A trade agreement in negotiations between Canada and the EU is drawing the ire of generic drugmakers, provincial governments and patient advocates over proposals to extend drug patents by several years in Canada, a move that critics say would delay the arrival of generic medicines to market in that country and inflate healthcare costs.
According to Canada’s Department of Foreign Affairs and International Trade, Canada imports C$8.4 billion ($8.2 billion) of pharmaceutical products from the EU annually, making Canada the fifth largest export market for the continent’s drugmakers. The sweeping Comprehensive Economic and Trade Agreement (CETA) could add another $2.8 billion to the annual bill, according to a report by health economists Paul Grootendorst, from the University of Toronto, and Aidan Hollis, from the University of Calgary (J. Generic Med. 8, 81–103, 2011). This cost is largely shouldered by the provincial and territorial governments, which pay for healthcare.CETA—first proposed in 2009 and subsequently leaked in 2010—calls on Canada to beef up its intellectual property rights for pharmaceuticals. The proposed changes would add five years to patents for drugs that are unduly bogged down in the regulatory approval process, lengthen the period of time clinical trial data is kept off-limits for use by generics companies from eight years to ten years (or even longer in the case of pediatric drugs) and grant brand-name companies an appeal process to challenge generics companies on their patent compliance. (more…)
Nature Medicine 18, 991 (2012)
Published online 06 July 2012
