WRITTEN QUESTION E-2409/01by Imelda Read (PSE) to the Commission
(21 August 2001)Subject:
Single Market in PharmaceuticalsIn April 1999 the European Parliament adopted its resolution on the Communication from theCommission on the Single Market in Pharmaceuticals(
). In its resolution the European Parliamentexpressed its belief that it is vital to complete the internal market in pharmaceuticals and asked theCommission when making its proposals, to include a time-frame for evaluation of progress in achievingthe single market.Can the Commission specify what action it proposes to take and when it will be putting forwardproposals?
Answer given by Mr Liikanen on behalf of the Commission
(29 October 2001)
Significant progress has been made in improving the operation of the single market in pharmaceuticalproducts with respect to the following three strategic areas: the development of a European procedure for marketing authorisations, the development of high levels of protection for intellectual property and the development of the pharmaceutical market itself.As regards marketing authorisations, the EU will in future have a centralised system which, whilst ensuringsafety and public confidence, will also enable a time to market that can be described as certainly theshortest in the world.Nevertheless, it is always possible to improve the system. This is why, as planned, the Commission carriedout a detailed assessment of the operation of the system in the course of 2000 in order to specify new procedures which would make it even more efficient. Following this assessment, a draft revision of thepharmaceutical legislation was finalised, and this will shortly be sent to Parliament and the Council. This isof prime importance as a contribution to further improving public health in the EU.As regards intellectual property, the proposed reform of pharmaceutical legislation provides for a systemwhich both encourages the production of new medicines and stimulates competitiveness, throughprovisions which promote the development of generic products. These measures are supplemented by thelegislation agreed by the Community institutions in 1998, which had already introduced the possibility of patenting innovations in the field of biotechnology the key field par excellence for this sector.These important proposals have recently been followed up with the creation of a high-level group oninnovation and the supply of medicines, more commonly called ‘G10’. This group is composed of theMember of the Commission responsible for enterprise policy and the Member responsible for health andconsumer protection, together with health ministers and representatives of the pharmaceutical industry,patient associations and social security bodies.This group is charged with eliciting proposals which encourage innovation and competitiveness whilstensuring a high level of public health.The final report will be structured around the following three issues: the supply of medicines for patients, the single market, competitiveness, regulation and innovation.C81E/172 EN 4.4.2002Official Journal of the European Communities