The U.S. has declared monkeypox a public health emergency. Luckily, monkeypox is not a new disease, so there is a vaccine. It was originally developed for smallpox, but it works. The bad news, however, is that it’s hard to get. In many big U.S. cities, finding the two coveted doses is a struggle.
Right now, the world’s only supplier for monkeypox vaccine is this tiny company in Denmark called Bavarian Nordic. It has a small factory that is capable of producing 30 million doses a year. This already limited capacity has been constrained by an unfortunately timed lab renovation.
And while production, distribution, and supply chains all limit vaccine access, one of the biggest obstacles rarely gets discussed: intellectual property rights, the exclusive monopolies pharmaceutical companies obtain over a vaccine after it’s developed.
On Sunday’s Episode of What Next: TBD, I spoke with Zain Raivi, who researches pharmaceutical innovation and access to medicine for the advocacy group Public Citizen, about how pharmaceutical companies’ intellectual property rights get in the way of public health and what that means for the monkeypox crisis. Our conversation has been edited and condensed for clarity.
Emily Peck: When a pharmaceutical company invents something, they get a patent, an exclusive right for a limited time period to their invention. What should we know about intellectual property, especially trade secrets, here?
Zain Rizvi: Intellectual property is about power. It’s the power to make decisions about how medical technologies are produced, where they’re produced, for whom they’re produced, at what price they’re produced, and how many of them are produced. You see this operate through a range of different legal forms, so you have patents. Patents give you the right to exclude someone from making an invention, so if you have a patent and someone else starts making your invention, you can say, “You are forbidden from making my invention,” and you have a legal right to enforce that claim.
Trade secrets is more about the secret sauce, the recipe that goes into making the vaccine or the health product in question. With complex medical technologies like vaccines, there’s an interplay of both patents and trade secrets.
Let’s take a step back and talk about COVID vaccination and intellectual property. In 2020, Moderna announced they wouldn’t enforce the patent on their vaccine. Did it help at all?
When we talk about the Moderna vaccine and what Moderna has done, really what we’re talking about is what the U.S. government and Moderna have done together. Moderna is is built off a technology that was funded by taxpayers. You had this constant federal support in the background as this company was developing its technology. 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 knowhow. So the key question, for COVID 19, for monkeypox, but also for any kind of health disease in the future, is: “Should the knowledge that is funded by taxpayers be kept a secret? Should that knowledge be kept a secret if it can help end an epidemic?”
In terms of keeping this a secret on monkeypox 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 appointments, etc. Is that because of IP and secret hoarding also?
It is in a sense, because right now the decisions are being made by this company sitting in Denmark—about how doses are allocated, about how doses are delivered, and how they’re filled and finished. And so we are introducing again, this layer of scarcity by allowing this mechanism of IP to interfere. What a better [way] would look like would be the U.S. government stepping up, taking some responsibility, disclosing how many doses exist in the world right now, disclosing what production capabilities are at Bavarian Nordic. What can be done? What other partners are out there that can make this?
It seems the U.S. on the front end is spending billions of dollars on these drugs that we all have a big public health interest in. And then when push comes to shove at the end of the day, they don’t exercise that power and leverage it into distribution. It’s like, what are we waiting for here?
The pharmaceutical industry is one of the most powerful industries in the world. There are 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.
The main argument in favor 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. Everyone says, “Well, look, that’s the perfect example. They wouldn’t have done it without IP.” Would you agree?
No matter how small or no matter how large the reform, the argument will always be, “You’re about to kill innovation. How could you do that?” There’s many different ways to proceed. One is that, of course, under the existing system we understand that it’s not just industry that’s driving innovation. The public sector is playing this huge role in supporting and propelling innovation forward. The National Institutes of Health alone spends $40 billion a year on biomedical research and development. And so when you’re talking about supporting R&D, it’s important to be inclusive of public sector R&. What is the return 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?
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.
It should not be up to Pfizer’s CEO to dictate to national governments, “Well, you’re going to get X, you’re going to get Y supply. You’re going to get Z supply. ” I think that’s what’s really the core of the problem.
So you’re saying abolish patents? I think you’re saying that.
The term I wouldn’t use is abolish necessarily, but I think the patents certainly need to be overridden for the public interest. The U.S. government has existing authority that it actually uses all the time in different sectors. Perhaps my most compelling point here is that the Defense Department doesn’t care about patents. The Defense Department, when it needs a technology, it uses that technology. 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 a patent holder to sue the U.S. 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.” For some reason, the Department of Defense doesn’t do that, but the CDC, the NIH, the HHS, and our public health apparatus cannot stand up to pharmaceutical corporations in the same way. And so when we talk about going beyond IP based systems of drug development and innovation, we can look to actually what we do elsewhere.
One thing that really struck me in reading about vaccine sharing with COVID was the hoarding. It really seems like that comes around full circle and hurt us. The U..S had hoarded vaccines, 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. 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.
The U.S. government is in a little bit more delicate position for monkeypox than it might seem because the factory is located in Denmark and not in the U.S. Had the Danish government taken the same response to monkeypox that the U.S. did for COVID 19, there actually would be no monkeypox vaccines in the U.S. right now because you could imagine that the Danish government, the European Union, and others starting to hoard their vaccines.
Where do you see the monkeypox outbreak going and future disease outbreaks if nothing changes with the current IP structure?
I think one thing we can say for sure is that this is not the last time this happens. We are living in an interconnected 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 think on what we can do to prepare and respond to that. And our understanding is that one key component of that is this distributed global network of manufacturers, 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 promising initiatives underway including at the World Health Organization to set up mRNA capabilities around the world, so we can better respond to new outbreaks. But I think until we get there, and until really we take public health seriously, 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 anytime soon, so we do need ways to manage it better.