EMA’s clinical transparency rules come under fire

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EMA’s clinical transparency rules come under fire

Home/Policies & Legislation | Posted 06/03/2015 0 Post your comment

The German Institute for Quality and Efficiency in Health Care (IQWiG) has once again questioned the transparency of the European Medicines Agency’s (EMA) clinical trials database.

In April 2014, legislation was approved in Europe by the European Parliament, which aims to increase transparency with respect to clinical trials by making the results publicly available. EMA was commissioned by the European Parliament to create a database where all interested parties could view comprehensive data from clinical trials.

The IQWiG points out that the European Parliament made it clear that data from clinical trials in general are not business secrets and cannot therefore be readily excluded from publication in the database. It also states that it was also made clear that any exceptions must be well founded, as these may affect public interests such as the health of patients.

The position of the IQWiG is that neither the results nor the methods of clinical trials are trade secrets. However, the Institute finds that, in recent redactions, ‘the decision to keep the data secret is, more or less, left to those who carry out the studies’, according to Dr Beate Wieseler, Head of Drug Assessment Department, IQWiG. She adds that ‘this is contrary to the spirit of the EU Regulation and the objective of transparency in clinical research. Furthermore, not to publish or to severely delay publication of study results and methods is inconsistent with ethical principles for human studies, as laid down in the Declaration of Helsinki’.

EMA recently launched a public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database. Stakeholders were invited to send their comments to EMA before 18 February 2015. In its announcement, EMA states that ‘the public will be able to access extensive details of each trial including the major characteristics of the trial, the start and end of recruitment, end date of the trial and substantial modifications to the trial. These details will be made public as they occur starting with the decision on the trial. A summary of results and lay summary will be published 12 months after the end of the trial’.

The agency lays out the following exceptions:

Protection of personal data
Protection of commercially confidential information
Protection of confidential communication between Member States in the preparation of their assessment
Protection of the supervision of clinical trials by Member States

However, the agency has been criticized for its redaction of AbbVie’s data [1] and is obviously not meeting the standards of the IQWiG. The institute concludes that non-disclosure of information must remain the absolute exception. Manufacturers who wish to black-out records, must in each case justify their reasons to EMA and the agency must examine the justifications meticulously.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA criticized for redaction of AbbVie’s data [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: www.gabionline.net/Policies-Legislation/EMA-criticized-for-redaction-of-AbbVie-s-data

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Source: EMA, IQWiG