Webinar: Weekly COVID-19 Pandemic Briefing – Perspective from the Pharmaceutical Industry

Emma Ross

Thank you for joining us for this week’s COVID-19 briefing with Chatham House Distinguished Fellow, David Heymann. Our guest today is Thomas Cueni, Director-General of the International Federation of Pharmaceutical Manufacturers & Associations, the IFPMA, which is the global trade association for the pharma industry. In his position, he has a very good grip on what’s going on across the industry globally, and what it really takes to get these things through and into the hands of those who need it. The IFPMA, just to clarify, represents research-based biopharmaceutical companies, mostly what many of you will recognise as big pharma. The organisation is a partner in the ACT Accelerator, that’s the WHO-led initiative on which a lot of hope is being pinned to accelerate the development, production and equitable access to COVID-19 pharmaceutical products. So, a very big welcome to you, Thomas, and thank you for joining us today.

Thomas Cueni

Good morning, Emma. Thanks for inviting me.

Emma Ross

Can we start with you, Thomas, for a general framing? As we know, there’s a huge push to develop COVID pharmaceutical products and get them into the hands of everyone who needs them as quickly as possible. So, what does the industry see as its role in this and how is it playing into this effort, including relative to universities, biotechs and others working on developing COVID products? And, as Head of IPFMA, what role are you personally playing in this picture?

Thomas Cueni

Thank you, Emma. Complex question, but I’ll try to be short and succinct. Basically, when you look at COVID-19, we knew SARS-CoV-2 since January 10. We are now getting towards the end of July, it’s amazing how far we have gone. I think one of the industry’s recognitions early on was a huge responsibility because we do hear a lot about academics, WHO, CEPI, Gavi, Unitaid, and many others involved. But, at the end of the day, when you think about the tests, the therapeutics, and the vaccines, which will need to be available at scale, which means in tremendously large volumes, only big pharma companies do have to know how the experience and proven track record to do it, and that puts a tremendous responsibility on the industry.

Emma Ross

What role are you personally playing as IFPMA relative to the companies individually in the pandemic and bringing the industry along, so to speak?

Thomas Cueni

Of course, at the end of the day, it’s the companies doing the research, the development, and the manufacturing, but on my role, my personal one, is an important one because we became a founding partner of the call to action on April 24, we are a founding partner of the ACT Accelerator. Therefore, personally, I’m having – every Thursday evening, we have basically two hours with Dr Tedros, WHO leadership, Gates Foundation, Wellcome Trust, CEPI, Gavi, and the other major players, where we talk about the co-ordinating elements. In addition to that, I’m personally involved in the COVAX facility. I’m acting as the Sherpa to our representative on the CCM, which is the organisation which, at the end of the day, will have a role to make sure that no-one is left behind, that also citizens in low-income countries get access. And I’m also involved in the Therapeutics Accelerator because our companies do research on treatments, and they’re in contrast to the vaccines, where you have to work from end-to-end, you didn’t have a vaccine, sort of, in the closet. In the treatments, the primary focus has been on repurposing, on finding, among medicines approved for the diseases, which one would work for COVID-19.

Emma Ross

Okay and before we get onto specific questions, I thought we should just explore to what extent is there an industry perspective? I mean, in normal times, companies have different stances and approaches, and different levels of engagement with global health issues, but this obviously is an extraordinary situation. Do companies have a common approach to this pandemic? Is there an industry perspective?

Thomas Cueni

It’s actually quite amazing. I’ve been in industry association business for no more than 30 years. I’ve never seen something like this, because, historically, you have very heterogeneous points of view, you have industry occasionally going all over the place, but here, the industry has come together. I was personally really amazed how easy it was to get a concerted industry view on the policy issues, on, for example, the importance of the industry stepping in, the industry working 24/7, but the industry also committed to public health responsibilities. The reason, I think, is fairly simple. Since 1918, the Spanish flu, we never had a global pandemic of this magnitude impacting our personal lives, public health, combined with an economic impact, which is, you know, comparable to the financial crisis of 2008/2009, and this really puts a tremendous responsibility on the industry. And when I look at the way the industry has reacted, aligned, co-ordinated and, in my view, in a way you would hope it would react.

Emma Ross

Thank you, that’s really interesting, and I’m surprised there’s so much cohesion and solidarity within the industry, ‘cause, as you know, Dr Tedros calls for solidarity in all corners, and I was wondering about whether there is a sense of solidarity within the industry or from the industry with the world. So…

Thomas Cueni

Both, actually. Within the industry, we, for example, have organised a number of global media briefings on therapeutics, on vaccines, on the role of the industry. And, when you listened to, you know, the industry leaders there, they were, sort of, singing all from the same hymn sheet, which is surprise, given that we didn’t have rehearsals beforehand. And there’s a collective sense, look, of course every company wants to be the first with a vaccine, every company hopes that their treatment will work, but, at the end of the day, you have this collective sense, whoever is there, it’s good for the global – you know, the global public health, it’s good for the industry. And I think something, which is worth mentioning, from the beginning, there was a sense this is not business as usual. I’ve heard nobody talking about looking at the stock exchange, at the quarterly results, it is really this sense, “We need to deliver,” and not the sense, “Will we make money with it?”

Emma Ross

Thank you for that. David, I wanted to come to you on what is the ask of the global public health community for big pharma in this pandemic? What should we expect from the industry, what should we not expect, and have you seen anything different in the way they’re playing into the response compared with similar events, or compared with business as usual?

Professor David Heymann CBE

Well, you know, thank you, Emma, it differs from vaccines to – as Thomas said, to therapeutics. Therapeutics are repurposed drugs that are being tested right now, but the research and development area in vaccines is quite amazing to see how the academic institutions, the small biotechs, and big pharma are working together to try to make sure that there’s not only development and innovation in new vaccines, and in some therapeutics, such as studies of plasma and convalescence serum in using antibody to see if prevention or treatment is possible. So, this innovation is very important. The innovation is leading to new partnerships, it’s leading to understanding that big pharma is the group that can produce the vaccines in the quantities necessary, and, therefore, these partnerships are very crucial. Whether or not the full production capacity will be available is not clear at present. We’ve seen unique instances where countries have provided – even before vaccines are licensed, while they’re still in study, they’ve been – they’ve given advanced purchase commitments and are providing funding now to make sure that that research and development continues, so that the vaccines are prepared, should they be possible – possibly effective. So, we’re seeing lots of new things going on, as Thomas said, but at the base of all this lies innovation. There has to be excellent innovation, in order to develop these new therapeutics and new biologicals.

Emma Ross

Thank you. I wanted to go back to Thomas on this concept of global public goods, and to what extent does the industry buy into the idea that pharmaceuticals for COVID-19 are global public goods, or to that term in general, and has the pandemic prompted the industry to think, to any degree, about its business model for these types of situations? Are they thinking about their business model differently for COVID? You’ve said about the solidarity and the coming together, but what about the business model?

Thomas Cueni

I think this is really a time where we are dealing with unchartered territory, where we are talking about business as unusual, and, therefore, from an industry perspective, again collectively, there are limits to what we can commit to collectively because of anti-trust rules. But it was relatively easy to get the industry buy in to the commitments for available, affordable, equitable, which means this is – if you were to have value-based pricing here, you know, the sky would be the limit of a vaccine or cure. Here, everybody understands that the industry has, I think, a unique chance for game change, for really repositioning also its image by, on the one hand, our Scientists, our Engineers, are holding the keys to getting out of the pandemic. But also, doing so, we need to be seen as doing this in a responsive way.

Having said that, we are firmly committed that, at the end of the day, no-one is safe until everyone is safe, and Seth Berkley from Gavi, you know, makes that point again and again, in terms of the importance of getting a vaccine to everyone. Having said that, I’m too much of an Economist, by background, to let’s say easily use a term, which Politicians have coined on this one, the ‘global public good’, because global public good – and a public good implies that you have non-excludable, non-rivalrous. Now, fact of the matter is you will have, if somebody gets a vaccine, somebody else doesn’t get the vaccine. That’s why we do have the discussions on allocation and allocation priorities, within the COVAX facility, with WHO because you will need to make, you know, decisions, hopefully based on solidarity rather than who pays the highest price. But clean air, for example, is a public good.

But the vaccine, until we have sufficient quantities, is not a feasible public good. It contradicts all, you know, my learnings from my economic university days. But, having said that, I think the important matter is we really need to strive to make these vaccines as fast as possible, available, and accessible to everyone, whether they are free at the point of service, as normally they are, for example, in the NHS, or whether you will use insurance system or others, that’s a matter for countries to decide. The one common factor is, we will need solidarity, and we will need richer countries subsidising the vaccines for the poor countries.

That’s why, yesterday and last Friday, I spent quite some time in doing the commercials for the COVAX facility first with rich countries because, if they don’t pay in, it will be challenging for CEPI, WHO and Gavi to do the job they are supposed to do for the poor income countries. And, after this one, I will talk to the francophone developing countries, yesterday it was the anglophone, because we really need to be in this together, and the industry can play a big role, but we do not want to be caught in the middle. And there, the experience of H1N1, I think was a lesson we learned because there, the rich countries basically early on bought up all the supplies of antivirals and vaccines, and the poor countries were left stranded. This created an awkward situation for the industry, but it was also an absolutely unacceptable political situation, and I think we have a solid understanding that we can’t afford and we don’t want to have a repeat of that.

Emma Ross

But it seems like that is going on, that there – at least to some extent, we have reports of countries making advance deals and they’re still going to benefit. For the audience, the COVAX facility is a Gavi-run thing of advanced market commitment, so paying in advance and guaranteeing every country, rich or poor, enough doses to cover 20% of their population, am I right?

Professor David Heymann CBE

Maybe I would just add…

Emma Ross

Well, well, yeah, maybe you could…

Professor David Heymann CBE

Yeah.

Emma Ross

…come in on the COVAX facility and whether that is going to stop countries from cornering the market, buying up – there was an article by Maria Cheng from the AP last week saying it does not – it still allows rich countries to buy up the supply. Is – do you have any confidence that this can be overcome or stopped?

Professor David Heymann CBE

Well, Emma, the limiting factor will be the production capacity of a vaccine. We know that vaccines can be produced in quantities sufficient for many of the advance commitments that are already made, but we don’t know what more vaccine can be produced, and that will be the limiting step. We know that vaccines are very difficult to produce, with the quality that’s required, and they’ll require facilities to do that, but there is hope, as Thomas said earlier. The Pandemic Influenza Preparedness Framework, negotiated by member countries of WHO and industry, provides 10% of pandemic influenza vaccine to WHO to distribute to those people at greatest risk in developing countries. That’s a model that hopefully, has been successful and hopefully, will be followed, as we move ahead with COVAX and many other initiatives, which are now being developed to make sure that there is access of the pharmaceuti – of the countries to vaccines that are being developed.

Emma Ross

Well, do you think that the – it is, in any way, the pharmaceutical industry’s responsibility to police who gets what allocation of vaccine, or is that somebody else’s responsibility? Whose responsibility is it?

Professor David Heymann CBE

The ACT Acc…

Emma Ross

Presumably pharma can choose who they sell to, but to what extent is – whose responsibility is all that?

Professor David Heymann CBE

Well, I think that’s the responsibility of the ACT Accelerator, the accelerator which is working with WHO coordination to figure out the mechanisms that will make this vaccine available to others, not just to the countries that have the money to buy them. And so, it will be a very big challenge, but I think that we can have optimism that things are changing, that people understand that vaccines must be available to people throughout the world, in order to prevent this pandemic from continuing to spread internationally and nationally. And, once that’s understood, and especially protecting the populations who are at greatest risk, then we can relax a little bit with what’s going on. So, looking at the future, it may not be that we need vaccine for every person in the world, but we certainly do need vaccine for those people who are at risk of serious illness if they are infected, and that includes the elderly and it includes those with comorbidities. So, we’re looking at many different viewpoints as to what can happen.

But, you know, with the public private partnerships that have been developed in the past through public monies into private sector, we’re seeing innovation continue in new and different ways. And I believe this all began around 2003, when WHO had its own commission on intellectual property and innovation, looking for ways that industry can be supported, without having to always rely on intellectual property. And that’s what spun off some of these ideas where there’s public sector investment in public private partnerships, using industry and public sector together to develop new drugs or new vaccines, such as the Medicines for Malaria Venture, such as DN – Drugs for Neglected Diseases, and other frameworks, such as CEPI, which is working on the same principles on vaccines.

Emma Ross

Okay. Do we have Thomas back? Thomas fell off and froze, but I don’t know if we have him back. Thomas, are you with us? Thomas, let’s move onto R&D, and there’s a lot going on and coming out in the news right now on the progress in vaccines and drugs, and we’ve heard vaccine by September, vaccine by Christmas, plus, we’ve seen results from Phase I clinical studies, even animal studies, being discussed seriously when normally you don’t get excited about a candidate product until you see some results from Phase III trials. Is all this talk realistic, justified, or is it hype? What are the reasonable expectations to have, particularly when it comes to vaccines?

Thomas Cueni

There are two elements, Emma, if I may briefly come back to the issue of nationalism and who gets the vaccines. I’m…

Emma Ross

Sure.

Thomas Cueni

You know, I’m a realist, no country can ignore their own citizens, and whether it’s the US, the UK, or France, they’re all trying to do their deals, in addition to making statements about solidarity. I’m cautiously optimistic that we will see a mix of the two. We will see, you know, a really serious attempt to get 20% of the population, the healthcare workers and the vulnerable one, vaccinated as soon as possible, and the COVAX facility will play a major role. When it comes to time expectations, I have to admit I’m a bit nervous about people talking about vaccines in mass, available by Christmas. I’m – they are more inclined to be with what Ken Frazier, from MSD said last week, I think we are probably lucky if we do have vaccines at scale available next summer, and I’m more concerned about, you know, pushing too fast and cutting corners.

And I do trust the regulatory agencies, be it the FDA, be it the MA, and the appropriate bodies of WHO, to do their job and make sure that, before a vaccine is really used widely, you are sure that it is effica [audio cuts out – 20:57]. Now, the issue, of course, and that’s something which is rarely talked about, even knowing the results, and I’m cautiously optimistic, based on the conversations I’m having with the vaccine’s manufacturers. Even once we get the approval, we will not have the clear data yet on persistence, which means the question, how long does the vaccine last, do you need to use this once a year or even twice a year? We do not know yet then, what difference it has on [audio cuts out – 21:36] that, normally, the body’s immune system is weaker on the elderly, on the above 65, when you look at the clinical trials done so far.

Professor David Heymann CBE

I’ll just pick up on…

Emma Ross

Yeah, go on.

Professor David Heymann CBE

…what Thomas is saying, that I think there is reason for optimism. Hopefully, there will be a vaccine, hopefully it will be available, and I think that the amount of work that’s going on, especially under the ACT Accelerator with WHO trying to co-ordinate access to goods such as vaccines, drugs, and also to diagnostic tests, will have benefit. Already, we’re seeing the diagnostic testing, which is the only really real tool that we have today to deal with this outbreak, is increasing in countries because of the effect of the ACT Accelerator and increased research into access to diagnostic tests that exist. Hopefully, the Accelerator will also make the new tests that are necessary, to make it more a reasonable and more close to the patient where diagnosis can be made. So, we’re seeing progress, we’re seeing changes. We’ve seen these occurring, as Thomas said, when – since the 1980s, when IP was the only way that industry would innovate. Now they’re innovating with public sector funding in projects such as CARB-X, which is developing new antibiotics, and CEPI, which is developing vaccines. So, we’re seeing changes in the way things occur. Those changes won’t be rapid, but certainly, this pandemic will speed up our thinking as to how we can really deal with these outbreaks in the future and make sure there’s more equitable access to the goods that are needed to deal with these pandemics.

Emma Ross

We’ll go to the general questions, the audience questions, to see if we can get through some of those. Let’s see if this one – from Trisha de Borchgrave, “Will these partnerships and collaboration lead to greater development of more bespoke drugs of merit for future rather than just blockbuster, profit-driven treatments?” Do you have any thoughts on that, David? I’m not sure whether that’s something…

Professor David Heymann CBE

Yeah, you know…

Emma Ross

…you can address.

Professor David Heymann CBE

…there’s been hope on the postgenomic agenda, if you would, that, now that we’re able to sequence genetically organisms and understand where they attach to various human cells, there will be a possibility of developing designer drugs or designer vaccines, and that’s going on today with some of the vaccine development, and also, some of the drug development. Hopefully, that will be realised, because that will be a major way forward in not just doing trial and error, but actually developing a vaccine which fits into the site where that vaccine is necessary to fit in the human body, either – and the same for drugs. So, we’re seeing a change, it hasn’t been realised as rapidly as hoped, but it will make a change in the way drugs and vaccines continue to be developed in the future, and that will also, I think, in the end, change the model that industry is using. Already, industry is using more academic institutions in the more private sector – more public sector to develop the goods that they use, and then they’re standing by in partnerships, as we see with Imperial, with partnerships to go on and produce what’s developed by the small academic institutions or the biotechs. So, yes, changing – there is a changing climate. Where that will end up, I don’t think anybody can predict at the future, but certainly, Thomas will have some good ideas on that when he comes back on.

Emma Ross

Okay, well, we’ll keep that question in the bag for when he comes back…

Professor David Heymann CBE

Yeah.

Emma Ross

…as well. Here’s an upvoted question, most upvoted, Ugar Killick, “How can we trust the vaccine developed in a short timeframe? Will there be any potential risks to use vaccines too early?” So, I guess that is the balance of…

Professor David Heymann CBE

Yeah.

Emma Ross

…going quickly and just having to get it out there. Where do we draw the line and what are the risks and how are we going to manage those?

Professor David Heymann CBE

Well, in the vaccine development that’s going on, there can be no compromise for safety. These vaccines that are used in humans must be shown to be safe in humans, and that requires study, which several of the candidate vaccines have now gone through. They’ve shown to be safe, at least in the populations that are being studied, which are the fairly young populations. What they will do in the elderly has to be determined in the future, but, for now, we know that these vaccines that are in study to see if they’re effective are safe in humans. The next will be effectiveness, and, once they’ve been shown to be effective, they will likely then be licensed with an emergency-type licence, which will continue to require, in addition to use of that vaccine, study of the effects of that vaccine, how long that immunity lasts. It will also be important to see if there are any rare side effects that have developed because of that vaccine, and this can’t be done in rapid studies, this has to be in long-term studies, in what’s called post-licensing studies. So, it’s likely that, early on, these vaccines will have an emergency licence, will be used in populations, China’s already using one of their vaccines, for example, in their military. And then, by using them, this will not be a licence to just forget about them, but they will have to be studied after that, these same people, to see how long immunity lasts, and whether or not a booster dose is required, and whether or not there are any long-term, unexpected side effects. So, it’s a long process, but it’s likely that the first licensing of a vaccine will be an emergency licence, which will require continued study of the people who are vaccinated.

Emma Ross

And what are you feeling or seeing out there about the likely uptake of the vaccine in that circumstance when it’s an emergency licence, it’s not fully, you know, understood yet? Do you think that’s going to affect demand?

Professor David Heymann CBE

Well, you know, people should have enough information now, with all the communications that have been going on, to make their own risk assessment. And that vaccine will likely not be offered to everyone at first, it will be offered to those people who have the greatest risk of serious illness, should they be infected, and that would include the elderly, it would include those with comorbidities and, of course, health workers. So, then it’s up to the individual risk assessment of those persons, whether or not they will accept the vaccine, but, in that risk assessment, they also have to understand that, by becoming vaccinated, they protect others, as well as themselves. So, a health worker who doesn’t accept an influenza vaccine, for example, is putting themself at risk of not being protected against a new strain of influenza, but also is be – putting at risk patients who they’re dealing with, should they become infected and transmit to others.

So, it’s a complicated risk assessment, and it’s even more complicated because there are websites now, which are anti-vaccination, which are talking against vaccination. Those sites really have no evidence behind them to show that they are correct, and it’s very important that people, when they do their own risk assessments about whether to accept a vaccine or not, look at all sides, not just at what one side is saying, but what the communications coming from legitimate agencies are saying, as well as the side effects that might be occurring, should they become infected with the virus.

Emma Ross

Okay. There’s a question from Ashleigh Furlong from POLITICO, and it looks like it’s related to what I was discussing with Thomas earlier, about what can the industry do to stop hoarding. Do you think the pharmaceutical companies have a responsibility to ensure that, if they produce a successful vaccine, it isn’t just bought up by developed nations? Should they be ringfencing doses for lower income countries?

Professor David Heymann CBE

Well, I think that’s a question for Thomas to answer when he comes back on, but I can just say that there is 10% of vaccine production capacity of certain companies, such as GlaxoSmithKline, such as [inaudible – 30:11] in India, which is reserved – and this is pandemic influenza vaccine, which is reserved for WHO to distribute to those people at greatest risk in developing countries. So, there are models that have been developed at present, whether or not industry will continue to use that in the future will depend on how well the negotiations are going in the ACT Accelerator that WHO is leading on the access areas of all – of vaccines, of therapeutics, and of diagnostic tests. So, we’re still at the beginning, but I myself am optimistic that the models that have been done in the pa – that have been set up in the past to make sure that vaccines are available, will carry over to diagnostic tests and therapeutics, as well. But it will…

Emma Ross

And the allegations…

Professor David Heymann CBE

…take negotiation. It will take negotiation, Emma. It’s nothing that just is automatic, and the…

Emma Ross

Yeah.

Professor David Heymann CBE

…pharmaceutical companies will be – have to – would be willing to negotiate with the public sector, in addition to the countries which have already bought up their vaccines.

Emma Ross

And the COVAX facility, or any of the other initiatives that are trying to do the allocation job, are those allocations going to be enough to cover and to keep those countries protected? I guess from…

Professor David Heymann CBE

Well…

Emma Ross

…you know…

Professor David Heymann CBE

Yeah.

Emma Ross

…presuming that the vaccine is a protected vaccine.

Professor David Heymann CBE

Well, these are all really worthwhile and important innovations, but the limiting step of availability will, of course, be the production capacity for the vaccine. And if vaccines can’t be produced in a capacity, which can be more equally distributed around the world, then we’ll run into the same issue, that vaccines can’t be produced to meet the demand. This happened often with influenza vaccine, and what was realised, in the 1990s, was that the production capacity for influenza vaccines was limited to the market which was in industrialised countries. There have been a whole series of steps since then to increase production capacity of seasonal influenza vaccines, so that, when there is a pandemic, that production capacity can be switched to the pandemic vaccine. And that, we saw in the H1N1 pandemic in 2009, was effective in increasing production in a way that it was made more equitably distributed in countries, but it’s not yet a perfect situation, and we must continue to strive for that perfect situation, and whether or not industry will be a collaborator all along the way is something for Thomas to answer and not for me.

Emma Ross

Okay, so, we’ll keep that question, too. We hope we’ll get Thomas back, I’m not sure on the progress of that, but they’re working on it. In the meantime, we will go to Dina Mufti. “Do ionisers deactivate COVID-19 in the same way they deactivate other viruses, and are bronchodilators and steroid inhalers effective as a therapeutic?”

Professor David Heymann CBE

That I can’t answer because I’m in an Epidemiologist and not a Clinician. Thomas might be able to answer that, but it’s a question that I can’t answer at present. What I can say is that the research that’s going on is considering all of these different approaches because what Thomas said for therapeutics still holds true, that there’s a repurposing of all drugs that we know have a respiratory effect, including immune stimulus, and including bronchodilation, to see whether these do have an effect in treating infections. But the most important, remember, is to prevent infection, and that’s why the vaccine research is so important, and, at the same time, we need to be sure we can deal with patients today, and we do have some tools at our disposition, such as dexamethasone and remdesivir, when – which can make a difference, but which are not perfect.

I think what we need to be watching for is the studies on the antibody preparations, either the convalescent plasma which contains antibodies, which is being concentrated and used, or the monoclonal antibodies, because we saw that they are effective in Ebola. They have been shown to be effective in rabies and other diseases in the past, and hopefully, they will be a line that continues in research to develop goods that can be used in preventing infection, by giving antibody to people who have been exposed or could be exposed, and also, in early treatment.

Emma Ross

Last week, when we had Jeremy Farrar on talking about therapeutics, he mentioned that, going forward, there need – we need to rethink the funding partnership models for R&D and access, when it comes to these kind of diseases that are either orphaned or pandemic-prone. Do you agree that we need to rethink that and what…

Professor David Heymann CBE

I think…

Emma Ross

…kind of ideas might work?

Professor David Heymann CBE

Yeah, you know, what’s clear is, if public sector takes the risk, private sector will be more likely to develop the goods, and how do you take the risk in the public sector? You provide funding to the private sector to take the risk, and that’s what’s happening. It’s happened right along with the National Institutes of Health in the US, which has provided a lot of funding for preclinical research on fairness, therapeutics, and on vaccines, and it’s going on in other parts of the world, as well. We see now these new models, CEPI, which is taking public sector funding, putting it into the private sector to develop vaccines, or to – in the case of CEPI. And we see it for drugs in public private partnerships like the Medicines for Malaria Venture, which takes public sector money, takes private sector knowledge and data, and bases of their therapeutics that they’ve had in the past that show action against malaria, and together they’re working to develop new drugs. This is the future of public private partnerships, and how they can be best innovated remains to be seen, but certainly we have some good models now, and, going forward, we have to support these models because they will be finetuned and maybe new ideas will come along. But innovation is at the heart of all this, and this has occurred since the West African Ebola outbreaks, where CEPI has been developed specifically to create public private partnerships that will increase vaccine research and development and, at the same time, make access to those vaccines more equitable in a world where there’s great need for vaccines.

Emma Ross

What about – this is a shame that we haven’t got Thomas with us, ‘cause he definitely could answer this question. I wanted to talk about affordability, obviously that’s a major pillar of access, and what are your feelings on pricing for COVID products? Do you think there needs to be some discussion or some plan for pricing, or is that something that is really up to the industry to sort out for themselves? Price obviously is a major issue, and where do you think we are with this, or where do we have to be with this?

Professor David Heymann CBE

Yeah, well, it’s an interesting question, there are several models. I might start just with a story about a transfer of technology to develop a vaccine for sub-Saharan Africa, a meningitis vaccine, at 50 cents a dose. That technology transfer occurred to an industry in India, the vaccine was produced, licensed and available in Africa, and African countries didn’t buy it at 50 cents a dose, they waited until Gavi provided it to them. And so, maybe we’ve got to do more work on getting governments engaged in providing what they can provide to match what industrialised countries are providing. Instead of just having a culture of, “We will give to you,” we need a culture where those governments are engaged enough to do that.

There’s a story about The Global Fund on AIDS, TB and malaria, which is also an innovation, which is making drugs available to countries, and which is requiring matching funding, although it isn’t often enforced, but it will be more and more enforced, and that is a facility that gives funding and drugs to developing countries for AIDS, TB and malaria. This institution was begun in the 1990s, and it was begun because there was a justification as to why medicines were needed for certain infections. That came from the WHO macroeconomics commission and health, which concluded that good health had to be at the centre of rapid economic development, and, with those arguments and with many other arguments created within the G7 and other parts of the world, there was this facility set up, which finally was able to capture funding from industrialised countries to provide for drugs for developing countries. That was unheard of before the year 2000. Then, it was only vaccines that development agencies were willing to invest in, now it’s both vaccines and drugs. So, we have many models moving forward, and we have to make sure, and I know that Peter Sands at The Global Fund is thinking about models that can be used for making greater access to therapeutics for COVID when they become available.

Emma Ross

But what about industry pricing strategies? Do you think there’s any role for the industry to look at its – the way it prices medicines across countries or between countries for COVID?

Professor David Heymann CBE

Well, country – companies often have what they call tiered pricing, which is different prices for different societies. The negotiations that develop the tiered pricing are kept confidential, and I’m not clear exactly what they result in many times. But I think it’s a very big challenge for the private sector, which is run by the stock market, by investment of private persons into the stock market, to create vaccines at a price that would be acceptable in developing countries. But there are ways that that can be addressed. There’s the orphan drug laws that I think someone mentioned earlier, which makes it possible for industry to develop drugs and make them affordable, or more affordable, while making sure that they can gain a profit from other drugs, which are industrialised markets only and which are coming close to the period when their patent will be no longer valid, so that they can continue to make their profit from those drugs. So, there are many, many different mechanisms, Emma, I can’t speak about them all, but all of those have to be pulled together at some point to understand which is working better, whether it’s an orphan drugs law, or whether it’s a public private partnership, or a combination of advanced market commitments, which Gavi does, to pull vaccines through the development phase, a whole series of activities that need to be evaluated, and the final outcome will be, hopefully, better access to everyone.

Emma Ross

Okay, thank you. They’re still – our team are still working on getting Thomas back, so please hang in there, everybody, and apologies for this, but there is a question I know you can definitely handle, David. This is from William Crawley at the BBC. “If there are unpleasant side effects from a potentially successful vaccine, and younger people, who are generally less at risk, are reluctant to take a vaccine up, will that reduce the effectiveness of a wider vaccination programme for everybody else?”

Professor David Heymann CBE

Well, certainly it could. We also what – we all saw what happened with the Wakefield publication about the association that he had found, or he thought he had found, or he had fabricated, between autism and vaccines. This derailed vaccination programmes in UK and in many other parts of the world, and, as a result, there were outbreaks of measles that occurred because measles vaccine was no longer being accepted by the population, because the anti-vaccination movements had picked this information up and others. We saw the same thing happen with polio vaccination programmes derailed in Sub-Saharan Africa because of fears that were promulgated by the web that polio vaccine was not safe to use in young girls.

And so, we’ve seen all kinds of different rumours on the world wide web talking about vaccines, and hopefully, the public will be sensitised enough and have the right information to accept vaccination, if there is a COVID vaccine available, but there’s always a risk that there will be vocal people, respected people, who are saying that that vaccine is not safe, and that could derail programmes. That’s why it’s so important, Emma, that people understand how to do their own risk assessment to decide whether they’re at risk, and whether or not they need to take that vaccine. So, we can’t just put it in the government hands, although government does a good job. As we heard from David Salisbury, the government was able to very effectively encourage the use of HPV vaccine in the United Kingdom, through a series of information activities, which helped people understand the value of that vaccine. So, there’s hope, there are precedents set, and we just need to make sure that we make sure that the voice of reason and that the voice with scientific evidence is heard.

Emma Ross

How – I don’t know how much you’ve heard of what we’ve been discussing while you’ve been working on your tech issues. Is there anything you’ve heard that you particularly want to come in on before I pick?

Thomas Cueni

No, I – actually, I didn’t hear much. I just heard David’s concerns about the anti-vaccs movement, which I fully share, and that’s one of the reasons why one needs to move as fast as possible, but also, as slow as necessary with, you know, getting the vaccines to the people.

Emma Ross

I guess, I can go back to some of the questions we asked that we were waiting for you on. Ashleigh Furlough from POLITICO of “Whether the pharmaceutical industry thinks they have a responsibility to ringfence doses for lower income countries to stop richer countries buying up all the supply. Is that the industry’s problem or is that somebody else’s problem?”

Thomas Cueni

I think the industry’s risk is that it’s caught in the middle, and we do not want to run that risk, and that’s why we are fully committed to the COVAX facility. But, in terms, of course, of getting the support for the facility, you need solidarity from the richer countries willing to subsidise and cross subsidise the poorer countries. And what I see is encouraging signals from the European Union, from countries committed to the COVAX, but, when you look at the overall financial problem, and Jeremy Farrar addressed this already last week, right now, it looks as if a lot of conversation on the ACT Accelerators, and this goes for diagnostics, therapeutics, as well as vaccines, is stuck in the overseas development assistance pocket. And the overseas development assistance budgets are not increased right now, when you look at the financial constraints many governments have and, unless one can really escape that, unless one can make the macroeconomic argument, when you look at the impact of COVID-19 on the global economy, the cost of $375 billion a month, it should be possible to really make sure that, you know, countries and multilateral institutions, such as multilateral development funds, are willing to raise the money, which will allow the COVAX facility and the ACT Accelerators to do the job, for which they were set up, namely support people in low-income countries. And this is something, which is not something which the industry can do.

Emma Ross

Understood, thank you for that. We’re, unfortunately, running short on time, so I’m going to go back to some of the central questions that we didn’t have a chance to get to, and moving on from R&D and realistic timelines to access issues. And, first of all, of course, intellectual property is a sensitive topic, when it comes to talking about how to enhance access to medicine, and, of course, there’s a debate around how to keep companies motivated to invest in R&D, COVID products, while working out ways that people in low and middle-income countries can get affordable access to them.

There seems to be one of – at least one of the initiatives – access initiatives from the pandemic – for the pandemic that a slew of countries have signed up to, that has invited industry to participate in, that has seen some big industry players bristling, and that’s the C-TAP, which is the COVID-19 Technology and Access Pool, which supposedly creates a one-stop shop for technologies that are going to be useful by pooling scientific knowledge, data, and intellectual property rights, on a voluntary basis, to speed up development. And it’s touted as an opportunity for drug makers to change the conversation and work with governments that might otherwise take a more confrontational stance and pursue a compulsory licence, which is where they can just allow a generics manufacturer to copy a patented drug without the permission of the patent owner. Is the industry worried about compulsory licences being invoked or used during COVID, especially given that some countries have, recently, over the last few months, positioned themselves to be able to do that more easily?

Thomas Cueni

In my view, it’s a kind of forced debate. When you look at the Costa Rica proposal, which is behind the C-TAP, it, sort of, came after the ACT Accelerator. The ACT Accelerator, sort of, replaced discussions, because IP, in principle, has been an enabler. We wouldn’t be where we are, in terms of the clinical trials, whether it’s on remdesivir, dexamethasone, which is off patent and cheap, when you look at the chloroquine and hydroxychloroquine discussions, the anti-inflammatories, and many other leads, which are pursued, we wouldn’t be where we are if the industry wouldn’t have started from a flourishing innovation ecosystem.

Now, we also would have a much fiercer debate on IP if the industry or IP was seen as hindering access. What I see is the many companies have taken at risk investments, in terms of clinical trials, be it through the Solidarity, the WHO, be it with the FDA and Active, be it the RECOVERY trial in the UK and others, and in parallel, not knowing yet whether their treatments will work, are already ramping up production, have already reached out to partners for, for example, volunteer licensing, and we do have an established pool with the Medicines Patent Pool, which has widened their scope, during the pandemic, and, therefore, we have plenty of tools available, we have platforms available. And I think the simple reason why very few countries have signed up to the Solidarity Call for Action, and the pharma industry hasn’t signed up to that, is, one, it’s not necessary, but to – on the other hand, it is also seen as a potential distraction and undermining, because, at the end of the day, we need innovation and we need huge innovation for the next pandemic, and that will rely on IP.

And a lot of the problems, when you look at the C-TAP is, it goes way beyond what the MPP does, because the MPP looks at how can we make sure that people in developing countries also get the access? Now, I know quite many companies who have, for example, reached out to me and asked, “Can you open the doors with WHO, so that we can have early talks about prequalification, because [inaudible – 51:20] are serious?” or, “Can you open the doors,” for example, “to The Global Fund or UNICEF?” Because they don’t even want to sell their medicines, they’re willing – some of them are willing to donate, but all of them are concerned, “How can we make sure that our drugs, if they work, are not just getting to persons in rich countries?” Therefore, the IP right now is really not the hindrance to access.

Emma Ross

Okay. Well, that brings me onto another big issue in access and that’s affordability. I was just wondering, does the industry have a policy or a plan on affordable pricing for COVID products in low and middle-income countries? Or has that not…

Thomas Cueni

When you look…

Emma Ross

…been…?

Thomas Cueni

…at the industry commitments more, and be it from offside BMA, be it from our colleagues at the European Association, or at pharma in the US, all of us have a commitment to equitable, available, and affordable. But, of course, the affordable also means you do work with governments, you do work with donors and others, and you do need to get the distribution systems, that’s why we are part of the ACT Accelerator, where you do have the likes of UNICEF, you have the World Bank, you have The Global Fund, and Unitaid. And, when it comes to therapeutics, I expect that Global Fund and Unitaid will play a major role, same as diagnostics. In the vaccines, it will be CEPI playing a major role, and Gavi, in terms of this delivery, and we are working with them and also, companies are using the networks, because they are committed to equitable, available and affordable.

Emma Ross

Okay. I think we have time for one more question, and I wanted to bring back to last week, we were talking with Jeremy Farrar from the Wellcome Trust, and his parting shot last week was that there needs to be talk about a new partnership model for funding R&D and access to pharmaceuticals for these kind of situations. Do you agree that we need to rethink that? Kind of, in peacetime, after the pandemic is over, to, kind of, set us up for the next time. I mean, how well prepared were we to kick this all into action this time?

Thomas Cueni

Now, to be honest, I think, post-pandemic, there needs to be a proper analysis, what went right, what went wrong, where were we well-prepared and not, and that’s on the global level, as well as at national level. In my view, the industry, over the last 20 years, has already shown that it is willing to accept that the industry’s business model, which, overall, is working extremely well, which has given us so many innovative, transformative treatments for so many diseases, there are areas where we need new partnerships. The neglected tropical disease, for example, we launched a couple of weeks ago the AMR Action Fund, you know, the industry putting a billion dollars into a fund to fund clinical trials for antibiotics, where right now, everybody knows there’s no business modelling there, and, on that one, we say governments need to step up too, they need to be willing to do reforms.

In terms of pandemic preparedness, I do believe that there’s a role for the industry. We need to look, in terms of how can we strengthen antiviral research, because pandemics, most of times, come from viruses? We need to look into is there a possibility to create a [inaudible – 55:17] vaccine facility, or several of them. And we also, I think, need to address one element, which was, in my view, neglected in the global public health debate. When you look at the Pandemic Preparedness Council, chaired by Gro Brundtland and others, there was not a single private sector person in there. I do believe that the industry is open to enter into such conversation. We need to be openminded about what will be the outcome of that, but I also believe that, if we want to be better prepared, the private sector needs to be involved early on.

Emma Ross

Thank you for tuning in. This is an addendum to Wednesday’s Chatham House Weekly COVID-19 Pandemic Briefing on the topic of Pharmaceutical Industry Perspective. Our guest this week is Thomas Cueni, Director-General of the International Federation of Pharmaceutical Manufacturers & Associations, the IFPMA, who is joining us to discuss what’s going on with the development and access to test drugs, vaccines, and other pharmaceutical products for the coronavirus. We, unfortunately, had some technical issues on Wednesday, when Thomas dropped out of the conversation intermittently, so he very kindly agreed to return today to finish up some of the questions that we either rushed through or didn’t have a chance to get to. So, thank you, Thomas, for coming back.

Thomas Cueni

Thank you, Emma.

Emma Ross

We will dive right in. I wanted to get back to something we were discussing on Wednesday, right when we had the technical issues, which was on the R&D question on the timing of vaccines, and I had asked you about how realistic you thought it was to have a vaccine by Christmas and governments are starting to prioritise who they’re giving it to before Christmas, and whether all this talk is realistic or justified or hype, and what are the reasonable expectations. You had said that we would be lucky to have any vaccine at scale by next summer. So, I just wanted to go back to that, as to what do you think is realistic for the timing of vaccine doses at scale and what it really takes to get that.

Thomas Cueni

Very complex question and I don’t believe that anybody can give you an absolutely firm answer to that. We may have a vaccine approved by Christmas. It’s unlikely that we will have huge doses available by Christmas, and one of the reasons is that there’s so many unknowns, there’s so many variables, in terms of the testing. We do have encouraging results, from early clinical tests, but we do not know yet how it works when you expand the tests to large populations, therefore, the realistic assumption is we may have vaccines at scale available next spring or summer, maybe some earlier, but we need, I think, a lot of luck to get that far.

Emma Ross

And what exactly does it take? Does that mean by summer everybody who needs it will be able to get a vaccine, or only 10% of those who need it, and then it’ll roll out over a year? What is – what does it actually take to get it into the hands of the people who need it, once we’ve got a proven, approved vaccine?

Thomas Cueni

When you look at the number of doses needed, the world has a population of eight billion and it’s estimated, in order to create immunity, you would need to vaccinate about 80% of these. By now, most people expect that you will need at least two doses to create immunity you want, which means we are talking about a magnitude of 15 billion, up to 15 billion. The dose numbers available we talk about is more in the order of two billion plus next year, therefore it’s absolutely crystal clear that there will need to be decisions on who gets it first and how are the allocations made.

Emma Ross

And then, to get to the herd immunity numbers figure, what are we talking about then, another year before everyone else, the non-priorities get it?

Thomas Cueni

It depends on which of the vaccines work, how many vaccines we have, and I think we all keep our fingers crossed that we will not have one vaccine, that we may have four to five, seven or eight would be even better. Some of the technology platforms allow scaling up easier and faster and more flexible, but on the other hand, there is other technologies where no vaccine has been approved yet, where no at scale manufacture has been done yet, and you have a lot of technical issues, also in terms of manufacturing, such as, for example, the glass vials you need. To give you just one, you know, example, normally, traditionally, you have one vaccine dose per glass vial, that’s what you use when you get your flu shot. Here, because everybody knows that we will not have enough specialised glass vials, we are talking about 20 doses per vial, so that you can rationalise the glass. Now, how this will work out and which vaccine work, we, I think, have reason to be optimistic that the vaccine approaches, which are pursued, do work, but, for example, if it doesn’t, we may not have a vaccine next year.

Emma Ross

And do you agree with David, on Wednesday, he had said that production capacity is going to be the major bottleneck, do you agree with David that that is going to be the sticking point?

Thomas Cueni

Fully agree with him and there’s no way that you can escape some of the bottlenecks, which exist there. To give you another example, the highest dose, maxim dose, which has been produced historically was 250 million, and now we talk about five to ten billion, all the experts I talk to agree there’s no way that you can get this fixed within one year. You will need more than one year to reach these targets and, of course, the other question also is, you may run into problems because not everybody may want to get the vaccine.

Emma Ross

Sure, and do we really know how many people will need the vaccine?

Thomas Cueni

Terms of need, I think one of – and that’s reason for more optimism, when I look at the discussions we have in Geneva, for example, with CEPI, Gavi and WHO, pretty much everybody agrees that you need to provide the vaccines to the frontline healthcare workers first. That is a much smaller number. Worldwide, it’s about 1% of the global population. When you look at the elderly, you get the higher number, it’s about 8% of the global population above 65. In Japan, it’s more than 25%, therefore your different countries, different needs. And then, you also look at people with pre-existing morbidities, such as diabetes, hypertension, the vulnerable population, that’s why the discussions, for example, in terms of global allocation plans is that one hopes and aims to provide vaccines for 20% of the population in the first step.

Emma Ross

And that would cover those groups?

Thomas Cueni

That would cover those groups.

Emma Ross

Okay, great. I think that’s it on that question. Well, actually, one more thing, is it – you said it’s impossible to get past some of these bottlenecks, is it not possible to, now that we know that those are going to be bottlenecks, is there anything we can do, such as repurpose some factories, or just – like we do to expand capacity with the hospital beds, can we not, with a bit of foresight, just chuck up more capacity now, so that we don’t have a bottleneck?

Thomas Cueni

Emma, we do not talk about repurposing a few 1,000s or a few 10,000s hospital beds, we are talking about setting up new vaccine manufacturing plants, which normally takes five years to get a new plant. Here, we talk about getting this fixed within months, and global vaccine capacity has been estimated at five billion right now, but that is for polio, for measles, for yellow fever, for flu, for whatever, and here we talk about the need of maybe up to 15 billion, and, by the way, something which I think has been ignored to some extent is, we do not yet – we will know whether the vaccine is safe. We will have some data about the efficacy, but we do not know how long, will it last. It may be that the immunity lasts for a year, maybe for six months, maybe for two years, that would mean if you would need to vaccinate again, like a seasonal flu shot, and, of course, you can imagine what’s that impact on capacity needs.

Emma Ross

Thank you. I want to move onto the access question and one thing that we didn’t quite get to the bottom of on Wednesday and that is the issue of poorer countries and low and middle income countries that may not be able to buy the vaccine, or get enough doses through the COVAX facility. Positioning themselves at the moment to pave the way, so that they could invoke what’s called compulsory licences, which is when they allow generics’ manufacturers in their countries to start copying, making generic versions of vaccines, without the permission of big pharma patent holders and that they might be allowed to do that. Is the industry worried about those manoeuvres going on right now and talk of that happening?

Thomas Cueni

We are concerned about any talk, which undermines intellectual property, because, at the end of the day, the ability to respond so fast, so quickly to COVID-19 with therapeutics, with vaccine development too, is a reflection of our business model of the competitive research, which is rewarded by – through IPs, from ab IP, and the successful research therefore, is protected. Now, talk about compulsory licensing in vaccines shows a bit of an ignorance about the nature and the challenges of vaccine manufacturing. To the best of my knowledge, we have done quite a bit of research, there hasn’t been a compulsory licence on a vaccine in the past, which means historically, and we really were digging deep, simple reason is, it is much more about knowhow, you cannot steal that. It is about the quality assurance, it is about skilled workers on the finishing lines, on the manufacturing lines.

To give you one example of the complexity of vaccines, per one person in a therapeutic plant looking after quality assurance, in a vaccine plant, you have 50 person. Therefore, the importance of quality assurance, and the reason is fairly straightforward, because a medicine you apply on a sick person potentially fighting for his or her life, and therefore, you are willing to accept risks in the balance for benefit versus risk. A vaccine is used on healthy populations therefore, you can’t run any risk. You don’t want to cut corners and this is knowledge, which has built up over decades, and that’s why the compulsory licensing issue is talked about in the vacc sense, it’s much more relevant in the treatment area, but in vaccines, it hasn’t meet government policy, it wouldn’t work.

Emma Ross

But what’s the danger that they might invoke it for drugs? I agree, obviously, it’s more useful with drugs and it has been used for HIV drugs and they don’t mean they can just reverse engineer the drug, can’t they? They can just make it, they don’t need the technology transfer, so is it a danger for COVID drugs?

Thomas Cueni

For drugs, it has been used in the past and, of course, we are concerned because the industry’s business model, our innovation system, depends on IP. I’m, honestly, not that much worried about it and one reason is, the industry and generally for our sector last week, I think is pretty much doing right now what everyone would hope the industry to do, which means working 24/7, scaling up manufacturing capacity, reaching out for voluntary licences, establishing large networks. When you look at drugs, there’s also a difference between chemical molecules. Small chemical molecules are generally easier to copy, they’re generally easier to reverse engineer. When it comes to biologics, it is challenging and also, with chemical molecules, it depends on the complexity of production. I’ve heard somebody say, even if one would try to impose a compulsory licence, you would take 18 months before you have the first shipment, that does not really help, because I think all of us hope that within 18 months, we can travel again, we are – we do have some vaccines. We hopefully, also have more progress in treatments.

Emma Ross

And when you say voluntary licensing, you had said on Wednesday that the industry has already started reaching out for voluntary licence to partners for voluntary licensing agreements, can you explain what’s the difference between a compulsory licence and a voluntary licence and what talks are going on? I mean, how – obviously, with voluntary licensing, it depends how many countries are covered and what exactly it is, as to the depth of that commitment. What exactly is going on at the moment with that?

Thomas Cueni

A compulsory licence would normally be for a country, which means single country imposes a compulsory licence and if then the manufacturer would export it to another country where you have a patent, you could sue as manufacture infringement. That’s why, generally, a voluntary licensing approach, I think, is the far preferred approach for governments, as well as for manufacturers, because it’s based on a company picking their partners, trusting that they can do and provide the manufacturer with the same quality, offering them technology assistance and technology transfer. That’s what we have seen and there are two models of that. One is, companies do it bilaterally and we have seen this, for example, with Remdesivir, or the other example, which has been used widely on HIV/AIDS drugs, is through the Medicines Patent Pool.

Medicines Patent Pool is a platform, which has been established in Geneva, especially for HIV/AIDS, for malaria and for TB, widely used in HIV/AIDS, but, again, it’s based on voluntary, and the Board of the Medicines Patent Pool has decided, during the duration of the pandemic, to expand its scope, so that all COVID-19 therapies would be covered and that’s something, which we from the industry, we endorse a voluntary approach. And the third element, of course, is I see companies really scaling up their own production capacity.

Emma Ross

So, does that mean that any country, through the Medicines Patent Pool, would be allowed to make COVID drugs under licence, or, excuse my ignorance of how the mechanics of how that works?

Thomas Cueni

It’s a good question. It depends on the contract. It depends on the contract, because the contract between the MPP and the company will cover what’s the geographic scope, which countries are covered, which are not.

Emma Ross

And do we know what that’s going to be for COVID, has that been sorted out yet? Is there anything you can tell us?

Thomas Cueni

Actually, there are examples, which have already been done and they’re widely communicated and some of them went way beyond traditional MPP countries. It’s like when you look at, for example, the Global Vaccines Alliance, Gavi, they normally are there for 73 countries and it’s really 73 low and middle-income countries, it’s the poorer countries. When we – when you look, for example, what we discuss right now within this COVAX facility, which is the collaboration of CEPI, Gavi, and WHO, for vaccines’ development, the scope is much broader and actually one of the objectives of Gavi is really, really to go beyond their traditions, 73, and actually they do need high income countries paying into Gavi because they need cost subsidisation for the poorer countries.

Emma Ross

Okay, great. My last question, before I go onto audience questions, is about pricing. We did get to this on Wednesday, but we didn’t quite finish this, and what I was asking is, does the industry have a policy on pricing of how much they’re going to charge? So, separate to going through the COVAX facility, so for the other of, outside of that, have they decided, are there any discussions? I guess, yesterday we had the news of the first price that had been stated for the AstraZeneca vaccine, the deal they did with the US for $40 per person, of kind of setting a benchmark for that. But, obviously, that’s going to be too expensive for a lot of low-and middle-income countries, but what can you tell us about what the intention of the industry is on pricing, as pricing is a major pillar of access?

Thomas Cueni

I need to correct you, Emma, it wasn’t the first one.

Emma Ross

Oh, please do. Please do.

Thomas Cueni

Two days before, you had the US signing a contract with Pfizer BioNTech for 100 million doses.

Emma Ross

Oh, sorry, Pfizer, sorry, Pfizer, not AstraZeneca.

Thomas Cueni

Yeah, AstraZeneca was yesterday with the US and AstraZeneca had different…

Emma Ross

A different deal.

Thomas Cueni

Therefore, you will – from an industry point of view, there, I have to admit, I’m somewhat restrained. If we would discuss pricing approaches collectively, you know, I, as DG of the Global Industry Association, my legal counsel would get a heart attack and I might end up in jail. There are really strict limits, under which we can have discussions. What we can is policy approaches. When you look at the industry commitment, and we had many CEOs from companies joining us in global media things, all of them are committed to the notions of equitable, available, affordable. Now, when you look at affordable, on the one hand affordable is in the eye of the beholder, therefore, there may be different views from different people. On the other hand, affordable is different in Sudan, for example, versus the US, or even in Switzerland versus Bulgaria. Therefore, I, personally, believe that we will see different approaches and in order to make the vaccines or treatments available, is absolutely crucial that you do get some tiered pricing.

Emma Ross

Sure.

Thomas Cueni

However, in some countries, the poor people, they can’t afford even 50 cents, therefore, they will rely on the…

Emma Ross

And has the industry committed to COVID products at no profit overall? I understand the tiered pricing and the rich countries subsidising the poor, but, overall, have – has the industry or any companies committed that they’ll do this at no profit, no – or kind of breakeven?

Thomas Cueni

Some companies did commit. Some companies did commit at no profit. Again, collectively, as industry, we couldn’t. We simply could not. However, pretty much every company committed to the notion of affordable, and pretty much every commit – company committed to socially responsible. And it also, you know, the price will depend, for example, on – some companies, they went for risk sharing agreements, where the US Government copayed for the development cost, where some governments shared the risk of building up huge manufacturing capacities, at the time when you have no clue whether your vaccine will ever reach the market. Other companies said we don’t want to have money from the governments. It will depend on the technology you use therefore we will see differences. We will also see differences because some vaccines will be 50% efficacious, and that’s, by the way, the target of the FDA. Others, hopefully, will show 80% efficacy. We may see differences, but the cost award, I would expect at least the companies, which 100% within IFPMA, which are the big multinational corporations, they all committed to the notion of affordability.

Emma Ross

Okay, great. I’m going to go to a few audience questions, and I’m going to start with a question from Charles Clift, “Many governments like the UK are already making bilateral deals with different manufacturer – vaccine producers, in the hope that one or more will be successful. What does this mean for the success of the COVAX facility?”

Thomas Cueni

It is a challenge and, let’s face it, it is challenging, because there’s a race from governments to buy up capacity, to sign deals left and right, and with all the rhetoric, which we have heard, that the call to action from global leaders, the same global leaders, and it’s not just the US, they do sign bilateral deals big way. Having said that, and we need to be realistic, no government, whether it’s Boris Johnson, or Emmanuel Macron, or Chancellor Merkel, can ignore what their own citizens want, as fast as possible access to vaccine. Having said that, I do sense a strong feeling we cannot afford to go back to what we had when we had the swine flu, H1N1, where the rich countries bought up all the vaccines, all the antivirals, and the poor ones were left shouting and screaming.

We have learnt from that, for example, in terms of the C – of the pandemic flu preparation. We have an agreement between vaccine manufacturers and WHO for stockpiling, to put some capacity to WHO, and COVAX does this now on a much larger scale. When you look at the COVAX ambition, they tried to have one to two billion doses available next year, and they really – it’s meant that is based on an allocation system where WHO, and I already mentioned it, agreed, you want to vaccinate the healthcare workers first. You want to treat the vulnerable, and I think I’m cautiously optimistic it will work, but the crunch of it is, in order to do that and to deliver, CEPI and Gavi will need money from the rich countries, so that you can get the doses to the poor countries.

Emma Ross

Sure. Okay, this is a question from Mita du le Parla, and she says, “It has become clear that public/private partnerships have been exalted during the pandemic, how much of a step change do you think this will have on collaboration models adopted by the industry?”

Thomas Cueni

I’ve seen movements in the past. The industry, 20 years ago, would have said nothing but the industry’s business model works. We have realised, for example, in the collaboration with the Global Fund, in the collaboration on neglected tropical disease, that there are areas where public/private partnership are really the way forward, and I would expect that post-pandemic we will have a day of reckoning where we will sit down. I strongly believe that the industry’s business model, for most of the medical challenges is the best one to work. But in terms of pandemic preparedness, all of us have to admit that one could have done better, in terms of investments in antiviral research, in terms of investing in, for example, [inaudible – 81:50] vaccine plant, and I do agree with Jeremy Farrar who said that “One really needs to look at are we better prepared?” And one of the elements, and there I’m pretty assertive, historically, the industry was left outside the door, when you had these discussions, the dignity discussions on pandemic preparedness does not…

Emma Ross

Sure. We went over that last time. We went over that last. So, I don’t want to – and just to squeeze in one more question. Sorry to cut you off there, but we’ve gone over already, but this is from Dina Mufti and this is one that was asked on Wednesday, while you weren’t around, so I’d love to get back to it, “Are bronchodilators and steroid inhalers showing to be effective as a treatment?”

Thomas Cueni

I don’t know.

Emma Ross

Okay, great. Well, then, I can squeeze in one more, and that is, “Can you talk about any issues that have hampered efforts to repurpose medicines for COVID-19, or to get candidate drugs through the necessary clinical trials?” And that’s from Ian Sample at The Guardian.

Thomas Cueni

I try to think about it, but, by and large, we have seen an unprecedented collaboration, and I’ve never heard so much praise from industry leaders, for example, for regulatory agencies, because normally, there’s tension because you feel that they try to hold you back, to delay. But whether it’s the FDA, whether it’s EMA, whether it’s ICMRA, that’s the coalition of the leading medicines regulatory agencies, whether it’s WHO, everybody is keen to work together. But one element that I think is crucial, and that’s where the industry is firm, you really need to do proper clinical trials. You need to await the results, and one of – honest, one of, in my view, shortcomings I’ve seen over the last few months, the rush to publication. And it’s not the headlines in the daily newspapers, it’s in publication in, you know, the leading journals, such as Lancet, and then, oh my God, within two or three weeks, you have to retract that. I think that is not good and one really needs to do one step after the other and wait until you have proper evaluation of the results.

Emma Ross

Well, that gives us a very good segue into next week’s discussion, which will be with Richard Horton, the editor of The Lancet, so thank you for that segue. And we have run out of time again, but I think we got through quite a few of the remaining questions and thank you so much for explaining that. To do the makeup, the makeup sessions, so, it blended while you were out there.

Thomas Cueni

Yeah, we didn’t have any technical hitch this time.

Emma Ross

No, perfect.

Thomas Cueni

And this audience, thank you.

Emma Ross

Okay.

Thomas Cueni

All the best.

Emma Ross

Well, thank you very much.

Thomas Cueni

Thank you.

Emma Ross

And that’s it, then. Thank you. Bye.

Thomas Cueni

Bye.

End of webinar and start of Q&A.

Emma Ross

Good morning, and thank you for tuning in. This is an addendum to Wednesday’s Chatham House weekly COVID-19 pandemic briefing on the topic of pharmaceutical industry perspective. Our guest this week is Thomas Cueni, Director-General of the International Federation of Pharmaceutical Manufacturers and Associations, the IFPMA, who is joining us to discuss what’s going on with the development and access to tests, drugs, vaccines, and other pharmaceutical products for the coronavirus. We unfortunately had some technical issues on Wednesday when Thomas dropped out of the conversation intermittently, so he very kindly agreed to return today to finish up some of the questions that we either rushed through or didn’t have a chance to get to. So, thank you, Thomas, for coming back.

Thomas Cueni

Thank you, Emma.

Emma Ross

We will dive right in. I wanted to get back to something we were discussing on Wednesday, right when we had the technical issues, which was on the R&D question on the timing of vaccines, and I had asked you about how realistic you thought it was to have a vaccine by Christmas and governments are starting to prioritise who they’re giving it to before Christmas, and whether all this talk is realistic or justified or hype, and what are the reasonable expectations. You had said that we would be lucky to have any vaccine at scale by next summer. So, I just wanted to go back to that, as to what do you think is realistic for the timing of vaccine doses at scale and what it really takes to get that.

Thomas Cueni

Very complex question and I don’t believe that anybody can give you an absolutely firm answer to that. We may have a vaccine approved by Christmas. It’s unlikely that we will have huge doses available by Christmas, and one of the reasons is that there’s so many unknowns, there’s so many variables, in terms of the testing. We do have encouraging results, from early clinical tests, but we do not know yet how it works when you expand the tests to large populations, therefore, the realistic assumption is we may have vaccines at scale available next spring or summer, maybe some earlier, but we need, I think, a lot of luck to get that far.

Emma Ross

And what exactly does it take? Does that mean by summer everybody who needs it will be able to get a vaccine, or only 10% of those who need it, and then it’ll roll out over a year? What is – what does it actually take to get it into the hands of the people who need it, once we’ve got a proven, approved vaccine?

Thomas Cueni

When you look at the number of doses needed, the world has a population of eight billion and it’s estimated, in order to create immunity, you would need to vaccinate about 80% of these. By now, most people expect that you will need at least two doses to create immunity you want, which means we are talking about a magnitude of 15 billion, up to 15 billion. The dose numbers available we talk about is more in the order of two billion plus next year, therefore it’s absolutely crystal clear that there will need to be decisions on who gets it first and how are the allocations made.

Emma Ross

And then, to get to the herd immunity numbers figure, what are we talking about then, another year before everyone else, the non-priorities get it?

Thomas Cueni

It depends on which of the vaccines work, how many vaccines we have, and I think we all keep our fingers crossed that we will not have one vaccine, that we may have four to five, seven or eight would be even better. Some of the technology platforms allow scaling up easier and faster and more flexible, but on the other hand, there is other technologies where no vaccine has been approved yet, where no at scale manufacture has been done yet, and you have a lot of technical issues, also in terms of manufacturing, such as, for example, the glass vials you need. To give you just one, you know, example, normally, traditionally, you have one vaccine dose per glass vial, that’s what you use when you get your flu shot. Here, because everybody knows that we will not have enough specialised glass vials, we are talking about 20 doses per vial, so that you can rationalise the glass. Now, how this will work out and which vaccine work, we, I think, have reason to be optimistic that the vaccine approaches, which are pursued, do work, but, for example, if it doesn’t, we may not have a vaccine next year.

Emma Ross

And do you agree with David, on Wednesday, he had said that production capacity is going to be the major bottleneck, do you agree with David that that is going to be the sticking point?

Thomas Cueni

Fully agree with him and there’s no way that you can escape some of the bottlenecks, which exist there. To give you another example, the highest dose, maxim dose, which has been produced historically was 250 million, and now we talk about five to ten billion, all the experts I talk to agree there’s no way that you can get this fixed within one year. You will need more than one year to reach these targets and, of course, the other question also is, you may run into problems because not everybody may want to get the vaccine.

Emma Ross

Sure, and do we really know how many people will need the vaccine?

Thomas Cueni

Terms of need, I think one of – and that’s reason for more optimism, when I look at the discussions we have in Geneva, for example, with CEPI, Gavi and WHO, pretty much everybody agrees that you need to provide the vaccines to the frontline healthcare workers first. That is a much smaller number. Worldwide, it’s about 1% of the global population. When you look at the elderly, you get the higher number, it’s about 8% of the global population above 65. In Japan, it’s more than 25%, therefore your different countries, different needs. And then, you also look at people with pre-existing morbidities, such as diabetes, hypertension, the vulnerable population, that’s why the discussions, for example, in terms of global allocation plans is that one hopes and aims to provide vaccines for 20% of the population in the first step.

Emma Ross

And that would cover those groups?

Thomas Cueni

That would cover those groups.

Emma Ross

Okay, great. I think that’s it on that question. Well, actually, one more thing, is it – you said it’s impossible to get past some of these bottlenecks, is it not possible to, now that we know that those are going to be bottlenecks, is there anything we can do, such as repurpose some factories, or just – like we do to expand capacity with the hospital beds, can we not, with a bit of foresight, just chuck up more capacity now, so that we don’t have a bottleneck?

Thomas Cueni

Emma, we do not talk about repurposing a few 1,000s or a few 10,000s hospital beds, we are talking about setting up new vaccine manufacturing plants, which normally takes five years to get a new plant. Here, we talk about getting this fixed within months, and global vaccine capacity has been estimated at five billion right now, but that is for polio, for measles, for yellow fever, for flu, for whatever, and here we talk about the need of maybe up to 15 billion, and, by the way, something which I think has been ignored to some extent is, we do not yet – we will know whether the vaccine is safe. We will have some data about the efficacy, but we do not know how long, will it last. It may be that the immunity lasts for a year, maybe for six months, maybe for two years, that would mean if you would need to vaccinate again, like a seasonal flu shot, and, of course, you can imagine what’s that impact on capacity needs.

Emma Ross

Thank you. I want to move onto the access question and one thing that we didn’t quite get to the bottom of on Wednesday and that is the issue of poorer countries and low and middle income countries that may not be able to buy the vaccine, or get enough doses through the COVAX facility. Positioning themselves at the moment to pave the way, so that they could invoke what’s called compulsory licences, which is when they allow generics’ manufacturers in their countries to start copying, making generic versions of vaccines, without the permission of big pharma patent holders and that they might be allowed to do that. Is the industry worried about those manoeuvres going on right now and talk of that happening?

Thomas Cueni

We are concerned about any talk, which undermines intellectual property, because, at the end of the day, the ability to respond so fast, so quickly to COVID-19 with therapeutics, with vaccine development too, is a reflection of our business model of the competitive research, which is rewarded by – through IPs, from ab IP, and the successful research therefore, is protected. Now, talk about compulsory licensing in vaccines shows a bit of an ignorance about the nature and the challenges of vaccine manufacturing. To the best of my knowledge, we have done quite a bit of research, there hasn’t been a compulsory licence on a vaccine in the past, which means historically, and we really were digging deep, simple reason is, it is much more about knowhow, you cannot steal that. It is about the quality assurance, it is about skilled workers on the finishing lines, on the manufacturing lines.

To give you one example of the complexity of vaccines, per one person in a therapeutic plant looking after quality assurance, in a vaccine plant, you have 50 person. Therefore, the importance of quality assurance, and the reason is fairly straightforward, because a medicine you apply on a sick person potentially fighting for his or her life, and therefore, you are willing to accept risks in the balance for benefit versus risk. A vaccine is used on healthy populations therefore, you can’t run any risk. You don’t want to cut corners and this is knowledge, which has built up over decades, and that’s why the compulsory licensing issue is talked about in the vacc sense, it’s much more relevant in the treatment area, but in vaccines, it hasn’t meet government policy, it wouldn’t work.

Emma Ross

But what’s the danger that they might invoke it for drugs? I agree, obviously, it’s more useful with drugs and it has been used for HIV drugs and they don’t mean they can just reverse engineer the drug, can’t they? They can just make it, they don’t need the technology transfer, so is it a danger for COVID drugs?

Thomas Cueni

For drugs, it has been used in the past and, of course, we are concerned because the industry’s business model, our innovation system, depends on IP. I’m, honestly, not that much worried about it and one reason is, the industry and generally for our sector last week, I think is pretty much doing right now what everyone would hope the industry to do, which means working 24/7, scaling up manufacturing capacity, reaching out for voluntary licences, establishing large networks. When you look at drugs, there’s also a difference between chemical molecules. Small chemical molecules are generally easier to copy, they’re generally easier to reverse engineer. When it comes to biologics, it is challenging and also, with chemical molecules, it depends on the complexity of production. I’ve heard somebody say, even if one would try to impose a compulsory licence, you would take 18 months before you have the first shipment, that does not really help, because I think all of us hope that within 18 months, we can travel again, we are – we do have some vaccines. We hopefully, also have more progress in treatments.

Emma Ross

And when you say voluntary licensing, you had said on Wednesday that the industry has already started reaching out for voluntary licence to partners for voluntary licensing agreements, can you explain what’s the difference between a compulsory licence and a voluntary licence and what talks are going on? I mean, how – obviously, with voluntary licensing, it depends how many countries are covered and what exactly it is, as to the depth of that commitment. What exactly is going on at the moment with that?

Thomas Cueni

A compulsory licence would normally be for a country, which means single country imposes a compulsory licence and if then the manufacturer would export it to another country where you have a patent, you could sue as manufacture infringement. That’s why, generally, a voluntary licensing approach, I think, is the far preferred approach for governments, as well as for manufacturers, because it’s based on a company picking their partners, trusting that they can do and provide the manufacturer with the same quality, offering them technology assistance and technology transfer. That’s what we have seen and there are two models of that. One is, companies do it bilaterally and we have seen this, for example, with Remdesivir, or the other example, which has been used widely on HIV/AIDS drugs, is through the Medicines Patent Pool.

Medicines Patent Pool is a platform, which has been established in Geneva, especially for HIV/AIDS, for malaria and for TB, widely used in HIV/AIDS, but, again, it’s based on voluntary, and the Board of the Medicines Patent Pool has decided, during the duration of the pandemic, to expand its scope, so that all COVID-19 therapies would be covered and that’s something, which we from the industry, we endorse a voluntary approach. And the third element, of course, is I see companies really scaling up their own production capacity.

Emma Ross

So, does that mean that any country, through the Medicines Patent Pool, would be allowed to make COVID drugs under licence, or, excuse my ignorance of how the mechanics of how that works?

Thomas Cueni

It’s a good question. It depends on the contract. It depends on the contract, because the contract between the MPP and the company will cover what’s the geographic scope, which countries are covered, which are not.

Emma Ross

And do we know what that’s going to be for COVID, has that been sorted out yet? Is there anything you can tell us?

Thomas Cueni

Actually, there are examples, which have already been done and they’re widely communicated and some of them went way beyond traditional MPP countries. It’s like when you look at, for example, the Global Vaccines Alliance, Gavi, they normally are there for 73 countries and it’s really 73 low and middle income countries, it’s the poorer countries. When we – when you look, for example, what we discuss right now within this COVAX facility, which is the collaboration of CEPI, Gavi, and WHO, for vaccines’ development, the scope is much broader and actually one of the objectives of Gavi is really, really to go beyond their traditions, 73„ and actually they do need high income countries paying into Gavi because they need cost subsidisation for the poorer countries.

Emma Ross

Okay, great. My last question, before I go onto audience questions, is about pricing. We did get to this on Wednesday, but we didn’t quite finish this, and what I was asking is, does the industry have a policy on pricing of how much they’re going to charge? So, separate to going through the COVAX facility, so for the other of, outside of that, have they decided, are there any discussions? I guess, yesterday we had the news of the first price that had been stated for the AstraZeneca vaccine, the deal they did with the US for $40 per person, of kind of setting a benchmark for that. But, obviously, that’s going to be too expensive for a lot of low-and middle-income countries, but what can you tell us about what the intention of the industry is on pricing, as pricing is a major pillar of access?

Thomas Cueni

I need to correct you, Emma, it wasn’t the first one.

Emma Ross

Oh, please do. Please do.

Thomas Cueni

Two days before, you had the US signing a contract with Pfizer BioNTech for 100 million doses.

Emma Ross

Oh, sorry, Pfizer, sorry, Pfizer, not AstraZeneca.

Thomas Cueni

Yeah, AstraZeneca was yesterday with the US and AstraZeneca had different…

Emma Ross

A different deal.

Thomas Cueni

Therefore, you will – from an industry point of view, there, I have to admit, I’m somewhat restrained. If we would discuss pricing approaches collectively, you know, I, as DG of the Global Industry Association, my legal counsel would get a heart attack and I might end up in jail. There are really strict limits, under which we can have discussions. What we can is policy approaches. When you look at the industry commitment, and we had many CEOs from companies joining us in global media things, all of them are committed to the notions of equitable, available, affordable. Now, when you look at affordable, on the one hand affordable is in the eye of the beholder, therefore, there may be different views from different people. On the other hand, affordable is different in Sudan, for example, versus the US, or even in Switzerland versus Bulgaria. Therefore, I, personally, believe that we will see different approaches and in order to make the vaccines or treatments available, is absolutely crucial that you do get some tiered pricing.

Emma Ross

Sure.

Thomas Cueni

However, in some countries, the poor people, they can’t afford even 50 cents, therefore, they will rely on the…

Emma Ross

And has the industry committed to COVID products at no profit overall? I understand the tiered pricing and the rich countries subsidising the poor, but, overall, have – has the industry or any companies committed that they’ll do this at no profit, no – or kind of breakeven?

Thomas Cueni

Some companies did commit. Some companies did commit at no profit. Again, collectively, as industry, we couldn’t. We simply could not. However, pretty much every company committed to the notion of affordable, and pretty much every commit – company committed to socially responsible. And it also, you know, the price will depend, for example, on – some companies, they went for risk sharing agreements, where the US Government copayed for the development cost, where some governments shared the risk of building up huge manufacturing capacities, at the time when you have no clue whether your vaccine will ever reach the market. Other companies said we don’t want to have money from the governments. It will depend on the technology you use, therefore, we will see differences. We will also see differences because some vaccines will be 50% efficacious, and that’s, by the way, the target of the FDA. Others, hopefully, will show 80% efficacy. We may see differences, but the cost award, I would expect at least the companies, which 100% within IFPMA, which are the big multinational corporations, they all committed to the notion of affordability.

Emma Ross

Okay, great. I’m going to go to a few audience questions, and I’m going to start with a question from Charles Clift, “Many governments like the UK are already making bilateral deals with different manufacturer – vaccine producers, in the hope that one or more will be successful. What does this mean for the success of the COVAX facility?”

Thomas Cueni

It is a challenge and, let’s face it, it is challenging, because there’s a race from governments to buy up capacity, to sign deals left and right, and with all the rhetoric, which we have heard, that the call to action from global leaders, the same global leaders, and it’s not just the US, they do sign bilateral deals big way. Having said that, and we need to be realistic, no government, whether it’s Boris Johnson, or Emmanuel Macron, or Chancellor Merkel, can ignore what their own citizens want, as fast as possible access to vaccine. Having said that, I do sense a strong feeling we cannot afford to go back to what we had when we had the swine flu, H1N1, where the rich countries bought up all the vaccines, all the antivirals, and the poor ones were left shouting and screaming.

We have learnt from that, for example, in terms of the C – of the pandemic flu preparation. We have an agreement between vaccine manufacturers and WHO for stockpiling, to put some capacity to WHO, and COVAX does this now on a much larger scale. When you look at the COVAX ambition, they tried to have one to two billion doses available next year, and they really – it’s meant that is based on an allocation system where WHO, and I already mentioned it, agreed, you want to vaccinate the healthcare workers first. You want to treat the vulnerable, and I think I’m cautiously optimistic it will work, but the crunch of it is, in order to do that and to deliver, CEPI and Gavi will need money from the rich countries, so that you can get the doses to the poor countries.

Emma Ross

Sure. Okay, this is a question from Mita du le Parla, and she says, “It has become clear that public/private partnerships have been exalted during the pandemic, how much of a step change do you think this will have on collaboration models adopted by the industry?”

Thomas Cueni

I’ve seen movements in the past. The industry, 20 years ago, would have said nothing but the industry’s business model works. We have realised, for example, in the collaboration with the Global Fund, in the collaboration on neglected tropical disease, that there are areas where public/private partnership are really the way forward, and I would expect that post-pandemic we will have a day of reckoning where we will sit down. I strongly believe that the industry’s business model, for most of the medical challenges is the best one to work. But in terms of pandemic preparedness, all of us have to admit that one could have done better, in terms of investments in antiviral research, in terms of investing in, for example, [inaudible – 25:57] vaccine plant, and I do agree with Jeremy Farrar who said that “One really needs to look at are we better prepared?” And one of the elements, and there I’m pretty assertive, historically, the industry was left outside the door, when you had these discussions, the dignity discussions on pandemic preparedness does not…

Emma Ross

Sure. We went over that last time. We went over that last. So, I don’t want to – and just to squeeze in one more question. Sorry to cut you off there, but we’ve gone over already, but this is from Dina Mufti and this is one that was asked on Wednesday, while you weren’t around, so I’d love to get back to it, “Are bronchodilators and steroid inhalers showing to be effective as a treatment?”

Thomas Cueni

I don’t know.

Emma Ross

Okay, great. Well, then, I can squeeze in one more, and that is, “Can you talk about any issues that have hampered efforts to repurpose medicines for COVID-19, or to get candidate drugs through the necessary clinical trials?” And that’s from Ian Sample at The Guardian.

Thomas Cueni

I try to think about it, but, by and large, we have seen an unprecedented collaboration, and I’ve never heard so much praise from industry leaders, for example, for regulatory agencies, because normally, there’s tension because you feel that they try to hold you back, to delay. But whether it’s the FDA, whether it’s EMA, whether it’s ICMRA, that’s the coalition of the leading medicines regulatory agencies, whether it’s WHO, everybody is keen to work together. But one element that I think is crucial, and that’s where the industry is firm, you really need to do proper clinical trials. You need to await the results, and one of – honest, one of, in my view, shortcomings I’ve seen over the last few months, the rush to publication. And it’s not the headlines in the daily newspapers, it’s in publication in, you know, the leading journals, such as Lancet, and then, oh my God, within two or three weeks, you have to retract that. I think that is not good and one really needs to do one step after the other and wait until you have proper evaluation of the results.

Emma Ross

Well, that gives us a very good segue into next week’s discussion, which will be with Richard Horton, the editor of The Lancet, so thank you for that segue. And we have run out of time again, but I think we got through quite a few of the remaining questions and thank you so much for explaining that. To do the makeup, the makeup sessions, so, it blended while you were out there.

Thomas Cueni

Yeah, we didn’t have any technical hitch this time.

Emma Ross

No, perfect.

Thomas Cueni

And this audience, thank you.

Emma Ross

Okay.

Thomas Cueni

All the best.

Emma Ross

Well, thank you very much.

Thomas Cueni

Thank you.

Emma Ross

And that’s it, then. Thank you. Bye.

Thomas Cueni

Bye.