Bouvenot Gilles
Service Médecine Interne et Thérapeutique, Hôpital Sainte-Marguerite, Marseille, France.
Therapie. 2006 Jan-Feb;61(1):13-6. doi: 10.2515/therapie:2006013.
In France the role of the French National Medicines Assessment Committee, which is a part of the French National Authority for Health (HAS), is to evaluate the expected performance of new drugs in comparison with that of existing drug or non-drug treatments. This process includes evaluation of degree of innovation generally based on whether the drug can be considered as possibly, likely or certain to represent a factor of progress. However innovation and progress are not always synonymous. Progress is defined in terms of improvement in efficacy or tolerance determined by estimating the impact of the new product in comparison with existing modalities on the health of a subgroup of patients that can be readily defined, identified and studied. In general the committee considers any originality as positive since a new chemical or pharmacological class or a new mechanism of action may allow treatment of patients that did not respond to or tolerate existing products. However, when confronted with a concept without clear clinical benefits, the committee must distinguish between true and false innovation so that deliberation focuses more on recognition and quantification of progress than on systematic evaluation of innovation.
在法国，法国国家药品评估委员会是法国国家卫生管理局（HAS）的一部分，其职责是将新药的预期表现与现有药物或非药物治疗手段进行比较评估。这一过程包括对创新程度的评估，评估通常基于该药物是否可被视为可能、很可能或肯定代表着进步因素。然而，创新和进步并不总是同义的。进步是根据疗效或耐受性的改善来定义的，这是通过估计新产品与现有治疗方式相比对一组易于定义、识别和研究的患者健康状况的影响来确定的。一般来说，委员会认为任何新颖性都是积极的，因为新的化学或药理学类别或新的作用机制可能使那些对现有产品无反应或不耐受的患者得到治疗。然而，当面对一个没有明确临床益处的概念时，委员会必须区分真正的创新和虚假的创新，以便审议更多地集中在对进步的认识和量化上，而不是对创新的系统评估上。
