European Medicines Agency ordered not to disclose toxicology study reports from marketing authorisation dossier

26/07/16

Case T-729/15 MSD Animal Health Innovation and Intervet international v European Medicines Agency, 20 July 2016.

The President of the General Court has granted an interim injunction to prevent the European Medicines Agency (‘EMA’) from releasing a toxicology study report to which access had been requested under the Transparency Regulation (No 1049/2001). Such injunctions are comparatively rare (see also the PTC decision of the same date). The Transparency Regulation has an exception requiring EU institutions to deny access to documents 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 (Article 4(2)). Until 2010, the EMA had treated studies submitted for the purpose of marketing authorisation applications as confidential on the basis of this exception; however, “in an abrupt change of policy” in November 2010, the EMA decided to treat most of the contents of the marketing authorisation dossier as disclosable once the marketing authorisation has been granted. This judgment considers the legality of that new policy, which has still never been examined in a final hearing.

Intervet holds a marketing authorisation for Bravecto, which is used to treat tick and flea infestations in dogs. In order to obtain the marketing authorisation for Bravecto, Intervet had to submit a series of study reports to the EMA, including the reports of five toxicology studies sponsored by MSD Animal Health. Following the grant of the marketing authorisation, Bravecto benefits from an eight-year period of data exclusivity, during which other companies are required to conduct their own studies if they wish to obtain marketing authorisations for the same indication; after the expiry of the data exclusivity period, other companies may rely on the data submitted for Intervet’s marketing authorisation for Bravecto as a ‘bridge’ allowing them to obtain marketing authorisations for products which are ‘essentially similar’ to Bravecto.

Another pharmaceutical company requested access from the EMA to MSD Animal Health’s toxicology reports under the Transparency Regulation. The EMA considered the request in two batches and in accordance with its new policy decided to disclose the three reports in the first batch, subject to minimal redactions. MSD Animal Health and Intervet applied for an interim injunction to restrain the EMA from releasing the documents. They argued that the entirety of the reports should be treated as confidential, because they 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 the study reports under the Transparency Regulation.

By his judgment of 20 July 2016, the President of the General Court granted their application for an interim injunction. He held that the applicants’ 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 EMA itself saw value in its release. He rejected the EMA’s argument that the applicants were sufficiently protected by Bravecto’s data exclusivity, pointing out that competitors could easily exploit the data outside the EU. He suggested that it might be open to the EMA to grant limited access only for academic purposes. It was therefore proper 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.

The judgment is here.