European Union: Update On Transparency Of Clinical Data

Legal clarity on the meaning of 'commercially confidential information' within sight

Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate. Recent academic studies, published in Current Medical Research and Opinion and the British Medical Journal, have systematically assessed the disclosure policies of trial data arising from studies sponsored by pharmaceutical companies. In the EU, the European Medicines Agency (EMA) has adopted policies and guidance setting out its approach to data disclosure. Certain aspects of the adopted policies are currently being considered by European Courts, to address the nature of the balance to be struck between the public interest in transparency and the interest (both public and private) in protecting innovative research from unfair commercial use. In a broader context, the prevailing legal framework is based on a need for coherence and equilibrium between the general regulation governing public access or freedom of information and the sector-specific legislation regarding authorisation and supervision of medicines. In this blog post, we provide a summary of these cases, as heard in the European Courts to date.

Regulation (EC) No. 1049/2001 (the Transparency Regulation) confers on EU citizens and legal entities a right to access documents held by EU public institutions. However, that right is subject to the principles, conditions, and limits provided for in the Transparency Regulation. The right of access can be denied in circumstances where disclosure would undermine the commercial interests of a natural or legal person, including intellectual property rights, unless there is an overriding public interest in disclosure.

In order to manage an increasing number of requests for access to documents, the EMA has adopted a policy (Policy 0043) that seeks to implement the Transparency Regulation by setting out specific guiding principles with regard to reactive disclosure. In its transparency policy, the EMA has categorised such information that is not liable to disclosure as 'commercially confidential information' (CCI).

The EMA's position on reactive disclosure of clinical trial data, as set out in Policy 0043, has been challenged in the European Courts. On 25 April 2013, the European General Court granted interim relief applied for by InterMune (Case T-73/13, InterMune UK and Others v EMA) and AbbVie (Case T-44/13, AbbVie v EMA, and Case T-29/13, AbbVie e.a. v EMA), in connection with the parties' applications for annulment of two EMA decisions to disclose to third-party competitors detailed pre-clinical and clinical data contained in the marketing authorisation dossiers of the applicants' respective products. The applicants argued that disclosure of the data would damage their legitimate commercial interests and that there was no demonstrable public interest in disclosure. In granting interim injunctive relief, the General Court should be satisfied that the parties had a prima facie case in both fact and law. However, the interim procedure is not designed to establish the legality of the disclosure policy or lawfulness of the EMA's acts to disclose specific documents contained in the marketing authorisation dossiers. Abbvie and InterMune withdrew their applications for annulment of the EMA decisions before the General Court had the opportunity to review substantive elements of these two cases.

In a recent string of cases, the EMA's reactive disclosure policy has again been challenged in the European Courts. In each of the following cases, the applicants have been granted interim relief (upheld on appeal) to prevent disclosure of the data in question pending resolution of the substantive proceedings.

  • Pari: Case T-235/15, Pari Pharma GmbH v EMA (interim relief granted on 1 September 2015 and substantive hearing held on 14 February 2017). This case concerns an application for disclosure of two reports prepared by the Committee for Medicinal Products for Human Use (CHMP), which underlie a similarity and clinical superiority assessment issued by the CHMP and on the basis of which the medicinal product Ventobra was granted a marketing authorisation.
  • MSD/Intervet: Case T-729/15, MSD Animal Health Innovation and Intervet International v EMA (interim relief granted on 20 July 2016 and substantive hearing held on 16 May 2017). This case concerns an application for disclosure of non-clinical toxicology study reports submitted as part of the marketing authorisation application for the veterinary medicinal product Bravecto.
  • PTC: Case T-718/15, PTC Therapeutics International v EMA (interim relief granted on 20 July 2016 and substantive hearing held on 14 July 2017). This case concerns an application for disclosure of a clinical study report for the medicinal product Translarna, which holds a conditional marketing authorisation.

The European Court has heard the substantive points of these cases, and the final decisions are eagerly awaited by the industry. The cases turn on the question of what constitutes CCI, and whether or not the EMA has failed to carry out a balancing exercise as required by law in deciding whether certain documents contained in the marketing authorisation dossiers should be disclosed to third parties.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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