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Row breaks out over EMA Brexit decision to limit clinical trial transparency

What difference will the EMA decision make?


A European Medicines Agency (EMA) decision to scale back its policy of releasing landmark clinical trial data has attracted criticism.


The changes are said to be a part of its planning for staff losses in preparation for Brexit. The EMA headquarters is moving from London to Amsterdam, and the agency issued a press release outlining its plans to cut back services in early August.


Publishing of new data packages under its clinical data publication policy has been suspended and public access to documents in the regulators’ archives including clinical trial data is now limited to EU citizens only, the British Medical Journal (BMJ) has reported.


Transparency advocates have described the changes as a blow to transparency and have said that it could have implications for patient safety.


The Nordic Cochrane Centre’s influential director Peter Gøtzsche has called the decision very unfortunate, pointing out that access to the data is needed because deaths and other serious harms are under-reported in published trials.


Gøtzsche is credited with changing EMA policy on transparency following an appeal to the European ombudsman over a denied request for data.


Further information

BMJ: EMA scales back transparency initiatives because of workload

EMA: Access to documents

EMA: Brexit preparedness: EMA to further temporarily scale back and suspend activities