FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau, Anne-France Moreau and Lorraine Maisnier-Boché, McDermott Will & Emery
Medical Devices Medical devices for individual use in hospitals are primarily financed through hospital stays. Expensive and innovative medical devices are financed separately, in addition to the hospitali- sation price. In such cases, they are included in the list of products and services chargeable in addition to hospital stays ( liste en sus ) and are reimbursed based on an invoice issued by hospitals. Medical devices for individuals used in ambula- tory settings may be reimbursed subject to regis- tration on a specific list called “List of Reimburs- able Products and Services” ( Liste des Produits et Prestations Remboursables or LPPR). Access to reimbursement is based on the therapeutic value of the medical devices assessed by the HAS (see 8.4 Cost-Benefit Analyses for Phar - Pharmaceuticals and Medical Devices In France, cost-benefit analyses play a signifi- cant role in determining both the price and the reimbursement status of pharmaceuticals and medical devices. The HAS (Transparency Committee for the phar- maceuticals and The National Committee for the Evaluation of Medical Devices and Health Tech- nologies for medical devices) is responsible for conducting such health technology assessment. maceuticals and Medical Devices ). 8.4 Cost-Benefit Analyses for
After reviewing the dossier submitted by the company and the other available scientific data, the HAS publishes a scientific opinion evaluating the actual clinical benefit and the clinical added value of the product. Reimbursement decisions are based on the rat- ing and, while the rating is not the only factor, it is the primary criterion which supports the pricing by the CEPS (see 8.1 Price Control for Pharma- ceuticals and Medical Devices ). 8.5 Regulation of Prescriptions and Dispensing by Pharmacies To ensure cost efficiency in pharmaceutical pre- scribing and dispensing: • physicians are required to prescribe pharma- ceuticals using the Non-Proprietary Name, which is the globally recognised name for the active substance; and • pharmacists are allowed to substitute brand- ed pharmaceuticals with generic/biosimilar pharmaceuticals, under certain conditions, unless the physician writes on the prescrip- tion that the pharmaceutical cannot be sub- stituted for medical reasons.
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