CHIFFRES CLES BAT
5/12/08
11:22
Page 28
Each member state is responsible for the control of its own market and the AFSSaPS created a vigilance system that clearly identifies responsible parties at every level: public or private laboratories, other health professionals and industry officials. The system requires the declaration of incidents concerning devices. The AFSSaPS regularly evaluates products and can decide to remove from the market those that do not meet defined criteria. Until December 7, 2003, CE-labeling of reagents will coexist with the AFSSaPS registration system validated by the CCER (Commission Consultative d’Enregistrement des Réactifs or Reagents Registration Advisory Commission) composed of experts and AFSSaPS representatives. Two SFRL representatives are also members of this commission. Industry management is free to choose one procedure or the other. Once the AFSSaPS registration procedure is no longer valid, registered products will be able to circulate until December 7, 2005 when they must be replaced by CE-labeled products. To accomplish its various regulatory missions, AFSSaPS greatly enlarged its structure and sought industry funds to participate in the financing of its activities. The 2001 finances law implemented a tax on in vitro diagnostics medical devices marketed in France set at 0.15% of the turnover excluding VAT. This tax is to be paid by the manufacturers or European representatives. But,
discrimination between French and foreign manufacturers was soon noted. French manufacturers pay the tax on the turnover earned from their clients in France while foreign manufacturers pay the tax on the cost of transfer to their branches or suppliers in France. Though this discrepancy was brought to the attention of the officials concerned, this tax has been applied according to the conditions defined. The SFRL has decided to bring an appeal to the Council of State requesting abrogation of the text.
Clinical Analyses and Health Costs Each year, the law governing social security finances defines an ONDAM (Objectif National des Dépenses d’Assurance Maladie or National Heath Insurance Costs Objective) describing nonhospital health costs: physician and dentist fees and prescriptions (drugs and clinical analyses). This objective, determined without prior study of the real needs of the population and based on unrealistic principles, is regularly exceeded. The social security “debt” is a theme of the beginning of all Parliamentary sessions and various plans have been implemented to correct the problem. 2001 was no different and for all health plans, the ONDAM was exceeded by 3 billion euros. Though it was set to increase by 3.5% in 2001 compared to 2000, the CNAM increased its spending by 6% (clinical analyses increased by 28
