In an important decision on transparency under EU law for pharmaceutical and biotech clients, the Vice-President of the Court of Justice of the European Union (CJEU) has upheld interim orders of the President of the General Court in two proceedings suspending the release by the European Medicines Agency (EMA) of certain documents requested by third parties under Regulation (EC) No 1049/2001. This marks the first time that the CJEU has upheld such an interim order in relation to an EMA decision to release documents to a third party and the decisions provide further clarity regarding the grounds for obtaining such orders. The decisions were delivered in Cases C-512/16 P(R) EMA v MSD Animal Health & Intervet and C-513/16 P(R) EMA v PTC Therapeutics.
These decisions follow applications by PTC Therapeutics and by Intervet for interim measures to suspend the release by the EMA of a clinical study report that was included in the dossier for PTC Therapeutics’s Translarna, a therapy for Duchenne muscular dystrophy, and three toxicology study reports submitted as part of the marketing authorisation application for Intervet’s Bravecto, a tick and flea infestation treatment for dogs, respectively. The documents were requested in each instance by an unidentified pharmaceutical company. The interim orders were made pending the outcome of PTC Therapeutics’ and Intervet’s actions for annulment of the EMA’s decisions to grant access to the documents.
The EMA issued a press release announcing the dismissal of its appeals against the interim orders and stating that it will not release the documents in question until the General Court rules in the main proceedings. It also said that it will continue to process requests under Regulation (EC) No 1049/2001 and its 2010 policy on access to documents (a revised draft of which is currently subject to a public consultation).
The Vice-President of the CJEU’s findings, in summary, were:
- the EMA’s first ground of appeal was an attempt to challenge the President of the General Court’s findings on the facts, which is not permissible on appeal unless the EMA established that the evidence had been distorted (which it did not);
- there was no error in law in finding that the applicants had established that they had a prima facie case in support of their applications for annulment;
- the President of the General Court had not erred in finding that disclosure of the reports at issue would, with a sufficient degree of probability, place the applicants at risk of serious and irreparable harm; and
- the President of the General Court was fully entitled to find that the applicants’ interests in obtaining suspension of the operation of the decisions at issue outweighed that of the EMA in obtaining the immediate implementation of the decisions.
Whilst we will need to await the outcome of the main proceedings in order to know if the EU Courts consider that these challenges have merit, these latest decisions confirm the correctness of the approach applied by the General Court in deciding the applications for interim measures in these actions. The hearing on the merits before the General Court in a separate access to documents challenge by Pari Pharma took place on 14 February 2017. As such, it may not be long until we receive the first decision on the merits in a challenge to the EMA’s policy on access to documents.