37 TRIPS, IPR and Human Rights

Dr. N. Rajkumar

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AIMS OF THE CHAPTER:

  • To understand the issue of IPRs violating human rights and justifications of intellectual property.
  • To appreciate the provisions like compulsory licenses which are put in place to keep check and balances in the Intellectual Property Regime.
  • To appreciate the need for checks and balances in the system of IPRs to protect human rights.

I. INTRODUCTION

A mere mention of the terms intellectual property rights and human rights does not ring any bell in the back of one’s mind signifying any direct or major connection between the two fields of law and they appear to be quiet distinct and apart from one another. However, once a person moves beyond the superficial layer of the two fields of law, one would realize that there exists a unique relationship between the two fields of law. The term intellectual property rights refers to any right to intangible property, namely, trademarks, designs, patents or any other similar intangible property under any law,1 that is the protection accorded to any Intellectual property which generally includesthe creations of the mind, such as inventions, literary and artistic works, designs and symbols, names and images used in commerce, etc.2 The World Trade Organisation (WTO) introduced intellectual property rules into the multilateral trading system for the first time through its Agreement on Trade Related Aspects of Intellectual Property Rights which was negotiated in the 1986-94 Uruguay Round. TRIPS gave prominence to the protection of intellectual property and the areas of intellectual property that are covered under the TRIPS agreement arecopyright and related rights, which includes the rights of performers, producers of sound recordings and broadcasting organizations, trademarks including service marks, geographical indications including appellations of origin,industrial designs, patents including the protection of new varieties of plants, the layout-designs of integrated circuits, and undisclosed information including trade secrets and test data.4 The Agreement comes with a basic obligation on each of the Member countries to accord the treatment with regard to the protection of intellectual property as provided for under the Agreement to the persons of all other Member countries. The term Human Right arises from the concept that all human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.5 The concept of human rights, despite beginning to gain importance from the beginning of the 20th Century came into limelight and started to get noticed more with the adoption of the Universal Declaration of Human Rights, 1948. Even though the two branches of law are over a century old, their paths never crossed one another during their initial course of development as a plain reading of the definition of the two terms that they deal with completely various aspects of law i.e. while one deals with the protection of the rights accrued to certain intangible assets and the other deals with human life and the concept of treating all human life as equal one.

The relationship between Intellectual Property Rights and Human Rights is often referred to as one that has come to light only in the recent times and until then they were always treated separately and never any discussion linking the two fields came into the forefront but for certain remote references such as in the UDHR, wherein it lays down that everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author. The conflict of interest in the protection of intellectual property rights and human rights rose up to limelight only at a later point of time especially after certain activities adopted at the international level, such as the implementation of the TRIPS agreement by the WTO, which had resulted in a circumstance wherein the two branches of law are at an intersection wherein it is debated that in certain cases the grant or the protection of one right is made at the violation of the other right. The way the intellectual property rights and human rights have come to cross one another’s paths in the last few decades have been portrayed in the words of L.R. Helfer as follows: –

“Human rights and Intellectual property rights that were once strangers are now becoming increasingly intimate bedfellows. For decades, the two subjects developed in virtual isolation from each other. But in the last few years, international standard setting activities have begun to map previously uncharted intersections between intellectual property laws on the one hand and human rights law on the other.”

Even though there exists a range of debate on numerous issues whereby one may find a conflict between human right and accord intellectual property right, especially post the TRIPS agreement, this unit primarily focuses on introducing the readers with the issues revolving around pharmaceutical patenting.

II. CONFLICTS IN PROTECTION OF INTELLECTUAL PROPERTY RIGHTS AND HUMAN RIGHTS

The interaction and debates on the conflict of intellectual property rights and its protection being violative of human rights in certain instances have been concentrated on several major conflicting points and some of the points wherein the protection of intellectual property rights especially in a period post the implementation of the TRIPS agreement and the protection of human rights are at cross roads are pharmaceutical patenting and the changes brought about in it, protection of traditional knowledge, increasing costs of food and food articles, etc. The United Nations Sub- Commission on the Promotion and Protection of Human Rights has also recognised this issue and has even went ahead and criticised the curtailment of human rights with the implementation of the TRIPS agreement and has pointed out the same in one of its resolutions wherein it has described the conflict points of Human Rights and Intellectual Property Rights especially since the implementation of the TRIPS Agreement in the following manner:

“Since the implementation of the TRIPS Agreement does not adequately reflect the fundamental nature and indivisibility of all human rights, including the right of everyone to enjoy the benefits of scientific progress and its applications, the right to health, the right to food, and the right to self-determination, there are apparent conflicts between the intellectual property rights regime embodied in the TRIPS Agreement, on the one hand, and international human rights law, on the other.”

The major and the often-discussed debate pertains to a point wherein the provisions of the TRIPS Agreement and its commitment to protect the intellectual property and the protection of Human Rights pertains to thelife-saving issues viz. the access to essential medicines, especially in less developed countries. The recognition of the human right to the highest attainable standard of health is present in the constitution numerous national, as well as in several legally binding international human rights treaties. The adoption of the TRIPS agreement and the subsequent implementation of it, advocates a strong protection regime forpatients and clinical trial data, as well as heightened measures restricting parallel imports while mandating the seizure of in-transit generic drugs has ultimately led to the demise of the generic drug manufacturing industry which was instrumental in keeping the prices of medicines at a low point and thereby making it accessible to a large number of people and on the other hand resulted in a situation of spiraling costs of medicines. This factor of the increase in the cost of essential medicines especially in developing countries and thereby by keeping these essential medicines away from the reach of the economically weaker section has opened the Pandora’s box raising issues that certain aspects of TRIPS and the protection of IPR are violative of Human Rights and has led to a major debate. The debate concerning access to essential medicines implicates both the right to life and the right to health.11 Article 3 of the UDHR explicitly lays down that “Everyone has the right to life, liberty, and security of person.” Similarly, Article 25(1) of the UDHR further recognizes that every person has “the right to a standard of living adequate for the health and well-being of himself [or herself] and of his [or her] family, including food, clothing, housing and medical care and necessary social services.” In a manner that echo’s this provision, the preamble to the World Health Organization’s Constitution declares,“The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

A. An analysis of the Indian and African situation

One of the best examples to illustrate how TRIPS has a direct impact on access to cheaper medicines is the Indian scenario wherein the passing the Patent Amendment Act, 2005 so as to meet the deadline of January 1, 2005 to comply with requirements of the WTO, as set out in the TRIPS and thereby directly affecting the percentage of population having access to medicines.14 The new amendment has caused repercussions on access to medicines to many who cannot afford them and in fact,India has finally moved from price driven mentality to a proprietary technology driven mentality.15 The Amendment Act, deviating from the earlier procedure set in place, extended product patents to products from all sectors including pharmaceuticals. As a matter of fact, until the 2005 amendment, which came into effect as a direct consequence of the TRIPS agreement, the Indian patent act only provided for the grant of process patenting for pharmaceutical products and no product patent was granted thereby opening up an avenue of reverse engineering the pharmaceutical products and thereby lowering the prices of such medicines. However, due to the fact that India became a signatory to the TRIPS agreement, India was required to provide for product patenting by 2005 as laid down under the TRIPS arrangement.16The 2005 amendment also set the term of patent protection for a uniform period of 20 years.17 The amendment further closed the option of reverse engineering, which largely contributed to the growth of Indian pharmaceutical industry and thus it was no longer possible to produce the patented product by adopting a different process. This thereby led to the spiraling costs of life-saving drugs not only in the country but also dealt a huge blow to many developing nations and under developed nations where a huge chunk of pharmaceutical products was being exported from India.

Access to medicines is a vital feature of the right of everyone to the highest attainable standard of health.19 Antiretroviral therapies (ARVs) can significantly reduce morbidity and mortality in people living with HIV.20 Yet at the beginningof the year 2008, only about three million people living with HIV were receiving antiretroviral therapy, which meant that over 69% of those who needed the life- saving ARV treatment were not receiving it.21 The situation is significantly worse for over 2 million children under the age of 15 living with HIV. Studies have pointed out that while over 780000 children living with AIDS need ARVs, only about 15% are receiving the life-savingtreatment. In sub-Saharan Africa, out of the total percentage of children in need of ARVs, those who are receiving them are as low as 6%.22 The cost of antiretroviral therapy, especially those medicines that under patent, has remained a major barrier for providing treatment at an affordable cost to all those who need it. The availability of generic medicines would not only be an efficient way to reduce the cost of life-savingtreatment butfurther, it would be an important aspect of ensuring the long-term sustainability of a country’s HIV treatment programs in Africa wherein economy in several nations especially those with high HIV percentage is already reeling under pressure.

Thus, to provide access to live saving treatments at an affordable cost and with minimal impact to a nation’s economy, it appears that it is imperative that generic medicines are made available to the public at large to ensure that they have a right to live a healthy life and thereby protecting their human right. However, post the implementation of the TRIPS agreement the generic medicine manufacturing industry in India has been severely affected and that has also led to a major adverse impact in the African nations wherein a major chunk of generic medicines for treating HIV/AIDS were being exported from India.

B. Compulsory licensing

The TRIPS agreement has set in place certain checks and balances to curb the misuse of the protection accorded for patients and especially in the case of pharmaceutical patenting for protecting the patient’s right of access to medicines and thereby protect the human right of such persons. Compulsory licensing is a method to place a check and to ensure that there is no abuse of the patent right while also ensuring that the intent and purpose of the patent law is not defeated. A compulsory license is an involuntary contract between a willing buyer and an unwilling seller imposed and enforced by the state.25 Compulsory licensing is the system in place under which a country may grant alicense to an applicant subject to certain conditions to produce or use any patented product or sell such product in the open market even in the case where the holder of the patent for such product doesnot consent for the same. the TRIPS agreement has provided for states to grant compulsory licensing toprovide a leeway to the Member States to smoothen the creases created by the potential conflict between competition policy and Intellectual Property laws. Articles 30 and 31 of the TRIPS Agreement primarily deal with the authority of the states for permitting thenon-voluntary use of patents.26 Member nations may “adopt measures necessary to protect public health and nutrition and to promote the public interest in sectors of vital importance to their socio-economic and technological development.”27 Further, TRIPS handles compulsory licenses as an exception to the agreement’s minimum requirement that all Member States afford a patentee a right of exclusivity during the complete patent term. The TRIPS agreementlay out a set of circumstances provided which any Member State can issue acompulsory license. The compulsory licenses that are allowed must fall into either of the two categories viz. where there is an overriding public interest or where the patent rights are being used in an anticompetitive manner.

In the Indian scenario, section 92 of the Patents Act, 197028, which encompasses the principles contained in Article 31(b) of the TRIPS agreement, gives sweeping powers to the Government of India in public interest to grant acompulsory license. It lays down that compulsory license may be granted to an invention in cases where in the central government satisfies that certain extraordinary circumstances exist for such a grant viz. in circumstances of national emergency or in circumstances of extreme urgency or in cases of public non-commercial use. Similar use of compulsory licensing is also witnessed in several Asian nations especially in cases concerning life-saving ARV’s used for treating HIV/AIDS and in the case of Malaysia compulsory license was specifically issued to theimportation of generic version of patented ARV for treating HIV/AIDS.29

III. CONCLUSION

The accord of protection for intellectual property rights especially posts the TRIPS agreement has often cited as one that in certain circumstance lead to aviolation of human right. The most debated issue in this is with respect to pharmaceutical patenting post the TRIPS era wherein it has become mandatory for nations to provide for product patent to medicines which is generally referred to as a violation of human right by several scholars and activists as the same results in rising costs of medicines and thereby limiting the access to life-saving drugs especially for the poor. While those advocating in favor of the protection accorded to IPR post TRIPS cite the existence of the compulsory licensing as a measure that has been set in place to check the misuse of patents, red-tapism has limited the use of compulsory licensing. However while the debate on whether the protection of intellectual property rights, especially after the TRIPS agreement in certain cases, violates Human Rights is an ongoing one there is also a new debate that is gaining popularity in the recent times on the question whether the accord of protection of intellectual property rights in itself is the protection of human right. As a matter of fact even the Universal Declaration of Human Rights, 1948 appears to be in support of this view and the same is evident from Article 27 (2) of the UDHR.30Similarly, Article 15.1 (c) of the ICESCR recognizes the right of everyone to benefit from the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.31 These provisions act as an illustration of the fact that fundamental human rights covenants recognize anintellectual property right as being a human right and have been repeatedly used to fuel numerous debates in order to argue and substantiate the question on whether it implies that all intellectual property rights are human rights. Those in favor of the existing norm of protecting intellectual property right often justify the need for patent protection for medicines as that is the only means that ensure anadequate return on investments made and thereby the same would encourage and promote further research and development, which is instrumental in thedevelopment of medicines.32 Thus, the need of the hour is to decide the point wherein a rightful exploitation of intellectual property right crosses the line and becomes a violation of ahuman right so as to have adequate checks and balances in place to ensure that both the protection of intellectual property right and human right go hand in hand.

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Reference

  • Intellectual Property: protection and enforcement, available at https://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm last visited on 25th September 2015.
  • Overview: the TRIPS Agreement, available at https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm last visited on 28th September 2015.
  • Yu, Peter K., Intellectual Property and Human Rights in the Nonmultilateral Era, 64, Fla. L. Rev. 1045 (2012) available at http://scholarship.law.ufl.edu/flr/vol64/iss4/6, last visited on 1st
  • Laurence R. Helfer, Human Rights and Intellectual Property: Conflict or Co-Existence?, 5 Minn. Intell. Prop. Rev. 47 (2003).
  • Tamvada, Subramanya Sirish, TRIPS and Human Rights: The Case of India, Jindal Global L.
  • Julian-Arnold G, International compulsory license: the rationale and the reality, IDEA, the J. of L. and Tech., 33 (2) (1993) 349.
  • Love, James, Remuneration guidelines for non-voluntary use of a patent on medical technologies, Health Economics & Drugs, TCM series No. 18, WHO (2005).
  • Gupta, Radhika, Compulsory Licensing under TRIPS: How far it addresses public health concerns in developing nations, J. Intell. Property Rights, Vol. 15, Sept. 2010, 357.
  • Subramanian, Arvind, Has the intellectual property pact opened a Pandora’s box for the pharmaceutical industry? Finance & Development, 2004,availableat https://www.imf.org/external/pubs/ft/fandd/2004/03/pdf/subraman.pdf, last visited on 4th October 2015.WHO, UNAIDS and UNICEF (2008)Towards Universal Access: Scaling up Priority HIV/AIDS Interventions in the Health Sector: Progress Report 2008 WHO, Geneva at: http://www.who.int/hiv/pub/towards_universal_access_report_2008.pdf, last visited on 2nd October 2015.
  • UNICEF, UNAIDS and WHO (2008) Children and AIDS: Second Stocktaking Report UNICEF, New York at:
  • http://www.unicef.org/aids/files/ChildrenAIDS_SecondStocktakingRepor t.pdf, last visited on 2nd October 2015.