TRIPs协议下药品平行进口研究

发布时间：2018-02-11 22:46

本文关键词： 药品平行进口权利穷竭原则 TRIPs灵活性公共健康　出处：《中国政法大学》2011年硕士论文　论文类型：学位论文

【摘要】：自20世纪70年代起,伴随着经济全球化,传染性疾病迅速地在欠发达国家蔓延,使这些国家陷入了公共健康危机。在面对公共健康危机时,发展中国家显得无能为力,关键在于由TRIPs协议对药品专利权的高标准保护导致了国民难以承担高昂的医药费用。药品平行进口,作为公共健康与药品专利权的一个平衡点,一方面对增加药品的可及性、解决公共健康危机起到举足轻重的作用,而与此同时也备受国际社会争议。本文通过对TRIPs协议进行详细分析,阐明其对药品平行进口的态度以及发展中国家应当如何援引TRIPs协议的灵活性条款实施药品平行进口。在结构上,本文分为四章: 第一章是关于药品平行进口的概述,界定了何为药品平行进口、其构成要件以及对公共健康的意义,并详细阐述了药品平行进口的理论基础——权利穷竭原则,为后面的论述做好铺垫。第二章则通过法条分析,对TRIPs协议下药品平行进口的合法性进行了详细的论述。首先,第6条关于权利用尽的规定将权利穷竭原则交由各国自行决定,也就说说药品平行进口的合法性问题属于各国的主权裁量事项。其次,第7条和第8条表明了TRIPs协议的宗旨和原则并非仅仅为了保护药品专利权,也要兼顾公共健康,允许成员国在必要时实施药品平行进口,但须与TRIPs协议的规定相符合。多哈宣言后通过的TRIPs第31条修正案虽然对成员国实施药品平行进口设置了诸多限制,但它第一次明确地将药品平行进口纳入了协议中,得到了正面肯定。可见TRIPs协议对药品平行进口给予了一定的认可度,但由于条款的模糊性往往也给发展中国家带来了一定的阻碍。第三章主要从TRIPs协议的角度评析了三个具有代表性的关于药品平行进口案例,包括39个跨国医药公司诉南非政府案、美国和加拿大炭疽危机以及菲律宾2008年颁布的《广泛获得的价廉物美药品法》,反映了发展中国家与发达国家在药品平行进口问题上对TRIPs协议的不同理解与斗争,进一步阐明了TRIPs协议在实际纠纷中对解决药品平行进口合法性发挥着何种作用。第四章先总结了目前的TRIPs协议在实践上究竟赋予了药品平行进口多大的认可度以及目前存在的不足,从而阐述了发展中国家应当如何援引其灵活性条款应对公共健康危机。笔者认为成员国在遵循TRIPs协议的前提下可以实施国际权利穷竭原则,允许药品平行进口合法化。同时,在对本国药品专利法进行修改或制订时应当以保障公共健康为目的,并需要采取多种措施防止药品平行进口的滥用。
[Abstract]:Since 1970s, with the globalization of the economy, infectious diseases have spread rapidly in less developed countries, plunging these countries into public health crises. In the face of public health crises, developing countries seem powerless. The key lies in the high standard protection of drug patents by the TRIPs agreement, which makes it difficult for the people to bear the high medical expenses. As a balance point between public health and drug patent rights, the parallel import of drugs, on the one hand, increases the availability of drugs. Solving the public health crisis plays an important role, but at the same time it is also controversial in the international community. This paper analyzes the TRIPs protocol in detail. This paper expounds its attitude towards parallel import of drugs and how developing countries should invoke the flexibility clause of TRIPs agreement to implement parallel import of drugs. Structurally, this paper is divided into four chapters:. The first chapter is an overview of parallel import of drugs, which defines what is parallel import of drugs, its constituent elements and its significance to public health, and expounds in detail the theoretical basis of parallel import of drugs-the principle of exhaustion of rights. Lay the groundwork for the following discussion. The second chapter discusses in detail the legality of parallel import of drugs under the TRIPs Agreement through the analysis of articles of law. Firstly, the provisions of Article 6 on exhaustion of rights refer the principle of exhaustion of rights to the discretion of each country. Secondly, articles 7 and 8 show that the purposes and principles of the TRIPs Agreement are not only to protect drug patents, but also to take into account public health. Allow member States to import drugs in parallel if necessary, subject to the provisions of the TRIPs agreement. The amendment to Article 31 of the TRIPs, adopted after the Doha Declaration, imposes a number of restrictions on the implementation of parallel imports of medicines by member States. But for the first time, it explicitly incorporated parallel drug imports into the agreement, which was positively affirmed. It can be seen that the TRIPs agreement has given a certain degree of recognition to parallel drug imports. However, the ambiguity of the provisions often brings some obstacles to the developing countries. The third chapter analyzes three representative cases of parallel drug import from the perspective of TRIPs agreement, including 39 multinational pharmaceutical companies v. the Government of South Africa. The anthrax crisis in the United States and Canada and the widely available and inexpensive Medicines Act of 2008 in the Philippines reflect the differences in understanding and struggle between developing and developed countries over the issue of parallel importation of drugs to TRIPs. This paper further expounds the role of TRIPs protocol in resolving the legality of parallel import of drugs in practical disputes. Chapter 4th summarizes how much recognition the current TRIPs protocol has given to the parallel import of drugs in practice and the shortcomings of the current agreement. The author thinks that the member countries can implement the principle of exhaustion of international rights and legalize the parallel import of drugs under the premise of following the TRIPs agreement, and how to invoke its flexibility clause to deal with the public health crisis. The purpose of the revision or formulation of national drug patent law should be to protect public health, and various measures should be taken to prevent the abuse of parallel drug imports.
【学位授予单位】：中国政法大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：D997.1

【引证文献】