Appeal of judicial review of Minister of Health; September 10, 2008

The Court of Appeal dismissed an appeal of a decision from the Trial Division where the Trial Judge dismissed the application. 

The Minister of Health had rejected an ANDS because it did not contain comparative bioavailability studies of one of the two active ingredients in the proposed new drug. The Trial Judge found that the Minister had committed no reviewable error when he found it necessary to for Pharmascience to provide the bioavailability characteristics of that component.

The dispute in question concerns the applicability of a section of the Food and Drug Regulations, and thus the standard of review is unreasonableness. The Court held that the Minister’s decision to reject the ANDS was within the range of acceptable and rational solutions and the dismissal of the application for judicial review was not in error.

The full text of the decision can be found at:

http://decisions.fca-caf.gc.ca/en/2008/2008fca258/2008fca258.html