I. Introduction
Just three weeks after the World Health Organization (WHO) recognized COVID-19 as a global pandemic, novelist Arundhati Roy wrote: ‘Historically, pandemics have forced humans to break with the past and imagine their world anew. This one is no different. It is a portal, a gateway between one world and the next.’Footnote 1
Nothing has illustrated that gateway more than the development of safe and effective COVID-19 vaccines. In January 2021, WHO Director-General Dr Tedros Ghebreyesus warned of the threat of global inequity in COVID-19 vaccine access. Echoing Roy, he urged governments to avoid mistakes made in the past, ‘to write a different story’.Footnote 2
The right to health is enshrined in the International Covenant on Economic, Social and Cultural Rights,Footnote 3 which specifically refers to the ‘the prevention, treatment and control of epidemic diseases’.Footnote 4 Reference to the right to health also appears in the constitution of the WHO,Footnote 5 and in at least 115 national constitutions around the world.Footnote 6 Access to vaccines has explicitly been recognized as a necessary element of the full realization of the right to health.Footnote 7 A range of human rights actors including the Committee on Economic Social and Cultural Rights,Footnote 8 the Office of the High Commissioner for Human Rights (OHCHR),Footnote 9 and UN special proceduresFootnote 10 have called for a rights-based approach to COVID-19 vaccine manufacturing and distribution.
Yet global COVID-19 vaccine access remains inequitable. By June 2021, most high-income countries had achieved around 50 per cent vaccination of their populations, while lower-income countries were struggling to achieve 1 per cent.Footnote 11 COVAX, the global vaccine procurement mechanism on which many low- and middle-income countries depend, had no vaccines to give in June and is struggling to deliver even on its modest goal to provide at least 20 per cent coverage.Footnote 12
In this piece, we explore key power dynamics determining access to lifesaving COVID-19 vaccines and other health products. In section II, we outline states’ human rights obligations (particularly around international cooperation and private sector regulation) and the private sector’s independent human rights responsibilities. We then discuss in section III the power of a small number of high-income governments at the World Trade Organization (WTO) to influence the debate over a temporary waiver of some intellectual property rules for the COVID-19 response. We explore the politics that have allowed commercial interests to thwart the work of the WHO. In section IV, we analyse the shortcomings of relying on voluntary action by the private sector to make lifesaving health care available and affordable for all, and how governments have failed to regulate pharmaceutical companies to enhance global vaccine availability and affordability. This has interfered with low- and middle-income governments’ abilities to fulfil their human rights obligations.
We conclude this piece in section V by arguing that delivering vaccine equity requires sharing the benefits of scientific research widely, breaking with the past and making long-overdue power shifts, some of which could happen through a proposed pandemic treaty.
II. Human Rights Frameworks
The stark global inequity in access to COVID-19 vaccines has severe human rights consequences, impacting the rights to life, health, and an adequate standard of living.Footnote 13 Government response measures implicate a broad range of other rights such as education, freedoms of speech, assembly, access to information, and political participation.Footnote 14
International law recognizes the right of everyone to benefit from scientific progress.Footnote 15 Since the onset of the pandemic, the UN special procedures and OHCHR have repeatedly reiterated that states have an obligation to share the benefits of scientific research.Footnote 16
States have obligations concerning international cooperation.Footnote 17 They should refrain from actions that interfere, directly or indirectly, with the enjoyment of rights in other countries: no state should act in ways that frustrate the efforts of other states to fulfil their human rights obligations, including when negotiating international agreements or participating in decisions as members of international organizations.Footnote 18
Governments’ right to health obligations include learning from previous missteps and preventing recurrence of rights failuresFootnote 19 and taking measures to prevent third parties, such as businesses, infringing on human rights not only domestically but also extraterritorially in other countries.Footnote 20 States should regulate the international operations of pharmaceutical companies domiciled within their territory or jurisdiction to ensure that they ‘do not violate economic, social and cultural rights abroad’.Footnote 21
Private entities also have an independent responsibility to respect human rights. Private entities, including those developing and manufacturing vaccines and other health products, should ensure that their operations are aligned with the UN Guiding Principles on Business and Human Rights (UNGPs) and the 2008 Human Rights Guidelines for Pharmaceutical Companies issued by the UN Special Rapporteur on the right to health.Footnote 22
III. The World Trade Organization is Not a Global Health Forum
Intellectual property is a barrier to swiftly scaling up and diversifying the production of COVID‑19 health products, including vaccines.Footnote 23 In October 2020, India and South Africa introduced a proposal to temporarily waive certain rules in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). They cited the exceptional circumstances posed by the pandemic and the urgent need for member states to collaborate ‘to ensure that intellectual property rights … do not create barriers to the timely access to affordable medical products including vaccines and medicines.’Footnote 24 The proposal would cut through the morass of laws and restrictions governing intellectual property that impede widespread manufacturing and exports.Footnote 25
By that time, rich governments were aggressively signing bilateral deals with pharmaceutical companies to pre-book future COVID-19 vaccines for their own populations.Footnote 26 Many of these same governments, facing intense and aggressive lobbying from the pharmaceutical industry,Footnote 27 have blocked the TRIPS waiver proposal from moving forward despite support from more than 100 governments,Footnote 28 the WHO Director General,Footnote 29 Nobel laureates and former world leaders,Footnote 30 lawmakers,Footnote 31 labour unions,Footnote 32 the People’s Vaccine Alliance,Footnote 33 and countless civil society organizations.Footnote 34 The WTO typically makes decisions through consensus, giving enormous power to a small number of countries to block action.
The Biden Administration announced its support for a waiver in May 2021 after it concluded that ‘[t]hese extraordinary times and circumstances … call for extraordinary measures’Footnote 35 and broke ranks with the European Union, Australia, and a few other states in opposition.Footnote 36
The blockade at the WTO by a handful of high-income countries backed by powerful pharmaceutical companiesFootnote 37 undermines other governments’ abilities to act on their human rights obligations to deliver vaccines and other health products to curb the spread of COVID-19.Footnote 38 Disregarding the obligation of international cooperation and obstructing a rapid health response is likely to inhibit low- and middle-income countries’ ability to achieve the Sustainable Development Goals.Footnote 39 The process has left the WHO and public health authorities throughout the world hamstrung by a protracted debate at the WTO – whose mandate is to promote free trade and which has, historically, pursued that as a priority over health, environment or human wellbeingFootnote 40 – in the midst of a public health catastrophe.
IV. The Benevolence of Pharmaceutical Companies is Not a Rights-Based Solution
Governments have poured billions of dollars of public funds into research and development of COVID-19 vaccines.Footnote 41 However, only a few contracts with vaccine developers have been published. Those that are publicly available are often heavily redacted and mostly public due to leaks, freedom of information law requests, or investigative reporting.
However, the limited information availableFootnote 42 suggests that states subverted their human rights obligations to commercial interests. They gave pharmaceutical companies and other private entities the power to treat publicly funded research as private intellectual property without any conditions that would prioritize stopping the spread of COVID-19 over commercial interests.Footnote 43 As a result, today, private developers of vaccines effectively control when and where to distribute vaccines, to whom and on what terms they will license their technology, and at what prices they will sell these vaccines to governments around the world because this power flows from their ability to protect their intellectual property. This system is not new, but the pandemic exposed how deeply flawed it is when juxtaposed against an urgent imperative to combat the pandemic and realize the right to health.
As far back as May 2020, the Costa Rican government spearheaded a Solidarity Call to Action with the WHO to create the COVID-19 Technology Access Pool – a common shared pool of rights to technologies, data, and know-how that everyone around the world could use to manufacture health products needed to tackle COVID-19, including vaccines.Footnote 44 More recently, the WHO created mRNA technology transfer hubs.Footnote 45 To date, no government has used its regulatory or funding clout to incentivize pharmaceutical company participation in these platforms, and no large vaccine maker has voluntarily joined them.
Another avenue to increase the supply of health products during public health crises is compulsory licenses, whereby governments can issue a license to use patented technology without the permission of the patent-holder. This is expressly permitted as part of the TRIPS Agreement and is widely referred to as the ‘flexibility’ given to governments to prioritize public health over intellectual property rights. In practice, though, compulsory licenses are ridden with practical barriers and are not an effective solution, especially for vaccines, which require not just sharing patented technology but also know-how.Footnote 46
Still, companies have tried to prevent compulsory licensing. For example, Gilead unsuccessfully sued the Russian government for issuing a compulsory licence to manufacture Remdesivir, a drug used to treat COVID-19.Footnote 47 Similarly, pharmaceutical industry associations lobbied against the Hungarian government’s compulsory license for Remdesivir.Footnote 48
Even in the absence of regulations and contractual obligations, private entities have independent human rights responsibilities.Footnote 49 Private entities include not just corporations that research, develop and manufacture vaccines and other health products, but also supranational private organizations like the Coalition for Epidemic Preparedness Innovations (CEPI), and Gavi, the vaccine alliance, which research and develop, and procure vaccines, respectively. CEPI and Gavi are public–private partnerships, and they have collaborated with the WHO to form COVAX, the global vaccine initiative. COVAX’s governance and operations should abide by all human rights standards applicable to private entities.
According to the UNGPs, a private entity’s human rights due diligence should be ongoing and developed in consultation with relevant stakeholders and ‘potentially affected groups’,Footnote 50 which in the context of COVID-19 vaccines should include independent human rights groups, public health and intellectual property rights experts, and patients’ organizations. These stakeholders and the WHO have identified supply deficits, intellectual property barriers, a lack of geographically diverse manufacturing, and high prices as risks that impede equitable COVID-19 vaccine access globally.Footnote 51
Companies should publicly disclose how they plan to respond to these and other risks, demonstrate the steps they are taking to address them, and track progress. Such corporate disclosure is central to, and part of, effective human rights due diligence.Footnote 52 A lack of transparency by private entities, coupled with their extensive use of non-disclosure agreements, interferes not just with the overall pandemic response but also impedes accountability in public procurement.
There have been some small steps in the right direction. COVAX, for example, publishes forecasting for how countries that it supplies will receive vaccines and maintains a delivery tracker (such as the one published by UNICEF).Footnote 53 But it still does not publish the prices at which pharmaceutical companies supply vaccines to COVAX, which deviates from UNICEF’s long-standing good practice for other vaccines.Footnote 54
Private entities supplying governments should at least publish supply forecasts and delivery trackers, and disclose procurement prices. They should also exempt pricing data and vaccine procurement contracts from the purview of non-disclosure agreements. These transparency measures are strong antidotes to corruption risks and are key to holding both governments and companies accountable.
V. The Way Forward: Sharing Knowledge as Justice Footnote 55
The pandemic has laid bare the dangers of governments relying on corporate voluntary action to deliver universal and equitable vaccine access. The concentration of power and know-how among a handful of pharmaceutical industry leaders and governments that refuse to regulate them, combined with centering a significant policy discussion on a global health crisis at the WTO and not the WHO, has created deep inequities in access to the health products that can save lives.
A gulf has emerged between a rights-based and equitable approach to ending the pandemic and the prerogatives of powerful interests. A shift needs to happen to move from voluntary action to enforceable global health norms, and from hoarding the benefits of scientific research to sharing it.Footnote 56 The COVID-19 pandemic has shown the system needs a long-overdue course correction where the WHO is empowered, and not undermined, by the WTO.
The WHO will hold a special session in November 2021 to discuss a proposed ‘pandemic treaty’.Footnote 57 While the pandemic treaty has generated vocal support, governments’ focus on the next generation of mechanisms distracts from efforts to utilize the tools available now to address the current crisis. This abdication of responsibility will be on full display if a pandemic treaty fails to enact binding mechanisms that allow for equitable access to life-saving measures.
Negotiations on a new treaty could take years. If discussions progress, any pandemic treaty should include triggers for automatic intellectual property waivers, require transparency and accountability mechanisms for supranational public–private partnerships, and regulate the use of confidentiality clauses by all private and government entities. It should create pathways for de-commodifying life-saving medical products to have meaningful impact on global health.Footnote 58
Participating in WHO technology sharing platforms and temporarily waiving intellectual property rules are critical ways forward. Yet foot-dragging and equivocation among a powerful minority continues even as infections and deaths soar and the virus mutates.Footnote 59 Instead, this pandemic should be the portal through which the world emerges stronger and centered on rights, justice and equity.
