FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
Code. France has implemented and activity-based tariff system for hospitals. However, the price of (i) expensive and innovative pharmaceuticals included in the list of pharmaceuti- cals chargeable in addition to hospital stays ( liste en sus ), for which payments are made in addition to the hospitalisation price, and (ii) pharmaceuticals available in pharmacy hospitals for direct sale to outpatients, included in the list of pharmaceuticals prescribed on a retrocession basis ( liste de restrocession ), is nego- tiated between the CEPS and the pharmaceutical company. The ministers responsible for Health and Social Security may set a maximum sale price for pharmaceuticals with a risk of unjustified spending or for pharmaceuticals that are particularly costly for institutions. The price of reimbursed pharmaceuticals prescribed to outpatients is determined through negotiations between the pharmaceutical company and the CEPS, based on various factors, including: • the improvement in medical benefit of the pharma- ceutical; • the results of health economic assessment; • the prices of other pharmaceuticals in the same therapeutic field; • the expected or actual sales volumes; • the expected and actual conditions of use of the pharmaceuticals; and • the security of supply to the French market guaran- teed by the location of production sites. If no agreement is reached between the CEPS and the pharmaceutical company, the CEPS has the authority to unilaterally set the price. The Ministers of Health, Social Security and the Economy may oppose this decision within 15 days. When generic or biosimilar pharmaceuticals enter the market, specific discount rates are applied by the CEPS to determine their price, and the prices of the reference pharmaceuticals are reduced accordingly. The Ministers of Economy and Health may also con- trol the margins of reimbursed pharmaceuticals. Dis- counts, rebates and any other commercial and finan-
cial benefits, including service fees, on reimbursed pharmaceuticals, granted by a supplier to pharma- cists, cannot exceed, per calendar year and per prod- uct line for each pharmacy, 2.5% of the manufacturer price excluding tax. For generic pharmaceuticals, this is capped at 40% of the manufacturer’s price. Medical Devices Rules applicable to medical devices used in hospitals are the same as for pharmaceuticals used in hospitals or healthcare institutions. For medical devices prescribed to outpatients, the maximum price that the public can be charged and the tariff on which SHI reimbursement is based are determined through negotiations between the phar- maceutical company and the CEPS. The determina- tion of the tariff primarily takes into account: • the medical benefit or the improvement in medical benefit of the medical device; • if applicable, the results of the medico-economic assessment of tariffs of comparable products or services; • the planned or observed sale volumes; • planned or observed amounts reimbursed by SHI; • the estimated conditions of use; and • in some cases, the establishment of production sites in France. 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. Discounts, rebates and any other commercial and financial ben- efits, including service fees, granted by any supplier to retailers of reimbursed MDs, may soon be capped under French law. A ministerial order is expected to limit such discounts, rebates and benefits, per calen- dar 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.
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