Dubromel Amélie, Geffroy Loïc, Aulagner Gilles, Dussart Claude
Pharmacy Department, Hôpital d'Instruction des Armées Desgenettes, Lyon, France.
Laboratoire Parcours Santé Systémique, Université Claude Bernard Lyon, Lyon, France.
J Mark Access Health Policy. 2018 Apr 4;6(1):1458575. doi: 10.1080/20016689.2018.1458575. eCollection 2018.
In France, a significant part of health expenditure is publicly funding. This put a heavy burden on society. In an economic context requiring tight control of public spending, it seems relevant to control the diffusion of medical innovations. That is why health technology assessment is subject to an increasing interest at national level for management and approval decisions. This article provides an overview of the assessment and diffusion of medical innovation in France. The data are extracted from French authorities or organisations websites and documents and from French legislative texts. In addition, regarding discussion, a search in MEDLINE database was carried out. An overview of the assessment and diffusion of medical innovation in France is given by presenting the different types of medical innovations according to French health system definition (I); introducing French authorities participating to health technology assessment and describe assessment procedures of medical innovations (II); and giving details about market access process of innovative health product in France (III). Key opportunities and challenges of medical innovation assessment and diffusion in France are discussed at the end of this article. In France, medical innovation is considered as a crucial component for quality of care and performance of healthcare system. The aim of health technology assessment is to promote a secure and timely access to innovation for patients. Nevertheless, it appears necessary to improve regulatory mechanisms.
在法国，很大一部分医疗支出由公共资金提供。这给社会带来了沉重负担。在需要严格控制公共支出的经济背景下，控制医疗创新的传播似乎是合理的。这就是为什么卫生技术评估在国家层面对于管理和批准决策越来越受到关注。本文概述了法国医疗创新的评估与传播情况。数据取自法国当局或组织的网站、文件以及法国立法文本。此外，在讨论方面，还在医学文献数据库（MEDLINE）中进行了检索。通过按照法国卫生系统定义介绍不同类型的医疗创新（一）；介绍参与卫生技术评估的法国当局并描述医疗创新的评估程序（二）；以及详细说明法国创新卫生产品的市场准入流程（三），对法国医疗创新的评估与传播进行了概述。本文结尾讨论了法国医疗创新评估与传播的主要机遇和挑战。在法国，医疗创新被视为医疗质量和医疗体系绩效的关键组成部分。卫生技术评估的目的是促进患者安全、及时地获取创新成果。然而，改进监管机制似乎很有必要。
