Authorization under the Special Access Programme Is Not Previous Approval for the Purpose of the Data Protection Regulations

Teva Canada Limited v. Canada (Health) / ELOXATIN 2012 FCA 106 Stratas JA: Blais, Noël JJA aff’g 2011 FC 507 Campbell J

The main question in this appeal was whether widespread authorization for sale under the Special Access Programme of the Food and Drug Regulations means that a drug is not eligible for listing on the Register of Innovative Drugs. ELOXATIN had been sold by Sanofi from 1999 to 2005 under the Special Access Program, C.08.010(1) (SAP). In 2007 Sanofi received a NOC for ELOXATIN on the basis of an NDS, and ELOXATIN was then listed on the innovative drug register. Consequently, it was eligible for data protection for an eight and a half year term running from the 2007 issuance of the NOC. Teva challenged this listing in 2010 on the basis that authorization under the SAP meant that ELOXATIN was “previously approved” and so did not qualify for listing as an “innovative drug” under the definition in C.08.004.1(1).

Campbell J dismissed Teva’s application for judicial review of the Minister’s decision to list ELOXATIN (blogged here). The FCA has now affirmed, essentially for the same reasons given by Campbell J. First, “sales under the Special Access Programme alone are not evidence of a determination by the Minister of the safety and efficacy of a drug” [28]. Second, a test that looks at whether the Minister in fact had sufficient information to evaluate the safety and effectiveness of Eloxatin “creates lack of clarity and uncertainty” [30]. For this reason, the issuance of a notice of compliance and a drug identification number constitutes “the magic moment” of approval [31]. And third, the data protection regulations are intended to implement TRIPS and NAFTA, and those treaties imply that the approval in question is marketing approval, and in particular issuance of a notice of compliance and a drug information number [37].

While these reasons strike me as persuasive, there is some merit to Teva’s underlying complaint, which was that the authorization of ELOXATIN under the SAP was widespread, and the Minister had received “massive” amounts of information regarding ELOXATIN’s safety and efficacy [29]. In response Campbell J pointed out that “the SAP sales record proves nothing about oxaliplatin’s safety and effectiveness; it proves that many seriously ill people were willing to take the unapproved ELOXATIN in a hope of getting well” [FC 27]; and as the Stratas JA noted, a case by case inquiry looking beyond authorization itself, to the amount of information actually available to the Minister, would undermine the goals of clarity and certainty [32]. While I agree with both these observations, the result is potentially a kind of evergreening, if Sanofi can sell its product under the SAP and then get data protection once the patent has expired. This contrasts with the paradigmatic use of data protection, which is to provide some form of protection to a drug that is not patentable in the first place. If that is the real problem, then it would be better to respond, institutionally at least, by controlling the use of the SAP in the first place. I should emphasize that I am not suggesting that the SAP was in any way misused in this case, as that point was not in issue in this case. It may be that this was simply a case in which the SAP, properly used, nonetheless resulted in widespread authorization. In that case the lesson may be that the complex administrative structure for regulation and protection of drug products cannot deliver ideal results in all cases.