 Good day folks. I'm just letting people trickle into the zoom for another minute or so and then we'll get going Okay, welcome every night everyone. My name is Matthew Herter I'm the director of the health justice Institute at Dalhousie University Which is located in McMoggy the ancestral and unceded territory of the Mi'kmaq people We are all treaty people It's my pleasure to be hosting you on zoom today with we have an exciting speaker Professor Chris Morton who's joining us from New York and Columbia University's law school. I'll introduce Chris in a moment Just a couple of housekeeping points for the seminar If you have questions that come to mind that you'd like to raise in the discussion that will follow Chris's presentation Please feel free to put those in the chat I'll be sort of moderating the discussion and reading those questions as much as people should be able to see them on the chat So please feel free to engage during the talk, although we'll save the questions until the end But without further ado, I'd like to welcome Professor Chris Morton as our seminar speaker for this To start this semester. We're about halfway through our seminar series for the academic year Professor Morton is an associate clinical professor of law at Columbia Law School in New York City And he's the founding director of Columbia's Sheik or science health and information clinic. He holds degrees in law and chemistry His work as a clinical professor In that work Chris seeks to serve the public interest by seeking more equitable access to scientific Technical and medical knowledge his scholarship grows out of his clinical work and considers how law and policy Shape the ways that knowledge flows through our economy our society more broadly and how law and policy Influence how new technologies are invented validated manufactured distributed and used Some of his recent publications describe the US Food and Drug Administration's legal authority to publicize a trove of valuable scientific Data that it currently keeps secret or has kept secret Other work analyzes the US government's power to use privately patented technologies in the service of the public interest And he presents a progressive vision for the pharmaceutical and biotech sectors of our economy and society Post-COVID-19 Chris in my view is is someone who doesn't just criticize Powerful corporate actors like big pharma. He articulates a positive vision And that's something that is is is really Needed in this conversation about how do we Remake the world of pharmaceutical knowledge production technology and so on Professor Morton joined Columbia law faculty in 2021 before that He was the deputy director of the technology law and policy clinic at New York University School of Law a Fellow at NYU's Engelberg Center on innovation law and policy a Supervising attorney and clinical lecturer in Yale law schools media Freedom and information access clinic so known as the mafia clinic. How do you come up with such good? And the staff attorney at Yale's collaboration for research integrity and transparency or print. Maybe that's that's the weakest of the bunch. I'm sorry He remains a visiting fellow of Yale's global health justice partnership and affiliate fellow of Yale's information society project The four beginning is teaching career Professor Morton worked as a litigation associate and patent agent at American law firms We're so pleased to have you join us Chris over to you for a presentation that I'm really excited to hear Thank you all so much Matt for that very generous introduction. Can you all hear me? Okay? I'm coming through Okay Thank you all for for having me. I'm truly sorry that I'm not there in Halifax in person I very dearly want to visit Dowel visit Halifax. I'm some family medical problems in a nasty chest cold of my own have kept me in New York City Please excuse me by the way if you hear me cough or I need to take a break for a sip of water And I apologize for looking like like death warmed over Once again, just thanks so much for including me in this amazing event series I've watched a number of the Recordings of these past lectures and so it's really an honor for me to be among your presenters. So thanks to Matt Thanks to Sheila. Thanks to Ashley and everyone involved in making this event happen Okay, I'm gonna try to share some slides and As Matt knows, I'm gonna try to do something a little bit flashy, which I hope will work I'm gonna try to make my slide deck my virtual background. So I hope you all see me Kind of talking over my slides if that's not the case then someone, please unmute and give me a shout So I'm here today to talk about my and my student clinics partnership with T1 international on public pharma initiatives in the United States I'm gonna say much more about what to international is what public pharma is and what my clinic is I'll start just by saying this is a legal practice project That's been underway for just over a year now and I have not written a paper on this or given a formal talk on this before so you all are In one sense, I guess unlucky guinea pigs getting an untested talk But you're also getting a first look at hot off the presses work that my students and I have done Okay, so Here's a roadmap to how I propose to use my talk I'm gonna start with a very brief background on myself then explain what my legal clinic is and does I'm gonna talk a bit about who we represent in the abstract And then I'm gonna focus on one beloved client T1 international, which is a diabetes patient group Now I'll get to the heart of the talk, which is public pharma And I'll first introduce what I mean by the phrase public pharma or a public option in pharma and biotech And then I'll give you the longer version I'll look backward and explain how to an international's public insulin project arose And then I'll talk about what my students and I have done with the insulin for all activists at T1I And then I'll talk a little bit about what I think the future holds for public insulin public pharma more broadly in the United States And I'm gonna close with a short bit of meta reflection on what this work means to me and why I think it's among the most important stuff that I do And I will acknowledge some of the folks at T1 international and my students and various allies to make this work possible And then I'm eager to take your questions So very briefly about me as Matt said I trained as a chemist. I kind of burned out of academic chemistry I got recruited my sort of highest and best use according to the market was to work at a law firm as a patent agent and advisor on patent cases fighting over, you know ownership and and Profits from Blockbuster pharmaceuticals and other medical products that got me interested in law and especially in the areas of law including patents that structure the creation dissemination of new technologies I went to law school. I practiced patent law for a few years and then became a law teacher in 2018 The lawyers in the audience will know what a law clinic is and Dell has some amazing ones But non-lawyers may not so I thought I'd explain briefly what a law clinic is Effectively Columbia pays me to teach the practice of law to my students. I teach skills. I teach problem solving strategic strategic thinking and So I'm rather than teaching a set body of doctrine like contract law I Represent clients pro-boto. I am their lawyer and I bring them into Columbia law school I'm into the legal services organization that lives within Columbia law school and my students then represent those clients with me This is experiential learning. This is students actually going to court going to Congress going to agencies and learning from the real world of legal work I also do a bit of more traditional law professor stuff I write articles sometimes, but most of my job is is practicing law and teaching students to practice law with me through the clinic So word on the clinic. It's called the science health and information clinic or chic or chic We can't seem to decide how to pronounce the acronym. I usually say chic like the razor As Matt said, it's a newish clinic founded in 2021 The name science health and information clinic is a bit of word salad perhaps But I consciously wanted to avoid naming the clinic around any specific doctrine of law So we're not specifically an intellectual property clinic or an administrative law clinic or privacy law clinic We work on all those areas, but I like to think that we enter into each client relationship and each project with an open mind about the The right legal tools the right areas of law the right sort of rights and remedies to invoke to try to solve our clients problems Shick is part of a pro bono legal services organization called morning side Heights legal services That's housed within Columbia Law School, but it is technically independent It's a legal services organization that provides pre free legal help to indigent clients clients that can't afford lawyers on their own Currently my clinics clients are all nonprofit organizations They are mostly patient activists and consumer advocacy groups I strive to work with groups that are not just formally nonprofit, but that are fully independent of industry funding I Won't get into depth about clients other than T1 international But I'll just briefly mention three of my clinics longtime clients one is universities allied for essential medicines Ua em Which is an international student organization committed to promoting health equity and access to medicines around the world Doctors for America, which is an independent and progressive medical organization Focus not on doctors bottom lines, but on patient care public health and health equity And prep for all an independent HIV HIV AIDS patient advocacy org In Q&A if folks have questions about specific work. I've done with these clients I'm glad to talk more, but I want to turn to T1 international and tell you a bit about Who they are so T1 international is the name suggests is an international organization It's a not-for-profit that advocates for people living with diabetes in T1 eyes own words T1 international is a global type 1 diabetes advocacy organization led by people with type 1 diabetes for people with type 1 diabetes T1 international believes in a world where everyone with type 1 no matter where they live has everything they need to survive and achieve their dreams and in 2024 T1 international was part of the launch of the Insulin for all campaign which has grown into a global movement T1i is a health justice organization But it's also an intersectional social justice organizations committed to racial justice to gender justice And to meeting the needs of patients around the world not just in the u.s. And other global north countries Currently T1 international has I think it's 41 or 42 chapters in various u.s states and it has chapters or Partners and advocates in more than 20 countries around the world T1 international also prides itself On not accepting any money from the pharmaceutical or medical device industries Incidentally, I'm a bit embarrassed to say that I know little about T1i's presence in Canada I know that they have volunteers and campaigns here But unfortunately can't share much more than that as a u.s. Lawyer. I've really worked with their u.s chapters So I mentioned that they're independent Another thing that attracted me to T1 international makes me proud to represent them Is that they are Or they aspire at least to be a true patient led member led organization As I said, they have dozens of chapters across the u.s. And some of those chapters have Hundreds of volunteers and the chapters and various working groups that work on specific issue areas Become the engines of the organization Chapters and working groups vote on priorities and then T1i's leadership their staff Implements those priorities. It's not the other way around On screen here are three of the current priorities voted on by T1i's u.s. Federal working group Those are a federal price cap on insulin new legislation for that an end to tax breaks for big pharma And patent reform T1 international also has a state level working group They currently have four priorities noted on by their chapters by their members One is alex law which creates an insulin safety net for people at risk of having to ration Or go without insulin Kevin's law which allows pharmacists to dispense insulin if a patient is in crisis and can't reach a prescriber public insulin production and procurement which will be the focus of my talk And formula reform and non-medical mid-year plan switching to try to prevent patients from experiencing stressful and dangerous changes to their insulin options So, uh I I've already said this and I I guess I don't want to belabor this but um I will stress that T1i has declined any funding from pharma and medical device companies They're transparent about their funding and you can check their website um They currently rely on a mix of planter piece and small dollar donors. I personally give every month Patient groups as many of you know, um, even non-profit patient groups and patient groups that do in many cases really important work Are often not independent of the pharmaceutical industry. There's a report that public citizen put out last month That I think is really eye-opening shows that that there are some patient groups that Derived the majority of their funding from pharma and biotech companies and not not surprisingly end up adopting positions preferred by Those companies on the American Diabetes Association much larger organization than T1i For example, received at least 11 million dollars in grants from sanofi And at least 7 million from Eli Lilly between 2010 and 2022 Sanofi and Eli Lilly of course two of the big three insulin manufacturers So T1i is different in that regard um, and because T1i is independent it can be um, I think Uh critical and adversarial and even confrontational and what I first heard about T1 international It was I think in 2018 or so Through Greg Consolvis the professor at Yale where I was working at the time Greg is a veteran of ACT UP the HIV AIDS and the lgbtq and the health justice Organization that's legendary in New York at least And Greg called T1i the ACT UP of diabetes The comparison is inexact, but I think T1i does capture some of ACT UP's ethos and energy here for example as a picture Um a news coverage of one of T1i's actions stopped the greed protest at Eli Lilly's headquarters in Indianapolis calling for price cuts on Lilly's insulin products um, okay, so back to the robot that was uh an introduction To me in my clinic and my client T1i international. So let me now get to the main event, which is public pharma What do we mean by that phrase? I'm going to start with an introduction of just a few minutes In short, I think it's fair to say that by public pharma We mean a public option in pharmaceuticals more precisely. We mean state actors or government actors In the u.s. That can be local. It can be state. It can be federal government actors Taking over some or all of the functions the private companies currently play in the ecosystem of pharma That can mean government agencies manufacturing drugs can mean government agencies researching developing drugs It can mean government agencies distributing drugs to patients It can mean government agencies negotiating the prices of drugs and establishing formularies for different insurers um and more To international and I sometimes talk about all of this public manufacturing public distribution and so on as a public option Because public agencies don't necessarily have to completely displace the private companies that we currently rely on to get medicines to patients Or largely rely on In a second, I'll show you that there's actually public pharma already existing in the u.s So some patients are already benefiting from public pharma agencies. Um in our view Public pharma can complement and compete with private pharma without completely displacing it Dana brown at the democracy collaborative Is probably the leading historian and theorist and an exponent of public pharma in the united states This is one of her many excellent papers on public pharma Her medicine for all paper from 2019 And she uses this framing a lot a public option This this uh document again, I I'm going to share at the end of my talk some Kind of further reading for folks who are interested, but this place is a great this this piece from dan is a great place to start um Okay, so uh to get more exact public pharma canon does mean a lot of different things as dana brown and others have shown um There are a lot of different points in the life cycle in the network and the ecosystem of pharmaceuticals where public agencies could get involved um And in fact, they already are involved in lots of these places public laboratories can and do basic science Uh and drug discovery, of course in the u.s and canada public labs do lots and lots and lots of this disproportionate shares Of the most important breakthrough medical products emerge from government labs um and public agencies like the u.s National and suits of health can and do fund design and conduct clinical trials um the usna h actually runs and uh funds more trials than any other entity on earth um I think there's a kind of conventional wisdom at least in the u.s That public laboratories are pretty good, uh, or even very good at early stage development But don't have the right knowledge Or incentives or internal structures to do late stage development. Um, including phase three trials and other work that um That is needed to get regulatory approval But that's not true either and there are examples to the contrary and one Terrific counter example comes from um map actually and jannis graham and richard gold Who published this paper on mercs? I put that in quote Ebola vaccine which showed that actually all or essentially all of the relevant development work including manufacturing of hundreds of doses and completion of the key Uh clinical trials was done not by merc but by the national microbiology lab in winnipeg Which is part of the public health agency of canada, of course So, uh to go back to this kind of taxonomy of all the places public agencies can get involved I think public agencies can and do uh and have done Everything that private pharma companies private wholesalers private pharmacies do public agencies can get products through regulatory approval They can manufacture api and final formulated products. They can get products to warehouses to clinics to pharmacies And to patients front doors public agencies can even do their own kinds of marketing What we might I think better term patient education or public education or patient outreach Think here in the u.s. At least of the centers for disease control and prevention Which informs the american public about products like cova vaccines and encourages people to get them And part of what i'll share in a few minutes about the work that i've done with t1 international Is just this trying to support a public insulin initiative and thinking about how to use both government resources and Patient group activist group resources to inform patients about public insulin options that are on the horizon now um So, uh, one remarkable thing that dana brown and other scholars of public pharma have shown is that even in the u.s That's supposed bastion of free market capitalism There are a number of public pharma enterprises already up and running. Um, some of these are decades old We have for example the cow rx public drug Manufacturing initiative in california Which has been funded with tens of millions of dollars which has announced an intent to begin manufacturing and distributing Not just insulin which i'll focus on in the remainder of my talk, but also in the lock zone and they're promising drugs getting to patients in The next few years But we have other accident public manufacturing initiatives like mass biologics, which is a division of the university massachusetts medical school established over a century ago Mass biologics continues to make vaccines and other biologic products And distribute them throughout the u.s In canada, of course, you had the famous lauded cona labs in in toronto on the original insulin manufacturer Which manufactured distributed insulin on a non-profit basis for many years And we have public labs in the u.s Doing procurement as well using the bargaining power of large purchases of bulk purchases to drive prices down for patients And then distributing the drugs that they procure to clinics to pharmacies Or directly to patients the minnesota multi-state contracting alliance for pharmacy Aka m cap and m cap impuse A public group purchasing organization in this one existing example in the u.s It procures and distributes drugs to public health care facilities such as state agencies counties cities and school districts The u.s federal government's operation warp speed is arguably the most ambitious public procurement effort undertaken here in the u.s In generations the u.s department of health and human services spent many billions Negotiating bulk purchases of vaccines therapeutics and distributing them typically through straight governments to clinics and pharmacies around the country Uh, and we have a major public pharmacy benefit manager as well here in the u.s now a public pbm pbms as many of you probably already know intermediate between insurance providers and pharmaceutical manufacturers Although pbms private pbms are increasingly owned by and integrated with those same insurance providers pbms create insurance formularies and pharmacy networks. They negotiate rebates with manufacturers. They review drug utilization They process claims And public agencies can do this work too array rx is a public pbm that seeks to displace for-profit pbms Uh, it started in washington in oregon and has now expanded to nevada and connecticut too It uses the pooled buying power of publicly insured people In those four member states to negotiate lower drug prices and pass savings on to patients I've learned that array rx is a very lean operation. It's just a few people It doesn't distribute any drugs. It just negotiates lower prices on them I mean yet it claims to have saved residents hundreds of millions of dollars in its lifetime Okay, so I'm just going to briefly mention One more kind of general point on public pharma, which is there's this book from thomas hannah Our commonwealth the return of public ownership in the united states Uh, thomas is a colleague or former colleague of danis. They work together at the democracy collaborative And he published this book in 2018 and it makes the case that public enterprise not just in pharma but across many sectors of our society and economy I have a long and proud tradition in the u.s And it's a terrific place to start if you want to learn more of that history Excuse me just a second while I cough and I will come right back on screen Okay, sorry about that Okay, so this gives me an opportunity to talk a bit more at a high level about why we might want public pharma over private. I think I've gestured a bit at this And in a second I'm going to get specific about why t1 international thinks that public agencies can do a better job of manufacturing and distributing insulin than for-profit companies can But let me give you some high-level arguments first. Dana lays these out really beautifully in the piece on screen First and foremost probably is cost savings. It's a truth. I'm most universally acknowledged That healthcare is broken in the u.s. And that part of that is the prescription drug prices these brand name drug prices are too high I'm not going to get into the why and how I'm glad to talk more in q&a But I think high prices in the u.s. Are the number one driver of interest in public pharma Medicines are usually cheap to make once developed Brand name drugs are often sold at a massive multiple 50 or 100 times their manufacturing costs public drug manufacturers Can and do make and sell some of the same medicines at much lower prices They can sell them at cost or they can even give them away for free And lower prices have all kinds of beneficial spillover effects poor on and under insured people who suffer Most from high drug prices get better access to these products Public insurers and public health agencies can allocate could reallocate spending that currently goes to big for-profit drug companies to other kinds of healthcare and so on Glad to talk more about cost saving point, but I'll I'll pivot to Another that I think is critical and a little bit less widely known which is control of the r&d agenda So the for-profit pharmaceutical company has for many decades neglected Some of the most pressing areas of research from a public health perspective things like tropical diseases antibiotics vaccines and more We pay higher and higher prices for products that often provide Little therapeutic benefit to individual patients and little benefit to overall public health r&d oriented public pharma labs can focus on the research likely is to produce real breakthroughs And public development and manufacturing capacity can take promising discoveries already emerging from public labs like NIH And create alternative pathways to get them to patients The public pharma can also mean resilience against drug shortages. So the usfta reported a record number of generic drugs in shortage last year Hospitals report rationing cancer and other drugs Generic drug companies say the profit margins on many of these drugs are too low to keep them interested in manufacturing them A public laboratory a public manufacturer Could make essential generic medicines and help ensure a steadier supply And in the u.s senator elizabeth warren and representative jan schikowski have proposed a bill that would do exactly this And there are more potential benefits that the data and others have outlined things like data sharing and open science A not-for-profit public lab could commit itself to doing the highest quality science and then providing broad and prompt and equitable access to that science It's an industrial policy move public pharma labs and manufacturing plants could provide stable high-paying jobs I think especially appealing in an industry that's grown increasingly financialized where jobs are Where workers are experiencing stagnant salaries And the mere prospect or threat of viable public pharma options In manufacturing and procurement and pbm and elsewhere may chill some of the most egregious behavior from private pharma companies From pbms And other for-profit entities in other words, we may not need to realize public pharma completely to begin seeing some of its benefits I think the pharma system in the u.s. Is so profoundly broken That there's a lot of room for improvement and experimentation public pharma doesn't have to be perfect or perfectly efficient to outcompete Some of the private companies currently preying on american patients Okay, so that was an overview. I hope helpful Now I want to get to my specific work with t1 international And let me start with some history. How did this project arise? I mentioned that i'm a patent lawyer and the very first work that I did with t1 international Was patent reform work. We developed comments on proposed us pto and fta rulemaking and policies urging some reforms of patent examination And i'm glad to talk about that work But as we were doing that work together California's public insulin initiative was really taking off in late 2022 or so So, uh, california enacted a statute in 2020 that committed the state to direct some money and resources to make and distribute Or make or distribute I should say low-cost insulin and perhaps some other drugs Um, t1 international is california chapter was involved in the enactment of the law by the way to my knowledge Um, and in fact, uh in 2020 before the california law was enacted t1 international published a white paper with public citizen advocating for a range of state legislative solutions to the problem of high insulin prices In the u.s. Including public manufacturing of insulin Um, but it was in 2022 that calorex insulin really sort of took off Hit the headline so that was the year that california confirmed that it would commit itself not just to procuring low-cost insulin But actually making it and it promised an ambitious timetable. It promised insulin in patients hands as early as 2024 uh california's governor gavin newson gave a splashy press conference where he said nothing epitomizes market failures more than the cost of insulin And that california is now taking matters into our own hands As of 2022 the big three insulin manufacturers were charging over $300 for vial of insulin to patients without insurance And many patients, especially those with type one diabetes need multiple vials per month of multiple insulin products to live A recent national survey, um, I think in 2022 actually found that about 17 percent of all people living with diabetes ration their insulin Human international's own surveys suggested it might be even higher like a quarter Calorex promises to charge just 30 dollars a vial Much lower price a price at which many fewer people should have to go without 30 vials of insulin could transform the lives of many people in california And put pressure on the big three manufacturers to lower their prices in other states too So t1i and i thought this is an opportune moment to try to shape the calorex initiative and make sure it serves patients Especially on and under insured patients patients in rural areas and other disinvested areas And so on we thought t1i could marshal its energy its volunteers its voice to make calorex a success I hadn't done much on public pharma. I was a patent lawyer after all I had written a short piece in 2020 with dana brown and now it's lost in the frame quickly Urging for public vaccine rnd in manufacturing and distribution But I had a lot to learn about insulin and the unique challenges But just kind of personally and selfishly the more I learned and thought about calorex insulin The more excited I was to be personally involved Not just on and and to make calorex insulin a success not just on california's terms but on t1 international success for all people living with diabetes in california I think Gavin Newsom's splashy press conferences and the news coverage in 2022 and 2023 Has made calorex for better or for worse the poster child for public pharma in the u.s So if calorex succeeds public pharma will have its biggest and boldest proof of concept yet if calorex fails as The wall street journal editorial board hopes for profit drug companies and their boosters will use its value to argue that public pharma was misguided From the start Okay, excuse me. I'm gonna take a quick drink break and come right back again. I'm so sorry for this Okay, sorry about that. This cold was truly kicking my butt So So let me tell you now finally what t1 international my students and I Have done and are continuing to do these if you cal rx. I want to highlight six things That we've worked on Six things to help calorex succeed and we hope succeed in ways that really Meet the needs of the patients who need lower cost insulin most and i'm trying to move my head out of the way so you can actually see the six The six things are making insulins plural making products that patients need most ensuring transparency and a voice for patients ensuring that those patient voices are independent Analyzing calorex's contracts and advocating strong contract rights Analyzing and solving distribution challenges and building a market for calorex insulin So let me start with making insulins plural those in the audience who live with diabetes or have loved ones who do You already know But I confess I did not know before I started working with t1i Pharmaceutical insulin is not a single thing different kinds of pharmaceutical insulin have very different pharmacodynamics different effects on the body Some insulins are rapid acting Or short acting some are intermediate some are long acting Many patients require more than one kind of insulin to keep their blood glucose levels and their health Stable so an early advocacy goal of t1i is was to convince calorex to make not just one insulin product But multiple and wouldn't be enough for patients to just get one kind of insulin at $30 a vial This turned out to be an early advocacy win for t1i and other patient groups in california Calorex is now committed to making and distributing three kinds of insulin List pro aspart and gargene Those are rapid acting rapid acting and a long acting respectively And ultimately I think it's fair to say that t1i would like to see calorex and other manufacturers provide even more types of insulin to patients Okay, so a second thing t1i and I have worked on is ensuring transparency and a voice for patients in the calorex initiative Um to explain that I need to give you a little bit more background calorex is a california state owned pharmaceutical brand It's owned and managed by the department of health care access and information hcai But hcai doesn't actually have a factory to make insulin It doesn't have a cadre of scientists or engineers. It has no track record of pharmaceutical development or manufacturing and it actually has a Surprisingly small number of people overseeing the calorex initiative What california really has is Law on the books committing this state agency hcai to build a factory and to become an insulin manufacturer But no state owned drug manufacturer really exists yet. So to get insulin to patients soon The original plan was by 2024 hcai has contracted with a private insulin manufacturer called civica rx Civica is a not-for-profit generic drug company. It was founded by hospitals and some philanthropies It's recruited lots of seasoned experts from for-profit pharma and it now has Dozens of FDA approved products And it's ambitiously targeted selling low-cost insulin on a non-profit basis not just in california, but around the united states The notion The Notion behind the hcai and civica public-private partnership Is that hcai provides civica with valuable funding and a market for its insulin Which hcai will rebrand under its own state owned calorex label and in return hcai gets low-cost insulin in patients hands as soon as possible It also gets seats on civica's board and crucially it gets access to some of civica's expertise So as to catalyze the state agency's efforts to eventually create fully public manufacturing Seems like a reasonable and practical quick probe quote perhaps But with that public private partnership has come some concerns over transparency And long-term vision For example, civica has claimed trade secret like proprietary interests in some of the knowledge that it's contributing to the partnership And has shielded that information from disclosure to californians to team international to the broader public And civica's incentives aren't exactly the same as california's were patients For example, civica would presumably prefer to have hcai rely on civica for insulin manufacturing for many years to come Rather than see hcai transition to its own fully public manufacturing in the next few years And while the current hcai civica contract imposes price constraints on civica Longer term civica will probably want to raise its prices So long story short t1i has an interest in keeping the hcai civica partnership transparent and accountable To patients And this was just reported. I think last week in the american prospect so I can talk about it more My students that i've been working with t1i to try to create Working with t1i and with hcai the state agency to try to create a robust patient advisory council That will advise decisions made by hcai and civica that will have some visibility into their decision making We want this patient advisory council as part of the sort of permanent structure of hcai and calorex a permanent voice for patients My students now for example helped t1i draft a proposed charter for the advisory council laying out its rights and responsibilities We're still talking with calorex with hcai about this T1i doesn't just want any patient voices shaping calorex. It wants independent patient voices I already talked about this that not all patient groups are independent So another kind of legal task that we've worked on is trying to create a workable definition of what an independent patient group is And encouraged hcai and civica to bake that into The patient advisory council for the record t1i doesn't insist on having one of its own members on the council Though I think it would happily place one or more. There are other terrific independent patient groups Representing people living with diabetes in california like health access california, for example Um Excuse me Another big thing that we've done with two women international Is contract analysis. So even before the patient advisory council has been created and populated We've been offering informal advice to hcai officials responsible for calorex and responsible for contracting with civica um, we've urged hcai to fight for rights to Um Certain kinds of information certain things that we think will position hcai to shift to fully public rnd And fully public manufacturing in the years to come and that includes rights to things like regulatory data to intellectual property And more the first major hcai civica contract was announced and released just this past march My students and I have done a detailed post mortem of the contract and one of my students Nicole coons and I had a short article in the works analyzing what we think is good about the hcai and and civica contract um, but also some thoughts on what we think could be improved And we're thinking about this piece not just as shaping calorex, but also shaping public and school initiatives and public pharma initiatives more broadly in other states as well um Let me digress just briefly and say that the hcai civica contract illuminates how slippery the term public pharma can be Calorex is undoubtedly a public pharma initiative We have a state government agency owning a pharmaceutical trademark. It claims or intends when by all rights by all indications it will procure and distribute drugs on a non-profit basis But it's not totally clear that calorex or hcai as it stands now is really a public manufacturing initiative And public manufacturing is sort of as you drill down you realize Can mean a lot of different things it can mean fully public manufacturing where government agencies own and operate the factories It can mean government owned but contractor operated factories It can perhaps even mean things like publicly traded even for-profit companies where a government agency owns a controlling share of the stock And you have other things like public benefit non-profit corporations and even like worker owned co-ops with board seats for government officials and there's maybe some kind of spectrum or Or panoply of options within this This category of public pharma So one of the things we sort of learned my students and i and t1i Is that you have to look under the hood of public pharma You have to look sort of at the function and not just the form To see who has control of the infrastructure who has control of the knowledge he writes The other vast digression here i'll just say is there's just we've seen incredibly rich opportunities for lawyering here You know contract interpretation looking at state corporate law Thing about charters and bylaws This is not my traditional specialty But i've done my best to to learn enough to keep up with my students and to give t1i and hci the best advice I can um, okay, sorry, let me get back on track and say the last two things that i've worked on with With t1i vis-a-vis calrx are distribution challenges and public education. So um, distribution challenges will be real Manufacturing insulin and getting fj approval would be major achievements, but not enough necessary but insufficient We have to get that insulin to patients and as audre steenan described in her american prospect piece last week Um hc ai and calrx may need to devise some new strategies to distribute calrx insulin because the pbms the distributors the middlemen The pharmacies that currently get insulin from manufacturers to patients Uh, they take a hefty cut of the sort of the the current price of insulin They have incentives in the to perpetuate the current system. They may not want to play nice with a low cost alternative I can't talk too much about this work because it's not yet public but i will say We think the distribution challenges will be a major part of the work of the patient advisory council I think audre reported on that and we're looking at some creative solutions including things like getting insulin to patients by mail And also think about how we can work within an existing california state pharmacy law to encourage pharmacies to stock calrx Um, last thing i'll say is that t1i my students have started already doing some outreach and education work to build awareness Maybe even might say build a market for calrx insulin in california This is much more t1i's work, but my students and i've been proud to be part of it Kevin ran for example who's uh, who wasn't till very recently the chapter leader in the state of california He was on the radio last year with chris noble from health access california to talk about calrx insulin on the horizon and why patients should care Patient outreach and education Knowledge and resource sharing among people living with diabetes is a is a core part of t1i's work And so it's a core part of my clinic's work too I'll just say briefly like t1i part of what it sees as its job is It's you know, it's not just kind of winning these big policy victories It's also building and sustaining mutual aid networks and knowledge networks And after every legislative victory that t1i has won like for example getting emergency insulin loss passed in minnesota and other states t1i has done outreach To patients to educate them to inform them about these laws that provide You know new rights new access to insulin So that's part of what we're thinking We need to do when calrx insulin find their launches Okay, um, so i'm going to turn briefly to the future of calrx and other public insulin efforts before i close The challenges are very real Even vis-a-vis calrx, which is the big banner initiative in the u.s. So far Um, you know, i've mentioned some challenges already transparency accountability Distribution challenges another one very practical challenges that civica has apparently fallen behind its ambitious development timetable So in november Excuse me, uh Bloomberg reported the civica is not yet ready to file for FDA approval And the patients are now unlikely to see calrx brain insulin before 2025 um At the same time, I think the calrx insulin remains a vital, uh, and even transformative intervention into the broken insulin market in the u.s I'll say to kind of uh anticipate some questions that i've gotten Talking about this or parts of this work before Many of you may know that in early 2023 And again actually last week the big three insulin manufacturers sanofi nominatus canioli lili Announced massive price cuts to the list prices on some of their products Some as big as 80 percent and some products Are now Officially at least priced at less than 30 dollars per vial T1 international and i2 uh are wary Unsure that these price cuts are actually reaching patients, especially the patients who need the most last year t1 i did a survey of pharmacies And patients across the u.s. Have found that most people were unable to get the promise 25 or 30 dollar vials of insulin um, and one major manufacturer nova nordis withdrew an older product called levin mirror from the market completely in the u.s. After promising to cut its price a few months prior um, so, uh team and I and I continue to think that public pharma as imperfect and and uh, uh Uncertain as it is still offers, um Uh A promising alternative to um this sort of track record of broken promises and exploitation from these big for-profit manufacturers um To that end, um, two and i is trying to get more states to embrace public insulin manufacturing And my students genie lay in kyla allston. Nicole coons and zelly rosa have written an extensive toolkit What we call a toolkit to guide t1 i and other patient activists as they advocate for public insulin Not just manufacturing procurement and pbms in various states around the country. Um, we're continually updating this document with research Genie and kyla wrote an op-ed with t1 international staff member allison heart last year I'm encouraging more states to look at the calorex model Um, and I think it's fair to say even despite the challenges calorex has encountered Momentum is building for example the state of main has established a commission to explore the possibility of public insulin manufacturing there um allison heart of t1 international is one of about a dozen experts on the commission Uh, also connecticut just joined the array rx public pbm. Um, so that public pbm is growing Hopefully insulin will be cheaper for patients living in california um All right, I think i'm going to try to wrap it up and reflect and close as I've already talked longer than I intended um I just want to offer a handful of quick reflections on why I find this public pharma work exciting um inspiring even um one is that there's so many places to start as I I tried kind of roughly to taxonomize before a public pharma can mean public rnd in manufacturing But it can also mean public distribution public pbms Uh figuring out how to get meds to people by mail um There are opportunities I think to rethink every link in the chain from sourcing starting materials to getting medicines Actually to patients. So there's just lots of opportunities to do work here Um, and it kind of on that point There are not nearly enough practicing lawyers at least in the us working on this. I think we need more help T1 international has questions that we haven't been able to answer and I know From conversations. I've had there other patient and consumer groups You know kind of representing people living with other kinds of diseases and conditions Looking for legal help. Um, everyone from cancer patients There's been you know dozens of cancer drugs and shortage in the us in the past couple years People living with adhd adhd drugs have been in shortage So folks are looking for help to kind of get new public pharma initiatives off the ground I'm glad to put lawyers with time and interest in touch with some of those organizations if you're listening A third reason I find this work exciting is it for me It sort of reminds me of my my limits the limits of law the limits of lawyers A lot of what we do on public pharma is quote-unquote non-legal. We're doing factual research. We're doing policy work. We're doing Advocacy or we're simply like sharing knowledge building knowledge with our client with its members When with allies, um, there's lots of traditional legal work too doing legal research writing memos and You know, even doing things like drafting charters or public records requests But uh, yeah, the boundary is blurry and I like this project in part because it's forced me to embrace a more Rebellious or movement lawyering approach And T1 international volunteers that the people living with diabetes Themselves are really the stars and drivers of this story. I'm not us lawyers Um, two more quick reasons why I care about this work One is just I'm working at the state level in the us often feels to me more hopeful More fertile or less defensive and depressing than work at the federal level. Um, whether that's the federal courts or us congress I suspect everyone listening knows about us federal courts and congress. I won't say more than that but There are good things happening in in the states Um, and the last thing I'll say is I see and I feel on this public pharma work In real solidarity with other Legal and and activist and political movements fighting for greater public control of other parts of our economy and society in the us In housing in energy and transportation In information technology and telecommunications are much more The fight for public pharma is in some sense a fight against powerful corporate interests for an industrial policy that better serves people It's a fight over who controls the agenda for innovation a fight over who enjoys the benefits of new technologies and who suffers the harms of new technologies um And in some sense public pharma because it's happening in the us offers a key test it like calorex, for example Poses the question can we build at the state level in the us viable alternatives to increasingly predatory? An unsustainable corporate structures Searching for ever higher returns. I think so. I hope so And I hope that what works in public pharma or what doesn't work in public pharma informs our efforts to You know to remake energy to tackle the climate crisis and to do so much else In the united states and and elsewhere Um, and I wrote a little bit along those lines in a recent piece in boston review with rachel rama chandra Any new captions game which is on screen? Okay, uh, so sorry to go long Let me just very quickly acknowledge and thank the people who really did this work so four of the student attorneys who've Done a disproportionate share of it are kyla allston genie lay jelly rosa and the colcoons All of them were in my clinic at various points. I'm all amazing and talented. I can't wait to see what they do in the world as lawyers. I'm also want to credit two internationals Staff and their member volunteers. I'm covering chewy but For folks who've been involved in public pharma worker. Shayna casper policy and advocacy director elson heart Development manager kevin wren. Um, who's a member and volunteer but also california state chapter leader And chewy lamb also an advocate member. This is california There are many many more who I need to think Folks researching and advocating public pharma whom i've learned from i'm including matt herter and jannis graham at dowl dana brown at democracy collaborative chris nobel An insulin advocate in california I'll say very briefly dana brown and I gave a talk a very informal talk On public pharma in september To universities allied for essential medicines and we compile the list of further reading. It's on screen here I'm glad to circulate it to folks after the talk or even drop it into the zoom chat if that's helpful Dana is really the expert on public pharma in the u.s. So I encourage you to check out her stuff Okay, that's it. Let me stop talking and i'm eager to hear your reaction and questions. Thanks Thank you chris if we were fortunate enough to be in person. You hear lots of applause. I'm sure Before I open it up to questions I misdirected folks earlier. I think I said put questions in the chat Use the q&a function. We've got one there Now but that's the best place to put your questions and I'll articulate Them for you. We have a bit of time. We have until about 25 after the hour For discussion. So the first question Hey matt. I'm so sorry. I heard you say the first question, but then I I haven't heard you say anything since then I think I tapped on mute by accident But it was just that little fragment that you missed, right? I didn't just if you could start the question over I'd appreciate. Sorry. Yeah, sure. I haven't got it So our first question is from Colleen Fuller Thanks you for the very interesting presentation T1 international have done a terrific job on a number of fronts including public education I've been working to support an increased range of options in the insulin market including animal sourced insulin Cannot lab inventories show it had produced six standard types of insulin and both beef and pork in two concentrations plus Half of these were for insulin for a small number of people is t1 looking at this type of diversity yeah, um short answer is yes, and uh, the The advocates of t1i will know more about this than I do. Um I think long term t1i has embraced or endorsed public pharma for like all of the forms of insulin and other medicines like especially Insulin is not the only medicine that people learn with diabetes rely on For now, I think The calorex initiative has decided to target just three forms of insulin And so we're sort of hoping that those the calorex succeeds in getting those three to patients But then I think part of the longer term strategy is getting calorex to go fully public and getting calorex Sort of portfolio of insulin products to expand So that answer the question I think so and and Colleen we welcome a follow-up if you want to add one into The q&a box and please others feel free to do so in the meantime chris. I was really um uh, you know excited to hear the connection with this I this broader movement to sort of Take back control and have a stronger public presence in all sorts of sectors But so I wanted to kind of ask a question about social movements and political strategy because I think You know part of the value of this work in pharma in particular in terms of building up a movement is Naming all of these things that are in fact already public pharma, right? And that's how you point to like how it's all these things and more Um, and I think that's powerful to showcase the value that the public sector already does And perhaps identify areas where it's not there enough But I guess I wanted to invite you to reflect on whether there are downsides to not being more specific about that vision um And I'm getting at that because of like the example you gave of how You know without t1's involvement the focus on a more diverse set of insulin products may not have been possible without that input So having maybe public pharma has to mean public participation in very concrete ways But i'm also thinking about some of the other things you listed like fill and finish You know some manufacturers of vaccines. I've been speaking with other manufacturers and state controlled enterprises in basil They will say we will never do fill and finish because it leaves us vulnerable to supply chain problems And so we can't address local needs. So for them part of public pharma That's our words. Not their language is having full control over the whole process Yeah, so I guess i'm wondering i'm inviting you to think out loud about Whether we need to be more specific about what we mean or if we're nearing that political moment um Yes, uh, so I think If I so I think you've asked a really Um important and kind of like central question. Um At least if I understand you correctly and I think I'll start by saying There's both like value and hazard in looking To historical examples and looking at the kind of patchwork of public pharma efforts that exist in the us and You know, there's there's value in those examples because number one They show that it can be done that it's not totally implausible for public agencies to replace private companies doing many of these things um And to the extent that they've made mistakes. Um, we can learn from those lessons but part of the hazard is looking at um what already exists or has existed existed is that it can kind of narrow your Um your vision and make you think that like the only things that are possible are what we've tried before Um, and I think they're in the world of public pharma I think Dana brown will be one of the first people to talk about this and she indeed has already started writing about this And I think others thinking about kind of public governance of important kinds of infrastructure Um, all are grappling now with questions about How to create Institutions whether those are public agencies or public benefit corporations or other Whatever the precise formulation is institutions that are democratically accountable that serve patients that also kind of respond to a broader democratic public And yet are not so I don't like you want some level if it's a drug manufacturer You want some level of independence, right? You don't want I think like the research agenda getting reset every election or something so Long story short. I think um one of the deep theoretical questions in the area of public pharma is like what are the Ideal arrangements within these institutions if we have in the u.s. At least right we have like You know volumes and volumes and volumes written on corporate law and how to orient organizations or in orient firms around You know shareholder return maximizing returns for shareholders and we have boards of directors and executives and securities litigation and all of this law that exists to structure those organizations in ways that serve shareholders um if Shareholder profit shareholder returns is not the ultimate You know goal of a public pharma agency We presumably need very different rules and different incentives, but I don't know that we know exactly what those are yet Um, and I think people are starting to write about this in different ways in different places and data is among them Um, I have a colleague at Columbia law school named katerina pistor who's teaching A class this semester that i'm going to try to sit in on call the law of non capitalist enterprises That looks at worker-owned co-ops and looks at other kinds of um, uh sort of non-profit seeking or Institutions for which profit is not the only or main goal. Um, and basically I hope to learn more I've just given you a rambling answer With no punch, but this is where we need people writing and thinking about this desperately. I think yeah, yeah And the color Conversation about how do we change the status quo? People don't define what actually the essential features of this status core and one alternative flex conversely, but The q&a is starting to fill up. So I'm going to make sure to pivot to some of the other questions, but that that was very helpful um So another participant asked that they understand private pharma companies are engaged in lots of political lobbying in different ways But do private companies ever provide the government directly with funds to conduct public pharma activities? And how much of a barrier do you think big pharma's political agenda plays in a shift to a more public pharma? Hmm Good questions. Um, well, I certainly think big pharma's political agenda plays An enormous role in the shift or in the In resisting the shift to public pharma And I think that some of the news coverage, for example Like when california enacted its law in 2020 there was very critical news coverage I mean with lots of kernels of truth, but critical news coverage and said, um, you know Public agencies like command and control economies have failed governments are bad at innovation um But also there are all these like practical considerations that governments won't state agencies won't be able to crack like you have Refrigeration you have supply chains. You have like this very complex interplay of many many many actors Um, and how are a few government bureaucrats sitting in sacramento going to figure all of this out? Um, uh Yeah, so so I don't know all of those narratives are being Echoed by big pharma and certainly like calorex has been Calorex has been kind of uh Both vilified and dismissed by the big tree right sometimes big three will say like well, we don't really think calorex is going to get there Um, we're not really worried because it's not going to succeed um But then they'll also say If it does get there, it's going to hurt patients because they're not going to be making the right kinds of stuff in the right kind of way We can't trust these agencies to do the right um So i'm not sure anyway, so I do think the kind of like the the power of uh for profit pharma and the political economy is incredibly important um at the same time, uh, these for profit companies that resist I think the kind of principle of public pharma or uh resist certain implementations of it benefit from it in a million different ways um I don't know of many examples of private companies funding public pharma activities per se Um, but certainly they partner with public agencies and especially at like an early stage research for example, right? Like it's almost the paradigm in the u.s. Where early stage research is done in a government lab or a government funded academic lab Uh, and then the technology gets transferred to um To a private company Yeah um Just moving on just to make sure we get through a few more questions because they're they're really helpful um Harrison asks seeing the drugs price very differently country to country What pressure can you put on big pharma companies to lower prices in their countries? That do not have a robust patient advocacy system Yeah, and there is no t1 international Yeah, so one thing is um, you know, hopefully, uh, we will have more robust patient advocacy in more countries around the world And t1 i does a lot in india for example, um where like insulin rationing is a huge problem um But there's no easy. I mean to some extent this is a this is such an important question But to some extent is the question inextricable from like questions of like imperialism and and extraction and and and and and power global power So I don't have like a specific public pharma solution to this except that my hope is that a public pharma manufacturer Like calorex could make and sell its products at low cost all over the world Not just in the place where they're made and that goes back to incentives, right like calorex um, I hope that calorex's goals are not to maximize revenue and thus if calorex sells to other states or other countries It's not charging illy-lilian like prices. I hope instead that you have, you know, honestly what we've seen for example with Like cuban vaccines where you have manufacturers selling products at low costs all over the world Yeah very true Sheila wildman asks a few questions. I'll just for the sake of time try to drill down on one or two First can you comment on challenges of course strategies around access to mipha pristone in particular? and then Also this this thought around whether focusing on public pharma might skew things away from other clear, you know Drivers of health outcomes the social determinants of health and alternatives to pharmacopharmacological interventions So is there space for those that sort of wider set of questions and possible interventions? In the context of public pharma as she I hope i'm doing justice your question Yeah, thanks for those questions. Um, i'll take the second one first just to say um Yeah, I at least think of public pharma work as kind of a subset of public medicine work in the u.s. And then you have and I say that because I think a lot of the folks who embrace public pharma are among the folks who are skeptical of the Like sort of silver bullet like the pharmaceutical solution to health problems And would really like to see universal health care universal health insurance in the united states Whether that's medicare for all or in the another system and the development of more um public health infrastructure in the u.s I think of this work as complementary and not contradictory I mean part of the problem in the u.s part of the story of disinvestment in public health in the u.s Has been that we pay so much for drugs and we have this kind of Like, you know, we allocate x billions of dollars every year We have the story of innovation the story of like silver bullet solutions. I think about things for example, like State prison systems in the united states spending so much money on safas pavir the hepatitis c cure That they couldn't afford other kinds of health care So anyway, I hope the work is complementary and not It doesn't displace other work and Gosh mipha pristone. I haven't I don't know of any public pharma effort on mipha pristone Mipha pristone in my mind would be a good candidate because it's a generic drug. It's relatively simple to make You know so much of the kind of the turmoil in the u.s Over mipha pristone has not been about price, but just about whether the drug's approval will survive That's being challenged right now and whether states like west virginia will be allowed to create their own effective bands on the drug If that's the case, I'm not sure that having a public source versus a private source makes makes a huge difference But something I want to think about more and that's separate work that actually my students and I have done with a different client doctors for america On access to mipha pristone Um, just do one more because we only have time but it's it's great to see that this talk has provoked such a good discussion Um, so amanda porter writes this talk was excellent. Thank you While I see some of the benefits of distributing mail by mail medications to patients directly I did by myself wondering about potential risks of skipping the pharmacist's usual role in providing patient education Assessing appropriateness and so on It seems like empowering pharmacists to work side outside of for-profit pharmacies might be an area to explore so that we can Both obtain financial benefits for patients while also reducing risks that might arise from cutting the pharmacist As opposed to the pharmacy out of the picture Terrific point. Um, I think there are real trade-offs there. I think the sort of meds by mail. I mean there are advantages Um, I know for the first time for example, there have been major improvements in access To the drug achieved through the legalization of mipha pristone by mail in the u.s But there are also harms that attach to like removing a professional And an opportunity for advice to patients. Um, I think right now it's uh I think that mipha that that um insulin by mail is maybe not the optimal solution But might be a workable solution for calrx and perhaps rather public Insulin initiatives, but this goes to a broader point that like to some extent What we're trying to do is figure out how to get public pharma initiatives started Against the backdrop of these private actors that are really unwelcoming to those initiatives But over time, you know, perhaps we could imagine I don't I don't actually know if there's any history of public pharmacy infrastructure in the u.s I'm sure there is actually with the da and I'm absolutely certain there is Yeah, so, you know, perhaps there's a longer term solution where we can have kind of both We can have public pharma, but also have pharmacists advising patients through these choices that they make Yeah, it's a really important point to think about it. Um Well, thank you. I will thank you again in a moment. I just uh, we'll have to close the discussion there In keeping with our practice, but before I do, um, thank you once again I Wanted to mention for folks who've joined us online that our next seminar Is going to be actually in person So if you're in the area, hopefully you can make time to take part It is on February 9th. I had the the Schedule in front of me. Yes, and the next presentation is by alexa yakubovich And the title of her presentation is how is the health system responding to violence against women in Nova Scotia So she's a member of the house these community health and epidemiology department within the faculty of medicine and that is on Friday February 9th, so roughly a month's time. Hopefully folks will be able to get together on that date With that said, I just wanted to thank you again chris not just for a provocative talk But also kind of a courageous performance with the symptoms you're enjoying right now You don't look like death But we really feel your pain. I think uh, it's you know, it's such a rich topic And um, I really appreciate you persevering through the presentation I'm so grateful to uh for you all to to have invited me and I Appreciate your patience forbearance as you I sort of felt like performance aren't at points as I like You know sweat and coughed my way through various parts of the talk, but thank you Of course, and it is also just powerful to see working closely In a kind of traditional lawyering way but in a way that's really supportive of interest that perhaps traditional lawyers don't Uh welcome and working with the students in your midst to to create these opportunities for advocacy and effective change Um inside, you know, these powerful spaces. Um, where perhaps a lot of people don't have access so it's just such important work and Uh, really appreciate you bringing it to us on this day, uh, even from a distance So on that note, thank you again chris. Um, thank you everyone online for joining us Uh, we look forward to seeing you again soon. And can I say one more thing which is email me? I'm going to put my email. Sorry. I'm now I'm blasting the poor zoom chat, but I've I've dropped a link to the list of further reading that dana and I compiled a few months ago And I've just put my email address in there too. So glad to hear further questions and reactions. I have to I think cut and paste that to make sure oh, sorry of it. Sorry. Sorry. Okay, and I'm gonna extra work No, no, it's it's totally okay. But I will just suggest if folks look up the health justice institute at dow and want to email me I can relay that information Um, just as people start to drop off the call. So I want to Thank you once again. Thanks so much. Thank you all Take care everyone