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Session 2: Innovation in the life sciences: what has Innogen contributed?

 

Professor Theo Papaioannou convened this session about innovation in the life sciences, more specifically about the achievements of the Innogen Institute. The panel comprised Professor Joanna Chataway, former from OU and Innogen and now Professor and Head of Department of Science, Technology, Engineering and Public Policy at UCL; Maureen Mackintosh, Professor of Economics at the Open University. Unfortunately another colleague couldn’t come, Julius Mugwagwa also formerly OU and now in Joanna’s dept at UCL. But he has added some thoughts into this summary. We also have Dr Geoff Banda, Senior Lecturer in Innovation at the University of Edinburgh, and Professor Dinar Kale Professor of Innovation and Development at the Open University. He proposed two questions. First, what has Innogen contributed to the study of innovation in the Life Sciences, and Innovation more generally? Second, what have been the big contributions to theory policy and practice from this work? He asked Joanna first about of her influential work around public, private partnerships, and other work in Innogen.

Joanna: The first thing to say is Innogen was, and is, a big beast, and a huge amount of work went on under the auspices of Innogen. I won’t begin to try and summarise the quantity, the quality of work that went on over the ten years of ESRC funding and since. The work that I with others developed in during those years focused on public-private partnerships and product development partnerships in particular. When I think about the current context, I think about COVID-19 and the successes and failures associated with COVID-19. My perspectives on that were heavily influenced by the work that we did during those years and the perspectives we developed during those years.

One important result that came out of the team that worked on public, private partnerships and development, I think, was this notion that you could see the science as, the scientific and technical challenges that those partnerships were trying to address. But actually the message from those partnerships and from our work was that if you have a scientific and technological challenge in front of you, ask a social scientist to get on board, don’t forget the social science, don’t forget the institutional or the organisational dimensions of the problem. Because if you don’t do that it’s very unlikely that you will solve those scientific and technical challenges in a way that meets the needs of society.

If we think about COVID-19, the vaccines were hailed as a tremendous scientific breakthrough which they were. What was done was quite incredible in the time people had to develop the vaccines. But in the end, although they got us through a very tight spot in some countries and in some contexts, I heard someone the other day saying ‘actually we can look at all this in a different way and see them as failed technologies, because that in many cases the vaccines require cold storage, they’re difficult to transport, the infrastructure that’s needed to distribute to people, to the public engagement that’s needed to make it successful isn’t there’. And that takes me back to the research we did in Innogen, because in many cases the issues were the same. In fact you could make the case that there was a more heightened awareness of the social and infrastructural institutional challenges that existed at that earlier time of product development partnerships. That for me is a key element of the work that we did at Innogen which stays with me in very real ways, and continues to be a big part of what I do.

Theo interposed: I was just thinking about the other work you did about social technologies and I was wondering whether that also played some role for us to understand the situation with the Covid and the development of the technologies, and the implementation of the technologies and the failures. Because even if we managed to develop the physical technology, the social technologies don’t seem to be in place?

Joanna: Absolutely, that’s it. That’s the point about those vaccines now, the COVID vaccines, we haven’t managed, outside of wealthy countries. There’s a huge deficit in terms of what the vaccines have been able to do and that’s a social technology issue, not a physical technology issue.

Theo: For quite some time in Innogen we’ve been focusing on pharmaceutical products and processes, and with the debate about the biotech revolution. But health innovation systems are not just about drugs. Dinar Kale works on medical devices and biologics. I would like to ask Dinar about how the Innogen approach, the Innogen methodology helped that kind of work?

Dinar: Thanks for reminding me of the medical device diagnostic work and where it started in Innogen. I will give you a bit of background. Before beginning my PhD at the Open University I was working in a medical device company, and I could see the issues of access and affordability a bit. When joined Innogen, that’s where my perspective changed. I remember a conversation with Jo, she said: ‘what’s the research question, is it about the public? is it about local production? Because the issue was that 70% of medical devices were being imported. In Innogen, I first came across the importance of the role of regulation. With Shawn Harmon at Edinburgh I wrote a paper, published in Technology in Society which looked at medical device organisations in India. We argued that lack of regulation was really affecting the development of the industry. The second insight was the work we did about industry association and I started discussing with Dave. I noticed that the industry associations in India at that time were not picking up the medical device and diagnostic industries. It was around 2007 and we were struggling with conceptualising what impact the lack of industry association interest was causing and that’s where we come up with the term of collaborative action, where you needed the industry associations, the entrepreneurs, and regulators to work together to change policy.

That interest developed further into work with Geoff and Maureen here on the issues of medical devices in African countries. India is doing a little bit more innovative work on making inclusive products, but there’s scope for African countries as well. Diagnostics provides totally different entry barriers. Innogen’s integrated conceptual approach helps bring out the differences with this sector.

Theo: Regulation has always been a substantive part of the work that we did within Innogen, but you also mentioned the work on industrial associations, and when we started doing that work there wasn’t so much attention to the intermediaries within innovation systems. These groups play a major role to alert regulators about how to regulate specific industries. And it wasn’t just the UK, it was key for developing countries, including in Africa. Maureen Mackintosh has done a lot to highlight the gulf between industrial policy and health policy, particularly in Africa, offering suggestions about how to bridge that gap. I would like to ask Maureen about the importance of this work in terms of policy and practice, and thinking particularly about the impact on health systems in Africa.

Maureen: When I was thinking about this discussion I was thinking about the book that we did [Promoting Innovation, productivity and industrial growth and reducing poverty, 2009, Routledge], and the paper we wrote with Marc Wuyts in 2008 for the book/special issue, which was called Bridging the Policy Gap, and it was absolutely the policy gap between healthcare and industrial innovation. I was trying to think how much have we done to bridge the gap. We’ve built the odd span, something has happened, we’ve been building. But there are huge gaps still, and I was trying to reflect on that. Why is that gap really so difficult. I’ve just been doing a talk on The Lancet Commission on Cancer in Africa, which came out two weeks ago. That report mentions manufacturing in one sentence, in the entire commission report. The sentence is about vaccines of course. The whole local production debate is now on the WHO website. Our work, and a lot of the work from people here and all the other networks. But it’s still not in their reports. And that was a disappointment perhaps, but also a kind of measure of how big that gap is. The work from the Making Medicines book [Making medicines in Africa: the political economy of industrializing for to local health, Palgrave], on innovative procurement: I can’t count the number of citations I’ve seen of that chapter, but no movement. On intermediaries, it’s clear that procurement, pharmaceutical, and pharmacists, those whole networks are crucial intermediaries. But then they’re not getting a grip, institutionally they’re really not, they’re finding it very difficult. Because of COVID-19 in Africa, there’s been real innovation, real recognition that there’s a very long supply chains around disaster, on all sides, manufacturing and health.

But I just thought I’d say one more thing which is about what’s blocking us conceptually. I think Marc probably mentioned multidisciplinary work and its difficulties this morning. I think one of the things we’ve learned is that it is very difficult for each of us to get a grip on each other’s conceptual worlds. What we have done is to listen hard, pick up from each other: from the health systems side and the innovation side. I’ve been fascinated by innovation work for 20 years without being really part of it. We pick up aspects of it that we understand, but we find it very difficult to pull it together. On the one hand you still see innovation work which doesn’t recognise the commercialisation of health systems. So I’ve recently seen a piece of innovation work that shall be nameless which uses an example of a primary healthcare facility as an example, and never says whether it was in the public or private sector, despite the fact that they’re taking about demand, and demand is completely different depending on whether you’re a public or a private facility. So there’s a gap there, and I’m quite sure that it works the other way too, that the health systems people of which I’m one, really find it hard to get a grip on what’s being said by many of the innovation researchers.

I was just looking at social technologies, the history of, because social technologies was an attempt to get across that, didn’t work very well. So my final thought is therefore that we might maybe spend a bit more time trying to think about how we conceptualise each other, and in particular it seems to me that there’s a space which is kind of hanging out there. Which I want to call big commercialisation. This is the ways in which the last ten years have seen this enormous coming together of big private insurance, really big private healthcare chains, which are much more powerful globally than they were 15 years ago when we did the commercialisation work. And on the other hand, the ways in which industrial innovation is being driven, maybe by more monopolised entities. I’d be interested to know if that’s true. I wonder if there’s a kind of big commercialisation story about how private health, private insurance, private innovation interconnect, and its implications for universal healthcare, which I think might be quite serious, if it is happening.

Geoff: My interest is in looking at the firm level, the technological capabilities that can be built, how would you build the skills that allow people to do a certain production, and then move forward. So I am not comfortable with focus on policy level discussions. When we’re saying how do you develop a model of policy, well I don’t think it’s just policy. Maybe just throw an entrepreneur into the place and give them the right support.

Theo: I was wondering whether, in order to build policy you need to sort out the conceptualisation problem, to get the academics talking to each other. I wanted to ask Joanna, who is doing lots of work on policy, is that the case, or is it the case that there is a deeper problem for policy to grasp what’s needed on the ground. Does policy need conceptualisations, in other words in order to move on to resolve some of the issues on the ground?

Joanna: Just as academics can be removed from reality, the worst sort of policy can also be removed from reality, and we see that in this country day after day, in policy statements that have absolutely nothing to do with what’s going on the ground. And cognitive biases rather than anything else. So I take your point, policy isn’t necessarily the place to start, but there’s a serious challenge isn’t there, to put the counter argument in a way. The Elon Musk’s, the Mark Zuckerberg’s, they don’t wait for policy, their answer to the question ‘is policy necessary’, is a big no. If it is, it’ll do what we tell it to do after we’ve done what we’re going to do. So there’s a sort of power play that goes on around the relationship precisely coming back to public and private. Because industry is mainly in the private sector much disregard of policy is a disregard of public. I think there’s a really interesting set of questions there, about the relationship between policy and industry. About the higher degrees of commercialisation, and but also because of the failures of public policy to tackle what’s hitting it in the face. It is this challenge really.

Theo: Maureen Geoff, Julius and Dinar have done so much work to push the argument forward that in Africa medicines can be produced: there are capabilities on the ground, there are companies on the ground. That has not been recognised that much in policy terms. I was wondering, why is it that all the stuff that is in the Making Medicines book, that was publicly available, doesn’t seem to be changing policy and practice.

Maureen: Well it’s interesting isn’t it. I mean that book has been downloaded 90,000 times. So it’s out there and people want to read it, that suggests something’s going on underneath the radar. One of the things that really struck me this morning doing the discussion of The Lancet Report on cancer in Africa, is that this is the first Lancet report I’ve seen that has mentioned decarbonisation, and it’s substantially written by a large number of African scholars, as well as lots of others, but also one of the authors is Richard Sullivan who’s one of the global health scholars who’s taken decarbonisation seriously. It’s quite interesting that there’s a lot of front and centre discussion of the importance of a science base in Africa, and the decolonisation of frameworks. Coming back to what you said earlier on Joanna about the importance of social science, that is acquiring some purchase in the discussions. It seems to me that more broadly the recognition is kind of out there, not in the policy world, but in the world of those discussing this stuff. I think quite a lot of downloads of that book are students actually reading, and I think there’s some recognition that you can’t do without social science. So, coming back to your question at last, I think there is hope that the local production of medicines situation is changing a bit and in the countries that we’ve been studying there are some new investments. They are widening the product range, they are beginning to talk more about medical devices, it’s really small, but it is there.

Theo: Yes, thank you, if Julius was here we’d probably make a reference to the discussion we had some time ago about political will and politics, What does politics have to do with all this? Also thinking about interdisciplinary methodologies, we used to approach these issues with a triangle of the innovators, the regulators, that the public, and all of these relations are power relations, somehow manifesting into politics and into the debates behind policy. So, what do you think about the politics dimension.

Geoff: I think there are two things: policy and politics, I will start with the policy issue. I think we need to make a distinction between high value products and others. Some of the products can easily be brought to market and don’t create that much risk, you can get away without much regulation and cost. But the problem comes when you’re dealing with medical health technologies that need, for example clinical trials. That necessitates policy, if you’re working in a highly regulated environment then you can’t run away from policy. So, in the life sciences you need policy before you create an industry. Second, politics. I’ve been reflecting for quite some time why local production of medicines was not high on the agenda. Someone reported to me about a conversation she had with a president and he said ‘you know what, you are one voice talking to me about local pharmaceutical production, someone else is coming to me to talk about building schools, someone is coming to me and talking about building roads, and someone wants me to build hospitals’. It is a dynamic around what do you prioritise first. Someone is coming to you and saying I need you to support the acceleration of the pharmaceutical sector. So under normal circumstances local production is pushed aside What Covid did was crystallise the existential threat that you have, when you can’t start to produce at least some basic forms of medicines to supply your people when the world shuts down. So politics comes in there, and how does it come in, it comes in from this pressure from the public to say ‘get our resources, what are you doing to protect us?’

Julius: I would add here that the pressure helped to galvanise or crystallise politics not only into political will, but political action as well. The mechanisms for and extent to which the will and the action can be sustained was part of some Innogen thinking early on in relation to health system strengthening. There are indeed multiple contending factors at any point in time.

Geoff: I have been looking at the work that we did a long time ago. For a very long time there was absolutely no citation. Then, all of a sudden this. An existential threat can bring something to the fore that people were ignoring, and it forces politicians to do something. That’s why you look at Ghana, you look at Uganda, you look at Kenya, you look at South Africa, you look at Nigeria, all of them are talking of biggish investments in local manufacture. The politics emerges when there is public pressure.

Julius: This in many ways is a manifestation of the blurring of the boundary between politics (the right to govern) and policy (measure/plans) in moments of heightened public attention or societal pressure. This was the case in the GM-debates in different parts of the world (when political rhetoric could be equated to policy, or could by-pass policy and go directly into directing practice. Innogen did work on this.Geoff: Whilst on that question, we’re now sort of post-COVID. I’m scared we’ve learned the wrong lesson from COVID. The South Africa intravenous line, which was set up by Aspen is about to be shifted from vaccine packing back to sterile anaesthetics, because there’s no demand. You have this peak demand, but peak demand doesn’t create the basis for an industry. A health industry is built from a range of different kinds of products. There is a danger of looking at medicines as just any other commodity that you can get on the market. There is demand. If you look at the pharmaceutical drug market I think it’s around about $25 billion in Africa. But the challenge is who is buying the drugs, is it the state using its own funds? If so, it has this latitude to improve procurement, to shape industry and to support industry. But if it is the NGO sector that are buying the drugs, then they have different priorities.

Maureen: I couldn’t agree more. Demand isn’t something that falls from the air. It’s a choice, you can decide to support your local industry or you can decide to let it sink. Aspen [the large South Africa based pharma company] is very powerful, it’s the eighth largest generic multinational in the world. But it’s also got a sensitivity to its local base, and the issue of how what it sells locally is made locally, and how much of what it can make locally is bought locally. The fiscal choices are in a way quite straightforward, you can decide to sustain this industrial base or you can decide to let it sink. And you know, taking on Aspen’s not straightforward, but it’s also far from impossible, and Aspen’s got its own, you know, road to home. It’s a good example in a way of the importance of what dealing with big commercialisation is about, because we’re not talking about small firms when we’re talking about Aspen. A lot of the local producers are SMEs, they’re medium sized firms, medium sized family firms which have, you know, gone on through crisis after crisis in Africa, Aspen’s a different beast altogether, it’s a huge multinational, it can be pressurised to better supply local demands around COVID, there you are.

Geoff: In Africa the countries that had a broad base, and not only for pharmaceuticals, but in plastics, in metals, in the chemical industry, everything else, they were very agile in readapting to producing for COVID. They were also able because of the crisis to get to universities and their technical capabilities. Hopefully, COVID was a wake-up call, it’s another question whether the policymakers and politicians will stay awake. It’s about these capabilities that were demonstrated and how do you feed the fire, so that the flame doesn’t die, and how do you create these opportunities that ordinarily are closed. Let me give you an example of that. A local firm in South Africa, prior to COVID they were struggling, because someone in government was saying why should we be privileging them and giving them the tender to bringing all the vaccines for South Africa and distributing them, and they ran from pillar to post looking for support, but they were about to lose that tender, and if they’d lost it, it would have been so difficult for them. Then COVID hits, and South Africa is all of a sudden isolated, and the policymakers look around, and this firm has the capabilities to store vaccines. What they don’t realise was that this capability was built over many years. When they were in trouble who did they turn to? Covid was a wake-up call

Maureen: There’s a very long industrial debate within South Africa about where you put industrial support. And a good deal about that is about public investment and places to invest. What I was talking about is where you buy your medicines, public procurement, people in South Africa, huge quantities of medicines, you can buy them in a whole range of different places, and they have completely different impacts on the economy, this is a fiscal choice. South Africa has chosen to protect its medicines market, so that medicines are more expensive in South Africa than they are for example in Tanzania or Kenya or Ghana, that’s political choice already. Which is made in part because of the large private sector in South Africa. Given that you’ve got a choice, you can buy them locally, you can make locally, you can encourage generic producers to produce a wider range, you can offer longer-term contracts, so that they can get into those markets, or you can choose to go out and buy them somewhere else.

This is innovative procurement. Joanna’s been writing about it for years, patiently, and is now getting much more citations. This is one of the complicated things. When people talk about policy, they sound like they’re talking about national cancer plans for example, which are nice to have and important to have. But policy is actually about: you’ve got this very large sum of money to buy medicines, what are you going to do with it, and is it going to have a multiplier effect on the economy and how much and why, and what are you doing to make it happen? It’s a complicated politics, because you know, this is the procurement thing, the people who are most able to think that through are sitting between the two big ministries, health ministry, and there are lots of contradictions, and they’re being leaned on by external people.

Joanna: I agree with all that you said, but there’s another angle on it which is about promoting a science and technology innovation perspective. If you look at most life science innovation it doesn’t come from big breakthrough science, it comes from years and years of investment, and cumulative capabilities, and actually it usually comes from a really interesting interaction between clinicians, and industrial innovators, and scientists. About how you can adapt. What things work in practice. These weird things that happen as a result of drugs that were developed for completely different conditions working in other conditions. So there is a need for sort of a patient investment as Mariana Mazzucato would put it. Things will fail. You need to keep putting money in. I mean we wouldn’t have the AstraZeneca vaccine without years and years, decades of investments in malaria vaccines actually. So, both from a procurement end and a fiscal end there’s an argument to be made you need to support local innovators, public and private. And also from the innovation end you certainly need to support when things don’t work. It doesn’t work like that, you don’t invest in big bang science and then immediately produce a result, it just doesn’t, once in a blue moon it happens, yeah.

Maureen: Can I say something about post COVID? It seems to me that in the global health world, which does have a lot of money floating around in it, there is a shift in thinking which I think is real. Including the notion that global health money isn’t something which is top down. There’s been huge problems with that. That there are other ways of doing it, and that local initiatives are important. I think there’s a long way to go, but I don’t think that shift in perception is going away.

Geoff: And Maureen adding to that, this is your concept that you developed, the local health notion, not as a counter argument but as complimentary to the global health issue. The work that we did, from a standpoint that manufacturing in Africa is global health security does not stand in a vacuum, is built on strong local health security. If each country has got strong local health security it becomes easier to ensure global health security, that’s one thing that came from Covid.

Julius: This argument is also about the global-local nexus, which is often ignored, given little attention, or assumed to ‘just happen’. Our arguments through the work on PDPs, and now exemplified through Covid, are on the need to deliberate action and investment in mechanisms and institutions that refract and embed knowledge and capabilities into local contexts.

Question from the audience: You mentioned at the beginning about physical technologies and social technologies and then we’ve come back around to talking about social science and public understanding and public health, this is maybe not a quick question, apologies, but what do you think would have happened if there was more awareness of social science and how to look at what looked like sort of physical science problems as in Covid, what do you think would have happened if for example states have looked at Covid with a more social science lens, than just a physical science lens, what do you think would have happened to where the investment went?

Joanna: That’s such a great question, what difference would it have made. There are many different ways I think you could answer that and begin to think about it. One aspect was that the first kind of tranche of policy measures refered almost exclusively to epidemiological models, and the charismatic characters around those epidemiological models. They were enormously influential, and I think policy got very wrapped up and grounded in a narrow body of evidence that did not include social science at all. There were narrow, bits of behavioural economics, behavioural psychology that came eventually to play a role, but there could have been so much more reference to social science in order to understand both the development of policy, how the policy was going to be developed, how it would be implemented and reacted to. Social science would have made a huge difference to that.

Can I add one thing to that. If there’d been more awareness of overseas social science, then we might have done tracing early on, and we didn’t at all really, whereas other countries early on did it very successfully, having learned from SARS. We didn’t learn from other countries, and where would you learn it, well you’d learn it in public health and social science public health, and those lessons weren’t made.

Finally, lots of people have said it over the last hour, one thing Covid-19 has done is to shift the conversation around local manufacturing, local production, the importance of breaking down supply chains which fail huge swathes of the population at critical moments.