Answer given by Mr Andriukaitis on behalf of the Commission
One of the main drivers of the Commission proposal(1) for the revision of the veterinary medicines legislation is the lack of availability of veterinary medicines in the EU. As explained in the related impact assessment(2), there is a decline in the number of applications for new veterinary medicines whilst there is a growth in the number of generic applications.
Data protection stimulates investment in new veterinary medicinal products. The establishment of periods of exclusivity should balance the dual objectives of providing continued incentives for investment in the development of new products, while allowing the generic veterinary medicines' industry to enter the market at a point in time where investment from innovators has been recovered.
The rules on the protection of technical documentation currently in force do not adequately address the difficulty in recovering investments spent in the development of certain new products.
Therefore, the Commission proposal put forward a number of measures, including new rules on exclusivity periods that aim to foster the development of new products in particular for minor uses and minor species for which there is an acute lack of suitable medicines. While developing the proposal, the Commission engaged closely with all stakeholders, including generic industry as well as European farmers and food producers, and took into account their concerns.
Proposal for a regulation of the European Parliament and the of the Council on veterinary medicinal products, COM(2014)0558 final of 10.9.2014 http://ec.europa.eu/health/files/veterinary/vet_2014-09/regulation/reg_part1_en.pdf