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EPF internal workshop on Clinical Trials Regulation

In the context of EPF's membership consultation process on the European Commission’s legislative proposal on Clinical Trials, an internal workshop was organised on 13 December at EPF offices, bringing together representatives of EPF’s member organisations and Commission officials who have worked on the proposal. The second round consultation has now ended and EPF will prepare a final position by the end of February. 

This internal meeting focused on specific issues in the commission’s proposal that needed further deliberation. Participants discussed in particular EPF proposals regarding implementation of Article 9 on patient involvement. The group concluded that the modalities of patient involvement should be further explored but that one token patients participating would not be enough. Therefore there needs to be a support structure in place, preferably a European wide network.

Discussing information and informed consent, the participants unanimously agreed that core elements or standards should be developed at EU level to ensure consistent quality of information everywhere in the EU and to empower patients to make a truly informed choice.

Regarding transparency and access to clinical trials information and results, the group agreed that the provisions of the regulation should be strengthened. In the meantime EPF should reflect further on its position regarding data transparency, to find a balance between greater transparency and patient confidentiality concerns.

A report of the meeting was circulated to all EPF’s members in December.

Indicative timeline for the first reading in Parliament


18/19 February 2013 – Consideration of draft report prepared by Glenis Willmott MEP
26 February 2013 – Deadline for amendments
20/21 March 2013 – Consideration of amendments
24 April 2013 – Vote scheduled in Committee
10 June 2013 – Indicative plenary sitting date

The Parliament is keen to complete the legislative process before the European Parliament elections, which will take place in June 2014.