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At a workshop on the impact of the Clinical Trials Directive, academics have criticised the law for deterring research.

The Directive 2001/20/EC was implemented in 2004 in an attempt to raise the standard of medical trials, i.a. by revising the rules for testing and producing pharmaceuticals and amending the procedure to gain ethical approval for trials.

Since its implementation the number of trials has decreased significantly. Researchers have identified several issues to explain this development. Most importantly, cross-border cooperation is said to be hindered by diverging national interpretations of the Directive. The high costs and bureaucratic burdens that are caused by the new specifications further dissuade testing. Only the revised process of applying for ethical approval is seen as an improvement.

[Source: EurActiv, “EU medical trials law 'putting brakes on science'”, 25.08.2009, http://www.euractiv.com/en/health/eu-medical-trials-law-putting-brakes-science/article-184777]