On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database.  The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the application of the exceptions to the disclosure of information, and invites stakeholders to comment.

The new Clinical Trials Regulation

The new Clinical Trials Regulation aims to increase the level of publicly available information on each clinical trial carried out in the EU/EEA via a new clinical trials portal and database.  A portal will allow the public to access a range of information about trials on the database, including the trial’s major characteristics, start and end dates of recruitment, end date, substantial modifications, and summary of results. Information will be made public unless one of the following exceptions applies:

  • ·         Protection of personal data;
  • ·         Protection of commercial confidential information (“CCI”), taking into account the marketing authorisation status of the medicine, unless there is an overriding public interest;
  • ·         Protection of confidential communication between Member States in the preparation of their assessment; and
  • ·         Protection of the supervision of clinical trials by Member States.

The new clinical trials portal and database will be used for the submission and maintenance of clinical trial applications and authorisations in the EU/EEA.  The EMA will be responsible for the development and maintenance of the portal and database.  The new transparency rules will apply to clinical trials that are registered once the Clinical Trials Regulation takes effect, which will not be before 28 May 2016.

Consultation Document

In its consultation document EMA discusses the practical application of the transparency rules for the clinical trials portal and database.  Chapters two to four of the consultation document explain the purpose, legal background and interpretation of the transparency requirements of the Clinical Trial Regulation.  Chapter four also asks stakeholders to comment on proposals for a number of areas, including:

  • ·         Whether the names of Member State experts, clinical trial sponsor personnel, marketing authorisation holder personnel or details of clinical investigators should be made public;
  • ·         How the status of marketing authorisation should be applied to the transparency requirements;
  • ·         The triggers for the timing of publication of clinical trial information; and
  • ·         Whether draft assessment reports between Member States should be made public.

Stakeholders should send their comments using this template to CTReg@ema.europa.eu by close of business on 18 February 2015.