Federal Court of Canada Orders Health Canada to Issue NHP Product Licence

On April 6, 2016, Canada’s Federal Court (FC) released its judgment in The Winning Combination Inc v Canada (Minister of Health), 2016 FC 381, allowing an application for judicial review brought by The Winning Combination Inc (TWC) from a series of decisions by Health Canada refusing TWC a product licence under the Natural Health Product Regulations for TWC’s product Resolve® (RESOLVE), a smoking cessation aid. 

In the summer of 2007, Health Canada issued two decisions refusing a product licence for RESOLVE.  Health Canada’s first refusal was on the grounds that TWC had submitted insufficient evidence to support the safety and efficacy of RESOLVE.  The second refusal was on the grounds that RESOLVE was a drug not a NHP, and not subject to the Natural Health Product Regulations.  TWC sought reconsideration of these decisions from 2007-2012. Health Canada maintained its position that RESOLVE was not a NHP and that efficacy had not been established, but withdrew its safety objections.  TWC sought judicial review of Health Canada’s initial two decisions and its reconsideration (the Decisions).

The FC found that Health Canada’s Decisions were unreasonable and ordered them quashed.  Importantly, the FC agreed with TWC that the standard of proof required for NHP efficacy under the Natural Health Product Regulations does not rise to the level of clinical studies, like those required for drug licensing. The FC also accepted TWC’s expert evidence that RESOLVE was a NHP.

Rather than returning the matter for reconsideration by Health Canada, the FC issued a mandamus order that Health Canada issue a product licence for RESOLVE. The FC found that:

[b]oth sides have been involved in a protracted and bitter dispute and I see no point in directing reconsideration when the evidence clearly established [that RESOLVE meets the requirements for a product licence].

The FC also found that Health Canada dealt with TWC in a manner that was procedurally unfair and biased:

My own feeling is that TWC has been subjected to a dysfunctional licensing process during the course of which normal and procedurally fair safeguards were abandoned and Dr. Marles was allowed to pursue a course of action aimed at denying a PLA licence to TWC on spurious grounds.

[…]

Health Canada strayed from its established processes, demonstrated bias and pre-judgment and prevented TWC from ever fully comprehending the standard to which its NHP was being held. 

TWC was awarded full indemnity solicitor-client costs on its application.  The federal Minister of Health has filed a notice of appeal.

For news report on this case, see:

       Globe and Mail