ORDER OF THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
17 July 2014 (*)
(Confidentiality — Challenge)
In Case T‑73/13,
InterMune UK Ltd, established in London (United Kingdom),
InterMune, Inc., established in Brisbane (United States),
InterMune International AG, established in Muttenz (Switzerland),
represented by I. Dodds-Smith, Solicitor, A. Williams, Solicitor, T. de la Mare QC, and F. Campbell, Barrister,
applicants,
supported by
European Confederation of Pharmaceutical Entrepreneurs (Eucope), represented by F. Louis and P. Gey, lawyers,
intervener,
v
European Medicines Agency (EMA), represented by T. Jabłoński, N. Rampal Olmedo and A. Spina, acting as Agents,
defendant,
supported by
French Republic, represented by D. Colas and F. Fize, F. Gloaguen, acting as Agents,
Portuguese Republic, represented by A.P. Antunes and L. Inez Fernandes, acting as Agents,
European Consumer Organisation (BEUC), represented by S. Pappas, lawyer,
interveners,
APPLICATION for annulment of Decision EMA/24685/2013 of 15 January 2013, granting a third party access to certain documents containing information submitted as part of an application for authorisation to place the medicinal product Esbriet on the market, 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), inasmuch as that information is not yet within the public domain,
THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
makes the following
Order
Facts and procedure
1 On 11 February 2013, the applicants, InterMune UK Ltd, InterMune Inc and InterMune International AG, brought an action under Article 263 TFEU for annulment of Decision EMA/24685/2013 of 15 January 2013, granting a third party access to certain documents containing information submitted as part of an application for authorisation to place the medicinal product Esbriet on the market, pursuant to Regulation No 1049/2001, inasmuch as that information is not yet within the public domain.
2 Pursuant to Article 24(6) of the Rules of Procedure of the General Court, the summary of the application initiating proceedings in Case T‑73/13 was published in the Official Journal of the European Union of 20 April 2013 (OJ 2013 C 114, p. 38).
3 By documents lodged at the Court Registry on 19 February 2013, 27 May 2013 and 19 July 2013 respectively, the Portuguese Republic, the French Republic and the European Consumer Organisation (BEUC) sought leave to intervene in support of the form of order sought by the EMA.
4 By documents lodged at the Court Registry on 27 May 2013, the European Confederation of Pharmaceutical Entrepreneurs (Eucope) sought leave to intervene in support of the form of order sought by InterMune UK Ltd, InterMune Inc and InterMune International AG.
5 By documents lodged at the Court Registry on 22 April 2013, 17 June 2013, 25 June 2013 and 27 August 2013, InterMune UK Ltd, InterMune Inc and InterMune International AG requested confidential treatment of certain items contained in the annexes to the application and in the defence, in relation to all the interveners.
6 By orders of 11 September 2013 of the President of the Seventh Chamber of the Court, the Portuguese Republic and the French Republic were granted leave to intervene in the present case in support of the form of order sought by the EMA. By order of the same day, the President of the Seventh Chamber also granted the European Consumer Organisation (BEUC) leave to intervene in support of the form of order sought by the EMA. However, in accordance with Article 116(6) of the Rules of Procedure, the President of the Seventh Chamber allowed the European Consumer Organisation (BEUC) only to submit its observations during the oral procedure on the basis of the Report for the Hearing which was to be communicated to it.
7 After a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Fourth Chamber, to which the present case was, consequently, assigned.
8 By document lodged on 3 October 2013, the Portuguese Republic raised objections against all of the applicants’ requests for confidential treatment. The intervening French Republic and the European Confederation of Pharmaceutical Entrepreneurs (Eucope) did not raise an objection against the requests for confidential treatment.
9 By order of 28 November 2013 of the President of the Fourth Chamber of the Court, the European Confederation of Pharmaceutical Entrepreneurs (Eucope) was granted leave to intervene in the present case in support of the form of order sought by InterMune UK Ltd, InterMune Inc and InterMune International AG.
Law
Subject-matter of the requests
10 The applicants have submitted requests for confidential treatment relating to certain data and information contained in the annexes to the application and in the defence. Specifically, those items are:
– the text redacted in Annex A3 to the application;
– the text redacted in Annex A4 to the application;
– the text redacted in Annex A6 to the application;
– the text redacted in Annex A8 to the application;
– the text redacted in paragraph 158 of the defence.
The merits of the requests for confidential treatment
11 Article 116(2) of the Rules of Procedure provides that:
‘[i]f an intervention for which application has been made within the period of six weeks prescribed in Article 115(1) is allowed, the intervener shall receive a copy of every document served on the parties. The President may, however, on application by one of the parties, omit secret or confidential documents.’
12 That provision lays down the principle that interveners are to receive a copy of every pleading served on the parties and permits only by way of derogation that certain secret or confidential documents or information not be sent to them (order of 4 April 1990 in Hilti v Commission, T‑30/89, EU:T:1990:27, paragraph 10).
13 In that regard, first, the party who makes an application for confidentiality has the task of specifying the documents or information covered and of duly stating the reasons for which they are confidential (order of 22 February 2005 in Hynix Semiconductor v Council, T‑383/03, ECR, EU:T:2005:57, paragraph 31).
14 Second, when a party makes an application under the second sentence of Article 116(2) of the Rules of Procedure, the President is to give a decision solely on the documents and information the confidentiality of which is disputed (order in Hynix Semiconductor v Council, EU:T:2005:57, paragraph 13 above, paragraph 36).
15 The challenging of the request for confidentiality by the interveners must relate to precise items of the procedural documents which have been redacted and indicate the reasons for which confidentiality with regard to those items should be refused. Therefore, a request for confidential treatment must be upheld in so far as it concerns items which have not been disputed by the intervener, or which have not been disputed expressly and precisely (order of 15 June 2006 in Deutsche Telekom v Commission, T‑271/03, ECR, EU:T:2006:163, paragraphs 12, 14 and 15).
16 Third, in so far as the application presented under the second sentence of Article 116(2) of the Rules of Procedure is disputed, it is for the President first to examine whether each document and item of information, the confidentiality of which is in dispute and in relation to which a request for confidential treatment has been submitted, is secret or confidential in nature (see, to that effect, order in Hynix Semiconductor v Council, EU:T:2005:57, paragraph 13 above, paragraph 38; and order of 14 October 2009 in vwd Vereinigte Wirtschaftsdienste v Commission, T‑353/08, EU:T:2009:402, paragraph 15).
17 The requirement that the applicant state reasons for the application for confidentiality must be assessed in the light of the secret or confidential nature of each document and item of information covered. A distinction must be drawn between, on the one hand, information which is inherently secret, such as business secrets of a commercial, competition-related, financial or accounting nature, or confidential, such as purely internal information, and, on the other hand, documents or information which may be secret or confidential for a reason that the applicant must provide (see, to that effect, orders in Hynix Semiconductor v Council, EU:T:2005:57, paragraph 13 above, paragraph 34, and in vwd Vereinigte Wirtschaftsdienste v Commission, EU:T:2009:402, paragraph 16 above, paragraph 16).
18 Thus, the secret or confidential nature of the documents or information for which no statement of reasons is provided other than a description of their content will be accepted only in so far as that information may be considered to be inherently secret or confidential (order of 18 November 2008 in Zhejiang Harmonic Hardware Products v Council, T‑274/07, EU:T:2008:508, paragraph 25, and order in vwd Vereinigte Wirtschaftsdienste v Commission, EU:T:2009:402, paragraph 16 above, paragraph 27).
19 Fourth, where his examination leads him to conclude that some of the documents and information whose confidentiality is disputed are secret or confidential, the President is then to assess and weigh up the competing interests, for each document and piece of information (orders in Hynix Semiconductor v Council, EU:T:2005:57, paragraph 13 above, paragraph 42, and in vwd Vereinigte Wirtschaftsdienste v Commission, EU:T:2009:402, paragraph 16 above, paragraph 24).
20 Where confidential treatment is requested in the interests of the applicant, this assessment leads the President to weigh in the balance, for each document or piece of information, the applicant’s legitimate concern to prevent serious harm to his interests and the equally legitimate concern of the interveners that they should have the information necessary for exercising their procedural rights (orders in Hynix Semiconductor v Council, EU:T:2005:57, paragraph 13 above, paragraph 44, and in vwd Vereinigte Wirtschaftsdienste v Commission, EU:T:2009:402, paragraph 16 above, paragraph 25).
21 In any event, an applicant for confidential treatment must, given the adversarial and public nature of the judicial proceedings, envisage the possibility that some of the secret or confidential documents or information which he has decided to place on the file appear necessary for the exercise of the interveners’ procedural rights and, consequently, must be disclosed to them (order of 29 May 1997 in British Steel v Commission, T‑89/96, EU:T:1997:77, paragraph 24, and order in Hynix Semiconductor v Council, EU:T:2005:57, paragraph 13 above, paragraph 46).
22 The requests for confidential treatment lodged in the present case must be examined in the light of those principles.
23 At the outset, it is appropriate to determine the redacted items to which the Portuguese Republic’s challenge to the request for confidentiality relates.
24 It must be noted that, within the context of its challenge to the request for confidentiality, the Portuguese Republic points out, first of all, that the representatives of the Member State involved in the present case are legal officers employed in the public administration and that those professional practitioners are all subject to the duty of professional secrecy. Next, the Portuguese Republic observes that the National Authority of Medicinal and Health Products and the Portuguese experts working with the EMA have access to confidential information on medicinal products. In addition, the Portuguese Republic submits that the disclosure of information in the context of legal proceedings is not equivalent to the general disclosure provided for in the decision of the EMA which is the subject of the present case. Finally, the Portuguese Republic invokes the principle of equality of arms in order to justify its right of access to all information relevant to the present proceedings.
25 It must be held that the arguments of the Portuguese Republic seek to challenge in a general manner the confidential nature of the information covered by the applicants’ requests for confidential treatment and cannot be regarded as ‘a sufficiently precise and express challenge’ to the items redacted in the annexes to the application and in the defence (see, to that effect, order of 8 September 2010 in Performing Right Society v Commission, T‑421/08, EU:T:2010:365, paragraph 24). In accordance with the case-law referred to in paragraph 15 above, as regards those items, the President is unable to weigh up the applicant’s legitimate concern to prevent substantial damage to its business interests and the interveners’ equally legitimate concern to have the necessary information for the purpose of being fully able to assert their rights and to state their case before the Court (see, to that effect, order in Deutsche Telekom v Commission, EU:T:2006:163, paragraph 15 above, paragraph 14).
26 In those circumstances, the applicants’ request for confidential treatment must be upheld in so far as it concerns items which have not been disputed expressly and precisely by the interveners. In the present case, since none of the items were disputed expressly and precisely, all of those items must be granted confidential treatment. Those items are:
– the text redacted in Annex A3 to the application;
– the text redacted in Annex A4 to the application;
– the text redacted in Annex A6 to the application;
– the text redacted in Annex A8 to the application;
– the text redacted in paragraph 158 of the defence.
27 In the light of the foregoing, the applicants’ request for confidential treatment should be granted.
On those grounds,
THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
hereby orders:
1. The request for confidential treatment in relation to the Portuguese Republic, the French Republic and the European Confederation of Pharmaceutical Entrepreneurs (Eucope) is granted as regards the following items:
– the text redacted in Annex A3 to the application;
– the text redacted in Annex A4 to the application;
– the text redacted in Annex A6 to the application;
– the text redacted in Annex A8 to the application;
– the text redacted in paragraph 158 of the defence.
2. The Registrar shall communicate the non-confidential version of the Report for the Hearing, if any, to the European Consumer Organisation (BEUC) on the basis of which that intervener will be able to submit its observations during the oral procedure.
3. The costs are reserved.
Luxembourg, 17 July 2014.