Lessons from the pandemic: the failure to think globally | #ukscams | #datingscams | #european


In the latest in a series of video interviews on lessons from the COVID-19 pandemic, Brink Lindsey speaks with Priti Krishtel, a health justice lawyer and the co-founder and co-executive director of the Initiative for Medicines, Access & Knowledge (I-MAK). They discuss the failure to mount an effective global response to the global pandemic – and, in particular, the role of patent law and the pharmaceutical industry’s patent-based business model in inhibiting the development of global manufacturing capacity for vaccines and treatments.

Transcript

Brink Lindsey: Hello. My name is Brink Lindsey. I’m a vice president at the Niskanen Center where I help to run our project on rebuilding American state capacity. Problems with American state capacity have been painfully and tragically obvious in our faltering response to the COVID pandemic. And so as part of this project on state capacity, we’re doing a whole series of interviews with experts on various facets of pandemic response. Reviewing what went wrong and every once in a while, what went right. With a view towards how do we upgrade our institutions and policies to be better prepared for next time, because there’s going to be a next time.

I’m delighted to have with us today, Priti Krishtel, who is a co-founder of I-MAK, which is short for Initiatives for Medicines, Access and Knowledge. It is an organization devoted to greater access to medicines in general, and to patent reform in particular and reforming the patenting process surrounding pharmaceuticals. So you are now in the public eye as a stringent critic of patenting policy, but your own background is not one that indicates any kind of deep hostility to the purposes of patenting, since you come from a family of people with patents. So tell us a little bit about your background and how you then made it to where you are now at I-MAK.

Priti Krishtel: Sure. So my father was a pharmaceutical scientist. He was a scientist who was born in India and immigrated to Detroit in his twenties. And we spent most of my childhood either in Boston or in California, where my dad spent most of his career trying to bring a drug to market. And he actually did that just as he was retiring, which was pretty amazing for him.

My dad held several patents. And so definitely I appreciate what you said. In my family, we definitely had a love for my dad’s quest for science. We also had a love for his patents. My early career was actually in legal aid and in health lawyering. I ran a legal aid clinic working with low-income patients or patients living below the poverty line in India in particular, and across the global South with patients who couldn’t afford their medication.

And it was there that I met my co-founder, Tahir Amin, who had worked at law firms in the UK and served as in-house council for major corporations, handling their IP for over a decade. And he had come to India actually on vacation when I met him and we were organizing a protest around the cost of medication and India’s reform of its patent law. And I met him there and we started talking about the ways in which the patent system is leveraged by private industry now, really over the last 40 years, to take it away from the integrity of its original purpose. The patent system was supposed to be about invention or true scientific progress. And it’s really over time become a tool for rewarding incremental improvements and really to drive investment.

And so we grappled with that together in the context of the patients and the families that I was working with. And around that time, we also met professor Joe Fortunak, who would go on to become our lead pharmaceutical scientist on our team. And together, the three of us spent the better part of the last 15, 20 years working to identify patent or other regulatory barriers to access to HIV treatments, to hepatitis C treatments, and other pandemic-related testing, treatments, or vaccines that people need to stay alive. And then we work to remove those barriers so that everyone can get medicines that they need.

Brink Lindsey: Great. We’re going to eventually tie this conversation of patents and intellectual property for pharmaceuticals to the COVID crisis. And in particular to the less than rapid global rollout of vaccines for distribution beyond the rich countries to less developed in poor countries. But first, let’s back up a little and just talk about patents. So patents, you come up with a new invention. You apply to the patent and trademark office for a patent. If the new invention is novel and useful, then a patent is awarded. And basically you get a 20 year temporary monopoly that is nobody can make that invention without your permission. And if you want to block them all together, you can. But if you want to give them permission, they’re going to have to pay for a license to produce.

So we have this system that’s been in place since the founding of the Republic for sort of decentralized encouragement of innovation. That is, the government isn’t going to figure out what people should be trying to invent. But, if you come up with something novel and useful, we’re going to give you a 20 year kind of exclusivity on that.

Priti Krishtel: Yes.

Brink Lindsey: And at least in theory, the case for the need for granting this monopoly is probably strongest or extremely strong in the case of pharmaceuticals. So basically, the heavier the upfront innovation costs and the lower the downstream imitation costs, the greater the risk that someone could come up with some innovation, plow all this money into it, and then when they’re trying to scale up their own production, some copycat would come in and take the market away from them. And so they couldn’t recoup their upfront investment. And fears of that – the idea is, the fear that that’s what would happen, that some copycat would scoop you, would deter innovation.

So the idea is that, even if we slow down the diffusion of new innovations by giving people 20 year monopolies, we will so ramp up the number of innovations out there through this incentivization so much that overall will come out ahead of the game. And again, for pharmaceuticals, it seems like a strong case because the upfront costs for developing a new drug are astronomically high. And at least if you’ve successfully reverse-engineered it, or you know the formula and you have the manufacturing capacity, the actual manufacturing costs of producing the nth little pill are pennies. Right? So there is at least a strong theoretical case for patenting pharmaceuticals. How does the patenting status quo for pharmaceuticals go wrong?

Priti Krishtel: Yeah. So I think that is the underlying theory behind the system we have today. Unfortunately, of course, the system is very opaque because of a lack of transparency and a lack of willingness, frankly, on the part of government or the state to require that transparency. So we actually have no idea how much it costs because we don’t require pharmaceutical companies to tell us how much it takes to do the research or develop a drug. There’s also complexity around so much of the research that happens with public funding in public settings, like universities or through government research. And so these are some of the challenges to really unpacking how is the system actually doing. And this is of one of our biggest pushes right now. Not specifically on that issue, but how can we meaningfully understand how the system is working in practice now, when it is so opaque? How can we bring more of the system into the public view? How can we get more of the information we need as civil society or as the public to understand how that theory has matched up in practice?

And so part of our work has been to try to bring more transparency to more of the practices that are happening. We testified, for example, in front of Congress last year, to show that we know the best-selling drug in the country, Humira, that Europeans are getting competitive versions and more affordable versions of that drug product five years before Americans are. This is true of other drugs as well. And so trying to understand what it is unique about our patent system. How do we allow for more patent applications? How do we grant more patents? And what does that mean in terms of all of the other exclusivities we also allow on given drug products? What does that actually mean for how long a product gets to stay on the market without any competition? And is that ultimately what’s best for the public in the long run?

Brink Lindsey: Yeah. So if you just look at the most superficial level of the abstract standards for patenting, they sound like they make sense. Something novel, something useful. But how those terms are applied in practice is the devil in the details. And it appears as if the standards for novelty, the standards for usefulness, have been lowered substantially over time. So that one might expect a new breakthrough drug, well, that’s patentable. Right? But in fact, we find your typical drug is covered with dozens, sometimes hundreds of patents. And so little tiny aspects of drug manufacturing, or little tiny improvements in the sort of consumer experience, changing it from a three-times-a-day tablet to a one-a-day tablet, that kind of thing. Those can then be patented and extend the life of the patent beyond the originally contemplated 20 years.

Also, the usefulness thing is sometimes not so nailed down. I think to me the poster child for what’s wrong with pharmaceutical patents is Theranos, the scam company that promised to have finger stick blood testing. There never was any operating technology that worked. And yet they had hundreds of patents. So how you can have hundreds of patents for something that doesn’t even work at all, and never had a prayer of working? It suggests that the requirement that you’ve actually achieved a breakthrough is weak. How you can have hundreds of patents on one drug also undermines the claim that you’re doing something novel. And so I know I-MAK did research a few years back on looking at the 12 top selling drugs and found big patent thickets around those drugs. Much longer than 20 year protection terms and, consequently, big hefty price hikes.

Priti Krishtel: Yeah. When we testified in front of Congress last year, we updated that data from that report. We found that on average, the companies on these 12 bestselling products had applied for 131 patents per product. They were granted nearly 70 of those, which is a pretty high number. And most are being filed after marketing approval. So that implies, or it suggests, that as we get closer to the expiration of the original patent, companies are looking for ways to extend their patents’ life on the market, the period in which they can block competition altogether. And in December, the House Oversight Committee in Congress published their own three-year investigation, where they had secured a number of statements from the companies themselves, from internal discussions and presentations. Where the companies are very candid, that this is absolutely what they’re doing. This is a commonly accepted business practice.

Brink Lindsey: There’s a term called evergreening. Right?

Priti Krishtel: Yeah.

Brink Lindsey: To keep your patents fresh by little cosmetic changes in the underlying drug.

Priti Krishtel: Evergreening, I think is one term that’s used. The companies themselves just talk about extending the life cycle of their product.

Brink Lindsey:Sure.

Priti Krishtel: How can they stay on the market? And so that’s always been interesting to me in the case of, for example, there’s a cancer drug called Revlimid, which I’m sure you know, Brink. By a company named Celgene. Now we should have seen competition on that drug by 2019. And you’re talking about patentability criteria, right? So to get a patent, you have to show that something is new, it’s not obvious and it’s useful. But what the companies do is that they file for additional patents. In this case, there are two additional patents in particular, on the crystalline form or the crystal form of this drug. Now crystalline forms by their very definition should not be considered inventive when the companies submit their data to the FDA.

Or if you talk to anybody in industry, or if you read the literature, this is just a screening that happens to see if there are other forms for this product. We often say it’s like you have a patent on water, and then you try to go get the patent for ice. Is it inventive? Is it new? Is it useful? And so what happened in the case of Revlimid is that those extra six years now that they’re going to get to control the market, including controlling other companies and licensees, that’s an extra $46 billion that Americans are going to spend on that drug during that time period. 

And so this is where we see, on the best-selling drugs in particular, these practices of extending the life on the market actually have a huge price tag. For $46 billion, we could have managed COVID relief. We could have given families… We could have helped with student debt. We could have helped with rent during the pandemic. There are just so many things we could have done with that amount of money. So I think that for me, that’s the question, there are families today, when you think about diabetes and insulin, there were 100,000 deaths in 2020, 100,000 deaths in 2021. Part of that was due to the affordability of insulin. So what would it mean for families to get more affordability sooner, is of course the primary question. But even in terms of when you think about Medicare and what it spends, the cost savings, what we could do with those billions of dollars is staggering and something has to be done about this problem.

Brink Lindsey: So let me back up and talk about some of the other arresting findings you had when you were looking at the top-selling drugs, and perhaps you’ve updated these numbers. But so you mentioned the 100 plus patent applications per product and 70, or thereabouts, on average patents actually granted per product. The legislative patent period is 20 years, but these drugs are getting substantially longer protection than that. As I recall, back in 2018, you were saying 38 years, I don’t know if that’s been updated or not, but basically double the statutory term.

Priti Krishtel: Yeah. And I think it’s important that we clarify that what we were talking about is attempted protection and potential protection. So a lot of caveats there. But what we were trying to shine a light on when we were talking about that attempted potential protection is, what are companies trying to do? What’s the strategy? They’re trying to extract as much life out of their products as possible. So, as I mentioned with Humira, Europeans are getting it five years earlier. What we’re seeing is that companies are applying for far more patents here than they are in other countries or regions like Europe, like Japan, who have similar patent regimes and patent office standards. That was also the case for Enbrel, another best-selling drug.

So what we’re seeing is that companies know that they can apply for a lot more in terms of patent protection. So they’re going to try to maximize that because they have to, they’re ultimately accountable to their shareholders. And what we learned from that House Oversight investigation actually is that pressure is so significant that’s put on the companies to maximize revenue. That is a driving force in their decisions on how to try to extend that patent protection and that monopoly life. And so it has really, I think, opened up a Pandora’s box in terms of wait, what’s really going on here? What are they… How long of a life on their product are they trying to extract from the current system? And why isn’t Congress doing anything about it?

And I think part of it is, of course, the pharmaceutical lobbies are very, very strong, but I also think this is a system that remains very technical, very out of reach. Most Hill staffers, most members of Congress, feel like it’s a very complex system, let’s leave it to the IP lawyers. But then you’re leaving it to the world of people who have incentives to preserve the status quo. And that’s why the role of public interest groups now, and academics, is becoming more and more important so that we can keep shining a light on what’s really going on in the system in the hopes that the state is actually going to intervene.

Brink Lindsey: You had mentioned the big ramp-up in patent applications and patents granted in the pharmaceutical space, but that’s just a piece with what’s happened more globally in the US. So the number of patents the US Patent and Trademark Office grants every year is about five times what it was in the early 1980s. So either the United States just became more inventive manyfold over the past few decades – but that’s not born out in productivity growth statistics or any other forms of measuring of the pace of innovation. In most areas outside of information technology innovation seems to be flagging. Or the standards for granting patents, or the scope of products to which that are now eligible for patents, has expanded. So either the standards have relaxed or the scope has expanded. Both of those have happened, and that’s happening in pharmaceuticals.

One striking number that I’ve seen from I-MAK is the percentage of new patents that are about existing medicines, it’s something like 80% of new patents are related to preexisting medicines, not to new cures, new therapeutics.

Priti Krishtel: Yeah. That’s actually research from professor Robin Feldman over at Hastings. I cite it a lot, so that’s probably why he thought it was us, but it’s 78% of patents associated with drugs are actually for older drugs. And it’s a very stark number when you think about it. And I think it makes perfect sense. When you think about the early eighties, the introduction of the Hatch-Waxman Act and how so many commentators now are saying that the intent of the act, which was to bring in generic competition, has just been eroded over time because the branded pharmaceutical industry had to figure out, as you know, in the face of Hatch-Waxman, in the face of congressional commitment to trying to bring competition to the market, as rational market actors, they had to figure out how they were going to survive and thrive. And so what they did was they gamed the patent system.

Today we’ve seen a proliferation of patents on improvements, incremental improvements, secondary patenting is another term for it, like you noted. Everything from dosage forms to the crystalline forms I mentioned to combination tablets, we’ve seen an explosion in this kind of patenting. And so this is why I think now, 40 years in, the time is ripe for Congress to really take a look at these practices and say, “Have they served their intended purpose? And if not, what are we going to do about it?”

Brink Lindsey: Okay, let’s now switch gears and carry this general patenting discussion over to the impact on COVID vaccines and their availability around the world. So here we’ve got a brand new drug for a brand new disease, so clearly novel. Developed at quasi-miraculous speed relative to what we’ve ever achieved in the past, so a real fantastic scientific breakthrough in mRNA vaccine technology. Developed with that mRNA technology, developed over decades, with substantial government support from the US government and from foreign governments as well. At least one of these vaccines, the Moderna mRNA vaccine, developed with substantial US R&D support. The Pfizer vaccine, which Pfizer produced a vaccine invented by a smaller company, BioNTech, but it had substantial German government support. So anyway, a lot of public funding behind these things.

But then, we switched them over to the patent model where now these companies that produce these drugs have intellectual property over the formulas and production processes for these-life saving medicines, and they’ve got them for 20 years, and they are being produced by companies within an industry that has now developed a business model built on maximizing the revenue potential from patent protection. So all of that sounds like – so now you’ve got these profit-seeking companies armed with market exclusivity, and they’re headquartered mostly in the United States and Europe, these vaccine manufacturers. Then you have a world that needs vaccinating, and a global pandemic such that if we’re not vaccinated everywhere we’re not safe because new variants can arise and defeat immunity created by old vaccines.

But somewhat unsurprisingly, this model did not result in dramatic vaccination of the world. We had efforts to have a donation model where rich countries would donate vaccines. And there was an organization called COVAX, which is a spearhead for that effort. But just tell me a little bit about how that has panned out in practice.

Priti Krishtel: Yeah. So I think we’re at a really poignant moment in the pandemic where, by official count, right now, we’re at over 6 million deaths. So it’s been two years, we’re at 6 million deaths. Over half of the world has been fully vaccinated in the sense, when we say that, we mean with two vaccine, with two shots. Not with the booster which is, of course, most effective at this point.

What else about where we’re at? And I was reading yesterday that the WHO is going to come out and say that by their… Because we don’t have accurate surveillance everywhere. And we don’t actually know in a thorough way exactly whether that 6.2 million deaths number is actually right.

Brink Lindsey: In fact, it’s almost certainly wrong. It’s almost certainly an under-count.

Priti Krishtel: Yeah. They’re saying it’s probably closer to 15 million, if not more. And so it’s a really good moment, I think, in the pandemic to take stock of how things have happened. Like you said, I think years of public funding coupled with a really amazing effort from academic institutions and the private sector has resulted in these vaccines, and now treatments and diagnostics, to be able to help tackle the pandemic. Unfortunately, we see that some people are getting these medical products first, some aren’t getting them at all. The entire continent of Africa is still lagging behind, for example.

Brink Lindsey: I think the vaccination rate there, as of late April 2022, is about 15% for two shots.

Priti Krishtel: It’s extremely low. I think that there are whole parts of Latin America that are not getting affordable access to the treatments, as well. So there’s a lot to grapple with.

I will say that I think the Moderna example is a very good one to show what went well in the pandemic. In part, public funding coupled with a relationship with the private sector resulted in so many Americans being able to get vaccinated and now boosted. That was progress, certainly, but this is a global pandemic. We know that, as you say, none of us are safe until all of us are safe. There are still new variants emerging. And so, in the case of Moderna it was almost entirely publicly funded. And so $2.6 billion went into that vaccine’s development. If you look at last year’s numbers and this year’s, Moderna’s on track to make $40 billion in this two-year period, they’re also applying the technology to other diseases and are poised to, some analysts say, make about $100 billion is what we can expect to see for Moderna in the coming years.

And so I think we have to ask, is this the right system where we socialize the risk and then privatize the profit? When the government is just grappling with how they’re going to pay for so much for what American families are going through. Where we’re trying to be helpful in other parts of the world, like in Ukraine and in other places, when we’re trying to support other global public health needs or other global… World hunger, there’s so many things we’re trying to be helpful on, and we’re trying to take care of our people. Was this the right move? And, for me, it comes back to, I think there’s an over-reliance in global public health, or in governance of pandemics, on a business approach, or what I’ll call a business approach.

I think we got a bad deal on the Moderna vaccine. I think how we approach public funding in general is not right. I think that the government needs to have better contracts. I think we need to have a different contracting structure and licensing structure. When I think about investors, nobody would have agreed to this deal. So why do we as the government, or why do we as taxpayers allow the government to agree to a deal like this? So these are the questions when we’re thinking about reflecting, and what’s the way forward, to me this is one of the core pieces that needs to get solved for. And I think this administration can and should take this inquiry a few steps farther.

Brink Lindsey:

Yeah. So, as I said, there’s a generally strong theoretical case for pharmaceutical patents, but it seems to me that case all but collapses under the specific conditions of the market for vaccines. So, again, it’s a decentralized incentivization approach. So if we don’t know what the next great invention is going to be, let a hundred flowers bloom. If you come to the patent office with a good new idea, we’re going to make sure that you can recoup your cost by giving you this exclusivity, assuming it’s a commercial success. But at least you’re not going to get scooped by a copycat.

But in the case of a vaccine, we know exactly what we want an invention about. Right? We want a vaccine for this particular pathogen. So, and furthermore, in the Operation Warp Speed model, and in similar models pursued in Europe, there were big advance purchase commitments made by the government. The government said, “If you produce a vaccine that works, we’re going to buy 100 million doses, 200 million doses, whatever, at X price.” So, in the patent case, the normal patent case, there’s no clear public policy goal of inventing invention X. It’s just, you do what you want, but then once you do what you want, it’s not only got to work, but it’s got to be commercially successful. You’ve got to pass the market test. So, you’re going to have technological risk, and you’re going to have market risk.

But if it is marketable, then you’re going to get backstopped by market exclusivity. But here the market risk is gone, right? So, if you produce something that works, we’re going to pay you whatever it is we agreed to pay you for however many doses. If you sign the contract, then you thought that was a good deal, right? You thought, okay, I’m going to recoup my costs and make money with that contract. So, in that case, what is the market exclusivity on top of that accomplishing, other than just bestowing additional windfall rewards on a company? The purpose of patents is to make sure that inventions see the light of day, because innovators can recoup their investment costs. Here, that’s guaranteed. So, to me, it’s like a category error to even have to have patents in this kind of context, where you’ve got the advanced purchase commitments, and there is no market risk at all.

Yeah, and it’s actually also, there’s a huge public health threat here. Right now, the moving conversation is that other countries should be happy that supply is going up, and they’re going to get our vaccine. But what people aren’t really talking about is that they’re getting yesterday’s vaccine. Those vaccines were effective when they first came out. When was that? December 2020. It’s not clear that these are the right vaccines for now. That’s why we’re waiting for Moderna and Pfizer to continue to develop their vaccines and give us the newest and best for the variants we have. So, from a public health perspective, we want the rapid diffusion and decentralization of this technology, and that’s not happening, and that’s a big mistake.

That’s what the administration’s focus should be right now, or subsequent administrations, is how do we, when we structure these arrangements — that’s fine if we need to make sure that Moderna makes some kind of profit. I mean, in these two years, they’re going to be making $40 billion. That seems like a lot when we took all the risk, but understandably different people are going to have a different view on that. What seems not okay, is why doesn’t the government still have the ownership stake to be able to take that technology, and make sure that countries and companies all over the world have access to it, so they can be developing appropriate, adaptive, effective technologies in real time for their own populations, which could really help not only curb this pandemic, but help prepare them for pandemics of the future.

Brink Lindsey: So, contrasting an alternative arrangement where the vaccine formula is public knowledge, then that will remove a barrier, perhaps not the most important barrier, but a barrier to companies all around the world saying, okay, there’s now a way to produce this new kind of vaccine that’s much more effective than traditional vaccines. So, and we’ve got the formula. So, there is another barrier though – actually there’s complex manufacturing processes to produce these drugs, and produce them at scale. But at least the initial barrier of having permission to do it is gone in the context where this stuff is treated as in the public domain.

We will talk a little bit about how much  of a barrier is that, given the possibility that countries can do compulsory licensing at the national level. How much did this waiver that is being sought at the World Trade Organization on, from TRIPS, the TRIPS Agreement, the Trade Related Intellectual Property Agreement, how much does that matter. But, backing up, at the contracting stage, when the US government was setting, was striking agreements with drug manufacturers under Operation Warp Speed, it had the potential, without changing US patent law one iota, it had the power at that time to solve the market exclusivity problem, and also solve the tech transfer problem.

So, it could have, we have different authorities. There’s so-called section 1498. There’s also march-in rights under Bayh-Dole, where the government can take patent rights, and license third-party manufacturers to produce things if they compensate, if they provide reasonable compensation to the patent holder. So, it’s kind of eminent domain for patents that the government has that power. So, it could have threatened to use that power or flexed that muscle, and struck a deal with companies. We’re going to pay you not only this amount per dose, but then on top of that, we’re going to pay you an extra chunk to … We’re going to take the patent rights on this. This is going to be in the public domain, but we’re going to pay you for that.

Then, on top of that, we’re going to pay you extra, so that you’re going to make a lot of money sharing this technology with other countries, with manufacturers in other countries. So, we could have had an Operation Warp Speed that was global in ambition, rather than just strictly national in ambition. Under existing US law, we could have made both the patent barriers and the tech transfer, trade secrets barriers go away with appropriate contracts.

Priti Krishtel: With appropriate contracts. So, it’s really bewildering why that didn’t happen. I think that’s just something that has to be looked at, and has to be incorporated into pandemic response going forward, and frankly, into all public funding of research going forward, particularly in cases like this, where it was like nearly 100% of the funding came from taxpayers. I don’t think that we as taxpayers should accept anything less from government.

Brink Lindsey: So, right now you’ve got this legal barrier of unclear oomph, since companies, at least some companies, have said, they’re not going to enforce their patents during the pandemic, but what during the pandemic means is not quite clear.

Priti Krishtel: Or even enforcing their patents.

Brink Lindsey: Right.

Priti Krishtel: Just the way we’re seeing it play out in practice is, it doesn’t give rise to a great feel of optimism. There have been efforts to obstruct. WHO has a tech transfer hub, where they’ve been trying to get mRNA production off the ground, especially on the African continent. It’s pretty clear the industry doesn’t really want that to happen. They haven’t supported it. They have not been involved in it, and there was a BMJ investigation that happened, that also showed that there were efforts to try to stop it. But I think what the tech transfer hub is showing us is, with the right partnerships between international bodies, national governments, the private sector, there is a lot of capability.

So, with the right tech transfer, we can get many more companies going to start to develop these vaccines, but also to apply technology to other diseases that are really affecting the continent. For example, HIV, TB, malaria. Then we’re seeing actually, even without the tech transfer … There are companies, I don’t know if you’ve been following Gennova in India. There was a whole narrative happening. I talked about it a lot actually during the pandemic, that other countries don’t have the capability….

Brink Lindsey: Right. So, that’s the line in defense of the status quo, is that patenting really isn’t a barrier. The barrier is knowhow.

Priti Krishtel: Yeah.

Brink Lindsey: Of course, that barrier could have been overcome with incentivizing, but put that aside. But, so, at any rate, the patent restrictions are no practical restrictions, because the rest of the world just doesn’t have the competence to produce these drugs.

Priti Krishtel: Yeah.

Brink Lindsey: So, we’re the only ones who do, and you’ve got to count on us, and we’ll donate a good share, and we’ll work with all deliberate speed with other countries, et cetera.

Priti Krishtel: Yeah.

Brink Lindsey: But, and that was a line that we heard during the worst days of the HIV-Aids crisis in Africa, as pharmaceutical companies dragged their feet on sharing that technology. Maybe tell us a little bit about that experience, because we’ve heard this before.

Priti Krishtel: Yeah. We’ve heard it before in the, and of course, treatments and vaccines are of course different, but the reasoning becomes the same. In the ’90s, when HIV treatments first emerged, the industry’s line was that they were very complicated new drugs to make. Nobody can make them cheaper. It was at a European Commission meeting that the Indian generics industry stood up and said, “We’ll make it for a tenth of the cost,” and then they proceeded to do exactly that. They were able to do that for a number of reasons related to patent laws in those countries, and flexibilities that were available. But that is how we put millions of people on treatment. Then later, we saw that same story play out with the Hep-B vaccine, where companies in India again were told, “You don’t have the capability.”

Not only were they able to do it, that is how we scaled again, globally putting millions of people, getting millions of people immunized. So, when the same line started to be trotted out for this vaccine, our organization has worked for over 15 years in many of these countries. We can speak firsthand to the capability in countries like Thailand or South Korea, India, even Brazil, Argentina. I mean, there’s so much capability in so many of these countries, in terms of domestic manufacturing. So, it’s hard to tell, is this just a deflection technique by the industry, or are they really unaware of the capability? I can tell you that there were dozens of manufacturers who wanted to be sub-licensees.

They didn’t even want to rock the boat on IP, and get into all of this waiver. They were just like, “Give us a sub-license. We can get going”, and the industry didn’t want that. They don’t want to share the tech, and I think there is where you really start to see very clearly, proprietizing this technology is what leads to the greatest profits, and that’s where the incentives are really in the wrong place for the tech.

Brink Lindsey: So, under existing law, and under existing international agreements, a pandemic arises, rich countries of drug producers have produced a vaccine. You’re a country with a biomedical industry of some standing, like Thailand or, or South Korea or India. Under existing WTO agreements, you have the right to do compulsory licensing. That is, you have the right to at least apply. You have a right to meet certain criteria, and then, and if you meet certain criteria to issue compulsory licenses. But that only applies then to producing drugs within your country, right? You can’t, if you’re India, you can issue a compulsory license to produce a patented drug under the, without violating the TRIPS Agreement, but only for Indian consumption. You can’t then set up an export capacity. So, and my understanding is that the criteria for, and processes for nailing down TRIPS- compliant, compulsory licensing are arduous and clumsy, and nobody does them much.

So, as a result, India and South Africa, back in November 2020, I think, went to the WTO and applied for a waiver from the TRIPS Agreement for all intellectual property pertaining to COVID vaccines and treatment, for the life of the pandemic. Then we have experienced what a lot of people who watch the WTO for a living experience, which is watching paint dry, watching glaciers move. Nothing much has happened over a long period of time.

Priti Krishtel: Yeah.

Brink Lindsey: Apparently, some compromise was or was reported back a month ago or so, but I don’t think it’s seen the light of day. Meanwhile, we’re in year three of the pandemic.

Priti Krishtel: Yeah. On the question of compulsory licensing or overriding patents, countries have tried over the last 30 years to do that, 20, 30 years. It’s nearly impossible. The only time I remember actually seeing a success story, and we tried working alongside community groups and country governments to see how countries really evaluate their options in that regard. The only time I remember seeing it be successful was during the HIV pandemic. It was 2007, and Thailand decided to issue a license because Abbott Laboratories, who today is AbbVie, the company who owns the best-selling drug in America. AbbVie Laboratories was not willing to, again, license two companies in other countries to bring down the cost to scale HIV treatment. The Thai government decided to override the patents, faced huge pushback from the United States Trade Representative, from country governments, from the pharmaceutical industry.

And I remember being in New York City at the Clinton Foundation’s press conference where former… I think at that time it was former President Clinton stood with the Thai Health Minister and said, I stand in solidarity with this move, which was really unprecedented before a US head of state, current or former, to say something like that. But it really spoke to how many lives were being lost to HIV at that point and the unnecessary suffering and death that was happening.

So compulsory licensing is not a viable option. We’re seeing that right now with the COVID treatment Paxlovid. I don’t know if I’m saying that, right?

Brink Lindsey: Yeah.

Priti Krishtel: I’ve only read it in print.

Brink Lindsey: Same here. I don’t know. The fact that we don’t know how to say it is one indicator that it really hasn’t broken into a widespread use.

Priti Krishtel: But the DR, the Dominican Republic, started conversations about issuing a compulsory license because they’ve been left out –there’s a global agreement with the medicines patent pool that Pfizer has to license the drug, bring down the cost for lower income countries, but the DR is not included. And what we’re seeing there is that, and I’m sure you heard about this, Brink, when the Dominican Republic started talking about issuing a compulsory license, Pfizer was pushing back really hard. In fact, they even went so far as to argue that their intellectual property is their human right and it’s being violated by the DR. So that has, as you can imagine, advocacy groups around the world up in arms. They’re comparing the human right to health or life to their intellectual property rights.

But again, it’s just a classic example, Europe has been trying to argue this a lot, which is that countries under the current World Trade Organization framework have the right to issue a compulsory license or to override the patent. It’s just not politically or pragmatically viable to go country by country, medical product by medical product and face this kind of clap-back trade sanctions, it doesn’t work. We’ve seen that it doesn’t work except in rare exceptions. And so I think that is why South Africa and India are supported by over 120 countries now, have asked for a blanket waiver so they can do what they need to do.

And last April for example, it’s a year ago now, when India was going through one of its worst surges the need became very apparent. We needed everything. We needed oxygen, ventilators, testing, treatment, vaccines, and we needed them to be rapidly produced. And we did not at the time as a global community have the ability to do that, which is why this delay has been just unacceptable on the waiver. And it’s now we’re talking about a really watered down form of it, which you mentioned.

Brink Lindsey: So, where we are now is, we basically had rich countries get access to vaccines before middle-income countries and middle-income countries get access before poor countries. We had apparent favoritism, that countries paying top dollar got ahead of the queue of countries that didn’t. And so that has something to do with why rich countries got ahead of middle-income countries and poor countries. So you’ve got the people who can pay for themselves, paying in a kind of queue given how much they’re willing to pay. And then for everybody else, it’s just relying on donations and the United States thus far has donated about a billion doses, and it is promised to donate, I think, 2 billion plus before a year from now, I think. The US donations amount to about 40% of global donations, so say that the been about 2.5 billion doses donated. Given the number of arms and two shots per arm, that’s about a quarter of the way there. They needed 10 billion rather than a 2.5. So as a result here we are in year three and African in particular is 15% vaccinated, the world is 60% vaccinated.

Now things have gone so long that at least in Africa right now vaccine supply isn’t the main holdup. They’ve received 700 million vaccines, they’ve only delivered 400 million of them, that because they’ve waited so long and because so much of their population apparently has been exposed to COVID anyway, given that they’re a much younger population, it’s been much less ravaging there and they have fewer of those comorbidities that ramp up fatalities. Anyway, I saw a WHO study that now that even before Omicron hit, as much as 65% of Africans had already been infected. So, when vaccines eventually get there, they’re coming so late in the day that now other health priorities in poor countries are more pressing than getting COVID vaccines. So we may never have high vaccination rates for poor countries around the world, given how long it took to make them available and still have not made them available.

Priti Krishtel: Well, and this is where I go back to, we’re asking countries to take yesterday’s vaccine and we know that these vaccines don’t prevent against transmission of the new variants as much, we know that they’re less effective. And so what’s going to happen when the next variant hits in this pandemic or when the next pandemic hits, how are we going to make sure that the African continent and many other countries around the world are getting the best and newest technology to save as many lives as possible at the outset?

I think what we’ve learned to your earlier point is that the donation-based model doesn’t work. It just does not work. The voluntary models do not work. COVAX does not work, it was predicated on the idea….

Brink Lindsey: So COVAX has delivered about a billion doses and it had hoped to have delivered like 2 billion by now, so it’s been disappointing in the extent to which it’s been able to mobilize donations. Way behind where we need to be.

Priti Krishtel: And it’s just predicated on a model where an underlying assumption seems to be that there’s no national self-interest in the world. What leader of a country is going to turn to their constituents and say, I have a choice between vaccinating you and vaccinating other people, and I’m choosing to give away some of your shots. It’s not realistic. It wasn’t baked into the design.

And same with the donations, I think about a lot, like the US’s standing in the world, because I’ve lived and worked all over the world. I think a lot about what other countries think of us in terms of public health, but also just relationships, power, all of these things. I think in terms of donations, pledged China has met 75% of its pledges, the US hovers a little bit over 15%. And so what message are we also sending to other countries and how is that going to impact us in the long run? It’s something I think our elected leaders need to be thinking about very seriously and preparing for as we start to think about, okay, what’s our pandemic response going to be next time as we start to put in place pandemic response units into government and think about how to staff them. Thinking about how are we going to design out of the donation based model and come up with something more sustainable, it has to be a key priority going forward.

Brink Lindsey: Yeah. So you say the current model of private companies maximizing private returns plus donations isn’t up to the challenge-

Priti Krishtel: Does not work.

Brink Lindsey: So thinking about next time, given that what we’re worried about here is a global phenomenon and therefore if we’re not safe everywhere, we’re not safe anywhere. And given the inevitability of vaccine nationalism, that is, if there’s a company in your country that’s producing vaccines and your government is involved in that, of course, you’re going to want to make sure your citizens get those vaccines first. So, you’re always going to prioritize your citizens first. So given that, just seems that the obvious compelling crying need is for broad-based global vaccine manufacturing capacity. And given the wonderful development of this mRNA technology that is not only highly effective for this particular pathogen that we’ve had to deal with, but looks very promising for a whole range of different of illnesses and communicable diseases. That what we want to do is have worldwide capacity, at least every region’s got some big players that are in the game.

The WHO right now is set up this technology hub in Africa working with some South African companies and then creating spokes to agreements with producers in countries in Africa and other countries in less developed countries. They’ve got a vaccine, they’re producing sort of lab level of batches. They’re looking, I think, to get to clinical trials by the end of this year and then full approval by 2024. So it’s still way on out there, but there is at least some movement right now. There are organizations trying to spread capacity for this kind of vaccine technology globally. So, what’s your take on how they’re doing and how that effort might be fortified?

Priti Krishtel: I think it’s very promising. Unfortunately, we did not see cooperation from the biggest pharmaceutical players early on in this pandemic, or really at all, to support an effort like the hub. It’s really a lost opportunity. This is how we start to decentralize regional manufacturing capacity, bolster local production, and diffuse technologies rapidly. So people are getting the best available technology worldwide during a pandemic.

But the WHO Tech Transfer Hub is doing well regardless. I mean, most of the leading experts in the world are saying that it’s doing really well, and that what they’re going to be able to develop is going to be applicable to other diseases, like I was saying, that are facing the continent, HIV, TB, malaria. And I think that effort coupled with a lot of the players who are working to develop their own mRNA vaccines like Gennova in India, I think we’re in a good place. I mean, people are showing it can be done, it’s just taking a lot longer, unfortunately, and a lot of lives are being lost along the way. And I was just reading this morning that Doctors Without Borders issued a press statement saying that there are nearly 100 manufacturers ready to go, ready to get in the game, but it would be predicated on Moderna sharing its technology. So Doctors Without Borders is calling on Moderna to do that, which of course, they’ve said multiple times they’re not going to do-

Brink Lindsey: But there are other outfits now that are developing their own vaccines and some of them are developing them with the intent of making the invention public. This is such a grim topic and so much bad news associated with it that I’m going to seize upon the fact that you mentioned that the WHO hub is promising and the idea that there really is the capacity out there, if it’s given a chance to ramp up and make us better prepared for next time that I’m going to wrap things up here on a semi hopeful note, a little ray of hope shining through the clouds. So Priti Krishtel, thank you so much for spending this hour with me and talking through all of these complex technicalities that have such a huge life and death bottom line.

Priti Krishtel: Thank you Brink.

Brink Lindsey: Thank you.

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