Clifford Chance
Law n°2011-2012 of 29 December 2011 improving the safety of medicines and health products
16 February 2012
A new law aimed at improving the safety of medicines and health products was published in the Official Journal dated 30 December 2011 (the "Ethics law").
The Ethics law aims at restoring public confidence in medicine approval processes and reforming the prescription system after the controversy caused by the prescription of Servier’s diabetes drug Mediator®.
The reform of the French health system is based on three main principles i.e. (i) the prevention of conflicts of interest and transparency of decisions, (ii) the monitoring of health products and (iii) the improvement of training and information of health professionals and patients. Following to the case of the "PIP®" breast implants, medical devices ("dispositifs médicaux") will probably be subject to closer scrutiny (iv).
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