Future of the European Union regulatory network in the context of the uptake of new medicines

With the European economy in the midst of the deepest recession since the 1930s and countries struggling to weigh up national and community interests, one may overlook accomplishments made in other areas of the European co-operation. Since the start of the European Union (EU) medicines approval system in 1995, the European regulatory environment has faced many challenges, but also made ample progress. Significant achievements are seen in unifying and improving regulatory practices, streamlining the way of bringing medicinal products to the clinic, thereby improving how new medicines become available to patients in the EU in a harmonized and evidence-based way 1, 2. With the European Medicines Agency (EMA) co-ordinating a wide array of regulatory procedures, EU member states are contributing in many ways to the regulatory network, e.g. as rapporteur of individual dossiers, by work sharing, guideline development and cross learning. Recently, both the EMA and the Heads of Medicines Agencies (HMA) published their future strategy papers (i.e. European Medicines Agency Road Map to 2015: The Agency's contribution to Science, Medicines, Health and the HMA; A Strategy for the Heads of Medicines Agencies 2011–2015), aiming at strengthening the European regulatory network and its contribution to patients' access to medicinal products, public health and innovation 3, 4. While the crucial role of the EMA as the engine of the European pharmaceutical regulatory system is evident, the roles of national competent authorities remain equally important. Apart from the EMA, the EU regulatory network consists of around 31 national competent authorities who are responsible for an array of regulatory tasks related to human medicinal products in their national systems 5. They also provide scientific footing of the system via the membership of the EMA scientific committees, such as the EMA Committee for Medicinal Products for Human Use (CHMP). The CHMP is mainly composed of the members nominated by the 27 EU member states and the EEA-EFTA states Iceland and Norway, who heavily rely on support from their national agencies with respect to the reviewing and assessment of the claims in the dossiers submitted by industry and the benefit-risk assessment related to a product application 6. The system of rapporteurs is seen as the backbone of the EU Centralized Procedure, but there are concerns about the large variation among EU member states regarding their individual contributions in terms of the number of (co-)rapporteur roles. Both previously mentioned strategy reports underpin the importance of a re-balance between member states in work-sharing and showing leadership in Centralized Procedures.