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The legal context and EMA administrative practice were summarised as follows in paragraphs 1 to 11 of the order under appeal: ‘1 [The EMA], established by Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), has as its main responsibility the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. To that end, the EMA is responsible for the scientific evaluation of applications for European Union [MAs] for human and veterinary medicines (centralised procedure). Under the first subparagraph of Article 57(1) of Regulation No 726/2004, the EMA is to provide the Member States and the institutions of the European Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use which is referred to it. 2 Under Regulation No 726/2004, certain categories of medicinal products, including medicinal products resulting from biotechnology such as Esbriet, which is the subject-matter of the present proceedings, must be approved under the centralised procedure pursuant to that regulation. That procedure entails the submission, by the pharmaceutical company concerned, of an application for [an MA], which is examined by the EMA, and a decision by the European Commission on the MA. The information which an MA applicant is to provide to the EMA must include a quality dossier (particulars on product composition and description of the manufacturing processes), non-clinical data (physico-chemical, biological or microbiological and results of animal tests) and results of clinical trials (actual tests and data assessing the use of the product in humans), in support of the intended therapeutic use of the product. Once the MA has been granted, the details thereof may be amended; amendments may range from mere administrative changes to more significant amendments, such as adding a new therapeutic indication. 3 The first paragraph of Article 73 of Regulation No 726/2004 states that [Regulation No 1049/2001], a regulation which is aimed at guaranteeing the broadest public access possible to documents held by the European Union administrative bodies, is applicable to documents held by the EMA. 4 Article 4(2) of Regulation No 1049/2001 provides that the institutions are to refuse access to a document where disclosure would undermine, inter alia, the protection of commercial interests of a natural or legal person, including intellectual property, unless there is an overriding public interest in disclosure of the document in question. As regards third-party documents, Article 4(4) of Regulation No 1049/2001 provides that the institution is to consult the third party with a view to assessing whether an exception in paragraph 2 is applicable, unless it is clear that the document must or must not be disclosed. Pursuant to Article 4(6) of Regulation No 1049/2001, if only parts of the requested document are covered by any of those exceptions, the remaining parts of the document are to be released. 5 Under the first paragraph of Article 80 of Regulation No 726/2004, the EMA is to adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the authorisation or supervision of medicinal products which is not of a confidential nature. Thus, on 19 December 2006, the EMA adopted rules implementing Regulation No 1049/2001 on access to its documents. Article 4 of those rules provides that EMA documents are to be classified in one of the following three categories: public, restricted or confidential. 6 Under a policy governing access to its documents which the EMA applied consistently until 2007, public access to documents contained in the dossier submitted by a company for the purposes of an MA, including clinical study reports, was generally refused on the ground that such data fell under the exceptions contained in the aforementioned implementing rules, and more particularly Article 3(2)(a), which, mirroring the provisions of the first subparagraph of Article 4(2) of Regulation (EC) No 1049/2001, refers to the protection of commercial interests of a natural or legal person, including intellectual property. 7 In 2007, a research and information centre in the field of health care contacted the EMA, requesting access to clinical study reports concerning two medicinal products. The EMA refused access on the grounds that it would undermine the commercial interests of the producers of those medicinal products. The research and information centre then filed a complaint with the European Ombudsman who, following an investigation into the relevant reports, concluded that they did not contain information on the composition of the medicinal products or other commercially confidential information. In its view, their disclosure would consequently not undermine the sector’s commercial interests. In its draft recommendation, the Ombudsman therefore called on the EMA to disclose the documents. 8 In its reply of 31 August 2010, the EMA stated that it had decided to grant access to those reports and committed itself to taking appropriate measures in order to implement the Ombudsman’s draft recommendation. In line with the Ombudsman’s recommendations, on 30 November 2010 the EMA adopted a new policy on access to its documents. In the press release accompanying the adoption of this policy, the EMA stated that documents submitted to it as part of an MA application, such as clinical trial reports, could henceforth be disclosed, provided that the decision-making process for the application in question was finalised. The policy on access to EMA documents became effective on 1 December 2010. 9 Under its new policy, the EMA drew up an output table for the various documents in its possession. More specifically, MA dossiers or updates and amendments to those dossiers, including clinical trial reports, are considered to be public, that is to say, they may be disclosed once, inter alia, the Commission’s MA decision is available for the medicinal product concerned. In March 2012 the output table was complemented by guidelines from the EMA and heads of national medicines agencies regarding the types of information included in an MA application that can be publicly released after the final decision on the application. The objective is to enable a consistent approach to be adopted in order to provide guidance on the identification of commercially confidential information which must be protected after an MA has been granted. 10 According to the guidelines, the following are considered commercially confidential information: detailed information concerning the quality and manufacturing of the medicinal products; information concerning the development of the product, including detailed information on the synthesis and manufacturing of the active substance; formulation, test procedures, validation, as well as manufacturers and suppliers of the active substance and excipients; and detailed descriptions of the manufacturing and control processes for the finished product. By contrast, information encompassing clinical and non-clinical development of a medicinal product is not per se commercially confidential. Accordingly, as a rule the data included in clinical trial reports is regarded as data that can be disclosed. Non-clinical studies are intended, inter alia, to identify the pharmacological properties and to understand the toxicological profile of the medicinal product, whilst clinical trials are studies that are intended to discover or verify the effects of one or more investigational medicines. Regulation of those trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible. 11 Consequently, since its new policy on access to documents has been in place, the EMA has been releasing documents submitted as part of MA applications, including clinical study reports, on request pursuant to Regulation No 1049/2001.’