Jaume Vidal
Jaume Vidal: I'm going to be talking for about 50 min more or less, and then hopefully, we'll have some sort of exchange. I am going to be talking about like a presentation of HAI, and then we're going to get into the subject of today's lecture and that’s IP . But it's more than IP . In a sense, it's not only IP, but also the R And D model. It's what happened with Covid. What's going to happen after Covid and the challenges that we face. Before we start with, what is health action international, for those of you don't know us, we are an organization that have been around for 4 decades and our mission is to promote access to save effective, portable, and quality-assured , medicines for everyone, and everywhere. You see we have mended the mission/mandate a little bit. Now we not only work for access to medicines, but also health technologies. We have different projects. I work the European projects where I deal with WHO, I did also with the institutions, and also what's going on with Netherlands. But we have, a project working on access to insulin. Another project working on access to, anti-venom for snake bites we have also a new project that is dealing with the implications of artificial intelligence for public health. And we have one project on several African countries for access to like sexual and reproductive health goods, and also one on health system advocacy for African countries. As you see, we work in a lot of places, on a lot of issues, but also in connection with pharmaceutical policy.
So today we are talking IP, and the issue with IP is it’s not one consequence of the market economy. It's not just like a creature of capitalism. It’s deeply entrenched in what we understand is the current biomedical research and development model. This model has 3 characteristics: non transparent. It's profit driven. And it's IP-centred. These 3 factors are connected among themselves. We see in a sense that this non transparency allows for companies to really not be clear on how much a medicine cost to develop, and then asking price proportional to what they say they have spent in the developing. Also, the royalty of patents have grown with the years in the sense that right now when it's manager acquisitions of pharma companies before it was what do they have in the portfolio. Now It's like, what patents do they have? So I think it's important to see that this has real consequences. It's not just a matter of inefficiency in the designation of prices but it also affects the decision that policy makers take in the public health policy domain
And this graphic. It's a campaign that we did in 2017 on the prices of medicines in the development. But I think it could be applied everywhere. The issue here is it’s really, especially when it comes with partner, they say there's no innovation without IP. I think we like to really challenge this in the sense that we believe that IP an incentive can be replaced. IP cannot be the sole driving force, with the development of medicines. But it's really interesting that they say we need patents. We need monopolies, to recoup your early investment. Remember what we were saying about the lack of transparency. We don't know how much they have spent developing this medicine, but they need to recover from this investment. So that's already something that we take the exception with. Also we've seen how patents have an average duration of 20 years are being extended more and more for second users or, for example, in the case of the European union we have supplementary protection certificates where you have like medicines being under patent and under an effective monopoly for over 50 years. So that has consequences in terms of lack of competition and high prices. Finally, it's an issue that patterns are being granted not always, in a justified manner in the sense that we are talking about products that don't really have, any therapeutical value. They are not really an innovation. There's not an improvement from products that were already in the market. In a sense I would recommend, this strange organization called Prescreen. Every year they make a ranking of the drugs that have really good performance. Then they realize they studied the effectiveness, the efficacy of the drugs and they compare it with already existing products in the market, and they realize that year after year there’s medicines that are authorized for marketing which will not improve on the existing products. So the idea here, is it's important that we are granting protection, we are granting a privilege of monopoly. That it's not really justified or deserved.
I think it's important that here I'm sure that we are all familiar with the TRIPS agreements. It's really nice. You realize that you have grown on. Because now I work with people that say, “I have seen TRIPS agreement since I was born.”. Yeah, I mean these people, the TRIPS agreement was in 1994. It’s quite recent, but at the same time, it's already more than 20 years. It was a game changer. The TRIPS agreement was really something, because IP and especially patent protection, had been like domestic property, especially when it comes to pharmaceutical. In a sense the WTO was a little bit like the gateway of the globalized board? If you wanted part of this globalized society, you want to engage in trade with our members. You have to be a member of the WTO, and you have to sign these treaties. For the European countries that meant that for the first time they were really enforcing patents of pharmaceutical products. So I think it's really an important idea of tensions and constraints seeds the beginning of the whole system of the treaty, and the WHO. The resistance from the global style, from society. Once you signed the TRIPS agreement there is no need for patent protection. It was supposed to be like this ceiling of protection. There wouldn't be asking for further protection of IP. But we see that already from the beginning there are some issues. The most known is the trial of the Slovakian government which was brought to justice by pharmaceutical companies between 1999-2000. I mean in the midst of the Aids pandemic the Slovakian government was accused by pharma companies of breaking the terms of agreement when acted alone trying to make new flexibilities. I think it's important that we look at this medical history. The fact that pharmaceutical companies were taking the Slovakian government to court, it just was not like pharmaceutical companies.
But these brought us to the Doha declaration. The Doha deceleration is really clearly phrased in what's the use of IP, especially in what is the compulsory license. The compulsory license is a use of the patent. The government decides if the patent holder, for a number of reasons, doesn't deserve to have this monopoly and allows itself to take control of this. So I think it’s important in the sense that it was 2001 we see the declaration in a way that it's really placating what was really there. So in the sense, there was already this feeling that they got a raw deal with that. So I think it's interesting that we see the Doha declaration was very well, “Yeah, we appeal for the right of governments to use compulsory licenses beyond mentions. There’s one better. This paragraph 6 was how do countries that have no pharma capabilities make use of these flexibilities? So the issue here because this was 2001, I think they were supposed to conclude on how they would make this work in one year. And then they got a position in 2003. That was really, a new article of the TRIPS agreement that took almost 17 years to come into force. So I think it's important that we see these in the sense that even though when there is consensus, there's always some details that are really hard to negotiate; In a sense this contains trade-offs, because let's, remember the agenda of Doha is still being negotiated today. We were in the last ministry of conference last June and they were still discussing subsidies. But I think this issue of the countries, with no pharmaceutical manufacturing, I think it's really important for what we are going to be discussing next. And what's interesting is at the end of 2010s, we started seeing a multiplication of agreements, bilateral agreements that Bypass WTO and go beyond TRIPS. What we call TRIPS+. Those of us that live in the European Union, but also, the UK in this case, we live in territory that has extended protection, there’s data exclusivity that allows for an addition of time for the monopoly. We see how the WTO was losing ground as a space to discuss and really get this big grand agreement. We see how difficult it was.
So we arrive to the pandemic, no one had foreseen. But there were already some cases i.e. H1, Ebola, SAR, MERS. So the issue of the pandemic, was there was opportunity. Especially with Ebola when it was seen that it could also affect Western countries, there was some sort of action from governments. There are like 3 issues which are really important to understand what happened in the response to Covid-19. There's the underfunding of the region, something that has been chronic for the last, I think, 10-15 years, I mean governments, keep on asking the WHO to do more things and they don't contribute to the intervention, but to like project when they're paid projects. So really the basic control of diseases hurts. Let’s talk about poverty imbalances in the terms of you cannot really pretend that we live in international society when they are private companies, or companies that have more power than some sovereign governments. Especially the relationships between developing countries and western nations, are really unequal. And finally technology dependence. Technological dependency, that’s something that we believe to be really important, because there was no vaccine manufacturing in the African continent when this Covid 19 happened. I mean that's really huge in the sense that the fact that all
vaccines for Covid-19 were manufactured in either European countries or US/Canada. That really shows like the imbalances we are talking about. So I think here it's really like these 3 issues that are really key. This limited manufacturing capabilities that were bolstered by monopolies. Pfizer were manufacturing it Michigan and they could be producing in other sites, but they choose not to. The whole thing by EU and in other countries, I think it's very important that, as Eu citizens, we are aware of what happened on our behalf. In a sense I think countries like France, Spain, Netherlands was buying like 7 times the number of doses that they needed to vaccinate all their citizens. At the same time we have health care workers in African countries, that have no access to that, that really shakes the debate, and that really makes the debate about access to health technology, it turns it really political and finally it's important to see that those mechanisms like the Covex facility, that were supposed to deliver on equal access; and I remember when we had discussions on the waiver but they didn’t deliver. Because again those created the vaccines didn't support these mechanisms and I think here finally, there are 3 issues which are very clear, that will help us understand where should be helped. Industry had really achieved an amazing R&D breakthrough; in the sense they have really brought vaccines in light speed. I think that everybody was really acknowledging this achievement. But then you see profiteering. How they resisted any talk, about IP amendments, or any sort of flexibility; and then, second factor was the knowledge of Governments. At the end of the day, where were all these discussions about IP what was happening at the WTO. Why is it not happening in the UN assembly. Why was it not happening at WHO or UNESCO? Here it’s really a matter of the fact that the knowledge governance does not depend on any sort of knowledge generator institution. And so that's the issue, and that's the key. How we really separate these discussions of knowledge governance issues. It's difficult to talk about access to medicines, and I think this difficulty about talking, it's really the third title that we need to address. The transparency of negotiations there has been, at WHO when they are holding these bilateral meetings, at the European Commission negotiating contracts, or any other kind of dialogue where public interest is at stake. Accountability in the sense that it's important to know who took decisions, Why the decisions were taken. It's really important that when it comes to decisions by the UK government, or European authorities of really supporting the development of vaccines and other health technologies with public money and have nothing like in Britain, I mean there were no guaranteed access or some sort of discounts. Inclusivity in the sense that there have been many instances that we're clearly undemocratic. It's not only WTO with the really little meetings, but also when the decisions of who lives and who dies are not taken at WHO. And that has real implications for all of us as societies. So I think that there are like 3 issues which are really clear, and that really shed this failed global response. The lack of political will to really address the issue, I mean in the beginning they were talking about global public goods, but that didn't last. The weakness of the global health government system, it has failed in responding to covid and the limits of all paradigms. And here it's something that I really think is interesting because the pandemic has really seen new ideas, especially when it comes to IP. We have this proposed TRIPS waver and I think this issue with the waiver, because I was very much involved with supporting this; I think it's really interesting in the sense that we have 2 developing countries, but division of powers like South Africa and India coming with these proposals, saying: Okay, let's really wait and certain articles of the TRIPS agreement for any health goods that are necessary to fight Covid-19. So simple. So why, did no one think that it was going to get any traction, but it did indeed. It gained the support of over 60 countries, like a mobilization of civil society that had not been seen since Doha, and the issue that they debated really is there. Even now we are talking about that. The sense that it was very clear that that the issue of IP was affecting, the liberty of lifesaving health technologies. Also important to see for example, institutions such as WHO created the covid 19 technology access pool because we see also that technology transfer is now envisioned as well. Why is the vision there even though each part of the TRIPS agreement is supposed to be one of the goals of the TRIPS agreement in the sense there was: you enforce intellectual property but we will make sure you get this innovation at some point. It's really: okay, how can we make it effective? And we have this set up like a stop where you can go there and get the IP, the IP rights. And you can start owning and manufacturing the property. The problem is, licenses are being supported, and there's the collaboration with Parma companies. Only one government, the Spanish Government has so far licensed one property, even though the US has promised to license the horror portfolio of the NIH which is quite impressive. I think it is interesting that we are talking now about concepts that were really fringe maybe 3 years ago, like open-source development, for example, what's happening in the South Africa based mRNA and tech transfer hub. Okay, these people came, these people got the vaccine from Moderna, and they really did something that it's really impressive in the sense that they reverse engineered the vaccine without any help from the company, and they are going to be first, transferring the knowledge to other hubs in the African continent, and elsewhere. They are going to be working on mRNA Technology for other diseases. That's something that we are going to be talking about later.
And finally another concept that is really in the double vision is this access, the public funding for R and D. The need for public return. We've seen all the us taxpayers really fund the government of some of these vaccines, never get anything in exchange. The Europeans like the Germans. There were tax credit subsidies for biotech and now I mean no one is returning any of the profits that they've got. So I think that there's a demand, there’s a public call for greater accountability on this. I think these are the 4 values that that we look at because the issue here, I think it's important that when we talk about IP, a new paradigm new covenant; it’s not only IP : it has to be a conceptive effort at different levels and also, I think that we should go beyond the idea of this pandemic, or the next. I mean, we should be working already on non-communicable diseases or neglected tropical diseases, and also universal healthcare. If not, we will keep all thinking on silos like today we talk about it a bit. Tomorrow, we talk about antimicrobial resistance. No, we have to be working on something, but keeping an eye on the other things.
In terms of process, we have, 3 that are very clear. First the negotiations of a pandemic treaty convention at the region through the inter-governmental body, members of states in collaboration with WHO. Its hard to have an IP chapter in this treaty, but I think it's important to have the discussion. I think that sometimes the discussion is as important as the end product. In this case to really show the Europeans that the one behind this initiative, that the time to really rethink IP has come. Like the Ministerial Conference where we got that solution on the waiver, that is not a solution, not a waiver. And now there's a discussion about extending that little amendment improvement for the export of vaccines, to therapeutics and diagnostics. It's not a good deal, but it's better than no deal. So we have to support this. We cannot be rejecting; we cannot really be not wanting to play. We have to be part of the game. Also in this sense the different EU policy proposal process from the commissions to reform certain aspects of the EU legal framework, especially consultation with compulsory license, protection on supplementary protections certificates. That's like places where we can really talk about the need to reframe IP in a way that helps, not the other way around. Potentially these are like long shots. The sense that we didn't need WHO to work on IP, on a health oriented IP. But they need the Mandate, and they need the mandate really strong worded for a WHO Revolution? If not, they will keep on working with WTO and WIPO , and that's a whole different agenda. With WTO, I think that South Africa, still has appetite after the waiver to keep on pushing for reforms. There's a clear call from like southern countries to really reform the organization in the way they deal with their demands, and I think that an amendment to the TRIPS agreement is a possibility. Having said so, remember when we were talking about paragraph 6 approved, like the text in 2002, It took 17 years to have a new article in the agreement. But the issue is that we need to really show this long term commitment that all the actors have. And finally, I think it's important that, for example, next year is the presidency of the Spanish Government, of the European Union, and the Spanish government has made global health one of the top issues of the foreign policy. So it's an opportunity to raise some topics like IP issues at the European level that we can use.
Finally, I would like to increase publicity of my organization and what we are doing on terms of IP. And we are working especially TRIPS flexibilities. There are 2 things which I am proud of. A policy paper on IP and access to Health technologies and that’s almost finished. Right now we are just finalizing consultation with partners and could be launched in October. I trust that Consilium scientific can distribute it. And also TRIPS facilities navigator which is really a tool for all of you out there, academics, policymaker, researchers that want to know more about how to use flexibilities to improve access to potential medicines, especially on compulsory license. That's the idea: to educate, to inform, and to empower, I hope.
Leeza Osipenko: So I think it's more to do with TRIPS and my understanding of it. I might be wrong so correct me there. If TRIPS agreement is used to produce a medicine in a particular country, it can be used only in this country. Is this correct for the population of this country?
Jaume Vidal: I think you are referring to TRIPS flexibilities, and the issue of compulsory license. The compulsory license is just to be for every problem so you would need a compulsory license for each one. For a medicine it’s simpler. You will need just one, but for the country. So they would not be able to export. If they want to export, they should be using that solution what we were talking about the paragraph 6. It would be really cumbersome.
Leeza Osipenko: The reason I ask this question is my understanding once again is that TRIPS is used much more in third world or developing countries, rather than in developed countries, because they're rich, they can get what they want. But the paradox is that developed countries have a lot of resources and the knowledge that they can much more easily reverse engineer technologies. They have capacities to develop these products while developing countries who would really need it might not have these technologies in place to actually replicate these medicines, especially smaller countries. How is this being dealt with? So, for example, if the country wants to trigger it but they just don't have scientific capacity to do that, because we're talking about South Africa and Thailand, maybe Argentina, India. These are big countries. They have a lot of research institutes, and they have a lot of population to serve. But there might be other countries actually with bigger population. I don't know how well Indonesia is doing in this, for example, how well other countries which are quite significantly populated but not having these resources, what are the options for them?
Jaume Vidal: I think there are 2 issues here which are really interesting in the sense that you see, for example, in developed countries, like the European Union, there's no use of compulsory license, of TRIPS facilities because of the legal framework. I mean, in the European case, it's because the European Union Directive on, I think it's rare diseases, is like that exclusivity, that greed nullifies the ability of countries to take the compulsory license. Then it's like what I was saying with technological dependency of the vast majority of countries. And I think it's interesting, like precisely the examples that you are mentioning. I mean Indonesia, Thailand, South Africa, India. You know that more or less, they have the ability to at least reverse engineer medicines. But I remember I used to work in a Brazilian health organization in/around 2007, and someone in the Brazilian government told me that their talks with Roche before they were going to issue a compulsory license and they were at the table, and they showed the Roche representative, here is the medicine that we have been able to reverse engineer. So that says what kind of negotiation they can engage. But then in, for example, countries like Nigeria, that they can have amazing human capability. And the University is great and they have researchers, but when it comes to the last mile of the technological, they are not there. I think that they have they have no options. For example you see what the Canada did, they tried to use paragraph 6, the compulsory license when you have no manufacturing capabilities. Bolivia tried to do that during this pandemic and didn't go anywhere with Canada. So I don't know. For me it’s the WHO that really provides this technical expertise. It's complicated because the issue, at the same, we are always talking about issues that really require, 10-15 years of really sustained government policy, sustained government funding. I'm sorry I don't have a better or more optimistic answer on this one
Leeza Osipenko: No, it just the really highlights how complex the landscape is, and even though there are attempts at institutional solutions, they are solutions for some, but definitely not for all. Smaller countries pretty much have no options. So there is a question for you from Sophia in the chat.
AUDIENCE QUESTION: I'm particularly interested in learning of successful examples of technologies that have benefits from the TRIPS agreement, and where?
Jaume Vidal: Well, the issue here is there are some examples, and for me it’s the compulsory licenses, the compulsory licenses that Brazil needed in 2007. The compulsory license that Thailand needed in 2008. I think these are success in the sense that they used flexibilities, and they were able to either produce the medicine or gain a reduction in price by the patent holder. These are successes in the sense that the tool from TRIPS agreement works
Leeza Osipenko: Are you talking about HIV treatments?
Jaume Vidal: Yes, in the case of Brazil it’s HIV treatments and in the interesting case of Thailand in 2008 is that they issued a compulsory license on a cancer drug. That was really a big thing, because up to then, most like flexibilities being used were for HIV but this one was for a non-communicable disease. I'm trying to think other successful experiences.
Leeza Osipenko: Well, I can give you one, there was obviously Vertex with Orkambi in cystic fibrosis. To me that's why I asked you the first question, because some British parents actually flew to Argentina to buy it, but these were very rich families who could, I mean it wasn't as expensive as from Vertex, but it was still expensive, because I think Argentina could not do anything like providing for the UK patients, because of these limitations. So this is an example to you of a very (relevant example), well it’s the UK, and they did not exercise crown license and that was a big problem in that particular instance. They actually had to throw away the medicines which expired instead of giving it to patients so unfortunately it didn't work. They threw away 8,000 boxes of medicines in the UK instead of giving it to patients, because the agreement on reimbursement was not reached in 4 years. But unfortunately, it's also an issue in developed countries and, from what you say, there's very little room for developed countries to do anything because of the regulation that you just listed. Because quite a few, for example, expensive cancer drugs, and I'm not going to comment on which ones, because some of them probably should not be on the market, but patients cannot get access to them. And all the developed countries do have capacity potentially to replicate the product, and they can't. So it's a problem not just in the developing world or small countries without manufacturing capacity.
Jaume Vidal: Here I didn't know the case of Orkambi in the UK and Argentina. I remember, there was the issue in the Netherlands in 2017-2018 and it was really bad.
Leeza Osipenko: There was a big scandal about the very rare drug that the university developed. Yeah, can you tell that story?
Jaume Vidal: Yeah, there was a drug that had been originally developed by a Dutch medical Research centre that later on was patented by one of the researchers and then bought by one pharmaceutical company and they were asking. And the issue is what is said. When the government says, “There's nothing we can do, because it's legal”.
Leeza Osipenko: They hiked the price like 500 times, so it was really expensive.
Jaume Vidal: But something also on the on the compulsory licensing is I think it's interesting to see that, for example, Germany, when it started like the pandemic issue, a sort of compulsory license on a problem that they thought they needed. So in the sense it’s always a matter of political. But the issue is that governments don’t use possibilities as another policy. We need policy space to do that. There is no need for exception and no need for emergency and pandemics.
Kieran Harkin: I hope I’m not going off topic with this question but if I am just say so. But it seems to me that at the moment, we spend a lot of time talking about the problems associated with the IP incentive for R&D, but not as much time talking about one of the alternatives. And of course pharma said “Well, we're not stopping, go ahead, if there's another model and a better way of doing it just do it.” And I know that there have been some progress groups like DNDI, which has come up with drugs, but there's no big commercial or anybody else jumping at alternatives; nor governments, looking at alternative models. And I'm just wondering if you could comment on you know why is there such little progress on developing alternative models given the problems with IP incentives.
Jaume Vidal: Yeah, I think that's a fair question. Now, in the sense that there has always been talk about prices like setting up a prize for example, “whoever like develops an effective antibiotic gets X money”. Medically there is this idea that especially now with what Europeans are talking about, and some of the international efforts on AMR, it's really to find a sort of price. But in a way it's not a prize really, It's more of an advanced market commitment. It's like telling companies, If you develop, we are going to buy it. That's a witness of the civil society that we should really work on in the sense of course, we criticize the IP, But what's the alternative? I think that that's a challenge. You see in the sense: what we are now really working on is really to be clear that we are not against IP . We are against misuse, and abuse. You see, in the sense, to support me like this, because it's clear I mean this this line proof. The issue here, it's really that I don't know where income can come from, you see because we are really working on abstract concepts, and then it’s difficult to get the attention of people. There are people that have been working for example, Jamie Love has worked a lot on this with me and Jamie is dedicated. And it’s always at the last mile where they tried something for i.e. for Tb treatments (I remember there was some work on that). But it showed that, a lot of things is possible. It's like the work from Andrew Peer from the University of Liverpool showing that the cost of developing some drugs, monitoring some drugs is not what the industry says.
Leeza Osipenko: I just put a Link in the chat of the organization, that Jaume, you might know. So they also do quite a bit of work, and I wonder if you can comment. I found their reports quite fascinating and useful as one of the learning resources.
Leeza Osipenko comment: https://www.i-mak.org/
Jaume Vidal: Yeah, the problem is after listened to me, you will read the reports and you will see that they're really good. They are really good, and they issued a report, I think it was last week, showing the impact of excessive patenting for taxpayers and patience. Remember what I was saying about how we extended the protection in the US. The issue, is I think it's really interesting what they are doing in the US, really placing the issue in the agenda. If you have time check their website because they have a link to The New York Times, 6 months ago on the need to reform patents. It’s the reform of patent laws. That's happening in South Africa and it’s happening in several countries and it's really interesting, because also something that I mentioned is we need to be propositive. We need to really come with ideas. And I think what Kieran was saying as well, It's in this direction. You do not agree with this. What's the alternative? What are we suggesting?
Leeza Osipenko: This I.mak group is really impressive in terms of the work. They produce very visual, very tangible, and it looks like a cold shower. I think one other thing that you were talking about patent evergreening, which I think is excessively abused in the US. But, as I understand, and once again I'm not the specialist in this area, this is completely country-specific, and if this evergreening happens in the US the drug might be off patent in Europe, and that less generics in the market easier, or it might be off patent in the developing world. Is this correct or not really.
Jaume Vidal: What happens many times is that some products are not introduced in the developing world. You see the generics comes first before the patented drug. Because you see, for example, in the country Bangladesh that has no Patent protection for pharmaceuticals yet because it’s a NIC and for Bangladesh you would think we would have some assumptions, but they are Bangladesh. They are a generic manufacturer. Let's be clear that the situation in the US, It's really extreme. I mean many depths. 2 weeks ago they approved that the Government would be able to negotiate with pharmaceutical manufacturers the price of some medicines. For them It's really a victory. We are not in much better shape here in Europe in terms of prices. Prices are not as high as in the Us, but in terms of evergreening with supplementary protection certificates and flexibilities, the issue here for us, I think the burden that we have is with rare diseases and paediatric formulation. The issue here also is that it's a really, politically, and also personally, it's a really difficult topic in the sense that these are children. I mean how can you justify not paying any amount to save the life of a of a kid. But behind that there's a business model.
