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Clinical research ‘at risk’ from health reforms

A group of biotech and research organisations have called on the French government to address the “alarming state” of clinical research in France, which they say could worsen if reforms to the health system go through.

An open letter to Marisol Touraine, the minister for health and social affairs, was published on 15 April. It says that two factors have slowed or halted clinical research in France: growing delays in getting approval for trials from the ANSM, the national agency for the safety of medicines; and a strike by six local ethics committees, which also grant approval for trials. The strike is against government plans to tax committee members’ personal allowance of €67 per clinical trial.

The letter also warns of the potentially severe consequences of health system reforms that the government hopes to implement. The "single contract" element, in particular, would bypass the hospital research physicians who run clinical trials in France on a largely ad hoc basis. Hospitals, pharmaceutical and biotech companies and research organisations would all work within the same framework.

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