8 January 2020 - Forthcoming judgment must uphold public access to clinical data

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.” Unfortunately, however, the European Court of Justice may soon put an end to it.

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