ORDER OF THE VICE-PRESIDENT OF THE COURT
28 November 2013 (*)
(Appeal – Order for interim measures – Regulation (EC) No 1049/2001 – Access to documents of the institutions – Documents held by the European Medicines Agency in the context of an application for authorisation to place a medicinal product on the market – Decision to grant a third party access to the documents – Serious and irreparable damage – Evidence)
In Case C‑389/13 P(R),
APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 5 July 2013,
European Medicines Agency (EMA), represented by T. Jabłoński, A. Humphreys, A. Spina and N. Rampal Olmedo, acting as Agents,
appellant,
the other parties to the proceedings being:
AbbVie, Inc., established in Wilmington (United States),
AbbVie Ltd, established in Maidenhead (United Kingdom),
represented by P. Bogaert, advocaat, and by D. Anderson QC, and D. Scannell, Barrister, instructed by B. Kelly and G. Castle, Solicitors,
applicants at first instance,
THE VICE-PRESIDENT OF THE COURT,
having heard the First Advocate General, P. Cruz Villalón,
makes the following
Order
1 By its appeal, the European Medicines Agency (EMA) seeks to have set aside the order of the President of the General Court of 25 April 2013 in Case T‑44/13 R AbbVie v EMA (‘the order under appeal’), whereby the President of the General Court suspended the operation of EMA decision EMA/748792/2012 of 14 January 2013 (‘the contested decision’) granting 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 (OJ 2001 L 145, p. 43), to Clinical Study Reports M02‑404, M04-691 and M05-769 (‘the clinical study reports’) submitted by AbbVie, Inc. and AbbVie Ltd (together, ‘the AbbVie companies’) as part of an application for authorisation to place the medicinal product Humira, used to treat Crohn’s Disease, on the market (‘the MA’), and ordered the EMA not to disclose those reports.
Legal context and EMA administrative practice
2 The legal context and EMA administrative practice were summarised as follows in paragraphs 1 to 12 of the order under appeal:
‘1 [The EMA], established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), has as its main responsibility the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. To that end, the EMA is responsible for the scientific evaluation of applications for European Union [MAs] for human and veterinary medicines (centralised procedure). Under the first subparagraph of Article 57(1) of Regulation No 726/2004, the EMA is to provide the Member States and the institutions of the European Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it.
2 Under Regulation No 726/2004, certain categories of medicinal products, including medicinal products resulting from biotechnology such as Humira, which is the subject-matter of the present proceedings, must be approved under the centralised procedure pursuant to that regulation. That procedure entails the submission, by the pharmaceutical company concerned, of an application for [an MA], which is examined by the EMA, and a decision by the European Commission on the MA. The information which an MA applicant is to provide to the EMA must include a quality dossier (particulars on product composition and description of the manufacturing processes), non-clinical data (physico-chemical, biological or microbiological and results of animal tests) and results of clinical trials (actual tests and data assessing the use of the product in humans), in support of the intended therapeutic use of the product. Once the MA has been granted, the details thereof may be amended; amendments may range from mere administrative changes to more significant amendments, such as adding a new therapeutic indication.
3 The first paragraph of Article 73 of Regulation No 726/2004 states that [Regulation No 1049/2001], a regulation which is aimed at guaranteeing the broadest public access possible to documents held by the European Union administrative bodies, is applicable to documents held by the EMA.
4 Article 4(2) of Regulation No 1049/2001 provides that the institutions are to refuse access to a document where disclosure would undermine, inter alia, the protection of commercial interests of a natural or legal person, including intellectual property, unless there is an overriding public interest in disclosure of the document in question. As regards third-party documents, Article 4(4) of Regulation No 1049/2001 provides that the institution is to consult the third party with a view to assessing whether an exception in paragraph 2 is applicable, unless it is clear that the document must or must not be disclosed. Pursuant to Article 4(6) of Regulation No 1049/2001, if only parts of the requested document are covered by any of those exceptions, the remaining parts of the document are to be released.
5 Under the first paragraph of Article 80 of Regulation No 726/2004, the EMA is to adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature. Thus, on 19 December 2006, the EMA adopted rules implementing Regulation No 1049/2001 on access to its documents. Article 4 of those rules provides that EMA documents are to be classified in one of the following three categories: public, restricted or confidential.
6 Under a policy governing access to its documents which the EMA applied consistently until 2007, public access to documents contained in the dossier submitted by a company for the purposes of an MA, including clinical study reports, was generally refused on the ground that such data fell under the exceptions contained in the aforementioned implementing rules, and more particularly Article 3(2)(a), which, mirroring the provisions of the first subparagraph of Article 4(2) of Regulation (EC) No 1049/2001, refers to the protection of commercial interests of a natural or legal person, including intellectual property.
7 In 2007, a research and information centre in the field of health care contacted the EMA, requesting access to clinical study reports concerning two medicinal products. The EMA refused access on the grounds that it would undermine the commercial interests of the producers of those medicinal products. The research and information centre then filed a complaint with the European Ombudsman who, following an investigation into the relevant reports, concluded that they did not contain information on the composition of the medicinal products or other commercially confidential information. In its view, their disclosure would consequently not undermine the sector’s commercial interests. In its draft recommendation, the Ombudsman therefore called on the EMA to disclose the documents.
8 In its reply of 31 August 2010, the EMA stated that it had decided to grant access to those reports and committed itself to taking appropriate measures in order to implement the Ombudsman’s draft recommendation. In line with the Ombudsman’s recommendations, on 30 November 2010 the EMA adopted a new policy on access to its documents. In the press release accompanying the adoption of this policy, the EMA stated that documents submitted to it as part of an MA application, such as clinical trial reports, could henceforth be disclosed, provided that the decision-making process for the application in question was finalised. The policy on access to EMA documents became effective on 1 December 2010.
9 Under its new policy, the EMA drew up an output table for the various documents in its possession. More specifically, MA dossiers or updates and amendments to those dossiers, including clinical trial reports, are considered to be public, that is to say, they may be disclosed once, inter alia, the Commission’s MA decision is available for the medicinal product concerned. In March 2012 the output table was complemented by guidelines from the EMA and heads of national medicines agencies regarding the types of information included in an MA application that can be publicly released after the final decision on the application. The objective is to enable a consistent approach to be adopted in order to provide guidance on the identification of commercially confidential information which must be protected after an MA has been granted.
10 According to the guidelines, the following are considered commercially confidential information: detailed information concerning the quality and manufacturing of the medicinal products; information concerning the development of the product, including detailed information on the synthesis and manufacturing of the active substance; formulation, test procedures, validation, as well as manufacturers and suppliers of the active substance and excipients; and detailed descriptions of the manufacturing and control processes for the finished product. By contrast, information encompassing clinical and non-clinical development of a medicinal product is not per se commercially confidential. Accordingly, as a rule the data included in clinical trial reports is regarded as data that can be disclosed.
11 Consequently, since its new policy on access to documents has been in place, the EMA has been releasing documents submitted as part of MA applications, including clinical study reports, on request pursuant to Regulation No 1049/2001.
12 Some clinical study reports have also been published by the EMA, inasmuch as assessment reports of its Committee for Medicinal Products for Human Use (CHMP) reproduce information contained in clinical study reports submitted by MA applicants. Those assessment reports are published after deletion of any information of a commercially confidential nature, as is the European Public Assessment Report (EPAR), giving a summary of the product’s characteristics that is understandable to the public (Article 13(3) and point (b) of the second subparagraph of Article 57(1) of Regulation No 726/2004).’
Background to the dispute and procedure before the President of the General Court
3 The background to the dispute was set out as follows in paragraphs 14 to 23 of the order under appeal:
‘14 By correspondence of 28 March 2002, [the AbbVie companies] had filed an MA application in respect of the medicinal product Humira, containing the active substance Adalimumab. By decision of 1 September 2003, the Commission granted the MA sought.
15 In 2006, [the AbbVie companies] submitted [the clinical study reports] to the EMA as part of an application for extension of the therapeutic use of Humira for the treatment of Crohn’s Disease. The documents concerning those two clinical studies cover the safety and efficacy of Humira in the treatment of Crohn’s Disease. The extension of the indication was authorised by the Commission on 4 June 2007.
16 Clinical study report M05-769 was submitted to the EMA by [the AbbVie companies] in 2009 as part of a variation procedure directed at updating the summary of the product characteristics and removing a recommendation of use of the medicinal product. That report demonstrated the safety risks associated with the concomitant use of Humira with corticosteroid drugs. By decision of 1 July 2010, the Commission updated the summary of the product characteristics for Humira.
17 In August and September 2012, the EMA notified [the AbbVie companies], pursuant to Article 4(4) of Regulation No 1049/2001, that it had received a request from the pharmaceuticals company UCB Pharma under Regulation No 1049/2001 for access to the documents filed by [the AbbVie companies] as part of their MA application for Humira.
18 On 26 September 2012, [the AbbVie companies] informed the EMA that they opposed disclosure of the documents requested, relying, firstly, on the exception provided for in Article 4(2) of Regulation No 1049/2001 and, secondly, on there being no overriding public interest requiring disclosure. They reiterated on a number of occasions their refusal to disclose the documents due to their confidential nature.
19 By decision of 5 November 2012, the EMA granted the request for access to the documents, on the grounds, inter alia, that it was under no legal obligation to consider all of the information submitted in connection with an MA application as confidential information and that clinical information concerning the safety and efficacy of a medicinal product authorised for treatment in human beings need not be considered commercially confidential. However, UCB Pharma withdrew its request for access on 8 November 2012, which did not prevent [the AbbVie companies] from bringing an action on 17 January 2013 to have the decision of 5 November 2012, registered under number T‑29/13, annulled.
20 On 13 November 2012, a university science student submitted a request to the EMA for access to [the clinical study reports], in connection with the preparation of a Master’s (MSc) thesis.
21 On 19 November 2012, [the AbbVie companies] reiterated their refusal to consent to disclosure of the documents referred to in the student’s request, stating that the three clinical study reports were covered by the exception in Article 4(2) of Regulation No 1049/2001 and reiterating the concerns expressed in relation to the previous request for access to similar documents concerning Humira.
22 By the contested decision, the EMA granted the request for access filed by the student, referring to the grounds stated in the decision of 5 November 2012, to the effect that clinical study reports on medicinal products could not be regarded as confidential information. The contested decision was notified to [the AbbVie companies] on 16 January 2013.
23 By correspondence of 23 January 2013, the EMA notified [the AbbVie companies] that the documents covered by the contested decision would not be disclosed if an application for interim measures was lodged within 10 days.’
4 By application lodged at the Registry of the General Court on 29 January 2013, the AbbVie companies brought an action for annulment of the contested decision. In support of that action they argue, in essence, that the contested decision infringes Article 4(2) of Regulation No 1049/2001 and their fundamental right to protection of confidential information under Article 7 of the Charter of Fundamental Rights of the European Union (‘the Charter’), Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’), and Article 339 TFEU.
5 By a separate document, lodged at the Registry of the General Court on the same date, the AbbVie companies made an application for interim measures, whereby they claimed, in essence, that the President of the General Court should:
– suspend the operation of the contested decision until the General Court has ruled on the main action;
– order the EMA to refrain from disclosing the clinical study reports; and
– order the EMA to pay the costs.
6 In its observations on the application for interim measures, lodged at the Registry of the General Court on 22 February 2013, the EMA contended that the President of the General Court should:
– dismiss the application for interim measures; and
– order the AbbVie companies to pay the costs.
The order under appeal
7 In paragraphs 28 to 33 of the order under appeal, the President of the General Court, having noted that there is a dispute between the parties as regards the question whether certain parts of the clinical study reports are already accessible to the public, with the result that those reports could no longer be considered confidential in their entirety, observed that, if those reports did enjoy a general presumption of confidentiality, the question of partial disclosure of the public components of those reports under Article 4(6) of Regulation No 1049/2001 would not arise, since a document covered by such a presumption falls outside the scope of the obligation to disclose its contents, in whole or in part. He added that the case before him did not involve the issue of the possible confidentiality of only a few bits of specific and isolated information, but rather concerned the possible confidentiality of three reports comprising over 850 pages in total and that neither arguments by the parties about the accuracy of a non-confidential version of those reports nor an assessment of those arguments by the judge hearing the application for interim measures would be compatible with the expeditiousness required in interim proceedings and the summary nature of the proceedings.
8 The President of the General Court, referring to his order of 11 March 2013 in Case T‑462/12 R Pilkington Group v Commission (ECR II‑0000, paragraphs 24 and 25), observed, in paragraphs 34 to 38 of the order under appeal, that the grant of interim measures is subject to two cumulative conditions relating, first, to the urgent nature of their grant, in so far as it is necessary, in order to avoid serious and irreparable harm to the interests of the party applying for the measures, that those measures be ordered and take effect before a decision is reached in the main action, and, secondly, to the finding that the grant of those interim measures is justified, prima facie, in fact and in law (fumus boni juris). Moreover, the President of the General Court indicated, that, where appropriate, the judge hearing an application for interim measures must also weigh up the interests involved. He pointed out that the judge hearing such an application enjoys a broad discretion and is free to determine the manner in which those various conditions are to be examined and, considering that he had all the information needed to rule on the application without its being necessary to hear oral argument from the parties, he decided first to examine together the questions relating to the weighing up of interests and to urgency.
9 In paragraphs 39 and 40 of the order under appeal, the President of the General Court, referring to paragraphs 28 and 29 of the order in Pilkington Group v Commission, noted that the weighing up of the various interests involved requires the judge hearing the application for interim measures to determine whether or not the applicant’s interest in obtaining those measures outweighs the interest in immediate application of the contested measure by examining, in particular, whether annulment of that measure by the court ruling on the main application would allow the situation which would be brought about by its immediate operation to be reversed, and, conversely, whether suspension of its operation would prevent it from being fully effective in the event of the main application being dismissed. The President of the General Court added that the decision made by the judge hearing an application for interim measures is, by its nature, interim in the sense that it must not prejudge the future decision on the substance of the case, nor render it illusory by depriving it of its effectiveness.
10 The President of the General Court continued by pointing out, in paragraphs 42 and 43 of the order under appeal, that in order to protect the effectiveness of a judgment annulling the contested decision, the AbbVie companies had to be able to ensure that the EMA would not allow access to the clinical study reports, because such a judgment and, accordingly, its enforcement, would be deprived of effectiveness if the application for interim measures were to be dismissed, since the consequence of that dismissal would be that the EMA would be free to grant immediate access to the clinical study reports, notwithstanding the fact that even the actual disclosure of those reports would probably not deprive the AbbVie companies of an interest in bringing proceedings for the annulment of the contested decision.
11 Consequently, in paragraph 44 of the order under appeal, the President of the General Court, weighing up the interests involved, considered that the interest defended by the AbbVie companies prevailed over the EMA’s interest in the dismissal of the application for interim measures, a fortiori as the grant of the interim measures requested amounted to no more than maintaining, for a limited period, the status quo which had existed since the disputed reports were submitted to the EMA in August 2006 and in December 2009. The fact that the party requesting disclosure of those reports had a right of access to documents under Article 15(3) TFEU did not call that conclusion into question, since the exercise of that right would merely be delayed if the interim measures were granted, whilst the competing right of the AbbVie companies to protection of the confidentiality of those reports would be reduced to nothing if the application for interim relief were dismissed.
12 In paragraph 45 of that order, the President of the General Court found that since the balance of interests involved was in the AbbVie companies’ favour, there was a clear urgency, from that perspective, in protecting the interest defended by them, but that it remained to be determined whether those parties were likely to suffer serious and irreparable harm in the event of their application for interim measures being dismissed. In that regard, the AbbVie companies maintained that the situation that would result from disclosure of the clinical study reports would be irremediable.
13 The President of the General Court noted, in paragraph 46 of the order under appeal, that, according to the AbbVie companies, disclosure of the clinical study reports before the end of the main proceedings would deprive them of their right to an effective remedy, enshrined in Article 6 of the ECHR and Article 47 of the Charter. Such a disclosure would also infringe their fundamental rights under Article 339 TFEU, Article 8 of the ECHR and Article 7 of the Charter. An infringement of those fundamental rights would constitute serious and irreparable damage, a fortiori because disclosure of a document under Regulation No 1049/2001 has erga omnes effect, preventing the relevant institution from objecting to dissemination of that document to other parties requesting access and allowing anyone to have access to it, as the General Court held in paragraph 116 of its judgment of 21 October 2010 in Case T‑439/08 Agapiou Joséphidès v Commission and EACEA (not published in the ECR). Consequently, even if access to the disputed reports were granted only to one student, the confidential information could be disclosed to anybody, including current or potential competitors of the AbbVie companies.
14 In paragraphs 47 and 48 of that order, the President of the General Court held that the condition relating to urgency was, in principle, satisfied. He found that disclosure of the clinical study reports would irreparably infringe the AbbVie companies’ right to the protection of their business secrets under Article 339 TFEU, Article 8 of the ECHR and Article 7 of the Charter. Moreover, the AbbVie companies’ fundamental right to an effective remedy, enshrined in Article 6 of the ECHR and Article 47 of the Charter, was likely to be jeopardised if the EMA were to be authorised to disclose the clinical study reports before the General Court adjudicates on the main action.
15 In paragraph 49 et seq. of the order under appeal, the President of the General Court rejected the EMA’s arguments to the contrary. In that respect, he found, in paragraph 50 of that order, that the EMA’s assertion that the grant of the interim measures sought by the AbbVee companies would confer a ‘confidential’, as opposed to a ‘public’, nature on the clinical study reports, was irrelevant to the examination of the requirement of urgency, since it related rather to the requirement that there be a prima facie case. He also found, in paragraphs 51 to 52 of that order, that the EMA’s arguments concerning the purely financial nature of the damage could not succeed, since, in the area of disclosure of allegedly confidential information, an approach that reduces the breach of professional secrecy to a purely financial loss is not appropriate inasmuch as it disregards the fundamental rights relied upon. Referring to paragraph 53 of the order in Pilkington Group v Commission, the President of the General Court stated in that regard that, at least since the entry into force – on 1 December 2009 – of the Treaty of Lisbon, which raised the Charter to the level of primary European Union law and which, under the first subparagraph of Article 6(1) TEU, provides that it is to have the same legal value as the Treaties, an imminent risk of a serious and irreparable breach of the fundamental rights conferred by Articles 7 and 47 of the Charter in that field has had to be regarded, in itself, as harm justifying the grant of the interim protection requested.
16 In paragraph 54 et seq. of the order under appeal, the President of the General Court examined the condition that there be a prima facie case. Having noted, in paragraph 54, that the condition in question is satisfied where at least one of the pleas in law put forward by the applicant for interim measures in support of the main action appears, prima facie, to be relevant and in any event not unfounded, he observed, in paragraph 55 of that order that, in the specific context of interim protection for information alleged to be confidential, the judge hearing the application for interim measures – if he is not to disregard the intrinsically ancillary and provisional nature of proceedings for interim measures and the imminent risk of negation of the fundamental rights relied on by the party seeking interim protection of those rights – may, as a rule, conclude that there is no prima facie case only where the information in question is obviously not confidential.
17 It was on the basis of those considerations that the President of the General Court examined, in paragraph 56 et seq. of the order under appeal, the first plea in law raised by the AbbVie companies in support of their main action, whereby they claim that the EMA infringed Article 4(2) of Regulation No 1049/2001, inasmuch as it did not act in conformity with the Court’s case-law on access to documents in the context of a regulated administrative procedure, according to which Article 4(2) should be applied in the light of the procedural rules governing the administrative procedure under which the documents were provided, and a third party may not rely on Regulation No 1049/2001 to obtain more extensive access to the documents than that provided for under the applicable specific procedural rules. It can be seen from paragraph 58 of the order under appeal that the AbbVie companies claimed, consequently, that a general presumption of confidentiality applies to the documents provided to the EMA by an MA applicant and continues even after the close of the administrative procedure. According to the AbbVie companies, Regulation No 1049/2001 does not prevail over the approval procedure for an MA under Regulation No 726/2004.
18 It is apparent from paragraphs 59 to 61 of the order under appeal that, according to the AbbVie companies, clinical study reports, such as those at issue in the present case, contain proprietary information and specialist technical know-how of the company which produces them. Regarding more specifically the clinical study reports relating to the medicinal product Humira, the AbbVie companies submitted that disclosure would undermine the protection of their commercial interests, given, inter alia, the erga omnes effect of disclosure of a document under Regulation No 1049/2001. In particular, those clinical study reports describe the manner in which the AbbVie companies planned and implemented the clinical trials necessary in order to obtain the MA for that medicinal product for the indication of Crohn’s disease and therefore provide a very specific road map for a company wishing to develop a medicinal product in the very competitive field of tumour necrosis factor (TNF) antagonists. Furthermore, it would be possible to obtain approvals for competing products in countries outside the European Union on the basis of clinical study reports and detailed clinical overviews of the medicinal product Humira.
19 In paragraphs 62 and 63 of the order under appeal, the President of the General Court noted that, according to the EMA, the disclosure of the clinical study reports was based solely on its new policy on access to documents, which became effective on 1 December 2010. The EMA submitted, moreover, that there is no provision in European Union law indicating that the documents submitted by an MA applicant containing information on the results of a clinical trial must be deemed to be confidential. The EMA did not dispute that some parts of the extensive documentation submitted by MA applicants do contain information which is commercially confidential, but submitted that it is unreasonable to claim that clinical study reports, which contain information relating to the safety or efficacy of the medicinal products on human health and the environment, should enjoy the same level of protection.
20 It was on the basis of those considerations, set out in paragraphs 56 to 63 of the order under appeal, that the President of the General Court held, in paragraphs 64 to 67 of that order, that the documents in the case did not support the conclusion that there was clearly no prima facie case. He observed that there was no case-law enabling an answer to be given easily to the question on which judgment would have to be delivered subsequently on the substance, that is to say, whether the contested decision, based on the EMA’s new disclosure policy, infringes the AbbVie companies’ right to professional secrecy, as guaranteed by Article 339 TFEU, Article 8 of the ECHR and Article 7 of the Charter, on the ground that the disputed reports are confidential in nature and must therefore be protected against any disclosure. The President of the General Court concluded that such a question of principle could not be ruled on for the first time by a judge hearing an application for interim measures, but rather required an in-depth examination in the context of the main proceedings. The President of the General Court added, in paragraph 68 of the order under appeal, that the AbbVie companies’ argument concerning the content, value and characteristics of the three disputed reports, which comprise over 850 pages, raised complex questions which deserved to be resolved through a thorough examination, which could not be done by the judge hearing the application for interim measures.
21 The President of the General Court also held, in paragraph 69 of the order under appeal, that, in any event, it was for the court adjudicating on the substance of the case to decide whether an overriding public interest justifies disclosure of the clinical study reports, by weighing the AbbVee companies’ commercial interest in not having those reports disclosed against the general interest guaranteeing the broadest public access possible to documents held by the European Union. Lastly, the President of the General Court observed, in paragraph 71 of the order under appeal, that inasmuch as the EMA emphasised the importance of transparency in the decision-making process in the assessment and supervision of medicinal products in order to ensure efficient pharmacovigilance, it did not set out the reasons why the question of principle which is the subject-matter of the main proceedings should receive a particularly expeditious answer. In that respect, the President of the General Court added that it was open to the EMA to include in its statement of defence an application for an expedited procedure under Article 76a of the Rules of Procedure of the General Court.
22 It is on the basis of all of those considerations that the President of the General Court decided to grant the interim measures sought by the AbbVie companies, without ruling on the various applications for leave to intervene that had been lodged. Paragraphs 1 and 2 of the operative part of the order under appeal are worded as follows:
‘1. The operation of [the contested decision] is suspended.
2. The EMA is ordered not to disclose the [clinical study reports].’
Procedure before the Court of Justice and forms of order sought
23 The EMA claims that the Court should:
– set aside the order under appeal; and
– order the AbbVie companies to pay all the costs of the proceedings, including those incurred before the General Court.
24 The AbbVie companies contend that the appeal should be dismissed and the EMA ordered to pay the costs.
25 On 14 October 2013, the parties presented oral argument and replied to questions put to them by the Court at a joint hearing with Case C‑390/13 P(R) EMA v InterMune UK and Others, pending before the Court.
The appeal
26 In support of its appeal, the EMA relies on three grounds, alleging respectively:
– incorrect interpretation of the case-law leading to a manifestly erroneous definition of the subject-matter of the case;
– an error of law in the assessment of the weighing up of the interests and the urgency condition; and
– a failure to state reasons and a manifestly incorrect assessment of the condition that there be a prima facie case.
27 It is appropriate to begin by examining the second ground relied on by the EMA in support of its appeal, relating to the weighing up of interests and to urgency. By that ground of appeal, which is composed of two parts, the EMA claims, in particular, that the President of the General Court erred in his application of the case-law, thereby vitiating the order under appeal by an error of law, in so far as he found, first, that the balance of interests was in favour of the AbbVie companies and that the condition relating to urgency was met and, secondly, that the interests claimed by the AbbVie companies were protected by the fundamental right to private life under Article 8 of the ECHR and Article 7 of the Charter.
28 More specifically, it is appropriate to examine, in the first place, the first branch of the second ground relied on by the EMA in support of its appeal, in so far as it is based on an error of law allegedly made by the President of the General Court in finding that the condition relating to urgency was met in the present case.
Arguments of the parties
29 The EMA claims, in essence, that in the order under appeal, in assessing whether the condition relating to urgency was satisfied, the President of the General Court erred in law in his assessment inasmuch as, in particular, he failed to examine whether the AbbVie companies had demonstrated that the harm resulting from the alleged potential loss of a competitive and commercial advantage could not be sufficiently compensated in the context of an action for damages. It submits that, contrary to settled case-law, the President of the General Court did not take into account the fact that the harm resulting from the loss of an advantage would, in any event, be of a purely financial nature.
30 At the hearing, the EMA added, in reply to questions put to it by the Court, that the order under appeal is vitiated by the same error of law as the order of the President of the General Court in Pilkington Group v Commission, for the reasons set forth in the order of the Vice-President of the Court of 10 September 2013 in Case C‑278/13 P(R) Commission v Pilkington Group ([2013] ECR I‑0000). It submitted, at that hearing, that the AbbVie companies can establish a risk of damage affecting them only if they can prove that the disclosure of the three clinical study reports is liable to provide a commercial advantage to their competitors, and they have not demonstrated that this is the case. In any event, even if such damage were established, it would not be irreparable since it would be pecuniary damage, which could be remedied in the context of an action for damages. Such damage, resulting from the disclosure of scientific evidence to third parties, is not comparable to that which was at issue in the Commission v Pilkington Group case, which arose from the publication on the Internet of specific commercial information, in particular to the extent that, in contrast to that at issue in abovementioned case, the damage invoked in the present case may be identified and quantified.
31 At the hearing, the AbbVie companies acknowledged that, in the light of the order in Commission v Pilkington Group, the existence of a risk of serious and irreparable harm cannot be regarded as arising from the mere alleged infringement of certain fundamental rights such as the right to property or the right to protection of confidential information. They submitted, however, that although the damage that they are liable to suffer is, inter alia, of a financial nature, in practice it is impossible to assess it, given the many ways in which the clinical study reports could be used by an indeterminate number of competing undertakings throughout the world, before an indeterminate number of regulatory authorities.
32 The AbbVie companies indicate that the financial damage that they are liable to suffer – arising from the future use of the information contained in the clinical study reports by their competitors in order to develop a medicinal product which would compete with the medicinal product Humira – cannot be identified and quantified, within the meaning of paragraph 54 of the order in Commission v Pilkington Group, essentially for five reasons. First, even if those reports were disclosed to only one person, they would become ‘public’, since the decision to disclose a document has erga omnes effect; secondly, the person having access to the disclosed document would not be bound by specific confidentiality obligations imposed by the EMA; thirdly, the AbbVie companies would not have any way of identifying all of the persons who had obtained a copy of the clinical study reports following their disclosure; fourthly, the EMA does not inform MA holders, such as the AbbVie companies, when it receives a request for access concerning the contents of their file; and, fifthly, the AbbVie companies would have no effective means of knowing whether their competitors had actually used the clinical study reports in order to obtain approval for a medicinal product which would compete with the medicinal product Humira, in particular in the case of an approval sought outside the European Union.
Findings of the Court
33 It must be pointed out, first of all, that, in accordance with Article 278 TFEU, actions brought before the Court of Justice of the European Union are not to have suspensory effect, but the Court may, if it considers that circumstances so require, order that application of the contested act be suspended or, in accordance with Article 279 TFEU, adopt other necessary interim measures. Thus, the grant of interim measures represents an exception to the general rule that the acts adopted by the European Union institutions enjoy a presumption of legality and are, in principle, enforceable.
34 Article 104(2) of the Rules of Procedure of the General Court provides that applications for interim measures must state ‘the subject-matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measures applied for’. Thus, the judge hearing an application for interim relief may order the suspension of operation of an act, or other interim measures, if it is established that such an order is justified, prima facie, in fact and in law (fumus boni juris) and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that an application for interim measures must be dismissed if either of them is absent (order in Commission v Pilkington, paragraph 35 and the case-law cited). Where appropriate, the judge hearing such an application must also weigh up the interests involved (order of the President in Case C‑445/00 R Austria v Council [2001] ECR I‑1461, paragraph 73).
35 In that respect, it must be noted that the purpose of interlocutory proceedings is to guarantee the full effectiveness of the final future decision in order to ensure that there is no lacuna in the legal protection provided by the Court of Justice. To attain that objective, urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief (see, to that effect, order of the President of 14 December 2001 in Case C‑404/01 P(R) Commission v Euroalliages and Others, ECR I‑10367, paragraphs 61 and 62). It is for that party to prove that it cannot wait for the outcome of the main proceedings without suffering damage of that nature (see order of the President of 12 October 2000 in Case C‑278/00 R Greece v Commission ECR I‑8787, paragraph 14).
36 Although in order to establish the existence of serious and irreparable damage it is not necessary for the occurrence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage is foreseeable with a sufficient degree of probability, the party seeking an interim measure is nevertheless required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (order of the President of 14 December 1999 in Case C‑335/99 P(R) HFB and Others v Commission ECR I‑8705, paragraph 67).
37 It must be pointed out that, in the present case, the damage invoked by the AbbVie companies is that which would arise from the disclosure to an individual of three clinical study reports which contain allegedly confidential information capable of being used by competitors of those companies, which could thus produce and obtain marketing approval for their own medicinal products. In particular, those reports are said to describe the manner in which the AbbVie companies planned and implemented the clinical trials necessary in order to obtain the MA for the medicinal product Humira for the indication of Crohn’s disease.
38 In order to assess whether there was a risk of serious and irreparable damage, and without prejudice to the examination of the condition that there be a prima facie case, which is linked to but distinct from that assessment, the President of the General Court necessarily had to start from the premiss that the allegedly confidential information was indeed confidential, as claimed by the AbbVie companies, both in the main action and in the proceedings for interim relief.
39 In that respect, it must be pointed out that, in paragraphs 47 and 48 of the order under appeal, the President of the General Court inferred the existence of a risk of serious and irreparable damage from the fact that the AbbVie companies’ fundamental right to the protection of their business secrets, as well as their fundamental right to an effective remedy, were liable to be seriously and irreparably breached by the immediate disclosure of their allegedly confidential information. It is apparent from paragraphs 51 and 52 of that order that the President of the General Court held that, in the area of disclosure of allegedly confidential information, an approach that reduces the breach of professional secrecy to a purely financial loss is not appropriate inasmuch as it disregards the fundamental rights relied upon by the person seeking interim protection for that information. In support of that line of reasoning, the President of the General Court referred, inter alia, to the entry into force of the Treaty of Lisbon and the resulting enhanced protection of the rights enshrined in the Charter.
40 However, according to the settled case-law of the Court of Justice, the argument that harm is, by definition, irreparable because it falls within the scope of fundamental freedoms cannot be accepted, since it is not sufficient to allege infringement of fundamental rights in the abstract for the purpose of establishing that the harm which could result would necessarily be irreparable (see, to that effect, the order of the President in Case C‑43/98 P(R) Camar v Commission and Council [1998] ECR I‑1815, paragraphs 46 and 47). That case-law is not called into question by the enhanced protection of fundamental rights brought about by the Treaty of Lisbon, since those rights, in particular the rights invoked in the present case, already enjoyed protection under European Union law before the entry into force of that treaty (order in Commission v Pilkington Group, paragraph 40).
41 It is true that the infringement of certain fundamental rights, such as the prohibition of torture and inhuman or degrading treatment or punishment, enshrined in Article 4 of the Charter, is liable, because of the very nature of the right infringed, to give rise by itself to serious and irreparable harm. Nevertheless, in accordance with the case-law referred to in paragraphs 35 and 36 of the present order, it is still for the party seeking an interim measure to set forth and establish the likelihood of such harm occurring in its particular case.
42 That is the case, in particular, where one undertaking seeks the adoption of interim measures in order to prevent the disclosure of information allegedly covered by the obligation of professional secrecy. The extent to which the disclosure of such information causes serious and irreparable harm depends on a combination of circumstances, such as, inter alia, the professional and commercial importance of the information for the undertaking which provides it and the utility of that information for other undertakings which are liable to examine and use it subsequently.
43 It follows from all of the foregoing considerations that the President of the General Court erred in law in finding, in particular in paragraphs 47 and 48 of the order under appeal, that the alleged infringement of the AbbVie companies’ fundamental right to the protection of their business secrets, enshrined in Article 339 TFEU, in Article 8 of the ECHR, and in Article 7 of the Charter, and of their right to an effective remedy, enshrined in Article 6 of the ECRH and Article 47 of the Charter, was sufficient in itself to establish the risk of serious and irreparable harm in the circumstances of the present case.
44 As regards the inferences that should be drawn from that error of law, it must be noted that, according to the AbbVie companies, the harm that they are liable to suffer is serious and irreparable because the disclosure of a document, under Regulation No 1049/2001, acquires erga omnes effect. Moreover, those companies claim that the harm they would suffer would indeed include a financial component, but that that component would be impossible to identify and quantify, given the many ways in which the clinical study reports could be used by a number of competing businesses and before an indeterminate number of regulatory authorities. In that regard, the AbbVie companies stated during the hearing the specific reasons why the financial harm they would suffer could not be identified and quantified in the present case. It is necessary to examine whether those arguments, relating to financial harm which would allegedly arise from the use, for commercial purposes, of the three clinical study reports by competitors of the AbbVie companies, may justify a substitution of grounds, as in Commission v Pilkington Group.
45 As regards the irreparable nature of that harm, it is undisputed that if the General Court were to annul the contested decision in the main action, it would not eliminate the harm already suffered and thereby bring about a restitutio in integrum. Indeed, if the disclosure of the clinical study reports is not prohibited until the decision in the main action has been delivered, the harm arising from the potential use of those reports by competitors of the AbbVie companies during the course of the main proceedings could no longer be reversed.
46 However, damage of a pecuniary nature cannot, otherwise than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he suffered the damage. Any such damage could be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 TFEU and 340 TFEU (order in Commission v Pilkington Group, paragraph 50 and the case-law cited).
47 Nevertheless, it must be pointed out that harm of a financial nature may be considered to be serious and irreparable if the harm, even when it occurs, cannot be quantified (order of the Vice-President of the Court of 7 March 2013 in Case C‑551/12 P(R) EDF v Commission ECR I‑0000, paragraph 60 and the case-law cited).
48 It is true that the uncertainty of obtaining compensation for pecuniary damage if an action for damages is brought cannot in itself be regarded as a factor capable of establishing that such damage is irreparable within the meaning of the case-law of the Court of Justice. At the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage if an action for damages is brought following annulment of the contested measure is necessarily uncertain. Interlocutory proceedings are not intended to act as a substitute for an action for damages in order to remove that uncertainty, since their purpose is only to guarantee the full effectiveness of the final future decision that will be made in the main action (in this case an action for annulment), to which the interlocutory proceedings are an adjunct (order of the President of 14 December 2011 in Case C‑446/10 P(R) Alcoa Trasformazioni v Commission, paragraphs 55 to 57).
49 However, the situation is different where it is already clear, when the assessment is carried out by the judge hearing the application for interim measures, that, in view of its nature and the manner in which it will foreseeably occur, the harm alleged, should it occur, may not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good that harm by bringing an action for damages (order in Commission v Pilkington Group, paragraph 54).
50 In that respect, it must be noted that the risk of the financial harm alleged by the AbbVie companies in the present case, concerning the use of the three clinical study reports for commercial purposes by competitors of those companies following the disclosure of those reports, is not comparable, in principle, particularly as regards its nature and the manner in which it will foreseeably occur, to the risk arising in the case which gave rise to the order in Commission v Pilkington Group from the publication on the internet of specific and purportedly confidential commercial information relating to matters such as the identity of customers, the number of parts supplied, price calculations and price changes. The financial harm invoked in the present case would allegedly arise from the future use by third parties of the information contained in the three clinical study reports.
51 As noted in paragraph 36 of the present order, although it is not necessary for the occurrence of the damage to be demonstrated with absolute certainty, it must be foreseeable with a sufficient degree of probability and, moreover, the party seeking an interim measure is required to prove the facts forming the basis of its claim that serious and irreparable damage is likely.
52 However, in the present case, it cannot be excluded, in the light of the foregoing considerations, so far as concerns information contained in the three clinical study reports, considered individually or as a whole, the disclosure of which, according to the AbbVie companies, is liable to cause them serious and irreparable harm, that they will be able to establish the existence of such a risk with regard to some of that information, while ultimately being unable to do so with regard to the potential disclosure of other information contained in those reports.
53 In that respect, and contrary to the President of the General Court’s conclusion in paragraph 32 of the order under appeal, the expeditiousness required in interim proceedings was not in itself such as to preclude the judge hearing the application for interim measures from examining one by one in the present case, the arguments and evidence put forward at first instance by the AbbVie companies and intended to prove the necessity of maintaining the confidentiality of certain information or of certain documents in order to prevent serious and irreparable harm to those companies. Moreover, it is clear from the case-law, of both the Court of Justice and the General Court, that the judge hearing an application for interim relief may, where he considers it appropriate, adopt temporary solutions, in particular by granting an application seeking the suspension in part of the operation of an act (see, to that effect, orders of the President in Case 71/74 R and BR Nederlandse Vereniging voor de Fruit- en Groentenimporthandel and Nederlandse Bond van Grossiers in Zuidvruchten en ander Geimporteerd Fruit v Commission [1974] ECR 1031, paragraphs 5 to 8, and in Joined Cases 43/82 R and 63/82 R VBVB and VBBB v Commission [1982] ECR 1241, paragraphs 9 to 12, and the order of the President of the General Court in Joined Cases T‑24/92 R and T‑28/92 R Langnese-Iglo and Schöller Lebensmittel v Commission [1992] ECR II‑1839, paragraphs 30 to 35 and points 1 and 2 of the operative part).
54 In the event that the AbbVie companies produce such proof with regard to certain information or certain documents, the principle of effective legal protection, enshrined in Article 47 of the Charter, requires that the interim measure sought be granted to them, in respect of that information or those documents only.
55 It should be pointed out in that respect that, in the part of their application for interim relief before the General Court concerning the condition that there be a prima facie case, and more particularly, by reference to the third part of their first plea in law in support of their application for annulment, the AbbVie companies noted that, in their letters of 26 September and 12 October 2012 and by a reference to those letters in an e-mail of 19 November 2012, those companies had proposed the redaction of certain information set out in the ‘Humira Crohn documents’. It was therefore for the President of the General Court to examine, in the light of those proposals, whether it was possible to authorise partial access to the three clinical study reports, without that authorisation’s creating a sufficiently probable risk of serious and irreparable damage to the AbbVie companies.
56 In those circumstances, the order under appeal must be set aside and, since the state of the proceedings does not permit final judgment to be given, it must be referred back to the General Court for judgment, in accordance with Article 61 of the Statute of the Court of Justice of the European Union.
On those grounds, the Vice-President of the Court hereby orders:
1. The order of the President of the General Court of the European Union of 25 April 2013 in Case T‑44/13 R AbbVie v EMA is set aside.
2. The case is referred back to the General Court of the European Union.
3. The costs are reserved.
[Signatures]