Intellectual property protection on life-saving inventions and medicines has always been a controversial issue. More recently, the controversial questions of patents for vaccines have been raised with respect to the intellectual property waiver for the COVID-19 pandemic. While patents (as well as the other IPRs) have been considered to be important for the development of science and innovative processes, the value of the IPRs system has also been tested from time to time, and more particularly in the context of the developed-developing world dichotomy, which is the particular area that this essay seeks to engage with against the background of the current COVID-19 pandemic. For students who are struggling with the intricacies of intellectual property law and its implications in the area of public health, seeking expert guidance and law dissertation help provide invaluable support.
During the COVID-19 pandemic, the IPRs system has played a key role in development and availability of multiple vaccines, but at the same time, there are questions on how the system may also impede the access to vaccines and life saving technologies in countries that are poor and unable to negotiate on pricing of vaccines. There are also questions with regard to the scaling up of the vaccine manufacturing so that access is maximised and global herd immunity to Covid-19 can be achieved. Against this background, there has been emphasis by India and South Africa on the waiver of the IPRs under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) so as to increase access to vaccines and other COVID-19- related technologies. This essay critically engages with the issue of waiver of patents for vaccines and other COVID-19- related technologies. The essay argues that the waiver of patents for a limited time period until herd immunity can be achieved is necessary because the TRIPS agreement does not for the flexibility needed to ensure equitable access to vaccines in this period. Furthermore, the essay argues that it is moral and ethical that such waiver should be provided for a limited time period.
First, to provide the background of the TRIPS agreement and its link to patents for pharmaceutical products, the TRIPS agreement is the first multilateral treaty, which sets out the criteria for patentable subject matter. It is also under the TRIPS agreement that a level of global harmonisation of IPRs has taken place even through developing countries have been strongly opposed to many aspects of IPRs particularly in the field of pharmaceuticals as this essay will discuss later. The TRIPS agreement is the result of the strong demand for internationally harmonised IPRs with effects for the compulsory extension for patent protection of pharmaceutical products. However, Article 8 of TRIPS agreement allows WTO member countries to adopt measures necessary for protection of public health insofar as these measures are consistent with the TRIPS agreement. Thus, when countries have public health needs, they may adopt necessary measures but in doing so they have to seek a balance between international law and their own national needs. As this essay will demonstrate, the so called ‘flexibilities’ allowed under the TRIPS agreement under Articles 27 and 31, have not been adequate to meet the needs of many countries in the Global South to inoculate their populations against COVID-19.
The TRIPS system guarantees protection to pharmaceutical companies including time limited monopoly on marketing of their products so that the innovators can profit off their inventions; this essentially is the principal motivation for innovations and investments in innovations. TRIPS system is also aimed at liberalisation of international trade and protection of IPRs. At the same time, states are allowed autonomy to decide upon the method by which they would protect IPRs under their own jurisdiction (Article 1) and balance their private and public rights in protecting public health and nutrition and economic and technological development (Article 8). Apart from these provisions, there are some other provisions in the TRIPS agreement that set out the relationship between countries and IPR protection. Thus, patent preconditions are given in Articles 27 to 30 with an exception provided under Article 27(2), which excludes members from patentability of invention for larger public interests to protect human health. Countries can also use (without authorisation of right holder) under a compulsory license under Article 31, provided there is completion of certain conditions such as reasonable amount of time to negotiate with right holder, domestic use, and national emergency. This is the general scheme of TRIPS agreement related to patents with applicability to the pharmaceutical industry. Essentially, the IPS waiver demands that this scheme be waived with respect to the COVID-19 vaccines and other life saving material during the period of the pandemic. With regard to pharmaceutical products, the introduction of patent protection for 20 years also has implications for market‐based conditions for pharmaceuticals in international trade. Because innovations are protected for 20 years under the patent rules of the TRIPS system, states allowing use of the innovations in this period of time risk trade disputes under the WTO. This allows the innovator to control the price and accessibility of the innovations for a period of 20 years. In the case of a global pandemic, a pertinent question may be raised as to whether it is advisable to allow the protection of a 20 year period when time is of the essence in inoculating maximum global populations and bringing the pandemic to an end by achieving herd immunity. This question though raised in the narrower context of COVID-19 pandemic, can be seen as a part of the wider debate on ethical and legal issues involved in patenting life saving medicines and technologies which see the developing world placed in a disadvantageous position.
Mercurio does accept that there is a contentious relationship between IPR law and the access to medicine, and that this has been brought more sharply in focus during the COVID-19 pandemic when the access to vaccines has been one of the pressing issues of the time. IPRs are considered to be essential to development of new processes and technologies because they encourage investment and innovation, but the challenging aspect of patents is that they provide limited-term monopoly rights to the innovator or investor which can interfere with the access to medicine and innovative processes for the developing countries as monopolies result in artificially high prices. The COVID-19 pandemic, which is a Black Swan event with global impact, brought these issues into sharp focus because while on one hand, patents played a role in encouraging rapid development of vaccines, they also made access to the vaccines limited. Therefore, the demand of the countries in the developing world articulated through the proposal to waive the TRIPS protection for COVID-19 products, can be seen in the context of the problems of access to vaccines and challenges involved in negotiating for fair pricing of these vaccines for the importation purpose. The proposal nevertheless involves a dilemma because of the need to balance the interests of innovation with the interests of public health during the time of the pandemic.
The proposal by India and South Africa for the waiver of TRIPS related to COVID-19 vaccines and technologies was tabled at a meeting of the TRIPS Council in October 2020, and it asks for waiver of IPRs “relating to and having an impact on the “prevention, containment or treatment of COVID-19.” Many developing countries have supported this proposal, while members like the United States have opposed it although the US did eventually reverse its position in May 2021 and agreed to negotiate the perimeters of a waiver. The European Union (EU), Canada, Australia, Norway, Switzerland, the United Kingdom, Brazil, Chile and Mexico have remained opposed to the waiver. The question is how far is it appropriate to waive IPRs for COVID-19 vaccines, but as mentioned earlier, this question is a part of the wider debate on how patents may impact the accessibility of life saving medicines and technologies for peoples of the developing world. Arguments are made both in favour of waiver as well as against it and it is useful to engage with both sides of the debate, which is done next in this essay.
It has been argued that the proposal (and its revised version) put forth by India and South Africa was never conducive to negotiations between the members of the WTO as it contained no limits for product coverage, scope, notification requirements or safeguards and was essentially a proposal for an IPR waiver for indefinite period. Mercurio goes so far as to state that the “proposal perhaps reveals India’s and South Africa’s true intent to use the COVID-19 pandemic as an excuse to roll-back IPRs rather than a good-faith effort to rapidly increase access to lifesaving vaccines and treatments around the world.” In fact, Mercurio argues that he does not support a TRIPS waiver for IPRs or even a limited waiver for patents because this would not amount to speeding up the Covid-19 vaccination rate in Global South. He notes that “it seems inexplicable that the world would abandon the system without any evidence that IPRs are limiting during the current crisis” when “innovators have been generous in licensing technology transfer and production and one would be hard-pressed to find credible reports of qualified generic producers being refused a license.” However, patent licensing and injunction cases demonstrate this this is not that simple. In one case, the UK Patent Court has held that a patent for expiratory limbs of breathing circuits to reduce condensation was novel and not obvious over prior art even when it involved only one inventive step.
The principal arguments made by Mercurio can be summarised as arguments related to practicality (can a waiver actually see scaling up of vaccine production) and related to legality (use of TRIPS agreement to negotiate for licencing technology transfer where appropriate). This essay argues that these arguments are based on a limited premise and do not engage with the broader problems and issues associated with the relationship between IPRs and access to medicines and life saving technologies that are now being witnessed during the COVID-19 pandemic.
Indeed, the counterargument to the ones presented by Mecurio, can be located in literature that is justifying the waiver of the TRIPS agreement; it is argued that because such waiver would only be applicable to drugs, vaccines, treatments, diagnostics, medical supplies and test data for the purpose of controlling of the COVID-19 pandemic, it can be said that the waiver is narrow in nature and only relates to essential life saving technologies. Furthermore, it is argued that the waiver would be limited in time to the period when sufficient number of people have been vaccinated to achieve global herd immunity and the other TRIPS rules would be unaffected by such waiver. This argument is counter to Mercurio’s premise that the waiver is sought indefinitely by South Africa and India. Finally, it is argued that the waiver would allow many WTO member states to engage in research and manufacturing of COVID-19 vaccines and other life saving technologies and would help the world to scale up such products without fear of a trade dispute under the TRIPS agreement. This may be seen as a response to the argument that even if waiver is allowed, this does not mean that the countries in the Global South would be able to scale up the production of the vaccines. In fact, Mercurio’s argument that scaling of vaccine production will not happen even if waiver is provided is flawed because it does not take into account the immense pharmaceutical potential of countries like India; it may be mentioned that India is the largest vaccine producer in the world at this time and is also producing AstraZeneca’s vaccine. Voluntary licencing was used to manufacture AstraZeneca in India. Therefore, the argument that the developing countries like India and South Africa lack the technological resources and infrastructure to produce COVID-19 vaccines even if patent waiver is given, is one that can be viewed with some scepticism.
The TRIPS Agreement provisions require WTO members to grant patents with a minimum term of 20 years for inventions in all fields of technology. A question that can be asked here is whether it is viable to have a 20 year protection period for COVID-19 vaccines and other life saving technologies. The COVID-19 pandemic is a world wide phenomenon at this time and it has now lasted for almost 2 years. If the 20 period protection is provided to current vaccine makers who are predominantly situated in the Global North, the world would lose out on a significant opportunity to manufacture a higher number of vaccines and enhance the ability to provide access to these vaccines to the maximum number of people throughout the world. In other words, a waiver may have the effect of potentially shortening the pandemic life by vaccinating people before further mutations to the virus makes the current vaccines irrelevant.
If the vaccines are continued to be manufactured predominantly in the Global North, there is a possibility that border closures and lockdowns may make imports of vaccines challenging and expensive for many developing countries who will continue to face vaccine shortages. It may be a credible argument that IPR waivers will not necessarily lead to vaccine availability in developing countries that do not have the necessary technology and materials to develop vaccines on their own. Furthermore, arguments may be made that TRIPS agreement already contains provisions that allow importation into countries without domestic manufacturing capacity (“paragraph 6 system”) and also permits compulsory licences, which have been utilised for HIV medicines under the justification of high prices. However, trade disputes involving HIV medicines and vaccines in South Africa when that country passed a law to permit generic off patent drug manufacturing show that pharmaceutical companies have used TRIPS to seek to prevent production of even life saving medicines for profitability concerns.
Thus, these systems do not necessarily help the world in achieving the goal of inoculating the majority of the world population. With regard to importation, even if countries that lack vaccine technology were to import these, there are tariffs and nontariff measures (NTMs) that influence the trade in these vaccines. Even if the importing developing country does not apply import tariffs, there are border surcharges payable across the complex distribution chains that products go through and this will impact the final pricing of the vaccines in the importing country regardless of its waiver of tariffs. Therefore, prices of products are amplified across the distribution chain. Because many of the COVID-19-related vaccines and medicines are being imported into developing countries, the availability and price of these vaccines in these countries are impacted by all these factors. It can be argued that the WTO mechanism may not necessarily lead to vaccine equity so long as the countries that do not have vaccines rely on importation alone.
From a legal perspective, it would be pertinent to consider whether the TRIPS agreement itself contains ‘flexibilities’ that would permit scaling up of COVID-19 vaccine movement across the world because Mercurio’s argument is that TRIPS itself contains appropriate provisions that allows member states access to vaccines without having to waive the IPRs protection. The flexibilities under the TRIPS includes a country’s right to issue compulsory licenses under Article 31 in a public health emergency and import generics from other countries. However, there are many conditions required to be fulfilled before countries can issue compulsory licenses which makes it a less than perfect mechanism in a situation involving a global pandemic. Compulsory licensing applies generally on a case-by-case and product-by-product basis and involves complex conditions. Thus, in a situation of global pandemic when countries across the world are facing national health emergencies, the compulsory licensing regime is only likely to slow down their ability to scale up production of COVID-19 products. Importation is also a complex process involving negotiation of formal contracts and complex distribution systems. Thus, strictly from the perspective of the legal arguments under the TRIPS rules, which are premised on the availability of flexibilities under Articles 27 and 31, there are problems associated with both the compulsory licencing regime and importation regime. They make these regimes less than ideal for scaling up access to vaccines and products in a situation of public health emergency like the COVID-19 pandemic. It can be reasonably argued that the time taken for negotiating on compulsory licenses or bilateral agreements for purchase of COVID-19 supplies, often with the result of higher pricing of the products, it may be more appropriate for WTO members to consider an IPR waiver under TRIPS agreement.
A moral argument for allowing IPRs waiver for COVID-19 vaccines and other life saving technologies has been made by Rueda-Barrera, who premises his argument on a ‘fairness based approach’. He argues that IPRs have caused and even exacerbated global inequalities related to vaccines because IPRs have promoted a scheme of each-country/each-company negotiations for vaccines and this puts low-income countries in a disadvantageous position. At the same time, even middle-income countries have reduced their budgets for meeting other social needs in order to pay for the vaccines during the pandemic. Rueda-Barrera also notes that the COVAX programme, which was designed to ensure the availability of vaccines to the Global South, was never able to effectively do so because of the dominant scheme of negotiations that took place for COVID-19 vaccines. Finally, he argues that the exceptional mechanisms under the WTO for increasing vaccine availability under the current IPR regime did not work because there are many precise conditions that must be fulfilled, which many low and middle income countries were not able to fulfil. Given the nature of the pandemic, with many lives lost and many more threatened in the absence of vaccines, the waiver of IPRs has been termed as a morally crucial demand by him. Thus, the debate on IPRs waiver is not just related to legal concepts and principles, but there is also the involvement of an ethical and moral perspective in the debate.
“I need to be blunt: the world is on the brink of a catastrophic moral failure – and the price of this failure will be paid with lives and livelihoods in the world’s poorest countries. Even as they speak the language of equitable access, some countries and companies continue to prioritize bilateral deals, going around COVAX, driving up prices and attempting to jump to the front of the queue. This is wrong.”
What the above statement refers to is the bilateral negotiations that have been conducted for vaccines imports from the producing countries to many of the low and middle income Global South countries despite the creation of the COVAX programme. These bilateral deals have been considered to be central to the problem of the prices of the vaccines being driven higher and some countries being able to get access to more vaccines than is equitable considering the needs of the other countries. Thus, some writers have pointed out the ‘moral catastrophe’ involved in the way the COVID-19 vaccines have been made available at higher prices to poorer countries of the world. For instance, there have been reports of AstraZeneca charging more from South Africa than it did from EU countries. There were reports of developing countries paying a higher price per vaccine dose than developed countries and countries like South Africa and Uganda have gone on record to state that they have paid more price per dose as compared to many of the developing countries. The question of pricing per dose is also part of the larger debate on the IPR waiver for COVID-19 vaccines. Countries with the lack of patents for making the vaccines, but the potential to make such vaccines, such as India and South Africa, ended up paying more per dose of vaccines whereas many other countries in the Global South, particularly in Africa, were constrained to pay more for vaccines because of lack of cheaper alternatives.
Therefore, there is an inevitable ‘moral’ element in the question as to the IPR waiver under the circumstances. The broader question that can be considered here is how to balance the desire of profitability with the principle of sustainable innovation in the field of medicine and pharmaceuticals. Although in the context of COVID-19, vaccine innovation was not just propelled by private investment and in most countries, there was significant public funding to support the efforts of the innovators, the question of profitability and sustainable innovation in the field of medicine is one that is linked to the issue of IPR waiver. It has been said that the “ratio legis of intellectual property rights, including patents on life-saving, essential drugs, is to secure necessary public goods through sustainable innovation.” Therefore, the basic principle of sustainable innovation is part of the question of IPR waiver. However, when profitability becomes the sole driving factor, then there may be problems of access due to higher pricing of vaccines. While this problem affects the developing countries more because of the limitations of their economies, this problem is one that has acute significance for the global pandemic because as long as the virus is active anywhere in the world, it is a global threat.
The question is whether the TRIPS waiver for COVID-19 vaccines can be justified. In this context, it is important to understand the stance of the pharmaceutical industry as well as the developed countries that have opposed TRIPS waiver. The pharmaceutical industry is against IPR waiver on the ground of waiving of the IPRs will inhibit research and development of future prospects. However, this stance is based on profitability concerns. From an ethical point of view, these profitability concerns can be countered with more utilitarian arguments on how lack of access to COVID-19 vaccines and life saving technologies poses a threat to the whole world because the virus is likely to keep mutating unless herd immunity can be achieved. A utilitarian argument is based on the ethical need to consider how actions can lead to the greatest good. In this situation, it may be questioned whether the profitability concerns of the few pharmaceutical companies should be allowed to trump the greater good of the global community, which is in the end of the pandemic and which can only be achieved through a herd immunity.
The debate on whether there should be an IPR waiver for COVID-19 vaccines and other technologies is a part of the larger debate on the application of IPR in the developed-developing world dichotomy and it is important to frame the debate on waiver for COVID-19 vaccines on the arguments and theory that has been advanced with respect to IPRs and the developing world. It is important to note at the outset that the developing countries have framed the debate over IP rights based on their arguments on their structural weakness and inequality as compared to the developed countries. This is the broader aspect of the debate around the developed-developing wold dichotomy that has been explained by social theorists beginning 1960s, as a situation that involves the developed countries and the rest of the world in relationships of “dependency” thus preventing developing countries from achieving economic development to the same level as the developed countries. This larger debate is framed against the legacy of colonialism, which saw major European powers extract raw materials from Asian, African and American nations. It is argued that the current global system of trade is the result of the exploitative political and economic relationships of the 19th and 20th centuries.
Thus, it is argued that the lack of infrastructure and markets in many Asian and African countries due to their earlier exploitation has led to the situation where they are still dependant on the developed countries of the world and that even when colonialism has officially ended, the continued dependency of the developing countries are part of a neo-colonial world order. With regard to IPR laws, it is argued that stronger IP laws increase the price of technologies in developing countries because they are obliged to provide protection of IP rights of foreigners with the effect that domestic firms may find it challenging to compete with the foreign firms of developed countries and provide cheaper alternatives to technologies. From the perspective of developing countries, the problem with stricter IPR protection may then be linked to the potential lack of affordable accessibility of technologies, and consequently the lack of choice of cheaper alternatives for the consumers of the developing countries.
On the other hand, IPRs system has played an important role in helping in the promotion of invention in some industrial sectors, and this is particularly relevant to the pharmaceutical industry where the recognition of the patent system has been considered to be essential to innovation and development of new medicines, vaccines and technologies. This is also relevant to some developing countries where innovation has been found to have increased due to IPR protection under the domestic laws. In such countries, economic development started from lower levels and then increased with imitation of developed countries’ technologies facilitated by low levels of IPR law and then economic development accelerated with the encouragement of domestic innovations (instead of imitation), facilitated by an increasingly higher degree of protection of IPR law.
However, one can clearly note here that beneficial IPR protection is not generalisable to all developing countries because it depends on the level of economic and technological development and only those countries that have attained certain level of technological advancement will be able to incentivise domestic innovation through IPR protection. Furthermore, even for those countries in the developing world where IPR protection was strengthened, imitation first played an important role. In other words, it is a paradoxical situation where developing countries first have to achieve a certain level of economic and technological advancement, generally through imitation and lower levels of IPR protection, in order to increase IPR protection. Thus, it has been noted that “a rational developing country will choose an optimal level of IPRs, depending on its level of economic development.” It can be said that in their relationship to IPRs generally, developing countries develop IPR laws based on their internal conditions of technological and economic development and not the external conditions, such as, TRIPS agreement.
To conclude this essay, an argument can be made for the waiver of TRIPS system for the COVID-19 vaccines and other life saving technologies so that the patent monopoly of 20 years does not impede the potential for scaling up the production of these technologies. It is essential to scale up production and to provide cheaper vaccines so that these are accessible even to the poorest countries in the world. The TRIPS system does include flexibilities, but these have been proved to be ineffective in achieving vaccine equity during the time of the pandemic. Furthermore, the negotiating system for vaccines under the WTO has only led to the higher pricing of the COVID-19 products, despite the creation of the COVAX regime. Thus, vaccine equity has been unachievable so far. A waiver of patents at this time would allow countries with adequate technology to scale up the production of vaccines. This will allow for pricing correction of the vaccines at this time and provide more options to the developing countries to purchase vaccines at lower prices. The current system has avoided these outcomes as research indicates that countries like South Africa and Uganda have paid more per dose as compared to European nations. Given the differences in their economic conditions, this seems unlikely to increase vaccine equity. Provided that the waiver is only limited to vaccines and life saving technologies and limited in time period to such time when herd immunity is achieved globally, a TRIPS waiver is not only necessary but also ethically and morally justified.
Dig deeper into Idea-Expression Dichotomy in the Creative Industries with our selection of articles.
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