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Apotex 81 mg ASA Not Bio-Equivalent with Bayer ASA – Decision of Minister to Refuse to Issue a Notice of Compliance to Apotex Upheld by Federal Court
Apotex Inc. v. Canada (Health) 2009 FC 452 (Phelan, J.)
May 5, 2009
H.B. Radomski and Daniel Cohen for the Applicant, Apotex Inc. (“Apotex”)
Rick Woyiwada for the Respondents, Minister of Health (“Minister”) and Attorney General of Canada
Apotex brought a judicial review of the decision of the Minister of Health who refused to issue a Notice of Compliance to Apotex for an 81 mg enteric-coated tablet of acetylsalicylic acid (ASA). The underlying fact which drove this decision was a problem with Apotex’s data wherein two subjects for the fed study to prove bioequivalence did not meet the Minister’s standards. Apotex took the position that the referenced drug was defective and this was the reason for the difference between the referenced product and its product.
Apotex raised three issues in the judicial review:
- whether the Minister fettered his discretion by rigidly following its Guidelines;
- whether there were no intelligible reasons for the Minister’s decision that the product was not safe and effective; and
- whether there was unfairness in the system used by the Minister particularly given the Settlement Agreement from a prior external appeal.
On the standard of review, the Court found that the real issue in dispute was the decision that the ANDS did not have enough data to satisfy the Minister that Apo-ASA was safe and effective. This was largely a factual determination by an expert body and therefore was reviewable on the standard of reasonableness.
The Court found that the Minister’s decision not to accept Apotex’s demand for an NOC on the basis of non-compliant data was not unreasonable. The record showed that the Minister applied the guideline requirements in a manner which recognized the possibility of exceptions; but was not satisfied, on reasonable grounds, that an exception should be granted. The Court found that the Minister’s decision was based on lack of evidence presented, and not on an unreasonable refusal to vary the bioequivalence guidelines.
On the issue of absence of intelligible reasons, the Court found that the Minister’s decision included lengthy and detailed reason for his concern about the bioequivalence data. Ultimately, the Court found that what was remaining was a difference of opinion between the Minister and Apotex. It was not the Court’s role in this instance to resolve the difference. It was sufficient that the Minister’s opinion or lack of satisfaction was rationally based and adequately explained.
With respect to the breach of procedural fairness allegation, the Court found that if there was a breach of the terms of settlement, this was a matter of contract and which would more properly be the subject of an action at the Federal Court.
Secondly, there was a lack in an evidentiary base upon which to make any determination of non-compliance with an agreement, much less any conclusion as to the legal ramifications flowing from alleged non-compliance. The Court found no procedural unfairness.
For all these reasons, the judicial review was dismissed with costs.
By: Peter W. Choe, Gowling Lafleur Henderson LLP
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