The Australian Government must intervene in global negotiations to ensure that global health is not compromised by efforts to water down a proposal to waive intellectual property rights for COVID-19 vaccines, treatments and tests, writes Associate Professor Deborah Gleeson, a public health policy scholar at La Trobe University.
Deborah Gleeson writes:
For almost 18 months, negotiations at the World Trade Organization over a proposal to waive intellectual property rights for COVID-19 vaccines, treatments and tests have been stalled due to opposition by the EU and other wealthy countries. Last week, a compromise was hammered out by four parties in an attempt to break the impasse.
But unless other countries insist on improvements, elements of the original proposal that are critical for improving access to life-saving products will be lost.
The leaked compromise ‘solution’, developed by the United States, European Union, India and South Africa, is drastically limited in scope compared with the earlier proposal endorsed by 63 countries in May 2021.
The earlier proposal would have applied to all products and technologies needed to prevent, treat, and contain COVID-19, including vaccines, treatments, diagnostic tests, medical devices and personal protective equipment. It was intended to waive all the rules in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that impede access, including those applying to patents, undisclosed information, copyright and industrial designs. And it could have been used by any of the WTO’s 164 members.
In contrast, the compromise solution is limited only to COVID-19 vaccines (at least in the first instance), applies to a narrow sub-set of intellectual property rules and would only be available to some developing countries.
Narrowing the waiver to vaccines alone is very short-sighted. Treatments such as the new oral antiviral medicines Paxlovid (made by Pfizer) and Lagevrio (made by Merck, Sharpe & Dohme with Ridgeback Biotherapeutics) are playing an increasingly important role in managing the pandemic. There is not enough supply to go around, even in wealthy countries like Australia.
While licensing deals have been struck to enable low-income countries to access cheaper generic versions of these treatments, many middle-income countries that would struggle to afford the high prices set by Pfizer and Merck are excluded. And diagnostic tests are important not just for monitoring the pandemic’s progression, but also for identifying those who need treatment.
Second, the compromise solution only applies to some of the intellectual property rights in TRIPS. It applies to patents, enabling eligible countries to authorise the use of ‘patented subject matter’ including ingredients and processes needed for manufacturing vaccines, without the consent of the rights holder. It also enables suspension of monopoly rights on test data submitted to regulators for marketing approval purposes, which could otherwise prevent generics from entering the market even when patents are out of the way.
But making vaccines also requires access to detailed know-how about the manufacturing process, currently protected as trade secrets, and the compromise solution does nothing to make this available.
The compromise proposal would only apply to developing country WTO members that exported less than ten percent of world exports of COVID-19 vaccines in 2021. This restricted scope would exclude China, which provided around one third of world exports, along with non-WTO members (which include many Pacific island countries) and countries like Brazil that have voluntarily given up their developing country status at the WTO. Even Least Developed Countries, which along with non-WTO members are likely to be in the greatest need, seem to have been inadvertently excluded.
Making matters worse, the compromise solution includes onerous obligations for those countries that decide to use it. For example, when authorising the use of patents related to a vaccine, they would need to list all relevant patents – an incredibly difficult task given the complexity of the patent landscape and the large number of patent applications in process globally.
And countries would have to notify the WTO of measures they take to implement the waiver as soon as possible after utilising it, providing information about which companies will make the vaccines, the quantities that will be made and which countries they will be supplied to. This requirement could result in countries being pressured to have all of the arrangements settled before they start using the waiver, essentially putting the cart before the horse. These new procedural obligations exceed the requirements placed on member states by the TRIPS Agreement – the very rules that the TRIPS waiver is meant to ease.
An effective TRIPS waiver would cover all COVID-19 health products and technologies and all relevant TRIPS rules that present barriers to access. It would be available to all WTO members and it would reduce the burden of WTO compliance rather than introducing new complexities.
The Australian Government has previously affirmed its support for the TRIPS waiver. Honouring this commitment means it should endeavour to reverse the limitations of the compromise ‘solution’ and support a waiver that would actually work.
See Croakey’s archive of stories on COVID vaccine equity.
Leave a Reply