Case: Apotex Inc. et al v Minister of Health and Attorney General of Canada, 2016 FC 673 (Court File No. T-1653-15)
Nature of case: Application for judicial review of decision of Minister of Health
Successful party: Apotex Inc.
Date of decision: 15 June 2016
Summary
Apotex Inc., Apotex Pharmachem India Pvt Ltd.
(APIPL) and Apotex Research Private Limited
(ARPL) (collectively, Apotex)
sought judicial review of a decision of the Minister of Health
(Minister) to vary the terms and conditions of the
Drug Establishment Licence (DEL) held by APIPL and
ARPL (August 2015 Decision) and maintain the
import ban on drugs manufactured at Apotex's APIPL and ARPL
facilities.
This was the second judicial review brought by Apotex in connection
with the initial import ban that Health Canada had imposed on
Apotex products in September 2014. In the first judicial review
(First Judicial Review), Apotex sought to have the
Minister's decision to impose an import ban on Apotex quashed.
The Court did so, holding that the Minister had not afforded Apotex
adequate procedural fairness.
Apotex brought the second judicial review application in response
to the Minister's August 2015 Decision and continued import ban
on its products. In this instance, the Court held that there was no
evidence to support maintaining the import ban and declared Health
Canada's August 2015 Decision unlawful.
Background
The First Judicial Review
On September 30, 2014, following inspection reports initially
conducted by the United States Food and Drug Administration noting
data integrity issues at Apotex's APIPL and ARPL facilities and
a subsequent inspection of the facilities by Health Canada, and in
the face of media scrutiny and political pressure, an import ban
was imposed on drug products coming into Canada from those
facilities. Subsequently, the Minister made amendments to
Apotex's DELs to prohibit the import of all products except
those deemed medically necessary.
Apotex brought the First Judicial Review application to challenge
the Minister's decision to implement the initial import ban and
amend Apotex's DELs. The Court's decision in the First
Judicial Review, dated October 14, 2015, quashed the Minister's
decision to impose the import ban, finding that the import ban was
motivated by an improper purpose and that Apotex was not afforded
adequate procedural fairness. The Court further ordered Health
Canada and the Minister to retract public statements connected to
Apotex and the import ban made in the media.
The August 2015 Decision and Second Judicial
Review
In the August 2015 Decision, Health Canada advised Apotex that it
had further amended the terms and conditions of its DELs, requiring
additional testing and reporting requirements for drug products
made after June 10, 2015.
In March 2016, the Minister issued a decision removing all terms
and conditions from Apotex's DELs affecting APIPL and ARPL
(March 2016 Decision). However, the Minister
continued to request data integrity information for Apotex's
regulatory drug submissions, including for any of Apotex's
Abbreviated New Drug Submissions (ANDS) where the
ANDS included data generated at ARPL or APIPL prior to June 10,
2015, despite the removal of the DEL terms and conditions that
required this information.
Apotex brought a second judicial review application seeking a
judgment on the issue of whether the August 2015 Decision and
resulting continuation of the import ban was unlawful on the basis
of its connection to the decision quashed in the First Judicial
Review and the evidence supporting the Minister's decision.
Application moot
As a preliminary matter, the Minister argued that Apotex's
application for review of the August 2015 decision was moot in
light of the March 2016 Decision.
The Court agreed that the matter was moot, but exercised its
discretion to hear the application. The Court relied, in
particular, on the existence of an adversarial context between the
parties, stating that an adjudication on the merits would have
"collateral and practical significance on the parties'
rights," including in another pending judicial review
application and in an action for damages that Apotex intended to
commence.
Minister's decision unlawful and continued import ban quashed
Apotex argued that the August 2015 Decision should be quashed on
the grounds that the Minister acted unlawfully in maintaining the
import ban by varying the terms and conditions of the DEL in the
August 2015 Decision, notwithstanding the judgment of the Court
quashing the import ban in the First Judicial Review. Apotex also
argued, among other things, that the Minister acted and rendered a
decision that was contrary to the provisions of the Food and
Drug Regulations.
The Court found that the August 2015 Decision was not independent
from the 2014 import ban quashed in the First Judicial Review. The
Court stated that the "two decisions are inextricably
interconnected" and the facts suggest that the August 2015
Decision was not a "free-standing and uninfluenced decision,
such that it was not also affected by the improper purpose that
motivated the Import Ban."
On this basis, Justice Manson granted Apotex's judicial review
application. He concluded that there was no evidence to justify the
Minister's August 2015 Decision as a basis for maintaining the
import ban, and declared the August 2015 Decision unlawful.
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