中国药品数据保护的研究

发布时间：2019-04-09 09:00

【摘要】：知识产权的保护是发达国家与发展中国家之间利益冲突的体现。乌拉圭回合首次在多边贸易体制中触及这一领域，并最终达成高保护标准的TRIPS协议。TRIPS协议第39条第3款明确要求对药品数据提供保护。药品数据保护是通过赋予品牌药一定期限的市场垄断使原研药公司收回投资成本并获取利益，从而刺激新药研发。期限届满之后，仿制药公司可使用这些药品数据提出仿制药的上市申请。严格的说，药品数据保护的目的是原研药与仿制药之间的利益平衡。然而，药品数据保护是一把双刃剑。过强的药品数据保护将滋生原研药长期垄断市场，从而导致药价居高不下而严重影响药品的可及性。相反，如果没有有效的药品数据保护将造成竞争者“搭便车”从而形成不公平竞争，其结果将挫伤新药研发的积极性。本文从影响美国药品立法的两件药害事件入手，深层次地剖析了药品数据对药品审批的重要性，介绍了药品数据保护的产生，评析了TRIPS协议与美国各自由贸易协定下的药品数据保护以及若干国家的立法，并同时希望能为我国药品数据保护提供借鉴。本文除绪言和结语外，共六部分。主要结构如下：第一章是药品数据保护概论。首先，笔者阐述了药品数据的来源及其价值。然后，阐述了药品数据保护的诞生。第二章是药品数据保护的理论基础及其意义。首先，笔者阐述了药品数据保护存在的正当性和必要性。然后，笔者揭露了药品数据保护的本质，并指出药品数据保护对医药行业的影响，同时提出不建议仿制药公司在药品数据保护期届满前自行获取药品数据的观点。第三章是TRIPS协议以及美国自由贸易协定下的药品数据保护。首先，，笔者介绍了TRIPS协议下药品数据保护的立法背景，并对TRIPS协议下的药品数据保护的五个条件进行解析。然后对美国各自由贸易协定下的药品数据保护进行了简单的介绍。第四章是药品数据保护在医药发达市场和医药新兴市场中的立法情况。首先，笔者介绍了药品数据保护在以美国、欧盟为代表的医药发达市场，以及以印度、墨西哥为代表的医药新兴市场中的立法情况。此外，笔者还介绍了药品数据保护在加拿大和中国台湾地区中的立法情况。第五章是药品数据保护与公众健康。第六章是我国药品数据保护的问题与对策。笔者介绍了有关我国药品数据保护的立法现状，同时指出我国药品数据保护目前所存在的问题，并提出建议。
[Abstract]:The protection of intellectual property is the embodiment of conflict of interest between developed and developing countries. The Uruguay Round addressed this area for the first time in the multilateral trading system and culminated in a TRIPS agreement with high protection standards. Article 39 (3) of the trips Agreement specifically calls for the protection of drug data. Drug data protection is to stimulate research and development of new drugs by giving brand drugs a market monopoly for a certain period of time to recover investment costs and gain benefits from the original drug companies. After the expiry of the time limit, generic drug companies can use these drug data to apply for generic drugs to market. Strictly speaking, the purpose of drug data protection is to balance interests between original and generic drugs. However, drug data protection is a double-edged sword. Too strong drug data protection will breed the long-term monopoly market of original drugs, which will lead to high drug price and seriously affect the accessibility of drugs. On the contrary, the lack of effective drug data protection would create unfair competition by hitchhiking competitors, and the result would be a debilitating incentive to develop new drugs. In this paper, the importance of drug data to drug examination and approval is deeply analyzed, and the generation of drug data protection is introduced, starting with two drug damage events that affect the drug legislation in the United States. This paper reviews the drug data protection under the TRIPS Agreement and the free trade agreements of the United States and the legislation of several countries, and hopes to provide reference for the drug data protection in our country at the same time. In addition to the preface and conclusion, this paper consists of six parts. The main structure is as follows: the first chapter is the introduction to drug data protection. First of all, the author expounds the source and value of drug data. Then, the birth of drug data protection is expounded. The second chapter is the theoretical basis and significance of drug data protection. Firstly, the author expounds the legitimacy and necessity of the existence of drug data protection. Then, the author reveals the essence of drug data protection, and points out the influence of drug data protection on pharmaceutical industry. At the same time, the author puts forward the view that pharmaceutical companies should not obtain drug data by themselves before the expiration of drug data protection period. The third chapter is about drug data protection under TRIPS Agreement and American Free Trade Agreement. Firstly, the author introduces the legislative background of drug data protection under TRIPS protocol, and analyzes the five conditions of drug data protection under TRIPS protocol. Then a brief introduction is given to the drug data protection under the free trade agreements of the United States. The fourth chapter is about the legislation of drug data protection in medicine developed market and medicine emerging market. First of all, the author introduces the legislation of drug data protection in the developed pharmaceutical markets represented by the United States and the European Union, as well as in the pharmaceutical emerging markets represented by India and Mexico. In addition, the author also introduces the legislation of drug data protection in Canada and Taiwan. The fifth chapter is drug data protection and public health. The sixth chapter is about the problems and countermeasures of drug data protection in China. This paper introduces the legislative status of drug data protection in China, points out the problems existing in the protection of drug data in China, and puts forward some suggestions.
【学位授予单位】：中国社会科学院研究生院
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：D997.1

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