Pressure increases on EMA to release drug assessments
EU ombudsman accuses EMA of maladministration
The European ombudsman has made another demand that the European Medicines Agency (EMA) release information about pharmaceuticals gathered during market approval assessments.
P. Nikiforos Diamandouros has branded EMA guilty of maladministration when it refused Danish researchers access to clinical study reports and trial protocols for two antiobesity drugs, not named in his ruling. The researchers wanted to conduct an independent analysis of their concerns about potential biased reporting on drug trials.
EMA refused disclosure because it would undermine the drug producers' commercial interests.
This was refuted by the ombudsman who concluded that ‘the documents did not contain information on the composition of the antiobesity drugs, nor…other commercially confidential information’, and so ‘their disclosure would…not undermine commercial interests’.
The ruling follows an Irish case in May, in which the ombudsman ruled against EMA.