The Ethics of Vaccine Patent Waivers

Introduction

On November 26, 2021, the World Health Organization (WHO) announced that the recently discovered B.1.1.529 strain of Sars-CoV2, first detected in South Africa, was a variant of concern.^[1] They gave it the Greek designation, Omicron. In response, on the following day, US President Joseph Biden called on the countries meeting at the World Trade Organization (WTO) the following week to agree to temporarily waive the intellectual property/patent protections for the COVID-19 vaccines.^[2] This would allow low-income countries to produce generic versions of the vaccines for their own vulnerable populations. 

In this essay, we consider the ethics of vaccine patent waivers during a time of pandemic. We begin by summarizing the ethical framework for protecting intellectual property. We then examine the arguments for and against waiving the patent protections from the perspective of the Catholic moral tradition. We propose that vaccine waivers can be justified, and are in fact morally obligatory, during a time of pandemic, because intellectual property rights are only a common good of a company and an industry, and as such are necessarily subordinated to the common good of a country or of the global community.

^[1] WHO, “Classification of Omicron (B.1.1.529): SARS-CoV-2 Variant of Concern,” November 26, 2021.

^[2] Reuters, “US President Biden calls for intellectual property protection waivers after Omicron discovery,” November 27, 2021.

1. The Ethical Framework of Protecting Intellectual Property

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the global, multilateral agreement on intellectual property (IP) that is used to resolve international trade disputes involving IP.^[3] As the WTO defines them, intellectual property rights are “the rights given to persons over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creation for a certain period of time.”^[4]

^[3] WTO, “TRIPS — Trade-Related Aspects of Intellectual Property Rights“.

^[4] WTO, “What are intellectual property rights?“. Our discussion of IP rights is heavily indebted to this WTO document.

Intellectual property rights are customarily divided into two categories. The first class includes copyright and rights related to copyright, which protect the rights of authors of literary and artistic works for a minimum of fifty years after the death of the author. Also protected in this class of IP rights are the rights of performers and broadcasting organizations. According to the WTO, the primary purpose of these rights is “to encourage and reward creative work.”^[5]

^[5] Ibid.

The second class includes industrial property rights. Once again, this class can be divided into two categories. The first involves protecting distinctive signs including trademarks and geographical indications, which identify a good as originating in a place where a given characteristic of the good is essentially attributable to its geographical origin. The designation of a sparkling wine as a “champagne” is one example of a geographical indication.^[6] The second involves protecting inventions, which are protected by patents, industrial designs, and trade secrets. The protection is usually given for a finite term, typically twenty years for a patent. The primary purpose of these rights, according to the WTO, is “to provide protection for the results of investment in the development of new technology, thus giving the incentive and means to finance research and development activities.”^[7]

^[6] Tim Jay and Madeline Taylor, “A Case of Champagne: A Study of Geographical Indications,” Corporate Governance eJournal 29 (2013): 1-31. 

^[7] WTO, “What are intellectual property rights?”.

In the Catholic moral tradition, intellectual property, like other forms of private property, is an authentic human good that should be protected and promoted in human societies. However, it has to remain ordered to the common good which seeks first and foremost, the flourishing of the human person and the human community. In an address to the WTO, Archbishop Diarmuid Martin, representing the Holy See, acknowledged that the legal protection of intellectual property is “necessary for progress and for the just compensation of researchers and producers.”^[8] Thus, the Catholic Church affirms the good of rewarding human creativity and industry with copyrights and patents. However, the archbishop also emphasized that these intellectual property rights must remain subordinated to the more basic duty of meeting the basic needs of every person:

^[8] Monsignor Diarmuid Martin, “Intervention by His Excellency Mons. Diarmuid Martin to the Plenary Council of the World Trade Organization on Trade-Related Aspects of Intellectual Property Rights,” June 20, 2001.

The Holy See, consistent with the traditions of Catholic social thought, underlines that there is a “social mortgage” on all private property, namely, that the reason for the very existence the institution of private property is to ensure that the basic needs of every man and woman are met and sustained. This “social mortgage” on private property must also be applied today to “intellectual property” and to “knowledge”.^[9]

In other words, intellectual property rights have a place in a hierarchy of goods that are ordered towards the human flourishing. As we will discuss below, we propose that IP rights in general and vaccine patents more specifically can be conceived of as a common good for a company or an industry that is necessarily subordinated to the universal common good of the society or the global community, especially in a time of pandemic. As such, the patents can be waived if they prevent companies from properly serving the universal common good.

^[9] Ibid.

2. Arguments for Covid19 Vaccine Patent Waivers

The primary argument made by proponents for waiving the Covid19 vaccine patent protections is that these waivers would correct the stark disparity in vaccine access between high and low-income countries.^[10] As of November 29, 2021, 74% of the people who live in high income countries had received at least one dose of a Covid19 vaccine compared to 5.8% in low-income countries.^[11] This is gravely unjust.

For the most part, this inequity can be explained by both the vaccine nationalism of high-income countries who have bought more vaccines than they need, and the pricing structures established by the Covid19 vaccine manufacturers. First, high-income countries, particularly those in the Global North, have been hoarding vaccines. For example, the United States has supply agreements with numerous vaccine manufacturers for 3.210 billion doses of vaccines, which is about 9.7 doses for each US citizen.^[12] Similarly, the European Union has agreed to procure 3.961 billion doses, which is about 8.7 doses for each European citizen.^[13] Recall that for most of the Covid19 vaccines, two or three doses are needed for full vaccination or boosted vaccination status. Citizens of low-income countries may have the money to buy vaccines but there simply are not enough on the market for them to purchase any.

^[10] For a representative statement, see the following: Parsa Erfani, Agnes Binagwaho, Mohamed Juldeh Jalloh, Muhammad Yunus, Paul Farmer, and Vanessa Kerry, “Intellectual property waiver for covid-19 vaccines will advance global health equity,” BMJ 374 (2021): n1837. Also see the following: Editorial, “A patent waiver on COVID vaccines is right and fair,” Nature, May 25, 2021; Medecins Sans Frontieres, “WTO COVID-19 TRIPS waiver proposal,” Briefing Document, December 2020.

^[11] Our World in Data, “Statistics and Research: Coronavirus (COVID-19) Vaccinations,” November 29, 2021.

^[12] UNICEF, “COVID-19 Vaccine Market Dashboard,” November 29, 2021.

^[13] Ibid.

Second, many of the Covid19 vaccine manufacturers have established pricing structures for their vaccines that often exceed the purchasing power of low-income countries. One report from the People’s Vaccine Alliance determined that Pfizer and Moderna had sold over 90% of their vaccines to rich countries, charging up to twenty-four times the potential cost of production.^[14] Estimates suggest that that these vaccines could be made for as little as USD 1.20 per dose.^[15] However, Pfizer is still charging the African Union USD 6.75 per dose, which is equivalent to what Uganda spends per citizen on health in a whole year.^[16] For many low-income countries, the Covid19 vaccines are expensive.

^[14] Anna Marriott and Alex Maitland, “The Great Vaccine Robbery,” The People’s Vaccine Alliance, July 29, 2021.

^[15] Ibid.

^[16] Ibid.

WHO Director-General, Tedros Adhanom Ghebreyesus has condemned the structural and social forces that have prevented low-income countries from vaccinating their population: “I will not stay silent when companies and countries that control the global supply of vaccines think the world’s poor should be satisfied with leftovers. Because manufacturers have prioritized or been legally obliged to fulfill bilateral deals with rich countries willing to pay top dollar, low-income countries have been deprived of the tools to protect their people.”^[17] United Nations Secretary-General Antonio Guterres has done the same. Moreover, he has emphasized, as many others have done, that the vaccine inequity between the Global North and the Global South is prolonging the COVID-19 pandemic because viral variants will continue to appear until everyone is vaccinated: 

^[17] Jamey Keaten, “WHO chief urges halt to booster shots for rest of the year,” AP News, September 8, 2021.

Vaccine inequality is aiding and abetting the Covid19 pandemic. It is allowing variants to develop and run wild, condemning the world to millions more deaths, and prolonging an economic slowdown that could cost trillions of dollars. […] All the vaccination effort made in developed countries to vaccinate the whole of the population, one, two, or three times—all that effort will fall apart. And these people will not be protected.^[18]

Guterres concluded: “So not to have equitable distribution of vaccines is not only a question of being immoral: it is also a question of being stupid.”^[19]

^[18] Agence France-Presse, “Unequal Covid-19 jabs roll-out immoral, stupid: UN” October 8, 2021.

^[19] Ibid.

To begin to address this stark global vaccine inequity, South Africa and India, in October 2020, asked the WTO to temporarily suspend intellectual property rights so that the Covid19 vaccines and other drugs used to fight the pandemic would become accessible to low-income countries.^[20] Today, more than 100 countries, including the United States have formally backed the request for a WTO waiver.^[21] The European Union is currently opposed to it.^[22] As noted in the introduction, the WTO is scheduled to meet during the first week of December 2021 to consider the international request for a TRIPS waiver for vaccines and drugs for Covid19. 

^[20] Reuters, “India and South Africa ask WTO to waive rules to aid COVID-19 drug production,” October 4, 2020. Also see, Ann Danaiya Usher, “South Africa and India push for COVID-19 patents ban,” The Lancet, December 5, 2020.

^[21] Andrea Shalal, Jeff Mason, and David Lawder, “U.S. reverses stance, backs giving poorer countries access to COVID vaccine patents,” Reuters, May 5, 2021.

^[22] Silvia Amaro, “EU leaders raise doubts over U.S. plan to waive Covid vaccine patents,” CNBC, May 10, 2021.

3. Arguments against Covid19 Vaccine Patent Waivers

Opponents of the WTO waiver request make one principled argument and one practical one. First, they argue that a patent waiver today would disincentivize innovation tomorrow. As Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), the world’s largest advocacy association for biotechnology, put it, “this decision [of the USA to support a WTO patent waiver] will disadvantage patients by undermining existing incentives to develop vaccines and therapeutics for future pandemics.^[23] More recently, the British Health Secretary Sajid Javid, in response to a question in the British Parliament on the UK’s opposition to the WTO patent waiver request, explained: “U.K. does not believe that waiving patent rights, intellectual property rights, on these vaccines would be helpful. It would certainly mean that in the future there would be a huge disincentive for vaccine companies, pharmaceutical companies to come forward and help the world with their technology.”^[24]

^[23] BIO Biotechnology Innovation Organization, “Support of ‘TRIPS’ Waiver Sets Dangerous Precedent,” Press Release, May 5, 2021.

^[24] Andrea Germanos, “‘That’s for Them to Decide’: UK Secretary Rebuked for Claiming Vaccine Patent Waiver Won’t Be ‘Helpful’ to Global Poor,” November 29, 2021.

Opponents also make the practical argument that lifting the vaccine patent protections would not increase the vaccine supply significantly since countries in the Global South do not have the know-how, the infrastructure, nor the ingredients to actually make COVID-19 vaccines. The editorial board of the Wall Street Journal opined: “Vitiating patents will stifle innovation and make it harder to end this pandemic and the next one. It’s not clear developing countries even have the ability to manufacture large-scale, complex technologies like Moderna’s mRNA vaccine or Eli Lilly’s monoclonal antibody cocktail—let alone distribute them.”^[25] In the end, according to opponents, the WTO waiver request would not only exacerbate the current Covid19 pandemic but would also endanger those future patients who would face a future one by suffocating innovation and creativity.

^[25] The Editorial Board, “A Global Covid Vaccine Heist,” The Wall Street Journal, November 19, 2020.

4. Analysis: Vaccine Patent Waivers and the Common Good

In our view, the debate over the Covid19 vaccine patent waiver needs to be grounded in a robust account of the common good. According to the Compendium of the Social Doctrine of the Church, the common good “does not consist in the simple sum of the particular goods of each subject of a social entity. Belonging to everyone and to each person, it is and remains ‘common’, because it is indivisible and because only together is it possible to attain it, increase it and safeguard its effectiveness, with regard also to the future.”^[26] Each human community – whether it is a family, a city, a company, or a nation – has a common good. Indeed, one human community is distinguished from another precisely because they have different common goods.

^[26] Pontifical Council for Justice and Peace, Compendium of the Social Doctrine of the Church, §164

What is the common good of a company? What are the members of the business supposed to accomplish together that they cannot accomplish on their own? According to classic capitalist accounts, the telos of the firm is profit maximization: A business is meant to increase the wealth of shareholders and in doing so it benefits society.^[26]. According to this account, intellectual property rights are good because they allow a company to maximize its profits from the inventions it has licensed to manufacture and distribute.

^[27] Milton Friedman, “The Social Responsibility of Business is to Increase its Profits,” The New York Times Magazine, September 13, 1970.

In contrast, though the Catholic moral tradition acknowledges the importance of profit for the firm and its employees – the Catechism of the Catholic Church teaches: “Profits are necessary… They make possible the investments that ensure the future of a business and they guarantee employment”^[28] – the common good of a company, according to Catholic social teaching, is not mere profit maximization. Rather, like all other human communities, a company is called to serve the universal common good of society. As Pope St. John Paul II taught:

^[28] Catechism of the Catholic Church, §2432.

In other words, virtuous companies have to promote human flourishing. Anything short of this, according to Pope Francis, is a form of idolatry:

^[29] John Paul II, Centesimus Annus, §35.

Concern with the idols of power, profit, and money, rather than with the value of the human person has become a basic norm for functioning and a crucial criterion for organization. We have forgotten and are still forgetting that over and above business, logic and the parameters of the market is the human being; and that something is men and women in as much as they are human beings by virtue of their profound dignity: to offer them the possibility of living a dignified life and of actively participating in the common good.^[30]

For the Catholic moral tradition, intellectual property rights are good because they allow a company to serve not only its stockholders in particular but also society as a whole, from the profits that flow from the inventions it has licensed to manufacture and distribute. IP rights are meant to serve the common good of the company AND the common good of human society.

Returning now to the ethics of Covid19 vaccine patent waivers during this time of pandemic, we propose that these waivers are not only morally justifiable but may even be morally obligatory, especially for the duration of a global health crisis, given that the current intellectual property protections are hindering our global effort to end this pandemic, putting the lives and livelihoods of billions in the Global South at risk. As we explained above, IP rights are meant to serve the common good, not only the common good of the company and its shareholders, but also the universal common good. They should therefore be waived if they are not fulfilling their purpose. Though waiving the patent protects would decrease the profit earnings of the vaccine manufacturers, the universal common good trumps the individual common good of the firms because the former promotes the flourishing of more individuals than the latter. 

It is important to highlight that waiving the patent protections for the Covid19 vaccines does not mean that the companies that initially manufactured them should not avail themselves of any profits whatsoever. These companies can and should continue to make a profit from sales of their vaccines to those high-income countries in the Global North that can shoulder the cost. However, the WTO patent waiver would allow companies in low-income countries to make generic versions of the Covid19 vaccines that they could sell at a reasonable profit to low-income countries, we would add, and only to low-income countries, with pricing structures that are commensurate with the purchasing power of the developing countries in the Global South. In this way, companies in both the Global North and the Global South would be able reap reasonable profits by marketing their products either branded or generic in specific geographical regions. 

^[30] Francis, “Address of Pope Francis to the Centesimus Annus Pro Pontifice Foundation,” May 25, 2013.

But what about the argument that waiving the Covid19 patent protections would disincentivize innovation tomorrow, especially during a future pandemic? Or the argument that low-income countries simply do not have the industrial capacity to take advantage of a Covid19 patent waiver? First, it is not clear to us that the primary incentive for producing the Covid19 vaccines, especially the mRNA vaccines, was a commercial one. The scientists who worked on them were motivated primarily by a desire to use the fruits of scientific innovation to help end a global health crisis.^[31] It is likely that the scientists of the future will be as motivated to develop a vaccine to end a future pandemic as the scientists of today, regardless of the potential profits that they could accrue. Second, as we explained above, companies that would manufacture and distribute vaccines for a future pandemic would still be able to make a profit, and this profit would still be substantial given the large numbers of individuals around the world who would have to be vaccinated. They simply cannot maximize profits to the detriment of global public health. This in itself should provide incentive enough for a company to invest in a future vaccine.

^[31] For example, listen to the New York Times interview with Dr. Katalin Kariko, who was one of the pioneers of the mRNA vaccines: “The Unlikely Pioneer Behind mRNA Vaccines,” June 10, 2021.

Turning now to the practical concerns raised by opponents of the WTO waiver request, it is clear that countries in the Global South do have the capacity to manufacture generic versions of the Covid19 vaccines, even the gold-standard mRNA vaccines developed by Pfizer and Moderna. The New York Times identified ten companies across the developing world that could produce these mRNA vaccines if they were allowed to do so.^[32] These companies have existing facilities, human capital, regulatory systems for medicines, and political and economic climates that would allow them to manufacture and distribute generic Covid19 vaccines to low-income nations. As for the resources that are needed to make these vaccines, experts have pointed out that if there are enough ingredients for the manufacturers in the Global North to produce these vaccines for the world, then in principle, there are enough ingredients for companies in both the Global North and the Global South to produce them. The challenge now is to nudge these companies to share what is there to the benefit of the global community. It is a call to virtue. As Pope Francis has said: “In the name of God, I ask all the great pharmaceutical laboratories to release the patents. Make a gesture of humanity and allow every country, every people, every human being to have access to the vaccines.”^[33]

^[32] Stephanie Nolen, “Here’s Why Developing Countries Can Make mRNA Covid Vaccines,” The New York Times, October 22, 2021.

^[33] Ed Silverman, “‘Make a gesture of humanity’: Pope Francis urges drug makers to release Covid-19 vaccine patents,” STAT News, October 18, 2021.

Conclusion

In conclusion, many may see this dispute over patent rights as a conflict between charity and prosperity. However, what they would not understand is that both can and should be considered in public health deliberations to end the pandemic. Pharmaceutical companies can serve the common good in charity while still serving their shareholders in prosperity. The distinguished Thomist, Josef Pieper believed that prudence is the most important virtue for practice reasoning. Nations and companies will need prudence to shape their economic policy making to seek the good of the many over the good of the few.