European Medicines Agency (EMA) softens its conflict of interest policy: Does this further open the door to undue influence instead of closing it?

28 November 2014 

Joint Press Release

At the end of November 2014, the European Medicines Agency has announced the adoption of a “more balanced approach to handling conflicts of interests” to become effective on 30 January 2015. In reality, this revised EMA COI policy relaxes EMA’s position in relation to the conflicts of interest of experts with pharmaceutical companies. The evaluation of the efficacy and harms of medicines must be free from undue influence and be based on scientific data, so that the Agency’s work can benefit public health. The Agency’s integrity is at stake


EMA’s final policy on access to clinical data: proactive access to some data, but strings attached

On 2 October 2014, the European Medicines Agency (EMA) finally adopted its policy on access to clinical data. From 1 January 2015 onwards, the general public will be able to “view on screen” selected parts of trial reports submitted in support of marketing authorisations, and academic and non-commercial researchers will be allowed to download this data. The policy, unfortunately, also gives pharmaceutical companies the upper hand in deciding the contents of the clinical reports by allowing them to redact data on the grounds of “commercial confidentiality”. The implementation of the policy will need careful monitoring.