ORDER OF THE PRESIDENT OF THE GENERAL COURT
20 July 2016 (*)
(Application for interim measures — Access to documents — Regulation (EC) No 1049/2001 — Documents held by the EMA concerning information submitted by an undertaking as part of its application for authorisation to place a medicinal product on the market — Decision to grant a third party access to the documents — Application for suspension of operation of a measure — Urgency — Prima facie case — Weighing up of interests)
In Case T‑718/15 R,
PTC Therapeutics International Ltd, established in Dublin (Ireland), represented by G. Castle, B. Kelly, H. Billson, Solicitors, M. Demetriou QC, and C. Thomas, Barrister,
applicant,
supported by
European Confederation of Pharmaceutical Entrepreneurs (Eucope), established in Brussels (Belgium), represented by S. Cowlishaw, Solicitor, and D. Scannell, Barrister,
intervener,
v
European Medicines Agency (EMA), represented by T. Jabłoński, A. Spina, A. Rusanov, S. Marino and N. Rampal Olmedo, acting as Agents,
defendant,
APPLICATION pursuant to Articles 278 TFEU and 279 TFEU for, in essence, the suspension of operation of Decision EMA/722323/2015 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 containing information submitted in the context of an application for marketing authorisation for the medicinal product Translarna,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
Background to the dispute, procedure and forms of order sought
1        The European Medicines Agency (EMA), established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), has as its main responsibility the protection and promotion of public and animal health, through the evaluation and supervision of medicinal products for human and veterinary use. To that end, the EMA is responsible for the scientific evaluation of applications for EU marketing authorisations (‘MAs’) for medicinal products (centralised procedure). Under the first subparagraph of Article 57(1) of Regulation No 726/2004, the EMA is to provide the Member States and the institutions of the European Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it.
2        Article 6 of Directive 2001/83/EC of the European Parliament and of 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, provides that no medicinal product for human use may be placed on the market of a Member State unless an MA has been issued by the competent authorities of that Member State in accordance with that directive or under the centralised procedure in accordance with Regulation No 726/2004. That procedure entails the submission, by the pharmaceutical company concerned, of an MA application, which is examined by the EMA and on which the EMA produces an opinion, and a decision by the European Commission on the MA. The documentary information which an MA applicant is to provide must allow the EMA, in the interest of public health, to take its decision on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, in order to assess the risk-benefit balance of that product. Exclusive responsibility for preparing the EMA’s opinions on all questions concerning medicinal products for human use is to be vested in a Committee for Medicinal Products for Human Use (‘CHMP’).
3        Under Article 13(3) of Regulation No 726/2004, the EMA is to publish the European Public Assessment Report (‘EPAR’) on the medicinal product for human use drawn up by the CHMP, namely a summary of the product’s characteristics that is understandable to the public, and the reasons for its opinion in favour of granting the MA, after deletion of any information of a commercially confidential nature.
4        The first paragraph of Article 73 of Regulation No 726/2004 states that Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43), a regulation which is aimed at ensuring the widest possible public access to documents held by the EU administrative bodies, is applicable to documents held by the EMA. Under Article 4 of Regulation No 1049/2001:
–        the institutions are to refuse access to a document where disclosure would undermine, inter alia, the protection of commercial interests of a natural or legal person, including intellectual property, unless there is an overriding public interest in disclosure (paragraph 2, first indent);
–        as regards third-party documents, the institution is to consult the third party with a view to assessing whether an exception notably in paragraph 2 is applicable, unless it is clear that the document must or must not be disclosed (paragraph 4);
–        if only parts of the requested document are covered by any of the exceptions, the remaining parts of the document are to be released (paragraph 6);
–        the exceptions as laid down, in particular, in paragraph 2 may apply for a maximum period of 30 years or may, if necessary, continue to apply after that period (paragraph 7).
5        Regulation No 726/2004 confers on the EMA the power 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. In December 2006, the EMA adopted rules for the implementation of Regulation No 1049/2001 on access to its documents. In order to further enhance its transparency, the EMA then amended its policy on access to EMA documents (‘policy on access’) in November 2010, in order to ensure the widest possible access to EMA documents concerning any matter related to the policies, activities and decisions falling within the EMA’s remit and responsibilities, prioritising access to documents containing essential scientific information concerning the safety and efficacy of an authorised medicinal product. That new policy on access provides, in particular, that documents submitted to the EMA in connection with an MA application may be disclosed from the moment the decision-making process in respect of that application has been finalised.
6        The applicant, PTC Therapeutics International Ltd, 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 used to treat a condition called ‘Duchenne muscular dystrophy’ (‘DMD’), a medicinal product which is sold by the applicant under the trade name Translarna.
7        DMD is a rare, disabling and ultimately fatal genetic disorder which primarily affects males and which gradually causes weakness and loss of muscle function. DMD is caused by several types of mutations in the gene for the protein ‘dystrophin’, a protein which is critical, in particular, to the structural stability of myofibers in skeletal, disphragmatic and cardiac muscle. There are fewer than 20 000 individuals with DMD in the European Union. Approximately 13% of patients with DMD have the disorder due to a so-called nonsense mutation. Translarna treats DMD caused specifically by such a nonsense mutation. Apart from Translarna, no curative therapies are available for DMD, management of the disorder being based on prevention and management of complications, notably through the use of corticosteroids.
8        In October 2012, the applicant submitted an MA application to the EMA, under the centralised procedure, for Translarna, for the treatment of DMD resulting from a nonsense mutation in the dystrophin gene, in patients aged 5 years and older, stating that the presence of a nonsense mutation in the dystrophin gene had to be determined by genetic testing. In January 2014, the CHMP decided against granting an MA, on the ground that the benefits of Translarna had not been shown to outweigh its risks. Following the applicant’s request for re-examination, the CHMP recommended, in May 2014, the grant of a conditional MA for Translarna, as provided for in Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2006 L 92, p. 6), which meant, in particular, that Translarna addressed an unmet medical need for patients suffering from a life-threatening disease, but that comprehensive clinical data were not yet available.
9        On 31 July 2014, the Commission granted a conditional MA for Translarna for the treatment of DMD in patients aged 5 years and older who are able to walk, requiring the applicant to generate further confirmatory data on the benefits of the product. The applicant is currently working on the final report, which involves the completion of a global, confirmatory Phase 3 clinical trial for the use of Translarna to treat nonsense mutation DMD and the submission of additional efficacy and safety data from the trial.
10      The conditional MA was granted for Translarna as an ‘orphan medicinal product’, within the meaning of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1), that is to say, medicinal products intended for the diagnosis, prevention or treatment of rare conditions. In order to promote the development of effective treatments for patients affected by rare conditions, that regulation introduces a system of incentives to encourage pharmaceutical companies to invest in research, development and the bringing to the market of orphan medicinal products.
11      According to recital 8 of Regulation No 141/2000, the strongest incentive for the pharmaceutical industry to invest in the development and marketing of orphan medicinal products is where there is a prospect of obtaining market exclusivity for a certain number of years during which part of the investment might be recovered. Consequently, Article 8 of Regulation No 141/2000 provides, in essence, that orphan medicinal products in respect of which an MA has been granted enjoy market exclusivity for a period of 10 years, during which no other MA will be issued for the same therapeutic indication or in respect of a similar medicinal product. That exclusivity may, however, be removed if, inter alia, another undertaking can establish that its medicinal product is safer, more effective or otherwise clinically superior.
12      On 13 October 2015, the EMA informed the applicant that, on 29 July 2015, a pharmaceutical company had sent it a request pursuant to Regulation No 1049/2001 for access to a clinical study report that was included in the Translarna dossier. The report is a Phase 2B placebo-controlled efficacy and safety study of Ataluren in subjects with nonsense mutation Duchenne and Becker muscular dystrophy. The document is the main clinical study conducted prior to the granting of a conditional MA in respect of Translarna (‘the report at issue’).
13      On 5 November 2015, the EMA refused the applicant’s request for the report at issue to be treated as confidential in its entirety. In its response of 12 November 2015, the applicant maintained its stance that the entire report at issue should be treated as confidential, which was why it refused to redact particular passages.
14      On 25 November 2015, the EMA adopted Decision EMA/722323/2015, granting to a third party, pursuant to Regulation No 1049/2001, access to the entire report at issue, subject to certain redactions made by the EMA itself, such as references to discussions on protocol design with the competent United States authority, batch numbers, materials and equipment, exploratory assays, the quantitative and qualitative description of the method for drug concentration measurement, and the start and end dates of treatment and further dates that could lead to the identification of the patients (‘the contested decision’). In support of that decision, the EMA claimed, in essence, that access to the whole document could not have been refused unless the applicant had demonstrated that each and every element of the document was confidential. In the absence of such proof, the EMA stated that it was difficult for it to conceive that the entire content of the document was covered by the confidentiality of commercial information and personal data.
15      By application lodged at the Court Registry on 9 December 2015, the applicant brought an action for annulment of the contested decision or, should the Court not consider the report at issue to be confidential in its entirety, for the case to be remitted to the EMA for further consideration and the applicant to be given the opportunity to identify specific passages of that report for redaction. In support of that action, it alleges, in essence, infringement of Article 4(2) of Regulation No 1049/2001.
16      By separate document, lodged at the Court Registry on the same date, the applicant brought the present application for interim measures, in which it claims, in essence, that the President of the General Court should:
–        suspend the operation of the contested decision;
–        order the EMA to refrain from any form of disclosure of the report at issue;
–        order the EMA to pay the costs of the proceedings for interim measures.
17      On 10 December 2015, the EMA informed the applicant for access that an action had been brought for annulment of the contested decision and an application made for interim measures, and that, in those circumstances, it was not in a position to release the report at issue before the end of the proceedings for interim measures.
18      At the request of the applicant and with the agreement of the EMA, the President of the General Court decided, on 18 January 2016, to stay the present proceedings for interim measures, pursuant to Article 69(c) of the Rules of Procedure of the General Court, until a final decision had been given in the proceedings before the Vice-President of the Court of Justice in Case C‑550/15 P(R) concerning the appeal brought by the EMA against the order of 1 September 2015 (Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587). Following the order of 17 March 2016 in EMA v Pari Pharma (C‑550/15 P(R), not published, EU:C:2016:196), in which the Vice-President of the Court of Justice ruled that there was no need to adjudicate on that appeal, the present proceedings for interim measures were resumed.
19      In its observations on the application for interim measures, which were lodged at the General Court Registry on 11 April 2016, the EMA contends that the President of the General Court should:
–        dismiss that application;
–        order the applicant to pay the costs.
20      The applicant responded to the EMA’s observations in a pleading of 25 April 2016. The EMA adopted a final position on that pleading in a pleading of 13 May 2016.
21      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 over 900 European pharmaceutical and biotech companies, including small and medium-sized enterprises, was granted leave to intervene in support of the form of order sought by the applicant. On 25 April 2016, it lodged its statement in intervention, in which it endorses the applicant’s submissions. By pleadings dated 12 and 13 May 2016, the main parties commented on the statement in intervention.
Law
General
22      It is apparent from Articles 278 TFEU and 279 TFEU, read in conjunction with Article 256(1) TFEU, that a judge hearing applications for interim measures may, if he considers that circumstances so require, order that application of an act contested before the General Court be suspended or prescribe any necessary interim measures, and he may do so pursuant to Article 156 of the Rules of Procedure.
23      Article 156(3) of the Rules of Procedure provides that applications for interim measures must state the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for. Thus, suspension of the operation of an act and other interim measures may be ordered by the judge hearing the application if it is established that such an order is justified, prima facie, in fact and in law and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached on the main action. Those conditions are cumulative, so that an application for interim measures must be dismissed if either of them is absent (order of 14 October 1996 in SCK and FNK v Commission, C‑268/96 P(R), EU:C:1996:381, paragraph 30).
24      In the context of that overall examination, the judge hearing the application enjoys a broad discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (orders of 19 July 1995 in Commission v Atlantic Container Line and Others, C‑149/95 P(R), EU:C:1995:257, paragraph 23, and of 3 April 2007 in Vischim v Commission, C‑459/06 P(R), not published, EU:C:2007:209, paragraph 25). Where appropriate, the judge hearing such an application must also weigh up the interests involved (order of 23 February 2001 in Austria v Council, C‑445/00 R, EU:C:2001:123, paragraph 73).
25      Having regard to the material in the case-file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties. In the circumstances of the present case, it is appropriate to examine first of all whether the condition relating to a prima facie case is satisfied.
Whether there is a prima facie case
26      According to settled case-law, the condition relating to the establishment of a prima facie case is satisfied where at least one of the pleas in law put forward by the applicant for interim measures in support of the main action appears, prima facie, 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 (see order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 22 and the case-law cited).
27      In the present case, the applicant maintains that the contested decision infringes, inter alia, the first indent of Article 4(2) of Regulation No 1049/2001, Article 339 TFEU and its fundamental rights as regards the protection of privacy and of professional data under Article 7 of the Charter of Fundamental Rights of the European Union, as interpreted in the judgment of 14 February 2008 in Varec (C‑450/06, EU:C:2008:91, paragraphs 47 to 49). The report at issue should be presumed to be confidential and, therefore, protected under those provisions, since its release would seriously undermine its commercial interests and there is no overriding public interest in disclosure. In any event, in compliance with the principle of proportionality, the EMA should have considered whether there were alternatives to the report’s full disclosure with erga omnes effect (see paragraph 114 below), such as limiting its communication to independent academic researchers, who would not use it for commercial purposes.
28      The applicant notes that the context for the contested decision is a change in policy on the part of the EMA (see paragraph 5 above). Until November 2010, it was the EMA’s policy to treat the contents of MA dossiers, notably clinical study reports, as presumptively confidential in nature. However, in an abrupt change of direction, the EMA adopted a new policy, pursuant to which most of the contents of such dossiers are disclosed once an MA has been granted. That new policy has never been examined by the Courts of the European Union in a final hearing. The applicant submits that the proper resolution of this issue is of profound importance to the stakeholders in the wider pharmaceutical market and in particular to the applicant, whose business depends on proper protection of its know-how concerning its flagship product Translarna.
29      The applicant submits that the development and manufacture of medicines is a very expensive process. An MA holder has absorbed considerable expense and invested significant time and expertise in navigating the regulatory process. Clinical and regulatory documentation generated as part of the MA process thus represents the fruits of significant commercial investment on the part of the MA holder. The applicant submits that the need to ensure that MA applicants’ incentives are properly aligned applies with special force in relation to orphan medicines, the market for which is quite small and, therefore, potentially non-profitable, given that the very small number of eligible patients makes performing safety and efficacy studies difficult. Consequently, the first-off-the-mark originator who has dared to invest in bringing an orphan medicinal product to market should be able to benefit fully from the commercial exclusivity granted. However, that advantage would be lost if the originator’s know-how were disclosed to competitors who could use it both inside and outside the European Union to develop their own rival product, to obtain an MA for their own orphan medicinal products or to obtain an MA for a product similar to or even — outside the European Union — identical to the originator’s product. Those factors are further magnified in the case of Translarna, an ‘ultra-orphan’ medicinal product, since the condition treated affects only 1 in 50 000 persons.
30      According to the applicant, the report at issue relates to the most important clinical study in the Translarna MA dossier. The report provides in-depth evaluation of the data collected, insights into study design, criteria selection and statistical approach, and a detailed description of how the applicant runs its clinical studies. Further, as a formal submission to a regulatory agency, the report was subject to the level of quality control suitable for documents of that nature. Therefore, the report demonstrates how information can be presented effectively to a regulator.
31      The applicant asserts that the summaries of clinical trials proposed to be made public pursuant to Regulation No 1049/2001 are short and of a very different nature from documents submitted in an MA dossier. They provide only a brief summary of a trial and its results, with a level of detail comparable to the discussion of clinical trial results in the EPAR, whereas non-clinical and clinical study reports (such as the report at issue) provide a comprehensive discussion and interpretation of the results of the trials and may contain much proprietary information.
32      The applicant states that the report at issue should be treated as confidential in its entirety, even if parts of that report have already been disclosed in the EPAR or in scientific journals. It maintains that it assembled in that report the trial data, study design, analysis, and presentation of clinical information following an inventive strategy. According to the applicant, the report at issue thus forms an inseparable whole with economic value, and it is therefore irrelevant that some elements of information contained in it may already be in the public domain.
33      The applicant submits that the report at issue must be covered by a general presumption of confidentiality. Where access to documents is sought under Regulation No 1049/2001 within a context to which specific legislation pursuing different objectives applies, the EU judicature must endeavour to ensure that each body of measures is applied in a manner which is compatible with the other and which enables the coherent application of them both, unless there is a provision expressly giving one primacy over the other. Thus, the case-law recognises that documents submitted in the context of an administrative procedure covered by specific sectoral legislation are protected by a general presumption of confidentiality for the purposes of Article 4(2) of Regulation No 1049/2001, subject to the possibility of demonstrating, by reference to the particular circumstances of the case, that a particular document falls outside that presumption, or that its disclosure is justified by an overriding public interest. In that context, the applicant relies, in particular, on the judgments of 29 June 2010 in Commission v Bavarian Lager (C‑28/08 P, EU:C:2010:378), and of 28 June 2012 in Commission v Agrofert Holding (C‑477/10 P, EU:C:2012:394).
34      The applicant states that Regulations No 141/2000, No 726/2004 and No 507/2006 are characterised by a system of well-defined rules as regards the treatment of documents obtained and generated by the competent authorities in the context of the regulation of medicinal products for human use. Those rules thus constitute a comprehensive legislative code laying down specific requirements for the release of information by the EMA so as to ensure transparency, while giving effect to the need to protect commercially confidential information.
35      The applicant concludes from this that the three key documents to be disclosed from the MA dossier are the summary of product characteristics, the patient information leaflet and the EPAR. In its view, all that information together is more than sufficient to provide adequate information to the public regarding the medicinal product in question. Regulations No 141/2000, No 726/2004 and No 507/2006 thus contain detailed provisions as to the information contained in an MA dossier which the EMA must make publicly available. In the context of the competitive and innovative pharmaceutical industry, and particularly in the sensitive context of orphan and ‘ultra-orphan’ medicinal products, those provisions strike a balance between, on the one hand, the interests of transparency, legitimate public interest considerations, and the desirability of avoiding duplicative research, and, on the other hand, the need to give undertakings a proper incentive to invest in research and development without their having to fear that competitors will be able to ‘free-ride’ on their innovation.
36      The applicant observes that the documents provided to the EMA by an MA applicant represent the expensive output of that applicant and are potentially of significant value to competitors in that they provide details of the pathway to obtaining the MA. Consequently, the MA holder is entitled to a period of exclusivity, during which its data can only be used by the regulator, and competitors who wish to obtain an MA for the same active ingredient are obliged to invest in their own research, tests and clinical trials. Even after the period of exclusivity has ended, the information is not disclosed to competitors, the position being simply that the requirement for competitors to undertake a full suite of trials themselves is waived. It is therefore of the very essence of the MA regime that all documents submitted as part of an MA dossier, and in particular reports relating to clinical and non-clinical studies, are entitled to the protection of a general presumption of confidentiality for the purposes of Article 4(2) of Regulation No 1049/2001.
37      Relying on the judgments of 28 June 2012 in Commission v Éditions Odile Jacob (C‑404/10 P, EU:C:2012:393), and of 12 May 2015 in Unión de Almacenistas de Hierros de España v Commission (T‑623/13, not published, EU:T:2015:268), the applicant submits that the period during which that general presumption of confidentiality applies cannot expire once the decision to grant an MA has been made. It maintains that there is nothing about the date of that decision that changes the confidential nature of the documents which the MA applicant has entrusted to the EMA. Furthermore, Article 4(7) of Regulation No 1049/2001 itself contemplates that commercial confidentiality may endure for more than 30 years.
38      The intervener observes that the applicant for access in the present case is an unknown pharmaceutical company, so as to emphasise that that is more often than not the case. Thus, requests for access under Regulation No 1049/2001 to documents forming part of MA dossiers have increased in recent years, primarily because of the EMA’s about-turn as regards its policy on access. That development is troubling, according to the intervener, since such requests have for the most part been made in a purely commercial context by competitors of the companies to which those confidential documents belong. The competitor companies requesting such access are often substantially larger and better-resourced than the companies whose confidential documents they seek to obtain. They are able to act swiftly upon receipt of the confidential information, capitalising on it both within and beyond the European Union’s external borders.
39      The EMA replies that the results of clinical trials submitted by a pharmaceutical undertaking that has received an MA for a medicinal product for human use benefit, under Article 14(11) of Regulation No 726/2004, from a data exclusivity period of eight years — which may be extended — during which competitors of that undertaking are unable to make use of that information in order to support their own MA applications. In view of that data exclusivity, there is no provision in Regulation No 726/2004 or Directive 2001/83 for the confidentiality of information contained in clinical study reports submitted by MA applicants.
40      The EMA denies that the release of the report at issue would provide competitors of the applicant with a road-map for obtaining an MA for a medicinal product containing the same active ingredient as Translarna. First, that report does not contain any information on the composition or manufacturing of Translarna and, second, the EMA had agreed to redact commercially confidential information concerning references to discussions on protocol design with the competent United States authority, batch numbers, materials and equipment, exploratory assays, the quantitative and qualitative description of the method for drug concentration measurement, and the start and end dates of treatment and further dates that could lead to the identification of the patients. Far from disputing the fact that some parts of the report at issue may contain commercially confidential information, the EMA maintains that it actually protects that information. However, it cannot be claimed that the information related to the clinical effects of Translarna should be subject to the same level of protection.
41      The EMA also disputes the argument that disclosure of the report at issue would provide the applicant’s competitors with useful information on the long-term clinical development strategy and study design over and above the information on Translarna that is already publicly available. Very detailed and publicly available clinical information has already been published in the EPAR on Translarna, including on the clinical study methods (participants, treatments, objectives, end points, sample size, randomisation, blinding (masking), statistical methods), recruitment, conduct of the study, baseline data, numbers analysed, outcomes and estimations, as well as ancillary analyses. The EPAR also contains a summary of the main study, a detailed description of the post-hoc analysis of the primary effect on a sub-population and the conclusions that can be drawn from the study results as regards the efficacy and safety profile of the medicinal product. In addition, the overall study programme is provided in the EPAR, showing the clinical strategy of the product development in the indication. Moreover, according to the EMA, the most relevant clinical data contained in the MA dossier for Translarna have already been published in scientific journals.
42      The EMA adds that all clinical trials included in applications for MAs for medicinal products for human use must have been carried out in accordance with the requirements set out in Directive 2001/83, as regards the format, presentation and content of the studies to be reported. Furthermore, one of the major roles of the EMA is to produce public guidance on the conduct of the various clinical studies that are necessary in order to secure an MA. Thus, the EMA has published scientific guidelines on clinical trials, including clinical safety, following agreement on a harmonised approach between the European Union, Japan and the United States of America by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Those guidelines provide pharmaceutical companies, including the applicant, with information on how to present the dossier in support of an MA application. Consequently, according to the EMA, the applicant has not produced proof of any innovation.
43      In so far as the applicant maintains that the report at issue is covered in its entirety by a general presumption of confidentiality, the EMA submits that that interpretation, if upheld, would constitute a serious set-back in the development of the right of access to documents held by the EU institutions. The general presumption invoked by the applicant would create a category of documents excluded from the general provisions on access to documents under Regulation No 1049/2001, which would be contrary to the aim, purpose and spirit of that regulation and its interpretation by the Court of Justice. The applicant’s position fails, in particular, to recognise the fundamental nature of transparency and the particular and restricted circumstances in which the case-law accepts a general presumption of confidentiality.
44      In that context, the EMA states that the Court of Justice has recognised that documents relating to the State-aid review procedure, to merger control proceedings, to the pre-litigation stage infringement procedure and to the Article 101 TFEU enforcement procedure, as well as pleadings in court proceedings enjoy a general presumption of confidentiality (see, to that effect, judgments of 29 June 2010 in Commission v Technische Glaswerke Ilmenau, C‑139/07 P, EU:C:2010:376, paragraph 51; of 21 September 2010 in Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 94; of 28 June 2012 in Commission v Éditions Odile Jacob, C‑404/10 P, EU:C:2012:393, paragraph 123; of 14 November 2013 in LPN and Finland v Commission, C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 65; of 27 February 2014 in Commission v EnBW, C‑365/12 P, EU:C:2014:112, paragraph 93; and of 16 July 2015 in ClientEarth v Commission, C‑612/13 P, EU:C:2015:486, paragraph 77). In each of those five categories, the refusal of access related to a set of documents which were clearly defined by the fact that they all belonged to a file relating to ongoing administrative or judicial proceedings, and the Court had emphasised the requirement that the presumption of confidentiality be applied strictly.
45      The EMA goes on to recall that the General Court has recognised the existence of general presumptions of confidentiality in three additional situations, in cases concerning: the bids submitted by tenderers in a public procurement procedure in the event that a request for access is made by another tenderer (judgment of 29 January 2013 in Cosepuri v EFSA, T‑339/10 and T‑532/10, EU:T:2013:38, paragraph 101); the documents relating to a specific procedure, the ‘EU Pilot’ procedure (judgment of 25 September 2014 in Spirlea v Commission, T‑306/12, EU:T:2014:816, paragraph 63); and the documents sent by the national competition authorities to the Commission pursuant to Article 11(4) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101 TFEU] and [102 TFEU] (OJ 2003 L 1, p. 1) (judgment of 12 May 2015 in Unión de Almacenistas de Hierros de España v Commission, T‑623/13, not published, EU:T:2015:268, paragraph 64).
46      According to the EMA, it follows from that case-law that the application of general presumptions is essentially dictated by the need to ensure the operation of the specific procedures at issue, by limiting intervention by third parties. In the present case, the establishment of a general presumption of confidentiality as claimed by the applicant finds no precedent in the abovementioned case-law, has no basis in EU law and is incompatible with the requirement that such a presumption must be applied strictly, since that presumption is an exception to the rule that a specific and individual examination must be made of every document that is the subject of a request for access, and to the principle of the widest possible public access to documents held by the EU institutions. Furthermore, the administrative procedure concerned is no longer ongoing, having been concluded with the granting of an MA for Translarna in 2014.
47      The EMA adds that, in the case-law referred to above, the presumption of confidentiality was accepted in order to prevent a third party from being put in a more favourable position than the party obliged to accept access being given to its documents. In the present case, however, access to the report at issue would not harm the applicant’s interests, since access would be given only after the procedure for issuing the MA for Translarna had been completed, the competitive advantage of the applicant being protected under the relevant provisions of EU pharmaceutical legislation granting data and market exclusivity. In addition, Regulation No 726/2004 does not establish a specific access regime for documents. Rather than impose on the EMA specific requirements to protect commercially confidential information, that regulation provides, in Article 73, for Regulation No 1049/2001 to be directly applicable. In particular, there is no provision of Regulation No 726/2004 or of EU law indicating that clinical study reports submitted by MA applicants must be considered to contain commercially confidential information.
48      In so far as the applicant submits that the general presumption of confidentiality invoked is applicable after the date on which the MA was granted in respect of Translarna, the EMA contends that the report at issue forms the basis for the risk-benefit assessment of that medicinal product with regard to human health. Once a medicinal product has received an MA, the obligation of the EMA to disclose scientific information contained in the MA dossier, under Regulation No 1049/2001, stems from the obligation to ensure that patients and healthcare professionals are not provided with incomplete and selective information. According to the EMA, the applicant’s contrary view disregards the fact that the main pillar of EU pharmaceutical law is the protection of public health.
49      In response to the complaint that the EMA failed to weigh up the various interests, the EMA notes that it is only if there is a general presumption of confidentiality that it is obliged under Article 4(2) of Regulation No 1049/2001 to assess whether an overriding public interest justifies the disclosure of the relevant documents. Yet the report at issue does not enjoy the benefit of such a presumption. The applicant makes a fundamental error by overlooking the fact that any document held by the EMA is generally accessible to the public, unless there is an exception to protect legitimate commercial interests. Since the exception referred to in the first indent of Article 4(2) of Regulation No 1049/2001 does not apply to the report at issue, it is not necessary to justify its disclosure on the basis of an overriding public interest.
50      The EMA explains that healthcare professionals have warned of the harmful consequences, from a public health perspective, of concealing scientific data on clinical, pharmacological and toxicological experiments. Such concealment is said to delay the development of knowledge and entail the risk that consumers of a drug may be injured unnecessarily. The EMA submits that the scientific community fears that confidentiality may prevent the scrutiny of the scientific basis of an MA, which makes it impossible to determine the extent of commercial influence, particularly since drug companies have an interest in not publishing research that is not favourable to their products. It states, however, that this should not be taken to mean that it is implying that MA applicants submit misleading or incomplete data. In any event, the data submitted in the framework of an MA application is reviewed by experts from competent authorities, including the EMA, before an MA is granted.
51      Lastly, the EMA disputes the applicant’s argument, based on fundamental rights, that it should have considered whether there might be less restrictive alternatives to full disclosure. Under Article 73 of Regulation No 726/2004 the EMA is obliged to apply the provisions of Regulation No 1049/2001 to all the documents held by it, including those submitted by pharmaceutical undertakings for the purpose of obtaining an MA. The widest possible access should be granted not only to patients and doctors or researchers but also to other actors in the market. Consequently, the EMA is not in a position to refuse access to the report at issue in its entirety, given that the applicant failed to demonstrate how each element of that document was confidential. Access to a document held by the EMA may be refused in its entirety only if one or more of the exceptions laid down in Article 4 of Regulation No 1049/2001 apply to the whole of the document, that is to say, to each and every one of its elements, whilst, under Article 4(6), if only parts of the document are confidential, the remaining parts must be released.
52      Having regard to those arguments, it must be stated that, as regards disputes concerning interim protection in respect of information alleged to be confidential, the judge hearing an application for interim measures — if he is not to disregard the intrinsically ancillary and provisional nature of proceedings for interim measures (see paragraph 82 below) — may, as a rule, conclude that there is no prima facie case only where the information in question is obviously not confidential (see order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 29 and the case-law cited).
53      The documents submitted for consideration by the President of the General Court do not support an initial conclusion that there is clearly no prima facie case as regards the plea relating to the confidential nature of the report at issue.
54      It should be borne in mind that, by this plea, the applicant maintains, in essence, that the contested decision infringes Article 339 TFEU and Article 7 of the Charter of Fundamental Rights, as interpreted by the judgment of 14 February 2008 in Varec (C‑450/06, EU:C:2008:91, paragraphs 47 to 49), and the first indent of Article 4(2) of Regulation No 1049/2001, as the EMA disregarded the general presumption of confidentiality which applies to the report at issue in its entirety.
55      According to the applicant, the report at issue must be considered confidential in its entirety, since it discloses the company’s inventive business strategy for carrying out the clinical studies necessary for the purpose of obtaining the MA for Translarna. The applicant further argues that, if that report — which is of a clinical nature — were disclosed, its competitors could use it for their own clinical studies without having to incur the substantial development costs needed for that purpose. That would provide them with a pathway to the rapid grant of an MA for medicinal products containing the same active ingredient or other compounds used and would therefore allow them to accelerate the development of competing products in a highly competitive market, both inside and outside the European Union.
56      This argument, which is central to the applicant’s case, cannot, at first sight, be regarded as clearly incorrect.
57      First, the EMA expressly accepts that, before the change in its policy on access, it generally refused access to documents contained in the dossier submitted by an undertaking for the purpose of obtaining an MA, in particular access to clinical study reports, on the ground that such data had to be protected in the commercial interests of the undertaking concerned. It follows that, before that change in policy, the EMA would itself, in all likelihood, have classified the report at issue as confidential and refused to disclose it to third parties under Regulation No 1049/2001.
58      Although the EMA has stated that the contested decision is based on its new policy on access, it should be noted that neither the lawfulness of that policy, which has been in place since 2010, nor the question of the possible confidentiality of clinical reports submitted to the EMA in connection with an application for an MA, have yet been ruled on by the Courts of the European Union.
59      Following the withdrawals in Case T‑44/13, AbbVie v EMA (not published, EU:T:2014:694, removed from the register on 17 July 2014), and in Case T‑73/13, InterMune UK and Others v EMA (not published, EU:T:2015:531, removed from the register on 29 June 2015), the Court no longer has before it any issues of a pharmaceutical nature — similar to those raised in the present case — regarding the possible confidentiality of clinical and non-clinical study reports on a medicinal product that have been submitted to the EMA for the purpose of obtaining an MA. Moreover, a decision is still pending in Case T‑235/15, Pari Pharma v EMA, which relates to issues — also similar to those raised in the present case — concerning the possible confidentiality of reports on similarity and superiority drawn up in the field of ‘orphan medicinal products’ by an EMA committee on the basis of information provided by the applicant undertaking, with the result that the General Court has not yet given a ruling on the confidential nature of those reports. The same is true of Case T‑189/14, Deza v ECHA, which concerns issues of confidentiality in the chemicals sector.
60      Accordingly, there is no case-law in the pharmaceutical field that would make it possible to give a ready answer to the questions of confidentiality that fall to be decided in the present case by the future judgment on the substance. They are novel questions of principle which cannot be resolved, for the first time, by the judge hearing an application for interim measures; rather they require thorough examination within the main proceedings.
61      Moreover, it is apparent that even a judgment given by the General Court would not be sufficient to enable the judge hearing the application for interim measures to give such a ready answer to questions of confidentiality; rather it would be necessary to wait, to that end, for the Court of Justice to give a ruling on those questions. In its judgment of 28 January 2015 in Evonik Degussa v Commission (T‑341/12, EU:T:2015:51), the General Court, having found the information provided by an undertaking to the Commission during proceedings concerning an infringement of the competition rules not to be confidential, dismissed the action brought by that undertaking seeking annulment of the Commission’s decision refusing its request for confidential treatment of that information. The undertaking brought an appeal against that judgment of the General Court and applied for interim measures with a view to the Court of Justice ordering the Commission to refrain from publishing the information at issue until delivery of the judgment bringing the appeal proceedings to a close. In its order of 2 March 2016 in Evonik Degussa v Commission (C‑162/15 P-R, not published, EU:C:2016:142), the Vice-President of the Court of Justice granted that application for interim measures, considering that it was not apparent that the information at issue was obviously not confidential, in spite of the fact that the Commission’s decision had already been examined by a Court of the European Union and that that court had dismissed the action brought against that decision as unfounded.
62      Second, it should be noted that, to justify its former policy on access, which was in place before 2010, the EMA had itself considered that clinical study reports constituted integrated full reports, the disclosure of which would undermine the commercial interests of their authors, since competitors could use the data contained in those detailed and exhaustive reports as a starting point for developing the same or a similar medicinal product on their own, using the data for their own economic advantage, and gathering valuable information on the long term clinical development strategy of the authors of those reports. That concern to protect such pharmaceutical reports and to prevent them from being exploited by their authors’ competitors therefore cannot be considered in any way unreasonable.
63      In this case, the EMA has abandoned the approach it took before 2010 and takes the view that the applicant’s commercial interests would in no way be jeopardised if the report at issue were disclosed, whilst the applicant considers that such disclosure would confer many valuable advantages on its competitors. In order to determine whether the report at issue merits confidential treatment, it is thus necessary to determine the degree — high, moderate or insignificant — of the likely harm to the applicant’s commercial interests if the report were to be disclosed. It must be noted that the report at issue — namely a Phase 2B placebo-controlled efficacy and safety study of Ataluren in subjects with nonsense mutation Duchenne and Becker muscular dystrophy (see paragraph 12 above) in the specific pharmaceutical field of ‘orphan medicinal products’ — consists of approximately 250 pages and that a determination as to whether it may be confidential in nature raises issues involving highly technical scientific evaluations. In examining that report and the question whether the EMA made errors in rejecting the applicant’s confidentiality request, the President of the General Court is thus confronted with complex scientific issues which cannot be immediately resolved in the context of proceedings for interim measures, but rather call for a detailed examination in the main proceedings.
64      In that context, it must also be borne in mind that the interim relief procedure, which is based on a prima facie examination, is not designed to establish the truth of complex and much debated facts. The judge hearing an application for interim measures does not have the means necessary in order to carry out such examinations and in numerous instances he would have difficulty doing so in sufficient time (see order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:C:2015:587, paragraph 39 and the case-law cited).
65      Third, in so far as the EMA emphasises that large parts of the report at issue are already accessible to the public, it is true that confidential treatment cannot be claimed in respect of a specific element, such as a piece of information of financial significance for an undertaking, which has already been published and made accessible to interested persons. In the present case, however, the issues of confidentiality raised do not concern a particular item of information, but rather several complete passages of text, which the applicant submits are not, in the precise configuration and assembly of their components, generally known among the public or among operators in the pharmaceutical sector. The question therefore arises whether the fact that the applicant compiled scientific data known to the public and added secret scientific data in order to produce a body of complex information which, as such, is not readily accessible may justify treating that body of information as confidential. That question also raises issues which cannot be immediately resolved in the context of proceedings for interim measures (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:C:2015:587, paragraph 52 and the case-law cited).
66      There are no reasonable grounds for ruling out, at this stage, that the Court, when it adjudicates on the substance, may hold that the applicant’s specific use of confidential and non-confidential information for the purposes of the assessment, by the EMA and the Commission, of its MA application for Translarna should be treated as confidential, inasmuch as an inventive strategy of that kind bestows a scientific added value on the non-confidential elements taken in isolation. In any event, it will be for the Court adjudicating on the substance of the case to evaluate, if necessary, whether the degree of novelty and the scale of the investment made by the applicant in terms of time and cost for that purpose are sufficient to justify the confidential treatment sought (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:C:2015:587, paragraphs 53 and 54 and the case-law cited).
67      Moreover, although the EMA asserts that the EPAR on Translarna contains numerous details of the clinical trials to which the report at issue relates, that the applicant has already published various articles on the subject, and that the report at issue was drawn up strictly in accordance with public guidelines (see paragraphs 41 and 42 above), it should be noted that the pharmaceutical company that lodged the request for access underlying the present dispute clearly took the view that reading those public documents and knowing that the report at issue complied with the guidelines was not sufficient to satisfy its scientific or commercial needs. Thus, the fact that that undertaking considers it useful to have access to the whole of the report at issue may be regarded as a clear indication of the scientific and commercial value of that document, which militates in favour of its being treated as confidential, as requested by the applicant. Moreover, even the EMA appears implicitly to recognise that value, since it declares itself in favour of its full disclosure in the interests of public health, although substantial passages have already appeared in the EPAR and in medical publications.
68      Fourth, in so far as the EMA submits that the general presumption of confidentiality invoked by the applicant is not covered by the case-law which has thus far recognised eight categories of that presumption (see paragraphs 44 and 45 above), suffice it to note that, in the light of the foregoing considerations, it cannot clearly be ruled out that the Court adjudicating on the substance of the case may recognise a further category, namely that of clinical documents submitted to the EMA by an undertaking seeking to obtain an MA, precisely because of the complex and highly technical nature of the information contained in those documents. Nor is it possible to accept the EMA’s claim that such a presumption, as an exception to the principle of the widest possible public access to documents held by the EU institutions, would be incompatible with the requirement that that exception must be applied strictly. That same requirement did not prevent the Courts of the European Union from recognising the eight categories of general presumption of confidentiality mentioned by the EMA.
69      It must be added that, as is apparent from the recent case-law cited by the EMA (see paragraphs 44 and 45 above), the application of the general presumptions of confidentiality recognised thus far is essentially dictated by the need to ensure the proper operation of the various procedures at issue in the cases referred to and to ensure that their objectives are not compromised. Thus, the application of specific rules provided for by a legal measure relating to a procedure conducted before an EU institution for the purposes of which the documents requested were produced is one of the criteria for recognising a general presumption of confidentiality (see, to that effect, judgment of 11 June 2015 in McCullough v Cedefop, T‑496/13, not published, EU:T:2015:374, paragraph 91, and Opinion of Advocate General Cruz Villalón in Council v Access Info Europe, C‑280/11 P, EU:C:2013:325, point 75). As regards specifically the exceptions to the right of access to documents set out in Article 4 of Regulation No 1049/2001, the EU judicature considered that they could not be interpreted without account being taken of the specific rules governing access to those documents, laid down by the regulations concerned.
70      When it comes to determining whether the relevant provisions of Regulations No 141/2000, No 726/2004 and No 507/2006 restrict the use of the documents in an MA dossier concerning a medicinal product for human use, it is not possible to qualify as clearly incorrect the applicant’s argument that those regulations — in particular, Articles 11, 12(3), 13(3), 14(11), 24, 26, 57(1), point (1), 57(2), 76 and 80 of Regulation No 726/2004, Article 4(7) of Regulation No 141/2000 and Articles 5(3), 6(3) and 8 of Regulation No 507/2006 — establish a specific set of rules on transparency and confidentiality, under which the three key documents of an MA dossier to be disclosed are the summary of the product characteristics of the medicinal product for human use, the patient information leaflet, and the EPAR, and that those documents contain all the data necessary to provide the public with adequate information on the medicine in question. Viewed from that perspective, disclosure of the report at issue could jeopardise the balance which the EU legislature sought to strike between, on the one hand, the confidential nature of the documents included in an MA dossier concerning a medicinal product for human use and, on the other, the obligation to disclose the three aforementioned documents forming part of that dossier (see, to that effect and by analogy, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 53).
71      As regards the first paragraph of Article 73 of Regulation No 726/2004 which provides for Regulation No 1049/2001 to be directly applicable, the applicant stated, in its pleading of 25 April 2016, without being challenged in that respect by the EMA in its pleading of 13 May 2016, that:
–        Regulation No 1049/2001, which concerns only documents held by the European Parliament, the Council and the Commission, would not apply to the EMA were it not for Article 73;
–        whilst the disclosure obligations under Regulation No 726/2004 are expressly limited by the duty not to disclose commercially confidential information, Regulation No 1049/2001 goes further, in that it permits the disclosure of such information where an overriding public interest so requires;
–        Regulation No 1049/2001 invites the EMA to respond to individual requests for access to disclosable documents which the EMA has not disclosed on its own initiative.
72      The President of the General Court considers that those arguments relating to the broad logic, scheme and purpose of the rules on transparency and confidentiality put in place by Regulations No 141/2000, No 726/2004 and No 507/2006, on the one hand, and by Regulation No 1049/2001, on the other, do not appear to be entirely irrelevant. Consequently, it cannot be ruled out that the Court adjudicating on the substance may follow the applicant’s reasoning, based on the foregoing considerations, that there is no provision in that regime expressly giving one body of rules primacy over the other, which means that each must be applied in a manner that is compatible with the other and that enables them to be applied consistently. To that end, the special body of rules, namely the provisions of Regulations No 141/2000, No 726/2004 and No 507/2006, should prevail over the general body of rules, namely the provisions of Regulation No 1049/2001, with the result that the latter should be interpreted in such a way as to preserve the practical effect of the former.
73      As regards the relevance, in the present case, 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), which the EMA maintains is intended to make publicly available information about all clinical trial applications assessed and all clinical trials conducted in the European Union, and thus provides, for the first time, a direct legal basis for the release of clinical trial results and clinical study reports, it is sufficient to note that the contested decision was not based on that regulation, which cannot therefore be properly relied on in these proceedings. Consequently it will be for the EU judicature to adjudicate, in any future dispute, on the compatibility of Regulation No 536/2014 with primary law, that is to say, Article 339 TFEU and Article 7 of the Charter of Fundamental Rights, and on the question as to whether that regulation forms part of the special body of rules mentioned above.
74      The EMA further regards the general presumption of confidentiality relied on by the applicant as superfluous, since the applicant benefits, under EU pharmaceutical legislation, from an exclusivity period of 8 to 13 years during which its competitors are unable to make use of the report at issue in order to support their own applications for a second MA for a generic or similar medicinal product for human use or to market such a product (see paragraphs 39 and 47 above). In that regard, it is sufficient to point out, however, that the protection of data and restrictions on marketing are limited to the territory of the European Union. The applicant must clearly also be protected against the machinations of competitors operating in third country markets who, were the report at issue to be disclosed, could freely exploit the report, particularly as the EMA expressly acknowledges the dynamic nature of pharmaceutical markets and the high level of investment made in developing medicinal products. It follows that the protection conferred by a general presumption of confidentiality cannot properly be replaced by the data protection and marketing restrictions resulting from EU law. For the same reason, as regards preventing the report at issue from being exploited in markets outside the European Union, that presumption does not cease to apply on the date on which the MA is granted for the medicinal product for human use at issue, since that date is completely immaterial as regards protection beyond the borders of the European Union.
75      In so far as the EMA objects to the recognition of a general presumption of confidentiality on the basis of the fundamental right of EU citizens to access to documents of the institutions, enshrined in Article 42 of the Charter of Fundamental Rights and in Article 15(3) TFEU, it should be noted that that citizens’ right has not prevented the EU judicature from recognising the eight categories of general presumption of confidentiality mentioned by the EMA above. It cannot therefore, by itself, preclude such a presumption from being accepted in relation to the report at issue. Moreover, the applicant also relies on a right protected by primary law, namely Article 339 TFEU and the fundamental right provided for in Article 7 of the Charter of Fundamental Rights, as interpreted in the judgment of 14 February 2008 in Varec (C‑450/06, EU:C:2008:91, paragraphs 47 to 49). Consequently, it will be for the Court adjudicating on the substance to weigh up those opposing rights, reconciling the right of the applicant for access to obtain disclosure of the report at issue and that of the applicant in this case to benefit from a general presumption of confidentiality in respect of the whole of that report.
76      As has been stated, it does not appear that it can be clearly ruled out that, in reconciling those rights, the Court adjudicating on the substance may grant the applicant the benefit of the presumption sought, on the ground that the summary of the product characteristics of the medicinal product for human use in question, the patient information leaflet and the EPAR contain all the data necessary to provide useful information on that product (see paragraph 70 above). Nor can it be ruled out that, instead of recognising a general presumption of confidentiality, the Court adjudicating on the substance may permit the report at issue to be disclosed to applicants for access from the academic sphere — a criterion not satisfied by the pharmaceutical undertaking seeking disclosure in the present case — who would establish a strictly scientific interest and sign a confidentiality agreement, with a penalty clause and lump sum compensation, prohibiting them from using that document for commercial purposes. That solution would admittedly require a broad interpretation of Article 6(1) of Regulation No 1049/2001, under which ‘the applicant [for access] is not obliged to state reasons for the application’, as meaning that the applicant for access would be required to disclose his identity. However, in the light of the fundamental right to confidentiality enjoyed by the applicant, it would not be manifestly unacceptable, inasmuch as it is less stringent than the solution of ruling out any access by the application of a general presumption of confidentiality.
77      It follows that, if the Court adjudicating on the substance were to accept the applicant’s arguments and consider the report at issue to constitute, in its entirety, a specific category of information enjoying a general presumption of confidentiality, the contested decision would have to be annulled for infringement, in particular, of the first indent of Article 4(2) of Regulation No 1049/2001. The EMA would have disclosed that report in disregard of the fact that it was covered by that presumption and without having considered whether there was an overriding public interest that might justify its disclosure. Furthermore, in that situation, the question of partial disclosure of public information contained in the report at issue would not arise, since a document covered by a general presumption of confidentiality is not subject to the obligation of partial disclosure. Moreover, it would not be appropriate to carry out an individual examination of each of the elements in the report at issue, in order to verify whether disclosure of that element in particular could specifically and actually undermine the applicant’s business interests (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 55 and the case-law cited).
78      The question whether the report at issue constitutes a specific category of information enjoying, on account of its very nature, a general presumption of confidentiality should lead the Court adjudicating on the substance to evaluate whether, as the applicant claims, the public and non-public elements of the report at issue form an inseparable whole with economic value which is, as such, exempt from Article 4(6) of Regulation No 1049/2001. In any event, for the purposes of the present procedure, it would appear to be irrelevant — and of no use to the pharmaceutical undertaking which requested the EMA to grant it access to the report at issue — to allow, by way of proceedings for interim measures, disclosure that is strictly limited to data already in the public domain. That undertaking, which belongs to the professional circle concerned by that type of information, should easily be able to access those passages of the report at issue by means of the appropriate online search tools (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 56 and the case-law cited).
79      In the light of the foregoing considerations, it is not obvious that the report at issue, taken in its entirety, is not confidential (see, to that effect, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 69).
80      It must therefore be found that there is a prima facie case as regards the plea based on the confidentiality of the report at issue in its entirety and alleging infringement of Article 339 TFEU, Article 7 of the Charter of Fundamental Rights and the first indent of Article 4(2) of Regulation No 1049/2001.
The weighing up of interests
81      According to settled case-law, the weighing up of interests requires the judge hearing an application for interim measures to determine whether or not the applicant’s interest in obtaining the measures sought outweighs the interest in the immediate application of the contested measure, by examining, more specifically, whether the possible annulment of that measure by the Court when ruling on the main application would allow the situation that would have been brought about by its immediate operation to be reversed and, conversely, whether suspension of operation of the measure would prevent it from being fully effective in the event of the main application being dismissed (see order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 64 and the case-law cited).
82      As regards more particularly the condition that the legal situation created by an interim relief order must be reversible, it must be recalled that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future decision on the main action. Consequently, that procedure is merely ancillary to the main action to which it is an adjunct, and accordingly the decision made by the judge hearing an application for interim relief must be provisional in the sense that it cannot either prejudge the future decision on the substance of the case or render it illusory by depriving it of practical effect (see order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 65 and the case-law cited).
83      It necessarily follows that the interest defended by a party to interim relief proceedings does not merit protection where that party’s request is that the judge hearing the application should adopt a decision which, far from being a merely interim measure, would serve to prejudge the future decision on the main action and to render it illusory by depriving it of practical effect (order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 66).
84      In the present case, the Court will have to adjudicate, in the main proceedings, on whether the contested decision — by which the EMA rejected the applicant’s confidentiality request and stated its intention to disclose the report at issue to a third party — must be annulled for disregarding the confidential nature of that report, in that its disclosure would constitute an infringement of, inter alia, Article 7 of the Charter of Fundamental Rights, Article 339 TFEU and the first indent of Article 4(2) of Regulation No 1049/2001. In that respect, it is clear that, in order to preserve the effectiveness of a judgment annulling the contested decision, the applicant must be able to ensure that the EMA does not unlawfully disclose that report. A judgment ordering annulment would be rendered illusory and deprived of practical effect if the present application for interim measures were to be dismissed, since the EMA would then be free to disclose the report at issue immediately — the confidential nature of the report being irreversibly lost as a result — and thereby effectively prejudge the future decision in the main action, namely that the action for annulment would be dismissed (see, to that effect, orders of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 67, and of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 105).
85      It follows that the interest defended by the applicant must prevail over the EMA’s interest in the dismissal of the application for interim measures, a fortiori since the grant of the interim measures requested would amount to no more than maintaining the status quo for a limited period, while the EMA, far from alleging that disclosure of the report at issue is necessary to meet an overriding need to protect public health in the light of a specific danger of the medicinal product Translarna — which is, moreover, difficult to reconcile with the granting of the MA for that product —, merely invokes, inter alia, the importance of the general principle of transparency in the interest of human health as well as that of doctors and of patients (see, to that effect, orders of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 68, and of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 114).
86      The EMA submits that such reasoning risks enabling pharmaceutical undertakings, such as the applicant, to pursue a dilatory strategy aimed at curtailing the public’s right of access to documents relating to medicinal products. It would be sufficient for any undertaking challenging a decision granting access to pharmacological documents systematically to seek interim relief and to allege that those documents are confidential in order to benefit automatically from interim measures preventing their disclosure. Given the current length of judicial review proceedings before the General Court, that strategy would affect the concrete availability of information concerning a medicinal product.
87      In that regard, it should be noted, however, that the grant of an interim measure presupposes that the party seeking it has established a prima facie case. Since the President of the General Court has determined that there is a prima facie case, that party’s application for interim relief can hardly be described as a delaying tactic.
88      As regards the length of judicial proceedings criticised by the EMA, it must be noted that the average duration of proceedings in the General Court was less than two years in 2014 and in 2015 (see statistics concerning the judicial activity of the General Court in the Annual report 2015 of the Court of Justice of the European Union, p. 173). If the EMA deemed it necessary for the principle of transparency to be invoked more quickly in the present case, it was open to it to submit a request for an expedited procedure to be applied, under Articles 151 and 152 of the Rules of Procedure, on the basis that disclosure of the report at issue was particularly urgent in the circumstances of the case. In that context, it should be borne in mind, by way of example, that under the expedited procedures applied in the cases giving rise to the judgment of 8 June 2011 in Bamba v Council (T‑86/11, EU:T:2011:260), and to the judgment of 10 November 2015 in GSA and SGI v Parliament (T‑321/15, not published, EU:T:2015:834), judgement was delivered within only four and five months, respectively.
89      Furthermore, although the EMA did not make a request for an expedited procedure in good time and in the proper form, that is to say, by separate document lodged at the same time as its defence in the main proceedings in Case T‑718/15, it can always suggest that the General Court initiate such a procedure of its own motion, in accordance with Article 151(2) of the Rules of Procedure, or that the case be given priority over others, in accordance with Article 67(2) of those rules.
90      In the light of those considerations, it must be concluded that the balance of the interests in this case is tipped in favour of granting the interim measures sought, the interests of transparency defended by the EMA being sufficiently satisfied — pending delivery of the judgment in the main proceedings — by the publication of the summary of the product characteristics of the medicinal product Translarna, the patient information leaflet and the EPAR.
Urgency
91      The applicant maintains that release of the report at issue in its entirety would allow its competitors in the field of orphan medicinal products generally to benefit from its insights on study design, which would be particularly detrimental to it given the difficulties of designing studies with small patient populations for orphan and ‘ultra-orphan’ conditions. It submits that those of its competitors which are seeking to produce a direct rival to Translarna in the European Union in relation to other rare nonsense mutation diseases for which Translarna has not yet obtained an indication would thus be able to save time and benefit from the applicant’s expertise by benchmarking their own studies against the report at issue, inasmuch as they will learn the focus of the regulatory authorities as regards their view of various efficacy end-points: those competitors will thus be able to tailor their own studies accordingly, to compare their studies with the applicant’s results and not to have to pursue lines of enquiry which the applicant has not pursued.
92      The applicant also submits that its competitors will also be able to mine the data in the report at issue in order to restructure their own clinical trials and avoid some of the trial-and-error development which it had to undertake. The release of the report at issue in its entirety would confer a competitive advantage on those of the applicant’s competitors that are seeking to produce a direct rival to Translarna in the European Union in relation to the nonsense mutation DMD indication by claiming that their new product is safer, more effective or otherwise clinically superior (see paragraph 11 above). In particular, such release would provide them with information on the development of the precedent orphan product and the design of clinical trials which the EMA has accepted demonstrate the efficacy and safety of a product for the relevant condition: that is particularly valuable in the case of ‘ultra-orphan’ conditions. In addition, the report at issue could be used in the European Union to support MA applications for similar products or, in the long run, for generic MA applications once Translarna has lost all exclusivity.
93      The applicant emphasises that release of the report at issue could cause particularly serious harm to its interests outside the European Union, in countries in which the 10-year period of marketing and data exclusivity does not apply and its competitors, using its data, would have free rein to submit their own MAs for products competing with Translarna. Thus, it is possible that, as soon as the report at issue is in the public domain, competing products might immediately be approved by the regulator on the basis of a small number of studies, including in Australia, Brazil, China and Chile. Furthermore, release of that report gives rise to a risk that the applicant’s competitors may be able to use the World Health Organisation’s import/export Certificate of Pharmaceutical Product scheme in order to obtain other authorisations in emerging markets across the world, thereby exponentially multiplying the potential harm.
94      The applicant is especially concerned about these possibilities in the light of its future plans for Translarna, both within and outside the European Union. It submits that it is working on obtaining MAs for other indications for Translarna for the treatment of other rare genetic diseases caused by nonsense mutations, including cystic fibrosis (for which the confirmatory Phase 3 clinical trial has commenced) and mucopolysaccharidosis type I (for which research is at an early stage). Those plans could be thwarted if competitors were able to secure commercially sensitive information and use it to put their own products on the market. The applicant submits that there are competitors who are developing treatments for DMD and cystic fibrosis who would be able to use the report at issue to assist with their own study design. It also claims to be aware of manufacturers of generic medicinal products who are likely to seek to enter the market with generic versions of Translarna, in particular in countries where the applicant’s patent protection is inadequate.
95      In the applicant’s opinion, the obvious commercial value to its competitors of obtaining access to the report at issue can also be inferred from the fact that the applicant for access comes from the pharmaceutical sector. The applicant contends that, in all likelihood, the entity concerned is a competitor which sees value in being able to use the information in question for its own purposes. The applicant asserts that there is a huge amount at stake for it, since Translarna is its flagship product and the only product from which it expects to derive commercial revenue over the coming years. Bringing Translarna to the market has taken an enormous investment of money and expertise on the applicant’s part. Since any detriment to the integrity of that investment is irreversible, the applicant submits that its loss of market share could be significant and that its viability as a company could be at stake.
96      The applicant submits that, if the report at issue were disclosed under Regulation No 1049/2001, such disclosure would acquire an erga omnes effect in that the report could be communicated to other applicants for access and any person would have the right to access it. Thus, the report will, in the applicant’s submission, in principle be available to all its existing and potential competitors worldwide for use for any purpose whatsoever, including that of competing with the applicant by filing MA applications in third countries using the applicant’s data.
97      The applicant thus concludes that the harm likely to be caused to it by disclosure of the report at issue will be irreparable. First, confidentiality, once lost, is, in its view, lost forever. Second, it will be impossible adequately to identify and quantify the harm sustained, so that it will not be possible to make good that harm by bringing an action for damages. Indeed, if the report at issue is disclosed, the applicant will have no means of knowing which of its competitors have seen the confidential information, or for what purposes they propose to use it, since the applicant does not know the identity of the applicant for access or the reasons for which it has made that application. Moreover, given the erga omnes effect of that disclosure, the report is likely to be passed to the applicant’s competitors without its knowledge. The applicant submits that it has no way of knowing when another manufacturer has used its information to derive a competitive advantage, either for the purpose of assisting in making an accelerated MA application in an emerging market, since the fact that an MA application has been made is not generally disclosed, or for the purpose of accelerating the development of competing drugs.
98      The EMA contends, to the contrary, that disclosure of the report at issue would not cause the applicant serious and irreparable harm. Contrary to the applicant’s assertion, such disclosure would not provide its competitors with a ‘road-map’ on how to file an MA application for a competing product. The applicant has given no concrete example of a specific secret methodology or innovative result in the report at issue which could result in commercial damage if disclosed. Consequently, the applicant’s claim regarding the know-how allegedly contained in the report at issue is somewhat vague and, in any event, is not supported by the particular features of that document.
99      The EMA adds that the alleged harm is not even directly linked to the contested decision but rather to the hypothetical granting of an MA for a competing product. However, the positive outcome of an MA procedure is anything but guaranteed and the applicant has failed to demonstrate that the MA granted to a competing product for the indication in question would be based on the unfair use of the report at issue by a competitor. The applicant only assumes that the pharmaceutical company that has requested access to the report is a competitor which has its own interest in using the report. The applicant’s claim in that regard is purely hypothetical and should, for that reason, be rejected.
100    The EMA does not dispute that markets for medicinal products are innovative and dynamic and are characterised by the technical complexity of the products and the high level of investment. It nevertheless maintains that the applicant has adduced no precise evidence that would allow an assessment of the extent to which its competitive advantage could be negatively affected and of the actual risks that unfair use of the report at issue could entail. The EMA also fully acknowledges the costs associated with the development of medicinal products, including the costs borne by MA applicants for the production of scientific information aimed at demonstrating the effects of medicinal products on human health. However, under EU law, that information benefits from a substantial data and market exclusivity period, in which competitors are unable to make use of the clinical and non-clinical information submitted by other pharmaceutical companies in order to support their own MA applications. The rationale for that exclusivity model is precisely to permit the undertaking which is the originator of the data to recover its investment, and the disclosure of information under Regulation No 1049/2001 cannot endanger that purpose.
101    As regards more particularly the possibility for the applicant’s competitors of obtaining a derogation from the market exclusivity granted to Translarna in its capacity as an orphan medicinal product (see paragraph 11 above), the EMA recalls that, in such a situation, it is the task of the CHMP to assess the similarity of the two medicinal products and the superiority of the product for which the new MA application has been submitted. For that purpose, contrary to what the applicant maintains, disclosure of the report at issue would not confer any competitive advantage on its competitors, given that the relevant information on the development of the product and on the design of clinical trials which the EMA has accepted are already provided in the publicly available EPAR on Translarna.
102    The EMA submits that the argument that the report at issue could be used to obtain MAs for competing medicinal products outside the European Union must be rejected since it is vague and hypothetical and would, in any event, render meaningless the right of the public — conferred by EU law — to have access to information concerning authorised medicinal products. Moreover, the regulatory bodies of third countries are at liberty to rely on the authorisation of a medicinal product in the European Union in order to grant any manufacturer access to their own markets, without requiring the submission of any clinical or pre-clinical data. Lastly, the EMA states that it is unclear to it how disclosure of the report at issue could possibly affect — as the applicant maintains it does — future plans for the development of other indications for Translarna.
103    In that respect, 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 EU judicature. For the purpose of attaining that objective, urgency must be assessed in the light of the need for an interlocutory order in order to avoid serious and irreparable harm 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 (see order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 82 (not published) and the case-law cited).
104    In the present case, the alleged harm would result from the disclosure of information claimed to be confidential. For the purpose of assessing the existence of serious and irreparable harm, the starting point for the Court hearing the application for interim measures must necessarily be the premise that the information that is purportedly confidential is in fact confidential, as claimed by the applicant, since the examination relating to the establishment of a prima facie case did not support a conclusion that that information was clearly not confidential. Consequently, it must be held, for the purposes of the present examination of urgency, that the report at issue is confidential (see, to that effect, orders of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraphs 84 and 85 and the case-law cited, and of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraphs 84 and 85).
105    Starting from that premise, the disclosure of the report at issue would necessarily cause significant harm to the applicant (see, to that effect, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 86).
106    As regards more specifically the harm alleged by the applicant in the present case, it has been held that financial damage which is objectively considerable, or even not insignificant, may be considered ‘serious’, without it being necessary in every case to relate that damage to the turnover of the undertaking which fears suffering that harm (see, to that effect, order of 7 March 2013 in EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraphs 32 and 33; see also, by analogy, order of 8 April 2014 in Commission v ANKO, C‑78/14 P-R, EU:C:2014:239, paragraph 34).
107    The report at issue containing scientific evaluations of a pharmaceutical nature is part of the dossier prepared by the applicant on the basis of which an MA was granted in respect of the medicinal product for human use: Translarna. That report therefore concerns the applicant’s manufacturing and commercial activity. Given the dynamic nature of pharmaceutical markets, the high level of investment made in developing new medicinal products and the interest shown by a pharmaceutical company in having access specifically to the report at issue, it is apparent that that report is objectively capable of being used for competitive purposes, since any competitor of the applicant could exploit it for its own scientific and commercial needs (see paragraph 62 above). It follows that that report is an intangible asset that may be used for competitive purposes, whose value could be reduced not insignificantly, that is to say, seriously, within the meaning of the case-law mentioned in paragraph 106 above, were it no longer to be secret (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 89).
108    In any event, as has been stated above, the existence of a prima facie case has been recognised, inter alia, because the question whether the degree of harm to the applicant’s commercial interests resulting from the disclosure of the report at issue would be high, moderate or insignificant meant that the judge hearing the application for interim measures was confronted with complex scientific issues which could not be immediately resolved in the context of proceedings for interim measures, but rather called for a detailed examination in the main proceedings (see paragraph 63 above). That assessment, which supported the conclusion that a prima facie case had been established for granting the interim measures sought and the presumption, for the purposes of the proceedings for interim measures, that the report at issue is confidential, cannot be called into question in the context of the assessment of urgency by a denial of the seriousness of the harm alleged (see, by analogy, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraphs 84, 85 and 107). Such a denial would effectively answer the question posed above in the negative at the interim relief stage, when an answer negating the confidential nature of that report must be reserved to the Court adjudicating on the substance. It follows that the judge hearing an application for interim measures is required to assume, for the purposes of the assessment of urgency, not only that the report at issue is confidential, but also that the damage that may be caused to the applicant by disclosure of that report is serious (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 90).
109    Consequently, the applicant has established, to the requisite legal standard, the serious nature of the financial damage it is liable to suffer if the report at issue is disclosed.
110    That conclusion is not called into question by the fact that the applicant requested, in the alternative, that it should be given the opportunity to identify the specific elements of the report at issue in respect of which redaction is essential (see paragraph 15 above). In fact, that request was made only as a precaution, in case the Court does not accept that the report at issue is confidential in its entirety. It cannot be inferred from this that only the disclosure of those specific elements would be liable to cause the applicant serious harm, since, otherwise, it would be penalised for having chosen, as a precautionary measure, a procedural strategy aimed at protecting itself as much as possible. In those circumstances, the applicant’s procedural approach must be interpreted as meaning that disclosure of the report at issue, as a whole, would cause it ‘serious’ harm, whereas the harm suffered in the event of disclosure of the particularly sensitive elements, referred to in the alternative head of claim, would be ‘extremely serious’.
111    As to whether the harm alleged is irreparable, it must be pointed out at the outset that annulment of the contested decision could not reverse the effects of disclosure of the report at issue, since once a person has acquired knowledge of that report by reading it, that knowledge cannot be erased (see, to that effect, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 90 and the case-law cited).
112    Next, as regards the harm that could be caused to the applicant by the disclosure of the report at issue to the third party which submitted a request to that effect to the EMA, it is true that such disclosure of information to an individual person is of a different nature to the publication of information on the Internet, such as that at issue in the order of 10 September 2013 in Commission v Pilkington Group (C‑278/13 P(R), EU:C:2013:558). In the latter case, the immediate cause of the damage feared by the undertaking concerned is not the online publication as such. The persons potentially interested in the information in question, in particular competitors, must also be informed of that publication and take cognisance of the information, in order to use it for purposes harmful to the undertaking concerned. Such online publication therefore merely places the undertaking concerned in a situation of general vulnerability; that situation may be exploited at any time by interested persons, which is liable to cause damage to that undertaking (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 94).
113    Disclosure of the report at issue to the third party which made a request to that effect to the EMA pursuant to Regulation No 1049/2001 would place the applicant in a vulnerable situation at least as threatening as that examined in the order of 10 September 2013 in Commission v Pilkington Group (C‑278/13 P(R), EU:C:2013:558). That third party would immediately take cognisance of that report and could use it straightaway for any purpose it deemed useful, since Article 6(1) of Regulation No 1049/2001 does not require the party requesting access to give reasons explaining that request. The applicant would thus have to expect that the disclosure of that report would be liable to weaken its competitive position. It would therefore be in a vulnerable situation which would entail, for it, a risk of damage (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 95).
114    In addition, the individual disclosure of a document pursuant to Regulation No 1049/2001 has an erga omnes effect, in that the document disclosed enters the public domain; it may be communicated to other applicants for access and any person has a right of access to it (see, to that effect, judgments of 21 October 2010 in Agapiou Joséphidès v Commission and EACEA, T‑439/08, not published, EU:T:2010:442, paragraph 116, and of 26 April 2016 in Strack v Commission, T‑221/08, EU:T:2016:242, paragraph 128). Consequently, if the report at issue were disclosed, all the applicant’s competitors could themselves apply to the EMA in order to obtain that report directly. The aforementioned erga omnes effect would even allow the EMA to publish the report at issue on its own initiative. As is apparent from point 4.4 of document EMA/110196/2006 of 30 November 2010, entitled ‘EMA policy on access to documents (related to medicinal products for human and veterinary use)’ (annexed to the application for interim measures), the EMA’s new policy on access consists precisely in making public, inter alia, any document which it holds and to which access has been granted upon written request.
115    While it is thus true that disclosure of the report at issue pursuant to Regulation No 1049/2001 and its publication on a different legal basis are legally distinct, it appears that, in the circumstances of the present case, such disclosure would lead to a situation that is comparable, in terms of practical effect, to that brought about by publication. Disclosure of the report at issue, triggering the erga omnes effect mentioned above and the automatic application of the EMA’s new policy on access, would necessarily entail an unlimited number of third parties becoming aware of that report, the confidentiality of which would, consequently, no longer be protected (see, to that effect and by analogy, order of 2 March 2016 in Evonik Degussa v Commission, C‑162/15 P-R, not published, EU:C:2016:142, paragraph 50).
116    Once the report at issue is disclosed, it is highly likely that current or potential competitors of the applicant with a genuine interest in exploiting that report would attempt to obtain it, in order to use it for their own scientific and commercial needs, particularly with a view to producing a medicinal product similar to Translarna and obtaining authorisation to market that product on many different markets within or outside the European Union. Although the EMA appears to doubt the usefulness of the report at issue for the purposes of competition, it is sufficient to note that the judge hearing an application for interim measures is not particularly well placed to make an informed and accurate prediction as to the manner in which the applicant’s competitors could exploit that scientific information, following its disclosure, according to their individual interests as regards research, development and marketing (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 97).
117    Consequently, the possibility of the applicant sustaining financial damage as a result of such future exploitation of the report at issue by its competitors cannot be characterised as purely hypothetical. Rather, it is foreseeable with a sufficient degree of probability that the vulnerable situation in which the applicant would be placed in the event of disclosure of that report would become one entailing financial damage to it (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 98).
118    Furthermore, since the taking cognisance and use, by interested persons, of information published online were not considered to be hypothetical in the order of 10 September 2013 in Commission v Pilkington Group (C‑278/13 P(R), EU:C:2013:558), the same must be true of the taking cognisance and use, by interested persons, of information which, after being disclosed to a third party, would become freely accessible to all the competitors of the undertaking holding that information. From that perspective, the difference between the two modes of access consists solely in the means of communication actually used (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 99).
119    As to whether the financial damage that the applicant would be likely to suffer in the event of disclosure of the report at issue may be quantified, it should be noted that the applicant would have to expect that an undetermined and potentially unlimited number of current and potential competitors all over the world will obtain that report in order to exploit it in numerous ways, which, depending on the status of their research and development programmes, could entail harmful effects in the short, medium or long term, liable to thwart any expansion strategy on the applicant’s part. It might even be the case that that report, made publicly accessible, could reach its competitors without the applicant being informed, which would in particular be the case if the EMA published it under its new policy on access. The applicant would therefore be confronted with the insurmountable difficulty of setting up a monitoring system to detect, at a global level, how its competitors were exploiting the report at issue in the short, medium or long term so as to derive competitive advantages, particularly so as to market, with or without authorisation, the medicinal product at issue in third countries (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 100).
120    In particular, disclosure of the report at issue would be liable to compromise future development plans of other indications of Translarna, initiated by the applicant (see paragraph 94 above), neither the existence nor the specific nature of which has been questioned by the EMA. The exploitation of the report at issue could objectively lead to competitors of the applicant launching plans similar to the applicant’s, which would have an impact on its economic and financial interests.
121    It is therefore impossible to assess the actual impact that disclosure of the report at issue could have on the applicant’s economic and financial interests. Accordingly, the damage that the applicant is liable to suffer in the event of disclosure of that report cannot be quantified adequately.
122    In view of the foregoing considerations, it must be found that the condition relating to urgency is met in the present case, since the likelihood of the applicant suffering serious and irreparable harm has been established to the requisite legal standard. Having regard to the particular features of proceedings for the protection of allegedly confidential information, the applicant is not required to establish, in addition, that it would be in a position that would imperil its financial viability or that its market shares would be seriously and irreparably affected if the interim measures applied for were not granted (see, to that effect, and by analogy, order of 8 April 2014 in Commission v ANKO, C‑78/14 P-R, EU:C:2014:239, paragraph 26 et seq.).
123    In any event, even if the damage alleged by the applicant could not be classified as irreparable, the judge hearing the application for interim measures would be required to protect the report at issue in its entirety against the disclosure envisaged by the EMA and could not examine the confidentiality of each individual piece of data in the report at issue with a view to possibly upholding the application for interim measures only in part (see, to the effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 103).
124    First, it would be inconsistent for the judge hearing an application for interim measures to find that there is a prima facie case on the basis of the nature of the information covered by a confidentiality request as well as the complex nature of the confidentiality issues raised, stating that the resolution of those issues calls for a thorough examination to be carried out by the Court when it adjudicates on the substance, but then reverse that result in the context of the urgency assessment by allowing the disclosure of certain specific pieces of data, when it cannot be excluded that the Court adjudicating on the substance may refuse to carry out such a specific and individual examination of the confidential nature of the individual pieces of information and prefer to examine whether the categories of information invoked by the applicant must, by their very nature, enjoy a general presumption of confidentiality (see paragraph 108 above).
125    Second, the judge hearing an application for interim measures must also take into account, in the context of the urgency assessment, the intrinsically ancillary and provisional nature of proceedings for interim measures by comparison with the main action, as well as the need to avoid prejudging, at the stage of the proceedings for interim relief, the outcome of the main action. Since those considerations concerning the nature of proceedings for interim measures are decisive for the outcome of those proceedings, they cannot be confined solely to the examination of whether there is a prima facie case and the weighing up of interests. The prohibition on the judge hearing an application for interim measures from rendering illusory, by an order for interim measures, the future judgment in the main proceedings by depriving it of practical effect is intended, inter alia, to ensure that the consequences of the decision to be given subsequently on the substance of the action are not neutralised in advance (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 106 and the case-law cited).
126    The consequences and practical effect of any judgment annulling the contested decision and bringing the main proceedings to an end would not be limited to a finding that the report at issue is confidential and that its disclosure would be unlawful. Rather, in the event that the contested decision is annulled, the consequences and practical effect of that judgment would consist for the applicant in the assurance that no data in the report found to be confidential by the Court ruling on the main action would be disclosed, irrespective of whether such disclosure would cause it reparable or irreparable damage. Thus, a clear distinction must, in particular, be made between the present proceedings, which relate to the protection of allegedly confidential information, and proceedings relating to the lawfulness of payment obligations imposed by a decision of the Commission, such as a fine or the obligation to reimburse State aid. In the latter category of proceedings, the dismissal of an application for interim measures on the ground that the serious and irreparable damage condition is not met cannot neutralise in advance the consequences of a future annulment of the contested decision, since the applicant would obtain repayment of the sum paid or reimbursed, including interest, and would therefore be fully restored financially (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 108).
127    Nor is it appropriate, in view of the specific features of proceedings seeking the protection of allegedly confidential documents, for the judge hearing an application for interim measures to consider a partial solution consisting in protecting only certain pieces of information, while allowing access to other pieces of information to be granted. If the Court adjudicating on the substance accepted that the report at issue were covered by a general presumption of confidentiality, that report would not be subject to an obligation of partial disclosure (see paragraph 77 above). The judge hearing an application for interim measures, given his purely ancillary powers, cannot therefore authorise partial access without depriving the judgment on the substance of practical effect (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 109).
128    Moreover, if — after the specific and individual examination of the various pieces of allegedly confidential information contained in the report at issue — the judge hearing an application for interim measures allowed information to be disclosed in the present case which the Court adjudicating on the substance subsequently categorised as confidential, he would effectively be assuming the jurisdiction of that court, which alone is empowered to rule, in the decision closing the main proceedings, on whether that information is confidential and, in consequence, on the definitive authorisation to disclose it. By thus interfering — intentionally and on an informed basis — in the prerogatives of the Court adjudicating on the substance, the judge hearing an application for interim relief would be liable to be in breach of the principle of the right to be heard by a court or tribunal established in accordance with the law, resulting from Article 6(1) of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’) (judgment of 13 December 2012 in Strack v Commission, T‑199/11 P, EU:T:2012:691, paragraph 22), a principle which aims to ensure, in particular, that disputes are determined only by a court which has jurisdiction in relation to the subject matter (see, to that effect, ECtHR, 22 June 2000, Coëme and Others v. Belgium, CE:ECHR:2000:0622JUD003249296, § 99, and ECtHR, 20 July 2006, Sokurenko and Strygun v. Ukraine, CE:ECHR:2006:0720JUD002945804, § 24).
129    Given that the aim of the ECHR is to guarantee practical and effective rights and that the organisation of the judicial system cannot be left to the discretion of the judicial authorities (ECtHR, 22 June 2000, Coëme and Others v. Belgium, Nos 32492/96, 32547/96, CE:ECHR:2000:0622JUD003249296, § 98), it matters little whether the principle of the right to be heard by a court or tribunal established in accordance with the law is breached by a court hearing the dispute in question without the requisite jurisdiction for doing so or, within the same court, by the judge hearing an application for interim measures who, deliberately disregarding his purely ancillary rule, makes an order which has the effect of neutralising in advance the consequences of the future decision likely to be taken by the Court adjudicating on the substance and depriving that decision of practical effect. Such deliberate intervention in the prerogatives of the Court adjudicating on the substance cannot be described as a simple procedural error that could fall outside the scope of Article 6(1) of the ECHR.
130    It follows that the judge hearing an application for interim measures must not apply the criterion linked to the irreparable nature of the financial damage alleged — a criterion that arises solely from the case-law and which appears neither in the Treaties nor in the Rules of Procedure —, since it cannot be reconciled with the need to provide effective provisional protection (see, to that effect, order of 23 April 2015 in Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 30). Articles 278 TFEU and 279 TFEU, which are primary law provisions, authorise the judge hearing an application for interim measures to order the suspension of operation of a measure if he considers ‘that circumstances so require’ and to prescribe any ‘necessary’ interim measures. As mentioned above, those conditions are met in the present proceedings relating to the protection of allegedly confidential information (see, to that effect, order of 1 September 2015 in Pari Pharma v EMA, T‑235/15 R, EU:T:2015:587, paragraph 110 and the case-law cited).
131    Accordingly, since all the necessary conditions are met, the application to suspend the operation of the contested decision must be granted. In addition, the EMA must be ordered not to disclose the report at issue.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1.      The operation of Decision EMA/722323/2015 of the European Medicines Agency (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, access to Clinical Study Report ‘Ataluren (PTC124) PTC124-GD-007-DMD’ on a Phase 2B efficacy and safety study of Ataluren in subjects with nonsense-mutation-mediated Duchenne and Becker muscular dystrophy, is suspended.
2.      The EMA shall not disclose the report referred to in point 1.
3.      Costs are reserved.
Luxembourg, 20 July 2016.
E. Coulon
M. Jaeger
Registrar
President
* Language of the case: English.