Order of the President of the General Court of 20 July 2016 —

PTC Therapeutics International v EMA

(Case T‑718/15 R)

‛Application for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents — Application for suspension of operation of a measure — Urgency — Prima facie case — Weighing up of interests’

1. 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 — Balancing of all the interests involved — Order of examination and method of verification — Discretion of the court hearing the application for interim relief (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3)) (see paras 23, 24)

2. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Prima facie case — Prima facie examination of the pleas in law put forward in support of the main action — Action against a decision of the European Medicines Agency (EMA) granting access to reports on clinical trials to a third party — Plea based on the existence of a general presumption that an exception to the right of public access under Regulation No 1049/2001 applies — Plea revealing the existence of complex legal questions — Plea not prima facie lacking in foundation (Arts 278 TFEU, 279 TFEU and 339 TFEU; Charter of Fundamental Rights of the European Union, Art. 7; European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent) (see paras 26, 52, 60, 64-66, 77-80)

3. 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 information submitted by an undertaking in the context of its application for marketing authorisation for a medicinal product — Need to maintain the effectiveness of the decision of the General Court in the action in the main proceedings (Arts 278 TFEU, 279 TFEU and 339 TFEU; Charter of Fundamental Rights of the European Union, Art. 7; European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent) (see paras 81-85)

4. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Financial loss — Damage resulting from the disclosure of allegedly confidential information — Assessment of the seriousness of the damage by the court hearing the application for interim measures (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3)) (see paras 103-107)

5. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Financial loss — Assessment according to the circumstances of the case — Damage arising from the disclosure of confidential information under Regulation No 1049/2001 — Undertaking concerned placed in a vulnerable position by reason of the probability that the information will be exploited by its competitors — Damage not hypothetical by nature (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001, Art. 6(1)) (see paras 112-114, 117, 118)

6. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Serious and irreparable damage — Financial loss — Unquantifiable damage caused by the publication of confidential information likely to be exploited by competitors to the detriment of the undertaking concerned — Irreparable character (Arts 278 TFEU and 279 TFEU) (see paras 119, 120, 122)

7. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Assessment in litigation on the protection of confidential information — Serious and irreparable damage — Sufficient where probability of that damage is shown (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3)) (see para. 122)

8. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Decision of the European Medicines Agency granting a third party access to information submitted by an undertaking in the context of its application for marketing authorisation for a medicinal product — No jurisdiction for the court hearing the application for interim relief to authorise partial access (Arts 278 TFEU and 279 TFEU; Rules of Procedure of the General Court, Art. 156(3)) (see paras 123-127, 130)

Re:

APPLICATION pursuant to Articles 278 TFEU and 279 TFEU for, in essence, the suspension of operation of Decision EMA/722323/2015 of the EMA of 25 November 2015, granting to a third party, 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), access to certain documents containing information submitted in the context of an application for marketing authorisation for the medicinal product Translarna.

Operative part

1. Operation of Decision EMA/722323/2015 of the European Medicines Agency (EMA) of 25 November 2015, granting to a third party, 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, access to Clinical Study Report ‘Ataluren (PTC124) PTC124-GD-007-DMD’ on a Phase 2B efficacy and safety study of Ataluren in subjects with nonsense-mutation-mediated Duchenne and Becker muscular dystrophy, is suspended.

2. The EMA is ordered not to disclose the report referred to in point 1.