Burcu Kilic, research director for Public Citizen’s Access to Medicines Program, discusses the complex web of COVID-19 intellectual property protection, and the new possibilities of emerging manufacturing capacity in the Global South. This interview is part of Politics of Vaccine Equity: Conversations on the Frontline and was originally published in Pandemic Discourses.
Fukuda-Parr: Thank you very much for agreeing to this interview for The New School blog, Pandemic Discourses. These are exciting times. The announcement of the US support for the waiver of TRIPS provisions for COVID-19 vaccines has been a game changer in the politics of vaccine equity. And congratulations to you and your colleagues at Public Citizen and other advocacy groups in the US for your hard work behind the ‘David beats Golilath’ win.
IP is a key obstacle to taking production to the scale needed for mass, universal, vaccination, but not the only one. So I’d like to ask you about the broader question of technology transfer to scale up manufacturing which is urgently needed to meet global demand.
Kilic: Thank you. Since October, we’ve been working really hard to raise awareness and advocate for the US support for the waiver. Now our European allies are doing some of the same things we did to get the EU to support the waiver.
When we talk about complex technologies, we talk about a complex web of intellectual property protections. And this includes not only patents, but also trade secrets, copyright, industrial designs, and undisclosed information. Today’s vaccine technology is very different from the small molecules that we worked on as access to medicine advocates for HIV/AIDS antiretrovirals. For those, there were only one or two patents issued, and with compulsory licenses, boom, you were ready to go. But with vaccines, that’s not the case.
We’ve done a network analysis for mRNA vaccine technology and you can see a web of intellectual property protections. One company doesn’t necessarily own all the patents on its own technology, but needs sublicenses from other companies. So mRNA is a complex technology – sets of instructions – a software-like code that directs cells in the body to make proteins. Digitization is a key enabler for mRNA platforms, which rely on artificial intelligence systems. That’s what makes mRNA an exact thing for the future of medicine. There are also other intellectual property protections such as trade secrets, copyright, and industrial designs that we didn’t think about before COVID-19. That’s why the IP barriers are a serious challenge. Many people say that IP protections are not a big issue; they say that because they don’t know which patents or other IP protections are relevant to these technologies. To date, there hasn’t been a detailed network analysis done. And it’s not easy to do.
But apart from that, there are also other barriers to scaling up production. We don’t have enough manufacturing capacity; but this is a chicken and egg problem, right? There are IP barriers, and that’s why we don’t have enough manufacturing capacity.
But apart from that, there are also other barriers to scaling up production. We don’t have enough manufacturing capacity; but this is a chicken and egg problem, right? There are IP barriers, and that’s why we don’t have enough manufacturing capacity. When you look at the vaccine manufacturing landscape, it’s not that our main problem is we have limited vaccine manufacturing capacity. That’s very clear. Remember last year at this time, we had no mRNA manufacturing capacity anywhere in the world. We built the existing capacity in the last six months. And all the pharmaceutical companies, they invested their resources into it. And now we have mRNA vaccine manufacturing capacity, then this doesn’t mean that other companies cannot do that either. If you’re a biotech company, if you’re working on biopharmaceuticals, it should not be hard to repurpose existing capacity. But you need to invest money, time, and expertise, and you need to be sure that you are not infringing anyone’s IP.
I’ve been hearing a lot from the companies about experts, that they’re only a limited number of people who are working on this technology, and that they work for Pfizer, Moderna… But mRNA is not a new technology. People have been working on mRNA for like 30 years, and not many people took it seriously. There was a really great article in the New York Times about the inventor of the mRNA. She couldn’t get funding, and no one believed her. And all around the world, there have been people working on mRNA technologies. Go through academic papers before 2020 and you will see papers from researchers in Brazil, Mexico, China, India.
Fukuda-Parr: So let’s say, if you were charged with planning a strategy for rapid scale up of manufacturing, where would you find companies that could come up to speed? Would they be in the United States, Europe, or where else in the world?
Kilic: There are companies in Africa like in Senegal, South Africa, Nigeria, and Egypt. In Southeast Asia, they have some capacity in Indonesia, Singapore, Malaysia, and Thailand. Thailand has been working on its own Thai mRNA vaccines. In Latin America, we have Brazil, Argentina, and to a certain extent, Mexico. So I mean, if you look for it, you’ll find it.
Fukuda-Parr: Are these pharmaceutical companies specialized in vaccines? Do you need training?
Kilic: You don’t really need to be a vaccine manufacturer. Because mRNA is a new technology, it seems it would be easier if you are a biotech company. If you’re a researcher working on this technology, it won’t be hard for you to figure that out. When we talk about technology transfer, we always think about transfers from one company to another. But – this is something I’ve identified in my own research – if you want to have a sustainable technology transfer, you need to involve local universities and researchers, so they can observe the technology and they build on that. So when it comes to mRNA, we need to broaden our horizons and bring together local manufacturers, local researchers, government agencies, and regulatory agencies, and come up with a plan. So it’s more complex than people think. It’s not like “hey, we’ll go to a company and we’ll carry your stuff and then we’ll do the tech transfer.” That’s not technology transfer.
Fukuda-Parr: You mean you need to develop capacity for the longer term?
Kilic: Yes. In the short term we can also work with voluntary licenses. But voluntary licenses are not an ideal solution because the pharmaceutical companies dictate the terms and conditions. And companies don’t necessarily have an appetite to give voluntary licenses. Contract manufacturing is not technology transfer. We need to build broader capacity in those countries, because like the Pfizer CEO indicated, we will need a booster for these vaccines in twelve months. There will be an ongoing need for vaccines, so every country needs capacity sooner or later. It may take a little bit longer, but we need governments to be in control, and we need to include the regulatory agencies because it’s more complex than it sounds. And it’s not just a public health issue but also an issue of national security.
Do you think that this is a moment when governments are reconsidering the importance of developing capacity in the pharmaceutical sector?
Fukuda-Parr: It’s very interesting that you say that governments have to be involved. In fact, they need industrial policy, right? Do you think that this is a moment when governments are reconsidering the importance of developing capacity in the pharmaceutical sector?
Kilic: Yes. We have finally reached that point. Ten years ago I wrote my PhD about local manufacturing, and it was one of the policy recommendations I made. I went around the world and I did all this advocacy around local manufacturing, and not many people liked it because it’s a long term solution, and it’s complicated. And they say “we’ll get it cheaper from India.” But now the governments are realizing the risks. This is a growing advocacy movement for building local manufacturing. I say movement because finally people are advocating for local manufacturing capacity. Government officials have been talking about it because they saw that short term decisions brought us here. And politically, there is now a will. I’m seeing the landscape changing. And it’s very timely; this is not the first pandemic and it’s not going to be the last one. The African Union and the African CDC have taken regional leadership to try to get manufacturing capacity to be developed in Africa.
Fukuda-Parr: Do you see some interesting examples of countries that are starting to be proactive, not just in words, but actually taking steps to develop pharmaceutical manufacturing capacity?
Kilic: South Africa, along with other African countries, has been taking the lead. They really want regional hubs for drug manufacturing in Africa because they’ve relied on India for such a long time and they can no longer do that. In Asia, I know that the Indonesian government has always been interested. But this situation triggered interest in local manufacturing. It should also be noted that Sputnik has been going around the world and giving out volunteer licenses, such as to India, Turkey, Egypt, Brazil, and Argentina. These are voluntary licenses, and we don’t know the terms and conditions, but still, this is a first step to technology transfer.
This is starting a New Era because those countries are getting into vaccine manufacturing. Maybe in two years or three years time we will have a better vaccine manufacturing landscape.
This is starting a New Era because those countries are getting into vaccine manufacturing. Maybe in two years or three years time we will have a better vaccine manufacturing landscape. Middle income countries that have some kind of capacity, expertise, and local research are interested in investing. It’s interesting because it triggers other initiatives. We are using mRNA technology for COVID-19 vaccines, but was initially developed for cancer and can be used for other diseases.
Fukuda-Parr: Do you see the geography of the pharmaceutical sector changing in the New Era? You mentioned Russia providing voluntary licenses to other countries. Presumably, China also has been doing the same. Some countries like Cuba and Brazil are investing in their own industries. What will that do to the hegemony of the Western Big Pharma?
Kilic: That’s an interesting question. Big Pharma has been protective of their monopoly-based business model and that’s what we relied on for many years. It failed us. Now you see China and Russia going around the world, giving voluntary licenses, offering free technology transfer, and even investment. If we cannot come up with a solution to address IP barriers, it’s going to change. The companies that manufacture Russian vaccines will continue to manufacture Russian medicines and those that manufacture Chinese vaccines will manufacture Chinese medicines.
COVID-19 has become a national security issue. People are dying and economies are closed. We should change our mindset about the monopoly-based Big Pharma business model.
Currently the pharmaceutical companies have the power and the control. We need to shift the power to governments. Until now, everyone was talking about voluntary licenses, like AstraZeneca and the Serum Institute; see what’s happened. No company can manufacture that vaccine in India, because it is exclusively licensed to Serum. COVID-19 has become a national security issue. People are dying and economies are closed. We should change our mindset about the monopoly-based Big Pharma business model.
Fukuda-Parr: Where do Russia and China stand in the context of international negotiations over IP – such as the TRIPS waiver proposal at the WTO or mechanisms like C-TAP?
Kilic: Reportedly, although China is not opposing these initiatives they are also not wholeheartedly supporting them. Russia hasn’t taken a very strong stand against the waiver. And the countries which get licenses from Russian and Chinese companies, they’re okay because it opens up new possibilities for them. So, apart from the usual suspects – the US, EU, UK, Canada, Australia, Japan – the rest of the world has been okay. We’ve run out of options. Let’s try this. I mean, that the interesting thing is one hundred plus countries, they’ve been saying that this is what we need.
Fukuda-Parr: And do you see the access movement – led by Western based progressives – embracing Chinese and Russian efforts? Will they work with those companies?
Public health policies are made by Global North elites, and those people think that they know better than the people living in those countries.
Kilic: That’s a good question. There are all these discussions about the effectiveness of Chinese and Russian vaccines. A very good example of that is my parents who live in Turkey. They’re both vaccinated with Chinese vaccines. BioNTech owners are children of Turkish immigrants and they were very particular about supplying to Turkey. Still, it was difficult for Turkey to get timely access to BioNTech vaccines. In Turkish Phase III trials, Chinese vaccines came out around 83.5% efficacy, and Pfizer came out around 90%. These are statistically similar. The Turkish trials had roughly 11,000 participants. Some commentators were sceptical of the Turkish and Brazilian Phase III trials. Both Turkey and Brazil have highly-rated regulatory systems and they independently reported their assessments. This is exceptionalist thinking, and that’s our problem in global public health. Public health policies are made by Global North elites, and those people think that they know better than the people living in those countries. They keep saying ‘Chinese vaccines are not efficacious’ because the results are not being reported by Sinovac or Sinopharm. The regulatory agencies in different countries reported results of different independently run trials in different countries. It is not fair that people sit in your comfy chair in Washington, DC and question the results of independently run regulatory trials in Brazil and Turkey because you cannot read explanatory documents published by these regulatory agencies. This is partly because these documents are not in English but this does not mean that their information is not there.
People in the Global South are getting frustrated. In one of our meetings among fellows in a research project, people were saying “I got vaccinated, I got vaccinated, I got vaccinated” and then we started to discuss vaccine passports. And we had some African colleagues, and they were like: “What are you talking about? There is no plan for us. I don’t think that I will get the vaccine until 2023. Like, yeah, it’s just like, there are people like me, my country, like people, we are not numbers, we are people. And there is no time for us.” So I think that’s the missing part. You know, in public health when they talk about developing countries, they see developing countries as a concept, and forget there are people living in those countries, and they have daily lives. It’s very patronizing.
I’m not a big fan of Russian or Chinese policies. But many governments are buying those vaccines because they don’t have other options to timely vaccinate their people.
I’m happy my parents received the Chinese vaccine in February. I’m glad the Turkish government made the timely move with Chinese vaccines. We have BioNtech vaccines in Turkey now, but I believe early vaccination of high-risk age group people saved many lives in Turkey.
I strongly believe that TRIPS waiver can be a unifier and bring together all the countries and even our own global health community.
Burcu Kilic is a scholar, lawyer and digital rights advocate. Her work is divided between digital rights and access to medicines. She directs the Digital Rights Program and is also the research director for Public Citizen’s Access to Medicines Program.