The View from Geneva: A TRIPS Waiver Update

In this episode of OnAir: Health Care, senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Geneva senior policy advisor Jan Walter, who discusses the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, waiver issue.

Among the topics:

• The TRIPS agreement and vaccine waiver.
• IP rights and vaccine development.
• China’s role in the negotiations.
• International coordinating mechanisms.

Transcript

Matthew Hittle: Welcome to another episode of Akin Gump's OnAir: Health Care, a podcast that focuses on the intersection between health care policy and politics. My name is Matt Hittle and I am a senior policy advisor here at Akin Gump.

Mario Ramirez: And I'm Dr. Mario Ramirez, a consultant here at Akin Gump, and I'm super excited about this discussion today, Matt. We're going to be joined by Jan Walter. He is based out of our Geneva office, and I think we're going to have a really interesting discussion about what's happening out there in Geneva, what's happening with the World Health Organization, and a whole host of pandemic-related issues.

Matthew Hittle: Definitely. We found that a lot of our clients are interested, increasingly so, in what's going on overseas, particularly at WTO [World Trade Organization], World Health Organization. Geneva is a hotbed for this kind of activity, as you know. And having our first public law and policy practice staffer stationed overseas, Jan has been a real boon because he used to work in the U.K. mission to the WTO. The guy has been entrenched in this world for quite some time and actually helped work on some of the first iterations of the TRIPS [WTO Agreement on Trade-Related Aspects of Intellectual Property Rights] waiver, which we'll be discussing here with him. So, really excited, Mario, and without further ado, on to the interview.

Mario Ramirez: Jan, thank you so much for coming on the show. As we mentioned, you are new to Akin Gump, so why don't you start by introducing yourself and telling us a little bit about your background so that our listeners know who they're speaking with today.

Jan Walter: Thanks very much, Mario, and thanks very much for having me. Happy to be here. Well, I did join Akin Gump quite recently, in September last year. We're recording this very early in 2023, so, quite recently still. It was joining the private sector after 15 years in public service, 12 of which were in Geneva. I would say that I do know Geneva quite well—all the mountains, the lake—as well as some of the policy issues dealt with here in Akin Gump, by joining specifically the public law and policy practice, or PLP, if you will, which, interestingly enough, I joined as the first PLP person outside of the U.S. It is quite an interesting development for Akin Gump as well as for myself really, because it's quite telling that Geneva was chosen by the firm as the place for the first ever outside-of-the-U.S. person joining the policy practice.

I believe that is because there is a recognition both on the firm's side as well as, I believe, on the client side, that the multilateral debates, and we'll get a little bit more into it, do influence the policy cycles throughout both the U.S. side as well as internationally. I can tell you, Geneva, while a bit of a global village as a relatively small town by land and inhabitants, it is quite big when it comes to multilaterals. There are 40-plus organizations in Geneva dealing with all sorts of issues, basically anything that you can think of, and there are about 700-plus NGOs and associations that are looking into dealing with those issues.

Really, what I can do, given my background and given that I've been sitting in many of those negotiating rooms in Geneva, what I can do for existing, as well as potential, clients, hopefully, is to really set out or identify trends going forward, because, obviously, it is important to be involved from early on to be able to influence and to get the narrative straight on any international treaties, getting them right. I can obviously influence as well if clients have had issues, and they see an opportunity, they see a risk. That's where I would come in.

I perceive this really as a two-way street. One, I set out with the trends and what are the risks and opportunities to our clients, as well as potential clients, would engage with me to see what can be done. Because this is a non-visual podcast, if somebody wants a hint about me in visual settings, people can and do also recognize me by my signature accessory, which is a wooden bow tie. So I'm the guy with a wooden bow tie.

Mario Ramirez: Well, Jan, it's wonderful to have you and your signature accessory here on the podcast today. Maybe someday, we'll transition to visual podcasts so that they can see your bow tie in its full glory. But I know that your photo is up on our website, and I think you're wearing that bow tie in our firm photo as well.

Jan Walter: It's an awful photo though. Well, I'm not visually pleasing in any way, but yeah, the bow tie is trying to make up for that.

Mario Ramirez: Well, we'll let the listeners be the judge, but I'm sure they also want to hear about the TRIPS waiver, which is what we came here to discuss today.

Matthew Hittle: That's right. Well, let's get down to business. You're here to talk about the Trade-Related Aspects of Intellectual Property Rights agreement, known as the TRIPS agreement, and more specifically some of the goings-on with respect to the COVID-19 vaccine. It's kind of commonly known as the TRIPS waiver issue. A year ago, Mario and I hosted Clete Willems, who's a partner here at Akin Gump, a couple of times. Clete talked with us about the ins and outs of the TRIPS waiver and then gave us a sense of the discussions ahead.

But since then, the WTO has approved an agreement on a waiver with respect to vaccines; I think that happened in June, as well as a mandate to negotiate its extension to diagnostics and therapeutics. This is a lot bigger than when we spoke with Clete last. Can you give us an update? Talk about what the waiver does and doesn't do, and then what the current extension discussions look like.

Jan Walter: Very, very happy to, and look, being with the U.K. mission, and many of the listeners probably know what the U.K. stance was on that file, particularly one of the last countries sending when it came to a really trying to get that agreement that would be both reasonable for the existing system as well as actually make a both legal and substantive difference.

I was the chief negotiator of that file for the U.K. I have to say that the TRIPS waiver, as you rightly mentioned, it was a part of my professional life, and as my wife would probably tell you, my personal life as well for the last two, two-and-a-half years. Look, the discussions were very, very heated, very motivated, especially in June. I would say that we did put up a good fight for practicability of that instrument both legally and substantively.

Now the fact that it came out as it came out is another matter. Political decisions are sometimes departed from substantive ones. But anyway, look. You rightly ask what it does and what it doesn't do because there are some misconceptions. I'll start with what it does not do. It does not dismantle the international IP framework, as sometimes it’s perceived that this is the end of the international IP framework, this is the end of TRIPS agreement. That was the original proposal which was attempting to do that. But eventually the final agreement is not doing that.

I would say that while it is not the end, it might be the beginning of the end of the TRIPS agreement, but let me get to that. That was on the legal side. In practical terms, what it doesn't do is to actually help get more vaccines. The easy proof of that is that there hasn't been a single use of that mechanism since the adoption in June, right? There was a lot of talk about urgency and lot of talk about we must have this immediately. Eventually when this was done, when this was agreed in June, nobody has ever used it since then. Now we can go into a little bit of detail about why that is indeed the case.

What it does is it does set a precedent, and this kind of leads to me saying slightly alarmist-ly, but if the train goes faster and faster on that side, it could be the beginning of the end. It created also a lot of dissonance, especially when politics came into it. Eventually politics prevailed over policy on that file. That's why I'm saying that while we are trying to get some sense into the agreement, eventually, there is some but not too much in the key parts. But I don't want to be all negative about it. I do want to bring in some of the positives.

It did show that WTO members can come to an agreement on a very, very difficult topic with a lot of history. That's on the positive side. Also on the positive, and I know that some may not like this, but let me expand a little bit, it did force many stakeholders to look at how existing mechanisms operate and start talking about improving them. Unfortunately, the international IP system was sacrificed in that process as a bit of a scapegoat with most of the discussions, not focusing on how the system can be improved but how it needs to be rejected. There was this dissonance between, do we need to throw it all out and start a new, which was argued for by the demanders, but it did start up a bit of a discussion of what can be done. This kind of came, and we'll get to it I guess, on the World Health Organization side.

Now you also asked about the expansion, which is paragraph eight of this decision, of the instrument. Once again, that paragraph, whoever can look at it, it is unclear. The wording is simply unclear. We did try in the negotiating rooms. We did try to clarify it since there was difference of opinions and somewhat of an attempt to go with an ambiguity, what in Geneva we call “constructive ambiguity”—we'll leave the text ambiguous so that we can actually get to an agreement. It stayed there, so now some members or some countries would argue that we all agree that this instrument will be expanded, we just need to make it happen. And some would argue that we still need to talk about whether or not it should be expanded.

Mario Ramirez: On that note, Jan, as I understand the agreement, it allows developing countries to export all of the vaccines to other developing countries. But a key issue at the heart of these negotiations has been issues around intellectual property rights, trade secrets, copyrights. Of course here in the United States, all of this is overlaid I think by rising questions of Chinese competitiveness and where that sits. Certainly that was an issue at hand in the negotiations. Can you talk to us a little bit about that?

Jan Walter: You’re right. The debate has been circling a lot around all the IP rights, trade secrets, copyright. We even talked industrial designs and how they relate to the pandemic and whether there are any registered industrial designs on, for example, the syringes. This is the level of non-substance that we got into a little bit, but all of this was definitely included in the original proposal by the demanders. What ended up in the decision is purely on patents and patent subject matter, so really patents on vaccines. That's it.

Now I'm talking about the expansion. However, this comes back to very earlier what I was talking about. If we are looking at this as a one-off, as an urgent measure that was done mostly politically, then yeah, I think everybody can live with it, and, ultimately, everybody does live with it. But if we are looking at it as some countries are looking at it, as kind of a first slice of a longer term process, then, obviously, we're probably going to come back to talking about copyright. We're probably going to go come back to talking about trade secrets and so on and so forth. And by the way, trade secrets and the “undisclosed information” in the TRIPS agreement is what some of the countries and some of the demanders are definitely after. That's their biggest pet peeve.

I should mention that the discussion right now is looking at whether we expand and how do we expand. That's where the U.S. came in, swooped in, in December, basically saying, "Look, we need more time. We need to hear from our ITC, from the International Trade Commission, on the impact," so they asked [for] an investigation. To be honest, this is quite an unprecedented process for a file like this because it does ask to go internationally, it does ask to explore what will be the impacts, both domestic in the U.S. and internationally.

I am definitely happy to now be part of Akin Gump, an organization which has the know-how, both procedural, substantive, and strategic to help any organization or government that wishes to take part in this. So if anybody is listening and wants to take part in it, in the U.S. ITC investigation on this file, do get in touch with any of us.

Matthew Hittle: So, what's that China angle here? How is China affected? What role has China played in these negotiations thus far?

Jan Walter: That is a very good question. I bet there’s a lot of interest in the U.S. in that and elsewhere as well.

Matthew Hittle: Also in Congress too, because, as we know, the House Republicans have started this China committee, which is going to be getting started here. We are recording this on the 10th of January and the Congress is still becoming organized, but I think this might be a topic of discussion of the China committee here fairly soon.

Mario Ramirez: Yeah, absolutely.

Jan Walter: You're very right, and there's a lot of viewing on what the role of China is in all of this, not just by the U.S., but look, let me be honest, I didn't mention in my introduction, so I think our listeners must hear it by now that I'm not British. I'm not an American. I'm Czech by nationality, to hear it from my accent, so I'd be very frank and say that both the U.S. and China have been playing a very political role in this process. And China, under a lot of pressure from the U.S., eventually opted out from the June instrument, so it cannot use the mechanism directly. However, many would argue that it could theoretically use it via subsidiaries in developing countries. But that’s another matter.

Now, this may be slightly different outside of vaccines with products such as therapeutics or diagnostics, which are usually repurposed products. It's not primary research and development for a vaccine. But usually those products, especially on the therapeutics side, those are long-term research and projects which have been repurposed for COVID-19.

In that sense, China has moved to a very clear supporter of the waiver expansion to therapeutics and diagnostics. It is rumored, but I would say it's pretty clear now, that if there is an expansion, China will not be willing to opt out. They are kind of pushing in that direction. The discussion between the U.S. and China hasn't happened yet. Everybody who wants to push this forward is avoiding it because they know that that will likely be a big fight because China wants to opt out, whereas my understanding of the domestic narrative in the U.S. is that it cannot be done with China benefiting.

Mario Ramirez: See, you sort of alluded to this a little bit earlier, Jan, in terms of criticism of the waiver and whether or not it can really actually achieve what its writers had hoped. From where I sit as a physician, it strikes me that one of the reasons that the waiver hasn't been used so forcefully now is because we came to these negotiations, or they came to a head once vaccine was already in ample supply around the world. And then we didn't have to force the hand of the issue. But you made the good point that this may be something closer towards setting a precedent for the next time that there's this sort of an emergency. But a lot of people wonder whether there is a continuing role for international coordinating mechanisms, like COVAX, which we know is in the process of being disbanded a bit. Is that the model for future pandemic response, and where does the TRIPS waiver fit into that discussion?

Jan Walter: Yeah, on the criticism, I think depends on who you talk to. If you talk to some people, they would tell you, "Well, it came too late because there was a lot of opposition, and we wanted it quicker, and that's why it doesn't work." If you talk to others, they would tell you, "Well, we are glad that we didn't have that mechanism because it would only hamper the efforts which eventually delivered the vaccine in a record time, unprecedented record time." But I honestly believe that both sides are somewhat right, and the criticism is correct. During the negotiations, it often felt like a scene from my favorite British show, which is called Yes, Prime Minister, with the kind of narrative, all cats have four legs, my dog has four legs, therefore it is a cat. In a similar fashion: something must be done, this is something, therefore it must be done.

It came in June especially. It was felt like there's so much demand for something to come out of this long process that, hey, this is something, let's just do it and be done with it. That brings me, and you rightly pointed to those mechanisms that actually delivered some difference in the world such as COVAX. But there are a couple of others that there were some warnings about pandemics coming prior to this one. But I would argue that not many mechanisms were set up for such a global, such a heavy, pandemic. These were done on the go, including COVAX. By definition, all these mechanisms were imperfect, some more imperfect, and some less.

The key message I have here is that nothing, let alone a global pandemic, can be solved by dismantling one element. In this case, IP or intellectual property. Scapegoating IP doesn't really make sense. It would actually be useful to look at it in a more complex way, which many organizations tried. The emotions around the TRIPS waiver caused that, especially in the WTO, but also elsewhere. It was really not possible to really engage in a conversation with trust on both sides.

I admit from the U.K., I didn't really trust all of the other countries when we were negotiating, because there was a lot of mistrust, a lot of emotions flying around. One example to give you. A key factor, not the only one, but a key one of why COVAX could not deliver early vaccines to those that needed it was that one of the major vaccine producers or vaccine-producing countries closed its borders by banning exports of vaccines. Simply just from day one to day two, enacted a ban, and it was not possible to produce. And this has nothing to do with IP, yet all that country talked about in Geneva and elsewhere, quite emotionally, I would say, was intellectual property and kind of deflecting from the real issue. In a way, the emotive debate caused the real debates to be pushed away.

Matthew Hittle: So COVAX and other kinds of international coordinating mechanisms didn't necessarily work as well as they could have worked for this particular pandemic. There are those who oppose the waiver, who think that they could theoretically be leveraged in the future, and potentially other controls on orders and pricing, just to provide that equity that was the whole point behind the TRIPS waiver. Do you think that there's a “there” there when it comes to those other kinds of remedies, or are we likely to see this again?

Jan Walter: Yes, yes. The simple answer is yes. Again, to give you one example is the Medicines Patent Pool. It's an organization which is very much linked to the World Health Organization, but it used to work a little bit out of the radar. It had a mandate. It was funded by various organizations in various countries and it had a mandate to deal only with three diseases. Relatively niche diseases. Its purpose was to negotiate with developers of the world pharma industry, with developers of medicines, to negotiate with them a general non-exclusive license so that it could provide the terms of that license in developing countries to be able to produce under license, under that license, to produce and supply the whole world.

Now, what the pandemic did, and we were trying to do this with the U.K. before the pandemic as well, was f expand the mandate, because that model has worked for those three diseases. We wanted that to expand beyond, for example, to oncology, and it wasn't really possible. There was no real appetite for that. What the pandemic did quite early on, the mandate of the Medicines Patent Pool or MPP, got expanded to COVID-19. You now have companies that were not really keen on working with MPP before that now actually working with the Medicines Patent Pool.

The narrative shifted, and it's the positive about this whole debate that it did make people rethink a little bit the existing system. The trouble is that some or many are pushing it to an extent that they want. Rather than an evolution of the existing system, they're looking for a revolution, and it's not. That's the trouble. I don't think I actually responded to your question on waivers going ahead. Look, this was not a one-off. The TRIPS waiver proposal back in October 2020 from India and South Africa was not the beginning of the story. That story was deeply seeded back from the 1990s. A number of organizations looking at, or having a lot of issues with, both the IP system as well as how various companies are using it. This was more of an opportunity, a top of the iceberg, rather than anything else.

Yes, this story doesn't end here. It will likely go beyond health. It is likely to go to any crisis that you can think of. Now, the President has been said, and it is likely, and some countries are already mentioning that we should be looking at TRIPS waivers when it comes to climate change, for example.

Mario Ramirez: Well, and so maybe on a related point, Jan, in a recent Akin Gump newsletter, I think you made the point about some of the spillover effects related to this, and you just touched on this. But I wonder as well whether or not eventually this starts to spill beyond WTO, right? And there are negotiations at the WHO on other issues related to pandemic preparedness. How wide does this spill, and what are the other institutions and organizations that are likely to become involved?

Jan Walter: To be honest with you, it has been a bit of a whack-a-mole from the very beginning. I do remember that we were reacting a lot of times, really in a reactive mode, to various processes happening in various forums, in New York, in Vienna, and in Addis Ababa, or even in some of the regional gatherings. This did take a lot of bandwidth needed for substantive debate, as I mentioned here, and brought about a lot of the mistrust that caught other countries off guard.

It has already spilled to elsewhere, but in more serious terms, I would expect this to spill over further, especially in processes looking at pandemic preparedness or those that are addressing non-health crises, such as the climate crisis. But the pandemic preparedness, I think that's where it's going to feature heavily.

Matthew Hittle: So, then, I guess finally to round us out, Jan, everybody's talking about the TRIPS waiver and everything associated with that process. What are the other processes in Geneva that are focused on pandemic preparedness? I know that, in Congress, they're going to be talking about pandemic preparedness quite a bit in the new Congress. I believe the Pandemic and All Hazards Preparedness Act is up for reauthorization. It's kind of the topic du jour.

Jan Walter: Yes. Well, look, the key one is the so-called WHO, or World Health Organization, CA+ negotiations. Let me explain a little bit. It used to be called the Pandemic Treaty, which launched back in March 2021. It has been a lot of procedural discussions and kind of throwing in all elements since then. This February, February 2023, that's when the real negotiations will kickstart. So, from Pandemic Treaty, as it was called back then, it morphed into CA+, meaning convention or agreement, or possibly expanding into regulations. I won't worry with legal jabber, but the idea of the CA+ mention is because not every country is convinced that it needs to be a legally binding instrument. But from the legal jabber, it is quite good that this process is and will be important going forward.

The deadline that countries set themselves is May 2024 to finalize the instrument, so we're looking really at one year of hard negotiations. It will be messy. Some even call it a once-in-a-lifetime opportunity for an international health treaty, so we can imagine with 180-190 countries involved, it will be quite messy and quite difficult to navigate or influence so that at the end it does actually make sense and actually delivers what it intends to, which is improving global preparedness and response strategy to pandemic. That's the idea on the WHO side. There are other processes, for example, looking at economic and social resilience in times of pandemics ongoing in Geneva or at migration and refugee patterns in times of health crisis. But I would say the WHO CA+ is the key process which is going to get the most attention.

Matthew Hittle: Great. Jan, thank you very much for joining us today, fresh from the halls of the WTO and the shores of Lake Geneva. It's been a pleasure.

Jan Walter: Thanks very much for having me. It's been an absolute pleasure, and I hope to join you sometime soon.

Matthew Hittle: Absolutely. We look forward to having you back as things progress.

Jan Walter: I should also say that since I'm relatively new and since this is a relatively new project for Akin Gump, please do get in touch with me if you want any details. Any listeners, anybody from within Akin Gump or outside, I'd be happy to discuss anything with anybody.

Mario Ramirez: Thanks so much, Jan.

Matthew Hittle: Thanks, Jan.

Mario Ramirez: Well, Matt, I think that was just a really fascinating discussion. I know I personally learned a ton just listening to Jan.

Matthew Hittle: Yeah, every time I talk to that guy, I just end up learning a bunch more about how things really work when you kind of peel back the press releases from the WTO and how those negotiations actually take place. It's cool to have that kind of peek behind the curtain.

Mario Ramirez: Absolutely. So with that, why don't we go ahead and wrap up. I'm Dr. Mario Ramirez.

Matthew Hittle: And I'm Matt Hittle.

Mario Ramirez: Thanks again for joining in another episode of OnAir: Health Care.

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