Keywords

Subject of the case

Operative part



Keywords

Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Prima facie case — Urgency — Serious and irreparable damage — Cumulative nature — Weighing-up of the interests — Discretion of the court hearing the application for interim relief (Arts 256(1) TFEU, 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 104(2)) (see paras 23-25)

2. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Balancing of all the interests involved — Suspension of operation of a decision of the European Medicines Agency granting a third party access to reports of clinical trials — Need to maintain the effectiveness of the decision of the General Court in the action in the main proceedings (Art. 278 TFEU) (see paras 28-33)

3. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Risk of serious and irreparable damage to fundamental rights (Arts 6(1), first para., TEU, 278 TFEU, 279 TFEU and 339 TFEU; Charter of Fundamental Rights of the European Union, Arts 7 and 47) (see paras 36, 37, 41)

4. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Prima facie case — Examination prima facie of the pleas in law put forward in support of the main action — Action against a decision of the European Medicines Agency granting a third party access to reports of clinical trials — Pleas concerning the confidentiality of information covered by business secrecy — Pleas revealing the existence of complex legal questions — Pleas not prima face unfounded (Arts 278 TFEU and 339 TFEU; Charter of Fundamental Rights of the European Union, Art. 7) (see paras 43, 44, 51-55)

Subject of the case

Re:

APPLICATION, in essence, for suspension of operation of EMA Decision EMA/24685/2013 of 15 January 2013, granting a third party access to certain documents containing information submitted as part of an application for authorisation to place the medicinal product Esbriet on the market, pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), inasmuch as that information is not yet within the public domain.

Operative part

Operative part

1. The operation of EMA Decision EMA/24685/2013 of 15 January 2013, granting a third party access, under Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, to the documents ‘2.4 Non-clinical Overview; 2.5 Clinical Overview; 2.6 Non-clinical Summary; and 2.7 Clinical Summary’, submitted as part of an application for authorisation to place the medicinal product Esbriet on the market, is suspended in so far as those documents contain information which is not yet publicly available.

2. The EMA is ordered not to disclose the documents referred to in point 1 of the operative part of this order in a version which is more detailed than the edited version of those documents as provided by InterMune UK Ltd, InterMune, Inc., and InterMune International AG to the EMA on 8 October 2012.

3. Costs are reserved.