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TRIPS Article 39.3 Does not Require Data Exclusivity Provisions: A Critical Issue for Access to Medicines and Incentives to Encourage Medicines for Paediatric use: Why Data Exclusivity Should not be Used

EGA POSITION

A. TRIPS Article 39.3 Does not Require Data Exclusivity Provisions: A Critical Issue for Access to Medicines

Article 39.3 obliges WTO Member States to protect clinical data made for registration purposes against “acts of unfair competition”. Certain pharmaceutical companies are now claiming that Article 39.3 requires the introduction of “data exclusivity” provisions as operated in the EU or USA.

However, “exclusivity” and “protection from acts of unfair competition” are not the same and should not be confused.

Data exclusivity prevents the regulatory authority from making reference to the original clinical data for a set period, during which no authorisation of generic medicines may take place. Data exclusivity, therefore, provides a form of market exclusivity. However, what Article 39.3 requires is a form of data protection so as to prevent unfair commercial use of the data by third parties. The intention of the Article 39.3 is not to create a form of market protection.

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