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On 5th December 2013 the Court of Justice of the European Union (CJEU) published its decision on the appeal of the European Medicines Agency (EMA) to the order of the European Union General Court (EGC) for interim measures concerning the access of a third party to documents held by the EMA in relation to an application for authorisation to place a medicinal product on the market. We reported in November 2013 that, in contrast to the decision of the EMA to grant a third party access to clinical study reports in regard to medicinal products¹, the EGC had held that the EMA decision be suspended and that the EMA is ordered not to disclose the documents in question.

However, the CJEU has held in C-390/13 that the order of the EGC is set aside and the case is referred back to the EGC. The CJEU stated that the argument that harm is, by definition, irreparable because it falls within the scope of fundamental freedoms cannot be accepted – it is not sufficient to allege infringement of fundamental rights in the abstract when trying to show that the harm which could result from disclosure would necessarily be irreparable. According to the CJEU, it is still for the party seeking an interim measure to set forth and establish the likelihood of such harm occurring in its particular case. That is the case, in particular, where one undertaking seeks the adoption of interim measures in order to prevent the disclosure of information allegedly covered by the obligation of professional secrecy.  In order to prevent serious and irreparable harm to companies, the EGC is not precluded, when hearing an application for interim measures, from examining one by one the arguments and evidence put forward and intended to prove the necessity of maintaining the confidentiality of information redacted in the edited version of the requested documents. Nevertheless, the CJEU acknowledges that, as the present case concerns information contained in the edited version of the requested documents, the disclosure could be liable to cause serious and irreparable harm.

The proposal for a trade secrets Directive of the European Commission

The European Commission has recently presented a proposal for a directive on the “protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure” (COM(2013) 813 final). This proposal focuses on the field of economic espionage with rules for compensation, remedies and sanctions. However, it may also become quite important in the argumentation on access to trial data, as regards the future transparency policy of the EMA and the legislative procedure for the future EU regulation on clinical trials.

View our previous article on clinical-trial data.

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