1 Boring Old Man

Dear Madam/Sir,

In recent weeks, the Commission has received numerous emails, addressed to Ms Testori Coggi, in which citizens voiced their concern regarding the draft policy of the European Medicines Agency (EMA) on the publication of clinical data. We appreciate the interest that this topic triggered. The Commission values transparency as an important tool to increase the understanding of and trust in all decisions and assessments around the authorisation of medicinal products.

The new policy of EMA aims at fostering transparency by pro-actively publishing clinical data on which EMA’s scientific opinions are based. This includes clinical study reports that have been submitted to and were assessed by the Agency in the framework of a marketing authorisation procedure for human medicinal products. While the Agency is not required under its founding Regulation to publish such data, it is believed that a proactive release of clinical data will contribute to strengthening confidence in the system of authorising medicines in line with a global trend towards more transparency. Additionally, it may enable the independent secondary analysis of the evidence reviewed by the Agency and is expected to lead to public health benefits. Up to now, the clinical data concerned is only available through individual access to document requests under Regulation (EC) No 1049/2001.

In 2013 EMA launched a general consultation to which it received more than 1000 comments with sometimes competing views. In December 2013, the Agency proposed some basic principles of the future policy that were agreed by the EMA Management Board, which has to endorse the new policy. On the basis of those principles, the initial draft was reviewed and subsequently made subject to a targeted consultation in May 2014.

While there was large support for more transparency, you will certainly understand that such approach requires certain safeguards to ensure that any published data is used for legitimate purposes only. Those legitimate purposes include academic research, but exclude unfair commercial use by competitors.

The EMA policy can be seen as a preparatory step in view of the application of the new Clinical Trials Regulation (Regulation (EU) No 536/2014) and the publication requirements established thereunder, which will start to apply at the earliest from mid-2016. This Regulation requires that clinical study report covered by its scope be uploaded on an EU database, once the authorisation is granted, refused or the application withdrawn. The data and information contained in the database, including clinical study reports, will in principle be publicly accessible, except for personal data and commercially confidential information.

At the meeting of the Management board of EMA on 12 June 2014 the draft policy was further discussed, including some additional modifications. According to this latest revision, it will be possible to download, save and print the trial data for academic and non-commercial research purposes. The suggestion indeed corresponds to requests notably from research networks who feared that a view-on-screen-only access would be detrimental to any (re-)analysis of the data for non-commercial research purposes. The Management Board agreed in principle to this policy and on the basis of the discussion and comments received, the policy is intended to be adopted by the Management Board through a written procedure in July 2014.

Best regards,