In The Winning Combination Inc. v. Canada
(2016 FC 381), the Federal Court found that Health Canada
demonstrated bias, prejudgment and prevented The Winning
Combination ("TWC") from fully and fairly participating
in the licensing process. Accordingly, the Court quashed Health
Canada's decisions and awarded TWC full costs.
This was a judicial review of a series of related Health Canada
decisions regarding the TWC product Resolve, a smoking cession aid.
There is a long history associated with this dispute, involving a
convoluted set of decisions by Health Products and Food Branch
Inspectorate ("HPFBI") and the Natural and
Non-Prescription Health Products Directorate (as they are now,
"NHPD"), as well as a trade complaint submitted by
Pfizer. As a result, TWC was required to deal with Health Canada
from both a licensing and compliance perspective. Between the
initial Product Licence Application ("PLA") in 2004 and
the final rejection in 2012, there were two major decisions at
July 2007 decision to reject
TWC's PLA based on safety and efficacy concerns; and
August 2007 decision to reject
TWC's PLA on the basis that Resolve was not a Natural Health
Despite these two major decisions, NHPD continued to consider
and invite reconsideration applications from TWC suggesting that
NHPD was open to changing its mind. In this judicial review, TWC
alleged both individual and institutional bias, as well as
The Court determined that Health Canada did not provide
procedural fairness regarding the declassification of Resolve as a
NHP. Based on the evidence before the Court, this decision was
hurriedly instigated, without notice or warning, and despite the
fact that previous decisions and communications confirmed the
understanding that Resolve was considered a NHP. The Court found
that the process was fraught with unfairness because:
The Health Canada experts were deeply
connected with Dr. Marles, the Director of the Bureau of Clinical
Trials and Health Science, and would more likely than not support
his opinion. For example, one of the experts was Dr. Marles'
postdoctoral supervisor and he had co-authored a number of
scientific reports with the experts.
No independent lab testing was
conducted to refute TWC's testing.
A peer-reviewed, scientific
publication supported TWC's assertion of the NHP in
Health Canada relied on allegations
and arguments without providing TWC with the opportunity to
The Court also noted that an administrative decision made
without procedural fairness cannot be cured by allowing a
Remedies were problematic in this case. Typically, in a
successful judicial review, the remedy is to quash the decision at
issue and return the matter for reconsideration by a differently
constituted tribunal. Based on the history in this case, including
bias, substantial unfairness and sustained unreasonableness in this
case, the Court was of the view that it would be unlikely that this
approach would even be possible.
Furthermore, the Court stated that most of the errors it had
identified related to the conduct of Dr. Marles, whose role was
supposed to have been no more than a scientific advisor, in a
system with checks and balances. The Court concluded that system
had not functioned properly. Accordingly, it was not evident to the
Court that that the same system could fairly reconsider this
matter. Besides, any reconsideration that TWC experienced up to
this point was far from impartial and fair.
Additionally, the Court found that the evidence before it
There were no outstanding safety
concerns over Resolve.
The NHP efficacy test (as construed
by the Court) was satisfied.
The active ingredient in Resolve is a
Accordingly, there was no justification for the Minister to
withhold the PLA licence for Resolve.
Due to the prolonged dispute, TWC had been unable to market
Resolve for eight years for no justifiable reason. The Court
recognized the dysfunctional licensing process that TWC was
required to contend with and described Health Canada's
behaviour as reprehensible. Accordingly, the court awarded
TWC full costs, estimated to be $1-million. Furthermore, the
decisions at issue were quashed and an, in their place, an order
for mandamus was issued requiring the Minister to grant a
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).