Photocure ASA v. Canada (Health)

Photocure ASA v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2015-08-10
Neutral citation
2015 FC 959
File numbers
T-1774-14
Decision Content
Date: 20150810
Docket: T-1774-14
Citation: 2015 FC 959
Ottawa, Ontario, August 10, 2015
PRESENT: The Honourable Madam Justice Kane
BETWEEN:
PHOTOCURE ASA
Applicant
and
THE MINISTER OF HEALTH AND
THE ATTORNEY GENERAL OF CANADA
Respondents
PUBLIC JUDGMENT AND REASONS
[1] This is an application for judicial review of a decision of the Minister of Health [Minister], dated July 21, 2014, which found that CYSVIEW (previously known as HEXVIX) is not eligible for data protection pursuant to section C.08.004.1 of the Food and Drug Regulations, CRC, c 870 [Regulations], made under the Food and Drugs Act, RSC 1985, c F-27 because it is not an “innovative drug” and, as a result, will not be added to the Register of Innovative Drugs [Register].
Overview
[2] The applicant, Photocure ASA [Photocure], submitted the drug CYSVIEW for approval by the Minister in accordance with the Regulations. The Minister (in a decision made by the Office of Patented Medicines and Liaison [OPML] by Ms Anne Bowes, Director of the Office of Submissions and Intellectual Property, Therapeutic Products Directorate, Health Canada, on behalf of the Minister) determined that the drug’s medicinal ingredient, hexaminolevulinate hydrochloride [HAL HCl], is an ester variation of a previously approved medicinal ingredient, aminolevulinic acid hydrochloride [ALA HCL].
[3] Section C.08.004.1 of the Regulations provides that new drugs are eligible to receive data protection if they contain a medicinal ingredient that has not been previously approved in a drug by the Minister or are not a variation of a previously approved medicinal ingredient, such as a salt, ester, enantiomer, solvate or polymorph. The Director considered the application of Photocure, provided a preliminary opinion, considered written submissions and then oral submissions at an in person meeting, and determined that CYSVIEW (HAL HCI) is an ester of a previously approved medicinal ingredient, and is not eligible for data protection and cannot be listed on the Register.
[4] On this judicial review the applicant argues that the Minister erred and was incorrect in finding that HAL HCl is an “ester” of a “previously approved medicinal ingredient”. The applicant argues that the issues are the interpretation of “innovative drug” and the scope (or as described by the applicant, the “metes and bounds”) of “medicinal ingredient”, which are questions of law and, therefore, the standard of correctness applies.
[5] The applicant also argues that the Minister erred in interpreting the enumerated variations; because HAL HCI is both a salt and an ester, it would not fall within the variations and should have been considered as an “arguable variation” of a previously approved medicinal ingredient. As such, the Minister should have considered the clinical data submitted and should have granted data protection.
[6] The applicant notes the importance of data protection, which recognizes the value of the research, the process for approval, and the need to promote innovation and access to beneficial drugs. The applicant also notes that the Notice of Compliance has been issued for CYSVIEW, but without data protection, a third party (generic drug manufacturer) could rely on Photocure’s data to support the third party’s own Abbreviated New Drug Submission [ANDS].
[7] The applicant also submits that because the decision is incorrect, the Court could and should direct that HAL HCI is not an ester of the previously approved medicinal ingredient and the only issue to refer back to the Minister for determination is whether HAL HCI is an arguable variation of a previously approved medicinal ingredient.
[8] Alternatively, the applicant argues the decision is unreasonable.
[9] The applicant now seeks to admit the affidavit of Dr James Wuest, an expert in organic chemistry to support its position. This affidavit was not provided to the OPML, which makes the decision on behalf of the Minister. The applicant argues that this affidavit provides the Court with helpful background and scientific information.
[10] The applicant argues that the affidavit of Ms Bowes, which was submitted by the respondent in response to the affidavit of Dr Wuest, is not admissible, at least in part, because Ms Bowes is not an expert witness on matters of chemistry and her affidavit seeks to supplement the reasons for the decision.
[11] The respondent submits that the question on judicial review is one of fact or at most mixed fact and law and, therefore, the reasonableness standard applies. The Minister’s decision that HAL HCI is an ester of a previously approved medicinal ingredient is based on a comparison of the medicinal ingredients. This involves science, more specifically, chemistry, and is not a question of statutory interpretation.
[12] The respondent argues that Dr Wuest’s affidavit is inadmissible; it was not part of the record before the decision-maker and it includes argument and opinion on the very issue that the Minister is responsible for deciding.
[13] The respondent seeks to admit the affidavit of Ms Bowes, in response to the affidavit of Dr Wuest. Ms Bowes’ affidavit describes the process for data protection in general, the particular proceedings and elaborates on the decision making process.
[14] The admissibility of the affidavits is addressed below as a preliminary issue.
[15] I find that the affidavit of Dr Wuest is not admissible. It includes opinion evidence on the very question the Minister is responsible for deciding and did decide. Although the applicant seeks to recharacterize the issue as a question of law and argues that Dr Wuest does not offer any opinion on the question of law, the question on this judicial review is not a question of law. I also find that the affidavit of Ms Bowes is not admissible.
[16] This judicial review focuses on the Minister’s decision whether HAL HCI is a variation of a previously approved medicinal ingredient. This is based on an assessment of the medicinal ingredient in HAL HCI which involves the facts, and more particularly, the science.
[17] The reasonableness standard applies and the decision is reviewed on the basis of the record that was before the Minister. For the reasons elaborated upon below, I find that the Minister’s decision is reasonable and the application is, therefore, dismissed.
The Minister’s Decision Under Review
[18] Photocure filed a New Drug Submission [NDS] seeking approval for CYSVIEW in December 2013.
[19] CYSVIEW is used as an imaging agent for the detection and management of non-muscle invasive bladder cancer. CYSVIEW contains the medicinal ingredient HAL HCl.
Preliminary Decision Letter
[20] On January 20, 2014, the OPML issued a preliminary decision which set out the definition of “innovative drug” in section C.08.004.1 of the Regulations, the medicinal ingredient in CYSVIEW and its chemical structure, and the chemical structure of ALA HCI. The OPML found that the medicinal ingredient of CYSVIEW, HAL HCl, is an ester of ALA HCI or HCL, which was previously approved by the Minister and is known as LEVULAN KERASTICK, and indicated its preliminary position that CYSVIEW is therefore not an “innovative drug”.
[21] The OPML invited Photocure to make submissions in response to this preliminary decision.
Submissions by the Applicant to the OPML/Minister
[22] Photocure’s submissions, dated March 17, 2014 argue that the definition of “innovative drug” does not expressly exclude CYSVIEW, because HAL HCl is a salt of HAL, which has not previously been approved; HAL is an ester of ALA, which has also not previously been approved; and, therefore, HAL HCl is not an ester of ALA HCl. Photocure concludes that CYSVIEW is not a drug containing a salt, ester, enantiomer, solvate or polymorph of a previously approved medicinal ingredient and is not excluded from the definition of “innovative drug”.
[23] Photocure noted that other variations – i.e., those not specifically enumerated and excluded as minor variations – are considered on a case-by-case basis. Photocure argued that the data submitted with its NDS was new and significant, that the NDS does not include any comparative studies against previously approved drugs, and that CYSVIEW is not simply a minor change to LEVULAN KERASTICK. Photocure further submitted that other named drugs (that are esters or prodrugs of previously approved medicinal ingredients) have been previously approved by the Minister.
[24] The submissions also explain that CYSVIEW is a prodrug for the intracellular delivery of ALA, and then note in detail the differences between ALA and HAL.
[25] Photocure provided several articles from medical and pharmacological journals describing the results of various experiments and developments in the detection of bladder cancer dated from 1995 to 2006.
[26] Photocure also requested an in person meeting with the OPML, which was held on May 21, 2014.
[27] At the meeting, Photocure presented slides reiterating its position as noted above and as set out in its written submissions. The slides indicate that HAL HCI is a salt of HAL (which was not previously approved) and that HAL HCI is an ester of ALA (which was not previously approved) and concludes that HAL HCI is, therefore, not an ester of ALA HCI (which was previously approved) within the meaning of “innovative drug”.
[28] The slides also compare the Minister’s treatment of HAL HCI and ALA HCI to that of temsirolimus and sirolimus, noting that temsirolimus and sirolimus were both found to be innovative drugs.
[29] The slides address the “other variations”, noting the factors for a case- by-case analysis as set out in the Guidance Document. The slides note that CYSVIEW is a prodrug for the intracellular delivery of ALA and highlight the differences between ALA and HAL, as described in the written submissions, and the new, significant and extensive data provided in the NDS. The slides also state that CYSVIEW is not a minor change to LEVULAN KERASTICK, note that its indications are very distinct, and describe the distinctions.
The Final Decision Letter
[30] The decision of Ms Bowes of the OPML, on behalf of the Minister, was set out in a letter dated July 21, 2014. The decision acknowledges the written and oral submissions of Photocure that CYSVIEW is not a variation of a previously approved medicinal ingredient within the meaning of “innovative drug,” but disagrees. The decision notes the definition of “innovative drug” and the relevant part of the Regulatory Impact Analysis Statement [RIAS] which accompanied the 2006 amendments that added C.08.004 [definition] to the Regulations, explains the list of excluded variations, and notes that data submitted in support of the approval is relevant only when the variation is not explicitly enumerated. The decision also notes the interpretation of “innovative drug” established by the Federal Court of Appeal in Takeda Canada Inc v Canada (Minister of Health), 2013 FCA 13 at paras 125-126, 440 NR 346 [Takeda]. In addition, it indicates that each determination of data protection is case-specific and, consequently, previously approved drugs are not a relevant consideration.
[31] The decision acknowledges that HAL HCI is a salt of HAL and that HAL is an ester of ALA and that both HAL HCl and ALA HCl are salts. The decision then concludes that, because the structure of HAL HCl is identical to ALA HCl, both of which are salts, but with the addition of an ester group, HAL HCl is an ester of ALA HCl. The decision includes a depiction of the structure of HAL HCI, ALA, HAL and ALA HCI in making the relevant comparisons.
[32] The decision concludes that CYSVIEW is a previously approved medicinal ingredient and is specifically excluded from the scope of data protection in accordance with the definition of “innovative drug”.
The Relevant Provisions of the Regulations
C.08.004.1 (1) The following definitions apply in this section.
C.08.004.1 (1) Les définitions qui suivent s’appliquent au présent article.
“abbreviated new drug submission”
“abbreviated new drug submission” includes an abbreviated extraordinary use new drug submission. (présentation abrégée de drogue nouvelle)
« présentation abrégée de drogue nouvelle »
« présentation abrégée de drogue nouvelle » S’entend également d’une présentation abrégée de drogue nouvelle pour usage exceptionnel. (abbreviated new drug submission)
“innovative drug”
“innovative drug” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante)
« drogue innovante »
« drogue innovante » S’entend de toute drogue qui contient un ingrédient médicinal non déjà approuvé dans une drogue par le ministre et qui ne constitue pas une variante d’un ingrédient médicinal déjà approuvé tel un changement de sel, d’ester, d’énantiomère, de solvate ou de polymorphe. (innovative drug)
“new drug submission”
“new drug submission” includes an extraordinary use new drug submission. (présentation de drogue nouvelle)
« présentation de drogue nouvelle »
« présentation de drogue nouvelle » S’entend également d’une présentation de drogue nouvelle pour usage exceptionnel. (new drug submission)
“pediatric populations”
“pediatric populations” means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique)
« population pédiatrique »
« population pédiatrique » S’entend de chacun des groupes suivants : les bébés prématurés nés avant la 37e semaine de gestation, les bébés menés à terme et âgés de 0 à 27 jours, tous les enfants âgés de 28 jours à deux ans, ceux âgés de deux ans et un jour à 11 ans et ceux âgés de 11 ans et un jour à 18 ans. (pediatric populations)
[33] The data protection provisions were described by Justice David Near (as he then was) in Takeda Canada v Canada (Minister of Health), 2011 FC 1444 at paras 11-13, 401 FTR 259 [Takeda (FC)]:
The Regulations provide protection for data submitted as part of the drug marketing approval process leading to the issuance of a NOC. This protection can, however, only be extended to an “innovative drug” defined in subsection C.08.004.1(1) as a “drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.”
Once deemed eligible for listing on the Register, an “innovative drug” receives data protection consisting of two formal restrictions. Firstly, a generic drug manufacturer cannot file a submission based on a comparison to an “innovative drug” within the first six years of the eight-year period after the drug has received a NOC (subsection C.08.004.01(3)(a)). Secondly, the Minister may not issue a NOC to the generic drug manufacturer before the end of the eight-year period (subsection C.08.004.01 (3)(b)).
As stated in subsection C.08.004.1(2), the data protection provisions apply to the implementation of Article 1711 of the North American Free Trade Agreement, 1992, 32 ILM 296 (NAFTA) and paragraph 3 of Article 39 in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 1869 UNTS 299 (TRIPS). Where a person submits undisclosed data for approval of a pharmaceutical product, and the product utilizes a “new chemical entity”, signatory states commit to preventing other persons from making “unfair commercial use” of that data and (for a reasonable time) from relying on that data in their own applications for approval.
The Preliminary Issue: Admission of the Affidavits
Dr Wuest’s Affidavit
[34] The applicant filed the affidavit of Dr Wuest in support of its application for judicial review. Dr Wuest is an expert in organic chemistry. His affidavit provides a “chemistry primer” relating to covalent bonds, esters, salts, the ranking of functional groups and how chemists would classify a salt with an ester group; how the chemistry primer relates to HAL HCl; how a chemist would understand the relationship between HAL HCl and ALA HCl; and whether a chemist would consider temsirolimus (a medicinal ingredient that was approved by the Minister) to be an ester of sirolimus.
Ms Bowes’ Affidavit
[35] In response to the evidence of Photocure, the respondent filed the affidavit of Anne Bowes. As noted above, Ms Bowes is the Director of the Office of Submissions and Intellectual Property, Therapeutic Products Directorate, Health Canada, of which the OPML is a Division, and made the decision on behalf of the Minister. Ms Bowes provides a background of the relevant regulatory scheme; general scientific information regarding the scientific terms in the regulations (including esters); the process the OPML applies in determining whether a drug is an “innovative drug”; the specific process that took place in the decision under review (including that the affidavit of Dr Wuest was not provided to the OPML by Photocure in its written and oral submissions); and the basis upon which the OPML disagrees with the characterization of “esters” by Photocure and Dr Wuest.
The Respondent’s Motion to Strike the Affidavit of Dr Wuest
[36] The respondent moves to strike Dr Wuest’s affidavit and submits that it should be addressed at the outset of the hearing of the application for judicial review.
[37] The applicant argues that because the admissibility of the affidavit is linked to the characterization of the question on judicial review, the motion to strike should be considered simultaneously or in the context of the merits of the judicial review.
[38] The Court heard arguments on the admissibility of the affidavits at the outset of the hearing but reserved decision on their admissibility. The parties’ position on the merits provided context for their arguments on the admissibility of the affidavits. The arguments on the merits could not be isolated or divorced from consideration of the admissibility of the affidavits.
The Respondent’s Submissions on the Motion to Strike the Affidavit of Dr Wuest
[39] The respondent argues that Dr Wuest’s affidavit does not comply with Rule 306 of the Federal Courts Rules, SOR/98-106 [Rules] and does not fall within any of the recognized exceptions to the principle that only the material that was available to the decision-maker should be considered on an application for judicial review (Association of Universities and Colleges of Canada v Canadian Copyright Licensing Agency (Access Copyright), 2012 FCA 22 at para 20, 428 NR 297 [Access Copyright]; Ochapowace First Nation (Indian Band No 71) v Canada (Attorney General), 2007 FC 920 at para 9, 73 Admin LR (4th) 182 [Ochapowace First Nation]).
[40] The respondent acknowledges that the Court has identified exceptions to the principle that no new material or evidence should be admitted on judicial review that was not before the decision-maker, but argues that this affidavit does not fall within any of the exceptions recognized to date (Access Copyright, at para 20). The respondent submits that the issue is not one of procedural fairness; the evidence does not provide general background to assist the court in understanding the issues on the judicial review and there was ample evidence on the record for the decision to be made, therefore the affidavit does not highlight the lack of evidence before the decision-maker.
[41] The respondent submits that Dr Wuest’s affidavit does not provide general or helpful background that would assist the Court; on the contrary, the chemistry primer offered in the affidavit confuses the issues by offering alternate scientific propositions to contradict the Minister’s findings after the fact.
[42] The respondent also submits that the affidavit includes improper opinion evidence seeking to bolster the record and lead to a de novo determination on the issue of whether HAL HCI is an ester of ALA HCI, which is the decision the Minister should make and did make. Dr Wuest offers his opinion on the very issue that the Minister is responsible for deciding.
[43] Photocure had a full opportunity to advance its position before the decision-maker and could have presented this evidence with its submissions. The respondent submits that, although some of the evidence in Dr Wuest’s affidavit is the same as in Photocure’s submissions, Dr Wuest provides additional opinions to bolster the submissions and to suggest the Minister’s decision is wrong from the perspective of a Harvard scientist.
[44] The respondent notes that Dr Wuest’s affidavit describes his mandate at paragraphs 9-12, with the key task at paragraph 11: “to determine whether a chemist would consider HAL HCI to be an ester of aminolevulinic acid hydrochloride (“ALA HCI”)”.
[45] Dr Wuest provides his opinion at paragraph 16 on the very issue that the OPML is responsible to decide on behalf of the Minister, and Dr Wuest takes the opposite view.
[46] The respondent also notes the recent decision in Delios v Canada (Attorney General), 2015 FCA 117, [2015] FCJ No 549 (QL) [Delios], which provides further clarity regarding the admissibility of affidavits under the “general background” exception, noting that it is limited to non-argumentative statements and should not include any spin or advocacy (at para 45). More importantly, the Court of Appeal noted at para 46:
But “[c]are 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”: Access Copyright, above at paragraph 20(a).
[47] In the present case, the respondent submits that Dr Wuest’s affidavit goes beyond the acceptable limits; it provides evidence on the merits and usurps the role of the Minister as fact finder and merits decider; and it opines on the question the Minister was to determine, which was whether HAL HCI is a variation of a previously approved medicinal ingredient.
[48] In response to the submission by Photocure that the admission of expert evidence is permissible to provide context and explanation where the legal and scientific issues are linked, the respondent argues that the facts in Apotex v Canada (Minister of Health), 2013 FC 1217, 69 Admin LR (5th) 1 [Apotex], relied on by the applicant, differ as the substance of the evidence in the affidavits was already before the decision-maker and was not in dispute and, therefore, did not contravene Rule 306 of the Rules.
[49] The respondent notes that the parts of the affidavit regarding Dr Wuest’s qualifications are not in dispute, but all of the other parts are linked to his opinion on the central issue and the paragraphs cannot be isolated. Therefore, the respondent objects to the affidavit in total.
[50] Contrary to the applicant’s assertion that Dr Wuest’s affidavit is not challenged, the respondent points out that it disputes Dr Wuest’s affidavit in the Ms Bowes’ affidavit. The applicant notes that upon receipt of the affidavit, the Minister immediately noted its objection.
[51] The respondent submits that the issue in the present case is the application of the facts and the science to the definition (i.e., the Minister’s decision was a factual one, based on the science) and is not a question of law. The issue is whether the decision-maker considered the relevant information on the record and made a reasonable decision.
The Applicant’s Submissions on the Motion to Strike the Affidavit of Dr Wuest
[52] Photocure’s position regarding the admissibility of Dr Wuest’s affidavit is linked to its position on the merits of the application, in particular the characterization of the question for this judicial review and the applicable standard of review. This is elaborated upon later in the decision.
[53] Photocure submits that the statutory interpretation of “innovative drug” and the approach to considering “medicinal ingredient” is the issue. When the entirety of the medicinal ingredient is considered, the conclusion can only be that HAL HCI is a salt of HAL, HAL is an ester of ALA and, therefore, HAL HCI is not an ester of ALA HCI. The Minister did not interpret the medicinal ingredient correctly because the Minister did not consider its structure in its entirety.
[54] Photocure argues that once the issue is understood as the proper interpretation of “innovative drug” and “medicinal ingredient,” it is clear that Dr Wuest’s affidavit does not opine on the legal question that the Court must now deal with but does provide helpful background on matters of science.
[55] Photocure notes that there are well-recognized exceptions to the general rule that the Federal Court should not admit evidence that was not before the decision-maker. These exceptions include where the evidence is general background information and where the evidence provides context and knowledge not otherwise in the Court’s knowledge or on the record and where the legal and scientific issues are linked (Access Copyright, at paras 19-20; Apotex, at para 60; and Abbott Laboratories Ltd v Canada (Attorney General), 2008 FC 700 at para 16, 329 FTR 190 [Abbott]). The list of exceptions is not closed (Access Copyright, at para 20).
[56] Photocure submits that Dr Wuest’s affidavit provides helpful background to assist the Court in understanding how a chemist would assess a salt with an ester functional group, particularly because the Minister’s decision is silent on this issue.
[57] With respect to the recent guidance in Delios, Photocure submits that Dr Wuest’s affidavit does not advocate a position on the legal issue the Court must address, which is the correct interpretation of “innovative drug” and/or “medicinal ingredient” and it does not usurp the role of the Minister, spin the information, nor is it argumentative, (Delios, at para 45). Dr Wuest sets out the same position advanced by Photocure in its submissions to the Minister.
[58] Dr Wuest’s mandate focused on whether the medicinal ingredient is a salt or an ester and of what other chemical. The applicant submits that Dr Wuest takes the correct approach by focusing on the entire medicinal ingredient. The applicant notes that it is not in dispute that HLA HCI is a salt of an ester of ALA.
[59] If Photocure is correct on the legal interpretation of medicinal ingredient, the decision-maker must look at the entirety of the structure, and then must find that HAL HCI is not an ester of ALA HCI.
[60] Photocure also notes that in Apotex, I admitted parts of the expert affidavits because their content was already before the Court and submits that this is also the case regarding the content of Dr Wuest’s affidavit; the same submissions were made regarding HAL HCI by Photocure in its memorandum of argument.
[61] The applicant submits that even if Dr Wuest’s affidavit is not admitted, the decision is clearly incorrect or unreasonable. The Minister failed to look at the entire structure of the medicinal ingredient in determining whether it is an ester of a previously approved drug.
The Applicant’s Submissions Regarding Ms Bowes’ Affidavit
[62] Photocure objects to the admission of paragraphs in Ms Bowes’ affidavit which includes “inadmissible opinion evidence on technical matters of chemistry,” specifically paragraphs 6, 24, 25 and 37-41. Photocure submits that Ms Bowes is not qualified as an expert and, as a result, the paragraphs of her affidavit that opine on matters of chemistry are not admissible.
[63] Although Photocure noted its objection to specific paragraphs in its submissions, it also indicates that it is content to permit at least parts of the affidavit to remain on the record to show Ms Bowes’ reasoning process, with the qualification that it should not be considered as opinion evidence on technical matters of organic chemistry.
[64] Photocure argues that Ms Bowes’ affidavit puts forward new grounds for the decision which were not in the decision letter. Ms Bowes refers to excerpts from Photocure’s own NDS which were not set out as reasons for the decision (for example, that Photocure refers to […]). Ms Bowes noted that the word “ester” was included in the chemical name of CYSVIEW. Photocure argues that even if this information were taken from its own submission, it was not part of the original decision.
The Respondent’s Submissions Regarding Ms Bowes’ Affidavit
[65] The respondent submits that Ms Bowes’ affidavit is confined to facts within her personal knowledge and therefore respects the scope of Rule 81(1) of the Rules. Her affidavit relates to the drug submission and review process regarding the data protection provisions, and is related to her office and qualifications (Canada (Minister of Citizenship and Immigration) v Pierre, 2012 FC 1169 at para 23, [2012] FCJ No 1257 (QL)). Her evidence regarding the determination for CYSVIEW is related to her understanding of official Health Canada records, her personal knowledge of organic chemistry and her participation in the final decision.
[66] The respondent notes that Ms Bowes’ affidavit was tendered in response to the respondent’s submission of the affidavit of Dr Wuest and that Ms Bowes was not put forward as an expert witness.
[67] The respondent submits that paragraphs of the affidavit that Photocure argues are “inadmissible opinion evidence on technical matters of chemistry” simply summarize the decision, provide a chemical formula and refer to a standard organic chemistry textbook. These portions of the affidavit would assist the Court understanding what an “ester” means within the Regulations.
[68] In response to Photocure’s submission that Ms Bowes offers new reasons that were not part of the decision, the respondent acknowledges that they were not part of this decision, but submits that Ms Bowes’ affidavit does not set out new reasons or new evidence. Paragraphs 37-41 respond to a statement in Dr Wuest’s affidavit that HAL HCI is not an ester of ALA HCI by pointing to […].
[69] The respondent notes that Photocure has indicated that it does not object to this evidence remaining in the record to explain the Minister’s interpretation of the provision.
The Affidavits are Not Admissible
[70] To some extent, the issue of the admissibility of both affidavits is tied to the characterization of the issue in this judicial review.
[71] Photocure argues that the question on this judicial review is a question of law to be determined on the correctness standard and that the decision is not correct. It argues that Dr Wuest’s affidavit does not opine on this question of law and should be admissible to assist the Court to correctly interpret the meaning of medicinal ingredient and/ or innovative drug. Photocure alternatively argues that even if the Court finds that the issue is one of fact; whether HAL HCI is an ester of a previously approved medicinal ingredient, based on the application of the facts and the science, Dr Wuest’s affidavit should still be admitted because Dr Wuest’s opinion on the science would be helpful to the Court.
[72] The general rule is that the Court should not admit evidence that was not before the decision-maker.
[73] In Ochapowace First Nation the Court of Appeal noted two exceptions to the general rule: where the evidence was introduced to support an argument going to procedural fairness or jurisdiction; and, where the material is considered general background information that would assist the Court.
[74] In Access Copyright, at para 20, the Court of Appeal recognized three exceptions, noting that the list of exceptions is not exhaustive, but that these exceptions only exist where the new evidence is not inconsistent with the differing roles of the court and the decision-maker:
[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 FTR 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 OR (2d) 513 (CA). 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]
[75] The only exception noted in Access Copyright which is relevant to the present case is (a), general background.
[76] As the applicant pointed out, Apotex and Abbott support the view that, where the legal and scientific issues are linked, the Court may benefit from expert affidavits that were not before the decision-maker (which generally falls within exception (a) from Access Copyright).
[77] In Apotex, which dealt with the Minster’s decision on identical medicinal ingredients, I found that parts of the affidavits were admissible, noting that the content was already before the Court in other affidavits which were not objected to; however, I struck the parts of the affidavit which stated an opinion. I noted, at para 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.
[78] In Abbott, which dealt with patent construction, the substance of the evidence included in the affidavit had been admitted orally before the decision-maker (noted in the Federal Court of Appeal decision, Abbott Laboratories Ltd v Canada (Attorney General), 2008 FCA 354 at para 40, 382 NR 280).
[79] The Court of Appeal reiterated that new evidence on judicial review is exceptional, noting the key reasons for the general rule at para 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.
[80] More recently, the Federal Court of Appeal provided additional guidance regarding the receipt of evidence on judicial review under the general background exception in Delios.
[81] The Court of Appeal first noted the basic principles established in Access Copyright: that the reviewing court cannot allow itself to become a forum for fact-finding on the merits of the matter (at para 41) and that the general rule is that the evidentiary record before the Federal Court on judicial review is restricted to the evidentiary record that was before the administrative decision-maker (at para 42). The Court of Appeal then clarified the limitations on the “general background” exception to the general rule established in Access Copyright noting at paras 44-46:
Under this exception, a party can file an affidavit providing “general background in circumstances where that information might assist [the review court to understand] the issues relevant to the judicial review”: Access Copyright, above at paragraph 20(a).
The “general background” exception applies to non-argumentative orienting statements that assist the reviewing court in understanding the history and nature of the case that was before the administrative decision-maker. In judicial reviews of complex administrative decisions where there is procedural and factual complexity and a record comprised of hundreds or thousands of documents, reviewing courts find it useful to receive an affidavit that briefly reviews in a neutral and uncontroversial way the procedures that took place below and the categories of evidence that the parties placed before the administrator. As long as the affidavit does not engage in spin or advocacy – that is the role of the memorandum of fact and law – it is admissible as an exception to the general rule.
But “[c]are 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”: Access Copyright, above at paragraph 20(a).
[82] Dr Wuest’s expert evidence provides additional scientific background information that is more detailed than the evidence that was before the Minister, the written representations submitted on March 17, 2014 and the presentation that accompanied the May 21, 2014 meeting, regarding the issue of and the approach to determining whether HAL HCI is a variation of a previously approved medicinal ingredient. For example, it advances the notion that the presence of a salt should take precedence over an ester in the nomenclature of chemical compounds, and that chemists would regard HAL HCI as simply HAL, which reflects its core molecular structure, and would regard CYSVIEW first, as a salt of HAL and secondly, as an ester of ALA. This information may have been helpful to the decision-maker, but it was not provided to the decision-maker. It might also be helpful to the Court in some circumstances. However, the affidavit goes beyond the acceptable limits of exceptions to the general rule.
[83] Dr Wuest opines on the very issue the Minister was asked to determine and the very issue that Photocure addressed in its submissions to the Minister, albeit with more and different details. Although the applicant seeks to recharacterize the