The Urgency of Universal Access to the Covid-19 Vaccine

Over the past year, the Covid-19 pandemic has put our health at risk, brought the global economy virtually to a standstill and disrupted our lives in ways we never imagined. The magnitude of the global catastrophe prompted the World Health Organization (WHO) to commission an independent panel of experts to assess the situation. The panel was chaired by former New Zealand Prime Minister Helen Clark and former Liberian President Ellen Johnson Sirleaf.[1]

The concluding report states that the current situation was avoidable. It argues that the SARS-CoV-2 virus was allowed to evolve into a “catastrophic pandemic” that has killed more than 3.4 million people and devastated the world economy. Such a disaster could have been averted with a more prompt global response. Experts have denounced the absence of global political leadership. Some countries “have underestimated and discredited” science, denying the seriousness of the disease, with fatal consequences.

The report calls for significant steps to be taken to end the current tragedy and ensure that it does not happen again. The WHO and the World Trade Organization (WTO) should bring together vaccine-producing countries, as well as vaccine manufacturers, to try to increase supplies worldwide, and to consider suspending the manufacturers’ intellectual property rights (IPR), as has been requested by lower-income countries. The reports call for a more fully resourced WHO.

The current alert system has proven slow and too subservient to rich countries. A new pathogen with pandemic potential could appear at any time. The WHO should be strengthened so that it can establish a new surveillance system that is based on complete transparency. It should be granted power to publish information on potential pandemics without having to seek the permission of the governments involved. And it should have the freedom to send experts to assess threatening situations in any country at the shortest possible notice.

The grave situation calls patents into question

While the mistakes made in terms of policy, prevention and containment are there for all to see, it must be acknowledged that the discovery of Covid-19 vaccines occurred quickly and their development was completed with impressive speed. This was an extraordinary achievement. Unfortunately, however, this scientific miracle has been overshadowed by limitations in vaccination worldwide and clear inequalities in the distribution of vaccines.

As of May 4, less than 8 percent of the world’s population had received at least one dose of any Covid-19 vaccine, but 80 percent of the vaccinations had taken place in only 10 nations. This is not only because rich countries purchased all the available doses, but also because there were simply not enough doses to meet demand.[2] Moderna’s entire production and more than 96 percent of Pfizer/BioNTech’s were purchased by developed countries, and the AstraZeneca/University of Oxford vaccine went predominantly to Europe. According to estimates by GAVI, the Global Alliance for Vaccines and Immunization,[3] developed countries have stockpiled enough doses of the major vaccines to immunize their citizens three times over, while poorer nations can count themselves lucky if they can administer one dose for every 10 inhabitants during 2021.[4]

This shortage is largely intentional. Vaccine production has been limited by the refusal of pharmaceutical companies to share knowledge and technology. Despite the fact that the companies producing the approved vaccines have enjoyed public subsidies and publicly funded research, they have still taken advantage of the protection of their patents to maintain monopolistic power, limiting production to their laboratories and to the small number of companies they have licensed.

According to the Devex[5] global development community media platform, governments have allocated an astronomical USD37.7 billion in public funds to vaccine research, development, distribution and application, while the private sector has invested a quarter of that amount: USD9.5 billion. In addition, licensing agreements with individual countries have not been made public, and the proposal submitted to the WTO by India and South Africa to suspend the payment of IPR for these vaccines for the duration of the pandemic has been opposed.[6]

This WTO protection had already been activated in the case of AIDS, following an international campaign to make available generic treatments that could be manufactured at lower cost by other nations. The proposal to repeat it for Covid-19 has the support of a hundred or so countries, but is opposed by several countries that are home to large pharmaceutical companies.

Recently, the important news came that the President of the United States, Joe Biden, has announced his administration’s endorsement of this initiative to obtain the suspension of WTO’s intellectual property rights, which have so far allowed a monopoly on vaccines. For some time the Biden administration had been under strong pressure to take action to remove this counterproductive measure. On April 15, an open letter, signed by former heads of state and government and several Nobel laureates, was addressed directly to the U.S. Head of State in these terms: “A WTO waiver is a vital and necessary step to bringing an end to this pandemic. It must be combined with ensuring that vaccine know-how and technology is shared openly. This can be achieved through the World Health Organization COVID-19 Technology Access Pool, as your Chief Medical Advisor, Dr. Anthony Fauci, has called for. This will save lives and advance us toward global herd immunity.”[7]

A WTO agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) allows for the prosecution of countries that produce a patented product or process without the prior consent of the owner. Most WTO member states have proposed a temporary exemption from IPRs for technologies needed to fight the pandemic, i.e. to suspend the TRIPS rules. Unfortunately, the TRIPS Council of the WTO has blocked even this small step, because rich countries have put the interests of big pharmaceutical companies before those of global health.[8] It remains to be seen whether President Biden’s intervention will be able to facilitate a WTO agreement that will provide the legal certainty that governments and manufacturers around the world need in order to increase production of vaccines, treatments and diagnostic tests. The suspension is clearly urgent. Covid-19 is rampant throughout South America and India, where overburdened health services have been overwhelmed at times and, as a result, the loss of life has been catastrophic. Moreover, the rapid spread of the virus has already given rise to dangerous new variants. It is imperative, for the good of all, that as many people as possible be vaccinated before vaccine-resistant variants emerge.

Vaccines against Covid-19 have been developed by scientists around the world using a scientific platform supported by numerous governments. In fact, the basic technology used by the Moderna vaccine for example, was funded in association with the U.S. National Institutes of Health, in other words, with U.S. taxpayer money. It is only fair that the citizens of that country and the rest of the world benefit.

Finally, it is necessary to consider the proposals of some health experts and U.S. activists calling for the implementation of the Defense Production Act (in practice, a law for a wartime situation) to ensure that the vaccine can be properly administered in the U.S. and the rest of the world. “For less than the U.S. government spends on the COVID-19 response daily,” reports the organization PrEP4All, a health advocacy group, “you can build a facility capable of producing enough messenger RNA (mRNA) vaccines to vaccinate the entire world in a year, at a cost of only $2 per dose.”[9]

The arguments of the pharmaceutical companies

The initiative advocated by India and South Africa sparked a heated debate, with arguments both in favor and against. The Economist was critical, describing the proposal as “at finest an empty gesture and at worst a cynical one.”[10] On the other hand, influential economists such as Joseph Stiglitz[11] and Jeffrey Sachs[12] have spoken out in favor of suspending IPR. In the political world, an ambivalent reaction can be seen. If the EU is willing to discuss the exemption of the Covid-19 vaccine from intellectual property rights, at the same time Germany is leading the opposition to this proposal.[13]

The pharmaceutical industries exert the strongest opposition. They argue that a suspension is unnecessary, given that the current WTO regulatory framework is flexible enough to allow access to technology. They add that it would also be ineffective, because producers in developing countries lack the means to produce the vaccine, and in any case the incentives for research would be lost, the earnings of Western companies would be reduced, and in addition it would help China and Russia to defeat the West in the geopolitical arena. They claim that suspension would set a disastrous precedent. As expected, the “market” confirms their analysis. This is demonstrated by the collapse of the share prices of the major vaccine manufacturers immediately after the Biden administration announced its intervention in the suspension negotiations. If these go through, more vaccines will be made available, prices will fall, and so will earnings.

Data to consider

Joseph Stiglitz, quoted above, responds firmly to the arguments of multinational health care corporations, citing the following.

1) U.S. and European vaccine manufacturers have already established manufacturing agreements with foreign companies, such as the Serum Institute of India (the world’s largest vaccine manufacturer) and Aspen Pharmacare in South Africa, and indeed these partners have had no difficulty implementing them.

2) The International Coalition for Epidemic Preparedness Innovations (CEPI) has already identified about 250 companies that would be able to produce vaccines. In this regard Stiglitz recalls the clear denunciation of the South African delegate to the WTO: “Developing countries possess advanced scientific and technical capabilities. The scarcity in the production and administration of vaccines is caused by rights holders who impose restrictive agreements useful for their monopolistic purposes, putting revenues before lives.”

3) Pharmaceutical companies argue, as noted above, that a suspension would not be necessary in light of the “flexibility” already introduced by the WTO. They point out that companies in developing countries have not applied for compulsory licenses (those by which governments allow domestic companies to produce a patented pharmaceutical item without the consent of the licensee). But this apparent lack of interest is due to the fact that Western pharmaceutical companies have tried so hard to create legal entanglements involving licenses, copyrights, patented industrial processes, and trade secret “exclusivities,” that the aforementioned flexibility would never be able to resolve them. Because mRNA vaccines contain more than 100 components worldwide, many of which are subject to some form of intellectual property protection, it is nearly impossible to coordinate compulsory licensing between countries to manage such a supply chain.

4) Another factor behind low vaccine uptake is fear, both at the corporate and national level. Many countries fear that the United States and the European Union will stop providing funds for their development or even impose sanctions if they issue compulsory licenses. However, if there were a suspension by the WTO, those governments and companies would be shielded from corporate claims, judicial mandates and other such risks.

5) It is claimed that a suspension of intellectual property rights would reduce earnings and discourage research and development in the future. In fact, it would only prevent monopolistic pharmaceutical groups from deciding to stop further production. A suspension, on the other hand, would prompt them to sign voluntary agreements. Vaccine manufacturers will be able to enjoy handsome profits even if the WTO decides to do so. Projections say that in 2021 alone, revenue from Pfizer’s and Moderna’s Covid-19 vaccines will reach $15 billion and $18.4 billion respectively, and this despite the fact that governments have funded much of the basic research and provided substantial upfront funds aimed at marketing the vaccines.

In Stiglitz’s view, the real problem for the pharmaceutical industry is not that manufacturers of pharmaceuticals would be deprived of a high return on their investments, but rather the fear of losing monopoly profits, including those that could be expected from the supply of annual recalls, which will undoubtedly be sold at high prices in rich countries.

6) The last card played by the industry is the fear that a suspension would help China and Russia gain access to U.S. technology. But vaccines are not a U.S. creation. Collaborative research between countries on messenger RNA and its medical applications has been conducted for decades, particularly since Hungarian scientist Katalin Karikó made the initial breakthrough in 1978. The mRNA technology in the vaccine produced by Pfizer is owned by BioNTech (a German company founded by Turkish husband and wife immigrants), which has already granted the Chinese manufacturer Fosum Pharma a license to manufacture the vaccine.

Stiglitz finally points out the worrying inability of the United States to develop a constructive diplomacy regarding Covid-19. To date, the U.S. has blocked exports of vaccines that it is not even using. The authorities only considered releasing their unused doses of AstraZeneca after the second wave of infection began to devastate India. Meanwhile, Russia and China have not only made their own vaccines available, but have engaged in significant technology and knowledge transfer, established partnerships around the world, and helped accelerate the global vaccination effort.

Considerations

Unequal access to vaccines puts lives at risk just about everywhere. The fewer people vaccinated globally, the more likely it is that vaccine-resistant variants will arise. If the Covid-19 and HIV pandemics have taught us anything, it is that viruses know no borders. The more we allow these variants to spread, the more people will die. The remedy to ensure our safety and economic recovery is global vaccination.

To accomplish this, more than 8 billion doses would have to be manufactured, distributed, and populations inoculated; the question comes down to how to manage the emergency within the current legal framework for protecting IPR.[14]

When it came to the HIV/AIDS epidemic, it took years of passionate campaigning and millions of deaths before WTO countries agreed on the need to allow compulsory licensing of intellectual property to ensure access to medicines. The 1994 WTO Doha Declaration on the TRIPS and Public Health Agreement and the 2001 WTO Member Agreement provide the right to grant compulsory licenses in the event of a national emergency, including a health crisis. There is, however, a requirement for royalties to be paid to pharmaceutical companies, “but drug companies never gave up on doing everything possible to undermine this principle. It is partly because of the pharmaceutical industry’s tight-fistedness that we need a waiver in the first place. Had the prevailing pharmaceutical IP regime been more accommodating, the production of vaccines and therapeutics already would have been ramped up.”[15]

Critics of patent liberalization argue that the costs are too high to allow poorer countries access. They believe that governments should directly fund all innovation and acquire products at the cost of manufacture. The key point, however, is that payment for research and development costs is separate from administering the products. Therefore, patents should not mean universally high prices. We should expect diversified or staggered pricing. Research and development costs are recovered from wealthier countries that pay higher prices based on consideration of the health of their citizens. Poorer countries get prices close to or equal to manufacturing costs.

Ultimately, the position of the pharmaceutical industry is clear, but the reality is something else. Recent promises by these companies to get doses of vaccine to at-risk populations in poorer countries may assuage their guilt, but will not contribute significantly to global vaccination. Yet something seems to be moving, there are some signs of hope. Last May 22, 2021, during her visit to the Holy Father, Ursula von der Leyen said, “Team Europe has committed to providing 100 million doses to Covax. It is critical now to provide free vaccine doses because they are in short supply everywhere. […] Our partners BioNtech-Pfizer, Johnson & Johnson and Moderna have pledged to deliver another 1.3 billion doses this year, specifically to low-income countries at no cost and to middle-income countries at reduced prices. These three paths – export, donation and industrial partnerships – have as their priority the creation of vaccine production facilities in Africa […], obviously not in the short term.”[16]

What is the nature of the situation? Is there a conflict of interests at stake: the individual versus the collective? It seems to be so. On the one hand, there is private property, understood as an absolute right of the IPRs, and, on the other, the right to health, which insistently claims access to the tools to protect themselves. A clear path is evident: the only way out of the current crisis is a vaccine with universal access; no one is protected until we are all protected.

The very serious accusation repeatedly leveled at pharmaceutical companies is that they are purely profit-oriented entities, focused primarily on profits and not on global health.[17] In the present situation their true nature and , their true objective have come to light: to maintain all the power they can get in the market for as long as possible, in order to maximize profits. But in circumstances such as those in which we find ourselves, it is up to governments to intervene more directly to solve the problem of vaccine administration. In the legal systems of Western countries, the right to property is not absolute, but is related to the common good, from which comes the legal concept of expropriation (which, however, is practiced by ensuring compensation or reparation). For its part, the social doctrine of the Church has always affirmed the social function of property. Saint John Paul II wrote: “The Christian tradition has never sustained this right as something absolute and untouchable. On the contrary, it has always understood it in the broader context of the common right of all to use the goods of the whole of creation: the right of private property as subordinate to the right of common use, to the universal destination of goods” (Laborem Exercens, No. 14).

Most of us consider health a “right.” We believe that a sick person should have access to health care services regardless of their financial resources. That is why we are outraged to hear that a person injured in a serious accident or seriously ill was not accepted into a hospital because they had no money or health insurance. Because health services are essential and people have a right to use them, this reality is in direct conflict with the idea that money is the only discriminator in the distribution of health-related services.

Who can deny that health is a national priority and a responsibility of governments? We are talking about the common good: this is the key concept. The Church’s social doctrine clearly formulates the following points:

– “The responsibility for attaining the common good, besides falling to individual persons, belongs also to the State, since the common good is the reason that the political authority exists” (Compendium of the Social Doctrine of the Church, No. 168).

– “The demands of the common good […] concern […] the provision of essential services to all, some of which at the same time are human rights: food, housing, work, education and access to culture, transportation, basic healthcare” (ibid., No. 166).

– “We must not forget the contribution that each nation is duty-bound to make to true international cooperation, with a view to the common good of all humanity, including for future generations” (ibid.).

Relevant to the issue at hand, the Church’s own social doctrine states: “Entrepreneurs and those responsible for public bodies involved in research, production and selling of products derived from the new biotechnologies must take into account not only legitimate profit, but also the common good. This principle, which holds true for every type of economic activity, becomes particularly important for activities that deal with food supply, medicine, health care and the environment […]. By their decisions, entrepreneurs and public agency directors involved in this sector can guide developments in the area of biotechnologies toward very promising ends as far as concerns the fight against hunger, especially in poorer countries, and the fight against disease” (ibid., No. 478).

Many aspects of the health care systems from the treatment of transmissible diseases to the development of basic science to find effective treatments, to the necessary licensing of new drugs by state health agencies are public goods that the market does not efficiently provide. The justification for public intervention in the health sector is based on considerations of effectiveness and equity. It is necessary here to understand, as a decisive factor, the importance of market limits, the realization that we are talking about a public good that has enormous consequences. Individual health contributes to collective health and vice versa.

With the role of the public sector admittedly fundamental, the challenge facing the EU and the U.S. is to manage innovation in health by directing research, getting prices right, ensuring that patents and competition work properly, setting the conditions for reinvestment, and protecting health-care delivery. The goal of shared prosperity for all humanity requires recognition that “health is wealth,” that we are only as healthy as our neighbors, and that no one is protected until everyone is.

A reflection on our responsibility

We would like to conclude by recalling two facts: firstly, the errors and negligence committed in the first moments of the pandemic; secondly, the situation created by the limitations of worldwide access to vaccines and the inequities in their distribution.

When calamity strikes, evil is felt with great force. If God is all-powerful, the Creator of an ordered and good world, and takes care of all his creatures, why does evil exist? This is not the place to dwell on that question. But, as the Catechism of the Catholic Church affirms, “there is not a single aspect of the Christian message that is not in part an answer to the problem of evil” (No. 309).

If we are faced with a chronic illness, or a widespread crisis such as hunger, we find an answer in the Gospel: “You yourselves give them something to eat” (Luke 9:13). Provide for one another, that is, take care of your brothers and sisters, cure each other’s illnesses. However, in the beginning there was negligence, and now there is insensitivity and avarice.

Don Quixote, conversing with Sancho after they found themselves with nothing to put in their mouths, reminds him that “God, who is the provider of all things, will not abandon those who are in his service as we are, if he does not abandon even the mosquitoes of the air, or the worms of the earth” (Don Quixote de la Mancha, I, 18). At another time he had told him, “Trust in God, Sancho, that all will be well and perhaps even better than you think, for no leaf moves that God does not want” (II, 3). When Sancho remarks that he has heard that “the one they are calling by the name of Fortune is a drunken and fickle female, and above all blind, so she does not see what she is doing, and does not know who she is knocking down and who she is raising up,” Don Quixote replies: “What I can tell you is that there is no such thing as luck in the world, nor do the things that happen in it, whether good or bad, proceed by chance, but by a special Providence of heaven, and hence confirms what is usually said: that each person is the author of his or her own fate” (II, 66).[18] For Cervantes there is no contradiction, because Providence does not take away freedom at all, and the human being is solely responsible for the attitude and position taken toward the things that happen to him or her.

We are in the midst of a catastrophe, and it would be a misfortune for all if the EU and the U.S. were not up to the situation and did not work to resolve it as best they can. Not to promote universal vaccination is untenable, from any point of view. If those institutions do not take up this responsibility, they will be remembered forever for their insensitivity and selfishness.

DOI: La Civiltà Cattolica, En. Ed. Vol. 5, no. 7 art. 8, 0721: 10.32009/22072446.0721.8

[1].      See H. Clark – E. Johnson Sirleaf, Main Report. COVID-19: Make it the Last Pandemic (theindependentpanel.org/mainreport).

[2].      See J. Ghosh, “Next Steps for a People’s Vaccine”, in Project Syndicate (www.project-syndicate.org/commentary/us-wto-waiver-expanded-production-knowledge-sharing-by-jayati-ghosh-2021-05), May 7, 2021.

[3].      See apps.who.int/iris/handle/10665/84367

[4].      See M. Mazzucato – R. Grynspan, “Biden and the Promise of the People’s Vaccine”, in Newsweek (www.newsweek.com/biden-promise-peoples-vaccine-opinion-1568259), May 19, 2021.

[5].      See L. Cornish, “Interactive: Who’s funding the COVID-19 response and what are the priorities?”, in DEVEX@WHA 2021
(www.devex.com/news/interactive-who-s-funding-the-covid-19-response-and-what-are-the-priorities-96833).

[6].      See R. Grynspan, “Vacunas, un bien público global”, in El País (elpais.com/economia/2021-02-20/vacunas-un-bien-publico-global.html), February 21, 2021.

[7].      “Open Letter: Former Heads of State and Nobel Laureates Call on President Biden To Waive Intellectual Property Rules for COVID Vaccines”, April 14, 2021, in www.unaids.org/en/resources/presscentre/featurestories/2021/april/20210414_letter-waive-intellectual-property-rules-COVID-vaccines

[8].      Cf. J. Ghosh, “Next Steps for a People’s Vaccine”, op. cit.

[9]  .    PrEP4All, “Hit Hard, Hit Fast, Hit Globally”, March 19, 2021, at www.prep4all.org/news/hit-hard-hit-fast-hit-globally

[10].    “Ten million reasons to vaccinate the world”, in The Economist (www.economist.com/leaders/2021/05/15/ten-million-reasons-to-vaccinate-the-world), May 15, 2021.

[11].    See J. E. Stiglitz – L. Wallach, “Will Corporate Greed Prolong the Pandemic?”, in Project Syndicate (www.project-syndicate.org/onpoint/big-pharma-blocking-wto-waiver-to-produce-more-covid-vaccines-by-joseph-e-stiglitz-and-lori-wallach-2021-05), May 6, 2021.

[12].    See J. D. Sachs, “Share the Intellectual Property on COVID-19”, in Project Syndicate (www.project-syndicate.org/commentary/covid19-intellectual-property-waiver-is-a-moral-imperative-by-jeffrey-d-sachs-2021-04), April 29, 2021.

[13].    See Euronews – AP, “COVID-19 vaccine patents: EU nations divided over lifting intellectual property rights”, in Euronews (www.euronews.com/2021/05/06/us-backs-waiver-on-intellectual-property-rights-for-covid-19-vaccines), 17 May 2021; M. Berdud – M. Jofre-Bonet – D. Kourouklis – A. Towse, “Would Waiving COVID-19 Vaccines Patents Save Lives?”, in OHE (www.ohe.org/news/would-waiving-covid-19-vaccines-patents-save-lives), May 18, 2021.

[14]. For a detailed discussion of this topic, see K. Reinert, International Economics, Cambridge, Cambridge University Press, 2021, 155-159.

[15]. J. E. Stiglitz – L. Wallach, “Will Corporate Greed Prolong the Pandemic?”, art. cit.

[16].    M. Galgano, “A fianco della Santa Sede su clima e salute”, interview with Ursula von der Leyen, in L’Osservatore Romano, May 22, 2021.

[17].    Both Stiglitz and Sachs assert this.

[18].    Cf. M. de Cervantes, Don Quixote de la Mancha, Turin, Einaudi, 2005.