Looking back at 2013 - from Guido Rasi, Executive Director

2013 was an exciting year for the European Medicines Agency (EMA). It was a very busy year and it has demonstrated once again that the environment in which we are operating is ever-changing, continuously presenting us with new challenges. Out of the many projects, initiatives and achievements of 2013, there are three that I would like to highlight because they have had or continue to have a profound effect on the Agency and the way we operate.

The first is our commitment to publish and giveaccess to clinical trial data submitted to the Agency as part of a marketing authorisation application. Our initiative has prompted a lively global debate across all stakeholder groups on the benefits to patients, to research and more generally to society, of giving access to clinical trial data. It has been a catalyst for various initiatives from other organisations, such as other regulators, the pharmaceutical industry, healthcare payer bodies and academic centres in this direction. We have welcomed this debate which has provided the best evidence from all parties on the best way forward and we will continue to discuss our approach to achieve this goal with our stakeholders so that we finalise a policy that is carried by a broad consensus.

The second area is the evolving nature of our interaction with health technology assessment (HTA) bodies. They are a major actor in providing access to medicines for patients and our close collaboration with them is critical to allow new medicines to reach patients. The milestones achieved in 2013 include the publication of the first joint work plan with EUNetHTA, a network of European health technology assessment organisations, outlining key areas of collaboration and the firstworkshop bringing the regulatory and HTA worlds together. Building on the growing number of parallel scientific advice procedures that we have conducted since 2010, we are now moving towards running in parallel the currently separated processes of regulatory and HTA assessments with the aim of accelerating and facilitating access to authorised medicines for patients.

The third aspect I would like to highlight is the reorganisation of the Agency. Our aim is to re-shape the Agency so that it is fit for the future and ready to seize opportunities. The new structure has at its core four new divisions with responsibilities through the whole lifecycle of a medicine for human use, from development to use in patients. The heads of divisions and departments were appointed in 2013 and we have started the redesign of our processes. The aim of these changes is to give our scientific committees the best possible support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions. These changes will enable us to use our resources more efficiently and effectively and ensure that the Agency is better prepared for future legislative, policy and scientific challenges.

At the end of the year, I would like to thank all our partners, in particular our colleagues in the competent authorities in the European Union Member States and the European Commission, for the continuous excellent and committed hard work, which is the cornerstone for the success of the EMA and the European medicines network.

I would also like to thank our stakeholders, who have shared their views, concerns and experiences with us in 2013. Their feedback is invaluable to us in delivering our work.

And finally, I would like to thank my staff for their continuous dedication to the mission of the EMA.