T-90-01
2004 FC 959
Merck Frosst Canada & Co. (Applicant)
v.
The Minister of Health Canada (Respondent)
Indexed as: Merck Frosst Canada & Co. v. Canada (Minister of Health) (F.C.)
Federal Court, Harrington J.--Montréal, May 17, 18, 19, 20 and July 6, 2004.
Access to Information -- Judicial review of decision by Minister of Health to release information on new drug submission -- Innovator drug company (applicant) having given confidential trade secrets to Minister in seeking notice of compliance -- Whether Minister had right to disclose -- Third-party information as exception to principle government information available to public -- Applicant objecting to disclosure of all information not already in public domain -- Purpose of access to information legislation -- Question being whether information on drug as presented by applicant was in public domain -- Disconnected snippets of releasable information not reasonably severable -- While judicial review under s. 44 triggered by giving of show cause notice to third party, Department could not escape independent review by failure to give notice.
Food and Drugs -- Innovator drug company gave Health Canada confidential trade secrets in seeking notice of compliance (NOC) for asthma drug Singulair® -- Judicial review of decision to release records on new drug submission under Access to Information Act -- Act treats third-party trade secrets differently than government's own information -- Applicant arguing release of comprehensive summary, clinical evaluations, chemical information would reveal strategy, know-how, business plan -- Applicant had legitimate expectation information kept in confidence by respondent -- Did not matter there is information on Singulair® in public domain -- What matters: whether information as presented by applicant in public domain -- Even if only snippets of information released, requester perhaps able to connect dots, gaining insight from what disclosed, what deleted -- NOC only releasable.
This was an application for the judicial review of a decision of the Minister of Health to provide a requester access to information in respect of applicant's drug Singulair®, which is used in the treatment of asthma.
Applicant had provided chemical and manufacturing information, including the results of clinical studies, in order to secure a notice of compliance with the Food and Drug Regulations. This full disclosure divulged trade secrets and confidential financial information. Its competitive position could be prejudiced if this information were made public.
When Health Canada received a request, under the Access to Information Act, for its records related to the new drug submission, Merck Frosst was notified that the Department intended to disclose part of the information requested. Applicant's position was that the Department had no right to divulge any of the documentation requested.
While the Act is based on the principle that government information should be available to the public, the statute does set forth certain exemptions to the general right of access, the only relevant one herein being with respect to third-party information. The Act treats such trade secrets differently than it does similar information belonging to the government itself. If an institution head intends to release, in whole or in part, a record that might contain information that is protected by the Act, the third party must be given an opportunity to make representations against disclosure. And, under subsection 44(1), the third party may seek review in Federal Court.
Health Canada's position was that it is obliged to divulge as much information as possible, even though it appreciates that most access requests are made by competitors. In the instant case, the Department, without consulting applicant, released the notice of compliance (NOC) and some other information it considered not to be confidential while other information considered to be protected under subsection 20(1) was severed. Certain information not found in published studies was deleted. Being uncertain as to the confidential nature of some of the information, applicant was contacted and given 20 days to make written representations explaining the confidentiality of the information along with the extent of the injury that would result from its disclosure.
It was urged by applicant that confidentiality is a cornerstone of the regulatory scheme established by the Food and Drug Regulations, the Patented Medicines (Notice of Compliance) Regulations and the North American Free Trade Agreement. It disagreed as to where the balance between disclosure and non-disclosure should be struck. Applicant objected to the disclosure of all information not already in the public domain. It suggested that release of the comprehensive summary would reveal its strategy, know-how and business plan. This applied as well to clinical evaluation reports and to chemical and manufacturing information.
Held, the application should be allowed.
All of the information requested, including the notes of Departmental reviewers or outside experts retained by it, were considered to be third-party information. They would not exist but for applicant's new drug submission. As La Forest J. said in Dagg v. Canada (Minister of Finance), the principal purpose of access to information legislation is to facilitate democracy. It helps to ensure that both politicians and bureaucrats remain accountable to citizens. Under Act, section 2, decisions on the disclosure of government information should be reviewed independently of government.
Everyone is entitled to know whether a drug on the market has been approved; the Department was entitled to release the NOC without consulting applicant. But the comprehensive summary is, in its pith and substance, third-party confidential information. The institutional head was, at the outset, required to refuse to disclose any part of it. Again, Act, section 20 applies to reviewers' notes and correspondence as much as it does to the comprehensive summary.
Two questions remained to be decided: (1) whether the information had lost its original confidentiality; and (2) could any non-confidential information be reasonably severed making it open to release?
The information when submitted was confidential, and was always treated as confidential by applicant, who had a legitimate expectation that the information would be kept in confidence by respondent. It did not matter that there is information regarding Singulair® in the public domain. What did matter was whether the information as presented by applicant is in the public domain. If not, confidentiality has not been lost. The possibility that non-confidential information could be severed was considered but it had to be concluded that the comprehensive summary, reviewers' notes and correspondence were exempt from disclosure in their entirety. Disconnected snippets of releasable information taken from otherwise exempt passages could not be said to be reasonably severable. The portions of sentences not deleted by respondent were incomprehensible to the Court, but perhaps a requester would be able to connect the dots and gain insight from what was disclosed and what was deleted.
Respondent raised the procedural objection that this review is governed by sections 28 and 44 of the Act and that the latter section is triggered by the show cause notice given to a third party. Here, respondent had made disclosure of a few pages of material without giving notice. But a government institution cannot escape independent review by failure to give the notice contemplated by the statute. While the point is moot in that the damage has been done, since this issue is bound to again arise it was declared that Health Canada should not have acted as it did.
statutes and regulations judicially
considered
Access to Information Act, R.S.C., 1985, c. A-1, ss. 2, 4(1) (as am. by S.C. 2001, c. 27, s. 202), 13 (as am. by S.C. 2000, c. 7, s. 21), 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 27, 28, 29, 44, 74.
| Federal Court Rules, 1998, SOR/98-106, rr. 8, 302. |
| Food and Drug Regulations, C.R.C., c. 870. |
| North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America, December 17, 1992, [1994] Can. T.S. No. 2. |
| Official Secrets Act (The), S.C. 1939, c. 49. |
| Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. |
| Security of Information Act, R.S.C., 1985, c. O-5, s. 1 (as am. by S.C. 2001, c. 41, s. 25). |
cases judicially considered
applied:
Dagg v. Canada (Minister of Finance), [1997] 2 S.C.R. 403; (1997), 148 D.L.R. (4th) 385; 46 Admin. L.R. (2d) 155; 213 N.R. 161; AB Hassle v. Canada (Minister of National Health and Welfare), [2000] 3 F.C. 360; (2000), 5 C.P.R. (4th) 149; 253 N.R. 284 (C.A.); Air Atonabee Ltd. v. Canada (Minister of Transport) (1989), 37 Admin. L.R. 245; 27 C.P.R. (3d) 180; 27 F.T.R. 194 (F.C.T.D.); Canadian Jewish Congress v. Canada (Minister of Employment and Immigration), [1996] 1 F.C. 268; (1995), 102 F.T.R. 30 (T.D.); Aluminerie Alouette inc. c. Commission d'accès à l'information du Québec, [1991] R.J.Q. 417 (Sup. Ct.); Waddle v. Wallsend Shipping Company, Ltd., [1952] 2 Lloyd's Rep. 105 (Q.B.); N.M. Paterson & Sons Ltd. v. St. Lawrence Seaway Management Corp. (2004), 322 N.R. 83; 2004 FCA 210.
considered:
Boyer v. Regem, [1948] B.R. 829; (1948), 94 C.C.C. 195; 7 C.R. 165 (Que. C.A.); Home Office v. Harman, [1982] 1 All E.R. 532 (H.L.).
referred to:
Kruger Inc. v. Baltic Shipping Co. (1989), 57 D.L.R. (4th) 498 (F.C.A.); Susan Hosiery Ltd. v. Minister of National Revenue, [1969] Ex. C.R. 27; [1969] C.T.C. 353; (1969), 69 DTC 5278; The Putbus, [1969] 2 All E.R. 676 (C.A.); Siemens Canada Ltd. v. Canada (Minister of Public Works and Government Services) (2002), 21 C.P.R. (4th) 575; 2002 FCA 414; H.J. Heinz Co. of Canada Ltd. v. Canada (Attorney General), [2005] 1 F.C.R. 281; (2004), 241 D.L.R. (4th) 367; 14 Admin. L.R. (4th) 123; 32 C.P.R. (4th) 385; 320 N.R. 300; 2004 FCA 171.
APPLICATION for judicial review of a decision by the Minister of Health to release certain records relating to a new drug submission, pursuant to an Access to Information Act request. Application granted.
appearances:
Karl Delwaide and Karine Joizil for applicant.
Sébastien Gagné for respondent.
solicitors of record:
Fasken Martineau DuMoulin LLP, Montréal, for applicant.
Deputy Attorney General of Canada for respondent.
The following are the reasons for order and order rendered in English by
Harrington J.:
OVERVIEW
[1]What right, or duty, does the Government of Canada have to give public access to information it has received in confidence?
[2]Singulair® is a drug prescribed worldwide in the treatment of asthma. It was developed in Canada by Merck Frosst, at a cost of many millions of dollars. Before Singulair® could be marketed here, Merck Frosst had to convince Health Canada that it was safe and effective. This is a very important regulatory function of government.
[3]Regulatory approval takes the form of a notice of compliance which certifies that the new drug submission complies with appropriate Food and Drug Regulations [C.R.C., c. 870]. Before such a notice is issued, the drug company must provide chemical and manufacturing information, and indeed virtually all information known about the drug including the results of pre-clinical and clinical studies. The submission is reviewed in detail by multi-disciplinary teams of Health Canada, who may also bring in outside counsel. Extensive correspondence is generated as part of this critical analysis, an analysis which may result in changes from the submission as originally filed.
[4]At the heart of a new drug submission is the comprehensive summary prepared by the drug company. In short, in order to obtain approval, Merck Frosst was obliged to make a full and frank disclosure of all its knowledge and information, a disclosure which contained trade secrets and financial, commercial, scientific and technical information of a confidential nature, as well as information which, if made public, might cause it financial loss or prejudice its competitive position.
[5]After Singulair® was approved and on the market, Health Canada received a request under the Access to Information Act, R.S.C., 1985, c. A-1, as amended, for records related to the review of the new drug submission. More specifically, the request was for the:
| - notice of compliance; |
| - comprehensive summary; |
| - reviewer's notes; and |
| - correspondence between Health Canada and Merck Frosst |
[6]Health Canada informed Merck Frosst that it intended to disclose part of the requested records. It said that it had already severed some information from the documents as being confidential third-party information, exempt from disclosure under the Act and said that other parts might also be confidential, but that it was unable to make that determination. Merck Frosst was called upon to explain the confidentiality of the remaining information or the nature and extent of the injury that would result should the information be disclosed.
[7]It was subsequently revealed that Health Canada had disclosed part of the information to the requester, who is one of Merck Frosst's competitors, without prior consultation.
[8]For all intents and purposes, Merck Frosst took the position that Health Canada had no right under the Act to divulge any of the requested documentation. This led to a great deal of correspondence and to an application by Merck Frosst to this Court for a review of Health Canada's position. There have been waves of affidavits from both sides, some public, and some protected by confidentiality orders.
[9]This consultative, or perhaps I should say argumentative, process did not result in an agreement and so it falls upon the Court to decide whether or not the information requested is exempt from disclosure.
[10]I will briefly set out the process by which Singulair® was approved so that the importance of the documents under scrutiny can be appreciated. I will then outline the scheme of the Access to Information Act, set out the position of the respective parties, and finally apply the Act, in the light of the case law, to the documents in question.
NEW DRUG SUBMISSION
[11]As mentioned, before a new drug is placed on the market by a pharmaceutical company, often called an "innovator", a new drug submission must be reviewed by Health Canada. The submission must contain virtually all information known about the drug, including the results of pre-clinical and clinical studies for intended dosage strengths. All aspects of a submission are critically reviewed by multi-disciplinary teams. Health Canada may retain the services of outside experts. All this naturally leads to extensive correspondence and the generation and exchange of other documents. This may lead to changes to the original submission.
[12]The submission includes a product monograph, which in its final form is made available to health professionals, and so is a public document. During the review process, revisions may also be made to the monograph as originally submitted. Once the drug is found to be satisfactory, a notice of compliance is issued permitting the manufacturer to sell the product according to the approved product monograph.
[13]Once the innovator's drug is on the Canadian market, the sponsor of a similar, or reformulated drug (often referred to as a "generic") may submit an abbreviated new drug submission. While the sponsor of a new drug submission must prove evidence of safety and efficacy, the abbreviated new drug submission need only establish that when compared to the innovator, it is so similar that the two can be used interchangeably.
[14]The comprehensive summary part of the new drug submission is pivotal to the review process. It contains descriptions of the methodology, and evaluations and results of relevant investigational and clinical studies.
[15]The innovator drug company obviously wishes to recoup its research and development costs and hopefully, from its point of view, make a profit. The development of new medicines is extremely costly. To recoup the investment, pharmaceutical companies are dependent upon patent protection and protection of data submitted to government authorities. However, there is a balance to be struck as generic companies help keep the cost to the patient down. Since the generic companies do not start from the beginning, they can lower the price of the drug without having to be concerned about recovering extensive research and development costs.
ACCESS TO INFORMATION
[16]One can imagine Merck Frosst's reaction had its competitor requested the information from it directly! However, the information requested is to be found in Government of Canada files. The current political philosophy is that government files are open to the public unless specifically and explicitly exempted.
[17]The core of the Access to Information Act, is found in subsections 2(1) and 4(1) [as am. by S.C. 2001, c. 27, s. 202]. They say:
2. (1) The purpose of this Act is to extend the present laws of Canada to provide a right of access to information in records under the control of a government institution in accordance with the principles that government information should be available to the public, that necessary exceptions to the right of access should be limited and specific and that decisions on the disclosure of government information should be reviewed independently of government.
. . .
4. (1) Subject to this Act, but notwithstanding any other Act of Parliament, every person who is
(a) a Canadian citizen, or
(b) a permanent resident within the meaning of subsection 2(1) of the Immigration and Refugee Protection Act,
has a right to and shall, on request, be given access to any record under the control of a government institution.
[18]Subject to the Act, the requester is entitled to the information it seeks.
[19]Exemptions to the general right of access are set out at sections 13 [as am. by S.C. 2000, c. 7, s. 21] through 24 of the Act. They break down into exemptions pertaining to the responsibilities of government, operations of government, statutory prohibitions, personal information and third-party information.
[20]The only exemption which may have application in this case is that of third-party information. Subsections 20(1), (5) and (6) provide:
20. (1) Subject to this section, the head of a government institution shall refuse to disclose any record requested under this Act that contains
(a) trade secrets of a third party;
(b) 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;
(c) 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; or
(d) information the disclosure of which could reasonably be expected to interfere with contractual or other negotiations of a third party.
. . .
(5) The head of a government institution may disclose any record that contains information described in subsection (1) with the consent of the third party to whom the information relates.
(6) The head of a government institution may disclose any record requested under this Act, or any part thereof, that contains information described in paragraph (1)(b), (c) or (d) if that disclosure would be in the public interest as it relates to public health, public safety or protection of the environment and, if the public interest in disclosure clearly outweighs in importance any financial loss or gain to, prejudice to the competitive position of or interference with contractual or other negotiations of a third party.
[21]Subsection 20(5) has no application because Merck Frosst, as third party, has not consented to the disclosure of any record. Subsection 20(6) has not been invoked by Health Canada and is not of application either.
[22]Some of the exemptions set forth in the Act are obligatory, while others are permissive. Subsection 20(1) is obligatory or mandatory in that Health Canada "shall refuse" "est tenu [. . .] de refuser" to disclose.
[23]The Act treats trade secrets and confidential financial, commercial, scientific or technical information it receives from third parties differently from similar information which belongs to the government itself. Consider paragraph 18(a):
18. The head of a government institution may refuse to disclose any record requested under this Act that contains
(a) trade secrets or financial, commercial, scientific or technical information that belongs to the Government of Canada or a government institution and has substantial value or is reasonably likely to have substantial value; [Emphasis added.]
[24]These exemptions have to be considered in the light of section 25 which provides:
25. Notwithstanding any other provision of this Act, where a request is made to a government institution for access to a record that the head of the institution is authorized to refuse to disclose under this Act by reason of information or other material contained in the record, the head of the institution shall disclose any part of the record that does not contain, and can reasonably be severed from any part that contains, any such information or material.
[25]Sections 27 through 29 go on to provide that in instances where the head of a government institution intends to release, in whole or in part, a record that might contain information exempt from disclosure in accordance with section 20, the third party must be notified in order to be given the opportunity to make representations as to why the record or the part thereof should not be disclosed. If this process fails, the third party is entitled to have the Federal Court review the matter pursuant to subsection 44(1).
44. (1) Any third party to whom the head of a government institution is required under paragraph 28(1)(b) or subsection 29(1) to give a notice of a decision to disclose a record or a part thereof under this Act may, within twenty days after the notice is given, apply to the Court for a review of the matter.
[26]This brief summary is only intended to cover disputes between government institutions and third parties. I make no mention of the other type of dispute covered by the Act, one between the government and a requester who has been denied access. When it comes to third-party information, the requester is informed that the third party has taken issue with the request, and is given the opportunity to participate in the judicial review. In this case it has chosen not to do so.
HEALTH CANADA'S POSITION
[27]The evidence of Health Canada is to be found in a number of affidavits filed by responsible officials of the department, Serge Durand, Margery Snider and Merry Joy Bujaki, who were all cross-examined. They have a great deal of experience with access to information requests and a very detailed knowledge of the Singulair® file.
[28]Health Canada's position has been stated eloquently, and with candour. Although Merck Frosst disagrees with Health Canada's proposed application of the Act to the Singulair® file, it went to considerable lengths to emphasize that it accepted without question that Health Canada was acting in good faith. Health Canada considers that it is obliged to divulge as much information as possible, even though it knows perfectly well that the majority of requests for access to information, as well as the request in this case, come from competitors.
[29]Upon receiving the request for access to information, it collected the documents which related thereto, 549 pages all told.
[30]It decided that the notice of compliance for Singulair® and 14 other pages contained no confidential information and so could be disclosed without consulting Merck Frosst. In fact, it deleted a portion of one of the pages on the grounds that the information fell within paragraphs 20(1)(b) and (c) of the Act. The remaining pages were reviewed, and information considered by Health Canada to be covered by subsection 20(1) of the Act was severed. It was conceded at the outset that the records requested contained information relating to the drug approval process. That information was deleted unless contained in published studies or other documents which had become public by the time the drug was marketed, or were rendered public through other sources. For instance, a great deal of information is in the product monograph prepared by Merck Frosst, and ultimately approved as part of the new drug submission and sent to health professionals. As a result, information contained therein can no longer be considered confidential. An example of information otherwise becoming public is the United States of America, Food and Drug Administration New Drug Approval Package for Singulair®, which is available on the internet.
[31]In its review of the remaining 534 pages (15 having already been disclosed to the requester) Health Canada determined that there was confidential information in 32, but that there might also be other information of a confidential nature.
[32]This is why it said in its letter of August 16, 2000:
Some parts have been severed pursuant to subsection 20(1) of the ATIA [confidential third party information]. Other parts may also be subject to subsection 20(1), however we are unable to determine this at this time.
In accordance with section 27 of the Act, you have 20 days from the receipt of this notice to make written representations to the undersigned explaining the confidentiality of the information or the nature and extent of the injury that would result from the disclosure of the information contained in the requested records.
You must clearly state what portions, if any, of the records you consider confidential and make reference to the appropriate paragraph of subsection 20(1) of the ATIA. [Emphasis in original.]
[33]After reviewing Merck Frosst's representations, which went on in stages, both before and after legal proceedings were instituted, Health Canada now considers that information has to be deleted from 425 pages, at least!
MERCK FROSST'S POSITION
[34]As this matter proceeded by way of application, rather than by trial, Merck Frosst's evidence was also in affidavit form, with some cross-examination thereon. Affidavits were filed by Annie Tougas, Manager Regulatory Affairs, Anne Mayrand, in-house counsel responsible for coordination of access to information litigation matters, and Cynthia Frendo, Merck's Director of Market Planning. Additional affidavits were filed by Joanne Guarda, an outside marketing research specialist, and Robert Sarrazin, an outside consultant, who was called as an expert witness. For many years he was the director of regulatory affairs of another pharmaceutical company. More recently, he has been president of his own consulting firm which has been retained by pharmaceutical companies for advice with respect to gaining regulatory approval for new drugs. Although Health Canada acknowledged that Mr. Sarrazin could be considered an expert, it objected to his evidence on the basis that it was not useful to the Court. As the witnesses called by both sides were either experts in their own right, or lay persons with considerable experience with new drug submissions and access to information, I found Mr. Sarrazin's evidence to be useful, as he was one step away from the fray.
[35]The evidence on both sides was a mixture of fact and philosophy. Fortunately, both sides realized the evidence for what it was and let the philosophy go, except that Health Canada objected to parts of one of the affidavits of Anne Mayrand as being argumentative, rather than factual in nature. Although the portions in question were argumentative, since Maître Mayrand combines legal training with regulatory experience, it can be difficult to draw a sharp distinction between fact and law. In any event, Merck Frosst's counsel could, and did, repeat the same points in argument, and so I decided to leave the affidavit intact.
[36]Although subject to fine tuning, as affidavit upon affidavit were exchanged between the parties, Merck Frosst's position is well set out in the initial affidavit of Annie Tougas, its Manager Regulatory Affairs of the medical division, dated 19 February 2001 and her supplementary affidavit, given on 1 June 2001 after the Court had granted confidentiality orders.
[37]Following the initial notice Merck Frosst received from Health Canada in the form of the letter of Margery Snider dated 16 August 2000, on 11 September 2000 Health Canada provided it with the pages which it had already released to the access to information requester. Merck Frosst set out its general position in a letter Ms. Tougas sent to Ms. Snider 25 September 2000. She said, and it is not disputed, that the development of medicines is extremely costly and that in order to recoup the investment, pharmaceutical companies are dependent upon patent protection and protection of confidential data submitted to governmental authorities. Generic companies attempt to copy the innovator's product where possible and launch the product at a lower price level. They can do so because they do not have to be concerned about extensive research and development costs. Apart from access to information, it was alleged that the information provided to Health Canada was protected by the North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United Sates of America [[1994] Can. T.S. No. 2] of 17 December 1992 (NAFTA). Merck Frosst took the position that "confidentiality" is a cornerstone of the regulatory scheme set out in the Food and Drug Regulations [C.R.C., c. 870], and the Patented Medicines (Notice of Compliance) Regulations [SOR/93-133], as well as in the NAFTA. It submits that there must be a balance between disclosure and non-disclosure (Health Canada agrees but has a different view as to where the balance should be struck). It considers that Health Canada's initial review was very cursory and that it had "shovelled" its responsibility onto Merck Frosst.
[38]Merck Frosst did not object to the disclosure of any information already in the public domain, such as the product monograph, as well as published studies. With those exceptions, it objected to the disclosure of other information. More particularly, Merck Frosst took issue with the documents which had already been released on the basis that information such as control and file numbers provides valuable and competitive information which is helpful for tracking purposes, and allows the requester to assess the various phases of the review process and the speed at which the review progressed. This kind of information can be used for "bench-marking" and performance evaluation, and can indicate if a company is on the right track or not.
[39]The comprehensive summary sets forth the development of Singulair® and the methodology that was used. The conclusions highlight the significant findings. Releasing this information would, according to Merck Frosst, reveal its strategy, know-how and business plan. The same holds true with pre-clinical and clinical evaluation reports. Chemical and manufacturing information, if released, could be expected to result in a material financial loss and prejudice its competitive position. The faster a competitor gains information to get approval of a similar or generic product, the less time Singulair® would benefit from exclusivity on the market.
[40]On a philosophical tone, the letter says that providing information to a competitor reduces the incentive to develop and market new products in Canada.
ANALYSIS--Part I
[41]A distinction must be drawn between information the government generates itself, and information it has received from third parties. I consider all the information requested, including the notes of reviewers either in the employ of Health Canada or retained as outside experts, to be third-party information. If it were not for Merck Frosst's new drug submission, these notes would simply not exist.
[42]I take the main thrust of the Access to Information Act to be that as expressed by La Forest J. in Dagg v. Canada (Minister of Finance), [1997] 2 S.C.R. 403, at paragraph 61:
The overarching purpose of access to information legislation, then, is to facilitate democracy. It does so in two related ways. It helps to ensure first, that citizens have the information required to participate meaningfully in the democratic process, and secondly, that politicians and bureaucrats remain accountable to the citizenry.
[43]Although given in the context of a confidentiality order, consider the words of Décary J.A., speaking for the Court, in AB Hassle v. Canada (Minister of National Health and Welfare), [2000] 3 F.C. 360 (C.A.), at paragraph 7:
Let us not be naïve. There is little, if any, public interest in knowing the specific content of drug processes and no one can seriously argue that the issuance of protective orders of the type at issue in NOC proceedings imperils the principle of open justice.
[44]With that in mind, I turn, as I believe the Act requires me to turn, to the 549 pages in dispute (Air Atonabee Ltd. v. Canada (Minister of Transport) (1989), 37 Admin. L.R. 245 (F.C.T.D.)). Indeed, section 2 of the Act states that "decisions on the disclosure of government information should be reviewed independently of government".
| Notice of Compliance |
[45]Everyone, competitor or not, is entitled to know whether a drug which is on the market has been approved. This is not a confidential document. Indeed, there is no specific objection to its production. I consider it a stand-alone document, and that Health Canada was entitled to release it to the requester without consulting Merck Frosst.
| Comprehensive Summary |
[46]Health Canada acknowledges that this document includes information which is exempt from disclosure by virtue of paragraphs 20(1)(a), (b), (c) and (d) of the Act. However, the main source of exemption is (b) "financial, commercial, scientific or technical information that is confidential". To again rely upon Décary J.A. in AB Hassle, at paragraph 4:
First, whether one looks at it from the perspective of a brand name pharmaceutical manufacturer or from that of a generic drug manufacturer, the perceived confidentiality of information is a cornerstone of the regulatory scheme set out in the Food and Drug Regulations, C.R.C., c. 870, s. C.08.001 [as am. by SOR/95-172, s. 4] and in the Patented Medicines (Notice of Compliance) Regulations:
The perceived confidentiality of information flowing from a drug manufacturer to the Department of National Health and Welfare is a cornerstone of the system pertaining to the processing of new drug submissions and the issuance of notices of compliance. For this system to function effectively, the confidential nature of the relationship ought to be honoured and maintained to the extent possible. . . . (My emphasis.) (Apotex Inc. v. Canada (Attorney-General) (1993), 48 C.P.R. (3d) 296 (F.C.T.D.), at p. 305, McGillis J.)
[47]In my opinion, the comprehensive summary, in its pith and substance, is third-party confidential information. There is no sectional division into information which is confidential, and that which is not. Consequently, I am of the opinion that the "head of the government institution" in question, Health Canada, was initially required to refuse to disclose any part of the record.
[48]The initial presumption under the Act is that information in the hands of the government should be disclosed. However, once a mandatory exception has been established, different considerations apply. One might ask who has the burden of proving an exception to an exception (see Kruger Inc. v. Baltic Shipping Co. (1989), 57 D.L.R. (4th) 498 (F.C.A.), at pages 501-503). Consider also the decision of Heald D.J. in Canadian Jewish Congress v. Canada (Minister of Employment and Immigration), [1996] 1 F.C. 268 (T.D.), at pages 279, 283, 296, 300 and 301.
[49]The burden of proof should be of very limited application in cases such as these. Either the information is confidential or it is not. As Forget J. said in Aluminerie Alouette inc. c. Commission d'accès à l'information du Québec, [1991] R.J.Q. 417 (Sup. Ct.), at page 427:
The Commission's role is delicate since confidentiality only exists once. If confidential information is improperly disclosed, the damage cannot be repaired. The Commission must therefore be cautious when the rights of third parties may be affected by these decisions.
No one has put it better than Devlin J., as he then was, in Waddle v. Wallsend Shipping Company Ltd., [1952] 2 Lloyd's Rep. 105 (Q.B.), at page 139:
In a case where substantially all the facts have been brought to light, it is no doubt legitimate to argue that some cause must be found, and therefore the one that has most to be said for it should be selected. Where it can fairly be said that all possible causes have been canvassed, the strongest must be the winner. But in a case where all direct evidence is missing, there is no ground for saying that the most plausible conjecture must perforce be the true explanation. The answer that may well have to be given is that not enough is known about the circumstances of the loss to enable the inquirer to say how it happened. All that he can say is that no theory advanced has been able to collect enough support from the facts to make it more likely than not that it happened in that way and not in any other.
Later on in these reasons I refer to N.M. Paterson & Sons Ltd. v. St. Lawrence Seaway Management Corp. (2004), 322 N.R. 83 (F.C.A.), and agree that it should be fairly easy to ascertain if the information is in the public domain, and thus confidential, or not.
REVIEWERS' NOTES AND CORRESPONDENCE
[50]As aforesaid, these documents, even if they could be treated separately, would not exist were it not for the new drug submission. Section 27 requires the head of a government institution who has reason to believe a record might contain third-party information, to give that third party prior notice. The notice requires a description of the record, or part thereof, that "belong to, were supplied by, or relate to the third party". Thus, section 20 of the Act applies to reviewers' notes and correspondence just as much as it does to the comprehensive summary.
ANALYSIS--Part II
[51]The application before me does not rest with my conclusion that the documents in their genesis were provided by, or relate to, the third party and were confidential in nature. Two questions remain: (1) has the information, in whole or in part, lost its original confidentiality; and (2) can non-confidential information be reasonably severed so as to make it available to the requester?
| Confidentiality |
[52]One of the leading cases dealing with the confidentiality of documents under section 20 of the Act is Air Atonabee. MacKay J. held that the confidentiality of documents depended on their contents, their purpose and the circumstances under which they were compiled and communicated. Although Health Canada made reference to all four paragraphs of subsection 20(1) to justify its decision to delete certain information sought by the requester, in nearly all cases, only paragraphs 20(1)(b) and (c) were relied upon. Under paragraph (b), if the information is of a financial, commercial, scientific or technical nature and is confidential as defined therein, the information is exempt from disclosure. Unlike paragraph (c) it is not necessary to consider whether the disclosure might result in material financial loss or gain, or prejudice the third party's competitive position. Basing myself on AB Hassle, I have no hesitation in finding that the information when submitted was confidential, was always treated by Merck Frosst as confidential, and that Merck Frosst had a legitimate expectation that the information would be kept in confidence by Health Canada.
[53]Some of that information appears to be currently in the public domain. However, to draw upon the testimony of Mr. Sarrazin, the question is not really whether or not there is information in the public domain concerning Singulair®, the question is whether the information as presented by Merck Frosst is in the public domain. If that information in the form presented "comme telle" (as such) is not in the public domain, confidentiality has not, in my opinion, been lost. Consider the exemption of solicitor-client privilege. Admittedly the analogy is not perfect as documents covered by solicitor-client privilege are subject to a discretionary exemption under section 23 of the Act, while third-party confidential information benefits from a mandatory exemption. A well thought-out brief on a case involving complex issues of fact and law is bound to make reference to cases previously decided. Nothing is more public than the decisions of our courts. Imagine if the head of a government institution deleted everything in the brief except the references to the court cases cited therein. The mere fact that certain cases were cited would give another party great insight. One case might deal with the best evidence rule, which would serve as an indication that a party may have difficulty proving its point. Couple this with cases dealing with hearsay and the other side to a dispute would have a tremendous advantage. This is what Heald D.J. had to say in Canadian Jewish Congress, at page 298 (quoting from Susan Hosiery Ltd. v. Minister of National Revenue, [1969] 2 Ex. C.R. 27, at page 33):
Turning to the "lawyer's brief" rule, the reason for the rule is, obviously, that, under our adversary system of litigation, a lawyer's preparation of his client's case must not be inhibited by the possibility that the materials that he prepares can be taken out of his file and presented to the court in a manner other than that contemplated when they were prepared. What would aid in determining the truth when presented in the manner contemplated by the solicitor who directed its preparation might well be used to create a distortion of the truth to the prejudice of the client when presented by someone adverse in interest who did not understand what gave rise to its preparation. If lawyers were entitled to dip into each other's briefs by means of the discovery process, the straightforward preparation of cases for trial would develop into a most unsatisfactory travesty of our present system.
These words have guided me in my review of the 549 pages.
[54]The importance of confidentiality cannot be overemphasized. Merck Frosst's competitor is just as able as Health Canada is to search the Internet for references to Singulair®. What it wants is "access to government information" (subsection 2(2)). What is the point of providing it with information that is available elsewhere?
[55]What is important here is the context in which the information is situated within the records held by the government.
[56]It has been well-established that documents produced during the discovery stage of litigation are subject to a confidentiality rule, until they are filed or read into the record in open court. In Home Office v. Harman, [1982] 1 All E.R. 532 (H.L.), Lord Diplock said at page 534:
What this case is about is an aspect of the law of discovery of documents in civil actions in the High Court. The practice of compelling litigating parties in the course of preparing for the trial of a civil action to produce to one another, for inspection and copying, all documents in their possession or control which contain information that may, either directly or indirectly, enable that other party either to advance his own cause or to damage the case of his adversary or which may fairly lead to a chain of inquiry which may have either of these two consequences, is peculiar to countries whose systems of legal procedure are inherited from the English courts of common law and from the Court of Chancery (in which discovery originated). [Emphasis added.]
[57]In N.M. Paterson & Sons Ltd. v. St. Lawrence Seaway Management Corp., the Court dealt with a contempt of court motion brought against a solicitor for providing information received during the discovery process to a newspaper. The defence was that the information was otherwise publicly available when disclosed, such that the implied obligation of confidentiality no longer applied. It was also argued that a document in question was central to the case and would inevitably be read in at trial. Although the incident giving rise to the litigation had generated considerable notoriety (a lift-bridge was lowered onto plaintiff's ship as she was passing through the Welland Canal), the actual documents in question, in their particular form, were not public. The Court upheld the contempt of court charge.
[58]Sexton J.A. speaking for the Court has this to say about the burden of proving that information was otherwise publicly available (at paragraph 12):
I also note that Mr. Marler's argument would place an impossible burden on the party attempting to establish that the implied obligation of confidentiality has been breached. That party would have to prove a negative by establishing that the document was not publicly accessible from any source whatsoever. Accordingly, once the necessary elements of the charge have been made out, the onus is on the person alleged to have breached the implied obligation of confidentiality to establish a defence that the information was otherwise accessible to the public. In my opinion, this is not an onerous burden. After all, before a person is justified in disclosing information received during the discovery process to a third party, that person must have knowledge that the information is otherwise publicly available. It should be relatively easy for that person to point to the source from which the information was accessible.
It is clear that the comprehensive summary, as such, is not publicly available.
[59]It has been said that the Access to Information Act aids industrial espionage. What about actual espionage? Consider the case of Boyer v. Regem, [1948] B.R. 829 (Que. C.A.). Boyer was convicted of conspiracy to violate The Official Secrets Act 1939 [S.C. 1939, c. 49] (now called the Security of Information Act, R.S.C., 1985, c. O-5 [s. 1 (as am. by S.C. 2001, c. 41, s. 25)]). He was charged with communicating information having or capable of having as its object, direct or indirect, use to a foreign power. Boyer did research work in inorganic chemistry pertaining to war projects and the chemistry of explosives. He was involved with an explosive known as RDX which had been known as a possible explosive since 1899, the preparation of which had remained a laboratory process. In 1930, a process of industrial manufacture was established and published. The accused searched for and found other easier processes of industrial manufacture which included combining RDX together with other materials well-known up to that time. His argument that he did not commit a crime by reason of the publicity then given to RDX fell on deaf ears.
THE 549 PAGES
[60]Although the documents, with the exception of the notice of compliance, all contained third-party confidential information, and as such are prima facie exempt from disclosure in accordance with section 20 of the Act (Canadian Jewish Congress, at pages 300-301), we must now consider whether non-confidential information can be severed, whether in the manner Health Canada thinks it can or, should I disagree with Merck Frosst's main argument that none of the information can reasonably be deleted, in accordance with the broader exemptions it urges as its secondary position. However, when all is said and done, my review should be considered a de novo review (Air Atonabee).
[61]Section 25 provides that information is to be disclosed if it can "reasonably be severed from any part that contains" exempted information. This is a manifestation of the overall philosophy of the Act. Exceptions to the right of access "should be limited and specific", as per subsection 2(1). As La Forest J. said in Dagg, at paragraph 80:
While it is true that Act speaks of access to a "record", I do not believe this should be interpreted as meaning only an entire physical document. Under any practical, contextualized definition, "record" would refer to a particular piece of information under the control of a government institution, regardless of whether that piece is located within a larger "document". If the physical nature of the document is such that non-personal information appears together with personal information, it generally should be possible to disclose only the non-personal portion of the document. As the Minister's actions demonstrate, it was possible in the instant case simply to excise the identification numbers and signatures from the sign-in logs. Indeed, s. 25 of the Access to Information Act requires the Minister to disclose any portion of a record that does not contain information that he is authorized to withhold, so long as the portion can reasonably be severed from any part that does contain such information.
[62]I have come to the conclusion that the comprehensive summary, the reviewer's notes and correspondence are exempt from disclosure in their entirety. I again rely on Canadian Jewish Congress Heald D.J. said at page 296:
Associate Chief Justice Jerome stressed the importance of the requirement that information only be disclosed if it could reasonably be severed in the decision of Canada (Information Commissioner) v. Canada (Solicitor General), wherein he stated the following:
| Indeed, Parliament seems to have intended that severance of exempt and non-exempt portions be attempted only when the result is a reasonable fulfillment [sic] of the purposes of these statutes. |
. . .
| Disconnected snippets of releasable information taken from otherwise exempt passages are not, in my view, reasonably severable. [Emphasis in Heald D.J. original.] |
[63]Although the comprehensive summary is set out in a form prescribed by Health Canada itself, and the index is in a required format, Merck Frosst has added some subtitles which would allow a competitor to have a better appreciation of what studies were carried out. The report includes tables of various studies. Parts of each page of these studies have been removed by Health Canada in virtue of paragraphs 20(1)(b) and (c). In some cases, all that is left is the number of the table. Even the nature of the study has been removed. However, there is no consistency. Great portions of the reviewer's notes of a deleted study remain intact. If the study is to be deleted, the reviewer's notes must be deleted as well. There have been various studies on humans and animals. Sometimes, the identity of an animal is masked. Why? Would a competitor be put on notice? To paraphrase Lord Diplock [in Harman], "might the deletion fairly lead to a chain of inquiry"? In one study, age ranges are given, but the upper end of the age range has been deleted from some of the tables.
[64]We are left with portions of sentences which are incomprehensible to me. If they are comprehensible to the requester, it is because it is able to connect the dots and gain insight not only from what has been disclosed, but also from what has been deleted.
[65]This review brings to mind the words of Lord Denning, M.R. in The Putbus, [1969] 2 All E.R. 676 (C.A.), at page 678:
I will not read the section. It is not a piece of English. It is only a collection of word-symbols.
[66]After having read the record, the question remains: what is the point?
CONCLUSION
[67]The review of the documents not released by Health Canada to the requester is covered by sections 28 and 44 of the Act. Section 44 is said by the respondent to be triggered by the notice given by the head of a government institution to a third party to show cause why the record or part thereof should not be disclosed. What about 14 of the 15 pages disclosed without notice, notwithstanding that in my view notice should have been given? Health Canada raised two objections to Merck Frosst's request that that decision be reviewed by this Court.
[68]The first objection was of a procedural nature. The Rules [Federal Court Rules, 1998, SOR/98-106] provide that unless the Court orders otherwise an application for judicial review shall be limited to a single order in respect of which relief is sought (rule 302). During the hearing I ordered that to the extent, if any, the communication to Merck Frosst by Health Canada on 11 September 2000 that 15 pages had been disclosed constituted a separate decision, Merck Frosst's application would cover it as well. To the extent the application might be tardy, an extension of time was given pursuant to rule 8.
[69]The more important issue is that Health Canada did not really give a notice of its decision to disclose part of the record. Rather, it informed Merck Frosst as a courtesy, as it took the position, wrongly, that it could release 15 pages from the record on the grounds that they did not contain confidential information. Can it be that the head of a government institution may make a decision which cannot be reviewed independently of government (section 2) simply by not giving a third party notice as contemplated by the Act? I emphasize that Health Canada's good faith is not in question, so that section 74 of the Act has no application. That section reads:
74. Notwithstanding any other Act of Parliament, no civil or criminal proceedings lie against the head of any government institution, or against any person acting on behalf or under the direction of the head of a government institution, and no proceedings lie against the Crown or any government institution, for the disclosure in good faith of any record or any part of a record pursuant to this Act, for any consequences that flow from that disclosure, or for the failure to give any notice required under this Act if reasonable care is taken to give the required notice.
[70]It must be remembered that procedure is the handmaiden to substance. Section 44 cannot be ousted because a notice which was not given should have been given. Indeed, it has been held that third parties may seek redress under section 44 even if the basis of their complaint is a section of the Act other than section 20 (Siemens Canada Ltd. v. Canada (Minister of Public Works and Government Services) (2002), 21 C.P.R. (4th) 575 (F.C.A.); H.J. Heinz Co. of Canada Ltd. v. Canada (Attorney General), [2005] 1 F.C.R. 281 (F.C.A.).
[71]Although the point is moot in the sense that the damage has already been done, since the severance of information from comprehensive summaries and related documents is bound to come up again, I declare that what was done should not have been done.
[72]Although third-party confidential information is not personal information within the meaning of the Act, in a broader sense such information is personal. The parties had much to say about striking a balance between the need to disclose and the right to privacy. However, the balance was struck by Parliament itself. To again draw upon the words of La Forest J. in Dagg, [at paragraph 45]:
This appeal involves a clash between two competing legislative policies--access to information and privacy. For obvious reasons, the appellant and respondent have opposing views as to which of these policies should prevail in this case. It should also come as no surprise that the litigants have markedly different conceptions of the statutes that embody those policies. Recognizing the conflicting nature of governmental disclosure and individual privacy, Parliament attempted to mediate this discord by weaving the Access to Information Act and the Privacy Act into a seamless code. In my opinion, it has done so successfully and elegantly. While the two statutes do not efface the contradiction between the competing interests--no legislation possibly could--they do set out a coherent and principled mechanism for determining which value should be paramount in a given case.
[73]"Privacy" has its own Act which sets out exceptions to the non-disclosure rule. Section 20 has its own exceptions built in. For this reason it was not necessary to consider the NAFTA submissions.
[74]All this talk of striking a balance brings back thoughts of Philosophy 101 and Aristotle's "virtue is a mean". Perhaps more thought should be given to Thomas Hobbes who said that life was "nasty, brutish and short". Life is not as nasty, not as brutish and not as short for countless Canadians and people worldwide thanks to modern wonder-drugs.
[75]To conclude (AB Hassle, at paragraph 4):
For this system to function effectively, the confidential nature of the relationship ought to be honoured and maintained to the extent possible.
ORDER
The application for judicial review is allowed. It is declared that with the exception of the notice of compliance, the Minister of Health's decision to provide the requester access to any part of the record it sought was invalid.
The Minister shall not disclose any other part of the requested record as the record in its entirety is exempt from disclosure pursuant to subsection 20(1) of the Access to Information Act.
The applicant shall have its costs.