European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network

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Press release

08/07/2010

European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network

Conference on outcomes of evaluation of the European Medicines Agency brings together some 150 partners and stakeholder representatives

The European Medicines Agency and the European Commission held a joint one-day conference on 30 June 2010 to discuss the outcome of the recent evaluation of the Agency and how the findings of the exercise can be used in preparing the Agency for future challenges.

In 2009, the European Commission engaged Ernst & Young to carry out a comprehensive assessment of the effectiveness and efficiency of the European Medicines Agency and the European medicines system as a whole in delivering high-quality scientific opinions on medicines for human and veterinary use.

Following publication of the outcomes of the evaluation in April 2010, the conference brought together some 150 partners and key stakeholders from the European Commission, the national competent authorities for medicines regulation in the EU Member States, patients and healthcare professional associations and the pharmaceutical industry associations. The conference focused on the architecture of the Agency’s scientific forums, ways to assure long-term availability of scientific resources of the network and the coordinating role of the Agency. Reflection on issues specific for veterinary medicines and an exchange of views about the funding of the Agency concluded the discussion on outcomes of the evaluation.

Speaking on behalf of EU Health Commissioner John Dalli, his Deputy Head of Cabinet Nils Behrndt said "The Ernst & Young report has shown that the European Medicines Agency and the whole of the European Medicines Network have been a success story for Europe so far. However, the system will have to adapt to take on all the new responsibilities in the pipeline. This conference is the beginning of a process of reflection to make sure that the European Medicines Agency is equipped for the future.”

The Agency’s Executive Director, Thomas Lönngren said: “The success of the European Medicines Agency is a result of the work of the national competent authorities, the European Commission and the Agency. This network model has worked very well for the first 15 years. However, as the scientific, political and societal parameters of our environment are changing, we need to look at the architecture of our ‘house’ again to make sure it is fit for purpose. We are opening up this process of reflection to our stakeholders to get the broadest possible consensus on the direction the Agency is taking in the future.”

Some of the key questions of this reflection process include: How can the Agency deal effectively with the increasing globalisation of the pharmaceutical industry? Is it fit for new scientific developments, for instance advanced therapies or personalised medicines? How can regulators respond to requests from patients and healthcare professionals for more participation and transparency? How can the particular requirements of veterinary medicines best be accommodated?

The Agency and the European Commission will prepare a joint conference report, which will detail the ideas and proposals made during the conference. Some of these will already be included in the Agency’s road map to 2015. For most other proposals the Agency and the European Commission will propose a process for their further consideration.

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Contact point:

Martin Harvey Allchurch or Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu