《TRIPS协议》及《多哈宣言》下药品专利法律问题研究

发布时间：2018-11-27 20:03

【摘要】：《TRIPS协议》的实施，使发展中国家被迫采取与发达国家相同的标准来保护知识产权。在《TRIPS协议》的要求下，药品这种关系到人类健康和生命的特殊商品也必须受到专利保护。药品被授予专利权后，专利权人取得独占性权利，这就使得药品的价格由于缺乏竞争而非常昂贵。发展中国家的患者难以承担如此昂贵的药价，使得公共健康利益与专利权人的利益之间的冲突变得异常尖锐。《多哈宣言》的通过为发展中国家在TRIPS框架下解决公共健康问题指明了方向——充分利用《TRIPS协议》为公共健康目的所给予的灵活性来制定和实施其药品专利制度。本文从国际法的视角就《TRIPS协议》下药品专利制度的发展、规则、缺陷等问题进行考察，并对《TRIPS协议》关于保护公共健康的灵活性条款进行了系统分析，探讨了国际社会及中国在面临公共健康问题时面临的问题及对策。在结构上，本文分为三章：第一章“《TRIPS协议》与药品专利”本章首先回顾了《TRIPS协议》签订的背景及其实施对WTO各成员药品专利制度的影响。对药品实行专利保护是实施《TRIPS协议》的直接结果，也是造成药价昂贵的直接原因。随后论述了药品专利保护和维护公共健康之间的矛盾以及对TRIPS框架下药品专利制度的反思，指出《TRIPS协议》过于强调保护药品专利权人的利益，而严重损害了发展中国家的公共健康利益，同时也对发展中国家的药品研发和制药产业产生不利影响。第二章“《多哈宣言》对公共健康问题的应对”主要对《多哈宣言》签署的背景；它的内容、意义及后续发展进行了论述。本章指出，发展中国家由于药品的可及性问题引发公共健康危机，使得国际社会对专利权人的私权与公众的健康权孰轻孰重有了新的认识，并最终导致《多哈宣言》的通过。本章还阐释了《TRIPS协议》中可用于解决公共健康问题的灵活性条款，对这些条款的研究、利用，有利于发展中国家维护公共健康。第三章“我国解决公共健康问题的策略”主要涉及我国在《TRIPS协议》框架下解决公共健康问题的方法和途径。首先，对中国的药品专利制度进行了综述，并对其从公共健康的角度进行了评析，主要关注于我国药品专利制度中没有充分利用的灵活性措施。其次，，本章还分析了我国有必要实施专利药品的强制许可来增加仿制药的竞争，使社会公众从中受益。最后，本章指出应从公共健康角度审查药品专利，鼓励药品的研发和制药企业的发展。
[Abstract]:The implementation of the TRIPS Agreement forced developing countries to adopt the same standards as developed countries to protect intellectual property rights. Under the requirements of the TRIPS Agreement, drugs, a special commodity related to human health and life, must also be protected by patents. When drugs are patented, patentees obtain exclusive rights, which make the price of drugs very expensive because of lack of competition. Patients in developing countries cannot afford such expensive drugs. The conflict between the public health interests and the interests of the patentee has become acute. The adoption of the Doha Declaration points the way for developing countries to solve public health problems within the framework of the TRIPS-making full use of the < TRIPS Agreement The flexibility granted for public health purposes to develop and implement its drug patent system. From the perspective of international law, this paper examines the development, rules and defects of the drug patent system under the "TRIPS Agreement", and makes a systematic analysis of the flexibility provisions of the "TRIPS Agreement" concerning the protection of public health. This paper discusses the problems and countermeasures faced by the international community and China in the face of public health problems. In terms of structure, this paper is divided into three chapters: chapter one, "TRIPS Agreement" and Drug Patent, this chapter first reviews the background of the signing of the "TRIPS Agreement" and the impact of its implementation on the drug patent system of the members of WTO. Patent protection is the direct result of the implementation of the TRIPS Agreement and the direct cause of the high drug price. Then it discusses the contradiction between the protection of drug patents and the maintenance of public health, and reflects on the drug patent system under the framework of TRIPS, and points out that the "TRIPS Agreement" emphasizes too much on the protection of the interests of drug patentees. It is harmful to the public health interests of the developing countries, and has a negative impact on the drug research and development and the pharmaceutical industry in the developing countries. The second chapter, "the response of the Doha Declaration to Public Health issues", mainly discusses the background of the signing of the Doha Declaration, its content, significance and subsequent development. This chapter points out that the public health crisis caused by the problem of drug accessibility in developing countries makes the international community have a new understanding of the private rights of patentees and the right to health of the public and ultimately lead to the adoption of the Doha Declaration. This chapter also illustrates the flexible provisions of the TRIPS Agreement that can be used to solve public health problems. The research and utilization of these provisions will benefit developing countries to maintain public health. The third chapter, "Strategies to solve public health problems in China", mainly involves the methods and approaches of solving public health problems under the framework of "TRIPS Agreement". First of all, this paper summarizes the drug patent system in China, and evaluates it from the perspective of public health. It mainly focuses on the measures that are not fully utilized in the pharmaceutical patent system in China. Secondly, this chapter also analyzes that it is necessary to enforce compulsory licensing of patented drugs to increase the competition of generic drugs and to benefit the public. Finally, this chapter points out that drug patents should be reviewed from a public health perspective to encourage drug research and development.
【学位授予单位】：华东政法大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：D997.1

【参考文献】