[Immunization: process of elaborating guidelines and their evolution in France].
French guidelines for immunization are elaborated by a permanent advisory committee (Comité technique des vaccinations), which is part of the Public Health Council. This committee is composed of 20 experts from the different medical specialties involved in the immunization process, who are appointed for 3 years by the French Ministry of Health. Other members, without voting power, represent de different agencies, affiliated to the health minister, other ministers and different institutions. All members have to declare and update their potential conflicts of interests. The committee establishes official guidelines concerning topics submitted from the National Health Care Authorities, industrial firms awarded marketing approval for a new vaccine, or in the event of a modification concerning a previous registration. The advisory committee can also decide itself to establish official guidelines on a given topic. A submission usually leads to the creation of a specific working group assigned the task of preparing a report and an advice project. The project is proposed for committee vote and subsequently validated by the Commission for Transmissible Diseases of the Superior Public Health Authority (Haut Conseil de la santé publique). The committee guidelines stipulate whether the vaccine should be recommended or not, the target population (universal or limited to a selected population) and the immunization schedule. The committee's advice statement may also mention the need for a specific survey of the impact of the vaccination on epidemiology, as well as a broader survey related to its safety. Usually, when a vaccine is recommended, the Transparency Commission of the Haute Autorité de santé and the economic committee on drugs decide on its reimbursement by the public health care fund. The guidelines become part of the immunization schedule, which is updated annually and published in the Official Bulletin of the Minister of Health and in the Bulletin épidémiologique hebdomadaire.
Floret
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Hôpital Femme-Mère-Enfant, université Claude-Bernard Lyon-1, Bron, France. daniel.floret@chu-lyon.fr
D004059:Diffusion of Innovation; D005602:France; D006077:Government Agencies; D017408:Guidelines as Topic; D006801:Humans; D007114:Immunization / Q000331:legislation & jurisprudence / Q000592:standards*; D007115:Immunization Schedule; D011634:Public Health