No Vested Right to an NOC When Health and Safety is in Issue

Apotex Inc v Canada / omeprazole 2012 FCA 322 Dawson JA: Sharlow, Trudel JJA aff’g 2011 FC 1308 Barnes J (blogged here)

            omeprazole magnesium tablets

In March 2003 the Therapeutic Products Directorate advised Apotex that the examination of Apo-Omeprazole had been completed but Apotex’s application for a NOC was on patent hold. In the fall of 2009, while the application was still on patent hold, the TPD revoked the approval status on the basis that the bioequivalence study filed by Apotex with its ANDS had not been appropriately conducted. The TPD refused to reconsider this decision (for a review of the facts see 2010 FC 1310, [3], a motion to strike on this application). Apotex challenged the TPD’s decisions by way of an application. Barnes J dismissed the application as untimely under the Federal Courts Act s 18.1(2), and he held that time should not be extended. On the only substantive point that was discussed, Barnes J held that there can be no vested right to an NOC. The FCA has now affirmed the decision of Barnes J. Again, the important substantive point was whether Apotex had a vested right to an NOC. The issue was fully argued [21], and therefore, like Barnes J, the FCA gave full consideration to the point, notwithstanding its conclusion that the motion should be dismissed as being out of time.

The FCA held that to hold that Apotex had a vested right to an NOC would be contrary to the purpose of the Food and Drugs Act, which is “‘to encourage bringing safe and effective medicines to market to advance the nation’s health’ . . . The primary responsibility of the Minister under the Act and the Regulations is to the health and welfare of Canadians” [29].

[30] When the Minister exercises her discretion under section C.08.004 of the Regulations to issue a NOC, she must be satisfied that the drug is safe and effective. Nothing in the wording of the Regulations compels the contrary conclusion and it would, in my view, be an absurd result to construe the Regulations in such a way that the Minister could be compelled to issue a NOC even if she was not satisfied that the drug in question is safe and effective.

This strikes me as a compelling argument.

The FCA distinguished its earlier decision in Apotex v Canada / enalapril [1994] 1 FC 742, aff’d [1994] 3 SCR 1100, in which it had held that Apotex did have a vested right to an NOC, on the basis that safety and efficacy was not at issue in that case [43]. In Apotex / enalapril the Apotex's application for an NOC for apo-enalapril had been examined and all the existing statutory requirements were satisfied, but Bill C-91 had just been passed imposing new legal requirements (to address patents on the register), which had not been met by Apotex's existing application. A key holding was that “it cannot be said that in the exercise of his statutory power under the FDA Regulations the Minister was entitled to have regard to the provisions of Bill C-91 after they were enacted but before they were proclaimed in effect.” In Apotex / enalapril the FCA expressly stated that “the principal question to be answered by the Minister: Is Apo-Enalapril a safe drug?,” and consequently expressly recognized that “‘if the health or safety of the public is endangered), there will be considerable hesitation to recognize vested rights’” (quoting Côté on The Interpretation of Legislation in Canada. The FCA also stated that “as Apo-Enalapril has met the safety and efficacy requirements under the FDA Regulations, no issue with respect to public health and safety arises.” Thus the FCA in this case was on perfectly solid ground in distinguishing Apotex / enalapril, as the ground for the distinction had been expressly anticipated in the earlier decision.