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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 \u2014 a surprise move for the administration, which had initially resisted taking such a step.<\/p>\n
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.<\/p>\n
There is unanimous agreement on one thing: There is a lot <\/em>of work to be done to speed up vaccine manufacturing and vaccinate the world. As the WTO\u2019s 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.<\/p>\n 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.<\/p>\n The debate has raged for the past several weeks \u2014 with Bill Gates as a notably outspoken defender of IP rights \u2014 but recently intensified as the Covid-19 crisis in low-income countries worsens.<\/p>\n Wednesday\u2019s announcement unambiguously puts the US on record in support of such a waiver, a reversal from its previous position. \u201cThe Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,\u201d US trade representative Katherine Tai said in an announcement.<\/p>\n Done correctly, making the IP associated with these vaccines available to the world can be a good first step \u2014 the more information-sharing here, the better. But it\u2019s a small <\/em>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.<\/p>\n While the Biden administration\u2019s 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.<\/p>\n Patents, trade secrets, and what you need to know to make a vaccine<\/p>\n To unpack what the Biden administration\u2019s move means, it\u2019s important to understand the role patents play in vaccine manufacturing.<\/p>\n 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 \u201cgeneric\u201d versions of the drug, which are generally a lot cheaper.<\/p>\n Simple enough, right?<\/p>\n When it comes to Covid-19 vaccines \u2014 and many modern pharmaceutical products \u2014 the situation is much more complicated than that.<\/p>\n 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.<\/p>\n 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\u2019s going on in this IP web. It\u2019s 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.<\/p>\n The other complication is that, while there are legal barriers to copying the existing vaccines, that\u2019s not what\u2019s really making them impossible for other companies to start manufacturing. Experts I spoke with emphasized that, generally speaking, the world\u2019s entire supply of critical raw materials is already going into vaccines, and there are no factories \u201csitting idle\u201d waiting for permission to start making them. What\u2019s more, changing a factory\u2019s processes to produce a new kind of vaccine is a difficult, error-prone process \u2014 which went wrong, for example, when a plant converted to make Johnson & Johnson vaccines spoiled millions of doses.<\/p>\n 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 \u2014 get the PR bump from the announcement without suffering the financial drawbacks.)<\/p>\n 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.<\/p>\n 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\u2019s patents \u2014 and disputes when countries suspect each other of ignoring IP concerns \u2014 tend to be mediated by the WTO.<\/p>\n Although the Biden administration\u2019s announcement is a win for the pro-waiver side, the US isn\u2019t 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\u2019s about-face may well be decisive.<\/p>\n The case against IP waivers<\/p>\n 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.<\/p>\n 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.<\/p>\n \u201cFor the industry, this would be a terrible, terrible precedent,\u201d Geoffrey Porges, a research analyst at SVB Leerink, an investment bank, told the New York Times. \u201cIt would be intensively counterproductive, in the extreme, because what it would say to the industry is: \u2018Don\u2019t work on anything that we really care about, because if you do, we\u2019re just going to take it away from you.\u2019\u201d<\/p>\n Perhaps most prominent among those who\u2019ve taken this stance is Bill Gates. \u201cThe thing that\u2019s holding things back, in this case, is not intellectual property,\u201d Gates said in a controversial interview on Sky News. \u201cIt\u2019s not like there\u2019s some idle vaccine factory with regulatory approval that makes magically safe vaccines. You\u2019ve got to do the trials on these things, and every manufacturing process has to be looked at in a very careful way.\u201d<\/p>\n Instead of intellectual property, Gates\u2019s 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\u2019re 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.)<\/p>\n 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\u2019t make this information available.<\/p>\n This isn\u2019t 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\u2019s potential for wider, cheaper sharing as AstraZeneca scaled up production slower than was hoped.<\/p>\n Why would advocates for global health want partnerships with for-profit pharmaceutical companies?<\/p>\n 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 \u2014 say, by a university \u2014 might have no luck being manufactured at the needed scale. \u201cAt our foundation, we believe that IP fundamentally underpins innovation, including the work that has helped create vaccines so quickly,\u201d Mark Suzman, CEO of the Bill and Melinda Gates Foundation, wrote in February.<\/p>\n \u201cFrom 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,\u201d Justin Sandefur, senior fellow at the Center for Global Development, a nonprofit think tank based in London and Washington, DC, told me. \u201cTo their credit, they worked on this really early on. They convinced themselves that IP was important.\u201d<\/p>\n (In May, after the Biden administration\u2019s reversal, the Gates Foundation actually reversed course, too, expressing support for a limited waiver.)<\/p>\n Many other global health experts have also made the case that waivers would be a bad idea. Vaccine makers \u201care already cooperating widely with competitors and generic manufacturers, including via voluntary licenses, contracted production, and proactive technology transfer,\u201d the CGD\u2019s Rachel Silverman argued in a CGD-hosted debate about whether to waive IP. \u201cDiluting that commercial incentive may reduce their interest in pursuing the voluntary horizontal collaborations that are already driving scale.\u201d<\/p>\n The case for IP waivers<\/p>\n 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.<\/p>\n \u201cThere\u2019s a question of where the onus of proof lies in this situation,\u201d Sandefur told me. \u201cThe standard line you hear is, \u2018Well, there aren\u2019t that many factories that can do this.\u2019 And I can\u2019t point you to the [specific] factory that\u2019s ready to produce AstraZeneca, but we want to free up the market to let the discovery happen.\u201d<\/p>\n 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\u2019s 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\u2019t quite as out of reach as the mRNA vaccines from Pfizer and Moderna, and years of this fight are still ahead \u2014 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.<\/p>\n What\u2019s implicit in that argument is there\u2019s actually only a small chance of seeing benefits from waivers. But, proponents of waivers argue, there\u2019s also not much chance of harm. If it\u2019s true other companies can\u2019t make the vaccines easily, the IP waivers won\u2019t undercut sales for the existing companies or disincentivize future R&D. Conversely, the only way the IP waivers could actually cut into existing companies\u2019 profits is if they successfully incentivize more vaccine development. If that actually happened, the thinking goes, that\u2019d be worth it.<\/p>\n 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\u2019ve spent their careers fighting for the world\u2019s poor also see IP waivers as a counterproductive step. Smart people disagree on whether this approach does, in fact, increase vaccine access where it\u2019s needed most, and whether it damages our preparedness for the next pandemic. <\/p>\n What the intense focus on IP waivers misses<\/p>\n 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\u2019 access to the vaccine.<\/p>\n Many people who aren\u2019t opposed to IP waivers nonetheless caution against advocating for them because it could distract from better solutions. Silverman called waiver advocacy \u201can inefficient use of limited global advocacy\/political capital for vaccine access.\u201d IP is \u201cnot the point in the medium term,\u201d Amanda Glassman, director of global health policy at CGD, tweeted Wednesday.<\/p>\n Her focus: urging governments to give money to Covax so there\u2019s 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.<\/p>\n \u201cI think [waiving IP protections] is almost as much of a PR move as anything else,\u201d Derek Lowe, a medicinal chemist who works on drug discovery in the pharmaceutical industry, told me. \u201cThere are a lot of people who are convinced that the only thing that\u2019s holding back the generic vaccine is the patents, so the Biden administration said, \u2018Okay, let\u2019s see.\u2019\u201d<\/p>\n Indeed, the attention the debate over patent waivers has generated in the past week has obscured an important point: There\u2019s 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\u2019t do so without committed buyers \u2014 and that\u2019s where committing to help poor countries purchase them really becomes essential.<\/p>\n In other words, it would be a mistake to take a victory lap following the Biden administration\u2019s 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\u2019re to conquer Covid-19 in every corner of the globe.<\/p>\n