ORDER OF THE PRESIDENT OF THE GENERAL COURT
25 April 2013 (*)
(Application for interim measures – Access to documents – Regulation (EC) No 1049/2001 – Documents held by the EMA containing information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market – Decision to grant a third party access to the documents – Application for suspension of operation of a measure – Urgency – Prima facie case –Weighing up of interests)
In Case T‑73/13 R,
InterMune UK Ltd, established in London (United Kingdom),
InterMune, Inc., established in Brisbane, California (United States),
InterMune International AG, established in Muttenz (Switzerland),
represented by I. Dodds-Smith and A. Williams, Solicitors, T. de la Mare QC and F. Campbell, Barrister,
applicants,
v
European Medicines Agency (EMA), represented by T. Jablonski, N. Rampal Olmedo and A. Spina, acting as Agents,
defendant,
APPLICATION, in essence, for suspension of operation of EMA 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 GENERAL COURT
makes the following
Order
Legal context and EMA administrative practice
1 The European Medicines Agency (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 marketing authorisations 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 Esbriet, 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 marketing authorisation (‘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 (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), 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 and non-clinical information, 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 healthcare contacted the EMA, requesting access to clinical study reports concerning two medicinal products. The EMA refused access on the ground 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 and non-clinical information, 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 and non-clinical information, 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 the clinical and non-clinical development of a medicinal product is not per se commercially confidential and accordingly can be disclosed. Non-clinical studies are intended, inter alia, to identify the pharmacological properties and to understand the toxicological profile of the medicinal product, whilst clinical trials are studies that are intended to discover or verify the effects of one or more investigational medicines. Regulation of those trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible.
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 and non-clinical information, on request pursuant to Regulation No 1049/2001.
Background to the dispute, procedure and forms of order sought
12 The applicants, InterMune UK Ltd, InterMune, Inc. and InterMune International AG belong to the pharmaceutical and biotech group InterMune, founded in 1998 in the United States, whose focus is on the research and development of innovations in the field of respiratory and orphan fibrotic diseases. Since February 2011, they have held an MA from the Commission for the medicinal product Esbriet, which contains the active substance Pirfenidone and is authorised for the treatment of idiopathic pulmonary fibrosis (IPF).
13 In August 2012, the pharmaceuticals company Boehringer Ingelheim GmbH, a competitor undertaking of the applicants, requested the EMA to grant it access to documents that the applicants had submitted as part of their MA application for the medicinal product Esbriet. The request concerned the following documents: ‘2.4 Non-clinical Overview; 2.5 Clinical Overview; 2.6 Non-clinical Summary; and 2.7 Clinical Summary’ (‘the disputed documents’). Those documents contain information relating to the trials carried out on human beings and animals to establish the safety and efficacy of the medicinal product Esbriet for the purposes of obtaining an MA.
14 After being informed by the EMA of that request for access, the applicants, by letter of 8 October 2012, set out their objections to disclosure in detail and provided an edited version of the disputed documents, adding that that version could be disclosed to Boehringer Ingelheim. It also identified data which were not yet in the public domain which they considered confidential and liable to be of value to a competitor, explaining why disclosure would harm their commercial interests.
15 Nevertheless, by its decision EMA/24685/2013 of 15 January 2013, the EMA informed the applicants that it was prepared to grant the request for access to the disputed documents in their entirety under Regulation No 1049/2001 (‘the contested decision’).
16 By application lodged at the Registry of the General Court on 11 February 2013, the applicants brought an action for annulment of the contested decision, inasmuch as it envisages disclosure of information which is not yet publicly available. In support of that action they argue, in essence, that the decision to disclose infringes Article 4(2) of Regulation No 1049/2001 and their fundamental right to protection of information covered by business secrets and being of a confidential nature under Article 7 of the Charter of Fundamental Rights of the European Union (OJ 2010 C 83, p. 389) (‘the Charter’).
17 By a separate document, lodged at the Court Registry on the same date, the applicants brought this application for interim measures, in which they claim, in essence, that the President of the General Court should:
– suspend the operation of the contested decision, inasmuch as it envisages disclosure of information which is not yet publicly available, until the General Court has ruled on the main action;
– order the EMA to refrain from disclosing that confidential information, until the General Court has ruled on the main action;
– order the EMA to pay the costs.
18 In its observations on the application for interim measures, lodged at the Court Registry on 5 March 2013, the EMA contended that the President of the General Court should:
– dismiss the application for interim measures;
– order the applicants to pay the costs.
19 By application lodged at the Court Registry on 2 April 2013, the European Confederation of Pharmaceutical Entrepreneurs (Eucope), which represents the interests of over 900 European pharmaceutical and biotech companies, including small- and medium-sized enterprises, applied for leave to intervene in support of the forms of order sought by the applicants.
Law
The subject-matter of the application for interim measures
20 The applicants acknowledge that the disputed documents contain certain clinical and non-clinical information relating to the medicinal product Esbriet which is already publicly available and in respect of which they do not argue that any confidentiality should apply. That is, moreover, the reason why the applicants provided the EMA with a list of the data which they considered to be confidential together with an edited version of the disputed documents which, in their view, could be disclosed to third parties. The EMA does not express a position on the merits of that edited version or the actual confidential nature of the various data relied on by the applicants, but takes the view that the disputed documents must, by virtue of their very nature, be disclosed in their entirety.
21 In those circumstances, the expeditiousness required in interim proceedings and the brevity of the present proceedings preclude the President of the General Court from ascertaining which passages of the disputed documents, which comprise over 1 000 pages, are already publicly available and also from assessing the merits of the list, comprising 11 pages, of individual data which the applicants consider to be confidential. The amount of effort required to conduct a specific individual assessment of the clinical and non-clinical information obscured in the edited version of the disputed documents (‘the information at issue’) would go beyond what is required of a judge hearing an application for interim measures (see, to that effect and by analogy, Case T‑2/03 Verein für Konsumenteninformation v Commission [2003] ECR II‑1121, paragraphs 111 and 112, and the case-law cited). For the purposes of the present interim proceedings, it is therefore necessary to examine whether it is because of its very nature that the information at issue must enjoy temporary protection because it was provided to the EMA as part of an MA application for a medicinal product.
22 Consequently, the examination by the President of the General Court will focus on the nature of the information at issue as a whole, as presented in the applicants’ letter of 8 October 2012.
General remarks
23 In accordance with Articles 278 TFEU and 279 TFEU, read in conjunction with Article 256(1) TFEU, the judge hearing an application for interim measures may, if he considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures.
24 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 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 and that it is urgent in so far as, in order to avoid serious and irreparable harm to the interests of the party applying for the measures, it must be made and produce its effects before a decision is reached in the main action. Where appropriate, the judge hearing such an application must also weigh up the interests involved (see order of the President in Case T‑462/12 R Pilkington Group v Commission [2013] ECR I-0000, paragraph 24, and the case-law cited).
25 In the context of that overall examination, the judge hearing the application enjoys a broad discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order in Pilkington Group v Commission, paragraph 25, and the case-law cited).
26 Having regard to the material in the file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures, without its being necessary first to hear oral argument from the parties.
27 In the circumstances of the present case, it is necessary first to weigh up the interests involved and to assess whether the condition of urgency is satisfied.
Weighing up of interests and urgency
28 In accordance with settled case-law, 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 the interim measures sought outweighs the interest in immediate application of the contested measure by examining, more specifically, whether annulment of that measure by the Court when ruling on the main application would allow the situation which would have been 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 (see order in Pilkington Group v Commission, paragraph 28, and the case-law cited).
29 As regards more particularly the condition that the legal situation created by an interim relief order must be reversible, it must be recalled that the purpose of the procedure for interim relief is merely to guarantee the full effectiveness of the future decision on the main action. Consequently, such a procedure is merely ancillary to the main action to which it is an adjunct, and accordingly the decision made by the judge hearing an application for interim measures is by its nature interim in the sense that it must not either prejudge the future decision on the substance of the case or render it illusory by depriving it of its effectiveness (see order in Pilkington Group v Commission, paragraph 29, and the case-law cited).
30 It necessarily follows that the interest defended by a party to interim relief proceedings does not merit protection where that party’s request is that the judge hearing the application should adopt a decision which, far from being a merely interim measure, serves to prejudge the future decision on the main action and to render it illusory by depriving it of its effectiveness. Moreover, for that very reason an application for interim measures in which the judge hearing the application was asked to order the ‘provisional’ disclosure of allegedly confidential information held by the Commission was declared to be inadmissible inasmuch as an order acceding to such an application might have nullified in advance the effects of the decision to be subsequently delivered on the main action (see order in Pilkington Group v Commission, paragraph 30, and the case-law cited).
31 In the present case, the General Court will be called upon to rule, in the main action, on whether the contested decision – whereby the EMA rejected the applicants’ request that it refrain from granting access under Regulation No 1049/2001 the information at issue – should be annulled, inter alia, because of the disregard for the confidentiality of that information in so far as its disclosure would constitute an infringement of Article 339 TFEU and Article 7 of the Charter. In that regard, it is obvious that, in order to protect the effectiveness of a judgment annulling the contested decision, the applicants must be able to ensure that the EMA will not unlawfully allow access to the information at issue. A judgment ordering annulment would be rendered illusory and would be deprived of its effectiveness if this application for interim measures were to be dismissed, since the consequence of that dismissal would be that the EMA would be free immediately to grant access to that information and therefore de facto to prejudge the future decision in the main action, namely that the action for annulment would be dismissed.
32 Those considerations are not called into question by the fact that even were the information at issue actually to be disclosed, the result would probably not be that the applicants would be deprived of an interest in bringing proceedings for the annulment of the contested decision. That is because, inter alia, any other interpretation would make the admissibility of the action dependent on whether or not the EMA had disclosed that information and would enable it, by the creation of a fait accompli, to avoid scrutiny by the courts by making such disclosure even though it was unlawful. However, notwithstanding that formal continuation of an interest in bringing proceedings for the purposes of the main action, it remains the case that a judgment ordering annulment delivered after disclosure of the information at issue would no longer have any practical effect for the applicants (see order in Pilkington Group v Commission, paragraph 32, and the case-law cited).
33 Consequently, the interest defended by the applicants must prevail over the EMA’s interest in the dismissal of the application for interim measures. Moreover, although it is true that the company requesting disclosure of the information at issue can also rely on a right of access to documents of the Union institutions, bodies, offices and agencies under Article 15(3) TFEU, the fact remains that the exercise of that right would merely be delayed if the interim measures sought by the applicants were granted, which would entail a temporal restriction on the exercise of the right, whilst the corresponding right of the applicants to protection of confidentiality of that information would be reduced to nothing if the application for interim relief were dismissed. The applicants’ interest must thus prevail over that of the party requesting access.
34 Since, following the weighing up of interests, the balance is thus in the applicants’ favour, there is a clear urgency in protecting the interest defended by them, provided that they are likely to suffer serious and irreparable harm in the event of their application for interim measures being dismissed. In that regard, the applicants maintain, in essence, that the situation which would result from disclosure of the information at issue could not be undone.
35 Referring to the order of the President in Case T‑345/12 R Akzo Nobel and Others v Commission, order of 16 November 2012, not yet published in the ECR, the applicants state that, should the information at issue be disclosed before a decision is given on the main action, they risk finding themselves without any effective remedy for the infringement of their fundamental rights, including the right to protection of their professional secrets. The harm which is likely to be caused to the applicants, who manufacture and market only a single medicinal product, by the disclosure of a much broader class of truly current and critical confidential data, is of a different order of magnitude to the data which prompted the grant of interim relief in Akzo Nobel and Others v Commission. The fact that the disclosure is sought by a competitor for what can only be use intended to improve (irreversibly) their competitive position merely strengthens this analysis. If the confidential data is authorised for release into the public domain, any subsequent annulment of the contested decision would be merely an ‘empty shell’.
36 In that regard, it must be stated that if it were to be established, in the main proceedings, that the information at issue is confidential and that its disclosure, as proposed by the EMA, is incompatible with the protection of professional secrecy under Article 339 TFEU, the applicants could rely on that provision, which confers on them a fundamental right, in order to object to that disclosure. As the Court of Justice has recognised in its judgment in Case C‑450/06 Varec [2008] ECR I‑581, paragraphs 47 and 48, referring to the case‑law of the European Court of Human Rights, it may be necessary to prohibit the disclosure of certain information which is classified as confidential in order to protect the fundamental right of an undertaking to respect for its private life, enshrined in Article 7 of the Charter, it being made clear that the concept of ‘private life’ cannot be interpreted in such a way that the commercial activity of a legal person is excluded. Moreover, the Court of Justice added that it had already acknowledged that the protection of business secrets is a general principle and that the undertaking concerned might suffer ‘extremely serious damage’ if there were improper communication of certain information (see, to that effect, Varec, paragraphs 49 and 54).
37 Given that the EMA, if the present application for interim measures were dismissed, could immediately disclose the information at issue, there is a risk that the applicants’ fundamental right to the protection of their professional secrets, enshrined in Article 339 TFEU and Article 7 of the Charter, would irreversibly lose any meaning in relation to that information. At the same time, it is likely that the applicants’ fundamental right to an effective remedy, enshrined in Article 47 of the Charter, would be jeopardised if the EMA were to be allowed to disclose the information at issue before the General Court has adjudicated on the main action. Consequently, since the applicants’ fundamental rights may be seriously and irreparably harmed, subject to an examination of the condition that there should be a prima facie case (see, in respect of the close link between that condition and the condition of urgency, the order of the President of 8 April 2008 in Joined Cases T‑54/08 R, T‑87/08 R, T‑88/08 R and T‑91/08 R to T‑93/08 R Cyprus v Commission, not published in the ECR, paragraphs 56 and 57), it is clearly urgent to grant the interim measures requested.
38 None of the EMA’s arguments to the contrary calls those considerations into question.
39 Thus, firstly, the EMA’s assertion that the grant of the interim measures sought by the applicants confer a ‘confidential’, as opposed to ‘public’, nature on the information at issue, as is the case since December 2010, when its new policy on access to documents became effective, is irrelevant to the examination of the requirement of urgency, since it relates more to the requirement that there be a prima facie case. It will accordingly be examined in that light below.
40 Secondly, in the EMA’s submission, the applicants state simply that the disclosure of the information at issue would confer a competitive advantage on their competitors, including Boehringer Ingelheim, who could take advantage of the money and work invested by the applicants in obtaining the confidential data to develop, test and have authorised their own products competing with Esbriet. Since the damage caused by that alleged loss of competitive advantage is purely financial, the applicants have failed to show why financial compensation for that loss would not be sufficient reparation if the contested decision were to be annulled in the main proceedings. Moreover, since the applicants are not currently suffering any loss, they have failed to establish that the MA for a competing product for the relevant indication is based on the information at issue. Their line of argument on this point is therefore purely hypothetical.
41 In that regard, it must, be stated that, in the area of disclosure of allegedly confidential information, an approach consisting of reducing breach of professional secrecy to purely financial loss is not appropriate inasmuch as it disregards the fundamental rights relied upon by the person seeking interim protection for that information. 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 provides that it is to have the same legal value as the Treaties (first subparagraph of Article 6(1) TEU), 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 (see, to that effect, order in Pilkington Group v Commission, paragraph 53).
42 Consequently, since the condition relating to urgency is met so far as the information at issue is concerned, the Court will consider whether or not there is a prima facie case in that regard.
Whether there is a prima facie case
43 According to settled case-law, the condition relating to a prima facie case 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, in that it reveals the existence of difficult legal issues the solution to which is not immediately obvious and therefore calls for a detailed examination that cannot be carried out by the judge hearing the application for interim measures but must be the subject of the main proceedings, or where the discussion of issues by the parties reveals that there is a major legal disagreement whose resolution is not immediately obvious (see order in Pilkington Group v Commission, paragraph 58, and the case-law cited).
44 With regard more particularly to disputes concerning interim protection for information alleged to be confidential, it should be added that 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 (see paragraphs 29 to 31 above) and the imminent risk of negation of the fundamental rights relied on by the party seeking interim protection of those rights (see paragraphs 36 and 37 above) – may, as a rule, conclude that there is no prima facie case only where the information in question is obviously not confidential (see order in Pilkington Group v Commission, paragraph 59).
45 In the present case, the applicants state that the information at issue is covered by business secrecy and industrial property rights. The EMA failed to make a detailed assessment of the arguments and evidence submitted by the applicants about the confidential nature of the information at issue before adopting the contested decision, Nor did the EMA conduct the slightest weighing up in order to determine whether there was a specific overriding public interest justifying its disclosure. Instead, contrary to its earlier consistent decision-making practice, the EMA applied an inflexible, purely mechanical policy approach of complete disclosure of the disputed documents, on the basis of an alleged automatic priority in favour of the general public interest in transparency.
46 The applicants state that the EMA did not make a proper weighing up as required under Article 4(2) of Regulation No 1049/2001, in order to determine whether there was a public interest in disclosure of the confidential information at issue which took priority over the need to protect their commercial interests against the harm resulting from that disclosure. Although the applicants, in their letter of 8 October 2012 (see paragraph 14 above), focused on the data which had not yet been published which were likely to have a commercial value for a competitor, explaining why disclosure of the information at issue would harm their commercial interests, the EMA failed completely to address those detailed arguments in the contested decision. The contested decision is thus based on an inflexible policy favouring disclosure.
47 The applicants again note the requirements for protecting business secrets resulting, inter alia, from Article 80 of Regulation No 726/2004, under which information on supervision of medicinal products is to be made available to the public, provided that that information is not confidential. In a number of recent judgments, the Court of Justice has insisted on the need to interpret the exceptions provided for in Article 4(2) of Regulation No 1049/2001 in such a manner as to ensure coherence with the interests protected by other European Union legal measures (Case C‑404/10 P Commission v Éditions Odile Jacob [2012] ECR I-0000, paragraphs 110 to 126). Lastly, the request for access to the disputed documents came from a competing undertaking and there is nothing to indicate that any specific public interest justifies disclosure of the information at issue. Consequently, there is no specific public interest liable to prevail, for the purposes of Article 4(2) of Regulation No 1049/2001, over the harm which the applicants would suffer, a fortiori because much of the information about the safety and efficacy of Esbriet is already publicly available.
48 The EMA states by way of reply that, according to the clear wording of the contested decision, the disclosure of the clinical and non-clinical information at issue was based solely on its new policy on access to documents, which became effective and publicly available on 1 December 2010, of which the applicants must have been aware. There is, moreover, no provision in European Union law indicating that the documents submitted by an MA applicant containing clinical and non-clinical information must be deemed to be confidential; nor do the applicants give any specific reason as to why professional secrecy should prevent disclosure of the information at issue, which is not confidential in nature.
49 The EMA does not dispute that some parts of the extensive documentation submitted by MA applicants do contain information which is commercially confidential, including information about the manufacturing of the product and other technical and industrial specifications about the quality processes adopted to manufacture the substance. That information is indeed protected under the applicable rules and policies. However, it is unreasonable to claim that the information at issue, relating to the safety or efficacy of the medicinal products on human health and the environment, should enjoy the same level of protection.
50 It is clear, in the light of the foregoing discussion, that the documents in the case do not support the conclusion that there is clearly no prima facie case.
51 It is common ground that, before the EMA amended its policy on disclosure of clinical and non-clinical information, the EMA itself classified that information as confidential and refused to disclose it to third parties under Regulation No 1049/2001. Moreover, although the EMA has stated that the contested decision is based on its new policy on access to documents, it should be noted that the lawfulness of that policy, which has been in place since 2010, has not yet been ruled on by the European Union courts. Furthermore, the EMA expressly recognises that, in the present case, it is one of the first times since the EMA’s new policy was implemented that an MA holder has requested the suspension of operation of a decision to disclose such information under Regulation No 1049/2001.
52 Consequently, there is no case-law enabling an answer to be given easily to the question on which judgment will 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 applicants’ right to professional secrecy, as guaranteed by Article 339 TFEU and Article 7 of the Charter, on the ground that the information at issue is confidential in nature and must therefore be protected against any disclosure (see paragraph 31 above). This involves a question of principle affecting the functioning of the pharmaceuticals and biotechnology sector in Europe and worldwide. The EMA points out that one of its principal roles consists in generating information for the public on the conduct of the various clinical and non-clinical trials necessary for obtaining an MA. The EMA adds that scientific guidelines on clinical trials, including clinical safety and clinical study reports, are also published following agreement on a harmonised approach between Europe, Japan and the United States of America by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The EMA further states that it provides guidelines for non-clinical trials of medicinal products, intended for pharmacology, pharmacokinetics and toxicology.
53 Such a question of principle cannot be ruled on for the first time by a judge hearing an application for interim measures, but rather requires an in-depth examination in the context of the main proceedings. At that time, the Court, when it adjudicates upon the substance, will have to examine, inter alia, the possible relevance for resolving the dispute in the main proceedings of the case-law relied upon by the applicants in order to justify the confidential treatment to be given to the information at issue, namely Commission v Éditions Odile Jacob.
54 Lastly, even if the information at issue could be considered to be covered by the exception provided for by Article 4(2) of Regulation No 1049/2001, the question whether an overriding public interest might nevertheless justify disclosure will call for a weighing up of the applicants’ commercial interest is not having the information disclosed and the general interest intended to guarantee the broadest public access possible to documents held by the European Union. Such a weighing up of the various interests present will call for delicate assessments which must be a matter for the Court adjudicating on the substance of the case. In any event, it is not obvious from the documents in the file that, following that weighing up of interests, the balance will clearly be in favour of the public interest defended by the EMA.
55 In view of the foregoing considerations, it is clear that the present case raises complex and delicate questions which cannot, prima facie, be considered to be clearly of no relevance, while their resolution calls for thorough examination within the main proceedings. Accordingly, it must be held that there is a prima facie case.
56 Since the EMA emphasises the importance of transparency in the decision-making process in the assessment and supervision of medicinal products in order to ensure efficient pharmacovigilance and observes that, in order to enhance transparency and public confidence in the European regulatory system for medicinal products, as much clinical data as possible must be disseminated in the public domain, the possibility cannot be ruled out that such factors may be taken into consideration in resolving the dispute in the main proceedings. However, the EMA does 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, which would preclude granting the interim relief sought.
57 Lastly, if the EMA fears that a suspension of operation of the contested decision may give rise to an ‘unnecessary conflicting relationship’ between the provisions of Regulation No 1049/2001 and those of Regulation No 726/2004, which would disturb the balance between the public’s right of access to documents of European Union institutions and the protection of confidential information provided as part of an MA application procedure for a medicinal product, suffice it to observe in that regard that it may in any event include in its statement in defence an application for an expedited procedure under Article 76a of the Rules of Procedure, in order to preserve the opportunity to have the main case heard expeditiously.
58 It follows that, since all the requisite conditions are satisfied, the application for interim measures must be upheld, without its being necessary to rule on the application for leave to intervene lodged by Eucope.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The operation of EMA Decision EMA/24685/2013 of 15 January 2013, 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, to the documents ‘2.4 Non-clinical Overview; 2.5 Clinical Overview; 2.6 Non-clinical Summary; and 2.7 Clinical Summary’, submitted as part of an application for authorisation to place the medicinal product Esbriet on the market, is suspended inasmuch as those documents contain information which is not yet publicly available.
2. The EMA is ordered not to disclose the documents referred to in point 1 of the operative part of this order in a version which is more detailed than the edited version of those documents as provided by InterMune UK Ltd, InterMune, Inc., and InterMune International AG to the EMA on 8 October 2012.
3. Costs are reserved.
Luxembourg, 25 April 2013.