Apotex Inc. v. Canada (Health)

Apotex Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2013-12-23
Neutral citation
2013 FC 1217
File numbers
T-942-12
Decision Content
Date: 20131223
Docket:
T-942-12
Citation: 2013 FC 1217
Ottawa, Ontario, December 23, 2013
PRESENT: The Honourable Madam Justice Kane
BETWEEN:
APOTEX INC.
Applicant
and
MINISTER OF HEALTH and
ATTORNEY GENERAL OF CANADA
Respondents
PUBLIC REASONS FOR JUDGMENT AND JUDGMENT
(Confidential Reasons for Judgment and Judgment Issued December 4, 2013)
[1] This is an application for judicial review of a decision of the Director General of the Therapeutic Products Directorate [TPD] of Health Canada on behalf of the Minister of Justice, dated April 12, 2012, which refused to review the Abbreviated New Drug Submission [ANDS] of Apotex for a Notice of Compliance [NOC] for its generic drug, Apo-Telmisartan.
Overview
[2] Health Canada regulates and oversees the drug submission process in Canada. Drug manufacturers, such as the applicant, are required to file a New Drug Submission [NDS] or an Abbreviated New Drug Submission [ANDS] pursuant to the Food and Drug Regulations, CRC, c 870 [Regulations] enacted pursuant to the Food and Drugs Act, RSC 1985, c F-27 [the Act], in order to have a new drug product approved. The Minister of Health may then issue a Notice of Compliance for the drug, in accordance with the Regulations, if the drug is deemed to be safe and effective.
[3] Telmisartan is an angiotensin receptor blocker used for the treatment of hypertension. It is marketed under the brand name Micardis which is the Canadian Reference Product [CRP] or, in other words, the original product on the market. Several generic versions (also referred to as second entry products) have been approved.
[4] Apotex seeks to market its generic version of Micardis, which is Apo-Telmisartan, and cannot do so until it receives a NOC. Apotex submits that Apo-Telmisartan is pharmaceutically equivalent to the CRP (Micardis).
[5] Apotex submits that the only medicinal ingredient in its product is telmisartan, but notes that the non-medicinal ingredients or excipients include potassium hydroxide. Like Micardis, Apo-Telmisartan is made by a wet granulation process which may cause the medicinal ingredient to interact with an excipient.
[6] Apotex notes that an acid-base chemical reaction may take place in Micardis given the non-medicinal ingredient in that product is sodium hydroxide and some portion is converted to a salt form of telmisartan which would be telmisartan-sodium in the finished tablet (as disclosed in the Screening Rejection Letter). Once ingested, the two disassociate and the telmisartan (i.e. the medicinal ingredient) is absorbed in the body.
[7] In the Apotex product, potassium hydroxide is used. Through the wet granulation process the acid-base chemical reaction may take place converting some of the telmisartan into a salt form of telmisartan which would be telmisartan-potassium. Again, once ingested, the two disassociate and the telmisartan (i.e. the medicinal ingredient) is absorbed in the body.
[8] Apotex agrees that the non-medicinal ingredients differ, but emphasizes that the medicinal ingredient, as the term “ingredient” should be understood, is identical in substance and in quantity; it is telmisartan.
[9] The TPD, which makes the decision on behalf of the Minister of Health, determined that the finished product differs because Micardis is in fact telmisartan-sodium and Apo-Telmisartan is in fact telmisartan-potassium. The Minister has taken the position that the medicinal ingredient found in the finished product or dosage forms must be identical to the CRP.
[10] Apotex submits that this interpretation differs from earlier interpretations and the approval process of other generic manufacturers. In other words, Apotex’s position is that it has been treated differently and held to a different and unprecedented interpretation of the provisions and definitions in the Regulations than other generic drug manufacturers.
[11] Apotex raised two key issues: whether the Minister of Health erred in interpretation of “identical medicinal ingredient” in the definition of “pharmaceutical equivalent” and whether the Minister breached the duty of procedural fairness in the approval process, in particular, by not adhering to the Reconsideration Policy.
[12] As a preliminary issue, the Minister of Health moved to strike two affidavits submitted by Apotex on this application.
[13] For the reasons that follow, the application for judicial review is allowed. The affidavits sought to be admitted by the applicant are admitted in part. Although there were some irregularities in the approval process and in the application of the Reconsideration Policy, these irregularities, on their own or cumulatively, do not result in a breach of procedural fairness. With respect to the decision of the Minister, and acknowledging that deference is owed to the Minister’s decision, which in such matters is delegated to and made by the Director General [DG] of the Therapeutics Products Directorate [TPD] of Health Canada, the decision is not reasonable. The interpretation advanced by the TPD to support the rejection of the ANDS does not reflect the principles of statutory interpretation. In addition, it is apparent that Apotex has been subjected to a different interpretation and treatment than other generic drug manufacturers. The questions put to the Reconsideration Panel were narrowed and avoided the key issue raised by Apotex. The Panel’s recommendation for more clarity in the definitions highlights the very issue Apotex sought to have addressed. While the position of the Minister may be preferable from a policy perspective, there must be a consistent approach to the ANDS process which cannot be achieved if the Minister may interpret the regulations differently based on the particular circumstances or chemical composition of the drug in question. The position advanced by the Minister should and could be clearly reflected in the Regulations if this is indeed what the Minister intends to be the policy.
The Regulatory scheme
[14] The respondent notes that the regulatory scheme has been accurately summarised in Reddy-Cheminor Inc v Canada (Attorney General), 2003 FCT 542, 233 FTR 271 [Reddy-Cheminor] by Justice Layden-Stevenson, and I have, therefore, set out the relevant paragraphs (6-12):
[6] The relevant provisions of the Regulations are attached to these reasons as Schedule "A". Reference to specific provisions will be included herein as required for ease of reference and convenience. Subsection 30(1) of the FDA authorizes the Governor-in-Council to enact regulations with respect to, among other things: the sale of any drug; the method of manufacture, preparation and testing of any drug in the interest of or for the prevention of injury to the health of the purchaser or consumer; the method of manufacture, preparation, preservation, packing, storing and testing of any new drug; the sale or the conditions of sale of any new drug and defining, for purposes of the Act, the expression "new drug". The provisions regarding new drugs are contained in Division 8, Part C of the Regulations.
[7] It is common ground that drug manufacturers are prohibited from advertising or selling a new drug in Canada without obtaining a NOC. To seek a NOC, a manufacturer files a drug submission with the Minister (in practice, TPD Health Canada) pursuant to Division 8, Part C of the Regulations. Specifically, subsection C.08.002(1) provides that no person shall sell a new drug unless the manufacturer has filed a NDS or an ANDS that is satisfactory to the Minister and has obtained a NOC.
[8] Subsection C.08.002(2) delineates the content requirements of a NDS. The NDS must include, among other things, detailed reports of the tests conducted to establish the safety of the new drug for the purpose and under the conditions recommended, as well as substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended. The evidence indicates that this information is typically voluminous, ranging from 100 to 300 volumes of data.
[9] A different form of drug submission is available to manufacturers who wish to copy a marketed drug without having to provide the voluminous detailed reports and substantial data demonstrating clinical safety and effectiveness. This form of submission is known as an ANDS. The ANDS requires the use of a Canadian reference product i.e., a drug for which safety and efficacy have already been demonstrated. The Canadian reference product is typically a brand-name drug and the proposed generic copy is required to be the pharmaceutical equivalent. The generic manufacturer uses the Canadian reference product to demonstrate bioequivalence rather than making a direct assessment of the clinical safety or efficacy of the generic drug on the basis of extensive clinical studies.
[10] Specifically, subsection C.08.002.1(1) provides that a manufacturer may file an ANDS for a new drug where, in comparison with a Canadian reference product, the new drug is the pharmaceutical equivalent of the Canadian reference product. In general, the two products must be bioequivalent, the route of administration must be the same, and the conditions of use of the new drug must fall within those approved for the Canadian reference product.
[11] Subsection C.08.002.1(2) outlines the submission content requirements for an ANDS. An ANDS must include sufficient material for the Minister to assess the safety and efficacy of the new drug. This includes, but is not limited to, material to establish that the new drug is the pharmaceutical equivalent of the Canadian reference product and, where the Minister considers it necessary, material to demonstrate that the drugs are bioequivalent, including the evidence from any studies conducted to demonstrate pharmaceutical equivalence and bioequivalence. The terms "Canadian reference product" and "pharmaceutical equivalent" are defined in section C.08.001.1, which reads as follows:
Canadian reference product" means
(a) a drug in respect of which a notice of compliance is issued pursuant to section C.08.004 and which is marketed in Canada by the innovator of the drug,
(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued pursuant to section C.08.004 cannot be used for that purpose because it is no longer marketed in Canada, or
(c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph (a);
"pharmaceutical equivalent" means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients;
"specifications" means a detailed description of a new drug and of its ingredients and includes
(a) a statement of all properties and qualities of the ingredients that are relevant to the manufacture and use of the new drug, including the identity, potency and purity of the ingredients,
(My emphasis)
« produit de référence canadien » Selon le cas :
a) une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 et qui est commercialisée au Canada par son innovateur;
b) une drogue jugée acceptable par le ministre qui peut être utilisée pour la détermination de la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, lorsqu'une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 ne peut être utilisée à cette fin parce qu'elle n'est plus commercialisée au Canada;
c) une drogue jugée acceptable par le ministre qui peut être utilisée pour la détermination de la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, par comparaison à une drogue visée à l'alinéa a).
« équivalent pharmaceutique » S'entend d'une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d'ingrédients médicinaux identiques, sous des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux.
« spécifications » S'entend de la description détaillée d'une drogue nouvelle et de ses ingrédients, notamment :
a) la liste des propriétés et des qualités des ingrédients qui ont trait à la fabrication et à l'emploi de la drogue nouvelle, y compris leur identité, leur activité et leur pureté;
(Je souligne)
[12] Where a submission satisfies the requirements under Part C, Division 8, a NOC is issued pursuant to section C.08.004. The issuance of a NOC for an ANDS serves not only the function of permitting the manufacturer to sell or advertise the new drug, but also constitutes a declaration that the new drug is equivalent to the Canadian reference product and thereby assists the provinces and other interested parties in identifying the acceptability of the new drug for use as a substitute for the Canadian reference product.
Chronology of the ANDS
[15] The chronology of the steps taken to date with respect to Apotex’s ANDS for Apo- Telmisartan provides the necessary background and context for these reasons
.
[16] Apotex submitted an ANDS for its Apo-Telmisartan on December 16, 2010. On April 4, 2011 the TPD of Health Canada sent the Screening Deficiency Notice to Apotex and requested it to demonstrate that the medicinal ingredient in the Apo-Telmisartan tablets is identical to the medicinal ingredient in Micardis.
[17] The letter was sent by Valerie Walker (TPD) to Mr John Hems, Director Regulatory Intelligence, Apotex and indicated:
“… the following Screening Deficiency Comments have been identified;
1. You are requested to provide the results of an investigation to demonstrate that the medicinal ingredient in Apo-Telmisartan is identical to that in the CRP Micardis® by Boehringer Ingelheim. The focus should be on establishing that both the innovator product and Apo-Telmisartan tablets contain the same chemical form of Telmisartan. It should be noted that Telmisartan is a carboxylic acid and the drug substance is treated with excess amount of potassium hydroxide in methyl alcohol based wet granulation during the proposed drug product manufacturing process; therefore, conversion to potassium salt is likely. Meanwhile, the innovator Micardis® contains a different base sodium hydroxide in its composition according to the CPS. You are advised that in order to meet Section C.08.001.1 requirement of the Food and Drug Regulations, a subsequent – entry product must contain “ identical amounts of identical medicinal ingredients” compared to Canadian Reference Product (CRP)in accordance to the TPD Policy : Interpretation of “Identical Medicinal Ingredient” 2003”.
[18] Apotex responded on May 17, 2011 and provided the results of analyses it relied on to establish that the same chemical form of Telmisartan is present in Apo-Telmisartan and in the CRP. Apotex indicated, among other information:
The results of the studies unequivocally demonstrated that the manufacturing process for Apo-Telmisartan tablets does not induce any chemical reactivity between the active ingredient and the potassium hydroxide used in methyl alcohol based wet granulation. The chemical species of active ingredient present in Apo-Telmisartan tablets is Telmisartan. This is pharmaceutically equivalent to the active ingredient present in the Canadian Reference Product Micardis.
[19] On June 21, 2011, TPD sent a Screening Rejection letter indicating that the Apotex product was rejected because it did not comply with the Regulations or with the 2003 TPD Policy on Interpretation of Identical Medicinal Ingredient.
[20] The June 21 letter was sent from Andy Hus (TPD) to John Hems (Apotex) and indicated:
Your response to our Screening deficiency Notice dated April 4 2011 has been carefully reviewed and is considered to be incomplete and inconclusive…..
Your response failed to include detail and discussion of the analytical techniques, sample preparation and results. In addition it is unclear from your data if your drug product or the Canadian Reference Product contains pure active pharmaceutical ingredient or a mixture of chemical species (a mixture of potassium salt / free acid or sodium salt / free acid. Therefore, the data submitted did not provide conclusive evidence that your drug product contains “identical amounts of identical medicinal ingredient” and is pharmaceutically equivalent to the Canadian Reference Product.
[21] On August 25, 2011, Apotex requested a reconsideration of the Screening Rejection letter in accordance with the Reconsideration Policy and set out two issues of contention and its grounds for the dispute.
[22] First, Apotex objected to the Screening Rejection letter which stated that its response to the Screening Deficiency Notice was incomplete and inconclusive. Apotex responded that this was an incorrect statement: “The studies that were provided did conclusively show that the active moiety, telmisartan, is identical in the two products, and is exactly what is claimed on the label for both products.”
[23] Second, Apotex objected to the conclusion set out in the Screening Rejection letter that the data provided did not provide conclusive evidence that the Apotex product contained identical amounts of identical medicinal ingredients as required by the Regulations. Apotex noted:
“It appears that TPDs position asserted in this case is that, not only must the generic product use, in production of the drug product, the identical active ingredient as used in the CRP and as stated on the label, but, in addition, in the final drug product, the active ingredient must be in the identical ionic associations (salt form or forms) as in the CRP, even if the active ingredient is dissolved with other ionic substances in the manufacture of the drug product. What is in contention is whether or not this interpretation of Section C.08.001 and the Policy is correct.”
[24] On September 26, 2011 TPD advised Apotex that a Reconsideration Panel would be convened and requested that Apotex forward the name of their choice for member of the Panel. Apotex also commented on the proposed names submitted by TPD and in January 2012 confirmed their agreement on the three member panel.
[25] On February 7, 2012 Apotex provided background and questions for the Panel to consider.
[26] Apotex first requested clarification from TPD on related questions and noted that the question for the Panel would depend to some extent on how TPD responds. Apotex set out the following questions for the Panel, in the absence of such clarification:
1. What, if any, is substantively different about the Apo-Telmisartan compared to the other examples cited in our reconsideration which led TPD to take a different decision leading to the Screening Rejection of the Apo-Telmisartan?
2. In light of point 1 and in light of Apotex’s Request for Consideration, does the Panel agree that the Apo-Telmisartan ANDS is acceptable for review?
3. Does the Panel agree that the appropriate basis of an ANDS should be that the submitted product uses the identical active ingredient (API) to the CRP without a requirement to prove that any ionic associations between an active ingredient and one or more ionic excipients are the same between the test product and CRP?
[27] The questions were revised following comments from the Bureau of Pharmaceutical Science [BPS] and Apotex agreed to the revised questions on February 17, 2012. Apotex also provided background information for the Panel.
[28] The preamble to the questions noted the requirements of C.08.002.1 and C.08.001.1 of the Regulations and referred to the IMI Policy 2003 (Interpretation of ‘Identical Medicinal Ingredient’). The questions, as revised, were:
1. Is the medicinal ingredient in Apo-Telmisartan, as described in ANDS Control Number 143046, identical to the medicinal ingredient in the Canadian Reference Product, Micardis (Boehringer Ingelheim Ltd)?
If yes
2. Did Apotex provide sufficient information on the identicality of the medicinal ingredient to justify acceptance of the submission for review as an ANDS.
[29] The Reconsideration Panel met on March 5, 2012. Apotex and the BPS at Health Canada had an opportunity to make comments following the presentations and questioning. The Panel then met in camera.
[30] The DG, Barbara Sabourin, was not in attendance at the hearing as she had excused herself at the start of the hearing and advised that Dr Stewart would replace her. Dr Stewart was in attendance for the entire hearing.
[31] On April 12, 2012, the DG sent a letter to Apotex indicating that she had accepted the recommendation of the Office of Science, which had reviewed the Panel’s report, to uphold the decision to reject the ANDS. The Letter included the Panel’s report.
[32] The Panel’s Report responded to the first question noting that the Screening Rejection Letter of June 21, 2011 and the earlier Screening Deficiency comments had alerted Apotex to the conversion and had advised it to focus on establishing that Apo-Telmisartan contains the same chemical form of Telmisartan. The Panel then stated:
The Screening Rejection Letter and Screening Deficiency Comments of the Therapeutic Products directorate should have made it clear to the Sponsor that the interpretation of “Identical Medicinal Ingredient” refers to the active substance as it appears in the final product and not the starting active substance (API as per WHO) definition”.
(My emphasis)
[33] Based on the Panel’s earlier comments, I interpret the phrase “should have made it clear” to mean that it was, in fact, made clear to Apotex. The Panel went on to state that:
As a consequence of the above the Panel concludes that the Sponsor has not demonstrated that the medicinal ingredient in Apo-Telmisartan is identical to that in the Canadian Reference Product.
However, the Panel agrees unanimously that the current Guidance (Interpretation of “Identical Medicinal Ingredient” 2003-07-03) should provide a definition in the glossary of “Medicinal Ingredient” to avoid potential misinterpretation of the guidelines. In the guidelines a clear distinction should be made between the starting active substance (API as per the WHO definition) and the “medicinal ingredient”, which is defined as the active substance as it occurs in the finished product. A clear definition of the term “Medicinal Ingredient” should avoid any misinterpretation in the future.
According to the Panel’s assessment, the information provided by Apotex satisfies GMP requirements with regards to the starting active substance Telmisartan (API as per WHO definition). However, as far as the identicality of the medicinal ingredient (as defined above) is concerned, the Sponsor has not addressed this issue.
[34] The Panel concluded with the recommendation:
In the Notice of 2003-07-23 regarding the Interpretation of “Identical Medicinal Ingredient” the term “medicinal ingredient” should be clearly defined as being the active substance as it appears in the finished product. This would avoid confusion for Sponsors in cases where the starting active substance (API as per WHO definition) potentially undergoes chemical changes during processing into the final dosage form.
[35] Apotex wrote to the TPD on April 18, 2012 requesting that the TPD rescind its decision. The TPD replied that the April 12, 2012 decision was final.
Standard of Review
[36] Apotex submits that the standard of review is correctness because the issue at stake is the interpretation of the regulations, which is a matter of statutory interpretation and a legal issue.
[37] While the issue involves the interpretation of the regulations, this interpretation is inextricably bound up with the science involved and with issues that fall within the expertise of the TPD at Health Canada.
[38] In Reddy-Cheminor the Court conducted a standard of review analysis and concluded that the appropriate standard of review for a decision similar to the present case was that of patent unreasonableness.
[39] The Federal Court of Appeal upheld the decision in Reddy-Cheminor (see 2004 FCA 102, 319 NR 185) and with respect to the standard of review, noted at para 8:
[8] Second, I agree with Layden-Stevenson J. that the pragmatic and functional analysis indicates that the decision under review is entitled to a high degree of deference. The drug approval process is a complex and technical area of public administration with a direct impact on the health of Canadians. Determining whether two products contain "identical medicinal ingredients" requires scientific understanding and regulatory experience, rather than knowledge of the law or legal principles.
[40] I also note that the applicant, in seeking to admit affidavits of experts to assist the Court, argues that the issues at stake regarding the interpretation of the regulations, past practice for approval of drugs and the science or chemistry of drug production are matters beyond the ordinary knowledge of the Court. Therefore, the applicant could not disagree with the standard of review which recognises the same reality. I do appreciate that Apotex views the key issue as more of an issue of the interpretation of the regulations – i.e. a legal issue - than an issue of mixed law and fact - but in my view, it is the latter.
[41] In the post Dunsmuir era (Dunsmuir v New Brunswick, 2008 SCC 9, [2008] 1 SCR 190) the standard of review for a decision of mixed fact and law which also requires scientific knowledge as part of the factual component is reasonableness.
[42] Apotex has also raised issues of procedural fairness regarding the approval process including whether the Reconsideration Policy was followed. Issues of procedural fairness are reviewed on the standard of correctness.
The Issues
[43] As a preliminary issue the respondent moved to strike two affidavits submitted by the applicant. The motion was heard at the same time as the application for Judicial Review.
[44] Apotex has raised issues regarding the reasonableness of the decision and procedural fairness.
Preliminary Issue - The Applicant’s Affidavits
[45] The respondent moved to strike the affidavits filed by the applicant of Dr Kibbe and Ms Wehner on several grounds including that these affidavits were not before the decision maker and included argument and opinion.
[46] The respondent argues that the affidavits of Dr Kibbe and Ms Wehner are unhelpful and irrelevant and introduce extrinsic expert evidence which was not before the TPD or the Reconsideration Panel (i.e. the decision maker). In addition, the affidavits include opinions and seek to interpret the provisions of the regulations, which is one of the key issues in this judicial review.
[47] The respondent does not challenge the affidavits of Mr Sherman, the CEO of Apotex, or of Mr Goldberg, the Principal Scientist of Apotex, and submits that these affidavits provide the information about the applicant’s view of the process for approval and Apotex’s process for the manufacture of the drug and other information of benefit to the Court.
[48] The respondent submits that in applications for judicial review, the only material that should be considered is that which was before the decision maker (Ochapowace First Nation (Indian Band No 71) v Canada (Attorney General), 2007 FC 920 at para 9, 316 FTR 19) [Ochapowace First Nation].
[49] The respondent also relies on Abbott Laboratories Ltd v Canada (Attorney General), 2008 FCA 354 at para 37, [2009] 3 FCR 547 [Abbott]:
[37] The general rule in an application for judicial review is that the record before the Federal Court should not include any documentary evidence that was not before the maker of the decision sought to be reviewed. The rationale for this rule is judicial efficiency. In an application for judicial review, unlike an originating application (such as an application for prohibition under the NOC Regulations), the Federal Court is not the decision maker of first instance, but rather is reviewing the decision of someone else, in this case the Minister. Judicial resources would be wasted if the parties to an application for judicial review of the Minister’s decision, having failed to put their best foot forward before the Minister, could hope to provide additional evidence in the Federal Court to impugn the Minister’s decision.
[50] The respondent argues that the expert affidavits do not meet the test set out in R v Mohan, [1994] 2 SCR 9, [1994] SCJ No 36 [Mohan] of relevance, necessity in assisting the trier of fact, the absence of an exclusionary rule and a properly qualified expert. The respondent does not take a position on the qualifications of the affiants as experts. The key concern is the relevance and necessity of the affidavits.
[51] In the context of a judicial review, the respondent submits that the Court focuses on the reasonableness of the decision and issues of procedural fairness which are legal issues, not technical or scientific issues. The respondent disputes Apotex’s position that this expert evidence will assist the Court in assessing the reasonableness of the decision. An opinion cannot be introduced about the reasonableness of the decision nor can a legal argument be introduced about the interpretation of the regulations, as this is the issue for the Court to address.
[52] The applicant, Apotex, responds that while the issue on the judicial review is a legal issue, i.e., a question of interpretation, it is about a scientific process and must be informed by scientific knowledge as the two are integrally linked. The parties have a sophisticated understanding of the approval process, the drug making process and the various chemical reactions, but the Court does not have that same understanding or knowledge nor is the Court familiar with the specialised terminology used. Apotex submits that the Court must consider the interpretation of “identical medical ingredient” in the Regulations and cannot do so without the additional background knowledge offered by the affiants.
[53] Apotex acknowledges that the affidavit of Ms Wehner includes her opinion on the meaning of the regulations at issue and that these parts of her affidavit should be struck, but submits that otherwise, both affidavits will inform the Court.
[54] Apotex agrees that, generally, the only material that should be considered on judicial review is that which was before the decision maker (citing Ochapowace First Nation) but notes that the respondent has not objected to the Sherman or Goldberg affidavits, which were also not before the decision maker. Moreover, the respondent has filed the affidavit of Andrew Adams.
[55] In addition, Apotex argues that there are exceptions to the rule, including where matters of a scientific nature are at stake (Alberta Wilderness Association v Canada (Minister of the Environment), 2009 FC 710, 349 FTR 63) [Alberta Wilderness] and where the affidavit will assist the decision maker (Abbott, above, at para 39).
[56] Apotex relies on Association of Universities and Colleges of Canada v Canadian Copyright Licensing Agency, 2012 FCA 22, 428 NR 297 [Association of Universities] which noted the exceptions to the rule and that the categories of exceptions remain open.
[57] Apotex submits that the affidavits of Dr Kibbe and Ms Wehner fall into such an exception because they provide general background that may assist the Court in understanding the issues relevant to the judicial review.
[58] In Association of Universities, the Court noted:
[20] There are a few recognized exceptions to the general rule against this Court receiving evidence in an application for judicial review, and the list of exceptions may not be closed. These exceptions exist only in situations where the receipt of evidence by this Court is not inconsistent with the differing roles of the judicial review court and the administrative decision-maker (described in paragraphs 17-18, above). In fact, many of these exceptions tend to facilitate or advance the role of the judicial review court without offending the role of the administrative decision-maker. Three such exceptions are as follows:
(a) Sometimes this Court will receive an affidavit that provides general background in circumstances where that information might assist it in understanding the issues relevant to the judicial review: see, e.g., Estate of Corinne Kelley v. Canada, 2011 FC 1335 at paragraphs 26-27; Armstrong v. Canada (Attorney General), 2005 FC 1013 at paragraphs 39-40; Chopra v. Canada (Treasury Board) (1999), 168 F.T.R. 273 at paragraph 9. Care must be taken to ensure that the affidavit does not go further and provide evidence relevant to the merits of the matter decided by the administrative decision-maker, invading the role of the latter as fact-finder and merits-decider. In this case, the applicants invoke this exception for much of the Juliano affidavit.
(b) Sometimes affidavits are necessary to bring to the attention of the judicial review court procedural defects that cannot be found in the evidentiary record of the administrative decision-maker, so that the judicial review court can fulfil its role of reviewing for procedural unfairness: e.g., Keeprite Workers’ Independent Union v. Keeprite Products Ltd. (1980) 29 O.R. (2d) 513 (C.A.). For example, if it were discovered that one of the parties was bribing an administrative decision-maker, evidence of the bribe could be placed before this Court in support of a bias argument.
(c) Sometimes an affidavit is received on judicial review in order to highlight the complete absence of evidence before the administrative decision-maker when it made a particular finding: Keeprite, supra.
(Emphasis added)
[59] Apotex also submits that the affidavits meet the admissibility test as established in Mohan: the evidence is relevant as it provides information to assist the court in interpreting the term “identical medical ingredient”; it is necessary to provide the Court with a scientific understanding in order to determine if the Minister of Health made a reasonable decision; and, there is no exclusionary rule.
The affidavits are admitted in part
[60] I agree that in appropriate circumstances on judicial review, such as in this case, where the legal issues and scientific issues are linked, the Court may benefit from expert affidavits which were not before the decision maker in order to provide important context and knowledge not otherwise in the Court’s knowledge or on the record.
[61] Parts of the affidavits of Dr Kibbe and Ms Wehner fall squarely into the exception to the general rule noted in Association of Universities as they provide general background that will assist in the Court understanding the issues on the judicial review.
[62] I find that the respondent has not been prejudiced by the applicant’s submission of the two affidavits given that the respondent has had ample time to cross examine the affiants and has done so.
[63] Moreover, a great deal of the information included in the affidavits is repetitive of the information included in the affidavit of Mr Sherman and Mr Goldberg, neither of which was objected to. I also note that the respondent’s affiant, Mr Adams, comments on passages of the affidavits in dispute. In addition, the parties have made written and oral submissions on the matters deposed to. Practically, while the respondent validly objects to the reliance on affidavits that were not part of the record before the decision maker, and the opinions expressed that focus on the issue before the Court, the content of the two affidavits has been otherwise put before the Court.
[64] However, I do not agree that the opinions expressed in the affidavits meet the exceptions as noted in Abbott and Alberta Wilderness and I am mindful of the caution in Association of Universities. While the opinions may indeed be relevant, they are not necessary – or at least they are no longer necessary - as similar opinions have been expressed in the written arguments and oral submissions and particular passages of these affidavits seek to buttress those positions. In addition, the opinions, and to the extent that legal argument is embedded in these opinions, focus on the issue that is before the Court.
[65] I have reviewed both affidavits and both include a significant amount of information on the approval process, the formulation of the drugs (i.e., the chemical background, which is not in dispute and is addressed in the other affidavits and the arguments) and the experience of the affiants regarding the approval process for other drugs.
[66] The respondent declined my request to identify parts of the affidavits of Dr Kibbe and Ms Wehner that would be acceptable to the respondent. I have, therefore, identified the parts of the two affidavits that express opinions, including the opinion on how the term “identical medicinal ingredient” should be interpreted, and have excluded those parts.
[67] In the affidavit of Dr Kibbe, paragraphs 23, 43-52, and 54 are struck.
[68] In the affidavit of Ms Wehner, paragraphs 16, 30, 36-42, 49, 50, 54-62, 66 and 67 (her opinion on interpretation) and 76-80 (her opinion on bioequivalence) are struck. As noted above, Apotex agreed that the paragraphs expressing her opinion should not be admitted. I also note that paragraphs 43-48 provide information already acknowledged by the respondent that Micardis is in fact mislabelled and should be labelled as telmisartan-sodium.
Was Apotex denied Procedural Fairness?
[69] Apotex submits that it was denied procedural fairness primarily because the Reconsideration Policy was not followed: Apotex requested an informal process; the questions put to the Panel were skewed; the DG was not present at the hearing yet made the decision; and Apotex did not receive the Panel’s Report and had no opportunity to make submissions on the Report prior to the DG making the decision.
[70] The respondent submits that procedural fairness requires that the party know the issues, have an opportunity to respond and receive adequate reasons for the decision and that, considering the process as a whole, these requirements were met: Apotex was provided with every opportunity to make submissions in the approval process including the Reconsideration Process; the TPD reviewed the ANDS and provided sufficient reasons for its decision; and, the TPD provided opportunities for Apotex to respond at every stage.
There was no breach of procedural fairness
[71] The Reconsideration Policy (Guidance for Industry, Reconsideration of Final Decisions Issued for Human Drug Submissions) was last updated in 2006 and is a public document. The policy applies to a range of drug submissions including ANDS and applies to all sponsors and to the TPD. It is described as a formal dispute resolution process. It sets out the roles and responsibilities of all the parties, including the DG, the Drug Submission Sponsor, the Office of Science, and the Scientific Advisory Committee or Reconsideration Panel.
[72] The Policy provides that the DG is responsible for deciding on the process for the disposition of the Request for Reconsideration and deciding on the use and membership of the Scientific Advisory Committee or Reconsideration Panel. The DG is responsible for making the reconsideration decision.
[73] With respect to Apotex’s submission that the process was not fair or was breached because the panel was convened fi