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‑44/13 R,
AbbVie, Inc., established in Wilmington, Delaware (United States),
AbbVie Ltd, established in Maidenhead (United Kingdom),
represented by P. Bogaert and G. Berrisch, lawyers, B. Kelly and G. Castle, Solicitors, D. Anderson QC and D. Scannell, 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/748792/2012 of 14 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 Humira, used to treat Crohn’s Disease, 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),
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 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 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 1 or 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 healthcare 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, procedure and forms of order sought
13 The present interim proceedings concern EMA Decision EMA/748792/2012 of 14 January 2013 granting a third party access under Regulation No 1049/2001 to three clinical study reports: M02-404, M04-691 and M05-769, submitted by Abbott Laboratories Ltd – the legal predecessor of the applicants, AbbVie, Inc. and AbbVie Ltd – as part of its MA application for the medicinal product Humira, used to treat Crohn’s Disease (‘the contested decision’). Until January 2013 the applicants were part of the Abbott group, which was subsequently split into two groups of companies, the AbbVie group and the Abbott Laboratories group. In the following the term ‘applicants’ will be used to refer to both applicant companies and to Abbott Laboratories.
14 By correspondence of 28 March 2002, the applicants 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 applicants submitted clinical study reports M02-404 and M04-691 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 applicants 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 applicants, 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 applicants as part of their MA application for Humira.
18 On 26 September 2012, the applicants 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 applicants 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 abovementioned clinical study reports M02-404, M04-691 and M05-769, in connection with the preparation of a master’s (MSc) thesis.
21 On 19 November 2012, the applicants 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 applicants on 16 January 2013.
23 By correspondence of 23 January 2013, the EMA notified the applicants that the documents covered by the contested decision would not be disclosed if an application for interim measures was lodged within 10 days.
24 By application lodged at the Registry of the General Court on 29 January 2013, the applicants brought an action for annulment of the contested decision. 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 confidential information under Article 7 of the Charter of Fundamental Rights of the European Union (OJ 2010 C 83, p. 389) (‘the Charter’), Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’) and Article 339 TFEU.
25 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 until the General Court has ruled on the main action;
– order the EMA to refrain from disclosing clinical study reports M02-404, M04-691 and M05-769 relating to the medicinal product Humira;
– order the EMA to pay the costs.
26 In its observations on the application for interim measures, lodged at the Court Registry on 22 February 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.
27 By documents lodged at the Court Registry on 22 February and 12 March 2013, the BMJ Publishing Group Ltd and the European Ombudsman sought leave to intervene in these proceedings for interim relief in support of the form of order sought by the EMA whilst, by documents lodged at the Court Registry on 4 March 2013, the Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America sought leave to intervene in support of the forms of order sought by the applicants.
Law
The subject-matter of the application for interim measures
28 The applicants submit that clinical study reports M02-404, M04-691 and M05-769 must be protected in their entirety against any disclosure under Regulation No 1049/2001, as those documents are by their very nature confidential. Referring inter alia to Case C‑404/10 P Commission v Éditions Odile Jacob [2012] ECR I‑0000, paragraph 123, they take the view that there is a general presumption that the disputed reports are covered by the exception provided for in Article 4(2) of Regulation No 1049/2001.
29 Observing that a summary of any clinical study report must be made public under Article 57 of Regulation No 726/2004 (see paragraph 12 above), the EMA states by way of reply that the applicants have failed to explain which specific information in the three disputed reports was strictly confidential and could therefore be protected because it was not yet publicly available. In particular, the applicants did not contest the publication, in the EPAR for Humira, information which they now claim is confidential.
30 As this discussion raises the question whether certain parts of clinical study reports M02-404, M04-691 and M05-769 are already accessible to the public, with the result that those reports can no longer be considered confidential in their entirety, it is true that information loses its confidential nature once it enters the public domain. It is also true that the case-file in the present case contains a 4‑page ‘EPAR summary’ relating to the medicinal product ‘Humira – Adalimumab’, followed by a ‘summary of product characteristics’ of approximately 160 pages (Annex B.5 to the EMA’s observations). Furthermore, the EMA has referred to numerous publications, accessible via its webpage, relating to various areas in which Humira is used.
31 However, if the applicants’ argument that the disputed reports enjoy a general presumption of confidentiality should be successful, then the question of partial disclosure of the public components of those reports under Article 4(6) of Regulation No 1049/2001 does 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 (Commission v Éditions Odile Jacob, paragraph 133). In other words, the confidential nature of those reports per se is not affected by the mere fact that they include one or more non-confidential components. Consequently, the applicants cannot be required to draw up a non-confidential version of the disputed reports containing only information which is already publicly available solely for the purposes of the present proceedings.
32 Furthermore, the present case does not involve the issue of possible confidentiality of only a few bits of specific and isolated information, but rather concerns possible confidentiality of three reports (attached as Annex A.6 to the application for interim measures) comprising over 850 pages in total. Arguments by the parties about the accuracy of a non-confidential version of those reports and an assessment of those arguments by the judge hearing the application for interim measures would not be compatible with the expeditiousness required in interim proceedings and the summary nature of the present proceedings. Lastly, the interests of transparency advocated by the EMA would not be unduly compromised if the temporary protection sought for those reports were to extend to information which is already publicly available, since that information would in any event remain in the public domain and could be used by any interested party.
33 Consequently, the examination by the President of the General Court will focus on the nature of clinical study reports M02-404, M04-691 and M05-769 as a whole.
General remarks
34 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.
35 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).
36 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).
37 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 it being necessary first to hear oral argument from the parties.
38 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
39 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).
40 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).
41 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).
42 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 to clinical study reports M02-404, M04-691 and M05-769 – should be annulled, inter alia, because of the disregard for the confidentiality of the reports in so far as their disclosure would constitute an infringement of Article 339 TFEU, Article 7 of the Charter and Article 8 of the ECHR. 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 disputed reports. 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 the reports and therefore de facto to prejudge the future decision in the main action, namely that the action for annulment would be dismissed.
43 Those considerations are not called into question by the fact that even were the disputed reports 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 those reports 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 reports 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).
44 Consequently, the interest defended by the applicants must prevail over the EMA’s interest in the dismissal of the application for interim measures, a fortiori where the grant of the interim measures requested amounts to no more than maintaining, for a limited period, the status quo which has existed since the disputed reports were submitted to the EMA in August 2006 and in December 2009. Finally, although it is true that the party requesting disclosure of the disputed reports can 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 those reports 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.
45 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 disputed reports could not be undone.
46 The applicants state that disclosure of the disputed 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 (see, to that effect, Case T‑439/08 Agapiou Joséphidès v Commission and EACEA, judgment of 21 October 2010, not published in the ECR, paragraph 116). 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.
47 In that regard, it must be stated that if it were to be established, in the main proceedings, that the reports in question are confidential and that their 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 8 of the ECHR and 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).
48 Given that the EMA, if this application for interim measures were dismissed, could immediately disclose the disputed reports, there is a risk that the applicants’ fundamental right to the protection of their professional secrets, enshrined in Article 339 TFEU, Article 8 of the ECHR and Article 7 of the Charter, would irreversibly lose any meaning in relation to those reports. At the same time, it is likely that the applicants’ fundamental right to an effective remedy, enshrined in Article 6 of the ECHR and Article 47 of the Charter, would be jeopardised if the EMA were to be allowed to disclose the reports 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.
49 None of the EMA’s arguments to the contrary calls those considerations into question.
50 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 clinical study reports 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.
51 Secondly, in the EMA’s submission, the applicants state simply that their competitors may use the disputed reports to improve their competitive position with products (actually or potentially) competing with Humira in the highly competitive class of tumor necrosis factor (TFN) antagonists. 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 disputed reports. Their line of argument on this point is therefore purely hypothetical.
52 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 (and by the corresponding provisions of the ECHR) 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).
53 Consequently, since the condition relating to urgency is met so far as the disputed reports 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
54 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).
55 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 40 to 42 above) and the imminent risk of negation of the fundamental rights relied on by the party seeking interim protection of those rights (see paragraphs 47 and 48 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).
56 In the present case, in their first plea the applicants submit, inter alia, that the contested decision infringes Article 4(2) of Regulation No 1049/2001 inasmuch as it runs counter to the case-law on access to documents in the context of a regulated administrative procedure (Case C‑139/07 P Commission v Technische Glaswerke Ilmenau [2010] ECR I‑5885; Case C‑477/10 P Commission v Agrofert Holding [2012] ECR I-0000; and Commission v Éditions Odile Jacob). According to that case-law, 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. If the EMA had followed that case-law, it would have found that there was a general presumption that the disputed reports are covered by the exception provided for by Article 4(2).
57 In the applicants’ submission, in Commission v Technische Glaswerke Ilmenau, (paragraphs 56 and 57), concerning a request from a State aid recipient to consult the file, the Court of Justice held that there was a general presumption that the documents in the administrative file were confidential because, under the rules governing State aid, aid recipients do not have a right to consult the administrative file. In Commission v Éditions Odile Jacob (paragraph 123) et Commission v Agrofert Holding (paragraph 64), the Court of Justice applied the same principle to a request for access to documents which had been provided as part of a procedure under Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (OJ 2004 L 24, p. 1). The Court held that generalised access, on the basis of Regulation No 1049/2001, to the documents exchanged in the context of such a procedure by the undertakings concerned would jeopardise the balance which the Union legislature wished to ensure between, on the one hand, the obligation on undertakings to communicate possibly sensitive commercial information and, on the other, the guarantee of protection attaching to professional and business secrecy for the information so provided.
58 The applicants further submit that that general presumption of confidentiality, which continues even after the close of the administrative procedure (Commission v Agrofert Holding, paragraph 66, and Commission v Éditions Odile Jacob, paragraph 124), applies in the same manner to confidential documents provided to the EMA by an MA applicant. Regulation No 1049/2001 does not prevail over the approval procedure for an MA under Regulation No 726/2004. That procedure is a bilateral procedure between the MA applicant and the EMA, and third parties do not have a right of access to the file (Case T‑326/99 Fern Olivieri and EMEA v Commission [2003] ECR II‑6053, paragraph 94). Moreover, Regulation No 726/2004 strikes a balance between, on the one hand, the protection of the very detailed information necessary for the MA for a medicinal product and, on the other, transparency of the information needed by the public and health professionals for safe and effective use of the product. That balance would be disturbed if the commercially sensitive documents contained in the file submitted by an MA applicant were to be disclosed, as those documents are covered by professional secrecy.
59 As regards the clinical study reports, the applicants state that they represent the proprietary information and specialist technical know-how of the originator company. A clinical study report, which commonly comprises hundreds of pages, contains the full intellectual analysis and states why a certain clinical trial design was chosen, how the inclusion and exclusion criteria were arrived at and why a particular statistical approach was chosen. The applicants infer therefrom that those reports contain a substantial amount of commercially confidential information and know-how which is the result of the relevant company’s significant investment, unique expertise and decades of experience. The reports reflect inter alia the company’s scientific judgment in developing a strategy for demonstrating the safety and efficacy of the medicinal product; in designing and implementing clinical trials; in selecting the types of data sets and in distilling the key data; and in evaluating the findings that are key to obtaining an MA.
60 Regarding more specifically the clinical study reports relating to Humira, the applicants submit that disclosure would undermine the protection of their commercial interests. Given the erga omnes effect of disclosure of a document under Regulation No 1049/2001 (see paragraph 46 above), the applicants’ competitors could use the disputed reports to improve their competitive position with (actually or potentially) competing products in the highly competitive class of TFN antagonists. The clinical study reports relating to Humira describe the manner in which the applicants planned and implemented the clinical trials necessary for obtaining the MA for the medicinal product for the indication of Crohn’s Disease. Those reports therefore provide a very specific road map for a company wishing to develop a TNF antagonist for the therapeutic use in question, by enabling it to develop a similar ‘biologics/biosimilar’ strategy in order to produce a follow-on medicinal product or to add new therapeutic indications to an existing medicinal product. The reports also provide information about some of the hurdles the applicants had to overcome, which could reduce the development process for a medicinal product by two to three years.
61 The applicants add that, in gaining access to the clinical studies on the use of Humira in certain patient populations, such as Crohn’s Disease patients, a competitor who already has some clinical data available for another TNF antagonist in that patient population can compare the details of the clinical results with the two products and on that basis seek to demonstrate a high similarity. This may in turn allow a variation for an indication of the second product for that therapeutic use to be approved without the complete set of data that would normally be expected by the EMA. Furthermore, it is possible to obtain approvals for competing products in countries outside the EU on the basis of clinical study reports and detailed clinical overviews of Humira. Those approvals are based on the international reputation of the EMA and can as such harm the applicants because they result in additional competition with Humira.
62 The EMA states by way of reply that, according to the clear wording of the contested decision, the disclosure of the clinical study reports in question was based solely on its new policy on access to documents, which became effective on 1 December 2010, whereas the applicants’ entire line of argument is based on the situation predating the 2007 decision of the European Ombudsman and its own decision to follow the Ombudsman’s recommendations and grant access to the clinical study reports under Regulation No 1049/2001 (see paragraphs 7 to 9 above). There is, moreover, 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; nor do the applicants give any specific reason as to why professional secrecy should prevent disclosure of the clinical study reports in question, which are not confidential in nature. Nor do the applicants take into account the more than 1.5 million pages released to date on clinical information about authorised medicinal products.
63 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 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.
64 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.
65 It is common ground that, before the EMA amended its policy on disclosure of clinical study reports, the EMA itself classified those reports as confidential and refused to disclose them 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 the first time since its new policy was implemented that an MA holder has requested the suspension of operation of a decision to disclose such reports under Regulation No 1049/2001.
66 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, 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 (see paragraph 42 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 it has released over 1.5 million pages of information on clinical trials since its new policy on access to documents became effective and 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.
67 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 general presumption of confidentiality attaching to the clinical study reports: Fern Olivieri and EMEA v Commission; Commission v Technische Glaswerke Ilmenau; Agapiou Joséphidès v Commission and EACEA; Commission v Agrofert Holding; and Commission v Éditions Odile Jacob.
68 Moreover, the applicants’ argument concerning the content, value and characteristics of the three disputed reports (see paragraphs 59 to 61 above), which comprise over 850 pages, does not appear prima facie to be entirely unfounded in terms of the allegedly confidential nature of those documents. In any event, that line of argument raises complex questions which deserve to be resolved through a thorough examination. This cannot be done by the judge hearing the application for interim measures, but rather must be examined in the context of the main proceedings.
69 Lastly, even if the disputed reports 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 reports 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.
70 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.
71 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. In that regard, 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.
72 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 applications for leave to intervene lodged by the BMJ Publishing Group, the Federation of Pharmaceutical Industries and Associations, the Pharmaceutical Research and Manufacturers of America and the European Ombudsman.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The operation of EMA Decision EMA/748792/2012 of 14 January 2013 of the European Medicines Agency (EMA), granting a third party access to Clinical Study Reports M02-404, M04-691 and M05-769, submitted as part of an application for authorisation to place the medicinal product Humira, used to treat Crohn’s Disease, 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, is suspended.
2. The EMA is ordered not to disclose the documents referred to in point 1 of the operative part of this order.
3. Costs are reserved.
Luxembourg, 25 April 2013.