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Pharmaceutical Patent Protection In Conflict With Public Health And International Coordination Mechanisms

Posted on:2007-03-04Degree:DoctorType:Dissertation
Country:ChinaCandidate:J YangFull Text:PDF
GTID:1116360185954371Subject:International Law
Abstract/Summary:PDF Full Text Request
The reason why the patents regimes had been created is that it could promote technology innovation, especially the pharmaceutical patents. Being one of the special commodities, pharmaceutical is an essential composition to realize fundamental human right and can play an important role. Therefore people from all over the world should gain access to it. Although the pharmaceuticals could be developed for a long period and at a high cost, they could be easily copied. In this regard, it would disbennifit the improvement of the public health if the intellectual property were not protected. Patents regimes are definitely not perfect as they can make the pharmaceutical manufacturers to arbitrarily decide the price of the pharmaceuticals, redeem the investment on research and development and get considerable profits. When the commercial cost, risk and profit all consist of the considerations of the medicine pricing, the price of the medicines might be much higher than the direct production cost. It might make many people, especially the patients of the developing countries not afford to buy some medicines and thus result in issues of access to pharmaceuticals. When there were no cheaper alternatives for the pharmaceuticals to cure the deadly diseases, the conflicts between the pharmaceutical manufacturers'interests and public health, the commercial needs of the manufacturers to get higher profits in higher risk and the rights to health of poor patients would become extraordinarily strident.The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) for the first time brought the Trade-Related Aspects of Intellectual Property Rights into the WTO regimes. Because of the complexity of it, TRIPS Agreement had been one of the issues with many disputes. Under TRIPS Agreement, no matter the developed countries or developing countries, all members bear the obligations to protect the pharmaceuticals and their manufacturing methods. Therefore, the TRIPS Agreement has a significant impact on research and developing of the pharmaceutical technologies, the protection for the pharmaceuticals and their manufacturing methods. The pharmaceuticals differentiate from the other properties. On the one hand, since the consumers cannot discern the position of a medicine, such as its qualities and classifications, it should be supervised and regulated by the country to guarantee its securities. On the other hand, the access to the pharmaceuticals is not only fairly related to maintain the human public health and lasting of human lives but also the crucial component to realize the basic human rights (rights to health). Recently, the trans-border public health crisis, in which millions of people living in developing countries cannot gain access to pharmaceuticals for treatment of malaria, tuberculosis and HIV/AIDS, has prompted the World Trade Organization (WTO) to address health issues as crucial and imperative trade issues.In background of the World Health Organization (WHO), related human rights committee of the United Union, the Non-government Organizations (NGO) and many developing countries having prompted to primarily consider the public health policies, the United States of America and the EC started to change their policies and directly treated the concerns of the developing countries on the public health. In June, 2001, TRIPS Council for the first time negotiated the issues of intellectual properties under public health regimes and passed the special public health related declaration unprecedentedly, namely the Doha Declaration. It had led the TRIPS Agreement and the access to medicines to a new progress.Although the deal is a victory of sorts for the developing nations, it is no wonder that groups that campaigned for increasing access to drugs and for relaxation of TRIPS provision for the benefit of poor patients are disappointed. WTO Council reluctantly passed the Decisions to the implementation on Paragraph 6 of the Doha Declaration on Aug. 30, 2003. However, the deal had been criticized for the burden and the inefficiency to prevent the competent manufacturer to produce lower prize generic versions of a drug.WTO Members on Dec.6, 2005 approved changes to the intellectual property agreement making permanent a decision on patents and public health originally adopted in 2003 to allow countries with insufficient pharmaceutical manufacturing capacity to import generic versions of drugs still under patent. However, some health administration institutions, pharmaceutical manufacturers, and NGOs from all over the world have criticized the agreement as being too burdensome and the amendment was "based on a mechanism that has failed to prove it can increase access to medicines."Since 2001, Doha Ministerial Conference has got important improvement in decision-making for international public health and development under WTO framework. It has provided more specific legal certainty for pharmaceutical patents and also offered ways for settlement of some issues. This dissertation will focus on this topic and address on the measures to treat the public health and access to pharmaceuticals for the developing countries under pharmaceutical patents regimes of TRIPS Agreement. Then some advices will be provided to the decision-makers for references.This dissertation consists of 7 chapters, complemented by a short introduction and an epilogue:Chapter One analyzes the reason of the conflict between pharmaceutical patents and public health, and explores some issues needed to clarify. It points out that the intellectual properties attribute not only to possess private rights, but also to possess human rights. The regimes of some international treaties were stressed. After the obligations of a country to protect public health have been specified, the conclusion is made as that the access to pharmaceuticals is the basic guarantee for realizing rights to health. The indicators to realize the rights to health are also demonstrated. Then the dissertation points out that the human rights prior to the intellectual property rights when conflicted and the compulsory licensing helps to overcome the limitations of the patent protection. As to the disputes about the effects of pharmaceutical patents on research and development, innovation, trade and investment, and technology transferring, the dissertation analyses them one by one and indicates that the degradation of patent protection will not result in negative influences on research and development, innovation, trade and investment, and technology transferring. It's fair that the developing countries regard the health rights prior to the property rights.Chapter 2 reviews the history of patent regimes evolved from privilege to private rights, and shows that almost every country had made use of compulsory licensing before the negotiation of Uruguay Round. It was said that the granting of patent monopoly was used for encouraging the inventers but the compulsory licensing was used for overcoming the defections of patent regimes. So patent regimes and compulsory licensing regimes supplement each other, and the developing history of compulsory licensing to some extent can be regarded as the developing history of patent regimes. This chapter also introduces the whole stage when compulsory licensing regimes were brought into Paris Convention and the evolvement of them in England, the USA and Canada before the TRIPS Agreement was concluded. Lastly, the chapter discusses the position of developing countries on pharmaceuticals and addresses that compulsory licensing regimes have been used by the developing countries as getting indispensable technologies and as the important measures to meet the needs of them.Chapter 3 reviews the conflicts in the course of the conclusion of TRIPS Agreement and shows that the attitudes toward the TRIPS Agreement between the developed countries and the developing countries were widely divergent and they were the origin of disputes between them. As to developing countries, the considerations on development and public health are more important. Although the compulsory licensing has been introduced into TRIPS Agreement, it's very hard to apply it. Therefore, the developing countries looked TRIPS Agreement only as the reflection of the developed countries and their pharmaceutical manufacturers to control the interests of pharmaceutical market because the application of these exceptional clauses was strictly limited. When the developing countries used the exceptional clauses to reduce the prices of the pharmaceuticals, they would suffer the resistance of the developed countries. The developed countries claimed that the developing countries violate the obligations of TRIPS Agreement and infringe their intellectual property rights.Chapter 4 firstly presents the typical cases resolved by DSB of the WTO on pharmaceutical patents and health care, including AIDS pharmaceuticals disputes between the USA and South Africa, the USA and Brazil, and the case on Indian pharmaceuticals and chemicals patent protection. The dispute between the USA and South Africa aroused universal responses and possesses reference value and profound impacts. The dispute between the USA and Bayer AG on Cipro patent reflected the double standard of the United States about the compulsory licensing regimes and the full repercussions from this act have yet to be fully realized.Chapter 5 mainly introduces the forming process of Doha Declaration and demonstrates the central contents and legal significance of it. According to this chapter, even Doha Declaration had clarified some issues on TRIPS Agreement and public health, it had some limitations and had not overcome the conflicts between public health and pharmaceutical patents. Severe disputes happened between the developed and developing countries on paragraph 6 about the compulsory licensing. Therefore, WTO Council had not formed the Decision on the Implementation of Para 6 of Doha Declaration until August 30, 2003. The new development of the negotiation of TRIPS Council on public health is also presented in this chapter.Chapter 6 firstly discusses the rationalities for patent protection and points out that patent protection is an instrument but not an objective, then analyses the cost for patent protection and deems that fair and just conception should be used to rebalance the interests for pharmaceutical patent protection. Ten measures are presented to resolve problems of access to pharmaceuticals in developing countries and will separately analyzed, such as the extension of a transitional period of pharmaceutical patents, implementation of the compulsory licensing, the suspension of the disputes offered to WTO, and parallel imports of pharmaceuticals.Chapter 7 reviews China's legislation development in the field of pharmaceuticals then summarizes present situation of public health in China, and at last presents some strategies for overcoming the public health crisis and the problem of access to pharmaceuticals.
Keywords/Search Tags:Public Health, TRIPS Agreement, Pharmaceutical Patents, Compulsory Licensing
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