The pharmaceutical sector is heavily regulated, with significant costs associated with both developing a new medicinal product and generating the data required to get a product to market. Protecting that data is therefore important.  Data exclusivity is a form of product exclusivity right for medicinal products in Europe, and market exclusivity is a related form of additional protection.

These two rights are in addition to any granted patent exclusivity right covering a medicinal product.

The rationale for granting data and market exclusivity is to compensate the innovator company for the investment it has put in to developing the new medicinal product and to generating the data required to obtain a marketing authorisation.

Regulatory approval for medicinal products requires applicants to provide information about the efficacy and safety of their product to regulatory authorities. The first applicant…