CJEU decides on access to clinical study reports and toxicity studies - no general assumption of confidentiality

In recent years, an increasing trend towards transparency has been observed among the European authorities, especially the European Medicines Agency (EMA). Many pharmaceutical companies observe this trend with conflicting feelings. On the one hand, transparency may jeopardize the confidentiality of their own sensitive information; on the other hand, it may give them the opportunity to obtain information about competitors that would otherwise not be publicly available. Not without reason, according to information provided by the EMA, 385 of a total of 812 access to documents requests from the pharmaceutical industry were made in 2018 on the basis of Policy 0043, 119 by consultants, 36 by healthcare professionals and only 100 by patient or consumer organisations (EMA, Annual Report 2018, pp. 88 and 89). The Court of Justice of the European Union (CJEU) has now strengthened the transparency movement and, in the proceedings PTC Therapeutics International / EMA (C-175/18 P) and MSD Animal Health Innovation and Intervet International / EMA (C-178/18 P), has confirmed the generous approach of the EMA.

Background

Both proceedings were aimed at setting aside the judgments of the General Court of the European Union (GCEU) of 5 February 2018, by which the GCEU dismissed actions for annulment of two decisions of the EMA. In both decisions, EMA decided to grant access to a document contained in the file of a marketing authorisation application for a medicinal product to a third party in accordance with Regulation (EC) 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 (OJ 2001 L 145, p. 43).

Crucial points of the CJEU’s reasoning

The applicants put forward several grounds in support of their appeals. None of the grounds of appeal was successful. The most important ones were the first and the second ground of appeal which were the same in both proceedings.

By the first ground of appeal, the appellants submit, first, that the GCEU erred in law in not finding that the reports at issue must be protected by a general presumption of confidentiality (C-175/18 P, paragraph 41; C-178/18 P, paragraph 38). Secondly, the appellants submit that in the judgment under appeal the GCEU misapplied the criteria governing recognition of a general presumption of confidentiality in the present case (C-175/18 P, paragraph 43; C-178/18 P, paragraph 40).

The CJEU points out that Article 1 of Regulation 1049/2001 provides that the regulation is to grant the public a right of the widest possible access to documents of the EU institutions
(C-175/18 P, paragraph 54; C-178/18 P, paragraph 51). Since exceptions to the principle of the widest possible public access to documents deviate from the rule, they must be interpreted and applied strictly (C-175/18 P, paragraph 56; C-178/18 P, paragraph 53). An institution, body, office or agency of the Union is not obliged to base its decision on a general presumption of confidentiality of a document, but may at any time carry out a concrete examination of the documents covered by the application for access and give concrete reasons for its decision (C-175/18 P, paragraph 60; C-178/18 P, paragraph 57).

By the second ground of appeal, the appellants submit that, in the present case, the GCEU failed to have regard to the protection of commercial interests afforded by the first indent of Article 4(2) of Regulation No 1049/2001 (C-175/18 P, paragraph 69; C-178/18 P, paragraph 66).

With this respect, the CJEU states as follow: In so far as a company identifies a specific and reasonably foreseeable risk that a competitor of that company may use certain unpublished data contained in a report such as the one at issue, which are not generally available knowledge in the pharmaceutical industry, in one or several non-member countries in order to obtain a marketing authorisation and thus benefit unfairly from the work carried out by the company in question, this could be sufficient evidence of an adverse effect to be taken into account in the decision about access to the document (C-175/18 P, paragraph 81; C-178/18 P, paragraph 80). However, according to the CJEU, this requires a specific and precise identification of critical parts of the document in scope (C-175/18 P, paragraph 82; C-178/18 P, paragraph 81). Furthermore, a weighing of interests would only need to be carried out when one of the exceptions under Article 4 of Regulation 1049/2001 applies. Where it is apparent that documents need not be protected by one or more of these exceptions, there is no obligation to determine or evaluate the public interest in disclosure of the document, nor to weigh it against the appellant’s interest in preserving the confidentiality of the document (C-175/18 P, paragraph 86; C-178/18 P, paragraph 85).

The CJEU also emphasises that, where an institution, body, office or agency of the EU to which access to a document has been requested decides to refuse the request on the basis of one of the exceptions to the fundamental principle of transparency laid down in Article 4 of Regulation 1049/2001, it must explain in principle how access to that document could specifically and actually undermine the interest protected by that exception. The likelihood of such an impairment must be “reasonably foreseeable and not purely hypothetical” (C-175/18 P, paragraph 94; C-178/18 P, paragraph 93). Admittedly, the risk of misuse of data contained in a document to which access is requested may, in certain circumstances, harm the commercial interests of an undertaking. However, the existence of such a risk must be specifically demonstrated. The unproven reference to a general risk was not held to be sufficient (C-175/18 P, paragraph 96; C-178/18 P, paragraph 95).

Furthermore, the CJEU states that it is for the owner of the document to explain to the EMA, before a decision is taken, the nature, purpose and scope of the data, the disclosure of which would harm their business interests. Documents submitted subsequently after the decision was taken are irrelevant (C-175/18 P, paragraphs 109 and 117).

The CJEU also rejected incompatibility with Article 39 of the TRIPS Agreement in its PTC judgment: Article 39(3) of the TRIPS Agreement did not serve to define the concept of commercial interests (C-175/18 P, paragraph 114). Furthermore, the requirement to provide evidence for the application of an exception under Article 4 of Regulation 1049/2001 is compatible with Article 39(3) of the TRIPS Agreement.

Impact of the CJEU decisions

Based on these decisions of the CJEU, the requirements to successfully claim that certain information are commercial confidential information in accordance with Article 4(2) of Regulation 1049/2001 and by that should not be disclosed are high. It is necessary to lay down specifically how disclosure of (parts of) that document could actually undermine the commercial interests protected by that exception. Therefore, it is of utmost importance that companies submitting documents to European institutions or authorities have a solid review process in place prior to the actual submission in order to identify any potential commercial confidential information and take all necessary steps either to obtain protection as IP right or to claim protection upfront. Otherwise, when consulted by a European institution or authority dealing with a third party access to document requests, due to the tough and strict timelines to respond and to claim commercial confidential data protection, being prepared and having a line of argumentation ready is clearly advisable.