EMA scales back transparency initiatives because of workloadBMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3513 (Published 14 August 2018) Cite this as: BMJ 2018;362:k3513
- Peter Doshi
- The BMJ
The European Medicines Agency has scaled back its landmark clinical trial data policies, the drug regulator has announced.
Policy 0043, which granted public access to documents in the regulators’ archives, including clinical trial data, is now limited to EU citizens only, and work related to publishing new data packages under its clinical data publication policy (policy 0070) has been suspended. The agency said that the cutbacks were a response to an “excessive workload”1 and were part of its planning amid substantial staff loss as it prepared for Brexit.2
Transparency advocates have described it as a blow to critical transparency efforts with potential patient safety ramifications.
“Deaths and other serious harms are much under-reported in published trials, and we therefore need unhindered and immediate access to clinical study reports and other relevant documentation that the EMA holds,” said Peter Gøtzsche, director of the Nordic Cochrane Centre. Gøtzsche is credited with “opening up” the EMA after his successful appeal to the European ombudsman over a denied request for data a decade ago.3 He said that the EMA’s announcements were “very …