Date: 20040311
Docket: A-272-03
Citation: 2004 FCA 102
CORAM: SEXTON J.A.
EVANS J.A.
SHARLOW J.A.
BETWEEN:
REDDY-CHEMINOR, INC.
Appellant
and
THE ATTORNEY GENERAL OF CANADA
AND THE MINISTER OF HEALTH
Respondents
Heard at Toronto, Ontario, March 10th, 2004.
Judgment delivered at Toronto, Ontario, on March 11th, 2004.
REASONS FOR JUDGMENT BY: EVANS J.A.
CONCURRED IN BY: SEXTON J.A.
SHARLOW J.A.
Date: 20040311
Docket: A-272-03
Citation: 2004 FCA 102
CORAM: SEXTON J.A.
EVANS J.A.
SHARLOW J.A.
BETWEEN:
REDDY-CHEMINOR, INC.
Appellant
and
THE ATTORNEY GENERAL OF CANADA
AND THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
EVANS J.A.
[1] This is an appeal by Reddy-Cheminor, Inc. ("Reddy") from a decision of Laydon-Stevenson J. in which she dismissed Reddy's application for judicial review of the Minister of Health's rejection of its Abbreviated New Drug Submission ("ANDS") in respect of its omeprazole capsules: Reddy-Cheminor, Inc. v. Attorney General of Canada, 2003 FCT 542.
[2] A person wishing to market a new drug in Canada must first satisfy the Minister that the drug is safe and efficacious. When so satisfied, the Minister must issue a Notice of Compliance ("NOC"). A NOC may be obtained on the basis of an ANDS only when "the new drug is the pharmaceutical equivalent of the Canadian reference product": Food and Drug Regulations, C.R.C. c. 870, C.08.002.1(1)(a). C.08.001.1(c) defines "pharmaceutical equivalent" as
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.
[3] The Minister decided that Reddy's ANDS was deficient and rejected it at the screening stage of the process without a full examination. The defect identified was that the Canadian reference product to which Reddy sought to compare its omeprazole capsules, AstraZeneca's omeprazole magnesium tablets, did not contain "identical amounts of the identical medicinal ingredients". The Minister was of the view that, because omeprazole and omeprazole magnesium are different chemical compounds, they are not "identical medicinal ingredients", a term that the Regulations do not define.
[4] As a result, Reddy was advised that it could not seek regulatory approval for its omeprazole capsules on the basis of an ANDS, but must make a New Drug Submission ("NDS"), which requires different supporting material, and is much more expensive and time-consuming to prepare.
[5] The issue to be decided in this appeal is whether the Minister committed a reviewable error in determining that omeprazole and omeprazole magnesium are not "identical medicinal ingredients" on the ground that they are different chemical substances.
[6] Counsel for Reddy says that the Minister could not lawfully decide whether the drugs contained "identical medicinal ingredients" without first considering the evidence contained in Reddy's ANDS. In particular, he argues, the Regulations require an applicant for a NOC to include in its ANDS evidence to support its claims, including the claim that the applicant's drug and the reference drug contain "identical medicinal ingredients". The Minister is not entitled to rely simply on the fact that the active ingredients in the two products have different names. Hence, he submitted that the Minister was obliged to review Reddy's evidence establishing that, when ingested, omeprazole and omeprazole magnesium produce the same metabolite, which has the therapeutic effect on the patient.
[7] Despite counsel's able argument, I cannot agree. First, it is clear from the record that, whether or not she had examined the evidence included in Reddy's ANDS, the Minister understood the essential point being made on Reddy's behalf. This is made abundantly clear in the assessment prepared for Reddy's second level of internal administrative appeal by the Office of Science of Health Canada's Therapeutic Products Directorate (Appeal Book, vol. IV at 330):
There is no dispute between the sponsor and Programme regarding the need for identicalness [of the medicinal ingredients]. Both sides accept that omeprazole and omeprazole magnesium are different chemical entities albeit closely related. The difference in position is the interpretation of medicinal ingredient. The sponsor holds that omeprazole and omeprazole magnesium are identical medicinal ingredients as drug products containing these ingredients exert similar therapeutic effects.
It is accepted that the actual chemical substance responsible for the biological effect of a drug product is not always the same as the medicinal ingredient incorporated into the product. ... However, different chemical entities that ultimately result in the delivery to the body of the same chemical substance cannot be considered to be identical medicinal ingredients. [emphasis added]
[8] Second, I agree with Laydon-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.
[9] Third, like the Applications Judge, I am not persuaded that it was either patently unreasonable, or unreasonable simpliciter, for the Minister to conclude that only drugs comprising the same chemical entities contain "identical medicinal ingredients", even though the active ingredients of drugs may deliver the same chemical substance to the body with the same therapeutic effects.
[10] Finally, I should mention an argument made to us in the written submissions, but not pressed by counsel at the hearing. AstraZeneca had originally obtained a NOC for omeprazole capsules, but subsequently filed a Supplement to a New Drug Submission ("SNDS") for a NOC for omeprazole magnesium tablets, which it obtained. On the basis of this, Reddy contended that, in issuing a NOC to AstaZeneca for omeprazole magnesium tablets, the Minister must have decided that omeprazole capsules and omeprazole magnesium tablets contained identical medicinal ingredients. Therefore, it is argued, Reddy should be able to seek a NOC for omeprazole capsules on the basis of an ANDS comparing them to omeprazole magnesium tablets.
[11] In my opinion, this argument is misconceived because the statutory criteria for obtaining a NOC on the basis of a SNDS are materially different from those governing the issue of a NOC on the basis of an ANDS. A SNDS may be filed by a person when a NOC has been issued in respect of a drug and some change has been made to the product, its manufacture or marketing.
[12] However, a SNDS can only be filed if, inter alia, "the specifications of the ingredients of the new drug" are not "significantly different from the information or material contained" in the NDS: C.08.003(1), (2)(c). In contrast, a NOC can be obtained on the basis of an ANDS only when the sponsor can establish that its drug and the reference drug contain "identical medicinal ingredients".
[13] For these reasons, I would dismiss the appeal with costs.
"John M. Evans"
J.A.
"I agree
J. E. Sexton"
J.A.
"I agree
Karen R. Sharlow"
J.A.
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-272-03
STYLE OF CAUSE: REDDY-CHEMINOR, INC.
Appellant
and
THE ATTORNEY GENERAL OF CANADA
AND THE MINISTER OF HEALTH
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: MARCH 10, 2004
REASONS FOR JUDGMENT BY: EVANS J.A.
CONCURRED IN BY: SEXTON J.A.
SHARLOW J.A.
DATED: MARCH 11, 2004
APPEARANCES:
Douglas Deeth
Gordon Jepson
FOR THE APPELLANT
F.B. Woyiwada
FOR THE RESPONDENTS
SOLICITORS OF RECORD:
DEETH WILLIAMS WALL LLP
Barristers & Solicitors
Toronto, Ontario
FOR THE APPELLANT
Morris Rosenberg
Deputy Attorney General of Canada
Toronto, Ontario
FOR THE RESPONDENTS
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