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Welcome to BIOTECH NATION !!! With understandable interviews requiring no background in science, BTN attracts a wide global audience. From everyday people looking for hope in treatments in development, to bioentrepreneurs interested in the experience of their fellow travelers, to venture capitalists looking for possibilities in cutting-edge breakthroughs, to scientists simply interested in the work of others, BioTech Nation is the voice of human endeavor, driving science to new realities for everyone. These interviews are drawn directly from the public radio program, "Tech Nation", which also can be heard in numerous global radio and podcasting venues.
Our response to the COVID pandemic required rapidly creating inventive vaccines, diagnostics, and treatments. Given the international trading rules in place, how could we possibly get the 15,000,000,000 vaccine doses we needed to every country no matter their economic status? I speak with doctor Anthony Toffman, the director of the intellectual property division at the World Trade Organization. He outlines the challenges and how we responded. Tony, welcome back to Tech Nation.
Dr. Antony Taubman:Thank you so much. Good to be back.
Dr. Moira Gunn:Over the years, we've talked about many topics. Certainly, we've talked about the pharmaceutical and biopharmaceutical space and protecting the intellectual property rights of the creators of those treatments and diagnostics. But we've also talked about protecting the rights of indigenous people, about getting the newest medicines to both rich countries and poor countries alike, and about human rights. But today what I really want to talk about, now that we can do it in hindsight, are the lessons learned from the COVID nineteen pandemic. And so let me set the stage, we were all there, A global pandemic in which brand new vaccines had to be innovated.
Dr. Moira Gunn:Brand new virus we hadn't seen before as well as the tests and the treatments. And there was no time for the normal length of time it takes to prove a treatment or vaccine works, and no time for the standard country by country patent process, which enables global international trade. Now you had an exceptional view of this from start to finish. Tell us this story What were the challenges? What were the greatest ones?
Dr. Moira Gunn:And what really went well almost unexpectedly?
Dr. Antony Taubman:The fact is we're still digesting this, enormous experience and and and still thinking through the the practical lessons. But here's a few preliminary thoughts at least. Firstly, indeed, completely, unprecedented challenge, not only to health systems, not only to the innovation and access system for for new medicines, but for international governance generally. And to some extent, we saw this as a a challenge for how governments, our countries, can and should work together faced with a common crisis of this character. So there's really lessons to be learned at every level there.
Dr. Antony Taubman:The good news is indeed that we saw unprecedented innovation. We saw the most rapid, development and production and dissemination of of vaccines in human history by a very long mark. Ultimately, we've seen almost 400 candidate vaccines put forward as, possible vaccines against a a new pathogen. As you say, a pathogen that was unknown as late as December 2019. 400 candidate vaccines, at various levels of development, various levels of success, responding to that to that new health challenge.
Dr. Antony Taubman:And an entirely new vaccine platform that had never been operationalized, industrialized, developed into a a major vaccine.
Dr. Moira Gunn:This would be the m and r a vaccines.
Dr. Antony Taubman:Exactly. The m and a platform. However, we also saw absolutely appalling inequities in access. At the height of the pandemic, we saw a range between those countries that had 4 times as many vaccines as population. And, at the very same time, countries that had vaccines for fewer than 1% of their population.
Dr. Antony Taubman:And as we know, inequitable access to to vaccines is not only a moral and ethical issue, it's also a cause of the kind of variations in in the pathogen that lead to new variants. We saw a classic case of this here in the w two when we were calling together a ministerial conference at the end of 2021 with trade ministers around the world coming together to work on this and other issues. It had to be postponed because a couple of days before, it we saw the emergence of the omega variant and a a new phase in the in the pandemic. So it became impossible to actually to have a meeting to address the problem that that, ministers were tasked with. And indeed, we we can attribute that in part to uneven, inequitable, access to to vaccines.
Dr. Antony Taubman:So to to step back, the sources of the success are are various, are multiple. It's worth bearing in mind that, for example, those mRNA vaccines, the the technology was not new. The technology had been carefully developed for more than a decade. And a lot of the patent portfolio actually covers the mRNA platform rather than specific, mRNA vaccines for COVID 19. And that represents a great deal of, private investment, very high risk investment, a lot of fundamental scientific research without any sense that a a novel pathogen was just around the corner and would actually be the the first use case for this this new vaccine platform.
Dr. Antony Taubman:And that's one reason why we could see, the very rapid development of new new vaccines. The technology was there. The platform was there. But, many obstacles to rolling it out. We worked, in the w two.
Dr. Antony Taubman:We worked with, many of the producers talking through some of the challenges they were facing and there were there were numerous. First of all, we're moving from a a new vaccine technology that had only ever been used to develop part of level production. And suddenly, very suddenly, we we want 15,000,000,000 doses. And it's never been produced in an industrial sense, in a in a mass production sense at that level before. So even developing and applying the necessary production capacity, getting hold of the necessary inputs, the carrier mediums for the vaccine.
Dr. Antony Taubman:This this was an enormous technical and and industrial challenge. And equally, there were regulatory challenges. There I think, the system showed its potential in governments working to ensure that regulators, had the necessary flexibility, could accept that this was an emergency situation to it to accelerate at least provisional approval for the new vaccines. But we did see problems in getting the smoothest possible regulatory cooperation between, you know, potentially nearly 200 different national jurisdictions. And the the IP landscape was was indeed very, very complex.
Dr. Antony Taubman:Whether we're talking about the mRNA vaccines or or the the many other vaccines that were under development. And this led to a huge debate about how best to work through that patent landscape, how to develop the necessary technology transfer and technology diffusion arrangements, how to make licensing work, particularly for for those technologies where a huge amount of manufacturing know how was was needed, not necessarily contained in the in the patent disclosure. Very, very complex set of set of demands. Likewise, it became political very quickly. And, of course, it did become political because as we know, governments around around the world were under enormous pressure to do one of the most fundamentally important tasks, which is to look after the the the health of the the very populations.
Dr. Antony Taubman:And we did see, particularly here in the WTO, a massive, very intensive debate about the rights and wrongs of the IP system, the patent system in particular, and our WTO agreement on intellectual property, the the the TRIPS agreement. And indeed, a a large number of, of our member governments said, look, there's a an unprecedented global crisis. Entire populations are being locked down. All sorts of emergency measures are being taken. Why don't we for now just suspend, our international intellectual property obligations, the obligations we've undertaken under this agreement, the TRIPS agreement.
Dr. Antony Taubman:So why don't we, waive the obligations to protect intellectual property under this this agreement? Well, it was an unprecedented proposal. Very controversial, I would say, but it had a lot of political momentum behind it. Particularly, it it was opposed by a number of our member governments. And it did lead to a major major set piece debate at the at the height of the pandemic about the the mechanics of the of the patent system, its relevance in innovation and dissemination of a vitally needed to medical technology.
Dr. Antony Taubman:And, exactly the kind of measures that government should have available, to take action. The kind of emergency measures that, that may be applied, outside of the the normal regulation of of the patent system. So, I might say in in retrospect, it's kind of unfortunate that that that dimension really did exhaust a lot of the bandwidth. A lot of the policy space, a lot of the space for a robust international conversation about all the necessary measures that that need to be taken in response to a crisis of this character. Because we we saw a range of other problems, difficulties in getting regulatory convergence at at critical times, trade restrictions that even impeded the regulatory process by limiting or restraining exports and sharing of materials.
Dr. Antony Taubman:So since then, we have had a a really rich and and excellent discussion here in the WTO looking at all these different aspects. Really thinking through the, the the practical lessons from from the pandemic. When it comes to intellectual property, for example, 2 important developments. 1, at the heart of the pandemic, in June 2022, a ministerial decision. So this is a 164 trade ministers from around the world agreeing on a common position when it comes to intellectual property and public health, COVID vaccines in particular.
Dr. Antony Taubman:And, basically, the the decision was a reaffirmation of this idea of balance that is inherent in the patent system. The idea that, in particularly in emergency circumstances, governments do have a reserve entitlement to override the exclusivity of patent rights in the public interest. But, this needs to be done in a in a way that preserves, equitable interest, is in a balanced and transparent way, subject to due process and so on. And that was really the the essence of a of a decision that came out at the height of the pandemic. And I I think that was very helpful in clarifying that existing balance that we all always see at the heart of the the IP system.
Dr. Antony Taubman:The idea that patent rights are not completely absolute, that, there is a reserve capacity in in every national system to to take steps to intervene in in in an emergency. Unfortunately, that decision has been has been, I think, misunderstood and and, its impact, overstated. I see it really as a a restatement of the existing understanding, clearing up doubts and uncertainty at the heart of this very politicized discussion. But in the end, it was a a technical decision clarifying the the rights, the agency that national governments do have working within the the existing rules to make sure that the public public interest is safeguarded particularly in a crisis. But since then, we've seen increasing interest in learning much more about what technology transfer, what technology diffusion, what effective voluntary licensing of critical health technologies looks like.
Dr. Antony Taubman:And we are seeing a really rich and forward looking discussion based on the that that really difficult contentious debate at the height of the pandemic to to better understand what are the drivers, what are the the the factors that make voluntary licensing and and technology diffusion work most effectively in the health area? And that is a a a very active, debate and discussion. Now there's huge amount of interest in learning, for example, from the practical experience of an initiative called the Medicines Patent Pool, here in Geneva, which specializes in working with, pharmaceutical originators and developing tailored pro equity, pro public health licensing arrangements for the most vulnerable countries. And that kind of model has has attracted enormous interest because somehow it's a voluntary system that works with pharmaceutical originators. It's focused on addressing, unmet needs for affordable medicines for those most vulnerable.
Dr. Antony Taubman:And it's very practical. It's very pragmatic. It actually works. It actually does lead to more widely distributed distributed, local production of of essential medicines. So we are seeing that, more grounded, more practical, more forward looking discussion about the I IP dimension today.
Dr. Antony Taubman:And, to my mind, that's a a really important legacy from from the pandemic, one that I think will yield a richer and more collaborative environment, in future.
Dr. Moira Gunn:Well, I know that the medicines patent pool, the MPP, is backed by the United Nations, a public health organization, and it's relatively new. And we should say that you participate on its governance board. It covers more than COVID related medicines. What else does it cover?
Dr. Antony Taubman:Yes. Indeed. It was, I mean, it's it's original, mandate was was focused particularly on, on HIV AIDS, on, for example, on fixed dose combinations of, antiretroviral medication. And it was really a very rapid decision by the board, with the onset of the of the pandemic for the EPP to to start to look at COVID, and to to look at some of the, the therapeutics in in that area. Because I think, it it was a model that had been tried and tested for for other other therapeutics.
Dr. Antony Taubman:And, it was it was able to be, adapted and applied, in a relatively short space of time in in the in the COVID space. But I think it's well, it goes into 2 levels. It it's understanding the specifics of the, of the of the licenses. I mean, one aspect of the NPP, for example, is, it's very transparent in the licensing arrangements reached. And that that's there's a lot to be learned from those as as case studies, if you like.
Dr. Antony Taubman:But also, it's of interest as a a broader model. The MVP has just put out a study, in fact, in collaboration with our sister organization, World Intellectual Property Organization, looking at how humanitarian voluntary licensing for this kind of distributed local production of medicines, essential medicines aimed at low income countries, how this is actually also good for business. So moving beyond that zero sum idea that either it's some kind of big pharma, you know, commercial strategy or it's charity, and sort of a sharp dichotomy between the 2. It's it's moving towards a more nuance. And I think a a a more grounded and and productive idea that where there is in particular, where there is this this appalling inequities in in access to to medicines.
Dr. Antony Taubman:There is a case both for humanitarian licensing, for greater distribution of of production capacity. And yet, this is not at the cost of legitimate business interests. Not purely measured in terms of of income, but for example, the study shows that there's greater staff retention in companies that do get involved in this this kind of humanitarian licensing, because it's greater greater satisfaction, of course, on the part of, of professionals, scientists, innovators. They want to see their their medicines to addressing public health challenges, not only for for those of us fortunate enough to be able to afford high prices, but for those who are, enormously vulnerable. So it is a worthy case study in itself, but it's also an indication of how we can rethink the interplay between innovation, product development, sustaining commercial viability on the one hand, and ensuring more equitable, more widely distributed, access to essential medicines.
Dr. Moira Gunn:One final question from me, and that would be, sometimes the words go by fast for listeners. The medicines patent pool is in fact, related to patents, not to a pool of medicines. But I'd like to relate that somehow, if it does to the World Health Organization has a list of essential medicines that every country may have. Do they interact in any way? Do they relate in any way?
Dr. Antony Taubman:So the the the Western Patent Pool, is, well, legally, institutionally, in terms of governments, quite distinct from the World World Health Organization. It's not part of the United Nations system as such. But of course the World Health Organization has a seat on the board and there is practical collaboration. And the most striking example of that is something called the mRNA hub initiative which is an initiative to strengthen technological capacity to work with the mRNA vaccine platform, not just for COVID, but the mRNA vaccine platform, with 15, developing countries around the world with with partner institutions. And so a lot of that expertise is managed within the WHO.
Dr. Antony Taubman:And so they are working together with the Medicines Patent Pool and a number of other partners to strengthen the technological capacity of of these 15 partner institutions around the globe so that they will be able to take up and make use of mRNA vaccine technologies for whatever future health challenges arise. So institutionally, legally, whatever, the the the government structures are distinct, but, there is a a positive level of of practical collaboration.
Dr. Moira Gunn:One likes to hear this. It's not just baked into the institution. Actually, humans are working here trying to make it all work.
Dr. Antony Taubman:Exactly. Yeah.
Dr. Moira Gunn:Well, Tony, it has been terrific. I really appreciate it. And, of course, you know you're always welcome on Tech Nation.
Dr. Antony Taubman:Well, it's it's great to be back. Keen fan. It's a it's a I mean, you know, even the discussion we're we're having today, it's it's a reminder of just how important it is to have this kind of searching open dialogue about how to make innovation work, how to make it work for, society. And, sometimes to dig into some of the the geekier detail because that's actually where, you know, delivery actually happens. And I guess that's what, you know, from where I sit, it ranges from, you know, very very politicized, very high level kind of, more abstract debate about the rights and wrongs of it, and very, very practical delivery oriented, equity oriented programs.
Dr. Antony Taubman:And, you know, the more we have this kind of discussion linking the 2 together, I think the better it is.
Dr. Moira Gunn:Fantastic. Thank you so much.
Dr. Antony Taubman:Okay.
Dr. Moira Gunn:Doctor Anthony Taubman is the director of the intellectual property division of the World Trade Organization. More information is available at wto.org.