This article highlights the pricing and reimbursement approval process in France. A product approved on the grounds of its safety, quality, and efficacy cannot be launched before it has passed, and been approved by, the Transparency Commission and a price has been agreed upon with the Pricing Committee. The reimbursement dossier is usually submitted to the Transparency Commission after the license has been obtained. These two committees, and how they make pricing and reimbursement decisions, are detailed. It is expected that both pricing and reimbursement decisions in France will become more stringent.
Recent Developments in France.Circular from the European Federation of Pharmaceutical Industries and Associations (EFPIA), October 28, 1998; Ref. MCP 46.582.
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“What is it for? The Transparency Commission.” (La Commission de la transparence.)IMPACT MEDECIN Hebdo. N° 415, June 1998.
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French SNIP calls for action. Scrip. No. 2414. Feb 24, 1999; 2.
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Council Directive 89/105/EEC.Relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion within the scope of national health insurance systems.Brussels: European Economic Commissions; December 21, 1988.
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French pricing system signed. Scrip. No. 2457. July 23, 1999; 2.
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Social Security Finance Law for 1999 from December 1998 (L 162-17-4). Loi de financement de la Sécurité Sociale pour 1999 du dec 1998.
