Pharma In Brief - Health Canada Ordered To Grant A Natural Health Product License For Smoking Cessation Product

Case: The Winning Combination Inc. v Canada (Minister of Health), 2016 FC 381 (Court File No. T-1381-07)

Drug: RESOLVE®

Nature of case: Application for judicial review of Health Canada's decision refusing marketing authorization under the Food and Drugs Act, RSC 1985, c F-27 (Act) and Natural Health Product Regulations, SOR/2003-196 (NHP Regulations)

Successful party: The Winning Combination Inc.

Date of decision: April 4, 2016

Summary

The Winning Combination Inc. (TWC) marketed a smoking cessation aid in Canada with a confidential active ingredient under the brand name RESOLVE®. Through a series of decisions, Health Canada required that TWC remove RESOLVE from the Canadian marketplace and refused to grant a Product License for RESOLVE under the NHP Regulations.

The Court allowed TWC's application for judicial review, finding that Health Canada's refusal to grant a Product License Application (PLA) for RESOLVE was unjustified. The Court concluded that TWC had been denied procedural fairness and that the PLA and subsequent reconsideration processes were unreasonable and biased. Health Canada's decisions rejecting the PLA were quashed and Health Canada was ordered to grant a licence for RESOLVE within 30 days of the order.

Background

In 2004, the PLA for RESOLVE was submitted to the Natural Health Products Directorate (NHPD). The NHPD initially concluded, based on the authoritative Dictionary of Natural Products (DNP), that RESOLVE met the definition of a natural health product (NHP) under the NHP Regulations. RESOLVE entered the Canadian market in 2006. Later that year, Health Canada revisited its assessment of RESOLVE's PLA in response to allegations of health concerns and non-compliance with certain advertising standards pertaining to the product.

RESOLVE was marketed in Canada as a NHP until July 2007 when the NHPD issued two decisions rejecting TWC's PLA. The first decision, issued in July 2007, rejected TWC's PLA on the basis that there was insufficient evidence to support the safety and efficacy of RESOLVE. The first decision was followed by a public advisory, stop-sale and recall of RESOLVE. The second decision, issued in August 2007, rejected the PLA on a new and separate ground that RESOLVE was not a NHP but should be re-classified as a drug. Consequently, RESOLVE should be subject to the Food and Drug Regulations.

TWC filed for reconsideration of the NHPD's decisions and continuously submitted material to Health Canada between...