Author: Raneem Alfaleh, LLM program in International commercial law at the City University of London, 2021-2022, e-mail: Raneem.alfaleh@gmail.com

Editor: Elnur Karimov, LLD (Doctoral Program in Law) at Kyushu University, 2021-2024, e-mail: elnur222@hotmail.com

 

Abstract

The recent global challenge of coronavirus enables an overview of how intellectual property (IP) has been used to address global health issues in the vaccine sector. This analysis aims to put into perspective the question of whether patents should be waived during a humanitarian crisis. The essay proceeds as follows: the introduction outlines the history of vaccines and patents and provides a definition of vaccines and their contents. It is followed by an overview of the recent challenges that were faced rolling out the COVID-19 vaccines. This research aims to pinpoint whether waiving a patent from the vaccines would be beneficial for the world, especially during a pandemic situation. 

Methodology: The research is based on an examination of existing literature. Also, the author relied on a process of critical thinking to provide an overview analysis of the question. Fundamentally, the author reviewed the possible challenges that the pharmaceutical sector might face in relation to vaccination and how waiving a patent might help in delivering vaccines. The research adopted the recent global COVID-19 crisis and the vaccination programme as a case study.

Findings: The author found that removing the patents of vaccines during a time of crisis would be the logical choice.  

Keywords: Intellectual property (IP); Patent; Vaccines; Trade-Related Aspects of Intellectual Property Rights (TRIPS).

1. Introduction

The physician Edward Jenner introduced the practice of vaccination to the world in a paper published in 1798. Jenner’s observation of the principle behind vaccination and the subsequent development of a smallpox vaccine has contributed remarkably to human health worldwide. Statistics show that vaccines prevent around 2.5 million deaths every year around the globe.

Vaccines are biological preparations that consist of damaged or dead versions of a disease-causing organism, which are introduced into the body to stimulate a natural immune response, thereby enabling resistance to specific diseases. In other words, a vaccination involves the preparation of dead or inactivated organisms or purified products from which the immune system elicits antibodies to protect against a specific illness (from parasites, viruses, or bacteria). The World Health Organization (WHO) defines a vaccine as any preparation designed to create protection against disease through the stimulation of antibody production. Vaccines include, for example, suspensions of dead or attenuated microbes, as well as microorganism products or compounds. So, vaccines are considered to be important, especially at the present time with different kinds of diseases and epidemics emerging, because vaccines can help in reducing the major impact of pandemics. To protect against the burden of disease, new vaccinations are still needed to battle illnesses such as HIV or malaria, and current vaccines need to be revised and enhanced owing to the introduction of new pathogen strains, such as in the case of influenza.  

However, despite the vital role played by vaccines in enhancing public health, there are certain challenges facing vaccine roll-out. For example, there is always a need for new vaccines to help prevent the spread of novel diseases and their variants, but it can take a long time to develop a vaccine. Moreover, vaccines are expensive to produce, resulting in many potentially effective vaccines being abandoned prematurely. More importantly, the common issue in the developing world is the problem of gaining access to vaccines, especially those used to combat tropical diseases.  

In addition, these problems are exacerbated by patents, which grant inventors the right, for a limited period specified by statute, to prohibit anyone from using, producing, advertising, offering for sale or importing their invention without permission. However, some argue that the power to patent inventions encourages innovation that is motivated by the desire to make money. Meanwhile, others argue that the waiver of patent rights is sufficient to remove the current obstacles to rapid growth in the supply of vaccines. The waiving of such rights could be considered especially important during pandemics when the physical health of populations must take priority over profit.  

In this paper, both the advantages and disadvantages of allowing vaccines to be patented will be considered, in order to form an opinion on whether vaccines should continue to be protected by patent in the future.

2. Vaccines and the Intellectual Property Framework

2.1 Patentability of Vaccines and Their Components

Vaccines and vaccine-related technology are subject to a variety of IP rights, including patents. Moreover, vaccines, as with medicines and other technologies, are protected by patents, which offer legal protection against copying. Patents provide producers with the right and mean to make more money with their discoveries – an incentive to stimulate innovation. However, according to the World Health Organization (WHO), the vaccine itself is not protected under the IP and patent rights because it contains multiple factors, as has been shown previously, such as antigens, adjuvants and excipients (see Section 2.2 Content of Vaccines above). Therefore, each one of those factors is instead protected under the IP and has its own patent right. In other words, vaccines contain multiple levels and each one is protected as an individual factor and has a patent right so each of these levels is protected and, in the end, they combine to produce the vaccines which are themselves not protected. Thus, patents can cover the formulation of the vaccination as well as the combination of therapeutic components. Patents might also be found in the vaccine administration equipment, such as in relation to an injectable delivery system or a capsule designed to release the substance in a specific location of the human body. Third parties may be prevented from exploiting clinical trial data submitted to regulatory bodies to get marketing authorization for the production of competitive products if the clinical test data is protected. 

On the other hand, according to the World Health Organization (WHO), some basic vaccines which were produced at least 20 years ago, such as “D, T, Pw, Pa, HepB, HiB, IPV, OPV, measles, mumps, rubella, yellow fever”, it is “impossible” that IP can constitute a barrier to their manufacturing, use, or sale as these are considered “classical” formulations. However, there are some exceptions highlighted by the WHO, such as “Improved formulations – Combinations, adjuvants, doses, delivery routes” and “Improved processes for manufacture”. 

2.2 Vaccines and the Other Intellectual Property Rights

IP captures the ideas, literary and artistic works, compositions, marks, titles and pictures used in trade. Patents, copyright, trademarks and trade secrets, for example, are legal mechanisms that allow individuals to be credited for or to obtain financial advantage from their inventions or ideas. Trademarks, which assist to create a relationship between products or services and a certain organization or individual creating or delivering them, may be used to protect a vaccine’s brand name. Copyright protects the expression of ideas and extends to vaccination explanatory materials and designs. Finally, trade secrets safeguard knowledge that inventors and corporations prefer not to publish, the knowledge that is non-codifiable, or knowledge that does not fulfil patentability standards.

Therefore, IP rights, as with patents, can also be used to gain control over vaccine manufacturing and distribution, for example, through licensing. This control can assist in ensuring the quality and safety of vaccines. Quality control is an important component in shaping public opinion of a vaccine’s quality and effectiveness. Similarly, trademarks serve as the foundation of quality assurance systems, allowing an inventor to capitalize on patients’ faith in the protected vaccination. In this context, it is crucial to highlight that public acceptance of a vaccine can be critical for immunization programme efficacy. Thus, the debate surrounding IP rights and vaccines should not begin and end with the application of one IP right to a vaccine. The debate should include considerations of different IP rights relevant to a vaccine and how they may be used in an integrated way within a plan targeted at helping the vaccine’s development and dissemination. Such an approach to IP rights for vaccines allows the integrated rights to be considered in light of the justifications for protecting vaccines with IP rights, as well as issues relating to specific IP rights for vaccines, such as compulsory license regimes, available humanitarian purpose IP credits, and so on.

The IP framework seeks to promote an atmosphere in which imagination and invention can thrive by finding the right balance between the needs of innovators and the wider public interest. Vaccine inventions enjoy a range of IP protection, including patents, trademarks, copyrights, and trade secrets. In particular, a patent is an IP right that can be sought in relation to vaccine technologies. Patents protect the composition of a vaccine, including the mix of pharmaceutical ingredients.  So, patents can cover the formulation of the vaccination as well as the combination of therapeutic components. 

In the case of vaccines, one of the major functions of IP rights is to promote the large R&D investments necessary for their creation. Vaccine innovation may not emerge in the absence of this incentive. Furthermore, IP rights such as patents can allow control over vaccine manufacturing and distribution, for example, through licensing. This control can assist to assure the quality and safety of vaccines. Therefore, control of quality is a crucial aspect of public perception of vaccination quality and efficacy. Similarly, trademarks serve as the foundation of quality assurance systems, allowing an inventor to capitalize on patients’ faith in the protected vaccination. In this context, it is crucial to highlight that public acceptance of a vaccine can be critical for immunization programme efficacy.

2.3 Patenting of Vaccines during the COVID-19 Crisis

As the COVID-19 epidemic spreads throughout the world, thousands of patients urgently require access to inexpensive medications. Based on previous experience with therapies for other life-threatening diseases, there is concern that access to any future vaccinations and therapies may be hampered by patents, leading to unaffordable high pricing. Therefore, there is a debate that, in some circumstances, the patent on vaccines should be waived. Given the uneven situation, the poor nations have proposed that IP rights in relation to COVID-19 treatments be temporarily suspended. They believe that patenting vaccines and other treatments concentrates the supply in the hands of wealthy countries, excluding poorer countries that have struggled to acquire access to them in the past. According to Steve Bates, chief executive of the Bioindustry Association, a trade group for innovative life sciences based in the United Kingdom, eliminating IP rights is “not a panacea”. In his estimation, handing a recipe book to a country’s government without the ingredients, protections, infrastructure, and large staff with the high skills required to administer safe and efficient vaccinations would not quickly offer aid to all the people who need it. The World Trade Organization has not yet granted the waiver, but if it does, analysts estimate that the world will not see increased capacity until at least 2022. For example, during a pandemic, such as the current COVID-19 pandemic, it could be determined that urgent action is required from pharmaceutical corporations to share IP with other countries.

On the other hand, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) stated that “[w]aiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle this global health crisis”.  However, it has been claimed that a waiver of IP rights is allegedly permitted for more readily shareable vaccination technologies. This would mean that in nations that have the production capability, generic or otherwise non-licensed manufacturers might commence manufacturing (such as in India and Brazil). Whereas, on the other side, the European Union president has stated that Europe has committed billions to help to produce the first COVID-19 vaccines in the world and to provide a worldwide shared benefit. However, if there were no strings or conditions attached to the original investment when it was converted into patented ideas, there is no “global common good” when such vaccine commodities can be appropriated and monopolized by patents. 

However, several firms appear to already own significant patents covering some of the vaccines. In a certain case of Moderna, the manufacturer has submitted a follow-up application to a prior patent application that included their vaccination technique for additional coronaviruses. Novovax’s vaccine is based on private technology that was already patented. In another situation (AstraZeneca), the corporation appears to have adopted both approaches, recently filing a follow-on patent application from a prior patent that included the technology utilized to build its current COVID-19 vaccine. In another situation (J&J), the corporation may end up depending on patents protecting vaccine production, or more specifically, big quantities of vaccine. Therefore, most of the companies will be using either an old patent right or a newer one in order to protect their drug.  Meanwhile, Bill Gates, whose private foundation has given to and partnered with Covax (a vaccine distribution mechanism in the developing world), has openly stated that vaccine manufacturers should not relinquish their patents. Yet, the main objection from vaccine manufacturers and their home nations is that just surrendering patents would not help anything. They argue it would be like sending someone a recipe without the ingredients or directions, as the patent protects the bare bones of the blueprint but not the exact manufacturing method. That is critical in this case, since mRNA vaccines, such as those made by Pfizer and Moderna, are a novel breed, and only a few individuals know how to manufacture them.

2.4 An Overview of Patents in the Pharmaceutical Sector 

The pharmaceutical sector is one of the most sophisticated in the world. It is distinguished by strict governmental control and, at times, by the clash of interests between the pharmaceutical industry and society. It also involves a variety of parties, including originators, marketing authorization organizations, generic businesses, doctors, pharmacies, and patients. Each of these parties contributes to the lengthy and complex process of converting a chemical substance into an effective and economical drug that is then prescribed, distributed, and consumed. Two essential actors – generic firms and originating firms – play critical roles in these intricate connections. Generic firms help society by providing cheaper counterparts of the originators’ medications, resulting in lower medication prices and more access to inexpensive medications. When the interests of these two actors are balanced, the advantages to society are maximized, as it obtains novel and better treatments, as well as timely access to generic pharmaceuticals. However, if the balance shifts in favour of one of the players, society suffer as a result of a lack of access to either new or economical medications. As a result, both pharmaceutical innovation and generic competition must be appropriately rewarded and safeguarded. 

Therefore, drug companies would prefer to be allowed to patent medicines, including vaccines, because the money generated helps to fund more research as trial costs are considered to be very expensive. There are various reasons for the high level of expense for pharmaceutical companies,  such as the intricacy of drug research and development, as well as the costly and time-consuming regulatory procedures required. Most importantly, pharmaceutical firms rely substantially on IP rights, particularly patents, to secure their enormous efforts and investments. According to Drugwatch, “new medicines that treat illnesses affecting the respiratory system are the most expensive trials to run and average about $115.3 million”. Therefore, as a result of the high cost to develop new drugs, “In 2012, pharmaceutical companies paid $39 billion for trials, while NIH [the US National Institutes of Health] paid $31 billion”. Therefore, the pharmaceutical sector relies heavily on patent protection. As medication research is both costly and time-consuming, pharmaceutical firms want enough protection to recoup their investments and produce revenues, allowing them to fund more R&D. Also, industry groups are concerned that without access to all of the know-how and parts, a waiver might result in quality, safety, and effectiveness concerns, as well as counterfeits. These groups point out that Moderna has previously said that it will not pursue anybody discovered to be infringing on their patent – yet no one has done so yet.

There is another view that waiving patents would not solve the issue of the shortage supply in vaccines, especially during the COVID-19 crisis, as it seems doubtful that lifting patent protection would be sufficient to overcome the present hurdles that are limiting quicker increases in supply. As it is, every vaccine producer has a strong incentive to maximize the amount of vaccine accessibly. There is substantial surplus demand around the world and maintaining an abundant supply of dosages in the short term is likely to result in major reputational advantages for the firms involved. Developing relationships with potential clients now increases the likelihood of winning more profitable contracts in the future. Despite massive worldwide demand — and strong incentives to expand output – severe supply constraints exist. This implies that the hurdles to growing supply go beyond patent ownership and IP rights in the relevant technology. Indeed, production capabilities and regulatory approvals are major obstacles for every business to overcome. For instance, the initial approval from the European Medical Association (EMA) for AstraZeneca to manufacture vaccines was granted in January 2021 – this covered manufacturing at sites in the UK, Belgium and the United States. However, a fourth site has been approved for manufacturing in the Netherlands – approval was granted in March 2021. Regulatory authorities in several countries have halted the deployment of some vaccinations due to health concerns. Similar difficulties would arise in underdeveloped countries, as well as for any firm wishing to supply such areas. Because this may undermine public trust in safety and effectiveness, and as a result, have a negative effect on the uptake rates of vaccinations, many would not regard the expansion of production at the expense of safety as an acceptable trade-off. 

3. An Alternative Perspective: Should Vaccine Patents be Waived? 

The issue of exorbitant medicine pricing is not new. Long before the pandemic, increasing healthcare expenses had posed a severe threat to the affordability and accessibility of medications for society. The success of an enterprise depends on its business performance in competitive marketplaces. Therefore, companies must innovate in order to compete in performance by providing higher quality and a broader selection of new and enhanced goods and services. Given the significance of safeguarding innovation as the major driver of economic growth, nations have put in place several measures to guarantee an appropriate environment for the development of innovation. They include providing property rights in the form of patents to the outcomes of the invention and the use of competition law to boost dynamic competition.  The promotion of inventions, which is the engine for economic growth and expansion, is one of the key reasons for the patent system. The patent system follows this purpose by providing patent proprietors with a time limit for exclusive rights in order to reward their original work and to promote subsequent inventions. Therefore, IP rules, and in particular patents, are considered a crucial component of undistorted domestic competition. To illustrate, patents and competition laws complement each other, since on the one hand current competition places demands on businesses, driving them to innovate, the so-called ‘stick,’ while on the other hand, patent law offers ‘the carrot.’ These two legislative entities are viewed as supplementary measures towards promoting an effective marketplace and dynamic innovation competitiveness in the long term. Their function is to encourage innovation and ensure the competitive use of it. As the European Commission has highlighted, “intellectual property rights and competition are required”. Moreover, the EU competition law prohibits methods which decrease innovation incentives for both ‘pioneers’ and subsequent innovators. This is codified in Article 102 TFEU (Treaty on the Functioning of the European Union), which bans abuses such as, among other things, restricting technical advancement. 

In AstraZeneca, for example, the General Court determined that the company’s practice of abusing the patent system had the potential to reduce its incentives to develop and was therefore anti-competitive. Courts ruled that the proprietors of IP rights misused their dominant positions in the cases of Magill and Microsoft by impeding their prospective competitors’ innovation. To illustrate, “Following the rationale of the General Court’s statement in AstraZeneca, the practice of the originator that extends its market monopoly by relying on the patent system ‘potentially reduces the incentive to engage in innovation, since it enables the company in a dominant position to maintain its exclusivity beyond the period envisaged by the legislator’. Such practices, according to the Court, act ‘contrary to the public interest’’. However, some pharmaceutical corporations may utilize the patent system for a different goal, such as obtaining several secondary patents that construct multi-layer protection around their profitable drugs in order to hinder merit-based competition. Such selective patenting enables pharmaceutical corporations to strengthen their monopolies and hence continue to charge exorbitant medicine costs. Such a situation can arise because a patent grants its owner the legal right to prevent others from utilizing their creation for a set number of years in return for exposing the innovation to the public. 

Therefore, patents can limit the ability of new manufacturers from less privileged nations to enter vaccination markets at any stage of the regulatory process, from preclinical research and development to scale-up, formulation, and licensure in the markets of choice. According to a recent research study, several firms in developing nations complain that the requirement to handle patents raises transaction costs and lengthens development timeframes. An exception that would suspend drug patents for vaccinations would make it possible for underdeveloped countries to enter the market. In the case of vaccinations, more than simply a waiver will be required; technical know-how and further knowledge transfer may also be required. Therefore, in terms of any regulatory processes ranging from preclinical R&D through scaling, formulation and licensing in the market of choice, patents might affect the capacity for new producers from poor nations to participate in vaccination markets. According to a recent research study, several manufacturers operating in developing nations say that the requirement to handle patents raises transaction costs and extends development timetables. Moreover, patents on vaccines and a key technology for vaccine development are just one of several variables influencing vaccine innovation and availability in underdeveloped nations. According to a recent study conducted in Brazil, the most significant barriers to boosting vaccination coverage include insufficient regulatory frameworks and processes, as well as low levels of investment in local capacity, human resources, technology, and logistics.  The case for systemic adjustments in incentives for health technology via IP legislation is not new. Therefore, the COVID-19 pandemic has re-energized the long-running debate over worldwide access to health technology by calling to light the problematic connection between IP law and global health. 

In their report on access to medicines in 2016, the United Nations Secretary-General recognized disruptions in the legal aspects, policy and practice of the right to health and international trade, especially in terms of conflicts between the rules of IP and the aims of public health. Thus, during the current pandemic, almost 51% of the global COVID-19 vaccines – which accounts for around 3.7 billion doses – have been taken by richer and developed countries. This has resulted in a major shortage of accessible dosages for purchase. As a result, the number of doses obtained by poorer nations – who rely heavily on World Health Organization non-profit programmes to purchase vaccinations on their behalf – is insufficient and only able to offer a full course of therapy to a tiny proportion of their people. Despite the fact that governments largely contributed to the research and development of the top vaccines, companies may still benefit from medications that governments sponsor due to IP regulations. In the United States, this is owing to the Bayh-Dole Act of 1980, which allowed firms to patent government-funded drugs. According to the economist Dean Baker, “the amount of money shifted from the rest of us to those in a position to gain from IP amounts to more than $1 trillion yearly.” Moreover, the current lack of COVID-19 vaccines, medical equipment, medicines, and diagnostics (referred to under the generic term ‘health technologies’) is due to the structure of global IP law as embodied in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement mandates the Member States, subject to standard assessments on novelty, creativity and industrial applicability, to make patents accessible for any product or process of discovery in all fields of technology, without discrimination. Patents and patent rights must also be available without prejudice as to the site of invention and whether items are imported or locally manufactured. Although equitable access to vaccines is in the moral, political, and economic interests of the global public and necessitates global solidarity, the phenomenon of COVID-19 ‘vaccine nationalism’ has highlighted the misalignment of current legal and financial incentives to produce and distribute vaccines equitably. The crisis also demonstrates the failure of high-income countries (HICs) to keep their promise made during TRIPS negotiations in 1994, that by agreeing to the TRIPS terms, lower and middle-income countries (LMICs) would benefit from technology transfer and the development of productive capacity. The present issue reveals limitations not only in the way global catastrophes might be addressed, but also shortcomings within the international patent agreement itself.

Therefore, the epidemic has worsened global inequities that already existed, none more so than in vaccine manufacturing and distribution Vaccination coverage varies dramatically by income level. Despite the fact that over 11 billion vaccine doses have been distributed, almost 70% of them have benefited rich and upper-middle-income countries. 4 As of March 19, 2022, 79% of people in high-income nations had received at least one dose of a covid-19 vaccination, but only 14% of those in low-income countries had. Moreover, the EU nations have been catching up: by this date, the cumulative uptake of one vaccination dose for adults over the age of 18 was 36% among EU/EEA countries. However, billions of people in Asia, Africa, and Latin America remain unvaccinated, and many of them have little possibility of obtaining a COVID-19 vaccine in 2021, 2022, or even 2023. Therefore, some countries have supported the idea of waiving patents in order to protect their nation’s public health. For example, in the United States, the Biden administration has indicated that it will accept the elimination of patents on COVID vaccinations but not on therapies or other disease-fighting technology. If the WHO approves the waiver, businesses creating COVID-19 vaccines across the world will be able to do so without fear of being sued by another organization that already has a patent on the product. India and South Africa called for a waiver that would “continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity”. This call has not been heeded at successive World Trade Organization meetings, though it received a recent boost in May 2021 via the US support for a narrower IP waiver applying only to vaccines against COVID-19. Although sometimes referred to in shorthand as a ‘patent waiver’, in both its original and revised forms the India/South Africa proposal is in fact a broad package, applicable to diagnostics, treatments and vaccines. It is currently co-sponsored by 62 World Trade Organization countries (including India and South Africa). The waiver would apply “in relation to prevention, containment or treatment of COVID-19”, covering not only the temporary waiver of patents (and, where relevant, copyrights) internationally, but also, crucially, the sharing of IP under the umbrella of ‘undisclosed information’ such as trade secrets and ‘know-how’. In principle, this kind of ‘sharing’ is not new. The 2011 WHO Pandemic Influenza Preparedness (PIP) Framework makes an explicit reference to technology transfer, albeit in the somewhat limited context of benefit sharing (in return for receiving biological materials), and it offers language that is sort of a legal obligation. However, some of the text bears repeating here. Section 6.13.4 states as follows: 

Influenza vaccine manufacturers who receive PIP biological materials may grant, subject to any existing licensing restrictions, on mutually agreed terms, a nonexclusive, royalty-free license to any influenza vaccine manufacturer from a developing country, to use its intellectual property and other protected substances, products, technology, know-how, information and knowledge used in the process of influenza vaccine development and production, in particular for pre-pandemic and pandemic vaccines for use in agreed developing countries. 

In general, IP’s legal incentives are organized in such a way that ideas that can be easily replicated tend to be patented since. Since, if a patent-protected invention is lacking, it will be readily read, reverse-engineered or copied by rivals. On the other hand, if an innovation is truly difficult to reproduce, it may make more strategic business sense to keep that innovative information as a trade secret — and perhaps then get longer protection than a patent permits. Companies who create and promote such a product rely on the fact that no one can easily ‘read’ it. Furthermore, many entrepreneurs, health policy specialists and government officials worry that the coronavirus will continue to spread and mutate if the vaccination campaign drags out because the vaccine capacity is dictated by IP regulations rather than by necessity. Continuing mutational change and propagation would have a harder influence on the international economy than the reduction of these artificial access barriers that protect the rich (and the global institutions involved) and would enable faster vaccination. The consequences of such short-sighted financial-led thinking are being felt in real-time, as new outbreaks of the virus ravage nations such as Brazil and India. It is believed that the TRIPS waiver is a crucial legal instrument to enable a radical increase in the capacity of COVID-19 vaccines.

Therefore, a temporary waiver of all applicable IP will be provided under the TRIPS waiver as anticipated by the India/South Africa proposal. This includes, but is not limited to, patents. The advantage of the universal exemption of patents on COVID-19 vaccines and health technologies is that, given the above problems of disclosure, transparency and overlapping of patents, producers could be free to operate without litigation and fear that exported vaccines could be seized and accused of alleged patent infringement. Thus, with the scope of the global public health problem and the concept of the patent thicket — a dense maze of trade secrets hidden behind an information interface — the existing IP system and its consequences are simply not suitable to solve civilizational challenges, such as COVID-19, and therefore they have to be re-evaluated. Essentially, legal talks on a TRIPS waiver provide a means of attempting to settle these matters politico-economically and may encourage the sector to volunteer information regarding its processes.

4. Conclusion

In the final analysis, vaccines have a long and complex history. In the past two hundred years they have been continually developed. They have contributed to improving human health and reducing the burden of disease. Yet, there are challenges relating to the time and cost of developing new vaccines, which are necessary to help prevent the spread of new diseases and their variants. There are also challenges in relation to access to vaccines in poorer countries around the world. As the debates about IP and patent protection have occurred recently due to the pandemic, a patent gives inventors the right to stop their discoveries from being copied. However, where worldwide pandemics are concerned, given that everyone stands to lose if they are not prevented or slowed down, it is counter-productive to place obstacles in the path of vaccination. The case for facilitating access to the COVID-19 vaccines by waiving patents at this time of crisis is that while the virus is allowed to spread unchecked in various parts of the world, variants are going to emerge. This has already happened in India and many other poor nations, where the huge population and its density in some areas, together with poor infrastructure, have made containment difficult. Closing borders and preventing the movement of people is detrimental to global trade and society. Therefore, immunization would seem to be a better response and measures should be put in place to assist in the sourcing of potentially useable vaccination technology in poor nations. For this to be effective, however, vaccination needs to be implemented worldwide. Thus, for financial reasons alone, aside from the health benefits, it would seem sensible to waive the patent on pandemic vaccines.

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