Patent term restoration provisions in CETA

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Patent term restoration provisions in CETA

Generics/Research | Posted 04/07/2014 0 Post your comment

Some of the provisions included in the Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada are seen as having the potential to have a negative affect on the generics industry in Canada [1].

One of the provisions seen as detrimental to the generics industry is patent term restoration.

Patent term restoration
CETA will provide pharmaceutical companies with up to two years’ extra patent protection to compensate companies for the time lost between when the patent application is filed and when the drug is eventually approved. Canada is currently the only developed nation that provides no form of compensation to innovative pharmaceutical companies for regulatory approval delays.

The argument for including this is to provide an incentive for the Canadian regulatory authorities to avoid delays in approving new drugs. One report has shown that Health Canada took 473 days (on average) to certify new medicines in 2010, while the European Medicines Agency (EMA) took only 315 days [2].

The Canadian Generic Pharmaceutical Association (CGPA), however, has questioned the validity of this argument. In a CGPA report it was found that when considering drugs approved by both EMA and Health Canada, the difference in approval times was just 10 days.

The CGPA has stated that ‘it is disappointed by the inclusion of a patent term extension in CETA’, and that the deal will ‘delay market entry of cost-saving generic prescription medicines in Canada in the future, increasing healthcare costs for provinces, employers that sponsor drug plans for their employees and Canadians who pay for their prescription medicines out-of-pocket’

The patent term restoration provision included in CETA will commit Canada to creating a new system of patent term restoration, which is thought could delay the entry of generics by up to two years.

Related article
Influence of CETA on generics

References
1. Lexchin J1, Gagnon MA. CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs. Global Health. 2014;10:30.
2. Rovere M, Skinner BJ. Access Delayed, Access Denied 2012: Waiting for New Medicines in Canada. Studies in Health policy. Fraser Institute. April 2012 [homepage on the Internet]. 2013 Mar 30 [cited 2014 Jul 4].

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