Brussels, 17/07/2012 (Agence Europe) - On 17 July, the European Commission adopted a draft regulation to boost clinical research in Europe. Clinical trials are vital to develop medicines and to improve and compare the use of already authorised medicines. Clinical trials, however, are undermined by a lengthy and opaque authorisation process. The commissioner for health and consumer policy, John Dalli, said that cutting bureaucracy would be sweeping but not to the detriment of patient safety, which would continue to be insured through respect for very strict standards. He added that, “Patients in Europe should have access to the most innovative clinical research... €800 million per year could be saved in regulatory costs and boost research and development in the EU, thus contributing to economic growth”.
Clinical research with over €20 billion of investment per year in the EU makes a significant contribution to the growth policy of the EUROPE 2020 agenda. The data generated in clinical trials are used by researchers in publications, and by pharmaceutical companies applying for marketing authorisations. Once implemented, the measures proposed today will speed up and simplify the authorisation and reporting procedures, while maintaining the highest standards of patient safety and robustness and reliability of data. The measures will also better differentiate the obligations according to the risk-profile of the trial, and improve transparency including on trials done in third countries. The new legislation will introduce a:
Single Portal: an authorisation procedure for clinical trials, which will allow for a fast and thorough assessment of the application by all member states concerned and which will ensure one single assessment outcome;
Simplified procedures: simplified reporting procedures, which will spare researchers from submitting largely identical information on the clinical trial separately to various bodies and member states;
Transparency: more transparency on whether recruitment for participating in a clinical trial is still ongoing, and on the results of the clinical trial;
Commission controls: the possibility for the Commission to conduct controls in member states and other countries to make sure the rules are being properly supervised and enforced.
The 2001 directive guarantees a high level of patient safety but differences that have occurred during its transposition and application by member states have complicated the process and have resulted in a 25% fall in the number of clinical trials carried out between 2007 and 2011. In 2007, more than 5000 clinical trials were applied for in the EU while by 2011 the number had dropped to 3800. The Commission is hoping that this proposal will help reverse this trend. It will take effect as of 2016, following approval by the European Parliament and the Council of Ministers. (IL/trans.fl)