发展中国家公共健康问题与TRIPS协议弹性机制研究

发布时间：2018-03-01 18:14

本文关键词： TRIPS协议药品专利发展中国家公共健康　出处：《吉林大学》2012年硕士论文　论文类型：学位论文

【摘要】：近年来，许多发展中国家（包括最不发达国家）面临着如艾滋病、肺结核及疟疾等传染病所导致的严重公共健康危机，其中因专利等知识产权制度赋予权利人市场独占权利导致药价高昂，是影响药品可得性的重要因素。在TRIPS协议通过前，各国根据自身的历史传统、文化背景、经济发展水平等采取不同程度的知识产权保护。也没有义务对药品给予专利保护。世贸组织成立后，TRIPS协议一体适用于所有成员，设定最低保护标准，并且把药品列为专利保护的对象，使得问题雪上加霜。考虑到公共利益及为防止专利权人权利滥用，TRIPS协议中也规定了一些涉及公共健康的弹性条款，然而在发展中国家根据TRIPS协议弹性条款维护其国家公共健康时，却被一些跨国制药企业及代表制药企业利益的美国认为违反TRIPS协议的规定而提起诉讼，这在国际社会上引起强烈的关注，促使国际社会思考作为基本人权的健康权与知识产权之间的冲突与协调，随后陆续通过了《多哈公共健康宣言》、《执行多哈公共健康宣言第六段决议》，最后TRIPS协议第一个修正案出台。在结构上，本文分为四大部分：第一部分“TRIPS协议对发展中国家的影响”主要论述TRIPS协议中关涉公共健康的条款之具体规定。由于TRIPS协议体例上采取最低标准保护，除符合过渡期间规定的成员之外，成员加入WTO后，必须修订其国内法，给予或者加强药品的专利保护，以符合TRIPS协议的要求。TRIPS协议中与公共健康有关规定，可以分为药品专利的相关规定，及为防止权利滥用的弹性规定两大部分。其中弹性规定对于发展中国家公共健康问题极其重要，在促进公共健康保护和药品可得性方面发挥着重要的作用。然后，，以“南非与制药公司案”和“巴西艾滋病防治计划案”为例论述TRIPS协议对发展中国家的影响，进而引发了WTO各成员对于TRIPS协议的思考与讨论，先后通过了《多哈公共健康宣言》和《执行多哈公共健康宣言第六段决议》，后来又通过了TRIPS协议第一个修正案。第二部分讨论了TRIPS协议的后续发展，包括多哈公共健康宣言、执行多哈公共健康宣言第六段决议和TRIPS协议第三十一条修正案等。分析其产生背景、主要内容及法律地位。为发展中国家维护公共健康指明了清晰的路径。第三部分探讨在TRIPS弹性机制在发展中国家的具体实践及检讨。因为TRIPS协议经过检讨修正所得出的成果并不能自动在各成员国内生效，所以需要各成员通过修订国内法来落实TRIPS协议弹性机制、《多哈公共健康宣言》及《执行多哈公共健康宣言第六段决议》的内容。在探讨发展中国家应对公共健康危机的举措时，以泰国和赞比亚为例，这些国家通过修改本国法律，应用专利强制许可制度保护本国药品生产企业，提高本国人民基本药品可得性，维护本国公共健康；加拿大为落实执行多哈公共健康宣言第六段决议，修改本国法律，向发展中国家出口治疗艾滋病的药物。可是就在这些具体应用中，依然存在种种问题。运用上述成果来解决发展中国家公共健康问题依然任重道远。第四部分回归我国，分析我国公共健康状况，并通过考察TRIPS协议弹性机制在我国立法中的体现，分析我国应如何应对所面临的公共健康危机，切实维护我国的公共健康，准确定位我国在发展中国家公共健康问题中所应扮演的角色。
[Abstract]:In recent years, many developing countries (including LDCs) faces such as AIDS, tuberculosis and malaria and other infectious diseases caused by the serious public health crisis, which due to the system of intellectual property rights give people the right to market lead to costly, are important factors of drug effects.
Before the adoption of the TRIPS agreement, countries according to their own historical tradition, cultural background, economic development level of the intellectual property protection in different degree. No obligation to grant patent protection on drugs. After the establishment of the WTO, one of the TRIPS protocol applicable to all members, the low standard setting protection, and the drug as object of patent protection that makes the problem. One disaster after another considering public interests and to prevent the abuse of patent rights, TRIPS protocol also provides some related public health elastic terms, but in developing countries according to the TRIPS protocol to maintain the flexibility provisions of national public health, but some multinational pharmaceutical companies and pharmaceutical companies on behalf of the interests of the United States that violate the provisions of the TRIPS protocol and the lawsuit, which caused strong concern in the international community, the international community to promote consideration of health right as basic human rights The conflict and coordination between intellectual property rights and public security were followed by the declaration of public health in Doha. The sixth paragraph of the Doha public health declaration was implemented. Finally, the first amendment of the TRIPS agreement came out.
In structure, this article is divided into four parts:
Specific provisions concerning public health first "influence" TRIPS agreement on developing countries mainly discussed TRIPS in terms of the agreement. The TRIPS protocol style to take the lowest standards of protection, in accordance with the provisions of the members during the transition period, members must be revised after joining WTO, the domestic law, give or strengthen the pharmaceutical patent protection, requirements the.TRIPS protocol with TRIPS protocol and public health regulations, can be divided into the relevant provisions of the pharmaceutical patent, and to prevent the abuse of rights of the provisions of the two elastic parts. The elastic regulation is very important for developing countries to public health issues, which plays an important role in the promotion of public health protection and drug availability then, in South Africa and pharmaceutical company case "and" Brazil AIDS prevention plan "for example to discuss influence of TRIPS agreement on developing countries, and It triggered the thinking and discussion of the members of WTO on the TRIPS agreement. It has passed the sixth resolutions of the Doha public health declaration and the implementation of the Doha public health declaration, and then passed the first amendment of the TRIPS agreement.
The second part discusses the subsequent development of TRIPS protocol, including the Doha declaration of public health, the implementation of the Doha declaration of public health sixth resolution TRIPS protocol and the thirty-first amendment. Analyze its background, main content and legal status. For developing countries to protect the public health indicate a clear path.
The third part discusses the specific practice and review on TRIPS elastic mechanism in developing countries. Because the TRIPS protocol through the results of the review and correction does not automatically in each country into effect, so the needs of the members through the revision of domestic law to implement the flexible mechanism of TRIPS protocol, the Doha public health declaration > > and < the implementation of the Doha declaration of public health sixth the resolution > content. On the developing countries to deal with public health crisis, taking Thailand and Zambia as an example, these countries by modifying its legal application, patent compulsory licensing system to protect the domestic pharmaceutical production enterprises, improve the people's basic drug availability, maintenance of national public health; Canada for implementation of Doha declaration of public health sixth a resolution to amend their laws, treatment of AIDS drugs exports to developing countries. But in these bodies should be In use, there are still problems. It is still a long way to use the above results to solve the public health problems in developing countries.
The fourth part regression analysis in China, public health in our country, and through the study of elastic mechanism of TRIPS protocol in the legislation of our country should reflect, analysis how to deal with the public health crisis, to safeguard our public health, accurate positioning of our country should play in the development of national public health problems the role.

【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R199;D996

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