FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
• the medical benefit or the improvement in medical benefit of the medical device; • if applicable, the results of the medico-eco- nomic assessment of tariffs of comparable products or services; • the planned or observed sale volumes; • planned or observed amounts reimbursed by SHI, and • the estimated conditions of use. If no agreement is reached between the CEPS and the pharmaceutical company, the CEPS has the authority to unilaterally set the price. The pricing of reimbursed medical devices may be reviewed at the initiative of the CEPS. The Ministers of Economy and Health may set the margins of reimbursed medical devices. Dis- counts, rebates and any other commercial and financial benefits, including service fees, grant- ed by any supplier to retailers of reimbursed MDs, may soon be capped under French law. A ministerial order is expected to limit such dis- counts, rebates and benefits, per calendar year and per product line, to a percentage of the product price (excluding tax) for each retailer, not to exceed 50% of the operator ( exploitant ) price. The implementing act for this provision is expected to be issued by the end of the year. 8.2 Price Levels of Pharmaceuticals or Medical Devices When setting and reviewing the price of reim- bursed pharmaceuticals and the tariff of reim- bursed medical devices, the CEPS may take into consideration the existence of lower prices or tariffs in Germany, Spain, Italy and the United Kingdom. The Framework Agreement between the trade association representing the pharmaceutical industry and the CEPS establishes the possi-
bility of benefiting from a pre-tax list price that cannot be lower than one of the prices applied in Germany, the United Kingdom, Italy and Spain for a pharmaceutical providing an ASMR I, II or III (see 8.4 Cost-Benefit Analyses for Pharmaceu - ticals and Medical Devices ) and whose main manufacturing stages (active ingredient, finished product, packaging) are carried out in France. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds The costs of pharmaceuticals and medical devices may be reimbursed from public funds at a variety of levels and under different pathways. Pharmaceuticals Pharmaceuticals used in hospitals are primar- ily financed through hospital stays. However, expensive and innovative pharmaceuticals, for which payments are made in addition to the hospitalisation price, are included in the list of pharmaceuticals chargeable in addition to hos- pital stays ( liste en sus ) and are reimbursed by the SHI based on invoices issued by hospitals. Pharmaceuticals used in ambulatory settings are reimbursed subject to registration on a positive list ( liste des spécialités pharmaceutiques rem- boursables ). Access to reimbursement and reim- bursement rate defined by the National Union of Sickness Insurance Funds ( Union nationale des caisses d’assurance maladie ) are based on the therapeutic value of the pharmaceutical ( service médical rendu ) assessed by the HAS (see 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices ). The final decision on reimbursement is taken by the Minister of Health by legal order.
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