{"attribution":{"source":"legal.exploreworldai.com","canonical":"https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-513-16-p-r","cite_as":"NovaCopilot, legal.exploreworldai.com (https://legal.exploreworldai.com/api/public/v1/judgment-text?id=eu:c-513-16-p-r)","license":"https://legal.exploreworldai.com/revision","version":"legal-2026-10-13","fingerprint":"ewai:eu:a03983","proof":"sha256:554a00ed96df2153360b87942c6e0b1a15261a750c26a75f52b79391ba50a774","jurisdiction":"eu","lang":"en","publisher":"NovaCopilot by ExploreWorld Legal","terms":"https://legal.exploreworldai.com/om"},"brand_source":"Source: NovaCopilot","item":{"schema_version":"1.0.0","id":"eu:c-513-16-p-r","jurisdiction":"eu","lang":"en","brand_source":"Source: NovaCopilot","brand":{"product":"NovaCopilot","platform":"ExploreWorldAI","infrastructure":"ExploreWorld Legal","infrastructure_url":"legal.exploreworldai.com","legal_entity":"Valkiv Ventures AB","permanent_url":"https://legal.exploreworldai.com/novacopilot","source":"Source: NovaCopilot","powered_by":"Powered by NovaCopilot","license":"https://legal.exploreworldai.com/licensvillkor"},"sections":[{"title":"Front matter","paragraphs":["para_1","para_2","para_3","para_4","para_5","para_6","para_7","para_8","para_9","para_10","para_11","para_12","para_13","para_14","para_15","para_16","para_17","para_18","para_19","para_20","para_21","para_22","para_23","para_24","para_25","para_26","para_27","para_28","para_29","para_30","para_31","para_32","para_33","para_34","para_35","para_36","para_37","para_38","para_39","para_40","para_41","para_42","para_43","para_44","para_45","para_46","para_47","para_48","para_49","para_50","para_51","para_52","para_53"],"kind":"front_matter"},{"title":"Findings of the Court","paragraphs":["para_54","para_55","para_56","para_57","para_58","para_59","para_60","para_61","para_62"],"kind":"assessment"},{"title":"The second ground of appeal","paragraphs":["para_63","para_64","para_65","para_66","para_67","para_68","para_69","para_70","para_71","para_72","para_73","para_74","para_75","para_76","para_77","para_78","para_79","para_80","para_81","para_82","para_83","para_84","para_85","para_86","para_87","para_88","para_89","para_90","para_91","para_92","para_93","para_94","para_95","para_96","para_97","para_98","para_99","para_100","para_101","para_102","para_103","para_104","para_105","para_106","para_107","para_108","para_109","para_110","para_111","para_112","para_113","para_114","para_115","para_116","para_117","para_118","para_119","para_120","para_121","para_122","para_123","para_124","para_125","para_126","para_127","para_128","para_129","para_130","para_131","para_132","para_133","para_134","para_135","para_136","para_137","para_138","para_139","para_140","para_141","para_142","para_143","para_144","para_145","para_146","para_147","para_148","para_149","para_150","para_151","para_152","para_153","para_154","para_155","para_156","para_157","para_158","para_159","para_160","para_161","para_162","para_163","para_164","para_165","para_166","para_167","para_168","para_169","para_170","para_171","para_172","para_173","para_174","para_175","para_176","para_177","para_178","para_179"],"kind":"assessment"},{"title":"Costs","paragraphs":["para_180","para_181","para_182","para_183"],"kind":"costs"},{"title":"On those grounds, the Vice-President of the Court hereby orders:","paragraphs":["para_184","para_185","para_186","para_187","para_188","para_189","para_190","para_191","para_192","para_193"],"kind":"operative"}],"paragraphs":[{"text":"Provisional text","paragraph_id":"para_1"},{"text":"ORDER OF THE VICE-PRESIDENT OF THE COURT","paragraph_id":"para_2"},{"text":"1 March 2017 ( * )","paragraph_id":"para_3"},{"text":"(Appeal — Order for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Directive 2001/83/EC — Regulation (EC) No 726/2004 — Regulation (EC) No 141/2000 — Regulation (EC) No 507/2006 — Documents held by the European Medicines Agency (EMA) submitted in connection with an applicati …","paragraph_id":"para_4"},{"text":"In Case C‑513/16 P(R),","paragraph_id":"para_5"},{"text":"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,","paragraph_id":"para_6"},{"text":"European Medicines Agency (EMA), represented by S. Marino, A. Spina, T. Jabłoński, A. Rusanov and N. Rampal Olmedo, acting as Agents,","paragraph_id":"para_7"},{"text":"appellant,","paragraph_id":"para_8"},{"text":"the other parties to the proceedings being:","paragraph_id":"para_9"},{"text":"PTC Therapeutics International Ltd, established in Dublin (Ireland), represented by M. Demetriou QC, C. Thomas, Barrister, and by G. Castle, B. Kelly and H. Billson, Solicitors,","paragraph_id":"para_10"},{"text":"applicant at first instance,","paragraph_id":"para_11"},{"text":"European Confederation of Pharmaceutical Entrepreneurs (Eucope), established in Brussels (Belgium), represented by D. Scannell, Barrister, and S. Cowlishaw, Solicitor,","paragraph_id":"para_12"},{"text":"intervener at first instance,","paragraph_id":"para_13"},{"text":"THE VICE-PRESIDENT OF THE COURT OF JUSTICE,","paragraph_id":"para_14"},{"text":"after hearing the Advocate General, M. Wathelet,","paragraph_id":"para_15"},{"text":"makes the following","paragraph_id":"para_16"},{"text":"Order","paragraph_id":"para_17"},{"text":"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, PTC Therapeutics International v EMA (T‑718/15 R, not published, ‘the order under appeal’, EU:T:2016:425), by which the latter o …","paragraph_id":"para_18"},{"text":"Background to the dispute, the procedure before the General Court and the order under appeal","paragraph_id":"para_19"},{"text":"2         Article 6 of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 (OJ …","paragraph_id":"para_20"},{"text":"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.","paragraph_id":"para_21"},{"text":"4         Under Article 13(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 human use (‘the EPAR’), containing a summary of the product’s characteristics that is understandable to the public, and the reasons for its opinion in favour of issuing an MA, after deletion of any information of a commercially confidential nature.","paragraph_id":"para_22"},{"text":"5         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 o …","paragraph_id":"para_23"},{"text":"6         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.","paragraph_id":"para_24"},{"text":"7         PTC Therapeutics International Ltd (‘PTC’), is a pharmaceutical company with expertise in the development of small-molecule compounds designed to correct or compensate for genetic defects. It designed Ataluren, which is the active ingredient in a medicinal product sold under the trade name …","paragraph_id":"para_25"},{"text":"8         On 31 July 2014, the Commission issued PTC with a conditional MA for Translarna, requiring it to produce further data confirming the benefits of the product. That conditional MA was granted to Translarna as an orphan medicinal product, within the meaning of Regulation (EC) No 141/2000 of t …","paragraph_id":"para_26"},{"text":"9         On 13 October 2015, the EMA informed PTC that it had received, from a pharmaceutical company, a request pursuant to Regulation No 1049/2001 for access to a clinical study report that was included in the MA application dossier for Translarna. That report is a Phase 2B placebo-controlled eff …","paragraph_id":"para_27"},{"text":"10       PTC requested that the report at issue be treated as confidential in its entirety. Nonetheless, that request was rejected on two occasions by the EMA.","paragraph_id":"para_28"},{"text":"11       Consequently, on 25 November 2015, the EMA, by the decision at issue, granted the third party applicant access to the entire report at issue, subject to certain redactions made of its own initiative, such as references to discussions on protocol design with the competent United States autho …","paragraph_id":"para_29"},{"text":"12       By application lodged at the Registry of the General Court on 9 December 2015, PTC brought an action for annulment of that decision.","paragraph_id":"para_30"},{"text":"13       By separate document, lodged at the Registry of the General Court on the same day, PTC also lodged an application for interim measures in which it claimed, in essence, that the President of the General Court should suspend operation of the decision at issue and order the EMA to abstain from any form of disclosure of the report at issue.","paragraph_id":"para_31"},{"text":"14       The EMA claimed that the President of the General Court should reject that application.","paragraph_id":"para_32"},{"text":"15       By order of the President of the General Court of 15 April 2016, the European Confederation of Pharmaceutical Entrepreneurs (Eucope), which represents the interests of more than 900 European pharmaceutical and biotechnological undertakings, was given leave to intervene in support of PTC.","paragraph_id":"para_33"},{"text":"16       On 20 July 2016, the President of the General Court ordered, by the order under appeal, that the operation of the decision at issue be suspended and EMA not to disclose the report at issue.","paragraph_id":"para_34"},{"text":"17       The President of the General Court considered, in the first place, that it was not obvious that the report at issue, taken as a whole, was not confidential and that it was therefore necessary to find that there was a prima facie case as regards the plea alleging confidentiality and infringe …","paragraph_id":"para_35"},{"text":"Procedure before the Court of Justice and forms of order sought","paragraph_id":"para_36"},{"text":"18       By its appeal, the EMA claims, in essence that the Court should:","paragraph_id":"para_37"},{"text":"–        set aside the order under appeal;","paragraph_id":"para_38"},{"text":"–        dismiss the application for interim measures seeking suspension of the operation of the decision at issue; and","paragraph_id":"para_39"},{"text":"–        order PTC to pay the costs, including those relating to the proceedings before the General Court.","paragraph_id":"para_40"},{"text":"19       PTC contends that the Court should dismiss the appeal and order the EMA to pay the costs.","paragraph_id":"para_41"},{"text":"20       Eucope asks the Court to dismiss the appeal.","paragraph_id":"para_42"},{"text":"The appeal","paragraph_id":"para_43"},{"text":"21       The EMA raises two grounds of appeal. The first alleges several manifest errors in the assessment of the facts and the second errors of law in the assessment of whether there was a prima facie case, urgency and the condition relating to the balance of interests.","paragraph_id":"para_44"},{"text":"The first ground of appeal","paragraph_id":"para_45"},{"text":"Arguments of the parties","paragraph_id":"para_46"},{"text":"22       Even though the appeal application is very difficult to read, it can be inferred that the EMA raises, in essence, two arguments in support of its first ground of appeal.","paragraph_id":"para_47"},{"text":"23       In the first place, it submits that paragraphs 57, 58 and 63 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 debatable.","paragraph_id":"para_48"},{"text":"24       In the second place, the EMA points out that the report at issue contains information submitted by PTC on the properties of the medicinal product Translarna and the effects of that product on patient health, in order to show the safety and efficacy of that product according to predefined sc …","paragraph_id":"para_49"},{"text":"25       In those circumstances, the EMA considers, in essence, that the President of the General Court was wrong, first, in paragraphs 66 and 107 of the order under appeal, to have apparently accepted that the report at issue is confidential and to have found that the information contained in the r …","paragraph_id":"para_50"},{"text":"26       In reply, PTC and Eucope contend, first of all, that the arguments advanced by the EMA repeat, to a great extent, those raised before the President of the General Court and seek to put in issue the latter’s assessment of the facts, so that, according to Eucope, they are inadmissible.","paragraph_id":"para_51"},{"text":"27       Next, as regards, more specifically, the EMA’s argument relating to the legality of its current policy on access to documents, PTC and Eucope state that the President of the General Court did not criticise that policy in the order under appeal.","paragraph_id":"para_52"},{"text":"28       Finally, PTC submits, in essence, that the report at issue, which sets out the results of the main clinical trial for Translarna, contains more details than the information available in the public domain. First, the combination of public data and secret data is, in itself, an inventive stra …","paragraph_id":"para_53"},{"text":"Findings of the Court","paragraph_id":"para_54"},{"text":"29       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.","paragraph_id":"para_55"},{"text":"30       It is clear from paragraphs 57 to 60 and 62 to 64 of that order that the President of the General Court merely observed that, before the adoption of that policy, the EMA would have considered clinical study reports, such as the report at issue, to be complex integrated documents the disclos …","paragraph_id":"para_56"},{"text":"31       In the second place, the arguments by which the EMA takes issue with the findings made by the President of the General Court in paragraphs 66, 107 and 120 of the order under appeal must be rejected as unfounded because, by those arguments, the EMA alleges that the President of the General C …","paragraph_id":"para_57"},{"text":"32       Those arguments must also be declared manifestly inadmissible in that they criticise the findings, set out in paragraphs 66, 107 and 120 of the order under appeal, that, first, the information contained in the report, taken as a whole, adds scientific value to data that, in itself, is publi …","paragraph_id":"para_58"},{"text":"33       By those arguments, the EMA seeks to call into question the President of the General Court’s assessment of the facts .","paragraph_id":"para_59"},{"text":"34       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 …","paragraph_id":"para_60"},{"text":"35       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.","paragraph_id":"para_61"},{"text":"36       It follows from all the foregoing that the first ground of appeal must be rejected as in part unfounded and in part inadmissible.","paragraph_id":"para_62"},{"text":"The second ground of appeal","paragraph_id":"para_63"},{"text":"37       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 relating to the balance of interests.","paragraph_id":"para_64"},{"text":"The first part of the second ground of appeal, alleging errors of law in the assessment of whether there was a prima facie case","paragraph_id":"para_65"},{"text":"–        Arguments of the parties","paragraph_id":"para_66"},{"text":"38       The EMA relies essentially on three arguments in support of the first part of its second ground of appeal.","paragraph_id":"para_67"},{"text":"39       In the first place, the EMA alleges, in essence, that the President of the General Court was incorrect to consider, in paragraph 67 of the order under appeal, that the fact that a substantial part of the information contained in the report at issue was already publicly available had no rele …","paragraph_id":"para_68"},{"text":"40       According to the EMA, the President of the General Court was also wrong, in paragraph 67 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.","paragraph_id":"para_69"},{"text":"41       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 report at issue, are confidential.","paragraph_id":"para_70"},{"text":"42       In that regard, the EMA submits, in essence, first, that, contrary to what appears to be accepted in paragraphs 70 to 72 of the order under appeal, the sector-specific legislation on marketing authorisation for medicinal products and orphan medicinal products for human use — namely, Regulat …","paragraph_id":"para_71"},{"text":"43       Secondly, it is clear from Article 37(4), Articles 80 and 81 and recital 67 of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ 2014 L 158, p. 1), that th …","paragraph_id":"para_72"},{"text":"44       Thirdly, the EMA submits that the general presumption that the report at issue is confidential, which underpins the order under appeal, and in particular paragraphs 74 and 75 thereof, has no basis in law.","paragraph_id":"para_73"},{"text":"45       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, documen …","paragraph_id":"para_74"},{"text":"46       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.","paragraph_id":"para_75"},{"text":"47       By contrast, the recognition that the presumption of confidentiality applies to documents submitted to the EMA for the purposes of obtaining an MA, such as the report at issue, is, according to the EMA, based on an incorrect comparison between that report and the eight categories of documen …","paragraph_id":"para_76"},{"text":"48       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 2001/83, which do not establish any confidentiality for documents such as the report at issue.","paragraph_id":"para_77"},{"text":"49       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.","paragraph_id":"para_78"},{"text":"50       Finally, the EMA considers that the reasoning relied on by the President of the General Court in support of his assertion that the report at issue is covered by a presumption of confidentiality, based on the risk that the report could be used outside the European Union, must be rejected because it is vague and hypothetical.","paragraph_id":"para_79"},{"text":"51       In the third place, the EMA submits, in essence, that the President of the General Court erred in law in considering, in paragraph 76 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 th …","paragraph_id":"para_80"},{"text":"52       In response, Eucope contends, as a preliminary issue, that the arguments raised by the EMA in the first part of its second ground of appeal should be declared inadmissible because, by those arguments, the EMA merely repeats the arguments it put forward before the President of the General Court.","paragraph_id":"para_81"},{"text":"53       As to the substance, PTC, supported by Eucope, contends that the President of the General Court did not err in law in finding that there was a prima facie case since it was not obvious that the report at issue was not confidential in nature.","paragraph_id":"para_82"},{"text":"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 report at issue, should enjoy a general presumption of confidentiality under Regulation No 1049/2001. The existence of such a presumption follo …","paragraph_id":"para_83"},{"text":"55       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 indus …","paragraph_id":"para_84"},{"text":"56       In addition, as with the eight categories of documents referred to in paragraph 45 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. In that …","paragraph_id":"para_85"},{"text":"57       Furthermore, in the same way as documents submitted by companies during procedures for reviewing state aid or mergers, the documents submitted in MA procedures are likely to contain commercially sensitive information.","paragraph_id":"para_86"},{"text":"58       Moreover, PTC and Eucope submit that the above reasoning cannot be called into question by the EMA’s argument that Regulation No 536/2014 enhanced the transparency of the documents submitted in an MA procedure. The President of the General Court was fully entitled to refuse to take that regulation into account as the decision at issue had not been adopted on the basis of that regulation.","paragraph_id":"para_87"},{"text":"59       In the second place, even though the report at issue contains 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 28 above, that disclosure of the report, in its entiret …","paragraph_id":"para_88"},{"text":"–        Findings of the Court","paragraph_id":"para_89"},{"text":"60       In order to rule on the first part of the second ground of appeal, it should be recalled, as preliminary matter, that a 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, a …","paragraph_id":"para_90"},{"text":"61       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 …","paragraph_id":"para_91"},{"text":"62       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.","paragraph_id":"para_92"},{"text":"63       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 report at issue is confidential, the EMA submits, in essence, that the President erred in law in consider …","paragraph_id":"para_93"},{"text":"64       Nonetheless, it should be observed, first, that that argument is based on a misreading of the order under appeal.","paragraph_id":"para_94"},{"text":"65       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 65 and 66 of the order. Thus, the President observed that the question arose as to whether the fact that PTC had compiled scientific data …","paragraph_id":"para_95"},{"text":"66       Second, the President of the General Court did not err in law in finding that that question raised issues which cannot be immediately resolved.","paragraph_id":"para_96"},{"text":"67       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 65 of the order under appeal, the President of the General Court noted that the present case did not concern a particular …","paragraph_id":"para_97"},{"text":"68       The President of the General Court was fully entitled to find, in paragraph 66 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 PTC used both confidential and non-confidential information for the purposes of its MA application, in that such an inventive strategy adds scientific value to elements that are not confidential in themselves.","paragraph_id":"para_98"},{"text":"69       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 debat …","paragraph_id":"para_99"},{"text":"70       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 report at issue was already in the public domain is unfounded.","paragraph_id":"para_100"},{"text":"71       To the extent that the EMA also criticises the President of the General Court for taking into account, in paragraph 67 of the order under appeal, the status of the person seeking access to the report at issue for the purposes of assessing whether that report is 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.","paragraph_id":"para_101"},{"text":"72       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 report at issue, it should be noted, at the outset, …","paragraph_id":"para_102"},{"text":"73       In so doing, the President of the General Court did not err in law.","paragraph_id":"para_103"},{"text":"74       It is true, as the EMA observes in essence, that neither Regulations Nos 141/2000, 507/2006, 726/2004 nor Directive 2001/83 establish a presumption of confidentiality for certain categories of information, nor do they expressly provide for the confidentiality of documents such as the report at issue. Moreover, Article 73 of Regulation No 726/2004 expressly provides that Regulation No 1049/2001 applies to documents held by the EMA.","paragraph_id":"para_104"},{"text":"75       However, the argument put forward by PTC at first instance that Regulations Nos 141/2000, 726/2004 and 507/2006 establish 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 medicinal product, the patient information leaflet and the EPAR, excluding all information covered by commercial secrecy, cannot be regarded as manifestly incorrect.","paragraph_id":"para_105"},{"text":"76       First, whilst, in particular, Article 11, Article 13(3) and Article 57 of Regulation No 726/2004 and Article 8 of Regulation No 507/2006 provide for the publication by the EMA of those three documents, those provisions specify that all information of a commercially confidential nature must …","paragraph_id":"para_106"},{"text":"77       Second, since neither Regulations Nos 141/2000, 726/2004 and 507/2006 nor Regulation No 1049/2001 contains any provision expressly providing that the latter regulation takes precedence over the first three regulations, or vice versa, it is impossible, prima facie, to say with certainty that …","paragraph_id":"para_107"},{"text":"78       In that regard, the argument, considered by the President of the General Court in paragraph 74 of the order under appeal, that the protection conferred by Article 14(11) of Regulation No 726/2004 does not replace that offered by a general presumption of confidentiality, in particular agains …","paragraph_id":"para_108"},{"text":"79       Finally, the President of the General Court was correct to find, in paragraph 73 of the order under appeal, that Regulation No 536/2014 could not properly be relied on by the EMA to demonstrate that there was no prima facie case because the decision at issue was not adopted on the basis of …","paragraph_id":"para_109"},{"text":"80       It follows from the foregoing that the President of the General Court did not err in law in considering that the argument advanced by PTC that there is a general presumption of confidentiality covering the report at issue is not manifestly unfounded.","paragraph_id":"para_110"},{"text":"81       That conclusion cannot be called into question on the ground that, as the EMA appears to suggest in the present appeal and as it submitted at first instance, the report at issue is not part of a dossier relating to an ongoing administrative procedure, since the procedure before the EMA was concluded upon the grant, on 31 July 2014, of a conditional MA for Translarna.","paragraph_id":"para_111"},{"text":"82       First, as PTC essentially observed, it is still required, in order to obtain a definitive MA for that medicinal product, to submit new clinical data to the EMA, complete ongoing studies or carry out new studies in order to confirm that there is a positive benefit/risk ratio for the product, in accordance with Regulation No 507/2006.","paragraph_id":"para_112"},{"text":"83       Second, and in any event, it cannot be ruled out outright that disclosure of documents such as the report 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 t …","paragraph_id":"para_113"},{"text":"84       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 report at issue, remaining confidential even after the closure of the procedure that led to the Commission issuing the MA in question.","paragraph_id":"para_114"},{"text":"85       The conclusion in paragraph 80 above is not undermined on the ground that neither the Court of Justice nor the General Court have, to date, recognised the existence of a general presumption of confidentiality in respect of documents such as the report at issue or on the ground that cases in …","paragraph_id":"para_115"},{"text":"86       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 report at issue only to applicants working in academia for reasons of strictly scientific academi …","paragraph_id":"para_116"},{"text":"87       It is clear from paragraph 76 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 72 to 85 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.","paragraph_id":"para_117"},{"text":"88       In those circumstances, it is necessary, regardless of its merits, to reject the argument raised by the EMA as ineffective.","paragraph_id":"para_118"},{"text":"89       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.","paragraph_id":"para_119"},{"text":"The second part of the second ground of appeal, alleging errors of law in the assessment of the condition relating to urgency","paragraph_id":"para_120"},{"text":"–        Arguments of the parties","paragraph_id":"para_121"},{"text":"90       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 PTC had not adduced any concrete evidence of the kind of harm that it might suffer …","paragraph_id":"para_122"},{"text":"91       In particular, the President of the General Court did not specifically assess the actual commercial value of the information contained in the report at issue, but assumed that it was substantial and that it would be lost if that report was disclosed as, in particular, paragraphs 63, 65 and …","paragraph_id":"para_123"},{"text":"92       Furthermore, the EMA submits, in essence, that in paragraphs 108 and 123 to 130 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.","paragraph_id":"para_124"},{"text":"93       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 measu …","paragraph_id":"para_125"},{"text":"94       In addition, the EMA submits that, in paragraph 122 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 granti …","paragraph_id":"para_126"},{"text":"95       PTC, supported by Eucope, disputes those arguments.","paragraph_id":"para_127"},{"text":"96       Accordingly, PTC contends, 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 report at issue was confidential, was entitled to infer from this that it could be presumed that disclosure of that report wo …","paragraph_id":"para_128"},{"text":"97       Eucope adds, in that regard, that the EMA’s arguments in respect of paragraph 108 of the order under appeal are ineffective because the grounds set out in that paragraph were included for the sake of completeness. In any event, it cannot be ruled out that those grounds are well founded. The …","paragraph_id":"para_129"},{"text":"98       Second, according to PTC, supported by Eucope, the harm caused by the disclosure of the report at issue would be irreparable. Such disclosure would deprive the decision to be given by the court adjudicating on the substance of its effectiveness. Furthermore, in addition to the financial har …","paragraph_id":"para_130"},{"text":"99       Finally, Eucope submits that the solution adopted in the 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), namely that the judge hearing an application for interim measures must examine, one by one, the arguments and e …","paragraph_id":"para_131"},{"text":"–        Findings of the Court","paragraph_id":"para_132"},{"text":"100     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 t …","paragraph_id":"para_133"},{"text":"101     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 p …","paragraph_id":"para_134"},{"text":"102     In addition, it should be noted that, in the present case, PTC alleged, before the President of the General Court, that even though it contained certain information in the public domain, the report at issue was, on the whole, confidential and disclosure of the report would be likely to cause …","paragraph_id":"para_135"},{"text":"103     Furthermore, it is clear from paragraphs 63 to 85 of this order that the President of the General Court considered, without erring in law, that a prima facie examination of the arguments made by PTC did not justify the conclusion that the report at issue, which is a body of complex information combining, in a consolidated form, public and non-public data, was obviously not confidential.","paragraph_id":"para_136"},{"text":"104     Consequently, the President of the General Court was required necessarily, for the purposes of assessing urgency, to start from the premiss that the report was in fact a body of complex information which, in itself, was confidential for the purposes of Article 339 TFEU, the first indent of A …","paragraph_id":"para_137"},{"text":"105     It is necessary to rule on the second part of the second ground of appeal in the light of those considerations.","paragraph_id":"para_138"},{"text":"106     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 …","paragraph_id":"para_139"},{"text":"107     Those two groups of arguments should be examined in turn.","paragraph_id":"para_140"},{"text":"108     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 sub …","paragraph_id":"para_141"},{"text":"109     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 …","paragraph_id":"para_142"},{"text":"110     Moreover, as stated in paragraphs 102 to 104 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 report at issue was confidential, not because each piece of information or each …","paragraph_id":"para_143"},{"text":"111     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 report at issue, taken individually.","paragraph_id":"para_144"},{"text":"112     As regards, in the second place, the serious and irreparable nature of the harm alleged by PTC, it must be noted that the President of the General Court found, starting from the premiss that the report at issue in fact constituted a body of complex confidential information, that disclosure of the report would necessarily cause significant harm to that company.","paragraph_id":"para_145"},{"text":"113     In that regard, the President of the General Court stated, in paragraph 107 of the order under appeal, that the report at issue, which contained pharmaceutical scientific evaluations forming part of the file prepared by PTC for the purposes of obtaining an MA, concerned the manufacturing and …","paragraph_id":"para_146"},{"text":"114     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 report at issue and of the risk.","paragraph_id":"para_147"},{"text":"115     It is true that the EMA disputes the factual findings made in paragraph 107. However, as stated in paragraphs 32 to 35 of this order, such an argument is inadmissible in an appeal.","paragraph_id":"para_148"},{"text":"116     Furthermore, while the EMA submits that the President of the General Court erred in law, in paragraph 108 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 …","paragraph_id":"para_149"},{"text":"117     Contrary to the EMA’s allegation, the President of the General Court did not assume a risk of irreparable harm but established it in the light of the arguments relied on by the parties.","paragraph_id":"para_150"},{"text":"118     Thus, after observing, in paragraph 111 of the order under appeal, that the annulment of the decision at issue could not reverse the effects of disclosure of the report at issue, the President of the General Court stated, in paragraphs 112 to 122 of the order, first, that such disclosure wou …","paragraph_id":"para_151"},{"text":"119     Finally, the President of the General Court stated that the financial harm that PTC might suffer if the report at issue was disclosed could not be quantified. In view of the erga omnes effect that disclosure of the report at issue would have, an indeterminate number of PTC’s competitors coul …","paragraph_id":"para_152"},{"text":"120     It must be observed, first of all, that the EMA does not call into question the conclusion of the President of the General Court relating to the possibility that third party applicants would exploit the report at issue, if it was disclosed, for whatever purpose, 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.","paragraph_id":"para_153"},{"text":"121     Next, while the EMA disputes the claim that disclosure of the report at issue might thwart the future development plans for Translarna, 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 32 to 35 above.","paragraph_id":"para_154"},{"text":"122     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 123 to 130 of the order under appeal, that it was necessary to recognise urgency even if the harm alleged by PTC could not be classified as irreparable. No …","paragraph_id":"para_155"},{"text":"123     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 …","paragraph_id":"para_156"},{"text":"124     In the present case, the President of the General Court established, in paragraphs 119 to 121 of the order under appeal, that having regard to its nature and the way in which it would occur, the financial harm claimed by PTC could not be quantified, a finding which, in itself, is not criticised by the EMA in the present appeal.","paragraph_id":"para_157"},{"text":"125     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, PTC was not required to establish, in addition, that it would be in a position tha …","paragraph_id":"para_158"},{"text":"126     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 report at issue would, with a sufficient degree of probability, place PTC at risk of serious and irreparable harm.","paragraph_id":"para_159"},{"text":"127     In those circumstances, the second part of the second ground of appeal must be rejected as in part inadmissible and in part ineffective.","paragraph_id":"para_160"},{"text":"The third part of the second ground of appeal, alleging errors of law in the assessment of the balance of interests","paragraph_id":"para_161"},{"text":"–        Arguments of the parties","paragraph_id":"para_162"},{"text":"128     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 report at issue, without waiting for the judgment on the substance, and that the balancing exercise should have been resolved in its favour.","paragraph_id":"para_163"},{"text":"129     However, 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 f …","paragraph_id":"para_164"},{"text":"130     In addition, by requiring, in paragraph 85 of the order under appeal, that the EMA prove that disclosure of the report at issue met an overriding need to protect public health from a specific danger posed by Translarna, the President of the General Court imposed an obligation on that agency …","paragraph_id":"para_165"},{"text":"131     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.","paragraph_id":"para_166"},{"text":"132     Eucope replies that the arguments advanced by the EMA should be declared inadmissible because they merely repeat arguments that were raised before the General Court.","paragraph_id":"para_167"},{"text":"133     As to the substance, PTC submits, in essence, that any interference with the public interest in transparency is merely temporary. Furthermore, the public already has information as a result of the publication of the summary of the characteristics of Translarna, the patient information leaflet and the EPAR. On the other hand, the rejection of the application for interim measures would deprive the main action of any practical effect.","paragraph_id":"para_168"},{"text":"–        Findings of the Court","paragraph_id":"para_169"},{"text":"134     For the purpose of ruling on the third part of the second ground of appeal, it should be recalled that, in accordance with 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 …","paragraph_id":"para_170"},{"text":"135     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.","paragraph_id":"para_171"},{"text":"136     In those circumstances, the dismissal of the application for interim measures by the President of the General Court and the subsequent disclosure of the report at issue by the EMA would clearly deprive any judgment annulling the decision at issue of any practical effect. From the very fact o …","paragraph_id":"para_172"},{"text":"137     The arguments advanced by the EMA do not support the conclusion that the President of the General Court erred in law in finding that PTC’s interests in obtaining the suspension it sought outweighed that of the EMA in having the application for interim measures dismissed.","paragraph_id":"para_173"},{"text":"138     The EMA essentially simply relies on the public interest in obtaining immediate access to the report at issue. Thus, in particular, as the President of the General Court observed in paragraph 85 of the order under appeal, the EMA did not argue that the immediate need to disclose the report, …","paragraph_id":"para_174"},{"text":"139     Thus, the President of the General Court did not err in law, in paragraph 90 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 characteristic …","paragraph_id":"para_175"},{"text":"140     In those circumstances, the President of the General Court was fully entitled to find that PTC’s interest in obtaining suspension of the operation of the decision at issue outweighed that of the EMA in obtaining the immediate implementation of that decision.","paragraph_id":"para_176"},{"text":"141     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 o …","paragraph_id":"para_177"},{"text":"142     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.","paragraph_id":"para_178"},{"text":"143     It follows that the appeal must be dismissed in its entirety.","paragraph_id":"para_179"},{"text":"Costs","paragraph_id":"para_180"},{"text":"144     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.","paragraph_id":"para_181"},{"text":"145     Since PTC has 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, in addition to its own costs, the costs incurred by PTC in these appeal proceedings.","paragraph_id":"para_182"},{"text":"146     In accordance with Article 184(4) of the Rules of Procedure of the Court of Justice, Eucope is to bear its own costs relating to the present appeal proceedings.","paragraph_id":"para_183"},{"text":"On those grounds, the Vice-President of the Court hereby orders:","paragraph_id":"para_184"},{"text":"1.       The appeal is dismissed.","paragraph_id":"para_185"},{"text":"2.       The European Medicines Agency (EMA) is, in addition to bearing its own costs, to pay the costs incurred by PTC Therapeutics International Ltd relating to the appeal proceedings.","paragraph_id":"para_186"},{"text":"3.       The European Confederation of Pharmaceutical Entrepreneurs (Eucope) is to bear its own costs relating to the appeal proceedings.","paragraph_id":"para_187"},{"text":"Luxembourg, 1 March 2017.","paragraph_id":"para_188"},{"text":"A. Calot Escobar","paragraph_id":"para_189"},{"text":"A. 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