Canadian Generic Pharmaceutical Association v. Canada (Health)

Drug: AVAMYS fluticasone furoate

This was an appeal of the decision of a Prothonotary to strike the application of the Canadian Generic Pharmaceutical Association (CGPA) for judicial review of the addition of AVAMYS to Health Canada’s Register of Innovative Drugs (the Register). Our summary of the Prothonotary’s decision is found here. The CGPA challenged the listing of the drug on the basis that fluticasone furoate is an ester variation of the previously approved medicinal ingredient fluticasone propionate, and therefore not eligible for listing.

The Court reviewed the decision and reasons of the Prothonotary and held that the issue must be considered de novo because the decision is vital to the issues in the proceeding. The Court agreed with the Prothonotary that the CGPA cannot be directly affected by the Minister’s decision to include a drug on the Register on the basis that it is not a drug manufacturer, it does not file new drug submissions, and it has never received a Notice of Compliance nor sold a drug in Canada. Accordingly, the Court found that the CGPA does not have standing to bring the application.

The Court also found that the CGPA does not meet the second prong of the three-part test set out for public interest standing, namely whether it has been established that the plaintiff is directly affected by the legislation or if not, does the plaintiff have the genuine interest in its validity. The Court also found that the CGPA fails the third prong, which requires that there be no other reasonable and effective manner in which the issue may be brought before the Court. The appeal was therefore dismissed.