Health safety of products intended for human consumption
The Act of 1 July 1998 introduced an innovative institutional and functional architecture forming a new step in health safety in France. This Act lays down that the Government and Parliament, through the Office parlementaire d’évaluation des choix scientifiques et technologiques (Parliamentary Office for Science and Technology Assessment) shall assess the implementation of all the Act’s provisions prior to their possible reconsideration. The report by Mr Claude Saunier, Senator (Côtes-d’Armor), continues the work by Mr Bernard Seillier, Senator (Aveyron), and corresponds to this referral by right. This assessment concerns the suitability of the institutions and mechanisms for the safety, reactivity and transparency aims set forth by the Act of 1998 and it also relates to the already made or on-going adjustments rendered necessary by recent events (heat wave of 2003, plant health products, medicinal drugs). The report itself comprises four sections: an overview of health safety; the Agence française de la sécurité sanitaire des aliments (AFSSA – French Food Safety Agency); the Agence française de sécurité sanitaire des produits de santé (AFSSAPS – French Health Products Safety Agency); and the clarification of some mechanisms and other competent bodies, particularly in the environmental field. * The general organisation of health safety today proves globally satisfactory, meeting the set objectives; the option for a single health safety agency for all products and all hazards was rightly dismissed in 1998 and the organisational principles set in place have been confirmed: separation between assessment and management of a hazard, the case of the AFSSAPS forming a justified exception. The implementation of the general principles of health and environmental safety must however be permanently adapted. The principles must be placed back in perspective to take account of the real hazards: environmental standards form a means of measuring a danger or a hazard and their amendment is only envisageable with respect to these dangers or hazards. Similarly, the gap between the high levels of safety attained (food field) and obvious threats due to risk behaviours (obesity) requires more attention than ever as regards the orientation and focussing of health vigilance on the real hazards. * The AFSSA has met the expectations and reached the goals assigned to it in the sphere of health safety, where crises have been avoided or mastered, and also in that of nutrition where it is contributing decisively to the prevention of obesity. Some adjustments can be made in concertation with the other players of the field, particularly at European level where the stakeholders have not all determined their positioning. * The AFSSAPS, whose powers are considerably broader than those of the Agence du médicament (Medicinal Drugs Agency) which preceded it, has had to cope with difficulties inherent in its setting up; further, it has undergone unending changes in the external administrative mechanisms which have impacted its workload and its relations with the other entities responsible in the health products field, particularly the health ministry. The market approval procedures have been correctly applied within the present reference framework, but the current worldwide Vioxx crisis is raising many questions and requires a collective rebound. Several essential recommendations are made in this respect, with the overarching desire to place progress at the service of the population. Expertise, for instance, must be radically reviewed both concerning the conceptions and the means which must necessarily be devoted to it. The creation of a high scientific expertise authority is therefore recommended. In addition, Parliament should address this issue by one of its monitoring and assessment procedures. Further, the risks of the trivialization of medicinal drugs, especially with Internet sales, are also signalled, particularly in view of the situation in the United States and Germany. * The clarification of some mechanisms proves necessary in the health safety field globally but also in specific fields such as health at work and chemicals. The specific issue of the positioning of the Agence française de sécurité sanitaire environnementale (AFSSE – French Environmental Health Safety Agency) (Act of 9 May 2001) is addressed and is the subject of a recommendation for it to be grouped for the time being with the AFSSA. The prospect of the creation, on new and ambitious bases, of an environmental agency is to be rapidly envisaged.
Short title:
Health safety
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Project leader:
Office Parlementaire d´Evaluation des Choix Scientifiques et Technologiques of the French Parliament (OPECST)