European Medicines Agency ordered not to disclose clinical study report from marketing authorisation dossier

26/07/16

Case T-718/15R PTC Therapeutics International Ltd v European Medicines Agency, 20 July 2016.

The President of the General Court has granted an interim injunction to prevent the European Medicines Agency from releasing a clinical study report (“CSR”) relating to the orphan drug Translarna. The CSR was submitted to the Agency by PTC, a pharmaceutical company, in support of its application for a marketing authorisation for Translarna (which the Agency ultimately granted). A request for the CSR was submitted to the EMA by another pharmaceutical company, pursuant to the EU’s freedom of information measure: the so-called Transparency Regulation (No 1049/2001).

PTC applied for an interim injunction to restrain the EMA from releasing the CSR pending an application to the General Court to restrain disclosure. It argued that the entirety of the report should be treated as confidential, because it formed an inseparable whole with economic value and because the submission of documents for the purpose of obtaining a marketing authorisation is governed by specific sectoral legislation, which lays down specific requirements for the release of information by the EMA so as to ensure transparency, while giving effect to the need to protect commercially confidential information, and the EMA should not undermine that code by releasing PTC’s study under the Transparency Regulation.

The European Confederation of Pharmaceutical Entrepreneurs intervened in support of PTC’s application, pointing out that requests for access under the Transparency Regulation have become increasingly common since the Agency amended its policy of non-disclosure in 2010. Requesting companies are able to act quickly to exploit the information obtained both inside and outside the EU.

By his judgment of 20 July 2016, the President of the General Court granted the interim injunction sought. He held that PTC’s arguments raised “novel questions of principle” and complex scientific factual issues which could not be resolved in the context of interim proceedings. The fact that a competing pharmaceutical company had requested access to the study was itself an indication of its scientific and commercial value, militating against disclosure, as was the fact that the Agency itself saw value in its release. He rejected the EMA’s argument that PTC was sufficiently protected by Translarna’s data and market exclusivity, pointing out that competitors could easily exploit the data outside the EU. It was appropriate to grant the injunction in order to maintain the status quo and to guarantee the effectiveness of the final proceedings. Importantly, he observed that the ‘serious and irreparable harm’ criterion identified in case-law on interim injunctions should not be applied in cases concerning the protection of allegedly confidential information, because it is inconsistent with the need to provide effective provisional protection.

Such injunctions are comparatively rare, having been granted in only a small number of pharmaceutical cases to date (in all of which members of Brick Court Chambers have represented the pharmaceutical companies resisting disclosure). 

The President's Order is here.