Canadian Generic Pharmaceutical Association Challenges the Regulations Amending the Food and Drug Regulations (Data Protection)

On November 14, 2006, the Canadian Generic Pharmaceutical Association (CGPA) commenced an application in the Federal Court of Canada (File No T-1976-06) for judicial review of the Food and Drug Regulations, CRC c 870 (1995 DP Regulations) data protection provision amended by the Regulations Amending the Food and Drug Regulations (Data Protection) (2006 DP Regulations). Where a generic manufacturer makes a direct or indirect comparison to an "innovative drug," the 2006 DP Regulations: (a) prohibit the Minister from issuing a Notice of Compliance (NOC) to a generic manufacturer for a period of at least eight years from the issuance of the innovator's NOC for the innovative drug (there is a six-month extension of the eight-year ban if the drug relates to pediatric health care); and (b) prohibit a drug manufacturer from filing a drug submission for a period of six years from the issuance of the innovator's NOC for the innovative drug. These changes are significant because, prior to the amendments, Canada provided only a five-year period of data protection (the period during which the use of the innovator's data is prevented) and the data protection period did not apply to generic manufacturers relying on an innovative drug to establish bioequivalence in an abbreviated new drug submission (ANDS) (see Bayer Inc v Canada (Attorney General), 87 CPR (3d) 293 FC). Motivating the changes, in part, was the assertion by the Canadian government, as indicated in the Regulatory Impact Analysis Statement, that the introduction of these changes will provide an adequate incentive for innovators to invest in research, and to develop and market their products in Canada and will also bring Canada into line with other jurisdictions in respect of the no-filing period. The Canadian government also wanted to clarify that reliance on an innovator's product to establish bioequivalence will give rise to an exclusivity period. In the application for judicial review, the CGPA contends that the 2006 DP Regulations are beyond the powers of the government because they exceed the authority conferred on the Governor in Council (Cabinet) under subsection 30(3) of the Food and Drugs Act (FDA). Section 30(3) of the FDA gives the Cabinet power to make only such regulations as it deems necessary for the purpose of implementing Article 1711 of NAFTA and Paragraph 3 of Article 39 of TRIPS. Specifically, the CGPA argues that the increase in the data protection period from five years, under the 1995 DP Regulations, to six years for the filing of a drug submission and eight years for the issuance of an NOC is unnecessary because the relevant trade treaties only require a member country to implement data protection provision(s) for a period of "not less than five years." The CGPA also takes issue with the fact that the 2006 DP Regulations are triggered when a generic manufacturer compares its product either directly or indirectly to an innovative drug. They argue that the 2006 DP Regulations take away the vested right of the generic manufacturer to file an ANDS under the Food and Drug Regulations and obtain an NOC without relying on the data previously submitted by the innovator. Both the Regulatory Impact Analysis Statement associated with the 2006 DP Regulations and the Federal Court of Appeal in Bayer recognized that an ANDS could be filed without triggering the 1995 DP Regulations if a generic manufacturer could establish the safety and effectiveness of its product based on bioequivalence studies without relying on confidential data filed by the innovator. For a copy of the Regulations Amending the Food and Drug Regulations (Data Protection), visit: http://canadagazette.gc.ca/partII/2006/20061018/html/sor241-e.html Summary by: Katharine McGinnis