Intellectual Property Rights Vis-A Vis Right to Health: A Critique

A. Chadha
{"title":"Intellectual Property Rights Vis-A Vis Right to Health: A Critique","authors":"A. Chadha","doi":"10.2139/ssrn.2529105","DOIUrl":null,"url":null,"abstract":"Health is a fundamental human right indispensable for the exercise of other human rights. The Article 25 of the Universal Declaration of Human Rights, 1948 mentioned health as part of the right to an adequate standard of living. The International Covenants, Treaties relating to human rights and the Constitutions of various nations recognize that a number of elements would be encompassed by the right to health from prevention to cure to access to drugs. However, health trends indicate that despite progress made in the last 35 years, millions of the people in the developing countries do not have access to the medicines which are required for treating diseases. One of the significant reasons for the lack of access of essential medicines required for needed treatment is the high prices fixed for those drugs. Strong intellectual property protection keeps prices inflated up to one hundred times the cost of manufacture of drugs. Monopolies are created by patents and they restrict competition in pharmaceutical market and permit patentee to set up high prices. It clearly indicates that the linkage between intellectual property rights and health has been the focus of much debate. Much initiative has been taken by World Intellectual Property Organization, World Trade Organization (WHO) and World Health Organization (WTO) through Trade-Related Aspects of Intellectual Property Rights Agreements (TRIPS), Doha Declaration and then the 30 August 2003 Compulsory License Import Export mechanism for providing safeguards to remedy the patent abuse, giving primacy to the public health over private intellectual property and also clarifying the WTO members States’ rights for using TRIPS safeguards. However, such measures failed to resolve the terrific issue ensuring production and export of generic medicines to developing countries that were incapable to produce them and also certain concepts remained un-clarified demanding clear guidelines to be issued in this respect at the international level for removing various types of controversies which still arise between developed and developing member States. Moreover, the intellectual property rules in TRIPS have been observed to be considerably less stringent than the rules developing countries are increasingly adopting in free-trade agreements known as \"TRIPS-plus\" agreements with the United States and other Western Governments which put greater restrictions on the use of TRIPS flexibilities like, compulsory licensing and parallel imports making it much more difficult for generic drugs to enter the market upon patent expiration and then extend patent periods beyond twenty years. Consequently, the developing countries that attempt to bring the price of the medicines down have to come under pressure from the industrialized countries and multi-national pharmaceutical industry for implementing patent legislation that goes beyond the obligations of TRIPS. However, in India Glivec case is remarkable because the judgment has a positive impact on affordability and accessibility of medicines. Now, it will be more difficult to indulge in ever-greening in India.This paper attempts to analyze critically at the global and national level two bodies of law, human right to health and intellectual property rights in order to examine certain core issues such as how despite the interactions concluded between both the bodies of law at the international level, the monopoly right conferred via intellectual property legislations transgresses the right to health particularly right to access to drug through the practice of ever-greening and threat of trade sanctions or corporate litigation from both pharmaceutical companies and developed countries. Further this paper aims to study various cases of external pressures put upon the developing countries from the side of developed nations in order to stop the entry of competitive generic medicines in the global market in the context of Indian landmark judgment and then to suggest various measures such as: making coherent, consistent and balanced legal norms at international level clarifying different concepts and issuing clearly stringent and mandatory guidelines/regulations in TRIPS providing a place of supremacy to fundamental right to health over intellectual property right; establishing high patentability standards at international level; developing Publicly funded research or pharmaceutical subsidies as well as creating policies to relax patents and increase the affordability of generic anti-retroviral through coordinated effort of global system. In order to achieve this objective, the doctrinal research is done by studying various Reports, Declarations, and Conventions of United Nations Organization and its different specialized agencies like; World Intellectual Property Organization, World Health Organization and World Trade Organization, free trade treaties among different nations as well as various other relevant national statutory enactments. The important works of a number of jurists contributing towards this field has also been the material of study.","PeriodicalId":230649,"journal":{"name":"Health Care Law & Policy eJournal","volume":"1 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2014-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health Care Law & Policy eJournal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2139/ssrn.2529105","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Health is a fundamental human right indispensable for the exercise of other human rights. The Article 25 of the Universal Declaration of Human Rights, 1948 mentioned health as part of the right to an adequate standard of living. The International Covenants, Treaties relating to human rights and the Constitutions of various nations recognize that a number of elements would be encompassed by the right to health from prevention to cure to access to drugs. However, health trends indicate that despite progress made in the last 35 years, millions of the people in the developing countries do not have access to the medicines which are required for treating diseases. One of the significant reasons for the lack of access of essential medicines required for needed treatment is the high prices fixed for those drugs. Strong intellectual property protection keeps prices inflated up to one hundred times the cost of manufacture of drugs. Monopolies are created by patents and they restrict competition in pharmaceutical market and permit patentee to set up high prices. It clearly indicates that the linkage between intellectual property rights and health has been the focus of much debate. Much initiative has been taken by World Intellectual Property Organization, World Trade Organization (WHO) and World Health Organization (WTO) through Trade-Related Aspects of Intellectual Property Rights Agreements (TRIPS), Doha Declaration and then the 30 August 2003 Compulsory License Import Export mechanism for providing safeguards to remedy the patent abuse, giving primacy to the public health over private intellectual property and also clarifying the WTO members States’ rights for using TRIPS safeguards. However, such measures failed to resolve the terrific issue ensuring production and export of generic medicines to developing countries that were incapable to produce them and also certain concepts remained un-clarified demanding clear guidelines to be issued in this respect at the international level for removing various types of controversies which still arise between developed and developing member States. Moreover, the intellectual property rules in TRIPS have been observed to be considerably less stringent than the rules developing countries are increasingly adopting in free-trade agreements known as "TRIPS-plus" agreements with the United States and other Western Governments which put greater restrictions on the use of TRIPS flexibilities like, compulsory licensing and parallel imports making it much more difficult for generic drugs to enter the market upon patent expiration and then extend patent periods beyond twenty years. Consequently, the developing countries that attempt to bring the price of the medicines down have to come under pressure from the industrialized countries and multi-national pharmaceutical industry for implementing patent legislation that goes beyond the obligations of TRIPS. However, in India Glivec case is remarkable because the judgment has a positive impact on affordability and accessibility of medicines. Now, it will be more difficult to indulge in ever-greening in India.This paper attempts to analyze critically at the global and national level two bodies of law, human right to health and intellectual property rights in order to examine certain core issues such as how despite the interactions concluded between both the bodies of law at the international level, the monopoly right conferred via intellectual property legislations transgresses the right to health particularly right to access to drug through the practice of ever-greening and threat of trade sanctions or corporate litigation from both pharmaceutical companies and developed countries. Further this paper aims to study various cases of external pressures put upon the developing countries from the side of developed nations in order to stop the entry of competitive generic medicines in the global market in the context of Indian landmark judgment and then to suggest various measures such as: making coherent, consistent and balanced legal norms at international level clarifying different concepts and issuing clearly stringent and mandatory guidelines/regulations in TRIPS providing a place of supremacy to fundamental right to health over intellectual property right; establishing high patentability standards at international level; developing Publicly funded research or pharmaceutical subsidies as well as creating policies to relax patents and increase the affordability of generic anti-retroviral through coordinated effort of global system. In order to achieve this objective, the doctrinal research is done by studying various Reports, Declarations, and Conventions of United Nations Organization and its different specialized agencies like; World Intellectual Property Organization, World Health Organization and World Trade Organization, free trade treaties among different nations as well as various other relevant national statutory enactments. The important works of a number of jurists contributing towards this field has also been the material of study.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
知识产权与健康权:批判
健康是行使其他人权不可或缺的一项基本人权。1948年《世界人权宣言》第25条提到健康是适足生活水准权的一部分。与人权有关的国际公约、条约和各国宪法都承认,健康权包括从预防到治疗再到获得药物的若干要素。然而,保健趋势表明,尽管在过去35年中取得了进展,但发展中国家仍有数百万人无法获得治疗疾病所需的药物。无法获得所需治疗所需的基本药物的一个重要原因是这些药物的固定价格过高。强有力的知识产权保护使药品价格膨胀到药品生产成本的100倍。垄断是由专利造成的,它们限制了制药市场的竞争,并允许专利权人设定高价。它清楚地表明,知识产权与健康之间的联系一直是许多辩论的焦点。世界知识产权组织、世界贸易组织(世卫组织)和世界卫生组织(世贸组织)通过《与贸易有关的知识产权协定》、《多哈宣言》和2003年8月30日的《强制许可进出口机制》采取了许多主动行动,为补救专利滥用提供保障。将公共健康置于私人知识产权之上,并澄清世贸组织成员国使用与贸易有关的知识产权保障措施的权利。然而,这些措施未能解决确保向没有能力生产非专利药品的发展中国家生产和出口非专利药品的可怕问题,而且某些概念仍然没有得到澄清,要求在国际一级发布这方面的明确准则,以消除发达成员国和发展中成员国之间仍然产生的各种争议。此外,据观察,《与贸易有关的知识产权协定》中的知识产权规则远没有发展中国家在与美国和其他西方国家政府签订的自由贸易协定中日益采用的规则严格,这些自由贸易协定被称为“与贸易有关的知识产权附加协定”,这些协定对使用《与贸易有关的知识产权协定》的灵活性施加了更大的限制,例如:强制许可和平行进口使得仿制药在专利到期后进入市场变得更加困难,然后将专利期限延长到20年以上。因此,试图降低药品价格的发展中国家不得不受到工业化国家和多国制药业的压力,要求它们执行超出《与贸易有关的知识产权协定》义务的专利立法。然而,在印度Glivec案是值得注意的,因为判决对药物的可负担性和可及性产生了积极影响。现在,在印度,要想纵情于绿化将变得更加困难。本文试图在全球和国家一级对人权、健康权和知识产权这两个法律体系进行批判性分析,以便审查某些核心问题,例如,尽管这两个法律体系在国际一级缔结了相互作用,通过知识产权立法授予的垄断权侵犯了健康权,特别是通过不断绿化的做法以及制药公司和发达国家的贸易制裁或公司诉讼威胁而获得药品的权利。此外,本文旨在研究在印度具有里程碑意义的判决背景下,发达国家为阻止竞争性仿制药进入全球市场而对发展中国家施加外部压力的各种案例,然后提出各种措施,例如:在国际一级制定连贯、一致和平衡的法律规范,澄清不同的概念,并在与贸易有关的知识产权方面发布明确严格和强制性的准则/条例,使基本健康权高于知识产权;在国际层面建立高可专利性标准;制定公共资助的研究或药品补贴,以及制定政策,通过全球系统的协调努力放宽专利,提高非专利抗逆转录病毒药物的可负担性。为了实现这一目标,理论研究是通过研究联合国组织及其不同专门机构的各种报告、宣言和公约来完成的;世界知识产权组织、世界卫生组织和世界贸易组织、各国之间的自由贸易条约以及其他各种有关的国家法规。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Role of Law in End-of-Life Decision-Making: Perspectives of Patients, Substitute Decision-Makers and Families Phasing Out Certificate-of-Need Laws: A Menu of Options Prospect Patents, Data Markets and the Commons in Data Driven Medicine. Openness and the Political Economy of Intellectual Property Rights Grandma Got Run Over by the Doctor: An Examination of the End of Life Choice Bill with Reference to the German Approach Credit, Default, and Optimal Health Insurance
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1