Speech Verheugen voor het medicijnen-agentschap EMEA (en)

SPEECH/06/250

Günter Verheugen

Vice-President of the European Commission responsible for Enterprise and Industry

European Medicines Agency

London, 10 April 2006

Ladies and gentlemen,

First of all, I would like to thank you for this opportunity to meet you all here at the European Medicines Agency. It is my first visit to the Agency. But I can assure you that I am following your work with great attention.

Pharmaceuticals are a highly regulated sector. And rightly so. The starting point of the Community's pharmaceutical legislation lies in the devastating experiences with thalidomide in the 60s. Since that moment, the protection of our patients has always been at the heart of pharmaceutical legislation in the Community.

Your agency was not the first "regulatory" European agency that was created. But it was designed according to a very special model. The idea was to bring together high-skilled experts from Member States that remain attached to their countries and are not "owned" by the Community. This networking function is one of the unique characteristics of the EMEA up to today.

The experience from the last ten years demonstrates that this decision for a European Agency and its special design was right. The EMEA has succeeded to pool national expertise to the benefit of patients throughout the entire Community.

Also at present the EMEA is contributing significantly to the priorities of the Barroso Commission.

The Lisbon Strategy, re-launched in 2005, has among its objectives the creation of more and better jobs in a more dynamic, innovative and attractive Europe, assuming that the objectives of this process can only be achieved if the Community and Member States work together.

The work of the European Medicines Agency is in many ways linked to the objectives of the Lisbon Strategy, since its mission, centred on the protection of public and animal health, contributes to the mobilisation and coordination of scientific resources from throughout the EU, towards stimulating the innovation and research of medicines in the EU, to allow faster patient access to new therapies and technologies.

2006 marks the first year of full application of the new EU pharmaceutical legislation which came into force in November 2005. There are a number of features in this new legislation which are relevant to the contribution of the Agency in this context, but also concerning the Commission commitment to reinforce competitiveness of European industry and ensure the protection of Public Health.

The EMEA provides an important contribution concerning development of new and innovative medicines, through the reinforcement of its advisory responsibilities for the conduct of research on medicines, as well as by providing support to small and medium-sized enterprises (SMEs). The creation in the Agency of a dedicated Office to SMEs will play an important role in our current industrial policy and it will certainly support the objectives of the forthcoming Competitiveness and Innovation Programme.

Also the innovation and research action plan, adopted by the Commission, is a major initiative to upgrade the conditions for research and innovation in Europe, strengthening Public Research-Industry cooperation, namely through the implementation of the so called European Technology Platforms.

The scientific environment is changing dramatically with the emergence of new technologies and advanced therapies, such as gene therapy, pharmacogenomics and proteonomics, just to mention some of the synonyms of innovation.

Faced with these challenges the EMEA, together with the National Competent Authorities congregated in the EU Medicines Regulatory Network, shall demonstrate the capacity to deliver high quality and commitment to move forward these new scientific areas and bring added value to the economy, science and health systems in the Member States.

European Technology Platforms, such as the one on Innovative Medicines, constitute important routes for the emergence of new research priorities. Being informal networks set up under the initiative of industry they can involve organisations like the EMEA in order to define medium to long-term research needs.

The Agency shall contribute under the different Commission initiatives to the stimulation of research and innovation. The identification of areas requiring further research, identification of innovative approaches to the development of innovative medicines and creating competences in the field of new therapies and new technologies will be some of the challenges you will face in the coming years.

But you are well prepared for these challenges: the EMEA Road Map to 2010, "Preparing the Grounds for the Future" has provided a strategy for your organisation and demonstrates leadership by the EMEA within the network of medicines agencies. The roadmap is insofar certainly a very important instrument having an impact beyond the Agency and for the collective network in which you operate.

I am therefore convinced that, with regard to new scientific avenues for medicinal products, the Agency shall take a leading role in identifying new technical requirements and assessment needs providing expertise to ensure a solid science based organisation in the context of the Community.

As a key player for one of the most innovative industries the EMEA fulfils thus an important role in the implementation of the Lisbon Strategy in the pharmaceutical sector.

But we should also not forget Better Regulation as an important element of the Lisbon Strategy. The Commission is committed to better regulation both regarding the development of new legislation and the simplification of the acquis.

The goal is that EU legislation, while contributing to the Commission and EU objectives, provides a maximum added value and respects proportionality and subsidiarity, but also that the administrative cost to companies and society is minimised.

In this context the European Medicines Agency is of key importance as it issues guidelines required to apply scientific and technical aspects of pharmaceutical legislation.

Through the scientific guidelines it complements legislative work of the European Commission, the other European institutions and the Member States. I firmly believe that the EMEA can and has to play an important role in supporting the better regulation initiative. Our success therefore highly depends on your commitment and efforts to implementing the principles of better regulation and reflects them on your guidelines. These should be limited to scientific aspects, they should be simple, efficient and restricted to the necessary.

Let me last but not least say some words on the EMEA role in a political initiative of the Commission, the new industrial policy, which is clearly driving forward the competitiveness of European industry.

Industrial policy is - and should remain - horizontal, meaning that it aims to create a better environment for all businesses, regardless of size or sector. At the same time, we must also be able to respond to sector-specific conditions and needs. This does not mean helping and sheltering some sectors from international competition but identify at sectoral level what may hamper their productivity growth.

As you know, the Commission has proposed a number of specific initiatives for individual sectors and horizontal cross-sectoral initiatives. We are now working on their implementation. To give an example related to the work of the EMEA, the Pharmaceutical Forum was established by the Commission at the end of last year to address particularly the fragmentation of the pharmaceutical market in the EU. The Forum consists of Member States, Members of the European Parliament, senior representatives of industry and other key stakeholders, such as patients and health professionals.

Information to Patients, relative effectiveness of medicines and pricing of pharmaceuticals were the areas chosen to be reflected upon in the context of the Pharmaceutical Forum. The work already initiated is very promising and we intend to have the first high level meeting with Ministers of the Member States' Governments and stakeholders next September to see the progress and set orientations to make this reflection achieve concrete and beneficial results for Europe.

The EMEA plays a significant role in this process, especially regarding the information to patients' strategy. The importance of increasing the availability and the quality of information on medicines, including the setting up of the European Database on Medicines, is a key objective of these activities.

Ladies and Gentlemen,

I have highlighted some of the areas that constitute priorities of the Commission and for which the EMEA can contribute importantly.

But I shall also refer to the important tasks the EMEA carries out as part of its primary mission to protect public health. The Agency is at the core of the European System which has functioned very well over the years. The Agency won confidence and appreciation of healthcare professionals and industry, and most importantly, of patients. The Agency now serves as a reference for the creation of other new agencies in Europe and, indeed, around the world.

The reinforcement of our Community system for ensuring the safety of medicines in Europe is a key challenge for all the regulators, both at EU or national level. The new legislation has introduced major advances in the area, such as risk management tools, but we shall continue improving the system. A public consultation on the recent study the Commission has published about the pharmacovigilance systems shall be the opportunity to consider the best way forward in order to reinforce patients' safety.

The monitoring of the safety of medicines utilisation, both when they are still ongoing clinical trials and when they are authorised and being prescribed by healthcare professionals and used by patients in Europe and elsewhere in the world.

The EU Pharmacovigilance Systems have evolved considerably to protect public health and the EMEA has made a notable contribution to this, not only by putting in place the database on adverse drug reactions, but also for coordinating these activities at EU level.

Patient safety remains a fundamental assurance for our system and I would like to thank you all for the work you do for the protection of public health.

The Commission will continue to give the necessary priority to improve the legal framework and policies to support such important responsibilities.

New challenges are coming. Soon the Agency will have responsibilities in implementing the new legislation on medicines for children. Like the orphan drug legislation this will be a major step in developing new medicines and reinforcing the health of children in Europe.

Furthermore, the new legislation on advanced therapies is an important regulatory measure which is at an earlier stage of discussion. Advanced therapies not only constitute the result of advances in science and technology, but also will have a major impact in terms of public health by providing new technology products inclusive for unmet medical needs.

The European system for medicines regulation and, above all the Agency, have achieved important results, at European level and beyond. But we need to move on in close cooperation and partnership with Member States, patients, healthcare professionals and industry.

Similarly, the important role the Agency plays at international level, either in the context of the International Conferences of Harmonisation (ICH) or within particular cooperation arrangements like with the FDA, the WHO and bilaterally with many countries, deserves recognition in the context of the Commission policies in the field.

The European Medicines Regulatory System is unique in many aspects and the EMEA acts as a world-class European Agency. Our model can certainly be a model to other parts of the world.

Conclusions:

I would like to thank you for the work you perform, each of you, in full support to the regulatory work of the Commission. I hope that there will be further opportunities of meeting you and I am now looking forward to answer your questions.

Thank you very much for your attention.