Date: 20050509
Docket: T-1997-01
Citation: 2005 FC 646
BETWEEN:
ASTRAZENECA CANADA INC.
Applicant
and
HEALTH CANADA, THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR ORDER
PHELAN J.
INTRODUCTION
[1] AstraZeneca seeks a review of the Minister's decision to release certain information pursuant to an Access to Information request related to a supplementary new drug submission for LOSEC (omeprazole magnesium) MUPS tablets.
[2] This matter was argued along with [2005] FC 645 (T-1633-01) and [2005] FC 647 (T-754-02). The same general issues were argued and have been disposed of in Reasons for Decision in [2005] F.C. 645.
[3] The general issues raised are:
(1) that the decision was a nullity because the person deciding the matter did not have the authority to do so;
(2) that despite the fact that much of the information to be disclosed is in the public domain and/or is generally understood, AstraZeneca's compilation of the information is unique and is confidential;
(3) that disclosure of how AstraZeneca obtained regulatory approval gives a competitor valuable information about the regulatory process which will allow it to secure regulatory approvals more quickly.
[4] Since these issues were disposed of in [2005] FC 645 those reasons are adopted here. These reasons, following generally the manner in which the case was argued orally, will deal with matters specific to this application.
BACKGROUND
[5] The drug known as LOSEC MUPS is a brand name with omeprazole magnesium as the active ingredient. It is part of the general group of drugs known as proton pump inhibitors marketed to reduce gastric acid secretion.
[6] The approval process for LOSEC MUPS followed the same path as the LOSEC drug referred to in [2005] FC 645, except that on December 24, 1007, AstraZeneca, under its former name, submitted a S/NDS for LOSEC with the active ingredient omeprazole magnesium for a new drug form - a multiple unit pellet system (MUPS) for 10 mg. and 20 mg. AstraZeneca obtained the applicable NOC on July 11, 2000.
[7] On May 16, 2001, the Health Canada Access Coordinator received an access to information request for:
Any and all information, including documents, records, submissions, correspondence, and other supporting materials on paper or in computer or other format, concerning a submission by ASTRAZENECA CANADA INC., its predecessor or parent companies for permission to market in Canada the drug omeprazole magnesium in a multi-unit pellet system, sometimes known by the proprietary name of LOSEC MUP.
[8] The request was handled in much the same manner as the request for information on LOSEC in that it was referred to the PSIA (Proprietary and Scientific Information Assessment Section of Health Canada) for document retrieval, relevance assessment and recommendation.
[9] PSIA identified and reviewed the requested documents. It also reviewed AstraZeneca's section 28 representations and recommended that the documents were not exempt from disclosure since a large amount of the information objected to could be found in the Product Monograph (PM) or in published literature or in other sources, or is generally known in the industry or is not confidential information.
[10] Although the Assistant Access Coordinator and the Access Coordinator reviewed the records and recommendation to release, AstraZeneca complains that the letter informing it of the decision to disclose was signed by the Assistant Access Coordinator only. It is this decision which is under review.
[11] AstraZeneca has categorized the documents in issue under 13 headings as follows:
1. Category 1 information consists of references to submissions or products, other than LOSEC MUPS.
2. Category 2 information consists of all direct and indirect references to LOSEC MUPS formulations that have not received regulatory approval and any information that would permit the drawing of an accurate inference with respect to the same. (e.g. references to drugs used for comparison purposes).
3. Category 3 information comprises references to:
(I) The quantitative composition of omeprazole or omeprazole magnesium products,
(ii) Product manufacturing processes and process validation studies,
(iii) Specifications and test methods for drug products and substances including references to the type of method and relevant validation of the method,
(iv) Excipient standards,
(v) Drug substance synthesis, and/or
(vi) Any information that would permit an accurate inference with respect to the above information.
4. Category 4 information comprises references to AstraZeneca's regulatory submission and marketing strategies, including the manner in which AstraZeneca was able to obtain regulatory approval and market its products.
5. Category 5 consists of information pertaining to unpublished:
(I) Study designs,
(ii) Safety data (including Adverse Events),
(iii) Dissolution and dispersion data, and/or
(iv) Any other scientific information provided to Health Canada that is neither published nor available to the public.
6. Category 6 information consists of investigator names, as well as references to third party manufacturers and any reference to AstraZeneca where the same would reveal what products AstraZeneca manufactures.
7. Category 7 information consists of references to studies in connection with non-marketed formulations (i.e. reference numbers 6, 7 and 8). (Studies in the C & M Summary are given reference numbers, so, for example reference 1 is the first study described).
8. Category 8 information consists fo references to confidential internal AstraZeneca test and study codes.
9. Category 9 information consists of references to AstraZeneca's product development plans and includes any description of unapproved international dossiers.
10. Category 10 information consists of references to impurities (including information that directly reveals the impurities) and limits.
11. Category 11 information consists of information relating to stability studies including, but not limited to, test methods, limits, results and conclusions.
12. Category 12 consists of information relating to package material specifications, non-marketed package formats and proposed labels for products not marketed.
13. Category 13 information consists of all drafts of the product monograph and information that permits a drawing of an accurate inference with respect to same (e.g. reviewer's comments).
N.B. Category 2 documents are no longer in issue as the Court was advised orally on Friday, November 19, 2004.
ANALYSIS
Decision is a Nullity
[12] The best evidence, based on the Assistant Access Coordinator's and the unit's usual course of practice, is that the Access Coordinator not only reviewed the documents but also reviewed the recommendations and made the final decision to release the records. Therefore the person holding the requisite authority made the decision which is under review. Therefore the decision is not a nullity on this ground.
[13] AstraZeneca complains that because the information is technical and no persons other than those in PSIA could meaningfully make the decision, the decision is in reality made by PSIA. For the reasons given in [2005] FC 645, and in particular based on the Court of Appeal's conclusions in Cyanamid Canada Inc. v. Canada (Minister of Health and Welfare) (1992), 45 C.P.R.(3d) 390 (F.C.A.), this objection is dismissed.
Documents Exemption
[14] If the decision is not a nullity, AstraZeneca contends that that information which has been severed and is to be disclosed is exempt under paragraphs 20(1)(a) (b) and (c) of the Act. Argument with respect to paragraph 20(1)(a) was not significantly advanced.
[15] As indicated earlier, the thrust of AstraZeneca's arguments have been disposed of in [2005] FC.645 This case, like that of its other two companion cases, is sufficiently similar to that of Cyanamid Canada, supra that they can be disposed of by reference to the Court of Appeal's conclusions at pages 403-404 of that decision. The Court of Appeal, in commenting on both the release of information and the further argument of the advantage conferred by virtue of release of this type of information, held:
. . . . Rights of secrecy and confidentiality fell away with the release of the product monograph; any injury, prejudice or advantage surely must flow from that release itself. . . .
. . . . 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. . . . The appellant itself made this information publicly available by releasing that document. In my opinion, it has simply not been shown that additional harm would flow to the appellant from release of the same information under the provisions of the Act.
[16] The following paragraphs contain this Court's specific conclusions regarding the named category of documents.
[17] Category 1: The documents refer to the NDS which is the core document upon which MUPS's S/NDS is based. Not only does the information relate to the access request, the information is common knowledge, in the public domain by virtue of being released by AstraZeneca in the Product Monograph.
[18] Category 3: This is largely quantitative information. The actual changes to specifications and processing information has been exempted. What remains is a matter of common understanding or disclosed in the patent itself.
[19] Category 4: This is principally the regulatory submission material. The Respondent has exempted that information which AstraZeneca has not publicly disclosed in its Product Monograph. The names of persons does not disclose anything of a confidential or harmful nature. The main argument of AstraZeneca is that of competitive harm from the "larger picture"; an argument directly rejected in Cyanamid Canada, supra page 403.
[20] Category 5: The first objection is that disclosure of a safety data, more particularly of type of study, would cause harm. However, it is known that such a study must be conducted and the information is found in the Product Monograph. Further, the adverse effects of the drug as found from the studies is in the public domain by virtue of the Product Monograph. The one adverse effect not in the Product Monograph has been exempted.
[21] Category 6: AstraZeneca objects to this information because it discloses what activities are performed at AstraZeneca's plants. It is information about the names of the companies and what they do. This is information which is readily observable. To perform certain of these activities, Health Canada issues a license - that licence information is available on Health Canada's website. Therefore all of this information is in the public domain in one manner or another.
[22] Category 7: The Minister has exempted non-marketed matters. What remains is mostly studies which are required to meet the Product Monograph's requirements. The results of the studies are contained in the Product Monograph. That these studies were done is a matter generally known in the industry.
[23] Category 8: The codes are said to be a numbering system internal to Health Canada. AstraZeneca has not provided sufficient evidence of how this information could be used and what harm would result.
[24] Category 9: AstraZeneca has not provided sufficient evidence to establish either confidentiality or harm except for those parts in Disputed Records 183 and 244 which Health Canada now agrees to exempt.
[25] Category 10: The issue of impunities information is the same as the "adverse effects" information in Category 5. That which is not disclosed in the Product Monograph has been exempted.
[26] Category 11: The stability tests are required by the Health Canada Guidelines and therefore their existence would be a matter of general understanding. Information concerning start times for the tests exposes no confidential information, particularly as there is no end date. There is no evidence of material harm.
[27] Category 12: Some of this information related to packaging is either disclosed in the Product Monograph or is in the public domain. To the extent that non-marketed package formats and proposed labels is not public, AstraZeneca has not shown that it was confidential in the manner described in paragraph 20(1)(b) or that disclosure would cause material harm.
[28] Category 13: With respect to reviewer's comments, the Court has previously described the circumstances and limits which are relevant to disclosure of this information. With respect to the draft product monographs, the Minister has exempted that information which did not appear in the final Product Monograph.
CONCLUSION
[29] For these reasons this application will be dismissed with costs.
[30] The Court wishes to recognize the efforts of both counsel in all three cases and acknowledge Ms. Lacombe's dedicated work at a time of personal loss.
(s) "Michael L. Phelan"
Judge
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1997-01
STYLE OF CAUSE: ASTRAZENECA CANADA INC. v. HEALTH CANADA, THE MINISTER OF HEALTH and THE ATTORNEY GENERAL OF CANADA
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: November 15, 2004
REASONS FOR ORDER: Phelan J.
DATED: May 9, 2005
APPEARANCES:
J. Sheldon Hamilton
Denise L. Lacombe FOR THE APPLICANT
Sadian Campbell
Derek Edwards FOR THE RESPONDENTS
SOLICITORS OF RECORD:
Smart & Biggar
Toronto, Ontario FOR THE APPLICANT
Mr. John H. Sims
Deputy Attorney General of Canada
Ottawa, Ontario FOR THE RESPONDENT