Recently, the Committee of Permanent Representatives (COREPER I) the Member States endorsed the agreement reached by the Lithuanian EU Council Presidency and the European Parliament on the Proposal for a Regulation on Clinical trials on medicinal products for human use (and repealing Directive 2001/20/EC). We have previously considered European clinical trials here.
The aim of the proposed Regulation is to facilitate the authorization procedure for clinical trials and as a result to increase the number of clinical trials in the European Union. In response to requests from scientists and in order to meet patients’ needs, the proposal aims to stimulate clinical trials conducted also by non-commercial sponsors like hospitals and university clinics. This proposal was presented in response to the fact that the share of clinical trials performed in the EU out of all clinical trials has decreased over recent years.
According to the Minister of Health of Lithuania Vytenis Povilas Andriukaitis, adoption of this Regulation is a major step towards innovative and more competitive Europe with a view to the health sector, whereas the ambition of a high level of protection for patients is a key thread. Andriukaltis said: “This legislative act paves way towards achieving an internal market as regards clinical trials and medicinal products for human use, taking as a base a high level of protection of health. It also sets high standards of quality and safety for medicinal products to meet common safety concerns. What is very important – both objectives are being pursued simultaneously.”
The new regulation on clinical trials comes 10 years after the original Clinical Trials Directive that enshrined Good Clinical Practice and set out to harmonize the approval and conduct of clinical trials throughout the EU. The regulation specifically clarifies the rules for conducting clinical trials in the EU, and also the acceptability throughout the Union of data generated in a clinical trial. It sets high standards for the quality and safety of medicinal products by ensuring that data generated in clinical trials is reliable and robust. Moreover, it sets high standards of subjects’ safety in clinical trials in the EU.
“We believe that timelines for authorization of clinical trials will be competitive and the harmonized authorization procedures in all EU countries will stimulate the conduct of clinical trials in the EU,” said the Minister.
However, Miriam Gargesi, Director of Healthcare at EuropaBio stated concerns in a release: “Whilst we welcome the revision of the Clinical Trials Directive as a commitment to stimulate clinical research in Europe, we are concerned that the proposal adopted today in the EU Committee of Permanent Representatives may not fully achieve the intended objective to provide a harmonised and efficient framework for clinical research in the EU. In particular, the Regulation should be carefully implemented so as not to jeopardise companies’ innovation potential and as patients’ timely access to innovative medicines.”
We will continue to monitor developments as they arise.