FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
The rules governing price setting are mainly outlined in the French Social Security Code and Framework Agreements entered into between the governmental body in charge of fixing prices ( Comité économique des produits de santé or CEPS) and industry trade associations. Pharmaceuticals The price of products used in hospitals is negoti- ated between the pharmaceutical company and the hospital, within the framework of the Public Procurement Code. France has implemented and activity-based tariff system for hospitals. However, the price of (i) expensive and innova- tive pharmaceuticals included in the list of phar- maceuticals 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 retroces- sion basis ( liste de restrocession ), is negotiat- ed 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 unjus- tified spending or for pharmaceuticals that are particularly costly for institutions. The price of reimbursed pharmaceuticals pre- scribed to outpatients is determined through negotiations between the pharmaceutical com- pany and the CEPS, based on various factors, including: • the improvement in medical benefit of the pharmaceutical; • 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 guaranteed 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 control the margins of reimbursed pharmaceu- ticals. Discounts, rebates and any other com- mercial and financial benefits, including service fees, on reimbursed pharmaceuticals, granted by a supplier to pharmacists, cannot exceed, per calendar year and per product line for each phar- macy, 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 hos- pitals 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 reimburse- ment is based are determined through negotia- tions between the pharmaceutical company and the CEPS. The determination of the tariff primar- ily takes into account:
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