EuropaBio Response to the European Commission Consultation on the Assessment of the Functioning of the Clinical Trials Directive 2001/20/EC

16.02.2010

EuropaBio Response to the European Commission Consultation on the Assessment of the Functioning of the Clinical Trials Directive 2001/20/EC

EuropaBio welcomes the European Commission initiative to conduct an impact assessment of the application of the Clinical Trials Directive 2001/20/EC with a view to improving the regulatory framework for clinical trials in the EU. We welcome the opportunity to submit these comments in response to the questions posed in the consultation paper and wish to offer our members’ suggestions for reform of the Directive.

The Directive was an important first step towards harmonisation of the requirements and processes between EU Member States, and the Directive could provide potential for synergies and time savings. However, these potential benefits have not been realised because of the uneven and inconsistent implementation by EU Member States. There is an increased bureaucracy and proliferation of Member State requirements, and this has resulted in different regulatory standards being applied in granting clinical trial authorisations.

Furthermore there is no supporting evidence that multiple layers of regulatory approvals required by Member States on a national basis would enhance the safety, rights and well-being of patients at a Community level, the very objectives of the Clinical Trials Directive. On the contrary, these administrative burdens undermine public health in the sense that they risk delaying important medicines being investigated in clinical trials and adding extra costs to product development unnecessarily.

EuropaBio believes that the Clinical Trials Directive should be reviewed and revised, and a new Regulation proposed in order to achieve harmonisation and consistency in the approval and conduct of clinical trials in the EU. The Regulation should describe the framework for a centralised assessment process for clinical trial applications that will run in parallel with the national approval process provided by the revised Clinical Trials Directive with the possibility of mutual recognition of national approvals by Member States concerned by the clinical trial. We believe these parallel Community procedures should seek to streamline the approval process for multicentre and multinational clinical trials in more than one Member State. In our view a revision of existing implementing guidelines will not address meaningfully the fundamental issues outlined in our responses below.

Latest Position papers