Provisional text

ORDER OF THE VICE-PRESIDENT OF THE COURT

1 March 2017 ( )

(Appeal — Order for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Directive 2001/82/EC — Regulation (EC) No 726/2004 — Documents held by the European Medicines Agency (EMA) submitted in connection with an application for marketing authorisation for a veterinary medicinal product — Decision to grant a third party access to the documents — Suspension of operation of that decision — Prima facie case — Urgency — Balancing of interests)

In Case C‑512/16 P(R),

APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 29 September 2016,

European Medicines Agency (EMA), represented by S. Marino, A. Spina, T. Jabłoński, A. Rusanov and N. Rampal Olmedo, acting as Agents,

appellant,

the other parties to the proceedings being:

MSD Animal Health Innovation GmbH, established in Schwabenheim (Germany),

Intervet international BV, established in Boxmeer (Netherlands),

represented by J. Stratford QC, C. Thomas, Barrister, P. Bogaert, advocaat, and by B. Kelly and H. Billson, Solicitors,

applicants at first instance,

THE VICE-PRESIDENT OF THE COURT OF JUSTICE,

after hearing the Advocate General, M. Wathelet,

makes the following

Order

1 By its appeal, the European Medicines Agency (EMA) seeks to have set aside the order of the President of the General Court of the European Union of 20 July 2016, MSD Animal Health Innovation and Intervet International v EMA (T‑729/15 R, not published, ‘the order under appeal’, EU:T:2016:435), by which it ordered the suspension of the operation of Decision EMA/785809/2015 of the EMA of 25 November 2015 granting to a third party, 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), access to certain documents submitted in connection with an application for marketing authorisation for the veterinary medicinal product Bravecto (‘the decision at issue’).

Background to the dispute and the order under appeal

2 Article 5 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ 2001 L 311, p.1), as amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ 2009 L 188, p.14) (‘Directive 2001/82’), provides that no veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation (‘MA’) has been granted by the competent authorities of that Member State in accordance with that directive or by the European Commission pursuant to the centralised procedure laid down in 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), as amended by Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 (OJ 2012 L 316, p. 38) (‘Regulation No 726/2004’).

3 The latter procedure entails the submission, by the pharmaceutical company concerned, of an MA application, upon which an opinion is given by the EMA, then a decision by the European Commission.

4 In accordance with the combined provisions of Article 31 of Regulation No 726/2004 and Article 12 of Directive 2001/82, that application must contain, in particular, a quality dossier including particulars on product composition and a description of the manufacturing processes, and the results of non-clinical tests, safety tests — including toxicological tests —, residue tests and clinical and preclinical trials in support of the intended therapeutic use of the medicinal product.

5 Under Article 38(3) of Regulation No 726/2004, the EMA, after examining the MA application, is to publish the European Public Assessment Report on the medicinal product for veterinary use (‘the EPAR’), containing a summary of the product’s characteristics that is understandable to the public, and the reasons for its opinion, after deletion of any information of a commercially confidential nature.

6 The first paragraph of Article 73 of Regulation No 726/2004 states that Regulation No 1049/2001 applies to documents held by the EMA. Article 80 of Regulation No 726/2004 provides, moreover, that 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. Therefore, in December 2006, the EMA adopted rules for the implementation of Regulation No 1049/2001.

7 In November 2010, the EMA amended its policy on access to its documents in order to enhance the transparency of its operations. That new policy provided, in particular, that documents submitted to the EMA in connection with an MA application may be disclosed from the time when the decision-making process regarding the application was finalised.

8 Intervet international BV (‘Intervet’) holds an MA, issued by the Commission on 11 February 2014, for Bravecto chewable tablets, a veterinary medicinal product used to treat tick and flea infestations in dogs. In its application for an MA, Intervet submitted to the EMA, in the form of detailed non-clinical study reports, five toxicology studies sponsored by MSD Animal Health Innovation GmbH (‘MSD’), which is part of the same group of companies as Intervet.

9 In August 2015, the EMA informed MSD that it had received a request from a pharmaceutical company seeking access to those five toxicology study reports on the basis of Regulation No 1049/2001. Since it intended to disclose three of those reports (‘the reports at issue’), the EMA invited MSD to provide it with any proposed redactions in those documents. In response, while taking the view that each of the reports at issue was legally protected in its entirety by a general presumption of confidentiality, MSD redacted the passages which it considered to be confidential. The EMA informed MSD that it accepted some of the proposed redactions, but rejected the vast majority of them on the ground that MSD had failed to show that disclosure of those reports would undermine its economic interests, competitive position or decision-making process and there was therefore a general presumption in favour of such disclosure.

10 Consequently, on 25 November 2015, the EMA, by the decision at issue, granted the third party applicant access to the reports at issue in their entirety, removing only certain passages relating, inter alia, to details on the concentration range of the active substances, details on the internal reference standard used for analytical tests and references to future development plans of MSD and Intervet.

11 By application lodged at the Registry of the General Court on 17 December 2015, MSD and Intervet brought an action for annulment of that decision.

12 By separate document, lodged at the Registry of the General Court on the same day, MSD and Intervet also lodged an application for interim measures in which they claimed, in essence, that the President of the General Court should suspend the operation of the decision at issue and order the EMA to abstain from any form of disclosure of the reports at issue.

13 The EMA claimed that the President of the General Court should reject that application.

14 By the order under appeal, the President of the General Court ordered that the operation of the decision at issue be suspended and the EMA not to disclose those reports.

15 The President of the General Court considered, in the first place, that it was not obvious that the reports at issue, taken as a whole, were not confidential and that it was therefore necessary to find that there was a prima facie case as regards the plea alleging confidentiality and infringement of Article 339 TFEU, Article 7 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and of the first indent of Article 4(2) of Regulation No 1049/2001. In the second place, the President found that the balance of the interests in the case weighed in favour of granting the interim measures sought, since the public interest in transparency raised by the EMA would be sufficiently satisfied, pending a ruling on the substance, by publication of the summary of the characteristics of Bravecto, the user information leaflet and the EPAR. In the third place, the President of the General Court held, having regard to the harm that disclosure of the reports at issue would cause MSD and Intervet, that the condition relating to urgency was also met.

Procedure before the Court of Justice and forms of order sought

16 By its appeal, the EMA claims, in essence that the Court should:

– set aside the order under appeal;

– dismiss the application for interim measures seeking the suspension of the operation of the decision at issue; and

– order MSD and Intervet to pay the costs, including those relating to the proceedings before the General Court.

17 MSD and Intervet contend that the Court should dismiss the appeal and order the EMA to pay the costs.

The appeal

18 The EMA raises two grounds of appeal. The first alleges several manifest errors in the assessment of the facts and the second alleges errors of law in the assessment of whether there was a prima facie case, of urgency and of the condition requiring a balance of interests.

The first ground of appeal

Arguments of the parties

19 Even though the appeal application is very difficult to read, it can be inferred that the EMA raises, in essence, three arguments in support of its first ground of appeal.

20 In the first place, it submits that paragraphs 51 and 52 of the order under appeal suggest, wrongly, that, in 2010, it implemented an arbitrary change to its policy on access to documents and that the legality of its current policy is doubtful.

21 In the second place, the EMA submits that paragraph 57 of that order did not reflect the arguments put forward by the EMA before the President of the General Court. Contrary to what is stated in that paragraph, the EMA did not accept that disclosure of the reports at issue would enable the competitors of MSD and Intervet to benchmark their own toxicology programmes and study results. In fact, it simply observed that such benchmarking, if it were accepted, would not procure any significant competitive advantage for those competitors since they would not be able to use that benchmarking to accelerate the regulatory approval process for their medicinal product or their clinical trials.

22 In the third place, the EMA submits that the reports at issue, which are reports on toxicology studies, contain information provided by MSD and Intervet in order to show the safety and efficacy of Bravecto according to predefined scientific standards. First, a substantial part of that information is already publicly available on the EMA’s website and in specialist journals. Second, the strategy followed by MSD and Intervet in completing the tests undertaken was not innovative. That strategy merely followed the guidelines published in that regard by the EMA itself and by other international bodies and was based on analytical expertise that is widely available within the scientific community.

23 The EMA adds, in that regard, that it agreed to remove references to the future development plans of MSD and Intervet from the reports at issue. The other information contained in those reports did not relate to the manufacture of Bravecto, did not provide any new information on the long‑term development strategy of those companies and did not concern the commercial aspects of the development of that medicinal product on the market. Thus, the EMA submits, the reports did not contain commercially confidential information.

24 In those circumstances, the EMA considers, in essence, that the President of the General Court was wrong, first, in paragraphs 60 and 98 of the order under appeal, to have apparently accepted that the reports at issue were confidential and to have found that the information contained in those reports, taken as a whole, added scientific value to data which is, in itself, publicly available, was an intangible asset that may be used for competitive purposes and concerned the manufacturing and commercial activity of MSD and Intervet. Second, the EMA submits that the finding in paragraph 111 of that order that disclosure of that information would be liable to compromise the completion of the future development plans for other indications of Bravecto is also incorrect.

25 MSD and Intervet contest the EMA’s arguments.

26 As a preliminary point, they submit, in essence, that a large part of those arguments repeat those made before the President of the General Court and that they seek to call into question the latter’s assessment of the facts.

27 As to the substance, regarding, in the first place, the EMA’s argument relating to the legality of its current policy on access to documents, MSD and Intervet observe that the President of the General Court did not criticise that policy in paragraphs 51 and 52 of the order under appeal.

28 In the second place, MSD and Intervet contend that, contrary to what the EMA alleges, it is clear from the documents before the General Court that the EMA had in fact accepted that the information contained in the reports at issue could be used by the competitors of those two companies in order to benchmark their own toxicology programmes and study results.

29 In the third place, MSD and Intervet maintain, in essence, that, contrary to what the EMA submits, the reports at issue contain much more detail than the information that is available in the public domain. Thus, the information, both public and non-public, contained in those reports forms an indivisible whole that has its own economic value, which is different from that attaching to each item of information taken individually. Indeed, that information, considered as a whole, would reveal in detail the strategy followed by MSD and Intervet in the choice of studies carried out and the statistical approach adopted by those companies in order to prepare reports meeting the EMA’s requirements for an MA to be issued. That strategy and that approach are innovative because they are not known in the industry and do not reflect the EMA guidelines or those of other international bodies. That strategy could be used by competitor undertakings in order to prepare their own toxicology studies, in particular with a view to ensuring that they have considered all the relevant scientific hypotheses, which would enable them, ultimately, to accelerate the development of products that compete with Bravecto in a highly competitive market. Furthermore, the combination, in those reports, of confidential and non-confidential information is, in itself, an innovative strategy. Therefore, the President of the General Court was fully entitled to find, in paragraph 111 of the order under appeal, that disclosure of the reports at issue would risk compromising future development plans for other indications of that medicinal product.

Findings of the Court

30 In order to rule on the first ground of appeal, it is necessary, in the first place, to observe that the EMA’s argument that the President of the General Court suggested, wrongly, that the legality of the new policy on access to documents adopted by that agency in 2010 was doubtful and that the change in policy was arbitrary, is based on a misreading of the order under appeal and is, therefore, unfounded.

31 It is clear from paragraphs 51 to 53 of that order that the President of the General Court merely observed that, before the adoption of that policy, the EMA would itself, in all likelihood, have classified the reports at issue as confidential and refused to disclose them to third parties on the basis of Regulation No 1049/2001. That observation is not challenged by the EMA in the present appeal. The President also pointed out, without calling into question the legality of that policy, that neither it nor the question of the confidentiality of non-clinical reports on toxicology studies submitted to the EMA in connection with an MA application has yet been the subject of a decision by the EU judicature, which is also not contested by the EMA. In paragraph 54 of the order under appeal, the President therefore concluded that there was no case-law that made it possible to give a ready answer to the questions of confidentiality that fell to be decided in the present case.

32 As regards, in the second place, the EMA’s argument that paragraph 57 of the order under appeal does not accurately reflect the position which it advocated before the President of the General Court, it must, regardless of its merits, be rejected as ineffective. The fact that, contrary to what is stated in that paragraph, the EMA did not acknowledge that disclosure of the reports at issue would enable competitors of MSD and Intervet to benchmark their own toxicology programmes and study results does not, in any event, have any effect on the finding, made in the same paragraph, that the assessment of the potentially confidential nature of those reports raises complex questions requiring highly technical scientific evaluations, which cannot be immediately resolved in the context of proceedings for interim measures but rather call for a detailed examination by the court adjudicating on the substance.

33 In the third place, the arguments by which the EMA takes issue with the findings made by the President of the General Court in paragraphs 60, 98 and 111 of the order under appeal must be rejected as unfounded because, by those arguments, the EMA alleges that the President of the General Court accepted, wrongly, that the reports at issue were confidential. Those arguments are based on a misreading of the order under appeal. Thus, in paragraph 60, the President of the General Court did not accept that those reports are confidential, but merely stated that it could not reasonably be ruled out that the court adjudicating on the substance would decide that they are confidential.

34 Those arguments must also be declared manifestly inadmissible in that they criticise the findings, in paragraphs 60, 98 and 111 of the order under appeal, that, first, the information contained in the reports, taken as a whole, adds scientific value to data that, in itself, is publicly available, secondly, that information is an intangible asset that may be used for competitive purposes and concerns the manufacturing and commercial activity of MSD and Intervet, and, thirdly, the disclosure of that information would be liable to compromise the completion of the future development plans for Bravecto.

35 By those arguments, the EMA seeks to call into question the President of the General Court’s assessment of the facts.

36 Pursuant to Article 256 TFEU and Article 58 of the Statute of the Court of Justice of the European Union, which also apply to appeals brought under the second paragraph of Article 57 of that Statute, an appeal is limited to points of law. The appraisal of the facts, which is a matter solely for the General Court, does not therefore, save where the clear sense of the evidence has been distorted, constitute a point of law which is subject, as such, to review by the Court of Justice at the appellate stage (see, to that effect, order of the Vice-President of the Court of 19 December 2013, Commission v Germany, C‑426/13 P(R), EU:C:2013:848, paragraph 56 and the case-law cited).

37 In that regard, it must be observed that the EMA has not established, or even alleged, that the evidence has been distorted in any way by the President of the General Court.

38 It follows from all the foregoing that the first ground of appeal must be rejected as in part unfounded, in part ineffective and in part inadmissible.

The second ground of appeal

39 The second ground of appeal is divided into three parts, alleging errors of law in the assessment of whether there was a prima facie case, urgency and the condition requiring a balance of interests.

The first part of the second ground of appeal, alleging errors of law in the assessment of whether there was a prima facie case

– Arguments of the parties

40 The EMA relies essentially on three arguments in support of the first part of its second ground of appeal.

41 In the first place, the EMA alleges, in essence, that the President of the General Court was incorrect to consider, in paragraph 61 of the order under appeal, that the fact that a substantial part of the information contained in the reports at issue was already publicly available had no relevance for the purpose of assessing whether those reports are confidential. Article 4(6) of Regulation No 1049/2001 requires the EMA to disclose all information falling within the public domain.

42 According to the EMA, the President of the General Court was also wrong, in paragraph 61 of the order under appeal, to take into consideration, for that purpose, the fact that the request for access had been made by a pharmaceutical company. The position adopted by the President of the General Court is manifestly contrary to Article 6 of Regulation No 1049/2001, which provides that the applicant is not required to state the reasons for its request.

43 In the second place, the EMA submits that the order under appeal is vitiated by an error of law inasmuch as it bases the existence of a prima facie case on the recognition of a general presumption that documents submitted by an MA applicant to the EMA, such as the reports at issue are confidential.

44 In that regard, the EMA submits, in essence, first, that, contrary to what appears to be accepted in paragraphs 64 to 66 of that order, Regulation No 726/2004 and Directive 2001/82 do not establish a specific set of rules on transparency and confidentiality which prevails over that established by Regulation No 1049/2001. Indeed, Article 73 of Regulation No 726/2004 expressly provides that Regulation No 1049/2001 applies to documents held by the EMA.

45 Second, the EMA submits that the general presumption that the reports at issue are confidential, which underpins the order under appeal, and in particular paragraphs 67 and 71 thereof, has no basis in law.

46 It is true that the Court has previously recognised a general presumption of confidentiality in respect of five types of document, namely documents in an administrative file relating to a procedure for reviewing State aid, the pleadings lodged by an institution in court proceedings, documents exchanged in the course of merger control proceedings, documents concerning infringement proceedings during the pre-litigation stage and documents relating to proceedings under Article 101 TFEU. The General Court has, furthermore, accepted that there is such a presumption in three additional cases, namely the bids submitted by tenderers in a public procurement procedure, the documents relating to an ‘EU Pilot’ procedure, and the documents sent by the national competition authorities to the Commission in the course of proceedings brought under Articles 101 and 102 TFEU.

47 However, according to the EMA, at issue in each of those cases was a set of documents that were clearly defined by the fact that they all belonged to a file relating to ongoing administrative or court proceedings. Thus, the application of a general presumption of confidentiality was dictated by the overriding need to ensure the proper functioning and integrity of the conduct of the proceedings.

48 By contrast, the recognition that a presumption of confidentiality applies to documents submitted to the EMA for the purposes of obtaining an MA, such as the reports at issue, is, according to the EMA, based on an incorrect comparison between those reports and the eight categories of documents mentioned in paragraph 46 of this order. Moreover, the information contained in those reports is not comparable to that which was at issue in the orders of the Vice-President of the Court of Justice of 10 September 2013, Commission v Pilkington Group (C‑278/13 P(R), EU:C:2013:558), and of 2 March 2016, Evonik Degussa v Commission (C‑162/15 P-R, EU:C:2016:142), and in the order of the President of the General Court of 11 April 2014, Deza v ECHA (T‑189/14, not published, EU:T:2014:225), cited on numerous occasions in the order under appeal. In particular, in contrast to those documents and that information, the information contained in the reports at issue concerned neither the identity of the clients of MSD and Intervet nor the description of the products manufactured or marketed by them, their share of the business, prices, the manufacturing process of Bravecto, or its quality and chemical safety.

49 Furthermore, to establish such a presumption would be without precedent in the case-law of the Court of Justice and the General Court and no such presumption is provided for either by Regulation No 726/2004 or by Directive 2001/82, which do not establish any confidentiality for documents such as the reports at issue.

50 In addition, the recognition of that presumption would be contrary to the requirement to interpret and apply the general presumptions of confidentiality accepted by the Court of Justice and the General Court strictly.

51 Finally, the EMA considers that the reasoning relied on by the President of the General Court in support of his assertion that the reports at issue are covered by a presumption of confidentiality, based on the risk that those reports could be used outside the European Union, must be rejected because it is vague and hypothetical.

52 In the third place, the EMA submits, in essence, that the President of the General Court erred in law in considering, in paragraph 69 of the order under appeal, that it could not be ruled out that, instead of recognising a general presumption of confidentiality, the court adjudicating on the substance might authorise disclosure of the reports at issue only to applicants working in academia for reasons of strictly scientific interest and subject to a confidentiality agreement prohibiting them from using the reports for commercial purposes. Such a possibility is in stark contradiction with the letter and spirit of Regulation No 1049/2001.

53 MSD and Intervet respond that the President of the General Court was fully entitled to find that there was a prima facie case since it was not obvious that the reports at issue were not confidential in nature.

54 In the first place, all documents submitted in connection with an MA application and, in particular, clinical and non-clinical studies, such as the reports at issue, should enjoy a general presumption of confidentiality under Regulation No 1049/2001.

55 The existence of such a presumption follows from the system established by the sector-specific legislation applicable to marketing authorisation for veterinary medicinal products, in particular by Article 36, Article 37(3), Article 38(3) and Articles 57, 76 and 80 of Regulation No 726/2004 and Articles 13 and 76 of Directive 2001/82. That system ensures the protection of confidentiality of information submitted in connection with an MA application and the respect for professional secrecy, whilst also guaranteeing access for the public, inter alia, to the summary of the product characteristics, the leaflet containing information for the user and to the EPAR, from which information covered by industrial and commercial secrecy has been deleted.

56 It is true that Article 73 of Regulation No 726/2004 provides that Regulation No 1049/2001 applies to documents held by the EMA. It follows from the above that, in accordance with Article 4(2) of the latter regulation, the EMA must grant applications for access to documents covered by industrial and commercial secrecy when justified by an overriding public interest in disclosure. However, the latter regulation must be interpreted in such a way as to preserve the effect utile of the former regulation and the balance that the European Union legislature intended to strike between, on the one hand, the requirement for transparency, the protection of public health and the need to avoid the duplication of trials and, on the other hand, the objective of protecting the confidentiality of industrial and commercial information.

57 In addition, MSD and Intervet submit that, as with the eight categories of documents referred to in paragraph 46 of this order, the recognition of a general presumption of confidentiality is, in the present case, necessary for the preservation of the effectiveness of the administrative procedure before the EMA. Furthermore, in the same way as the documents submitted by companies in procedures for reviewing State aid or mergers, the reports submitted in connection with procedures for the MA of a medicinal product are likely to contain commercially sensitive information.

58 In the second place, even though the reports at issue contain certain information that is already in the public domain, it is, in any event, reasonably foreseeable, having regard in particular to the considerations set out in paragraph 29 above, that the disclosure of those reports, in their entirety, would seriously affect the commercial interests of MSD and Intervet and cause serious harm to the EMA’s decision-making process. Consequently, according to MSD and Intervet, those reports are covered by the exceptions laid down in Article 4(2), first indent, and Article 4(3) of Regulation No 1049/2001. The EMA has not demonstrated that, in the present case, an overriding public interest nevertheless justifies disclosure of the reports at issue.

– Findings of the Court

59 In order to rule on the first part of the second ground of appeal, it should be recalled, as preliminary matter, that the prima facie case requirement is satisfied where at least one of the pleas in law put forward by the party seeking interim measures in support of the main action appears, at first sight, not unfounded. That is the case, inter alia, where one of the pleas relied on 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 (order of the Vice-President of the Court of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 22 and the case-law cited).

60 As regards disputes concerning interim protection for information alleged to be confidential, the judge hearing the application for interim measures — if he is not to disregard the intrinsically ancillary and provisional nature of proceedings for interim measures — may, as a rule, conclude that there is no prima facie case only where the information in question is obviously not confidential, (order of the Vice-President of the Court of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 29 and the case-law cited).

61 It is in the light of those considerations that the three arguments advanced by the EMA in support of the first part of its second ground of appeal should be examined.

62 As regards, in the first place, the matters that the President of the General Court was required to take into account for the purpose of the prima facie assessment of the claim that the reports at issue are confidential, the EMA submits, in essence, that the President erred in law in considering the fact that a substantial part of the information contained in those reports was already publicly available was irrelevant, even though the EMA was required to disclose all information that was already within the public domain.

63 Nonetheless, it is necessary to observe, first, that that argument is based on a misreading of the order under appeal.

64 As the EMA has recognised in the introductory part of its appeal, the President of the General Court expressly took that fact into account in paragraphs 59 and 60 of the order. Thus, the President observed that the question arose as to whether the fact that MSD and Intervet had compiled scientific data known to the public, to which they had added secret scientific data in order to produce a body of complex information which, as such and in that form, was not readily accessible, could justify treating that body of information as confidential.

65 Second, the President of the General Court did not err in law in finding that that question raised issues which cannot be immediately resolved.

66 It is true, as the EMA submits, that information or a document that is already publicly available cannot, as a rule, be classified as confidential. However, in paragraph 59 of the order under appeal, the President of the General Court noted that the present case did not concern a particular piece of information or document that was already in the public domain — a finding which is not, in itself, contested by the EMA —, but a body of complex information combining public information and other information not known to the public.

67 The President of the General Court was fully entitled to find, in paragraph 60 of that order, that it could not reasonably be ruled out that the court adjudicating on the substance would recognise the confidentiality of the specific way in which MSD and Intervet used both confidential and non-confidential information for the purposes of their MA application, in that such an inventive strategy adds scientific value to elements that are not confidential in themselves.

68 There is no case-law of the Court that enables a ready response to be given to the issue of confidentiality of such information, which is the subject of major legal disagreement between the parties. Furthermore, the resolution of that issue requires the examination of complex and much debated facts. The interim relief procedure is not designed to establish the truth of such facts, as the judge hearing an application for interim measures does not have the means necessary in order to carry out such examinations (see, by analogy, order of the President of the Court of 24 April 2008, Commission v Malta, C‑76/08 R, not published, EU:C:2008:252, paragraph 36).

69 It follows from the foregoing that the EMA’s argument alleging that the President of the General Court failed, wrongly, to take into account the fact that a substantial part of the information contained in the reports at issue was already in the public domain is unfounded.

70 To the extent that the EMA also criticises the President of the General Court for taking into account, in paragraph 61 of the order under appeal, the status of the person seeking access to the reports at issue for the purposes of assessing whether those reports are confidential, it suffices to observe that that point was made purely for the sake of completeness, with the result that the EMA’s argument is, in any event, ineffective.

71 As regards, in the second place, the EMA’s argument that the order under appeal is vitiated by an error of law in that it bases the existence of a prima facie case on the recognition of a general presumption of confidentiality covering the reports at issue, it should be noted, at the outset, that the President of the General Court did not accept that there was such a presumption. He merely stated that it could not reasonably be ruled out that the court adjudicating on the substance would recognise such a presumption.

72 In so doing, the President of the General Court did not err in law.

73 It is true, as the EMA points out, that neither Regulation No 726/2004 nor Directive 2001/82 establishes a presumption of confidentiality for certain categories of information, nor do they expressly provide for the confidentiality of documents such as the reports at issue. Moreover, Article 73 of that regulation expressly provides that Regulation No 1049/2001 applies to documents held by the EMA.

74 However, the argument put forward by MSD and Intervet at first instance that Regulation No 726/2004 and Directive 2001/82 establishes a specific regime of transparency and confidentiality under which the main documents in an MA application file to be disclosed are the summary of the characteristics of the veterinary medicinal product, the user information leaflet and the EPAR, excluding all information covered by commercial secrecy, cannot be regarded as manifestly incorrect.

75 First, whilst, in particular, Article 36, Article 38(3) and Article 57 of Regulation No 726/2004 provide for the publication by the EMA of those three documents, those provisions specify that all information of a commercially confidential nature must be deleted from the EPAR. Furthermore, Article 76 of that regulation provides that EMA’s servants are required not to disclose information of a kind that is covered by the obligation of professional secrecy. In addition, the combined provisions of Article 39(10) of Regulation No 726/2004 and Articles 13 and 13a of Directive 2001/82 guarantee protection for documents such as the reports at issue against any use for the benefit of other MA applicants for a period of 8 to 13 years.

76 Second, since neither Regulation No 726/2004 nor Regulation No 1049/2001 contains any provision expressly providing that one takes precedence over the other, it is impossible, prima facie, to say with certainty that the court adjudicating on the substance would consider that it is necessary to recognise that the documents in an MA file, such as the reports at issue, enjoy a general presumption of confidentiality, in order to ensure consistent application of those regulations, and to maintain the balance between, on the one hand, the need to protect the commercial interests of the applicants for an MA and, on the other hand, the overriding requirements of transparency and the protection of public health.

77 In that regard, the argument, considered by the President of the General Court in paragraph 67 of the order under appeal, that the protection conferred by the combined provisions of Article 39(10) of Regulation No 726/2004 and Articles 13 and 13a of Directive 2001/82 does not replace that offered by a general presumption of confidentiality, in particular against the exploitation of those reports in a third country, does not appear to be entirely irrelevant. The period of data protection provided by those provisions does not apply outside the European Union.

78 It follows that the President of the General Court did not err in law in considering that the argument advanced by MSD and Intervet that there is a general presumption of confidentiality covering the reports at issue did not appear to be wholly unfounded.

79 That conclusion is not called into question on the ground that the procedure for issuing the MA has, in the present case, been concluded. It cannot be ruled out outright that disclosure of documents such as the reports at issue might damage the commercial interests of MA applicants, including after the closure of the procedure to grant such authorisation, having regard in particular to the nature of the information contained in those documents. Besides, Article 4(7) of Regulation No 1049/2001 provides that the exceptions to disclosure concerning commercial interests may apply for a period of 30 years, and even beyond that period if necessary (see, by analogy, judgments of 28 June 2012, Commission v Éditions Odile Jacob, C‑404/10 P, EU:C:2012:393, paragraphs 124 and 125, and of 28 June 2012, Commission v Agrofert Holding, C‑477/10 P, EU:C:2012:394, paragraphs 66 and 67).

80 Moreover, it is precisely the fact of holding an MA, which is accompanied by a period of exclusivity and data protection, that may justify the information on the basis of which that MA was granted, such as the information in the reports at issue, remaining confidential even after the closure of the procedure that led to the Commission issuing the MA in question.

81 That conclusion is not undermined on the ground that neither the Court of Justice nor the General Court has, to date, recognised the existence of a general presumption of confidentiality in respect of documents such as the reports at issue or on the ground that cases involving a general presumption of confidentiality must be interpreted and applied strictly. Neither such a fact nor such a requirement has prevented the Court from recognising the five categories in which there is a general presumption of confidentiality referred to in paragraph 46 above.

82 As regards, in the third place, the EMA’s argument that the President of the General Court failed to have regard to Regulation No 1049/2001 in contemplating the possibility of disclosure of the reports at issue only to applicants working in academia for reasons of strictly scientific interest and subject to a confidentiality agreement, it should be pointed out that that observation by the President of the General Court was made purely for the sake of completeness.

83 It is clear from paragraph 69 of the order under appeal that the President contemplated that possibility only in the event that the court adjudicating on the substance decided not to recognise that there was a general presumption of confidentiality. However, it is clear from paragraphs 71 to 81 of this order that the President of the General Court did not err in law in finding that there was a prima facie case based on the recognition of such a presumption.

84 In those circumstances, it is necessary, regardless of its merits, to reject the argument raised by the EMA as ineffective.

85 Having regard to all the foregoing considerations, the first part of the second ground of appeal must be rejected as in part unfounded and in part ineffective.

The second part of the second ground of appeal, alleging errors of law in the assessment of the condition relating to urgency

– Arguments of the parties

86 In the second part of its second ground of appeal, the EMA submits, in essence, that the President of the General Court erred in law in finding that the condition relating to urgency was satisfied even though MSD and Intervet had not adduced any concrete evidence of the kind of harm that they might suffer in the event that the reports at issue were disclosed. The President of the General Court thus accepted that that condition was satisfied without verifying, by examining, one by one, the arguments and evidence presented by the parties, whether disclosure of the various documents and information contained in the reports would, with a sufficient degree of probability, lead to a risk of MSD and Intervet suffering serious and irreparable harm. Accordingly, the President of the General Court failed to apply, inter alia, the order of the Vice-President of the Court of Justice of 28 November 2013, EMA v AbbVie (C‑389/13 P(R), not published, EU:C:2013:794).

87 In particular, the President of the General Court did not specifically assess the actual commercial value of the information contained in the reports at issue, but assumed that it was substantial and that it would be lost if those reports were disclosed as, in particular, paragraphs 57, 59 and 60 of the order under appeal show. It was incorrect to conclude that those reports contained information revealing an inventive strategy developed by MSD and Intervet and that disclosure of that information might harm their competitive position and jeopardise their future development plans.

88 Furthermore, the EMA submits, in essence, that in paragraphs 99, 114 and 116 to 121 of the order under appeal, the President of the General Court also made assumptions as to the serious nature of the harm and failed to have regard to the condition that it must be irreparable in nature, in breach of the Court’s settled case-law.

89 The position thus adopted by the President of the General Court would mean that, in every case in which an undertaking claimed that the disclosure of documents alleged to be confidential would cause allegedly unquantifiable financial harm, the judge hearing the application for interim measures would presume that, by definition, that harm was serious and irreparable. Such a position is contrary to the settled case-law that an alleged breach of an undertaking’s fundamental right to the protection of its professional secrets does not suffice, in itself, to establish the risk of serious and irreparable harm.

90 In addition, the EMA submits that in paragraph 113 of the order under appeal, the President of the General Court also failed to apply the Court’s settled case-law that harm resulting from the alleged loss of a competitive advantage that was of a purely financial nature justified the granting of interim measures, on that basis, only if the persons or companies concerned were in a situation in which their economic survival might be jeopardised or their share of the market put at risk of being seriously and irremediably affected if those interim measures were not granted.

91 MSD and Intervet dispute the merits of those arguments.

92 In particular, they contend, first, that the President of the General Court, who concluded that there was a prima facie case because it could not be ruled out that the reports at issue were confidential, was entitled to infer from this that it could be presumed that disclosure of those reports would necessarily cause them significant harm. Besides, and in any event, as the President of the General Court stated in paragraph 98 of the order under appeal, the harm that MSD and Intervet might suffer as a result of disclosure of those reports was in fact serious.

93 Second, that harm would be irreparable. Disclosure of the reports at issue would deprive the decision to be given by the court adjudicating on the substance of its effectiveness. Furthermore, in addition to the financial harm suffered, which is unquantifiable, there would be a risk of damage to the reputation of MSD and Intervet. Although the President of the General Court stated, in paragraph 121 of the order under appeal, that it was necessary for him not to apply the condition relating to the irreparable nature of the harm pleaded, he nevertheless verified whether that condition was satisfied in paragraphs 102 to 112 of that order.

– Findings of the Court

94 At the outset, it must be noted that the purpose of interim proceedings is to guarantee the full effectiveness of the final future decision in order to ensure that there is no lacuna in the legal protection provided by the Court of Justice. It is for the purpose of attaining that objective that urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable damage to the party seeking the interim relief. It is for that party to prove that it cannot wait for the outcome of the main proceedings without suffering harm of that nature (orders of the Vice-President of the Court of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 36, and of 7 July 2016, Commission v Bilbaína de Alquitranes and Others, C‑691/15 P-R, not published, EU:C:2016:597, paragraph 40).

95 While it is true that, in order to establish the existence of serious and irreparable damage, it is not necessary for the occurrence of the damage to be demonstrated with absolute certainty, it being sufficient to show that damage is foreseeable with a sufficient degree of probability, the party seeking interim measures is nevertheless required to prove the facts forming the basis of its claim that serious and irreparable damage is likely (order of the Vice-President of the Court of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 37 and the case-law cited).

96 In addition, it should be observed that, in the present case, MSD and Intervet claimed, before the President of the General Court, that, although they contained certain publicly available information, the reports at issue were, on the whole, confidential and their disclosure would be likely to cause harm to those companies because the reports would reveal the inventive strategy they used to carry out their tests and would therefore be likely to be exploited by their competitors for the purposes of their own MA applications, which would risk compromising the future development plans for the medicinal product Bravecto.

97 Furthermore, it is clear from paragraphs 62 to 81 of this order that the President of the General Court considered, without erring in law, that a prima facie examination of the arguments put forward by those companies did not justify the conclusion that the reports at issue, which are bodies of complex information combining, in consolidated form, public and non-public data, were obviously not confidential.

98 Consequently, the President of the General Court was required necessarily, for the purposes of assessing urgency, to start from the premiss that the reports were in fact a body of complex information which, in itself, was confidential for the purposes of Article 339 TFEU, the first indent of Article 4(2) of Regulation No 1049/2001 and Article 7 of the Charter, as claimed by MSD and Intervet (see, by analogy, order of the Vice-President of the Court of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraphs 83 to 85).

99 It is necessary to rule on the second part of the second ground of appeal in the light of those considerations.

100 Even though the appeal application is very difficult to read, it is apparent from that application that the EMA raises essentially two groups of arguments in support of this part. First, the EMA submits, in essence, that the President of the General Court failed to apply the Court’s case-law in finding that the condition relating to urgency was met without examining, in respect of each piece of information or each of the documents contained in the reports at issue, one by one, the arguments of the parties and the evidence submitted by them. Secondly, the EMA alleges that the President of the General Court assumed that a risk of serious harm would arise, without carrying out a concrete assessment of the value of those reports and of that risk, and that he made various errors in the assessment of the irreparable nature of that harm.

101 Those two groups of arguments should be examined in turn.

102 For that purpose, it is necessary, in the first place, to note that the expeditiousness required in interim proceedings certainly does not preclude the judge hearing the application for interim measures from examining, one by one, the arguments put forward by the parties and the evidence submitted by them and intended to prove the necessity of maintaining the confidentiality of the documents concerned in order to prevent the party seeking interim measures from suffering serious and irreparable harm (see, to that effect, order of the Vice-President of the Court of 28 November 2013, EMA v AbbVie, C‑389/13 P(R), EU:C:2013:794, paragraph 53).

103 However, it does not follow that the judge hearing the application for interim measures is required to verify whether disclosure of each of the pieces of information included in the documents concerned, taken individually, is likely to cause that party such harm if it did not rely on such an argument. Thus, where, as in the present case, the party seeking the suspension of the operation of a decision claims confidentiality in respect of all the documents affected by the disclosure, taken as a whole, the judge hearing the application for interim measures is merely required to examine, on the basis of a global analysis of those documents, whether the arguments relied on by the parties — in this case, by MSD and Intervet on the one hand, and by the EMA on the other — justify granting the application for suspension or rejecting it.

104 Moreover, as stated in paragraphs 96 to 98 of this order, in the present case the President of the General Court was required necessarily, for the purposes assessing urgency, to start from the premiss that the reports at issue were confidential, not because each piece of information or each of the documents contained in those reports might be confidential, but because those reports combined, in consolidated form, information that was in the public domain and other information that was not known to the public, creating a complex body of information which, in itself, was confidential. In those circumstances, the President of the General Court was required only to examine whether, having regard to the arguments relied on by the parties, disclosure of that body of information, taken as a whole, would be likely to cause, with a sufficient degree of probability, serious and irreparable harm to MSD and Intervet.

105 In those circumstances, the EMA cannot legitimately criticise the President of the General Court for not examining whether the condition relating to urgency was satisfied, having regard to each piece of information or each of the documents included in the reports at issue, taken individually.

106 As regards, in the second place, the serious and irreparable nature of the harm alleged by MSD and Intervet, it must be noted that the President of the General Court found, starting from the premiss that the reports at issue in fact constituted bodies of complex confidential information, that disclosure of those reports would necessarily cause significant harm to those companies.

107 In that regard, the President of the General Court stated, in paragraph 98 of the order under appeal, that the reports at issue, which contained pharmacological and toxicological scientific evaluations forming part of the file prepared by MSD and Intervet for the purposes of obtaining an MA, concerned the manufacturing and commercial activity of those companies. The President concluded from this that, taking into account the dynamic nature of pharmaceutical markets, the high level of investments made in developing new medicinal products and the interest shown by a pharmaceutical undertaking for access specifically to those reports, the reports were objectively liable to be used for competitive purposes. Indeed, according to the President of the General Court, any competitor of MSD or Intervet could exploit those reports for its own scientific and commercial needs by using the information contained within them as the starting point for developing independently a medicinal product the same as or similar to Bravecto and by extracting valuable information on the long-term clinical development strategy of MSD and Intervet. The President of the General Court concluded that the reports at issue were an intangible asset that might be used for competitive purposes, the value of which could be reduced significantly, that is to say seriously, if they did not remain secret.

108 In so doing, the President of the General Court did not, contrary to the submissions made by the EMA, assume that a risk of serious harm would arise, but established that there was such a risk in the light of the arguments put forward by the parties, carrying out a concrete assessment of the commercial value of the reports at issue and of the risk.

109 It is true that the EMA disputes the factual findings made in paragraph 98. However, as stated in paragraphs 34 to 37 of this order, such an argument is inadmissible in an appeal.

110 Furthermore, while the EMA submits that the President of the General Court erred in law, in paragraph 99 of the order under appeal, by stating that the judge hearing the application for interim measures was required to assume, for the purpose of urgency, that the harm liable to be caused to MSD and to Intervet would be serious, it should be noted that that paragraph contains grounds included for the sake of completeness, which, even if they were unfounded, could not, in any event, lead to the annulment of that order. Hence, regardless of its merits, the argument raised by the EMA must be rejected as ineffective.

111 Contrary to what the EMA claims, the President of the General Court did not assume that there was a risk of irreparable harm, but established that there was such a risk in the light of the arguments relied on by the parties.

112 Thus, after observing, in paragraph 102 of the order under appeal, that the annulment of the decision at issue could not reverse the effects of disclosure of the reports at issue, the President of the General Court stated, in paragraphs 103 to 113 of the order, first, that such disclosure would allow the third party applicant immediately to take cognisance of those reports and to use them straightaway for any purpose it deemed useful. Second, according to the President of the General Court, that disclosure would have erga omnes effect, in the sense that the reports would fall within the public domain and could be read by an unlimited number of third parties. Consequently, such disclosure would have an effect comparable to the publication of those reports. The President of the General Court considered that, once the reports at issue were disclosed, it would be highly likely that current or potential competitors of MSD and Intervet with a genuine interest in exploiting those reports would attempt to obtain them in order to use them for their own scientific and commercial needs within or outside the European Union. Such exploitation could, objectively, lead those competitors to launch plans similar to those of MSD and Intervet and thus thwart the future development plans for Bravecto.

113 Finally, the President of the General Court stated that the financial harm that MSD and Intervet might suffer if the reports at issue were disclosed could not be quantified. In view of the erga omnes effect that disclosure of the reports at issue would have, an indeterminate number of competitors of MSD and Intervet could obtain them, without those companies even being informed. Furthermore, the harmful effects of the use of those reports by those competitors could be felt in the short, medium or long term, depending on the precise use made of them by competitors.

114 It must be observed, first of all, that the EMA does not call into question the conclusions of the President of the General Court relating to the possibility that third party applicants would exploit the reports at issue if disclosed, for whatever purpose they may serve, and to the erga omnes effect of such disclosure, which formed the basis of the assessment of the irreparable harm alleged. On the contrary, it expressly accepts that there is such an erga omnes effect.

115 Next, while the EMA disputes the claim that disclosure of the reports at issue might thwart future development plans for Bravecto, it should be noted that such an argument, which seeks to call into question the findings of fact made by the President of the General Court, is inadmissible in an appeal, as stated in paragraphs 34 to 37 above.

116 In addition, it is true that the EMA submits, in essence, that the President of the General Court erred in law in finding, in paragraphs 114 to 121 of the order under appeal, that it was necessary to recognise urgency even if the harm alleged by MSD and Intervet could not be classified as irreparable. Nonetheless, it is clear, regardless of the merits of such a finding, that those paragraphs were included by way of subsidiary consideration and for the sake of completeness and that they did not undermine the finding made by the President of the General Court in paragraphs 103 to 113 of the order under appeal that the harm alleged was in fact irreparable. Hence, the argument advanced by the EMA is ineffective.

117 Finally, to the extent that the EMA takes issue with the President of the General Court for considering that harm caused by the alleged loss of a competitive advantage could be regarded as irreparable, it should be recalled that, in accordance with an established line of the Court’s case-law, financial harm may be considered to be irreparable where it is clear that, in view of its nature and the manner in which it will foreseeably occur, it is not possible for the harm adequately to be identified or quantified and that, in practice, it will not therefore be possible to make good that harm by bringing an action for damages (see, to that effect, order of the Vice-President of the Court of 10 September 2013, Commission v Pilkington Group, C‑278/13 P(R), EU:C:2013:558, paragraph 54).

118 In the present case, the President of the General Court established, in paragraphs 110 to 112 of the order under appeal, that having regard to its nature and the way in which it would occur, the financial harm claimed by MSD and Intervet could not be quantified, a finding which, in itself, is not criticised by the EMA in the present appeal.

119 Hence, the EMA’s argument that the President of the General Court erred in law in finding that, having regard to the particular features of proceedings for the protection of allegedly confidential information, MSD and Intervet were not required to establish, in addition, that they would be in a position that would imperil their financial viability or that their market shares would be seriously and irreparably affected if the measures applied for were not granted, cannot lead to the annulment of the order under appeal. In those circumstances, regardless of its merits, that argument must be rejected as ineffective.

120 It follows from all the foregoing that none of the arguments raised by the EMA in support of the second part of its second ground of appeal demonstrate that the President of the General Court erred in law in finding that disclosure of the reports at issue would, with a sufficient degree of probability, place MSD and Intervet at risk of serious and irreparable harm.

121 In those circumstances, the second part of the second ground of appeal must be rejected as in part inadmissible, in part unfounded and in part ineffective.

The third part of the second ground of appeal, alleging errors of law in the assessment of the balance of interests

– Arguments of the parties

122 By the third part of its second ground of appeal, the EMA submits, in essence, that when weighing the balance of interests, the President of the General Court did not give sufficient weight to the public interest in having immediate access to the reports at issue, without waiting for the judgment on the substance, and that the balancing exercise should have been resolved in its favour.

123 According to the EMA, while the President of the General Court noted that granting suspension of the operation of the decision at issue would merely maintain the status quo for a limited period of time until judgment was delivered on the substance, the non-disclosure of documents contained in the files for an MA application, such as the reports at issue, during that period was precisely the aim pursued by pharmaceutical companies which brought an application for interim measures simply as a delaying tactic. Thus, the order under appeal encourages such delaying tactics.

124 In addition, by requiring, in paragraph 78 of the order under appeal, that the EMA prove that disclosure of the reports at issue met an overriding need to protect public health from a specific danger posed by Bravecto, the President of the General Court imposed an obligation on that agency which was not laid down by Regulation No 1049/2001. The disclosure of a document cannot be subordinated to the existence of a specific public interest justifying disclosure. Furthermore, in so doing, the President of the General Court reversed the burden of proof without any justification. It is, for the party seeking interim relief to adduce proof of serious and irreparable harm, not for the EMA to prove a particular interest in disclosure of the documents at issue.

125 Finally, contrary to what the President of the General Court stated, the fact that the public might have other means of accessing the documents requested is irrelevant for the purposes of the application of Regulation No 1049/2001 and had no effect on the EMA’s obligation to grant such requests.

126 MSD and Intervet reply, in essence, that an interference with the public interest in transparency is merely temporary. Furthermore, the information contained in the reports at issue is not relevant for the evaluation by the public of the safety of Bravecto. The data necessary for properly informing the public is already published in the EPAR. On the other hand, the rejection of the application for interim measures would deprive the main action of any practical effect.

– Findings of the Court

127 For the purpose of ruling on the third part of the second ground of appeal, it should be recalled that, in accordance with the Court’s settled case-law, the risks associated with each of the possible disposals of the case must be weighed in the proceedings for interim measures. In practical terms, that means examining whether or not the interest of the party seeking interim measures in obtaining suspension of the operation of the contested act outweighs the interest in its immediate implementation. In that examination, it must be determined whether the possible annulment of that act by the judgment on the substance would make it possible to reverse the situation that would have been brought about by its immediate implementation and, conversely, whether suspension of its operation would be such as to impede the objectives pursued by the contested act in the event of the main action being dismissed (order of the Vice-President of the Court of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 103).

128 In the present case, the General Court will be called upon to give a ruling on whether the decision at issue should be annulled, inter alia on the ground of infringement of Article 339 TFEU, Article 7 of the Charter and Article 4(2), first indent, of Regulation No 1049/2001.

129 In those circumstances, the dismissal of the application for interim measures by the President of the General Court and the subsequent disclosure of the reports at issue by the EMA would clearly deprive any judgment annulling the decision at issue of any practical effect. From the very fact of that disclosure, those reports would have lost, irreversibly, the protection afforded by the confidentiality of industrial and commercial information, so that the dismissal of the application for interim measures would have de facto prejudged the future decision on the merits.

130 The arguments advanced by the EMA do not support the conclusion that the President of the General Court erred in law in finding that the interests of MSD and Intervet in obtaining the suspension they sought outweighed that of the EMA in having the application for interim measures dismissed.

131 The EMA, essentially, simply relies on the public interest in obtaining immediate access to the reports at issue. Thus, in particular, as the President of the General Court observed in paragraph 78 of the order under appeal, the EMA did not argue that the immediate need to disclose those reports, without waiting for the decision on the merits, met an overriding need to protect public health. In that regard, it must be stated that, contrary to what that agency submitted, there is nothing to prevent such an interest being taken into consideration by the judge hearing the application for interim measures when weighing the interests involved.

132 Thus, the President of the General Court did not err in law, in paragraph 83 of the order under appeal, in finding that the public interest in transparency was sufficiently satisfied, until judgment in the main proceedings is delivered, by the publication of the summary of the characteristics of Bravecto, the user information leaflet and the EPAR. While, as the EMA submits, a request for access to documents on the basis of Regulation No 1049/2001 cannot, as a rule, be rejected solely on the ground that the third party applicant has other means of obtaining the information sought, that fact may be taken into account when weighing up the interests involved.

133 In those circumstances, the President of the General Court was fully entitled to find that the interest of MSD and Intervet in obtaining suspension of the operation of the decision at issue outweighed that of the EMA in obtaining the immediate implementation of that decision.

134 Moreover, it should be noted that, contrary to the EMA’s submissions, such a solution is unlikely to encourage possible delaying tactics by pharmaceutical companies and does not mean that the court hearing an application for interim measures must always grant an application for suspension of operation of disclosure decisions made by that agency. The grant of such a suspension presupposes, in addition to the balance of interests being weighed in favour of the party seeking the suspension, that that party should establish that there is a prima facie case and that there is urgent need for suspension (see, to that effect, order of the Vice-President of the Court of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 21 and the case-law cited).

135 It follows from the foregoing that the third part of the second ground of appeal must be rejected as unfounded and, consequently, the second ground of appeal must be rejected in its entirety.

136 It follows that the appeal must be dismissed in its entirety.

Costs

137 Under Article 138(1) of the Rules of Procedure of the Court of Justice, applicable to appeal proceedings by virtue of Article 184(1) of those rules, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since MSD and Intervet have applied for an order that the EMA pay the costs and the EMA has been unsuccessful in all its pleas, it must be ordered to pay the costs of the appeal proceedings.

On those grounds, the Vice-President of the Court hereby orders:

1. The appeal is dismissed.







2. The European Medicines Agency (EMA) is to pay the costs of the appeal proceedings.





Luxembourg, 1 March 2017.





A. Calot Escobar A. Tizzano