药品实验数据的法律保护问题研究

发布时间：2018-03-18 11:12

本文选题：药品试验数据　切入点：数据公开　出处：《大连海事大学》2017年硕士论文　论文类型：学位论文

【摘要】：目前,国际上对药品试验数据的保护制度以TRIPS协议第三十九条第三款作为最低标准,其保护原则为"不披露和不依赖",即不得将药品试验数据披露给未经授权的第三方,不得依赖等数据进行生物等效性试验批准具有竞争力的仿制药品的上市申请。从制药商的角度,此种模式能够完全地保护其因拥有药品试验数据所带来的经济利益,但是这与公众尤其是用药者的知情权相悖。药品由于具有特殊商品的性质,其与公共健康权息息相关,如果公众对药品的知悉权仅停留在其成分和作用机理等基础之上,而不知悉药品的产生过程的话,对于公众可能不公平,尤其是近年来国际投资中的腐败现象和新药安全性事故频繁发生,TRIPS协议中药品试验数据的"不披露"规定之正当性面临质疑,其与公众对药品的知情权之冲突为笔者研究药品试验数据的法律保护制度提供了一个新的思路,即能否在披露数据的前提下做到"不依赖",可否构建一个以公开为基础的药品试验数据专用权保护制度?对于这个问题,本文以药品试验数据为研究对象,运用价值分析法探讨药品试验数据是否具有公开性的法律性质,并选取国际上最具代表性的TRIPS协议中有关药品试验数据保护的规定加以分析,将其与TPP协议中有关于药品试验数据保护的规定对比研究,在此基础上,根据我国药品试验数据保护制度的发展历程,分析我国药品试验数据保护制度的缺陷,提出构建以公开为基础的药品试验数据专用权保护制度的建议。第一章概述药品试验数据的法律性质、药品试验数据法律保护的目的和意义以及药品试验数据法律保护的立法范例。药品试验数据从法律性质上看,其在药品研发过程中属商业秘密,一旦制药商提交试验数据于一国政府以此获得药品上市审批许可,该数据应当具有公开性并为公众所知悉。药品试验数据保护制度的目的在于防止仿制药品的不正当竞争。药品试验数据法律保护的意义则在于维护制药商的利益及维护公共利益和制药商利益的平衡。第二章探讨TRIPS协议下药品试验数据的法律保护。TRIPS协议对药品试验数据的保护规定由"受保护的数据类型"、"新化学个体"、"经过相当的努力"、"未公开"四要件组成,笔者对此依次分析并提出自己的看法,认为四要件与药品试验数据公开性并不冲突。对于TRIPS协议下药品试验数据法律保护的例外规定,即"公共利益之例外"和"禁止不正当商业使用",内含公益性与公开性的统一,在公共利益出现紧急危机时,本国政府可直接使用并公开试验数据,而无需考虑各项利益的平衡。试验数据在国内予以公开后,本国政府应当采取法律方式对其加以保护,防止出现"不正当商业使用"的情况。第三章阐述跨太平洋伙伴关系协议(TPP)中药品试验数据保护条款与TRIPS协议相比的不同之处,具体表现为保护对象的扩张、保护期限的规定和救济程序的特定化。第四章介绍了 TRIPS协议对我国药品试验数据法律保护制度的启示以及我国对TPP协议药品试验数据法律保护制度的借鉴和应对,以及我国药品试验数据保护制度存在的缺陷,对此提出应当构建以公开为基础的药品试验数据专有权保护制度。
[Abstract]:At present, the drug test data protection system in the world in the third paragraph of article thirty-ninth of TRIPS agreement as the minimum standard, the principle of protection of "non disclosure and independent", which may not be the drug test data disclosed to unauthorized third parties, are listed for the bioequivalence test approved generic drugs may not be competitive rely on data from manufacturers. The point of view, this model can fully protect the drug because it has brought the test data and the public economic interests, but this particular use of the right drug contrary. Due to the nature of a special commodity, and the right of public health are closely related, if the public right to know only the drug stay on the basis of its composition and mechanism, and the process is not aware of the drug, the public may be unfair, especially corruption in international investment in recent years. And the phenomenon of drug safety accidents occur frequently, the TRIPS protocol of pharmaceutical test data "disclosure" provisions of the legitimacy of the question, which provides a new way of thinking and the public's right to know the drug on the conflict for the legal protection system of the study of drug testing data, whether in the premise of the disclosure of the data to achieve "do not rely on", will build a public based drug test data of special right protection system? For this problem, taking the drug test data as the research object, using the value analysis method to study the drug test data is not the legal nature of publicity, and select the relevant provisions of data protection and drug test representative the international TRIPS protocol analysis, the comparative research on regulations on drug data protection test and TPP protocol, on this basis, according to the drug test data of insurance in China The development of nursing system, analyze defect data protection of China's drug test system, and proposes to construct the public based drug test data exclusive right protection system. The first chapter outlines the legal nature of drug testing data, the legal protection of drug test data of the purpose and significance of the legal protection of drug test data. Examples of drug legislation the test data from the legal nature, it is a commercial secret in the drug development process, once the drug makers to submit test data on a country's Government in order to obtain the approval of the drug, the data should have open and available to the public. The drug test data protection system is to prevent unfair competition of generic drugs. The legal protection of drug test data significance lies in the maintenance of the drugmaker's interests and safeguard the public interests and the interests of the pharmaceutical manufacturers balance. The second chapter discusses the TRI The legal protection of.TRIPS protocol PS drug test data on drug test data protection provisions of the "protected data type", "new chemical entity", "after considerable effort", "unpublished" four elements of composition, the author successively analyzed and put forward their own views, that the four elements and drug test public data does not conflict. With the exception of law protection of drug test data under the TRIPS protocol, namely the "exceptional" public interest "and prohibit unfair commercial use, unified and open with the public, the public interest in the emergency crisis, the government can be used directly and openly test data, without need to consider the balance of interests. The test data to the public at home, the government should take the legal way to protect them, to prevent the emergence of" unfair commercial use ". The third chapter of the trans Pacific The partnership agreement (TPP) drug test data protection provisions compared with TRIPS protocol differences, specifically for the protection of the object expansion, specific provisions on the protection period and relief procedures. The fourth chapter introduces the inspiration of the TRIPS agreement on China's drug test data protection legal system and China's legal protection of TPP agreement drug test data reference system and response, and the defects of Chinese drug data protection test system, this paper should be built in the open based drug test data exclusivity protection system.

【学位授予单位】：大连海事大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：D997.1

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