title: Special funding schemes for innovative medical devices in French hospitals: the pros and cons of two different approaches.
abstract: Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices. This article explores two different French approaches to funding innovative in-hospital devices and collecting supplementary data: the coverage with evidence development (CED) scheme introduced under Article L. 165-1-1 of the French Social Security Code; and national programs for hospital-based research. We discuss pros and cons of both approaches in the light of CED policies in Germany and the UK. The CED policies for devices share common limitations. Thus, transparency of CED processes should be enhanced and decisions need to be made in a timely way. Finally, we think that closer collaboration between manufacturers, health authorities and hospitals is essential to make CED policies more operational.
authors.affiliation: Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 rue Leblanc, 75015 Paris, France; Pharmacoeconomics Research Unit, Faculty of Pharmacy, University Paris-Sud, 5 rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France. Electronic address: nicolas.martelli@egp.aphp.fr.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Martelli
authors.affiliation: Pharmacoeconomics Research Unit, Faculty of Pharmacy, University Paris-Sud, 5 rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France. Electronic address: helene.van-den-brink@u-psud.fr.
authors.forename: Hélène
authors.initials: H
authors.lastname: van den Brink
mesh_terms: D004864:Equipment and Supplies / Q000191:economics* / Q000592:standards; D005062:European Union; D005381:Financing, Organized / Q000458:organization & administration*; D005602:France; D006291:Health Policy / Q000191:economics; D006761:Hospitals; D062069:Inventions / Q000191:economics*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods*
keywords: Coverage with evidence development; Health technology assessment; Hospital; Innovation; Medical devices