ALMOST TWO-THIRDS of people in rich countries have had at least one dose of a Covid-19 vaccine, this figure is just one in 12 in poor countries. It is a two-tier pandemic: “vaccine apartheid” between rich and poor countries.
There is a moral imperative to address this, but also a self-interested one. The Omicron variant shows that where there are low vaccination rates in countries due to lack of access, this can lead to greater incidence of the virus, and risks of dangerous new variants emerging. This threatens control of Covid-19 for everyone everywhere, including Ireland.
Yet, during 2021 the EU and Ireland opposed one of the most strongly supported global mechanisms to help resolve this: the World Trade Organization (WTO) TRIPS waiver put forward in October 2020 by India and South Africa. This week the Seanad passed an important motion led by Senator Alice Mary Higgins calling on the Irish government and the EU Commission to change course and back the waiver.
The TRIPS waiver aims to temporarily suspend international intellectual property (IP) rights for Covid-19 vaccines, medicines and diagnostics clearing the way for countries to produce generic versions.
What the law says
IP law – especially on patents and trade secrets – is a key barrier to vaccine equity, because to reproduce an IP-protected technology, a permission (licence) from the rightsholder is needed.
Multiple IP rights apply over Covid-19 vaccines. To date, the pharmaceutical industry has not agreed to sufficient voluntary licensing agreements to create enough COVID-19 vaccines to meet global demands.
Voluntary proposals like the Technology Access pool (C-TAP) have been set up by the WHO’s to encourage industry to share IP rights and know-how to increase production for Covid-19 vaccines; yet it has not been supported by any vaccine manufacturer.
Meanwhile, COVAX which aims to donate vaccines to poorer countries is a useful short-term way to deliver some vaccines on the ground. But COVAX relies on charity and does not increase production capacity to enable countries to have sustainable supplies.
In the absence of sufficient voluntary licensing, the India-South Africa proposal to waive IP rights is vital. It would clear IP obstacles enabling greater production of vaccines in the global south. The proposal has the support of more than 100 WTO members, including the US, over 120 IP academics, and leading global figures such as Mary Robinson.
Who funded the vaccines?
However, it is opposed by industry which claims that IP is ‘inviolable’. It’s hard to stand over this argument. IP is a legal tool created by states to facilitate the public good. It gives rightsholders exclusivity enabling them to maintain an artificial scarcity of certain products, but it is justified only as a quid pro quo.
The idea behind IP e.g. patents is that companies risk their investments to fund Research and Development (R&D), in return, they get a 20-year monopoly on resulting inventions. This justification is not sustainable for Covid-19.
The public – not the private sector – has borne most of the cost of the key R&D for the Covid vaccines. The Moderna vaccine was co-created with the US National Institutes of Health, a government agency. Moderna also received $10bn from the US government, with BioNTech obtaining more than 400million Euros from the German government.
The AstraZeneca vaccine was the product of publicly funded research at the University of Oxford. Even though the R&D was de-risked by public funds, governments left the IP to private companies.
In a pandemic, artificial scarcity is not the approach to take: it should be an ‘all hands-on deck’ situation, with all viable producers licensed to produce vaccines.
That productive capacity in countries like India, South Africa and Brazil continues to go under-utilised is unconscionable. The principal way that developing countries emerged from the HIV/AIDS epidemic was through facilitating generic drug production in countries like India and South Africa. For Covid-19 vaccines, IP rules are enabling protectionism and hindering generic production.
What needs to change?
The legal effect of a waiver would be to limit IP rights internationally, but national rights would remain within each country’s sovereignty. Rich states could change their laws to allow know-how and data sharing globally, but the waiver would primarily be utilised by low-income states.
Countries like Ireland have no domestic need to waive national IP even if an international waiver passes. Pfizer and Moderna’s sales to rich countries are unlikely to be affected much, if at all, by the TRIPS waiver.
The EU counter proposal to the TRIPS waiver is a distraction – it largely reiterates existing TRIPS provisions. The EU proposal focuses on compulsory licensing, which allows a country to produce a technology under patent, without permission, under certain circumstances.
Yet compulsory licensing is cumbersome, and on its own is insufficient to deliver timely global vaccine access because it is a country-by-country, patent-by-patent approach. This would take too long. It also does not address other key IP rights for vaccines, like trade secrets. The EU proposal distracts from real solutions and from TRIPS waiver negotiations.
The Irish government should follow the Seanad motion by urgently reconsidering its position and using its leverage within the EU to support the India-South Africa proposal at the WTO.
Dr Luke McDonagh is Assistant Professor in Intellectual Property Law, London School of Economics (LSE) and Dr Aisling McMahon is Associate Professor, Department of Law, Maynooth University.
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