This episode features audio from Pharma Monopoly: The Battle for the Future of Medicines. It was recorded on October 19, 2026.
Tahir Amin discusses his new book on how to change the pharmaceutical industry for the better.
Tahir Amin and Rohit Malpani, two leading figures in the access to medicines movement, examine the origins of this system of rules that champions monopolies and innovation over the public interest and human well-being. They tell the story of how, move by move, governments have ceded control to and then empowered pharmaceutical companies, making it increasingly hard to undo the damage wreaked along the way. From their unique vantage points and experiences, the authors critique global health initiatives and philanthropists for maintaining the status quo and warn of a future dominated by financial markets and artificial intelligence that will reinforce the worst practices of yesterday and portends new injustices for everyone.
Announcer 0:00
Welcome to Engelberg Center Live, a collection of audio from events held by the Engelberg Center on Innovation, Law, and Policy at NYU Law. This episode features audio from Pharma Monopoly: The Battle for the Future of Medicines. It was recorded on october 19, 2026.
Christopher Morten 0:20
Hi, everyone! Thank you so much for being here. We have an action-packed program, so I'm going to get us started. I'm Chris Morton. I am tonight's moderator. I'm an associate professor here at NYU Law. I'm an affiliate of NYU's Engelberg Center on Innovation Law and Policy, which is the organizer and host of tonight's event. I'm also the director of NYU's Science, Health, and Information Clinic, which I co-teach with Patrick Lin. I want to first thank the Engelberg Center. If you don't already know about NYU's Engelberg Center, it provides an interdisciplinary environment where scholars examine the key drivers of innovation, as well as the law and policy that support it. Huge thanks to Engelberg Center Executive Director Michael Weinberg and Nicole and others at Engelberg for their behind-the-scenes work to provide us with this space and pull off tonight's event. Tonight's event is a conversation around the fascinating and important new book by Tahiramin and Rohit Malpani called *Pharma Monopoly: The Battle for the Future of Medicines*. And I forgot to carry my book up, so oh, it is on sale at the table right outside, courtesy of the NYU Bookstore, we're going to be talking about the book. But I will say in very brief, it's an analysis of the law and policy that govern and structure the pharmaceutical industry in the United States and around the world, and the law and policy that contribute to what many of us feel are crises today of affordability and access. The book is also a history of sorts, a kind of political economic history of the industry, of civil society, and of our wider society. We are joined tonight by Tahir Amin, one of the book's authors. He's asked me to keep my introduction very brief, so I will simply say, he's co-founder and CEO of the Initiative for Medicines Access and Knowledge, better known as IMAC. I M A K. IMAC is a nonprofit organization working to address the systemic inequities in how medicines are developed and distributed. He has over 30 years of experience in intellectual property law, during which he's practiced with two of the leading IP law firms in the UK. He served as IP counsel for multinational corporations. We will see where our conversation takes us tonight, but I may ask Tahir to reflect later on his journey from being a lawyer for pharmaceutical companies to being now one of the leading critics of the pharmaceutical industry and an advocate for reform, we are also very lucky to be joined by Dr. Reshma Ramachandran, assistant professor at the Yale School of Medicine and co-director of the Yale Collaboration for Research. I always screw this up. The Yale Collaboration for Regulatory rigor, integrity, and transparency. She's also a practicing family physician. Rachel is one of the leading lights, I would say, and I think many would say, of the access to medicines movement, the medical data transparency movement, and the health justice movement here in the United States, we are very lucky to have her in conversation with Tahir. In just a minute, I'm going to invite Reshma to take the mic and offer some introductory remarks, which I think will shed some more light on Tahir's work and his book, *The Past, Present, and Future of the Access to Medicines Movement*. Before I yield, a quick note on timing and logistics. The three of us plan to talk until about 7:15. I have a handful of questions I want to ask Reshma and Tahir. At around 7:15, I'll knock it off, and we will open the floor to Q&A with all of you. So please be collecting questions as you listen. And then I think we have this room till 8 p.m. I don't know, Anis or Michael's nodding. Great. So Tahir should have some time to sign copies of the book. There's more food, I think. So please feel free to linger and chat if you can. Important disclaimer: I forgot to say, views expressed here tonight do not necessarily represent those of NYU, NYU Law, or the Engelberg Center. Okay. With that, Reishma, the floor is yours. And you want to speak there?
Reshma Ramachandran, 4:47
Thank you, everyone, for coming, and especially thank you to Chris for such a generous introduction. I'm really thrilled to be here today. I was actually questioning why I'm here today, to be honest. You know, despite all. The nice things that Chris said. I met Tahir actually as a medical student, so quite a bit a while ago, when he was already a leader in the access to medicines field, and obviously has continued to be still today. But the context is actually pretty funny. We had this training for medical students through the American Medical Student Association around global health, and we had some sessions related to access to medicines. Now, the session was like timed the day after there was a much lauded agreement that was announced by the Medicines Patent Pool, which, if you've read the book, you might have seen referenced in there. But essentially, the Medicines Patent Pool is an organization that was initially founded to be able to help negotiate these voluntary agreements between the pharmaceutical companies that were selling brand name HIV/AIDS medications, also TB medications, and some others, mostly in the infectious disease space. Since expanded since from from then to actually increase access in low and low countries, in particular. There was a lot of adulation around this agreement. It was a second-line HIV/AIDS medication that was from Johnson and Johnson, and Tahir came to give a presentation and had a criticism of the agreement. One in terms of the scope of countries that were a part of the agreement that left out some key countries that had high prevalence of drug-resistant HIV/AIDS, in particular, that were left out, you know, purposely so in many ways because of their market power, and also kind of a criticism about this idea of these sort of voluntary mechanisms that we were congratulating as being moving forward on on access to medicines, it led to a very loud and hot debate. And this this is a bunch of medical students had no idea what access to medicines like policy was, what terms such as intellectual property or patents were. So they were getting a real crash course, and also kind of a debate about this mechanism that they were just learning about, and it was really amazing to watch to kind of see this sort of spectrum of where we kind of land on how we advance access to medicines policy. And one thing that I learned, you know, in watching this exchange is around this idea around integrity and kind of sticking to your values around what is the goal you're trying to achieve access for who, kind of the extent of it. What are we advocating for? And it was, you know, we had a long conversation actually afterwards around this in terms of understanding kind of the dynamic of the different groups and different stakeholders in the room and what it means to talk, what it means to actually be a part of a voluntary mechanism. This idea of also self-regulation when we talk about you know big ambitious ideas in terms of reimagining access to medicines, what are what should we be striving for? And all of those themes obviously still resonate today, even outside of access to medicines. When we talk about things like artificial intelligence, folks might have seen a lot of commentary around this idea of like, can we rely on companies to self-regulate. This has been a long conversation in pharmaceutical policy, in anywhere, in any sort of policy that deals with like corporations just generally. So we'll have hopefully some chatter about that today in terms of the pros and cons related to that, and whether or not it advances the field forward. It was also kind of think emblematic in terms of thinking about the role of civil society in terms of what we should be advocating for. Should we be advocating for compromises that are much more reasonable or practical or feasible in the short term, or should we be thinking about long-term sort of dynamic change, reimagining the system altogether? And so, for me, as someone who was kind of entering this space and understanding kind of the dynamics of pharmaceutical policy, it was it was a nice introduction in terms of where we should be and how we should be thinking about strategy.
Reshma Ramachandran, 8:45
I will say also, Tahir was also one of the instrumental folks that also brought the the lens of the global South. What's happening in low and income countries in terms of drug pricing really here to the U.S. and really to the global North. We obviously see kind of day in day out on the news a lot of talk about lowering drug prices and different mechanisms to address that. And those conversations were happening for decades in other countries. These terms like patents, in particular, things related to intellectual property, have been longstanding sort of dynamics that have been talked about in access to medicines on a global on a global scale, and Tahir was one of the the folks that really catalyzed the conversation here in the United States. So then now that people understand that patents can be a barrier in many ways to access medicines and contribute to high drug prices as well. So very grateful for his work in this field, and really lucky to be on the stage with him and Chris to talk about these issues today.
Speaker 1 9:43
Excuse me.
Christopher Morten 9:45
Hello. Wait. Is it on? I'm taking. I'm sorry. I'm so excited by Reshma's remarks that I'm taking a bunch of notes, and I forgot that I'm moderating. Thank you so much, Reshma. So. I'm going to ask you a few questions. And Tahir, I thought I'd start with you. Thank you again for joining us. Thank you. For those who have not read the book, can you give us a nutshell summary? What have you and Rohit written about? And can you clue us in also what motivated a book? Like why write this particular book now?
Tahir Amin 10:23
Yeah, first of all, I want to thank Reshma for casting my mind back. I don't know how long it was, almost like 15 years, where we were at Hopkins, and yeah, it was a fiery debate. And in a way, it connects with why Rohit and I wrote the book because, as many of you who may have followed the events of COVID, we were very much almost, and I think it was about 17, 18 years at that point when COVID started. We had been in this access to medicines movement that Reshma describes, and the solutions that were being put on the table of the biggest global health crisis that we've experienced in over 100 years were mostly voluntary, and it was that that really. And there was a lot of chatter amongst the sort of various chat groups that are on WhatsApps and what have you, and and being close to people in the global south because I spent two years in India, which is how I really cut my teeth once I let the left the corporate world. And also, my sort of ancestral heritage is my parents from India, Pakistan, and so I've always had this connection to the global south, and particularly when I think about justice and what played out during COVID, and I think this is the same for Rohit. I won't speak fully for Rohit, but I think we shared this value that we both felt that this was another moment where, you know, historically the injustices will be basically sort of a revisionist take will be made of it that actually everything was done perfectly, everything was great, and by some accounts, I think we were looking at 15 million lives were lost, mostly in low- and middle-income countries, because of intellectual property policies and various other policies that the wealthy nations that had imposed these knowledge systems, these knowledge governance systems, on the rest of the world, which we'll get into, I'm sure, a bit later in this conversation. So, watching all this play out and knowing that it was going to be a catastrophe, which it was, we just had these weekly Zoom calls, and we started to really wanting to unpack how we got here, and we went back to our origins of entering the access to medicines movement, which was around 2004, post the during the HIV pandemic, when South Africa had just been sued by 40 pharmaceutical companies, Nelson Mandela's government, just shortly after apartheid, the United States exerting all this trade pressure on South Africa. This is Bill Clinton, by the way. This is not the Republicans. So you know, and this book actually probably criticizes the Democrats more than anything. We know what the Republicans are, and we have to look at the Liberals. The Liberals are the gatekeepers, in my mind, of all the policies that we might want to see, but they prevent from happening. I'm not saying it's entirely at their feet, but that the book really does focus there, and we'll get into some of the history of that. And so, really, it was just through these conversations we sort of said, "What have we done in the last 20 years as global public health that we cannot actually have the solutions to to basically resolve for this biggest global health crisis, and so really that's where all this book started from. And we didn't want to write another access to medicines book. Not that they're not important, and there's some great ones out there, but we wanted to really understand what is the political ideology that drives the system that we are in. And so then we really landed on this this term, which often gets thrown around, is neoliberalism. Now, neoliberalism is can be used for a lot of things. It can mean a lot of things. I don't want to oversell it. Not everything is about neoliberalism, as many people will articulate. But and I think there's a there's a great book by an Italian economist, who's you know we call it neoliberalism, but neoliberalism is just a more dangerous form of capitalism. And so you know neoliberalism that's the term that we have been sort of stuck with for the last 50 years. But really, it is capitalism. It's just another form of racial capitalism.
Tahir Amin 14:42
It's just more finessed, more honed, and so we really wanted to unpack some of these things that have really driven the access to medicines movement. And so, the example that Reishma talks about, you know, the voluntary licensing mechanisms. I mean, we've talked about this in a way that just sort of, oh, it's access, it's medicines. But what is underlying it is the depoliticisation of people's rights through this Geneva bureaucratic office that was set up by civil society in many ways, but by civil society in the north at the expense of people in the south, who said we don't want this, and that was the battle that was took, and I remember that day that I said that you're shitting on the people in the global south, and the people in the global north said, "No, we're doing the right thing," and we were the ones with the hubris. And to this day, now, and these conversations are not public, and that's why we wanted to write about it. Is the origins of those things that were created by people in the global north who are telling people in the global south what is best for you, which is what the governments do. It's what the pharmaceutical companies do, and here our allies, who knew best, were telling people in the global south what was best for them when they were fighting a different battle. So this book is about that in many ways. That civil society needs to understand its role, and it needs to reach higher, as opposed to these voluntary measures, and basically really understand the legal systems that are created. Because, and we'll get into a little bit more. We know we teach law. I came through the law schools or whatever. It's a bit different in the UK. I don't know what it's like here in NYU. I've heard it's a lot better because you guys do a lot more deeper work on these things. But the thing is, the frameworks that we operate within. Who set those frameworks? Do we question them? I mean, the World Trade Organization. Like when I arrived in India, everyone was talking about trips flexibilities. And when I started during COVID researching of like what happened to get to this position, it is rarely talked about in law schools, in the corridors of Geneva. It's almost like trips just fell from the sky, and that was where the world started. And what we do in chapter two in the book is really talk about the history that the Global South countries, out of the broken empires of post World War II, the battles they fought to create a more equitable economy, a more just and equitable economy. But in a way, when the World Trade Organization landed, it was a recolonization of these places. That they were told that you must have these knowledge governance systems, and yet, you know, neoliberalism wanted to shape that because what it wanted to do, it wanted to take the sovereignty out of the question. It wanted to denationalize these debates because they were afraid that these countries would actually start doing things for themselves. And you know, the 70s battles with the new international economic order, which I knew nothing about when I arrived in India. Nobody told me about these things. Maybe that's my shortcoming. But I think when we teach our students, when we teach our new advocates in the access to medicine movement. That is where we should start. We should not start with, oh, what's flexible? This is the framework we're operating. That is a colonial mindset, and that's why I personally wanted to write this book was to basically, you know, put the question forward that actually, what are we working towards here, and is it really about justice, or are we just asking for access? Which is not really, as we say in the book, it's not really about freedoms.
Christopher Morten 18:29
Thank you so much, Tahir, for the book and then for that summary of how it came to be. There are a lot of threads in that short summary that I hope we can pull on in this discussion. One of them, I jotted down the quote: "Civil society needs to reach higher." I have to say, one of the things the book made me do is reflect on my own work as a as a pro bono lawyer, someone who tries at least to be a part of the access to medicines movement, especially here in the U.S. But think about the kinds of actions, the kinds of reforms, the kinds of change that I've worked toward with some of my clients and my students in the in the clinic here, and reflect on whether those projects, whether those demands were actually working towards real transformation or were just sort of reinforcing the the status quo that we live under. So maybe we can come back to that. Another thing I think you another connection you drew in your response to that question was the links between the global south and the global north. And you mentioned that COVID was not a success story. I think there's a way, and Reshma, I know you've written about this too, that that while we were able to invent vaccines and vaccinate large numbers of people, many millions of people died because they lacked access to vaccines. And in some sense, the story of COVID is of an incredible crisis, but also opportunity that we missed. We had a window of our. Opportunity to transform a system, and the system endured, and in some senses, stronger than it was ever before. Rishab, I know you've written about that, and I want to invite you in on this next question and tie here both, kind of about this. These these links between the global north and global south. We have now this globalized system, economic, political, and even legal, thanks to the the TRIPS Agreement and other international law, and in the book talk here, I think you you make the links very explicit. You write, I quote: "With the global North increasingly suffering a crisis in accessing affordable medicines due to the monopolistic practices of the pharmaceutical industry, we may now find that distinctions with the global South may be diminishing. Some of the worst consequences of inequitable healthcare are happening in the richest countries. Can I ask you both to elaborate on this, Reishma? Maybe I'll ask you to start. Do you think that's true? That the status quo is bad not just for people in poor countries, but also people here. And oh, and may I ask you also: Is there an opportunity to connect the organizing, the advocacy, the work that you and others do in the U.S. with advocacy globally?
Reshma Ramachandran, 21:10
Yeah, I mean, you know, obviously you write about this very starkly in the book. It was is interesting. Like, so this morning I got a message. I'm a primary care physician, so I take care. I have a small panel of like older adults, but also a lot of folks who are in New Haven who are underinsured or uninsured. And it's like one of the more rewarding aspects of my job. I think curious for folks who work in policy. Policy is very slow moving. You like hope for the most ambitious thing, but there's a lot of compromises that happen along the way. So for me, like practicing medicine and being able to like see people is a lot of immediate gratification, very selfishly, because I feel like I can do something at least right then, right there. But I get starkly reminded that there's obviously systemic issues that we work on a lot that I can't address in my clinic, and I see that like day in and day out, and increasingly so over this past year, and probably will be getting worse in the next few months as well. But I got a message that one of my patients, who's in her 50s, who's a bus driver in New Haven, died, and I was like pretty shook by it. In part because so many of the factors were preventable for why she passed, she has like small kids. You know, she was in the ICU for many days, and one of the big factors I remember about over a year ago is that we were trying to get her access to GLP-1s, the novel weight loss medications that are here in the U.S. and Medicaid in Connecticut had dropped coverage of this of these medications for weight loss unless you had certain other conditions, and she didn't fit into that criteria neatly. So we were trying to be able to get her to qualify in different ways, and like I knew like this would be like transformative for her in so many ways. Like she did not have access to healthy exercise because she was working as a bus driver day and night, and she also lived in a neighborhood where there's not even sidewalks. Like there were just like practical things that just could not lead lead us to like figure out other solutions outside of this. We had tried everything else, and we were getting to this point of trying to get this access to this medication for her, and so that for me was just like reinforcing in many ways that there there are these things that are just out of our hands, and this idea that in the U.S. we just don't negotiate drug prices, but we have like ceded this idea of intellectual property of innovation, and the definitions of it to companies, despite you know contributions from the NIH, from the VA, despite people in this room doing work on what it actually costs to produce these medications being pennies in comparison to what it costs for patients, so the I think that for me, is like a very stark reminder that what we're seeing in the global north is not that different from what we see in the global south. And COVID-19 was obviously very emblematic of that as well. These agreements that the U.S. government struck with pharmaceutical companies behind closed doors to give billions of dollars to develop these vaccines, which was pretty remarkable, but with no strings attached, right? And also allowing these companies to conduct clinical trials for these vaccines and also treatments in other countries, and not guarantee access in those countries. In many instances, we did some research work to actually look at this and finding that despite the many countries that were providing access to clinical trial infrastructure to patients to be able to test these vaccines and other COVID-19 treatments, they were not getting these sorts of agreements like in the United States in terms of having guaranteed numbers of doses for their patients. But here in the U.S., we were also seeing the precipice happening. That sure, they were able to negotiate prices for these vaccines during the time of COVID-19 that were somewhat affordable for the U.S. government. But as soon as the public health emergency ended, the prices went out of control, and the U.S.
Reshma Ramachandran, 25:18
government could not necessarily afford to purchase these vaccines for uninsured or underinsured populations to the same extent, and we're seeing this in real time right now, where people are foregoing some of these treatments or vaccines because of the prices as well. So, in many ways, I do think what we're seeing in the global north is very reminiscent, and in some ways worse, because in other countries, they actually have like national health programs, right? They actually do central centralized purchasing. In the U.S., we don't do that. Instead, we're like dropping millions of people from Medicaid at the end of the year, and we're seeing people already losing their insurance because of the ACA subsidies expiring, and our government saying that that's okay. So I do think, in many ways, like this, this idea of like healthcare now being a human right, it's just been so entrenched in our government and in other countries. It is something that they are fighting for, and I think it was emblematic, especially in COVID-19, that those countries were so loud about a lack of access. Like civil society in those countries, they they believed that healthcare was a human right. Their governments believed that healthcare was a human right, and they were willing to take to the streets about this. They were willing to advocate about this. They were willing to activate millions of people, including here in the United States and other countries, to actually speak on their behalf as well, or to at least work alongside with them. We're not that that lesson in many ways is lost when it comes outside of COVID-19. That here it's seen as to be like a personal responsibility in terms of accessing good healthcare, accessing medicines, thinking about even affordability as well. So yeah, 100% think it's very much aligned or in parallel with what's happening in the global south.
Tahir Amin 26:56
Thanks, Reshma. Tagger, do you want to? Yeah, I mean Reshma is on the front line, so I can't really add much to that. Other than every year, I think the Kaiser Family Foundation does a survey to really show the state of how prescription drug access is is shaping up in the United States, and it's usually sort of like one in four Americans can't afford to pay for their prescription, I think that's some like nearly 40 million people. Like they're cutting pills or they're skipping doses. We've heard the stories of how people have died because they were rationing their insulin or they were crossing the borders, and and now what you see is is I mean I spend a lot of time, sadly, or I guess this is what you have to do, you know, on the Hill in Congress, speaking to staffers and potentially trying to get people to understand what are the the issues really at heart here. Now, obviously, I come at it from a vantage point of the power that the pharmaceutical industry has through the intellectual property systems, the patents, the rights that they have to extend their monopolies and deter competition, and really, I think until we can start addressing the root and the power that these the pharmaceutical industry has, or whichever industry comes along, we are going to be in this situation. And in some ways, actually, I think the policies of neoliberalism that were pushed out through globalization in a way blow back onto the United States, and so there's been a blowback in several ways, not just in terms of you know we can get into the debates about China and everything else, but the thing is is actually the issues now that Americans are facing is largely because of the policies that were created to strengthen the corporate power, the corporate managerial class, in order to keep their fiefdoms both at home and abroad. And those policies have just snowballed, and I blame both parties for this. Many people like to say, "Well, it was Reagan and Thatcherism." No, it was Jimmy Carter first who opened the door to these kinds of policies. And basically, you know, when we talk about innovation policies and changing patent laws, all this stuff started with Jimmy Carter, and then it basically went through. Reagan was, you know, on on steroids, as was Thatcher, and then Clinton and Blair found this third way approach, which was a new face of neoliberalism, which is a lot of these voluntary solutions that we talk about. It was like basics trying to dress something up, but keeping the status quo. And all this stuff has basically allowed companies to amass power over power over power. And so basically, now when you try to change anything, it's impossible because all that money they make they recycle in lobbying, so that all that money is not just basically there to R and D, as they say. No, the R and D they're doing is on Congress. So basically, we have to understand these systems in very different ways. I mean, it's a it's a revolving door. Our institutions like the Patent Office, the FDA, are basically captured. It's a revolving door. Like, for example, if you look at the U.S. Patent Office, the acting director is now with a lobby group called C4IP, which is now basically trying to make sure that nothing changes in terms of the patent laws. And so it's just this sort of circuitous process. It's like a cycle, and they have the money and the power, and basically, it's it's it's because of the way they are able to extend their monopolies and generate these billions in revenue. They can then buy the laws that they want. They create the laws that they want. And those of us who are trying to push against these behemoth behemoth companies, it's it's a it's a it's an impossible task, but the thing is, at the end of the day, I think we're at a point now. We're at a precipice, a tipping point, where the American public is desperate when it comes to being able to access their medicines. And you know, everyone used to say, "Oh, well, it's a global south problem." It's happening in Europe too.
Tahir Amin 30:58
You look at Vertex's drug Trikafta, where many people weren't able, and people are back to campaigning or threatening to import generic versions from Argentina because there was no patent there. It's taking, it's going to that level, and the fact that people are crowdsourcing or crowdfunding to pay for their cancer treatment, and we talk about that in the book, and yet we have this situation now with President Trump, which I don't think will change actually too much under the Democrats, at least the more centrist Democrats. Is now we're talking about most favored nation pricing, where they're now trying to create this illusion where they'll say we'll match it with the prices in in Europe, which sounds like a good thing on paper, but behind it there's a trade pressure as well that they want the UK, the Europeans to pay more, and who's going to benefit the most out of that? The pharmaceutical companies, because you don't think you think the prices are going to drop that that much down here. You might see a few, but ultimately what's going to happen is the whole world is going to be paying the prices that they want, and so when you hear these like deals, these MFNs and what have you, I think you have to look at it with a critical lens because all it is about is like the way the World Trade Organization and intellectual property rules were designed to give power to the pharmaceutical industry so that they could actually protect their monopolies and charge with and control the marketplace. These most favored nation treatments is a version of that. It's got trade pressure. You've got the U.S. Trade Representative basically banging on the door, telling the U.K. just said agreed to pay I think 25% more for new new medicines between 2026 and 2036, and that, by some health economist accounts, could cost the UK $64 billion more, which is money they don't have and could be taken out from other aspects of their national health service. And I think, by some estimates, that could end up in about over 300,000 lives being lost. And that's what's happening here in the United States too, but we are told that America has got it right and the rest of the world has got it wrong. We would not get quote unquote innovation unless we follow these policies, and that is the stick they beat us with. That is the stick that the pharmaceutical industry will roll out every time you sit in these hearings. The first, you know, I mean, I literally do this in every hearing and even meeting I go to. Is to hear how many times somebody says innovation. Just, just listen. Just listen. Just, just sit there and listen to the number of times the word innovation pops up, and it just changes people's frame circuits. Because the more you hear it, the more you then culturally just accept it, and that's what we've become. That's what neoliberalism has done. We've just accepted these these framings, and that this is a way that the knowledge systems and pharmaceuticals can only can only work. And so, I think that is why we are in this mess here, but also the rest of the world.
Christopher Morten 33:59
Tari, I want to come right back in a second to this concept of innovation, and Reishma said a minute ago something like we've ceded the definition of innovation and of intellectual property to these powerful corporations rather than contesting what those terms mean or should mean. So preview. I'm going to ask you about that in just a second. But I want to observe just quickly to this point that as Americans, as patients here have struggled with the cost of medicines, with the cost of healthcare more broadly, I've observed at least it feels to me like patient groups working in the U.S. are increasingly global in their outlook. And disclosure and plug at the same time, we have representatives in the crowd tonight from Prep for All, an HIV/AIDS advocacy org based here in New York, T1 International, a diabetes patient organization. Both of those orgs work in the U.S. but also internationally, understanding that the the political, the economic, the legal systems that they're trying to transform are indeed global. So that to me has been something exciting. This the kind of feeling of like global solidarity and global coordination among patients and other advocates for change. Okay, so back to intellectual property and innovation. The book describes this term, intellectual property, as a concept bigger and more powerful than simply the collection of rights in information like patents, copyrights, trade secrets, and given that we're in a law school where many of us have taught or taken an intellectual property survey course, Tyr, can I invite you to say more about what that term means like, is it just a catch-all container for these various doctrines, or does the phrase intellectual property mean something more? Does it have power more than that?
Tahir Amin 35:51
Oh, I've been debating how to answer this question. So we did actually pre-arrange these questions.
Christopher Morten 35:58
Sorry,
Tahir Amin 36:00
not to not to let the cat out of the bag, but I want to first start with we again, you know, intellectual property is a term that we think is being around forever, and actually the first sort of first official I didn't know this at the time until I was writing the book. The first official institution that had the words intellectual property, and it was the World Intellectual Property Organization, and that wasn't created until 1967. And if any of you ever use n-gram, which is the Google sort of tool which tracks usage of words, you will find that the word intellectual property barely has a blip from 1800 until all of a sudden 1976, and it shoots up. And that is the time when, as we talk about in chapter two, that is the time when Pfizer CEOs at IBM were basically ratcheting up the the noise around intellectual property because the economy was shifting. We were going to a knowledge economy. We'd gone from the industrial manufacturing now a knowledge economy, and in the 70s there was stagflation. There was a global economic crisis, and it was actually President Carter who commissioned this report in 1978, which again you don't often hear about, and it was called the innovation policy, and it was basically there's a whole section on all the things that they felt the corporations were asking that the the administration to do to actually kind of weaken the patent law so that they could actually then convert what you may call the public invention, i.e., research into innovations, and then you get the Bay Dole Act. So this is public knowledge that is then handed over to the private sector. So basically, innovation is this kind of concept of commercializing what's already known. So we often think of our, you know, if you look at the Latin root of sort of innovation. It actually means to renew and to change. It doesn't mean to invent or discover anything new. But yet, when we think about it in the kind of colloquial sense, we think it's new, and that's how it's how it's used. But the concept of intellectual property is. I've been doing some thinking about it. It's actually probably the topic of my next book, and I want to. You know, when I go back to the historical underpinnings, and often, you know, it starts with the Lockean theory of labor. And often, I mean, there's a book out there by Mergers which is called Justifying Intellectual Property, and there's a whole chapter on, you know, Lockean theory of labor and the justification of putting your sort of sweat into the land and thingy, but often that's not discussed in these books, in the IP textbooks or the these kind of legal textbooks. Is you know John Locke was a colonialist, and the language of intellectual property is born out of colonialism. It's a dispossession of people's land. Now, there's a great example when we think about sort of you know these new psychedelic drugs, for example. I mean, we've been working on it with Mac and Max at the back there. We've been talking about what a company called Compass is doing with psilocybin, which Mesoamerican cultures have been using for 1000s of years, and now Compass has basically patented a kind of polymorphic form, which is a crystal form of the underlying substance, and now they're going to be charging $22,000 for a pill, is what's predicted, and that's their intellectual property, and so in a way, there's this this phrase which I didn't know about, which I've been kind of do some research around. It's intellectual property for me lands in this concept of cognitive colonialism. The West has shaped these laws and framed these laws of intellectual property, and saying all of the knowledge. Systems were primitive, and when you challenge them, basically, or you have to kind of exist. You have to exist within these frameworks, which is what the TRIPS Agreement was. And I just, I just wanted to kind of reason.
Tahir Amin 40:11
You know, it's a process by which a dominant power structure does not merely occupy territory or extract physical resources, but colonizes the framework through which people understand value and govern knowledge itself, and that's what intellectual property is, and that's what's become the norm. And AI is the next iteration of that. And I know Chris is doing a lot of work about the third enclosure. I don't want to give it away, but paper
Christopher Morten 40:38
forthcoming. Maybe if I ever finish.
Tahir Amin 40:40
But but but the thing is, I feel I don't know what it's I don't know what you teach in law schools. I I don't know. But certainly, I didn't grow go through law school learning about this. It was just a given. And so I think we need to be more critical and and challenge these knowledge systems the way they are, particularly as we now move into the new frontier of medicine, where more and more traditional biopiracy is happening more than ever before, because you know the pharmaceutical pipelines are drying up, so they need to find new frontiers. So yeah, that's my view on intellectual property. But it's it's still I still I I feel we need to be more critical of the origins and the sort of whole sort of Lockean theory that supports the underpinnings of intellectual property, which is often in every textbook that you read, and I'm like, this is who wrote this.
Christopher Morten 41:30
Do you want to jump in, Richard?
Reshma Ramachandran, 41:31
Yeah. So I'll speak about this from a regulatory standpoint. So a lot of my work is actually related to the Food and Drug Administration and how they approve new products, right? There's this whole idea that FDA is actually within its mission statement is an agency that actually incentivizes innovation, and they have various tools to do so. And one of the predominant tools that have happened over the last like 20, 30 years is actually using intellectual property incentives, not patents because that's not outside of their scope technically, but this idea of like exclusivities, giving kind of additional years of monopoly price protection for new products, and also preventing competitors from coming to the FDA with a generic or biosimilar version as well. And if you see, look at FDA legislation since the 1960s, when FDA was given the authority to actually look at effectiveness as a part of its mandate, you'll see oftentimes the preamble for various pieces of legislation that are related to the FDA. FDA is being an agency that incentivizes innovation, so they've created a lot of new designations for various types of products, things for rare diseases, for instance, diseases of unmet need, life-threatening or serious conditions, antimicrobials or other infectious diseases, they have these all these new designations that are tied with intellectual property incentives because this was seen as a way to incentivize innovation. But what we've seen is that the definition of innovation, again, as I mentioned before, has been ceded to the pharmaceutical industry. What do I mean by that? For me, as a doctor, what I care about is that patients live longer, they function better, and that they feel better. Right? These are like the main things that I want when I give somebody a new treatment, in particular, and that's what we call like a clinical outcome. Instead, what we've seen as a part of a way to kind of get these products to market faster, allow them have more monopoly price protections that are longer. That idea of clinical outcomes has been like replaced with other endpoints. Sometimes we see surrogate markers, so these proxy measures, so a changes in a change in a blood test, a change on an X-ray that might not necessarily be associated with a patient actually feeling, functioning, or surviving longer. We oftentimes see these new digital endpoints, for instance, and especially in the world of like AI, this is becoming more and more predominant. The idea of using these other things that we can detect through like a wearable, in particular, measuring these sorts of endpoints instead of actually how a patient's feeling, whether or not they're actually feeling better at all. We're also seeing other sorts of endpoints, these sort of patient-reported outcomes. So sometimes just asking kind of questions that might not be related to kind of the core disease whatsoever, and we're using that instead as a proxy for clinical outcomes. As a result of that, the U.S. has been leading in terms of approving a bunch of new products. So we have more treatments than ever before that are coming to market. Where FDA is saying, like, yes, this has met the threshold for safety and efficacy. We might actually have increasing uncertainty around efficacy because we're not actually measuring clinical outcomes that are meaningful for a patient or a physician, and we're going to see that. We, you know, we believe that these these new innovations are are better, even though we don't actually have evidence of that. And it's been interesting because increasingly, because of legislative changes that have been championed by the pharmaceutical industry, innovation has been kind of broadly defined as just being new, not necessarily being something that's actually better for a patient, not something that actually makes the patient actually survive longer. And it's it's been like fascinating just to see this in this history. We've been doing like a big review of legislation post 1960s. Of relate to the FDA, and that's like a repeated pattern of what we've seen. In addition to that, what's been coupled has been this idea of kind of automatically paying for these things. So there's been various pieces of legislation to say that Medicare and Medicaid are public programs have to pay for these products, despite kind of uncertainties around efficacy and as well as safety, because they've been FDA approved. FDA has defined innovation.
Reshma Ramachandran, 45:24
FDA has defined what you know new products should be. So if FDA has given its marker of approval, that means that it's going to be beneficial for patients, right? We're just going to assume that, and so Medicare, Medicaid should cover this, and they should not be able to negotiate prices for these products, right? We're going to allow them to come onto the market and have a monopoly period of time where they don't have competitors, and and Medicare, Medicaid has have to pay for it no matter what, and so it's been fascinating. Like, because now we've just accepted that for new treatments we should be able to pay as much as possible for it, right? Like, we are going to pay an arm and a leg for new innovations, because we're just going to assume that it's better, even though we don't have necessarily evidence of it, or the definition of innovation is kind of been manipulated by the pharmaceutical industry. Now, come to like where we are right now, right? There's a lot of discussion around new policies, or policies have been talked about before, like Medicare for all, right? You know, even like public options, for instance, the idea of having like universal healthcare coverage. One of the biggest arguments against this is the price, right? People saying like it just costs too much to do this because Medicare will have to cover all these new products, all these new innovations. They don't have enough money to do so. Like it just costs too much money to do so. And I keep thinking about this, being like, you know, well, one argument you could say is that okay? Medicare and Medicaid should have the ability to be able to decide what they cover, but people hate that death panels, right? That that term comes up again. Rationing comes up again, but it's also in this like atmosphere of where FDA is not actually playing a regular regulator role. It's not being the gatekeeper it should be for innovation, and also we don't actually have a system that actually demands evidence for what true innovation is, or actually redefines it in the way that we want it to be meaningful for patients and clinicians as well. So, in the context of affordability, this idea of innovation is manipulated in so many ways that I think about this in that sort of context of like we can't even talk about these like progressive policies about ensuring people access to healthcare, because what the arguments we come up against again and again is the cost of these new innovations, and we've just anchored the price to be whatever the company says it should be, and we've anchored the definition about what a new innovation is in terms of what the company wants as well. So it's been something that's been on in my mind quite a bit in terms of talking about you know this idea of like what are we seeding you know what are we compromising these definitions though have been put into place in such a way that we don't actually have a real conversation about what is actually meaningful at the end of the day for the end user for the patients and also for the clinicians that are involved as well.
Christopher Morten 48:00
Thank you both. I'm going to try to be brief because, kind of as predicted, the three of us have talked longer than we accounted for. So I'm going to jump. I'm going to preview. I'm going to ask just the last two questions that we had pre-cooked. One to invite you both to share something that you're working on right now. I'll come back. I'll tee it up a little better. And then Tahir, I'm going to ask you to offer advice to this group on career paths in health justice. So, flagging those two questions, just want to very quickly react to this last dialog. I think one of the things this conversation really, really, really emphasizes for me is that the fight that we are in is not just a fight over affordability; it is that, but it is also a fight over knowledge and regulation and power. That so a world where the medicines that we have are just cheaper than they are today is probably preferable to the one that we live in. But it's not enough, as Raishman points out. We also need better information about what technologies, what healthcare we're we're using? We need access to information. We need control of information. We need democratic, democratic and accountable public institutions, and all of these things are projects to work on. I think in concert. Okay, so can I ask you both to give us maybe a little bit of like a little ray of hope or something. Invite you both to share a project or two, something that you're working on. Could be locally here in New York or Connecticut. Tahir, for example, I know you are an advisor to Mayor Mamdani. So encourage you if you want to talk about the city level, but also federal work or work internationally. What's something you're doing, and could that work help us get to a more humane, more democratic healthcare system?
Reshma Ramachandran, 49:52
Sure. What are we working on? So I guess one of the rays of hope that I have in some of the work that we're doing. Well, you know, we'll see if it it bears out. But at least, at least in terms of like an intellectual exercise, and hopefully something that will have traction, given kind of the state where we're at right now, at a federal level, I think folks have probably seen like we're very much in a deregulatory environment, right? Like there's this idea that's like every person for themselves. You know, we should be able to like find our own information, and in some ways, it's actually a backlash against like the pharmaceutical industry, right? Like there's been, as Tyre mentioned, like a lot of industry capture, and some of those arguments have been adopted by the Trump administration to say that okay, we need to have this sort of environment where we deregulate because patients should be able to make choices for themselves. Enter like the world of compounding, right? You see like GLP-1s being sold by hims and hers that are of unclear quality. You see peptides that are coming to the market directly to patients as well. You see like hormone therapy that are available through like an app. You know all these sorts of environment. This whole environment where you don't have like agencies like an FDA involved. You don't necessarily have health insurers involved. This idea of like patients being able to just decide for themselves and also identify what knowledge that they want to have as well. So in light of that, you know, the FDA, to be frank, is being dismantled like left and right. Like we're we're just seeing kind of one you know over 25% of the workforce like leaving the agency or having been fired. We're just seeing like a lack of capacity at the agency. But there comes an opportunity to then reimagine like what an agency should be, and so we are working on like on a project 202029 for FDA to really rethink the idea of like what is an agency that's meant to be a regulator on behalf of patients. What should it look like as we see new technologies like AI coming onto the market? Like how is how should the FDA be positioned to be able to demand evidence, so patients actually can make informed choices about their healthcare. So you know, it's it's at least it's nice to kind of think about this sort of transition time, right? Like as things are going badly, you know, if we need to rebuild an agency that was really built in reaction to a lot of scandals and to a lot of like patient harm. An agency that can actually be protective and preventable in many ways for patients. How can we do that? And so there's been you know one nice thing is like there's been a lot of people interested in this in many ways. There's a lot of people who are thinking about FDA actually playing a role in drug prices, not just in terms of like monopoly price protection, but also as a gatekeeper for the word innovation. Like, how do we actually make that clear to the public as well? So that's been offer me some ray of hope to some extent, and hopefully we'll see some results of that with a new administration,
Speaker 2 52:43
Tiger.
Tahir Amin 52:45
I don't have anything juicy about Mamdani, so I can't tell you anything. Boo! I know. Other than trying to connect you guys for all your public options work that you're doing to get public options pharmaceuticals, Max at the back there, with the T1 chapter, where there's some state legislation that's hovering around to try and get sort of state state manufacturing, so public manufacturing for insulin, and I think that's a great move to try and get us away from the existing sort of monopolized private system. So that was my kind of little push in my role as on the transition committee to put that your what your guys's idea more front and center. And I hope that's getting some momentum, which I know it is. From a person from the work that I'm doing with my organization and myself. I think one thing that I'm excited about, although it's been one of those things that has been going on forever, we were just talking about it before we got into this talk, was South Africa's patent law. So, for any of you who don't know, South Africa doesn't examine its patents; it just grants them, and this is an old colonial legacy. And they've been forever trying to change that so that they can actually have some guardrails and prevent some of the the abuses that go on. So I was just in Cape Town with some colleagues from from the last 20 years that I've done this work with, and they're trying to restart that process. And I there's a great advocate there, Fatima San and Leena Mangani, who was somebody I worked with in India during the time of Indians patent law, they're driving that effort, and I I hope that we can get it to see the light of day. But there's a lot of political contestation, obviously, around this. The other thing that we're doing more here in in and the federal level is is kind of still kind of under the radar, but what we're trying to do is, and this is really born out of the work that we do as an organization, is trying to sort of uncover the industry's practices around how it basically builds up all these thickets of patents, so that they can extend their monopolies and what have you. And we built a public. Database. We've come in for a lot of criticism, particularly from people like Senator Tillis, who have attacked us. The USPTO have written reports trying to basically undermine our studies and give power to the lobbying groups. But using that, we're trying to flip the script, and we're speaking with a couple of people on the hill who may be willing to sponsor a bill, where we are saying that basically the companies, pharmaceutical companies, have to disclose every patent they have, whether they're going to use it in litigation or not. Because at the moment, there's this listing system that we have, the Orange Book, which basically only covers like the tip of the iceberg when it comes to the portfolio of patents that these companies have, and sadly that has become the methodology that most academics use, but actually is not painting the full picture. And I think we need to unpack that more, and that's what we're trying to do. And so, basically, maybe in the next Congress, if we can get the right ledge council to kind of back it and write it up in the right way, we may see that hopefully take some steps forward, and I know transparency is the baseline of anything. It's not some, you know, kind of sort of high upstream policy. But I think in when we're fighting these fights, it's something that could create the platform for others. But there's one thing, just a bit of wisdom that I've said. This is, you know, we're talking about where we started this conversation about voluntary solutions or whatever. The one thing I've said to my team is that basically, if this, as is with any idea and any legislation, if it gets watered down, we will not support it. And that is the fundamental error that everybody makes in this business. They get so attached to their ideas that they basically carry them through, knowing that they're going to get stripped down, they're going to get worn out, and they're going to basically become something completely different.
Tahir Amin 56:50
And so, as an organization, as at least while I'm in the hot seat, if it doesn't really like the way I want it, I ain't going to support it. And that means I've got, I might, you know, I'm not going to have some legislation that might have been born out of my push because I don't care for that. I care for the result, the real result. And I think that's not to criticize others in the field, but I think it's a bit of advice that when you're doing this kind of work, is stick to your values and keep your integrity, because there is none in the hill.
Christopher Morten 57:21
I think I have time for just one last quick question. Then we'll open it up to questions from all of you. So get ready, raise your hands in just a minute, and I will pass my mic. And Michael and Anise, do we have? Oh yeah, we might have some more mics too that can go around. Okay, so I will just ask my last question, which is, Tahir, this book is also a little bit of a memoir. It's a story of how you came to the work that you do, and you discuss in the book the fact that you spent the first decade of your career helping multinational corporations, including pharma companies procure and assert their intellectual property rights. So I wonder if there was a particular moment when you decided that you wanted to. I don't know. The other side is too simplistic, but that you wanted to work on the other side, work as a reformer. And then maybe particularly pertinent to this group, there I suspect a lot of law students or students in other fields here tonight, I remember being young myself and being interested in doing some kind of public interest work on healthcare and technology, but not knowing how to get there. Most of the entry-level jobs, at least for lawyers, or many of them, not all, not all. And come to me if you have questions about career paths. But a lot of the entry-level jobs are jobs at law firms or at companies. So, do you have advice for folks in law, medicine, other fields? How do you hold on to your goal of public interest work? How do you get there?
Tahir Amin 58:58
So, I had no vision of public interest work when I I came from a working class background in the north of England. It was a mining town. My father was a factory worker. The goal was to basically get up in the economic ladder. There was no I didn't know anything about human rights law or public interest law. I wanted to go to a big city law firm in London, and that for me was I'd made it. And so I got there and I started doing the work, and I started to sort of see how the system works a little bit. I also had a partner at the time who was working for an NGO who was in my ear telling me, "Do you know what you're doing?" So you know, I was listening to that too, which was I'm glad it really shaped how how I kind of saw the world, and then we started learning about the TRIPS Agreement and how basically I remember in the corporate law days we would say, "Oh, this is great! We can just tell other countries what to do now." And so all this kind of, but really, what what struck me was basically I learned sort of in about year three or four. I'm a slow learner. That I wasn't really practicing law; I was practicing power. And that, when that hit, when I could basically ride roughshod over whether it be a small trader for some trademark infringement, which basically wasn't really a case that we had, but because we had deep pockets, we could just totally kind of send them a cease and desist letter, and they would go away, and they would just pack up shop. And so, you know, time and time again, and also just being with sort of this this expansionist idea that you know to do the best for your client, you have to build your fence wider and wider and wider and wider in the intellectual property space. And you know this. When we think we talk about property, it's a kind of concept, same concept with intangibles, and so that's what really then made me start to reconsider. Like, really, is this what I want to do? And and we have, I'm sure that you have it here as well. You have this professional conduct rules. You have to do the best by your client, and I knew I couldn't meet that obligation. I knew I was either going to get debarred, or basically because there was no way I was I was putting up fights in in in the sort of Monday meetings with the partners and the other lawyers, and I realized this was not the place for me, and that's when I left and actually found a small NGO in in India who I'm grateful for that started me on this journey, so yeah, and I think one thing I do say, and this is for students out there, as as Chris has mentioned, it's not easy to get into the public interest aspects of these work because they're limited resources. I get a lot of people reach out to me, interns who want to do things, and we try to do as much as we can. I have one sitting over there, Jimmy, who was the first person that worked with my organization, and you know the thing is, is, is that I don't think it's a bad thing if you do go into private practice, but it's if you really have a vision and it's in your heart that you you want to do public service work or public interest work, just don't stay there too long. I'm surprised that I lasted 10 years and somehow got it out. But it can actually give you the skills that you need. It gives you credibility. Although I don't know how much credibility I have, but it basically it allows you to see talk about the other side how it works in practice. I mean, I know I've been in conversations where somebody has tried to argue that it doesn't work like that, and when you say I worked actually for these companies doing these various strategies, it's very hard for them to rebut that. So there is some power in that too.
Tahir Amin 1:02:30
So if you do embark on the private practice, make sure you don't get lost in it, and just keep your vigilance about you. Getting into the public interest spaces, you can do a lot of policy work, a lot of think tank work with some good organizations. It doesn't always have to be doing practicing law. So there are places out there that you can do this, and particularly with the next sort of knowledge frontier of AI, we're in it. There's going to be a lot of demand for ideas and people who can think through the legal mechanisms around that. So there may be new opportunities.
Christopher Morten 1:03:08
Terrific, thank you so much. All right, any questions from folks in the crowd? I see a hand. Okay, I see two. The first hand I saw was Yes, Grace Watcher. Yeah.
Speaker 3 1:03:25
First of all, thank you so much for being here. My name is Arjun. I'm not a law student. I'm actually an undergraduate student down the road at Stern. There are a couple of us here. Thanks for coming. First of all, like, thank you so much. You gave us such good context from someone from a non non law background. You know, really getting the context and understanding of the industry and you know the problems, both regulatory and political, was super, you know, insightful. So thank you so much. My question is around. I know we touched on Medicare for all. I was also born in England, where we grew up with the NHS. It's not perfect, but it's there, and you know when I moved to the U.S., this whole rhetoric of Medicare, Medicare for all, was kind of rising with the progressive part of the Democrats. And you know, you talked about how private pharma, the pharmaceutical industry, are really anchoring down prices, which is a a argument against Medicare for all, is there a pathway where that you know becomes a thing within the next within the foreseeable future? And what are the steps that need to happen to become to make the the healthcare industry more accessible to everyone, whether it's through that or another platform or a policy idea?
Reshma Ramachandran, 1:04:42
I don't think I have a great answer for this. In part, just because folks have like tracked the history of healthcare reform, a lot of what we see with the Affordable Care Act has been responses to corporate power. To be honest, so one of the big tenets of the. Affordable Care Act that has also contributed to high drug prices here in the U.S. is actually a big intellectual property giveaway related to a product class called biologics. So when the ACA was being negotiated, and this the Affordable Care Act was also a compromise. Remember, there was initially a lot of there was actually initially even in the 90s proposals around Medicare for all are a public option that tanked because there wasn't agreements and there was a lot of pushback from health insurers and also the pharmaceutical industry and employer-sponsored health plans as well in particular. So we had the ACA, but there was a public option, right? That was supposed to be like a kind of a pathway towards like Medicare for all potentially. That tanked initially. Also, this idea of like rationing, right? There was this idea of like it's just going to cost too much money. Death panels, like if you're going to like be able to try to contain costs by limiting access to certain products, including new treatments, you know you're having the government decide who gets what. Like that's not okay, right? And so that went away. So one of the big compromises was actually a negotiation between the White House and the pharmaceutical industry around this idea of actually giving additional years of exclusivity. So this is actually an intellectual property incentive that comes from the Food and Drug Administration upon FDA approval of a new product for a particular product class, and the pharmaceutical industry was actually asking for 14 years, one four, 14 years of exclusivity for biologics. So insulin's a biologic, cancer drugs that end with MAB, MAB are all biologics. Like we have a lot of products, increasingly so in this space. And the White House actually, or the Federal Trade Commission actually came forward and said, no, you don't need 14 years. We actually counterpropose zero years. Okay, the White House actually put out their own analysis and said, okay, we will we we could be okay with five years of of exclusivity. That that would be on par with other types of drugs, small molecule drugs in particular. Where did we land? We landed on 12 years. That was the compromise that was struck with the Affordable Care Act. We actually had a big campaign around this called Affordable Meds Now. We did actually Christmas carols in front of legislator houses around this. We sent Valentine's Day cards asking legislators to not sign a sweetheart deal around this as well. We and we put it. We published 25 op-eds. It was actually we had writing circles with medical students and faculty around the country, including some law professors, including a New York Times op-ed around this too. But it failed, and so that was a huge compromise that occurred. I say that just as a backdrop in terms of like the the barriers in many ways to this, that we have we have created a healthcare system that has many middlemen. We talk about pharmacy benefit managers as one of them, but there's many middlemen. Like there's different corporate actors that extract value from the healthcare system, that extract value directly from patients, in you know for their service. Health insurers are one, pharmaceutical companies, ones, PBMs are one, but there's actually many others as well, and like the discussions around healthcare reform have all been like we need to make compromises with these different groups to do so. So I mean, the proposals for Medicare for all I think are great because it's saying like forget these middle people. Like we're going to like not try to like compromise with all these things. Again, this idea of like voluntary mechanisms and compromises, right? Like they're saying, like let's do away with that. Let's actually just say we are going to change the age, you know, restrictions for Medicare, which is 65 and older, and lower it. There's been proposals to ratchet it down, to lower and lower. There's been like 50 years and above. There's so there are proposals to move this forward.
Reshma Ramachandran, 1:08:38
I think honestly, it's not a matter of like the path forward. I think it's political will. To be honest, like you need to have people in Congress that one like accept that healthcare is a human right, right? Like that everyone here should be guaranteed healthcare. Like we're seeing debates still today that you have to be like hardworking, like have a job to get healthcare. Like that is still an ongoing debate today. This is what happened with the one big beautiful bill, right? Medicaid has now work requirements because of that argument, but because there is not an acceptance that healthcare is a human right, right? This is you hear Bernie Sanders ask this to like basically every healthcare nominee who comes before him in a hearing, and like the responses are pretty striking to see from folks that people, even clinicians, like who are being nominated for like heads of agencies, will not say this. Like they will not say healthcare is a human right. So I do think it's like a big act of political will, and that and and I that I think is the biggest barrier to all this. It's not a great answer, but just because of the history of what we've seen so far, I honestly do think it's that is like the linchpin in this.
Tahir Amin 1:09:44
I would just say, and thank you for that, Reshma. I would just say there was a survey that just came out that two thirds of Americans want to have Medicare for all, and it's predominantly on the Democrat side. But there's, you know, there's I think a quarter, 25% of Republicans who. So the landscape is shifting. I think the cost of living crisis and affordability is is biting everyone, and people are looking for sort of yeah. So I think we might we might be a bit closer, but yeah, the ACA I think was I always call actually I'd be saying the book Obama was the ultimate Neil the old bro. So
Christopher Morten 1:10:21
I can't resist. I have a sort of call to action for anyone here who is an IP person or innovation law person. I know you're out there. I was a law student at this very institution, and I was like very interested in the law of science and technology, and also interested in health law more broadly and access to healthcare. Healthcare is a human right. But thinking like first and foremost, I care about the governance of scientific and technological. If that is you, not telling you what to believe, but know that there's a really, for me, fascinating literature on the links between single-payer systems, universal healthcare systems like a Medicare for all system, and innovation policy. Because in addition to giving more people access to care and guaranteeing them access to care. You also, with a central payer, have the ability to generate and wield information in ways that we just can't do with a fractured healthcare system. We have a lot of different actors who hold little fiefdoms of different kinds of knowledge. So, if you care about generating and validating the best new drugs, vaccines, devices, technologies for us as a country. Okay, let's take another question or two. Oh my God! I see a hand. I saw a hand. Yeah.
Speaker 4 1:11:52
Hi everyone. Thank you for the conversation. My name is Mohammed. I'm a pharmacist currently studying public health. Not the villain here. I come from a country where the government serves as a monopsony. Basically, they are the single buyer for medications, and with that, the prices of medications over there are quite controlled all over the country. My question is, like, in an ideal world, or like, according based on the law and regulations in America, what would be an ideal approach that could be implemented in order to control medications price? I know you touched on trying to eliminate the middlemen, just such as the pharmacy benefit managers. What's the legal? What's the legality of approaching something like that here in the state? Thank you so much.
Reshma Ramachandran, 1:12:46
No, that's a great question. I mean, there's been efforts. I will say, there's lots of legislative efforts. There's been some PPR reform efforts that have actually passed over this past year to try to at least make more transparent. For instance, the cuts that some of these middlemen get, including pharmacy benefit managers, there's been some efforts to try to delink the discounts that pharmacy benefit managers get from the prices of the medicines. So folks are not aware. So pharmacy managers are supposed to be working with insurers to be able to negotiate price of medicines with the pharmaceutical industry, the the revenue that they make is actually based on what discount they're able to secure between the list price that a pharmaceutical company puts forward and then the price that they negotiate. So there's an incentive in many ways to kind of make sure that delta, the difference between the two, is as big as possible because they get a cut of that, which sets kind of sets a weird incentive, right? Because a pharmaceutical company can then just jack up their price, so you can have a deep discount. But it actually, for a patient, at the end of the day, it doesn't make a difference. I say that though, but there's like plenty of studies to show that we can talk about pharmacy benefit managers. But the pharmaceutical companies who set the list price have probably the biggest association with the out-of-pocket cost a patient experiences at the time of purchasing, if they have insurance, and obviously outside of insurance, whatever they receive as well. So there's been a lot of proposals to talk about, like, can we like figure out what the therapeutic value of a new drug is, right? Based on you know its clinical effectiveness and safety, can we like set a price that's accord in accordance to that, that would require a lot more evidence generation, transparency, like demanding information from the company itself. And there's been some proposals around this, and that's what the Inflation Reduction Act, which we have to a modest extent, tries to do. They they do mandate information from the company to justify its therapeutic value, and are supposed to negotiate a price that the government is willing to pay in accordance to that. That negotiation, though, and again as a compromise, comes way after a drug is launched. Right. So initially there was proposals to actually have drug pricing negotiation at the time of launch. That became like drug price negotiation. For all drugs, but later on, and now we're with the Inflation Reduction Act, which is a step forward but pretty modest, saying that the government will negotiate, and specifically Medicare will negotiate prices of drugs, either nine years for a small molecule drug after launch, or 13 years for biologic medicine. So usually after their monopoly period is over, or you know, towards the tail end of it, there's been you know various costing analysis to show like how much savings does it have. It's a lot more modest than what we originally anticipated, but it's there to some extent. So you know, some of the like I think low hanging fruit that has been discussed is like obviously negotiate prices at launch, right? And based on a benchmark related therapeutic value, the concern obviously is gamification again, because the knowledge economy around a lot of these products is controlled by the pharmaceutical industry in terms of what sort of evidence is being provided. So they would have to be coupled with that, like you know, mandates for generation of evidence. If you don't actually show clinical benefit, companies need to do so, or else we're going to reimburse or like pay only a little bit for this. It also you also need to have protections in place, which some countries experience issues with, even with the centralized procurement, to make sure the pharmaceutical companies will still be willing to sell right in those countries in the United States if they do put these conditions in place. That's always been a concern, right? Like if the U.S. is not at an attractive market in terms of pricing, companies will just leave and not sell their products, which then creates issues in terms of having adequate supply.
Reshma Ramachandran, 1:16:28
So all that to say is, like, I would be in favor in many ways to one make sure there is going to be negotiation of drug prices at the time of launch, but it should also be for drugs that are proven to be beneficial, or at least where we have a system in place to mandate evidence generation. And we can talk about specific proposals related to that, but there have been some in in this space. But I do think that at least is a step forward. But I think it does require the government then to be a centralized purchaser, or at least if there be coordination from different entities, including the government and also private sector, to be able to work together to be able to set the rules of the game related to this. But curious to hear what you all think.
Christopher Morten 1:17:12
I agree. Wait, Michael, do we have time for one more question? Do you think? Okay, I got it. Oh, I got a thumbs up over there too. Let's let's take one more question, if we could. And I see white sweater front center.
Speaker 5 1:17:30
Hi, thank you for the talk. My name is Sophia. I'm a molecular biologist. Right now, I'm studying at the School of Public Health. Also, I'm a grad student there, and my question is: so I have a similar journey where I graduated from undergrad. I'm not from the U.S. Made it to this fancy pharma job, and I was like, "Yay, I made it!" Hated every single second of it because I realized that the medications we were working on would our patients would never be able to afford them, or if they would, then they would be. I don't know. They would waste all their money on it, and I say waste because there were a lot of side effects, like you have said, that I don't think they were necessarily helping the patient live a better life. So my question, I guess is how do you deal with this idea that is ingrained in both pharma and academia that if you don't have the monetary incentive, then you don't have the research or the development. Thank you.
Tahir Amin 1:18:40
Well, I'm going to land on something that I know Chris has been pushing. I think we need to take a lot of the R and D out of the private sector and take it back as public science. I mean, we talk about public production, but I think we need public science too, because a lot of the knowledge is often starts within academic academic centers and what have you, and I think what industry is really good at is is commercializing it and marketing it, and protecting it and getting value out of it that way. And I feel, and I think this is where the patent system comes into it too, because it kind of feeds the system. It sort of gives them the platform for all this power. I think a lot of the original discovery work, if you want to use that word, and inventive aspects of it, really starts in the public labs. Not everything, but a lot of it does. And and I think we should actually be building a system around that, such that basically we're not just talking about things that are off pattern, which is I know where we have to start with with the public sector approach, but we actually we're doing it from beginning to end, from research to product, and I think that's what the kind of system that I would like to see that is actually public based, is participatory with public patient groups. It's like a participatory economy, if you might want to say, which could actually apply to a lot of different facets of the economy. I know that sounds like a pipe dream, but if you think about the way that that public knowledge was handed over in the 80s under the Bayer Dole Act, why can't we reverse that? And I think that's something that we should be talking about. It was, you know, just one thing I want to say. It kind of the reason I say this is, I've heard Senator Bernie Sanders and Elizabeth Warren talking about how AI they're taking all this public knowledge and they're basically locking it up in algorithms, and it's it's this privatization that we're going to have to pay for, and it's going to become a utility, in the words of Sam Altman. Where were we 40 years ago when we were giving away all this knowledge on the Bay Dole Act, on the intellectual property systems? We need to reclaim that. That's ours. That's our our taxpayers' dollars. It should belong to the public. How is it that pharmaceutical companies have enriched themselves at our behest. So I think that's where we should be working towards not just a public sector approach, just to do things that somebody doesn't own, but we should own the basic science around it. And then basically, if I think we should reverse the whole script. If the industry wants to license it, they can, but we we get the benefit of the pricing. And at the moment, we give them the power, and then we're the ones who are asking for these voluntary measures.
Reshma Ramachandran, 1:21:26
Maybe it's a ray of hope as well, because at least Chris in academia and myself, we're not the only academics that believe in this idea of trying to make sure that there's going to be other incentives in place outside of just monetary incentives to do good science and also good medicine. I will say there is an opportunity this upcoming year. There is something called the Prescription Drug User Fee Act or the User Fee Act. This is actually how FDA is primarily funded. It winds up being this sort of big vehicle for a lot of other legislation. In the past, the pharmaceutical companies have called it like a Christmas tree, where they hang their ornaments of different incentives that they're pushing for, but in recent years we've actually had with you know patient groups really being at the forefront, other organizations that are consumer advocacy organizations really at the forefront as well. A push to actually rethink that legislation, and I think it's also coming to a head right now as questions around affordability are coming up, and also as there is distrust I think, in the pharmaceutical industry around you know their practices and their products and their pricing. So there is, I think, hope that there will be like a public pharma push related to this, and specifically related to public science. You know, we we I think there's an acceptance that like yes, we can have like new products come to market very quickly with some uncertainty, like some of the things that you might have been working on, and that might be okay as long as there's a way to force the companies to do better science, or at least have the government come in to do better science, right? If the companies aren't going to do this without a monetary incentive, why should we empower our agencies like FDA, NIH, and CMS to do those studies themselves, right? Things like comparative effectiveness. I want to know that a new drug is better than an old drug. Companies actually don't need to do that to get FDA approval. They oftentimes will test it against placebo or something that's not standard of care, which leaves a lot of questions unanswered about like whether or not I should use this new, more expensive product for a patient. Those are things that like academia, that government should fund and can do, and I think there is some thinking about this now that is a way to kind of ensure competition, to actually make sure that patients provide informed consent around new products. We can rethink this, and also in the context of affordability, like why are public programs paying so much for something that we don't know works and that we don't know is actually safe for patients, and so I think there is more interest in this using different methods, sometimes not necessarily like randomized controlled trials, but using other data sources that are coming about as well, including like mass electronic health records or systems, insurance claims data to be able to do this sort of work. And so, like us in academia, we're trying to figure this out as well. Like, how can we try to contribute to this? How can we set guardrails around this? And from a legislative perspective or policy perspective, trying to figure out ways the government can actually regulate or even take control of that sort of space, because we want these questions that companies are not incentivized to answer to be answered, and that's a perfect role for the government to play. That's what they did during COVID-19, right? Companies were not willing to actually do COVID-19 research until the government came to the table and said, "Here's the scientific, here's the basic science for this, here's the parameters for how clinical trials should be done, here's now money on top of this." Like they're the ones that set the enabling environment for this, and they could do that again, but also set really good conditions around it. And that's what we're hoping will be like something on the horizon in 2027, especially as people are worried about like the cost of their treatment, cost of healthcare, cost of their lives, just generally. That will actually have answers related to what they're actually purchasing in the first place.
Christopher Morten 1:24:54
I can't resist. I know we're over time. I'm going to make two quick points. One. Appreciate these responses, and I want to echo. I think what both Reshma and Tahir touched on, which is, we in in in the in the status quo we live in, in which I would say government research is underinvested. Like right now, there are massive cuts to the NIH research agenda. There's lots that we could do and aren't doing, and nonetheless, the research that happens in public laboratories and in publicly funded academic laboratories is hugely important. Indeed, a disproportionate share get the numbers, but disproportionate share of breakthroughs originate there. Now, of course, they don't get all the way to patients from those centers. We, under our current paradigm, as the book explains, we kind of assume the need for a pharmaceutical industry partner to get stuff to patients. But the point is, we know that innovation can happen in institutions that are incentivized in other kinds of ways. And I want to credit: we have like Melissa Barber from Doctor Without Borders here. Again, Jeremiah from Prep for All. Part of what civil society does is illuminate the fact that so much knowledge, so many discoveries come from these other places, and challenge the kind of dominant story that pharma companies tell that they are the only source of innovation and the only way to get new products is to make sure that we give them the biggest possible incentives. That's my first point. Second one, I'm so thrilled that we have this diverse audience, but I want to come back to law because I am a lawyer and we are in a law school, and just say one thing to think about in response to this really excellent question is remember that the the world of innovation law is bigger than just business law. Let's say so. We think like Tyre's book touches a lot on the intellectual property, the patent system, trade secrecy, and so on. These are areas of business law that create incentives for private company, property-like rights for these companies. hugely important, as the book explains. But the story of innovation is bigger because it includes government laboratories and universities, and they're incentivized in different ways, they get grants, they get direct funding, appropriations from Congress. There are contracts. So if you are a lawyer or a law student and you're interested in understanding how new knowledge is created, think about these other doctrines. Actually, as places we can play, like appropriations law or contract law, the kind of contracts that government agencies might cut with private drug manufacturers or insurance companies, et cetera, like these are also places where lawyers can exert power and change the balance of power, change the dynamic. So, a plug for all of these fields of innovation law, but also patents are really important too. Yeah, I think that's all the time we have. I think we're going to stick around for a bit. We'd love to chat with all of y'all. Thank you so much for coming. Huge round of applause, I hope, for Tahir and Reshma. Tahir, thank you for Pharma Monopoly, the battle for the future of medicines. I understand there will be the
Announcer 1:28:10
Engelberg Center Live Podcast is a production of the Engelberg Center on Innovation, Law, and Policy at NYU Law, and is released under a Creative Commons Attribution 4.0 international license. Our theme music is by Jessica Batke and is licensed under a Creative Commons Attribution 4.0 international license.