American Enterprise Institute

Web event — Confronting Joe Biden’s proposed TRIPS waiver for COVID-19 vaccines and treatments

Opening remarks: Michael Rosen, Adjunct Fellow, AEI

Panel discussion

Panelists: Andrei Iancu, Partner, Irell & Manella LLP Burcu Kilic, Director, Digital Rights Program, Public Citizen Hans Sauer, Deputy General Counsel, Biotechnology Industry Organization Lori Wallach, Director, , Public Citizen

Moderator: Michael Rosen, Adjunct Fellow, AEI

Thursday, June 17, 2021 9:30–10:30 a.m. Event page: https://www.aei.org/events/confronting-joe-bidens-proposed-trips- waiver-for-covid-19-vaccines-and-treatments/

Michael Rosen: Thanks very much to everyone at AEI and especially to Will Rau and to Kaamiya Hargis, to our panelists — our distinguished group of panelists — and to everyone tuning in on the livestream today. Now, ordinarily we say these thank-yous at the outset just to sort of “get them out of the way.” It’s almost a throat-clearing exercise for the real introduction that’s meant to follow it.

But today I want to dwell on the thank-yous, or maybe to say it differently, the thank-yous themselves really are the introduction. So what do I mean by that? Gratitude, said Cicero, is not only the greatest of virtues but the father of all the others. And at a moment like the present, here in Washington, in this room, where we’re able to get together in person, on stage for the first time in 18 months, elsewhere in the US, in Israel where I live, and in other parts of the world where life is finally returning to normal after a very challenging recent year and a half, at this moment, gratitude truly is the most important of all virtues.

So a very sincere thank-you to the frontline workers, the nurses, the doctors, the paramedics, the grocers, the DoorDashers, the Amazon delivery folks — everyone who has at great risk to themselves kept the rest of us healthy, safe, fed, and clothed. Thank you to the extraordinary and brilliant scientists, the men and women at Pfizer and Moderna and Johnson & Johnson and AstraZeneca and other pioneering companies around the world for developing miraculous vaccines in record time.

Thank you to the investors and the line workers and the executives at those companies for pouring resources into those projects and taking significant risk in an effort to quite literally save the world. And finally, thank you to the Trump and the Biden administrations for accelerating the process of making and distributing these vaccines across the country and increasingly around the world.

So with that as a segue, let’s jump into our discussion. But first, an introduction to our very distinguished panelists who encompass a wide range of opinions on the controversial topic that we’re going to be discussing today.

So starting at my immediate right is Andrei Iancu, who’s a partner at the law firm of Irell & Manella. After being unanimously confirmed by the Senate, Andrei was director of the US Patent and Trademark Office from 2017 to 2021, where he served as the Trump administration’s principal adviser on domestic and international IP issues.

Andrei accomplished a great deal during his directorship, presiding over improvements in the patent eligibility regime, enhancements to the Patent Trial and Appeal Board, procedures and regulations, a reduction and the pendency of patent applications and appeals, an exploration of computer-generated inventions, and the promotion of trademark filings. We’re very pleased to have him with us today. Welcome, Andrei.

To Andrei’s right is Lori Wallach, who directs Public Citizen’s Global Trade Watch Project. As the author of numerous books on trade and a frequent commentator in national news, Lori has testified before Congress on trade issues over 30 times and was named to the Politico 50 list of top visionaries and thinkers in 2016. Wallach also helped found the Citizens Trade Campaign and still serves on its board. For over 30 years, Lori has combined a lawyer’s expertise on the terms and outcomes of trade agreements with insight from the front lines of high-stakes trade debates. Welcome, Lori. To Lori’s right is Burcu Kilic, who serves as the director of the Digital Rights and Access to Medicines Program at Public Citizen. Her unique expertise in intellectual property, law and policy, information technology, innovation, and trade policy has made her a well-known and highly respected scholar and advocate in these fields. She works with governments, international organizations, and civil society groups across the world and has been quoted in a number of national news publications including , Politico, and Bloomberg. Welcome, Burcu.

And last but not least, to Burcu’s right is Hans Sauer, the deputy general counsel and vice president for intellectual property at the Biotechnology Innovation Organization (also known as BIO), a major trade organization representing more than 1,100 biotech companies from a number of different sectors. At BIO, Hans advises the organization’s board of directors, amicus committee, and various staff committees on patent and other intellectual property– related matters.

Before taking his current position at BIO, Hans served in a legal capacity for a number of pharmaceutical organizations. He is also an adjunct professor at Georgetown University Law Center. So welcome, Hans, as well.

And thank you again to the panelists for being here. As I said before, it’s really special to be on a stage. I know for some of you, this is actually your first time participating in a live panel in nearly a year and a half, so it’s a real treat.

So we’re going to jump right in, and I’m going to ask Lori to start. Can you please articulate the best case for the position that you disagree with on this TRIPS waiver issue and explain why that case itself is wrong?

Lori Wallach: Okay, so I would say it’s not a great case under any circumstances, but it has five main components. So number one, the argument is: The issue is not intellectual property; the issue is a lack of manufacturing. And in fact, the lack of manufacturing is an intellectual property barrier problem because the supply chain, for instance, for making these vaccines, much of the components are also under some form of intellectual property monopolies.

So we’re hearing a lot about: There aren’t enough lipids. But if you actually look at the article Burcu wrote in Nature, the prestigious science magazine, she actually mapped out all of the different connected patents. And you can see, part of the reason the supply chain is all jammed is because actually, the lipids are themselves under intellectual property protection. And that is true of many components.

So the TRIPS waiver — now is the counterargument. The TRIPS waiver would efficiently, without a lot of transaction costs, be able to lift temporarily, during this enormous crisis, the monopolies such that yes, the companies will get compensated depending on what the domestic laws are in the different countries, but they wouldn’t be able to say, “No, you can’t make any more of this.” So that’s number one.

Number two is the argument that the developing countries just aren’t capable. So even if you did lift the intellectual property barriers and other companies could make it, either they couldn’t do it at all, or what they would make wouldn’t be safe. And I just have to say upfront, that is a pretty racist-laden argument because in fact, a lot of times in the US when you get a vaccine, you are probably getting it from the Serum Institute in India, which is a world-class producer of generic versions of a lot of vaccines that are used worldwide.

But we have, around the world, world-class producers — some of them a legacy of sort of mid-2000s US government investment for flu vaccination manufacturing where there are numerous companies that are approved by the European — and the FDA — the health authorities to be able to already sell. And so are there companies everywhere? No. Do you need them everywhere? No. There are sufficient ones that are world-class that have the facilities, that have the trained people, that they actually could, were the intellectual property barriers lifted, able to produce safe, top-notch drugs and quickly.

The third argument is that this would be the end of rule of law, enormous theft, the end of innovation. And first of all, this is not a permanent destruction of the entire concept of intellectual property. This is in the worst health and related economic crisis in 100 years, trying to figure out how to get supplies to where they need to be.

And the temporary waiver is in the context of governments having invested billions, hundreds of billions of dollars, not just in the short term. For many of the vaccines like Moderna, the Europeans have invested in their counterparts in BioNTech and many governments in other of the vaccine candidates, but also in the preceding research so that, for instance, not just the NIH but other government agencies and around the world. Because the mRNA platform has been worked on for 30 years with government funding, with cooperation across universities and governments to get to the point where the miracle of the vaccine being able to be used in this platform was fortuitous. But based on decades of us taxpayers — who are the other people who ought to have been thanked in the intro — who made this possible.

This wasn’t pharma and the innovation myth of: They save their money by high prices and “whoa, we get the vaccine.” Thank you, taxpayers around the world, for the investment in science that led us to this moment that we are at a place that we could have this breakthrough when we needed it.

The fourth argument is: We don’t need more doses because the existing monopoly holders will be able to make enough. And that’s simply empirically wrong. So we keep hearing these great projections from the companies: We’ll have 12 billion doses by 2021. The reality is: We’re not at two and a half million, and we’re halfway — two and a half billion, pardon me — and we’re halfway through the year. And we’re seeing some of the candidate outcome trials that: Do we really want that one being scaled up? That’s not very effective against the variants.

So the notion that more production isn’t needed to get to the 10–15 billion doses needed to hit global herd immunity is just empirically not knowable — but in fact, on the data, is wrong. And then factor in: We’re going to need boosters, and that’s assuming we’re not going to get a vaccine-resistant strain that puts us all back at scratch and we have to start over with the whole world. So clearly, more production is needed.

And the final argument, which is one you and I have debated, is: If there is a waiver, this is the way for China to steal US technology. And I want to say two things. mRNA is not US technology. It’s been one of those wonderful global collaborations where originally, a Hungarian came up with an idea. And then the research went to the University of Pennsylvania. And then work was done around the world. And the BioNTech vaccine work, which we think of in the US as the Pfizer vaccine, but BioNTech is a Turkish immigrant and a German-born person who, husband and wife, came up with this innovation. This is a global project.

But even if it had been the US, because it really isn’t, already, BioNTech licensed a Chinese company for full information to make the so-called Pfizer vaccine in China. So if the cat was in a bag, the cat is out of the bag. But besides that, China already has two of its own domestic mRNA vaccines in final trials, because as I said, scientists around the world have been doing this. So that’s the case, and that’s the “eh” of the case.

Michael Rosen: Thank you. Thank you, Lori. That was very succinct and well said. So Hans, now you have your chance to make the case for the waiver and then shoot it down yourself.

Hans Sauer: Well, I’m crushed. I might as well go home because this was so scorched-earth, devastating.

Let’s see, the argument for the waiver. I think the waiver’s strongest appeal of this proposition is that it seeks to address a problem that is real. Everybody understands it’s really a very serious problem: the inequality of vaccine access, the unequal pace at which vaccines have become available around the world. And the reality that the longer the virus circulates around the globe, the greater the risk of emerging variants that will undo the gains made with vaccination campaigns that we’ve been running all along.

These problems are real, and they urgently need to be addressed and worked on. It’s not that nobody is working on them, but they need to be solved as soon as possible. Because otherwise, they will solve — at a minimum, they will poison the north-south climate and relationships for decades to come.

Unfortunately, none of this is genuinely news, right? It was entirely predictable from the very outset of the pandemic that there would be vaccine-rich and vaccine-poor countries. It was predictable that there would be unequal access to vaccines around the globe. It was predictable that governments of manufacturing countries whose obligations usually run to their own populations first would reserve vaccine that’s manufactured in-country for their own populations first before they start sharing with other countries. That’s why we saw the emergence of export controls. That’s why amongst other governments, the US government, even to this date, speaks about on-shoring of supply chains, repatriation of manufacturing, and implementation of the Defense Production Act in various ways that prioritize Americans.

But that was predictable. We knew this would happen. And so this got us to this place — nobody should be surprised that we ended up here. The problem with a waiver proposal is, even though it seeks to address a real problem, is that it won’t work, and it’s a false solution. It does not solve the problem that we seek to find a solution for.

But contrary to what Lori said, there are genuine real problems in the supply chain that are not caused by patents, that are simply caused by the unavailability and the constraints on existing capacity. There is in this world such a thing as maxed-out capacity that just can’t be increased on a dime. It’s not all due to intellectual property. This is true for existing vaccines as well as for vaccine raw materials.

There are trade barriers. There are export restrictions that we should all be aware of and that we need to work on. And there are very real political, I think, interests in finding an explanation for how we got to this place that absolve governments around the world from their own policy decisions that they made in the past.

In the United States, again, it was the declared policy of the previous administration, as well as this one, that we would vaccinate healthy college kids and go all down the line and offer a vaccine to everybody who wants it before we start sharing any with grandmothers in Burkina Faso. That was the policy. You can agree with it or disagree with it, but that was policy. We had export restrictions in place before a lot of other countries did. And that, too, contributed to unequal access of vaccines around the world.

Another thing that was predictable was that politicians and governments around the world who want to be seen as proactive, on the ball, in control, for a long time were actually very indecisive, very unsure about how to address the COVID problem, which has so many dimensions. Vaccines are only one of those. But with respect to vaccines, not many governments took decisive action, put money on the table, put bets on multiple horses, before we knew whether these vaccines would work, would be approved.

And it was governments in middle-income countries who now, I think, justifiably are concerned that they’re not getting fast enough access, who didn’t have the means and who didn’t have the decision-making structure to place the same bets on multiple horses, if you will, that were placed in the relatively more wealthy, global North and global West. But there is, I think, a really good and, with hindsight, predictable explanation of how we got to this place, and I think it teaches us something about how to fix the problem going forward.

So why will the waiver not work? Well, first of all, with complex technology like vaccines, Lori touched on it, reverse engineering, like you would for a small molecule drug, is much more difficult if not impossible. But it depends very much more than small molecule drugs on cooperation, on voluntary transfer of technology, and on mutual assistance.

We have seen as part of the pandemic response an unprecedented level of collaborations and cooperation and no indication that IP has stood in the way of the pandemic response. The waiver proponents have found zero credible examples of where IP has actually been an obstacle, where somebody has tried to block somebody else from developing a COVID vaccine or other COVID countermeasure, right? It’s not there.

Second, the myth of this vast global capacity to manufacture COVID vaccines that somehow exists out there is unsubstantiated and frankly, in my opinion, untrue. But there is no such thing as vast untapped, idle capacity that could be turned around on a dime to start making COVID vaccines within weeks or even months. This capacity needs to be built; it needs to be established. And at a time when time is of the essence to beat this pandemic, starting capacity-building discussions is helpful, but it won’t be the answer to beat this pandemic. It will be the answer if we do everything right to beating the next pandemic. And if we learn any lesson of this, and then I will stop, is that the COVID waiver as well as the situation in which we find ourselves — if anything, it’s a reminder that we definitely have to take global capacity-building more seriously than we did in the past. That is true for the global North, as well as for middle-income countries — all of whom have to dedicate themselves much more determinedly to pandemic preparedness. And there’s a need to invest both in preparedness and in public health systems that hasn’t happened in the wake of past pandemic threats.

This is what we will need to do. We will need to reduce export restrictions, and we will need to rededicate ourselves to preparing for the next pandemic. As far as this pandemic goes, there are 11 vaccines around the world that are already being shot into arms, only four of which come from the global North. How many more vaccines do we want? I don’t know, maybe 11 is enough if we start making more of them.

But there are manufacturers around the world who know how to do this — including in China, including in India, and including in Russia. All developed their homegrown vaccines, apparently without interference by IP rights, right? So let’s make more of those. I think that’s going to be the more practical and realistic answer to solving the problem. And we need to lean on governments to stop export controls and to dedicate themselves to more global equity.

Michael Rosen: Thank you, Hans.

Burcu, would you like to respond to any of that? And feel free to talk about any of your own work in particular in the supply chain and patent issues, if you will?

Burcu Kilic: Yeah, sure. Yeah, I was taking notes as I told him — “I will be taking notes,” and I was taking notes.

Hans Sauer: You did.

Burcu Kilic: Yeah, I did, like you see. So yeah, I have a few notes, and I think I have a couple of, like — there are a couple of issues that I really want to address here. Yeah, I mean, what you said that this was predictable: You’re right, this was predictable. Back in March 2020, I remember having my first call with my allies all around the world, access to medicines advocates. We knew that this was going to happen.

But there was also something very interesting at that time that we discussed. So in March 2020, this pandemic, it was new. And at that time, we didn’t have, like, diagnostic tests to test people. We had no treatments and we had no vaccines. And all those years, I’d been working on the ground, and I’d been working with developing countries on their access-to- medicines policies and IP policies. And we always face this argument that IP is very important for innovation.

I wrote a PhD thesis on pharmaceutical innovation. And one of the issues that I tried to highlight in my PhD research was: We need local capacity. We need to invest in global capacity. But there was a problem. You know, this is a chicken-and-egg problem. We don’t have enough global capacity because there were IP barriers and then IP policies that are pushed by the United States and European Union. I have notes from your special 301 submission, and you call us anti-IP activists because —

Hans Sauer: It sounds like it’s true.

Burcu Kilic: Yeah, like, I’m the anti-IP activist here. Anyway, so, like, biopharma and pharmaceutical companies here in the US and in Europe, they pushed for these policies. And the argument was, like: Patents, intellectual property, it is important for innovation.

So fast-forward to March 2020. We had nothing to do with — we had nothing. We didn’t have diagnostic, we didn’t have treatments, we didn’t have vaccines. And this is not the first coronavirus; this is the third time the coronaviruses leaped from animals to humans.

So we had SARS back in 2004 and then MERS back in 2012 and then COVID-19 back in 2019. But we didn’t have anything. We didn’t have the innovation. You had all the precious IP rights, IP protections. What happened? Why didn’t you invest in pandemic preparedness? Because we were hearing from the WHO, all the infectious diseases experts, that it’s coming, it’s coming, it’s coming, and we were unprepared.

So that’s why, like, when we talk about COVID-19, this innovation argument, it doesn’t really make sense. Because when we go back to March 2020, we had nothing. And then what happened? Like, we had the two leading vaccines, mRNA vaccines, mRNA vaccines — now everyone wants mRNA vaccines. I know that there are many vaccines, but, like, in Europe, like, they said that we don’t want AstraZeneca, we don’t want Johnson & Johnson, we want mRNA.

And mRNA is amazing. And you know, if you look at the literature, academic literature before 2020, people were talking about mRNA as a breakthrough in medicine — a hope for developing countries because it’s so easy to scale up. And the history behind mRNA is also very interesting because, as Lori mentioned, it’s the Hungarian researcher; she is the inventor of this platform. And there was a very interesting article in about her, and she was saying that all those years, like, my research was funded by the US government, public funding. I didn’t receive any funding from the companies, especially Big Pharma because, like, they weren’t interested in that.

But there were two companies who invested and believed in this technology — BioNTech and Moderna — and they are not big pharmaceutical companies. And I did the patent network analysis, and you can see when you look at the mRNA platform back in December 2020, you see that, like, Moderna, BioNTech, and all the small biotech companies, but not Big Pharma. Now, Big Pharma is entering into the mRNA business because they saw the potential.

So it is very interesting to highlight these, you know, and guide our discussions because I think these facts should guide our discussions. Because yeah: IP was important. We heard it for many, many, many years. And we told that to developing countries: Protect IP, it will bring innovation. It didn’t bring anything, and now the countries are: “Let us help ourselves.” And they think that they can do that. And I’ve been talking to the officials there, and they’re like, “Yeah, yeah, we can really, really scale up manufacturing. We can retrofit the existing capacity.” Yeah, we have a limited vaccine manufacturing capacity but mRNA is a new technology. I mean, it’s a new platform. And we put the existing capacity or retrofit the existing capacity over the last six months. So it happened here. Why can it not happen in other countries?

Michael Rosen: Andrei, would you like to respond to any of what you’ve heard so far? We’ll give you the anchor leg in the relay here.

Andrei Iancu: Sure. Thanks, Michael. And first of all, thank you to you and to AEI for bringing us here. It is my first time at a live conference at least in 12 months — I think 18 months, probably. Great to be with all of you again. Great to be with you, Lori, again.

So, look, just to first make the best case for the waiver proposal, which is: People are dying. We are in a historic crisis. There is inequity worldwide in the distribution of vaccines. Something has to be done. I agree with all of those things. And I certainly — and I think everyone on this stage — agrees that we need to solve those problems.

The only question really is, though, how to do that and whether waiving IP rights is the right approach to do so. If I thought that doing so, implementing a worldwide waiver to the TRIPS agreement would get a single additional shot in people’s arms, maybe there would be something to discuss. The problem with all the arguments on the waiver proposal side, though, is that they are not based on evidence. There is no evidence that it would work. There is no evidence that IP has actually been a problem. In fact, all the evidence is to the other side.

To go to Burcu’s main point: First of all, Burcu says, you know, where was — if IP works and innovation worked, where was the technology in March of 2020? Well, look, the fact of the matter is: This is a new coronavirus with a spike protein, something actually with a sequence that hasn’t been seen before. Within 12 months or less of the discovery of the sequence of this particular virus, there were not one but multiple vaccines — not just created, but also approved and already being delivered into people’s arms.

When else in history — what other example of a vaccine do we have on this scale to address this type of a pandemic that has been created as quickly as this one? It’s not even close. And the reason for it having worked so well is the years — and, in fact, as Lori indicates — decades of innovation that has preceded this crisis: innovation on the mRNA platform, on DNA sequencing, on so many other things that was consistently supported and backed by intellectual property rights with public and private funding all along the way. So the evidence suggests that actually, the system worked extremely well to create, in record time, multiple technologies to solve the crisis.

Second, the evidence indicates that the collaboration between companies worldwide is working at unprecedented rates. There are hundreds of collaboration agreements that are being made possible worldwide by the company’s security in their own intellectual property rights. So, big companies collaborating with big companies such as Johnson & Johnson and Merck. Also internationally, AstraZeneca with the Serum Institute of India, small companies, big companies like BioNTech and Pfizer — all of those and so many more, hundreds more, all of those enabled by the companies that have this intellectual property, relying on the security of the rule of law that their IP will be protected despite the collaboration. Where is the evidence that if we remove the IP, these collaborations would still exist, all of them, and in fact we would add more? I don’t think there is any such evidence. And in fact, I don’t think that there is evidence of any serious manufacturing entity that is ready and capable of doing high-level, high-end, complicated vaccine technology asking a major manufacturer that has this technology for a license, and the company refused simply because you know, we have patents or whatever, and we’re not going to share. All I’m asking for is: Where’s the evidence?

So I believe that the argument on the other side — which is attempting to solve a real problem — is misguided because (A) there is no evidence behind it that it’s needed; (B) there is a misunderstanding of what intellectual property does. Let me stop on that for a second. And there are a few more things. Well, let me just outline them: lack of evidence, misunderstanding of IP, no chance that it’s going to work, it would actually do more harm than good, and it hides the real issues that need to be solved.

So I already addressed the lack of evidence. The misunderstanding of the role of IP: IP, certainly over hundreds of years, has demonstrated that it enables innovation. But it’s also really important to understand that it enables disclosure and collaboration. Intellectual property might be counterintuitive to some, but intellectual property actually enables public disclosure and collaboration because the IP owners can rely on the rule of law and they don’t have to hide their technology and trade secrets and guilds as it used to be in the Middle Ages, and instead are willing to share with collaborators under the protection of license agreements and the enforceability of those agreements.

No chance that it’s going to work: Think about timing. I don’t even understand the argument that we can get there in time. These multilateral international agreements take years, sometimes decades to work, to get together. Best-case scenario, everybody here says the best-case scenario that we can get to an agreement is by the ministerial meeting at the end of November–December. That’s if it actually works and because the WTO, as we all know, works on consensus and all the countries, we already know that a number of countries are now willing to do it, but not just agree in principle, but also agree on the text-level negotiations that we can actually get to an agreement. So that’s November. That’s a few months from now. And then each country has to go to the national stage and ratify the new agreement.

Think about the United States. What does that take? In the United States, you need an act of Congress, both chambers agreeing, and then the president approving, signing it into law. Other countries have different approaches obviously for it, but there is a phase that they have to deal with it at the national level. How long will that take?

And then factories need to be stood up. Technology needs to be learned and transferred and implemented. We’re going to be, best-case scenario, well into 2022. And no matter what the predictions are exactly right now at this moment, we’ll definitely have billions of vaccine doses by then.

And beyond that, even if all that is true, what’s the actual proposal? What does this waiver mean? How will the technology be transferred? How will the trade secrets be transferred if companies are now willing to share the secret sauce, the formulas, because it’s well beyond patents, right? The proposal is that you have to transfer tech know-how and trade secrets. How will that work? Are armed guards going to show up at Pfizer’s doors or Johnson & Johnson’s or AstraZeneca and say you must give this technology to the public? I don’t even understand the proposal.

But here’s the biggest concern I have: We’re spending so much time in the public debate discussing these issues, which to a lot of us are super interesting and academic and thoughtful and so on. There are real problems out there such as export controls, capacity- building, distribution channels, regulatory controls, that are not being addressed.

Governments get to hide behind this debate and not work on the real problems that would actually solve what is needed here, which is more vaccines and more equitable distribution. And I really hope that we can refocus and get past this particular issue and really work on the things that will get more shots into people’s arms.

Michael Rosen: Thank you, Andrei. I see a lot of vigorous head shaking and nodding on the stage according to different folks here. So let’s go through sort of another round. There’s been a lot to respond to here.

Lori, I’ll let you take the first crack. And I would also ask everyone to sort of consider in your next line of remarks, also, the issue of: What would be the best alternative to a TRIPS waiver, and do you think that that would be better than a waiver? Or if not, why would that be inadequate? So Lori, take it away.

Lori Wallach: Okay well first, just some factual things. The US was not first in export restrictions. And if you want to actually see the global time sequence, go to tradewatch.org. That’s www.tradewatch.org. Because actually, first was China, then was India, the US was last — April 14. The EU was way before the US. And the US now has no export restrictions and, in fact, hasn’t had them for a very long time. So that’s just a myth right now.

If you look at the trade data, exports have gone through the ceiling on the actual supply chain for the vaccines from the US to the countries that are now arguing that there are export restrictions. So if you want to see political butt-covering, check out the Indian prime minister claiming there is actually an export restriction that doesn’t exist in the US versus their own political problems.

Number two, this whole notion that reverse engineering won’t work, there’s no way to ever get the production up, is just lunatic because of what Burcu said, which is: There were no doses anywhere when this crisis started. And in the spring, the companies were trying to make doses to do trials a year ago. So the companies themselves, from scratch, when BioNTech licensed Pfizer, Pfizer had to figure out how the hell to make this stuff. And it took them six months.

So yes, if there’s tech sharing, as the chief chemist of Moderna said, three to four months to get mRNA lines up. Because as Burcu said, it’s easier to start up. You guys know this; you don’t need to build, like, the three-story vats. You don’t have to have live cell lines replicating brewing. It’s all synthetic chemistry. You need clean manufacturing, which could be even in a chip factory. You need the negative pressure. You need the seals. You need all of the ventilation and filters. But then you’re talking synthetic chemistry. So if you have tech transfer, Moderna’s chief chemist said three to four months to get a new lineup. If you do it from scratch and you have to do what Pfizer did, or what Moderna did when they had to create, what BioNTech did with their German plant and, from scratch, figure it out, trial and error, okay, it could take six months. That’s a shame — three more months of people dying because there’s not tech transfer.

As far as how it would happen if there was a waiver or how tech transfer would happen, the equivalent to the Patent and Trademark Offices and the equivalent to the FDA have the filings. They have a lot of the information that had to be filed in order to get either the intellectual property licenses — because the waiver does cover not just patents, but the industry has created these steely webs of copyrights and industrial designs and trade secrets protections, in addition to the patents. And they’re all entangled to protect that monopoly.

So yes, a lot of that information is on file, and you would have university researchers, you would have the experts in these sprinkled around the world, world-class manufacturers looking at the information. You don’t need armed guards because it’s actually available in the countries.

But then the question is: There’s proof that the waiver has never been shown an obstacle. In fact, again, folks, I’m not going to go through the details. Just go to the WTO’s website and look for South Africa’s 60-page submission that actually documents all of the practical obstacles, because this is circular arguments. And by the way, it’s now down to just Germany pulling along the European Union with the UK and Switzerland hiding behind the EU — that is it. The whole rest of the world has come on side.

Since the US, thank you to the Biden administration and the Biden-Harris leadership and USTR Katherine Tai, Japan and all the APEC countries have come on side. It is true that President Trump had recruited about two dozen companies to join in blocking the waiver for the entire year since most of the world wanted it. It’s now 130-plus WTO countries saying, “Let’s do a waiver.” And then you have the EU saying, “Eh!” with the EU basically leading the obstacle, with Germany leading the EU.

So will there be a waiver? Yes, there will be. It’s going to probably be locked up sooner rather than later this summer. We’re not waiting until December. Too many people will die under that circumstance. And the prospect of the European Union blocking 130 other countries of the world from having the thing that those countries think — you know, we’re talking about an academic — we’re not talking about an academic debate. We’re talking about 130 sovereign governments saying this is the thing to save people’s lives in our countries and to stop this pandemic.

They are the visionaries saying this is what we as the sovereign governments need to do to do the thing that we’re responsible for doing. It’s not an academic debate. It’s sovereign nations trying to have a particular outcome to be able to have this.

And with respect to the notion that this would be dragged out forever; gentlemen, you both know the Uruguay Round Agreements Act explicitly delegates the authority to implement the entire Uruguay Round — i.e., the WTO — to the executive branch. Congress delegated that authority when it passed the legislation in 1995. There is no vote in the US on doing this. In fact, that delegation is so damn wide that the United States signed up for an entire 60-page financial services agreement, a telecommunications agreement, a trade facilitation agreement, and it never came for a vote to the US Congress. So the notion of implementing these existing rules clearly does not have, under any circumstances, a vote.

And then finally, as far as the dose is on the shelf, so don’t listen to me — listen to the WTO director-general. She’s the one who called the conference where a billion doses of untapped capacity right now, without having to build out anything, without having to create new facilities, are available. And that comes out of her manufacturing conference from May.

Michael Rosen: All right, thank you, Lori. Hans, you want to respond to that?

Hans Sauer: Yeah, you know, we’re now going to need maybe more time than we have available. Thank you for these words. I think, Lori, you really need to do your research because you’re not doing people a service by spreading more misinformation than you already have. Every single point that you said — you really need to do your research. I’ll take it in reverse order.

The URA Implementation Act requires the USTR to consult with Congress, especially on issues that would require amendment of US laws. There is a very clear system in US law that requires if we accede to international agreements that will change domestic laws, that will go to Congress. It’s not for the administration to decide how we’re going to change our domestic laws or not. Would you agree to that, or do you think that’s wrong, that there’s no vote in Congress if we start changing our laws here?

Lori Wallach: The waiver doesn’t require us to change our laws.

Hans Sauer: Oh, so you don’t think the waiver should be implemented in the United States? It’s just for other countries to implement over there, but we’re not going to implement it here in the US? I’d like to — see what I’m saying? Are we going to waive IP rights in the US according to your proposition?

Lori Wallach: It doesn’t require a change of US statute. The delegated —

Hans Sauer: Absolutely it does.

Lori Wallach: Okay, well, there’s your view —

Hans Sauer: How are you going to waive IP rights of any kind — whether it’s patent law or trade secret protections — in the United States without changing United States law? Because you know, if you know about TRIPS, then you know it’s not self-executing in the member countries.

Lori Wallach: So under the Defense Production Act under 1438 of the statute, for instance, there are all kinds of different uses that are possible for the US government to exercise intellectual property rights. The question is if your companies are going to sue them when they try and use those rights.

Hans Sauer: Oh, my God. Lori Wallach: And with the TRIPS waiver actually, it’s a worldwide signal: Investors, producers, now is the time to stand up and do the work —

Hans Sauer: Lori —

Lori Wallach: — and they won’t be able to sue you because we’re going to have a global agreement by sovereign nations that you can’t.

Hans Sauer: Yes, but this is not about signals. However much you would like to signal, the US still is a country that aspires to the rule of law. There is no mechanism —

Lori Wallach: And the Defense Production —

Hans Sauer: No, not in the Defense Production Act either. There is no mechanism currently in US law to just say we’re going to waive vested rights of whatever kind they are, whether it be patents. There is no mechanism that says, “Oh, we’re going to just take patents out of force for a while. And then maybe we’re going to reinstitute them.”

Lori Wallach: Do you deny that the US government has the right to exercise, to work various intellectual property rights under the Defense Production Act or under the exceptions to the statute?

Hans Sauer: No, I do not —

Lori Wallach: Are you trying to rewrite that US law?

Hans Sauer: No, absolutely not. You’re trying to turn this around. That’s — what you’re talking about is not a waiver at all. Lots of governments have rights to work IP rights for either government functions or in public emergencies. That’s not waiving rights. You know, these are often subject to certain minimum forms of due process, as well as subject to compensation.

Lori Wallach: Each country will implement according to what they need and what their laws are.

Hans Sauer: Yes, and how long do you think that implementation is going to take? Because it’s not going to be “Oh, now there’s the waiver and now all patents go away.”

Lori Wallach: In some countries, it will be. Certainly in parliamentary systems, it will be.

Hans Sauer: No, certainly in parliamentary systems there’s going to be more debate. What you’re talking about is the countries that don’t have so much of a parliamentary system, who can implement that more quickly.

Lori Wallach: If you’ve got the president and the parliament in the same party and the party supports the waiver, what is your vision of how it takes a long debate?

Hans Sauer: It still takes an act of parliament to do this. But maybe it’s going to be quick; we’re going to see what happens. You think it’s easy; I think it’s going to be difficult. I don’t see how the United States would waive, for example —

Lori Wallach: Let’s just — Hans Sauer: — the rights — let me finish, finish the — how the United States would waive the rights of companies to protect their industrial property from misappropriation because that’s what would happen. Congress would somehow have to override the trade secret laws of 50 states, right? We’d also have to waive patents. We’d have to amend the Food and Drug Act. We’d have to amend the Bayh-Dole Act. We’d have to amend a whole bunch of things to simply make possible what you say is so easy. And that’s just in law.

And that’s not going to help anyone at the end of the day because what you’re talking about is: You want to encourage production in the global South. But there are only a few countries who will be able to make relatively quick use of this technology, and it’s not countries in Africa. It’s China, it’s India, maybe Russia. Those will be the most immediate beneficiaries of your proposal. And it’s going to be an example of the kind of Walmart economics that you’ve been propounding forever, right? If we could have made it in China, we could buy it so much more cheaply here in the US. Wouldn’t we all benefit?

Lori Wallach: Wait, you’re saying Public Citizen supports that?

Hans Sauer: Oh, I totally —

Lori Wallach: We’re the leading organization that fought the China PNTR, and we’re the organization that’s working on Build Back Better to reset domestic supply chains.

Hans Sauer: Exactly. And now you’re pushing to offshore and give away US technology.

Lori Wallach: Let me tell you where it’ll be done.

Hans Sauer: Oh, yes?

Lori Wallach: Because these are places the pharma companies you said have never — one of you guys said — there’s never been a pharma company that has said no, and there’s no proof. So, ladies and gentlemen, extremely odd places to look but —

Hans Sauer: Yes, listen to this.

Lori Wallach: — The New York Times, , Foreign Policy, The Associated Press, just to list a few. Invicta in Bangladesh went to all the companies, got nos. Getz in Pakistan. Vacsera in Egypt. These are the ones I can remember off the top of my head. In South Africa — Burcu, do you remember the other company, not Aspen but the other —

Burcu Kilic: Bio legs? Bio, something bio.

Lori Wallach: Bio, yep there is — folks, just Google “vaccine production COVID” and then do New York Times, AP, et cetera and you will get a whole list. Foreign Policy has a great list actually. Institut Pasteur in Senegal, there’s a whole list of companies that —

Hans Sauer: You have to go there.

Lori Wallach: — explicitly, you have the companies saying, “We want to make it. We can make it. These companies will not give us the right to make it.” There are maybe going to be six billion doses at the end of the year if we’re lucky. We need 15 billion. These are companies that can do it right now. And they went to the WTO director-general and said that on the record.

And these companies that you represent want to be able to have a monopoly. Why? Pfizer said it on the record — so that next year when it’s time for boosters and the $20-a-dose pandemic pricing goes away, Pfizer said 150–175 bucks a dose for boosters to be sold in rich countries to maximize the profits. That’s why they don’t want to have the capacity in developing countries where there can be implementation quickly and there could be more doses.

Michael Rosen: Just briefly, Hans. In the interest of time, maybe briefly, and then I know Andrei, you want to jump in too.

Hans Sauer: I think you should take Lori’s word: Do your research, go to the websites, and see which manufacturers have expressed an interest and what the capacities are. The examples that you’re talking about, it is true, right? There have been a couple — there have been several, like, not really credible manufacturers who said, “Oh, if only we got a compulsory license and we got a couple of million dollars from the government. And if the companies give us the technology, then we too can participate now.” But in the case of Bangladesh —

Lori Wallach: Folks, read it. It’s not what it says.

Hans Sauer: Yeah, what’s mostly is being proposed is: You get interest from manufacturers who can do fill and finish. What the Bangladeshi company said was “If Johnson & Johnson were to send us bulk vaccine, then we could fill it into glass vials.”

Lori Wallach: They wanted to make mRNA actually. They weren’t J&J people.

Hans Sauer: No, it was actually J&J to start with, and then they started talking about mRNA. They’re willing to fill anything, which is fine, when in reality you need to think about whether taking another fill-and-finish provider under contract is really what’s needed right now. Because it doesn’t help to take yet another fill-and-finish line under contract if there’s no vial of vaccine to put into glass vials.

Lori Wallach: A place where all these links are located is tradewatch.org. If you go to our actual center of fact sheets on these questions, there’s a whole fact sheet on debunking myths. And we have all of the list of — I don’t remember all of them, and I apologize to the other countries and companies — but we have the list of all of the companies linked to all the reputable publications that lay out what exactly they were trying to do. And it was mRNA, and it was not fill and finish. Folks, the capacity is out there if these guys will just stop with their monopolies.

Hans Sauer: Yes, it’s great. And we’re in the world of alternative facts, great words, and so do that. I also encourage you to take Lori by the word and look up South Africa’s submission on the purported proof of where IP has been a problem. That list consists of a bunch of patents that haven’t been enforced, a handful of lawsuits that weren’t designed to stop anyone from doing anything. The rest was old narratives that have nothing to do with COVID and politician statements. If that is the proof, then we’re in bad shape. But please go look it up; proof is important. And alternative facts or the real facts, whatever they may be, you need to look at all of them.

Michael Rosen: And viewers can do all of that. And Andrei, let’s you have a response here and then we’ll finish with Burcu because we have only about five minutes left. We don’t have nearly enough time to encompass everything that we want to talk about, but we did our best.

Andrei Iancu: So very quickly, facts here are very important, and the evidence to support all these drastic proposals — really important to nail down. If Bangladesh wants to do this, is capable of doing this, why don’t they do it? The TRIPS agreement does not apply to Bangladesh. The TRIPS agreement does not apply to all of the least-developed countries. There is a list of the LDCs that the United Nations maintains. They already have a waiver to the TRIPS agreement until 2033. If they could do it, why don’t they do it?

In addition to that, part of TRIPS within the TRIPS agreement are exceptions to the agreement. Every single country could — including the United States, India, whoever — they could exercise those exceptions under the rule of law. And they could, if they wanted to, enter into compulsory license — pass compulsory license laws and the like. Already this exists for years on. Why haven’t they done it? If this were the actual solution, if these proposals were the solutions, how come countries haven’t done it?

Second, please keep a very close eye on the actual text of the proposal. Lori mentioned early on that it’s a temporary waiver in this moment of crisis. Look at the proposal from May 2021, the revised proposal that we have — yes, we all have copies here in our hands. It is a basically permanent de facto waiver for these intellectual property rights that are being proposed. What the proposal says is a minimum of three years after which the WTO, which works under consensus, has to come back together again and decide whether to end the waiver. If some countries object to ending the waiver at that point three years from now, it won’t end. So the current proposal is de facto a permanent waiver.

Finally, and this is really important in my mind. Where is the evidence that what we’re going to do here will not harm long-term innovation and saving people’s lives? We have worked in the Western world for 200-plus years under a regime of intellectual property rule of law. It has worked. The pace of innovation is unprecedented. The state of the human condition in comparison to past history, going back thousands of years, is at an unprecedented level.

We need to be extraordinarily careful that if we undo this established rule of law that we have become used to over the past couple of hundred years with respect to intellectual property, that we know for a fact that we’re not going to do more harm than good, and that we won’t cause less life-saving innovation that we will need to depend on for the next pandemic. We need the evidence that the proposal will not harm human life down the line — because what we do know is that the current system has worked to unprecedented levels.

Michael Rosen: Thank you, Andrei.

Burcu, we’ll let you have the last word here, and feel free to address any of that. Burcu Kilic: Thank you. I’d just like to highlight one publication. I think it’s very critical for this discussion. There was an article in Nature a couple of weeks ago. It was an interview with a Thai mRNA researcher. And they asked him, like, it’s not alternative facts — it’s Nature. It’s the most prestigious scientific journal. And that was — because Thailand has been working on their own mRNA vaccine, it’s now phase two. So they asked him, like, “Do you think the waiver will help you?” And he said, “Yes, it will help us a lot because it will provide us an access to technology which is patented so that we would be able to use that technology for our research.”

And they also asked him about manufacturing. And he said that “Yeah, we have a local company here in Thailand, and we’ve been talking to that local company to manufacture this Thai mRNA vaccine in Thailand.” So it can happen. It’s not easy. No one is saying that it’s easy. But it can happen. And there is a possibility. And when people are dying, I mean, we are all here without our masks back in the old days, like, you know, it’s also my first event after 18 months, like, discussing this issue. While we are discussing this issue, people are dying.

And as I said back in March 2020, we had nothing, and we got here thanks to science, thanks to all the scientists who believed in science and who continued their research in mRNA, in SARS, in MERS, where there was no, like, private funding, based on the public funding they received from the governments.

So science brought us here, and we can save lives. It won’t be easy, but it’s not impossible. It will take time. It’s not going to happen overnight because I heard from many people, “So the waiver is there, so what’s going to happen the next day?” Nothing is going to change the very next day, but this is a long process.

And we’ve been discussing this waiver since October. It has been eight months, you know? We could have had the waiver back in October, and we could have been discussing manufacturing. And thanks to waiver discussions, now, the companies — they’re talking about voluntary licenses. They are talking to — there was an interview with the BioNTech CEO, my fellow Turk Ugur Sahin, and he was saying that there is no reason to believe that we cannot do mRNA manufacturing in Africa.

And they are ready to do that kind of investment in Africa. And he thinks that “no, no, Africa has the capacity, and we will retrofit the capacity, build new capacity. Africa has their researchers, and we will do that. We will get there.”

That wasn’t a discussion before October 2020. The discussion before October 2020 before the waiver proposal was submitted, COVAX — you know, donations. And you know what happened to COVAX. COVAX relied on the Serum Institute, and I don’t understand why no one thought that the Indian government would not issue a, you know, export restriction for the Serum-manufactured vaccines.

So we relied on COVAX and the Serum Institute. We got here. And like many countries in Africa, they had no access to vaccines now. And we need to think about alternative solutions. And you ask: What is the best alternative solution? The best alternative solution according to PhRMA and BIO is the voluntary licenses. But we had all this time since March 2020. Why you didn’t do that, you know? Like, why was there only a limited number of voluntary licenses? And voluntary licenses, like, we don’t know the conditions. It’s not the technology transfer.

The problem is, as you very well, like, recognize, we need to improve our global capacity. This is an awakening moment for us. So the waiver will take us somewhere. Maybe it will be the beginning, but it seems that we don’t have an alternative solution.

Michael Rosen: Well thank you, Burcu. And we started with thanks, and we ended in your remarks with some thanks.

So once again, I’ll finish off by saying we’re not going to solve this issue together on this stage today. But I thank you all for engaging with each other’s arguments and engaging with the strongest of each other’s arguments, not the weakest of them. And hopefully, this debate will continue to shed light on issues of IP and public health. And may we all together hope and pray that this pandemic, globally, will come to an end very speedily.

So thank you very much, Hans. Thank you, Burcu. Thank you, Lori. Thank you, Andrei, for participating. And thank you all to all the viewers and listeners for tuning in today.

Hans Sauer: Thank you.

Andrei Iancu: Thank you.