Apotex Inc. v. Canada (Health)

Apotex Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2017-03-27
Neutral citation
2017 FC 315
File numbers
T-1915-15
Decision Content
Date: 20170327
Docket: T-1915-15
Citation: 2017 FC 315
Ottawa, Ontario, March 27, 2017
PRESENT: The Honourable Mr. Justice Russell
BETWEEN:
APOTEX INC.
Applicant
and
MINISTER OF HEALTH AND ATTORNEY GENERAL OF CANADA
Respondents
JUDGMENT AND REASONS
I. INTRODUCTION
[1] This is an application under s 18.1 of the Federal Courts Act, RSC 1985, c F-7 [Act] for judicial review of a decision of the Therapeutic Products Directorate of Health Canada [TPD] made in the Fall of 2015 [Decision], to continue an earlier decision of November 17, 2014, which required Apotex Inc. [Apotex] to provide certain additional information to TPD prior to TPD completing its review of Notice of Compliance [NOC] submissions for approval of certain new products that were manufactured or tested at two of Apotex’s manufacturing facilities in India, Apotex Pharachem India Pvt. Ltd. [APIPL] and Apotex Research Private Limited [ARPL]. At this time, Apotex is seeking an order from the Court:
(a) quashing the decision of the Minister of Health [Minister] to refuse to end her prohibition on granting a NOC for products manufactured at ARPL or having active pharmaceutical ingredients sourced from APIPL;
(b) in the nature of mandamus that all other submissions for products manufactured at ARPL or having active pharmaceutical ingredients sourced from APIPL be reviewed without requiring Apotex to provide further evidence to refute the same purported data integrity concerns upon which the Minister relied to ground her decision to impose the Import Ban that Justice Manson quashed in his decision of August 14, 2015; and
(c) awarding Apotex its costs of the within application.
II. BACKGROUND
A. Regulatory Regime
[2] The Food and Drugs Act, RSC 1985, c F-27 [FD Act] and the Food and Drugs Regulations, CRC, c 870 [Regulations] govern the manufacture, import, and sale of all drug products in Canada. Various guidelines and policies of Health Canada also help to interpret the FD Act and Regulations. Pursuant to the FD Act and Regulations, a manufacturer must obtain a NOC to sell or market a new drug in Canada. The Minister issues a NOC when satisfied that the manufacturer’s abbreviated new drug submission [ANDS] is in compliance with the Regulations, which requires the manufacturing process to adhere to mandatory standards and the new drug to be safe, effective, and adequately labelled as per the Regulations.
[3] In reviewing an ANDS, TPD relies on data generated by the drug manufacturer that sponsors the submission. In the event that an ANDS is deficient or lacks sufficient information, TPD may elect to issue a Clarifax, Notice of Non-Compliance, or Notice of Deficiency. All three issuances request additional information from the sponsor and provide an opportunity to respond to concerns. Additionally, when a new generic drug is awaiting the expiry of a patent or data protection period, it may be put on intellectual property hold [IP Hold].
B. The Parties
[4] The Applicant, Apotex, is the largest pharmaceutical manufacturer in Canada and is affiliated with the Indian companies APIPL and ARPL. APIPL produces active pharmaceutical ingredients [APIs] and ARPL produces finished dosage form [FDF] pharmaceutical products, both of which are purchased and imported by Apotex into Canada.
[5] The Respondent Minister is responsible for administering the FD Act and Regulations. Health Canada is the delegate responsible for regulating drug products in Canada and consists of various branches, including: the Minister and Minister’s Office; the Health Products and Food Branch, which includes the Inspectorate, the branch responsible for compliance and enforcement activities and oversight of establishment licensing for health products [Establishment Licence]; the Regions and Programs Bureau [RAPB], which inspects domestic and foreign facilities to evaluate Good Manufacturing Practices [GMP] compliance; and TPD, which issues NOCs.
C. The Facts
[6] In January 2014, the United States Food and Drug Administration [FDA] found issues concerning data integrity at APIPL during an inspection. The FDA found similar issues at ARPL during a later inspection in June 2014, although a joint inspection conducted by Health Canada and the United Kingdom’s Medicines and Health Regulatory Agency in February 2014 did not yield any data integrity issues. The issues identified by the FDA involved problematic laboratory practices; namely, investigating or reporting out-of-specification results, including re-testing a failing product until a passing result was achieved without addressing why initial test results had failed.
[7] Apotex acknowledged the data integrity issues and provided the Inspectorate with the FDA’s report of the ARPL inspection, referred to as a “Form 483”. The observations in the Form 483 gave rise to concerns about the reliability of test results. In response, Apotex advised the Inspectorate it would conduct a complete data review and assessment of the laboratory practices at ARPL, including retrospective reviews and unannounced internal audits.
[8] After discussions with Apotex, Health Canada concluded that all finished products containing APIs from APIPL should be re-tested in Canada to ensure health and safety. Subsequent on-site inspections in August 2014 also did not yield critical deficiencies that required immediate corrective actions. Meanwhile, TPD continued to issue NOCs for products that incorporated APIs made at APIPL, including a NOC for Apo-Linezolid issued August 18, 2014.
[9] On September 11, 2014, the Canadian media criticized APIPL and ARPL and suggested that Health Canada’s failure to implement measures against the companies put the health of Canadians at risk. As the negative publicity grew, the Minister demanded that action be taken against Apotex by relevant branches of Health Canada.
[10] TPD says it became aware of the data integrity issues at APIPL and ARPL on September 23 or 24, 2014 when the then-Director General of TPD, Barbara Sabourin, received a telephone call and an electronic copy of the Form 483 from a colleague at the Inspectorate. Shortly after, on September 30, 2014, the Inspectorate modified Apotex’s Establishment Licence to include a restriction against the importation of finished commercial drug products from APIPL and ARPL [Import Ban]. However, Apotex’s ANDSs were not initially affected, as TPD continued to review Apotex’s submissions, including those incorporating data from APIPL and ARPL.
[11] Subsequently, a draft NOC for Apotex’s Apo-Rasagiline was delivered to Ms. Sabourin. Since the ANDS for Apo-Rasagiline indicated that APIPL and ARPL would be responsible for manufacturing the drug product and release testing the substance, Ms. Sabourin declined to sign the draft NOC and telephoned the CEO and President of Apotex, Dr. Jeremy Desai, to discuss her concerns regarding the potential compromised reliability of the data in the Apo-Rasagiline ANDS on November 17, 2014. During this conversation, Ms. Sabourin informed Dr. Desai that NOCs would not be issued for submissions containing data from APIPL and ARPL until further notice [November 2014 Decision]. Further discussions took place and TPD continued to work through its reviews of ANDSs containing data from APIPL and ARPL, as indicated by a letter dated December 9, 2014 sent by TPD to Apotex that requested additional information.
[12] Meanwhile, Apotex implemented corrective and preventative action [CAPA] to address the concerns regarding data integrity at APIPL and ARPL. In May 2015, Apotex reported that it would recall 8 batches of finished commercial products as a result of unreported deviations and withdraw or amend 9 ANDSs made to the FDA due to unreported tests. Furthermore, the report acknowledged that 5 ANDSs submitted to Health Canada were affected by unreported tests. Apotex also committed to a retrospective data integrity review on its Empower 3 computer system, which contains data generated from September 2013 onwards. A review of the preceding computer system, Empower 2, has not yet been completed. The data on Empower 2 was used in two of Apotex’s ANDSs for Varenicline and Sitagliptin, which have not yet received NOCs because their submissions contained data from 2013.
[13] In June 2015, TPD conducted further inspections of the APIPL and ARPL facilities for the purpose of assessing the extent to which Apotex had successfully carried out its proposed CAPA. These inspections resulted in reports indicating that although the system controls and modified procedures satisfactorily addressed the data integrity concerns, additional supervision would be necessary to demonstrate sustainability and effectiveness at times of increased production. Additionally, the reports found that oversight was required because Apotex’s retrospective review of data generated before the conclusion of the June 2015 inspections were still ongoing. Overall, TPD’s recommendation conveyed that the inspection did not identify any instances of data integrity violations that had been observed during the June 2014 FDA inspection.
[14] Throughout 2015, TPD continued to send individual requests to Apotex for additional information for ANDSs containing data from APIPL and ARPL. However, in January 2015, TPD had developed an overarching policy regarding its approach to managing submissions containing data from sites where the integrity of data had been called into question. All drug manufacturers were eventually formally notified of this policy on May 22, 2015.
[15] Following the sufficient progress of Apotex’s CAPA, the Inspectorate advised Apotex by letter dated August 31, 2015 that it had amended the terms and conditions of Apotex’s Establishment Licences [August 2015 Decision]. This amendment removed the additional information requirement for ANDSs using data performed at the two sites after the June 2015 inspection, but continued to require additional information for any data from the sites prior to June 2015 which had not been reviewed. This date was later rolled back to January 2015.
[16] In the midst of these events, Apotex sought judicial review of two decisions rendered by the Inspectorate: the Import Ban and the August 2015 Decision. In a decision dated October 14, 2015, Justice Manson found that the Import Ban was motivated by the Minister’s improper purpose of quelling criticism in the media and in the House of Commons, rather than a legitimate concern for protecting Canadians’ health and safety, and that it was imposed without affording the procedural fairness required in the circumstances. Consequently, the Court quashed the Minister’s decision to impose the Import Ban. See Apotex Inc v Canada (Minister of Health), 2015 FC 1161 at paras 95-121 [Apotex 2015].
[17] Similarly, the August 2015 Decision was quashed by Justice Manson in a judgment issued June 15, 2016: see Apotex Inc v Canada (Minister of Health), 2016 FC 673 [Apotex 2016]. Justice Manson found that the decision could not stand as lawful when the close interconnection between the Import Ban and the August 2015 Decision was coupled with a dearth of evidence before the Minister that supported any reasonable belief that further restrictions on Apotex’s Establishment Licences were necessary in August 2015. The August 2015 Decision was determined to be tainted by the improper purpose that led to the quashing of the Import Ban.
[18] However, TPD’s additional information requirements for ANDSs involving APIPL and ARPL’s 2013 data did not change in the face of the aforementioned judicial review decisions or the Inspectorate’s decision to lift the restrictions on Apotex’s Establishment Licences on March 14, 2016. TPD took the position that since the decisions did not address the reliability of submission data generated at APIPL or ARPL prior to the implementation of Apotex’s CAPA, a change of policy was not required, which was communicated by Ms. Sabourin to Apotex at some point in the fall of 2015 [Fall 2015 Decision]. Instead, a fresh review conducted by TPD’s new Director General, Marion Law, found that additional information on a case-by-case basis was still necessary. Ms. Law outlined these reasons in a letter to Dr. Desai dated July 8, 2016 [July 2016 Decision].
III. DECISION UNDER REVIEW
[19] The Decision under review is the decision of the Minister of Health made in the Fall of 2015, and continued by Ms. Law in July 2016, to refuse to end her prohibition on granting a NOC for certain products manufactured at ARPL or having active pharmaceutical ingredients sourced from APIPL. Apotex says that the Decision continues an earlier decision made in November 2014 by TPD that was improperly made as a consequence of the Import Ban that Justice Manson struck down in Apotex 2015, above.
[20] In a telephone call between Ms. Sabourin and Dr. Desai on November 17, 2014, TPD informed Apotex that TPD would not be issuing NOCs for submissions containing products from APIPL or ARPL until further notice due to the data integrity concerns perceived by inspectors from the FDA. Ms. Sabourin advised Dr. Desai that TPD would work through the reviews of Apotex’s ANDSs and communicate any specific questions through the normal procedure.
[21] In effect, then, the subject of this judicial review comprises of three related decisions rendered by TPD that comprise a continuous course of conduct: the November 2014 Decision, the Fall 2015 Decision, and the July 2016 Decision.
[22] The November 2014 Decision consists of communications conducted via a telephone call and a face-to-face meeting. On November 17, 2014, in a telephone call between Ms. Sabourin and Dr. Desai, TPD informed Apotex that TPD would not be issuing NOCs for submissions containing products from APIPL or ARPL until further notice due to the data integrity concerns perceived by inspectors from the FDA. Ms. Sabourin advised Dr. Desai that TPD would work through the reviews of Apotex’s ANDSs and communicate any specific questions through the normal procedure. In a face-to-face meeting on November 27, 2014, TPD informed Apotex that TPD would not be issuing NOCs for submissions containing products from APIPL or ARPL unless additional information was provided to satisfy the data integrity concerns.
[23] The Fall 2015 Decision consists of two communications conducted via email and letter. In an email dated October 15, 2015, Ms. Sabourin informed Apotex that TPD would need to perform an analysis and understand the implications of Apotex 2015 prior to moving forward. A few months later, in a letter stamped December 17, 2015, Ms. Sabourin informed Apotex that TPD would continue to require additional information for products from APIPL and ARPL manufactured prior to June 10, 2015.
[24] The July 2016 Decision refers to a letter dated July 8, 2016, in which TPD took the position that, following a fresh review, additional information on a case-by-case basis was still necessary for submissions containing data generated at APIPL or ARPL prior to Apotex’s corrective and preventative actions, which was in accordance with the general policy communicated by TPD to all drug manufacturers in January 2015. In the letter, Ms. Law explained that the reason additional information would continue to be required was based on the fact that approximately 30 of Apotex’s other submissions containing data from APIPL or ARPL prior to January 2015 required additional information to address data integrity concerns. As a result, retrospective data analysis for submissions containing data from APIPL or ARPL prior to January 2015 would continue to be needed.
IV. ISSUES
[25] Apotex submits that the following are at issue in this application:
Did the Minister act unlawfully in the fall of 2015 in refusing to end the prohibition on granting NOCs for products manufactured or tested at APIPL or ARPL unless and until Apotex provided further evidence respecting data integrity at those two facilities?
Is the Minister continuing to act unlawfully in refusing to grant NOCs for products manufactured or tested at APIPL or ARPL unless and until Apotex provides further evidence respecting data integrity at those two facilities?
If the Minister’s continued requirement of further evidence respecting data integrity generated at APIPL and ARPL prior to January 2015 is not sufficiently related to the Import Ban and August 2015 decisions that were quashed or the November 14 Decision, is it reasonable?
[26] The Respondent submits the following are at issue in this application:
What is the nature of the administrative action under review?
What is the appropriate standard of review?
Is TPD’s policy of requiring additional information to confirm the reliability of data from APIPL and ARPL reasonable?
Is Apotex entitled to orders in the nature of mandamus compelling the Minister to return certain drugs to IP Hold?
V. STANDARD OF REVIEW
[27] The Supreme Court of Canada in Dunsmuir v New Brunswick, 2008 SCC 9 [Dunsmuir] held that a standard of review analysis need not be conducted in every instance. Instead, where the standard of review applicable to a particular question before the court is settled in a satisfactory manner by past jurisprudence, the reviewing court may adopt that standard of review. Only where this search proves fruitless, or where the relevant precedents appear to be inconsistent with new developments in the common law principles of judicial review, must the reviewing court undertake a consideration of the four factors comprising the standard of review analysis: Agraira v Canada (Public Safety and Emergency Preparedness), 2013 SCC 36 at para 48.
[28] Apotex submits that the November 2014 communications between Ms. Sabourin and Dr. Desai constituted a decision that is not sufficiently independent from the Import Ban, which was quashed on October 14, 2015. An assessment of whether a decision is unlawful on the basis of its close connection to a prior decision that has been quashed is subject to the standard of correctness: Apotex Inc v Canada (Minister of Health), 2016 FC 673. Alternatively, if the November 2014 Decision is sufficiently independent, Apotex submits that the November 2014 Decision and its continued enforcement is subject to the standard of reasonableness. Similarly, if TPD’s current policy of additional requirements imposed on submissions containing data generated from APIPL and ARPL before January 2015 is sufficiently independent from the November 2014 Decision, Apotex submits that it is subject to the standard of reasonableness.
[29] The Respondent submits that the standard of review is reasonableness because the matter at issue is TPD’s policy for submissions with data integrity concerns, which is part of the regulatory scheme governing the issue of NOCs. This is an exercise of the Minister’s broad discretion under s C.08.002.1(3) of the Regulations and must be accorded considerable deference: Apotex Inc v Canada (Minister of Health), 2009 FC 452 at para 23; Pharmascience Inc v Canada (Attorney General), 2008 FCA 258 at para 4.
[30] In my view, the assessment of whether a decision under review should be unlawful based on its proximity to a quashed decision is a legal question and should be reviewed using a correctness standard, particularly if the facts demonstrate the decision under review amends, carries forward, and maintains a decision that was quashed on the basis of unfair implementation and improper purpose: see Apotex 2016 at para 45.
[31] If the decisions at issue are not tainted by the quashed decision, then the Minister’s continuing requests for additional data should be reviewed on a reasonableness standard.
[32] When reviewing a decision on the standard of reasonableness, the analysis will be concerned with “the existence of justification, transparency and intelligibility within the decision-making process [and also with] whether the decision falls within a range of possible, acceptable outcomes which are defensible in respect of the facts and law.” See Dunsmuir, above, at para 47, and Canada (Minister of Citizenship and Immigration) v Khosa, 2009 SCC 12 at para 59. Put another way, the Court should intervene only if the Decision was unreasonable in the sense that it falls outside the “range of possible, acceptable outcomes which are defensible in respect of the facts and law.”
VI. STATUTORY PROVISIONS
[33] The following provisions from the Regulations are relevant in this proceeding:
New Drugs
Drogues nouvelles
C.08.002.1 (1) A manufacturer of a new drug may file an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for the new drug where, in comparison with a Canadian reference product,
C.08.002.1 (1) Le fabricant d’une drogue nouvelle peut déposer à l’égard de celle-ci une présentation abrégée de drogue nouvelle ou une présentation abrégée de drogue nouvelle pour usage exceptionnel si, par comparaison à un produit de référence canadien :
(a) the new drug is the pharmaceutical equivalent of the Canadian reference product;
a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien;
(b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics;
b) elle est bioéquivalente au produit de référence canadien d’après les caractéristiques pharmaceutiques et, si le ministre l’estime nécessaire, d’après les caractéristiques en matière de biodisponibilité;
(c) the route of administration of the new drug is the same as that of the Canadian reference product; and
c) la voie d’administration de la drogue nouvelle est identique à celle du produit de référence canadien;
(d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product.
d) les conditions thérapeutiques relatives à la drogue nouvelle figurent parmi celles qui s’appliquent au produit de référence canadien.
(2) An abbreviated new drug submission or an abbreviated extraordinary use 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:
(2) La présentation abrégée de drogue nouvelle ou la présentation abrégée de drogue nouvelle pour usage exceptionnel doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle, notamment :
(a) the information and material described in
a) les renseignements et le matériel visés :
(i) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), in the case of an abbreviated new drug submission, and
(i) aux alinéas C.08.002(2)a) à f), j) à l) et o), dans le cas d’une présentation abrégée de drogue nouvelle,
(ii) paragraphs C.08.002(2)(a) to (f), (j) to (l) and (o), and subparagraphs C.08.002.01(2)(b)(ix) and (x), in the case of an abbreviated extraordinary use new drug submission;
(ii) aux alinéas C.08.002(2)a) à f), j) à l) et o) et aux sous-alinéas C.08.002.01(2)b)(ix) et (x), dans le cas d’une présentation abrégée de drogue nouvelle pour usage exceptionnel;
(b) information identifying the Canadian reference product used in any comparative studies conducted in connection with the submission;
b) les renseignements permettant d’identifier le produit de référence canadien utilisé pour les études comparatives menées dans le cadre de la présentation;
(c) evidence from the comparative studies conducted in connection with the submission that the new drug is
c) les éléments de preuve, provenant des études comparatives menées dans le cadre de la présentation, établissant que la drogue nouvelle :
(i) the pharmaceutical equivalent of the Canadian reference product, and
(i) d’une part, est un équivalent pharmaceutique du produit de référence canadien,
(ii) where the Minister considers it necessary on the basis of the pharmaceutical and, where applicable, bioavailability characteristics of the new drug, bioequivalent with the Canadian reference product as demonstrated using bioavailability studies, pharmacodynamic studies or clinical studies;
(ii) d’autre part, si le ministre l’estime nécessaire d’après les caractéristiques pharmaceutiques et, le cas échéant, d’après les caractéristiques en matière de biodisponibilité de celle-ci, est bioéquivalente au produit de référence canadien selon les résultats des études en matière de biodisponibilité, des études pharmacodynamiques ou des études cliniques;
(d) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and
d) les éléments de preuve établissant que les lots d’essai de la drogue nouvelle ayant servi aux études menées dans le cadre de la présentation ont été fabriqués et contrôlés d’une manière représentative de la production destinée au commerce;
(e) for a drug intended for administration to food producing animals, sufficient information to confirm that the withdrawal period is identical to that of the Canadian reference product.
e) dans le cas d’une drogue destinée à être administrée à des animaux producteurs de denrées alimentaires, les renseignements permettant de confirmer que le délai d’attente est identique à celui du produit de référence canadien.
(3) The manufacturer of a new drug shall, at the request of the Minister, provide the Minister, where for the purposes of an abbreviated new drug submission or an abbreviated extraordinary use new drug submission the Minister considers it necessary to assess the safety and effectiveness of the new drug, with the following information and material:
(3) Le fabricant de la drogue nouvelle doit, à la demande du ministre, lui fournir, selon ce que celui-ci estime nécessaire pour évaluer l’innocuité et l’efficacité de la drogue dans le cadre de la présentation abrégée de drogue nouvelle ou de la présentation abrégée de drogue nouvelle pour usage exceptionnel, les renseignements et le matériel suivants :
(a) the names and addresses of the manufacturers of each of the ingredients of the new drug and the names and addresses of the manufacturers of the new drug in the dosage form in which it is proposed that the new drug be sold;
a) les nom et adresse des fabricants de chaque ingrédient de la drogue nouvelle et les nom et adresse des fabricants de la drogue nouvelle sous sa forme posologique proposée pour la vente;
(b) samples of the ingredients of the new drug;
b) des échantillons des ingrédients de la drogue nouvelle;
(c) samples of the new drug in the dosage form in which it is proposed that the new drug be sold; and
c) des échantillons de la drogue nouvelle sous sa forme posologique proposée pour la vente;
(d) any additional information or material respecting the safety and effectiveness of the new drug.
d) tout renseignement ou matériel supplémentaire se rapportant à l’innocuité et à l’efficacité de la drogue nouvelle.
VII. ARGUMENTS
A. Applicant
(1) Connection between the November 2014 Decision and the Import Ban
(a) Initial Submissions from November 2016
[34] Apotex submits that the November 2014 Decision (the effects of which have been continued by TPD in its refusal to end its prohibition on granting NOCs for products manufactured or tested at APIPL or ARPL) was not sufficiently independent of the unlawful Import Ban. While Ms. Sabourin asserts that the November 2014 Decision was solely connected to significant data integrity concerns and was not attributable to the Import Ban, this evidence is not credible for several reasons and should be rejected.
[35] First, all communications between Ms. Sabourin and Apotex regarding the November 2014 Decision began with a reference to the Import Ban.
[36] Second, TPD’s regulatory stance remained aligned with that of the Inspectorate’s until March 14, 2016, when the Inspectorate lifted all terms and conditions, while TPD continued to enforce the additional information requirement.
[37] Third, although Ms. Sabourin claims the November 2014 Decision was based solely upon concerns in the FDA’s Form 483s, other facts contradict the assertion that those concerns were serious enough to warrant a refusal to issue NOCs: TPD was aware of the FDA’s Form 483s, yet did not take any regulatory action for at least six months; Ms. Sabourin’s affidavit and cross-examination contradict when she first learned about the data integrity concerns; and TPD continued to grant NOCs for products manufactured at APIPL despite having knowledge of the Form 483s.
[38] Fourth, Ms. Sabourin’s testimony contains further inconsistencies that cast doubt on the Respondent’s position, including purporting to give evidence as to the reasons for the Import Ban when she had no involvement in the decision to impose the Import Ban.
[39] Fifth, Ms. Sabourin could not remember details and appeared to reconstruct events during her cross-examination.
[40] Sixth, despite a limited recollection of the facts and events at issue, Ms. Sabourin did not try to refresh her recollection by speaking with other TPD officials or by reviewing notes and other material related to the facts and events.
[41] Seventh, the complete lack of documentation evidencing deliberations for the November 2014 Decision indicates that Ms. Sabourin was merely following the Minister’s directive to take “stronger measures” against APIPL and ARPL.
[42] As the credibility of Ms. Sabourin’s evidence is disputed for the foregoing reasons, Apotex says that her assertion that the November 2014 Decision is unconnected to the Import Ban is not credible. The evidence suggests that the two decisions are linked and, since administrative decisions founded upon underlying decisions that are quashed cannot stand, neither can the Minister’s refusal to rescind the November 2014 Decision: Thambithurai v Canada (Minister of Citizenship and Immigration), 2006 FC 751 at paras 17 and 18.
(b) Further Submissions in February 2017
[43] Following the November 2016 hearing of this matter, additional evidence was produced and Apotex made further submissions regarding the connection between the November 2014 Decision and the Import Ban as well as the credibility of Ms. Sabourin’s evidence.
[44] The additional evidence is as follows: Ms. Sabourin recalled two telephone calls immediately preceding the November 2014 Decision. The first call involved a conference between TPD and officials from the Assistant Deputy Minister’s Office [November 10 Call], most notably Dr. Supriya Sharma, who was primarily responsible for the Import Ban. The second call involved only Ms. Sabourin and Dr. Sharma [November 14 Call]. Additionally, emails regarding this time period were also discovered.
[45] Apotex submits that the additional evidence supports a connection between the November 2014 Decision and the Import Ban. With regards to the decision-maker, Apotex contends that Dr. Sharma is responsible for both decisions. First, Dr. Sharma was significantly involved in both decisions, even though it is unusual for her to be involved in TPD’s NOC deliberations. Second, an email from one of Ms. Sabourin’s senior advisors confirmed that on the day of the November 2014 Decision, “Barb talked to Supriya and was told she couldn’t sign it.” Third, the reasons underlying both decisions are premised on the same data integrity concerns.
[46] As for the motivation underlying the decisions, Apotex submits they are also the same. First, an analysis of the issues facing TPD with regards to the Import Ban identified adverse media reports as a potential risk; this is notable because it constitutes the improper purpose that led the Import Ban to be quashed. Second, in the same analysis, the risk to public health and safety was not considered to be a matter of serious concern. This parallels the Import Ban since this Court found that the decision-makers did not consider health and safety to necessitate the Import Ban. Third, communications between TPD officials demonstrate that there were concerns regarding the prohibition of products from sites that retained GMP-compliant ratings, which was one of the key concerns of the Import Ban.
[47] Returning to the matter of Ms. Sabourin’s credibility, Apotex submits that the additional evidence further demonstrates the unreliability of the testimony that Ms. Sabourin provided. In her testimony regarding the November 2014 Decision, Ms. Sabourin did not recall either telephone call or Dr. Sharma’s involvement. Apotex contends that such a material omission from evidence going to a central issue of the case should give serious doubts about the reliability of the witness’ evidence. Additionally, Ms. Sabourin also did not recall other relevant conversations or events that were the subject of the new emails.
(2) Reasonableness of the November 2014 Decision
[48] Alternatively, Apotex submits that the November 2014 Decision was unreasonable.
[49] The decision was made with an overwhelmingly narrow focus and should not be considered reasonable. Despite the existence of a vast quantity of relevant evidence such as emails, memos, and letters exchanged between Apotex and Health Canada, Ms. Sabourin only reviewed the FDA’s Form 483 and Health Canada’s draft exit notice prior to rendering the November 2014 Decision. Ms. Sabourin also did not consult with the officials at RAPB who had conducted the inspections at APIPL and ARPL, or the officials at the Inspectorate that imposed the Import Ban.
(3) Reasonableness of the Continued Application of the 2014 Decision
[50] The Minister has not adduced any evidence as to why data integrity packages continue to be required for new products manufactured at ARPL or having active pharmaceutical ingredients sourced from APIPL. Ms. Sabourin is unable to provide insight on the matter and the Respondent has refused requests to examine other individuals who may have more knowledge on the matter, such as the current Director General of TPD. The complete lack of evidence demonstrates that there is no basis for the continued insistence on data integrity packages and, as such, the decision should be quashed as unreasonable.
B. Respondent
(1) Nature of the Administrative Action under Review
[51] The Respondent submits that the purported November 2014 Decision and its continuation is not a decision or administrative action that is amenable to judicial review. At the time of the telephone call between Ms. Sabourin and Dr. Desai on November 17, 2014, TPD was still developing an approach to submissions containing data from foreign sites with data integrity concerns. Policy development continued after the telephone call and was finalized in January 2015. As such, a direct challenge to the telephone call is precluded by the doctrine of prematurity, upon which courts will not interfere with ongoing administrative processes until they are complete, absent exceptional circumstances: Canada (Border Services Agency) v CB Powell Limited, 2010 FCA 61 at para 31.
[52] The matter at issue is actually TPD’s overarching data integrity policy which requires additional information to confirm the integrity of data from APIPL and ARPL. While an ongoing policy is subject to judicial review at any time, internal departmental policies do not attract a duty of procedural fairness or a duty to give reasons and are entitled to significant deference.
(2) Reasonableness of the Data Integrity Policy
(a) Initial Submissions in November 2016
[53] The Respondent submits that the policy is reasonable and contains no reviewable error.
[54] The Minister, and consequently TPD as the appointed delegate, has broad discretion to request any additional information considered necessary to assess the safety and effectiveness of a proposed new drug. TPD’s ongoing policy of requiring additional information to confirm the reliability of pre-January 1, 2015 data generated at APIPL and ARPL represents a reasonable response to a complex problem and does not warrant court intervention. The policy is supported by multiple reasons: the FDA made observations of problematic testing at these two sites, including re-testing failed results without reporting the prior failures; Dr. Desai acknowledged during cross-examination that only a specific, individual investigation into problematic testing could confirm whether the data was reliable, which is effectively what TPD requests in the additional data integrity packages; Apotex’s review of data acknowledged 5 Canadian submissions were affected by the data integrity problems; Apotex made modifications due to issues with data integrity in submissions where data integrity confirmation was requested; and TPD is unable to independently confirm the reliability of the data in submissions that may have been affected by the problematic testing.
[55] The policy is not unreasonably onerous for Apotex. TPD employs its own resources to review submissions on a case-by-case basis and to request additional information rather than rejecting submissions outright. These additional information requests are not limited to Apotex and apply to other drug manufacturers’ products as well.
[56] The requests for additional information were and are motivated by the same data integrity concerns which led to the imposition of the Import Ban, but not by the Import Ban itself. Ms. Sabourin’s notes from the call do not demonstrate that TPD acted solely on the basis of the Import Ban; instead, the notes reference “signification [sic] data integrity issues as perceived by inspectors from the US FDA” and Ms. Sabourin’s concerns about the integrity of the data contained in Apotex’s submissions. The evidence does not suggest that Ms. Sabourin was pressured by the Minister or was acting for an improper purpose. Instead, Ms. Sabourin took careful consideration of the matter: she asked her subordinates to review the matter; she convened a meeting of scientists to advise on how to handle concerns about the integrity and reliability of data in submissions; she drew her concerns regarding data integrity to Apotex’s attention upon reviewing a draft NOC on November 17, 2014; and she met with Apotex to discuss the matter. Months later, these considerations culminated in a policy that provided Apotex with notice of its concerns and an opportunity to respond.
(b) Further Submissions in February 2017
[57] Following the second hearing, the Respondent made further submissions regarding the additional evidence, documentary production and evidence, and clarification of prior evidence.
[58] With regards to the impact of the additional evidence, the Respondent submits that it is limited, entirely consistent with the original evidence, and immaterial. The Respondent contends that the November 10 Call is consistent with Ms. Sabourin’s evidence that: the analysis of the data integrity issues began in September 2014; her staff was developing a policy for submissions with data from affected sites before November 13, 2014; regular meetings concerning the policy and data integrity issues were held; and the affected sites were not limited to Apotex sites. The notes from the November 10 Call discussed data integrity concerns involving a variety of drug companies. Additionally, Ms. Sabourin’s inability to recall the November 10 Call is not surprising for the reason that her testimony was not delivered until 18 months afterwards.
[59] Likewise, the November 14 Call does not demonstrate any inappropriate influence on Ms. Sabourin’s decision-making. Ms. Sabourin testified that it was not unusual to consult with Dr. Sharma on a difficult file given that Dr. Sharma had held the same position of Director General of TPD. Moreover, Ms. Sabourin believes the November 14 Call likely involved d