In April 2014 the EU Parliament and Council commissioned the EMA (European Medicines Agency) to establish a publicly accessible database of data from clinical studies. The EU Parliament, according to IQWiG, made clear that clinical study data generally should not be considered commercially confidential an exceptions must be well justified.
IQWiG researchers, however, say that after reviewing the comprehensive EMA proposal for the database, they found a very broad definition of transparency.
Beate Wieseler, Head of IQWiG’s Drug Assessment Department, explained: “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.“
Specific groups’ interests “must be subordinate to the public interest in the swift and complete publication of study data and documents,” IQWiG said.
EMA has even left a loophole for publicly funded studies: If, for example, the publication of study data could affect the acquisition of further third-party funds, the study sponsors would be allowed to redact information, according to IQWiG.
Wieseler added: “The non-publication of certain information must be the absolute exception. Those wishing to redact documents must in each case provide a precise justification to EMA, and EMA must meticulously evaluate these justifications.”
Other Comments
On the other side of the discussion, the UK BioIndustry Association (BIA) also submitted comments to the EMA alongside EuropaBio, the European Association for Bioindustries.
The comments are related to ways to ensure that data that’s possibly commercially sensitive is further protected. The BIA said it has also supported calls for the EMA to consider further issues of relevance, including:
- A deferral for disclosure of information and summary results from Phase I trials, noting the commercial sensitivity of information on these trials;
- Considering how to ensure adequate protection of sensitive and commercially confidential information in relation to clinical trials on products without a marketing authorisation; and
- Ensuring alignment between these proposals and existing EMA policies regarding the preparation of clinical study reports to provide consistency and avoid unnecessary bureaucracy.