This Friday 20th December the EU’s Clinical Trials Regulation will be approved by the Council of the EU. This will mark the end of the Trilogue discussions which have being on between the Council of the European Union, Parliament and Commission in Brussels. We just received this message from Glenis Willmott MEP’s office:
“Just to give you an overview of some of the main points which we have (tentatively) agreed:
- A publicly accessible EU database, set up and run by EMA, containing:
- A register of all trials carried out in the EU
- A summary of results for all trials, uploaded 1 year after the end of the trial at the latest
- As well as a summary understandable for a layperson
- Clinical Study Reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn
- A statement that Clinical Study Reports should, in general, not be considered commercially confidential
- Fines to be imposed by Member States for non-compliance with the transparency requirements
- A requirement for all trials to be registered or published in order to be used to back up a new clinical trial authorisation (will encourage the retrospective registering/publishing of old trials)
- The Clinical Trial Master File retained for at least 25 years.
If agreed by the Member States the overall deal will need to be approved by the ENVI committee, and then the whole Parliament. ”
Glenis Willmott has been leading intense negotiations on the legislation and she has worked hard to ensure transparency is at its heart, helped by the hundreds of you who wrote to your MEPs in May and to your Health Ministers in October. Forty European medical, research and patient organisations sent a briefing document to those involved in the negotiations, urging their support for these amendments. If the Council of the EU agrees the above additions to the Regulation and Parliament approves it, it will change the future of clinical trial reporting in Europe and it will be thanks to Glenis and to all of you who wrote to your MEPs and ministers.
Edited on 18/12/2013 to correct European Council to Council of the EU