Australia needs to act now for compulsory licencing of the COVID-19 vaccine

By Samuel Berhanu Woldemariam, PhD (Law) Candidate, University of Newcastle,
and Prof Lisa Toohey, Professor, Newcastle Law School

Australia’s neighbours are struggling with serious COVID-19 outbreaks. Which means, as Samuel Berhanu Woldemariam and Professor Lisa Toohey write, Australia needs to take seriously its obligations as a good neighbour in helping to secure COVID-19 vaccines for the region.

Instead, Australia is sitting like the proverbial dog in the manger. It is refusing to support the broad alliance of countries in the World Trade Organisation that are seeking to make these vaccines accessible through the process of compulsory licencing.

What is compulsory licencing?

Compulsory licencing is a legal process that lets governments bypass patent protection without the permission of the patent holder. This process is recognised in the domestic laws of states and as well as in international law. The so-called Trade Related Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization recognises that there may be rare but important reasons that a patent holder’s rights should be revisited. One such exception is compulsory licencing. Article 31 of the TRIPS Agreement lists the conditions applicable in respect of a compulsory licencing which requires such authorisation be considered on its individual merits; not grant exclusive rights; be limited to the domestic market of the authorising state; limit the scope and duration of such use; and be subject to remuneration for the patent holder.

The requirement of Article 31 regarding limiting use to domestic market was dispensed with following the adoption of the Amendment of the TRIPS Agreement. The amendment authorised member states to issue a “compulsory licence to the extent necessary for the purposes of production of a pharmaceutical product(s) and its export to an eligible importing Member(s).”

However, Article 31 of the TRIPS agreement envisages “country specific measures such as in situations of a national emergency, extreme urgency or when the medicine is required for public non-commercial use.” It does not cover a pandemic situation such as the one the world is facing now. Recognising this difficulty and the impact that COVID-19 is having across the globe, South Africa and India submitted a waiver proposal to the WTO back in October 2020. In the letter, South African and India called on WTO member States:

to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.

The proposal called for a waiver of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement for an unspecified duration of time “until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity.”

What’s at stake?

The major tension with respect to compulsory licencing and the proposed waiver at WTO is the impact it may have on the protection of intellectual property (IP) rights. Arguments have been made that such waivers will discourage innovation and take away the incentive for investment in medical and pharmaceutical research. On the other hand, there are humanitarian considerations aiming to prioritise the protection of life and public health by imposing restrictions on IP rights.

Arguments have also been made to the effect that compulsory licencing and the proposed waiver does not provide the magic bullet for containing COVID-19. Experts have argued that the major barriers lie in the capacity to produce, scaling up production and the fact that the proposed waiver would not compel IP rights holders to share technical know-how.

It should however be clear that compulsory licencing or the proposed waiver and the protection of IP rights are not mutually exclusive. The proposed waiver and the authorisation of compulsory licencing does not necessarily lead to dismantling the protection of IP rights. The authorisation of compulsory licencing is subject to conditions and limitations that provide protections to IP rights holders. It is also unlikely that the proposed waiver will be approved as a blank waiver. There will be safeguards for IP rights holders any authorisation will likely be subject to condition. As such, equating the proposed waiver or compulsory licencing with the watering down of IP rights protections appears to be an exaggeration.

While it is also true that much needs to be done in terms of production barriers, a swift and coordinated action in this respect at the WTO goes a long way to provide lasting solutions. It also paves the way for future preparedness should we find ourselves in a similar situation. However, discounting these efforts on the premise that many nations, particularly developing countries, do not have the capacity to produce these vaccines is at best a shrug and inconsistent with the intention of the WTO Agreements to balance economic and social imperatives.

A growing support for waiver proposal

There is now a growing support for the waiver proposal, including from the United States, which reversed its previous stance on the matter. Australia should follow suit and support the waiver as it is in the best interest of the state. Ramping up vaccine production is not easy, but the waiver is an important first step. Making vaccines available to developing states will not eliminate the virus or cure disease, but it will help contain it. Until COVID-19 is contained everywhere, it is contained nowhere.

Though Australia is safe for now, it cannot continue to seclude itself from the rest of the world by closing its borders. Life must continue, and so must the economy. Critical industries like education and tourism rely on open borders. The sooner the international community cooperates in this regard, the sooner we will be able to get to normality and resume life as we know it. This calls for unprecedented cooperation and solidarity from states.

Ethical and moral considerations also call for swift actions before it is too late – so does economics. The situation calls for a deeper reflection on the ethical and moral commitment to prioritise the protection of human life to trade and IP issues. States and corporations tend to lose sight of humanity when engulfed with abstract analysis of their national or corporate interests. Yet, even on the most selfish analysis, it is in Australia’s best interests for compulsory licencing or a waiver to be used to help contain the outbreaks overseas.

The scale of humanitarian disaster unfolding in India and Papua New Guinea is unprecedented, and the uncontrolled spread of COVID-19 amongst neighbours has risks for Australia, even if most of the population is vaccinated. A WTO waiver is not the magic pill the world is hoping for, as vaccine production would still need to ramp up. The world has sat on its collective backsides for too long, and Australia needs to take a stand now.

Time to act

As of 21 May 2021, there are 164.5 million confirmed COVID-19 cases, and the virus has claimed the lives of more than 3.4 million people globally. The resurgence of the virus across different countries suggests that we are a long way from containing its spread. It is difficult to predict where the next global hotspot will be. What is predictable is that the virus will continue to spread until swift and coordinated international action is undertaken to secure an equitable distribution of vaccines. The removal of IP barriers is the first of many steps in this regard. It offers a great opportunity for the international community to demonstrate solidarity, the prioritisation of humanity and the protection of public health. Most importantly, this opportunity at the WTO should be seized to reflect on the deeper concerns of global inequality. Australia should demonstrate leadership in this respect and step up its efforts to be a moral leader.

Samuel Berhanu Woldemariam is a PhD (Law) candidate at the University of Newcastle and a former legal officer with the Ethiopian Ministry of Foreign Affairs. Samuel’s research interest spans across a range of areas in international law.

Lisa Toohey is Professor at Newcastle Law School and holds dual qualifications in law and international relations. She is a Senior Member of Universities Australia Executive Women Group and an Adjunct Professor at the Faculty of Law at the University of New South Wales. 

Banner image: COVID vaccines currently protected by patents. Credit: Marc Bruxelle, Shutterstock.

This article originally appeared on the Australian Institute of International Affairs' website on May 21, 2021.