In a recent decision, the Federal Court held that the Patented Medicine Price Review Board ("the Board") does not have jurisdiction to regulate sales of medicines made available to Canadians under a Special Access Program ("SAP") if the sale of the medicine occurs outside Canada. In this case, the U.S. company that sold the medicine did not have a Notice of Compliance to market the medicine in Canada. It was, however, permitted to sell the medicine to people living in Canada under SAP.

In this case, the Board accepted that the sale of the medicine itself occurred in the U.S. The Board, nevertheless, seized jurisdiction over the sale price of this medicine because it was being marketed in Canada. The Court rejected this argument finding that even though the drug in question is sold to Canadians, the medicine is not being sold in "any market in Canada"; it is sold in the U.S. and thus is outside of the jurisdiction of the Board.

For more information, please see:  

http://www.gowlings.com/resources/enewsletters/DrugPricingReimbursement/ Htmfiles/V3N06_20090420.en.html  

http://www.gowlings.com/resources/enewsletters/DrugPricingReimbursement/ pdfs/V3N06_20090420.pdf