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[过去两个世纪制药行业与法国政府之间的关系]

[Relationship between pharmaceutical industry and the French government during the last two centuries].

作者信息

Bonnemain Henri, Bonnemain Bruno

出版信息

Rev Hist Pharm (Paris). 2002;50(334):239-56.

Abstract

Between the law of germinal an XI and the 1941 law, the relationship between the pharmaceutical industry and the French government were driven by the official practice of pharmacy. The State trues pharmacist who has to contrôle financially and deontologically his company. After 1941, the State will more and more regulate and control all the activities of the pharmaceutical products industry due to the major financial impact of these products on Health Care and Social Security budgets. French State will be progressively concerned with medical information and good practices (good manufacturing practices, good laboratory practices...) It will also regulate the pricing of new drugs, the development process and will encourage the marketing of innovative products. These rules, on the basis of the European directive of 1965, will be more or less harmonized for all European countries. Since 1989, this harmonization process is looking for an expansion outside of Europe, at least for the marketing authorization, in order to facilitate the registration of innovative products in all countries. One can then observe on a period of two centuries the evolution from freedom of the pharmaceutical industry more and more to a strict controlled freedom.

摘要

在《生药法十一》和1941年法律之间,制药行业与法国政府的关系受官方药学实践的驱动。国家信任药剂师,药剂师必须在财务和道德层面上管理其公司。1941年之后,由于药品对医疗保健和社会保障预算的重大财务影响,国家将越来越多地监管制药行业的所有活动。法国政府将逐渐关注医学信息和良好规范(良好生产规范、良好实验室规范等)。它还将监管新药定价、研发过程,并鼓励创新产品的营销。基于1965年的欧洲指令,这些规则将或多或少在所有欧洲国家实现统一。自1989年以来,这一统一进程寻求在欧洲以外地区扩展,至少在营销授权方面,以便于创新产品在所有国家注册。在两个世纪的时间里,可以观察到制药行业从越来越自由到受到严格管控的自由的演变。

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