“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.” So say Zane Dangor, special adviser to South Africa's Minister of International Relations & Co-operation, and Associate Professor Franziska Sucker, of the the School of Law at Wits University.
They note that while at the outset of the pandemic the World Health Organisation (WHO) and the UN called for solidarity and co-operation on measures to stem the spread of the virus, the richer countries undermined this by practising vaccine nationalism – signing agreements with pharmaceutical companies to supply their own populations first.
Writing on the Daily Maverick site, the authors point out that 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. “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.”
In outlining a possible strategy, the authors argue that wresting control of vaccines from the private sector – particularly the intellectual property regimes of companies – is critical to meeting global vaccination targets.
International level: At an international level, South Africa should continue – in partnership with India – to push and lobby for a general waiver to the WHO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in relation to COVID-19 drugs, vaccines, diagnostics and other technologies. The authors say without a general waiver, countries would need to initiate individual action to obtain compulsory licences – a processes which is cumbersome and time consuming.
The waiver would not prevent innovation (there are 210 vaccines in the pre-clinical phase), nor would it prevent pharmaceutical companies from recouping research and development costs. It 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.
“Failure by the TRIPS Council 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.”
National level: 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. The authors point out that 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.”
Dangor and Sucker say that the manner in which vaccine nationalism is shaping the rollout of vaccines contravenes international law provisions. “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.”
They add: “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.”
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.
Full Daily Maverick report (Open access)