AstraZeneca Canada Inc. v. Health Canada, 2005 FC 1451

                                                                                                                                  Date: 20051025

                                                                                                                               Docket: T-720-02

                                                                                                                      Citation: 2005 FC 1451

BETWEEN:

                                                  ASTRAZENECA CANADA INC.

                                                                                                                                            Applicant

                                                                           and

                                  HEALTH CANADA, THE MINISTER OF HEALTH

                                     and THE ATTORNEY GENERAL OF CANADA

                                                                                                                                      Respondents

                                        CONSOLIDATED REASONS FOR ORDER

(issued for ease of reference purposes only -

official text of each set of Reasons shall be binding

in the event of any conflict)

PHELAN J.

INTRODUCTION

[1]                This is an application by AstraZeneca Canada Inc. (AstraZeneca) pursuant to section 44 of the Access to Information Act, R.S.C. 1985, c. A-1 (the Act) in respect of a decision by the Minister of Health dated April 12, 2002, to release certain records related to AstraZeneca's new drug submission (NDS) for NEXIUM (esomeprazole magnesium trihydrate) tablets. The drug is a sophisticated antacid pill.

[2]                AstraZeneca objected to disclosure of a significant amount of information claiming exemptions (either individually or in combination) under paragraphs 20(1)(a), (b), (c) and (d) of the Act. For the most part, the issues revolve around paragraphs 20(1)(b) and (c).

[3]                Since receipt of the access request and even after the conclusion of the Court's hearing of this matter, the parties were able to winnow down the number of documents in issue and to eliminate some categories of claimed exemption. The Court has been provided with an updated version of the records in dispute.

[4]                The parties were not required to submit public versions of their Memoranda of Fact and Law. In addition, some of the very description of the types of information in issue was said to raise exempt information. As a result, and in an effort to maintain the Court's Reasons open to the public (to the maximum extent possible), the parties were permitted 14 days in which to review these Reasons to ensure that there was not an inadvertent disclosure of exempt material in these Reasons.

[5]                AstraZeneca has raised the following issues in this application:

a)          whether the decision to release records is a nullity because the decision was made by a person other than the person delegated in accordance with paragraph 28(1)(b) of the Act;

b)          whether the disputed records (those portions of the records to be released) are exempt under any of paragraphs 20(1)(a), (b), (c) or (d) of the Act;

c)         whether the Minister has jurisdiction to disclose information which is not relevant to the request.

BACKGROUND

[6]                The access request in issue, which had been modified and distilled from its original version was for:

All correspondence and reviewer's comments on the Clinical and Chemistry Manufacturing position of the New Drug Submissions for the Nexium.

[7]                Unlike most access cases, in this instance, the identity of the requester was made known. The requester, Can Reg Inc., is a pharmaceutical consulting organization. It was believed by AstraZeneca that the only reason for this access request was to obtain commercial intelligence.

New Drug Submission Process/ NEXIUM

[8]                Before a drug is placed on the market by an innovator pharmaceutical company, a New Drug Submission (NDS) must be filed by the manufacturer and reviewed by the Health Protection and Food Branch (the HPFB) of Health Canada (the Department). The NDS must comply with section C08.002 of the Food and Drug Regulations.

[9]                The Department has provided manufacturers with guidelines for the completion of a NDS. Specifically, a NDS must contain sufficient information and material to allow the Minister to assess the quality, safety, and effectiveness of the new drug. The information required to be submitted includes, inter alia, the method of manufacture, detailed reports of the tests made to establish the safety of the new drug, substantial evidence of the efficiency of the new drug, draft labelling, and a statement of all representations to be made for the promotion of the new drug.

[10]            Failure to submit an NDS in the required form would result in the non-acceptance of the NDS for review. Any modification to the format of the NDS must be approved prior to its submission.

[11]            A drug submission is typically organized into five parts comprised of:

(1)         the Master Volume, which includes the Product Monograph (the "PM") and Label;

(2)         Chemistry and Manufacturing;

(3)         The Comprehensive Summary;

(4)         Sectional Reports; and

(5)        Raw Data.

[12]            Part 3, the Comprehensive Summary, is pivotal to the review process. It comprises factual, concise descriptions of the methodology, results, conclusions and evaluation of relevant clinical studies.

[13]            The PM is a factual, scientific document on the drug product that describes the properties, claims, indications and conditions of use of the drug. It also contains any other information that may be required for the safe and effective use of the drug. The PM is a synopsis of the information provided in the Comprehensive Summary.

[14]            Once a drug is approved, the PM is available on demand to any health care provider who requests it. The PM is used to demonstrate to health care professionals and patients the conditions of use of the formulation and the effect of the drug. The core information from the PM is also published in the Compendium of Pharmaceuticals and Specialties.

[15]            The Chemistry and Manufacturing section is Part II of the NDS and sets out chemistry and manufacturing for the drug substance (i.e. active ingredient), and the dosage form for which approval is sought.

[16]            Submissions range in size from a few pages to several hundred volumes. Multi-disciplinary teams of the HPFB review all aspects of the submission in order to ensure that it supports a manufacturer's claim about a drug. During the lengthy NDS review process, extensive correspondence and other documents are exchanged between the submitting manufacturer and the HPFB.

[17]            Of particular relevance to this case is the fact that each review of a NDS is a unique and specified process, and each NDS has its own specific issues that have to be resolved in order to receive regulatory approval.

[18]            When a drug submission is found to have met the requirements of theFood and Drug Regulations, a Notice of Compliance (the NOC) is issued. The NOC permits the manufacturer to sell and market the drug in Canada according to the approved PM.

[19]            The whole process is one of seeking and obtaining the exercise of the Minister's discretion to permit a drug to be sold in Canada. Nexium is a Proton Pump Inhibitor ("PPI"), with esomeprazole magnesium trihydrate as the active ingredient. Nexium is used to inhibit gastric acid secretion, thereby reducing the amount of acid in the stomach.

[20]            On August 17, 2004, the Applicant was granted a NOC to market Nexium MUPS tablets in Canada. The Nexium MUPS tablet is a tablet comprised of very small pellets that contain the active ingredient (i.e. esomeprazole magnesium trihydrate).

[21]            The PM for Nexium had previously been disclosed, in its entirety, to another ATI requester.

[22]            There are various proton pump inhibitors sold in the Canadian market place. AstraZeneca describes the market for these types of product as highly competitive.

ACCESS REQUEST PROCESS

[23]            This access request was first forwarded to the Proprietary and Scientific Assessment (PSIA) division of Health Canada for purposes of records retrieval and review for possible disclosure. The PSIA officers recommended partial disclosure subject to third party notification to AstraZeneca which would permit AstraZeneca to make representation as to such disclosure.

[24]            AstraZeneca's submissions were reviewed by the Assistant Access to Information Co-Ordinator who agreed to recommend that some additional information also be exempted. Other requested exemptions were denied because AstraZeneca had not provided sufficient basis to justify non-disclosure.

[25]            The Assistant Coordinator discussed the access request with the Coordinator who agreed with the recommendation. The Coordinator's acceptance of the recommendation has been described as an oral decision.

[26]            There is no internal document recording this decision. The consideration of the Assistant's recommendation occurred in a 5-10 minute meeting, an admittedly short period of time for what was a voluminous record of documents.

[27]            The Assistant Coordinator signed the April 12, 2004, notice to AstraZeneca advising it of the decision to release. The Assistant Coordinator held delegated authority to sign notice of decision documents - the Assistant Coordinator does not have authority to make the decision.

[28]            AstraZeneca takes the position that there is no valid decision on this matter by the Minister's appropriate delegate, the Coordinator. The usual internal decision document was never created for this decision to release, as contrasted with the creation of a decision document recording the decision to give notice to AstraZeneca that it could make submissions on the potential release of information. AstraZeneca says that it is obvious that the actual decision to notify, and to release, and the analysis supporting that decision rested with officials of PSIA who had the requisite technical knowledge.

CLAIMED EXEMPTION

[29]            AstraZeneca claims that some of the documents (particularly Category 8) are exempt from disclosure because they include trade secrets in accordance with paragraph 20(1)(a) of the Act. The trade secrets are known to a select group of employees within AstraZeneca and its

related companies. AstraZeneca claims a significant economic interest in the information which is worthy of legal protection.

[30]            AstraZeneca also claims that the records contain confidential information pursuant to paragraph 20(1)(b) and that this exemption applied to all categories of documents. The claim is that the information is financial, commercial, scientific or technical in nature; that it is and has remained confidential, not readily observably by the public and was expected to remain confidential when supplied to the Department.

[31]            The documents are also said to be covered by paragraph 20(1)(c) as causing material financial loss and competitive prejudice. AstraZeneca relies particularly on the claim that its competitor can use the information to accelerate their own regulatory submissions. This claim covers all categories of documents.

[32]            Lastly, AstraZeneca claims exemption under paragraph 20(1)(d) in respect of category 2. It is said that disclosure of this information would interfere with negotiations with provincial authorities for the listing of Nexium on provincial formularies.

CATEGORIES OF DOCUMENTS

[33]            There were initially 10 categories of documents in dispute. There are now only 9. The categories can be summarised as below with the caveat that the description of some has been modified since even the description is said to disclose the information which is claimed to be exempt.

[34]            The categories are:

a)          Category 1 - Reference to Nexium NDS itself: since it is alleged that release would result in the disclosure of reference to dates, submission volume numbering and location of documents.

b)          Category 2 - Misdescribed Claims: The particulars of any such claim is to be found in the reviewer's notes. AstraZeneca's alleges potential interference with provincial contract negotiations and to public relations difficulties by reason of disclosure of any alleged inaccuracies found in the reviewer's notes.

c)          Category 3 - Unmarketed Formulations: This is information which refers to formulations which are not marketed in Canada. The information is alleged to fall into both paragraphs 20(1)(b) and (c).

d)          Category 4 - Unpublished Scientific Data: This category includes chemical, pre-clinical or analytical data and other scientific data supplied to Health Canada. It is alleged that competitors would learn what type of studies are needed to secure regulatory approval and other aspects of the regulatory process. It is also said that some of the information could be used by competitors to make negative comments about NEXIUM in their own promotional materials (a form of comparative advertising).

e)         Category 5 - Product Development Plans and Regulatory Strategy: The basic objection is that this information would show how the information submitted was organized within the submissions and how arguments were put forth and explained.

f)          Category 6 - Draft Product Monograph and Reviewer's Comments: AstraZeneca alleges that a skilled reader could determine how AstraZeneca had initially structured its NDS and therefore what changes were necessary to obtain regulatory approval. The reviewer's comments are said to disclose the very information which is confidential and would allow competitors to secure a product monograph more quickly and with significantly less effort.

g)         Category 7 - Manufacturing Procedures and Process Validation: This information comprises references to the quantitative composition of Nexium's product manufacturing processes, validation studies, specifications and/or test methods and developmental pharmaceutics. It is claimed that this information is a trade secret, that it is and has always been confidential and a competitor, with this information, will be able to simplify their own efforts to obtain their own product approval.

h)         Category 8 - Stability Studies: AstraZeneca claims that data relating to shelf-life and/or stability studies is a confidential class of documents and disclosure will assist competitors with their own regulatory approvals.

i)           Category 9 - Products Unrelated to Nexium: AstraZeneca says that the fact that it used particular information to support its NDS is confidential. It further says that it would disclose AstraZeneca's submission strategy and, in event, it is irrelevant to the request.

[35]            Finally, AstraZeneca had objected to the Department proposing to disclose information which it had initially agreed not to disclose. This category, along with category 7, appears no longer to be in dispute.

[36]            As the Court understands, AstraZeneca's use of the term "severed material" is intended to cover information which is not to be disclosed. However, the term "severed" in these Reasons is used in its meaning consistent with section 25 of the Act to cover information which is to be disclosed. Section 25 of the Act establishes a regime by which the document containing the exempt information is identified and then the government department is required to "sever" from the document that information which is to be disclosed.

[37]            The evidence of the department came principally from Ms. Syed, a member of PSIA. AstraZeneca challenged her qualifications to give meaningful evidence since she has never worked in the pharmaceutical industry, knows little about what it takes, or how much it costs, to prepare a new drug submission, and has exhibited lack of experience and expertise in her evidence.

[38]            AstraZeneca's evidence came from Dr. Karen Burke, Vice President of Regulatory Affairs, who holds a PhD. in Chemistry and has worked in regulatory affairs for AstraZeneca and its predecessors since 1991. There was no objective third party evidence filed by AstraZeneca in these proceedings to support the opinion evidence of Dr. Burke.

[39]            AstraZeneca asks the Court to accept Dr. Burke's evidence as more credible than that of the department's witness. However, the Court is mindful that Dr. Burke, while no doubt believing sincerely that her evidence and opinions are true and correct, is not an objective witness. Given her purported expertise, the Court should draw an adverse inference from any failure to submit evidence of a type which is relevant and would assist AstraZeneca's case.

RELEVANT PROVISIONS

[40]            AstraZeneca relies upon subsection 20(1) of the Act and on all four paragraphs which read:

[41]            Subsection 20(1) creates two types of tests for exemptions. Paragraphs (a) and (b) create a "class" test where the nature or characteristics and treatment of the information is determinative. If a document falls within the class, no further inquiry is called for.

[42]            Paragraphs (c) and (d) create a "harms" test under which the party claiming exemption must establish material financial loss or gain or prejudice to competitive position or interference with contractual or other negotiations.

[43]            In each case, the burden of proof is upon the person seeking the exemption. It must be real proof, mere recitation in an affidavit of the legal test found in the statute is not sufficient. For example, phrases such as "release of the record will cause the company material financial loss" without a clear showing of how that result might occur is of little assistance.

[44]            While paragraphs (a) and (b) do not admit to speculation, paragraphs (c) and (d) do. The standard is "could reasonably be expected". The legislation recognizes that with respect to proof of harm, the Court must engage in reasonable speculation.

[45]            Adequacy of proof of expected harm must be flexible and the Court must recognize that in many circumstances a party cannot rely on harm from past disclosures as evidence of reasonably expected harm because past disclosure of that type of evidence may never have occurred.

[46]            Recognizing the inherently speculative nature of proof of harm does not however relieve a party from putting forward something more than internally held beliefs and fears. Evidence of reasonably expected results, like forecasting evidence, is not unknown to courts and there must be a logical and compelling basis for accepting the forecast. Evidence of past documents of information, expert evidence, evidence of treatment of similar evidence or similar situations is frequently accepted as a logical basis for the expectation of harm and as evidence of the class of documents being considered.

[47]            However, each case must turn on the evidence presented. It cannot be assumed that a certain type of document will be accepted for exemption from disclosure merely because a similar document was exempt in another case.

ANALYSIS

[48]            The starting point of any analysis of the application of the Act to a given situation is the purpose clause found in subsection 2(1):

[49]            The Act has been given quasi-constitutional status along with such legislation as that governing human rights, linguistic rights and privacy. The purpose clause is both an interpretative tool and a benchmark for the application of the law to specific facts. Of particular importance in this instance is the phrase "that necessary exceptions to the right of access should be limited and specific"

[50]            The basic right of every citizen or permanent resident, set forth in section 4, is to have access to "any record under the control of a government institution". The right recognized is part of the basis entitlement of citizens in a democratic and open society to know what their government knows and what it is doing with that knowledge. (see Dagg v. Canada (Minister of Finance) [1997] 2 S.C.R. 403 at 427-428).

[51]            The principles applicable to the application of section 20 are reasonably well settled, in particular, by reference to such seminal cases asAir Atonabee Limited v. Canada (Minister of Transport) (1997) 27 FTR 194 and Canada Packers Inc. v. Canada (Minister of Agriculture) [1989] 1 FC 47.

[52]            This Court has held that there is a heavy burden on the party attempting to prevent disclosure. (See Canada (Information Commissioner) v. Canada (Prime Minister) (1992), 49 CPR (34) 79).

[53]            However, subject to limited exceptions not at issue here, the head of a government institution does not have a discretion under section 20. If the information falls within the specific description in paragraphs (1) (a) to (d), the head must refuse disclosure subject to the obligation to sever non-exempt information.

PRELIMINARY OBJECTION

[54]            AstraZeneca alleges that there has never been a proper decision to disclose and therefore the decision is a nullity. The issue hinges on whether the Access Coordinator, in reality, made the decision on disclosure.

[55]            The evidence is that the Coordinator, in a brief discussion, accepted the recommendation fo the Senior Assistant and therefore made the decision to disclose. The law 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 Act.

[56]            Further, the fact that the decision to disclose was significantly influenced by the recommendations of the PSIA does not impugn the decision. The Act 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.

[57]            Where it might be procedurally preferable to have created a second decision document, a purely internal record, there is no legal requirement to do so. Such a procedure would eliminate any issue of improper delegation of decision making.

[58]            Therefore this objection is dismissed.

DISCLOSURE OF IRRELEVANT INFORMATION

[59]            AstraZeneca raises a further jurisdictional objection that the Minister intended to disclose information which was irrelevant to the request. AstraZeneca relies upon this Court's decision in Cistel Technology Inc. v. Canada (Correction Services), [2002] FCT 253.

[60]            In Cistel, the Court made only a comment on relevancy and then dealt with the merits of the exemptions. This Court had an opportunity inCanadian Tobacco Manufacturers' Council v. Canada (Minister of National Revenue), [2003] FC 1037 to more fully consider section 6 of the Act.

[61]            Neither section 6, nor section 7 import a relevancy test. To read in a requirement to deal with relevancy would run counter to the purpose clause of subsection 2(1) and the basic right found in section 4. To read in a relevancy test in respect of disclosure would add a further exemption to disclosure not spelled out in the legislation. The only grounds upon which AstraZeneca can rely are those in section 20 of the Act. This is not a case where the documents are so clearly not "a record requested under the Act".

MINISTER'S FURTHER DECISION

[62]            This Court granted a motion for reconsideration to deal with the issue (which the Court had initially understood as no longer being in dispute) of whether the Minister had the jurisdiction to "unsever" information (disclose information) which the Minister had previously decided should be severed (not disclosed). The issue is whether the Minister can change his/her mind and disclose information which the Minister had previously decided fit within one or more of the exemptions from disclosure under section 20(1) of the Act.

[63]            During the course of this litigation under section 44 of the Act, the Respondent decided, after reviewing the affidavit of an officer of the Applicant, that certain information should now be disclosed. This decision to disclose is a reversal of the Respondent's earlier decision that this specific information was exempt from disclosure.

[64]            The information at issue is also claimed by the Applicant to fall into one or more of the ten (10) descriptive categories of documents to which section 20(1) applies.

[65]            The Applicant argues that the Minister has no jurisdiction to make a second decision to disclose and that the original decision cannot be altered during the review of the decision. It puts its case succinctly that the Minister's decision to disclose cannot be made a "moving target". The Applicant relies upon the decision of Matol Botanical International Inc. v. Canada (Minister of National Health and Welfare) (1998), 84 F.T.R. 168 (F.C.T.D.).

[66]            For the reasons given by Justice Noël in Matol, I agree that the Minister cannot initiate another disclosure process after the Minister has made the decision not to disclose some of the information requested. There must be some other triggering event provided for under the Act to allow for this additional disclosure.

[67]            The Act provides an elaborate process to deal with third party information. The Act sets up a tension between the right of the public to know and the right of a third party to keep its affairs confidential. The Act provides for two opportunities where the Minister may change the original decision or at least take a position inconsistent with the original decision.

[68]            The first is found in section 29 where the Minister may, upon recommendation of the Information Commissioner, decide to disclose information which the Minister had originally decided was exempt from disclosure.

[69]            The second is inherent to the Court review process under section 44. It has been held in such cases as Air Atonabee, 3430901 Canada Inc. v. Canada (Minister of Industry), [2001] F.C.A. 254 and Wyeth-Ayerst Canada Inc. v. Canada (Attorney General), [2003] F.C.J. No. 916 that the Court review to be conducted is a de novo review in which the standard of review is correctness.

[70]            In my view, in the context of that review, a Minister is not required to sustain all or a part of the decision which the Minister no longer believes is sustainable. The Minister is free to argue that the exemption from disclosure no longer applies to the particular information. A third party is free to make of it what they will in respect of the Minister's change of position - no doubt contending that the Minister was correct in the first place and that there is no good reason in fact, law or both, for the change of mind.

[71]            It is for the Court to decide whether the exemption from disclosure is truly applicable and whether a requester is entitled to the information.

[72]            Therefore the Minister cannot, on its own initiative, reverse itself and start the disclosure process anew with the necessary notices, representations and other procedural steps. However, the Minister cannot be forced to defend in this Court, what it now believes is, an indefensible position regarding the particular information.

[73]            In the present case, the Minister was entitled to change its position and argue that the information should be disclosed. The Minister is neither functus nor estopped and the information cannot be exempt from disclosure solely on the basis that the Minister made an earlier and different decision. The information either falls within the section 20 exemption or it does not, based upon the evidence before the Court.

[74]            The information which the Minister now says can be unsevered has been assessed against the criteria in section 20 as more fully described in other portions of the Reasons.

CLAIMS UNDER PARAGRAPH 20(1)(a)

[75]            Strayer J. (as he then was) in Société Gamma Inc. v. Canada (Secretary of State) (1994), 79 FTR 42 held that the term "trade secret" is to be given a relatively narrow interpretation. A trade secret must be something of a technical nature which is very closely guarded and is of such peculiar value to the owner of the trade secret that harm to him would be presumed from its mere disclosure.

[76]            It is not so much a question of narrow or broad interpretation as it is determining whether the information falls within the common law meaning of trade secret. Parliament intended to protect genuine trade secrets.

[77]            Health Canada's Access to Information Act Third Party Information Operational Guidelines outlines the department's view of the criteria to be met:

-            the information must be secret in an absolute or relative sense (is known only by one or a relatively small number of persons);

-            the possessor of the information must demonstrate that he has acted with the intention to treat the information as secret;

-            the information must be capable of industrial or commercial application;

-            the possessor must have an interest (eg. an economic interest) worthy of legal protection.

[78]            The type of information which could potentially fall into this class includes the chemical composition of a product and the manufacturing processes used. However, it is not every process or test which would fall into this class particularly where such process or test is common in a particular industry.

CLAIMS UNDER PARAGRAPH 20(1)(b)

[79]            In Air Atonabee this Court described the qualifications which must be established for this information to be exempt from disclosure. It must be:

a)         financial, commercial, scientific or technical information as those terms are commonly understood;

b)          confidential in its nature by some objective standard which takes account of the information, its purposes and the conditions under which it was prepared and communicated;

c)         supplied to a government by the third party; and

d)          treated consistently in a confidential manner by the third party.

[80]            While the fact that government and third parties have kept the information confidential to date is one aspect of the test, it is not determinative, nor is the fact that the records have a notation related to them that they are not to be released without the third party's permission.

[81]            The Court, in Air Atonabee 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; that confidentiality would foster a relationship between the third party and the government for the benefit of the public.

[82]            To meet this test, one must have regard for 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 relationship in this case is quite different. It is that of an applicant seeking government approval where co-operation is not an important factor. The expectation of confidentiality must be less where a third party is attempting to persuade government to grant it some concession or licence, then where the third party is assisting government in carrying out its mandate.

[83]            Health Canada has Operational Guidelines which assist third parties in understanding how the department deals with information supplied to it. AstraZeneca seeks to claim confidentially beyond that which is contained in the Guidelines. In any event, those Guidelines do not have the force of law and cannot be the basis for refusing disclosure which otherwise ought to occur. At best, the Guidelines indicate the extent of any expectation of confidentiality.

[84]            As held in Canada (Information Commissioner) v. Atlantic Canada Opportunities Agency (1999), F.C.J. No 1723 (F.C.A.) even undertakings by government (of which there are none) are not determinative of confidentiality nor can they overside the obligations under the Act.

[85]            A determination of whether the information is confidential depends on its contents, its purposes and the circumstances under which it was compiled. Information which is readily available to companies in the same business cannot objectively be confidential - nor is information which can be obtained by observation, even where some degree of effort is required. (See Cistel and Air Atonabee).

[86]            Information about page and volume numbering, dates, location of information within the records and similar administrative detail is not scientific, technical, financial or commercial information.

[87]            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.

[88]            The analysis is not necessarily assisted by 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.

[89]            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. This is particularly the case where the approvals relate to people's health and physical well being.

CLAIMS UNDER PARAGRAPH 20(1)(c)

[90]            In order for a third party to establish the "harm" test of paragraph 20(1)(c), it must establish "reasonable expectation of probable harm". As discussed earlier, while there is an element of forecasting and speculation inherent in this criterion, there are methods of establishing the reasonableness of the expectation. Mere recitation of the fear by an officer of the company is not sufficient. The Court requires specific evidence that those outcomes are reasonably probable. As Justice MacKay put the problem quite simply:

Having examined the Record and the Proposal, it is not self-evident to me from the documents themselves that the applicant, whatever may be its concerns,

has demonstrated a basis for a "reasonable expectation of probable harm". That is the standard enunciated and applied by Mr. Justice MacGuigan in Canada Packers. The applicant does not demonstrate probable harm as a reasonable expectation from disclosure of the Record and the Proposal simply by affirming by affidavit that disclosure "would undoubtedly result in material financial loss and prejudice" to the applicant or would "undoubtedly interfere with contractual and other negotiations of SNC-Lavalin in future business dealings". These affirmations are the very findings the Court must make if paragraphs 20(1)(c) and (d) are to apply. Without further explanation based on evidence that establishes those outcomes are reasonably probable, the Court is left to speculate and has no basis to find the harm necessary to support application of these provisions. (SNC-Lavalin Inc. v. Canada (Minister of Public Works), 26 CPR(3^d) 407)).

[91]            In this case, there is a singular lacking of evidence of reasonable expectation of probably harm. The drug approval regime in Canada is similar to that of many developed countries, the USA being a logical comparator. AstraZeneca is part of a multinational pharmaceutical organization dealing worldwide. However there is no evidence from comparative regimes dealing with the same types of information.

[92]            A third party is required to establish that there could be a material financial loss, yet there is no significant evidence of materiality. Given AstraZeneca's expertise in the pharmaceutical area and it's economic size and the resources available to it, the absence of such evidence is significant.

[93]            AstraZeneca claims that if a competitor knew the information at issue, it could use that information to get its own products into the market faster than AstraZeneca did. However, there is 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 is no indication that there are competitors who wish to do so. On the other hand, there is evidence that AstraZeneca has competitors for similar products already in the market and who have already secured regulatory approval.

[94]            AstraZeneca has claimed exemption from disclosure of publicly available information. It does so on the basis that no one knows that it used the publicly available information nor how it used that information. As a general proposition, publicly available information is not exempt information under section 20 either as a class of documents or under the "harm's" test. It requires compelling evidence to dislodge the logical conclusion that information in the public domain will be used, particularly by knowledgeable users. AstraZeneca's evidence is at best speculative.

[95]            As a general proposition disclosure of information which would give insight into how government carries out its approval process is not the type of information which Parliament wished to exempt from disclosure. It is the very information about which the Act was established.

[96]            Section 20 in the sole section under the heading "Third Party Information". The information which is within this general category is information supplied by a third party or about a third party; not information about the operation of government.

[97]            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 was established, it is an

argument which has been rejected by the Court of Appeal in Cyanamid Canada v. Canada (Minister of National Health and Welfare) (1992), 45 CPR (3^d) 390 at 403:

An alternative argument is advanced under s. 20(1)(c). The appellant submits that although information may be publicly available, it is not available from a single source. However, if access were granted under the Act it would confer an advantage upon the requester by saving him time and expense of collecting that information from several other public sources and enable him to construct the "larger picture" to the detriment of the appellant. I am not persuaded by this argument.

CLAIMS UNDER PARAGRAPH 20(1)(d)

[98]            AstraZeneca's concern under this heading is 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.

[99]            Even potential problems with public relations has been held to be mere speculation. (See Air Atonabee Limited, supra). In this case the evidence is likewise speculative.

[100]        As held in Re. Saint John Shipbuilding Ltd. and Minister of Supply and Services (1990), 67 D.L.R. (4^th) 315 at 316 (F.C.A.), paragraph 20(1)(d) requires that there must be (i) contractual or other negotiations, and (ii) interference in the nature of obstruction is held in.

[101]        The process of obtaining government approval, for example at a provincial level, is not the type of negotiations to which this section refers. The term "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.

[102]        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.

FINDINGS ON CATEGORIES

Category 1 - References to NEXIUM NDS itself.

[103]        This category encompasses such information as the dates, volume numbering and location of information within the NDS. AstraZeneca argues that this information should be exempt from disclosure under section 20(1)(b) and (c) because it will allow a competitor to know AstraZeneca's regulatory strategy.

[104]        Firstly, AstraZeneca has not established that the information falls within section 20(1)(b). The information is purely administrative; not technical, commercial scientific by any objective standard.

[105]        Secondly, AstraZeneca has not established how the use of the knowledge of its regulatory process could cause it material harm. It is too speculative to suggest, that because one can discern how AstraZeneca secured regulatory approval, this is the type of information which a competitor could use to secure its own regulatory approval. The proposition, if it has any validity, assumes a competitor would apply for the same approval using the same drugs. There is no evidence to suggest that there is a reasonable likelihood of such a circumstance.

[106]        Each drug submission has its own time lines and its own issues. AstraZeneca has not provided a coherent explanation of how this information could be used to gain insight into AstraZeneca's approval process nor, more importantly, how a competitor might use the information to secure the advantage AstraZeneca claims.

[107]        Further, knowledge of how the regulatory process works is not the type of information which section 20 is designed to exempt from disclosure. Even if a competitor gains insight into the regulatory process, this is not third party information. To sweep this type of information within section 20(1)(c) would be to give too broad a scope to the limited and specific exemption intended under the Act. The type of information about how the government conducts itself is the very type of information to which the public was intended to have access.

[108]        AstraZeneca 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, and therefore exempt from disclosure.

Category 2 - Misdescribed Claims

[109]        Under this category there is agreement that some of the information is exempt. The issue is whether Health Canada has gone far enough in exempting disclosure.

[110]        As with many cases in this field, after the expression of general principles, their application becomes the problem and, to use a colloquial expression, "the devil is in the detail".

[111]        AstraZeneca is concerned that there are statements made which they believe are not accurate, in particular, with respect to its reliance for claims of bio equivalence on certain other products. It fears that competitors will use this misinformation against AstraZeneca and that such information will interfere with AstraZeneca's negotiations with provincial authorities for the listing of NEXIUM on provincial formularies. The comments in issue are found in reviewer's notes.

[112]        The comment on bio-equivalence and reliance on products, (found on page 51 of the disputed record), is similar to that on page 111 which AstraZeneca has not challenged. While this may have been an inadvertent omission, it does suggest that the issue is not one of such significance that AstraZeneca believed that it would suffer "material" harm.

[113]        The information from the reviewer's comments does not disclose information similar to those in the MOT inspection reports. (See Air Atonabee, supra at 205).

[114]        AstraZeneca has not shown how disclosure would result in material harm to it. Even if the comment discloses in accurate information, that is not sufficient reason for non-disclosure. (see Air Atonobee, supra).

[115]        The Court has, subsequent to its hearing this application, been advised by counsel of Justice Harrington's decision in Merck Frosst Canada & Co. v. Canada (Minister of Health), [2004] FC 959. I do not understand Justice Harrington to have laid down any new principles of law or to have cast a blanket over disclosure of such information as reviewer's comments, or other such information, merely because of the type of document under consideration. Reviewer's comments are not a type of document or contain a type of information which is per se exempt. It is the information itself that must be examined.

[116]        As Justice Harrington said at paragraph 55 of his judgment - "What is important here is the context in which the information is situated within the records held by the government." The reviewer's comments can contain the third party's confidential information, which would be exempt. The reviewer's comments may contain the opinion of the reviewer which does not disclose confidential information, in which case the information may, subject to other exemptions, be disclosed.

[117]        Justice Harrington then goes on to consider the reasonableness of severance. It has been held in other cases, that completely disconnected snippets of releasable information is not reasonably severable. The process of reaching the conclusion that the information is not reasonably severable is one which a Court ought to approach with caution. It is not an issue of "what purpose is to be served by disclosure" so much as an issue of "whether there is any information which is reasonably being conveyed by the exercise of severance".

[118]        From my review of the records in issue, there is more than disconnected snippets being disclosed and therefore the information is reasonably severable. Moreover, AstraZeneca has not established how it would be materially harmed by disclosure of the remaining information.

Category 3 - Unmarketed Formulations

[119]        In summary AstraZeneca argues that this information discloses what reliance it placed on other products when obtaining the NEXIUM approval, how it utilizes resources in its regulatory submissions, and therefore the information tells competitors how they could structure their own submissions. It also fears that such information may reveal possible future commercial activity.

[120]        The Respondent has already excluded specific information concerning Phase 3 clinical studies not found in the public domain. The remaining information about the use of studies is commonly understood and is a widespread practice in the industry.

[121]        Some of the information concerning other formulations is already contained in the publicly available Product Monograph. Other information concerning Phase III studies is found in the US FDA NDA package (information somewhat equivalent to that in the Canadian NDS process).

[122]        Information which is in the public domain (subject to limited circumstance where compelling evidence establishes otherwise) cannot be said to be within section 20(1), particularly paragraph (c). It is always incumbent on the person resisting disclosure to establish harm, a more difficult task where the same type of information is in the public domain including information available from similar regulatory sources. See Canada Packers Inc. v. Canada (Minister of Agriculture) 26 CPR(3^rd) 407 (FCA).

[123]        AstraZeneca has failed to establish either that the remaining information to be disclosed falls into paragraphs (b) or (c) of section 20(1). The information does not have the quality of confidentiality and any harm suggested is, at best, speculative.

Category 4 - Unpublished Scientific Data

[124]        The information at issue is unpublished clinical, pre-clinical or analytical data and other scientific data.

[125]        Some of the information is disclosed in the Product Monograph, other information is in the public domain. Any suggestion that the information will be miscast by competitors has been previously rejected in this and other cases as a grounds for non-disclosure. The fact is AstraZeneca has been issued with a Notice of Compliance confirming the drugs safety and effectiveness and is capable of rebutting any adverse publicity.

[126]        Similarly the submissions as to reviewer's notes and insight into the regulatory process has been earlier rejected where the truly confidential information of the third party has been severed. Again AstraZeneca has failed to establish either that it has some entitlement to exclusive knowledge of how the regulatory process operates, or that a competitor could cause AstraZeneca material harm by virtue of knowing what the regulatory process may be in respect of some other drug, at some other time.

Category 5 - Product Development Plans and Regulatory Strategy

[127]        As with respect to other categories of documents, AstraZeneca contends that even where the information such as studies is in the public domain, the fact of its reliance on those studies is confidential. AstraZeneca further contends that even where information of its reliance on similar studies is available in the US NDA, the information cannot be released.

[128]        As indicated earlier, the information in the studies and thus the studies themselves, cannot be said to be confidential information. Further where similar information is available in the US, it cannot be said, and AstraZeneca could not establish, that release of that type of information can or will cause material harm. One would have thought that is the availability of that type of information in the US caused such material harm, AstraZeneca would have been able to prove that fact and extrapolate from the US experience what the likely Canadian experience would be.

[129]        Regarding the claim that disclosure will give insight into the regulatory process and will allow a competitor to get to market with its drugs faster, that argument has been rejected earlier.

Category 6 - Draft Product Monograph and Reviewer's Notes

[130]        The objection to the disclosure of this information has been addressed earlier. AstraZeneca's submissions on insight into the structure of the NDS, as well as the reviewer's comments, the regulatory process and the harm which will flow, have also been rejected.

[131]        In this category there were substantial severances where the information qualified under paragraph 20(1)(b). The few remaining pieces of information meet neither the class test nor the harm test in paragraphs 20(1)(b) and (c).

Category 7 - Unapproved Indication

[132]        All issues regarding these documents have been resolved.

Category 8 - Manufacturing Procedures and Process Validation

[133]        The mere description of the category of documents suggests that issues of trade secret, confidential information and material harm arise. Had there been no severances, AstraZeneca's submissions might have carried more force.

[134]        However substantial severance has been applied and information, such as the actual result of tests, have been removed from disclosure. With respect to the remaining few pieces of information, AstraZeneca did not establish that they disclosed a trade secret as that term has been interpreted in Gamma Inc. v. Canada (Secretary of State) (1994), 79 FTR 42. Other remaining information concerning the type of studies is known in the pharmaceutical industry. AstraZeneca did not establish that the remaining information is either confidential or that disclosure would cause material harm.

Category 9 - Stability Studies

[135]        The Respondents severed much of the information on shelf life and stability studies. What remains is in the public domain.

[136]        AstraZeneca's claim that even if the information is public, its use of the studies and the extent of its use of the studies will impart valuable information to a competitor subsequently seeking drug approval. For reasons already provided, this submission cannot be accepted.

Category 10 - Products Unrelated to NEXIUM

[137]        These documents are covered by the Court's Reasons in respect to irrelevant information and in respect to Category 5 documents.

[138]        The Respondent contends, and the Court agrees, that to the extent that the information in issue is found in reviewers' comments, the information cannot, even if irrelevancy were a grounds for non-disclosure, be said to be irrelevant. This remaining information either does not disclose section 20(1)(b) information, since the comments are those of the reviewer, or the information is in the public domain.

CONCLUSION

[139]        The documents in dispute are contained in a post-hearing Joint Submission ("Disputed Severances"). For the reasons given these documents do not fall within any of the criteria of section 20 and therefore must be disclosed.

[140]        An order will issue dismissing the review, ordering release of the Disputed Severances documents and ordering costs in favour of the Respondent.

                                                                                                                         (s) "Michael L. Phelan"          

Judge

                                                 FEDERAL COURT OF CANADA

                            NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                           T-720-02

STYLE OF CAUSE:               ASTRAZENECA CANADA INC. v. HEALTH CANADA et al

PLACE OF HEARING:                     Ottawa, Ontario

DATE OF HEARING:                       April 26, 27, 28, 2004

(Reasons for Order dated February 8, 2005)

Dealt with without personal appearances

(Reasons for Order dated May 9, 2005)

CONSOLIDATED REASONS

FOR ORDER BY:                              Phelan J.

DATED:                                              October 25, 2005

SUBMISSIONS:

Mr. J. Sheldon Hamilton

Mr. James Pan                                                                                                FOR THE APPLICANT

Mr. Michael Roach                                                                                   FOR THE RESPONDENTS

SOLICITORS OF RECORD:

Smart & Biggar

Toronto, Ontario                                                                                             FOR THE APPLICANT

Mr. John H. Sims, Q.C.

Deputy Attorney General of Canada

Ottawa, Ontario                                                                                        FOR THE RESPONDENTS