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Good afternoon everyone.
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Welcome to Ethics Grand Rounds.
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Before I introduce our speaker,
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let me remind everyone that we, next month's presentation
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is from Jim Dubois who is the, who's a psychologist
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and ethicist and director of the ethics program
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at Washington University in St. Louis.
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And he has done a very interesting study,
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NIH funded study of several hundred physicians,
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it's a qualitative and quantitative study
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of several hundred physicians
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who got into situations of serious ethical misconduct.
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Things like inappropriate prescribing,
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sexual relations with patients and so forth.
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And so he's going to both present his findings
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and also some advice about how we can better serve
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those who are patients as well as those who offend.
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So please stay tuned for that.
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It's a special privilege to introduce Professor Steve Inrig,
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who has the paradoxical relationship to this institution
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being a colleague as well as a former colleague
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in that he spent, oh what, six years or so
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here at UT Southwestern in the then
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Department of Clinical Sciences
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and now the Department of Population and Data Sciences,
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where he continues to be an active collaborator
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particularly for that department's efforts
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in health surveillance, disparities, and prevention.
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And so in that way he's both a former colleague
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and a current colleague.
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His official position currently is as the associate,
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and can I announce your promotion?
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(laughing)
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No, okay, I can't announce it yet.
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But he is currently associate professor
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in health policy and management
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at Mount Saint Mary's University in Los Angeles.
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He's director of their graduate program
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and masters of science in health policy and management,
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director of interdisciplinary health care research
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at that institution.
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And he's in the Department of History and Political Science,
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Health Policy and Management, again at that institution.
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He has an extensive education,
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a BA from UNT in American history,
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an MA in intellectual history
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from Trinity International in Illinois.
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He got his PhD in history of medicine
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and health policy at Duke.
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He has a postdoctoral position completed
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at the University of North Carolina, Chapel Hill
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where he completed his first book about AIDS care
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in North Carolina.
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And then he came to us in 2014 at UT Southwestern,
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or left UT Southwestern to take his current position
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at Mount Saint Mary's.
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But while at UT Southwestern,
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in addition to functioning, he was one of the first I think,
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recipients of the masters degree in clinical sciences
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that we now have offered for many years.
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He's got dozens of publications,
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I just wanna mention a couple of his most,
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his two most recent books.
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One was the aforementioned,
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"North Carolina and the Problem of AIDS:
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"Advocacy, Politics, and Race in the South"
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Published by the UNC Press.
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And then more recently in 2017 his
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"History of the AIDS Pandemic:
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"Mobilizing the Global Response, Mobile Health Governments
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"in the WHO", that was in collaboration with Michael Merson
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who was a primary leader in those efforts.
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So without further ado,
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please welcome my colleague and friend Steve Inrig.
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(audience applauding)
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Well thank you very much for having me
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and I will do my best to not to fill up the whole time
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so we can talk, but it's great to be back
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and see a lot of very familiar faces and dear friends.
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So thank you for the opportunity to be here.
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I've written a lot, studied a lot on HIV among other things
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and what I wanna talk a little bit about today
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and I'll slam through all my slides on this,
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but when I was, the first book I wrote
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was talking in part about the epidemic in North Carolina.
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And North Carolina happens to be the place
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where the first drug that worked against HIV
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was developed and then brought to market.
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And the second book was about global governance,
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and one of the challenges was is the company
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that brought this drug to market, then refused
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to allow flexibility in patents so that the epidemic
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in Africa went, oftentimes without access
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or full access to drugs, both the first drug
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and a number of other drugs until the early 2000s
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when things changed.
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And so in terms of ethics, I just wanna think
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about something called the Health and Human Rights Framework
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which has really helped to push drug companies
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into getting involved and thinking about flexible ways
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to use their patents to give access
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as well as the governance structure
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that's opening up some of the restrictions
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that have been placed in there.
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So lemme just move forward.
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Obviously some of this stuff is gonna be really familiar
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for all of you, so I won't have to spend
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a lot of time on there.
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I'm not here to bad-mouth research,
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obviously it's been really tremendous in lots of ways.
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Biomedical research, we've developed lots of new vaccines,
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we're doing some fantastic things in cancer and HIV,
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and it is strengthened prevention and whatever,
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so it's very very important.
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And we're seeing all sorts of different diseases
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where burden of disease has fallen.
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So the international drug regime research and development
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is very very important.
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And we're seeing globally the burden of disease
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has actually dropped.
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If you take a look at that slide you'll notice
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there's kind of a little bolus there in the middle,
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or maybe a big bolus in the middle,
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and that's Sub-Saharan Africa
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where HIV claimed a lot of folks.
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And you can imagine what that would look like
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if that had been addressed differently.
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But in many respects, trends are moving
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in a very positive direction.
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That being said, there's still a lot of challenges.
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And this is the thing that certainly interests me.
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About two billion people globally
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still have inadequate access to needed medicines.
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World Health Organization
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will call them essential medicines,
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but generally speaking a list of medicines
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that countries need to have to be able to provide
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robust and comprehensive health to their populations.
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We have brought new medicines
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and essential medicines to market,
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37 over the past couple of decades,
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but that only accounts for 4% of new drugs
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that are coming to market,
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whereas neglected tropical diseases
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constitute about 11% of the disease burden globally.
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And obviously not everything needs to be equal,
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but it's one of the things where it affects
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a huge portion of the population,
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but it's underrepresented in the types of research
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and the types of drugs that are being brought to market.
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Some of that is just the nature of science.
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Some of these diseases are very, very difficult.
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It can't be a one to one correlation.
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But the reality is in fact
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that we have responded to a lot of these emergencies,
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particularly Ebola
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and other African viral hemorrhagic fevers,
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which causes great concern.
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And in the meantime, from 2009
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research in drug development and some of these other areas
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has actually declined.
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And so, there is an important need for us to continue
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work in this area.
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One of the challenges is is that globally,
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the global research and development market
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is focused on kind of a market-based model.
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And for HIV, that's been very, very important.
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But in other diseases,
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Zika, Ebola, Neglected Tropical Diseases,
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there are all sorts of people
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who do not have the power of the purse
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to be able to encourage drug companies
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to invest in diseases that they have.
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And so, countries, organizations
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have started to look to other mechanisms
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to try and spur drug companies,
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try to spur research organizations
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into moving into these areas
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and developing drugs that might not be,
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cost benefit analysis makes sense,
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but might have other value systems in play.
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And one of the value systems that people have looked to
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in spurring activism in these areas
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is something called the Health and Human Rights Framework.
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And so, I wanna talk a little bit about that.
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It comes out of the World Health Organization.
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World Health Organization,
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I don't need to go in too much detail,
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but it's the main body coming out of the United Nations
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after World War Two
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that was focused on addressing the needs
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of vulnerable populations around the world,
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and making sure to deliver healthcare.
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Since 1949, it has largely been the entity that's focused on
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the tropical diseases that have been neglected
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by a lot of Western countries,
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and that's kind of been its primary focus.
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So this has been a main driver.
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I don't need to go into all the details other than to say
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that in 1948, there were about 56 members.
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Right now, there are 192 different countries
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that are participants in this.
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Some countries belong to the World Health Organization
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that don't belong to the United Nations.
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And so, they have their own World Health Assembly
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where they go and share data, talk about health needs,
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and then try and come up with strategies
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and programs that impact them.
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One of the things
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that the World Health Organization has done
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is to really capitalize on the larger concept
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that the United Nations was built on,
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which is not just protecting people
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but preserving their rights.
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So avoiding war, but also thinking about human rights
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and instantiating them in everyday life.
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For the World Health Organization,
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this means that they consider health to be a human right.
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And they mean this in a very particular way,
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some of which seems rather audacious
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in the way they've worded it.
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First of all, they envision
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the highest attainable standard of health
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is a fundamental right for everyone.
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And how they define health is
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a state of complete physical, mental, or social wellbeing,
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not merely the absence of disease or infirmity.
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Which if you're a parent,
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there is no way you're ever gonna get to that
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just by the nature of the anxiety your kids cause you.
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So, but you understand that that's very aspirational.
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But the point is not merely that people aren't sick
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but they're living in robust health.
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But then what the World Health Organization
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and the United Nations in general says
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is that states have an obligation
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to create an environment for their people
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to move to that right of health.
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Now, they recognize that that can't happen
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just by snapping your fingers, that it's a process.
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And our dearly beloved coach
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liked to talk about working the process.
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And the WHO has a process in thinking through what it means
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in terms of moving towards the right to health.
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First of all, they recognize it's progressive realization,
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that countries have to have
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a strategy that they're moving towards.
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So even if they have not moved to comprehensive health
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for all their citizens,
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that they're at least trying to do that.
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But that they are using the maximum amount of resources
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including international assistance
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to move in that direction.
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Obviously, for low income countries
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there's a lot more international assistance
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that they're relying on.
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And there's huge debates as to what portion of one's budget
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one ought to set aside for health.
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World Health Organization has given targets,
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and those targets are looked at and smiled at
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and then people talk about reality,
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'cause it depends on what your circumstances are.
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If you're in the middle of a civil war,
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as to how much of your budget you're gonna designate
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to your health system.
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But the World Health Organization says
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that there are a core set of minimum obligations
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that all countries
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that belong to the World Health Organization
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need to uphold.
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One is that they should be
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nondiscriminatory in their health systems.
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Which means that racial groups, ethnic groups,
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religious groups should not be getting
275
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second-tier level of care,
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that everyone should be having access to care.
277
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As well as essential levels of food,
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essential levels of housing and shelter, sanitation.
279
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And then they talk about the provision of essential drugs.
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Again, this is not a whole panoply of the pharmacy
281
00:13:21.330 --> 00:13:22.390
that's available to people,
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but the major diseases that people are dealing with,
283
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both communicable and non-communicable,
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that the country would have those available to people
285
00:13:31.060 --> 00:13:32.660
to be able to access.
286
00:13:32.660 --> 00:13:33.530
And then finally,
287
00:13:33.530 --> 00:13:35.360
equitable distribution of health facilities
288
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and that kind of thing.
289
00:13:36.820 --> 00:13:40.150
For my talk today, I'm gonna focus on the provision
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of essential drugs.
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00:13:42.010 --> 00:13:44.290
I mentioned that the United Nations
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views rights and obligations as state-focused.
293
00:13:48.340 --> 00:13:52.420
The idea is, is that a state has limited sovereignty.
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It's granted sovereignty by its people.
295
00:13:54.947 --> 00:13:58.490
And other member states acknowledge the legitimacy
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of that sovereignty to the extent
297
00:14:00.691 --> 00:14:05.260
that the state actor provides rights and services
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to its citizens.
299
00:14:06.740 --> 00:14:10.520
So the obligation is to respect the rights of its citizens,
300
00:14:10.520 --> 00:14:13.230
which means that they don't interfere
301
00:14:13.230 --> 00:14:17.300
with its citizens from enjoying the rights.
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That they protect their citizens
303
00:14:19.080 --> 00:14:20.640
if there are other people who are gonna try
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00:14:20.640 --> 00:14:22.607
and take those rights away.
305
00:14:22.607 --> 00:14:25.360
And that they themselves work to fulfill those
306
00:14:25.360 --> 00:14:26.771
so that individuals can have
307
00:14:26.771 --> 00:14:29.283
a full realization of their rights.
308
00:14:31.340 --> 00:14:32.890
But what if you're a country
309
00:14:34.040 --> 00:14:36.550
and you can't afford drugs?
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00:14:36.550 --> 00:14:40.320
If you have a requirement to provide essential drugs
311
00:14:40.320 --> 00:14:42.140
to your people
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00:14:42.140 --> 00:14:44.320
but a multinational corporation
313
00:14:44.320 --> 00:14:47.910
owns the patents to those drugs and sets the price
314
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and it's not something you as a low income country can pay,
315
00:14:51.810 --> 00:14:53.530
what do you do?
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00:14:53.530 --> 00:14:54.510
Are you, as a country,
317
00:14:54.510 --> 00:14:57.740
violating the rights of your citizens,
318
00:14:57.740 --> 00:15:01.320
or are there some other mechanisms that you can use
319
00:15:01.320 --> 00:15:02.800
to fulfill those obligations?
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00:15:02.800 --> 00:15:05.260
Or do you just let them fall by the wayside?
321
00:15:05.260 --> 00:15:06.980
Who's gonna enforce it?
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00:15:06.980 --> 00:15:07.850
Who's gonna come and say,
323
00:15:07.850 --> 00:15:10.600
you're not doing a good enough job feeding your people?
324
00:15:11.486 --> 00:15:14.090
So this is the problem of essential medicines
325
00:15:14.090 --> 00:15:15.980
and some of these other things.
326
00:15:15.980 --> 00:15:18.350
Essential medicines satisfy the priority healthcare needs
327
00:15:18.350 --> 00:15:19.260
of a population.
328
00:15:19.260 --> 00:15:21.150
The World Health Organization has a list
329
00:15:21.150 --> 00:15:23.250
which they update every couple of years.
330
00:15:23.250 --> 00:15:24.800
It changes over time.
331
00:15:24.800 --> 00:15:26.420
Obviously, new diseases come,
332
00:15:26.420 --> 00:15:30.410
other diseases we get new technology and better medicines,
333
00:15:30.410 --> 00:15:32.446
and therefore those come into play.
334
00:15:32.446 --> 00:15:35.430
And different countries have different, you know,
335
00:15:35.430 --> 00:15:36.330
disease burdens.
336
00:15:36.330 --> 00:15:39.330
So what is true in Sri Lanka may not be the same
337
00:15:39.330 --> 00:15:40.350
as what's in Belarus.
338
00:15:40.350 --> 00:15:42.420
And so, those different countries
339
00:15:42.420 --> 00:15:44.500
have different requirements by the WHO
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00:15:44.500 --> 00:15:46.126
to provide those things.
341
00:15:46.126 --> 00:15:49.290
The reality is is that 30% of the globe
342
00:15:49.290 --> 00:15:53.040
does not have access to these essential drugs at all.
343
00:15:53.040 --> 00:15:54.700
And even in countries that are providing
344
00:15:54.700 --> 00:15:57.410
these essential drugs, in the lowest 27,
345
00:15:57.410 --> 00:16:01.170
in low income countries, the 27 lowest,
346
00:16:01.170 --> 00:16:03.600
only about 35% of their populations
347
00:16:03.600 --> 00:16:05.860
have access to enough of these
348
00:16:05.860 --> 00:16:09.060
for them to live disease-free.
349
00:16:09.060 --> 00:16:12.050
And so, the reality is is that essential drugs
350
00:16:12.050 --> 00:16:14.010
are a nice aspirational goal,
351
00:16:14.010 --> 00:16:15.680
but for a variety of reasons
352
00:16:15.680 --> 00:16:17.720
there are all sorts of people around the globe,
353
00:16:17.720 --> 00:16:19.440
as I mentioned, about two billion,
354
00:16:19.440 --> 00:16:22.070
who still are lacking access to those.
355
00:16:22.070 --> 00:16:23.930
So for states to fulfill their rights,
356
00:16:23.930 --> 00:16:25.305
how do they do that
357
00:16:25.305 --> 00:16:28.643
when they don't control access to those things?
358
00:16:29.550 --> 00:16:32.410
Well, this is where the history of HIV comes in.
359
00:16:32.410 --> 00:16:35.150
These have been problems for a long time.
360
00:16:35.150 --> 00:16:36.440
But, whoopsee daisy.
361
00:16:36.440 --> 00:16:37.510
Sorry about that.
362
00:16:37.510 --> 00:16:41.347
But AIDS really served as kind of a catalyst
363
00:16:41.347 --> 00:16:43.840
for people to analyze this system
364
00:16:43.840 --> 00:16:45.910
of research and development globally
365
00:16:45.910 --> 00:16:50.417
and the unequal distribution of drugs
366
00:16:50.417 --> 00:16:52.860
and other healthcare assets and start to say,
367
00:16:52.860 --> 00:16:55.890
we need to rethink some of these things.
368
00:16:55.890 --> 00:16:58.350
So I wanna say at the start,
369
00:16:58.350 --> 00:17:01.460
AIDS did not create the idea of health and human rights.
370
00:17:01.460 --> 00:17:02.540
That's been around for a while.
371
00:17:02.540 --> 00:17:04.670
Obviously the World Health Organization has had that
372
00:17:04.670 --> 00:17:06.380
since the 1940s,
373
00:17:06.380 --> 00:17:09.050
and there's groups like the International Red Cross,
374
00:17:09.050 --> 00:17:11.620
Amnesty International, Doctors Without Borders
375
00:17:11.620 --> 00:17:12.940
and Doctors of the World,
376
00:17:12.940 --> 00:17:15.570
which arose with this idea of protecting human rights
377
00:17:15.570 --> 00:17:17.250
and linking health to human rights.
378
00:17:17.250 --> 00:17:19.550
So this has been around for a while.
379
00:17:19.550 --> 00:17:22.930
But what HIV did was
380
00:17:22.930 --> 00:17:25.380
it forced people to rethink the paradigm
381
00:17:25.380 --> 00:17:28.133
based on how HIV was affecting people.
382
00:17:29.140 --> 00:17:31.040
Some of you in this room are not old enough
383
00:17:31.040 --> 00:17:33.380
to know about the advent of HIV,
384
00:17:33.380 --> 00:17:36.240
so you've lived in a world that always had HIV.
385
00:17:36.240 --> 00:17:39.470
But there are others of us who have gray hair like me,
386
00:17:39.470 --> 00:17:42.830
or color their hair so they don't have gray hair like me
387
00:17:42.830 --> 00:17:46.160
who can remember kind of when it emerged.
388
00:17:46.160 --> 00:17:49.050
And at first it was kinda something curious,
389
00:17:49.050 --> 00:17:51.140
and then it became something terrifying.
390
00:17:51.140 --> 00:17:54.930
In the United States, you can see the rise from 1980
391
00:17:54.930 --> 00:17:58.140
up until about 1995, '96,
392
00:17:58.140 --> 00:17:59.970
when protease inhibitors really changed things.
393
00:17:59.970 --> 00:18:03.000
But it became a dramatic killer
394
00:18:03.000 --> 00:18:06.550
of multiple groups of people across the country.
395
00:18:06.550 --> 00:18:09.020
It wasn't just across the country, but across the globe.
396
00:18:09.020 --> 00:18:10.930
And while we didn't initially realize it,
397
00:18:10.930 --> 00:18:15.080
in fact it had started in Africa many decades beforehand
398
00:18:15.080 --> 00:18:17.140
and had spread throughout the world
399
00:18:17.140 --> 00:18:19.280
long before we started to recognize it.
400
00:18:19.280 --> 00:18:21.770
But Africa was most severely hit.
401
00:18:21.770 --> 00:18:25.850
So in 1988 you can see these countries
402
00:18:25.850 --> 00:18:30.490
starting to get between 10% to 30% of the population.
403
00:18:30.490 --> 00:18:34.223
By 2003, Sub-Saharan Africa, particularly Southern Africa,
404
00:18:34.223 --> 00:18:38.350
had just outrageously high rates of HIV
405
00:18:40.779 --> 00:18:44.640
and the associated death.
406
00:18:44.640 --> 00:18:48.450
So AIDS was obviously a dramatic disease
407
00:18:48.450 --> 00:18:50.130
that needed to be addressed.
408
00:18:50.130 --> 00:18:52.550
Also though, it was a social disease
409
00:18:52.550 --> 00:18:55.562
that brought all sorts of taboos.
410
00:18:55.562 --> 00:18:58.140
It's been treated very, very differently
411
00:18:58.140 --> 00:19:01.000
than we think of things like Ebola
412
00:19:01.000 --> 00:19:03.260
or even tuberculosis, to a certain extent.
413
00:19:03.260 --> 00:19:05.810
There came with it discrimination and shame.
414
00:19:05.810 --> 00:19:07.524
So people could lose their insurance,
415
00:19:07.524 --> 00:19:12.524
gay men particularly had their social establishments closed,
416
00:19:13.400 --> 00:19:15.870
people were denied insurance or they lost jobs,
417
00:19:15.870 --> 00:19:17.910
there was housing discrimination.
418
00:19:17.910 --> 00:19:19.830
To this day, there's still violence towards people
419
00:19:19.830 --> 00:19:21.700
who are HIV positive.
420
00:19:21.700 --> 00:19:23.760
If you are a parent and you had HIV,
421
00:19:23.760 --> 00:19:26.090
oftentimes you could lose your parental rights.
422
00:19:26.090 --> 00:19:29.400
And so, this created a whole number of organizations
423
00:19:29.400 --> 00:19:31.880
that emerged to try and address
424
00:19:31.880 --> 00:19:35.020
not only the devastation of the disease
425
00:19:35.020 --> 00:19:38.483
but also the social implications and lack of social support.
426
00:19:41.600 --> 00:19:43.680
Early on, because of the recognition
427
00:19:43.680 --> 00:19:45.730
that this was more than just a disease
428
00:19:45.730 --> 00:19:49.380
but also a social phenomenon of discrimination,
429
00:19:49.380 --> 00:19:51.740
a number of groups started to think about
430
00:19:51.740 --> 00:19:54.100
the violation of human rights that was going along
431
00:19:54.100 --> 00:19:57.540
with the treatment of people with these diseases.
432
00:19:57.540 --> 00:19:59.780
And so, the Council of Europe,
433
00:19:59.780 --> 00:20:02.900
which is part of the European Economic Community,
434
00:20:02.900 --> 00:20:05.270
or now the EU,
435
00:20:05.270 --> 00:20:08.210
came out in the early 1980s and said that
436
00:20:08.210 --> 00:20:11.420
in terms of disclosing people's AIDS status
437
00:20:11.420 --> 00:20:12.530
that we need to do so
438
00:20:12.530 --> 00:20:14.823
in a context we're protecting their rights.
439
00:20:15.670 --> 00:20:17.850
The World Health Organization up until that time,
440
00:20:17.850 --> 00:20:21.240
even though it had been the one promulgating the idea
441
00:20:21.240 --> 00:20:24.660
of health and human rights,
442
00:20:24.660 --> 00:20:26.020
it didn't really talk about them.
443
00:20:26.020 --> 00:20:28.030
Health was a human right, they said,
444
00:20:28.030 --> 00:20:30.365
but then they didn't use that language.
445
00:20:30.365 --> 00:20:33.280
Starting about 1985 they noticed that people,
446
00:20:33.280 --> 00:20:34.730
particularly from Africa,
447
00:20:34.730 --> 00:20:36.610
were being denied entry and migration
448
00:20:36.610 --> 00:20:37.550
into other countries.
449
00:20:37.550 --> 00:20:38.900
And so they really started to think
450
00:20:38.900 --> 00:20:41.823
about disease status and immigration.
451
00:20:43.720 --> 00:20:48.720
In 1987, a nonprofit drug company named Burroughs Wellcome
452
00:20:52.670 --> 00:20:56.460
developed the first drug that worked against HIV.
453
00:20:56.460 --> 00:20:59.130
Initially it had been a cancer drug that had failed.
454
00:20:59.130 --> 00:21:02.150
It had been kinda kept on the shelves at Burroughs Wellcome.
455
00:21:02.150 --> 00:21:05.250
And then in the early 1980s they started using it
456
00:21:05.250 --> 00:21:08.500
against murine leukemia virus, found that it worked.
457
00:21:08.500 --> 00:21:11.420
And within three years, basically brought it to market.
458
00:21:11.420 --> 00:21:14.740
But the cost was extraordinary.
459
00:21:14.740 --> 00:21:17.870
In the early 1980s, the mid 1980s,
460
00:21:17.870 --> 00:21:21.080
it was $10000 to $12000 per year.
461
00:21:21.080 --> 00:21:23.210
Insurance companies, this was before HIPAA,
462
00:21:23.210 --> 00:21:25.540
so insurance companies were just dropping patients
463
00:21:25.540 --> 00:21:27.073
who had AIDS.
464
00:21:27.073 --> 00:21:29.693
And people didn't know how they could afford it.
465
00:21:30.780 --> 00:21:32.720
In fact, the price that Burroughs Wellcome
466
00:21:32.720 --> 00:21:36.040
put on HIV drugs sparked the creation
467
00:21:36.040 --> 00:21:38.060
of a new type of AIDS activist.
468
00:21:38.060 --> 00:21:40.870
The organization ACT-UP was created in part
469
00:21:40.870 --> 00:21:43.250
in protest to the way that a drug company,
470
00:21:43.250 --> 00:21:47.883
a nonprofit drug company, was profiteering off of,
471
00:21:49.040 --> 00:21:54.040
so they thought, HIV drugs and the AIDS crisis.
472
00:21:55.720 --> 00:21:58.290
Well, at the World Health Organization
473
00:21:58.290 --> 00:22:00.810
they weren't focused on drug access.
474
00:22:00.810 --> 00:22:02.290
The gentleman who'd started the program
475
00:22:02.290 --> 00:22:03.340
at the World Health Organization
476
00:22:03.340 --> 00:22:04.820
was a guy named Fakhry Assaad.
477
00:22:04.820 --> 00:22:07.610
In 1986 he died and he was replaced
478
00:22:07.610 --> 00:22:09.543
by a gentleman named Jonathan Mann.
479
00:22:10.400 --> 00:22:13.440
Jonathan Mann focused not so much on drug access
480
00:22:13.440 --> 00:22:15.360
as on removing travel restrictions,
481
00:22:15.360 --> 00:22:17.810
coming up with testing regimens that aligned
482
00:22:17.810 --> 00:22:20.010
with ethics and human rights.
483
00:22:20.010 --> 00:22:21.530
And he started talking about something
484
00:22:21.530 --> 00:22:23.770
called the third epidemic.
485
00:22:23.770 --> 00:22:25.410
So the first epidemic he talked about
486
00:22:25.410 --> 00:22:27.470
was the epidemic of the virus.
487
00:22:27.470 --> 00:22:30.300
As you know, the virus obviously can be latent in someone
488
00:22:30.300 --> 00:22:32.770
for about 10 years before they move to
489
00:22:32.770 --> 00:22:33.870
what we now call AIDS.
490
00:22:33.870 --> 00:22:36.240
They used to call it full blown AIDS,
491
00:22:36.240 --> 00:22:38.840
but it's obviously just the latest stage
492
00:22:38.840 --> 00:22:42.180
of the HIV infection.
493
00:22:42.180 --> 00:22:44.420
But he talked about a third epidemic,
494
00:22:44.420 --> 00:22:45.880
and this was what he was seeing
495
00:22:45.880 --> 00:22:47.223
in all of these different countries
496
00:22:47.223 --> 00:22:49.930
were the enormous social, cultural, economic,
497
00:22:49.930 --> 00:22:52.440
and political aspects of the pandemic.
498
00:22:52.440 --> 00:22:53.700
And so he started thinking
499
00:22:53.700 --> 00:22:56.610
about structural implications of AIDS.
500
00:22:56.610 --> 00:22:59.320
For example, if you want to stop
501
00:22:59.320 --> 00:23:01.100
the reuse of disposable needles
502
00:23:01.100 --> 00:23:03.060
in low income countries and Africa
503
00:23:03.060 --> 00:23:05.250
but the hospital doesn't even have the budget
504
00:23:05.250 --> 00:23:07.150
to pay for penicillin,
505
00:23:07.150 --> 00:23:09.010
it's really difficult to demand that
506
00:23:09.010 --> 00:23:12.223
as a way to help the hospital stop the spread of HIV.
507
00:23:13.830 --> 00:23:18.830
If you're trying to reduce the transmission risk of HIV
508
00:23:19.590 --> 00:23:21.593
in populations that are illegal,
509
00:23:23.210 --> 00:23:25.700
it's very, very difficult as a provider
510
00:23:25.700 --> 00:23:27.320
to talk with people who,
511
00:23:27.320 --> 00:23:29.730
if they came and disclosed their status to you,
512
00:23:29.730 --> 00:23:32.313
would be breaking the law just by doing so.
513
00:23:33.370 --> 00:23:35.360
And so, Jonathan Mann started to think through
514
00:23:35.360 --> 00:23:39.120
how do we address a disease like this?
515
00:23:39.120 --> 00:23:41.853
And at the heart of it, he saw, was discrimination.
516
00:23:43.820 --> 00:23:45.150
And so, he came up with something he called
517
00:23:45.150 --> 00:23:47.040
the public health rationale.
518
00:23:47.040 --> 00:23:48.530
Now, I've written a book about this,
519
00:23:48.530 --> 00:23:50.190
and this is a very, very slow process
520
00:23:50.190 --> 00:23:52.870
which I just shoved into one statement there.
521
00:23:52.870 --> 00:23:56.400
But his idea was that health and human rights,
522
00:23:56.400 --> 00:23:59.703
working against discrimination was a means to an end,
523
00:24:00.810 --> 00:24:02.580
that we wanna stop AIDS,
524
00:24:02.580 --> 00:24:06.140
so the way to stop AIDS is to protect people's human rights.
525
00:24:06.140 --> 00:24:08.170
If we protect people's human rights,
526
00:24:08.170 --> 00:24:12.160
then we can address their either risk for HIV
527
00:24:12.160 --> 00:24:13.710
or the fact that they have HIV.
528
00:24:15.140 --> 00:24:18.076
But he started immediately to move beyond nondiscrimination
529
00:24:18.076 --> 00:24:20.510
because a couple of things were happening.
530
00:24:20.510 --> 00:24:25.120
One is, if you allow, so the at-risk groups
531
00:24:25.120 --> 00:24:27.440
no longer are illegal in a country
532
00:24:27.440 --> 00:24:30.380
but those people still can't afford to buy condoms,
533
00:24:30.380 --> 00:24:32.010
you certainly have helped their social cause
534
00:24:32.010 --> 00:24:34.050
but you may not necessarily do anything
535
00:24:34.050 --> 00:24:37.540
about their disease state or their risk.
536
00:24:37.540 --> 00:24:39.460
And so he began to think about something called
537
00:24:39.460 --> 00:24:40.470
a positive environment.
538
00:24:40.470 --> 00:24:41.900
How does the World Health Organization
539
00:24:41.900 --> 00:24:45.400
create a positive environment in communities
540
00:24:45.400 --> 00:24:47.263
so that they can fight HIV?
541
00:24:48.380 --> 00:24:49.480
And so, he started thinking beyond
542
00:24:49.480 --> 00:24:52.500
just individual human rights to group human rights,
543
00:24:52.500 --> 00:24:54.650
that discrimination falls not only on individuals
544
00:24:54.650 --> 00:24:55.573
but on groups.
545
00:24:56.436 --> 00:24:58.550
And that if you're gonna address those things
546
00:24:58.550 --> 00:25:01.290
you need to think systemically.
547
00:25:01.290 --> 00:25:03.180
You have to support social environments
548
00:25:03.180 --> 00:25:07.500
and you have to explore clinical research that's going on
549
00:25:07.500 --> 00:25:09.690
that might affect these people
550
00:25:09.690 --> 00:25:13.863
and bring these therapies to vulnerable populations.
551
00:25:15.820 --> 00:25:17.900
You also need to think about low income countries
552
00:25:17.900 --> 00:25:19.400
that have discriminated people,
553
00:25:19.400 --> 00:25:20.630
can they even afford
554
00:25:20.630 --> 00:25:23.163
to provide the drugs to their own people?
555
00:25:24.740 --> 00:25:27.100
And he came up with this conclusion
556
00:25:27.100 --> 00:25:29.080
that AIDS-related support would remain inadequate
557
00:25:29.080 --> 00:25:30.920
in a given country if the larger system
558
00:25:30.920 --> 00:25:33.723
of health inequities and inequality remain.
559
00:25:36.490 --> 00:25:40.603
So he started talking about developing structural rights,
560
00:25:40.603 --> 00:25:43.116
that people had a right to a good health system,
561
00:25:43.116 --> 00:25:48.116
a continuity of care, accessible therapies, accessible care,
562
00:25:48.530 --> 00:25:49.633
all of these things.
563
00:25:52.240 --> 00:25:55.520
And this was what he thought needed to be done
564
00:25:55.520 --> 00:25:56.670
to build health systems.
565
00:25:56.670 --> 00:25:59.090
Now, the World Health Organization eventually adopted this.
566
00:25:59.090 --> 00:26:00.260
This was one of the big pushes
567
00:26:00.260 --> 00:26:01.370
that they've had in recent years
568
00:26:01.370 --> 00:26:04.650
is how do we help build the infrastructure in a country
569
00:26:04.650 --> 00:26:06.660
to give them a robust health system?
570
00:26:06.660 --> 00:26:09.370
And this came out of Jonathan Mann's recognition
571
00:26:09.370 --> 00:26:12.530
of the fact that if you wanna fight HIV in a country
572
00:26:12.530 --> 00:26:14.550
that you need to rebuild the health system
573
00:26:14.550 --> 00:26:16.850
such that it can have the capacity to do that.
574
00:26:18.360 --> 00:26:22.180
But as he focused on anti discrimination
575
00:26:22.180 --> 00:26:23.400
as a means to an end,
576
00:26:23.400 --> 00:26:25.450
a number of activists pushed back at him.
577
00:26:26.910 --> 00:26:29.440
He was giving a talk at one point in time,
578
00:26:29.440 --> 00:26:34.140
and he was saying, we need to work to prevent rape,
579
00:26:34.140 --> 00:26:36.840
because women are being raped and they're getting HIV.
580
00:26:38.070 --> 00:26:40.520
And a woman in the audience stood up and said,
581
00:26:40.520 --> 00:26:42.550
shouldn't we work to prevent rape
582
00:26:42.550 --> 00:26:44.250
because women shouldn't get raped?
583
00:26:45.980 --> 00:26:48.020
And he was just taken aback
584
00:26:48.020 --> 00:26:51.090
because he realized that he had this functional view
585
00:26:51.090 --> 00:26:51.923
of human rights.
586
00:26:51.923 --> 00:26:55.480
He was using human rights for a health goal
587
00:26:55.480 --> 00:26:59.100
instead of seeing that the context in which people lived
588
00:26:59.100 --> 00:27:01.230
was oftentimes violating their human rights
589
00:27:01.230 --> 00:27:02.480
and putting them at risk.
590
00:27:04.080 --> 00:27:06.800
And so, he saw the role of women in society
591
00:27:06.800 --> 00:27:08.743
as one of the key things for restructuring the way
592
00:27:08.743 --> 00:27:10.550
that he and the World Health Organization
593
00:27:10.550 --> 00:27:12.610
started to approach HIV.
594
00:27:12.610 --> 00:27:16.060
The Public Health Perspective was,
595
00:27:16.060 --> 00:27:17.740
if we wanna educate women about AIDS,
596
00:27:17.740 --> 00:27:22.350
we're gonna address their lack of literacy by making books
597
00:27:22.350 --> 00:27:24.340
that don't need words.
598
00:27:24.340 --> 00:27:26.370
Now, there's nothing wrong with that.
599
00:27:26.370 --> 00:27:27.293
That's brilliant.
600
00:27:28.270 --> 00:27:31.830
But Jonathan Mann started asking, why can't women read?
601
00:27:31.830 --> 00:27:35.270
What is it about a society that is structured as such
602
00:27:35.270 --> 00:27:37.060
that women don't have access
603
00:27:37.060 --> 00:27:39.883
to the knowledge and education to read?
604
00:27:40.740 --> 00:27:43.460
That doesn't mean we stop making these wordless books,
605
00:27:43.460 --> 00:27:44.620
but it does mean
606
00:27:45.880 --> 00:27:49.400
maybe health interventions include teaching women to read
607
00:27:49.400 --> 00:27:51.620
and using AIDS education material
608
00:27:51.620 --> 00:27:54.020
as some of the ways that they learn how to read.
609
00:27:54.860 --> 00:27:57.480
Because then you're addressing their human rights
610
00:27:57.480 --> 00:27:58.940
and you're not using human rights
611
00:27:58.940 --> 00:28:00.920
as a way to address disease.
612
00:28:00.920 --> 00:28:03.210
You're seeing them as an end in themself
613
00:28:03.210 --> 00:28:04.710
rather than a means to an end.
614
00:28:08.910 --> 00:28:11.180
So one of the things he said was that
615
00:28:11.180 --> 00:28:14.340
starting in late 1980s,
616
00:28:14.340 --> 00:28:16.200
that women needed to be a component
617
00:28:16.200 --> 00:28:18.220
in all interventions planned around them,
618
00:28:18.220 --> 00:28:20.710
whether it was research, vaccine trials, whatever.
619
00:28:20.710 --> 00:28:24.320
Also, gay men, injection drug users, vulnerable populations
620
00:28:24.320 --> 00:28:26.100
that they needed a seat at the table,
621
00:28:26.100 --> 00:28:28.870
that clinical research needed to include
622
00:28:28.870 --> 00:28:30.980
the people who were the object of that research
623
00:28:30.980 --> 00:28:33.760
in the design of those trials,
624
00:28:33.760 --> 00:28:35.610
in the design of those interventions.
625
00:28:37.700 --> 00:28:40.250
And then he started thinking beyond just women
626
00:28:41.890 --> 00:28:43.420
to saying, why were women
627
00:28:43.420 --> 00:28:46.100
and these vulnerable populations in these countries
628
00:28:46.100 --> 00:28:47.870
at greater risk for HIV?
629
00:28:47.870 --> 00:28:50.820
Why were HIV drugs, which by the late 1980s,
630
00:28:50.820 --> 00:28:53.610
it was still just AZT, why were they inaccessible
631
00:28:53.610 --> 00:28:56.913
to the majority of women in developing countries?
632
00:28:58.260 --> 00:28:59.890
And why were the diseases that affected
633
00:28:59.890 --> 00:29:01.110
these majority of women
634
00:29:01.110 --> 00:29:03.420
so understudied and lacking in therapies?
635
00:29:03.420 --> 00:29:06.850
Because as you know, HIV isn't just HIV infection,
636
00:29:06.850 --> 00:29:09.210
but there's all these other opportunistic infections
637
00:29:09.210 --> 00:29:10.043
that come along,
638
00:29:10.043 --> 00:29:14.730
and many of them are endemic in low income countries,
639
00:29:14.730 --> 00:29:16.950
but they're not affecting other parts of the world.
640
00:29:16.950 --> 00:29:20.320
And yet, we had very, very antiquated drug regimens
641
00:29:20.320 --> 00:29:22.390
to deal with those things.
642
00:29:22.390 --> 00:29:24.880
So this became the foundation of something
643
00:29:24.880 --> 00:29:26.370
that Jonathan Mann called
644
00:29:26.370 --> 00:29:28.473
the Health and Human Rights Framework.
645
00:29:29.730 --> 00:29:31.050
It was the idea that the right to health
646
00:29:31.050 --> 00:29:32.560
means addressing the structural barriers
647
00:29:32.560 --> 00:29:34.870
that make people vulnerable to disease,
648
00:29:34.870 --> 00:29:36.816
and likewise analyzing the limits
649
00:29:36.816 --> 00:29:39.950
that this discrimination puts on their access
650
00:29:39.950 --> 00:29:41.300
once they have the disease.
651
00:29:43.630 --> 00:29:48.310
Now, the problem was is Jonathan Mann lived in the world,
652
00:29:48.310 --> 00:29:51.623
and he didn't like his boss, and his boss didn't like him.
653
00:29:53.000 --> 00:29:54.510
So he quit.
654
00:29:54.510 --> 00:29:56.710
He quit right at this moment
655
00:29:56.710 --> 00:29:59.610
when he had come up with this fantastic framework
656
00:29:59.610 --> 00:30:02.900
for how he was gonna approach HIV globally.
657
00:30:02.900 --> 00:30:05.070
And the gentleman who took over for him
658
00:30:05.070 --> 00:30:07.000
thought it was really good
659
00:30:07.000 --> 00:30:09.850
but didn't know how to operationalize it.
660
00:30:09.850 --> 00:30:11.280
So, is that me?
661
00:30:13.536 --> 00:30:14.580
That is me.
662
00:30:14.580 --> 00:30:17.043
My alarm's going off, it's time for me to wake up.
663
00:30:17.950 --> 00:30:20.230
So how do you operationalize it?
664
00:30:20.230 --> 00:30:24.590
So Mike Merson, who's my coauthor in the second book
665
00:30:24.590 --> 00:30:25.600
is trying to think,
666
00:30:25.600 --> 00:30:27.840
we're running this global program, what do we do?
667
00:30:27.840 --> 00:30:30.400
And he went and interviewed Jonathan Mann.
668
00:30:30.400 --> 00:30:33.917
And Jonathan Mann handed him the United Nations
669
00:30:33.917 --> 00:30:38.917
Universal Declaration of Human Rights and said, use this.
670
00:30:39.010 --> 00:30:40.930
Well that's really not helpful.
671
00:30:40.930 --> 00:30:42.960
It may be true and insightful,
672
00:30:42.960 --> 00:30:46.890
but that doesn't tell you how to deal with drug companies
673
00:30:46.890 --> 00:30:48.640
or run a clinical trial
674
00:30:48.640 --> 00:30:50.790
that takes into consideration human rights.
675
00:30:52.210 --> 00:30:54.837
So one of the things Merson started to do
676
00:30:54.837 --> 00:30:56.760
was to work with Burroughs Wellcome.
677
00:30:56.760 --> 00:30:58.980
At the end of 1990, he met with Burroughs Wellcome
678
00:30:58.980 --> 00:31:01.010
and he asked them, can you lower your prices
679
00:31:01.010 --> 00:31:02.840
for these low income countries?
680
00:31:02.840 --> 00:31:04.763
And Burroughs Wellcome said no.
681
00:31:06.930 --> 00:31:09.070
And what they did say was, well,
682
00:31:09.070 --> 00:31:10.040
we would work with you
683
00:31:10.040 --> 00:31:12.350
to address mother to child transmission.
684
00:31:12.350 --> 00:31:14.600
We could come up with a short course
685
00:31:14.600 --> 00:31:17.570
where we would give women who are HIV positive
686
00:31:17.570 --> 00:31:20.200
AZT for a short period of time during their pregnancy
687
00:31:20.200 --> 00:31:25.200
to try and stop HIV transmission to the child.
688
00:31:25.240 --> 00:31:27.600
Well, this poses a bit of a quandary.
689
00:31:27.600 --> 00:31:29.070
Because what Burroughs Wellcome was doing
690
00:31:29.070 --> 00:31:30.090
was being willing to say,
691
00:31:30.090 --> 00:31:32.563
we'll stop kids from getting HIV,
692
00:31:33.400 --> 00:31:35.360
but we're not gonna give the drug to those women
693
00:31:35.360 --> 00:31:38.593
once the kid is delivered and is found not to have HIV.
694
00:31:40.720 --> 00:31:42.440
Well, if you're an international health organization,
695
00:31:42.440 --> 00:31:43.787
what do you do?
696
00:31:43.787 --> 00:31:44.890
Do you say yes or no to that?
697
00:31:44.890 --> 00:31:48.210
Because it seems profoundly valuable to those kids
698
00:31:48.210 --> 00:31:51.183
but profoundly unfair, and it sets an odd precedent.
699
00:31:52.570 --> 00:31:54.260
I'll come back to that in just a second.
700
00:31:54.260 --> 00:31:55.810
But they met later on that same year
701
00:31:55.810 --> 00:31:58.480
to try to get them to drop the drug prices,
702
00:31:58.480 --> 00:32:01.750
and they did so, suggesting that we will make sure
703
00:32:01.750 --> 00:32:04.500
that you have intellectual property protections.
704
00:32:04.500 --> 00:32:07.830
If you drop your prices, we won't let generic companies
705
00:32:07.830 --> 00:32:11.460
come in and create generics and undercut you in the market.
706
00:32:11.460 --> 00:32:12.810
Burroughs Wellcome said no.
707
00:32:14.000 --> 00:32:16.423
They gave them a couple of different options,
708
00:32:17.504 --> 00:32:19.490
and in fact, Burroughs Wellcome came back and said
709
00:32:19.490 --> 00:32:22.593
we will cover a small portion of the country.
710
00:32:23.520 --> 00:32:27.230
The World Health Organization said, well how do we do that?
711
00:32:27.230 --> 00:32:28.960
'Cause if you're only gonna give us enough drugs
712
00:32:28.960 --> 00:32:31.933
to cover 8% of the population who have HIV,
713
00:32:33.140 --> 00:32:33.973
who do we give it to?
714
00:32:33.973 --> 00:32:34.806
How do we decide?
715
00:32:34.806 --> 00:32:35.930
It's kinda the lifeboat thing,
716
00:32:35.930 --> 00:32:37.810
who do you push out of the lifeboat?
717
00:32:37.810 --> 00:32:39.980
And so, the World Health Organization said,
718
00:32:39.980 --> 00:32:43.573
that seems like not a strategy we can go with.
719
00:32:45.650 --> 00:32:48.270
GPA, which is the Global Program on AIDS,
720
00:32:48.270 --> 00:32:50.220
suggested maybe you could do flexible pricing.
721
00:32:50.220 --> 00:32:52.910
In the countries where there are more people with HIV,
722
00:32:52.910 --> 00:32:54.360
you have a lower price.
723
00:32:54.360 --> 00:32:56.190
In other countries where the burden is less
724
00:32:56.190 --> 00:32:59.130
or it's a higher income country, you can have higher.
725
00:32:59.130 --> 00:33:02.120
Burroughs Wellcome said, we're not interested in that.
726
00:33:02.120 --> 00:33:04.850
So the World Health Organization was at an impasse.
727
00:33:04.850 --> 00:33:07.540
What do we do, how do we break this logjam?
728
00:33:07.540 --> 00:33:10.240
They have patent rights, we don't know how to stop it.
729
00:33:15.220 --> 00:33:18.650
I mentioned this, what the World Health Organization did do
730
00:33:18.650 --> 00:33:20.470
is actually say, there's a lot of pregnant women
731
00:33:20.470 --> 00:33:22.360
around the world who are HIV positive,
732
00:33:22.360 --> 00:33:24.080
that's an investment we're willing to make.
733
00:33:24.080 --> 00:33:26.470
And so, they actually did short course trials,
734
00:33:26.470 --> 00:33:27.790
first initially with AZT
735
00:33:27.790 --> 00:33:30.160
and then ultimately with pentamidine
736
00:33:30.160 --> 00:33:32.860
and, what's the other one?
737
00:33:32.860 --> 00:33:33.970
Anyway.
738
00:33:33.970 --> 00:33:35.940
So they did short course trials to ensure
739
00:33:35.940 --> 00:33:38.940
that women who were pregnant in low income countries
740
00:33:38.940 --> 00:33:42.278
could at least get access to prevent the spread of HIV
741
00:33:42.278 --> 00:33:44.940
to their children.
742
00:33:44.940 --> 00:33:48.360
And that was, you know, dramatically valuable
743
00:33:48.360 --> 00:33:49.550
for those countries.
744
00:33:49.550 --> 00:33:51.620
On the other hand, it was hugely controversial,
745
00:33:51.620 --> 00:33:53.040
so much so that some of the board
746
00:33:53.040 --> 00:33:54.670
on the New England Journal of Medicine
747
00:33:54.670 --> 00:33:57.190
quit after an Op-ed came out
748
00:33:57.190 --> 00:33:59.320
saying that this was unethical.
749
00:33:59.320 --> 00:34:02.640
So it remains a very, very difficult case,
750
00:34:02.640 --> 00:34:06.950
one if you have an ethics case sometimes, thinking through,
751
00:34:06.950 --> 00:34:08.870
if you are doing a study
752
00:34:08.870 --> 00:34:11.510
where you give only temporarily people drugs
753
00:34:11.510 --> 00:34:13.573
that then you let them go afterwards
754
00:34:13.573 --> 00:34:15.840
and don't provide them access to.
755
00:34:15.840 --> 00:34:18.410
That's a very, very difficult set of costs and benefits
756
00:34:18.410 --> 00:34:19.660
to try and think through.
757
00:34:21.960 --> 00:34:26.960
But what changed was that a large foundation stepped in.
758
00:34:27.050 --> 00:34:29.460
Rockefeller Foundation, in 1994,
759
00:34:29.460 --> 00:34:31.500
saw that the World Health Organization
760
00:34:31.500 --> 00:34:33.830
hadn't gotten very far with Burroughs Wellcome.
761
00:34:33.830 --> 00:34:35.330
And so what they did is convene
762
00:34:35.330 --> 00:34:36.940
a number of global groups,
763
00:34:36.940 --> 00:34:39.610
including the World Health Organization and UNAIDS
764
00:34:39.610 --> 00:34:42.880
in Italy to try and think if they could create
765
00:34:42.880 --> 00:34:45.100
a public-private partnership
766
00:34:45.100 --> 00:34:48.870
that leveraged charitable money and government money
767
00:34:48.870 --> 00:34:51.300
to fund research with the idea
768
00:34:51.300 --> 00:34:54.040
that those vaccines that were developed
769
00:34:54.040 --> 00:34:57.910
would be sold as close to cost as possible.
770
00:34:57.910 --> 00:35:00.480
And people who joined that effort
771
00:35:00.480 --> 00:35:02.733
had to make those types of commitments.
772
00:35:04.470 --> 00:35:05.790
And then they launched something called
773
00:35:05.790 --> 00:35:07.530
the Global Health Technologies Coalition,
774
00:35:07.530 --> 00:35:10.420
which was a group of 30 nonprofit groups
775
00:35:10.420 --> 00:35:13.533
aimed at addressing the other gaps beyond HIV.
776
00:35:16.600 --> 00:35:20.100
In 1996, you may remember, protease inhibitors came out.
777
00:35:20.100 --> 00:35:22.713
And protease inhibitors were far beyond AZT.
778
00:35:24.380 --> 00:35:28.510
And the disease dramatically changed in terms of prognosis.
779
00:35:28.510 --> 00:35:32.950
All of a sudden, HIV was not something that
780
00:35:32.950 --> 00:35:35.160
you could live with for a while but would ultimately die,
781
00:35:35.160 --> 00:35:37.600
but now people could think of having HIV
782
00:35:37.600 --> 00:35:41.480
and having their disease managed and living into old age.
783
00:35:41.480 --> 00:35:44.300
And this meant that all sorts of countries,
784
00:35:44.300 --> 00:35:46.270
all sorts of organizations,
785
00:35:46.270 --> 00:35:49.680
had a really strong incentive to start thinking
786
00:35:49.680 --> 00:35:52.810
about rethinking global drug strategy.
787
00:35:52.810 --> 00:35:55.350
How do we price it, how do we develop those drugs?
788
00:35:55.350 --> 00:35:58.270
Because we now have a disease that we can manage
789
00:35:58.270 --> 00:36:02.050
that was killing people and now won't be killing people.
790
00:36:02.050 --> 00:36:05.573
But the way to do it is to address the financial needs
791
00:36:05.573 --> 00:36:07.800
that low income countries have
792
00:36:07.800 --> 00:36:10.830
while respecting the intellectual property rights
793
00:36:10.830 --> 00:36:12.623
of multinational drug companies.
794
00:36:14.000 --> 00:36:18.123
And that became the crux of the matter in the late 1990s.
795
00:36:20.630 --> 00:36:24.580
The reason is kind of a global trade agreement called TRIPS,
796
00:36:24.580 --> 00:36:26.660
Trade Related Intellectual Property Rights.
797
00:36:26.660 --> 00:36:28.880
It went into effect in 1995.
798
00:36:28.880 --> 00:36:31.350
Now, it was actually good in a lot of ways
799
00:36:31.350 --> 00:36:32.680
because up until that time,
800
00:36:32.680 --> 00:36:34.890
there was no kind of uniform standards
801
00:36:34.890 --> 00:36:37.000
for intellectual property.
802
00:36:37.000 --> 00:36:39.280
The problem was, high income countries
803
00:36:39.280 --> 00:36:41.280
where a lot of these drug companies were
804
00:36:42.430 --> 00:36:44.870
interpreted this very narrowly
805
00:36:44.870 --> 00:36:49.450
and said, no country can infringe upon a patent
806
00:36:49.450 --> 00:36:51.550
because the patent belongs
807
00:36:51.550 --> 00:36:53.820
to the intellectual property rights holder.
808
00:36:53.820 --> 00:36:56.690
And even if a country's in an emergency situation,
809
00:36:56.690 --> 00:37:00.690
it has to be a very, very rare situation
810
00:37:00.690 --> 00:37:03.530
for that country to be able to overlook the patent
811
00:37:03.530 --> 00:37:08.530
and get the resource, whatever it is, into its population.
812
00:37:08.960 --> 00:37:11.440
Well, low income countries didn't like that.
813
00:37:11.440 --> 00:37:14.627
And so, the Doha Declaration came out in 2001,
814
00:37:14.627 --> 00:37:17.190
and the World Trade Organization ultimately agreed
815
00:37:17.190 --> 00:37:18.680
with low income countries.
816
00:37:18.680 --> 00:37:21.700
It was part of the 2001 trade talks.
817
00:37:21.700 --> 00:37:24.360
And it recognized that in the writing of TRIPS,
818
00:37:24.360 --> 00:37:25.830
there were flexibilities
819
00:37:27.050 --> 00:37:29.750
that member states could,
820
00:37:29.750 --> 00:37:32.590
in situations of national emergency,
821
00:37:32.590 --> 00:37:35.883
take over a patent to use it for their needs.
822
00:37:36.750 --> 00:37:39.260
This gave countries the right to determine
823
00:37:39.260 --> 00:37:41.073
what the national emergency was.
824
00:37:41.910 --> 00:37:43.860
And it expressly included diseases
825
00:37:43.860 --> 00:37:47.053
like HIV and tuberculosis and malaria.
826
00:37:48.780 --> 00:37:53.000
And when they drew up this Doha statement or declaration,
827
00:37:53.000 --> 00:37:56.733
they drew on health and human rights as the rationale,
828
00:37:58.120 --> 00:38:02.730
that human rights trumps patent rights.
829
00:38:02.730 --> 00:38:05.830
And therefore, countries have the right to be able
830
00:38:05.830 --> 00:38:08.090
to do something for their people
831
00:38:08.090 --> 00:38:10.513
even if it violates international patent law.
832
00:38:13.290 --> 00:38:17.670
So this has transformed the way we think about
833
00:38:19.220 --> 00:38:21.650
global access to drugs.
834
00:38:21.650 --> 00:38:22.610
Now, we still have problems,
835
00:38:22.610 --> 00:38:24.050
but a lot of things have changed.
836
00:38:24.050 --> 00:38:27.790
One is the leadership at the UN agencies changed.
837
00:38:27.790 --> 00:38:31.080
And then the Rockefeller Foundation had set this example
838
00:38:31.080 --> 00:38:32.710
that started to get picked up.
839
00:38:32.710 --> 00:38:35.610
As well, social conservatives, political conservatives,
840
00:38:35.610 --> 00:38:37.950
at the end of the 1990s and the early 2000s
841
00:38:37.950 --> 00:38:41.030
really started to see that this global pandemic
842
00:38:41.030 --> 00:38:42.860
was something that they needed to get
843
00:38:42.860 --> 00:38:46.960
and engage political will to do something about.
844
00:38:46.960 --> 00:38:49.240
The Clinton administration actually came to its senses
845
00:38:49.240 --> 00:38:53.910
and recognized that it had been promoting these TRIPS rules
846
00:38:53.910 --> 00:38:56.720
that really closed the aperture on patents,
847
00:38:56.720 --> 00:39:00.030
and they had played a part in restricting access to drugs
848
00:39:00.030 --> 00:39:02.120
to these low income countries.
849
00:39:02.120 --> 00:39:03.765
And Al Gore wanted to be president,
850
00:39:03.765 --> 00:39:08.765
and so he spoke at the United Nations Security Council,
851
00:39:08.860 --> 00:39:12.150
but what was important was he called AIDS
852
00:39:12.150 --> 00:39:14.430
an international security risk.
853
00:39:14.430 --> 00:39:16.680
He recognized that with HIV
854
00:39:16.680 --> 00:39:19.010
disproportionately affecting low income countries,
855
00:39:19.010 --> 00:39:21.800
that it created situations of chaos and turmoil
856
00:39:21.800 --> 00:39:23.740
that then would create political instability.
857
00:39:23.740 --> 00:39:26.860
And therefore, the world had both a moral and ethical
858
00:39:26.860 --> 00:39:30.830
but also security rationale for doing something about AIDS
859
00:39:30.830 --> 00:39:31.963
and other diseases.
860
00:39:34.450 --> 00:39:35.800
So pharmaceutical companies
861
00:39:35.800 --> 00:39:38.113
started to face a lot of pressure.
862
00:39:39.290 --> 00:39:42.400
If this Doha agreement is out there,
863
00:39:42.400 --> 00:39:44.060
that countries can seize their patents
864
00:39:44.060 --> 00:39:46.141
in cases of national emergency,
865
00:39:46.141 --> 00:39:49.590
and international countries and organizations
866
00:39:49.590 --> 00:39:50.760
are starting to see AIDS
867
00:39:50.760 --> 00:39:53.410
as actually an international security issue,
868
00:39:53.410 --> 00:39:55.210
then we should probably do something
869
00:39:55.210 --> 00:39:57.180
to pick up our image a little bit.
870
00:39:57.180 --> 00:39:58.330
So what changed?
871
00:39:58.330 --> 00:40:00.460
Well, the Gate Foundations started in 2000,
872
00:40:00.460 --> 00:40:02.800
and they made their commitment
873
00:40:02.800 --> 00:40:04.750
to addressing HIV and other diseases.
874
00:40:04.750 --> 00:40:08.210
And in fact, they took the Rockefeller Foundation model
875
00:40:08.210 --> 00:40:10.270
and applied it not just to HIV
876
00:40:10.270 --> 00:40:14.820
but to other diseases that needed vaccines and immunization.
877
00:40:14.820 --> 00:40:19.300
And the GAVI alliance has been really profound
878
00:40:19.300 --> 00:40:21.299
in coming up with vaccines that have addressed
879
00:40:21.299 --> 00:40:23.220
diseases all around the world,
880
00:40:23.220 --> 00:40:24.596
in part because they've leveraged
881
00:40:24.596 --> 00:40:29.370
and created efficiencies in generic vaccination development
882
00:40:29.370 --> 00:40:30.810
in low income countries
883
00:40:30.810 --> 00:40:34.220
such that vaccines are able to be distributed in countries
884
00:40:34.220 --> 00:40:37.220
where they never had real access to them before.
885
00:40:37.220 --> 00:40:38.053
The other thing that happened
886
00:40:38.053 --> 00:40:39.480
is the Gates Foundation and other groups
887
00:40:39.480 --> 00:40:42.040
created something called the Global Fund.
888
00:40:42.040 --> 00:40:44.910
The Global Fund focused on malaria and tuberculosis
889
00:40:44.910 --> 00:40:46.180
as well as HIV.
890
00:40:46.180 --> 00:40:47.460
Malaria and tuberculosis
891
00:40:47.460 --> 00:40:48.690
had really come back into the picture
892
00:40:48.690 --> 00:40:50.990
because they were third world,
893
00:40:50.990 --> 00:40:53.360
or developing country diseases.
894
00:40:53.360 --> 00:40:56.480
And so, developments on malaria and tuberculosis
895
00:40:56.480 --> 00:40:57.633
had really lagged.
896
00:40:58.662 --> 00:41:00.270
High income countries
897
00:41:00.270 --> 00:41:01.910
didn't really struggle with those problems,
898
00:41:01.910 --> 00:41:04.740
so they didn't really need to do very much about them.
899
00:41:04.740 --> 00:41:07.120
But with HIV, all of a sudden,
900
00:41:07.120 --> 00:41:10.850
resistant tuberculosis and malaria were really severe
901
00:41:10.850 --> 00:41:13.390
and needed to become addressed by Western countries,
902
00:41:13.390 --> 00:41:15.490
both in their own countries and obviously globally.
903
00:41:15.490 --> 00:41:17.170
And so, the Global Fund was set up
904
00:41:17.170 --> 00:41:19.170
to be this huge pool of money to spur
905
00:41:19.170 --> 00:41:21.663
interventions and research in these areas.
906
00:41:23.080 --> 00:41:26.960
PEPFAR was also created in 2003.
907
00:41:26.960 --> 00:41:29.440
PEPFAR was a huge and important step,
908
00:41:29.440 --> 00:41:30.849
both because it targeted
909
00:41:30.849 --> 00:41:34.940
14 of the most hard-hit countries with HIV,
910
00:41:34.940 --> 00:41:36.500
but it also focused on two things.
911
00:41:36.500 --> 00:41:39.190
One, getting drugs to those countries
912
00:41:39.190 --> 00:41:42.350
and rebuilding the health infrastructure in those countries
913
00:41:42.350 --> 00:41:44.020
so that the health system was available
914
00:41:44.020 --> 00:41:45.293
to address those needs.
915
00:41:46.530 --> 00:41:48.440
But there started to be a lot of pressure then
916
00:41:48.440 --> 00:41:49.420
on drug companies
917
00:41:49.420 --> 00:41:51.320
to do something about the prices of their drugs.
918
00:41:51.320 --> 00:41:53.860
All of a sudden, you've got the US government buying drugs,
919
00:41:53.860 --> 00:41:56.520
they wanna get the best bang for their dollar.
920
00:41:56.520 --> 00:41:59.053
And Bill Clinton, oh whoops, sorry.
921
00:41:59.920 --> 00:42:02.600
Bill Clinton, who had felt guilty
922
00:42:02.600 --> 00:42:03.900
for some of the work he'd done
923
00:42:03.900 --> 00:42:05.660
protecting international patent rights
924
00:42:05.660 --> 00:42:08.020
started working through his foundation
925
00:42:08.020 --> 00:42:11.340
to try and find ways to get flexible patent rules
926
00:42:11.340 --> 00:42:12.603
in low income countries.
927
00:42:13.750 --> 00:42:17.030
The World Health Organization had gotten in a fight
928
00:42:17.030 --> 00:42:19.510
with the UNAIDS after UNAIDS was launched,
929
00:42:19.510 --> 00:42:21.270
and so it had actually stepped out
930
00:42:21.270 --> 00:42:24.670
of fighting global AIDS for a long time.
931
00:42:24.670 --> 00:42:26.670
But in the early 2000s it came back
932
00:42:26.670 --> 00:42:28.720
saying, this is something that we will commit to.
933
00:42:28.720 --> 00:42:31.690
And so, in the early 2000s they had the three by five plan,
934
00:42:31.690 --> 00:42:33.560
which was the idea of getting drugs
935
00:42:33.560 --> 00:42:36.820
to five million people by 2005.
936
00:42:36.820 --> 00:42:38.210
And that meant that all of a sudden
937
00:42:38.210 --> 00:42:41.500
you had a large organization trying to focus
938
00:42:41.500 --> 00:42:45.210
on streamlining and reducing costs and distribution.
939
00:42:45.210 --> 00:42:47.930
And so, drug companies started to feel the pressure
940
00:42:47.930 --> 00:42:49.240
and wanted to get on board.
941
00:42:49.240 --> 00:42:52.490
If you can, create an economy of scale.
942
00:42:52.490 --> 00:42:54.340
For these drug companies, all of a sudden
943
00:42:54.340 --> 00:42:56.320
it's in their best interest to reduce the cost
944
00:42:56.320 --> 00:42:57.503
as much as possible.
945
00:42:58.570 --> 00:43:00.340
So what these entities were doing
946
00:43:00.340 --> 00:43:03.940
was de-linking the production of drugs
947
00:43:03.940 --> 00:43:06.243
from the cost of those drugs.
948
00:43:07.110 --> 00:43:09.170
And the health and human rights framework was saying,
949
00:43:09.170 --> 00:43:10.930
we need to somehow come up with a way
950
00:43:10.930 --> 00:43:14.683
to de-link the costs of R and D from the cost of the drug.
951
00:43:16.440 --> 00:43:18.420
And so, drug companies actually started
952
00:43:18.420 --> 00:43:21.060
to create their own unique ways
953
00:43:21.060 --> 00:43:23.580
of delivering care in countries.
954
00:43:23.580 --> 00:43:27.600
Merck had started this back, focusing on River Blindness,
955
00:43:27.600 --> 00:43:29.410
and other companies started to recognize
956
00:43:29.410 --> 00:43:30.970
this is something we could do as well.
957
00:43:30.970 --> 00:43:31.803
It doesn't mean
958
00:43:31.803 --> 00:43:33.510
that we're just giving our drugs away necessarily,
959
00:43:33.510 --> 00:43:35.800
which Merck had done with River Blindness,
960
00:43:35.800 --> 00:43:37.750
but we could start to come up with programs
961
00:43:37.750 --> 00:43:39.730
in hard hit countries
962
00:43:39.730 --> 00:43:42.060
where we get these drugs to people,
963
00:43:42.060 --> 00:43:43.160
because they're gonna be taking them
964
00:43:43.160 --> 00:43:44.510
for the rest of their life.
965
00:43:44.510 --> 00:43:46.080
We need to come up with a way to address
966
00:43:46.080 --> 00:43:47.313
the economies of scale.
967
00:43:48.720 --> 00:43:51.700
At the same time, UNAIDS came up with its global program.
968
00:43:51.700 --> 00:43:54.470
I won't go into all the details on those.
969
00:43:54.470 --> 00:43:56.740
But we started to see globally
970
00:43:56.740 --> 00:43:58.893
a huge success in addressing HIV.
971
00:44:00.350 --> 00:44:03.530
The World Health Organization, seeing this success,
972
00:44:03.530 --> 00:44:06.380
decided, you know, we could create
973
00:44:06.380 --> 00:44:08.150
kind of a stakeholder group
974
00:44:08.150 --> 00:44:09.570
to think about other diseases
975
00:44:09.570 --> 00:44:11.660
that are hitting other countries
976
00:44:11.660 --> 00:44:13.850
as hard as HIV was hitting these countries.
977
00:44:13.850 --> 00:44:16.620
And we should start to become a catalyst
978
00:44:16.620 --> 00:44:19.520
to focusing research.
979
00:44:19.520 --> 00:44:22.180
And in fact, the international community built
980
00:44:22.180 --> 00:44:25.170
addressing research and development for drugs
981
00:44:25.170 --> 00:44:26.703
in their millennium goals.
982
00:44:27.670 --> 00:44:30.430
So, I already mentioned that we still have
983
00:44:30.430 --> 00:44:33.470
two billion people and 30% of the global population
984
00:44:33.470 --> 00:44:34.310
lacking these diseases,
985
00:44:34.310 --> 00:44:37.400
but we've seen, interestingly, in the past two decades
986
00:44:37.400 --> 00:44:38.900
some really strong movement
987
00:44:38.900 --> 00:44:40.640
towards addressing some of these things.
988
00:44:40.640 --> 00:44:42.210
It doesn't mean we're out of the woods.
989
00:44:42.210 --> 00:44:44.270
And the reality is drug companies
990
00:44:44.270 --> 00:44:47.960
still have a lock on a lot of the drugs
991
00:44:47.960 --> 00:44:49.600
that are necessary and out there.
992
00:44:49.600 --> 00:44:50.870
But one of the things that's happened
993
00:44:50.870 --> 00:44:53.940
is that people have focused on accountability.
994
00:44:53.940 --> 00:44:55.820
Not necessarily naming and shaming,
995
00:44:55.820 --> 00:44:58.440
but at least highlighting what drug companies are doing
996
00:44:58.440 --> 00:44:59.960
and the extent to which
997
00:44:59.960 --> 00:45:03.750
they are making their drugs available.
998
00:45:03.750 --> 00:45:05.870
And each year now, many companies
999
00:45:05.870 --> 00:45:07.380
are starting to come up with strategies
1000
00:45:07.380 --> 00:45:11.150
to try and provide access to these essential medicines.
1001
00:45:11.150 --> 00:45:13.700
So this comes from the Access to Medicine Foundation,
1002
00:45:13.700 --> 00:45:16.060
which every two years puts out a report
1003
00:45:16.060 --> 00:45:18.630
on which drug companies are doing something.
1004
00:45:18.630 --> 00:45:23.250
GlaxoSmithKline has, for the three reports, so six years,
1005
00:45:23.250 --> 00:45:24.577
been at the top of those.
1006
00:45:24.577 --> 00:45:27.300
Partly that's because after 2001
1007
00:45:27.300 --> 00:45:29.750
they had a tremendously huge scandal
1008
00:45:29.750 --> 00:45:30.990
and fired a whole bunch of people
1009
00:45:30.990 --> 00:45:34.060
and hired a doctor who decided
1010
00:45:34.060 --> 00:45:37.350
he was gonna run drug trials in transparent ways.
1011
00:45:37.350 --> 00:45:38.420
And this was one of his things,
1012
00:45:38.420 --> 00:45:40.620
is let's get drugs into the hands of people.
1013
00:45:41.540 --> 00:45:43.860
The other thing is, we've started to see
1014
00:45:43.860 --> 00:45:47.290
a number of partnerships, public-private partnerships
1015
00:45:47.290 --> 00:45:48.410
to develop.
1016
00:45:48.410 --> 00:45:49.942
So Merck obviously, as I mentioned,
1017
00:45:49.942 --> 00:45:54.942
had basically donated its drug to fight River Blindness.
1018
00:45:56.860 --> 00:45:58.960
But now we have public-private partnerships
1019
00:45:58.960 --> 00:46:00.960
for medicines for malaria,
1020
00:46:00.960 --> 00:46:03.600
there's the One World Health Institute
1021
00:46:03.600 --> 00:46:07.370
which focuses on neglected diseases,
1022
00:46:07.370 --> 00:46:10.720
the European Union has an Innovative Medicines Initiative,
1023
00:46:10.720 --> 00:46:12.064
there's something called
1024
00:46:12.064 --> 00:46:13.420
the Drugs for Neglected Disease Initiative,
1025
00:46:13.420 --> 00:46:18.420
and it has garnered $290 million over the past decade,
1026
00:46:19.140 --> 00:46:20.580
which means that the drugs
1027
00:46:20.580 --> 00:46:21.800
that get developed from those things
1028
00:46:21.800 --> 00:46:23.300
get sold at cost
1029
00:46:23.300 --> 00:46:26.663
because they don't have any need to recoup R and D prices.
1030
00:46:28.980 --> 00:46:31.960
And then there's something called the European Lead Factory
1031
00:46:31.960 --> 00:46:36.210
which focuses on waiving fees for nonprofit groups
1032
00:46:36.210 --> 00:46:37.250
that are fighting,
1033
00:46:37.250 --> 00:46:40.680
so they're basically a CRO that's run by the European Union
1034
00:46:40.680 --> 00:46:43.950
that tries to find promising drugs
1035
00:46:43.950 --> 00:46:45.660
and get them to market as soon as possible.
1036
00:46:45.660 --> 00:46:47.160
And if you're a nonprofit group,
1037
00:46:47.160 --> 00:46:48.590
they waive all sorts of fees
1038
00:46:48.590 --> 00:46:50.740
so that the cost, when it comes to market,
1039
00:46:50.740 --> 00:46:51.993
sells at a low price.
1040
00:46:53.090 --> 00:46:55.440
There's also all sorts of unique ways
1041
00:46:55.440 --> 00:46:58.080
of doing partnerships, developing partnerships.
1042
00:46:58.080 --> 00:47:00.710
Some are closed, so if you buy in
1043
00:47:00.710 --> 00:47:01.890
you get to reap the benefits.
1044
00:47:01.890 --> 00:47:03.410
But increasingly, they're moving towards
1045
00:47:03.410 --> 00:47:05.990
what are called open collaboration partnerships,
1046
00:47:05.990 --> 00:47:08.423
depending on the needs of the community.
1047
00:47:11.300 --> 00:47:15.590
Doha gave something called Compulsory License Flexibility.
1048
00:47:15.590 --> 00:47:17.910
And countries have tried to use this.
1049
00:47:17.910 --> 00:47:19.170
Kenya is the most obvious one,
1050
00:47:19.170 --> 00:47:21.640
they used it to fight HIV in their country.
1051
00:47:21.640 --> 00:47:22.750
Brazil did the same thing,
1052
00:47:22.750 --> 00:47:23.880
where they just grabbed the patents
1053
00:47:23.880 --> 00:47:26.250
and started producing protease inhibitors.
1054
00:47:26.250 --> 00:47:27.280
India did the same thing,
1055
00:47:27.280 --> 00:47:29.130
and ultimately created generic drugs.
1056
00:47:29.130 --> 00:47:32.747
So some countries have taken the patents of drug companies
1057
00:47:32.747 --> 00:47:35.450
and said, we have such a national emergency
1058
00:47:35.450 --> 00:47:37.240
that we are gonna try and combat
1059
00:47:37.240 --> 00:47:39.520
the high price of these drugs in our country
1060
00:47:39.520 --> 00:47:40.850
by seizing the patents.
1061
00:47:40.850 --> 00:47:41.870
It gets sued.
1062
00:47:41.870 --> 00:47:44.960
Sometimes the United States has backed the drug company,
1063
00:47:44.960 --> 00:47:48.280
other times they've backed the country.
1064
00:47:48.280 --> 00:47:50.280
But the point is, is this mechanism is there.
1065
00:47:50.280 --> 00:47:52.250
And a lot of researchers look at this and say,
1066
00:47:52.250 --> 00:47:54.130
this is kind of low-hanging fruit.
1067
00:47:54.130 --> 00:47:56.760
Countries should look at the largest disease problem
1068
00:47:56.760 --> 00:47:58.029
in their community
1069
00:47:58.029 --> 00:48:01.909
and either use Compulsory License Flexibility
1070
00:48:01.909 --> 00:48:04.820
or other mechanisms like parallel tracking,
1071
00:48:04.820 --> 00:48:07.960
which is to create a parallel track
1072
00:48:07.960 --> 00:48:10.790
that the government creates its own generic medicine
1073
00:48:10.790 --> 00:48:14.820
that it provides until the drug company drops its prices.
1074
00:48:14.820 --> 00:48:17.470
I have this little march-in thing here
1075
00:48:17.470 --> 00:48:18.700
because here in the United States
1076
00:48:18.700 --> 00:48:21.050
we actually have something called march-in rights,
1077
00:48:21.050 --> 00:48:25.370
which within the Bayh-Dole law back in 1990
1078
00:48:25.370 --> 00:48:26.210
about drug development
1079
00:48:26.210 --> 00:48:31.130
said that if the country needs to,
1080
00:48:31.130 --> 00:48:34.230
the NIH can actually step in and pressure a company
1081
00:48:34.230 --> 00:48:36.810
to use its patent or deliver it to someone else.
1082
00:48:36.810 --> 00:48:38.450
And it's been debatable, for example,
1083
00:48:38.450 --> 00:48:40.200
with situations like insulin,
1084
00:48:40.200 --> 00:48:43.340
if a company is price gouging on insulin,
1085
00:48:43.340 --> 00:48:46.420
can the NIH step in and say,
1086
00:48:46.420 --> 00:48:48.180
until you lower your prices,
1087
00:48:48.180 --> 00:48:51.410
we will give the patent license to someone else?
1088
00:48:51.410 --> 00:48:53.810
So far, it hasn't been able to succeed,
1089
00:48:53.810 --> 00:48:57.683
in part because the head of the NIH has said we can't do it.
1090
00:48:58.960 --> 00:49:00.750
We happen to have a Commander in Chief right now
1091
00:49:00.750 --> 00:49:02.590
who doesn't like to necessarily follow rules,
1092
00:49:02.590 --> 00:49:04.120
so this'd be a really great opportunity
1093
00:49:04.120 --> 00:49:06.390
for the Trump administration to lower prices
1094
00:49:06.390 --> 00:49:07.450
by using march-in rights
1095
00:49:07.450 --> 00:49:09.760
against people who are doing price gouging.
1096
00:49:09.760 --> 00:49:11.910
That's my just, political commentary there.
1097
00:49:13.220 --> 00:49:15.000
But there's other things we can do.
1098
00:49:15.000 --> 00:49:17.150
There's new funding innovations that are out there.
1099
00:49:17.150 --> 00:49:20.540
One of them is, is that countries become investors.
1100
00:49:20.540 --> 00:49:22.490
So a country that's hard-hit,
1101
00:49:22.490 --> 00:49:25.170
maybe at a stage III in drug development
1102
00:49:25.170 --> 00:49:29.680
actually could help partially fund the drug trial
1103
00:49:29.680 --> 00:49:32.570
in response for when the drug comes to market,
1104
00:49:32.570 --> 00:49:34.672
that country gets lower prices
1105
00:49:34.672 --> 00:49:36.770
than what the market would bear.
1106
00:49:36.770 --> 00:49:39.373
And so, there's some movement in this area.
1107
00:49:40.460 --> 00:49:43.010
The other thing is, states like California
1108
00:49:43.010 --> 00:49:44.640
are actually looking at creating
1109
00:49:44.640 --> 00:49:46.470
their own generic drug industry,
1110
00:49:46.470 --> 00:49:50.240
so that what they do is target generic drugs
1111
00:49:50.240 --> 00:49:52.330
that are costing their state
1112
00:49:52.330 --> 00:49:54.900
through their Medicaid program too much money
1113
00:49:54.900 --> 00:49:57.130
and actually start to produce those themselves.
1114
00:49:57.130 --> 00:49:59.410
California's even thinking about selling to other states
1115
00:49:59.410 --> 00:50:00.710
if they get the rights to actually do this.
1116
00:50:00.710 --> 00:50:01.700
So, just so you know
1117
00:50:01.700 --> 00:50:04.880
in case Texas wants to come up with something.
1118
00:50:04.880 --> 00:50:06.490
All right, I'll end here.
1119
00:50:06.490 --> 00:50:08.580
But we have a long way to go in these areas.
1120
00:50:08.580 --> 00:50:10.070
There's a lot of gaps.
1121
00:50:10.070 --> 00:50:11.740
But the health and human rights perspective
1122
00:50:11.740 --> 00:50:15.260
has started to see that people are ends in themselves,
1123
00:50:15.260 --> 00:50:17.870
and that patent law, patent rights
1124
00:50:17.870 --> 00:50:19.660
don't trump human rights.
1125
00:50:19.660 --> 00:50:22.300
And so, this health and human rights mechanism
1126
00:50:22.300 --> 00:50:24.530
that came out of the HIV movement
1127
00:50:24.530 --> 00:50:29.090
has started to push countries, organizations, entities
1128
00:50:29.090 --> 00:50:32.330
into rethinking how we do drug development,
1129
00:50:32.330 --> 00:50:34.749
and pushing back against some of the rules
1130
00:50:34.749 --> 00:50:36.680
that drug companies have set up.
1131
00:50:36.680 --> 00:50:39.240
So they're merging models of thinking
1132
00:50:39.240 --> 00:50:41.760
about pricing, partnerships, and patents
1133
00:50:41.760 --> 00:50:44.040
that ultimately de-link
1134
00:50:44.040 --> 00:50:45.730
the funding of research and development
1135
00:50:45.730 --> 00:50:49.223
from the cost that goes to the people in the market.
1136
00:50:49.223 --> 00:50:51.060
I wanna just highlight one last thing.
1137
00:50:51.060 --> 00:50:52.310
I'm not supposed to walk.
1138
00:50:53.632 --> 00:50:56.593
But I picked up the Wall Street Journal on the way here,
1139
00:50:57.770 --> 00:51:00.050
and this is the front page today.
1140
00:51:00.050 --> 00:51:03.920
Drug makers test new models to pay for costly treatments.
1141
00:51:03.920 --> 00:51:07.380
So the reality is, is that even drug companies
1142
00:51:07.380 --> 00:51:10.160
are feeling the pressure to do something about the costs,
1143
00:51:10.160 --> 00:51:12.270
whether it's globally or locally.
1144
00:51:12.270 --> 00:51:14.660
And thinking about health and human rights
1145
00:51:14.660 --> 00:51:16.480
as it applies to clinical research
1146
00:51:16.480 --> 00:51:19.370
is a way of trying to create a movement
1147
00:51:19.370 --> 00:51:20.620
towards health for all.
1148
00:51:20.620 --> 00:51:21.970
I'll just take some questions.
1149
00:51:21.970 --> 00:51:24.780
I guess I'm supposed to, the VA?
1150
00:51:24.780 --> 00:51:26.229
Okay, thank you.
1151
00:51:26.229 --> 00:51:28.479
(clapping)
1152
00:51:31.710 --> 00:51:33.993
Do I take selects before I take the VA, or?
1153
00:51:36.869 --> 00:51:38.469
Are there questions from the VA?
1154
00:51:40.840 --> 00:51:41.913
Selects on.
1155
00:52:20.240 --> 00:52:22.190
So, did everybody hear her question?
1156
00:52:22.190 --> 00:52:24.560
One of the things she talked about is the,
1157
00:52:24.560 --> 00:52:27.787
obviously increasingly we have international drug trials
1158
00:52:27.787 --> 00:52:29.173
and drug development.
1159
00:52:33.820 --> 00:52:36.740
While the companies are doing international trials,
1160
00:52:36.740 --> 00:52:38.680
the companies themselves are usually not based
1161
00:52:38.680 --> 00:52:39.610
in those countries,
1162
00:52:39.610 --> 00:52:41.670
although in India and China there are certain ones.
1163
00:52:41.670 --> 00:52:44.020
Japan, actually, is the second leading.
1164
00:52:44.020 --> 00:52:45.940
The real question is, and this has been the challenge,
1165
00:52:45.940 --> 00:52:48.290
is who owns the patents?
1166
00:52:48.290 --> 00:52:50.700
A lot of you are doing the basic research,
1167
00:52:50.700 --> 00:52:51.910
maybe not necessarily all of you,
1168
00:52:51.910 --> 00:52:53.960
but here at an institution like this,
1169
00:52:53.960 --> 00:52:55.770
a lot of the basic research is being done
1170
00:52:55.770 --> 00:52:59.700
that lays down the foundation that then gets capitalized on
1171
00:52:59.700 --> 00:53:01.980
by international companies.
1172
00:53:01.980 --> 00:53:04.520
And one of the things that the United States has focused on
1173
00:53:04.520 --> 00:53:09.520
is how do we tag into licenses and force companies
1174
00:53:09.660 --> 00:53:14.080
not necessarily to operate in ways that exploit
1175
00:53:15.410 --> 00:53:16.340
the end user.
1176
00:53:16.340 --> 00:53:17.640
And that's a real challenge,
1177
00:53:17.640 --> 00:53:22.080
because as international companies
1178
00:53:22.080 --> 00:53:23.240
develop drugs in other places,
1179
00:53:23.240 --> 00:53:25.870
actually, the Trans-Pacific Partnership,
1180
00:53:25.870 --> 00:53:29.390
which passed under the Obama administration,
1181
00:53:29.390 --> 00:53:32.130
and then the Trump administration pulled out of,
1182
00:53:32.130 --> 00:53:37.130
it actually had really strong protections for drug companies
1183
00:53:37.320 --> 00:53:38.420
so that no one could come in
1184
00:53:38.420 --> 00:53:39.670
and seize some of those patents.
1185
00:53:39.670 --> 00:53:40.900
And that's a real challenge.
1186
00:53:40.900 --> 00:53:44.500
Now, to that end I think the Trump administration
1187
00:53:44.500 --> 00:53:46.340
pulling out of the TPP was fine.
1188
00:53:46.340 --> 00:53:48.080
The point is, is I don't think most people think
1189
00:53:48.080 --> 00:53:51.860
that the Trump administration is going to come and say,
1190
00:53:51.860 --> 00:53:53.850
you know, we should have open patents to everybody.
1191
00:53:53.850 --> 00:53:55.790
That's not the reason they pulled out of the TPP.
1192
00:53:55.790 --> 00:53:57.110
But there are some concerns,
1193
00:53:57.110 --> 00:53:59.060
when they're developing in other countries,
1194
00:53:59.060 --> 00:54:01.410
to what extent do we lose control over leverage
1195
00:54:01.410 --> 00:54:02.870
to do something about those things?
1196
00:54:02.870 --> 00:54:05.470
And that's where TRIPS comes back in, and the Doha agreement
1197
00:54:05.470 --> 00:54:06.670
and the extent to which,
1198
00:54:07.820 --> 00:54:10.430
part of it is an act of will, too.
1199
00:54:10.430 --> 00:54:13.890
If the United States decided to defend countries
1200
00:54:13.890 --> 00:54:15.610
that were in national emergencies
1201
00:54:15.610 --> 00:54:18.170
trying to address the needs of their population,
1202
00:54:18.170 --> 00:54:21.510
they could go to the WTO on behalf of those countries.
1203
00:54:21.510 --> 00:54:23.310
And that's really a political will.
1204
00:54:23.310 --> 00:54:26.760
But oftentimes we go based on our companies
1205
00:54:26.760 --> 00:54:28.030
that have the patents in our areas,
1206
00:54:28.030 --> 00:54:30.480
and so that's been one of the crises in the past.
1207
00:55:18.242 --> 00:55:19.740
So, and it obviously depends.
1208
00:55:19.740 --> 00:55:23.340
Some protease inhibitors are now off patent.
1209
00:55:23.340 --> 00:55:25.260
And so, if that's in the public domain,
1210
00:55:25.260 --> 00:55:26.900
then a generic company in India,
1211
00:55:26.900 --> 00:55:29.260
and actually, India is some of the earliest fights
1212
00:55:29.260 --> 00:55:30.970
both against AZT and other things.
1213
00:55:30.970 --> 00:55:32.070
The companies will sue,
1214
00:55:32.070 --> 00:55:34.720
and they'll sue with the World Trade Organization
1215
00:55:34.720 --> 00:55:35.553
or they'll sue,
1216
00:55:35.553 --> 00:55:37.430
depending on where the country is originating.
1217
00:55:37.430 --> 00:55:39.480
And many times the companies have won
1218
00:55:39.480 --> 00:55:43.110
based on international intellectual property rights.
1219
00:55:43.110 --> 00:55:45.390
But I don't know in this particular situation.
1220
00:55:45.390 --> 00:55:48.400
But conceivably, if they're, you know,
1221
00:55:48.400 --> 00:55:50.440
using somebody else's patent illegally,
1222
00:55:50.440 --> 00:55:53.920
or outside the rules, they may well be stopped.
1223
00:55:53.920 --> 00:55:56.320
But that hasn't, Brazil did the whole,
1224
00:55:56.320 --> 00:55:57.770
they basically gave drugs away
1225
00:55:57.770 --> 00:56:00.000
and they said, fine, sue us.
1226
00:56:00.000 --> 00:56:01.817
Go ahead and sue us,
1227
00:56:01.817 --> 00:56:03.413
we're gonna give protease inhibitors to our people.
1228
00:56:08.263 --> 00:56:09.260
Correct.
1229
00:56:09.260 --> 00:56:10.430
'Cause the rule is, and we obviously know this
1230
00:56:10.430 --> 00:56:11.850
even with the Trump administration right now,
1231
00:56:11.850 --> 00:56:13.500
they're talking about re-importation of drugs.
1232
00:56:13.500 --> 00:56:15.010
The fear the drug companies have
1233
00:56:15.010 --> 00:56:19.640
is that if you can make a low-cost drug in Zimbabwe,
1234
00:56:19.640 --> 00:56:22.650
that somebody'll just take a big airplane to Zimbabwe,
1235
00:56:22.650 --> 00:56:23.530
buy all the drugs there,
1236
00:56:23.530 --> 00:56:26.030
and then fly back to the United States.
1237
00:56:26.030 --> 00:56:27.390
So drug companies recognize
1238
00:56:27.390 --> 00:56:29.350
that in a global society they wanna,
1239
00:56:29.350 --> 00:56:30.460
one of the challenges is though,
1240
00:56:30.460 --> 00:56:33.890
some of these drugs actually cost more in those countries
1241
00:56:33.890 --> 00:56:36.080
than they do, not necessarily in the United States,
1242
00:56:36.080 --> 00:56:38.720
but some European countries.
1243
00:56:38.720 --> 00:56:40.910
You can actually go to Mozambique or someplace like that,
1244
00:56:40.910 --> 00:56:42.970
and some of those drugs will cost more there,
1245
00:56:42.970 --> 00:56:45.280
either relative to people's income,
1246
00:56:45.280 --> 00:56:47.990
or in actual fact, they'll cost more there.
1247
00:56:47.990 --> 00:56:50.790
So one of the things is creating
1248
00:56:50.790 --> 00:56:53.170
some sensible sliding scales
1249
00:56:53.170 --> 00:56:55.960
for how drugs can be sold in developing countries.
1250
00:56:55.960 --> 00:56:57.850
But that's gonna take the World Bank
1251
00:56:57.850 --> 00:56:59.190
and the World Trade Organization
1252
00:56:59.190 --> 00:57:00.710
and countries like the United States
1253
00:57:00.710 --> 00:57:03.700
actually acting for health and human rights
1254
00:57:03.700 --> 00:57:05.390
rather than for company profit.
1255
00:57:05.390 --> 00:57:07.033
And that's a real difficult thing.
1256
00:57:31.210 --> 00:57:34.090
So that's the TRIPS agreement and the Doha Declaration.
1257
00:57:34.090 --> 00:57:36.710
Not the universal, the UN doesn't have that
1258
00:57:36.710 --> 00:57:38.802
in the Universal Declaration of Human Rights, no.
1259
00:57:38.802 --> 00:57:42.660
And that's, so low income countries have said
1260
00:57:43.640 --> 00:57:45.530
that, well, the TRIPS agreement says
1261
00:57:45.530 --> 00:57:47.620
countries get to declare what constitutes
1262
00:57:47.620 --> 00:57:49.363
a national emergency.
1263
00:57:51.650 --> 00:57:54.620
What other countries have done have pressured them not to.
1264
00:57:54.620 --> 00:57:55.810
So Columbia, for example,
1265
00:57:55.810 --> 00:57:58.610
was going to declare a national emergency,
1266
00:57:58.610 --> 00:58:00.330
and the United States and some other countries
1267
00:58:00.330 --> 00:58:03.200
where the drug companies were housed
1268
00:58:03.200 --> 00:58:07.100
basically threatened trade punishment against the country
1269
00:58:07.100 --> 00:58:09.210
if they did that, to protect them.
1270
00:58:09.210 --> 00:58:12.950
So a country can set its own national emergency.
1271
00:58:12.950 --> 00:58:14.390
Most people won't do it if it's not,
1272
00:58:14.390 --> 00:58:17.730
you know, if it's 0.5% of the population
1273
00:58:17.730 --> 00:58:18.563
they won't see that.
1274
00:58:18.563 --> 00:58:20.140
But I mean, you can think about some of the countries,
1275
00:58:20.140 --> 00:58:21.620
particularly with HIV and others,
1276
00:58:21.620 --> 00:58:24.900
where 20%, 30% of the adult population.
1277
00:58:24.900 --> 00:58:27.590
That seems like a national emergency to me.
1278
00:58:27.590 --> 00:58:29.397
But the Doha principles weren't in place at that stage
1279
00:58:29.397 --> 00:58:30.397
for them to do that.
1280
00:58:31.320 --> 00:58:34.123
Right, and that's the concern.
1281
00:58:45.070 --> 00:58:46.600
Yeah, he's dead so that'll be tricky.
1282
00:58:46.600 --> 00:58:48.287
I'll try and answer it for ya.
1283
00:59:17.040 --> 00:59:18.740
No, a lot of people are drawing on both of those.
1284
00:59:18.740 --> 00:59:21.993
Although, the US has only ratified one of those.
1285
00:59:21.993 --> 00:59:23.000
And so, because of that then they say
1286
00:59:23.000 --> 00:59:23.910
they're not bound by it,
1287
00:59:23.910 --> 00:59:25.990
and that's one of the tricky components of it.
1288
00:59:25.990 --> 00:59:27.670
But yeah, Larry Gostin and a lot of folks
1289
00:59:27.670 --> 00:59:29.050
in the health and human rights movement
1290
00:59:29.050 --> 00:59:30.380
have really drawn on those things
1291
00:59:30.380 --> 00:59:32.960
and actually clarified them in more recent years,
1292
00:59:32.960 --> 00:59:35.210
in part because they're very, very vague
1293
00:59:35.210 --> 00:59:36.950
and not operational.
1294
00:59:36.950 --> 00:59:38.740
So that makes it a little bit difficult.
1295
00:59:38.740 --> 00:59:42.300
But if the United States, back in 1966,
1296
00:59:42.300 --> 00:59:45.940
and so there was some implication by Southerners,
1297
00:59:45.940 --> 00:59:47.540
as you can imagine, that adopting those things
1298
00:59:47.540 --> 00:59:48.870
might mean that then, you know,
1299
00:59:48.870 --> 00:59:50.550
Jim Crow would have to go away.
1300
00:59:50.550 --> 00:59:54.360
And you know, so the United States didn't sign
1301
00:59:54.360 --> 00:59:55.193
all of those themselves.
1302
00:59:55.193 --> 00:59:57.770
So then they say they're not bound by those.
1303
00:59:57.770 --> 00:59:58.603
Oh, we're done.
1304
00:59:58.603 --> 01:00:00.073
Oh, I'm sorry.
1305
01:00:00.073 --> 01:00:01.540
Oh, so you can ask questions up here afterwards
1306
01:00:01.540 --> 01:00:02.373
but I think we're done.
1307
01:00:02.373 --> 01:00:03.749
Thank you.
(clapping)
1308
01:00:03.749 --> 01:00:04.582
Thank you.