After many years of debate and consultation, the European Commission published in July the legislation for the control of clinical trials across Europe. The Commission chose a Regulation to avoid the problems which have been all too evident in the current legislation. Member States will not be able to implement the new requirements with any differences. The proposals have won significant support from key Stakeholders. Nevertheless, the journey through the Council of Ministers and the European Parliament will not be easy. The hope is to have the legislation agreed by early 2014, just before the election of the new Parliament. The new proposals would be brought in approximately 2 years later.
The major feature is that there will be a single submission dossier divided into two parts, Annex 1 (the general dossier) and Annex 2 (the national dossier). Submissions will be made electronically through a single European portal. This will apply whether a trial is to be undertaken in one Member State or several. A single decision will be made on Part 1 (the clinical trial application itself).
The proposals build on the voluntary harmonisation procedure introducing a streamlined assessment. Industry will be able to choose one agency to be the lead evaluator, the so called “reporting Member State”. We will now have to learn a new acronym not to be confused with the Reference Member State in the decentralised procedure. Evaluations will be performed according to a risk based process. The Regulation will cover all interventional clinical trials, independent of whether the sponsor is industry or academia. The part one assessment concerns the approval of the trial itself, whereas in part two there will be a separate national assessment including ethical committee evaluation. The legislation sets out detailed safety provisions. The sponsor will reportdirectly into the Eudravigilance system. The proposals on the ethics committees are likely to generate considerable debate. There are discussions about building coalitions of the willing for voluntary harmonisation between key players in Europe. It will be interesting to see how this progresses.
The timelines for evaluation are challenging and there is suspicion that some Member States will seek to have these extended. For low intervention clinical trials it is proposed that each Member State will provide insurance compensation. One wonders whether this will be acceptable to the Member States.
There is a strong role for the Commission in these proposals. They will be responsible for the portal and the database. They will also control and oversee inspections and will support the Member State coordination through a secretariat. The EMA has almost no role in these proposals. There has been much speculation as to why this has occurred. Has the Commission lost faith in the EMA or is this the Member States wanting to retain their control? It seems strange that there is a disconnect in these proposals in the so called single European system.
It is to be hoped that this regulation is passedand restoresthe opportunity for multinational trials to be rapidly approved and initiated across Europe.
MF are planning a series of meetings and discussions as these proposals move forward. Watch this space for more details