Data protection provisions in CETA

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Data protection provisions in CETA

Generics/Research | Posted 01/08/2014 0 Post your comment

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provisions are seen as the main culprits.

The data protection provision is one such provision seen as causing harm to the generics industry.

Data protection
In 2006, Canada extended data protection to eight years of market exclusivity with an additional six months if companies have studied the drug in a paediatric population. Generics companies are not allowed to make use of the brand-name companies’ data in their applications for a minimum of six years. The European Union, on the other hand, provides for 10 years of data protection and had been pushing for the same in Canada as part of the Comprehensive Economic and Trade Agreement (CETA).

Although CETA will not extend data protection, Canada has ‘agreed to lock in the current Canadian practice of providing eight years of market exclusivity’, making it virtually impossible for any future government to shorten the period.

The North American Free Trade Agreement (NAFTA) and the TRIPS agreement both specify that data should be protected for five years.

Up until CETA, data protection was only granted to new chemical entities, i.e. drugs that have never been sold in any form in Canada. During the negotiations, the EU was demanding that improved data protection be granted for any pharmaceutical product rather than just new chemical entities.

It is unclear if CETA will extend data protection to include products representing minor changes to an existing drug. If this is the case it is seen as offering a financial incentive to companies to engage in minor molecular manipulation to gain further data protection and produce drugs that offer no new therapeutic advances.

Related articles
Influence of CETA on generics

Patent term restoration provisions in CETA

Reference

1. Lexchin J, 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.

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