Commission consultation on the functioning of the Clinical Trials Directive

The European Commission has launched a public consultation to assess the functioning of the Clinical Trials Directive (2001/20/EC) (the "Directive").  The consultation is intended to gather feedback on the functioning of the Directive, which came into force in the UK on 1 May 2004, and to obtain input on how the Directive might be improved, while taking into account the increasingly international dimension of clinical trials.

Lawyers Tim Worden

The consultation document1 refers to a criticism – raised at a Commission / EMEA clinical trials conference in October 2007 – that the Directive has lead to a "significant decline in the attractiveness of patient-oriented research and related studies in the EU...having a negative impact on the development of new and innovative treatments and medicines". In addition, an increasing number of trials today are multi national and the authorisation process for such trials has become very complex. The consultation is designed to look in detail at a number of key issues that must be addressed to improve the functioning of the Directive and, in turn, to make the EU a more attractive place to carry out clinical research:

• Multiple and divergent assessment of clinical trials – the consultation reports that the rules for the authorisation of clinical trials are being applied differently by national competent authorities.  This in turn increases costs and slows down clinical trial initiation.  The consultation suggests greater co-operation between national competent authorities, as well as a possible "one stop shop" streamlined procedure for approval, reducing the need for state-by-state evaluations.
• Inconsistent application of the Directive – Member States differ in their interpretation of, for example, what should be considered a "substantial amendment" to a clinical trial.  Such differences in interpretation between Member States have, according to the Commission, led to an increase in notifications: the consultation document refers to a three-fold increase in the number of substantial amendments compared to 2003.
• A regulatory framework that does not adequately adapt to practical requirements – the consultation asks whether the Directive should be amended, or implementing guidelines adapted, to provide for a more risk-based assessment of clinical trials applications.
• Adaptation to peculiarities in trial design and trial participants – the consultation also seeks views on whether the Directive should be amended to include, for example, express provisions relating to clinical trials carried out in emergency situations.
• Ensuring GCP compliance in clinical trials performed in non-EU countries – the consultation cites the EudraCT database as providing evidence that approximately 25% of all clinical trials performed in the EU also involve at least one non-EU country.  The Commission proposes a number of options to help ensure that all such trials are carried out in accordance with GCP in all relevant non-EU countries.

The aim of the consultation is to make the clinical trial authorisation process in Europe more efficient without increasing the risks for the trial participants.  A single authorization could obviously reduce complexity but there would need to be a clear demarcation between the authorisation process (at an EU level) and ethics committee clearance (at a national level).

The Commission is seeking input from those impacted by the functioning of the Directive.  The deadline for responses is Friday, 8 January 2010.

If you would like to discuss the impact of the Directive on your business, and how you might best respond to the consultation, please contact Tim Worden or Gareth Morgan.