Yesterday, the US Biden administration declared its support for waiving intellectual property rights, including patents, for COVID-19 vaccines.
Author
Deborah Gleeson
Associate Professor in Public Health, La Trobe University
This decision represents a huge breakthrough in discussions at the World Trade Organisation (WTO) that have been deadlocked for more than six months.
Shortly afterwards, New Zealand's trade minister Damien O'Connor announced his country's support on Twitter, quickly followed by Canada's expression of support for the proposal.
Other nations that have so far resisted pressure to support the waiver are likely to fall like dominoes in the wake of the US in coming days.
Today, Australia's trade minister Dan Tehan said the waiver "will be an important part of trying to get a resolution in the World Trade Organisation", but it remains unclear whether Australia has unequivocally thrown its support behind the proposal.
Waiving intellectual property rights is a necessary first step to scaling up the global supply of COVID-19 vaccines and correcting worsening inequities in access to these desperately needed products.
A decision by Australia to support the waiver would indicate we value human lives more than pharmaceutical industry profits, and are committed to bringing the pandemic to an end globally.
Why do we need to waive intellectual property rights?
The exclusive rights to manufacture COVID-19 vaccines are currently held by a small number of companies that control the global supply. This is despite the huge amounts of public funding funnelled into their development.
Some of these companies have entered into licensing arrangements with other manufacturers to increase production, such as AstraZeneca's contracts allowing CSL in Australia and the Serum Institute of India to make its vaccine.
But most have not. And no pharmaceutical company has taken steps to share its intellectual property, know-how, and technology through the COVID-19 Technology Access Pool, a platform set up by the World Health Organisation (WHO) for this purpose almost a year ago.
The exclusive rights held by these companies are governed by the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, commonly known as "TRIPS". WTO members are required by TRIPS to provide patent terms of at least 20 years, along with other types of intellectual property protection, such as protection of trade secrets.
Suspending patents and other intellectual property rights relevant to pharmaceuticals will remove legal barriers, allowing vaccine developers to enter the market more quickly without worrying about the prospect of litigation over potential infringements of intellectual property rights.
It will also mean vaccines manufactured in one country can be exported to others without having to navigate a legal maze.
What's been happening at the WTO?
India and South Africa first put a proposal to the WTO in October 2020 for a waiver of certain intellectual property provisions in TRIPS for COVID-19 medical products for the duration of the pandemic. As envisaged by its sponsors, the waiver would apply to vaccines along with other medical products to fight the pandemic such as treatments, diagnostic tests and medical equipment.
Over the ensuing six months, more than 100 of the WTO's 164 members moved to support the TRIPS waiver proposal.
But several countries have prevented negotiations from moving forward, including the US, the European Union, the United Kingdom, Switzerland, Japan, Brazil, Norway and Australia. If Australia now adds its wholehearted support to the US proposal for a waiver for vaccines, this could help shift the dynamics at the WTO further towards a resolution.
Meanwhile, the pandemic has been accelerating and inequities in vaccine access have been worsening. The director-general of the WHO, Tedros Adhanom Ghebreyesus, noted in April that one in four people in rich countries had been given a vaccine dose, but only one in around 500 in low-income countries had received a dose.
It has become increasingly clear that unless governments take urgent action, the global supply of vaccines won't be adequate to meet demand for a long time to come. COVAX, the global program for equitable distribution of COVID-19 vaccines, has so far been able to deliver only 54 million of the two billion vaccine doses it planned to distribute by the end of 2021.
Why is the US about-face so significant?
Historically, the US has been the world's staunchest advocate for intellectual property rights. It has demanded its trading partners provide high levels of protection for IP in exchange for access to US markets, and has named and shamed countries it sees as providing insufficient IP protection, singling them out for trade sanctions.
The change in the US position signals how clearly the success of every country in fighting the pandemic depends on vaccinating the whole world. The risk of variants emerging in areas of uncontrolled transmission means no country can gain control of the situation just by vaccinating its own population.
The US move will give confidence to other countries to support the waiver and will isolate any countries that continue to oppose it.
Does the US support for the waiver go far enough?
The US has agreed to support a waiver only for vaccines. This is short-sighted. COVID-19 treatments could become a more important part of the medical toolkit for fighting the pandemic further down the track - as treatments called "antiretrovirals" have proved crucial to reigning in the spread of HIV. And many countries are lacking sufficient diagnostic tests, which are critical for getting outbreaks under control.
The waiver also isn't enough on its own: it's necessary but not sufficient. Governments will need to incentivise pharmaceutical companies - or if they continue to drag their feet, force them - to share their knowledge of manufacturing processes and their technology through initiatives like the WHO Technology Access Pool.
And governments will need to invest in building production capacity in low- and middle-income countries and find solutions to problems like shortages of raw ingredients, rather than relying on the market to solve these structural problems.
What needs to happen next?
Given the consensus-based decision-making process at the WTO, the TRIPS waiver will still need to win the support of the remaining countries standing in the way.
Gaining the EU's support will probably be the most difficult battle. The EU, where a large proportion of the world's pharmaceutical companies are headquartered, has so far emphasised donations of vaccines as the way out of the pandemic. But European Commission President Ursula von der Leyen has at least signalled the EU's willingness to discuss the US proposal.
Once consensus is reached, it will be important for the negotiations to be transparent, with draft texts shared publicly, as the benefits that flow from the waiver will rely on the detail of its wording.
Negotiations will also need to progress at speed. There have been millions of deaths from COVID-19 since the proposal was first tabled six months ago. The world can't afford another long wait.
Deborah Gleeson has received funding in the past from the Australian Research Council. She has received funding from various national and international non-government organisations to attend speaking engagements related to trade agreements and health. She has represented the Public Health Association of Australia on matters related to trade agreements and public health.
