Critics slam European Medicines Agency on transparency issues
- Many organizations, including BMJ, the AllTrials campaign and the Cochrane Collaboration among others, have accused the European Medicines Agency of lack of transparency based on its policy surrounding publication of clinical trial data. The agency evaluates pharmaceuticals developed for use in the European Union.
- EMA’s policy is to make clinical study reports (CSRs) available to researchers, but with numerous restrictions.
- There continues to be conflict between the concerns of the pharmaceutical industry, which wants to protect its data from unfair commercial use, and academic and clinical researchers, who want greater access and transparency.
EMA admits that its policy is still not finalized and that discussions are ongoing. A new clinical trials regulation, which outlines issues related to transparency, will not be implemented until at least May 2016. In the interim, the debate between industry and academia, as well as other stakeholders and interested parties, will continue.
Currently, access to CSRs is on screen only and often the documents have been redacted. Researchers have to be registered in order to access clinical trial content and even then they are subject to additional restrictions. Opponents claim that not allowing researchers to have broader access to CSRs ultimately has negative implications for public health, as researchers cannot find the data they need to progress their research.
On the industry side, last year, AbbVie and InterMune initiated court action to prevent EMA from releasing CSR data from their clinical trials, but both companies have dropped their cases. It seems as though the issue of transparency and public access to data will continue to be hotly contested in the UK.