Reddy Cheminor Inc. v. Canada (Attorney General)

Reddy Cheminor Inc. v. Canada (Attorney General)
Court (s) Database
Federal Court Decisions
Date
2003-05-14
Neutral citation
2003 FCT 542
File numbers
T-2294-00
Notes
Digest
Decision Content
Date: 20030514
Docket: T-2294-00
Neutral citation: 2003 FCT 542
BETWEEN:
REDDY-CHEMINOR INC.,
Applicant,
- and -
THE ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH,
Respondents.
REASONS FOR ORDER
LAYDEN-STEVENSON J.
[1] Reddy-Cheminor Inc. (Reddy) sought approval from the Minister of Health (the Minister) to market its version of the drug omeprazole pursuant to the Food and Drugs Act, R.S.C. 1985, c. F-27 (the FDA) and the Food and Drug Regulations, C.R.C., c. 870 (the Regulations). Reddy submitted an abbreviated new drug submission (ANDS) and referred to the Canadian reference product LOSEC. The officials acting for the Minister concluded that the medicinal ingredient in Reddy's drug is omeprazole while the medicinal ingredient in LOSEC is omeprazole magnesium. The Minister refused to process the submission and Reddy now seeks judicial review of the Minister's decision.
[2] Reddy requests an order directing the Therapeutic Products Directorate (the TPD) to review its ANDS in accordance with section C.08.002.1 of the Regulations, to place the ANDS in the review queue so that Reddy suffers no prejudice from the delay, and costs. At the hearing, it withdrew its request for a declaration that its product is pharmaceutically equivalent to corresponding strengths of the Canadian reference product, omeprazole magnesium tablets, for which a Notice of Compliance (NOC) was previously issued by the Minister.
FACTS
[3] On March 1, 1999, the applicant submitted its ANDS for omeprazole capsules to the TPD of Health Canada. Omeprazole is a drug that acts as a gastric proton-pump inhibitor and is used to treat ulcers. The ANDS referred to omeprazole magnesium tablets (LOSEC) marketed in Canada by AstraZeneca Canada Inc. (AstraZeneca) as the Canadian reference product. On July 2, 1999, the TPD issued a screening deficiency notice to Reddy asserting that the application could not proceed as an ANDS and that the applicant could obtain approval only by filing a new drug submission (NDS) pursuant to section C.08.002 of the Regulations.
[4] On August 16, 1999, Reddy responded to the screening deficiency notice explaining why the application should proceed as an ANDS. On September 13, 1999, the TPD issued a screening-based rejection letter on the same grounds as the initial screening deficiency notice. On December 6, 1999, Reddy submitted a Level I appeal in accordance with the TPD's published internal review process. On February 14, 2000, the Level I appeal was rejected. On March 10, 2000, Reddy requested a Level II appeal pursuant to the internal review policy. On June 23, 2000, the TPD Office of Science issued a report to the A/Director-General on the Level II appeal, recommending that the applicant's submission be reviewed as an ANDS. On July 18, 2000, the A/Director-General forwarded a memo to the Bureau of Pharmaceutical Assessment (the BPA) of the TPD wherein he concurred in the recommendation of the Office of Science. On the same date, he wrote to Reddy and advised that the Level II appeal had been resolved in its favour and that its submission would be returned to the BPA for review as an ANDS.
[5] On July 28, 2000, the Director of the BPA issued a memo to the A/Director-General in response to the latter's concurrence with the recommendation of the Office of Science and notification of such to Reddy. The BPA indicated an inability to follow the A/Director-General's directions on the basis that to do so would contravene the provisions of paragraph C.08.002.1(1)(a) of the Regulations. The BPA recommended that the A/Director-General rescind his position of July 18, 2000. The applicant's written argument references further discussions between Reddy and departmental officials, but there is no evidence in this regard. It is clear, however, that Reddy, on October 25 and November 8, 2000, wrote to the A/Director-General requesting a final decision regarding the Level II appeal of the screening-based rejection letter. By correspondence dated November 10, 2000, the A/Director-General notified Reddy that the Level II appeal was dismissed. The correspondence contains reasons that, briefly put, state that the Regulations require an ANDS drug to be the pharmaceutical equivalent of the Canadian reference product. Pharmaceutical equivalence requires that the drugs being compared contain identical amounts of identical medicinal ingredients in comparable dosage forms. Since omeprazole and omeprazole magnesium are different medicinal ingredients, the submission cannot be reviewed as an ANDS. It is with respect to this decision that Reddy seeks judicial review.
THE REGULATORY SCHEME FOR NEW DRUGS
[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,
« _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) 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
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) 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);
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).
"pharmaceutical equivalent" means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in
« _équivalent pharmaceutique_ » S'entend d'une drogue nouvelle qui, par comparaison à une autre drogue, contient les mêmes quantités d'ingrédients médicinaux
comparable dosage forms. But that does not necessarily contain the same non-medicinal ingredients;
identiques, sous des formes posologiques comparables, mais pas nécessairement les mêmes ingrédients non médicinaux.
"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,
« _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;
[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.
[13] The TPD has a published policy entitled "Management of Drug Submissions", the stated purpose of which is, to outline the manner in which the TPD will manage the information and material submitted by sponsors in accordance with the FDA and the Regulations. The policy applies to all submission types including, among others, a NDS, an ANDS and a SNDS (supplement to a new drug submission). It contains sections dealing with the filing of information and material, the screening of information and material, the evaluation of submissions, re-filed submissions, the appeal process and drug evaluation fees. Under the policy, the screening process is one whereby the information and material is screened for acceptability. If original information and material is found to be acceptable on screening, it is then accepted for review and considered to be a submission. If deficiencies are identified, a screening deficiency notice is issued identifying the deficiencies. A sponsor has 45 days within which to respond to a screening deficiency notice at which point (if the sponsor responds) a new screening period commences. The original information and material is considered a submission when all requested information is found to be acceptable. A sponsor may appeal a TPD decision to reject a submission at the screening level. There are two levels of appeal procedures. The first is to the Bureau Director responsible for the original decision. The second is to the Director-General of the Directorate and involves an independent review under the direction of the Director-General.
THE POSITIONS OF THE PARTIES
[14] Reddy takes the position that its ANDS should have been reviewed rather than rejected at the screening stage. A review, argues Reddy, affords the applicant a scientific assessment regarding the question of whether omeprazole and omeprazole magnesium are identical medicines and if so, pharmaceutically equivalent. No such scientific assessment was ever made by the TPD prior to refusing Reddy's submission. All correspondence, remarks and comments from the TPD flow from the initial, non-scientific decision.
[15] The foundation upon which Reddy's argument is built is the approach taken by the Minister regarding AstraZeneca's LOSEC. AstraZeneca and its predecessor companies have marketed omeprazole in Canada for many years. In approximately 1995, it submitted a SNDS to the TPD to change its product from omeprazole capsules to omeprazole magnesium tablets. Referring to section C.08.003, Reddy notes the conditions under which circumstances are considered to be sufficiently different to necessitate the filing of a SNDS. It contends that the section permits changes to marketed drugs but not the marketing of an entirely different drug. In short, Reddy submits that a SNDS cannot be used to approve a new drug. Since AstraZeneca's SNDS requested approval to change its product from omeprazole capsules to omeprazole magnesium tablets, the TPD must have considered the change, from omeprazole capsules to omeprazole magnesium tablets, not to have been a change in the drug itself. Thus, says Reddy, omeprazole and omeprazole magnesium must be the same medicine and therefore pharmaceutically equivalent.
[16] To bolster its position, Reddy refers to documents obtained under the Access to Information Act, R.S.C. 1985, c. A-1 relating to the AstraZeneca change and specifically relies on a handwritten minute from Dr. Klein (a reviewer of AstraZeneca's SNDS) to Dr. Lee that states:
Leo,
I want to discuss this with you on Tuesday. - Please see my notes on pages 18, 19, 21, 22, 23, 24; - As you can see I am in disagreement with you - I propose to do the following: - That you finalize the P.M. according to what we will discuss and based on my notes as above; - That I phone Astra and/or write them a note indicating that once we accepted the "bio" + pharmacodynamics for Losec tablets, the same condition will apply to any generic preparation. I will c.c. N. Pound for this info. AK.
[17] Reddy argues that this minute, and more particularly the phrase, ". . . the same condition will apply to any generic preparation", indicates that if an omeprazole to omeprazole magnesium comparison is valid for demonstrating safety and efficacy, then an omeprazole magnesium to omeprazole comparison must be equally valid. Therefore, according to Reddy, it follows that its product (omeprazole capsule) meets the test for submission of an ANDS in that it is the bioequivalent of the omeprazole magnesium tablet, the route of administration is the same as that of the AstraZeneca product, and its conditions of use fall within the conditions of use for AstraZeneca's omeprazole magnesium tablet.
[18] Relying on the Minister's position regarding the AstraZeneca product, Reddy submits that it satisfied the test and accordingly submitted its ANDS. The TPD's initial review did not involve a scientific review of the data and its decision was based solely on the difference in the names between the ingredients omeprazole and omeprazole magnesium. Reddy contends that the cross-examination of the A/Director-General confirms rejection at the screening stage.
[19] The applicant refers to the fact that "medicinal ingredient' is not defined in the FDA or in the Regulations. The affidavit of its expert, Dr. Thomas Foster, states that there exists no general basis upon which to determine the equivalence of the salt and base form of a drug. Dr. Foster's opinion is that omeprazole base and omeprazole salt differ not in their pharmaceutical natures but in non-therapeutic ways and therefore, whether salt or base, the substances are the same medicine. Thus, according to Dr. Foster, the medicinal ingredient in omeprazole magnesium is omeprazole, the same as in omeprazole simpliciter because only omeprazole is available at the site of absorption in the body.
[20] In relation to this issue, Reddy submits that the standard of review, for judicial review of an ANDS, is that of reasonableness. However, where the decision is made at the screening stage (a process not referred to in the Regulations), without the benefit of the review process (where the evidence regarding pharmaceutical equivalence is considered), the standard of review is correctness for it cannot be said that the Minister, at this stage, is assessing the safety and efficacy of the drug in question. Reddy refers to Novopharm Ltd. v. Minister of National Health and Welfare (1998), 78 C.P.R. (3d) 54 (F.C.T.D.) (Novopharm) wherein Hugessen J. determined that the Minister's functions under the Patented Medicines (Notice of Compliance) Regulations, SOR /93-133 are purely ministerial and that the standard of review is that of correctness.
[21] Lastly, Reddy takes issue with the A/Director-General's reversal of the Level II appeal and argues that it was denied natural justice. It submits that it was not informed of the request that the appeal be reopened and was not afforded the opportunity to make representations in this respect. Having made a decision with respect to the Level II appeal, the respondent could not then reopen the decision. Reddy should have been heard prior to the final decision being rendered.
[22] The respondent Minister submits that Parliament has entrusted the Minister and her officials with the authority to determine whether to permit a drug to be sold to the Canadian public. Reddy's application for judicial review, argues the respondent, constitutes a request that the court substitute its opinion for that of the Minister.
[23] The Minister, through the TPD, refused to process Reddy's submission for approval to market its version of the drug omeprazole because the Minister was not satisfied that the submission met the prerequisites established in Part C, Division 8 of the Regulations. The respondent argues that the interests affected by a decision to issue a NOC on the basis of an ANDS are much broader than those of the manufacturer alone. When a NOC is issued on the basis of an ANDS, it serves to indicate not only that the manufacturer is permitted to sell the drug and that the drug is considered safe and effective, but also to signal that the drug is equivalent to another. The definition of "pharmaceutical equivalent" in section C.08.001.1 of the Regulations states that it must contain identical amounts of the identical medicinal ingredients as the comparison drug.
[24] Regarding Reddy's reliance on the AstraZeneca approval, the respondent refers to the fact that the approval was in relation to a SNDS. The Regulations prescribe, in the case of an ANDS, that the drugs being compared contain "identical amounts of the identical medicinal ingredients". There exists no such requirement with respect to a SNDS. Thus, the respondent submits, the fact that the ingredients were not identical acted as a bar with respect to Reddy's ANDS. That was not the case with respect to AstraZeneca's SNDS. Moreover, says the respondent, the Minister is not bound by her previous decisions.
[25] Reddy's position, that once ingested and metabolized all forms of omeprazole are transformed into a sulfenamide metabolite (the substance having the therapeutic effect) and therefore the medicinal ingredients in both the omeprazole (base) and omeprazole magnesium (salt) are identical, is not satisfactory to the Minister. At best, this position suggests that the drugs are therapeutically equivalent. The respondent notes that Reddy does not dispute that the base and salt are different substances.
[26] Additionally, in relation to this argument, the respondent submits that before the Minister can be satisfied with an ANDS, the specifications of the drug's ingredients must be evaluated under paragraph C.08.002.1(2)(a) incorporating paragraph C.08.002(2)(c). These specifications are defined to include potency, purity, testing and examining methods and associated tolerances (C.08.001.1). The Minister cannot evaluate the specifications of a substance that is produced following in-vivo metabolism. The medicinal ingredient to be evaluated must actually be contained in the drug product. The respondent refers to Merck Frosst Canada & Co. v. Canada (Minister of Health) (2001), 185 F.T.R. 267, aff'd. (2001), 12 C.P.R. (4th) 383 (F.C.A.). This authority, says the respondent, underscores the importance of maintaining a distinction between a drug and its metabolites.
[27] Insofar as the reversal of the Level II appeal is concerned, the respondent maintains that even if an opportunity for further submissions had been granted, it would not have made a difference because a full opportunity to make submissions had already been provided. Although the Minister has established an internal process for appeal, she owes no duty to drug manufacturers to follow any particular process. The respondent refers to Martineau v. Matsqui Institution Disciplinary Board, [1980] 1 S.C.R. 602 and says that the decision is not of a nature that entitles Reddy to the procedural protection it seeks.
[28] Lastly, the respondent submits that Reddy seeks an order in the nature of mandamus and that it has not satisfied the requirements to obtain such an order. Relying on Apotex Inc. v. Canada (A.G.), [1994] 1 F.C. 742 (C.A.), aff'd. [1994] 3 S.C.R. 1100 (Apotex 1), Reddy must establish, among other things, that a public duty to act is owed to it and that it has a clear right to performance of the duty.
ISSUES
[29] The primary issue is whether the court should intervene in the respondent's decision that Reddy's application for an ANDS approval would not be processed allegedly due to its failure to meet the requirements of section C.08.002.1 of the Regulations. The answer to that question entails an examination of the process and procedure followed by the respondent as well as a determination of the appropriate standard of review applicable to the decision.
[30] Although the respondent also raised the question of the applicant's failure, on this application, to meet the requisite criteria to obtain relief in the nature of mandamus and Reddy did not contest this submission, neither did the respondent develop the argument to any significant degree. I do not propose to deal further with this question since, in my view, the application can be determined on the basis of the arguments advanced in relation to the issues delineated above.
ANALYSIS
[31] Excluding the question of the A/Director-General's dismissal of Reddy's Level II appeal by correspondence dated November 10, 2000, after having advised that the appeal was resolved in its favour on July 28, 2000, all other issues identified by Reddy are inextricably connected to and based upon the Minister's approach to and approval of the Canadian reference product, AstraZeneca's LOSEC. I therefore prefer to address this matter at the outset since determination of this issue may well be relevant to Reddy's other concerns. The question, as framed by Reddy, is: "Was the applicant entitled to rely on the mode of approval of the Canadian reference product and the scientific conclusions to be drawn therefrom?" I referred briefly to the circumstances regarding this issue when summarizing the applicant's position earlier in these reasons.
[32] In approximately 1995, AstraZeneca's predecessor submitted a SNDS to change its product from omeprazole capsules to omeprazole magnesium tablets. Following the approval of the SNDS by the TPD, Astra withdrew the capsule product from the Canadian market and sold only tablets. In making the decision to proceed as an ANDS rather than a NDS, Reddy took into account the attitude of the TPD to omeprazole capsules and omeprazole magnesium tablets as manifested in the access to information results from the AstraZeneca SNDS submission regarding transition from capsules to magnesium tablets. The purpose of section C.08.003 (the SNDS provision) is to permit changes to marketed drugs, not to permit the marketing of a new drug. A new drug can be approved only for a NDS or an ANDS. Reddy concluded that if the safety and efficacy of omeprazole magnesium tablets can be demonstrated to the satisfaction of the TPD by comparison to omeprazole capsules, then it must also be so that the safety and efficacy of omeprazole capsules can be demonstrated by comparison to omeprazole magnesium tablets.
[33] While Reddy's position appears both logical and rational, I have concluded that the question (Was the applicant entitled to rely on the mode of approval of the Canadian reference product and the scientific conclusions to be drawn therefrom?) must be answered in the negative.
[34] I agree with the respondent that Reddy's position confuses the principles governing an ANDS with those governing a SNDS. The specified circumstances requiring the filing of a SNDS include matters such as the plant and equipment to be used in manufacturing, the manufacturing methods, the tests and controls to be applied and (of particular relevance here) the specifications of the ingredients of the drug. The manufacturer cannot market the drug unless the changes have been fully described in a supplement to the original NDS and the Minister is satisfied that the drug remains safe and effective and issues a NOC. This differs from an ANDS that may be submitted provided, among other things, that the drugs being compared contain "identical amounts of the identical medicinal ingredients". No similar provision is prescribed for a SNDS. Approval for an ANDS involves comparison to a Canadian reference product whereas approval for a SNDS involves satisfying the Minister of the safety and efficacy of the drug. There is no requirement that the medicinal ingredients be identical in relation to the latter.
[35] More importantly and while recognizing that consistency is an admirable objective, it cannot be paramount over a proper, objective consideration of individual submissions on a case-by-case basis. This is particularly so when regard is had to the potential seriousness, in the drug approval process, of the possibility of repeating mistakes. At the hearing, I questioned Reddy's counsel in this respect and specifically asked, what if the Minister was wrong when the NOC issued to AstraZeneca on the basis of its SNDS? Should Reddy nonetheless be entitled to rely on it? No satisfactory response was forthcoming.
[36] Finally, and while not directly applicable to these circumstances, there is authority to the effect that the existence of a conflict in administrative decisions (if indeed a conflict exists) does not constitute an independent basis for judicial review: Domtar Inc. v. Québec (Commission d'appel en matière de lésions professionelles), [1993] 2 S.C.R. 756. It is also noteworthy that had the Minister considered herself bound by the approval granted to the AstraZeneca SNDS, it could be said that she fettered her discretion relative to the Reddy ANDS. I conclude that the applicant was not entitled to rely on the mode of approval of the Canadian reference product.
[37] Reddy's next areas of concern are presented as questions that ask:
(a) Did the respondent fully address the scientific questions of the equivalency of the medicinal ingredient of the Canadian reference product and the applicant's product?, and
(b) Did the respondent form a proper scientific conclusion regarding the equivalency of the medicinal ingredients?
[38] The substance of the argument is that the Minister erred in rejecting Reddy's ANDS at the screening level and should have reviewed it. The TPD's objection to the ANDS resulted in the screening deficiency notice that stated an ANDS is not acceptable, ". . . since the medicinal ingredient in Omeprazole Delayed Release Capsules (omeprazole) is not pharmaceutically equivalent to that in the Canadian reference product (Losec Delayed Release Tablets; omeprazole magnesium)". Reddy argues that at this stage, no scientific assessment of whether omeprazole and omeprazole magnesium may be identical medicines, and therefore pharmaceutically equivalent, had been made. It alleges that the cross-examination of Dr. Peterson establishes that this initial decision was based solely on the differences in names between the ingredients omeprazole and omeprazole magnesium. I digress briefly from Reddy's submissions to observe that, while Dr. Peterson did acknowledge that no scientific assessment had been made at the screening stage, his responses to counsel's questions in relation to the word "name" included the qualification that "name" meant the chemical designation of a compound.
[39] At the end of the day, Reddy argues that the Minister refused to review its ANDS on the basis that its product is not pharmaceutically equivalent to the Canadian reference product and in so doing she erred because the Regulations require pharmaceutical equivalence to be established during the review. At the screening stage, the Minister does not refer to another manufacturer's submissions, but at the review stage, the Minister is specifically authorized to do so by virtue of the Regulations. Had Reddy's ANDS been reviewed, the Minister would have been able to access the AstraZeneca file. Whether the drugs are pharmaceutically equivalent goes to the merits of Reddy's submissions. Because of the evidence required to establish safety and because of the AstraZeneca SNDS file, Reddy's ANDS should not have been rejected at the screening stage without consideration on the merits.
[40] Reddy argues that because it meets all the tests set out in section C.08.002.1, the only outstanding issue is whether omeprazole magnesium and omeprazole are identical medicinal ingredients. If they are identical medicinal ingredients, then Reddy's product and the Canadian reference product are equivalent. Reddy notes that neither the FDA nor the Regulations define "medicinal ingredient". Relying on Dr. Foster's affidavit, Reddy submits that the medicinal ingredient in omeprazole magnesium is omeprazole, the same as in omeprazole simpliciter because only omeprazole is available at the site of absorption in the body.
[41] In a nutshell, Reddy's argument is that, in the present circumstances, its submission ought to have been reviewed because no scientific assessment was conducted at this level and the evidence (AstraZeneca's SNDS submission) by implication establishes that the drugs are pharmaceutically equivalent.
[42] I have difficulty with the alleged basis upon which Reddy insists that the Minister was obliged to conduct a review of its ANDS and I am not persuaded, in the absence of error by the Minister, that Reddy is entitled to a review of its ANDS. The content of the ANDS, in relation to the information or evidence to be provided by the manufacturer, is a matter within the discretion of the Minister and those acting on her behalf to determine.
[43] The Minister has developed a comprehensive policy for the management of drug submissions. Those that are rejected at the screening level (which provides for two levels of appeal) are not processed further, i.e., they are not evaluated, assessed or reviewed. Any number of deficiencies may be identified at the screening level. In Reddy's case various deficiencies were identified, but its failure to submit a product that contained identical amounts of the identical medicinal ingredients as the Canadian reference product was fatal to its submission and Reddy was invited to submit a NDS for its product. I note that the determination that omeprazole and omeprazole magnesium are different medicinal ingredients was consistent throughout, i.e. screening and both levels of appeal.
[44] Having determined that Reddy did not meet the requirement set out in paragraph C.08.002.1(1)(a), the Minister concluded that the submission was not acceptable. Reddy has not referred to any specific provision in the Regulations that requires the Minister to proceed with a review of a submission when a sponsor fails to meet the submission content requirements. The Minister, here, adhered to the policy whereby submissions found acceptable on screening will be reviewed. Since Reddy's submission was not found to be acceptable, it was not reviewed. Unless the policy contravenes or contradicts the provisions of the FDA or the Regulations, the court will not intervene. It seems to me that if Reddy is to succeed, it must establish reviewable error on the part of the ministerial delegate, the A/Director-General, with respect to his determination that Reddy did not meet the requirement set out in paragraph C.08.002.1(1)(a).
[45] The cornerstone authority regarding judicial review of administrative decisions, where a statute delegates power to an administrative decision-maker, is Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982 (Pushpanathan). Since the hearing of this application for judicial review, the Supreme Court has rendered additional decisions wherein it unequivocally reaffirms the primacy of the pragmatic and functional approach to determining the standard of judicial review of administrative decisions: Dr. Q v. College of Physicians and Surgeons of British Columbia, 2003 SCC 19 (Dr. Q); Law Society of New Brunswick v. Ryan, 2003 SCC 20 (Ryan). In every case, the court must begin by determining the standard of review on the Pushpanathan pragmatic and functional approach, which demands a nuanced analysis based on consideration of a number of factors: Dr. Q. The objective of the approach is articulated by McLachlin, C.J. at paragraph 22:
To determine standard of review on the pragmatic and functional approach, it is not enough for a reviewing court to interpret an isolated statutory provision relating to judicial review. Nor is it sufficient merely to identify a categorical or nominate error, such as bad faith, error on collateral or preliminary matters, ulterior or improper purpose, no evidence, or the consideration of an irrelevant factor. Rather, the pragmatic and functional approach calls upon the court to weigh a series of factors in an effort to discern whether a particular issue before the administrative body should receive exacting review by a court, undergo "significant searching or testing" (Southam, supra, at para. 57), or be left to the near exclusive determination of the decision-maker. These various postures of deference correspond, respectively, to the standards of correctness, reasonableness simpliciter, and patent unreasonableness.
[46] Determination of the standard of review requires consideration of four contextual factors - the presence or absence of a privative clause or statutory right of appeal; the expertise of the decision-maker relative to that of the reviewing court on the issue in question; the purposes of the legislation and the provision in particular; and, the nature of the question - law, fact, or mixed law and fact. The factors may overlap, but consideration of the four factors enables the court to address the core issues in determining the degree of deference: Dr. Q at para. 26.
[47] The first factor focuses generally on the statutory mechanism of review. While the presence of a "full" privative clause is compelling evidence that the court ought to show deference to the decision-maker, the absence of a privative clause does not imply a high standard of scrutiny, where other factors bespeak a low standard: Pushpanathan at para. 30.
[48] The second factor, relative expertise, recognizes that legislatures will sometimes remit an issue to a decision-making body that has particular topical expertise or is adept in the determination of particular issues. Where this is so, courts will seek to respect this legislative choice when conducting judicial review. Yet expertise is a relative concept, not an absolute one. Greater deference will be called for only where the decision-making body is, in some way, more expert than the courts and the question under consideration is one that falls within the scope of this greater expertise: Dr. Q at para. 28 citing Moreau-Bérubé v. New Brunswick (Judicial Council), [2002] 1 S.C.R. 249. The analysis under this heading has three dimensions: "the court must characterize the expertise of the tribunal in question; it must consider its own expertise relative to that of the tribunal; and it must identify the nature of the specific issue before the administrative decision-maker relative to this expertise": Pushpanathan at para. 33.
[49] The third factor is the purpose of the statute, i.e., the general purpose of the statutory scheme within which the administrative decision is taking place. If the question before the administrative body is one of law or engages a particular aspect of the legislation, the analysis under this factor must also consider the specific legislative purpose of the provision(s) implicated in the review. As a general principle, increased deference is called for where legislation is intended to resolve and balance competing policy objectives or the interests of various constituencies, characteristics described as "polycentric" in Pushpanathan: Dr. Q at para. 30. Provisions that confer a broad discretionary power upon a decision-maker will generally suggest policy-laden purposes and, consequently, a less searching standard of review. Reviewing courts should also consider the breadth, specialization, and technical or scientific nature of the issues that the legislation asks the administrative decision-maker to consider. Here, the principles animating the factors of relative expertise and legislative purpose tend to overlap. A legislative purpose that deviates substantially from the normal role of the courts suggests that the legislature intended to leave the issue to the discretion of the administrative decision-maker and, therefore, militates in favour of greater deference: Dr. Q at para. 31.
[50] The fourth factor is the nature of the problem. In the context of judicial review of administrative action, the nature of the question is just one of four factors to consider. When the finding being reviewed is one of pure fact, this factor will mili