Defending transparency at European drug regulatorBMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m10 (Published 08 January 2020) Cite this as: BMJ 2020;368:m10
- Pierre Chirac, publication manager
- Revue Prescrire, Paris, France
In response to pressure, mainly from civil society, the European Medicines Agency introduced a policy to give public access to the documents on which it bases its decisions on marketing authorisation for new drugs. This policy follows from the provisions of European regulations 1049/2001 (on access to documents from European institutions and agencies) and 536/2014 (on clinical trials).1
In the words of the EMA management board, the policy “generates trust in the EU regulatory network, broadens the scientific knowledge base, fosters the development of medicines, and ultimately benefits public health.”2 Unfortunately, however, the European Court of Justice may soon put an end to it.
The court’s final decision is expected shortly, but one of its advocate generals has recommended that documents held by the EMA containing clinical data should be considered confidential.
The case began when two drug companies challenged the EMA’s right to grant access to documents that the companies deemed commercially confidential: a toxicity …