【作者】 傅小娟；

【导师】 刘亚军；

【作者基本信息】 吉林大学 ， 国际法学， 2010， 硕士

【摘要】 近年来,公共健康危机已成为全球共同面临的严峻问题。国际贸易体制下的药品专利保护导致药品价格过高,药品可及性问题在全球普遍存在,更加剧了公共健康危机。在探索提高药品可及性、解决公共健康危机途径的过程中,药品专利强制许可一直是其中的重点和热点议题。随着《多哈宣言》及其后续的一系列国际公约的达成,许多国家以国际公约为依据修改了国内的相关立法,一些国家通过实施药品专利强制许可或者利用强制许可的威慑力,成功地降低药价,促进了公共健康危机的解决。但药品专利强制许可制度在实践中仍然面临许多难题。发展中国家实施强制许可面临着来自内、外的困境和压力。因此,如何克服这些困难和阻力,使制度得到合理有效的应用,仍然是一个值得探讨的问题。本文采用实证研究、历史研究、比较研究等研究方法,在对药品专利强制许可制度的合理性辨析的基础上,通过对药品专利强制许可制度的国际立法和国家实践的考察,从国际立法、国家实践、强制许可实施的阻力与有利条件四个角度对制度的发展前景作出预测,并在此基础上结合中国面临的公共健康危机,以及中国药品专利强制许可立法的沿革与现状,探讨中国实施药品专利强制许可的可能性,最后从立法和政府工作两个角度提出相应的建议,以期有利于中国合理利用药品专利强制许可制度。更多还原

【Abstract】 In recent years, under the background that the whole world is facing increasingly serious public health crisis, the compulsory license system for pharmaceuticals patents has become the focal and hotspot issue of the international community. With the accomplishment of the Agreement of Doha Declaration and a series of the following-up international conventions, many countries carried out relevant legislation based on the international conventions. Some countries succeeded in reducing the drug prices and promoting the solution of the public health crisis by implementing the compulsory license for pharmaceuticals patents or using its deterrence. However, the compulsory license system for pharmaceuticals patents faces many difficulties in practice. The developing countries have the difficulties and pressures from inside and outside while implementing the compulsory license. Therefore, it is still worthy to explore how to overcome these difficulties and obstacles, and implement the system rationally. So, in the thesis, the author firstly analyzes the justifiability of the compulsory license system for pharmaceuticals patents, and then forecasts the developmental prospects of the system from the aspects of the international legislation, some countries’practice, the resistance and the favorable conditions for the implementation of the system through the study of the international legislation and domestic practice of the compulsory license system for pharmaceuticals patents. Thirdly the author sums up the public health crisis of China, reviews the legislative history, sets forth the legislative status, and probe into the possibility of implementing the compulsory license system for pharmaceuticals patents for China. In the end, the author gives suggestions for the rational use of the compulsory license system for pharmaceuticals patents from the perspective of the legislation and the government’s work. There are three parts in the thesis.Chapter one analyzes the justifiability of the compulsory license system for pharmaceuticals patents. It expands from four aspects. Firstly, from the perspective of the compulsory license system for pharmaceuticals patents itself and its evolution history, the institutional arrangement of the system has its justifiability and necessity. Secondly, on the background that the whole world is facing increasingly serious public health crisis,and that the international trade and patent protection causes unreasonable high drug prices, the existence and the application of the system has its necessity and justifiability. Thirdly, from the perspective of the influence of the system,the rational use of the system helps to overcome the shortcomings of the patent system and promote the realization of the value of the patent system. The system also help to balance the interests of patent holders and public interests,and the interests of developed countries and developing countries. Eventually the system will also helps to protect human rights, and form an international environment which respect and protect human rights. Meanwhile, there may inevitably be negative effects on innovation, the patentee, the countries which implementing the system, and the patients. The negative effects can not negate the justifiability of the system, but it can not be ignored. How to make rational use of the system, and overcome the possible negative effects, are crucial to the problem. Finally, from the perspective of the effectiveness of the system, many countries including developing and developed countries have effectively lowered the drug price, improved the drug availability, and facilitated the resolution of the public health crisis through the implementation of the system. Therefore, the compulsory license system for pharmaceuticals patents is a system of necessity, legitimacy, effectiveness and justifiability, which can effectively facilitate the resolution of the public health crisis.Chapter two studies the international legislation and national practice of he compulsory license system for pharmaceuticals patents, and forecasts the prospects of the system. Firstly, the author summarizes the international legislation of the compulsory license for pharmaceuticals patents. From the TRIPS agreement to the Doha Declaration on the TRIPS Agreement and Public Health, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, and the TRIPS Agreement Amendment, the international legislation of the system has developed from interest imbalance to balance, and from ambiguous and imperfect content to increasingly improved content. Secondly, the author inspects the practice of Brazil, Thailand, India and several other countries, and makes an analysis of their experience. Finally, the author forecasts the developmental prospects of the system from the aspects of the international legislation, some countries’practice, the resistance and the favorable conditions for the implementation of the system,and concludes that with the improvement of the international and domestic legislation,the developing countries have a more favorable legal basis in implementing the system. Many countries including the developing and developed countries have gained successful experience in implementing the system. Although the developing countries face pressure from the developed countries and difficulties of their own, the compulsory license system for pharmaceuticals patents will be used more widely, rationally, and effectively with the continuous improvement of the Intellectual property system, the development of the production capacity of generic drugs, the effective international cooperation among developing countries, and with more and more support from the international community. The compulsory license system for pharmaceuticals patents will contribute to reducing drug prices, improving the drug availability and promoting the resolution of the public health crisis.Chapter three explores the possibility of implementing the compulsory license system for pharmaceuticals patents for China. Firstly, through the assessment of the public health status and the drug availability status, the author concludes that it is necessary for China to implementing the system. Secondly, the author sums up the history of the system in China, and summarizes the system in the third revision of the Patent Law and the New Rules for the Implementation of the Patent Law. Next, the author explores the possibility of implementing the system for China and concludes that it is necessary and possible for China to implement the compulsory license for pharmaceuticals patents, but in order to implement the compulsory license smoothly and effectively, we have to be well-prepared in many ways. Finally, based on China’s national conditions, the author gives suggestions for the rational use of the compulsory license system for pharmaceuticals patents for China from the perspective of the legislation and the government’s work. In terms of the legislation, it is suggested that some of the important concepts which are vague and difficult to identify should be cleared. The over-strict rules that the applicant must have the implementation condition should be canceled. A simple, predictable standard of the compensation in line with our national conditions should be constituted. The fuzzy and blank security measures should be cleared and added. In terms of the governments’work, it is suggested that the government should assess China’s public health problems comprehensively and accurately, and improve the awareness of the effectiveness of the compulsory license system for pharmaceuticals patents. The responsibilities of the government’s departments should be cleared, and the cooperation among the departments should be strengthened. In order to enhance the national pharmaceutical industry’s capacity in research and development and in imitating, the government should increase the investment in R&D. The government should also enhance the corporate and public awareness of intellectual property. Finally, the government should cooperate with other developing countries, exchange the practical experience and technology, support each other and deal with the pressure from inside and outside together.更多还原