"Reform of EU Clinical Trials Rules - Europe can't afford to fail!", says Richard Bergström

EFPIA welcomes the proposal for a new Regulation on Clinical Trials on Medicinal Products for Human Use adopted today by the European Commission as a first step towards further cooperation in the clinical trials assessment process across the EU.

"Recent years have seen a significant decrease in the number of clinical trials conducted in Europe, this has to stop if we want Europe to continue to play a leading role in medical research" says Richard Bergström, Director General of EFPIA. According to the Commission the number of clinical trials applications in Europe has fallen by 25% from 2007 to 2011.

"The Commission's proposal provides a unique opportunity to create a competitive European medical research environment for the next 20 years capable of supporting the discovery and development of tomorrow's treatments for the benefit of European patients.

EFPIA considers that the Regulation proposed by the Commission is an important step in the direction of a much needed simplification and standardisation of clinical trials administrative processes. Nevertheless, EFPIA believes that integration of the scientific assessment processes should be pushed to its maximum operational level. While ensuring that patient safety remains of paramount importance, the new Regulation should enable an effective, coherent and consistent EU environment in order to reverse the recent downward trend and attract investments required to develop the medicines of tomorrow.

"A workable administrative and scientific cooperation for large scale clinical trials is the key to make the new system effective. We call on the European Parliament and Member States to take a responsible, ambitious and pragmatic approach when debating the Commission's proposal. They need to make sure that  the new Clinical Trials Regulation provides a legal framework that is fit for the future so that all European patients have an equal chance to swiftly access the latest medical research.", adds Richard Bergström.


Clinical trials are an essential part of the medical research as they aim at providing the community with the latest innovative treatments and state-of-the-art clinical practice while fuelling innovative thinking in the clinical scientists' teams for the benefit of European Patients.

They represent tremendous undertaking for sponsors, physicians, patients and regulatory authorities. Clinical Trials represent in average 58,6% of a product total development costs.

The current Clinical Trials Directive 2001/20/EC introduced a first level of harmonisation among Member States' procedures for Clinical Trials Approval. It carried provisions notably on protection of health and safety of clinical trials' participants which represent value for the Community.
However, a substantial lack of homogeneity subsists in terms of administrative requirements, which leads to delaying the conduct of clinical trials and increased costs.

The current Directive has set a fragmented environment which is a significant reason for the decline observed in the number of clinical trials conducted in Europe, impacting negatively the competitiveness of Europe's clinical research community.

According to the European Commission, there are some 12.000 clinical trials ongoing in Europe, of which 25% are multinational (involving 3-5 Member States). There has been a decline in clinical trials applications in the EU during the recent years (the decrease has been of 12% from 2007 to 2010). At the same time, costs for bureaucracy and resource requirements to handle paperwork have doubled, and delays have increased by 90%. Clinical trials are a key contribution to Europe's science base, R&D investment, jobs and growth. Today's clinical trials account for investments of over 20 billion Euros per year in the EU.

The Commission stated that approximately 60% of clinical trials are sponsored by pharmaceutical industry and 40% by other stakeholders, such as academics,

The Commission proposals will now be debated by the European Parliament and the Council (Member States) in the ordinary legislative procedure (co-decision). Final adoption of new legislation is not expected before 2014. 

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