“An estimated 2 billion people have no access to essential medicines, effectively shutting them off from the benefits of advances in modern science and medicine.[1]“[1]
– Dr. Chan, WHO Director-General.
Intending to set up a proprietary market advantage and protecting innovation in new medical technologies, the already advanced and well-equipped developed countries underpin the significance of implementing Intellectual property rights. In contrast, the poor and developing countries lack access to medicine even without intellectual property laws. What further reduces their access to medicines is imposing or strengthening IP protection laws as a result of trade agreements [2][2]. World Health Organization (WHO) estimates that one in three persons worldwide doesn’t have guaranteed access to their required medicines[3]. Sustainable development Goal (SDG) 3 recognized improving access to medicine “through ensuring healthy lives and promoting wellbeing for all at all ages” as one of its goals [4][3].
But due to excessive and unmerited patenting of medicines by big corporate pharmaceuticals, the promotion of health rights across the world has gotten much worse than it ever should have been; specifically after the WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) on access to medicines[5][4]. Whereas advancements, aiming at prolonged human survival, made in the medical field create epoch-making results, prevailing complexities in IP regime concerning pharmaceuticals bars individuals’ access to medicines; thus denying the right to health of that person.
The TRIPS agreement: Past and Present
Before the existence of TRIPS, the nations had complete autonomy in designing and implementing IP policies for different national sectors. In 1995, the Agreement Establishing the World Trade Organization (WTO) included the TRIPS agreement which reshaped the whole debate on national IP policies. It is the most comprehensive international agreement on the protection of intellectual property rights [6][5]. It requires all countries to grant pharmaceutical patents; creating a major and unprecedented shift in access to medicine.
Articles 27 to 34 of this agreement protect patents. These provisions give the patent owner legal protection which means the owner can prevent others from making, using or selling the new invention for a limited period. But there are some exceptions. Patent protection must last at least 20 years from the date of filing patent application [7][6].
In the course of the last two decades, there has been widespread spark and pushback from the developed world against the current IP system. This is because advanced nations have tried to force a one-size-fits-all model on the world [8][7], by influencing the rulemaking process at the World Trade Organization (WTO) and constraining their will through economic accords.
Article 30 of TRIPS allows researchers to use a patented invention for research to understand it fully or to obtain marketing approval from public health authorities. Developing a medicine requires a high research and development cost. These costs occur after granting of a patent, in an early stage. Sadly “Research is often directed at extending, broadening and leveraging the monopoly power granted through the patent and not at producing new products.[9]”
In reality, the IP regime, progressed nations favor normally are planned not to maximize innovation and scientific advancement, however, to amplify the benefits of huge pharmaceutical companies and others ready to influence trade arrangements. Humans, being ingenious creatures, invent new and innovative ideas every day requiring thousands of patents. These phenomena have given birth to an increasingly densely and alarming patent thicket. Therefore a reverse scenario has emerged where innovation is stifled and in some cases, more is spent on lawyers than on researchers.
Understanding the reverse relation between the TRIPS Agreement and access to medicine
The TRIPS requires minimal standards of protection for innovations, creation or invention of artistic works and goods. Generally, this protection extends to those which require, as on account of medicines, high sunk expense invested in research and development (R&D). What IP provisions do is they provide exclusive rights to the investors and the new and improved medicines get protected by the patent. As part of the creation of an IP protected monopoly market, the investors charge a very high price for these medicines. This price hike ends up reducing access of the general public.
One of the burning examples of Pharmaceutical price gouging is the absurdly high pricing of Insulin. Insulin stands out as a medicine to treat diabetes, a non-communicable disease. Its access remains problematic to this day[10][8] even though it was invented in 1921[11][9]. When the patent for insulin was first drafted in 1923, its inventors declined to be named on it. Both believed that insulin belonged to the public. Now, nearly 100 years later, insulin is inaccessible to thousands of people. The dominance of three multinational companies is responsible for creating such a barrier to access[12]. This particular problem often compels people to buy and use substandard or falsified drugs at a cheaper price and suffer deadly consequences.
Most relevantly, patenting of medicines, vaccines, testing kits, and other innovations for treating Covid-19 could have serious consequences on availability, access, and affordability to Covid-19 treatments. The poor and developing countries are the worst sufferer of this inequitable and inefficient IP regime[13].
The fundamental human right to health cannot be achieved without first securing access to essential medicines for proper treatment of diseases. Article 25 of the United Nations Declaration of Human Rights (UDHR)[14][10] recognizes every person’s “right to a standard of living adequate for the health and wellbeing of himself and of his family, including food, clothing, housing, and medical care and necessary social services.” It is now well established that women have distinct and to some extent complex physical health. Women’s right to health is hampered due to the non-accessibility of essential medicines. Article 12(1) of the 1979 Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) entrenches provisions for the consideration and protection of women’s right to health [15][11].
Patenting essential medicines by corporate pharmaceutical giants only violates the health rights of the general public. These violations will take a monstrous shape in a post-Covid world unless a global movement takes place against it. On a national level, it should be open to developing countries to make more sophisticated use of the available flexibilities under TRIPS. TRIPS leaves place for national discretion to a minimal extent while designing and implementing the IPR regime. Pharmaceutical price gouging should stop at once to ensure widespread access to medicines. Research and development should be aimed at solving problems and not at adding to new ones.
References
[1] World Health Organization (WHO), Access to medicines: making market forces serve the poor, Ten years in public health 2007–2017.
[2] Islam et al. Impacts of intellectual property provisions in trade treaties on access to medicine in low and middle income countries: a systematic review, Globalization and Health (2019) https://doi.org/10.1186/s12992-019-0528
[3] Supra Note 1.
[4] World Health Organization (WHO), SDG 3: Ensure healthy lives and promote wellbeing for all at all ages.
[5] Germán Velásquez, ACCESS TO MEDICINES AND INTELLECTUAL PROPERTY: THE CONTRIBUTION OF THE WORLD HEALTH ORGANIZATION, South Centre Research Paper 47 May 2013.
[6] Tara Leevy, Health law Intellectual property and access to medicine for the poor, American Medical Association Journal of Ethics December 2006, Volume 8, Number 12: 834-838.
[7] Reichman JH. Procuring essential medicines under the amended TRIPS provisions: the prospects for regional pharmaceutical supply centers. Paper presented at: Intellectual Property, Trade and Development Conference, Chicago-Kent College of Law; October 12-13, 2006; Chicago, Ill.
[8]Joseph stiglitz, Wealth before health? Why intellectual property laws are facing a counterattack, The Guardian, 19 Oct 2017 08.42 BST.
[9] Id.
[10] Beran D, Ewen M, Laing R. Constraints and challenges in access to insulin: a global perspective. Lancet
Diabetes Endocrinol. 2016 Mar;4(3):275–85.
[11]David Beran a, Zafar Mirza b & Jicui Dong, Access to insulin: applying the concept of security of supply to medicines, Bulletin of the World Health Organization 2019;97:358-364. Published online: 26 March 2019.
[12] Id.
[13] Supra Note 6.
[14] AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS.
[15] Jennifer H. M. Mike Access to essential medicines to guarantee women’s rights to health: The pharmaceutical
patents connection, Journal of World Intellect Property. 2020; 23:473–517.