This case (Apotex v. Canada (Health),
2016 FC 673) involves a very unique set of circumstances. An
underlying Health Canada decision was found to have been made for
an improper purpose and carried out unfairly. This decision was
apparently perpetuated in identical form in a subsequent decision
without an evidentiary or lawful basis to do so and the subsequent
decision was, therefore, found to be unlawful as well.
In September 2014, following a series of articles in the Toronto
Star criticizing the Health Canada's inaction in relation to
Apotex imports from India, Health Canada imposed terms and
conditions on Apotex's establishment licences at the facilities
in India that prevented the import and sale of drug products from
In June 2015, Health Canada inspected the facilities in India.
The overall inspection team recommendation conveyed that no
instances of data integrity violations were identified (a major
issue related to the terms and conditions). Accordingly, in August
2015 Health Canada advised Apotex that it has amended the terms and
conditions of the establishment licences—the products made
after the inspection were not banned completely, but were subject
to additional testing and reporting requirements.
In March 2016, the Minister issued a decision removing all terms
and conditions on Apotex's establishment licences at the
facilities in India.
Initial Legal Action
Apotex brought a first Judicial Review of Health Canada's
2014 decision to vary the terms and conditions of the establishment
licences and the import ban. Prior to the hearing for Judicial
Review, the Minister brought a motion for mootness. This motion was
dismissed (Apotex Inc v Canada (Health), 2015 FC 1157).
On Judicial Review, the Court quashed Health Canada's
decisions, finding that they were motivated by criticism in the
media and House of Commons, rather than the a legitimate concern
for the health and safety of Canadians (Apotex Inc v Canada
2015 FC 1161).
Most Recent Legal Action
In this second Judicial Review, Apotex sought an order declaring
the August 2015 decision unlawful, as well as an order prohibiting
Health Canada from further carrying into effect the importation ban
by varying Apotex's establishment licences for the facilities
Health Canada contended that its March 2016 decision removed the
terms and conditions imposed on the Apotex facilities. Essentially,
the relief sought by Apotex in this application had already been
The Court agreed that this Judicial Review was moot.
However, the Court exercised its discretion to hear the case and
found that the August 2015 decision was unlawful.
The Court reviewed the decision on a correctness standard. This
was a legal question that involved determining the effect of
amending, carrying forward and maintaining a decision that was
subsequently quashed on the basis that it was implemented unfairly
and for an improper purpose.
In the first Judicial Review, the Court found that the
importation ban was motivated by the Minister's desire to
silence criticism from the media and the House of Commons, an
In this case, the Court found that the August 2015 decision was
unlawful because of the close interconnection between the decision
and the importation ban, as well as the lack of evidence before the
Minister that supported any reasonable belief that the importation
ban was necessary in August 2015. Essentially, the August 2015
decision was the perpetuation of a decision motivated by a purpose
outside the Minister's authority, and therefore not in
accordance with the rule of law.
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