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)