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Friday 29 November 2013

Research, Innovation and Competition: the Reform of the Clinical Trials Legislation in the EU

One of the greatest challenges of the life sciences industry is the ever-changing regulatory landscape. Amid various planned reforms this year, one of the most welcome is the proposed reform of the law on clinical trials currently being debated by the EU Parliament.

The current law (a Directive implemented in the UK in 2004) introduced a standardised framework for clinical trials and has had positive effects from a safety and the ethical soundness standpoint. However, it has been criticised for increasing the costs and bureaucratic burden of conducting trials which in turn has lead to delays in launching them and has adversely impacted the competiveness of clinical research and patients’ ability to access new medicines and treatments. As a consequence, the number of applications for clinical trials in the EU fell by 25% in the period from 2007 to 2011.

Catherine McLoughlin
MH Corporate


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