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Implications of Canadian–European Trade Agreement for generics

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On 26 September 2014, Canada and the European Union (EU) successfully concluded negotiations on a trade deal, which will free the movement of goods, services, investment and labour between the two regions. However, some of the provisions in the agreement have been criticized by generics makers for delaying access to medicines by having a negative effect on the generics industry in Canada.

There are three provisions in the Comprehensive Economic and Trade Agreement (CETA) that are seen as causing issues for the Canadian generics industry:

Patent term restoration

This will allow patent holders to extend patents (currently 20 years in Canada) to allow for regulatory delay. This could delay the entry of generics by up to two years [1].

Data protection

CETA will lock Canada’s current term of data protection of eight years and create barriers for future governments wanting to reverse it [2].

Right of appeal

A new right of appeal under the patent linkage system will be implemented that will create delays of 6–18 months for the entry of generics [3].

Analysts have estimated that the average delay for generics to reach the Canadian market as a result of the CETA provisions would increase by 741 days, or 2.03 years, which represents an additional yearly cost of CA$1,645 million [4].

What happens next?
In order for CETA to become enforceable in Canada, it must be ratified and implemented by the passing of specific implementing legislation to amend Canada’s existing laws, e.g. the Patent Act, and the Food and Drug Regulations. This implementing legislation will specify the precise terms of patent term restoration and the mechanism for providing effective rights of appeal.

Related article
Data protection provisions in CETA

References
1.   GaBI Online - Generics and Biosimilars Initiative. Patent term restoration provisions in CETA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Generics/Research/Patent-term-restoration-provisions-in-CETA
2.   GaBI Online - Generics and Biosimilars Initiative. Data protection provisions in CETA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Generics/Research/Data-protection-provisions-in-CETA
3.   GaBI Online - Generics and Biosimilars Initiative. Right of appeal provision in CETA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: http://www.gabionline.net/Generics/Research/Right-of-appeal-provision-in-CETA
4.   GaBI Online - Generics and Biosimilars Initiative. Influence of CETA on generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 17]. Available from: www.gabionline.net/Generics/Research/Influence-of-CETA-on-generics

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Source: Canadian PM, Europa