The Court dismissed Apotex's application for judicial review, finding that Therapeutic Products Directorate of Health Canada's ("TPD") decision requiring additional information prior to completing its review of NOC submissions for approval of certain new products that were manufactured or tested at two of Apotex's manufacturing facilities in India to be neither improper nor unreasonable.
The decision provided a detailed overview of the facts, including the three related decisions rendered by TPD, as well two earlier decisions of the Inspectorate restricting importation of drugs from two of Apotex's drug manufacturing facilities, which were quashed by the Court in 2015 FC 1161 (our summary here) and in 2016 FC 673 (our summary here).
The Court first looked at whether TPD's decision under review should be unlawful based on its proximity to a quashed decision. The Court noted that this is a legal question and reviewed it using a correctness standard.
The Court found that the relief requested could only apply to two drugs, Varenicline and Sitagliptin, whose submissions contain data from stability studies subject to the data integrity concerns. The Court also pointed out that Apotex has complied with TPD's requests for additional information rather than seek judicial review for the other 30 submissions subject to the data integrity concerns
The Court found that the evidence suggested that the importation ban was a catalyst for TPD's decision. However, Apotex was not able to convince the Court that the Minister's refusal to end her prohibition on granting NOCs for products manufactured or tested at two of Apotex's manufacturing facilities in India is inextricably bound up with, and based upon, the quashed importation ban.
Satisfied that the decision at issue was not tainted by the quashed decision, the Court went on to review the TPD's continuing requests for additional data for submissions subject to data integrity concerns on a reasonableness standard. TPD no longer requires additional information to support data generated at these two locations after January 2015. This is because TPD was able to conclude that the corrective and preventative measures implemented by Apotex rendered post-January 2015 data reliable. The Court ultimately concluded that it was not unreasonable for TPD to conduct a fresh review and to request additional information to address the data intrigity concerns at those two locations, and those concerns for Varenicline and Sitagliptin in particular.