EMA v AbbVie

Editorial Note: Three months ago we launched an AbbVie campaign and followed it up with a petition calling on AbbVie ad InterMune to drop their action against EMA. The hope was to raise awareness of this critically important issue that had been sailing beneath the radar.

Over 6000 of you from more than 120 countries responded.

This interim judgement is not a victory. It may be more a stay of execution. See links here for how things are playing out in the press for example. But it does mean that for the moment EMA is open for business again – except for Humira trials –  so anyone who can should now access any trial data they can in case the window closes again.


———- Forwarded message ———-

From: Rasi Guido <Guido.Rasi@ema.europa.eu>
Date: 5 December 2013 11:10
Subject: Update on EMA appeal of EU Court interim measures decision in AbbVie and InterMune court cases

Dear colleagues and friends,

I have written a number of times over the past months to keep you informed of developments in the AbbVie and Intermune cases.

There is an important news I would like to share with you concerning the appeal procedures lodged by the EMA in Cases C-389/13 (P) R and C-390/13 (P) R.

As you recall, early in July this year the EMA lodged appeals against the Orders of the President of the General Court suspending the decisions to disclose under Regulation (EC) No 1049/2001 documents contained in the dossier for marketing authorisation of the medicinal products Humira and Esbriet.

We have been recently notified of the two Orders of the Vice-President of the Court of Justice annulling the previous Orders and referring back the cases to the General Court for a new decision on the interim relief applications. The ordinary procedures will follow their normal course.

In the Orders, the Vice-President of the Court of Justice concludes that the President of the General Court erred in law in finding that the alleged infringement of the companies’ fundamental right to the protection of their business secrets and of their right to an effective remedy was sufficient in itself to establish the risk of serious and irreparable harm in the circumstances of the present cases.

Accordingly, the Vice-President of the Court of Justice asks the President of the General Court to examine one by one, the arguments and evidence put forward by the companies and intended to prove the serious and irreparable harm to those companies. In the event that the companies produce such proof with regard to certain information or certain documents, the Vice-President of the Court of Justice explicitly provides that the interim measure sought be granted to them, in respect of that information or those documents only.

The full text of the Orders will shortly be available on the website of the Court of Justice www.curia.europa.eu

Although we have not won the case yet, this is a first important result since the litigation started. We would like to share with you our positive feelings and would like to thank you again for your continuing support, contribution and inspiration for the achievement of our common transparency objectives.

Kind regards


Guido Rasi

Executive Director
European Medicines Agency
7 Westferry Circus | Canary Wharf | London E14 4HB | United Kingdom

guido.rasi@ema.europa.eu www.ema.europa.eu


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  1. I feel a blog coming on. “Don’t Mess With Da Dr”

    Great work.

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