Criticism of EU law is often aimed at an amorphous “Brussels,” but in many cases member states are the problem—as with the proposal to revise the Clinical Trials Directive. The proposal envisages a central EU portal and database of applications, assessments, safety reports, and other information about clinical trials. How comprehensive will that information be, […]
Category: Jim Murray
Jim Murray: The EU, transparency, and access to clinical trial results
How is the EU involved in transparency and access to clinical trial results? Many readers will know this already, but perhaps not all. For obvious reasons, health professionals have tended to focus on the national and they might not all appreciate the strength of the “side-wind” blowing from the EU. The EU was formed on […]
Jim Murray: The EMA’s efforts to widen access to clinical trial results
The European Medicines Agency is trying to widen access to clinical trial results for medicines that have been authorised. Its efforts have been blocked, at least temporarily, by a legal challenge in the European Courts from AbbVie, in a case involving the medicine Humira. AbbVie is in effect the former medicines division of Abbot Laboratories. […]