On November 28 2013, the Vice-President of the Court of Justice of the European Union (CJEU) set aside two orders by the President of the General Court granting interim relief to AbbVie and InterMune in separate cases brought against the European Medicines Agency (EMA) concerning the planned release of clinical trial data to third parties.
Interim relief was sought by the companies early in 2013 to prevent the EMA from disclosing the clinical trial data concerned until the General Court had ruled on two underlying cases challenging the EMA’s decision to grant access to the data. The President of the General Court granted interim relief after determining that there was an urgent need to protect the interests of the companies and that disclosure of the data concerned would irreparably infringe the companies’ fundamental rights.
The EMA launched appeals against both orders in July 2013. In the orders adopted on November 28, the Vice-President of the CJEU held that the President of the General Court erred in law in finding that the alleged infringement of the companies’ fundamental rights was sufficient to establish a risk of serious and irreparable harm. Instead, according to the Vice-President, an examination should have been performed of the arguments and evidence put forward regarding the necessity of maintaining the confidentiality of specific elements of the clinical trial data to prevent serious and irreparable harm.
Both cases regarding the need for interim relief have now been referred back to the General Court for further assessment. In the meantime, it is expected that the EMA will not disclose the data concerned. However, in light of the findings of the Vice-President of the CJEU, it is possible that the General Court will decide that interim relief is not necessary with respect to certain elements of the clinical trial data, potentially leading to disclosure by the EMA.
In light of the potential consequences of the disclosure of confidential clinical trial data, innovative companies should closely monitor the outcome of these cases as well as other EMA initiatives to increase the transparency of clinical trial data, including in particular the EMA’s proposed policy on the proactive publication of clinical trial data.