EPF welcomes Wilmott report on clinical trials
EPF warmly welcomes the draft report of Glenis Willmott MEP (S&D, UK) and the European Commission’s legislative proposal for a clinical trial published on 31 January 2013. It is in our view very positive and we can broadly support it.
The rapporteur has introduced several amendments to the Commission’s original legislative proposal to strengthen the protection of trial subjects and to increase the transparency of clinical trials information and results, in line with EPF’s positions.
Pertinent information from all trials would have to be made available to the public through an EU data base, and one year from the end a full clinical study report including a lay friendly summary should be posted, with penalties for sponsors who fail to do so.
The rapporteur has also recognised the importance of patient involvement in assessing clinical trials. She puts forward a more concrete proposal from that of the Commission, mandating patient involvement in ethics committees and asking the Commission to develop guidelines for patient involvement at EU level.
Another very welcomed development is that the rapporteur takes on board EPF’s positions regarding information to patients and informed consent. The provisions concerning information to patients in the text are strengthened, and requirements for informed consent should now be assessed jointly by Member States rather than separately and should be based on guidelines developed at EU level to ensure information and the way it is presented is patient-friendly.
There are still some gaps in the draft report. These include need to address patients involvement in research priority-setting, to achieve clarity on the lay summary of clinical trials results, and to further strengthen the requirements concerning the application dossier.
However EPF is happy to support the approach taken by Ms. Willmott. We believe it is a constructive way forward towards a framework that will ensure better quality clinical research in future for the benefit of European patients.
Consideration of amendments tabled to the report will take place in March. The report is due to be voted in the ENVI committee on 24 April and in plenary sitting on 10 June.
The Wilmott report is available here: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML%2BCOMPARL%2BPE-504.236%2B01%2BDOC%2BPDF%2BV0//EN
The commission’s legislative proposal is available here: http://ec.europa.eu/health/files/clinicaltrials/2012_07/proposal/2012_07_proposal_en.pdf