Case T‑729/15

MSD Animal Health Innovation GmbH and Intervet international BV

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 veterinary medicinal product Bravecto — 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), 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 authorization for a medicinal product — General presumption that the exception to the right of access applies — Not included

   (European Parliament and Council Regulations No 1049/2001, Art. 4(2), and No 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 1049/2001 and 726/2004 in the light of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

   (TRIPS Agreement, Art. 39(2) and (3); European Parliament and Council Regulations No 1049/2001 and No 726 /2004; 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 — 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 public scientific studies containing non-confidential and confidential information — Included — Condition — Assembly constituting a commercially sensitive item of data which could undermine commercial interests

   (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 the decision-making process — Protection of documents drawn up under a procedure already closed — Scope

   (European Parliament and Council Regulation No 1049/2001, Art. 4(3), second para.)

8. 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 — Invocation of the principle of transparency — Need to put forward particular considerations in relation to the case

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

9. EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the principle of access to documents — Obligation to grant partial access to data not covered by the exceptions — Observance of the principle of proportionality

   (European Parliament and Council Regulation No 1049/2001, Art. 4(6))

1.  See the text of the decision.

   (see paras 22, 23, 25, 26)

2.  There is no general presumption of confidentiality of documents and reports of a file submitted to the European Medicines Agency (EMA) in the context of an application for marketing authorisation for a medicinal product arising from the application of the combined provisions of Regulation 1049/2001 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, Regulations No 726/2004 does not restrict the use of documents in the file relating to a marketing authorisation procedure for a medicinal product. It does not provide that access to the file is limited to the parties concerned or to complainants. Regulation No 726/2004 provides expressly 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 did not make any provision for a specific regulatory scheme on access to documents and, to that effect, did not establish a general presumption of confidentiality in respect of study reports submitted to the EMA in the context of an application for marketing authorisation for a medicinal product.

   (see paras 33-35, 37, 38)

3.  See the text of the decision.

   (see para. 48)

4.  See the text of the decision.

   (see paras 63, 64, 66)

5.  See the text of the decision.

   (see para. 65)

6.  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 an application for access to study reports submitted to the European Medicines Agency in the context of an application for marketing authorisation for a medicinal product which contains a number of items of information that were published, in order to be able to claim confidential treatment in respect of the entire reports, it must be shown 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. It is not sufficient, in that regard, to provide vague and generic explanations in order to show that that assembly could produce alleged consequent harm to the know-how and commercial secrets of a legal person. It is 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.

   (see paras 68, 81)

7.  See the text of the decision.

   (see paras 99-101)

8.  See the text of the decision.

   (see paras 120, 121)

9.  Article 4(6) of Regulation No 1049/2001 regarding public access to European Parliament, Council and Commission documents provides that, if only parts of the requested document are covered by any of the exceptions, the remaining parts of the document are to be released and that examination of partial access to that document must be carried out in the light of the principle of proportionality.

   It is clear from the very wording of Article 4(6) of that regulation that an institution or body is required to consider whether it is appropriate to grant partial access to the documents covered by a request for access and to limit any refusal to information covered by the relevant exceptions referred to. The institution or body must grant such partial access if the aim pursued by that institution or body, in refusing access to a document, may be achieved by merely redacting the passages which might harm the public interest to be protected.

   (see paras 132, 133)