The European Federation of Pharmaceutical Industries and Associations (EFPIA), a group of 33 European national pharmaceutical industry associations and 35 companies, welcomes the proposal for a new regulation on clinical trials on medicinal products for human use adopted July 23 by the European Commission as a first step towards further cooperation in the clinical trials assessment process across the E.U.
"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," said Richard Bergström, director general of EFPIA.
According to the E.C., 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,” said Bergström.
EFPIA believes the regulation is an important step in the direction of a much needed simplification and standardization 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 E.U. 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,” said Bergström. “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.”
The Commission proposal is being debated by the European Parliament and Member States in the ordinary legislative procedure (co-decision). Final adoption of new legislation is not expected before 2014.