This decision relates to Teva’s listing challenge of the drug Eloxatin on the innovative drug register. Over three years after Eloxatin was approved and listed, Teva wrote to the Minister seeking to have the drug de-listed on the basis that it was not an “innovative drug” as the drug had been sold pursuant to the Special Access Program (SAP) for several years prior to obtaining its NOC in 2007. The Court upheld the decision of the Minister and affirmed that it was correctly on the register.

The Court first made findings on two preliminary issues raised in the application. First, the Court held that, contrary to arguments by Sanofi, the Minister did have authority to make a further decision list/delist after having added the drug to the innovative drug register, especially considering that the Regulations speak of the Minister “maintaining” the register. In this regard, the Court rejected that Sanofi’s argument that at a minimum new facts would be required in order to reopen the review of the listing. Second, the Court held that Teva had standing to bring the application, once it had attempted to file an ANDS, and that ANDS was rejected.

On the issue of what is meant by “approval” in the definition of the term innovative drug , the Court agreed with the Minister, who took the view that SAP, while authorizing certain sales in certain circumstances did not qualify as “approval” because drugs sold under the SAP program have not undergone a full regulatory review and therefore, have not received market authorization by the Minister.

The Court found that approval does not solely mean the granting of an NOC, but refers to a two-step decision making process: (1) a finding by the Minister that the drug is safe and effective and (2) the formal granting of marketing approval. The Court held that there was no evidence of such a factual finding by the Minister that the drug was safe and effective as the SAP sales record proves nothing about the safety and efficacy. The Court concluded the Minister was correct in determining the meaning of “approved” and as a result the Minister’s decision was not a reviewable error.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2011/2011fc507/2011fc507.html