The French Parliament has adopted on 26 January 2012 a bill of law relating to the researches on human beings which may modify the French Public Health Code on non-interventional studies.
The bill of law distinguishes now between three types of studies (Article L.1121-1):
- interventional studies which include an intervention on the person which is not justified by usual care ;
- interventional studies which do not relate to medicinal products and include only minimal risks and constraints, for which a list will be fixed by Ordinance by the Ministry of Health after advice of the French Agency,
- non-interventional studies in which every act is practised and every product is used in a usual manner, without additional or unusual diagnostic, treatment or monitoring procedures.
According to the bill of law, the conduct of non-interventional studies will need to obtain the prior opinion of the CPP
. The Sponsor will have to send a copy of the opinion of the CPP and a summary of the study to the French Agency.
The patient will receive a preliminary information by the investigator and can refuse to be included in the study.
For non-interventional studies relating to the observance of a treatment which respond to a request of the French Agency, the Haute Autorité de Santé (HAS) or the EMA, a short information on the objective, methodology and length of the study is enough.Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Afssaps (French Food Safety Agency of Health Products), much criticized for its passivity towards the Servier in the case of the Mediator, is replaced by the National Security Agency of Medicines and Health Products (ANSM) , with increased powers (refer to Lemonde Article - in French).
Law No. 2011-2012 of 29 December 2011creates the « Agence nationale de sécurité du médicament et des produits de santé » (ANSM). Law No. 2011-2012 will enter into force at the date of publication of the corresponding Decree of application and by the latest on 1st August 2012. Until this date, AFSSAPS is still competent.
Acknowledgement: Cristina Lozano, Aurelie Vivet of Outcome and Paule Drouault-Gardrat of PDG Avocats
For further information, refer to: