Why is the Commission proposing to replace this legislation?
The Clinical Trials Directive has been criticised by patients, researchers and industry alike for its disproportionate regulatory requirements. High costs and a lack of harmonisation of the applicable rules necessary for multinational clinical trials are a few examples.
This has contributed to a significant decline of clinical trials in the EU. Between 2007 and 2011 the number of clinical trials conducted in the EU fell by 25%. The number of clinical trials applied for in 2007 (5000) dropped to 3800 by 2011.
Therefore, the Commission is proposing new legislation to cut red-tape and bring patient-oriented research back to Europe. The objective is to restore European Union’s competitiveness in clinical research and the development of new and innovative treatments and medicines for the ultimate benefit of patients.