Judgment — ECLI:EU:T:2019:456
Date: 2019-06-28
Language of the case: English
Court formation: Second Chamber
Subject matter: Provisions governing the Institutions;Access to documents
Procedure: Action for annulment - unfounded

summary disposal on which it intends to rely at the appropriate time in the context of the complaint lodged. That circumstance does not constitute an interest protected by Regulation No 1049/2001. 47 Finally, the argument concerning the absence of a specific public interest in disclosure must also be rejected as ineffective in the light of the finding in paragraph 42 above. 48 It follows from the foregoing that the first plea in law must be rejected. The second plea in law, alleging that the only acceptable outcome of a proper balancing exercise, under Article 4 of Regulation No 1049/2001, would have been a decision not to release the report at issue 49 The applicants claim that the contested decision should be annulled since disclosure of the report at issue would harm their commercial interests within the meaning of the first indent of Article 4(2) of Regulation No 1049/2001. According to the applicants, the only acceptable outcome of balancing their commercial interests against the public interest in disclosing that report would have been a decision not to release that report. 50 In that regard the applicants submit that: – they are likely to suffer severe harm if the report at issue is released in spite of the protections granted to Intercept Pharmaceuticals under US legislation, since that would place an unfair burden on Intercept Pharmaceuticals and would undermine its defence of meritless court proceedings. Intercept Pharmaceuticals would be required to devote to the dispute its scarce financial resources which would otherwise be allocated to the marketing of Ocaliva; – there is no specific and compelling public interest in disclosure capable of overriding the prospective harm to the applicants’ commercial interests; – disclosure would be contrary to the public interest in a broader sense: EMA and the FDA have entered into specific agreements to ensure that pharmacovigilance is shared between the agencies, and have agreed, as part of this, not to publicly disclose non-public information shared by the other agency; – a great deal of information about pharmacovigilance in general, and information in the report at issue specifically, has already been released. Those disclosures were made keeping in mind the careful balance between the need to provide information concerning safety and the level of information that it is appropriate to provide the public with concerning complex scientific matters; the disclosure of Batch 1 (and of Batch 2) would undermine that careful balance; – in view of those public announcements, it serves no public or public health interest to make the report at issue itself publicly available: the report at issue, which is a specialised scientific document, would be incomprehensible to the general public and would create a serious risk that the information contained therein could be misused to provide a misleading picture of the clinical safety and efficacy of Ocaliva. Nothing in the report at issue would materially add to the information already placed in the public domain by EMA and the FDA. 51 EMA disputes the applicants’ arguments and contends that the second plea in law should be rejected. 52 As recalled above in paragraphs 25 to 29 above, the purpose of Regulation No 1049/2001 is to give the widest possible effect to the right of public access to documents, which means that the exceptions to that law must be interpreted and applied strictly. Likewise, it is for the institution concerned which applies one of the exceptions laid down in Article 4(2) and (3) of Regulation No 1049/2001 to balance the particular interests to be protected by non-disclosure of the document against the public interest in the document being made accessible. 53 As regards the concept of commercial interests, it is apparent from the case-law that it is not possible to regard all information concerning a company and its business relations as requiring the protection which must be guaranteed to commercial interests under the first indent of Article 4(2) of Regulation No 1049/2001 without frustrating the application of the general principle of giving the public the widest possible access to documents held by the institutions (judgments of 15 December 2011, CDC Hydrogene Peroxide v Commission, T‑437/08, EU:T:2011:752, paragraph 44, and of 9 September 2014, MasterCard and Others v Commission, T‑516/11, not published, EU:T:2014:759, paragraph 81). 54 Consequently, in order to apply the exception provided for by the first indent of Article 4(2) of Regulation No 1049/2001, it must be shown that the report at issue contains elements which may, if disclosed, seriously undermine the commercial interests of a legal person. That is the case, in particular, when the requested document contains commercially sensitive information relating, inter alia, to the commercial strategies of the undertakings involved or to their customer relations or where that document contains information particular to that undertaking which reveals its expertise (see, to that effect, judgment of 9 September 2014, MasterCard and Others v Commission, T‑516/11, not published, EU:T:2014:759, paragraphs 82 to 84). 55 In the present case, it must be held that at no stage of the proceedings have the applicants put forward any arguments at all to indicate which part of the report at issue contained sensitive commercial information. The applicants merely indicate that the release of the report at issue would lead to a greater financial investment in connection with the court proceedings pending in the United States. 56 Such a justification does not relate to an interest protected by the exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001. 57 Since the exception relied on by the applicants is not applicable, their line of argument concerning the lack of specific public interest in disclosure is ineffective. 58 Likewise, the argument that the release of the report at issue is contrary to the agreements between EMA and the FDA cannot succeed. 59 In the first place, it must be observed that the confidentiality agreements between EMA and the FDA to facilitate the exchange of non-public information between those two authorities acknowledge that EMA is required to disclose information received from the FDA unless that information falls within the scope of any of the exceptions referred to in Article 4 of Regulation No 1049/2001. 60 In the second place, as EMA maintains, the report at issue was submitted to it by Intercept Pharma and not by the FDA. Accordingly, the abovementioned agreements are irrelevant in the present case. 61 Finally, it must be noted that the applicants themselves state that a great deal of information about pharmacovigilance generally, and information in the report at issue specifically, has already been released. The fact that the report at issue is of a scientific nature and is, to a certain extent, complex, detailed or specialised does not constitute a ground for non-disclosure. 62 It follows from all of the foregoing that the second plea in law must be rejected and, consequently, that the action must be dismissed in its entirety. Costs 63 Under Article 134(1) of the Rules of Procedure of the General Court, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. As the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by EMA. On those grounds, THE GENERAL COURT (Second Chamber) hereby: 1. Dismisses the action; 2. Orders Intercept Pharma Ltd and Intercept Pharmaceuticals, Inc. to pay the costs. Prek Schalin Costeira Delivered in open court in Luxembourg on 28 June 2019. E. Coulon E. Buttigieg Registrar President * Language of the case: English.