ALMOST TWO-THIRD of people in rich countries have received at least one dose of a vaccine against Covid-19, this figure is only one in 12 in poor countries. It is a two-speed pandemic: âvaccine apartheidâ between rich countries and poor countries.
There is a moral imperative to remedy it, but also a personal interest. The Omicron variant shows that where vaccination rates are low in countries due to lack of access, this can lead to a higher incidence of the virus and risks of emergence of new dangerous variants. It threatens the control of Covid-19 for everyone everywhere, including Ireland.
Yet in 2021, the EU and Ireland opposed one of the most supported global mechanisms to help tackle this problem: the World Trade Organization (WTO) TRIPS waiver proposed 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 European Commission to change course and support the waiver.
The TRIPS waiver aims to temporarily suspend international intellectual property (IP) rights for Covid-19 vaccines, drugs and diagnostics, thus paving the way for countries to produce generic versions.
What the law says
Intellectual property law – especially on patents and trade secrets – is a major obstacle to the fairness of vaccines, because to reproduce technology protected by intellectual property, an authorization (license) from the rights holder is required. .
Several intellectual property rights apply to Covid-19 vaccines. To date, the pharmaceutical industry has not entered into enough voluntary licensing agreements to create enough COVID-19 vaccines to meet global demands.
Voluntary proposals such as the Technology Access Pool (C-TAP) have been put in place by WHO to encourage industry to share intellectual property rights and know-how in order to increase production. Covid-19 vaccines; however, it has not been endorsed by any vaccine manufacturer.
Meanwhile, COVAX, which aims to donate vaccines to poorer countries, is a useful short-term way to deliver some vaccines to the field. But COVAX relies on charity and does not increase production capacity to allow countries to have sustainable supplies.
In the absence of sufficient voluntary licenses, the proposal by India and South Africa to waive intellectual property rights is vital. This would remove the obstacles to intellectual property allowing greater production of vaccines in the countries of the South. The proposal has the support of more than 100 WTO members, including the United States, more than 120 intellectual property academics and leading global figures such as Mary Robinson.
Who funded the vaccines?
However, the industry is opposed, claiming that intellectual property is “inviolable”. It is difficult to resist this argument. Intellectual property is a legal tool created by states to facilitate the public good. It gives rights holders an exclusivity allowing them to maintain an artificial scarcity of certain products, but it is only justified in return.
The idea behind intellectual property, for example patents, is that companies risk their investments to fund research and development (R&D), in return they get a 20-year monopoly on the resulting inventions. This justification is not tenable for the Covid-19.
The public – not the private sector – has borne most of the cost of key R&D for Covid vaccines. The Moderna vaccine was co-created with the United States National Institutes of Health, a government agency. Moderna also received $ 10 billion from the US government, while BioNTech got more than â¬ 400 million from the German government.
The AstraZeneca vaccine was the product of state-funded research at the University of Oxford. Even though R&D has been reduced at risk by public funds, governments have left intellectual property to private companies.
In a pandemic, artificial scarcity is not the approach to take: it should be an âall hands on deckâ situation, with all viable producers licensed to produce vaccines.
That production capacity in countries like India, South Africa and Brazil continues to be underutilized is unreasonable. The main way that developing countries emerged from the HIV / AIDS epidemic has been by facilitating the production of generic drugs in countries like India and South Africa. For Covid-19 vaccines, intellectual property rules allow protectionism and hamper generic production.
What needs to change?
The legal effect of a waiver would be to limit intellectual property rights internationally, but national rights would remain under the sovereignty of each country. Rich states could change their laws to allow for the sharing of know-how and data globally, but the waiver would be used primarily by low-income states.
Countries like Ireland do not need to waive national intellectual property even if an international waiver is accepted. Pfizer and Moderna’s sales to wealthy countries are unlikely to be much, if at all, affected by the TRIPS waiver.
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The EU’s counter-proposal to the TRIPS waiver is a distraction – it largely reiterates the existing TRIPS provisions. The EU’s proposal focuses on compulsory licenses, which allow a country to produce technology under patent, without authorization, under certain circumstances.
Yet compulsory licenses are onerous and insufficient on their own to provide rapid global access to vaccines, as it is a country-by-country, patent-by-patent approach. It would take too long. It also does not address other key intellectual property rights for vaccines, such as trade secrets. The EU’s proposal distracts attention from real solutions and the TRIPS waiver negotiations.
The Irish government should follow the Seanad motion by urgently reconsidering its position and using its influence within the EU to support the India-South Africa proposal at the WTO.
Dr Luke McDonagh is Assistant Professor of Intellectual Property Law, London School of Economics (LSE) and Dr Aisling McMahon is Associate Professor, Department of Law, Maynooth University.