Pricing and reimbursement of innovative pharmaceuticals in France and the new healthcare reform

Abstract

The French system for pricing and reimbursement for pharmaceutical innovation has been influential for the new German system of Early Benefit Assessment under § 35a of the Sozialgesetzbuch V (SGB V - the German social security code no. V) and for the new mandatory price negotiation for all innovative pharmaceuticals under paragraph 130b SGB V. The following essay describes the French system in general and analyses the developments and changes by the recent French healthcare reform. Innovative pharmaceuticals in France have been subject for a long-time to pricecontrol and cost-containment measures. France initiated a concept of an evaluation of medical benefit by cost-containment bodies and mandatory price negotiations even in 2004 when Germany was still abandoning the concept of price negotiation. While Germany copied part of the French system of price negotiation, it has not enacted any direct restriction on the volume of sales in the AMNOG (Act on the Reform of the Market for Medicinal Products) reform. France has the second biggest rank in terms of healthcare spending after the US. Pharmaceuticals represented around 19% of the budget of the Health Insurance funds in 2009 1). The average ratio of health spending to Gross Domestic Product (GDP) was around 11.2% in 2008 2) for a population of 65.8 million inhabitants. Markets are to be divided between hospital and pharmacy markets and special rules apply to innovative pharmaceuticals in both markets. In this regard, the growth by around 1.3% of the spending on pharmaceuticals expressed in manufacturer's price excluding VAT in 2010 was mainly driven by hospital medicines purchases (+6%). In the same time, the manufacturer's price excluding VAT of reimbursable pharmaceuticals sold in pharmacies increased by 0.5% compared to 2009 3). Over the last years, many cost-containment measures were implemented by the government leading to drastic price-cuts. New paradigms and healthcare models are emerging and health technology assessments are increasingly taken into consideration. The Debré-Even 4) report following the Mediator controversy and the consultation process on medicinal products (so-called "Assises du Médicament" 5)) were the basis for an extensive reform aiming at fostering safety reportings on medicinal products and medical devices. The reform consists of three pillars which are the prevention of conflicts of interests and the transparency of decisions, the regulation of off-label use and the promotion of better trained and informed health professionals. © ECV • Editio Cantor Verlag.