Canada - European Free Trade Negotiations

Canada is in the midst of negotiating the Comprehensive Economic and Trade Agreement (CETA) with the European Union. As part of this agreement the EU is asking for changes in the way that Canada handles intellectual property rights. The EU negotiating position strongly supports its international pharmaceutical industry on IPR issues, primarily by requesting data protection and patent term extension. The EU wants Canada to adopt European standards in both of these areas. Free trade negotiations are marked by negotiations over a broad range of topics and often lead to trade-offs whereby one nation or region makes concessions in one area to achieve its goals in another. In the area of data protection the EU is pushing Canada to extend its regime by an two years plus allowing an additional year if the market authorization holder demonstrates new significant therapeutic benefits for its product. The Europeans would also like to see Canada institute a system of “supplementary protection certificates” that would extend patent life to compensate for delays in either granting a patent or in regulatory review process. Both of these demands, if accepted by Canada, would result in a delay in the entry of generic products. At present generics account for 54% of all prescriptions filled in Canada but only one-quarter of the value of the prescription drug market. Canada already has the second highest per capita drug expenditure in the world behind the United States, delaying generic entry would further increase drug spending straining Canada's health care system.