Medico-legal: European Commission to review clinical trials directive

The European Commission has revealed plans to review the EU Clinical Trials Directive which came into force in 2004. The rules governing medical research across Europe have been under fire from the medicines industry and doctors, who say the law has bound researchers with red tape without boosting innovation.

The move could see an expanded role for the European Medicines Agency, with some stakeholders pushing for a harmonised EU clinical trials application procedure instead of the fragmented system that exists at present. However, this kind of harmonising has proven politically difficult in the past.

The directive was originally brought in as part of efforts designed to raise the standards of research in Europe but it has led to higher insurance costs and a steep increase in paperwork for researchers, regulators and ethics committee.

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