Source: EURLEX
Language: en
Format: md

Case T‑718/15

PTC Therapeutics International Ltd

v

European Medicines Agency

(Access to documents — Regulation (EC) No 1049/2001 — Document held by the EMA and submitted in the context of the application for marketing authorisation for the medicinal product Translarna — Decision to grant a third party access to the document — Exception relating to the protection of commercial interests — No general presumption of confidentiality)

Summary — Judgment of the General Court (Second Chamber), 5 February 2018

1. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Strict interpretation and application — Requirement that the institution should examine the documents specifically and individually — Scope — Exclusion of the obligation — Possibility to base reasoning on general presumptions applying to certain categories of documents — Limits

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2))
2. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Scope — Application to the documents of a file submitted in the context of an application for marketing authorisation for a medicinal product — General presumption that the exception to the right of access applies — Not included

   (European Parliament and Council Regulations Nos 141/2000, 1049/2001, Art. 4(2), 2nd indent, and 726/2004, Arts 11, 13(3), 36, 38(3), 57(1) and (2) and 73)
3. EU law — Interpretation — Methods — Interpretation in the light of the international agreements concluded by the Union — Interpretation of Regulations Nos 141/2000, 1049/2001, 726/2004 and 507/2006 in the light of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

   (TRIPS Agreement, Art. 39; European Parliament and Council Regulations Nos 141/2000, 1049/2001 and 726/2004; Commission Regulation No 507/2006; Council Decision 94/800)
4. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Refusal to grant access — Possibility of justification on the basis of the workload necessitated by the request for access — Not included

   (European Parliament and Council Regulation No 1049/2001, Art. 4(1) and (2))
5. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Refusal to grant access — Possibility of relying on general presumptions applicable to certain categories of documents — Obligation to have recourse to such presumptions — No such obligation

   (European Parliament and Council Regulation No 1049/2001, Art. 4)
6. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Strict interpretation and application — Obligation to make a specific and individual examination for documents covered by an exception — Scope

   (European Parliament and Council Regulation No 1049/2001, Recitals 2 and 11 and Art. 4)
7. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Scope — Assembly of public scientific studies containing non-confidential and confidential information — Included — Condition — Existence of a commercially sensitive item of data which could undermine commercial interests

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2), 1st indent)
8. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of the purpose of inspections, investigations and audits — Protection of commercial interests — Overriding public interest justifying the disclosure of documents — Requirement that the institution should weigh the opposing interests

   (European Parliament and Council Regulation No 1049/2001, Recital 2 and Art. 4(2), 1st and 3rd indents)

1. See the text of the decision.

   (see paras 34-36, 38, 39)
2. There is no general presumption of confidentiality of the documents of a file submitted to the European Medicines Agency (EMA) in the context of an application for marketing authorisation for a medicinal product, and in particular of clinical study reports, arising from the application of the combined provisions of Regulations Nos 141/2000 on orphan medicinal products, 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents, and 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use.

   Thus, unlike the situations in which it has been accepted that the general presumptions justifying refusal of access to documents apply, Regulations Nos 141/2000 and 726/2004 do not restrict the use of documents in the file relating to a marketing authorisation procedure for a medicinal product. They do not provide that access to the file is limited to the parties concerned or to complainants. More specifically, Regulation No 141/2000 does not contain any specific provision on access to documents. As regards Regulation No 726/2004, it provides in Article 73 thereof that Regulation No 1049/2001 is to apply to documents held by the EMA and that the EMA’s Management Board is to adopt the arrangements for implementing Regulation No 1049/2001. No other provision of Regulation No 726/2004 can be interpreted as evidence of the intention of the EU legislature to set up a system of restricted access to documents by means of a general presumption of confidentiality of documents.

   Regulation No 726/2004 requires the EMA, in Article 11, Article 13(3), Article 36, Article 38(3) and Article 57(1) and (2) thereof, to publish three documents, namely the European Public Assessment Report, a summary of the characteristics of the medicinal products concerned and the user package leaflet, after deletion of all information of a commercially confidential nature. Those provisions mention the minimum information, by means of the three abovementioned documents, that the EMA is required to make publicly available in a proactive manner. The objective of the EU legislature is, first, that the characteristics of the medicinal product concerned and the manner in which it should be prescribed to patients should be indicated as intelligibly as possible to healthcare professionals and, second, that the non-professional public should be informed in understandable language of the optimal method of using the medicinal product and of that product’s effects. That proactive scheme of publishing a minimum amount of information does not therefore constitute a specific regulatory scheme on access to documents which should be interpreted as meaning that all data and information not contained in the three abovementioned documents is presumed to be confidential.

   It follows that the prevailing principle in Regulations Nos 726/2004 and 1049/2001 is that of public access to information and that the exceptions to that principle relate to those referred to in Article 4(2) of Regulation No 1049/2001, including the exception relating to commercially confidential information. In view of the requirement of a strict interpretation of the exceptions to disclosure, it must be held that the EU legislature took the implicit view that the integrity of the marketing authorisation procedure is not undermined in the absence of a presumption of confidentiality.

   (see paras 46-49, 52, 53)
3. See the text of the decision.

   (see para. 62)
4. The administrative work related to providing public access to documents cannot be used as a valid justification for refusing access to documents. Moreover, no evaluation can be made in the assessment of whether a document or parts of a document can be released of the amount of work that a third party originator needs to make for assessing which part of the document is covered by any of the exceptions in Article 4(1) or (2) of Regulation No 1049/2001 regarding public access to European Parliament, Council and Commission documents. In addition, it is in the very interest of the consulted third party originator to provide justifications with a view to assisting the EU institution seised of a request for public access in order to apply, if appropriate, the relevant exceptions.

   (see para. 66)
5. An institution seised of a request for access under Regulation No 1049/2001 regarding public access to European Parliament, Council and Commission documents is not required to base its decision on a general presumption, if such a presumption exists. It may always carry out a specific examination of the documents covered by a request for access and provide reasons stemming from that specific examination.

   (see para. 70)
6. See the text of the decision.

   (see paras 79-83)
7. In order to apply the exception provided for by the first indent of Article 4(2) of Regulation No 1049/2001 regarding public access to European Parliament, Council and Commission documents, it must be shown that the documents requested contain elements which may, if disclosed, seriously undermine the commercial interests of a legal person. That is the case, in particular, where the requested documents contain commercially sensitive information relating, in particular, to the business strategies of the undertakings concerned or to their commercial relations or where those documents contain information particular to that undertaking which reveal its expertise.

   As regards a request for access to a report containing a number of items of information that were disclosed in the European Public Assessment Report drawn up by the Committee for Medicinal Products for Human Use of the European Medicines Agency, that report being publicly accessible and containing data emanating directly from that report, it is necessary to show that the assembly of the publicly-accessible data together with the data which is not publicly accessible constitutes a commercially sensitive item of data whose disclosure would undermine the commercial interests of a legal person. In that regard, an assertion that the whole is more than the sum of its parts is too vague to show that that assembly of information could undermine those commercial interests. It was all the more necessary to adduce precise and proper explanations since the exceptions provided for in Article 4 of Regulation No 1049/2001 derogate from the principle that the public should have the widest possible access to the documents and must therefore be interpreted and applied strictly.

   Moreover, it must be held that potential misuse of the report access to which has been requested by a competitor is not in itself a ground for considering that information is commercially confidential under Regulation No 1049/2001.

   (see paras 85, 89, 91)
8. See the text of the decision.

   (see paras 106, 107)

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