TRIPS协定下药品试验数据保护研究

发布时间：2018-05-07 23:17

本文选题：试验数据 + 药品　；参考：《复旦大学》2014年博士论文

【摘要】：本文旨在研究TRIPS协定下药品试验数据保护制度。引言提出本文研究的问题及其研究意义。正文各章主要内容如下：第一章对药品试验数据保护涉及的理论问题进行了探讨。第一节结合药学科学与国际条约规定对药品试验数据的内涵与外延进行界定,为全文探讨药品试验数据保护问题奠定基础。药品试验数据是制药企业在药品提出上市申请之前,为了证明药品安全有效而进行的一系列实验室试验与临床试验所获得的数据。根据TRIPS协定的规定,TRIPS协定中受保护的药品试验数据是作为成员政府批准药品上市的条件,从含有新化学实体的药品中,通过巨大努力而获得的未披露试验数据。第二节阐述了药品试验数据保护的知识产权属性。TRIPS协定首次将药品试验数据保护纳入知识产权国际保护范围,将药品试验数据作为知识产权进行保护具有法理上的正当性。同时,药品试验数据保护是一种自成一体的知识产权保护形式,与传统的知识产权既存在一致性又存在区别性。在药品知识产权保护领域,药品试验数据保护发挥着不同于专利保护、商业秘密保护等传统保护形式的作用,是一种特殊的未披露信息保护。这一保护制度的确立对药品知识产权保护的完善具有重要意义。第三节探讨了药品试验数据保护与公共健康的关系。药品是具有生命关联性的特殊产品,高标准的药品知识产权保护可能与公共健康产生冲突,如何看待药品试验数据保护对公共健康造成的影响。应当认识到实施药品试验数据保护对公共健康可能产生一定的负面影响,但同时也具有积极的推动与保护作用。寻求药品试验数据保护与公共健康协调统一的路径是研究与实践应达到的目的。第二章着重对TRIPS协定确立的药品试验数据保护国际义务进行分析。第一节首先追溯了TRIPS协定中药品试验数据保护规定的由来。通过对作为TRIPS协定中药品试验数据保护规定蓝本的《北美自由贸易协定》相关规定以及TRIPS协定谈判历史的回顾,梳理了TRIPS协定下药品试验数据保护制度的建立过程以及不同成员在TRIPS协定谈判中对待药品试验数据保护的不同立场,为理解条款设立的目的与宗旨提供了帮助。其次分析了TRIPS协定第三十九条第三款与TRIPS协定其他条款的关系,为理解该条款规定的药品试验数据保护义务含义奠定了基础。第二节讨论了成员应保护药品试验数据以防不公平商业使用的义务。保护试验数据以防不公平商业使用的义务是药品试验数据保护义务中的关键。通过条约解释的一般规则对“不公平商业使用”进行分析,可以认为政府药监机关依赖原创药品的试验数据批准仿制药的行为属于“不公平商业使用”。第三节探讨了保护药品试验数据不被披露的义务。药品试验数据的不披露义务是试验数据保护中的最起码义务,不披露试验数据义务的保护期限和前提,与“不公平商业使用”的理解有直接的关系。第四节探讨了由防止不公平商业使用义务引申出的保护药品试验数据不被依赖的义务。通过分析有关案例,得出政府在药品试验数据保护期间内依赖原创药品试验数据批准仿制药上市申请的行为应当受到不依赖义务的规范。第五节分析了药品试验数据保护的例外,在出于保护公众的必要以及已采取措施确保试验数据不被不公平商业使用两种情况下,WTO成员可以披露药品试验数据。第三章对部分WTO成员的药品试验数据保护制度进行比较法研究,以了解在相关国际义务下有关成员的具体法律实践。第一、二节分别介绍了美国、欧盟两个药品试验数据建立较早,制度相对成熟的WTO成员的域内法律制度。这两个WTO成员均采取了药品试验数据独占保护模式,即在一定的试验数据保护期内,不允许药品监管机关根据原创药品提交的试验数据批准仿制药的上市申请。第三节介绍了加拿大的药品试验数据保护以及部分发展中国家采取的药品试验数据非独占保护模式。发展中国家利用TRIPS协定的灵活度,采取这种保护模式,将药品试验数据保护义务要求尽量降到最低。第四节通过对制度的评价、鉴别和比较,对各成员在药品试验数据保护期限、保护范围、规定渊源方面的差异进行了归纳,提出了其他WTO成员药品试验数据保护规定对完善我国有关制度的可借鉴之处。第四章探讨了在TRIPS协定药品试验数据保护国际义务的基础上,后TRIPS时期由WTO成员间签订自由贸易协定(FTA)的实践催生的药品试验数据保护制度新的发展趋势以及可能对国际义务产生的影响。第一节对比了TRIPS协定生效前后FTA中药品试验数据保护规定的区别,指出后TRIPS时期FTA中药品试验数据保护的范围、方式等较TRIPS协定生效以前以及TRIPS协定的规定都有所变化。通过对比不同成员对FTA中规定药品试验数据保护的态度,初步得出一部分发展中国家因FTA中药品试验数据保护规定提高了其所承担的数据保护义务的结论。第二节介绍了FTA中建立的药品试验数据独占保护制度。以美国为典型代表的药品试验数据强保护国家,通过签订FTA的方式,向发展中国家推行了药品试验数据独占保护模式。尽管FTA中的药品试验数据保护制度在客观上削弱了发展中国家对TRIPS协定灵活度的利用,但有助于推动在全球范围内建立相对统一的药品试验数据保护标准。第三节介绍了后TRIPS时期生物药品试验数据保护制度的发展。生物药品的试验数据保护属于超TRIPS协定的保护措施,但是随着生物制药在制药产业中占据越来越重要的地位,药品试验数据保护在生物制药领域的适用成为药品试验数据保护制度发展中备受关注的问题。在《跨太平洋伙伴关系协定》(TPP)谈判中纳入生物药品试验数据保护,是目前药品试验数据保护制度发展中讨论最热烈的问题之一。如果在这方面所有进展,将对药品试验数据保护国际义务的发展产生相当重要的影响。第五章对我国的药品试验数据保护制度进行研究。第一节介绍了我国根据所承担的国际义务建立的药品试验数据保护制度。在分析我国制药产业现状与发展前景,药品注册审批程序法律规定以及药品注册审批实施情况的背景下,研究我国药品试验数据保护制度所能够发挥的作用以及与药品管理法律体系中其他药品行政保护手段之间的关系。第二节指出目前我国药品试验数据保护制度存在的问题,以及完善和发展我国药品试验数据保护制度的必要性与可能性。在完善我国相关制度时,应当始终在药品创新和公共利益之间寻求平衡的原则下,设计、细化与改进药品试验数据保护制度,力求制度设计既能够有效发挥药品试验数据保护制度激励和促进药品创新研发的效果,也能够平衡和降低药品试验数据保护可能对公共健康造成的不利影响。从而使创新制药企业与仿制药企业都能受惠于药品试验数据保护制度。
[Abstract]:The purpose of this paper is to study the data protection system of drug test under the TRIPS agreement. The introduction puts forward the problems and its significance in this paper. The main contents of the main body of the text are as follows: the first chapter discusses the theoretical problems involved in the protection of drug test data. The first section combines the connotation of pharmaceutical science and international treaty provisions on the connotation of drug test data. It is the basis for the full text to explore the protection of drug test data. Drug test data is the data obtained by a series of laboratory tests and clinical trials in order to prove the safety and effectiveness of drugs before pharmaceutical companies apply for listing. According to the provisions of the TRIPS agreement, the TRIPS agreement is protected. The drug test data is the condition that the member government approves the drug listing, the undisclosed experimental data obtained from the drugs containing new chemical entities through great efforts. The second section expounds the.TRIPS agreement on the intellectual property property of drug test data protection for the first time in the protection of drug test data into the international protection of intellectual property rights. There is a legal justification for the protection of drug test data as intellectual property rights. At the same time, the protection of drug test data is a form of intellectual property protection, which is consistent with the traditional intellectual property rights. In the field of drug intellectual property protection, the protection of drug test data is not full. The role of traditional protection forms such as patent protection and trade secret protection is a special kind of undisclosed information protection. The establishment of this protection system is of great significance to the improvement of drug intellectual property protection. The third section discusses the relationship between drug test data protection and public health. The drug is a special product with life relevance. The protection of high standard drug intellectual property rights may conflict with public health, how to look at the impact of drug test data protection on public health. It should be recognized that the implementation of drug test data protection may have a certain negative impact on public health, but it also has a positive role in promoting and protecting. The second chapter focuses on the analysis of the international obligations of drug test data protection established by the TRIPS agreement. The first section first traces back to the origin of the provisions for the protection of drug test data in the TRIPS agreement. According to the review of the history of the North American Free Trade Agreement (NAFTA) and the negotiation history of the TRIPS agreement, the process of establishing the drug test data protection system under the TRIPS agreement and the different members of the different members on the protection of drug test data in the negotiation of the TRIPS agreement are reviewed. The second analysis of the relationship between the thirty-ninth sections and third sections of the TRIPS agreement with the other provisions of the TRIPS agreement laid the foundation for understanding the meaning of the obligation to protect the drug test data set out in the article. The second section discussed that members should protect the drug test data to prevent unfair commercial use. The obligation of commercial use is the key to the protection obligation of drug test data. Through the analysis of the "unfair commercial use" through the general rules of the treaty interpretation, it can be considered that the government drug supervision agency depends on the experimental data of original drugs to approve the behavior of the generic drug as "unfair commercial use". The third section discusses the protection of drug test. The non disclosure obligation of the test data. The non disclosure obligation of the drug test data is the minimum obligation in the test data protection, does not disclose the duration and premise of the protection of the experimental data obligations, and has a direct relationship with the understanding of "unfair commercial use". The fourth section discusses the protective drugs derived from the prevention of unfair commercial use obligations. The fifth section analyses the exceptions to the protection of drug test data in order to protect the public. Measures have been taken to ensure that experimental data are not used for unfair commercial use in two cases, WTO members can disclose drug test data. The third chapter makes a comparative study of the drug test data protection system of part of the WTO members to understand the practical legal practice of the members concerned under the relevant international obligations. The first, second section introduces the United States respectively Two EU drug test data have been set up early, and the legal system of relatively mature WTO members of the system. These two WTO members have adopted the exclusive protection model of drug test data, that is, within a certain period of test data protection, the drug regulatory agency will not allow the application of the experimental data submitted by the original drug to approve the application of the generic drug. The third section introduces the protection of drug test data in Canada and the non exclusive protection model of drug test data taken by some developing countries. Developing countries use the flexibility of the TRIPS agreement to take this protection model to minimize the requirements for the protection of drug test data. The fourth section is identified by the evaluation of the system. And compare the differences between the members of the drug test data protection period, the scope of protection and the origin of the provisions, and put forward the reference of the other WTO member drug test data protection regulations to improve the relevant system in our country. The fourth chapter discusses the international obligations of the data protection of the drug test data in the TRIPS agreement, and the post TRI The new development trend of drug test data protection system generated by the practice of the free trade agreement (FTA) between WTO members during the PS period and the possible impact on international obligations. The first section contrasts the difference between the drug test data protection regulations in FTA before and after the entry into force of the TRIPS agreement, and points out the protection of drug test data in the post TRIPS period FTA. The scope and mode of the TRIPS agreement have changed before the entry into force of the TRIPS agreement and the provisions of the TRIPS agreement. By comparing the attitudes of different members to the protection of drug test data in the FTA, a preliminary conclusion is drawn to the conclusion that some developing countries have improved their data protection obligations under the protection regulations of drug test data in FTA. The exclusive protection system of drug test data set up in FTA is introduced. The country which is a typical representative of the drug test data is strongly protected by the United States, and the drug test data exclusive protection model is carried out to developing countries by the way of FTA, although the protection system of drug test data in FTA objectively weakens the developing countries to TRIPS The use of protocol flexibility helps to promote the establishment of a relatively unified standard for the protection of drug test data around the world. The third section introduces the development of the data protection system for the post TRIPS biodrug test. The protection of the experimental data of biological drugs belongs to the protection of the super TRIPS agreement, but with the biopharmaceutical industry in the pharmaceutical industry The application of drug test data protection in the field of biopharmaceuticals has become a major concern in the development of drug test data protection system. The inclusion of data protection in biodrug test in the TPP negotiations is the most discussed in the development of the pre eye drug test data protection system. One of the hot issues. If all progress in this area will have a very important impact on the development of the international obligations for drug test data protection. The fifth chapter studies the system of drug test data protection in China. The first section introduces the system of drug test data protection established in China based on the international obligations undertaken. In the background of the current situation and development prospect of our pharmaceutical industry, the legal provisions of the approval procedure of drug registration and the implementation of the drug registration examination and approval, the study on the role of the drug test data protection system in our country and the relationship with other drug administrative protection means in the legal system of drug management are discussed in the second section. The problems existing in the national drug test data protection system and the necessity and possibility of improving and developing the system of data protection for drug test in China should be perfected in our country. Under the principle of balance between drug innovation and public interest, the system of data protection for drug test should be designed, refined and improved to make every effort to be made. The degree design can not only effectively give full play to the effect of drug test data protection system to stimulate and promote drug innovation and development, but also balance and reduce the adverse effects of drug test data protection on public health. Therefore, both innovative pharmaceutical enterprises and generic pharmaceutical enterprises can benefit from the drug test data protection system.

【学位授予单位】：复旦大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：D997.1

【引证文献】