Europe blocks move that would massively expand Covid vaccine production capacity. Why?

Credit: Alexia Barakou

“If not now, when?” asked Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO)e. He was referring to a proposal to waive intellectual property rights for Covid-19 products during the pandemic. The demand was tabled at the so-called TRIPS council in the World Trade Organization back in October.

The initiative by South Africa and India was fiercely opposed by the EU, the US, Switzerland and Japan — all countries with a strong pharmaceutical industry.

This week, the TRIPS Council is set to meet again, on March 10. The waiver proposal now has the support of around 100 governments out of the 164 WTO member states, according to the aid organisation, Doctors without Borders. The list of supporters extends from South Africa and India to Afghanistan and Mali. Other sources report much higher numbers. Among supporters are also the Holy See and The People’s Vaccine, an alliance of aid groups and human rights organisations.

Credit: WTO
A proposal at the WTO by South Africa and India calls for the suspension of IP rights for Covid-19 products

A lot has happened since the proposal was first introduced. Back in October, there was no vaccine. Now, there are several, brought to life by major public funding. But they belong to a handful of companies that have patented them. 60 per cent of the expected vaccine supply has been pre-ordered by countries with only 16 per cent of the world’s population. Canada has ordered enough to vaccinate Canadians five times if all candidates succeed; Norway enough to do it three times over. Two months into vaccinations, 108 million doses of vaccine had been distributed worldwide. But 75 per cent of them had gone to just 10 countries, according to the WHO.

A recent report by the International Chamber of Commerce claims that the global economy stands to lose up to USD 9.2 trillion if governments don’t ensure access to Covid-19 vaccines to all. Half of this loss would fall on rich countries.

Even the rich are vulnerable

Europe is the world leader in vaccine production; more than 75 per cent of all vaccines are produced on the continent. But even the EU Commission — which has signed agreements with six vaccine makers for a total of 2.6 billion vaccine doses for over 450 million Europeans — found itself helpless at the first hurdle with one of the producers, AstraZeneca.

Across the continent, people have entered a phase of lockdown fatigue. All governments are under immense pressure to speed up vaccine deliveries so that people can have their lives back. But when AstraZeneca announced that it had manufacturing problems — which would mean the EU would get much fewer initial doses than laid out in the agreement — there was very little the Commission could do, other than make loud complaints.

“Lack of production capacity is a real problem for everyone, not only for developing countries,” says John-Arne Røttingen, Norway’s ambassador for global health. He points to the challenge: 3.5 billion doses of vaccines — against all kinds of diseases — are usually produced globally every year. The need for Covid-19 vaccines is 15 billion doses, and all of them are required now.

“If IP rights are temporarily suspended, and companies would also share their know-how, production could start in a couple of months.”

Dimitri Eynikel, Doctors Without Borders

The risk of mutations

The main vaccine producers are working around the clock to increase production. But they are nowhere near meeting the demand, according to Tedros Ghebreyesus. The virus continues to mutate in unprotected populations. More contagious variants than ‘version 1.0’ have appeared, and there is a risk that the virus may become more deadly, with catastrophic effects. The WHO director calls on governments and companies to come together to overcome what he labels “artificial scarcity”.

How much more capacity?

Nobody knows exactly how much production could be ramped up, and how fast, if patents were lifted and recipes shared. But the news agency AP recently found three factories — in Denmark, Bangladesh and South Africa — whose owners say they could start producing hundreds of millions of Covid-19 vaccines on short notice if only they had the blueprints and technical know-how.

The new mRNA vaccine technology adds opportunities, according to Dimitri Eynikel, policy coordinator at the Access campaign of Doctors without Borders (MSF). The Pfizer, Moderna and Curevac vaccines are mRNA-based.

“These vaccines are much easier and cheaper to reproduce and to adapt to new variants. And the main advantage is that the processes are closer to the production of certain medicines,” Eynikel tells Investigate Europe. “This means many production sites that never made vaccines before, can produce this vaccine.”“If IP rights are temporarily suspended, and companies would also share their know-how, production could start in a couple of months,” he adds.

North-South divide

Decisions in the WTO are usually made by consensus, which does not exist in the TRIPS Council. There, the EU Commission speaks for all EU countries and is opposed to the proposal by South Africa and India, just like the US, Japan, Switzerland and Norway. According to people familiar with the situation, there is an ocean between the two sides, and many meetings since October have resulted in little more than heated exchange.

Meanwhile, around 100 of the 164 WTO members have thrown their weight behind the demand for a waiver, according to MSF. If no consensus can be reached in the TRIPS council, a decision can formally be made in the General Council by a three-fourths majority, which requires the support of 123 countries. But this would be a dramatic move and highly unlikely, say observers. Instead, supporters are pushing for text-based, real negotiations on some sort of waiver.

EU Commission: Patents not the issue

Waiving patents will not solve production capacity problems, claims the EU Commission. The best option is rather that major countries state clear expectations and put pressure on industry, goes the thinking. This side sees collaboration with industry as the way forward, with IP rights as the framework.

“We need to find measures that preserve the incentives to innovate and invest into the research related to health, while disseminating the technology and know-how through collaboration between vaccine developers and producers,” an EU Commission spokesperson states in an email to Investigate Europe. This is happening, but needs to be scaled up, it says.

The bottlenecks

This is in line with the view of the pharma industry, which clearly sees the waiver as a threat. 32 CEOs of biopharmaceutical companies in the US, including the biggest, put their signatures on a letter to president Joe Biden dated March 5. They urged him to “maintain this longstanding support for innovation and American jobs by continuing to oppose the TRIPS IP waiver”.

“I really think the issue is not an issue of patents, it is an issue of manufacturing capacity around the world, and we are all working to increase it as quickly as we can,” said Pascal Soriot, CEO of AstraZeneca. He appeared in a hearing at the European parliament with other CEOs of vaccine producers in early March.

It is not so easy to add a production site, Soriot said. “People having access to our patents will not help them much if they don’t know how to manufacture the vaccine. We have to teach them.” AstraZeneca sends engineers to many sites, but this takes time. “Our teams are absolutely stretched to the maximum, there is no way they could train more people,” Soriot stated.

Parliamentarians: Put your money where your mouth is

115 members of the European Parliament are not content. They recently urged the EU Commission and the EU Council, which consists of the 27 EU governments, to reconsider the waiver. Both the Commission and several heads of state have spoken about Covid-19 medical products as “global public goods”, but they have not acted to make this a reality, the politicians say. Don’t block the waiver, they tell the EU Commission and Council. So does MSF, urging the governments that continue to block the waiver, to “immediately reverse their stonewalling and allow formal negotiations at the WTO to start”.

COVAX, the aid solution

Fair access to vaccines for everyone globally is a top priority of the EU, assures the Commission. They see COVAX as the main instrument to achieve this. COVAX was a historic initiative taken last year to buy vaccines on behalf of the whole world and make sure the doses were distributed fairly. It has become something much less, more similar to an aid project, as rich countries have made purchasing agreements with the vaccine companies directly.

COVAX started spreading some hope on the ground on March 1. That was when the first COVAX-funded vaccines were administered — health workers in Ghana were given a shot in the arm of the AstraZeneca vaccine, produced in India and shipped to Africa. Côte d’Ivoire, Nigeria, Angola and others followed.

The AstraZeneca vaccine being administered in Ghana, as part of the COVAX rollout

The EU has funded COVAX with over €2.2 billion, and other G7 countries have recently increased their financial support. Still, the initiative remains deeply underfunded. It aims to deliver 1 billion doses of vaccine to 92 low- and middle-income countries this year. But this will only be enough to protect the most vulnerable of the people in these countries, leaving the virus to circulate and mutate.

South Africa rejects ‘philanthropy’

South Africa’s government sees COVAX as a good initiative, but not one that will secure a victory over the virus. However much money donor countries may throw at the problem, philanthropy is not the solution, said the South African representative at a TRIPS meeting in late February: It doesn’t help to have money to buy if there is nothing to buy. He compared the crisis of the pandemic to World War II and urged the opponents of the waiver to leave their ‘business as usual approaches’.

“We have no choice. It has to happen,”, Mustaqeem de Gama, Counsellor at the South African Mission to the WTO, says about the waiver. “God forbid that this virus jumps into another much more virulent [strain]. Already the EU is considering waiving IP rights. The Biden administration has said that we should waive rights to a certain extent so that we can ramp up the production. There are cracks appearing,” he tells Investigate Europe.

“Maybe not everything in the waiver will come to fruition. But if we focus on the most important and immediate outcome, we have a credible landing zone. The quicker we do it, the better for everyone,” de Gama says.

Life and death diplomacy

South Africa is currently the chair of the TRIPS Council. This week’s meeting will see Norway’s WTO ambassador, Dagfinn Sørli, take over the job. Norway has asked South Africa and India to come up with a revised, narrower proposal. Sørli faces a steep task in trying to find a middle ground between a desperate and determined global South and a group of rich northern countries hosting pharma giants with global monopolies to protect. But both sides face a common enemy that can only be defeated with unified action.

Thiru Balasubramaniam, the Geneva representative of the social justice NGO, Knowledge Ecology International, is following the drama playing out in Geneva. Chairing the TRIPS council right now is a grave responsibility, he says.

“The world is grappling with the biggest challenge of our generation, apart from the AIDS pandemic. The weight of these expectations will rest on ambassador Sørli’s shoulders.”

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Factbox: What is TRIPS?

Short for Trade-Related Aspects of Intellectual Property Rights, TRIPS is an agreement on intellectual property (IP) within the World Trade Organization (WTO). 164 countries are part of it. TRIPS concerns trade in knowledge and creativity, resolution of trade disputes over IP, the latitude WTO members have to achieve domestic policy objectives.

The waiver proposal

On October 2, 2020, South Africa and India proposed to temporarily waive patent rights over products to prevent, contain or treat covid-19. The purpose: To let anyone capable of producing the vaccine, do it.

“The waiver should continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity hence we propose an initial duration of [x] years from the date of the adoption of the waiver.”

The waiver proposal relates to sections in the TRIPS agreement that deal with copyright and related rights, industrial designs, patents, and protection of undisclosed information.