A9te3l5b_ayh0lx_4hc.tmp 122 THE ETHICS OF INTELLECTUAL PROPERTY LAW IN THE AREA OF PHARMACEUTICAL DRUGS AND VACCINES DURING TIMES OF PANDEMICS Peeraput Thiendej and John Giordano ABSTRACT The course of the Covid 19 pandemic, has demonstrated the serious obstacles to the availability and access to vaccines for many less-developed countries. One obstacle involves the pharmaceutical patents which limited the ability of the intellectual property laws created by the World Trade Organization and TRIPS agreement has shown itself to be unfair to less-developed countries. This is also seen as a problem in global justice. There is an increasing belief that pharmaceutical patents should be waived in times of emergency. But the question is how to justify these waivers? One approach might be the idea of the commons which underlies intellectual property in it most basic form. This paper explores ways of reforming intellectual property law in light of the recent problems connected to the Covid pandemic. Keywords: Intellectual Property Rights; Vaccine Patents; Intellectual Commons; Pandemics Vol. 23 no. 1 January to June 2022, 122-132 © 2000 by Assumption University Press 123 Introduction It is the very nature of pandemics that research on cures and vaccines and their distribution needs to be accomplished very quickly. During the covid-19 global pandemic countries around the world had to rush to ensure that their citizens were fully vaccinated. This placed the pharmaceutical companies in a position of great power. It allowed them to to dictate prices of vaccines which created problems in vaccine access. Wealthier countries were able to secure large vaccine contracts, This highlighted a serious problem concerning intellectual property in relationship to the distribution of vaccines in times of serious pandemics. There is an increasing belief that pharmaceutical patents should be waived in times of emergency. But the question is how to justify these waivers? One approach might be the idea of the commons which underlies intellectual property in it most basic form. This paper explores ways of reforming intellectual property law in light of the recent problems connected to the Covid pandemic. Pharmaceutical Patents COVID-19 patent battle,” explained the necessity of pharmaceutical patents. According to them, pharmaceutical companies have always is the high expense of research and testing to prove the medicines are safe, control once they are on the market in order to gain a good return on their initial investment. But the result of these strict patent laws often leads to monopolies over production and distribution, and makes new drugs and vaccines expensive and less accessible.1 So it is often argued that to solve this problem of accessiblity during times of serious pandemics, there should be a temporary waiver of intellectual property protection. The pharmaceutical companies have argued against such waivers based upon the same arguments they 124 use to defend strict intellectual property laws. They argue that patent waivers would reduces the return for patent holders on their R&D investment in the vaccine; they argue that the research and development of vaccines involves heavy investment in highly specialized equipment, technologies and infrastructure. If vaccines patents are waived in the time there is a similar emergency? In addition, they argue that the waiver of patent rights would create chaos, and even lead to the increase in fake vaccines. That it is a matter of production safety standards, and it is not easy for just any country to have the infrastructure availabile to produce vaccines with reliable medical technology.2 Critics of a patent waivers also claim that it would not give an immediate increase in supply, as establishing production of a new type of vaccine would take months. Another concern is that waivers would jeopardize existing supply chains. For example, during the Covid 19 86 suppliers in 19 countries. Competition for access to the raw materials could slow net production and result in an even lower supply. In addition, the waiver would discourage future innovation. Most importantly, the were only possible through years of research and development from the public and private sector. Jecker and Atuire have attempted to investigate ethical arguments for vaccine waivers. They looked at both sides of the argument. At one point they cite the industry argument which contends that if companies investments in the pharmaceutical industry drop. This could lead to a decline in new technologies, leaving us unprepared for the next pandemic.3 Yet as Jecker and Atuire show, there have been good arguments for such waivers. They argue that a pandemic is a global public health problem, and that strict patent laws slow the production of vaccines to meet demand. During the Covid-19 crisis there were many manufactures 125 with the capacity to produce vaccines at factories in Bangladesh, Denmark, Canada, Israel, and India. Unfortunately, these countries were unable to contribute to the production of vaccines because they did not have the right to the patents. In addition, such waivers would give governments the freedom to collaborate on technology transfers and exports. It would enable governments around the world to be prepared for a long-term response to future pandemics. A mechanism for waiving intellectual property rights could help to build diverse regional manufacturing hubs and protect the rest of the world from future pandemics. So this becomes an ethical question; how to balance the rights of investors in research and technology with the needs of the world population involves understanding what lies at the very basis of patent law, that is, intellectual property. And to understand the ethics of intellectual property is to investigate the very essence of property itself and how it is related to the commons. The Commons Locke has created the way we usually think of private property. that all humans are equal under God, and all have ownership over their extension of their bodies, and so, whenever a person mixes their labour with nature, he thereby makes it their property. The nature available to is called the commons. Locke created two limitations on this claim over the commons. We claim only “where there is enough, and as good left in common for others” and “As much as anyone can make use of to any advantage of other words, individuals can have a right to their claims of property as long as there is enough left for others, and if the property can be used 126 These two limitations are to help to create a balance between the interests of individuals who have gained access to properties from commons and for society in general.4 Yet , as Locke recognized, a complication comes in with the introduction of money that allows unequal control over resources. Locke accept this accumulation of property, but be an unlimited commons available for appropriation. Locke sometimes It is important in a society for provisions to ensure the access to the commons. This should be the role of the government. A particular government should provide its citizens with public goods. Public goods are nonexcludable and nonrivalrous. That means that it is wrong to exclude someone from using the good. Therefore, this shows that the very idea of the commons implies a certain public good. And certainly in the case of vaccines during the time of pandemics, they can be considered as a public good.5 Similarly, In the book , Peter Drahos shows complications in the meaning of intellectual property. Drahos suggests that Intellectual Property Rights are often rights of exploitation of information. Information is becoming “the prime resource” in modern economics these days. To Drahos, there are two frameworks in intellectual property rights. Drahos suggests that intellectual property rights considered within the framework of “proprietarianism” as it is today gives too many advantages to the ownership. The owner of rights the intellectual property rights. Intellectual property in the framework of “proprietarianism” is therefore inappropriate and creates a negative 6 So Drahos contends that viewing intellectual property rights from the framework of “Instrumentalism” is more appropriate. Such an approach gives more importance to society. It shows the role of intellectual property in enabling society to operate properly. The instrumental view is supported by the very idea of the commons which makes property 127 idea is that the commons exists to be exploited by whoever can lay claim to it. The positive idea is that the claim to the commons needs to be shared or balanced with the interests of the citizens. Our question, then, is whether there are reasons to favour comes to making decisions about the relationship between community and the intellectual commons. One assumption we make without defending it is that communities have an interest in encouraging the creativity of their members. A way to proceed to an answer is to come to some understanding of the role that the intellectual commons has in aiding creativity of all kinds.7 Ths idea of the commons and the community which relies upon it, forms the very possibility not only of property, but of the creativity and innovation which issues from it. Therefore a strict adherence to intellectual property laws not only limits creativity and innovation, it also leads to exploitation. The dangers of negative community for the intellectual commons come when technology makes new kinds of appropriation possible or when the regulatory conventions protecting it for one reason or another cease to work. The intellectual commons then becomes a hunting ground for the economically strong and the technologically capable.8 This emphasis on creativty and indebtedness is also described by Jecker and Atuire. They cite the words of a physician, who received the work possible: 128 My gratitude starts with scientists who years before this pandemic, perfected the ability to extract DNA from viruses, sequence it and transcribe it to RNA… the scientists the spike proteins that the virus uses to invade our cells; those who made the mRNA that corresponds to that DNA womb to protect that precious mRNA payload during its deltoid musculature.9 Therefore, both Jecker and Atuire and Drahos, recognize that every innovation is indebted to what has been prepared for by the researchers humanity, intellectual property rights need to be considered in relationship community. The Commons and Public Health The ethics of intellectual property is now becoming increasingly important. But it is especially important with regards to the pharmaceutical industry during pandemics. The discipline of bioethics can help determine ethical choices through four key principles which harmful. Justice has to do with being fair.10 How to fairly allocate vaccines is one of the critical ethical issues in the times. It will violate the bioethical principles, if the vaccines are made available fairly to all. For example, elites can receive a vaccine in hospitals sponsored by the government, while many patients in the poor and middle-class were turned away from hospitals without treatment in Bangladesh.11 129 In addition, developed counties have taken control over the creation and distribution of vaccines, making the global distribution of such vaccines unequitable.12 Yet this exclusion creates dangers. The longer a pandemic spreads among humans, the higher chance that it can lead to new mutations. Such mutant viruses lead to the possibility that vaccines will become obsolete. Moreover, areas of the world denied access to vaccines will become the breeding ground for new strains. Therefore, It is not a question of should wealthy nations help developing and poor During pandemic situations, both developed and developing countries must have provisions to make intellectual property rights more of deaths. Intellectual property rights are supposed to be based on the idea of a positive community or commons. Therefore, the health of the Conclusion The issue of vaccine patents has now become a symbol of a fragmented society. A patent system is a government-supported, guaranteed monopoly on commercial products. The only possible reason for governments to support this is that small groups of investors will All the concerns over Covid-19 vaccine patents are far less important than the lives of millions of people. The patent systems may be neither clearly positive nor negative from the perspective of social responsibility. However, what is more relevant is how much more we opening the economy. The patent system should be ethically judged by its impact on humanity as a whole. Therefore, vaccines should be considered in relation to the commons as Locke would insist we should use only “where there is enough, and as good left in common for others.” Medical innovation and 130 ethics are related to one another in pharmaceutical industries. The impact of covid-19 pandemic shows the importance of balancing intellectual property rights and service to the community at large during times of crisis. Large pharmaceutical companies have the right to protect their investments through patents. However, the question may remain, if the companies deserve such rigid rights during a global crisis. The Covid-19 crisis seems to have passed. But what of the next pandemic? An ethical is a positive community which make certain demands upon the use of the commons, both for property in general and for intellectual property. 131 ENDNOTES 1 battle,” (International science council, 2020). 2 Siripurapu, A, “The Debate over a patent wavier for covid 19 vaccines. What to know.” accessed 7 June 2021. https://www.crf.org. 3 Jecker and Atuire, “What is yours is ours: Waving intellectual property protections for Covid-19 vaccines”, accessed 10 May 2021. https://www.jme.bmj.com 4 Locke, J, Two Treatises of Government, (Cambridge U.P, 1960). 5 Boyce, P, “What are Public Goods.” accessed 8 December 2021. https:// www.boycewire.com 6 Drahos, P, A Philosophy of Intellectual Property, Hampshire, (Ashgate Publishing Limited, 1996). 7 Ibid, 60 8 Ibid, 66 9 Jecker, N, “What is yours is ours: Waving intellectual property protections for covid-19 vaccines,” accessed 10 May 2021. https://www.jme.bmj.com. 10 Clark, D. et. al., “Biomedical ethics and clinical oversight in multisite Observational neuroimaging studies with children and adolescents: The ABCD experience,” (Developmental Cognitive Neuroscience, 2018),32,143-154 11 Siraj, M. S., et. al., A, “The Infectious Diseases Act and resource allocation during the COVID-19 pandemic in Bangladesh” (Asian Bioethics, 2020), Review, 12(4), 491-502. 12 McMahon, A, “Global equitable access to vaccines, medicines and diagnostics for Covid-19: The role of patents as private governance,” (Journal of Medical, 2020) Ethics, 47, 142. 132 REFERENCES Boyce, P, “What are Public Goods.” accessed 8 December 2021. https:// www.boycewire.com Clark, D. B., et al. “Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience,” (Developmental Cognitive Neuroscience, 2018), 32, 143–154. John Locke, , (Cambridge U.P, 1960). Peter Drahos, , Hampshire: (Ashgate Publishing Limited, 1996). Peter Drahos & John Braithwaite, , (New York: The New Press, 2003). Jecker and Atuire, “What is yours is ours: Waving intellectual property protections for covid-19 vaccines,” accessed 10 May 2021. www.jme.bmj.com. 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