EU General Court: EMA may not disclose clinical trials data
On 25 April, the President of the General Court of the European Union (“GC”) issued interim measures for suspension of operation of two decisions by the European Medicines Agency (“EMA”) granting third parties access to clinical trials data filed by pharmaceutical companies InterMune and AbbVie (jointly, the “Pharmaceutical Companies”) for their medicinal products “Esbriet” and “Humira” respectively (jointly, the “Medicinal Products”).
In particular, the requests to access such data concerned clinical and non-clinical information on Esbriet requested by the pharmaceutical company Boehringer Ingelheim GmbH, and three clinical study reports on Humira requested by a university student (the “Requested Data”). Against EMA’s decision granting the requested access, the Pharmaceutical Companies commenced legal action before the GCEU for annulment of EMA’s decisions, further than submitting motions for interim measures, requesting urgent suspension of said decisions (proceedings T-44/13R and T-73/13R).
According to the Pharmaceutical Companies, disclosure by EMA of the Requested Data would infringe Article 4(2) of Regulation no. 1049/2001 regarding public access to documents held by EU institutions, stating that “the institutions shall refuse access to a document where disclosure would undermine the protection of commercial interests of a natural or legal person, including intellectual property, (…) unless there is an overriding public interest in disclosure”. In addition, such disclosure would infringe the right to the protection of confidential information granted to the Pharmaceutical Companies by Article 7 of the EU Charter of Fundamental Rights and Article 8 of the Convention for the Protection of Human Rights and Fundamental Freedoms, further than breaching the obligation not to disclose information covered by professional secrecy set forth by Article 339 of the Treaty on the Functioning of the EU.
On its hand, EMA claims that its conduct complies with its new policy of 2010 and relevant guidelines of 2012 (adopted based on the European Ombudsman’s recommendations). These rules point out which documents submitted as part of an MA application can be publicly released after the final decision on the application: amongst said documents the Requested Data would be included. Moreover, according to EMA, there is no provision at Community level which expressly indicates as confidential the clinical study reports submitted by an MA applicant. Actually, EMA does not dispute that some documents submitted for an MA application are confidential, but it argues that the Requested Data are not of the kind, because they contain information of public interest relating to the safety and efficacy of the medicinal products on human health and environment.
In the orders at issue, the President of the GCUE firstly highlights that EMA’s policy – the lawfulness of which has not yet been assessed by the EU courts – is different from the previous one which used to classify the Requested Data as confidential, preventing third parties from accessing them under Regulation no. 1049/2001. Secondly, the President underlines that it is the first time since EMA’s new policy was implemented that an MA holder has requested the suspension of operation of a decision by EMA authorizing data disclosure; as a consequence, there is no case-law enabling an answer to be given easily to the question whether disclosure by EMA of such data infringes confidential information of the Pharmaceutical Companies. Moreover, such a question cannot be ruled on for the first time by a judge hearing an application for interim measures, but rather requires an in-depth examination in the main proceedings. On the other hand, the arguments and documents submitted by the Pharmaceutical Companies does not appear prima facie to be unfounded in terms of the allegedly confidential nature of the Requested Data.
In addition – the President remarks – as regards the weighing up of the various interests, the granting of the interim measures applied by the Pharmaceutical Companies, on one hand protects the Requested Data looking forward to the judgment on the merits, on the other hand would restrict only for a limited period of time the public interest in transparency that could be fully satisfied in a second time should the main proceedings be in favor of EMA. On the contrary, in case of dismissal, EMA would immediately grant free access to the Requested Data and the following judgments on the merits ordering definitive annulment of EMA’s decisions would no longer have any practical effect for the Pharmaceutical Companies. Hence the injunction which prevents EMA from disclosing the Requested Data, looking forward to the final rulings of the GC in the main proceedings.