Can we move beyond vaccine apartheid? Examining the determinants of the COVID-19 vaccine gap

ABSTRACT

While global health leaders call disparities in access to COVID-19 vaccines an ‘apartheid,’ this gap is not the first such disparity. The recurrence of these gaps in low and middle-income countries and especially in Africa, raises questions about their determinants and about the persistent failures of global health institutions to remediate them. We interrogate these determinants and questions by examining: (1) the distribution of COVID-19 vaccines; (2) primary determinants of vaccine access including availability and affordability; (3) factors affecting availability (hoarding, COVAX, and manufacturing capacity); and (4) factors affecting affordability (pricing, intellectual property rights (IPR), the TRIPS waiver and a potential pandemic treaty). We conclude that IPR constrained the affordability and availability of COVID-19 vaccines in ways inadequately addressed by COVAX and a waiver compromise thwarted by political, corporate, and philanthropic interests. While stronger limits to IPR in a pandemic treaty and a reformed International Health Regulations will not resolve structural inequities, they could meaningfully expand LMIC autonomy to protect public health. We urge equity-seeking Global South and North actors to fight for such IPR reforms as small and meaningful steps towards a more equitable global health order. Otherwise, criminally racist ‘apartheids’ will continue to be the norm when it comes to the distribution of essential health goods during global health emergencies.

KEYWORDS:

• COVID-19
• vaccines
• TRIPS waiver
• COVAX
• intellectual property rights
• global health equity

Introduction

Global access to COVID-19 vaccines has been marked by deep and disturbing disparities. As late as February 2023, over thirty percent of the global population lacked access to even a first dose of a COVID-19 vaccine, with most vaccines administered in high income countries (HICs) (Ritchie et al., 2023). These disparities have threatened public health in low and middle-income countries (LMICs) and especially on the African continent, violated a range of human rights including to health and life, and undermined the efficacy of global pandemic responses. The extent of this gap is so deep that key global health leaders have called it ‘vaccine apartheid’ (Achiume, 2022; Byanyima, 2021; Ghebreyesus, 2021), while scholars and advocates have framed this gap as a form of ‘necropolitics’ (Otieno-Sumba, 2021) and as tantamount to a crime against humanity (Hassan et al., 2021). Unsurprisingly given the commercial and public health interests at stake, the causes of and solutions to these disparities are heatedly disputed: HICs and pharmaceutical companies suggest that international aid and distributive mechanisms like the COVAX facility are sufficient to resolve this gap. In contrast, LMICs and civil society groups have argued that what is needed instead of aid and donations are wholesale waivers of IPR under the World Trade Organization (WTO) Agreement on Trade-Related Intellectual Property Rights (TRIPS) to enable local manufacturing and distribution of affordable vaccines (Kavanagh et al., 2021).

Yet the COVID-19 vaccine gap is neither the first nor presumably the last gross disparity in the allocation of an essential public health good during a public health emergency. Nor is it a unique exemplar of disputes over the public health impact of IPR, as prior struggles over antiretrovirals (ARVs), H1N1 vaccines, and affordable medicines more generally illustrate. In this light, the scale and recurrence of these disparities raises broader questions not simply about their determinants, but about the persistent ethical, legal, and political failures of global health institutions to prevent or resolve such foreseeable gaps.

In this paper, we delve into these debates and questions by analysing the key determinants of the global COVID-19 vaccine gap. To do so, we first overview the rapid development and inequitable distribution of COVID-19 vaccines. Second, we consider recognised determinants of global access, focusing on availability and affordability. Third, we consider factors affecting availability, including vaccine hoarding, the COVAX mechanism, and limited manufacturing capacity. Fourth, we consider factors affecting affordability including vaccine pricing, TRIPS, and a TRIPS waiver. We also consider the potential contribution of prospective global health law reforms to the governance of future pandemics. We conclude by considering what these political actions and compromises over COVID-19 vaccines and IPR tell us about the determinants of such disparities, and indeed about the efficacy of global health actors and governance more broadly.

The rapid development and inequitable distribution of COVID-19 vaccines

There is no historical precedent for the speed and scale with which COVID-19 vaccines were developed. The Pfizer-BioNTech vaccine was the first COVID-19 vaccine to receive emergency use approval by a national regulatory body with first shots being delivered to vulnerable and high-exposure members of the public in many Western nations by December 2020 (Ledford, 2020). By December 2022, a dizzying array of other COVID-19 vaccines were in use or development: 11 vaccines approved for emergency use by the World Health Organization (WHO), 50 vaccines given some form of approval by at least one country, over 240 other vaccine candidates, and 821 vaccine trials (COVID-19 Vaccine Tracker, 2022).¹ To contextualise this pace, before COVID-19, the 10 years it took to develop a measles vaccine was considered rapid, it took over a century to develop a vaccine for typhoid (Maxmen, 2021), and it took on average forty-two years from vaccine development to achieve forty percent coverage versus the eleven months it took in COVID-19 (Glassman et al., 2022).

Since the first COVID-19 vaccines began to be more widely administered in early 2021, over 13 billion vaccine doses had been administered globally by mid-2023 (WHO, 2023a). By early 2023, almost 70 percent of the world's population had received at least one dose and almost two thirds of the global population had been fully vaccinated (Ritchie et al., 2023). Global progress in the administration of these vaccines has been nothing short of remarkable. Yet inequities in their global distribution have been stark, particularly through 2021, a peak period of the global COVID-19 pandemic. By 2023, the highest density of these vaccinations remained in Europe and North America, where close to two thirds of the population had been fully vaccinated (Ritchie et al., 2023). In Asia and Latin America there have been wider variations in full vaccinations, ranging from approximately 90% in China and Chile to 45% in Myanmar and 40% in Guatemala (Ritchie et al., 2023). The lowest extent of full vaccination occurs in Africa: from 63% in Morocco (uniquely high amongst African countries), to 25%–35% in South Africa, Zimbabwe, and Mauritania. In the Democratic Republic of Congo and Madagascar, only 5%–10% of the total population are vaccinated (Ritchie et al., 2023).

As these figures illustrate vaccine disparities have been consistently greatest in low-income countries, with the United Nations (UN) noting in 2021 that around 68 vaccines were ‘administered for every 100 people in Europe and Northern America compared with fewer than 2 in sub-Saharan Africa’ (2021a, p. 3). WHO recommendations to add booster doses to vaccine regimens (WHO, 2022a) have only reinforced these disparities, with access ranging from around 38% in Asia to 53% in Oceania, to under 5% in Africa (Ritchie et al., 2023).

These alarming global disparities have been decried as a form of vaccine apartheid by Dr. Tedros Ghebreyesus, the Director General of the WHO, Dr. Winnie Byanyima, the Executive Director of UNAIDS, and Ms. E. Tendayi Achiume, the UN Special Rapporteur on contemporary forms of racism (Achiume, 2022; Byanyima, 2021; Ghebreyesus, 2021). Other UN leaders, like Antonio Guterres, the UN Secretary-General, have framed the global distribution of vaccines as the ‘biggest moral test before the global community’ (UN News, 2021). These uses of the language of ‘apartheid’ are notable: an ‘apartheid’ is not a naturally occurring phenomenon, but the intentional and foreseeable outcome of policies, laws, and practices designed to systematically oppress specific groups through gross violations of basic human rights and the infliction of serious bodily harm (UN, 1974). The legal and moral severity of apartheid is such that it has repeatedly been defined in international treaties as a crime against humanity (UN, 1974; UN General Assembly, 1998). In this light, even if global health leaders are using the term ‘apartheid’ to denote gross ethical failures rather than egregious violations of international law, its gravity and implicit evocation of racist criminality cannot, and should not, be ignored. Indeed, that the greatest of these disparities has occurred in Africa gives uncomfortable truth to this framing. The use of the term ‘apartheid’ by global health and human rights leaders should raise pressing questions about the causes of such disparities and their solutions, and about the nature of a global health system which frequently permits and rarely remediates such gaps.

Key determinants of global disparities in access to vaccines

A long-standing WHO conceptual framework identifies the key determinants of access to medicines (including vaccines) as (1) rational use of essential medicines, (2) the existence of health system and supply chains, (3) affordable pricing, and (4) sustainable financing (WHO, 2004). In the context of COVID-19 vaccines, Wouters et al. (2021) identify the determinants of access to primarily include: (1) the development and production of vaccines, (2) affordability as determined by pricing and sustainable funding, (3) their allocation through sufficient availability and multilateral support, and (4) their wide deployment in domestic and regional infrastructure in the context of public confidence to assure uptake.

The emphasis in both frameworks on affordability and financing underscores the key contribution these variables play in determining access and availability more broadly: In LMICs, most drug expenditures are out-of-pocket and make up one of the largest public health expenditures by national health care systems (Bigdeli et al., 2015; Lu et al., 2011; Velásquez et al., 1998; Wirtz et al., 2016). Indeed, many essential medicines beyond COVID-19 therapeutics remain unaffordable and insufficiently available in LMICs, and in many countries, ‘medicine availability is poor countries … (particularly in the public sector), prices are high, and treatments, especially those for noncommunicable diseases, are unaffordable for those on low wages’ (UN MDG Gap Task Force, 2015, p. 58).

This focus on affordability and availability is similarly apparent in the Sustainable Development Goal (SDG) on health (SDG3) which calls for ‘access to safe, effective, quality, and affordable essential medicines and vaccines for all’ as a key part of achieving universal health coverage (UN, 2015). It is notable in this context that SDG3 on health not only affirms affordable access to medicines and vaccines for all as a universal goal but affirms the right of ‘developing countries to use to the fullest extent, flexibilities in TRIPS to protect public health, and, in particular, provide access to medicines for all’ (UN, 2015, SDG3.b).

The centrality of the affordability and availability of essential medicines is similarly underscored in international human rights law which holds these as essential elements of rights to health and science that impose duties on states in multiple realms (UN Committee on Economic Social and Cultural Rights (CESCR), 2000, 2020a, 2020b). For example, under the right to health, states hold obligations to assure access to accessible, affordable, and good quality health care, with essential medicines identified as part of a state's most essential and core obligations under this right (UN CESCR, 2000). In the context of the right to health, affordability is defined as a key element of accessibility, alongside non-discrimination, physical accessibility, and informational accessibility (UN CESCR, 2000). When it comes to IPR, states have duties ‘to prevent unreasonably high costs for access to essential medicines … from undermining the rights of large segments of the population to health, food and education’ (UN CESCR, 2005, para. 35). Under the human right to science, states have duties to use TRIPS flexibilities to ensure access to essential medicines, and to refrain from granting disproportionately long patents to new medicines to allow the production of generic medicines with a reasonable time frame (UN CESCR, 2020a, 2020b). During COVID-19, UN human rights bodies have gone further by urging states to consider the TRIPS waiver as an important means and ‘essential element’ of complementary strategies to assure the global affordability and availability of vaccines (UN CESCR, 2020a, 2020b, 2021).

As these interpretations indicate, affordability and availability are key dimensions of human rights protections around health and medicines. Certainly, these variables cannot be separated from other determinants of access, including the research and development (R&D) that produces patentable products, and factors that impact vaccine deployment including health systems, cold chain storage, and vaccine hesitancy. Yet empirical, scholarly, and legal analysis and interpretation makes clear that affordability and availability are particularly important determinants of access to medicines and vaccines that hold heightened importance in public health, international human rights law, and ethics. Moreover, the COVID-19 pandemic has reinforced the extent to which availability has been fundamentally controlled by the supply of COVID-19 vaccines, and the extent to which TRIPS-related IPR gave rights-holders control over supply quantities and their distribution. For these reasons, the remainder of this paper focuses on how affordability and availability have factored into global disparities in access to COVID-19 vaccines.

The availability of vaccines: Vaccine hoarding, COVAX, and manufacturing capacity

The availability of vaccines has been deeply shaped by vaccine hoarding and the limitations of both the COVAX mechanism and domestic manufacturing capacity. The following section explores these factors.

Vaccine hoarding and COVAX

Once COVID-19 vaccines became available, they were scooped up and hoarded by HICs. By the middle of 2020, HICs had purchased enough vaccines through advance market commitments (AMC) to vaccinate their populations several times over. AMC work through donor funding that subsidises initial purchases of a newly introduced vaccine to assure that companies can recoup R&D costs (Kremer et al., 2022). While these AMC were critical in enabling pharmaceutical companies to speedily bring vaccine candidates to market, they also effectively earmarked those vaccines to the countries that had pre-purchased them.

By the end of 2021, most HICs had purchased enough doses to vaccinate somewhere between 200 to 400% of their populations, which means that these countries had enough doses to vaccinate each person two to four times over (Duke Global Health Innovation Center, 2023). While several HICs engaged in this behaviour, this hoarding was most pronounced in Canada which, by May 2022, had purchased 418.9 million doses, enough to vaccinate the population 5.71 times over (Duke Global Health Innovation Center, 2023). While over 13 billion doses have been administered globally, over 18 billion doses were reserved, through confirmed purchased and negotiated purchasing deals (Duke Global Health Innovation Center, 2023). Yet of these 18 billion reserved doses, only 4.51 billion were procured by LMICs, and 645 million by low-income countries (Duke Global Health Innovation Center, 2023).

Vaccine access disparities like these are not unprecedented. During the 2009 H1N1 influenza pandemic, HICs bought up most of the global supply of the influenza vaccine through large advance orders. UN and WHO efforts to resolve the lack of access for LMICs yielded donation pledges from manufacturers and HICs that were insufficient for LMICs to cover their populations (Fidler, 2010). During COVID-19, the same practice of vaccine hoarding by HICs at a time when global manufacturing is limited has severely restricted the vaccines available to LMICs and to COVAX, the procurement mechanism launched in April 2020 by the WHO, the Global Alliance for Vaccines and Immunization (GAVI) and the Coalition for Epidemic Preparedness Innovations (CEPI). As these actors suggest, COVAX is a ‘multistakeholder initiative’ that brings together public, private, and philanthropic actors (Moon et al., 2022) and which has since expanded to include the Gates Foundation, UNITAID, the Global Fund, and industry groups such as the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). To this extent COVAX has been described benignly as a ‘super-public-private partnership’ (Storeng et al., 2021) and more critically as a ‘market-friendly charity regime’ (Sparke & Williams, 2022) and ‘philanthrocapitalist enterprise’ (Sparke & Levy, 2023).

COVAX was, and is, intended to operate as a global funding and procurement entity that would invest in the development, manufacturing, and eventual distribution of a large array of COVID-19 vaccines, especially in the early days of vaccine development when there was significant uncertainty regarding the potential effectiveness of any of the vaccines under development (Duke Global Health Innovation Center, 2023). COVAX relies on funding from wealthy countries and other partners to assure vaccines without charge for at least 20% of the populations of LMICs. This arrangement allows the 80 high-income, self-financing countries that are part of COVAX to purchase vaccines for $1.60–3.10 per dose (Geddes, 2021). 92 LMICs are eligible to receive subsidised vaccines through official development assistance and donations through COVAX. COVAX has followed the WHO Fair Allocation Framework (WHO, 2020) which outlines a strategy to initially provide all participating countries with enough vaccines to cover 20% of their respective populations – enough to protect vulnerable groups and frontline healthcare workers – before allocating vaccines to countries based on need. By guaranteeing a baseline number of vaccines, COVAX was intended to incentivize HICs to participate, thus providing the capital for COVAX to operate.

While the initial aim of COVAX was to make two billion doses available worldwide by the end of 2021, with 1.8 billion of these doses targeted to LMICs (BBC, 2021), COVAX had delivered less than 1 billion by the end of 2021 and only reached its target of 1.89 billion to 146 countries over a year later (UNICEF, 2023). COVAX's struggles to meet its goals have been attributed to its failure to address vaccine hoarding and nationalism (Eccleston-Turner & Upton, 2021), early funding shortfalls of up to USD$5.2 billion (GAVI, 2022), and supply chain issues given its initial reliance on Indian exports which were restricted in April 2021 after the Indian government earmarked vaccines for domestic use after the Delta variant emerged (Hunter et al., 2022; Mazumdar, 2021). The majority of these vaccines were to be supplied by the Serum Institute of India (SII), the largest single supplier to COVAX, which stopped shipments after exports were suspended (Mazumdar, 2021). SII's production of COVID-19 vaccines took place through voluntary licences with patent holders including AstraZeneca (to produce Covishield), Johnson and Johnson (to produce Janssen) and Gamalaya (to produce Sputnik-IV) (Koller et al., 2021). It is notable that some of SII's production was to be exported back to the U.K. under its agreement with AstraZeneca, and similarly that the U.S. and E.U. had also instituted export bans on COVID-19 vaccines (Ibrahim, 2021).

Others argue that COVAX's failures result from internal governance weaknesses, including a lack of transparency, accountability, and public participation (Moon et al., 2022; Storeng et al., 2021). More crucially the entity has been accused of privileging pharmaceutical industry concerns over those of LMICs (Eccleston-Turner & Upton, 2021; Stein, 2021) in ways that transformed the entity ‘from a risk-pooling and dose-sharing multilateral buyers’ club into a risk-managing, dose-rationing, donor-dependent agency’ (Sparke & Levy, 2023, p. 72).

COVAX's supply was also undermined by its members’ pursuit of bilateral deals, with the U.S., Canada, European Union (E.U.), U.K. and Gulf countries entering such agreements with pharmaceutical companies, and key middle-income countries like Russia, China, and India securing deals with domestic industries and entering bilateral arrangements with LMICs in Latin America, Africa, the Middle East, and Asia to directly sell or donate vaccines (Storeng et al., 2021; The Independent Panel for Pandemic Preparedness & Response, 2021; Wouters et al., 2021). COVAX's charity model thus did nothing to prevent HICs from hoarding vaccines and did little to assure sufficient quantities for LMICs through either its own mechanisms or through members’ bilateral agreements. These deficiencies underscore that what most LMICs needed was not ‘dose-rationing donor dependency’ (Sparke & Levy, 2023) but local and regional manufacturing capacity (Hunter et al., 2022), and access to knowledge and technology transfer to be able to produce within existing manufacturing sites.

Manufacturing capacity

The scale of need for COVID-19 vaccines has far outstripped global manufacturing capacity. Prior to COVID-19, annual global production capacity for any vaccine (including those without patent protection) was approximately 3.5 billion doses per year. This capacity is clearly insufficient given a global population of 8 billion people and a minimum two doses required for most COVID-19 vaccines on the market (Wouters et al., 2021). This capacity is further strained by moves to third, fourth, and sometimes even fifth vaccine doses (Chenchula et al., 2022). Yet current vaccine manufacturing capacity is concentrated in facilities located in the E.U., the U.S., China, Japan, Indonesia, Russia, and India, with 10 manufacturers estimated to provide 70 percent of all vaccine doses (WHO, 2023c). Africa and Latin America have very limited manufacturing capacity which has significantly limited the availability of COVID-19 vaccines. Notably, countries that manufacture vaccines also have a higher percent of their population vaccinated (Feinmann, 2021). In contrast, African countries have historically relied on imports for 99% of their vaccines (Geddes, 2021). While some African countries (including Egypt, Morocco, Senegal, South Africa, and Tunisia) have some vaccine manufacture capacity that could have been utilised for COVID-19 vaccines, these manufacturers have faced IPR barriers to utilising this capacity even in the absence of technology and know-how transfers. Moreover, in the majority of LMICs which lack manufacturing capacity, IPR holders have largely been unwilling to permit use of their technologies or to share production knowledge, a key determinant of efforts to expand global supply of COVID-19 vaccines (da Fonseca et al., 2023).

There have been several efforts to build production and manufacturing capacity on the African continent: the Africa Center for Disease Control (CDC) and African Union announced the Partnership for African Vaccine Manufacturing to scale up capacity for vaccine manufacturing in Africa and produce 60% of all routine vaccines in Africa by the year 2040 (Africa CDC, 2021). This initiative is being supported by several on-the-ground efforts: in June 2021, the WHO, Medicines Patent Pool, and Act-Accelerator established a technology transfer hub for mRNA vaccines in South Africa, which was followed by an announcement of 15 manufacturers across the continents who will be the ‘spokes’ of this hub (Medicines Patent Pool, 2022). Certainly, this progress is promising, but in the longer-term significant financing will be required to expand research capacity, provide regulatory support, and establish supply networks on the continent (Otu et al., 2021). At the same time, outside limited exceptions, vaccine manufacturers have largely refused to licence or transfer their vaccine technologies or manufacturing capacity to producers in LMICs. For the most part, IPR holders have preferred to maintain their own manufacturing capacity and enter select commercial partnerships to maintain control over vaccine supply and availability. For example, Moderna refused to share its mRNA technology and instead entered an agreement with Aspen Pharmacare in South Africa to produce 500 million vaccine doses supported by a World Bank, U.S., German and French funding package (Wingrove, 2021). Johnson & Johnson and Pfizer BioNTech also made direct bilateral agreements to open facilities, or transfer technology to existing facilities in Africa (Rodriguez, 2021; Wasserman, 2021). In the absence of cooperation, corporate and IPR constraints will continue to hamper the scale up and sustainability of manufacturing capacity in this region.

Affordability: Pricing, IPR, and a TRIPS waiver

The affordability of COVID-19 vaccines is determined by industry and government pricing, and by IPR held under TRIPS. In the following section, we explore these factors as well as the proposal for and compromise on a TRIPS waiver and the implications in this respect of a prospective pandemic treaty.

Pricing variability and the role of IPR

There is limited information available on the pricing of COVID-19 vaccines since many countries have entered bilateral deals with pharmaceutical companies where pricing information is typically kept secret (Apuzzo & Gebrekidan, 2021). What is known is that prices across all COVID-19 vaccines have ranged dramatically from USD$1.92 to as much as USD$40.00 per dose (UNICEF, 2023). While companies generally charged higher prices to HICs, there has also been indications that several LMICs have been charged more than HICs for the same vaccine. This was particularly the case for the AstraZeneca vaccine, despite the company's initial pledge not to profit on sales of its vaccines during the pandemic (Espiner, 2021). For example, while most European countries paid US$2.16 per dose of AstraZeneca vaccines, South Africa, a middle-income country, is reported to have paid US$5.25 (Dyer, 2021; Sullivan, 2021), while Uganda, a low-income country, is reported to have paid US$7.00 per dose (Nakkazi, 2021). Bangladesh, an LMIC, is reported to have paid US$4.00 per dose of AstraZeneca to the SII (Paun & Furlong, 2021); and Sri Lanka, another LMIC, paid US$15.00 per dose for the Sinopharm vaccine (Healthworld, 2021). In contrast, unit prices through COVAX were estimated to be US$1.66 per dose supplied (WHO et al., 2021).

The suggestion that these price differentials are justified by the lower extent of investment that LMICs had made into these vaccines (Dyer, 2021) offers a disturbing indicator of the extent to which commerce drives such global health inequities. This kind of regressive pricing for LMICs is enormously inequitable given how disproportionately pricing impacts medicines access in such countries, a financial burden compounded by the need for modified vaccines against new variants and waning efficacy over time (Wouters et al., 2021). While companies have kept secret the manufacturing costs of these (and other) vaccines, scholars have estimated that even when considering net manufacturing costs like building, staffing, and supplying manufacturing plants and shipping vaccines, the costs for 100 million vaccines doses range from US$ 0.54 to US$ 0.98 a dose (Light & Lexchin, 2021). These relatively low costs contrast with the multi-billion-dollar sales and profits companies made, with one estimate suggesting that in 2021, COVID-19 vaccines sold by the seven largest private vaccine producers generated a net profit of USD$50 billion in 2021, while Pfizer, BioNTech, Moderna and Sinovac alone generated US$D90 billion in profits in 2021 and 2022 (De Haan & Ten Kate, 2023). These profits were facilitated by ‘decades of research funded by public investment, billions in grants for development and production, and tens of billions in Advanced Purchase Agreements’ (De Haan & Ten Kate, 2023, p. 4).

Affordability challenges have deepened given the financial crisis sparked by COVID-19 and exacerbated by war in Ukraine. The pandemic has reversed decades of development progress with the global extreme poverty rate rising for the first time in over twenty years in 2020 and little progress made since then in catching up to pre-COVID-19 trends (UN, 2021a; 2022). The International Monetary Fund (IMF) estimates that the global economy shrunk by 4.4% in 2020, the worst economic decline seen since the Great Depression of the 1930s (Jones et al., 2021). These declines have seen rampant inflation and a cost-of-living crisis, with the IMF projecting that inflation will peak in 2023 amid continuing low-growth (IMF, 2023). While there are indications that official development assistance increased rather than declined over the course of the pandemic (Organisation for Economic Co-operation and Development, 2021; UN, 2021b, 2022a), the global recession is likely to impact global health outcomes for decades to come.

In this context, it is not surprising that LMICs sought almost from the start of the pandemic to ensure that the global IPR system under the WTO not simply be relaxed but waived when it comes to COVID-19 related therapies, diagnostics, and vaccines. State capacity to access affordable vaccines outside of COVAX is deeply determined by TRIPS, which requires states to offer strict 20-year patents to pharmaceutical companies that prevent any non-consensual use of drugs (including vaccines), diagnostics or therapeutics for the period of the patent (WTO, 1995). In practice, TRIPS allows drug companies to maintain high monopoly pricing for the duration of the patent. For example, in Malaysia, the introduction of patents saw drug prices rise by 28% on average per year between 1996 and 2005 (Smith et al., 2009). TRIPS includes provisions that allow the loosening of these IPR in service of public health, including by allowing compulsory licencing and parallel importing where countries respectively manufacture and import cheaper versions of patented drugs to meet public health needs. Yet the use of these flexibilities has been highly contested by pharmaceutical companies and their host governments (Forman, 2012). During the height of the HIV/AIDS pandemic these rules effectively blocked highly affected countries in Sub-Saharan Africa, Latin America, and Asia from accessing or manufacturing lower cost versions of antiretroviral medicines. TRIPS flexibilities have not offered meaningful policy space to remedy these constraints as the tightly constrained way they were codified, revised, and enforced makes them difficult, time consuming and expensive to use. In addition, LMICs that have tried to use flexibilities have faced significant political, economic, and legal opposition from pharmaceutical companies and their host governments in the U.S. and Europe in the form of trade sanctions, corporate litigation, and even stricter IPR in free trade agreements (Gleeson et al., 2019).

These pressures have persisted even as the right of countries to use these flexibilities has been reaffirmed continuously since the 2001 Doha Declaration on the TRIPS Agreement and Public Health first reiterated ‘the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose’ (WTO, 2001, para. 4). The 2015 SDG goal 3 on health cites, as a key mechanism for achieving access to affordable essential medicines and vaccines for all, that states provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration of the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the [TRIPS] Agreement regarding flexibilities to protect public health, and, in particular, provide access to medicines for all (UN, 2015).

The 2016 report of the United Nations High Level Panel on Access to Medicines reaffirmed that ‘WTO members should commit themselves, at the highest possible political levels, to respect the letter and spirit of the Doha Declaration on the TRIPS Agreement and Public Health, refraining from any action that will limit their implementation and use in order to promote access to public health technologies’ (UN Secretary General, 2016, p. 9).

Despite this plethora of global policy endorsements of the legality and necessity of using TRIPS flexibilities, countries still face the same full-court press of trade, economic, legal, and political pressures when they attempt to use these flexibilities, as was the case in India from 2012 to 2014 (Medecins Sans Frontieres, 2015), Malaysia in 2017 (New, 2019) and Colombia in 2018 (Goldman, 2018). Moreover, a 2005 amendment to TRIPS to better enable countries to use TRIPS flexibilities like compulsory licencing for export (the Article 31bis amendment) has proved cumbersome to implement (Forman et al., forthcoming). These barriers have been reinforced by other IPR-related barriers, as companies have been reluctant to share technologies or share trade secrets and know-how. They have also been reluctant to offer voluntary licences through the COVID-Technology Access Pool (C-TAP), which the WHO created in March 2020 to pool rights to technologies useful against COVID-19 by collecting voluntary licences or assignment of rights and allocating these on reasonable and affordable terms in member countries. The first licencing agreement with C-TAP was signed with Spain's National Research Council for a diagnostic test in November 2021 (Medicines Patent Pool, 2021), followed by an agreement with the U.S. National Institute of Health for 11 different COVID-19 health tools in May 2022, over two years after the launch of C-TAP (WHO, 2022b).

These delays and failures in utilising C-TAP underscore the limited contribution of philanthropy to resolving IPR-related challenges, and the need for more effective solutions. These failures also underscore that legal and policy gains achieved through and after AIDS treatment struggles did little to alter the restrictive impact of IPR on access to medicines. Nor did they do much to disrupt the dominance in global health of economic interests in the Global North or to augment the autonomy and technical capacity of countries in the Global South when it comes to medicines and IPR. These failures amplify scholarly arguments that a ‘neoliberal disease’ has deeply entrenched a ‘market-integrated and market-transformed body politic’ in global health that has proved disastrous in protecting public health (Sparke & Williams, 2022).

The TRIPS waiver: Contestation and implications

These conflicts and the historical insufficiency of voluntarism and philanthropy prompted India and South Africa in October 2020 to propose a temporary waiver of IPR in the TRIPS agreement, recognising the need for ‘unimpeded and timely access to affordable medical products including diagnostic kits, vaccines, medicines, personal protective equipment and ventilators’ (Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS Council), 2020a, preamble). The waiver proposal extended to a range of IPR implicated in COVID-19 beyond patents, including copyright, industrial design, and confidential information, the latter included specifically to enable involuntary technology transfer. The waiver proposal was prompted by global shortages of these precise goods throughout COVID-19 and the contribution of IPR in placing limits on domestic production to remedy these shortages. The waiver proposal noted the institutional and legal difficulties many countries, especially developing countries, face when using TRIPS flexibilities. It proposed that the TRIPS Council recommend to the WTO General Council a waiver from the implementation, application, and enforcement of key sections of TRIPS in relation to the prevention, containment or treatment of COVID-19 which would ‘continue until widespread vaccination is in place globally, and the majority of the world's population has developed immunity hence we propose an initial duration of [x] years from the date of the adoption of the waiver’ (TRIPS Council, 2020a, para. 13). In support of their proposal, sponsors cited multiple instances of IPR barriers and political pressures hindering the development, production, and supply of vaccines and medicines during and before COVID-19 (TRIPS Council, 2020b). These examples included political pressures against LMICs attempting to use TRIPS flexibilities, including U.S., Switzerland, and Novartis pressure over Colombia's intended issuing of a compulsory licence for Glivec, a cancer medicine produced by Novartis (TRIPS Council, 2020b). Multiple instances of IPR disputes over COVID-19 vaccine patents were also cited, including lawsuits against Pfizer and Moderna (TRIPS Council, 2020b).

Given the history of political contestation over the use of TRIPS flexibilities, it is unsurprising that the TRIPS waiver proposal kicked off a firestorm of contestation and debate about whether it is wise or even necessary to go this route. Despite broad support from over 100 LMICs and civil society, the TRIPS waiver was blocked from passage at the WTO by HICs, particularly the U.S. and E.U. (Amnesty International, 2021). While the waiver is unquestionably a more radical limitation of IPR than TRIPS flexibilities, there is little difference in the arguments raised by its opponents who questioned its impact on innovation and whether disparities were related to IPR rather than inadequate health systems, manufacturing capacity and insufficient development in LMICs (Green, 2021). Similar arguments were made about the impact of IPR on affordable ARVs at the height of the AIDS pandemic, yet lessons learned around IPR from that pandemic seemed to have counted for very little when it came to COVID-19 (Forman et al., forthcoming).

A snapshot of these positions is apparent in debates on the TRIPS waiver. For example, at a July 2021 meeting of the TRIPS Council, the U.K. argued in favour of maintaining IPR, as the ‘intellectual property frameworks support[s] innovation and collaboration in the form of R&D, manufacturing agreements and other technology transfer efforts’, and that the way forward lay within the framework of multilateral rules (TRIPS Council, 2021, para. 350). Switzerland argued that the TRIPS waiver would be harmful to efforts to assure global access to COVID-19 vaccines, and the E.U. argued that the suitable agreements ought to be sought through collaboration with the pharmaceutical industry and that existing international trade rules ‘reflect a careful balance between protecting intellectual property on one hand, which is crucial to innovation and promoting widespread access to medicines and healthcare, on the other hand’ (TRIPS Council, 2021, para. 381).

These are the same arguments used by industry. An October 2020 statement from the IFPMA fundamentally disagreed with arguments that IPR are barriers to R&D, public-private collaborations, or most importantly in this context, access to COVID-19 products (IFPMA, 2020). Instead, they argued that ‘IP is critical to the goals of innovation, collaboration and access, and [a waiver] would undermine these goals and fail to achieve what is urgently needed’ (IFPMA, 2020). They further elaborated that ‘[t]he international IP system already has rules and practices to permit customised solutions to real-world problems that may arise’ (IFPMA, 2020).

The pharmaceutical industry has long posed IPR as essential to global health innovation and as causally disconnected from gaps in access to essential medicines. During the HIV/AIDS crisis, pharmaceutical companies argued that the inaccessibility of ARVs in Sub-Saharan Africa was not due to the cost of drugs but because of the lack of adequately resourced healthcare systems and poverty. In litigation instituted by the global pharmaceutical manufacturers association against the South African government in the late 1990s after it attempted to introduce affordable medicines legislation that would use TRIPS flexibilities, industry argued that however laudable and legitimate the goal of access to affordable health care was, this did not make it acceptable to violate IPR: ‘The two issues are separate and distinct and should remain so’ (Pharmaceutical Manufacturers Association case, 1998, para. 10.8.5). A quote from a Pfizer executive in 2002 exemplifies the arguments the pharmaceutical industry put forward then and now about the unicausal and intractable nature of the global drug gap: ‘I know that some people in this room, incredibly, passionately believe that patents on pharmaceutical drugs are the reason that poor people lack access to basic medicines …  I wish it were as simple as that, because if it were this is a completely solvable problem’ (Commission on Intellectual Property Rights, 2002). Industry's position was that in the face of a multicausal wicked problem like the global drug gap, removing IPR was not simply insufficient, but was not in fact causally linked to these disparities.

This was and remains a misleading and self-serving position for pharmaceutical companies. It is also demonstrably wrong. When AIDS activists were able to pressure pharmaceutical companies and their host governments into dropping their opposition to LMICs using TRIPS flexibilities to manufacture and procure affordable generics, this transformed the mass disparities of the global HIV/AIDS crisis into one of the greatest rollouts of a medicine in modern times (t’Hoen et al., 2011). Access to ARVs has drastically altered the prevalence of and morbidity and mortality from HIV/AIDS in Sub-Saharan Africa (UNAIDS, 2023). It has thoroughly disproved the arguments of the day that African healthcare systems could not roll out these medicines, that innovation would suffer, that the IPR system would crash, and that IPR did not permit such restrictions (Forman, 2008).

This is not to suggest that the COVID-19 pandemic is identical to the HIV/AIDS pandemic. There are clear differences in the nature of the illness and its treatments, and in the extent to which, where IPR barriers remain in place, effective manufacturing of COVID-19 vaccines requires the cooperation of the companies themselves in offering trade-protected technological know-how to enable LMICs to scale up manufacturing. These restrictions on global manufacturing capacity have led some to argue that the TRIPS waiver is a necessary, but not sufficient, solution to advancing broad access to COVID-19 vaccines (Eccleston-Turner & Rourke, 2021), and that the legal right to manufacture would not be enough to enable production capacity since countries ‘lack the technical know-how and capacity to produce such technologies’ and transfer of biological materials would be needed to aid in the process of scale up. Yet one reason that countries lack technical know-how and capacity is because of the secrecy of intellectual property-protected patents and processes, despite the emphasis in TRIPS on technology transfer as a key objective of the protection and enforcement of its intellectual property protections (WTO, 1995). ARV campaigns achieved little to strengthen the autonomy and capacity of LMICs to produce medicines and vaccines through mechanisms like PEPFAR and the Global Fund or amendments of the TRIPS agreement. Moreover, ARV campaigns didn't focus on trade secrets or know-how which are far more central to the manufacture of COVID-19 vaccines.

In addition, unlike HIV/AIDS, the COVID-19 pandemic comes at a time when the dominance of states in global health governance has been transformed by the emergence of powerful, unaccountable, market-driven ‘philanthrocapitalist’ actors (Sparke & Levy, 2023). In this light, struggles over ARVs may have paradoxically strengthened the ability of both industry and the new private actors (like the Gates Foundation) that subsequently become major global health players to defend IPR, in the global policy sphere. For example, the Gates Foundation which played an outsize role in shaping global COVID-19 policy is reported to have opposed pressuring pharmaceutical companies to share their IPR as a detriment to vaccine development, pushed for C-TAP and the Medicines Patent Pool to exclude COVID-19 vaccines, and lobbied HIC governments to oppose the TRIPS waiver (Banco et al., 2022; Cheney, 2021; Zaitchik, 2021).

The TRIPS waiver Compromise and a prospective pandemic treaty

In June 2022, over a year and a half after the initial TRIPS waiver was proposed, a compromise regarding the TRIPS waiver was reached at the 12th WTO ministerial conference (WTO, 2022). The decision produced a waiver significantly reduced in scope, authorising ‘the use of the subject matter of a patent required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic’ (WTO, 2022, para. 1). As this text indicates, the waiver is limited to COVID-19 vaccines rather than extending to diagnostics and therapeutics. In addition, only LMICs can use this waiver, and only for a duration of five years. LMICs that have manufacturing capacity are not excluded, rather they are encouraged to make a binding commitment to not take advantage of the TRIPs waiver (WTO, 2022).

These compromises have been criticised by industry for not sufficiently protecting IPR and by civil society for offering insufficient tools to advance broader access (Green, 2022a; t’Hoen, 2022). Others argue that the agreement is overly restrictive, silent on key issues like production capacity problems, creative of new limitations that did not exist before (such as excluding developing countries with manufacturing capacity from the waiver), and unlikely to have significant impact on vaccine production in LICs without production capacity (Paquin & Plouffe-Malette, 2023).

Scepticism that WTO members would follow through on their commitment to decide whether to expand the waiver to COVID-19 diagnostics and therapeutics six months after the initial decision appears well founded (Green, 2022b). In December 2022, WTO members extended talks on this decision indefinitely (Suneja, 2023). At the same time, the U.S. Trade Representative (USTR) requested an International Trade Commission study by October 2023 that not only explores COVID-19 diagnostics and therapeutics but also considers how ‘the TRIPS Agreement promotes innovation in and/or limits access to COVID-19 diagnostics and therapeutics’ (USTR, 2022). There appears no end in sight to contestation over the role of IPR in limiting access to vaccines and medicines.

These debates have spilled over into the negotiation of a potential pandemic treaty and into potential revisions of the International Health Regulations (IHR). Regarding the IHR, some states are proposing the inclusion of a new article on ‘access to health products, technologies and know-how for public health response’ which would require States Parties to impose exemptions and limitations on the exclusive rights of intellectual property holders in order to facilitate the manufacturing, export and import of health products’ (WHO Working Group on Amendments to the International Health Regulations, 2023). This issue is also being directly addressed in a prospective pandemic treaty. In November 2021, a special session of the World Health Assembly established an Intergovernmental Negotiating Body (INB) to draft and negotiate a new WHO convention, agreement or other international instrument on pandemic preparedness and response (WHO, 2021a, 2021b). A zero draft was issued in February 2023 and will provide the basis for negotiations (WHO, 2023b). The imprint of these debates is apparent in the draft which devotes 11 of its 49 preambular principles to IPR, ranging from reaffirmations of the Doha Declaration to multiple versions of recognitions that the protection of IPR is ‘important for the development of new medicines’ and has negative effects on prices. Yet the draft goes considerably further than anticipated in article 7.4 which indicates that in the event of a pandemic, States will not only apply full use of TRIPS flexibilities but

will take appropriate measures to support time-bound waivers of intellectual property rights that can accelerate or scale up manufacturing of pandemic-related products during a pandemic, to the extent necessary to increase the availability and adequacy of affordable pandemic-related products (WHO, 2023b).

This effort to codify a right to time-bound waivers of IPR during future pandemics is a potentially meaningful legal development that signifies changes to how the legitimacy of TRIPS flexibilities is being assessed. Yet the extent of contestation over the TRIPS waiver suggests that it is not likely that this provision will survive the negotiation process. There is no indication that HICs, industry and key global health actors will do anything but continue to oppose and weaken future limitations or waivers of IPR.

Conclusion

Our analysis in this paper underscores that affordability and availability are key determinants of access to medicines and vaccines that hold heightened importance in public and global health policy and international human rights law. Yet during COVID-19, the availability of vaccines has been deeply limited by vaccine hoarding and the relative weakness and failure of the COVAX facility to address this hoarding and to prioritise the public health needs of LMICs over corporate IPR. What most LMICs needed was not a weak ‘dose-rationing’ charity model, but local and regional manufacturing capacity and access to knowledge and technology transfer to be able to produce within existing manufacturing sites. Yet African countries with vaccine manufacturing capacity have faced IPR barriers, and in the majority of LMICs which lack manufacturing capacity, IPR holders have largely been unwilling to permit use of their technologies or to share production knowledge. While COVID-19 related initiatives to build production and manufacturing capacity on the African continent are welcome, a continued lack of cooperation by IPR holders has seen IPR constraints significantly hamper the scale up and sustainability of manufacturing capacity in this region.

Similarly, the affordability of COVID-19 vaccines has been deeply determined by industry and government pricing sustained by trade-related IPR. Moreover, instances of regressive pricing of COVID-19 vaccines for LMICs are disproportionately inequitable given how pricing impacts medicines access in such countries, an impact amplified by COVID-19 related economic recessions. Pricing of this nature is hard to square with the extraordinary profits made by companies and the large extent of public moneys which enabled the development and production of these vaccines. The LMIC call for a TRIPS waiver was thus a legitimate response to pricing and manufacturing constraints, to the limitations of TRIPS flexibilities to appropriately resolve these restrictions, to continued political opposition to their use despite a plethora of global policy endorsements of their legality and necessity, and to corporate reluctance to share technologies, trade secrets and know-how or to offer voluntary licences through CTAP. Yet the waiver was ultimately bogged down in political and corporate contestation and successfully hemmed in by private actors like the Gates Foundation, seeing the adoption of a weak and tangled compromise agreement that is unlikely to do much to augment state autonomy in this domain.

These global failures to assure the equitable distribution of COVID-19 vaccines underscore that past campaigns for affordable medicines have done little to disrupt the dominance in global health of economic interests in the Global North, nor to augment the autonomy and technical capacity of countries in the Global South when it comes to medicines and IPR. At the same time, the global health institutions charged with assuring global health equity and effective global pandemic responses have failed to prevent or resolve disparities in access to COVID-19 vaccines even as they have suggested that these outcomes were potentially gross violations of human rights and international law.

Yet if the AIDS experience and now COVID-19 should teach us anything, it is that we cannot look to philanthropy, charity, or corporate largesse to resolve global drug gaps. If this is true in general, it is especially true when it comes to Africa, which in COVID-19 as in HIV and AIDS, has been persistently excluded from access to life-saving health goods. Experiences through COVID-19 illustrate that it is vital to address the impact of IPR on the pricing, manufacture, and movement of essential health goods and ergo on their affordability and availability. Pushing for meaningful limits to trade-related IPR is thus crucial to expanding the autonomy of LMICs to protect their populations against COVID-19 and future pandemic threats, as well as a major negotiating strategy for better collaboration and coordination with HICs and pharmaceutical companies.

In this light, codifying consequential limits on IPR within a pandemic treaty or amendments to the IHR could offer meaningful legal measures to permit states to more effectively respond to IPR's impacts on public and global health and human rights, even if they would only marginally address the drastic power and priorities imbalance within the global health architecture and its embeddedness within ‘interlocking systems of power’ such as ‘racism, coloniality, neoliberalism, and exploitative commerce’ (Yamin & Farmer, 2022). Yet if past (and present) are prologue, political contestation over any perceived weakening of IPR is very likely to avert any such meaningful reforms. Equity-seeking Global South and Global North actors must resist such efforts at all costs and fight for a stronger pandemic treaty and IHR as small yet meaningful steps towards a more equitable global health order. To do otherwise would be to accept criminally racist ‘apartheids’ as the norm when it comes to the distribution of essential health goods during and outside global health emergencies.

Acknowledgements

An early version of this paper was presented at the Connaught Global Challenge Seminar and the Mary and Phil Seeman Health Law, Policy, and Ethics Seminar Series in October 2021.The authors are grateful for the constructive feedback of anonymous reviewers and the editorial team at Global Public Health which exponentially strengthened this paper. The lead author gratefully acknowledges the generous funding support of the Connaught Global Challenge Award and the Canada Research Chairs Program, and the outstanding academic support provided by the Foundation Brocher in Geneva, Switzerland where this article was finalised. The authors thank Veronica Steck for research assistance.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by the Connaught Global Challenge Award under Grant [grant number 512634]; and the Canada Research Chair Fund under Grant [grant number 497890].

Notes

1 The 11 vaccines granted Emergency Use Listing (EUL) by the WHO are: Pfizer-BioNTech (Comirnaty), Moderna (Spikevax), Johnson & Johnson (Ad26.COV2.S), Oxford/AstraZeneca (Vaxzevria), Serum Institute of India (Covishield,Oxford/Astrazeneca formulation), Sinopharm (Covilo), Sinovac (Coronavac), Bharat Biotech (Covaxin), Novavax (Nuvaxovid), Serum Institute of India (COVOVAX, Novavax formulation), and CanSino (Convidecia).