While Western donors have stumped up significant funding for a programme to make Covid-19 vaccines in Africa, activists say more support is needed to help poor countries secure the intellectual property rights they need to produce mRNA vaccines beyond the pandemic.
Grants and loans from Western countries, including France, have driven momentum for a "made in Africa" vaccine.
The World Health Organization's programme to produce mRNA vaccines for the global south is well-funded at 80 percent of the total needed, says Charles Gore, executive director of the Medicines Patent Pool (MPP), a public health body assisting the project with licensing and fundraising.
The "hub" of the programme is a South African consortium that developed an mRNA Covid vaccine based on the version produced by US pharmaceutical giant Moderna. Fifteen other countries, the "spokes", will ultimately receive training and technology to manufacture the vaccine themselves.
Yet without more support to secure intellectual property (IP) rights, the future of manufacturing vaccines in low- and middle-income countries could be under threat, activists say.
“There is a level of hypocrisy because while they’re willing to support this, they’re not willing to support other structural changes,” says Anna Marriott, Oxfam's health policy manager, referring to Western donors.
Weakened waiver
Governments agreed to waive certain patents on Covid vaccines in June 2022 after negotiations at the World Trade Organisation that took more than 20 months.
The five-year agreement allows developing countries to produce vaccines, or the ingredients necessary to make them, without the consent of the patent holders – and then to export them to other low-income countries.
But the European Union and others effectively worked to dilute the deal, according to Marriott, who is also policy co-lead for the People's Vaccine Alliance, a global coalition of more than 100 organisations working for vaccine access worldwide.
While South Africa and India had called for a broader waiver of IP rights for Covid vaccines, tests and treatments, the existing agreement applies only to vaccines.
Critics say the EU and the US – where the pharma giants are based – have been too protective of vaccine and other Covid-related technologies to the detriment of poorer countries.
The German government mounted perhaps the biggest opposition to the waiver, says Marriott – issuing its own compulsory licence for Covid technologies.
“If another country had discovered an effective Covid vaccine that wasn’t available in Germany, they passed legislation nationally that they could override the patent … to produce for the German market.”
In the United States, legal allowances were also made to override patents during the pandemic.
Health is “not really global when the global south is still experiencing discrimination in terms of access to diagnostics and therapeutics,” says Barrack Owino of the African Alliance, a group that advocates for community healthcare.
Not investing enough on the African continent has led to this inequality, he says.
The WHO's hub-and-spokes project is designed to remedy two gaping disparities between rich and poor countries: lack of technology and lack of training.
Patent problems
The South African consortium – comprising biotech company Afrigen Biologics and Vaccines, specialist manufacturer Biovac and the South African Medical Research Council – will share its vaccine technology with other low- and middle-income countries and train them to adopt it, ultimately supporting them to scale up production to commercial quantities.
It is hoped the partnership could be extended to cover the development and manufacturing of future mRNA vaccines for other key diseases.
Yet wide-ranging South African patent laws could stymie the process.
The existing patent application system does not make a thorough check of whether a submission is truly new, and the criteria is lax, according to a technical brief released by Doctors Without Borders (MSF). Nor can patents be challenged efficiently by the public or civil society organisations under the apartheid-era law, MSF says.
“South Africa granted very broad patent claims to Moderna related to mRNA vaccine technology that were rejected in other countries, such as Japan, Israel and South Korea, due to lack of technical merits,” the MSF brief said.
Moderna filed at least three mRNA patents in South Africa, which were automatically accepted and will only start expiring in 2034.
Although Moderna initially said it would partner with the WHO programme, it later pulled out leaving Afrigen and its partners to develop its own Covid mRNA vaccine based on information about Moderna's formula that was available in the public domain.
“Moderna will never enforce its Covid-19 intellectual property rights in the Gavi-eligible AMC-92 countries, or against manufacturers who are producing Covid-19 vaccines for distribution in those markets,” Luke Mircea-Willats, director of Moderna’s media relations, told RFI.
Gavi-eligible AMC-92 countries are low- and middle-income countries identified by Gavi, the Vaccine Alliance, which works to increase access to immunisation in poor countries. South Africa is not on this list, but Moderna has promised, in comments to the media, that it will not enforce patents related to its coronavirus vaccine there either.
For vaccines beyond Covid, though, "we don't have Moderna's blessing", Petro Terblanche, Afrigen's managing director, told RFI.
"We'll have to look at how we'll get freedom to operate, or we'll have to licence. That's the challenge we'll have to manage."
'Protect the mRNA hub'
Vaccine activists and civil society leaders in South Africa have called on the government to change its legislation to clear the way for South Africa to create and manufacture mRNA vaccines.
“As Moderna’s conditional pledge covers only Covid-19 vaccines, the hub’s work and the investment in it remain under threat,” said a letter addressed to South African President Cyril Ramaphosa last month, signed by more than 35 individuals and groups in South Africa and across the African continent.
They stress that the programme is not just for Covid vaccines but ultimately for manufacturing mRNA vaccines against other diseases such as malaria, HIV and tuberculosis.
“Therefore, we urge you to do everything in your executive power to protect the mRNA hub and its spokes and safeguard the ability of low- and middle-income countries to research develop, produce, and register mRNA vaccines,” the activists wrote.
But beyond South Africa's legislation, vaccine campaigner Fatima Hassan, founder and director of Cape Town-based Health Justice Initiative, says the onus is on the big biotech companies to allow access – not to talk about it and then revoke it.
She fears that Moderna could file a lawsuit at any time.
Large vaccine access initiatives such as MPP and Covax, the Covid-19 Vaccines Global Access initiative, tend to “believe in the solidarity and goodwill of drug companies, which is not based on evidence,” says Hassan.
She says if the issue of intellectual property is not addressed, it limits the hub’s freedom to operate. “What we have is a situation where Moderna’s patents could potentially be the biggest stumbling block to the hub’s work, outside of Covid-19.”
Justice, not charity
“We are all aware of the fact that [intellectual property] might become an issue, and of course, measures must be taken before it becomes an issue. We all agree on that,” says Marie-Paule Kieny, head of the hub-and-spokes steering committee and chair of MPP.
There have been some positive comments on dealing with vaccine inequality from the US, most recently at the UN General Assembly in September.
“Equity is not charity alone,” acknowledged Loyce Pace, assistant secretary for global affairs at the US Department of Health and Human Services.
“We have to be sure to round out any donations or other support with issues or advances, like voluntary tech transfer or capacity strengthening or by, frankly, decentralising and distributing local and regional manufacturing.”
Vaccines and medications could be manufactured on the continent and distributed either for free or at a price set by the government, suggests community healthcare advocate Owino.
“The system has been designed to give us charity, but we don’t want charity," he says. "We want justice, so we can have autonomy and respect.”
