The European Commission has published proposals to amend the existing European Union (EU) Clinical Trials Directive. These are relevant for all NHS bodies carrying out clinical research on medicinal products. The 2001 Directive aimed to address the diverse approaches taken by European countries to regulating clinical trials. This was only achieved to a limited extent, as member states interpreted the directive differently and took varied approaches to implementation.
The proposed legislation will be in the form of a regulation, meaning the EU law will apply directly in each member state without the need for national regulation alterations. This will ensure that the rules for conducting clinical trials will be more consistent throughout the EU.
The key changes proposed are:
- Simpler authorisation procedure. This is particularly relevant to trials involving more than one EU country
- Protection of subjects and informed consent. The regulation does not change the substance of the rules, with the exception of new rules for urgent circumstances, however it does provide clarity
- Simpler safety reporting. The rules have been streamlined and follow the recommended guidance documents
- Conduct of the trial. The proposed regulation brings together rules contained in the 2005 commission directive and commission guidelines
- Investigational medicinal products, manufacturing and labelling. The proposed regulation brings together rules that are currently in different directives
- Co-sponsorship will be possible. Thus facilitating more partnership working between organisations
- Compensation for damages. This will remove the insurance requirements for clinical trials posing negligible risk and requiring member states to establish national indemnification schemes for non commercial trials
- Inspections. The proposed provides a legal basis for commission staff to perform inspections in member states
- Lighter regime for clinical trials defined as “low risk”
The proposed regulation will now pass through the EU legislative procedure and once agreed will repeal Directive 2001/20/EC. However, it is suggested that both sets of rules will apply in parallel for three years to ensure a smooth transition to the new regulatory regime.