A growing number of medical, epidemiological and public health experts are warning of an emerging vaccine apartheid triggered by the dire humanitarian consequences from an unequal distribution of SARS-CoV-2 (coronavirus) vaccines. As Fatima Hassan, founder of South Africa’s Health Justice Initiative observed, “if this is going to continue for another three years, we’re not going to get any kind of continental or global immunity.” Concerns about a “global vaccine apartheid” have also been expressed by Winnie Byanyima, Executive Director of UNAIDS.
High-income countries, representing only 16% of the world’s population, had secured 60% of the available vaccine doses
Further under-scoring these concerns, on 18 January 2021 the Director General of the World Health Organisation (WHO), Tedros Adhanom Ghebreyesus, warned that the world was on the brink of a catastrophic moral failure if wealthier nations did not ensure the equitable distribution of vaccines to combat the coronavirus pandemic.
But beyond the looming humanitarian and moral catastrophe (not to mention the stark reality that no population will be safe until all populations are safe) lie opportunities for mobilising international law, and particularly human rights, to compel states to take action, not merely in their own jurisdictions, but globally, to address deep and growing global inequalities.
The coronavirus vaccine rollout has been underway since early December in richer countries, while hardly any of the vaccines have made their way into the arms of the people living in the global South. Indeed, according to Sundaram and Chowdhury, as of 9 February 2021, high-income countries, representing only 16 per cent of the world’s population, had secured 60 per cent of the available vaccine doses, while the African Union has only managed to procure 670 million doses for the approximately 1.3 billion people on the continent.
One of the issues driving these deep global inequalities, and in particular the vastly greater ability to secure vaccines in richer countries, is the ability of these countries to more easily afford commercially-produced vaccines such as those produced by Pfizer-BioNTech and Moderna. The European Union (EU) has pledged billions to help develop and ensure equitable access to coronavirus vaccines, test and treatments on a global level. However, this is a fraction of what is needed, and already in November 2020, half of the anticipated global capacity had been spoken for, with the EU and five other wealthy countries having pre-ordered about half of the anticipated global capacity for vaccine production.
Even the less-expensive AstraZeneca (AZ) vaccine is beyond the reach of many poorer countries, especially as many have had to negotiate with the Serum Institute of India (SII), which obtained emergency use authorisation to manufacture the AZ vaccine. The SII has been producing many of the vaccines targeted for developing countries and is reportedly charging countries even more than European countries were charged for the vaccines procured directly from AZ. For example, in January 2021, South Africa was charged $5.25 per dose for the AZ vaccine from the SII, whereas EU countries were paying $3.03 per AZ dose.
A further initiative is the COVAX facility, which is a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual coronavirus vaccines. COVAX is an initiative of Gavi, a Foundation that was set up in 1999 with substantial funding by the Bill and Melinda Gates Foundation. Gavi describes itself as “an international organisation – a global Vaccine Alliance, bringing together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world’s poorest countries.” The intention of the COVAX facility is to provide vaccines to developing countries that have signed up to this scheme. However necessary, particularly in the context of emerging vaccine nationalism and turf wars, it is unlikely this arrangement will meet the considerable vaccine needs of the developing world, either in terms of the required volume of vaccines or their speedy rollout.
Waiving intellectual property rights
Faced with this reality, there has been a global legal mobilisation effort, spearheaded by India and South Africa, to temporarily waive the Intellectual Property (IP) rights of the relevant drug companies to enable faster and broader manufacturing of coronavirus-related vaccines and medicines by any country with the requisite manufacturing capacity.
Accordingly, on 2 October 2020, a formal proposal was submitted by India and South Africa to the World Trade Organisation (WTO) for a temporary waiver of IP on coronavirus drugs.
Supporters of this proposal – which include civil society organisations around the world such as Amnesty International, and United Nations human rights experts – point out that the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) patent exception process is complex and lengthy, requiring each country to apply individually. And in the past, TRIPS waivers for public health interventions have been vigorously opposed by richer states. In addition, supporters of the proposal highlight that significant public resources have been used for the development of many of the vaccines. This includes Pfizer-BioNTech, which received $445 million from the German government, and Moderna, which received over $1 billion from United States (US) government agencies, to develop their vaccine technologies. This contradicts arguments by wealthy nations that link IP rights to investments made by pharmaceutical companies in the research and development of the drugs. It also reinforces calls to regard such vaccines as ‘people’s vaccines’ rather than to restrict their access on the basis of a pharmaceutical company’s patents.
The Intellectual Property waiver proposal led by South Africa and India has encountered strong legal opposition by wealthier nations
The legal pushback by wealthier nations
Unfortunately, the IP waiver proposal led by South Africa and India has encountered strong legal opposition during the WTO deliberations, particularly from the US, the United Kingdom, Canada, Australia, Japan, Norway, Switzerland and the EU. State representatives from these countries argue that the relevant regulatory framework that binds WTO member nations – the TRIPS – offers a specific exception process.
Ignoring the immense bureaucratic hurdles that countries would have to overcome in order to use these TRIPS exceptions to apply for patent waivers for life-saving drugs, these countries furthermore argue that to provide a blanket waiver would discourage pharmaceutical companies from undertaking research and development.
Mobilising human rights obligations
Irrespective of the debates concerning the correct balance between patents and innovation on the one hand and the availability of drugs for public health purposes on the other hand, the realm of human rights offers a further avenue for legal mobilisation to address massive global inequalities in access to vaccines.
International human rights law obliges states to take action, provided they have ratified the relevant treaties (state parties), including the International Covenant on Economic Social and Cultural Rights (ICESCR) and the International Covenant on Civil and Political Rights (ICCPR). Each of these cornerstone international human rights treaties guarantees critical rights and outlines associated state obligations that are relevant to the issue of access to life-saving drugs.
The most directly relevant rights and obligations in the ICESCR include Article 12, which is the right of everyone to the highest attainable standard of physical and mental health. Regarding COVID-19, Article 12(2)(c) creates explicit obligations to prevent, treat and control epidemic diseases; and Article 12(2)(d) specifies that state parties have an obligation to create conditions to ensure all people have access to medical service and medical attention.
Moreover, access to drugs (including vaccines used to prevent, control and treat COVID-19), is a fundamental aspect of the right to health. In its General Comment No. 14, the Committee on Economic, Social and Cultural Rights (CESCR) established that article 12(2)(d) requires states to undertake “joint efforts to, inter alia, make available relevant technologies, using and improving epidemiological surveillance and data collection on a disaggregated basis, the implementation or enhancement of immunization programmes and other strategies of infectious disease control.”
Although international law primarily binds state parties regarding actions in their own states, Article 2(1) of the ICESCR establishes a broader responsibility to assist other member states in achieving the full realisation of Covenant rights, including not only financial resources, but also access to relevant technology.
Furthermore, according to Article 15 of the ICESCR, everyone has the right to “enjoy the benefits of scientific progress and its applications”. The CESCR has stated in its General Comment 25 that, pursuant to article 15, states “should fulfil this duty to the maximum of their available resources, including those available through international assistance and cooperation …”. The CESCR furthermore stated in this General Comment that “ultimately, intellectual property is a social product and has a social function and consequently, States parties have a duty to prevent unreasonably high costs for access to essential medicines”. Moreover, in General Comment 25, the CESCR has stated that “States parties should use, when necessary, all the flexibilities of the TRIPS Agreement, such as compulsory licences, to ensure access to essential medicines, especially for the most disadvantaged groups.”
All of the richer countries, with the exception of the US and Saudi Arabia, have ratified the ICESCR and therefore are legally bound to its obligations. The US has ratified the ICCPR. Article 6 of the ICCPR establishes a right to life, which, as clarified by the UN Committee on Civil and Political Rights in General Comment 36, requires States take appropriate measures to address the prevalence of life-threatening diseases, such as AIDS, tuberculosis and malaria, to take measures to ensure access without delay by individuals to essential health care and to develop strategic plans for advancing the enjoyment of the right to life.
Temporary Intellectual Property exception regarding coronavirus medicines is highly justified
Addressing vaccine apartheid through legal mobilisation
Applying a two-pronged legal mobilisation approach can be productive in addressing what many health experts characterise as a global, vaccine apartheid.
First, a blanket, temporary IP exception regarding coronavirus medicines and drugs is highly justified, and in everyone’s interests as the world continues to grapple with the global coronavirus pandemic. The global regime of intellectual property rights must not be allowed to undermine fundamental human rights recognised by all countries and guaranteed in international human rights law. This deserves much more visibility in the media, broad-based social awareness, and a legal front within WTO.
Second, ensuring that states must up live up to their international obligations to promote the right to health and to extend technical and financial resources to less well-off nations to address the global pandemic is also in everyone’s interests. This argument is further reinforced by insisting that the binding obligation to respect the right to life involves, at a bare minimum, to prioritise efforts to tackle the life-threatening consequences of the disease.
In other words, by mobilising multiple, international legal vocabularies as part of a visible campaign, efforts to reduce deep and growing inequalities may allow us to avoid a vaccine apartheid, a truly disastrous scenario where some lives matter than most.
Jackie Dugard (Associate Professor, School of Law, University of the Witwatersrand, South Africa; Jeff Handmaker (Senior Lecturer, International Institute of Social Studies of Erasmus University, The Netherlands) and Bruce Porter (Executive Director, The Social Rights Advocacy Centre, Canada). Dugard and Handmaker are currently at NIAS as part of a theme group analysing the potential for strategic legal mobilization as a legitimate means to hold governments, individuals and corporations accountable for violations of human rights, environmental and other laws.
This article was first published on Opinio Juris, a blog dedicated to the informed discussion of international law by and among academics, practitioners and legal experts.