster a relationship between the third party and the government for the benefit of the public.

To meet this test, one must have regard to the nature of the relationship between the government and the third party. In Air Atonabee there was an element of a co-operative relationship necessary to deal with on-going technical developments. In that case, transport officials needed Air Atonabee to keep it informed of developments related to a new aircraft. In addition, certain technical personnel of the company were both employees of the company and held delegated regulatory authority from the Minister. The Court noted that the relationship in the present case is quite different. It is that of an applicant seeking government approval where co-operation is not an important factor. Parties 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 in carrying out its mandate.

Information about dates, page, volume numbering and location of information within the NDS is not scientific, technical, financial or commercial information by any objective standard. The information is purely administrative.

Information which would give insight into how government carries out its approval process is information about the operation of government, not information supplied by a third party or about a third party.

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 information supplied by the third party can the information then be assessed against the other criteria of para. 20(1)(b).

The Court rejected the reference to the concept that "but for" the company's submissions, the information would not be in the possession of government. The response to that proposition is that, "but for" the desire to seek government approval, the documents would not have been created.

Paragraph 20(1)(c)

In order for a third party to establish the "harm" test of para. 20(1)(c), it must establish "reasonable expectation of probable harm". This requires specific evidence that the outcomes specified in para. 20(1)(c) are reasonably probable.

In the present case, there was no evidence from comparative regimes dealing with the same types of information, no significant evidence of materiality of financial loss and no evidence of how a competitor would use the information to get a competing product to market because of its new found understanding of the regulatory process. There was no indication that there are competitors who wish to do so. On the other hand, there was evidence that AstraZeneca has competitors for similar products already in the market and who have already secured regulatory approval.

As a general proposition, publicly available information is not exempt information under s. 20 either as a class of documents or under the "harm" test. Compelling evidence is required to dislodge the logical conclusion that information in the public domain will be used, particularly by knowledgeable users. AstraZeneca's evidence was at best speculative.

The fact that a competitor would or could save time and expense obtaining regulatory approval for a different drug has not been established. Even if it had been established, such an argument has been rejected by the Court of Appeal in Cyanamid Canada v. Canada (Minister of National Health and Welfare) (1992), 45 C.P.R. (3d) 390 (F.C.A.).

The very fact of AstraZeneca's reliance on studies which are in the public domain was not confidential information. Information contained in such studies--and thus the studies themselves--is not confidential information. Where similar information is available in the United States, it cannot be said that the disclosure thereof will cause material harm.

Paragraph 20(1)(d)

AstraZeneca's concern under this heading was that competitors may be able to use information disclosed in "negative" marketing, particularly to influence provincial governments who must approve the listing of drugs under provincial health and pharmaceutical programs.

The process of obtaining government approval, for example at a provincial level, is not the type of negotiations to which para. 20(1)(d) refers. The expression "other negotiations" following "contractual" indicates that those parties must be in a commercial or business context. Obtaining approval for provincial formularies is more in the nature of a regulatory context.

The second criterion requires proof that negotiations could reasonably be expected to be obstructed. The fact that provincial authorities would have some further and better information on the process by which a product was approved, does not inevitably lead to the conclusion that negotiations will be obstructed or interfered with.

Comments

AstraZeneca has filed an appeal against this decision.

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