美国Hatch-Waxman法案研究
发布时间：2019-03-15 07:56
【摘要】：1984年颁布的Hatch-Waxman法案在美国医药产业百年发展历程中具有里程碑意义。该法案有效平衡了品牌药创新与仿制药竞争之间的利益关系,在很大程度上被看作是美国卫生政策的成名史。而我国的药品监管法规在平衡相关利益的立法方面尚属空白。本研究基于美国国会图书馆等方面的珍贵档案史料,系统阐述Hatch-Waxman法案的出台背景与立法过程、主要内容、业内影响,并重点研究该法案的缺陷不足与后期完善。通过研究美国政府在Hatch-Waxman法案制定、实施与完善过程中所做的努力,探讨其不断寻求各方利益最佳平衡点的经验,为我国药品监管制度提供启示与借鉴。
[Abstract]:The Hatch-Waxman Act enacted in 1984 is a milestone in the development of American pharmaceutical industry in the past 100 years. The Act effectively balances the interests between brand-name drug innovation and generic drug competition and is largely regarded as a history of health policy in the United States. China's drug regulatory laws and regulations in balancing the relevant interests of the legislation is still blank. Based on the valuable archival historical data of the Library of Congress, this paper systematically expounds the background, legislative process, main contents, and industry influence of Hatch-Waxman Act, and focuses on the deficiency and later perfection of the Act. By studying the efforts made by the American government in the process of making, implementing and perfecting the Hatch-Waxman Act, this paper probes into its experience in constantly seeking the best balance of the interests of all parties, and provides inspiration and reference for the drug regulatory system in China.
【作者单位】： 北京大学医学人文研究院;
【分类号】：D971.2;DD912.1
，
本文编号：2440437
[Abstract]:The Hatch-Waxman Act enacted in 1984 is a milestone in the development of American pharmaceutical industry in the past 100 years. The Act effectively balances the interests between brand-name drug innovation and generic drug competition and is largely regarded as a history of health policy in the United States. China's drug regulatory laws and regulations in balancing the relevant interests of the legislation is still blank. Based on the valuable archival historical data of the Library of Congress, this paper systematically expounds the background, legislative process, main contents, and industry influence of Hatch-Waxman Act, and focuses on the deficiency and later perfection of the Act. By studying the efforts made by the American government in the process of making, implementing and perfecting the Hatch-Waxman Act, this paper probes into its experience in constantly seeking the best balance of the interests of all parties, and provides inspiration and reference for the drug regulatory system in China.
【作者单位】： 北京大学医学人文研究院;
【分类号】：D971.2;DD912.1
，
本文编号：2440437
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