This Decree, which entered into force on 1 October 2012, relates to the implementation of three financial penalties applicable to companies manufacturing medicines or medical devices, reimbursable by medical insurance, and to distributors of medical devices in case of failures.
Two of these penalties can be imposed by the Economic Committee for Health Products ("CEPS"). The first one is imposed on pharmaceutical companies which failed to comply with the commitment they had agreed on with the CEPS in respect of the implementation of means to limit the unjustified use of their medicines outside the marketing authorisation's instructions. The second penalty concerns pharmaceutical companies which have not met the annual targets to reduce medical visit.
Finally, the Ministers of Health and Social Security may sanction a manufacturer or a distributor of medical devices which has not conducted the complementary study (failure to file the study within the timeframe or filing of a study manifestly lacking the requested elements), to which may be subordinated the reimbursement of some devices used in health care institutions.
When the authorities (the CEPS or the Ministers, as the case may be) consider imposing a penalty on a company, they inform the company and specify their motives for considering such a penalty. The Company shall submit, within one month, its written observations as well as the details of its turnover which are necessary to the calculation of the fine. As of the day of the notice from the authorities informing the company of the motives and the amount of the imposed penalty as well as of the remedies and the period allowed for appeals, the concerned company must pay the penalty within one month.