EMEA and EU Commission – Topical News
European Commission Communication on Safe, Innovative and Accessible Medicines: A Renewed Vision for the Pharmaceutical Sector
Dr. Brigitte Friese
Rechtsanwältin, Wyk-Wrixum auf Föhr, Germany
In the last two years a focus of Commission’s activities had been laid on the question how to react to challenges caused by the ongoing globalisation, scientific development and development of society. The role of European pharmaceutical industry in worldwide competition had been analysed and it had been determined that availability and affordability of high quality medicines has become a growing problem for European Member States. The Commission evaluated its findings over the past months and now gave a résumé in its Communication on safe, innovative and accessible medicines, resulting in a renewed vision for the pharmaceutical sector. In its Communication the Commission presents proposals foraset of non-legal and legal measures which shall aim at improving better access to medicines for European patients, ensuring safe and high quality medicines to be available in Europe, answers to worldwide challenges of health threats and improving competitiveness of European pharmaceutical industry in research and development. The legal measures presented together with the Communication comprise three legislative drafts: a directive and regulation on information to patients on prescription-only medicinal products, a directive and regulation regarding amendments to pharmacovigilance provisions and a directive to prevent counterfeited medicinal products to enter into the legal supply chain. Details of the legislative proposals will be presented in the next issues of this journal.
pharmind 2009, Nr. 1, Seite 84