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

MSD Animal Health Innovation and Intervet international v EMA

(Case T‑729/15 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 — Order of examination and method of verification — 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. 156(3)) (see paras 19, 20)

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 — Pleas concerning the confidentiality of information covered by business secrecy and the existence of a general presumption that an exception to the right of public access under Regulation No 1049/2001 applies — Pleas revealing the existence of complex legal questions — Pleas not prima facie without foundation (Arts 15(3) TFEU, 278 TFEU and 339 TFEU; Charter of Fundamental Rights of the European Union, Art. 7; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent) (see paras 22, 46, 54, 58-60, 62, 68-73)

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 15(3) TFEU, 278 TFEU and 339 TFEU; Charter of Fundamental Rights of the European Union, Art. 7; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent) (see paras 74-78)

4. Application for interim measures — Suspension of operation of a measure — Conditions for granting — Urgency — Serious and irreparable damage — Financial loss — Assessment according to the circumstances of the case — Damage linked to the disclosure of information covered by business secrecy — Criteria for assessment — Importance of the information for the undertaking concerned and usefulness of it for other undertakings (Art. 278 TFEU; Rules of Procedure of the General Court, Art. 156(3); European Parliament and Council Regulation No 1049/2001, Art. 6(1)) (see paras 95-99)

5. Application for interim measures — Suspension of operation of a measure — Interim measures — Conditions for granting — Urgency — Serious and irreparable damage — Assessment in litigation on the protection of confidential information — 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 paras 104-108, 113)

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; European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent) (see paras 110, 112)

7. 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); European Parliament and Council Regulation No 1049/2001, Arts 4(2), first indent, and 6(1)) (see paras 114, 115, 117-121)

Re:

APPLICATION based on Articles 278 TFEU and 279 TFEU, in essence, for the suspension of operation of Decision EMA/785809/2015 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 veterinary medicinal product Bravecto.

Operative part

1. Operation of Decision EMA/785809/2015 of the European Medicines Agency (EMA) of 25 November 2015 is suspended, in so far as that decision grants a third party access, 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, to toxicity study reports C 45151/28-day dermal (6 hours semi-occlusive) toxicity study in wistar rats, C 45162/28-day oral (gavage) toxicity study in wistar rats, and C 88913/28-day dermal (6 hours semi-occlusive) toxicity study in wistar rats.

2. The EMA is ordered not to disclose the reports mentioned in point 1.