I. COVID-19 Vaccine Development and Distribution: The Pharmaceutical Industry Delivers a Miracle while Rich Nations Hoard Vaccine Supplies

The pharmaceutical industry, the industry that many (often for very good reasons) love to hate, delivered nothing short of a COVID-19 vaccine miracle. In less than a year (when the normal time for vaccine development can take up to a decade) they discovered and manufactured COVID-19 vaccines that have extraordinary safety and efficacy profiles.Footnote ¹ See Figure 1 for a comparison of the time it took to develop COVID-19 vaccines with the normal vaccine development time.

Figure 1.

COVID-19 versus average vaccine development.

Source: Johns Hopkins University School of Medicine Coronavirus Resource Center https://coronavirus.jhu.edu/vaccines/timeline#:~:text=A%20typical%20vaccine%20development%20timeline,vaccine%20doses%20for%20widespread%20distribution (accessed 21 April 2021).

Primarily due to the technical and managerial expertise of the pharmaceutical industry, citizens of rich countries have begun to emerge from our basements and Zoom meetings. Although there were significant setbacks in Europe, these vaccines are being rapidly distributed and administered to citizens in the United States and Europe with a reasonable expectation of vaccinating nearly the entire adult population by the end of 2021. However, while developments continue to unfold as this article goes to press, the inescapable conclusion is that, due to a number of factors including hoarding and ‘vaccine nationalism’, the majority of citizens in the global south will not be fully vaccinated for at least another year and in some cases longer. Soon we will be drinking in pubs, eating in restaurants, and enjoying live entertainment. Government officials, human rights advocates and scholars will resume work and start to attend conferences in Washington, Geneva, London, Paris, Hong Kong and New York. Our lives will start to return to normal. But it will be years before the same can be said of our fellow human beings in the global south.

The private pharmaceutical companies – well-established giants like Pfizer, Johnson & Johnson and AstraZeneca, and relative newcomers like Moderna and Novovax – produced miracles and delivered us from our basements and attics. Just as they developed anti-retroviral treatments a generation ago to combat the scourge of HIV/AIDS, pharmaceutical companies created hope to cure our abject despair. (It should be noted that unlike in the HIV/AIDS era, these companies have learned that they do not need to price gouge or, or for that matter, sue Nelson MandelaFootnote ² to make sufficient profits to replenish their innovation pipeline.)

Vaccine development, even when there is an important medical need, is fraught with too much uncertainty to develop optimally with only private capital investment. Thus, governments certainly played a large role in producing this miracle, providing the capital to enable vaccine discovery and development in the form of pre-payment for dosages. Academic scientists and universities also provided much of the basic research. But the pharmaceutical industry performed the most challenging steps requiring technical and professional expertise – most notably, designing rigorous and reliable research protocols and implementing good manufacturing practices. The ability to design and conduct rigorous testing protocols involving tens of thousands of patients across multiple global regions required a vast reservoir of institutional knowledge and capacity. The same might be said of the ability and know-how to manufacture, store and distribute vaccines.

It is no doubt a bitter pill to many human rights advocates, but one big lesson of COVID-19 vaccine discovery is that free markets and private enterprise worked. It would be foolish to kill the golden goose of private industry and expect universities and governments to protect us from the next global biological emergency. I, for one, am not ready to jettison the innovative and technical capabilities of the pharmaceutical industry, when, as is inevitable, the next pandemic, perhaps even scarier than this one, rears its ugly head.

Another lesson we have learned from the rollout of COVID-19 vaccines is that vaccine nationalism and our own desperation thwarts our better angels who would act with greater equity and justice for the rest of the world, especially for billions of citizens in the global south, including many living in poverty that are already medically vulnerable and underserved. People in lower-income countries decidedly do not have any chance of equality of access to COVID-19 vaccines in large part because we in rich countries, in our fear and desperation, are hoarding vaccine supply. The European Union attempted to impose export restrictions on vaccines produced within its borders. The United States has locked up 1.5 billion doses while the European Union has locked up 2 billion, both far more than necessary to vaccinate their entire populations approximately twice over. Canada has reserved nearly five doses per capita and the UK and Australia nearly three per capita.Footnote ³ Even global south countries have practised vaccine nationalism out of practical necessity. Owing to a tragically unfolding increase in COVID-19 infections and deaths, the Serum Institute of India, which had been slated to manufacture 200 million doses for 92 countries in a contract with COVAX, has delayed its shipments to other global south countries so as to concentrate on helping Indian citizens.Footnote ⁴

Apart from hoarding, rich countries have been stingy with financial aid that would support drug manufacturing and distribution to the global south. The United States and Europe have made but meagre contributions to COVAX, the World Health Organization initiative to ensure rapid and equitable global access to COVID-19 vaccines. (Overall, COVAX has received less than half of the $38 billion it targeted for relief efforts.)Footnote ⁵

Figure 2 illustrates the stark reality people in the global south face. To the extent they will receive any COVID-19 vaccines at all, they will receive vaccines that are easier to transport and storeFootnote ⁶, which makes sense given the capabilities of their health care delivery systems. However, as the chart also illustrates, they are more likely to get only the cheaper, possibly less effective and often-unproven vaccines developed in India, China and Russia.

Figure 2.

Covid-19 vaccine development (as of April 2021).

Source: public documents and reports.

II. The Moral and Human Rights Case for COVID-19 Vaccine Access

The most basic moral principle, at least in the Western ethical tradition, is the ‘golden rule’ to love your neighbour as you love yourself. Jagan Chapagain, the Secretary-General of the International Federation of the Red Cross, expressed this principle most eloquently in their entreaty to send a greater proportion of available vaccines to the global south: ‘Almost 70% of vaccinations so far have been sent to the 50 richest countries in the world, with just 1% of vaccinations going to the 50 most impoverished countries. This is alarming because it’s unfair … In the race to end this pandemic, we are all rowing in the same boat. We cannot sacrifice those at highest risk in some countries so that those at lowest risk can be vaccinated in others.’Footnote ⁷ WHO spokesperson Margaret Harris expressed a similar sentiment to the BBC: ‘We want to see vaccinations happening all around the world … We want to see vaccination of health workers, older people, in every country … So we’re asking every country to focus on prioritizing those groups.’Footnote ⁸

Quite simply, Harris and Chapagain are asking that Europe and the United States treat the rest of the world as part of the same moral universe that our own citizens inhabit. But the sad truth is that citizens in rich countries mostly do not view their counterparts in the global south as moral equals. Otherwise, how does one explain our de facto algorithm for vaccine distribution – to vaccinate everyone in rich countries first and then and only then to start to vaccinate the most vulnerable and essential workers in the global south. Put simply and in the moral parlance of our time, global south lives matter. It is only our tribalism and sense of entitlement that stand in the way of acknowledging our global moral responsibilities.

From a moral perspective, another troubling development is that, rather than speaking in the language of human rights, many pitch the importance of rich countries contributing to the COVAX fund in the corporate speak of enlightened self-interest, i.e. rich countries should help poor and disenfranchised people in the global south not because they have the human right to health care, but rather because it will lower their own GDP if they do not.Footnote ⁹ From a moral perspective, this is about as baseless an argument as can be made. People in the global north should care about people in the global south not because it is a ‘win-win’, but rather because justice demands it, because it is morally wrong to fail to consider their suffering, and because they have a human right to essential medicines.

Is there a human right to health care?Footnote ¹⁰ Not all states guarantee a legal right to health care. In the United States, for example, the provision of and payment for health care is mostly conducted through the private sector and tied to employment benefits. It is not explicitly contained in any constitutional rights or protections.Footnote ¹¹ Despite the lack of universal access to health care in the United States, however, the idea of a human right to health care is well established. Article 25 of the Universal Declaration of Human Rights, for example, provides that everyone has a right to medical care.Footnote ¹²

The contours of how the human right to medical care might apply to COVID-19 vaccine access developed by private pharmaceutical companies can be discerned by examining the Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines (the ‘Hunt Guidelines’) submitted to the United Nations General Assembly in 2008, by Paul Hunt, the Special Rapporteur on the right to the highest attainable standard of health. The Hunt Guidelines set forth specific responsibilities of pharmaceutical companies, as developers and sellers of medicines, with regard to access to medicines.Footnote ¹³ Essential medicines, as defined by the WHO, are the medicines that ‘satisfy the priority health care needs of the population’.Footnote ¹⁴ The WHO goes on to declare that ‘essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford’.Footnote ¹⁵ It is no great leap to conclude that if and when a COVID-19 vaccine or standard of therapeutic care is developed, it will be classified as an ‘essential medicine’ (EM) by the WHO.

The UNGPs do not explicitly address health care in the manner of the Hunt Guidelines. However, by general inference there are provisions in the UNGPs that could be considered relevant to establishing duties on behalf of drug companies to provide affordable access to citizens in the global south. The UNGPs were unanimously adopted by the UN Human Rights Council in 2011. They provide that businesses and member states each have distinctive responsibilities and obligations with respect to human rights. According to the ‘protect, respect, remedy’ framework, businesses bear responsibilities to ‘respect’ human rights: ‘this means that they should avoid infringing on the human rights of others and should address adverse human rights impacts with which they are involved’.Footnote ¹⁶ This responsibility requires that businesses: ‘seek to prevent or mitigate adverse human rights impacts that are directly linked to their operations … even if they have not contributed to those impacts’ (emphasis added).Footnote ¹⁷ The commentary indicates that business responsibility for adverse human rights impacts includes ‘both actions and omissions’.Footnote ¹⁸ As a result it might be inferred that failing to take steps to make COVID-19 medications available to under-privileged populations, including in the global south, would constitute such an omission by drug companies in violation of the UNGPs.Footnote ¹⁹

What do the human rights duties of drug companies with respect to COVID-19 consist of? Robert Shanklin and I have argued that the obligations of pharmaceutical companies are limited by their responsibilities to shareholders and the need to adequately and sustainably incentivize innovation.Footnote ²⁰ Nevertheless we argue that donations, differential pricing, and relaxation of patent rights are all policies, separately or in tandem, that drug companies can and should follow to assure greater access to people in the global south.Footnote ²¹ Indeed, in the very short time since they developed vaccines, all of the major pharmaceutical companies from the United States and Europe – including Pfizer, Moderna, Johnson & Johnson and AstroZeneca – have followed one or more of these policies in an effort to expand supply to the global south.

These voluntary efforts by pharmaceutical companies to act in a socially responsible manner were undermined by United States government when it signalled to the World Trade Organization (WTO) that it would support patent relaxation to increase global vaccine distribution. Apart from the dangerous precedent this set for incentivizing research and development for future pandemics, this gesture was particularly ineffectual for a number of other reasons. First, as even the WTO has acknowledged, the bottleneck for vaccine production is manufacturing capacity and storage requirements, not intellectual property.Footnote ²² Second, the United States can address the global pandemic more effectively by releasing the hundreds of millions of doses it is hoarding but does not need for its own citizens. Finally, another more effective intervention would have been to mirror its response to the HIV/AIDS crisis whereby since 2003 the United States has donated over $85 billion to pay for drugs and medical supplies to be distributed in the global south.Footnote ²³ In early June 2021, as this article was going to press, the Biden Administration announced a shift in policy to donate and aid in the distribution of 80 million vaccine dosages previously being hoarded.

III. The UNGPs and Human Rights Abuses by States: Closing the Accountability Gap

As the foregoing analysis demonstrates, the UNGPs have nothing to say (except by inference) about the vaccine nationalism and hoarding that lay at the root of why COVID-19 vaccines are not reaching many needy citizens in the global south. By design they are meant to invoke business responsibility for human rights violations and not state responsibility. However, it is a distinct and important shortcoming of the UNGPs that they offer no guidance in situations where states and business entities bear overlapping or complementary human rights duties.

The UNGPs are emblematic of a broad historical shift in focus among human rights advocates from government to business responsibility for human rights. This shift stems, in large part, from the human rights accountability gap that began to take shape as early as the founding of the United Nations in 1945. Except in rare instances where human rights violations constitute a threat to or breach of peace, or an act of aggression, pursuant to Article 39, the UN Charter failed to provide any mechanisms for preventing or redressing human rights violations by member states. Even after the adoption by the UN General Assembly of the Universal Declaration of Human Rights, and the promulgation of the Covenant on Civil and Political Rights and the Covenant on Economic, Social and Cultural Rights, there are no authoritative institutions that effectively monitor, prevent and remedy member state violations of human rights. The United Nations Human Rights Council was created in 2006 and charged with promoting and protecting human rights. The Council continues, however, to be plagued by many of the same problems of its predecessor, the Commission on Human Rights – the election of notorious human rights violators to its membership, selective and seemingly arbitrary focal points of concern, and a lack of power to hold member states accountable.

With no hope of holding member states accountable, human rights advocates have understandably turned to business as the focus of attention. After an initial hiccup in the form of the overly ambitious ‘Norms on the Responsibilities of Transnational Corporations’ which got pushback from the business community, the United Nations hit its stride in directing just the right level of scrutiny and responsibility of business in the form of voluntary guidelines. With promulgation of the UNGPs a decade ago the attention of scholars, lawyers, activists and governments has been re-directed from states to business entities and how they could be made to ‘respect’ human rights, to refrain from being complicit in human rights violations and to remedy human rights violations they have committed or been complicit in.

States, the UNGPs tell us, are responsible for holding businesses responsible for their human rights responsibilities. Beyond this responsibility to hold business responsible, the UNGPs do not address any human rights duties of states to themselves refrain from violating human rights. The ink was not yet dry on the UNGPs before lawyers began to call for a treaty to turn them into binding obligations. More recently, human rights advocates have pressed for states and intergovernmental associations to adopt ‘due diligence’ rules to help assure corporate compliance with the UNGPs. Lost in this quick shuffle (of great interest to lawyers particularly) from principles to binding treaties and due diligence is the enduring role of nation states in human rights violations.Footnote ²⁴ ‘Pillar One’ of the Guiding Principles speaks of the state duty to protect human rights, meaning from violations by business or other third parties, not from the state’s own violations of human rights. No wonder and no surprise that the UNGPs received unanimous approval by the member states of the UN Human Rights Council, including support from notorious human rights violating nations such as China and Russia. It is much easier and less controversial to point the finger of responsibility towards business rather than at yourself. As long as the spotlight remained safely on business and away from states, the United Nations became a convivial place to consider business and human rights. Thus, each Fall until the pandemic arrived, an astonishing number (in the thousands) of business and human rights advocates and the like descend each year upon Geneva for an annual Forum on Business and Human Rights hosted by the UN. As long as the focus remains on business and little mention is made of human rights violations by states, thousands in the human rights community will remain welcome at the elegant Palais des Nations to enjoy the magnificent view of Mont Blanc looming over Lake Geneva.

The problem, from a human rights perspective, is that the human rights community has been co-opted by the convening power and seductive prestige of the UN into a narrow perspective which sees no evil in the state violations of human rights that lay at the heart of nearly all business and human rights issues. Most business and human rights problems consist of overlapping state and business human rights violations. Indeed, one might reasonably argue they are the norm rather than the exception. In Brazil, for example, the government has constructed the Belo Monte Dam on the Xingu River, a major tributary of the Amazon. In the process, some 20,000 indigenous people were displaced and the rainforest will suffer environmental threats. To be sure, there are private contractors whose actions also have human rights consequences, but in the Bello Monte Dam case, the prime generator of human rights violations is the state. The role of business is ancillary to that of the state which controls land rights and sets development policies and environmental standards.Footnote ²⁵ In the Saramaka People case against Suriname before the Inter-American Court of Human Rights the connection between state and private enterprise is subtler. Multinational companies, mostly Chinese, invaded the territory of the Saramaka to log and mine.Footnote ²⁶ However, again this was done with the explicit permission of the state. In both of these cases, it is impossible to assign moral responsibility to the role of companies without seriously assessing the role of the state.

The persistent involvement of states in human rights violations where businesses operate takes place in every region of the world. In the United States, for example, the government has granted a permit to build the Dakota Access Pipeline under the Missouri River, threatening the main source of drinking water for the Standing Rock Sioux Tribe. Who is to blame for this environmental threat? It is tempting to assign sole blame for potential human rights violations to Texas-based Energy Transfer Partners, but that would ignore the crucial role of the US government.Footnote ²⁷ In another well-publicized case of atrocities committed against women and indigenous people at the Porgera Gold Mine in Papua New Guinea, where can one reasonably draw the line between the responsibility of the state and the responsibility of the Barrick Gold Corporation?

V. Beyond the UNGPs: Re-Emphasizing the Role of States in Human Rights

Without understanding the direct and complicit role of states in human rights violations involving business, we cannot understand the extent and limits of the moral responsibilities of corporations. Nation-states and local governments need to be at the forefront of our concern about human rights concerns. Businesses, along with NGOs, global civil society, and even international institutions, play important but ultimately secondary roles to states and local governments in protecting human rights and business responsibility for human rights must be understood in this context.

Given the reluctance of the UN to address human rights violations by its member states, a serious question arises of whether the UN is really the appropriate venue to centralize the business and human rights agenda. To pick but one example of how the UN is unsuited as a venue to address human rights concerns that mix state and business responsibilities, is it reasonable to expect that at the next meeting of the annual UN Global Forum on Business and Human Rights in Geneva that China would not seek to block a panel on the role of Chinese technology companies in surveillance used to deprive citizens of privacy and other political and civil rights?Footnote ²⁸ Or, for that matter, will it be possible to have a public conversation of the responsibilities of companies like H&M with respect to cotton sourced from Xinjiang in light of the human rights abuses against Uighurs?Footnote ²⁹

While there is much to be gained from the heightened scrutiny the UNGPs have focused on business, the emphasis has come at the cost of shifting attention away from the role of states. The good work of building on the UNGPs should continue, but as we look to the next decade it is time to start appreciating that the business and human rights movement is but part of the broader human rights movement that mostly should be directed against human rights violations by states. I have elsewhere described the business and human rights field as ‘both a multidisciplinary (and sometimes interdisciplinary) academic field drawing from, inter alia, business ethics, law and the social sciences, and a social, economic and political justice movement involving governments and inter-governmental institutions, as well as indigenous peoples, non-governmental organizations, and other civil society actors.’Footnote ³⁰ Highlighting the limitations of the UNGPs is not meant to diminish the galvanizing force they have played in bringing attention and interest to the business and human rights field. However, because the UN is not the ideal forum to reconstitute this focus, the business and human rights community must find other moral and legal language and geopolitical modalities to address human rights problems where business entities and states bear overlapping responsibilities in ways that the UNGPs do not adequately consider.