Change in Canadian exclusivity period may harm generics

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Change in Canadian exclusivity period may harm generics

Home/Policies & Legislation | Posted 29/04/2011 0 Post your comment

The EU is in negotiations for a comprehensive economic and trade agreement (CETA) with Canada. As part of these negotiations the EU has proposed changes to the length of data exclusivity for originator drugs in Canada to bring them in line with time periods used in the EU.

However, Canadian generics manufacturers believe that this will entail higher costs and harm the Canadian generics industry.

The EU wants Canada to offer the same term of data exclusivity as is offered in the EU, i.e. 10-years (plus paediatric extension), for a new pharmaceutical product, rather than the 8-year term currently used in Canada.

A report produced by the Canadian Intellectual Property Council and the Canadian Chamber of Commerce advised that Canada’s intellectual property rights must be strengthened to attract interest and investment in the pharmaceutical sector and bring the country on par with other leading industrialised countries. Most importantly, the report titled Innovation for a Better Tomorrow: Closing Canada’s Intellectual Property Gap recommended lengthening the data exclusivity period for innovator drugs in line with the EU’s proposals as part of the CETA.

However, the generics industry believes that could mean increased prescription costs for provincial governments and patients.

A report conducted by Canada’s generics industry shows that changes to the country’s drug patent system would add almost CAD$3 billion annually to its drug costs. The proposed changes would also lengthen considerably the period of market exclusivity for brand-name drugs in Canada and would provide ‘the most extensive structural protection for innovative drugs of any country in the world,’ according to the report’s authors.

The Canadian Generic Pharmaceutical Association (CGPA) commented that ‘extending market monopolies for brand-name drugs as proposed by the EU, however, will not reduce trade barriers. It will raise trade barriers for Canadian generic manufacturers and increase revenues for European-based drug companies at the expense of Canada’s healthcare system.’

The CGPA added that ‘the real cost of research and development to bring a new drug to market varies from US$13 to 204 million, a fraction of the US$1 used to justify ever-longer market monopolies.’

What happens next?

The last round of negotiations between the EU and Canada took place in Brussels, Belgium, in January 2011; and the next round is expected to take place in Ottawa, Canada, in April 2011.

Source: Canadian Chamber of Commerce, Canadian Generic Pharmaceutical Association, Europa