Prior to the enactment in 2006 of the amendments to section C.08.004.1 of the Food and Drugs Regulations (Data Protection Regulations), Canada did not have an effective regime of data protection exclusivity.
Under the former regulations, data protection arose only where the Minister of Health actually examined data contained in an innovator’s submission for drug approval in order to grant marketing approval for a competing generic drug. In actual practice, the Minister did not examine the data in the innovator’s dossier, but rather issued marketing approval to the competing generic drug based on a demonstration of bioequivalence of the generic drug to the innovative drug.
The 2006 amendments to the Data Protection Regulations acknowledged the former regime did not effectively implement Canada’s North American Free Trade Agreement and Trade-Related Aspects of Intellectual Property Rights obligations. In the 2006 amendments, the government chose to implement these international obligations by imposing an eight-year moratorium on approval for the marketing of a generic copy of a previously approved drug.
Court Challenge to the 2006 Data Protection Regulations
In December 2006, the Canadian Generic Pharmaceutical Association (CGPA) and generic manufacturer Apotex Inc. challenged the constitutional validity of the Data Protection Regulations, asserting the federal government does not have jurisdiction to enact the Regulations and that the Regulations impinge on the jurisdiction of the provinces. The applicants furthermore argued that the Regulations were not authorized by the Food and Drugs Act, their enabling legislation. In July 2009, the Federal Court Trial Division issued a decision that upheld the Regulations as a valid exercise of the federal government’s constitutional authority based on the federal trade and commerce power. This decision was appealed.
The appeal was dismissed by the Federal Court of Appeal in December 2010. Writing for the Court, Justice Nadon held that the Regulations are authorized by the Food and Drugs Act and constitute a valid exercise of the federal power over criminal law power, which includes within its scope matters in relation to health and safety. The Court found the true purpose of the Regulations is to ensure Canadians have reasonable access, at reasonable prices, to new safe and effective drugs. In other words, the Regulations serve to encourage research and the development of new medicines to improve the health of Canadians, who can only benefi t from the discovery and development of new medicines after the information and data generated in extensive pre-clinical and clinical trials demonstrate the innovative drug’s safety and effi cacy to the satisfaction of the Minister.
The CGPA and Apotex Inc. have sought leave to appeal to the Supreme Court of Canada. A decision as to whether the appellants will be entitled to pursue their appeal before Canada’s highest court is forthcoming.
Canada-EU CETA Negotiations
While the CGPA and Apotex Inc. continue to challenge the existing data protection regime, the issue of whether that protection is suffi cient has found its way into ongoing negotiations between Canada and the EU on a Comprehensive Economic and Trade Agreement (CETA).
Intellectual property rights, including data protection, are one of the more contentious areas within the negotiations. In a draft text leaked early in the negotiations, the EU proposed periods of data protection commensurate with the EU regime. This includes an eight-year no-fi ling period (during which a generic manufacturer would not be entitled to rely directly or indirectly on data submitted by an innovator in support of an application for marketing approval), while authorization to market a generic product would not be granted during a 10-year period. A further one-year period of exclusivity would be available for new therapeutic indications authorized within the fi rst eight years of data protection.
After six rounds of negotiations, it is diffi cult to predict whether Canada will agree with the EU demands regarding data protection. This issue is the subject of intense lobbying in Canada, with the CGPA claiming increased periods of protection would add $3 billion annually to Canada’s prescription drug bill, and the innovative pharmaceutical sector, represented by Canada’s Research-Based Pharmaceutical Companies (Rx&D), arguing the estimate is fl awed and effective data protection has led to the submission of new medicines for safety approval in Canada.