In April 2014 the EU Parliament and Council commissioned the European Medicines Agency (EMA) to establish a publicly accessible database containing comprehensive data from clinical studies. The deadline for comments on the transparency aspect of the database specifications was the 18th of February. 

The German Institute for Quality and Efficiency in Health Care (IQWiG), which has long been accompanying EMA on its path to more transparency, also submitted comments.

In 2014 the EU Parliament made clear that clinical study data generally should not be considered commercially confidential and cannot readily be exempt from publication in the EU study database. Exceptions must be well justified, and redactions or even the non-publication of whole documents must not interfere with overriding public interests, such as the health of patients. The precondition for a database fulfilling these requirements is a precise and narrow definition of “commercially confidential information”. IQWiG researchers have reviewed the comprehensive EMA proposal and found a very broad definition in several sections of the document.

Beate Wieseler, Head of IQWiG’s Drug Assessment Department, explains: “The decision on which data remain confidential is thus more or less left up to the study sponsors. This contradicts the spirit of the EU regulation and the aim of achieving transparency in clinical research. In addition, the non-publication or long delays in the publication of study results and methods would not be compatible with the ethical principles of studies in human beings, as, for example, stipulated in the Declaration of Helsinki.“

For more details, go to: https://www.iqwig.de/en/press/press-releases/press-releases/clinical-studies-broad-definition-of-commercially-confidential-information-endangers-transparency.6599.html