This decision relates to two applications for judicial review. The first application relates to a decision by Health Canada to reject an application by Wellesley for a Drug Identification Number (DIN). The second application relates to a decision by Health Canada to refuse the New Drug Submission (NDS) filed by Wellesley on the basis that it did not contain clinical data. The Court noted that, where the Minister of Health is entitled to exercise discretion, the standard of review is that of reasonableness but, when determining jurisdiction and some other questions of law, the Court must apply a correctness standard.
With respect to the decision relating to the DIN application, the Court found that Health Canada made no error in reaching its decision not to treat the application as a DIN application that would require the decision to be set aside and re-determined. However, with respect to the NDS decision, the Court found that the Food and Drug Regulations (the “Regulations”) do not require clinical test data; the requirement is that information be provided to Health Canada to allow a determination of safety and efficacy. The Court found that Health Canada would be acting reasonably and within the scope of the Regulations if it asked for clinical data in order to satisfy itself as to the safety and efficacy of a candidate drug. However, the Court found that the Regulations do not require that all NDS applications, regardless of circumstances, must be accompanied by clinical test data. In the within case, the Court found that Health Canada rejected the application because of the lack of clinical test data without considering whether there was sufficient data to establish safety and efficacy. As a result, the Court found Health Canada’s decision to reject the NDS application to be unreasonable and therefore set it aside and returned the application for review on its merits to Health Canada.