February 25
Anjum Shabbir
Anjum Shabbir
23rd January 2020
Consumer, Health & Environment Data, Tech & IP Institutional law

Analysis: “CJEU rulings on Protection of Commercial Interests and Third Party Access” by Anastasia Karatzia

Yesterday, the Court of Justice of the European Union (CJEU) delivered its first judgments on access to documents submitted by an undertaking in an application for marketing authorisation (MA).

The cases are PTC Therapeutics International Ltd v European Medicines Agency (EMA)(C-175/18 P) and MSD Animal Health Innovation and Intervet International v European Medicines Authority (EMA) (C-178/18 P).

Both appeals were against a Decision of the European Medicines Authority (EMA) to allow access to a third party to redacted versions of documents that the appellants (undertakings) had submitted to EMA with their application to obtain marketing authorisation (MA) for their medicinal products.

As well as being the very first CJEU judgments on access to documents regarding MA applications, the rulings are noteworthy for three main reasons. Firstly, they explore the process that the EMA should follow in making decisions for disclosure to third parties. Secondly, they clarify certain factors that the EMA should take into account when deciding whether to order disclosure. Thirdly, they set out the obligations for undertakings that wish to successfully argue against disclosure of their documents when the EMA consults them or when challenging an EMA’s decision to disclose. This analysis focuses on these three points.

The two judgments deal with Regulation 1049/2001 regarding public access to European Parliament, Council and Commission documents, which applies inter alia to all documents that the EMA possesses. The Regulation aims to confer on the public a wide right of access to the EU documents, subject to certain exceptions which protect public or private interests (Article 4). For our analysis, Article 4(2) is particularly important. It states that an EU institution ‘shall refuse access to a document where disclosure would undermine the protection of commercial interests of natural or legal persons, including intellectual property, unless there is an overriding public interest in disclosure’. In addition, the CJEU recognised the existence of ‘general presumptions of confidentiality’: where access to a category of documents is incompatible with the proper conduct of the EU institution’s procedures, the institution is allowed to limit intervention by third parties without individually examining each document in the requested file ClientEarth v Commission (Joined Cases T-424/14 and T-425/14).

The first point of interest in yesterday’s judgments is the clarification by the CJEU that, when an EU institution deals with a third party request for access to documents, it is not obliged to rely on a general presumption of confidentiality for the purposes of making a decision (see also LPN and Finland v Commission (Cases C-514/11P and C-605/11P)). Instead, the institution can engage in a specific and individual examination of the requested document(s), to examine whether any of the Article 4 exceptions should apply. Based on this clarification, the CJEU rejected the appellant’s argument that the EMA failed to apply the general presumption of confidentiality.

More broadly speaking, however, the Court has left a question unanswered: in the context of MA applications, can the EMA apply a general presumption of confidentiality, analogous to what the CJEU has recognised in other categories of documents? In the first instance cases, the General Court (GC) concluded that the EMA cannot apply the general presumption in MA authorisations. Although the appellants challenged this finding, the CJEU did not deal with it. It found the issue irrelevant to the case because the EMA was not obliged to decide on a general presumption of confidentiality. It remains to be seen whether this question will reappear before the GC in the future, if the EMA chooses to apply a general presumption of confidentiality in another case.

The second point of interest in the judgments concerns the obligation of an EU institution, when dealing with requests for disclosure, to balance overriding interests. Such a balancing exercise should be conducted only when the EU institution concludes that an Article 4 exception should be applied to prevent disclosure. For example, in the context of Article 4(2), the EU institution would have to balance the public interest in transparency and the need to protect the commercial interests of the undertaking. If, however, the EU institution concludes that none of the Article 4 exceptions apply to a document, there is no question of balancing contrasting interests: it should simply disclose the document or the parts of the document (Article 4(6)) that it does not consider confidential.

In the cases at hand, as the EMA concluded that Article 4(2) did not apply to certain parts of the documents, it was not obliged to weigh the public interest in disclosing those parts against the commercial interests of the undertakings. The conclusion of the CJEU here appears consistent with the spirit of the Regulation which – simply put – mandates access unless there is an overriding reason not to allow it. In this sense, the balancing exercise should help an EU institution decide whether access should not be allowed, as opposed to whether access should be allowed.

The CJEU also dealt with the factors that the EMA should consider when assessing the application of Article 4(2) in the context of MA applications. It explained that there is no need to show that commercial interests would be ‘seriously undermined’ for Article 4(2) to apply.  Any undermining of commercial interests could justify Article 4(2). Although this point was irrelevant to the cases, it can certainly guide other undertakings that may wish to argue in favour of protecting the confidentiality of their documents. Moreover, the Court stated that the risk of misuse of the disclosed data by a competitor may on its own be enough for the data to be considered confidential, as long as this risk is specific and reasonably foreseeable. Importantly, though, the responsibility to establish and furnish this level of risk to the EMA belongs to the undertaking.

The above observation takes us to the third and final point: undertakings that wish to rely on Article 4(2) have to prove that disclosure of their documents would harm their commercial interests. This responsibility applies both when the undertakings are consulted by the EU actor about the disclosure (Article 4(4)), and when they seek to challenge the respective decision before the CJEU. It is not enough for an undertaking to present unsubstantiated and generic claims regarding a vague risk of misuse of its data if these are made public. Instead, the undertaking needs to present EMA with details regarding the nature, purpose, and scope of the data, which substantiate the need to protect the confidentiality of the data against competitors. In the cases at hand, the appellants failed to demonstrate any specific reasons why the disclosure would be detrimental to their commercial interests.

Overall, the two judgments are positive regarding public access to documents based on Regulation 1049/2001, as they clarify matters pertaining to the process of assessing a request for disclosure to a third party. As such, the judgments should constitute useful guides both for the EMA, and for undertakings that wish to rely on Article 4(2) of Regulation 1049/2001 to either prevent disclosure of their documents or to challenge an EMA disclosure decision.


Anastasia Karatzia is Lecturer in Law at School of Law, University of Essex. Her research focuses on (EU) financial and banking law, and EU institutional and constitutional law. Her work has been published in the Common Market Law Review, European Law Review, and Cambridge Yearbook of European Legal Studies. Her most recent publication can be found in the European Law Review: Karatzia A. and Konstadinides T. “The legal nature of Memoranda of Understanding as instruments used by the European Central Bank” (2019) 44(4) ELR 447.



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