1. 

Appeal—Grounds—Mistaken assessment of the facts—Inadmissibility—Application to appeals directed against an order for interim measures

(Art. 256 TFEU; Statute of the Court of Justice, Art. 57, second para., and 58)

(see para. 36)

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 face unfounded

(Art. 278 TFEU; European Parliament and Council Regulations No 1049/2001, Art. 4(7) and No 726/2004, Arts 36, 38, § 3, 39(10), 57, 73 and 76; European Parliament and Council Directive 2001/82, Arts 13 and 13a)

(see paras 59, 60, 67, 68, 73-79)

3. 

Application for interim measures—Suspension of operation of a measure—Interim measures—Conditions for granting—Urgency—Serious and irreparable damage—Burden of proof—Damage foreseeable with a reasonable degree of probability—Assessment in litigation on the protection of confidential information—Reliance on the confidential nature of all of the documents concerned taken as a whole—Examination by the Courts of the Union, based on an overall analysis of the documents, of the likelihood of occurrence of serious and irreparable damage

(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 94, 95, 98, 102, 103)

4. 

Application for interim measures—Suspension of operation of a measure—Interim measures—Conditions for granting—Serious and irreparable damage—Financial loss—Damage not quantifiable—Damage not reparable by means of an action for damages—Whether irreparable

(Arts 268 TFEU, 278 TFEU, 279 TFEU and 340 TFEU)

(see para. 117)

5. 

Application for interim measures—Suspension of operation of a measure—Conditions for granting—Balancing of all the interests involved—Suspension of the operation of a decision of the European Medicines Agency granting access to the reports of clinical studies to a third party—Balancing the interest in maintaining the confidential nature of the information with the public interest in gaining immediate access to that information—Satisfying the public interest by publishing a non-confidential summary

6. 

(Arts 278 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 127, 128, 132, 134)

1) 

The appeal is dismissed.

2) 

The European Medicines Agency (EMA) is to pay the costs of the appeal proceedings.