On June 15, 2016, in Apotex Inc v Canada (Health), 2016 FC 673, Manson J of the Federal Court quashed the Minister of Health’s (Minister) 2015 Decision varying the establishment licenses for Apotex Inc’s (Apotex) Indian drug manufacturing facilities.  The 2015 Decision arose from Health Canada’s inspection of the Indian facilities to assess whether Apotex had successfully addressed its data integrity violations following Health Canada’s 2014 Import Ban against these facilities.  Although no instances of data integrity violations were identified, the Minister maintained its 2014 Import Ban on the pre-inspection products and imposed additional testing and reporting requirements on the post-inspection products.  Apotex sought a judicial review of this Decision. 

Before the hearing of this case, Manson J quashed the Minister’s 2014 Import Ban (Apotex Inc v Canada (Health), 2015 FC 1161, previously reported in E-TIPS® Newsletter). The Minister then removed all terms and conditions imposed by its 2015 Decision.

Manson J agreed that Apotex’s judicial review application was moot.  Nevertheless, he exercised his discretion to hear this case.  He held that the 2015 Decision was unlawful in view of the close interconnection between this Decision and the 2014 Import Ban, and the lack of evidence before the Minister supporting any reasonable belief that the Import Ban was necessary in 2015.  He held that the 2015 Decision was the perpetuation of the 2014 Import Ban which was found to be motivated by a purpose outside the Minister’s authority.

Summary By: Junyi Chen

E-TIPS® ISSUE

16 09 07

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