我国首仿药的法律状态及对策研究

发布时间：2018-05-11 06:06

本文选题：仿制药 + 首仿药　；参考：《中南大学》2014年硕士论文

【摘要】：专利悬崖期的到来会对制药行业产生深远的影响。“十二五”以来,我国大力发展仿制药产业,号召以专利到期高潮为契机改变我国仿制药产业大而不精的现状。而首仿药作为首先成功仿制的药品,直接关系到公众享有可负担医疗服务的时间,是最具代表性也最值得鼓励的仿制药。但目前我国首仿药的法律法规体系并不完善,因此本选题极具研究意义。相比之下,美国具备较完善的仿制药法律法规体系,主要包括Hatch-Waxman法案、《药品专利登记及ANDA停审期的管理规定》、仿制药价格及效益计划等仿制药的专门性法律法规。本文在研习美国先进制度的基础上,结合我国目前仿制药的法律法规现状,总结出目前我国仿制药法律法规体系中存在的问题：仿制药法律地位不明确；仿制药对照目录制度缺失,导致药品专利权信息和独占权信息不透明；缺乏有效首仿药激励制度以及仿制药使用制度不规范。针对上述问题,笔者在文章的最后提出了相应的对策和建议,包括：确立仿制药法律地位；建立仿制药对照目录制度；确立首仿药激励制度以及规范仿制药使用制度。
[Abstract]:The arrival of the patent cliff will have a profound impact on the pharmaceutical industry. Since the 12th Five-Year Plan, China has made great efforts to develop the generic medicine industry and called on the climax of patent expiration to change the status quo of China's generic drug industry. As the first successful imitation drug, it is directly related to the public access to affordable medical services, is the most representative and most worthy of encouragement of generic drugs. However, the current legal system of the first imitation drug is not perfect, so this topic is of great significance. In contrast, the United States has a relatively complete system of laws and regulations on generic drugs, including the Hatch-Waxman Act, the regulations on the Administration of Drug Patent Registration and ANDA suspension, and the specific laws and regulations on generic drugs, such as the price and benefit plan of generic drugs. On the basis of studying American advanced system and combining with the current situation of laws and regulations of generic drugs in our country, this paper summarizes the existing problems in the legal system of generic drugs in our country: the legal status of generic drugs is not clear; The absence of the generic drug control catalogue system leads to the lack of transparency of patent information and exclusive right information, the lack of effective incentive system for imitating drugs and the non-standard system of generic drug use. At the end of the paper, the author puts forward the corresponding countermeasures and suggestions, including: establishing the legal status of generic drugs; establishing the control catalogue system of generic drugs; establishing the incentive system of the first imitation drugs and regulating the use of generic drugs.
【学位授予单位】：中南大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

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