James Love, Director of Knowledge Ecology International, speaks with Manjari Mahajan on how global health institutions can work to overcome obstacles such as intellectual property rights and disparities in regional technological capacity.
Manjari Mahajan
There are a couple of topics I wanted to ask you about: the pandemic treaty, and the state of global health institutions overall. I feel as though we are at this moment of reckoning about a whole set of global health institutions that have been put into place in the last 15 years or so – the most recent ones being the ACT accelerator and COVAX. Most people acknowledge them as having been real failures. What lessons should we take from the design of these institutions?
James Love
I think the more fundamental issue is: can we develop an international framework on the supply of public goods? And a discussion about the pandemic treaty, should be a discussion about international cooperation in the supply of public goods.
Mahajan
This is a perfect segue to talk about the pandemic treaty. Could you reflect a bit on how you think the politics have shaped up? And where you think it should actually go?
Love
In the beginning, the push for the treaty was coming from Europe, particularly Germany. They were looking at export restrictions, access to pathogens, and information. So, a lot of it was surveillance, sharing of information, and a path for dealing with some of the hoarding issues.
As the conversation got started in early 2021, a working group was appointed. Colin McIff was a co-chair, coming from the United States’ HHS [Department of Health and Human Services]. He’s a well-known and well-liked negotiator on these issues. And the other co-chair was Ambassador Grata Endah Werdaningtyas from Indonesia, who is very, very capable. And under the leadership of those two people, there was wide participation. NGOs were allowed to participate in the working group, and we have been in many of the conversations. On these calls, there would sometimes be over 300 people participating in the conversation, where you would have IFPMA [International Federation of Pharmaceutical Manufacturers & Associations], and you also had MSF [Médecins Sans Frontières], Oxfam, TWN, and other groups like ours [Knowledge Ecology International]. And we were allowed to message negotiators during the textual negotiations on the report at this meeting.
The reason transparency has taken a backseat is because once people saw this as every country for itself, with vaccine nationalism, governments grabbing countermeasures and impounding masks and everything you can possibly imagine, it became a national security issue. And once it was a national security issue, nobody wanted to tell anyone else what they were doing.
Mahajan
So, what happened in the meetings?
Love
We thought that the treaty should have global norms and mechanisms to support the development of and access to medical and health countermeasures as public goods. We thought it should be about international cooperation, equity, equality, and solidarity. We thought it was important to single out transparency because transparency has been a missing element of this pandemic. The reason transparency has taken a backseat is because once people saw this as every country for itself, with vaccine nationalism, governments grabbing countermeasures and impounding masks and everything you can possibly imagine, it became a national security issue. And once it was a national security issue, nobody wanted to tell anyone else what they were doing. The companies liked the secrecy, the government’s wanted it for different reasons. The tradition in national security issues is a lot of secrecy. The work of the WHO in 2019 2009 to adopt a resolution on transparency were just ignored during the pandemic.
The public does of course have massive interest in the pandemic. People can’t put their kids in school, businesses are collapsing, economies are impacted, you have people dying in large numbers, inequality…People are afraid. There are a lot of rumors and misinformation. We think recognizing the important role of transparency should be a core, not a minor issue. It should be part of the deal and have its own section in the treaty.
Another thing we thought is the treaty should recognize that rights and obligations of countries should differ by the level of development. So, if you talk about funding, for example, for research and development, it should not be only something like a fraction of GDP. As countries are further along in development and have higher incomes, they should have a higher responsibility. Also, in terms of technology transfer, the agreement should try to actually improve the capacity to manufacture in areas that lack that capacity. And there has to be effective participation, it should not be a green room G20/Davos type of situation.
Mahajan
This is really interesting. At least one understanding of the treaty is that it’s about surveillance and reporting of new infectious outbreaks. But you are taking a divergent strand and saying it’s actually about knowledge production, sharing technology and norms that should be associated with those imperatives. And that’s at least in part because of NGOs like yours raised those issues at the outset.
Love
Some of our talking points were being echoed by delegations, North and South. And we were pretty gratified in the way negotiations went. Let me just say that there were some areas where different delegations would try and push things, areas that would be a little less challenging to the proprietary approach that has been taken in this particular pandemic. And other delegates push things back the other way. But we were very happy with the basic framing and the discussion of equity, the need to develop strategies and obligations to facilitate decentralized manufacturing technology transfer, to address issues about affordability, access, and intellectual property rights.
No one’s really committed to it being a treaty, but they’re sort of comfortable with the idea of a treaty or other instrument. People understand that if they can get it right, it could become a legally binding treaty under the WHO constitution, but that there may be some elements of it that don’t really fit there properly. So, the negotiations are a bit open ended, which I think is the right way to proceed. I think what’s important for them to do is to figure out to what degree there is consensus and then look at the best legal mechanisms to accomplish those objectives.
Another point is on financing R&D. If you don’t address how R&D is financed, it’s very difficult to have a global public goods approach. Suppose, for example, the US Congress appropriates billions of dollars on R&D and Europe puts up no money, and no one else did. Some members of Congress might say, “Why should we share our IP with the rest of the world?” Or “What if everyone puts up money, but we put up way more than everyone else?” You have to deal with the free rider issue. And so, you have to make an argument why it’s in our interests to share. And what makes it in our interest to share is if other people also have an interest to share and they have something to share. This idea that you can put conditions on government funding of research and development or require the global transfer of technology and sharing of outcomes is more compelling if you feel like you’re not the only government putting up the money. And that’s a very challenging thing to do in international negotiations in our experience.
In a way it’s easier for them to talk about intellectual property rights because the negotiators don’t have to write any checks. But to do things as public goods, you have to go a bit deeper and be more specific on the questions about how much money, who’s going to do what. And there’s not a lot of experience in success in this area in a broad multilateral format. There are some G20 discussions or small club discussions and things like that. But it’s important. The pathway of how you get from here to there should require some flexibility and creativity.
Mahajan
And you actually think that an international treaty would get into the weeds and hammering out a mechanism for financing R&D?
Love
Well not in the next couple of weeks. But I do think that there are paths to get there.
Climate change is a very good example and there are other agreements. Another is the Marrakesh Treaty for the Blind – an IP treaty which succeeded that had a completely different architecture. I wrote the first few drafts of the treaty out of our office in Washington DC. We co-convened a technical meeting with the World Blind Union, and worked with blindness groups from around the world, as well as academic experts.
We produced a draft treaty for something that had not been done before: A treaty that would mandate the use of exceptions and to make them global. There had been some small examples of mandatory exceptions for intellectual property rights as part of larger treaties, but never anything like this, where the primary beneficiary of the treaty was a marginalized population. And the idea was to make blind people and other people with disabilities more equal to the rest of us. So, it was a human rights objective of making a vulnerable population more equal. And what it did not do is take issue with the WTO rules, it did not take issue with the Berne Convention or any other copyright treaty. What it said was: without changing any of the existing treaties that are out there, the people that signed this treaty would be required to use the flexibility which exists within the existing international framework.
Access to books for visually impaired people was a sad state of affairs. The way it typically played out is there would be a fairly robust exception for blind people in many countries, but almost always limited to national use and did not permit cross-border use of the exceptions. So, the US had a very large collection of books and other materials for blind people that they would not share with other countries. Argentina would not share its collections with Uruguay. As a consequence, it was expensive to duplicate the task of making works available, and the global the collections were unnecessarily very limited. The collection in Uruguay, for example, was about 3000 books on magnetic tape and they relied upon one volunteer in a studio talking into a microphone, reading about one book a week. They get about 50 books a year for blind people in that country. So, the treaty says that every country has to have an exception for blind people to make works accessible. And that includes the rights to export and import, allowing the sharing of the works around the world. Some people initially thought that it was just was crazy legally, but then eventually people came around. It was a very tough fight.
But it was the fastest signed and the fastest ratified treaty in the history of intellectual property. It’s been very successful, and it also stimulated a lot of voluntary action. Some companies tried to divert and stop the treaty by saying that a treaty wasn’t needed, it would take too long, and mandatory measures were counterproductive and everything should be voluntary. But the voluntary proposals they made during the treaty negotiations were really inadequate, to say the least. What happened after the Treaty passed and began to be implemented was that the voluntary measures actually accelerated. And now the publishers have been far more forthcoming with voluntary measures. The existence of the mandatory exceptions has not eliminated voluntary cooperation. On the contrary, they work together and that’s been a very successful model.
I spent most of my life pushing for much broader access provisions than just pandemics. But the treaty will be a pandemic treaty and so the question is, will they have provisions in the pandemic treaty that are limited to what you do in a pandemic? And my guess is the answer will be yes.
Mahajan
Broadly speaking, though, there’s a strong argument out there that the pandemic treaty has to stay away from a politics of exception, right?
Love
Not really. I spent most of my life pushing for much broader access provisions than just pandemics. But the treaty will be a pandemic treaty and so the question is, will they have provisions in the pandemic treaty that are limited to what you do in a pandemic? And my guess is the answer will be yes. Now, it’s one thing to have a mandate that has some support among some member states to do something, it’s another thing to have a consensus document out the other end that’s delivered. So, I’m not suggesting that we’re there.
In 2020, Germany was the first out of the gate to do a waiver, in their national law. They actually waived patent rights for countermeasures right off the bat. Until they figured out they had two vaccine candidates. When they figured they had CureVac, and then Biotech, they were a little bit like, “let’s erase everybody’s memory, let’s pretend that we never did this.” And Germany then began claiming you definitely can’t do that because that would be horrible, even though they’d already done it.
In the beginning, nobody knows who will end up with an important technology. It could be somebody else. And that was, I think, Germany’s initial impression. They didn’t know what they had in their backyard.
Now, if you look at John Rawls’ theory of justice and the veil of ignorance, it’s an important concept in that, when nobody knows who will have the endowments, it’s easier to figure out what’s a just allocation in terms of the balancing between incentives and equity…than it is after you know what the endowments are. In a forward-looking pandemic treaty, you’re not talking about COVID-19, you’re talking about a different pandemic. We are back to the veil of ignorance. We don’t really know whether the Chinese, the Swiss, the Germans, the Americans, the Indians, the Argentine’s, we don’t know where the breakthroughs will come on countermeasures. So, it should be easier in a forward-looking [treaty] to have an agreement on sharing when you don’t know who’s the winner and who’s a loser on the sharing. This was discussed in the working group. And I think that resonated with a lot of delegates. They do understand that by the time that COVID-19 came out, and patents were flying around…it was a little too late at that point to do the best thing that was possible. One advantage of a treaty or a binding instrument of any type is that it makes it harder for things to go south like they did in this negotiation when it came to the lack of sharing.
I think the pandemic has been an embarrassment for health authorities around the world. Suppose for example you run the CDC or the NIH in the United States, or the Health Department in the UK, are you really proud of the way that you responded to the pandemic? I don’t think so.
Mahajan
What about political incentives? In TRIPS negotiations, let’s say in the Doha Declaration, there were important political incentives for governments. And that was because IP concessions were tied to all sorts of other trade concessions. What would be the political imperatives for parties across the table to pass a pandemic treaty which asks for exceptions?
Love
If it’s a treaty negotiation, then it’s no flash in the pan, it takes a while. People tried to talk us out of the Marrakesh Treaty because of the argument that treaty negotiations take forever. And I said, let’s look at the development of IP treaties to see how long they took to negotiate. Once you start the actual negotiation on the text, one year to two years is the typical timeframe. It took us five years for the Marrakesh Treaty, but the first four years were basically people trying to figure out if they would negotiate a text. And once they made the decision to really go into the text, things went pretty fast, and we got an agreement within a year.
I think the pandemic has been an embarrassment for health authorities around the world. Suppose for example you run the CDC or the NIH in the United States, or the Health Department in the UK, are you really proud of the way that you responded to the pandemic? I don’t think so. And I don’t think they want to be as unprepared, as disorganized, and flailing about the same way, if this happens a second time. We may not have a pandemic like this in our lifetime, or we may have one periodically, we don’t really know.
But the negotiators themselves are not your average citizen. They are technical people. And they tend to err on the side of caution. I would concede to them that a lot of the problem lies in the consensus format of these negotiations. If you have an opt-in treaty among like-minded people, under the WHO, you can get a stronger agreement than if you have agreement that any single member of the WHO could block. Like in the Marrakesh Treaty, it was hard to get an agreement to move ahead, because there was a lot of very clear opposition from some countries, including the US. And when you have a treaty, not everybody signs a treaty. I mean there’s no guarantee everybody would want to ratify and join it. But I think that if they do their homework right, they should be able to get something useful out of it. That’s our hope. And you know, what? What is the alternative? Sit back and wait for the next disaster to happen and then be embarrassed once again.
Mahajan
It’s a moment where there are multiple international law-making enterprises, but then there are also broader governance institutions that are having their day of reckoning. COVAX is being acknowledged widely as a failure. There are other global health institutions too which are now being acknowledged as kind of emperors without clothes. And one of the big reasons is because they didn’t take on IP issues head on and instead committed to all sorts of other kinds of mechanisms. Do you want to briefly reflect on these global health institutions and where we are at the moment?
Love
Well, there are a lot of problems in global health institutions. I think that C-TAP [COVID-19 Technology Access Pool] has to be one of the biggest missed opportunities. Costa Rica made a proposal to have global sharing, access to biologic cell lines, intellectual property rights, the whole nine yards. But the system didn’t step up to implement it. So C-TAP has not published any model agreements or any term sheets. The WHO rejected a request from People’s Vaccine Alliance to have a press conference every two weeks to talk about progress, to identify who they have approached. The WHO was asked to enter into agreements with governments that fund R&D that provide a pathway for the sharing of the intellectual property rights that come out of the funding agreements with WHO members. But there’s been no progress on any of that.
One of the issues that both the Medicines Patent Pool and the C-TAP have had is resistance in some public health quarters to deal with pipeline products. They don’t want the logo of the WHO to be put on something that may be a dangerous product, or maybe never goes anywhere. The WHO runs a pre-qualification program but is hesitant to make it sound like they have given prior approval to a technology for which they have not actually been able to evaluate the data on safety and efficacy and make an objective assessment. So, they wait. And there are some people in the public health community that only want to engage in a licensing conversation with things that have received approval from a high standard regulatory agency.
Now, if you’re trying to acquire rights, you really can’t do it that way. You have to engage people early on and you have to engage, more importantly, the funders of the R&D, particularly in the charitable sector and in the government sector. So, when the money that flows into CEPI, for example, from the Wellcome Trust, the Gates Foundation, governments of Norway, US, Germany, China, India, the European Commission, etc., we should at the same time have conversations about the provisions that you want in their funding agreements that guarantee that you can scale the manufacturing and acquire affordable prices of the products. So, I would have to say that there was no leadership that was focused expressly on those issues to the same degree that you saw leadership on the quality control issue. Also, in evaluating whether or not vaccines look like they are promising, governments haven’t stepped up with funding to pay for things like independent clinical trials. The governments that wanted to see C-TAP succeed didn’t put money on the table. And WHO didn’t do fundraising.
Mahajan
The action really seems to be in intergovernmental or national governmental forums and not in these global health institutions any longer. Wouldn’t you say that they too have been qualified failures?
Love
Well, it depends on your standard. I think that they certainly have fallen short on what they were advertising what they were able to do in 2020. Then, we were being told, “hey, don’t worry about manufacturing capacity.” This was the story we had: “You don’t need a TRIPS waiver, you don’t need C-TAP, you don’t need any of this stuff. We know who the manufacturers are and the minute we have the right vaccine, we’re ready to go. We know the best manufacturers; we can scale everything. We got this.” That is essentially what we were being told by the Gates Foundation people. And that just turned out to be wildly inaccurate.
And the other thing is that you have these embarrassments, like, “oh, let’s make our whole plan dependent on whether the Serum Institute, one company in one country, will solve all the problems for us.” And then you go like, “Oh, what a surprise. India put some export restrictions on the vaccines.” It would have happened with any country. It was just completely predictable that there would be export restrictions if the vaccine was perceived to be effective and people are watching their own people die. But there was no attention in 2020 for the need for more decentralized manufacturing capacity.
People were not doing the math. The problem is scale. Compare COVID with the HIV crisis. There were estimated 30 million people with HIV in Sub-Saharan Africa in the 1990s. With COVID-19 you’re talking about the entire population of the planet, right? To scale up access to anti-retrovirals, I remember, the target was “3 by 5”: 3 years to reach 5 million people. Nobody wants you to wait 3 years to do anything on the pandemic, and they certainly weren’t talking about 5 million people. So, the model of depending on not even a handful, but one Indian manufacturer, the Serum Institute, to scale production, was in no way realistic.
I don’t want to criticize the current people too much, but I would say that, in terms of the pandemic treaty, part of it should be an ongoing contingency plan about what to do when it happens so you’re prepared. You need to be taking a regular assessment of what is the state of technology for countermeasures. It changes over time. Then also some realistic ideas of the timeline for technology transfers. In the beginning of a pandemic, some claimed, “oh, it takes three or five years to do a technology transfer.” And then we did a study and the early voluntary technology transfer agreements took only about six months, on average, to work.
The clinical trials were a mess. Companies were given too much latitude in the design of the trials. The trials were not transparent enough. And you were not doing the kind of head-to-head comparisons and mix-and-match comparisons that would have been really helpful for health authorities. So, the trials, a lot of them subsidized by governments, were not optimal from the point of view of addressing the pandemic.
The funding and advanced procurement contracts the US wrote did a bad job of giving the U.S. government the leverage needed to scale and decentralize manufacturing. We have reviewed those, and I think as you have more transparency in licenses around the world, you’ll see some additional problems. One silver lining you should be able to get some lessons learned from this series of failures.
Mahajan
So, here’s really hoping that the pandemic critique can encapsulate some of those lessons and institutionalize them in different instruments.
Love
I tend to be kind of an optimistic guy!
James Love is the director of Knowledge Ecology International, a non-governmental organization with offices in Washington, D.C. and Geneva, that works mainly on matters concerning knowledge management and governance, including intellectual property policy and practice and innovation policy, particularly as they relate to health care and access to knowledge. He advises UN agencies, national governments, international and regional intergovernmental organizations and public health NGOs, and is the author of a number of articles and monographs on innovation and intellectual property rights.