Legal stoush looms over mRNA vaccine manufacture

Plans by the World Health Organisation (WHO) to support the manufacture of mRNA vaccines in South Africa through a “technology transfer hub” infringes the patents of some of the world’s pharmaceutical giants – and may yet be challenged in the courts, according to recent reports.

The charge, first reported by The BMJ and German newspaper Die Welt earlier this month, comes as kENUP Foundation, a specialist in “facilitating public and private investment into scientific innovations”, is promoting BioNTech’s proposal to ship mRNA factories housed in sea containers from Europe to Africa, initially staffed with BioNTech workers, in addition to a new regulatory pathway to approve the vaccines made in these factories.

“This is high-power politics,” says Bruce Baer Arnold, associate professor and patent law expert at the University of Canberra. “It’s about power, perceived national interest, high-tech corporations, and looking after big pharma. In effect, it’s about stopping a precedent.”

Intellectual property (IP) is a murky, complicated and confusing realm of law, essentially functioning as “national law within an international framework”, Arnold explains. And the IP stakes are particularly high when it comes to public health.

WHO’s technology hub, announced in June last year, is to be located in Cape Town, South Africa. It proposes to use publicly available information to re-create Moderna’s vaccine in low and middle-income countries by teaching African companies and scientists how to use mRNA technology. Through this initiative, WHO is seeking to scale up African production of COVID-19 vaccines from 1% to 60% by 2040.

It proposes to skirt IP restrictions by invoking the Doha Declaration on the TRIPS Agreement and Public Health, an agreement reached by members of the World Trade Organisation in 2001. “TRIPS” stands for the Trade-Related Aspects of Intellectual Property Rights. The agreement allows for “flexibilities” in exceptional circumstances when it comes to adhering to intellectual property law relating to public health problems affecting developing and least-developed countries.

“What we’re seeing now is that corporations and governments in the global north are wary about widening the door that’s available through the Doha Declaration on the TRIPS Agreement and Public Health, which allows nations to do what would otherwise be illegal under TRIPS,” says Arnold.

In this instance, this flexibility relates to South African law, which contains a provision allowing scientists and manufacturers to carry out research and development regardless of patent protection in exceptional circumstances, such as reverse engineering Moderna’s vaccine in order to create their own domestic version to ramp up production and vaccination rates in Africa.  

“South Africa wants to supply a desperately needed medication to a population where so many people are dying, but there will be a question whether this is permitted under international law, and whether it is justified under this special TRIPS agreement,” Arnold explains.

Ethically, the issue is a minefield.

“Wealthy countries have monopolised the supply of COVID-19 vaccines, and continue to allow pharmaceutical companies to maintain monopolies on the means of production,” explains Deborah Gleeson, public health expert and associate professor at La Trobe University.

“Moderna and Pfizer-BioNTech would ideally agree to share their technology and know-how with the mRNA hub, which would short-cut the process considerably,” she says. “As it stands, the mRNA hub in Africa is an important strategy to build regional capacity for vaccine development and manufacturing.”

However, as COVID-19 has shown, there is big business to be made through mRNA vaccines, which represent a superior alternative to conventional vaccine approaches due to their high potency, capacity for rapid development, and potential for low-cost manufacture and safe administration.

As a result, major pharmaceutical companies such as Moderna, CureVac, BioNTech and GSK (who collectively own nearly half of the mRNA vaccine patent applications), who have spent millions developing the vaccinations, have applied patents on the technology to ensure their investment is protected.

“These companies are thinking very strategically – they have a 50-year view of the world,” says Arnold . “If you’re a pharmaceutical company, you want the patent protection, which usually lasts 25 years. It’s expensive to get a drug through the approval process, so patents enable a longer period of protection.”

RNA expert Traude Beilharz, an associate professor at Monash University, says the current patents have cast “a very wide net to cover all possible mRNA modifications, when the companies are only using one”.

“Now that we know mRNA technology works, it can be rolled out to treat all sorts of health issues such as the common cold and basically any virus – even Epstein-Barr virus, which has been linked to multiple sclerosis and chronic fatigue,” she says. “But at the moment, anybody who wants to make a new vaccine against any virus will have to get a license if they want to use mRNA.”

Critics say the foundational patent for mRNA vaccines appears to be based on ground-breaking research by Dr Katalin Karikó and Dr Drew Weissman from the University of Pennsylvania, US.

“However, we won’t know for sure until a claim is tested in court, and there’s potentially quite different conclusions in several jurisdictions – even Australia and the US have different stances on gene patenting,” Arnold says.

Meanwhile, the longer it takes to vaccinate people in developing nations, the higher the death toll – as well as the likelihood of COVID-19 mutating and causing another, possibly more deadly variant, says Beilharz.

“Getting as many people vaccinated as quickly as possible is also an economic argument,” she says. “Our economies depend on it, trade depends on it. At the moment, we can’t stop having those reservoirs of populations where new variants are arising because we aren’t doing more to vaccinate them.

“Abandoning our neighbours and countries is going to cost us a lot, far more than actually providing the vaccines.”

Gleeson suggests that wealthy countries such as Australia could do far more to help, such as persuading other countries to support the waiver of the TRIPS Agreement for COVID-19 health products and technologies.

“We need to take more responsibility for removing the monopoly rights that allow a handful of companies to control the global supply and prevent more widespread manufacturing,” she says.

“Contracts for research and development funding could be tied to commitments to openly license the products, rather than allowing the companies that develop products with public funding to maintain control over where they are made, who can buy them, and how much they cost,” she says.

“Suspending intellectual property rights enshrined in the WTO TRIPS Agreement would allow more companies the freedom to manufacture them without having to wade through a legal quagmire.”

In their response to the BMJ investigation, kENUP strongly rejected assertions they are undermining WHO’s global vaccinations efforts, pointing to their support of private sector efforts in establishing vaccine manufacturing in Africa, including BioNTech’s initiative.

By all accounts, it is a complex geopolitical issue with billions of dollars at stake. And until the patents are challenged in court, vaccine shortages will continue to exist, leading to large populations of sick people acting as incubators for future pandemics, Arnold says. 

“We should be looking after the rest of the world as part of a broader national defense strategy,” he says. “Looking at this through an economic rational approach, it is clear that being generous to Africa and other developing countries just makes good dollars and sense”.