European drug regulator fears return to days of data secrecyBMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6133 (Published 22 October 2019) Cite this as: BMJ 2019;367:l6133
- Rebecca Coombes
- The BMJ
The agency that regulates drugs in Europe is nervously awaiting the outcome of an industry driven court case that aims to curb public access to clinical trial documents.
Two drug companies have argued that the European Medicines Agency (EMA) should stop making public any information on clinical trials that businesses consider commercially confidential. An initial ruling in February 2018 found in the EMA’s favour and said that, in general, clinical study reports should not be considered confidential.
But, in an appeal ruling on 11 September, advocate general Gerard Hogan found that disclosure of the documents would harm the companies’ commercial interests. These cases, taken by Merck and by PTC Therapeutics, are …