ORDER OF THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
28 November 2013 (*)
(Intervention – Interest in the result of the case – Representative associations – Confidentiality)
In Case T‑29/13,
AbbVie, Inc., established in Wilmington, Delaware (United States),
AbbVie Ltd, established in Maidenhead (United Kingdom),
represented initially by G. Berrisch, P. Bogaert, B. Kelly, G. Castle, D. Anderson and D. Scannell, and subsequently by P. Bogaert, lawyer, B. Kelly and G. Castle, Solicitors, D. Anderson QC, and D. Scannell, Barrister,
applicants,
v
European Medicines Agency (EMA), represented by T. Jabłoński, N. Rampal Olmedo and A. Spina, acting as Agents,
defendant,
supported by
Portuguese Republic,
Republic of Slovenia,
Republic of Finland,
Kingdom of Denmark,
The European Consumers’ Organisation (‘BEUC’),
interveners,
APPLICATION for annulment of decision EMA/685471/2012 of 5 November 2012, granting a third party access, under 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), to certain documents containing information submitted in a dossier in respect of an application for a marketing authorisation for the medicinal product Humira, which is intended for the treatment of Crohn’s disease,
THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
makes the following
Order
Facts and procedure
1 On 17 January 2013, the applicants, AbbVie, Inc. and AbbVie Ltd, brought an action, under Article 263 TFEU, for annulment of decision EMA/685471/2012 of 5 November 2012, granting a third party access, under Regulation No 1049/2001, to certain documents containing information submitted in a dossier in respect of an application for a marketing authorisation for the medicinal product Humira, which is intended for the treatment of Crohn’s disease.
2 Pursuant to Article 24(6) of the Rules of Procedure of the General Court, a summary of the application initiating proceedings in Case T‑29/13 was published in the Official Journal of the European Union of 16 March 2013 (OJ 2013 C 79, p. 26).
3 By documents lodged at the Court Registry on 6 May 2013, Pharmaceutical Research and Manufacturers of America (‘PhRMA’) and European Federation of Pharmaceutical Industries and Associations (‘EFPIA’), on the one hand, and EuropaBio and Biotechnology Industry Organisation (‘BIO’), on the other, sought leave to intervene in support of the form of order sought by AbbVie, Inc. and AbbVie Ltd.
4 The abovementioned applications were served on AbbVie, Inc., AbbVie Ltd and on EMA, in accordance with Article 116(1) of the Rules of Procedure.
5 By documents lodged at the Court Registry on 10 June 2013 and 27 June 2013, AbbVie, Inc. and AbbVie Ltd stated that they considered that EFPIA, PhRMA, EuropaBio and BIO had sufficiently demonstrated that they had a direct interest in intervening in the present case. Furthermore, they requested confidential treatment of certain information contained in the application and in the annexes thereto.
6 By documents lodged at the Court Registry on 13 June 2013 and 12 July 2013, EMA stated that it did not dispute EFPIA’s interest in intervening, but that, on the other hand, it objected to the intervention of PhRMA, EuropaBio and BIO.
Law
The applications for leave to intervene
7 Under the second paragraph of Article 40 of the Statute of the Court of Justice, applicable to the procedure before the General Court pursuant to the first paragraph of Article 53 of that statute, any person establishing an interest in the result of a case other than a dispute between Member States, between institutions of the Union or between Member States and institutions of the Union may intervene in that case.
8 It has consistently been held that the concept of an interest in the result of the case, within the meaning of that provision, must be defined in the light of the precise subject-matter of the dispute and be understood as meaning a direct, existing interest in the ruling on the forms of order sought and not as an interest in relation to the pleas in law put forward. The expression ‘result’ is to be understood as meaning the operative part of the final judgment which the parties ask the Court to deliver. It is necessary, in particular, to ascertain whether the intervener is directly affected by the contested decision and whether his interest in the result of the case is established (see order in Case T‑15/02 BASF v Commission [2003] ECR II-213, paragraph 26 and the case-law cited).
9 According to settled case-law, intervention is permissible by representative associations whose object is to protect their members in cases raising questions of principle that are liable to affect those members (orders of the President of the Court of Justice in Joined Cases C‑151/97 P(I) and C‑157/97 P(I) National Power and PowerGen [1997] ECR I‑3491, paragraph 66, and in Case C‑151/98 P Pharos v Commission [1998] ECR I‑5441, paragraph 6; orders of the President of the General Court in Case T‑53/01 R Poste Italiane v Commission [2001] ECR II‑1479, paragraph 51, and in Case T‑201/04 R Microsoft v Commission [2004] ECR II‑2977, paragraph 37). More particularly, an association may be allowed to intervene in a case if (i) it represents an appreciable number of undertakings active in the sector concerned, (ii) its objects include that of protecting its members’ interests, (iii) the case may raise questions of principle affecting the functioning of the sector concerned, and (iv) the interests of its members may therefore be affected to an appreciable extent by the forthcoming judgment (orders in Case T‑87/92 Kruidvat v Commission [1993] ECR II‑1375, paragraph 14, and in Case T‑253/03 Akzo Nobel Chemicals and Akcros Chemicals v Commission [2004] ECR II‑1603, paragraph 21; order of 18 October 2012 in Case T‑245/11 ClientEarth and The International Chemical Secretariat v European Chemicals Agency, not published in the ECR, paragraph 12).
10 The Court of Justice has stated that the adoption of a broad interpretation of the right of associations to intervene is intended to facilitate assessment of the context of such cases whilst avoiding multiple individual interventions which would compromise the effectiveness and proper course of the procedure (National Power and PowerGen, cited in paragraph 9 above, paragraph 66, and ClientEarth and The International Chemical Secretariat, cited in paragraph 9 above, paragraph 13).
11 It is in the light of that case-law that the applications to intervene submitted by EFPIA, PhRMA, EuropaBio and BIO must be examined.
12 In the first place, it must be ascertained whether the applicants for leave to intervene represent an appreciable number of undertakings active in the sector concerned and whether their objects include that of protecting their members’ interests.
13 In the present case, the applicants for leave to intervene are all professional associations which are active in the pharmaceutical sector.
14 First, as regards EFPIA, it is apparent from its application to intervene that it represents 39 large undertakings active in the research, development and manufacturing of medicinal products for human use as well as 33 national pharmaceutical industry associations. It is also apparent that, taking into account the members of those national associations, EFPIA thus represents 1 900 undertakings operating on a global scale.
15 Furthermore, the Statutes of EFPIA state that the purpose of the professional association is to promote pharmaceutical discovery and development.
16 Secondly, as regards PhRMA, it is clear, as is apparent from its website and from a document from 2013 showing the profile of the professional association, that it represents 55 research companies and centres, most of which are active on the European market, and that they constitute a significant portion of global biopharmaceutical research undertakings. It also states that PhRMA and its members carry out innovation, research and development activities on an international scale. It consequently points out that PhRMA and its members are active in the European biopharmaceutical sector and are directly affected by European regulations relating to the sector in which they operate, notwithstanding the fact that PhRMA’s offices are physically located outside the European Union.
17 In that regard, it submits a table indicating the amount of investments made by its members in pharmaceutical research and development. It is apparent from that table that its members are very actively involved in the pharmaceutical sector in the European Union.
18 Furthermore, it is apparent both from PhRMA’s certificate of incorporation and the content of its website that its objective is to protect the interests of its members, in particular, by encouraging public authorities to support the research and development of new medicinal products and by cooperating with professional associations in the health field, other industries and government authorities in the advancement of medical science, the improvement of public health and the advancement of the pharmaceutical industry, both in the United States and throughout the world. In that regard, the certificate of incorporation confers on it the power to carry out all the acts necessary or appropriate to the attainment of the objects and purposes set out therein.
19 Thirdly, as regards EuropaBio and BIO, it is important to point out that EMA does not dispute that they are two representative associations in the health-care and biotechnology sector and that, in general, they have an interest in intervening in proceedings which significantly affect the interests of their members.
20 In that regard, it is apparent from the documents submitted by EuropaBio that it represents more than 50 major undertakings in the research sector – about 30 of which are undertakings in the health-care and biotechnology sector involved in research, development and the manufacturing of biological medicinal products for human use – and 19 national professional associations in Europe. Furthermore, EuropaBio’s statutes state that it promotes the interests of the biotechnology industry in Europe, in the widest sense, in particular those of a scientific, technical, regulatory and institutional nature.
21 As regards BIO, it has submitted an extract from its website containing a list of many undertakings which are active in the medical biotechnology sector, inter alia in the European Union. It is also apparent from BIO’s website and articles of incorporation that it too has the object of promoting the interests of the biotechnology industry.
22 It is apparent from the foregoing that the applicants seeking leave to intervene represent an appreciable number of undertakings active in the sector concerned and that their objects include that of protecting their members’ interests in that sector.
23 In the second place, it is necessary to ascertain whether the interests of the members of the applicants seeking leave to intervene may be affected to an appreciable extent by the forthcoming judgment.
24 The applicants seeking leave to intervene point out that EMA has developed a new approach as far as concerns access to documents submitted in connection with applications for marketing authorisations. EMA now takes the view that the clinical data contained in the documents submitted by pharmaceutical undertakings in connection with such an application should not be regarded as confidential commercial information. Those applicants claim that such a question of principle affects, in Europe and throughout the world, the functioning of the biopharmaceutical sector which invests in research and development and provides comprehensive data to regulatory agencies in order to ensure the quality, reliability and effectiveness of medicinal products.
25 Moreover, the applicants for leave to intervene state that their members will be significantly affected by the judgment of the General Court inasmuch as most of them have submitted dossiers in respect of applications for authorisation to place medicinal products on the market to EMA.
26 In the light of those explanations, it is necessary to accept the arguments of the applicants seeking leave to intervene that they have a direct, existing interest in the granting of the form of order sought by AbbVie, Inc. and AbbVie Ltd to the effect that the contested decision should be annulled.
27 That finding is not called into question by EMA’s arguments.
28 EMA submits, first, that PhRMA has 10 offices in the United States and represents the American pharmaceutical research industry and American biotechnology undertakings. It submits that European Union legislation requires an undertaking which applies for a marketing authorisation for a medicinal product to be established in the territory of the European Union and that, therefore, it is not certain that the answer to the question concerning access to documents in these proceedings will directly affect the interests of American undertakings.
29 However, the question of access to documents in these proceedings concerns interests which go beyond the sole interests of pharmaceutical undertakings established in the territory of the European Union which have applied for a marketing authorisation for a medicinal product. The interest of undertakings located outside the European Union the subsidiaries or parent companies of which are situated in the territory of the European Union may also be directly affected by the answer provided by the Court to the question of principle, namely whether access is to be granted to documents and clinical study reports submitted in connection with an application for a marketing authorisation.
30 Furthermore, as is apparent from paragraph 17 above, the significance of the activities carried out by the American companies, which are members of PhRMA, in the territory of the European Union is borne out by the considerable investments in pharmaceutical research and development which they have made there. They therefore have a direct interest in the question of access by third parties to their clinical study reports.
31 Secondly, it does not avail EMA to rely on the individual conduct of certain members of EuropaBio and BIO in order to call into question the authority of those professional associations to represent the interests of their members effectively and consistently. The fact that certain members have requested access to clinical and non-clinical information similar to that in the case at issue and, therefore, their conduct could be at odds with the position taken by EuropaBio and BIO does not affect the right of the aforementioned associations to intervene in support of the form of order sought by AbbVie, Inc. and Abbvie Ltd. First of all, EuropaBio and BIO do not appear to take a position which is inherently contrary to the interests of the members which they represent. Secondly, professional associations cannot be required to show that all the members they represent adopt a position identical to that taken by those associations. Lastly, those associations do not appear to have taken the decisions to submit an application to intervene in support of the form of order sought by AbbVie, Inc. and AbbVie Ltd in contravention of their articles of association.
32 Thirdly, EMA states that EuropaBio and BIO justify their interest in intervening by the impact of the information disclosure policy on investments in the research and development of new medicinal products. According to EMA, those two associations do not have any manifest interest in intervening since they and their members were fully aware that, as from November 2010, the clinical studies which they had submitted to EMA were not confidential and that those studies had been disclosed in many cases. EMA states in that regard that it has already disclosed almost two million pages of clinical and non-clinical information and maintains that EuropaBio and BIO have not demonstrated the impact of that disclosure on the investments in clinical research made by their members.
33 That line of argument cannot succeed. First of all, EuropaBio and BIO continue to have an existing interest since a significant amount of information has not yet been disclosed. Secondly, EuropaBio and BIO cannot be required to demonstrate, with figures in support, that the policy to disclose clinical and non-clinical information has an actual financial impact on investments in research. Having regard to the importance of the question of principle which constitutes the subject-matter of the present dispute, the possibility of such an impact is more than enough to show that EuropaBio and BIO have a manifest interest in intervening.
34 Fourthly, EMA points out that the applicants seeking leave to intervene also rely on the need to protect patients’ privacy as a ground for their application. It takes the view that, as that issue has not been raised in the main proceedings, no leave to intervene should be granted to discuss it.
35 Those considerations on the part of EMA are, however, irrelevant as they arise from a confusion between the right to a third party to intervene and the inadmissibility of a plea which has been put forward by the intervener, but has not been raised by the applicant.
36 In view of all of the foregoing, the applications seeking leave to intervene in support of the form of order sought by AbbVie, Inc. and AbbVie Ltd must be granted.
37 As the applications to intervene have been submitted in accordance with Article 115 of the Rules of Procedure and the applicants seeking leave to intervene have shown their interest in the result of the case, the applications must be granted, in accordance with the second paragraph of Article 40 of the Statute of the Court of Justice, applicable to the procedure before the General Court pursuant to the first paragraph of Article 53 of that statute. As the communication in the Official Journal of the European Union referred to in Article 24(6) of the Rules of Procedure was published on 16 March 2013, the applications to intervene were submitted within the period prescribed in Article 115(1) of those rules and the rights of the interveners will be those set out in Article 116(2) to (4) of those rules.
The request for confidential treatment
38 AbbVie, Inc. and AbbVie Ltd have requested that, in accordance with Article 116(2) of the Rules of Procedure, certain confidential information in the file should be omitted from the documents communicated to the interveners and have, for the purpose of that communication, provided a non-confidential version of the pleadings and documents in question.
39 At this stage, the communication to the interveners of procedural documents served and, as the case may be, to be served on the parties must therefore be confined to a non-confidential version. A decision on the merits of the request for confidential treatment will, if necessary, be taken at a later stage in the light of any objections or observations which may be submitted in that regard.
On those grounds,
THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
hereby orders:
1. Pharmaceutical Research and Manufacturers of America, European Federation of Pharmaceutical Industries and Associations, EuropaBio and Biotechnology Industry Organisation are granted leave to intervene in Case T‑29/13 in support of the form of order sought by AbbVie, Inc. and AbbVie Ltd.
2. The Registrar shall communicate a non‑confidential version of each of the procedural documents served on the parties to the interveners.
3. A period shall be fixed for the interveners to submit any observations they may have on the request for confidential treatment. A decision on the merits of that request is reserved.
4. A period shall be fixed for the interveners to submit their statements in intervention, without prejudice to the possibility of supplementing them later, should the need arise, further to a decision as to whether the request for confidential treatment is well founded.
5. The costs are reserved.
Luxembourg, 28 November 2013.