Apotex Inc. v. Canada (Health), 2016 FC 673

Apotex et al. brought a judicial review (JR) of the Minister of Health's August 2015 decision that varied the terms and conditions of Apotex's Drug Establishment Licences in respect of its two facilities in India, such that products produced after June 2015 were subject to various additional testing and reporting requirements.

This is the second JR involving a decision of the Minister restricting importation of drugs from two of Apotex's drug manufacturing facilities. Our summary of the first JR can be found here.

Following the first JR decision, which quashed the Minister's 2014 Import Ban, the Minister issued a decision removing all terms and conditions on Apotex's establishment licences for the two facilities. Consequently, the Respondents' requested the dismissal of the second JR for mootness. While the Court was satisfied that the JR was moot, the Court decided that it ought to hear it upon considering the three factors set out by in Borowski v Canada (Attorney General), [1989] 1 SCR 342, namely: (a) the presence of an adversarial context; (b) judicial economy; and (c) the need for the Court to be sensitive to its role as the adjudicative branch of government.

The issue before the Court was whether the August 2015 Decision was unlawful on the basis that the amendment, in effect, sustained a decision quashed by this Court by maintaining in part, the 2014 Terms and Conditions in the 2015 Terms and Conditions. The applicable standard of review was correctness.

The Court noted that the lawfulness of the August 2015 Decision would depend upon:

  1. whether it is a sufficiently independent decision from the 2014 Import Ban, and
  2. whether it could nonetheless be justified in the evidence, such that the Minister's improper purpose in imposing the Import Ban did not also taint this subsequent and related decision.

The August 2015 Decision was not implemented as, nor intended to be, a new and independent decision from the 2014 Import Ban. Further, the Court found that there was a lack of evidence before the Minister that supported any reasonable belief an Import Ban was necessary in August of 2015.

The Court also noted that while the first JR found that the 2014 Import Ban was motivated by a purpose falling outside the Minister's delegated authority, this did not, in these circumstances, render it automatically void. Rather, the Court found that there was simply no evidence supporting any asserted basis for implementing or maintaining the Import Ban so as to support a finding that the 2015 Decision was justified or sufficiently separate from the 2014 Import Ban. The Court granted the JR and declared that the August 2015 Decision was unlawful.