The Biden administration has announced that it will work with the World Trade Organization (WTO) to negotiate a deal to suspend intellectual property rights associated with the Covid-19 vaccines — a surprise move for the administration, which had initially resisted taking such a step.
The reversal came as Covid-19 deaths are mounting in India and elsewhere. The vaccination program in the US is going well, but much of the world is still waiting for vaccines, which has made the role of pharmaceutical companies and intellectual property in the global vaccine effort the subject of intense debate.
There is unanimous agreement on one thing: There is a lot of work to be done to speed up vaccine manufacturing and vaccinate the world. As the WTO’s General Council meets this week, patents have risen to the top of the agenda. India and South Africa have asked the WTO to waive intellectual property (IP) rules relating to the vaccines so that more organizations can make them.
The case for waivers is simple: Waiving IP rights might enable more companies to get into the vaccine-manufacturing business, easing supply shortages and helping with the monumental task of vaccinating the whole world. The case against them: Taking IP rights from vaccine makers punishes them for work that society should eagerly reward and disincentivizes similar future investment. Opponents have also argued this step would do very little to address the vaccine supply problem, which has largely been the result of factors such as raw material shortages and the incredible complexity and tight requirements of the vaccine-manufacturing process.
The debate has raged for the past several weeks — with Bill Gates as a notably outspoken defender of IP rights — but recently intensified as the Covid-19 crisis in low-income countries worsens.
Wednesday’s announcement unambiguously puts the US on record in support of such a waiver, a reversal from its previous position. “The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” US trade representative Katherine Tai said in an announcement.
Done correctly, making the IP associated with these vaccines available to the world can be a good first step — the more information-sharing here, the better. But it’s a small thing to do at a time when bigger commitments are needed. Waivers might help, but ending the pandemic worldwide is going to require so much more.
While the Biden administration’s decision is a positive development, but debates over intellectual property can also distract the world from the policy measures that could really end the pandemic: building our vaccine-manufacturing capacity, committing to purchase the doses the rest of the world needs, and working directly with manufacturers to remove every obstacle in their path.
Patents, trade secrets, and what you need to know to make a vaccine
To unpack what the Biden administration’s move means, it’s important to understand the role patents play in vaccine manufacturing.
When a pharmaceutical company makes a drug, it applies for a patent. The patent protects its intellectual property for a fixed amount of time, typically 20 years, after which others can make “generic” versions of the drug, which are generally a lot cheaper.
Simple enough, right?
When it comes to Covid-19 vaccines — and many modern pharmaceutical products — the situation is much more complicated than that.
First, a modern vaccine is often in a web of different intellectual property rights, with the vaccine manufacturer having purchased the rights to some elements of its vaccine from either other pharmaceutical companies or researchers.
The lipids (shells that contain the mRNA molecules) used for mRNA vaccines, for example, are licensed to Pfizer and Moderna, but other companies have the rights to them. Patents held by the vaccine companies are actually a fairly small share of what’s going on in this IP web. It’s better to talk more broadly about all of the intellectual property that goes into a vaccine: licensing deals, copyrights, industrial designs, and laws protecting trade secrets.
The other complication is that, while there are legal barriers to copying the existing vaccines, that’s not what’s really making them impossible for other companies to start manufacturing. Experts I spoke with emphasized that, generally speaking, the world’s entire supply of critical raw materials is already going into vaccines, and there are no factories “sitting idle” waiting for permission to start making them. What’s more, changing a factory’s processes to produce a new kind of vaccine is a difficult, error-prone process — which went wrong, for example, when a plant converted to make Johnson & Johnson vaccines spoiled millions of doses.
Moderna is an instructive example here. The pharmaceutical company made a splashy announcement in the fall that it would not enforce its Covid-19 vaccine patents. Despite that move, there is still no generic Moderna vaccine, and none of the experts I talked to believed one was on the horizon. (It turned out well for Moderna — get the PR bump from the announcement without suffering the financial drawbacks.)
In the long run, though, a world where everything Moderna, Pfizer, Novavax, AstraZeneca, and Johnson & Johnson know about manufacturing their vaccines was freely available online would make vaccines easier for other manufacturers to make. It would also make them cheaper and more accessible to countries that have had trouble getting them.
At a meeting this week, the WTO is considering requests from India and South Africa to waive the patents for the duration of the emergency. Most countries have their own patent laws, but international agreements about how they enforce each other’s patents — and disputes when countries suspect each other of ignoring IP concerns — tend to be mediated by the WTO.
Although the Biden administration’s announcement is a win for the pro-waiver side, the US isn’t the only country that needs to be persuaded for the WTO to agree on a patent waiver. For their part, the EU, the UK, Japan, and Switzerland have expressed opposition. But the US is influential in these debates, and the Biden administration’s about-face may well be decisive.
Many global health researchers, Bill Gates (and the Bill and Melinda Gates Foundation), and some within the Biden administration have vocally opposed waiving IP rights on the Covid-19 vaccines, generally with two arguments.
First, they argue society should want pharma companies to invent vaccines like the ones they did for Covid-19, and waiving rights will make that less likely in the future by making similar projects less appealing targets for investment. Second, they contend that patent waivers will set that precedent without even speeding up vaccine manufacturing.
“For the industry, this would be a terrible, terrible precedent,” Geoffrey Porges, a research analyst at SVB Leerink, an investment bank, told the New York Times. “It would be intensively counterproductive, in the extreme, because what it would say to the industry is: ‘Don’t work on anything that we really care about, because if you do, we’re just going to take it away from you.’”
Perhaps most prominent among those who’ve taken this stance is Bill Gates. “The thing that’s holding things back, in this case, is not intellectual property,” Gates said in a controversial interview on Sky News. “It’s not like there’s some idle vaccine factory with regulatory approval that makes magically safe vaccines. You’ve got to do the trials on these things, and every manufacturing process has to be looked at in a very careful way.”
Instead of intellectual property, Gates’s argument goes, the problem is deep technical know-how: the important details of the process that goes into making a vaccine. This is an especially critical problem for the mRNA vaccines Pfizer and Moderna created because they use a new technique. (The mRNA vaccines give the body instructions it can use to make the spike protein on the coronavirus. From there, the body can recognize it and fight it off. This is different from the vaccines we’re all familiar with, which expose a patient to a dead or weak virus, or a chunk of a virus, to help prime the immune system.)
Moderna and Pfizer know not only the exact formula of their vaccines but also countless procedural details about making them successfully: equipment modification, temperature settings, how to troubleshoot common problems, different kinds of failure and what problems they indicate, and so on. Waiving IP protections won’t make this information available.
This isn’t an instance of Bill Gates going off message; it has consistently been the stance of his foundation. Last year, it worked to convince Oxford to partner with AstraZeneca on vaccine production, a partnership that has come under heavy criticism for having held back the Oxford vaccine’s potential for wider, cheaper sharing as AstraZeneca scaled up production slower than was hoped.
Why would advocates for global health want partnerships with for-profit pharmaceutical companies?
They contend that, if the world predictably waives patents for sufficiently critical medications and vaccines, companies will find it harder to attract investment when they work on those problems. And vaccines developed without a pharmaceutical partner — say, by a university — might have no luck being manufactured at the needed scale. “At our foundation, we believe that IP fundamentally underpins innovation, including the work that has helped create vaccines so quickly,” Mark Suzman, CEO of the Bill and Melinda Gates Foundation, wrote in February.
“From early in the pandemic, there were lots of smart people at the Gates Foundation thinking about how to structure financing and incentives for accelerating vaccine development,” Justin Sandefur, senior fellow at the Center for Global Development, a nonprofit think tank based in London and Washington, DC, told me. “To their credit, they worked on this really early on. They convinced themselves that IP was important.”
(In May, after the Biden administration’s reversal, the Gates Foundation actually reversed course, too, expressing support for a limited waiver.)
Many other global health experts have also made the case that waivers would be a bad idea. Vaccine makers “are already cooperating widely with competitors and generic manufacturers, including via voluntary licenses, contracted production, and proactive technology transfer,” the CGD’s Rachel Silverman argued in a CGD-hosted debate about whether to waive IP. “Diluting that commercial incentive may reduce their interest in pursuing the voluntary horizontal collaborations that are already driving scale.”
The case for IP waivers
The case for IP waivers is that, while there are definitely many other barriers to getting the world vaccinated, removing even one is better than letting it remain in place. As part of a no-holds-barred effort to get the vaccine to everyone, the world should do everything in its power to cut through some of the restrictions delaying vaccines, even if it will take additional steps for this particular action to make a big difference.
“There’s a question of where the onus of proof lies in this situation,” Sandefur told me. “The standard line you hear is, ‘Well, there aren’t that many factories that can do this.’ And I can’t point you to the [specific] factory that’s ready to produce AstraZeneca, but we want to free up the market to let the discovery happen.”
If you really want to get something done, it makes sense to address every possible thing standing in the way of getting it done, even if it’s not the biggest or most significant barrier. And while the vaccines genuinely are incredibly difficult to manufacture, those from Novavax, Johnson & Johnson, and AstraZeneca aren’t quite as out of reach as the mRNA vaccines from Pfizer and Moderna, and years of this fight are still ahead — time during which some company could, perhaps, pull off what has been dismissed as too difficult or even impossible and get generics off the ground a little faster.
What’s implicit in that argument is there’s actually only a small chance of seeing benefits from waivers. But, proponents of waivers argue, there’s also not much chance of harm. If it’s true other companies can’t make the vaccines easily, the IP waivers won’t undercut sales for the existing companies or disincentivize future R&D. Conversely, the only way the IP waivers could actually cut into existing companies’ profits is if they successfully incentivize more vaccine development. If that actually happened, the thinking goes, that’d be worth it.
Some supporters of IP waivers have argued the debate is essentially a matter of class warfare: Gates and Big Pharma against the global poor. But there are passionate defenders of the interests of low-income people on both sides of the IP waiver debate: Many experts who’ve spent their careers fighting for the world’s poor also see IP waivers as a counterproductive step. Smart people disagree on whether this approach does, in fact, increase vaccine access where it’s needed most, and whether it damages our preparedness for the next pandemic.
What the intense focus on IP waivers misses
Regardless of whether they were for or against IP waivers, everyone I spoke to agreed on one thing: IP waivers are much less important than just directly funding poor countries’ access to the vaccine.
Many people who aren’t opposed to IP waivers nonetheless caution against advocating for them because it could distract from better solutions. Silverman called waiver advocacy “an inefficient use of limited global advocacy/political capital for vaccine access.” IP is “not the point in the medium term,” Amanda Glassman, director of global health policy at CGD, tweeted Wednesday.
Her focus: urging governments to give money to Covax so there’s clear demand for increased manufacturing. Covax is supposed to purchase vaccines for the world but has found them scarce; the overwhelming majority of vaccines have been distributed in rich countries. Despite the devastating consequences of letting the pandemic rip through poorer nations, richer countries have been stingy with Covax, and it needs more resources to succeed.
“I think [waiving IP protections] is almost as much of a PR move as anything else,” Derek Lowe, a medicinal chemist who works on drug discovery in the pharmaceutical industry, told me. “There are a lot of people who are convinced that the only thing that’s holding back the generic vaccine is the patents, so the Biden administration said, ‘Okay, let’s see.’”
Indeed, the attention the debate over patent waivers has generated in the past week has obscured an important point: There’s no one trick to making vaccines widely available. Doing so is going to require commitments to buy billions of doses once companies make them, and months of hard work easing the supply bottlenecks that slow down production. Even if companies can manufacture generic versions of vaccines, they won’t do so without committed buyers — and that’s where committing to help poor countries purchase them really becomes essential.
In other words, it would be a mistake to take a victory lap following the Biden administration’s announcement. Even if legal barriers are addressed, countless practical barriers remain between here and vaccinating the world. If the IP waiver is a first step, great. But there are many steps to go if we’re to conquer Covid-19 in every corner of the globe.