EMA's Open Data Scheme

Forced by government and societal pressures to release clinical trial data - and caught between competing desires for open and restricted access - EMA has crafted a compromise policy that may not satisfy all the stakeholders but at least will fit within its existing regulatory framework.

The EU Parliament, Ombudsman and European member states have been applying political pressure for increased data transparency, and publishers, academics and patient advocates have been pushing an agenda of unqualified open access...