title: [How to apply the 4th March 2002 French law, making information to patients mandatory after the identification of a new risk?].
abstract: The 4th March 2002 French law, through its L. 1111-2 article, makes it mandatory to inform persons who received medical care, investigation or preventive intervention when a new risk is identified after the act was done. The article L. 1413-13 of the law adds that health authorities can summon responsible professionals if they establish a lack of information, unless it is impossible to find again exposed patients. The text relates conclusions of the working group set up in 2003 by the Chief Medical Officer whose mission was to identify what kind of situations fitted this new right and the consequences, in terms of action, of the qualification of an event as a "new risk". The two main outcomes were to clear up the basic ambiguity concerning the term of "new risk" and to propose a framework defining the multiple stages by which it has to be assessed. Furthermore, the diversity of potential situations to be faced in connection with the possible consequences of information raised the issue of objectives aimed by the lawmaker. Despite good intentions, the law as laid down appears insufficient to ensure that this new right will be always beneficial to the patients, in terms of public health.
authors.affiliation: CNRS, laboratoire d'économie et de sociologie du travail, 35, avenue Jules Ferry, 13626 Aix-en-Provence. michel.setbon@unimed.fr
authors.forename: Michel
authors.initials: M
authors.lastname: Setbon
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence*; D006801:Humans; D028701:Patient Rights / Q000331:legislation & jurisprudence*; D018570:Risk Assessment