Supervised by: Dr. Joanna Rhodes MChem, DPhil (Oxon), MRSC, Solicitor. Having completed both her undergraduate degree and DPhil at Oxford University, Joanna qualified as a solicitor and enjoyed a successful career in Corporate and Intellectual Property Law at a magic circle law firm. In addition to her work as Director of Sixth Form at a leading UK school, Joanna is a member of the European Centre for Space Law and has attended DLR Hamburg as a prospective ESA astronaut.
Abstract
The aim of this research paper is to analyse and evaluate the arguments for and against whether intellectual property rights should automatically be waived in a global health emergency. After describing the range of intellectual property rights that are available, and exploring the definition of a global health emergency, the paper evaluates the proposition, scrutinising Rawls’ moral and philosophical argument which contends that basic liberties, namely global health, must always supersede secondary rights, such as intellectual property rights, regardless of the circumstances. Next it considers South African and Indian proposals to temporarily waive intellectual property rights for vaccines in the context of the COVID 19 pandemic, along with the motivation behind, and consequences of, this move. In the second part, the article evaluates the arguments against the proposition that intellectual property rights should not be automatically waived in a global health emergency. We explore the economic reliance on intellectual property rights to enable pharmaceutical companies to survive financially in a competitive market, which in turn affects their ability to invest in the research and development of future medicines. To back up our arguments, our research paper explores the intellectual property rights connected with the COVID-19 vaccine. It also considers the complexities of mRNA vaccines and the early stages of development of these vaccines and the consequent effects on intellectual property rights. Finally, this paper contends that whilst the waiver of intellectual property rights during a global health emergency is commendable and can act to solve short-term goals, its limitations in terms of the appropriate technology and equipment needed demand the search of more effective alternatives – a number of which have been proposed.
Section 1 – An introduction to intellectual property rights
The first basis of intellectual property protection rights (IPR) appeared in a Statute of the Venetian Republic in 1474 (Cozzi 1973). The Statute of Monopolies followed 150 years later (Glendon, 1998) and since that time, intellectual property rights have expanded at a rapid rate. Usage of the term “intellectual property” began in the 19th century, though it was not until the late 20th century that intellectual property became commonplace in the majority of the world’s legal systems (Moore and Himma, 2011). Put simply, IPRs are the rights given to an individual over the creations of their minds, such as literary and artistic works, designs, names and images, inventions and symbols.
Intellectual property can take many forms, and each one of them has the potential to be highly protected but different forms of intellectual property are required to be protected differently. The seven IPRs include but are not limited to: copyrights, patents, industrial design rights, trade dress, trademarks, plant variety rights, geographical indications, and even trade secrets and ‘know-how’. These are briefly described below.
Copyrights
These are the original creators of a creative work protected by the right of copyright to not be stolen or given credits to anyone but the creator. Examples of copyright works are text, images, art works, music, sounds or even films and movies.
Patents
Patents are by far one of the most well-known and frequently used IPRs and the type of right with which we are primarily concerned in this research paper. They protect creative ideas and processes which are novel, beneficial, and un-obvious. A patent is an exclusive right granted for an invention, which is a process or product that provides a new idea, or a new way of doing something, or a new solution to a specific problem. Patents have been issued for everything from telephones, bluetooth, computers and the lightbulb, to google PageRank and the mangle, as well as pharmaceutical products such as drugs and vaccines.
Trademarks
Trademarks are a unique symbol or slogan used to represent a company or its product. After the symbol or slogan is registered, no other company can use this specific symbol as it belongs to the company who invented it. Some examples of trademarks in contemporary popular culture are “Twitter”, “Under Armour”, “Just do it” and “America runs on Dunkin”.
Design rights
Design rights are the rights of protection of creations such as drawings, paintings and computer models.
Trade secrets
A trade secret is a process of a company that is unknown outside of the company. Information that is a trade secret gives the company a competitive advantage against its rivals and competitors in the industry. Examples of trade secrets may include processes, information, codes, unpublished works and patent applications, business ideas and plans, budgets, methods of calculation, manufacturing processes and customer lists. Trade secrets are sometimes known as ‘know-how’ or confidential information. In the context of pharmaceuticals this may include confidential information or know-how on the synthesis of novel mRNA and DNA vaccines by a particular pharmaceutical company (Dolgin 2021).
How do IPRs vary around the world?
IPRs and their enforcement varies around the world and it is very important that originators keep up with their local intellectual property right laws and new enforcements. The extent to which IPRs can be protected around the world varies. U.S.-registered patents are only valid within the United States. An individual or company must protect its IP by filing for a patent in a specific country in which it or its competitors operate. IPRs may also be accompanied by contractual agreements such as licensing agreements. There are also a wide range of international agreements and systems of mutual recognition of IPRs around the world, most of which are beyond the scope of this research paper.
Depending on the industry, the patent system’s significance varies. Any industry with lengthy development cycles or high R&D costs needs a robust patent system. In the pharmaceuticals sector medical treatments and innovations leading to the discovery of new life-saving medications and drugs must be protected through IPRs. Without a patent system, a rival might simply wait for the new medication to hit the market before immediately reverse-engineering it and undercutting the inventor’s prices without bearing the cumulative development expenses. Consequently, no new medication will be produced due to lack of financial incentive or through the economic demise of the originator.
Patents therefore are legal rights that protect a product or idea. They are significant to the pharmaceutical industry because they provide players with the sole right to market their products and forbid anyone from copying or selling them for a period of 20 years following the filing of the patent. Additionally, patents also play an important role in encouraging competition, which fuels pharmaceutical innovations and promotes fierce economic competition. With the protection of a 20-year patent term, known as market exclusivity, pharmaceutical companies are able to establish a monopoly over the market. During this time, the government is prohibited from setting prices.
By encouraging and rewarding innovation and creativity, the intellectual property system is intended to support society. Some might argue that it is simply unrealistic that pharmaceutical companies would invest the time, money, and resources into such Research and Development without the guarantee of IPR protection since there would be no motivation to work so hard – and invest so much money – in a promising but extremely difficult technology. However, intellectual property right waivers could possibly speed up the distribution of vaccines during a global health emergency. Pharmaceutical companies argue that such a move would remove the motivation that encourages innovation.
Section 2 – Global Health Emergencies
Global health emergencies are described as a worldwide crisis that tends to happen and spread very fast (“World Health Organization Emergencies Programme” 2022). Examples of such emergencies include the spread of diseases such as Monkeypox, Zika virus, Ebola and COVID-19.
Monkeypox is described as an outbreak that has spread around the world rapidly, through new modes of transmission about which we understand ‘too little’, and which meets the criteria of an emergency under International Health Regulations (“Monkeypox”, WHO, 2022).
WHO’s (World Health Organization) public health emergency committee declared that the spread of the Zika virus (“Zika virus”, WHO, 2022) was an emergency of public health concern, triggering funding into research. To be classified as a public health emergency, the emergency has to be defined in the International Health Regulations (IHR) as “an extraordinary event which is determined to constitute a public health risk to other states through the international spread of disease and to potentially require a coordinated international response” (“Emergencies: International health regulations and emergency committees”, WHO, 2019).
Ebola is another powerful example of how IPRs have the potential to impede the public’s access to vaccinations and life-saving medications. Ebola mainly affects lower-income countries, primarily sub-Saharan Africa (“Ebola (Ebola Virus Disease)”, CDC). The Ebola virus is a deadly disease that is transmitted through bodily fluids, and has a 50-90% mortality rate (“Ebola (Ebola Virus Disease)” CDC). Thus far, several treatments have been created. On December 19th 2019, the FDA approved the Ebola vaccine rVSV-ZEBOV (called Ervebo) which was the first FDA approved vaccine for Ebola since it began (“Prevention and Vaccine | Ebola (Ebola Virus Disease)”, CDC). It has been found to be safe and protecting against the Zaire ebolavirus, which is one branch of the virus that has caused the largest and most deadly outbreaks to date (“Prevention and Vaccine | Ebola (Ebola Virus Disease)” CDC). Secondly on February 26th 2020, the Advisory Committee on Immunisation Practices recommended pre-exposure prophylaxis vaccination for adults over 18 who are at occupational risk for Ebola (“Prevention and Vaccine | Ebola (Ebola Virus Disease)”). Apart from vaccinations there are two current treatments approved by the FDA, the first having been approved in 2020: Inmazeb, which is a combination of three monoclonal antibodies (“Treatment | Ebola (Ebola Virus Disease)” CDC). The second is Ebanga, a drug made of a single monoclonal antibody. Many other different therapies are under large-scale research trials as well, however, “given the global drug-patenting paradigm with its 20-year delay on generic competition, patent holders can set drug prices as high as they want, effectively making their drugs inaccessible to poor populations” (Karan and Pogge, 2015). When these treatments pass clinical trials and reach the market, the price will be fundamentally unaffordable to poorer countries, which are those that are most heavily ravaged by Ebola (Karan and Pogge, 2015). Ebola may not be considered a global health emergency, seeing as it doesn’t affect the entire world, but it is an epidemic that has claimed thousands of lives. These lives could be saved by these therapies. However, if patent protections and IPRs are firmly in place, and generic copies can not be produced at cheaper prices, many more lives will continue to be lost. Similarly to COVID, there is essentially a race to develop new Ebola vaccines and treatment regimens, but again, the current patent system makes it unlikely that those in the most afflicted nations will have access when these medications are brought to the markets, unless they have the assistance of development aid initiatives from the United Nations (UN), World Health Organization (WHO) and the GAVI alliance, as well as other multinational global entities (Karan and Pogge 2015). Apart from patents, since there is a limited supply of these medications, wealthy nations may stockpile the drug as seen with the Tamiflu in 2009 (Karan and Pogge, 2015). There is no financial or political mechanism that will enable drugs or vaccines to be available and affordable to those in poorer nations (Karan and Pogge 2015). Apart from the patent system in place there is also a lack of incentive shown by pharmaceutical companies. “While there are programmes, such as the USAID Emerging Pandemic Threats programme, to detect potential pandemic illness, there is little financial promise for major pharmaceutical companies to invest in vaccines or drugs for these potential threats until they are a threat to countries that have consumers who can afford them” (Karan and Pogge 2015). All in all, Ebola is an excellent case study demonstrating why patents should be automatically waived in the face of outbreaks and pandemics that are having a large scale effect on poorer income countries, due to the lack of treatments that will be distributed due to cost and incentive from companies.
On December 12th, 2019 a cluster of patients in Wuhan, China first started experiencing symptoms of atypical pneumonia that didn’t respond well to standard treatments (WHO). There are a couple of key dates on which the outbreak escalated into public health energy. First, on January 22nd 2020, the WHO’s International Health Regulation Emergency Committee met and decided not to declare a Public Health Emergency of International Concern, and instead to monitor the situation (WHO). Finally, on March 11th, after more than 118,000 cases in 1,114 countries and 4,291 deaths, WHO declared COVID-19 a pandemic. This was a cornerstone moment in the pandemic itself. The issue of waiving IPRs has recently regained momentum due to: the unequal distribution of access to the COVID-19 vaccine, particularly in the Global South; unprecedented technological advancements in vaccine development; and the implementation of the Agreement on Trade-Related Aspects of IPRs (“TRIPS”) (Chander & Sunder, n.d.). In this paper we use COVID-19 as the primary illustrative example for and against the waiver of IPRs in a global health emergency owing to the large availability of published commentary on this issue.
Section 3 – Waiving intellectual property rights in a global health emergency: the moral and philosophical arguments
Despite the immediacy of the COVID-19 global health emergency, the contentious debate surrounding IPRs has been circulating throughout the course of history by philosophers, politicians, lawyers and laymen alike. Among these, the twofold moral argument of John Rawls presents a persuasive commentary on why IPRs should automatically be waived in a global health emergency.
John Rawls, born in 1921 and influenced by philosophical thinkers prominent in the Enlightenment Era such as Immanuel Kant and Jean-Jacques Rousseau, was a 20th century American political philosopher who is internationally acclaimed for his Fairness Principle, in which he established the notion of the ‘Veil of Ignorance’ (‘A Theory of Justice’, Rawls, 1971). As such, he emphasised the judicial need to detach from personal identity and status, combined with the holistic identity and status of the defendant to prevent self-interest from obstructing the swift, objective and fair process of justice. Rawls naturally built his moral and philosophical foundation from this logic, adopting this liberal egalitarian approach in his arguments that propose the waiving of IPRs in a global health emergency. Rawls’ argument centres primarily on two fundamental principles, namely the Liberty Principle and the Difference Principle, both of which act to contend, under the veil of ignorance, that the basic right to health is comparatively of ‘greater moral import’ (Gewertz & Amado, 2004) than – and hence must always supersede – the right to intellectual property.
Let us consider his first principle, otherwise known as the Liberty Principle, which states that ‘each person is to have an equal right to the most extensive basic liberty compatible with a similar liberty for others’ (‘A Theory of Justice’, Rawls, 1971). As mentioned here, the ‘most extensive basic liberty’ alludes to primary liberties, such as the right to health and security or the freedom of speech – rights that are most inherently difficult to live without. Through this categorisation, Rawls effectively relegates the right to intellectual property as a ‘secondary right’, which includes other social values, including but not limited to IPRs, economic efficiency and improving the welfare of low-income households. It is crucial, however, to make the distinction that Rawls is not asserting that such ‘secondary rights’ are not human rights, but rather that primary rights, such as the right to health, is so fundamental and should not be infringed under any circumstances that it naturally holds precedence over other less urgent human rights, creating a moral hierarchy. Hence, under this principle, in a situation similar to the COVID-19 pandemic, IPRs for COVID-19 vaccines would have been automatically waived on the basis that global health holds moral and logical precedence over pharmaceutical companies’ economic advantage and financial gain from obtaining IPRs.
On a similar note, Rawls’ second principle, the Difference Principle, states that ‘social and economic inequalities are to be arranged so that they are both (a) to the greatest benefit of the least advantaged and (b) attached to offices and positions open to all under conditions of fair equality of opportunity’ (‘A Theory of Justice’, Rawls, 1971). Focusing solely on social equality, the Difference Principle contends that it is justifiable for social and economic inequalities to exist if it meets a certain criterion. Firstly, part (a) of this principle argues that inequalities in society, such as the waiver of IPRs from the pharmaceutical industry, can be justified if its objective is to maximise the welfare of the ‘least advantaged’ or the poorest in society, which are usually those situated in the Global South or in conflict-stricken regions. The second part of his Difference Principle outlines the need for society to provide everyone with the fundamental resources, such as health care, to have an equal opportunity to engage in competition. Thus, these two principles both convey the Rawlsian theory that basic rights (the right to health) should always supersede secondary rights (IPRs), no matter the circumstances.
The international response to Rawls’ two principles on whether IPRs should be waived has differed vastly, largely in correspondence to the countries’ economic and financial status, their poverty rates and Gross National Income (GNI). At large, the Global South or Less Economically Developed Countries (LEDCs) mostly argue that the right to health should always take precedence over the protection of IPRs, no matter the circumstances, particularly due to the high poverty rate causing many sick patients to spread their illnesses due to lack of funds to afford high quality medicine. For example, South Africa and India, two LEDCs, have appealed to the World Trade Organisation to waive IPRs on COVID-19 vaccines for at least 3 years for the purpose of making the mitigation of the spread of coronavirus more affordable and effective. They contend that the decolonisation of the global health sector is crucial to ‘bring benefit to the least advantaged’, as stated in the Rawlsian theory, and to ensure vaccines are provided ‘equitably, transparently, freely and universally’ (Chander & Sunder, n.d.). On the other hand, countries in the Global North, such as the United Kingdom and member states of the European Union (EU), claim that whilst the Rawlsian theory may be commendable, IPRs play a crucial role in acting as an incentive for pharmaceutical companies to generate more innovative medicines and drugs, helping to save more lives in the future. Hence, this creates the ultimate conundrum: is it morally permissible, or in this case Rawlsian, to sacrifice countless lives to protect the health of a few citizens now by waiving IPRs? Now, instead of debating upon the precedence of the right of health over the right to intellectual property, it seems that the tables have turned.
To put this into realistic perspective, the use of the Rawlsian theory of basic human rights superseding secondary rights has been highlighted and utilised in a court case in Kenya in which the Petitioners brought forward and contested against the Anti-Counterfeiting Act 2008 which they argued infringed upon their human right to life, dignity and health under ‘articles 26 (1), 28 and 43 of the Constitution of Kenya’ by preventing them from accessing life-saving and affordable HIV and AIDS medicines, putting innocent civilians’ lives at risk. The Petitioners claimed that the Anti-Counterfeiting Act 2008 contained vague and ambiguous terms which enabled the Kenyan authorities to arbitrarily seize and restrict access to imported generic drugs. Furthermore, they argued that the authoritative restriction of access to these HIV and AIDS drugs infringes upon the Industrial Property Act 2001 and the HIV and AIDS Prevention and Control Act 2006 which already authorised the import of generic drugs to Kenya. After reviewing the contexts and facts behind the case, the Kenyan High Court ruled that under the Anti-Counterfeiting Act would be modified to remove any ambiguity and, most notably, that IPRs ‘should not override the right to life and health’ (Patricia Asero Ochieng v The Republic of Kenya [2012]). Taking into consideration that, as of 2022, 8.9 million Kenyan citizens live in extreme poverty, with 17% of their population living off just USD 1.90 daily, it is axiomatic that buying expensive original HIV medicines is simply out of the question. Before the rulings of this case, Kenyan HIV patients were obliged to pay approximately USD$50 monthly for HIV drugs – the price of health they just could not afford. However, with the adoption of Rawlsian theory, which places the right to health over IPRs, HIV patients in Kenya can enjoy HIV generic drugs for only USD$4 per pack. Ultimately, it is evident, at least in Rawls’ perspective, that although IPRs are important, the urgency of preserving health and the right to life (United Nations Universal Declaration of Human Rights, Article 3) should override all else.
Section 4 – WTO Proposal for waiving intellectual property rights in the COVID-19 pandemic
South Africa and India proposed to the World Trade Organisation (WTO) in October 2020 that it temporarily waive intellectual property protections upheld in the WTO TRIPS agreement ( (“WTO | intellectual property (TRIPS) – agreement text – contents” 1994) for COVID-19 health technologies, which will allow vaccine production in developing countries without worrying about legal action from major pharmaceutical firms (“IP/C/W/669/Rev.1 25 May 2021 (21-4307) Page: 1/4 Council for Trade-Related Aspects of Intellectual Property Rights Original: Eng”). The waiver aims to support increased production by alternative manufacturers and quicker, greater, and more equitable access to life-saving medical countermeasures. The proposal was drafted in anticipation of the deadly effects of vaccine apartheid.
Discussions surrounding vaccine equity have centred on the issue of this patent waiver. Advocates for the waiver of COVID-19 patents rely on a number of grounds to support their case. The first is that the right to vaccination access is a critical component of the human right to health, that must take precedence over IPRs. The terms of the TRIPS (Trade-Related Aspects of IPRs) agreement must not be read or used in a way that interferes with anyone’s ability to access vaccinations in a way that is affordable, just, and equitable. In this context, it is important to note that Article 7 of the TRIPS Agreement stipulates that IPRs must be “protected and enforced in a manner conducive to social and economic prosperity” (“WTO | legal texts – Agreement on Trade-Related Aspects of Intellectual Property Rights as Amended by the 2005 Protocol Amending the TRIPS Agreement”). In some aspects, patent waiver is more beneficial than TRIPS flexibility. A further argument made by proponents of the patent waiver plan is that vaccine manufacturers have attempted to take advantage of the price flexibility in an unfair manner. They contend that TRIPS paves the way for patent holders to set their own prices for their goods, which can be kept high and out of the reach of patients who are more in need of them. For example, AstraZeneca sold its vaccines to the EU (European Union) market for $2.16 per dosage, but South Africa paid $2.25 per dose (Dyer, 2021).
The COVID-19 vaccination has not been equally accessible throughout the pandemic. By the end of May 2022 only 16% of people in low-income countries had received a single vaccine dose compared to 80% in high-income countries (“COVAX calls for urgent action to close vaccine equity gap” 2022). By the end of June 2022, just 16% of residents of low-income nations had received two doses of a single vaccination, compared to 74% of residents of high-income nations (Loft, 2022). Unsurprisingly, Africa continues to have the lowest vaccination rates of any continent, with fewer than 15% of its people completely immunised as of early March 2022 (Loft, 2022). At the WTO (World Trade Organization), South Africa and India recommended in October 2020 that IPRs on COVID-19 vaccines and associated medications and therapies be waived for a minimum of three years. They claimed that doing so would permit the production of vaccinations in more places, and thus boost the availability of the drug worldwide. As one justification for sharing the technology, they also pointed to the extent of governmental expenditure in vaccinations (“Developing nations demand equal access to coronavirus vaccines”, 2021). According to reports, more than 100 additional states, including high-income nations, agreed with their viewpoint (“Developing nations demand equal access to coronavirus vaccines”). The Biden Administration also advocated a general waiver of vaccine-related IPRs in the middle of 2021 (Bose et al., 2021). In June 2022, the WTO released a compromise pact that was endorsed by all of its members and unveiled a compromise agreement in June 2022 that received support from all of its participants (“Ministerial Decision on the TRIPS agreement”, 2022). For a period of five years, developing nations will be permitted to authorise the use of patented components and materials in the production of Covid-19 vaccines without the approval of the owner of the vaccine production rights, for domestic and eligible markets. Holders of rights will get payment.
The African Alliance and the People’s Vaccine Alliance Africa estimate that Pfizer, BioNTech, and Moderna will collectively earn pre-tax profits of $34 billion a year, based on financial statements from the companies (“Pfizer, BioNTech and Moderna making $1,000 profit every second while world’s poorest countries remain largely unvaccinated”, Oxfam, 2021). Despite the fact that this amounts to more than $1000 per second, $65000 per minute, or $93.5 million per day, according to estimates, the cost to develop a new drug can range from less than $1 billion to more than $2 billion, taking into account capital expenses and money spent on drugs that don’t end up being commercially successful. Due to the monopolies these businesses hold, five new billionaires with a combined net worth of $35.1 billion have emerged during the pandemic. Less than 1% of the total vaccine supplies from Pfizer, BioNTech, and Moderna have been delivered to low-income nations (just 0.2% from Moderna). These companies have sold doses primarily to wealthy nations, while 98 percent of people in low-income countries lack all recommended vaccinations. Given the extensive profits made already by these pharmaceutical companies, one could therefore conclude that no harm would be caused to innovation should IPRs be waived in the event of a global health emergency.
Section 5 – Economic reasons against intellectual property waivers
Some might argue that without the certainty of IP protection, it would not have been possible to produce the most advanced and promising COVID-19 vaccines. In turn this would have had an influence on the advancement of knowledge required for promising products or innovations (Mercurio, 2021). The pharmaceutical sector serves as a good illustration of these concepts. The development of a new medication can take a decade or more and cost from less than $1 billion to more than $2 billion. If theoretically feasible, there is no way a private investor would accept such a significant R&D risk without a guarantee of return.
A World Trade Organization waiver is an extreme measure that should only be used when existing WTO obligations have proven inadequate. It is not necessary to waive IPRs to guarantee affordable access to medications for all populations around the world during the pandemic, given the advancement of reasonably priced patented treatments and vaccines; furthermore, it could be considered unwise because a waiver would prevent cooperative efforts which in turn might reduce the supply of essential medicines and vaccines.
While a waiver might allow members to escape their WTO obligations, it doesn’t affect national IP laws and regulations. IP is essential for ensuring vaccination safety and helping stop the entry of harmful goods. The possibility of fake or unsafe vaccines circulating in supply channels increases if all IPRs related to COVID-19 are waived. This could endanger the lives of millions of people and jeopardise the public’s trust in vaccines which is crucial to preventing the spread of harmful diseases both now and in the future (Srivastava, 2021).
As we have seen in Section 4 above, some nations have argued for a waiver of the IPRs for vaccines in order to supply the demand for COVID-19 vaccine. The UK and the European Union, among other nations, voted against the proposal at the WTO (Jecker and Atuire, 2019). They claim that the IP rights system has helped form innovative vaccines against COVID-19 and provided an incentive for additional research to address new variants of concern. Rather than promoting government mandated licensing of vaccines to allow third parties to produce doses, they have encouraged voluntary licensing.
Unsurprisingly, the trillion-dollar biopharmaceutical industry also reacted angrily to the waiver proposal, claiming that intellectual property, despite being essential, was not a problem, that new producers would disrupt and waste supplies, that it was impossible to duplicate the vaccines, that manufacturers could not dedicate the time to engage in technology transfer, and that it was impossible to trust manufacturers in other countries to produce vaccines of a certain quality (Byrne, 2022). Despite these statements, companies did build new manufacturing facilities in a matter of months and did transfer their vaccine technologies through 300 agreements. However, all the while they ignored the capacity of an additional 120 companies, the majority of which are based in developing nations. (Baker, 2022).
The COVID-19 pandemic has significantly altered the global economy and governments around the world have experienced significant budget shortfalls. This has resulted in investors panicking during the 2020 stock market crash and losing or selling all of their assets, which has caused inflation to rise significantly throughout the post-Covid era. The precautions necessary to contain the virus have resulted in an economic downturn with the severe lockdown measures put in place by governments and health officials worldwide to overcome the pandemic having a negative influence on global demand and supply. On the demand side, social activities like eating out, travelling, and tourism were curtailed completely for a significant period of time. “As a result, consumer spending dropped significantly, which has led to one of the greatest recessions in history”. Says Abdulla al Mazrouei, Deputy Director of fixed income department Abu Dhabi Investment Authority.
Pharmaceutical innovation is an expensive proposition that necessitates a significant use of time and resources (“Distributing COVID-19 vaccines globally”, UAE Government, 2021). The biopharmaceutical industry in the United States alone spends over $60 billion annually on research and development of new products. During a difficult global financial situation with an uncertain economic outlook it is unsurprising that they wish to retain their key sources of income. Companies must not only conduct clinical trials but also win over public opinion, soften regulations, and convince medical professionals of the advantages of their new products. The argument states that by making more money from the increased sales of approved medications, pharmaceutical companies will be encouraged to invest even more in research and development, which will result in significant advancements in the medical field. (“Research and Development in the Pharmaceutical Industry”, 2021).
Section 6 – Arguments against the idea that intellectual property rights should automatically be waived in a global health emergency
While there are arguments for the idea that in global health emergencies IPRs should automatically be waived, as we have discussed above, these arguments in general centralise ideas regarding the safety of distribution, a lack of technology, and a lack of notable difference that would be made regardless of patents or IPRs that would be waived. This section of the paper will focus heavily on how the influence of these disadvantages affected the current COVID-19 pandemic.
Shortly after the outbreak began hundreds of companies began scrambling to create vaccinations, and many were successful, at a much faster rate than ever before. This led to several complexities that make it a necessity to retain IPRs and patents in place. To understand the complexities of the vaccine rollout, one has to examine the production and the timeline of the vaccination production. What makes COVID-19 vaccines distinct from other viral infection vaccines is the fact that it is based on new and innovative mRNA technology. While this may have been seen as a new technological push that occurred this decade, mRNA has in fact been studied since 1984. In 1984 Paul A. Krieg, Ph.D., Douglas A. Melton, Ph.D., Tom Maniatis, Ph.D., and Michael Green, Ph.D., and their colleagues at Harvard University used a synthesised RNA enzyme to make biologically active messenger RNA (mRNA) in a lab (“History of COVID-19: Outbreaks and vaccine timeline”, n.d.). This eventually started the foundation of research that led to in 1987, Robert W Malone MD mixing RNA with fat droplets and discovering that when human cells are added to that mixture, they absorb the mRNA and make proteins (“History of COVID-19: Outbreaks and vaccine timeline” n.d.). These were considered the early steps in the development of the mRNA-based COVID-19 vaccines (“History of COVID-19: Outbreaks and vaccine timeline” n.d). In the 1990s mRNA was slowly introduced to treatments in rats and to influenza and cancer vaccines in mice, but mRNA is extremely sensitive to damage and expensive to produce, meaning many researchers struggled to get funding to pursue their work (“History of COVID-19: Outbreaks and vaccine timeline” n.d.).
A breakthrough year was in 2005 when Katalin Kariko Ph.D. and Drew Weissman M.D. Ph.D. discovered that modifying synthetic mRNA keeps the immune system from attacking the mRNA advancing the research forward (“History of COVID-19: Outbreaks and vaccine timeline” n.d). Finally, in 2020, when the pandemic reached its peak, vaccine clinical trial processes began. Researchers took what had been previously learned from vaccine studies of SARS-CoV, MERS-CoV, and other viruses to develop COVID vaccines (“History of COVID-19: Outbreaks and vaccine timeline” n.d). The FDA gave emergency use authorization to two mRNA vaccines, the Pfizer-BioNTech and the Modern vaccine (“History of COVID-19: Outbreaks and vaccine timeline” n.d). In 2021, the emergency use authorization was also given to the Janssen/Johnson and Johnson vaccine. The Pfizer-BioNTech vaccine, known also as Comirnaty, was approved also for people aged 16 and older and children aged 5-15 Many COVID vaccines remain in clinical trials and in 2022 the FDA approved the Moderna vaccine, known as Spikevax, to protect those 19 and older (“History of COVID-19: Outbreaks and vaccine timeline” n.d.). The authorisation process continues to this day, in which fourth vaccine doses are being produced to adapt the vaccines to the new COVID variants. For this paper, the investigation will focus specifically on the Pfizer vaccine and the Moderna vaccine and how they were affected by patents and IPRs.
Apart from the history of how mRNA has been integrated into furthering vaccines and technological advantages, it is important to highlight what makes mRNA so important and so precise. These limitations and advantages are one of the key factors that make it a necessity to maintain IPRs on vaccines. There are many advantages to mRNA vaccines (Liang et al., 2021). Some of those advantages include a simple production process, safety profiles better than those of DNA vaccines, and mRNA-encoded antigens that are readily expressed in cells (Liang et al., 2021). However, these advantages come with several key disadvantages that directly correlate to why patent protection is necessary. Disadvantages of mRNA vaccines include side effects such as allergy, renal failure, and heart failure, and they can degrade quickly after administration or cause cytokine storms which means there is a substantial challenge in delivery (Liang et al., 2021). The mRNA vaccine technology is incredibly intricate and complexm involving a 19-step procedure on how to isolate antigen plasmids, purify and test the genes, add helicase to open the DNA template and transcribe it to RNA, and more (Liang et al., 2021). It is not an easy technology to use and access, and only specialists can create, maintain and deliver the vaccine dosage. This is one of the arguments supporting patents and IPRs.
As stated and argued in Section 3 the main argument regarding waiving IPRs and patents is to attempt to increase vaccine distribution because it would allow any willing company to produce the vaccine, making them cheaper and more widely accessible in low-income nations (McMurry, 2021). As we have explained above, this was a specific request seen in a proposal submitted to the WTO sponsored by India and South Africa and has been endorsed by other countries including the United States (McMurry, 2021). Vaccine distribution isn’t as simple as simply allowing other companies to create generic copies. Those generic copies will require millions of dollars of technology, extremely detail-oriented procedures, lab equipment, and personnel to create. It isn’t as simple as simply generalising distribution (McMurry, 2021). Many different elements factor into that decision process. mRNA vaccines from Modern and Pfizer face big capacity issues. There are no spare mRNA manufacturing facilities, and few trained personnel to run the machines and ensure safety and quality control. It is structurally difficult to embed delicate mRNA vaccine molecules inside lipid nanoparticle shells at freezing temperatures (McMurry, 2021). While this is the more general, overarching argument regarding mRNA technology and why waiving patent rights would not make a significant difference in vaccine distribution due to the technological costs, the point can be made more specifically as regards Pfizer and Moderna.
It is worth examining the current infringement suit between Moderna and Pfizer. Moderna and Pfizer are companies big enough to produce their vaccines under their patents. Moderna Inc. has several articles protected by United States patents including the Spikevax COVID vaccine (“Moderna’s Patents and pending patent applications” 2010). Moderna Inc. also owns additional patents in the US and foreign jurisdictions (“Moderna’s Patents and pending patent applications”). Pfizer owns 37 US patents to protect its drugs (“PFIZER drug patent status, international patents”, 2021). These are big companies that have many patents from the United States and foreign jurisdictions protecting them and the materials they produce. Their patents encapsulate mainly their new mRNA technology and their vaccine production and have led to a resulting clash between the two companies. Moderna specifically took out many patents covering its mRNA technology and the use of mRNA in vaccines that they produce (Berinato, 2022). Moderna filed a patent infringement lawsuit against Pfizer (Berinato, 2022). Moderna had initially sworn not to file suits while developing and distributing COVID vaccines; however, it modified its pledge to enforce patents in higher-income countries (Berinato, 2022). Already, we can deduce that patents are more strictly enforced by higher-income countries, and do not attempt to target lower-income countries that are under-developed, which is normally the argument used to justify waiving all patents and protection rights.
Moderna has filed this suit because companies have a limited amount of time to reap the benefits of a patent before it expires, and once it does expire, a low-cost generic drug can wipe out billions of dollars (Berinato, 2022). These types of lawsuits are worthwhile investments to defend patents against lower-cost generics, but in this case, Moderna is competing against a product that came out virtually at the same time (Berinato, 2022). Moderna (along with other drug companies) will feel compelled to file patent-infringement lawsuits to defend “the principle of protections for innovation” and to also prevent future products that could potentially infringe their patents (Berinato, 2022). Pfizer has based its defence on the fact that the vaccine is based on its proprietary research and from research partner BioNTech, but Moderna secured critical U.S. patents first (Berinato, 2022). Moderna CEO Stéphane Bancel said “Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation,” which is why they filed the lawsuit (Cohen, 2019). Vaccine production, distribution, and advancements can not be done without patents and IPRs as has been witnessed firsthand during the pandemic. This case is one example of how while patents can lead to conflicts between large pharmaceutical companies, they are crucial in protecting the technology that can save millions of lives and create new vaccines.
Section 7 – Alternatives to vaccine waivers
Here we consider alternative solutions, apart from simply disbanding IPRs and patents, that are worth considering in the face of a global health emergency. These mechanisms facilitate distribution of vaccines without waiving any patents or IPRs. For example, the UAE is playing a major role in facilitating the distribution of COVID-19 vaccines to developing countries and aiding in the fight against the coronavirus pandemic. With its wide-ranging logistics networks, plentiful storage space, and strategic geographic location, the UAE is taking a novel approach to ensuring more nations have fair access to COVID-19 vaccines. More than 136 countries around the world have received more than 2,250 tons of medical supplies from the UAE, and the mission aims to deliver 18 billion vaccine doses by the end of 2022 (“Distributing COVID-19 vaccines globally”, 2021). There is therefore an argument for harnessing sound infrastructure, a stable macroeconomic environment, and one of the most advanced transportation systems, such as that found in the UAE, rather than investing in the generic manufacture of vaccines in situ under an intellectual property waiver. This approach has been advocated by leading philanthropists: ‘The most important priority is to stop the loss of life and the economic scarring as soon as possible. And that means working together to deliver COVID-19 vaccines to all countries, not just the richest ones. The global community has never done anything like this before. It will be a test of our humanity and our ingenuity. But with leadership from countries like the UAE, we can succeed.’ Says Mark Suzman, CEO, Bill & Melinda Gates Foundation. (Clarfield and Dwolatzky, 2021).
Another large contributor to distributing vaccines to low-income countries is COVAX, an international non-profit distributor which is aiming to deliver two billion doses to developing nations by the end of 2021 (McMurry, 2021). COVAX, as a non-profit vaccine distributor, is one example of a type of alternative solution to simply waiving patents and IPRs. Other solutions similar to COVAX involve a massive drive of technology transfer, capacity extension, and supply line coordination to bring vaccine supply in line with global demand (Lindsey, 2021).
To incentivise drugmakers to undertake research and development (R&D) costs without giving them rights over their production and sale during a public health crisis could be achieved by using direct government support (Lindsey, 2021). This would involve public funding for R&D, advance purchase commitments by the government, and other related payouts (Lindsey, 2021).
Longer term solutions to the dilemma of IPRs that have been proposed include altering the complex and lengthy medicine approval procedure to enable manufacturers to start recovering their expenses sooner rather than granting corporations a legal monopoly over their formulae. However, opponents argue this could reduce safety by compromising the robust clinical trial and approval processes. Additionally, a pricing structure would be established in order to compensate businesses for developing the necessary new drugs. On the other hand, it would still be critical to take into account other transitional measures, such as decreasing patent periods, because simply eliminating all patent rights would be unfeasible given the speed with which generic companies can reverse engineer drugs and go into manufacture themselves.
Lastly, drug companies could be offered large profits to allow them to prioritise their work for the public health emergency through the systems of taxation in developed high economic wealth countries, effectively subsidising through the tax system the development of drugs for the benefit of all (Lindsey, 2021).
Discussion and conclusions
To summarise the argument for the idea that IPRs should be automatically waived, Rawls’ principle formulates a strong argument for the idea that patents and property rights should be abolished. As mentioned in Section 3, Rawls focuses on preserving human life and health. That is difficult to do when there are patents and property rights blocking the production and distribution of generics that could save lives. Pharmaceutical companies are motivated by profits, and they reap the benefit of high profits by limiting access to their vaccines and controlling the technology used to produce them. Even though Rawls, as an example, values the importance of property rights, one has to examine the context in which those rights exist. As Rawls states that every person must have extensive liberty rights, most notably the right to health and security, this consigns intellectual property as secondhand. Under this principle, IPRs should automatically be waived, giving international health greater weight than the pharmaceutical companies’ economic gains. Ultimately, it should be considered that in a global health emergency, in which the health and wellbeing of the entire population is at risk, pharmaceutical companies’ IPRs are subordinate. They are sustainable businesses, and thus don’t need to profit from a global health emergency. As aforementioned, preserving health and the right to life should override all else and that is the argument as to why IPRs should be waived in the face of a global health emergency.
There have been numerous advocates for patent waivers, namely South Africa and India as previously mentioned in Section 4. South Africa continues to have one of the lowest vaccination rates of any nation, while nearly 70% of the total Indian population have been fully immunised. Nonetheless, we saw the effect of their arguments on the global increase of the availability and production of drugs, and we saw the Biden Administration supporting a waiver of vaccine-related IPRs just a year later. This shows that not only are developing countries frustrated with the general IPRs of pharmaceutics, but in fact it is a problem understood by both low and high income countries.
While there is merit to the arguments for the waiving of patents in a global health emergency, Sections 5, 6 and 7 demonstrate that not only is there a lack of foundation to some of those arguments, but there are also many more practical alternative solutions. To summarise the arguments against the waiving of patents, one must consider the technology, resources, and production rates that are currently being used.
Apart from a lack of easily accessible mRNA technology, there is also a shortage of raw materials. Suspending intellectual property protections plus allowing any manufacturer to try to produce the vaccines would increase the demand for scarce materials, driving up prices and blocking production. Furthermore, building new vaccine manufacturing facilities cost around 700 million USD, takes months or years to build and requires 4-6 months before producing vaccine doses, so hypothetically regarding the WTO waiver from India and Africa, it wouldn’t be until late into 2023 that any additional doses would become available through this manner (McMurry, 2021). That is slower than the current production rate, and according to Duke University Global Health Innovation Center, there will be enough vaccines produced in 2021 to vaccinate at least 70% of the global population, which is enough to achieve herd immunity. There is no visible production benefit that would occur from the waiving of the patents.
The relationship between IPRs and global pandemics has multiple different facets. More evidence supports the argument against the idea that those rights should be waived, and there also exist multiple alternative solutions. The foundation of the arguments for the idea of waiving IPRs focuses on production, and that if those rights were waived production would increase, distribution would increase, and generics could be produced. As seen in the paragraph directly above, that is not the case. There are also a number of viable alternative solutions we have described in Section 7.
To summarise, even though there are arguments for and against waiving IPRs in a global health emergency, we conclude that waiving IPRs in the face of a global pandemic would not automatically fix the issues regarding distribution and vaccination costs. While many actors, especially governments of LEDCs, have argued that the only reason pharmaceutical companies wouldn’t waive IPRs is their pursuit of profit, we have seen that is not strictly true. Yes, profit does have a part to play. However, there is data that proves that waiving patents and rights would actually inhibit production, and non-profit organisations are being created to allow for higher distribution. Lastly, mRNA technology is incredibly difficult to work with; advanced technology, specific conditions, and specialist knowledge are needed to produce it, and it isn’t as simple as producing other generic vaccines. There are other solutions, and the WTO as well as both high-income and low-income countries should begin investing in them.
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