Source: EURLEX
Language: en
Format: md

Case T‑235/15

Pari Pharma GmbH

v

European Medicines Agency

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

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

1. Actions for annulment — Jurisdiction of the EU judicature — Claim seeking that directions be issued to an institution — Inadmissibility

   (Art. 263 TFEU)
2. 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))
3. 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 reports of the Committee for Medicinal Products for Human Use of the European Medicines Agency — General presumption that the exception to the right of access applies — Not included

   (European Parliament and Council Regulations No 141/2000, No 1049/2001, Art. 4(2) and No 726/2004, Arts 11, 13(3), 36, 38(3), 57(1) and (2), and 73)
4. 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, Recital 11 and Art. 4)
5. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Duty to balance relevant interests

   (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 — Protection of commercial interests — Scope — Assembly of non-confidential information originating from published scientific studies — Assembly of non-confidential and confidential information originating from published scientific studies — Included — Condition — Requirement to demonstrate added value, resulting from compilation work or an inventive strategy, giving the undertaking a commercial advantage

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2), 1st indent)
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 — Burden of proving the confidential nature of the information in question — Need to show the importance of the information for the undertaking concerned and the utility of that information for other undertakings

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2), 1st indent)
8. 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(2); European Parliament and Council Regulations Nos 141/2000, 1049/2001 and 726/2004; Council Decision 94/800)
9. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Overriding public interest justifying the disclosure of documents — Need to put forward particular considerations in relation to the case

   (European Parliament and Council Regulation No 1049/2001, Art. 4(2), 1st indent)

1. See the text of the decision.

   (see para. 31)
2. See the text of the decision.

   (see paras 40, 41, 43, 44)
3. There is no general presumption of confidentiality of reports of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) 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 of confidentiality justifying refusal of access to documents apply, such a presumption does not result from Regulations Nos 141/2000 and 726/2004, which do not restrict the use of documents in the file relating to a marketing authorisation procedure for a medicinal product and 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 are 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 of a medicinal product is not undermined in the absence of such a presumption of confidentiality.

   (see paras 51-54, 56, 57)
4. See the text of the decision.

   (see paras 66, 67, 69)
5. See the text of the decision.

   (see para. 68)
6. In order to apply the exception relating to the protection of commercial interests provided for by the first indent of Article 4(2) of Regulation 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, it must be shown that the documents to which access is 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 extensive data which have been published in articles, studies or scientific reports, which are publicly accessible, the mere fact that those published data were compiled together cannot, as such, suffice to show that all those data reveal the content of the strategic know-how of the legal person concerned by those data and are thus confidential. Nor can the fact that that person performed a search of published information and compiled that information lead to the automatic conclusion that all the data are particular to that undertaking and reveal its expertise. In order to reach a finding that such know-how falls within the scope of commercial interest within the meaning of Article 4(2) of Regulation No 1049/2001, it is necessary to show that the compilation of those data which are accessible to the public and its assessments on those data provide added value — consisting of, for example, new scientific conclusions or considerations relating to an inventive strategy — giving the undertaking a commercial advantage over its competitors.

   As regards confidential and non-confidential information, it must be shown that there was a specific use of that information, that that method of use constituted an inventive strategy which bestowed a scientific added value on the non-confidential elements taken in isolation and that that strategy may consequently be considered confidential. It is all the more necessary for the legal person concerned to adduce precise and proper explanations since the exceptions provided for in Article 4 of Regulation No 1049/2001 must be interpreted and applied strictly because they derogate from the principle that the public should have the widest possible access to documents and since it is necessary to show how access to that document could specifically and actually undermine an interest protected by an exception laid down in that article.

   (see paras 71, 75-77, 79)
7. As regards the exception relating to the protection of commercial interests laid down in the first indent of Article 4(2) of Regulation No 1049/2001 regarding public access to European Parliament, Council and Commission documents, the person concerned by the information whose disclosure has been requested cannot merely plead the existence of inherent confidentiality, or merely allege infringement of fundamental rights in abstract terms. It is for that person to describe in specific terms the professional and commercial importance for it of the information and the utility of that information for other undertakings which are liable to examine and use it subsequently.

   (see para. 108)
8. See the text of the decision.

   (see para. 111)
9. See the text of the decision.

   (see para. 144)

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