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

1. Application for interim measuresSuspension of operation of a measureInterim measuresConditions for grantingPrima facie caseUrgencySerious and irreparable damageCumulative natureOrder of examination and method of verificationDiscretion 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 measuresSuspension of operation of a measureConditions for grantingPrima facie casePrima facie examination of the pleas in law put forward in support of the main actionAction against a decision of the European Medicines Agency (EMA) granting access to reports on clinical trials to a third partyPleas 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 appliesPleas revealing the existence of complex legal questionsPleas 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 measuresSuspension of operation of a measureConditions for grantingBalancing of all the interests involvedSuspension 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 productNeed 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 measuresSuspension of operation of a measureConditions for grantingUrgencySerious and irreparable damageFinancial lossAssessment according to the circumstances of the caseDamage linked to the disclosure of information covered by business secrecyCriteria for assessmentImportance 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 measuresSuspension of operation of a measureInterim measuresConditions for grantingUrgencySerious and irreparable damageAssessment in litigation on the protection of confidential informationSufficient 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 measuresSuspension of operation of a measureInterim measuresConditions for grantingSerious and irreparable damageFinancial lossUnquantifiable damage caused by the publication of confidential information likely to be exploited by competitors to the detriment of the undertaking concernedIrreparable 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 measuresSuspension of operation of a measureInterim measuresConditions for grantingUrgencySerious and irreparable damageDecision 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 productNo 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.

3. Costs are reserved.