Increased Data Protection Proposed for Canadian Drug Applications

The Canadian Government recently published proposed amendments to the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations dealing specifically with data protection. Data protection provisions are intended to encourage new drug innovation by ensuring that confidential information submitted in support of an application for a drug containing a new active substance cannot be relied upon, for a period of time, by other manufacturers to support their own applications. Although the Regulations currently include a five-year period of protection for data submitted in support of a drug containing a new active substance, the applicable regulations have been so narrowly interpreted by the courts that the period of data protection rarely applies. The proposed amendments were introduced to overcome these problems and to increase the period of data protection to eight years as encouraged by the WTO and NAFTA. This eight-year period can be extended by an additional six months if the data includes pediatric studies that were designed and conducted to increase knowledge about use of the drug in children. The proposed amendments were published in the Canada Gazette, Part I on December 11, 2004. A 75-day consultation period regarding the proposed amendments is currently underway. To view the proposed amendments to the Regulations, visit: http://canadagazette.gc.ca/partI/2004/20041211/html/regle3-e.html. Summary by: Sue Diaz