Ottawa, Ontario, the 29th day of April, 2005
PRESENT: THE HONOURABLE MR. JUSTICE O'KEEFE
BETWEEN:
DR. SHIV CHOPRA, DR. MARGARET HAYDON,
DR. CHRIS BASUDDE and DR. GERARD LAMBERT
Applicants
- and -
- and -
PUBLIC SERVICE INTEGRITY OFFICER
Intervener
REASONS FOR ORDER AND ORDER
O'KEEFE J.
[1] This is an application for judicial review pursuant to section 18.1 of the Federal Courts Act, R.S., 1985, c.F-7, of a report by the Public Service Integrity Officer ("PSIO") dated March 21, 2003, concerning allegations by the four applicants of wrongdoing at Health Canada.
[2] The applicants seek:
1. An order allowing the application for judicial review, with costs;
2. An order setting aside the decision of the PSIO;
3. An order referring the matter back to the PSIO with the direction that the applicants' complaints be sustained;
4. In the alternative, an order referring the matter back to the PSIO with the direction that the applicants' complaints be reconsidered in a manner consistent with the reasons of the Court.
Background
[3] On April 22, 2003, the applicants filed a notice of application in respect of the PSIO report. By order dated December 15, 2003, the PSIO was granted leave to intervene for the purpose of explaining the record and speaking to his jurisdiction.
[4] The four applicants, Dr. Shiv Chopra ("Dr. Chopra"), Dr. Margaret Haydon ("Dr. Haydon"), Dr. Gerard Lambert ("Dr. Lambert") and Dr. Cris Bassude ("Dr. Bassude"), now deceased, are or were employees of the Veterinary Drugs Directorate ("VDD") of Health Canada.
[5] The PSIO is a federal investigative body created pursuant to a Treasury Board of Canada policy adopted in accordance with the Financial Administration Act, R.S.C. 1985, c. F-11. On November 30, 2001, the President of the Treasury Board issued the Policy on the Internal Disclosure of Information Concerning Wrongdoing in the Workplace (the "Policy"). On November 6, 2001, the Governor General in Council, through an order in council, appointed Dr. Edward Keyserlingk as the Public Service Integrity Officer.
[6] The policy objective is to allow federal public service employees to disclose information concerning allegations of wrongdoing, and to ensure that they are treated fairly and that they are protected from reprisal when they do so in a manner consistent with the policy. The PSIO's mandate under the policy is to "act as a neutral entity on matters of internal disclosure of wrongdoing".
[7] Wrongdoing is defined in the policy as an act or omission concerning: (a) a violation of any law or regulation; (b) a breach of the Values and Ethics Code for the Public Service (in effect as of September 1, 2003); (c) misuse of public funds or assets; (d) gross mismanagement, or (e) a substantial and specific danger to the life, health and safety of Canadians or the environment.
[8] In April 2002, Dr. Lambert voiced concerns about the approval of new drug submissions ("NDS") for five Component with Tylan (Tylosin) veterinary drugs without the required submission of human safety data. It was subsequently discovered that the then Chief of Human Safety Division had decided in 1998 that a review by the Human Safety Division was not required for Component with Tylan. After Dr. Lambert voiced his concerns, the VDD decided to assign drug evaluators to complete a Human Safety Division review of the submissions and to report thereafter. Following receipt of the Human Safety Division report, VDD management confirmed in mid-May that Notices of Compliance ("NOCs") would be issued.
[9] The applicants then made a joint complaint to the PSIO on May 31, 2002. Following that meeting, the applicants sent to the PSIO, a letter dated June 4, 2002 in which they stated their complaints as follows:
...We, the undersigned employees at Health Canada, are being pressured by our supervisors to pass or maintain a series of veterinary drugs without the required proof of human safety ...
and
... each one of us has been reprimanded with a clear message to convey that we must either tow [sic] the management line to favour the pharmaceutical lobby or face departmental punishment(s).
[10] They attached a partial collection of material relating to litigation between themselves and the Crown on employment-related issues, including selected pleadings and decisions in grievances and court and tribunal proceedings.
[11] The PSIO responded by letter dated June 5, 2002 advising that his office would review the June 4, 2002 letter and would let the applicants know as soon as possible whether there would be an investigation of one or more of the allegations of wrongdoing.
[12] On July 18, 2002, the PSIO met with the Director General of the VDD, Diane Kirkpatrick. On August 1, 2002, the PSIO again met with the applicants.
[13] On September 19, 2002, the PSIO met with two of the applicants and told them by letter dated the same day that the office would further examine the two allegations raised in the June 4, 2002 letter.
[14] The PSIO added:
At the heart of the matter is the quality of the veterinary drug submissions and the data requirements as well as the interpretation of these by various scientists. In respect to these allegations, my Office will further examine the drug approval and decision-making process, as it is this aspect of the internal disclosure that does not have any alternative recourse and is of greater public interest. Accordingly, my Office will be arranging to meet again with representatives from the Veterinary Drugs Directorate to review a sampling of drug submissions, including the Tylosin submission.
[15] The PSIO also informed the applicants in his September 19, 2002 letter that the office
would not be reviewing other issues and concerns for which there existed an alternative recourse such as the grievance procedure.
[16] The PSIO or his staff held meetings or had discussions with the applicants (including on November 6, 2002), and departmental staff (including on October 22, 2002, and November 13, 2002), at various times between September 19, 2002 and the release of the report sent to the applicants under cover of a letter dated March 21, 2003.
[17] After conducting an investigation, the PSIO found that the allegations submitted by the applicants were unfounded. However, the PSIO did find an instance of reprisal against Dr.Lambert.
The PSIO Report
[18] The PSIO examined the following three distinct allegations of wrongdoing:
1. That five new drug submissions ("NDS"), for Component with Tylan products, intended for administration to cattle, were approved by the VDD without human safety data, contrary to the Food and Drugs Act, R.S.C. 1985, c. F-27 (the "Act") and Food and Drug Regulations,C.R.C., c.870 (the "Regulations");
2. That VDD drug evaluators "are being pressured by supervisors to pass or maintain a series of veterinary drugs without the required proof of human safety"; and
3. That drug evaluators face departmental punishment if they do not "toe the management line to favour the pharmaceutical lobby".
The Report stated in part:
The First Allegation: Notices of Compliance For Five Component with Tylan Products were issued without Human Safety Data
When asked about the allegation, managers and other scientists from the VDD denied that there was any wrongdoing. They stated that, notwithstanding the March 1998 decision that no human safety evaluation would be conducted for the Component with Tylan products, when concerns were raised by Dr. Lambert on April 18, 2002, an examination of the decision, including a scientific review was undertaken and key issues and concerns were identified, assessed and reported on.
The Regulations: Requirements for the Approval of New Drugs
The PSIO stated that the primary responsibility of the Minister under the legislation is to ensure the safety and effectiveness of the new drug for its intended purpose before it is sold in Canada. After reviewing the Act and Regulations, the PSIO concluded that the Regulations provide a regulatory framework under which many aspects of the decision-making process, and the determination of the source and degree of information needed in an NDS, are left to the discretion of the Minister, as represented by the VDD.
In the present instance, the allegation alludes to the missing "human safety data" from the NDS filed by Elanco, and the issuance of the NOCs without regard for the data requirements, therefore constituting a violation of the Regulations. The complainants insisted that "human safety" data were to be provided by the manufacturer and that the VDD could not waive the requirement imposed on the manufacturer.
"Human safety data" is not expressly mentioned in the Regulations. The expression is found in the Preparation of Veterinary New Drug Submissions Guidelines issued by Health Canada that specify for manufacturers the types of studies and reports that are generally required as part of the 'human safety data'. The Guidelines do not appear to provide the discretion to allow a manufacturer to omit to the provision of the studies and reports in question.
Nevertheless, although the Guidelines are written in prescriptive language, they remain guidelines and do not have the same obligatory force as the Regulations. The Regulations are written in more general terms and are the source for the Minister's discretion. On this basis, it is concluded that the NOCs for the five Component with Tylan products were issued in accordance with the requirements of the Act and Regulations. Accordingly, the PSIO concluded that the allegation of wrongdoing by violating the law is unfounded.
[19] Accordingly, the PSIO concluded that the allegation of wrongdoing by violating the law is unfounded.
The Second Allegation: Pressure to Approve Veterinary Drugs of Questionable Safety
The complainants claimed that the pressure to approve drugs of questionable safety emanates from the highest levels in the government. They maintained that pharmaceutical companies and their associations lobby the Health and Industry Ministers, Treasury Board and Privy Council Office and that this pressure makes its way to them.
The complainants, however, did not provide any specific examples and instances in which supervisors had pressured them to approve certain veterinary drugs contrary to their scientific opinion. VDD representatives deny that the drug evaluators are pressured to approve veterinary drugs contrary to the legislation. . . . Other drug evaluator scientists interviewed by the PSIO denied that they faced any pressure to approve new veterinary drugs without a thorough scientific review and that only scientific considerations formed the basis of their recommendations
In conclusion, a review of the evidence provided did not support the allegation that there was pressure from supervisors to approve drugs contrary to scientific opinion.
The Third Allegation: Punishment for "Not Toeing the Management Line to Favour the Pharmaceutical Lobby"
The applicants provided examples of disciplinary actions imposed on them not simply as alleged evidence of unjustified punishments, but more explicitly and narrowly as proof that in their capacity as drug evaluators, they were punished for resisting undue pressure from the manufacturers, via Health Canada managers. The examples provided were not considered by this office from the more general perspective of whether they were justified or not for a variety of other reasons.
In view of the circumstances involved in the examples provided by the applicants, the disciplinary actions appear to this Office to have been administered for activities or conduct not directly related to their role as drug evaluators within the scope of their duties and expertise. Accordingly, there is no evidence that the disciplinary actions were for their refusal to "favour the pharmaceutical lobby".
An Instance of Job Reprisal
However, a review of the 'internal disclosure' regarding the Component with Tylan products was also undertaken. In this instance, it was found that Dr. Lambert was the subject of reprisal for having expressed his concerns with the Department and that such reprisals for good faith disclosures of wrongdoing are expressly prohibited.
Issues
[20] The applicants framed the issues as follows:
1. What is the standard of review?
2. Did the PSIO conduct this investigation in accordance with its mandate?
3. Did the PSIO respect the requirements of procedural fairness before making the decision?
Applicants' Submissions
Issue 1: The applicable standard of review
[21] The applicants submitted that after applying the pragmatic and functional approach, the PSIO report should be reviewed on a standard of correctness.
(i) Privative Clause
[22] The Policy contains no privative clause, nor is there any implied indication that decisions of the PSIO ought to be subject to any deference on judicial review. The PSIO is effectively a body which considers a broad range of general legal issues on an ad hoc basis. These factors strongly favour no deference on judicial review.
(ii) Expertise
[23] The PSIO has no particular expertise in the issues raised. The PSIO has been called upon to interpret and apply general questions of law with which the Court has far more expertise. As a general investigating body, the PSIO may be called upon to consider a variety of technical legal or scientific matters with which it has no particular expertise.
(iii) Purpose of the Policy and Nature of the Problem
[24] The Policy is designed to ensure that employees in the federal public service may reveal information regarding wrongdoing with an assurance that they will not be subject to reprisal. Given the significant issues which the PSIO is called upon to investigate and protect, and the wide-ranging impact of its decisions, it is imperative that its jurisdiction be exercised correctly to ensure that the goals of the Policy are achieved. This calls for close judicial scrutiny of the PSIO's activities.
[25] Given the scope of work performed by employees in the federal public service, it is inevitable that issues will arise which concern acts of wrongdoing which, if undetected, may have a serious adverse impact on the health, safety and well being of all Canadians.
[26] Finally, to the extent that this application raises questions of procedural fairness, its decisions ought not to be reviewed on anything other than a correctness basis.
Issue 2: Did the PSIO conduct this investigation in accordance with its mandate?
[27] The applicants submitted that although they maintained that several types of wrongdoing as specified in the Policy had occurred, the PSIO failed to investigate all of the types of wrongdoing which were alleged including, gross mismanagement and the substantial and specific danger to the life, health and safety of Canadians or the environment.
[28] The applicants submitted that the PSIO primarily inquired into whether there was a violation of any law or regulation. The PSIO inquired into whether there was legal authority to dispense with the requirements for human safety data. However, the PSIO failed to do a proper analysis or make any findings on the issue of whether Ministerial discretion was properly applied in this case.
[29] The PSIO further erred in failing to conduct an analysis of issues of gross mismanagement and danger to life, health and safety. A central aspect of the applicants' allegations was that the process for approving and maintaining drugs did not have proper regard to objective scientific concerns. An investigation of those concerns could have turned up serious evidence of wrongdoing, something which the PSIO is responsible for.
[30] The applicants submitted that contrary to the Act and Regulations and departmental policy and Guidelines, a manufacturer was advised in March 1998 that it did not need to submit human safety data. As a result, in 2002 five NOCs were issued without the manufacturer supplying human safety data.
[31] The applicants advised the PSIO that they were subject to retaliatory measures in the form of negative performance appraisals, harassment and other workplace actions which continued to take place even during the course of the PSIO investigation itself. However, the PSIO refused to determine whether these actions were appropriate The applicants submitted it was a legal error to fail to examine whether certain punishments were justified.
[32] The applicants submitted that while they maintained that there is a culture within the Department that results in indirect pressure to pass or maintain drugs of questionable safety, the PSIO erred by failing to inquire into the systemic or managerial practices which might result in this pressure, as is done in human rights cases.
[33] The applicants submitted that their concerns focussed on the process for approving a number of different drugs, including the Component with Tylan drugs. The PSIO, however, proceeded on the basis that the applicants' allegations were centred only on the Component with Tylan drugs. The PSIO therefore failed to fully investigate the applicants' allegations or ignored relevant evidence in support of them.
Issue 3: The PSIO failed to respect the requirements of procedural fairness before making the decision.
[34] The applicants submitted that as the PSIO process consists of an investigation that culminates in a final decision with no interim step such as the preparation of an investigator's report which could be commented on, or, which could lead to a recommendation to hold a full hearing on the matter, the duty of procedural fairness clearly applies throughout the investigation stage.
[35] The content of the duty of procedural fairness is informed by the nature of the rights which are affected. As the allegations of wrongdoing are being exposed in the workplace context, the result of any PSIO decision will clearly affect the rights of the employee, the employer and the public. When the employee is not permitted to know, or respond to relevant submissions put forward by the employer, the employee has been denied his or her right to procedural fairness.
[36] The applicants were not informed of a substantial amount of the relevant factual information gathered by the PSIO and relied upon its decision. Consequently, they had no opportunity to respond to the allegations therein. The PSIO decision was therefore reached in violation of the requirements of procedural fairness, and ought to be set aside for this reason alone.
[37] The applicants submitted that in light of all the errors, it is imperative that this decision be set aside with specific directions as to the manner in which such an investigation ought to be conducted in this case and in the future.
Respondent's Submissions
Issue 1: The applicable standard of review
[38] The respondent submitted that the PSIO should be reviewed on a standard of patent unreasonableness or in the alternative, reasonableness simpliciter.
(i) Privative Clause
[39] The respondent submitted that since the PSIO makes a non-binding recommendation under a policy, there is no privative clause. In the statutory context, the Supreme Court of Canada has described the lack of a privative clause as a neutral factor.
(ii) Expertise
[40] In establishing the Office of the PSIO, Parliament contemplated that it would be a centre of expertise - both as a third-party resource for employees to go to for assistance in making disclosures, and as a professional screener and investigator of complaints in order to make recommendations to deputy heads on how to address problems in their departments. It is submitted that a high degree of deference is therefore appropriate on this ground.
(iii) Purpose of the Policy and Nature of the Problem
[41] The purpose of the Policy is not to determine rights or provide a mechanism for adjudication between parties in litigation. The work of the PSIO in processing a disclosure is fact-intensive and case-specific. The overall purpose of the Policy and role of the PSIO should incline the Court towards a high degree of deference in determining whether to intervene.
[42] The PSIO examined the allegations related to the drug approval process from the perspective of the legal and regulatory process for drug approvals under the Act and Regulations. It found that the NOCs for the Component with Tylan products had been issued in accordance with the Regulations. The PSIO therefore made findings of fact, and to the extent that it was called upon to interpret the legislative scheme, also made findings of mixed fact and law. For questions of mixed fact and law, more deference is called for if the question before a tribunal is fact-intensive, and less deference if it is law intensive. The highly discretionary and fact-based nature of the PSIO's work militates in favour of deference by the reviewing Court.
[43] In the alternative, should the Court decide to apply the standard of reasonableness simpliciter, the Court should ask itself whether the decision-maker's conclusions have "some basis in the evidence". The reviewing Court should stay close to the reasons given by the tribunal and look to see whether any of those reasons adequately support the decision.
Issue 2: The PSIO conducted the investigation in accordance with its mandate
[44] The respondent submitted that the applicants argued that the PSIO, having found that the Reguilations permit the exercise of discretion in determining what data are required for new drug submissions, failed to make a finding as to whether the discretion was properly exercised in the present case, specifically, with respect to the Component with Tylan (Tylosin) issue in May 2002.
[45] The respondent submitted that no finding on discretion is strictly necessary. Once the PSIO had answered the threshold question in the affirmative, that there was discretion under the Regulations as to what data to require, there was no need for him to ask himself the further question as to whether the Minister's discretion had been properly exercised in the instant case. Having said that, however, and in any event, the PSIO did make a finding that the discretion to approve the new drug submission was appropriately exercised in this case.
[46] The respondent submitted that the applicants themselves, in their complaint to the PSIO, expressed the issue as pressure on them to "pass or maintain a series of veterinary drugs without the required proof of human safety". The PSIO was entitled to determine how he would approach the file. Flexibility is built into the framework of the Policy. The same reasoning applies to the applicants' argument that the PSIO failed to address their scientific concerns.
[47] The respondent submitted that the applicants had defined the central issue at the outset of the investigation as being pressure on them to approve drugs without proof of human safety. The PSIO told them that his office was not going to look into matters for which there existed an alternative recourse. The materials provided by the applicants to the PSIO show that the applicants were aware of the legal recourses open to them for workplace-related complaints, and pursued those recourses.
[48] The PSIO determined a basis for not including certain matters in his investigation and supported it with reasons. It is submitted that this decision was reasonable and supportable and ought not give rise to review.
[49] The respondent submitted that the role of the PSIO is not to conduct a free-ranging inquiry into everything that might have happened in the Department over an indeterminate number of years which might amount to pressure on someone. The original complaint from the applicants was that ",,, we, the undersigned employees at Health Canada, are being pressured by our supervisors...". The PSIO followed-up by asking the applicants to provide concrete and up-to-date examples of pressure on them personally. The applicants did not provide any specific examples. The PSIO was therefore entitled to refine and focus the investigation.
Issue 3: The PSIO provided the appropriate level of procedural fairness
[50] The respondent submitted that under the Policy, the PSIO does not adjudicate rights or determine disputes in an adversarial context. Administrative action outside an adversarial context attracts a lower level of procedural fairness.
[51] The respondent submitted that the PSIO and his staff met with the applicants on a number of occasions. The PSIO and his staff went to considerable effort to clarify the concerns of the applicants and to keep them informed. No greater level of procedural fairness was required under the Policy. To impose on the Policy a requirement that the PSIO provide employees with copies of all material reviewed by the PSIO in the course of his investigation would be to create a level of procedural formalism inconsistent with the purpose of the Policy.
[52] The respondent requested that the application be dismissed with costs.
Intervener's Submissions
[53] The Policy delineates the responsibilities of the PSIO in exercising his jurisdiction. Among them, the PSIO receives, records and reviews disclosures of wrongdoing; protects from reprisal employees who disclose information concerning wrongdoing in good faith and receives complaints in that regard made by employees; establishes if there are sufficient grounds for further action and review; initiates investigation when required; and, prepares reports and recommendations.
[54] Appendix B to the Policy sets out in general terms, the administrative and investigative process to be followed by the PSIO leaving him with broad discretion with respect to the conduct of an investigation. The Policy does not provide additional guidance regarding the conduct of an investigation of wrongdoing by the PSIO, and moreover, it does not impose any rules or procedures to be followed.
[55] Following an investigation, the Policy stipulates that the PSIO will prepare a report, including recommendations to the concerned deputy head, and how to address or correct the matter that triggered the disclosure. The decision to take action or not, and to follow or not the recommendation of the PSIO, is entirely that of the deputy head.
[56] The nature of the PSIO jurisdiction is investigative and not adjudicative. As an investigative body, the PSIO does not issue a final decision and can neither decide, nor adjudicate, upon the rights of employees under review.
[57] The PSIO was given broad discretion under the Policy to determine the exercise of his jurisdiction. The exercise of this discretion must be made in good faith, relying upon relevant considerations within the scope of the jurisdiction.
[58] This Court has recognized that procedural obligations on an administrative entity may vary with the circumstances.
[59] In the conduct of an investigation, the PSIO will gather information, interview departmental representatives and employees and seek documents and other material. The PSIO considers the information and evidence provided by the employees making the disclosure in support of their allegations, as well as information from various other sources, including interviews with departmental colleagues, management representatives and experts, and other information in the public domain.
Relevant Statutory Provisions
[60] The relevant sections of the Food and Drugs Act Regulations, supra state:
| C.08.001. For the purposes of the Act and this Division, "new drug" means
. . .
(b) a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or
C.08.002. (1) No person shall sell or advertise a new drug unless
(a) the manufacturer of the new drug has filed with the Minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the Minister;
(2) A new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following:
. . .
(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug.
C.08.003.1. The Minister may examine any information or material filed with the Minister by any person pursuant to Division 5 or section C.08.002, C.08.002.1, C.08.003, C.08.005 or C.08.005.1 to establish the safety and effectiveness of the new drug for which the submission or supplement has been filed.
. . .
C.08.004(3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of a new drug submission or an abbreviated new drug submission or a supplement to either submission,
(a) if that submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or
(b) if that submission or supplement does not comply with the requirements of section C.08.002, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, notify the manufacturer that the submission or supplement does not so comply. |
|
C.08.001. Pour l'application de la Loi et du présent titre, « drogue nouvelle » désigne:
. . .
b) une drogue qui entre dans une association de deux drogues ou plus, avec ou sans autre ingrédient, qui n'a pas été vendue dans cette association particulière, ou dans les proportions de ladite association pour ces drogues particulières, pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de cette association ou de ces proportions employées comme drogue; ou
C.08.002. (1) Il est interdit de vendre ou d'annoncer une drogue nouvelle, à moins que les conditions suivantes ne soient réunies :
a) le fabricant de la drogue nouvelle a, relativement à celle-ci, déposé auprès du ministre une présentation de drogue nouvelle ou une présentation abrégée de drogue nouvelle que celui-ci juge acceptable;
(2) La présentation de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment:
. . .
n) dans le cas d'une drogue nouvelle destinée à être administrée à des animaux producteurs de denrées alimentaires, le délai d'attente applicable.
C.08.003.1. Le ministre peut examiner les renseignements ou le matériel que lui présente toute personne, conformément au titre 5 ou aux articles C.08.002, C.08.002.1, C.08.003, C.08.005 ou C.08.005.1, pour déterminer l'innocuité et l'efficacité de la drogue nouvelle visée par la présentation ou le supplément.
. . .
C.08.004(3) (3) Sous réserve de l'article C.08.004.1, après avoir terminé l'examen des renseignements et du matériel supplémentaires déposés relativement à une présentation de drogue nouvelle, à une présentation abrégée de drogue nouvelle ou à un supplément à l'une de ces présentations, le ministre:
a) si la présentation ou le supplément est conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, et à l'article C.08.005.1, délivre un avis de conformité;
b) si la présentation ou le supplément n'est pas conforme aux articles C.08.002, C.08.002.1 ou C.08.003, selon le cas, ou à l'article C.08.005.1, en informe le fabricant. |
Analysis and Decision
[61] Issue 1
What is the standard of review?
Applying the pragmatic and functional analysis (see Dr. Q. v. College of Physicians and Surgeons of British Columbia, [2003] 1 S.C.R. 226), I am of the view that the standard of review on this matter, with the exception of procedural fairness, would be reasonableness simpliciter. (i) Privative Clause
There is no privative clause or right of appeal. In this case, that is a neutral factor.
(ii) Expertise
The PSIO has no expertise as compared to the Court in its review of the Act and Regulations, and the extent of the Minister's discretion. Accordingly, no deference is due in that respect. However, the PSIO engages in both discretionary complaint screening and a fact intensive investigation. That element would result in a higher level of deference. The elements of the process which involve mixed fact and law, such as determining the application of statutory or regulatory provisions to the facts would result in some deference.
(iii) Purpose of the Policy
The purpose of the policy is to provide a mechanism to look into allegations of wrongdoing in the Public Service. While the process is fact driven, it also potentially involves issues and questions of wider public interest. Accordingly, some deference is due to the PSIO.
(iv) Nature of the Problem
The nature of the problem is both public and private. The public aspect involves the issue of whether the PSIO properly exercised its prerogative in looking into allegations of wrongdoing, including allegations of the Minister's failure to protect the public. The personal aspect involves the allegations of reprisals against the applicants resulting from their actions as whistleblowers. Accordingly, on this factor, some deference is owed to the PSIO.
[62] Other than on the question of procedural fairness of which the correctness standard always applies, I would find that a balancing of the four factors results in a standard of review of reasonableness simpliciter in this case.
[63] Issue 2
Did the PSIO conduct this investigation in accordance with its mandate?
The responsibilities of the PSIO include the responsibility to initiate investigations when required, to review the results of the investigations, to prepare reports and to make recommendations to deputy heads on how to address or correct the disclosure of wrongdoing. It seems to me that this would dictate that the PSIO must undertake a complete investigation of the issues raised by the applicants. The PSIO report at page 1 states the allegations of wrongdoing that were examined by him:
1. It was alleged that five new drug submissions (NDS), for Component with Tylan products, intended for administration to cattle, were approved without human safety data, contary to the Food and Drugs Act, supra and Regulations, supra.
2. It was alleged that VDD drug evaluators "are being pressured by supervisors to pass or maintain a series of veterinary drugs without the required proof of human safety."
3. It was alleged that drug evaluators face departmental punishment if they do not "toe the management line to favour the pharmaceutical lobby."
The substance and parameters of the applicants' complaints were arrived at through a series of meetings between the applicants and the PSIO. At their May 31, 2002 meeting, the applicants indicated that Component with Tylan was only one recent example of problems with the drug approval process, but they also gave the examples of the drugs Baytril and rBST (also known as rBGH).
[64] Step 4 of the Policy states:
If the matter cannot be solved, the Public Service Integrity Officer may initiate an investigation.
The Public Service Integrity Officer may decide to investigate right after the preliminary review of the disclosure.
The Policy does not provide any further detail concerning the conduct of the investigation.
[65] As stated in the policy, the PSIO has a mandate to investigate a number of categories of wrongdoing set out in the policy and the applicants contend that their allegations engaged at least three categories of wrongdoing that were identified in the Policy:
(a) a violation of any law or regulation;
(b) gross mismanagement; or
(c) a substantial and specific danger to life, health and safety of Canadians or the environment.
[66] Dr. Chopra stated in his affidavit at paragraph 8:
On May 31, 2002, we had our first meeting with Dr. Keyserlingk, Public Service Integrity Officer; Pierre Martel, Director of the PSIO and a third unidentified official. At that meeting Dr. Keyserlingk observed that he was new to the position and was not even certain if the PSIO was the "right" institution to deal with the matter. His fundamental concern was that there had to be a public interest component to our complaint in order to give the PSIO jurisdiction to investigate. At the meeting we discussed the following issues with the PSIO:
(a) That we had come to the PSIO in good faith at the direction of the president of PIPSC.
(b) That the Public Service Staff Relations Board had informed us that a public interest inquiry was not within their mandate.
(c) That our complaint, although containing allegations concerning us, was not a personal complaint but was being made in the public interest.
(d) That our complaint would also include any retaliatory measures taken against us by Health Canada Management in consequence to our complaint to the PSIO.
(e) That our complaint concerned the manner in which the VDD was approving certain hormones, antibiotics and combinations of the two and was comprised of three components:
i) we were concerned the approval process was not being applied with due diligence as required under the legislation.
ii) we were concerned with the integrity of the approval process which we believed was counter to the law.
iii) we were concerned that the approval process at the VDD was not being applied in a diligent and ethical manner.
(f) That the approval process applied to the Component with Tylan submissions was only one recent example of a pattern that had existed since the early 1990s.
(g) That the PSIO should familiarize itself with the following reports and documents:
a) Baytril: On the Roadblocks to the Human Safety Review, October 26, 2000", which is not in the PSIO investigation file.
b) The interim report of the Standing Sentate Committee of Agriculture and Forestry titled, "rBST and the Drug Approval Process", which is in the PSIO investigation file.
c) The transcripts of testimony before the Senate Standing Committee on Agriculture and Forestry by myself, Dr. Haydon, and Dr. Lambert, which is not in the PSIO investigation file.
d) The transcripts of testimony that Dr. Haydon, Dr. Basudde, Dr. Rajinder Sharma, Dr. Vilim, Dr. Lambert, Dr. Sudarshan Malik and myself gave before the Standing Senate Committee on Privileges, Standing Rules and Orders, which are not in the PSIO investigation file.
[67] Paragraph 21 of the applicants' memorandum of fact and law reads:
During the series of meetings with the PSIO on August 1, 2002, September 4, 2002, September 19, 2002, November 6, 2002, December 5, 2002, January 31, 2003, February 7, 2003, and through documentary submissions, the Applicants provided the PSIO with details of the following allegations:
(a) Problems with the drug approval processes for all of the following drugs: Revalor H, Synergistin Injectable Suspension, Baytril, rBST (rBGH) (particularly the Standing Senate Committee on Agriculture and Forestry Investigation), Carbodex, Baycox, Component with Tylan, and Eugenol.
. . .
[68] Paragraph 19 of Dr. Chopra's affidavit reads in part as follows:
On September 4, 2002 myself, the three evaluators and Martin Ranger, a PIPSC official, met with Judith Buchanan and Pierre Martel of the PSIO. At that meeting the following issues were raised:
a) . . .
b) . . .
c) I requested that there be a clear investigatory process consisting of taped interviews of all parties involved and the mutual opportunity to comment on the various representations made to the PSIO.
d) . . .
e) The specific drugs discussed at the meeting were rBST, Baytril, Revalor H, and C Component with Tylan.
f) The issue that all these veterinary pharmaceuticals had in common was that the VDD failed to follow the relevant human safety requirements of the Food and Drugs Act and Regulations.
g) . . .
h) The necessity of meeting with Dr. Keyserlingk personally to determine exactly how the PSIO investigation was to take place and precisely what it would be investigating.
[69] The applicants were concerned that the PSIO was limiting its investigation to only the Component with Tylan submissions instead of addressing the basis of their complaint which dealt with many more drugs.
[70] The applicant, Dr. Chopra stated at paragraph 23 of his affidavit:
On September 29, 2002, Dr. Keyserlingk and Ms. Buchanan met with myself and Dr. Haydon. At the meeting, Dr. Keyserlingk agreed that the scope of the investigation would initially include files concerning Component with Tylan and Baytril and then expand into other files and issues. It was agreed the allegations involving personnel issues would not be investigated unless they were directly relevant to the PSIO investigation. Specific issues relevant to our complaint that were as follows:
a) Our concerns were with human safety issues due to the approval of hormones, antibiotics, and a combination of the two for use in food producing animals.
b) rBGH was a prime example of the manner in which the approval process at the BVD was compromised contrary to the Food and Drugs Act and Regulations.
c) The manner in which the approval process for the veterinary drugs in question was being conducted could entail criminal sanctions being brought against everyone involved.
d) Our complaint involved the duly required human safety data under the Act and Regulations and not whether the drugs in question had been approved by other jurisdictions external to Canada.
[71] After the meeting of September 19, 2002, the following e-mails were exchanged:
1. E-mail dated September 20, 2002 at 7:28 a.m. from Dr. Chopra to Dr. Basudde:
Subject: Meeting Notes Re: PSIO investigation
The subject meeting was granted in response to our earlier request to meet with Dr. Keyserlingk of PSIO, prior to their investigation of our allegations of wrongdoing at Health Canada.
Date: September 19, 2002
Time: 11.00
Duration: 40 minutes
Present:
PSIO: Edward Keyserlingk, Judith Buchanan
"Alligators": Shiv Chopra, Margaret Haydon
As generally agreed, only Shiv and Margaret attended this meeting. Neither Cris nor Gerard and nor any PIPSC representative could attend. This was because the meeting was quickly organized at the request of PSIO saying that they wished to proceed with the investigation no later than the next week and that Dr. Keyserlingk was only available to meet with us on Thursday or Friday of the current week.
The reason for our request to meet with Dr. Keyserlingk was to establish a common understanding of both the scope and recording procedures of the proposed investigation.
Conclusions
Scope
The scope of the investigation will involve a thorough examination of the VDD's regulatory approval process in which Tylosine and Baytril files will be reviewed as the primary examples. The ultimate focus of this review will be to investigate public health impacts due to the use of growth hormones and antibiotics in food-producing animals.
Unless relevant to the regulatory process, no investigation will be pursued about the specific allegations involving a personal or personnel management of VDD employees.
Recording Procedures
A thorough examination and notes of the relevant VDD files on the regulatory approval of the various drug submissions and issues.
Tape recorded interviews with both the "alligators" and VDD management. Tapes to be retained by PSIO for their own reference only.
Shiv Chjopra, Margaret Haydon
2. E-mail from Dr. Lambert to Dr. Chopra dated September 23, 2002 at 10:34 a.m.:
Subject: Re: Meeting Notes Re: PSIO Investigation
Shiv thank you for your message but I suggest that the following changes are made. Under scope add a thorough examination of the VDD's and Health Canada regulatory approval process which Tylosin and Baytril (enrofloxacin) will be reviewed as the primary examples. etc
Recording Procedures
Tape recorded interviews with both the "alligators" and senior Health Canada management. etc
3. E-mail from Dr. Haydon to Dr. Keyserlingk (PSIO) dated September 24, 2002:
Subject: Re: Meeting Notes Re: PSIO Investigation
Dr. Keyserlingk;
Further to our meeting of September 19, 2002, please see our report to our colleagues and some additional comments from each of them. We trust that you are in agreement.
Margaret Haydon
4. E-Mail from Dr. Keyserlingk to the applicants dated September 24, 2002:
Dr. Haydon:
Thank you for your helpful note, report and comments from colleagues sent on September 24.
My only comment concerns one minor point in your report. I would remind you and your colleagues that the reason for the meeting was that I was told Dr. Chopra wished to meet me, and with some urgency. Since I knew I would be unavailable during the following week, the meeting had to arranged [sic] in a degree of haste to accommodate him and avoid delay.
Best Regards, EWK
Edward W. Keyserlingk
Public Service Integrity Officer
Government of Canada
The above excerpts persuade me that the report was to deal with more than just the issue of five new drug submissions for Component with Tylan products.
[72] A review of the investigation report shows that in regard to the first allegation, the PSIO only did an analysis with respect to drug products known as Component with Tylan. The applicants had alleged to the PSIO, however, that there were problems with the drug approval processes for the following drugs: Revalor H, Synergistin Injectable Suspension, Baytril, rBST (rBGH), Carbodex, and Eugenol.
[73] While the PSIO can decide whether a matter fits within the parameters of his jurisdiction, once he decides that it does, he must carry out an investigation of the issues. The correspondence satisfies me that the investigation was to include an investigation of the processes in more than Component with Tylan drugs. The issue of the other drugs was clearly before the PSIO and needed to be dealt with. I have no way of knowing what conclusions would have been reached by the PSIO had these other issues been considered.
[74] A consideration of these other drugs and issues raised by the applicants could have an effect on the second allegation, the pressure to approve veterinary drugs of questionable safety. For example, with respect to Baytril, the PSIO was asked to look at the October 26, 2000 report entitled, "Baytril: On the Roadblocks to the Human Safety Review", yet this document was not in the PSIO investigation file.
[75] Dr. Chopra gave the example of Health Canada's "Internal rBST Gaps Analysis Report" of which he was the primary author, and whose test he alleged he was asked to alter by BVD management. This document was not mentioned in the report. Dr. Chopra indicated that the PSIO staff were not concerned with rBST as it had not been approved. A review and analysis of this issue could have had an effect on the PSIO's decision. As no analysis was done, or consideration given to this issue, there is no way to know the effect, if any, it might have had.
[76] I am of the opinion that the PSIO's failure to address the concerns of the applicants that I have mentioned in these reasons caused the PSIO to err in law. The PSIO failed to conduct the investigation in accordance with its mandate in that it failed to investigate and analyze those issues.
[77] Because of my finding on this issue, I need not address the other issues raised by the applicants.
[78] The applicants' application for judicial review is allowed, the report of the PSIO is set aside and the matter is referred back to the PSIO for reconsideration.
[79] The applicants shall have their costs of the application.
ORDER
[80] IT IS ORDERED that:
1. The applicants' application for judicial review is allowed, the report of the PSIO is set aside and the matter is referred back to the PSIO for reconsideration.
2. The applicants shall have their costs of the application.
J.F.C.
Ottawa, Ontario
April 29, 2005
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-624-03
STYLE OF CAUSE: DR. SHIV CHOPRA, DR. MARGARET HAYDON,
DR. CHRIS BASUDDE and
DR. GERARD LAMBERT
- and -
ATTORNEY GENERAL OF CANADA
- and -
PUBLIC SERVICE INTEGRITY OFFICER
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: November 2, 2004
REASONS FOR ORDER AND ORDER OF: O'KEEFE J.
APPEARANCES:
David Yazbeck
Linda Wall
Jean-Daniel Bélanger
FOR INTERVENER
SOLICITORS OF RECORD:
Raven, Allen, Camberon & Ballantyne
Ottawa, Ontario
John H. Sims, Q.C.
Deputy Attorney General of Canada
Public Service Integrity Office
Ottawa, Ontario
FOR INTERVENER