South Africa has the legal tools to challenge the vaccine nationalism of rich countries
International and national legal frameworks could enable the government to ensure generic Covid-19 vaccines are manufactured locally and in other developing countries, particularly in Africa.
The latter point is important as South Africa, through its chairing of the African Union (AU) and its interventions at the United Nations, has emphasised a solidarity-based approach to the use of vaccines to combat Covid-19. This approach has been sought by UN Secretary-General António Guterres and Dr Tedros Adhanom Ghebreyesus, the director-general of the World Health Organisation (WHO).
Vaccine nationalism as a barrier to defeating Covid-19, and non-solidarity
At the outset of the pandemic, the WHO, the UN and leaders of countries across the world called for solidarity and cooperation on measures to stem the spread of the virus. Yet, while committing to work with UN-led initiatives such as the Covid-19 Vaccine Global Access Facility (Covax), ostensibly aimed at equitable and science-led global vaccine distribution, the richer countries undermined such collective processes by practising vaccine nationalism – signing agreements with pharmaceutical companies to supply their own populations in a manner that reduces equitable access for others, often leading to forms of vaccine apartheid between countries. As scientists started work on vaccines these countries bought up vast quantities. Hedging their bets as there was not yet enough evidence for which vaccines would be effective, they ordered most of the stocks of all the leading candidate vaccines, enough to vaccinate all their people a number of times. The result is that 14% of the world’s population bought out 53% of the available vaccines, excluding those produced by Russia and China – while, as indicated by Guterres, nine out of 10 people in poor countries are set to miss out on Covid-19 vaccines in 2021.
This situation has alarmed the UN secretary-general, who said recently vaccine nationalism is a barrier to defeating Covid-19, which can only be done through international cooperation. The WHO has also said that inoculating all the people in some countries while leaving the vast majority of the world’s population without access to the vaccines is not only morally reprehensible, but would do very little to stem the tide of the pandemic.
The health, social and economic challenges of the pandemic will continue unabated. Moreover, the differential pace at which the vaccine is rolled out may create conditions for increased political turmoil between regions and potentially inflame global tensions and instability.
The continued disruption of global supply chains means national economies would continue to suffer and the global economy would continue to stagnate. This would deepen inequalities within and between countries; the latter because some countries are able to access vaccines and treatments and so recover more rapidly than others; the former is due to the fact that the hardest-hit sectors have low wages and the most vulnerable of society have little or no resources to compensate for the cut in income.
The key to ending a pandemic is to inoculate a critical mass of people around the globe, more or less simultaneously in a manner that will effectively break the virus transmission chain. That is, unless the unstated impulse by the rich countries is to block out the rest of the globe’s population from their countries based on their lack of immunity.
Given the history of colonialism, slavery and genocides associated with the richer countries, such Darwinist instincts can, unfortunately, not be discounted. That the rich countries, which purport to champion global governance, acted contrary to and in a manner that undermined UN-led initiatives to create global governance bodies to allocate and distribute the vaccines based on science and ethics, underscores the sentiment in much of the global south that rich countries of the north instrumentalise the institutions of global governance in ways that are only beneficial to them.
The apparent ease with which vaccine nationalism was embraced by the rich countries has perhaps irrevocably damaged initiatives and institutions of global governance that foreground solidarity and global well-being.
The UN secretary-general and the director-general of the WHO have reiterated calls for more money to be made available for Covax, which sought to break the chain of viral transmissions by pool-buying viable vaccines as they became available and distribute them ethically. There would have been elements of redress with pooled funds from self-financing countries such as South Africa cross-subsidising countries that lack the resources.
The problem is that Covax has supply, governance, transparency and classification limitations. This might have contributed to rich countries not being committed to such an arrangement and instead concluding bilateral deals for most of the vaccine supplies to the extent that only about 20% (maximum) would be available to poorer countries through Covax. This translates to only about 3% of the population benefiting from the facility.
Thus, while South Africa should get what it can from Covax in its current form, it cannot depend on it to meet its vaccination targets for breaking the transmission chain. Rather than allowing big pharmaceutical companies to maximise profits and pressure the government to let go of its “one country, one plan approach” (which seeks to reduce skewed access to vaccines), the government should consider a strategy that puts maximum pressure on those companies using the multilateral system, in conjunction with international and domestic legal measures.
Decisive action towards an equitable vaccine strategy
An equitable vaccine strategy requires monitoring by states, because this pandemic is existential in nature for people and economies and cannot be left, primarily, to the private sector and especially pharmaceutical companies. Wresting control of vaccines from the private sector, particularly the intellectual property regimes of these companies, is critical to meeting global vaccination targets.
At international level, South Africa should continue, in partnership with India, to push and lobby for a general waiver to the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in relation to Covid-19 drugs, vaccines, diagnostics and other technologies.
South Africa and India seek to suspend rights related to copyrights, industrial designs, patents and undisclosed information (trade secrets) for the duration of the pandemic, “until the majority of the world’s population has developed immunity”, to enable World Trade Organisation (WTO) members to produce and export generics of the vaccines in a way that might meet national and global demand.
This request is being blocked by WTO members that have already ordered the vaccines (such as the US, the EU, the UK, Norway and Canada). They argue that the TRIPS flexibilities provide sufficient access to future vaccines for all people everywhere. In brief, the TRIPS provisions, as amended through the provisions of the Doha Declaration on the TRIPS Agreement and Public Health (Articles 31, 31bis and Annex 1), allow WTO members that cannot afford the original medicine but have the capacity to produce generics for its domestic market through the issuing of compulsory licensing. They also allow members that lack the manufacturing capacity to import medicines from those that produce them cheaply.
Why then a waiver? While these measures can and should be exploited, without a general waiver countries would need to initiate individual action to obtain compulsory licences. These processes are cumbersome and time consuming – which the people and economies of these countries can ill afford (particularly given the slow rollout of vaccines to developing countries).
Some licences require negotiations with right holders, and uncertainties exist around who determines what an adequate remuneration is (required according to Article 31(h) of the TRIPS Agreement). Despite South Africa having provisions for compulsory licensing, in more than a century of patent legislation no compulsory licence has been granted for pharmaceutical-related products. Moreover, some compulsory licences are only for public, non-commercial use, while the process does not apply to trade secret know-how and cell lines needed to copy vaccines and biologic medicines.
Importantly, some members, such as the US and the UK, where companies are working on the development of a vaccine, have not ratified the TRIPS amendment that allows imports from countries that produce under a compulsory licence. Attempts to bypass patent rules on several Covid-19 related medical technologies have already faced implementation barriers.
Hence the importance of the South African and Indian initiative around a general waiver for the duration of the pandemic. Notably, the waiver would not, as regularly argued, prevent innovation considering that there are 210 vaccines in the (pre-)clinical phase, nor would it prevent pharmaceutical companies from recouping research and development costs.
According to Labonte and Baker, governments have entered into $24-billion worth of advance-purchase agreements, which are expected to generate a 60% to 80% profit margin, not to speak of the $2-billion in public funding. A waiver would not change the fact that developing countries’ health-system capacities are underfunded or limited, but would create an environment for a more rapid solution to sharing manufacturing capacities and technical production knowledge that newer health technologies require, and allow export to countries in need, irrespective of the origin of the vaccine.
In the absence of consensus, which the WTO prefers, the adoption of the waiver requires a three-quarter majority – the support of 123 members. More than 100 developing countries, numerous NGOs, several UN agencies, the WHO and broader civil society support the waiver already. Thus, South Africa should continue to lobby and set a deadline for the General Council to decide on the issue.
Failure by the TRIPS members to adopt the waiver could trigger action by the South African government to produce and import the vaccines, using compulsory licences enabled by domestic legislation; potentially even invoking article 73 of the TRIPS Agreement (security exceptions). In contrast, a waiver could stipulate specific conditions that make allowance for some of the pharmaceutical companies’ interests.
South African patent law does provide for compulsory licensing and “state use” in an emergency. Section 4 of the Patents Act allows for “government use” of patents in cases of national emergency, subject to negotiations with patent owners, irrespective of the scale of the emergency.
Sections 55 and 56 provide for compulsory licences and, similarly, require a judicial process before the Commissioner of Patents. This involves time and costs associated with litigation.
Further, the Medicines and Related Substances Control Amendment Act and Section 57 of the Patents Act allow for parallel importation in general and would thus permit the import of generics produced under a compulsory licence in other countries, irrespective of South Africa’s manufacturing capabilities. This is inconsistent with the TRIPS provisions which only permit such export to least-developed countries and those without manufacturing capacity.
The Patents Amendment Bill, guided by the provisions of the government’s Intellectual Property Rights Policy, would allow for compulsory licensing without judicial processes, invoking “state use” and negotiations with patent holders. These amendments would accelerate the process of issuing a compulsory licence and should be tabled in Parliament as soon as possible. The passing of these amendments would also signal to the pharmaceutical companies and the WTO negotiators that all South African stakeholders, including all political parties and not only the government, are serious about ensuring equitable access to life-saving medication to all its people and people in the region.
Other than the patents legislation that may allow the government to immediately implement measures to produce and import generics, arguably, sections 7, 11 and 27 of the Constitution contain a positive obligation to fulfil the right to life and the right to access healthcare. In relation to Covid-19, and considering vaccine nationalism, the most obvious “necessary” measure to fulfil this obligation is for the government to issue a compulsory licence or import vaccines, enabled by the patent laws.
Big pharmaceutical companies that may pressure the government to let go of its “one country, one plan” approach can be referred to the government’s duty to consider international oblligations when fulfilling its peoples’ rights (section 39(1)(b)).
The International Covenant on Economic Social and Cultural Rights (ratified by South Africa) provides that access to the right to health and therefore, medicine, should be realised without distinction on the grounds of race, colour, sex language, religion, political or other opinion, national or social origin, property, disability or other status; and the International Convention on the Elimination of all Forms of Racial Discrimination (ICERD) (ratified by South Africa) provides for states to prohibit and eliminate racial discrimination in the enjoyment of public health and medical care.
The manner in which vaccine nationalism is shaping the rollout of vaccines arguably contravenes these international law provisions. Given the transboundary nature of the pandemic, it would not be far-fetched to argue for an extraterritorial state obligation to effect measures to remedy this.
Using existing legal tools to access vaccines
Experience in the global HIV/Aids struggle for affordable antiretrovirals suggests that when drug companies are threatened with state-use licensing or compulsory licences, they will consider voluntary licensing to avoid compulsory licences. The Netherlands recently threatened Roche over its technology in a testing kit. The drug company complied and shared the technology. To advance solidarity on the continent, these licences should rely on African and Global South manufacturers, where possible.
South Africa has the legal tools to challenge the exclusionary vaccine strategy of rich countries and pharmaceutical companies. It should use these measures nationally and mobilise bias around them in the international arena, to urgently get the rich countries and the pharmaceutical companies around the table to agree on a UN/WHO-led global Covid-19 vaccine strategy that is controlled by members.
The impact of this pandemic is the premier global emergency and has peace and security implications given its potential to degrade economies and undermine stability within states. The situation is too urgent and precarious to be left to the dictates of pharmaceutical companies and their drive for profits, and the narrow nationalist impulses of a few rich countries.
The national and global situation is such that patent rights should be secondary to patient rights. In this pandemic, all people in all parts of the world are patients, through the impact the pandemic has on health, lives and livelihoods. The vaccines should be first considered public health goods and then private goods, and their manufacture and distribution should be managed within that context. DM
Zane Dangor is Special Adviser to the Minister of International Relations and Cooperation and chairs the Institute for Economic Justice on a voluntary basis. He holds an LLM in International Law.
Franziska Sucker is Associate Professor, School of Law, University of the Witwatersrand. First State Exam in Law, Second State Exam in Law, LLM, PhD.
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