Vaccine scientists say patent waiver will not speed global vaccine roll-out

Two leading vaccine scientists have said that a proposed patent waiver on COVID-19 vaccines would not speed up roll-out in lower income countries.

Prof Robin Shattock, of Imperial College, London, and Dr Anne Moore, of University College Cork, Ireland, said tonight that patents had not been a block to rapid global manufacture and deployment of COVID-19 vaccines and that waiving patent rights would not have the desired short-term effect.

They both agreed that talk of a patent waiver was a distraction from the real priorities: improving technology transfer to, and manufacturing capacity in, lower income countries and agreeing appropriate costs for the vaccines in those countries.

The two scientists made their comments in response to calls from South Africa and India, backed by many emerging nations, to gain agreement at the World Trade Organisation to have IP rights on vaccines temporarily waived. The argument is that such a waiver could allow local manufacturers to produce the vaccine and therefore address the inequality in global roll-out.

Speaking at an online panel discussion organised by CIPA, Prof Shattock and Dr Moore were unequivocal in their view that patents were not the problem and that such a waiver could, in fact, harm efforts to develop vaccines for variants and future viruses by creating a disincentive to research and investment.

Prof Shattock, whose team at Imperial are working on vaccines for COVID-19 variants, said: “We have to remember that the race to develop vaccines was fuelled by these companies investing billions of dollars. And if they’d known that patents were going to be waived, I suspect they wouldn’t have come to our rescue.

“We need to be making vaccines against variants. And the next time this happens, we need to make sure that companies will jump in yet again. So it’s about sustainability as well. There is a big danger that, if you wipe away patents and you wipe away these very large investments, nobody’s going to come to our rescue the next time around.”

“At face value it sounds like: ‘Oh, this is great, waive patents, and everybody gets vaccines for free’. But that’s not the reality – it’s a much more complex situation.

Prof Shattock said he was critical of companies that wanted to make large amounts of money out of a pandemic and if he believed that waiving patents would reduce costs and accelerate the global rollout, he would be very much in favour.

“But remember,” he said, “if you waive patents, and a company starts making a vaccine independently, they’re going to have to invest a huge amount of money in developing that technology themselves and doing clinical trials to show equivalence independently. And ultimately, that’s going to take a longer time, and they’re going to want to recoup their money for doing it.

“A patent waiver isn’t going to make it cheaper or faster, unfortunately. I wish it were the case, but it’s too simplistic. At face value it sounds like: ‘Oh, this is great, waive patents, and everybody gets vaccines for free’. But that’s not the reality – it’s a much more complex situation.

“We need most of the world’s adult population to be vaccinated in the next 12 months and that issue of speed is particularly important when we think about technology transfer of very complex biological vaccines.

“I don’t think that patents are the issue. I think they’re a distraction. The most important things are ensuring manufacturing capacity, tech transfer and appropriate costing for low and middle income countries.

“We need to move away from simplistic issues. Most people think that patents are about profit. They’re not – they’re about protecting knowledge and that knowledge protection can actually enhance access.”

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Prof Shattock added that, even if patents were waived on COVID-19 vaccines, the expertise was not present in other companies to rapidly produce them.

He said: “There aren’t companies that can make some of these very complicated vaccines. So RNAs (ribonucleic acid), for example…there aren’t companies that are already experienced in making RNA vaccines sitting empty, desperate for the patent to be waived, because they can roll it out tomorrow.

“In fact, many of the companies have looked for and struggled to find manufacturing partners, commercials, collective management organisations, who have the experience to get the technology out of the door very quickly. So it’s not as if there are lots of people just waiting, desperate to make a vaccine and to turn on the tap. The plumbing needs to be put in place.  And the plumbing just doesn’t exist right now, for many of these vaccine candidates.”

Prof Shattock said there were many more effective, creative ways to incentivise access and technology transfer for low and middle income countries than a patent waiver,  such as speedier, lower cost approval processes and tax benefits.

Dr Moore, who has previously conducted clinical trials of vaccines in malaria endemic areas of Africa, agreed with Prof Shattock, saying: “Patents haven’t been a problem and aren’t involved in the accelerated  manufacturing deployment of vaccines.”

She explained that, every year, roughly six billion doses of vaccines were made for all viruses and that most of these were pediatric vaccines. In contrast, in 2021 it has been predicted that we will need to make 11 billion doses for COVID-19 alone. This was creating complex manufacturing and supply chain issues.

She said: “Multiple different materials are needed to make any type of vaccine. And every company that was making a vaccine wanted a certain number of them across the board – tubes,  vials, syringes, rubber stoppers, as a commonality, and then various materials that are specific for each vaccine. And they are in incredibly short supply at the moment. So that has been a huge issue for COVID-19 vaccines in the early part of this year.”

Dr Moore explained the complexity of the technology transfer challenge and why this had created a bottleneck for COVID-19 vaccine roll-out.

She said: “When a vaccine company is transferring its technology, even in-house to another facility that it owns, it’s quite a long process. It can take two to three years to just get the new facility up and running, validated and making a vaccine to the same quality and safety as the home site.

“And to do that it’s not just a question of building a factory. It’s also a question of having people trained and transferring not just the facility and resources, but the know-how as well. Many of these vaccines are being transferred to contract organisations as well as to other vaccine manufacturers.

“We’re not just talking about the people switching on the bioreactor and doing the assays. It’s also the commercial, the legal, the regulatory staff that have to have the expertise not just within that facility, but within that region as well within their country.

“Trained people must also be placed on the regulatory science side, to know how to handle the income, the import and export of materials, the import and exports of vaccines, and to understand what’s happening in that facility or within their region. There’s a huge amount needed in terms of capacity of facilities and expertise, to make a vaccine and use it within an area or region.”

In answer to a question about whether compulsory licensing would be a more effective way to speed up global vcaccine deployment, Simon Wright, Chair of CIPA’s Life Sciences Committee, said he could not remember ever seeing a European government or the US invoking compulsory licenses – and for good reason.

He said: “If you know that a government will potentially compulsory license your patent – they’ll take your technology, they’ll basically say this is the royalty we’re going to pay pay you for it – then that’s a risk to investment and a risk to the business.  And it will probably act as a deterrent to develop new technologies and commercialise new therapies.”

The panel agreed that public/private partnerships such as the COVAX initiative, which was using pooled procurement and equitable distribution to accelerate the manufacture of billions of vaccines globally, were a good model for the future but they required more backing from Governments and more investment.

The event, on Wednesday 16 June 2021, was chaired by CIPA’s Honorary Secretary Gwilym Roberts and can be viewed here.

Date published: 16 June 2021

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