FRANCE Law and Practice Contributed by: Emmanuelle Trombe, Anthony Paronneau and Anne-France Moreau, McDermott Will & Schulte
8.2 Price Levels of Pharmaceuticals or Medical Devices When setting and reviewing the price of reimbursed pharmaceuticals and the tariff of reimbursed medical devices, the CEPS may take into consideration the existence of lower prices or tariffs in Germany, Spain, Italy and the United Kingdom. The Framework Agreement between the trade asso- ciation representing the pharmaceutical industry and the CEPS establishes the possibility of benefiting from a pre-tax list price that cannot be lower than one of the prices applied in Germany, the United Kingdom, Italy and Spain for a pharmaceutical providing an ASMR I, II or III (see 8.4 Cost-Benefit Analyses ) and whose main manufacturing stages (active ingredient, finished product, packaging) are carried out in France. 8.3 Reimbursement From Public Funds The costs of pharmaceuticals and medical devices may be reimbursed from public funds at a variety of levels and under different pathways. Pharmaceuticals Pharmaceuticals used in hospitals are primarily financed through hospital stays. However, expensive and innovative pharmaceuticals, for which payments are made in addition to the hospitalisation price, are included in the list of pharmaceuticals chargeable in addition to hospital stays ( liste en sus ) and are reim - bursed by the SHI based on invoices issued by hos- pitals. Pharmaceuticals used in ambulatory settings are reimbursed subject to registration on a positive list ( liste des spécialités pharmaceutiques remboursa- bles ). Access to reimbursement and reimbursement rate defined by the National Union of Sickness Insur- ance Funds ( Union nationale des caisses d’assurance maladie ) are based on the therapeutic value of the pharmaceutical ( service médical rendu ) assessed by the HAS (see 8.4 Cost-Benefit Analyses ). The final decision on reimbursement is taken by the Minister of Health by legal order. Medical Devices Medical devices for individual use in hospitals are pri- marily financed through hospital stays. Expensive and
innovative medical devices are financed separately, in addition to the hospitalisation 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 ambulatory settings may be reimbursed subject to registration on a specific list called “List of Reimbursable Prod- ucts 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 Analy - ses ). 8.4 Cost-Benefit Analyses In France, cost-benefit analyses play a significant role in determining both the price and the reimbursement status of pharmaceuticals and medical devices. The HAS (Transparency Committee for the pharma- ceuticals and The National Committee for the Evalu- ation of Medical Devices and Health Technologies for medical devices) is responsible for conducting such health technology assessment. After reviewing the dossier submitted by the company and the other available scientific data, the HAS pub- lishes a scientific opinion evaluating the actual clinical benefit and the clinical added value of the product. Reimbursement decisions are based on the rating 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 Pharmaceuticals and Medical Devices ). Regulation (EU) 2021/2282 on Health Technology Assessment establishes an EU-level framework for assessing the added value, effectiveness, costs and broader impact of health care interventions, including medicines, medical devices and procedures. While the Regulation is not yet fully applicable, since Janu- ary 2025, new oncology medicines and advanced therapy medicinal products have been assessed at EU level.
98
CHAMBERS.COM
Powered by FlippingBook