The Monkeypox Vaccine Monopoly
Emily Peck: It’s hard not to feel a sense of dread about Monkeypox. The U.S. has declared a public health emergency to deal with outbreaks. The World Health Organization had already said it was a global emergency. But reality check. This is not March 2020. Monkeypox is generally not as deadly as COVID, though the pain can be debilitating. And this is not a new disease. There is a vaccine. It was originally developed for smallpox, but it works. The bad news, it’s hard to get in many big U.S. cities, finding the two coveted doses is a struggle, a.
Speaker 2: Line stretching city block after block. Hundreds waited, hoping to get a dose of the Monkeypox vaccine. San Francisco is trying to keep up with a low supply, met with very high demand.
Emily Peck: A lot of things went wrong here. The U.S. previously let millions of doses in the national stockpile expire. They also bought vaccine in bulk, but must wait months for those doses to actually be bottled. So now the U.S. isn’t expected to get an additional shipment until October, but consider us lucky. The entire continent of Africa, where this wave of monkeypox began and has existed for years, doesn’t have a single dose.
Speaker 3: There’s a sense of deja vu, right? It sounds like. You know, here we go again.
Emily Peck: That’s Zain Rizvi. He researches pharmaceutical innovation and access to medicine for Public Citizen, an advocacy group around the world. People are scrambling to get their hands on a shot of genius. The only FDA approved vaccine for monkeypox.
Speaker 3: There is one single manufacturer, this tiny company in Denmark called Bavarian Nordic, that is the world’s only supplier for monkeypox vaccine right now. It is a small factory that is capable of producing 30 million doses a year.
Emily Peck: And this already limited capacity has been constrained by an unfortunately timed lab renovation.
Speaker 3: The factory that is producing the drug substance of the Geneva’s vaccine has actually been closed for the past year, and it’s currently closed and it’s not going to open at the earliest until later this August.
Emily Peck: It’s a painful echo of what happened with the COVID vaccines. Remember, a study.
Speaker 2: Shows how rich countries are hoarding COVID 19 vaccines in the world’s poorer set to miss out.
Emily Peck: A handful of pharmaceutical companies basically controlled the global supply of a critical invention. This time, it’s just one company, a company that’s also received about $1 billion in public funding from the U.S. government.
Speaker 3: And so the reason we have this vaccine that is sitting there that is, you know, available in this emergency is because of the US government. But the problem is, despite the support of the US government all along, there’s essentially this lack of oversight, there’s a lack of stewardship of the technology itself.
Emily Peck: There are a lot of barriers that limit vaccine access, production, distribution, supply chains. But one of the biggest obstacles rarely gets discussed. Intellectual property rights. The exclusive monopoly is pharmaceutical companies obtain over a vaccine. After it’s developed.
Speaker 3: There is baked into the system an idea that monopoly control over a lifesaving vaccine or lifesaving health technology is not inherently ridiculous.
Emily Peck: So today on the show how pharma companies intellectual property rights get in the way of public health and what that means for the Monkeypox crisis. I’m Emily Peck filling in for Lizzie O’Leary. And this is what next TBD a show about technology, power and how the future will be determined. Stick around.
Emily Peck: Let’s take a step back. When a pharmaceutical company invent something, a vaccine, a medication, they get a patent, an exclusive right for a limited time period to their invention. It’s a kind of intellectual property, right. Known as IP in the biz. And some other time I can tell you about my stint as the editor of IP Worldwide magazine. But there are other kinds of IP, like a copyright to a book or a trademark to a brand name. There’s also the more mysterious kind of IP trade secrets.
Speaker 3: Intellectual property is about power. It’s the power to make decisions about how medical technologies are produced, where they are produced, for whom they’re produced, at what price they are produced, and how many of them are produced. And so you see this, you know, operate through a range of different legal forms. So you have patents. Patents are give you the right to exclude someone from making an invention. Right. And so if you have a patent and someone else starts making your invention, you can say, you know, you are forbidden from making my invention and you have a legal right to enforce that claim.
Speaker 3: Trade secrets is a little different. Trade secrets is more about the secret sauce, right? The recipe that goes into making the vaccine or health product in question. And so you often see with complex medical technologies like vaccines, that there’s an interplay of both patents and trade secrets. And so corporations will file dozens of patents to make sure that, you know, others cannot make that invention, even if they knew how. And, of course, they don’t also disclose how to make the invention, because there’s a lot of associated knowhow behind that.
Emily Peck: There were some government initiatives created during COVID, like COVAX, to share supply of already made vaccines, but they weren’t super successful, largely because wealthier countries took vaccines for themselves first. So a lot of access depended on where the vaccines were produced and who the pharmaceutical companies that made the vaccines decided to sell them to.
Speaker 3: It was, you know, in the words of the South African government, government, it was vaccine apartheid. Right. There was a huge inequality between the vaccine haves and the vaccine have nots. There were a handful of countries in the north that had the vaccine and many dozens around the south that did it. And the consequences were devastating. We lost, you know, hundreds and thousands of people around the world because of an inequitable access to vaccines within months.
Speaker 3: Right. And so when it comes to monkeypox, you know, thankfully, it’s a different virus, it’s a different disease. But already we are seeing a handful of rich countries scramble for the vaccines, hoard the vaccines. You know, everyone else is kind of not even in line right at this point. And so the reason where intellectual property comes into all of this is because we are in a moment of scarcity. Right. That is kind of unquestionable. What intellectual property does is it adds another artificial layer of scarcity into the system.
Emily Peck: A few small IP carve outs were granted during COVID. Most recently, the World Trade Organization settled a petition from South Africa and India to temporarily waive certain patent restrictions for COVID vaccines. But the deal doesn’t cover testing and treatments, which many countries are lacking at this stage. Other steps have been short term and COVID specific, and they won’t apply to Monkeypox.
Speaker 3: With Monkeypox treatment. We’re still studying how to figure out how to best use the treatments and how to deploy them because they were you know, they were approved based on some limited data for smallpox emergencies. And so there’s still kind of that initial work being done. However, we are still also seeing that simultaneously similar attempts at kind of monopolizing supply of treatments. But it’s clear from the past, you know, the past few years and the kind of the terrible inequalities that more should be done at the global level to kind of fix these these problems. Right. Because we sort of go from problem to problem without really addressing the structural reason that is creating the problem in the first place, which in this case, again, is IP. And that idea of of of. Letting a private corporation dictate the public health response rather than having it the other way around.
Emily Peck: COVID wasn’t the first time pharmaceutical companies came under fire for abusing IP rights during a global health crisis.
Emily Peck: In the 1990s, HIV was spreading around the world, particularly in Africa. Treatments were finally introduced, but they cost thousands of dollars. Many Africans couldn’t afford that.
Speaker 3: These HIV treatments came online, and it’s worth remembering actually just how effective they were, right? It was called the Lazarus Effect. Right. Because people were literally on their deathbeds with AIDS. And after taking these medicines, they would, you know, be okay within weeks and resume normal life. At the time, HIV was decimating sub-Saharan Africa. It was devastating. Right. There were there were lie. There are lines at at cemeteries. Right. There are lineups at cemeteries because there was just so much loss. And yet we had something that was life saving and it was priced out of reach.
Emily Peck: So in 1997, Nelson Mandela passed a law that allowed South Africa to import cheaper generic versions of the treatments. Essentially working around patent laws.
Speaker 3: And the pharmaceutical industry was pissed. They were so pissed they actually ended up suing as a consortium. They ended up suing Nelson Mandela’s government in South African court. They enlisted the muscle of the US government to kind of bully South Africa into submission. And instead, you know, a group of activists from around the world really pushed back and were able to generate sufficient outrage that both the US government and the pharmaceutical industry sort of backed down. And you know, we have seen now actually the the miraculous impact of generic HIV medicines around the world that have saved literally millions of lives. South Africa now has one of the world’s largest HIV AIDS treatment programs. And that was possible in large part due to getting over some of these IP barriers.
Speaker 3: And so, you know, it’s an amazing story. It’s a kind of a remarkable victory. But it was also an incomplete victory because we what we ended up getting was sort of this piecemeal solution to this specific disease area. And so we sort of won the battle for HIV, but we kind of lost the bigger war for IP reform globally.
Speaker 3: And so with COVID 19, you know, we saw some of those same themes emerge now with monkeypox, a different disease, different outcomes. But we’re starting to see some of those same patterns persist. How many more new disease threats do we have to see before we understand that actually a new approach is needed that prioritizes public health from the start?
Emily Peck: Well, I mean, to talk about that in 2020, I believe Moderna announced they wouldn’t enforce the patent on their vaccine. Was that a big step or did it help at all?
Speaker 3: So when we talk about, you know, the Moderna vaccine and what Moderna has done, really what we’re talking about is what the US government and modern have done together. Adani is a company that is built of a technology that was funded by taxpayers rights. And so you had this kind of constant federal support in the background as this companies was developing its technology. And then you finally got to the kind of commercialization, right? And what you heard was, wow, Moderna, what a company. You know, the small biotech, the scrappy biotech has done what no one else could have seen coming. And it’s like, yeah, you know what the behemoth behind it of the U.S. government. And so, yes, Moderna did this thing about patents, but it left out this whole other spectrum of action that it could have taken. And most importantly, what it could have done and what it did not do was actually share some of the know how.
Speaker 3: Right. And so the key question, both for COVID 19, for Monkeypox, but also for any kind of health disease in the future. Right. One question we have to kind of confront is. Should the knowledge that is funded by taxpayers. Be kept a secret. Right. Should that knowledge be kept a secret if it can help end an epidemic?
Emily Peck: In terms of keeping this a secret on monkeypox vaccine. So not only am I reading that African countries have no vaccine, I’m reading reports now daily in the United States that people can’t get vaccinated. The populations that need access are scrambling. They can’t get they can’t get appointments, etc.. I mean, is that because of IP and secret hoarding also?
Speaker 3: It is, you know, in a sense. And the reason I say yes is because. Right now, the decisions are being made by Bavarian Nordic Right. They are being made by this company sitting in Denmark about how doses are allocated, about how doses are delivered, about how doses are filled and finished. And so. We are introducing this kind of, again, this layer of scarcity by allowing this by allowing this mechanism of IP to to interfere.
Speaker 3: Right. And in this specific context, what a better would look like would actually be the just the US government stepping up. Right, taking some responsibility, disclosing how many doses exist in the world right now, disclosing what production capabilities are at the very Nordic, what can be done, what other partners are out there that can make this? So we’re not just reliant on this one single company and on this one single site in Denmark for so much of our public health security.
Emily Peck: Yeah. It seems like you’re really saying the U.S. on the front end is spending billions of dollars on these on these drugs that have all have a big interest in a big public health interest in the world does. And then when push comes to shove at the at the end of the day, whatever cliche I should use, they don’t exercise that power and leverage it into distribution. It’s like, what are they what are we waiting for here?
Speaker 3: Look, the pharmaceutical industry is one of the most powerful industries in the world. Right. This is there are huge, huge, huge sums of money at play. And the industry is. Let’s put it. Gently not in favor of proposals that would increase the role of the public sector in pharmaceutical production and pricing. And so I think that, unfortunately, sometimes outweighs the kind of clear and obvious public health needs that we’re seeing.
Emily Peck: After the break. These laws are so baked into our pharmaceutical system, would it be realistic to change them?
Emily Peck: The main argument in favour of strict intellectual property laws is that they spur innovation. Making vaccines and medication takes a ton of time, research and money. Pharmaceutical companies say that without these protections, they just wouldn’t have the incentive to develop new medical treatments. The COVID vaccine has been incredibly profitable for Pfizer and Moderna. We’re talking billions and billions and billions of dollars. And, you know, so everyone says, well, look, that’s the perfect example. They wouldn’t have done it without IP. I mean, would you agree?
Speaker 3: You know, no matter how small or no matter how large the reform, the argument will always be. You know, you’re about to kill innovation. How could you do that? So the the kind of response to that, you know, there’s, I think, many different ways to to to proceed. I perhaps will choose a couple. One is that. Of course, under the existing system, we understand that it’s not just industry that’s driving innovation. We understand that the public sector is playing this huge role in supporting and propelling innovation forward. And so, for example, when we look at the National Institutes of Health, that alone spends $40 billion a year on biomedical research and development. Right. And so when you’re talking about supporting R&D, it’s important to be inclusive just of public sector R&D as well as private sector R&D. So that’s kind of my first response.
Speaker 3: The second response is, of course, then the private sector R&D component. Right. How do you sustain that? How do you maintain that? And it comes down to the question ultimately, I think of. What is the return ride when we allow, for example, Pfizer to make $36 billion off of COVID 19 vaccines in the year 2021 alone? What investment did we actually need to induce that kind of research and development? How much is enough? To induce Pfizer to do this in the first place.
Emily Peck: IP laws don’t just allow pharma companies to set pricing. They allow the companies to choose who they’ll sell their products to. And when there’s a limited supply of a vaccine, the companies largely get to decide where those doses go.
Speaker 3: Perhaps the most pernicious problem is the idea of monopoly control, because really it should not be up to Pfizer’s CEO to act like a sovereign in the world and dictate to national governments that, you know, you’re going to get supply, you’re going to have y supply, you’re going to get these supply. And I think that’s what’s really at the core of the problem.
Emily Peck: So you’re saying. Abolish patents. I think you’re saying that.
Speaker 3: The term I wouldn’t use is abolished necessarily, but I think the patents should certainly need to be overridden for the public interest and the US Government has existing authority that it actually uses all the time in different sectors. Right. And this is actually perhaps my most compelling point here, which is that. The Defense Department doesn’t care about patents.
Speaker 3: Right. The Defense Department, when it needs the technology, it uses that technology. Right. It’ll get a contractor to use a patent. And if a patent holder wants to sue, they can do that. There is a law that allows the patent holder to sue the US government and get some compensation. But what the Defense Department does not allow to happen is for one contractor to get up and be like, Hey, I have a patent. You can’t use this invention. Now pay me. Right. For some reason, the Department of Defense doesn’t do that. But, you know, the CDC, the NIH, you know, HHS and our public health apparatus cannot stand up to pharmaceutical corporations in the same way. And so when we talk about kind of going beyond, you know, IP based systems of drug development, innovation, we can look to actually what we do elsewhere as well.
Emily Peck: Yeah, one thing that really struck me in reading about vaccine sharing with COVID was the hoarding. As an American at first, I remember we talked about this on another podcast I’m on and I said, Well, it makes sense that the U.S. would want to hoard vaccines for for the U.S. and be nationalistic about it. Like you want to take care of yourself first. But it really seems like that comes around full circle and hurt us because. Because the U.S. had hoarded vaccines and the global north had hoarded vaccines. COVID spread like wildfire in the global south. And we got these new strains. We got Delta, we got Omicron. So it turned out that hoarding wasn’t even in our best interest. And I wonder if the same thing’s going to happen now with monkeypox.
Speaker 3: The US government for monkeypox is in a little bit more delicate position than it might seem because the factory is located in Denmark and not in the US. And so had the Danish government taken the same response to monkeypox that the US did for COVID 19, there actually would be no monkey pox vaccines in the US right now. Right. Because you could imagine that the Danish government, the European Union and others are starting to hoard their vaccines. So it really goes to to highlight just the kind of need for that distributed global network.
Emily Peck: So, Zain, where do you see the monkey pox outbreak going and future disease outbreaks if nothing changes with the current IP structure?
Speaker 3: I think one thing we can say for sure is that this is not the last time this happens, right? We are living in a connected world where new viruses are emerging. There are new diseases, some old diseases that are making a comeback. And so we just really have to do a deep thing on. What we can do to prepare and respond to that in our understanding is that one key component of that is this distributed global network of manufacturers.
Speaker 3: Right. So there should be a vaccine manufacturer, for example, in sub-Saharan Africa, in Latin America, in North America, all around the world that is capable of rapidly shifting and rapidly pumping out doses for that next new disease threat. And there are, you know, promising initiatives underway, including at the World Health Organization, to set up, you know, many capabilities around the world so we can better respond to to to new outbreaks.
Speaker 3: But I think until we get there and until really we take public health serious here, right. Until we fund public health appropriately, until we take seriously the idea of making vaccines and treatments global public goods, this is not going to be a problem that really goes away any time soon. So we do need ways to manage it better.
Emily Peck: Zain, thank you so much. It’s been great.
Speaker 3: Yeah, no. Thanks for having me. And I appreciate you doing a deep dive into some pretty wonky topics.
Emily Peck: Zain Rizvi research is pharmaceuticals and access to medicine at Public Citizen. And that’s it for our show today. What next? TBD is produced by Anna Phillips and Evan Campbell or shows edited by Tori Bosch. Joanne Levine is the executive producer for what next? Alicia montgomery is vice president of Audio for Slate.
Emily Peck: TBD is part of the larger what next family TBD is also part of Future Tense, a partnership of Slate, Arizona State University and New America. If you’re a fan of the show, I have a request for you. Become a Slate Plus member. Just head on over to Slate.com. Slash, what next? Plus to sign up. We will be back next week with more episodes. I’m Emily Peck, filling in for Lizzie O’Leary. Thanks for listening.
