While the speed at which the COVID-19 vaccine was discovered was rightfully applauded, the rollout and distribution of the vaccine has been markedly different. Distribution not only within the United States but many other developed countries has highlighted the weakness of our underfunded public health infrastructures. Meanwhile, the problem is markedly worse for developing countries where, despite lofty promises made just a few months ago by world leaders for a “global public good,” people may not even see the vaccine until 2022 or later.
Ellen ‘t Hoen is a veteran in the access to medicines movement, a lawyer specializing in global health and intellectual property. She was Director of Policy Advocacy with Doctors Without Borders, or Médecins Sans Frontières (MSF), for ten years beginning in 1999, the year the organization won the Nobel Peace Prize and launched the Access to Medicines Campaign. She was also the first Executive Director of the Medicines Patent Pool, an organization backed by UNITAID with the goal of negotiating licenses for the production of low-cost generic medications, particularly for HIV. She is currently the director of Medicines Law & Policy and a global health law fellow at the University of Groningen in The Netherlands. She spoke to associate editor Sophia Crabbe-Field on January 18, 2021 about the failings of the patent system and the public funding of the COVID-19 vaccine, the prospects for improved vaccine rollout under a Biden Administration, and the need for true global solidarity in the fight against pandemics and other interconnected global threats such as climate change.
Sophia Crabbe-Field: You joined MSF as Director of Policy Advocacy for their Global Access to Medicines Campaign in 1999, which is the year they won the Nobel Peace Prize that allowed them to launch the campaign. And you were also the first Executive Director of the Medicines Patent Pool. I was wondering if you could tell our readers a little bit more about your work in both of these roles, since they’re both very important right now in the middle of this pandemic when so many people are going to be in need of a vaccine all around the world.
Ellen ‘t Hoen: I joined MSF in ’99 when MSF set up their Access to Medicines Campaign. That was at the time when antiretroviral medicines for the treatment of HIV had become available, but only in wealthy nations, while the disease was so much more prevalent in the South, in developing countries where those medicines were not available at all. Eight thousand people a day were dying of AIDS in the developing world. And they had no access to the medicines that were starting to keep people alive in rich countries. It became apparent that one of the problems was rooted in the way intellectual property is organized, meaning that pharmaceutical companies held the patents on these drugs. With those patents they could stop others from making them or from importing or using them. Even though, in some of the countries where the patents on HIV medications didn’t exist, generic manufacturers started to make low-cost versions of these medicines, they could not be sold in countries where the patents existed.
For example, companies had patents on HIV medicines in most of Sub-Saharan Africa where the need for the medicines was enormous. So a solution had to be found. A couple of things happened that I was directly involved in. One was the negotiations at the World Trade Organization to make the international patent rules a bit more flexible and encourage countries to intervene when patents were a problem, for example, through the use of compulsory licensing [Editor’s Note: This occurs when a government allows a third party to produce a patented good without permission of the patent holder in exchange for a royalty paid to the patent holder. These are usually given, in the case of medicines, to generic companies when the patented cost is deemed prohibitive to patients.] That led to the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001. And a few years later, we developed the idea of a patent pool because, while measures such as compulsory licensing can be very effective, they are taken drug by drug, country by country, actually patent by patent. So it isn’t terribly efficient when what you want is large-scale production and global circulation of the products. And an understanding that if you have a life-saving medicine, or if you have life-saving medicine for HIV at the time, you license your intellectual property so that others can produce and supply low-cost versions of these drugs.
To carry that from idea to an actual organization being established, that took some of my time, but in 2010—and I was of course not alone, there were many other people advocating for this—with the support of UNITAID, the Medicines Patent Pool was established. The first entity that gave licenses to the Medicines Patent Pool was the United States NIH. They had some intellectual property for one of the AIDS drugs, and they said: “We’re willing to license that to the Medicines Patent Pool.” This was a very significant move because it also came with the blessing of the then Obama Administration. It gave the Patent Pool a high profile and a very good first license agreement with the NIH. With the team, I negotiated the first licenses for the Medicines Patent Pool and today all WHO-recommended HIV treatments are licensed to the Medicines Patent Pool and available at low cost to most people living with HIV in developing countries. So that norm that, if you have an important medicine for the treatment of HIV, you license it to the Medicines Patent Pool, has become a reality, which is very good but it should be expanded to other disease areas.
Now, you would think that, from all of that, lessons should be learned for COVID-19. To a certain extent that is happening, because last year, in May, the WHO, upon the proposal by Costa Rica, established the COVID-19 Technology Access Pool (C-TAP). Of course, to be able to produce vaccines you need more than just patents. You need know-how, you may need access to cell lines, or direct tech transfer may need to happen. That is the idea behind the Technology Access Pool: that whatever is required to scale up the production of vaccines, therapeutics, diagnostics, would be available through the COVID-19 Access Pool. But unfortunately, as of today, that pool is still empty, and no entity has licensed to the Pool. So we’ve got a huge problem there.
SC-F: I want to come back to that, but I first wanted to quickly ask for your thoughts on what’s going on in the United States. I’m wondering if you know a little bit about the members of the Biden transition team, those who are working on the pandemic, and if you have any thoughts on the team that he’s put together.
EtH: I don’t have a lot of details. Some of the names are familiar and I think, “Oh, great.” I think everyone is waiting for the U.S. Administration to change course, but that doesn’t necessarily mean that everyone expects the United States to do the right thing. There is the historical perspective of U.S. administrations also under Democratic rule not exactly putting the interest of poor people in poor countries first; that is not a given. Of course, it couldn’t have been worse than in the last four years. Let’s be clear about that. And Biden has already said that he’s willing to share the vaccine, he’s used that language. He said, “I’m going to share whatever we come up with.” Tony Fauci said a few days ago that he thinks that NIH should join C-TAP. And NIH, of course, is financing a lot of the COVID-19 product development and holds IP that is relevant for COVID-19 products. So those are very important messages. But these words need to be followed with action and we are all eagerly waiting.
SC-F: Biden has promised to continue with the Trump Administration’s decision to make use of second doses that were being stored previously and to start vaccinating everyone over 65 with the intention that they will ramp up production. I’m just wondering, how likely do you think it is that they’d be able to do so while staying within the guidelines for administering second doses? And I’m also wondering how significant you think it is that Biden has promised to use the Defense Production Act in order to ramp up production?
EtH: The first question I can’t answer, because I just don’t know enough about the guidelines, and it would also require me to make medical commentary, and that’s not my field of expertise. The second part of your question points to a government willing to do whatever it takes to make sure that the production is there and intervene if the commercial sector does or cannot not deliver. And that’s of course exactly what needs to happen. But that does not necessarily give assurances for people in the developing world if there is not an international equitable distribution framework the United States, and European countries for that matter, to take part in. Without an international solidarity system, the benefits may not roll over to people in the developing world. And that is what really needs to happen.
SC-F: Why have we seen so many U.S. companies able to create vaccines in sort of record time yet now we’re witnessing such poor vaccine rollout and distribution?
EtH: Well, the fast development of the vaccines of course had to do with the unprecedented funding that became available almost overnight. If you ever need to answer the question again: How do you stimulate innovation? Well, pay for it. That’s how you stimulate innovation. You don’t need 20-year patents. No one said, “Oh, well, we’ve got this wonderful patent system. Let’s just sit back and wait, wait to see what the industry will come up with.” No, governments immediately said, “We’re going to have to finance this otherwise it won’t happen.” Companies actually said so. They said a year ago, “We’re not really interested in doing anything in this field unless we get more money.” They wanted upfront payment. That has been absolutely crucial. But then the plans for the production of these vaccines have been very different.
The only company that has licensed to high-volume producers in developing countries has been AstraZeneca. That’s the Oxford vaccine, and probably the fact that Oxford University holds the first IP, I imagine has something to do with it. They licensed to Indian producers, producers in Argentina, Brazil, Mexico, South Korea, Russia, China, as well as the United States, Belgium, Italy, and the UK. But others have not done so or not done so yet. Some vaccines are more complex to produce than others. There’s of course also the issue of the ultra-cold chain that is required for the Pfizer/BioNtech vaccine, for example. On the other hand, this is also true for the Ebola vaccine. But there’s been no attempt to actually share the technology to increase the production capacity. And that’s something that needs to be dealt with.
The other issue has to do with the inequity in distribution of the vaccines that do exist, because you would have expected an agreement for equitable distribution. There a global procurement and supply mechanism, COVAX. With all its faults, it had that principle of an equitable distribution mechanism whereby people at risk would get the vaccine first, so that you would not have a situation in which a young person at low risk in a high-income country would get a vaccine before a person at high risk or a health-care worker in a developing country. And everyone sort of agreed to that principle, but then did not follow through by joining the mechanisms to make that happen.
And now COVAX risks becoming a charitable endeavour through which countries give donations or money, but that is not the same as having a multilateral approach to access these vaccines based on solidarity. High-income countries have hoarded vaccines and bought up much of the production capacity, even multiple times over as compared to what they actually need. And the director-general of the WHO, Dr. Tedros, this morning [January 18] at the opening session of the WHO Executive Board, slammed that behavior in very strong language. He said, “The world is on the brink of a moral catastrophic failure.” He was referring to the lack of equitable distribution, equitable access to these vaccines. He said, “39 million doses have been used in 49 high-income countries while only 25 in the lowest income countries.” So that gives you some idea of how wrong things are.
SC-F: Right. I think here in Canada, where I am at the moment, we bought the most in the world in terms of vaccines, and there’s enough for seven rounds per person.
EtH: And that’s what you can do when you’re rich.
SC-F: But I think we’re seeing, even within the U.S., where the companies that hold the patents on these vaccines are based, distribution has been really poor. What would you attribute that to?
EtH: I am not a logistics person, but I would imagine that the dismantling of the public health system in the United States has not helped. You need a system in which you put these things, and if you don’t have a good public health system then that doesn’t help in the distribution of such products. But having said that, you see these problems everywhere, which is surprising. I think the world acts a bit as if this pandemic is a total surprise while the experts in this field have said for decades this is going to happen and urged politicians to prepare for. And here we are.
SC-F: Right. But we knew ramping up production was going to be an issue for a while now. I think just looking at it, one might wonder: Wouldn’t pharmaceutical companies have an interest in producing the maximum number of vaccines possible and selling the maximum number of vaccines possible. Why wouldn’t they have done more to ensure distribution could be ramped up?
EtH: I think that it’s very difficult for such companies to sort of get out of their logic of selling products in the markets that they know, which are the high-income markets. Some of these companies don’t have a great deal of experience with vaccines, and certainly not with global rollout of the vaccines. The failure in a way lies with the public sector that is spending all these billions on the development of the vaccines without putting conditions on that. To date, $64 billion in government funds has been spent, including advance market commitments. That money should have come with the conditions on those companies to transfer the technology, to work with other producers to make sure that the production capacity increases, and to make sure that know-how developed with that public financing is shared with others, and that has not happened. And that is a public policy failure.
SC-F: In your view, why did this idea of solidarity fall apart?
EtH: Countries started to go for themselves, self-interest, vaccine nationalism. Even within the European Union, it fell apart, where countries didn’t want the EU to do it at the EU level. They started to make bilateral deals with their own interests in mind, not what would serve the global good. And I think we perhaps somewhat naively expected a year ago that a crisis of such magnitude would bring out the best, but it seems the opposite is happening.
SC-F: And I know that these bilateral deals are usually also shrouded in a lot of secrecy. Why is that? And why is it important that they be made public?
EtH: Why the secrecy? I honestly don’t understand. In my country, the Netherlands, these vaccine deals have been labeled “state secrets.” That means that the Freedom of Information Act can’t even be used. It’s bizarre. And I can’t figure out why because, in fact, before COVID, the trend was to have more transparency. The World Health Assembly had adopted the Transparency Resolution to introduce new norms with regard to pharmaceutical transparency. All of that is now being rolled back. And it’s wrong for a number of reasons. First of all, just basic principles of democratic government. How can we hold our government accountable if we don’t know what they’re doing on our behalf? So, of course, there will always be elements in such agreement that, for whatever reason, need to be kept secret, but to say everything is confidential, makes no sense.
Second, in the context of vaccines, there’s also the need to create confidence in those vaccines. The public needs to trust these vaccines. And there is already quite a challenge there, where a lot of members of the public say, “I’m not sure I want to take the vaccine.” There’s distrust. So transparency can only help increase trust in these products, and that is important. The transparency should not only be about the purchase or funding agreements, but also transparency with regard to how they are regulated, the efficacy and safety data, you name it, all of that needs be open. As soon as you start keeping bits of it secret, certainly if such secrecy cannot be explained, it will only feed into the belief that perhaps, possibly there’s something wrong with these vaccines. And we really don’t need that.
SC-F: Has there been any sort of concerted effort or push to make them publicly available? Is there any hope that this might happen?
EtH: There is. The European Commission’s agreements have now been put in a reading room for the members of the European Parliament to look at. But that’s of course not the same as having transparency. They sit there and read through, it’s this sort of medieval way of transparency, I guess. I remember when I set up the Medicines Patent Pool, we decided that all of the agreements of the Patent Pool were going to be published in full text, on the website. And people then said, “Oh, you’re never going to be able to get the companies to agree to that, that will never happen. That is stupid. You’re dead in the water.” And I said, “I don’t see how we can say we are negotiating these licenses in the public interest, but the public will not be able to see what the result is. This simply not possible. We can’t do that.”
And, in fact, it turned out to be much less of a problem than we thought. All the licenses, full-text, are published on Medicines Patent Pool website, and it has never caused any problem whatsoever, other than that people who read them have things to say about it, and that creates a lot of work, but that’s only good because comments and criticism from outsiders has helped to improve the agreements. So I’m a great fan of transparency. It’s difficult, it sucks at times, but you can’t be working for the public interest and not subscribe to that
SC-F: I wanted to come back to C-TAP, which you had discussed earlier. I’m wondering if you could just explain a little bit how C-TAP is different from COVAX and why there has been so little investment or interest in C-TAP especially from wealthy countries.
EtH: Well, COVAX is a procurement mechanism which means it buys vaccines or finances the buying of the vaccines, and makes sure that the supply is there. And the original idea was that it would do that for all countries in the world, so that you have a solidarity-based distribution. C-TAP is a mechanism that provides the conditions for the production at low cost, at large-scale, of vaccines, therapeutics, diagnostics through the sharing of intellectual property, know-how, data, and technology. Fairly similar to what the Medicines Patent Pool has done for patents for HIV drugs. COVAX’s work would become much easier if there is an effective C-TAP, because C-TAP will help increase the production capacity of the various products.
Developing countries are concerned that C-TAP isn’t going to deliver. And they’ve put the issue of access to technology, know-how, and IP on the agenda of the World Trade Organization. South Africa and India have made a proposal for a waiver of the TRIPS Agreement [Editor’s Note: The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) is an international agreement between Member Countries of the WTO that sets minimum standards in all areas of intellectual property protection] to say let’s allow countries to not enforce IP in relation to COVID-19 products for the duration of the pandemic. It is interesting that now you see high-income countries coming out of the woodwork and saying, “Well, actually we don’t need this TRIPS waiver because we have C-TAP.”
So either something has to happen at the WTO or a mechanism like C-TAP at the WHO will be made to deliver. But not doing one of those is not really an option.
I am cautiously optimistic that things will change in the coming months. It’s easier in a way to advocate for something when a product actually exists. C-TAP was proposed to help solve a problem that wasn’t quite there yet. Now that the vaccines exist and are provided to people it becomes more urgent that access to the vaccines will be assured globally, and not only for the rich. I suspect that we will see some movement on C-TAP.
SC-F: Going back to the waiver that you just spoke about briefly at the WTO, from what I know it was rejected previously in October, if I’m not incorrect?
EtH: Negotiations are still on-going in the TRIPS Council of the WTO. There’s no conclusion yet. It’s an important political process, while it won’t solve things immediately, it may have indirect effects such as increased interest in C-TAP.
SC-F: What kind of long-term effects could it potentially have?
EtH: I think high-income countries are going to look at the voluntary mechanisms a bit more closely and perhaps make proposals to the countries that have proposed the TRIPS waiver that will have a similar effect, but do not require a suspension of the TRIPS Agreement. We may also see action in different multilateral organizations. Because often these discussions go back and forth between the WTO and the WHO. The good thing about that is the countries are talking to each other and, hopefully, find solutions. But it’s politically important that the pressure at the WTO is mounting.
It lays bare the deficiencies in the system because we have systems for the creation and protection of proprietary goods. We do not have a system for the creation and sharing of public goods. And that is something that may, as a result of this crisis change. There’s some talk by the European Commission to have a treaty on pandemic preparedness. You can’t have a treaty on pandemic preparedness without dealing with the issues of access to health technologies. So that may also be influenced by today’s developments at the WTO.
SC-F: My next question would be: Do you see anything changing at the international level that would mean that those lower-income countries that seem like they might not receive the vaccine, from how it’s looking right now, until 2022 or even later than that, might receive it sooner?
EtH: We’ll have to see. I think it’s good that the issue sort of stays in the public eye. I think that’s very important. It’s very good that people like yourself continue to write about it because the more attention there is, the more pressure there is on politicians to act and solve this problem. And without these international processes it would certainly not go any faster. That’s where a lot of the political pressure is exerted.
SC-F: So we know companies like Moderna—in the case of Moderna in particular, we know almost all of its research came from public funding, and I don’t believe that it’s never had a vaccine on the market before—are set to make huge revenues. So what does this tell us about the inherent problems in our existing research and development and IP system that have been maybe laid bare by the pandemic?
EtH: What it shows is if you give money to make innovation work, innovations take place in a way. It’s sort of a real-life experiment with “what would innovation look like if you would abolish the patent system” because, in fact, the development of these vaccines has not been dependent on the patent system. They’ve gone to market because of public financing, including the early financing of the basic research that was already there. So I think that is lesson number one. Lesson number two is if you then do allow companies to turn that knowledge into proprietary products you fairly quickly start to run into access problems. So making sure that those innovations are shared when you give the money to make the innovations happen is a key lesson.
SC-F: I wanted to ask you one last question. Having worked on access to HIV medicines with MSF, with the Patent Pool, and looking at what you’ve witnessed in terms of the HIV pandemic, but other pandemics as well, what lessons did we fail to learn from these previous pandemics that we could learn this time? My second question would be, do you think that there’s any chance that COVID could sort of be a turning point in how we look at patents in the same way that the HIV pandemic was at the turn of the century?
EtH: The world should have paid attention to the warnings that have been out there for a very long time that this pandemic was going to happen and that you need to be prepared for that. And that such preparedness should include the entire globe. You need a global solidarity underpinning the measures that need to be taken, otherwise the rich will be served and the poor will not. That’s sort of what happened now. Again, that could have been avoided.
Your second question was: Will this be the turning point? I am probably not alone when I say I certainly hope so. I started this year thinking this is a crisis of such magnitude, maybe this will bring out the best in all of us. That has not really happened. There’s a big disconnect between the rhetoric, the promises made on the vaccine as a “global public good,” and “no one will own a vaccine,” and “solidarity”—a lot of good words, a lot of great terms, but not the systems necessary to then actually transfer these promises into real deliverables. I hope this crisis will lead to a recognition that we need different mechanisms, a different set of rules internationally, to make sure that health for all becomes a reality and when the next crisis comes around, it is handled differently.
I also expect that we will see connections being made between the pandemic and other global crises. We have the antimicrobial resistance crisis, there’s the climate change crisis. And in a way they’re all connected, in the sense that you can bring them all back to the unacceptable exploitation of the earth by humanity. This pandemic is also a consequence of that. Perhaps there might be some positive fallout of this crisis for the way we deal with other global crises.