Coronapod: Waiving vaccine patents and coronavirus genome data disputes

Benjamin Thompson

Welcome to Coronapod.

Noah Baker

In this show, we’re going to bring you Nature’s take on the latest COVID-19 developments.

Benjamin Thompson

And we’ll be speaking to experts around the world about research during the pandemic.

Amy Maxmen

We’re entering a new era now. We have new COVID strategies, there’s some new unknowns and we’ve got a vaccine.

Noah Baker

Hello, and welcome to Coronapod. I’m Noah Baker, and joining me from California is Amy Maxmen. Amy, how are you doing?

Amy Maxmen

I’m good.

Noah Baker

So, last week we had a Coronapod special, which was a kind of a different take from what you might normally hear on the show, that was a documentary piece all about the reporting that you have done, Amy, in the San Joaquin Valley. I’d strongly recommend going and listening to that. It covers a lot of topics. It was a really fascinating piece for me to work on, and a lot of the background of that story was about the inequities that exist in American society but across the world with regard to public health. And this week, we’re back to a regular Coronapod and we’re going to lead with a piece of news which was really shocking and is linked, in many ways, to some of the many problems that were discussed in last week’s Coronapod, and that’s the shocking announcement from the US that they will support a relaxation of intellectual property rights on vaccines. Amy, can you tell us a little bit about what’s been going on in the last couple of days.

Amy Maxmen

So, yesterday, the US trade representative announced something that I think shocked everyone, which is that the US supports a waiver on patents that are used to make COVID-19 vaccines. It’s a temporary waiver and this is just their support for it, but the reason why it was so shocking is because, for as long as I’ve been alive, the US is like maybe the biggest, strongest supporter of IP. I think people were saying they should be waived, but nobody really expected the US to put their weight behind that. But they did.

Noah Baker

And so, for people that may not be up to date on this, can you tell us just briefly what we mean by intellectual property patents when it comes to things like vaccines, and why the US has been such a staunch defender of it in the past?

Amy Maxmen

So, the patents would cover all of the intellectual property that has anything to do with any of the COVID-19 vaccines, and the reason why the US has been a really strong defender of such patents is because we have a strong pharmaceutical sector, and the way that they sort of recoup all of these massive investments they put into research and development is to be able to hold a patent for some period of time – it’s 20 years from the point of filing – and then they get exclusivity on the market. So, that’s sort of their reward for having done all the upfront investment.

Noah Baker

And so, those laws exist to protect the pharmaceutical industry’s ability to make profits and recoup those investments, and yet there have been countries that have been calling for a relaxation of those laws around COVID treatments and COVID vaccines. So, South Africa have made that call, India have made that call, and now the US has said that they would support that as well. What’s the reaction likely to be to that political statement?

Amy Maxmen

So, right now, we’re in a particular point in time. So, that was the first day of a general council meeting at the WTO (World Trade Organization) that happened yesterday when the US announced this. Today is the second day of the meeting, so things might be drastically different by the end of today, and it’s Thursday today, the podcast comes out Friday, so keep in mind this might change somewhat. So, what could happen today is I’ve heard analysts say that they expect several countries, such as, for example, Brazil or Japan that haven’t supported waivers to maybe come over to the US side now that the US has kind of thrown their weight behind this. Some analysts speculate that maybe the European Union might be the holdout. The reason why that matters is because the WTO won’t go on to actually get into the details of which patents to waive until every country agrees that there should be some sort of waivers. Now, South Africa and India have pushed for waivers not just over the patents on vaccines but also on PPE and therapeutics and diagnostic tests and other technologies that have to do with COVID-19, and the US, in this statement, was really specifically about vaccines.

Noah Baker

And we should explain here that the reason that you might want to waive the patents on these vaccines is because it would allow generic manufacturers to produce them at a lower cost for countries that, so far, have not been able to vaccinate as many of their population as they would like, which is a lot of low- and middle-income countries around the world.

Amy Maxmen

Yeah, it’s drastic. Less than 1% of the population in low-income countries has been vaccinated. The US has more than enough vaccines to vaccinate everybody in its population. We’ve now made it so anybody over age 12 can be vaccinated. Meanwhile, you have people over age 70 and health workers and people at high risk in so many countries that have zero access to vaccines. And to give you any sense of how the world works if there isn’t measures that push this, at the moment the world needs about 11 billion doses of coronavirus vaccines just to immunise 70% of the world’s population. So far, even though the companies that exist have confirmed orders for 8.6 billion vaccines, 6 billion of those are going to high-income countries. Okay, so, to do some back of the envelope with that, that basically means that 70% of the world’s vaccines are going to 30% of the world because 70% of the world lives in middle- and low-income countries.

Noah Baker

Which simply can’t afford vaccines in the numbers that they need to vaccinate their populations while these patents are in place.

Amy Maxmen

It’s a complicated question, so it’s a little bit to do with that. I guess the point is, just simply letting the market do what it wants isn’t going to solve this problem.

Noah Baker

I think we should also say here that this sounds, in many ways, like an altruistic act on part of the US to try to waive some of the companies in the US’s possible profit margin or to support a waiver of that, but it is also something that we should state that we are not free from COVID until the world is free from COVID. If we want to open up borders again properly, if we want to allow travel again, then there’s lots of places that need to get vaccines to them, so there is kind of a reason for high-income countries to try to facilitate vaccinating people outside of their country as well.

Amy Maxmen

Oh for sure, and think about how much of manufacturing might happen in India and other countries like that. We’re a global world.

Noah Baker

And so, in many ways I hear this and I’m like, okay, the US has thrown its weight behind trying to find ways to make vaccines more accessible for lower- and middle-income countries. The pharmaceutical companies might lose out from this. What would be the arguments against doing this?

Amy Maxmen

So, I think the pharmaceutical industry is largely against the measure. The industry group Pharmaceutical Research Manufacturers of America – their acronym is PhRMA – right after the announcement, they put out a really scathing statement that talked about all of the reasons why this was a terrible move. Some others, some researchers, notably Bill Gates has said he’s against it, and there’s a few reasons they put forward for it. One is the major overruling idea is that the way that you encourage the pharmaceutical industry is to be able to allow them to make profits when they make huge investments upfront that can take many years. So, they’re saying this sets a dangerous precedent and that it’s not fair. What proponents of waivers are saying are a few things. Number one, this is a temporary waiver we’re talking about. Number two, it’s specifically about COVID. And then also, they note that there was public funding that went into all of the vaccines, some more than others, so that’s taxpayer money and so it’s not like the companies put up all of the investment for R&D upfront. And then also, just to note, companies are profiting from these vaccines. So, there was an article in the New York Times that said that in the first three months of 2021 this year, the Pfizer vaccine generated US$3.5 billion in revenue. And let’s just note that Pfizer had promised to contribute 2% of the doses that it made to COVAX, which is the WHO’s mechanism to supply low-income countries with vaccines, but Pfizer’s not even come close to fulfilling the goal of 2%.

Noah Baker

And there are also arguments that pharmaceutical companies might make and that indeed that Bill Gates made around safety of the vaccines. Can you explain what that argument is?

Amy Maxmen

So, what Bill Gates said was if you get generic manufacturers jumping in and producing these vaccines, it could give them a really bad name if a company had bad manufacturing practices, and then that’s really dangerous and they have a dangerous product. Again, what people will say back to that is that most of the drugs and the vaccines in the world at this point are generic, and there are standards for manufacturing which mean that we still can trust generic drugs and generic vaccines.

Noah Baker

I think we should also say here that it’s not just a case of making it legal for someone else to produce it, it’s also that you need to tell them how to make it as well, otherwise it’s still not going to actually solve the problem we’re trying to solve here, which is vaccinating the world.

Amy Maxmen

What everyone who’s been in support of these waivers who I’ve talked to says is that if a waiver goes through, the second thing that has to happen is the transfer of knowledge, the technology, transfer agreements. You need to have the companies or whoever knows how to make the vaccines teach other companies how to do it, what they need, what the reagents are, even maybe help them get those reagents, so that’s kind of the second thing that needs to happen. Now, generic companies will often figure out how to reverse-engineer a drug or vaccine once it goes off-patent, but that can take years and we don’t really have years. So, they’re saying, no, don’t make them just reverse-engineer this and try all the clinical trials again but actually teach them how to do it.

Noah Baker

And it feels like that’s a difficult step if already pharmaceutical companies are not approving of this first step because you surely need them onboard to make the second step happen.

Amy Maxmen

Yeah, I hear there are incentives, but I was writing a breaking story yesterday so I didn’t get into what those are, but maybe that’s a story in the future.

Noah Baker

So, we don’t know what’s going to happen with this shock move from the US. We don’t know whether or not patents will be waived for a temporary period with vaccines, and it’s something that we’re going to have to watch, but while we’re on this topic, if we think about equity and if we think about trying to provide access to something like vaccines all over the world, there are various other ways in which in the sort of sphere of science and research that equity is thought about, and one of those is data equity. So, that’s trying to make data freely accessible across the world so everyone can access that. And just like with the vaccine patents where there’s lots of sides to that discussion and lots of arguments, there’s a lot of nuance around open data as well, and that’s what you’ve been looking into this week.

Amy Maxmen

Yeah, so maybe it helps if I give the origin of this story. So, last month, there were sort of back-to-back pieces, one in Science, one in Nature, that talked about this data platform called the GISAID initiative. That’s the most popular place where scientists will upload their SARS-CoV-2 genome data. Right now, it’s got about 1.4 million sequences, and that is unprecedented in the sense that the data is coming from around the world and it’s prior to publication quite often. When I’m talking about GISAID, I’m talking about a site that I have access to, so I can see all of that genomic data, only I have to sign in. I have to log in, and when I log in with my email and a password, I have to agree to terms and conditions. So, the articles that came out in Science and Nature were from researchers who were just saying, ‘No, there shouldn’t be any sort of sign in and terms and conditions.’

Noah Baker

So, what are the kinds of terms and conditions that were being objected to at that point in time?

Amy Maxmen

What the objections were was that there is a gatekeeper, and if you want to do the kind of huge analyses that, in the US and in western Europe there’s lots of bioinformatics labs, they call them dry labs. Basically, researchers sit in rooms with computers and often they have whole clusters of computers that they’re working with, and they can do these massive genomic analyses where they crunch hundreds of thousands of genomes from different databases, and they come out with phylogenetic trees that tell you how the virus is evolving. These are huge studies. GISAID sort of slows that process down because if you’re going to publish a paper with these big analyses you have to give credit to all of the people who uploaded those sequences, and GISAID also suggests you make your best effort to reach out to them for collaboration. It sounds great, but also researchers have said this sort of slows them down.

Noah Baker

And therein lies the terms and conditions that lead to the kind of twist in this story. So, the kind of suggestion by GISAID that you collaborate with people that uploaded these sequences and the requirement to acknowledge those labs, those people around the world, slows up these big bioinformatics studies which are really useful and really helpful, but potentially disadvantages people that are uploading those data. Can you tell us more about why people might not want to remove these terms and conditions?

Amy Maxmen

Yeah, so these articles came out in Science and Nature, and I started hearing about how people were really upset about them. I can tell you, this is one of those stories that’s like bizarrely contentious. At first, I was like, I’m going to write about some databases, but it ended up being people on both sides being really passionate about this issue. What I did is I decided, okay, I want to talk to more people who we hadn’t heard from, like researchers working in Africa or South America, so I reached out to a lot of them. You can see their names on sequences in GISAID, so I emailed them and I talked to a number of researchers in both of those continents. And I would say, across the board, the reason they were sharing their data is because of the terms and conditions on GISAID and there’s a number of reasons for why. Now, one, I think because I’ve been to several of these countries, I can tell you it’s sort of unbelievably difficult to just do work that we find here might be simple. So, the first person I spoke with was somebody named Nnaemeka Ndodo, who I met in Nigeria a couple of years ago. He’s working at the Nigeria Centre for Disease Control. So, they’re doing the outbreak response. They’re trying to set up ways that different states in the country are responding to coronavirus. In addition, he’s doing all of the extraction of the RNA himself, he’s doing the sequencing of it, and he’s doing the uploading of it, and of course the internet there might not run fast enough in the day, so you’ve got to do your analysis and your uploading at night. Everything is just sort of a degree harder because of a lack of human resources, people, that are being paid enough to do these jobs, because of a lack of reagents, because of a lack of infrastructure in the country. So, suffice to say, they’re working really hard to do all of this, and they also want to do the analyses themselves. They’re not quite happy to just do all of the work and ship it off so that scientists in the west can then analyse it and get the really exciting papers out of it.

Noah Baker

Right, so that’s the kind of crux of it here, right. The value of the data on these big repositories, a big part of the value of that is that there is data from all over the world, so if you’re doing something like trying to track variants, you want to be able to get the biggest net you can, and so you want scientists to be able to contribute data from all over the world, and yet researchers in a lot of countries in the global south, they don’t want to be disadvantaged by not being able to be credited for all of that work.

Amy Maxmen

Exactly, they need to be incentivised. And it’s not just about their careers, because if you do the big, exciting papers, you get big publications, that can lead to grants, that can lead to patents, so all of that would really help these labs that are really under-resourced to begin with. So, no, they don’t want to just hand over the data. To give you another story, when I was in Democratic Republic of Congo, I had met some researchers at their national institute there (INRB), and one of them had worked in Guinea during the world’s largest Ebola outbreak in West Africa in 2014-2016. When he was working in Guinea, all of the samples, that primarily African doctors and researchers were collecting, were all being shipped out of the country. So, every single blood sample from anyone was shipped out for analysis in Europe or in the US and those turned around publications and patents, and pretty much all of the authors on the patents and most of the publications were all in the west. None of that work benefitted the labs in Guinea and, at this point in time, Guinea, Liberia and Sierra Leone, they can’t do genomic sequencing, so those labs were never built up.

Noah Baker

And I think it’s important as well to add in the context that the reason that scientists are doing this work is so that they can update vaccines, it’s so they can develop treatments, it’s so that they can find ways to help fight the pandemic. And those vaccines, those treatments, are also not getting to these countries that are going hell for leather and perhaps not even getting the credit for it.

Amy Maxmen

Yes, so that was something that a few researchers brought up to me too. I think the vaccine inequity right now puts a really sharp point on these fears. The idea, kind of the audacity, that the rich world would want to have all of these sequences so that we know if we’re going to need a booster to protect against a variant that arises in, say, South America or Africa or India, and yet we know that vaccines are not getting to these places. That was really hurtful to them. One researcher just told me it was incredibly demoralising.

Noah Baker

And yet you said that this is very controversial. People have had very strong opinions in the global south that you’ve spoken to about the idea of not getting credit for the work that they’re doing. People are on the other side arguing vehemently in the other direction as well. Is the other side to this argument just we can’t analyse data as quickly if we have to take the time to credit everyone and reach out to them for collaborations?

Amy Maxmen

Pretty much. Computer bioengineers, computer scientists, they feel like they’re going to be able to do better, faster analyses if there’s no gatekeeping in place, and what they’ll tell me is that, ‘Our analyses are saving lives. It’s a crisis. This must happen now.’

Noah Baker

I think it’s one of those stories that just gets more and more nuanced and complicated the more you think about it because you can understand on the surface of it, you might have the attitude of you send in your star quarterback at the time of crisis because that’s when we need to win this point, and so you want to put all of your money where you’ve got the resources.

Amy Maxmen

Right.

Noah Baker

But then this is a long game and there are lots of other nuanced reasons that maybe if you just do that and then you neglect all of your subs, then at some point when your quarterback is tired, then what happens next? You haven’t built anything up or what happens when – I mean, I’m really stretching my analogy here into a point that doesn’t work – but yeah, I think it’s important to think about these nuances, and these are the kinds of things that I think often get overlooked when people are making these big decisions.

Amy Maxmen

Exactly. That’s something I found myself thinking about. A researcher told me, ‘This is crucial. This is a crisis. This isn’t time to just enrich your career.’ And so, I put that to one scientist I spoke with in South Africa, like, ‘Hey, it’s a crisis. Why are you trying to enrich your career?’ And he said he absolutely agrees. It’s more important to help humanity than enrich his career. But he told me something sort of interesting. Basically, governments listen to their own scientists most of all. He was in South Africa, so when he saw the variant first discovered in South Africa pop up, he could communicate that to his government and his government listens to him most of all. So, by being able to make sure that they can do their own analyses, he’s effectively able to communicate that to his government so that his government can take direct action in controlling the spread of that variant. So, he kind of put it to me like, how do you think it would work if Boris Johnson learned about the B.1.1.7 variant – that’s the one that popped up in the UK that’s more transmissible – how would Boris Johnson feel if he heard about that because The New York Times reported on a study that was done in New York. He might not have reacted the same. So, his point is letting these studies be done in country actually does help save the pandemic.

Noah Baker

Okay, well, two big stories that I think are going to be playing out over the next months and years to keep watching, but for now, let’s leave it there. Amy, thank you so much for joining me and I’ll speak to you I’m sure about this again soon.

Amy Maxmen

Thank you.