On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report concerning the medicinal product Translarna granted by the General Court in July 2016. On the same day, by Order of its Vice-President, the CJEU upheld also the suspension of the release of certain non-clinical study reports concerning the veterinary medicinal product Bravecto.

This blog focuses on the case concerning the medicinal product Translarna. The two Orders issued by the CJEU Vice-president on March 1st rely, however, on similar arguments in point of law.

Background to the dispute: access to the study report for Translarna

In October 2015, the EMA informed PTC Therapeutics (“PCT”) that it had received a request for access to a clinical study report included in the marketing authorisation application (“MA”) submitted by PCT for Translarna. The request for access was submitted pursuant to Regulation (EC) No 1049/2001 (the “Transparency Regulation”), which sets out the principles, conditions and limits governing the right of access to the documents held by the EU Institutions and Agencies, including the EMA.

In response, PTC requested that the study report be treated as confidential in its entirety. EMA rejected PTC’s request and granted the third party applicant access to the study report, subject to certain redactions made of its own initiative.

PTC brought an action for annulment of EMA’s decision and also lodged an application for interim measures in which it asked the President of the General Court to order the EMA to abstain from disclosure of the study report.

On 20 July 2016, the President of the General Court ordered EMA not do disclose the report at issue. The EMA appealed this Order to the CJEU.

Order of the CJEU Vice-President

The Order of the CJEU Vice-President upheld the suspension of the release of the clinical study report, rejecting EMA’s appeal. The Order rejected the EMA’s argument that clinical reports are not confidential per se. The Order, in particular, underlines the scientific added value included in the elaboration of study reports submitted within an application for a MA and concluded that their disclosure can “objectively liable to be used for competitive purposes” (Paragraph 133).

The main arguments of the Order are the following:

  • information or a document that is already publicly available cannot, as a rule, be classified as confidential;
  • however, it is legitimate to argue that a body of complex information “combining public information and other information not known to the public” (Paragraph 67) might damage the commercial interests of MA applicants;
  • the specific way the in which PTC used both confidential and non-confidential information to redact the study report consisted in an “inventive strategy [that] adds scientific value to elements that are not confidential in themselves” (Paragraph 68);
  • holding an MA, which is accompanied by a period of exclusivity and data protection, may justify that the information on the basis of which that MA was granted remain confidential, even after the closure of the procedure that led to issuing the MA (Paragraph 84).

The awaited decision on the main cases may clarify whether the EMA’s approach is correct and, possibly, eliminate operational uncertainties for both the agency and stakeholders.