Open Medicine EU

Yesterday (2nd April) the Plenary Session of the European Parliament approved the final text of the Regulation revising the Clinical Trials Directive. The announcement from the Parliament can be seen here. Since this text was negotiated with the Commission and Council (the national governments) it will soon be agreed formally in Council.

Today (3rd April) I hear from BEUC that Abbvie are withdrawing their legal challenge to the new transparency policy of the European Medicines Agency. This may not be a coincidence since I think it would be harder for them to win their case with the passing of the new Regulation. At any rate, their decision is the right one for all kinds of reasons.

At time of writing I have no news of the position of Intermune who have launched a similar challenge against the EMA.

Attached is the text of the new Regulation as adopted by the Parliament. Strictly speaking it is a provisional text at this stage but I do not expect any significant changes.

Someone said recently that “Victory has a thousand fathers, but defeat is an orphan.” In this case I think the European Parliament has a special claim to paternity (or maternity in the case of Glenis Willmott MEP) but credit also to the European Commission (DG SANCO) and the 28 member governments in the Council.

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