CANADA EXTENDS DRUG EXCLUSIVITY PROTECTION

The Canadian government has amended its Food and Drug Regulations to extend the period of guaranteed market exclusivity for new drugs from five to at least eight years, with an additional six-month extension for drugs that have undergone clinical trials on pediatric populations.

For the first six years of the eight-year "data protection" period, generic manufacturers that want to copy an innovative drug are not even permitted to file a new drug or abbreviated new drug submission. The final two years are a "no-marketing period," during which the generic manufacturer can file an application but the government will not grant it a notice of compliance.

According to the Regulatory Impact Analysis Statement published Oct. 18 in the official Canada Gazette, "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. It will also bring Canada in line with a system similar to that of other jurisdictions in respect of the no-filing period." According to the government, the regulatory changes, which took effect Oct. 5 and did not need Parliament's approval, were necessary under two agreements to which Canada is a signatory: the North American Free Trade Agreement (NAFTA) and the Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The Canadian Generic Pharmaceutical Association blasted the regulatory change, saying that it establishes "yet another regime to provide brand-name drug companies with … [a] ban on competition, even for non-patented drugs."