Sir Andrew Dillon 

Sir Andrew Dillon: So there are any number of lessons that you could list out from an organization like NICE, it’s been operating for over 2 decades now, but these are 8 that I thought, going back to the points I just made, have broad application across the experience that NICE has had in its programs for the NHS and for social care and public health. I've got a slide on each of these things just to go through them, and I wanted to start off perhaps a bit oddly right at the end of the process with implementation because I mean, it's an obvious statement. That if it isn't implemented, it's not worth doing. But it's true, and actually took NICE, or at least took me a few years to understand the crafting, the most elegant guidance after the most rigorous examination of the evidence, done by the best informed people that you can get your hands on, doesn't mean anything at all unless it engages with the community of decision makers that it's intended to inform, and obviously the community of people who are using the services that the topic was addressing. And so I'll put it right at the top of the list, because in many respects I think it was the most important lesson that we learned, and certainly for the first few years or so NICE didn't really see itself, in an active or formal sense, being responsible for the implementation of its guidance. Back in the early 2000s, In the first few years of NICE’s existence, the assumption was that we would produce the guidance we'd hand it over to the NHS as it was just the NHS in those days, as the audience for NICE's guidance, and somebody then would take responsibility for putting it into place. If not a grateful community of clinical practitioners, then the national and middle tiers of NHS management who had responsibility for securing improvements in outcomes for patients. The reality is, of course, that some guidance  does get put into place very quickly, because people are just waiting for it. They're aware of some change in practice, some new intervention that's come through or been produced. The process of guidance being engineered and in day to day clinical practice is quite rapid, but in practice, in most cases, evidence based guidance needs to be actively engineered into practice. And because for health care professionals, and I think also for patients and for patients when I use that term in this presentation, we could substitute the words users in social care and public health practitioners, evidence is really important. The sense that there's something that underpins an assessment of the options that are available to us all when we use the health and care system, I think is really important.  Actually, it's incumbent on health professionals to be aware of that evidence and to weave it into the conversation that they have with us when we're looking for support from the health and care system. So the adoption efforts that the system puts in place to promote the use of guidance produced by NICE and other organizations like it, needs to focus on that evidence base, in order to make sure that the that the most powerful arguments for the application of the guidance are put in place. And it's not just the clinical evidence space that needs to be promoted, that's really important, because ultimately, if you can't convince clinical practitioners or those in social care or in public health of the argument that you're putting forward in the guidance, then no amount of pressure, no amount of incentives, is likely to get the guidance put into practice. That's true, but it's very important not to forget that those practitioners are enabled by a community people who are responsible, ultimately, for determining where resources go or for putting in place the resource infrastructure of people, buildings, and services that make it possible for clinical and other practitioners to do their job. So, arguing both the clinical and the business case for adoption in guidance is really important. And it's really important to make sure that we drive out low-value interventions, and that we don't inadvertently put in place incentives that either encourage or have the effect of encouraging those low value interventions at suboptimal practice to be maintained; so those clinical and business cases need to argue both, the point of the guidance in the first place, which is the focus on doing the right thing for patients, and ensuring that the health and care system is using its resources appropriately, and focusing on the specifics of the individual pieces of guidance that make the case, in those particular, circumstances. It's really important that professional communities and patient organizations are at one with the recommendations ideally, so that they can use their networks to promote what's being proposed in the guidance, and to do that is very important that they’re actively engaged in the development of the guidance, and I will come back to that a bit later on. But the art of persuasion in all of this is to make sure that the guidance addresses material uncertainty, things that people are concerned or uncertain about in the health and care system. That the evidence that's used to craft the recommendations is the best that's available, and that the case for whatever the recommendations are, is made as clearly as possible. So learning the lesson that it wasn't just enough to produce the guidance: that NICE had to work with the system in order to ensure that people are aware of the guidance in the first place, both in the system and those who are using the system, and making the guidance as usable as possible, as accessible as possible. Crafting it with real clarity, was all really important in the process of getting the guidance used in clinical practice. Once we decided that it was part of our responsibility to do that, or I should say once NICE decided that then there was a process over the years of building quite substantial resources inside the organization, including a field team working locally with NHS and public health and social care organizations, to raise awareness of the guidance and to promote its use. Lots of work, has gone into, and lots of resources have gone into tracking the use of the guidance, of understanding the barriers to adoption of the guidance in the NHS. And using that knowledge to craft resources for practitioners and those who support them to help them understand the impact of an individual piece of guidance locally, to share the experience from different parts of the system in meeting the challenges associated with adoption, and in creating tools that can be used by the health and care system in order to make sure that the guidance that NICE produces has got the best chance of being put into practice.

You need to be wanted as a producer of guidance in any healthcare system. There needs to be a broad acceptance that there's a place for a national point of reference or a health system wide point of reference that can be used by individual practitioners, and also accessible to patients. There needs to be a genuine desire for an organization that's going to fetter to some extent, the discretion that practitioners have in making decisions, or in making recommendations to their patients and their clients about the care and services that they need, and that can inform patients in helping them to make judgments, and also making it clear why, in some circumstances that things can't be made available. So there are circumstances inevitably in which an organization like NICE, producing the sort of guidance that it does, can be respected even if it's not necessarily light. 

So to make sure that in both of those circumstances, where something is weighted for, where there's a positive recommendation that's likely to be welcomed, and other circumstances in which there's some restriction on access to the services as a result of the guidance: the narrative needs to be compelling. So we absolutely need to be clear that what's recommended is ultimately going to improve outcomes for patients. We need to be clear about the ways in which the guidance is going to interact with that responsibility of clinicians and other practitioners in the health and care system to offer what they believe is in the best interests of individual patients. We need to make sure that those who are going to be affected by the guidance, those who've got responsibility for its implementation, its use, have the opportunity to influence the development of the guidance, that something of their voice, the voice of the professional communities, and the voice of patients comes through in the way the guidance is crafted, and in the arguments that are played out in the guidance for the specific recommendations that are being made. People need to have confidence that the guidance has the capacity to be amended in circumstances where the evidence is changing. So this is simply not just a one off decision which isn't doesn't have the ability to capture the evolving knowledge that we are inevitably going to have about a new intervention or a new form of practice. And that final point which I mentioned a moment ago about the necessity of explaining clearly in circumstances in which something that could be made available to users of a health care system but isn't going to be as a result of a recommendation that's made, it’s that that's explained clearly, not just in the guidance itself, but one of the things that I learned early on was the importance of standing up and explaining to professional communities, to patient groups in the national media why it was that NICE was saying No. Or not everything associated with this intervention or explaining whatever the restriction might be. It was just important that we didn't become some kind of part of the faceless bureaucracy, and that there were people behind it struggling, puzzling through incomplete evidence bases, trying to understand and to manage uncertainty and ultimately to make a decision that they could defend as being appropriate in the interests of the community of people who rely on the health and care system for their care. In circumstances in which we're dealing with our health, and everybody's affected by this, almost certainly everybody in the country is going to be affected by something that NICE has said something about over its 20 year existence; It's really essential that the way in which those recommendations are crafted and the arguments behind them are articulated as carefully and as sympathetically as possible and that the narrative is compelling. 

And just continuing or developing the theme of generating trust and confidence, gaining the support of communities that are essential in the development of guidance, as well as generating and maintaining support, of those who, are affected by the guidance. One of the most important things I think that it's really essential to do as a national body, making these decisions that have such significant impacts on individuals, and the health care system as a whole, is that you need to open up the processes through which recommendations are generated as much as possible. And that means publishing everything or at least almost everything. I mean, if you can publish everything, that's ideal. So it's essential to be clear about how the guidance has developed through the methods and processes that are used by the organization. Data from clinical trials, and from studies that are used to underpin evidence in the public health and social care, aspects of what NICE does. And the economic evaluations that are produced either, commissioned by NICE, or developed by pharmaceutical companies which is the process in the technology appraisal program, need to be made available to people who want to see them. Everything that people say, all of the consultees, all of the stakeholders in the process of developing guidance, needs to be put into the public domain. It simply isn't good enough for an organization to say “Well, we can't publish that, because that was confidential dialogue between ourselves, and an individual stakeholder”, unless there's a really compelling reason for doing this. So there need to be clear rules about how information, all the evidence, and all the evidence that’s used in the development of guidance are handled by NICE and the circumstances in which people can get access to that information. I mean clearly, there are some circumstances where it probably wouldn't be possible for NICE to make recommendations without reaching some kind of an agreement on confidentiality. But that I think only applies in circumstances where the legitimacy of the concerns from the stakeholder can be tested, and a clear justification for restricting access to that information can be set out. Leeza and the team here are aware of the evolution of NICE’s approach to confidentiality. Slower, perhaps, than it might have been over the years but gradually getting better, but still restricting access to some information generated through clinical studies and other academic endeavour, and circumstances in which the justification for that now is becoming increasingly obscure. The commercial confidentiality that NICE agrees with individual companies again is disputed. There are people who believe that that's not appropriate. That simply because something might harm the commercial prospects of an individual company's products is not of itself enough of a reason for restricting access to it as part of the NICE process. The difficulty, for NICE is, and inevitably it's a compromise, is it has to work with commercial organizations for whom that commercial sensitivity is a very real risk. So I think it's inevitable that there will be circumstances in which there will be data that has to be restricted, simply to make it possible for NICE to make recommendations in the first place. So it's very important, but obviously as a general principle, the more that you can reveal, that of the information that underpins the recommendation that you're making, the more likely you are to be able to explain why you've made particular recommendations and the more likely you are to gain and maintain the trust and confidence of your audiences.

And sort of closely associated with that concept of transparency, I think, is this question of making it possible for people to become involved in the development of the guidance. I think it's a general principle: the more you're involved in a process the more likely you are to share ownership of the outcome. Obviously, it doesn't apply if you fundamentally disagree with the outcome however much you might have been involved in it, you're probably not going to own it. But the fact that somebody who, in the end, ultimately disagrees with the recommendation and has been part of the process is still Nevertheless, really important. So I think there's a general principle that anybody who's affected by recommendations that are going to be made through a particular form of guidance should have the opportunity to have their views considered. I mean obviously there are practical considerations that have to be taken into account. There are potentially thousands of people who might want to comment on an individual piece of NICE guidance, whereas in the very early days of the organization, there was an attempt to literally try and involve individuals in that process. It became very quickly apparent that practically, the organization would never be able to produce anything if you tried to address all individual’s questions and issues, but there are ways in which it's possible to and enable access by individuals through professor communities or patient groups. For example, to have their voices heard, synthesize, and then presented to NICE in a way in which the organization can take those views into account. However it's done, it's really important that once the recommendations in a particular piece of guidance start to emerge, that's there's a genuine process that allows views to be expressed on whether all of the evidence has been taken into account, and to put views forward about the way in which that evidence is being interpreted. And if people disagree, there needs to be mechanisms/processes that allow them to put reasoned arguments forward for a different interpretation, and that consultation has to be genuine. So the organization that's receiving those comments: NICE in my case, needed to put the resources in place to show that it had been read, and that it had been responded to. There's always a risk that becomes a bit mechanistic: you know some general observation like “Thank you for your comment, which we've taken into account”. But nevertheless, to try hard to demonstrate that people's views were being listened to, and certainly in circumstances where substantive challenges were being made by former consultees in the process; that there was a clear response either accepting the points that are being made, or alternatively, in circumstances in which the organization didn't agree with this, a clear argument why that's was the case, and for that to be set out, so that both the consultee, and indeed everybody else who's interested could see why NICE was taking a particular position. That engagement is just natural justice. But it's just essential in making sure that the organization produces ultimately the best guidance It can, because NICE: the people who work in it, it’s advisory committees, don't have a monopoly on wisdom. They get things wrong. And consultation, the broader engagement processes that are built into the development of guidance is a way in which the organization can correct itself; can produce better guidance and not just better guidance, but also using that same principles ultimately produce netter processes and better methods for generating guidance in the future.

And just on that point of methods and processes, it’s absolutely essential to have them laid out for every guidance program as clearly as possible, essential for delivering consistency so that different groups of people, either groups that are established as standing committees to produce recommendations over a period of years or groups that are brought together for individual topics are clear about what NICE expects them to do. How NICE expects them to go about interpreting evidence and resolving uncertainty, and that they can apply that approach over multiple topics over a period of time.

 And it's essential that the methods are at a sufficient level of detail so that the organization's preferred approach, you see here assessment and interpretation of evidence is clearly laid out. I mean, that's essential: It says here to technology developers. But it's essential to anybody who's businesses or whose practices are going to be affected by NICE’s recommendations, can understand how what matters to them is going to be dealt with by NICE. It's very clear, it's very important that, particularly for technologies, the methods that NICE uses set out how the value that new interventions, new technologies, are bringing to the NHS is going to be established. So companies and others can use that not just when they're actually in and engaged with the NICE process on a particular topic but can also use that information to help inform how they develop new products in the future. It's essential they’re kept up to date, obviously and it's really important that the process is informed by the communities that the guidance is going to affect. So in a sense anybody who's got an interest in how NICE goes about developing its recommendations for health and care system ought to have the ability to engage in the periodic consultations on updating, changing, and developing those methods and the processes. And then the 3rd bullet point here, it's an important one too, because the way evidence is interpreted legitimately varies from one jurisdiction to another, because to some extent it reflects the preferences and priorities, and in particular, and certainly when you're using economic evaluation to inform recommendations, it reflects the risk appetites of the health system in which the guidance is being developed. And so, although those aspects of the methods that NICE uses are not informed by broad academic research on the process of assessing and interpreting, evidence, it's important that they're nevertheless woven into the guidance. And that means that NICE needs to consult with those who are ultimately responsible for the governance of the health and care system, the department of health. NHS England will have a legitimate interest in how NICE goes about the development of its guidance in applying its methods. And that's perfectly reasonable. NICE doesn't stand in isolation from the health and care system. It needs to make sure that the way in which it goes about developing its guidance recognizes the ambitions and constraints that the health and care systems work under. Then the final point about uncertainty again, really important. No evidence base looked at by a NICE advisory committee is complete, and the earlier that NICE looks at, for example, new health technologies, the more incomplete it is. So dealing with uncertainty is right at the heart of the process of developing guidance. So how uncertainty is dealt with. How it's addressed, and how committees go about ultimately crafting recommendations in the face of uncertainty needs to be clearly set out in the methods that the organization uses

Just thinking about those decision makers. Right at the heart of the NICE process is the work of the advisory committees, these groups of people drawn from the sort of clinical public health and social care communities who sit with people who've got particular academic skills and technical skills alongside people who are representing the interests of users in the health and care system, who do it without being paid. They do it because it's important. They see value in it. They see it as a general contribution ultimately to improving what the health and care system is offering. It's important that NICE creates a space, a safe space, in which they can puzzle through the evidence that's put to them that they can take into account the evidence that's presented on outcomes for patients and other users of healthcare systems. That they get a good understanding through the economic evaluation that NICE presents to them about the impact on health system resources of the evidence that they're looking at, and that they've got the opportunity to see the views, as I've been saying earlier on, that have been expressed by stakeholders, and to bring all that into a space for debate and discussion that is not insulated from the world in which the guidance is going to be produced, but is protected. So, in other words, that people feel that they can speak freely, express concerns, uncertainties. Put different competing views around the table. They can do all of those things in the knowledge that what they're doing, and the way they're going about it is going to be respected by Nice and by the wider communities that the guidance is affecting, and that they can apply ultimately their judgment, particularly in circumstances where there is uncertainty about the right thing for the health and care system to do in individual cases. 

And just sort of thinking more broadly now about rather than just inside NICE itself and the way it goes about things as an individual organization, NICE doesn't operate in isolation, it obviously relies on other organizations in the health and care ecosystem in order to be able to do its job. In order for that to be an environment in which the kind of guidance that NICE produces to have an effect, it's essential that all the key partners in that health care system are aligned in sharing their ambitions and in helping to reduce the risk that they're all running. And there are lots of partners, there's NICE, there's the MHRA. There are the companies that produce technologies, the Department of Health, the Treasury there’s the NHS itself, or the academic communities. A whole range of entities that do things that's NICE relies on and or have an impact on how NICE goes about its work and there are some things that are really important, I think. If you stand back and look at that whole ecosystem, some of them are listed here. I think it's really important that health systems are clear about their priorities and ambitions. So what do they want to focus on, what outcomes are they looking for? What kind of innovation are they going to value most, and be prepared to pay for? How important is it that's new forms of practice make a contribution to improving the efficiency with which health system resources are used. Companies need to offer sustainable value propositions. Some do. Many don't. Many take too long, and drag out the processes that NICE, and other organizations have to go through to get to the point where the value proposition becomes realistic and possible for the health system to avoid. And one way in which we can move more rapidly towards getting close to a value proposition that's both sustainable and likely to be supported by organizations like NICE is early upstream engagement, through scientific advice and market access advice. It was one of the big lessons that we learned I think, but it was a good 10 years after NICE was established. That it wasn't just enough for us to have well-crafted ways of testing value propositions at the point at which they were presented to NICE in an individual guidance program. If we were really committed to making sure that the best practices were promoted as quickly as possible then it was important that NICE engaged with companies as early as possible, in order to help them understand what an advisory committee at NICE was likely to be looking for. To explain, going back to that point about methods, about how NICE synthesizes and interprets evidence so that companies could build that knowledge into their research and development programs as early as possible. So putting in place arrangements for that early dialogue when the organization went NICE finally did it was an important development Working closely with the regulatory body, the MHRA upstream, and NHS England, when it was created downstream again, was something curiously that NICE had to learn. It's not that NICE didn't speak to the MHRA or ignored the reality of the role NHS England was playing, but equally it wasn't simply the case that efficient business arrangements between those different components in the system just simply existed. They had to be creative, and worked at and again so, learning the fact that there had to be an active process of making those business transactions work efficiently, and constantly looking for opportunities of making them work more efficiently, challenging long held assumptions about for example, the sequencing of decisions taken by the regulator and by NICE. That meant that improvements could be built into the way in which guidance was produced so it turned out to be possible for NICE to start it process of evaluation before a new technology, for example, before the MHRA had produced its final recommendation without compromising the independence of the MHRA, and without ultimately compromising the value of the guidance that NICE produces. So all of those things which in many ways just seem blindingly obvious. But for whatever reason, took time for all of those organizations to learn and understand, and they're still in the process of refining those relationships even today.

And just to finish, but it was never going to be perfect. NICE, Isn't a council of perfection. It never was, and it's never going to be. But it's not bad. It's pretty good at what it does, I think. It would have been even better if we could have learned some of these lessons and applied some of that learning earlier in the evolution of the organization and just picking out a few things that we might have done better. That point about focusing on adoption and implementation of guidance ought to have been a strong theme, right from the beginning of NICE's work. We could have introduced a single technology appraisal program from the outset, which would have enabled the organization to move more quickly from dealing with drugs that have been licensed for sometimes more than 10 years, to moving much more quickly towards the drugs that were being introduced into the system at the time that NICE started work. I think also it would have been helpful, again just focusing on the technology appraisal program, to introduce the idea of conditional approval which conventionally inside NICE or the NHS is being framed around the cancer drugs fund, but is now broadened out to an innovative drugs fund because there were so many circumstances in the early years of NICE where the evidence base simply wasn't sufficiently mature, or complete, to enable an advisory committee to call a decision definitively one way or the other, and the only option that NICE had, was in those circumstances, was either to take a huge risk, and say yes, or to take a huge risk and say no. There was no opportunity to say, “well we're not sure, but if we use it carefully in these circumstances, and we collect this data and we take another look at this point, then we're going to be able to be much more confident about the recommendation.”. I think that's something that could have been introduced much earlier in the process, and that wasn't a decision that NICE could have taken. It would have required the department of Health ultimately, as the budget holder to move more quickly to do that. That stream engagement I talked about, again a fairly recent development in NICE’s evolution and certainly only really being promoted significantly in NICE’s second decade, and something that could have been put in place earlier in the process. And then just thinking more broadly about how NICE presents its recommendations. So across all of its programs, technology appraisals, clinical guidelines, interventional procedures. Across all the programs that that NICE has, for a long time I think there was a focus inside the organization on almost a silo like basis that this was the technology appraisal, and this is an interventional procedure, this is a clinical guideline. The reality of clinical practitioners is that there is a care pathway, essentially, and in order to find out what NICE is saying about a particular disease or condition, or indeed how to deal with options and challenges at particular points on a care pathway required a fairly deep knowledge of NICE’s website in order to find that information. It's much better now. Much better presented than it was originally, but I think we could move more quickly to a care pathway presentation of our guidance rather than a guidance type presentation which is what happened. And then finally, I think you know one of the big surprises to me in the early years of NICE was the enormous global interest in the organization. I mean, it probably says something about me, and my knowledge of what NICE could be, and indeed the world of evidence-based practice. But it came as an enormous surprise to me that NICE was such a focus of interest around the world. It was difficult in those early days. It was such a small organization to devote much time to taking advantage of the leadership role that NICE developed quite quickly as a result of the very public way in which it went about its work and the influence that NICE had on the NHS practice. I think one of the things that we might have done would be to invest earlier, more substantively in capitalizing on that interest and then promoting the role that NICE had, and still has, in leading the world in the interpretation of evidence to inform practice.

David Colquhoun: I'm a huge admirer of NICE on the whole, but I think the place where it has fallen down a bit is in situations where there aren't any good treatments, and it is just not said so for too often in in my view. Especially when that gives an entrée for various sorts of quackery. Acupuncture, one guidance group recommended in some sort of chronic pain, I forget which now, which was revised, they didn't recommend it. Then another guidance group for a slightly different sort of chronic pain recommended it again. A big change that has happened over the last 15 years is the people have realized just how a reproducible loss of evidence is. For example 100% of trials of acupuncture that come from China or Russia are positive and that's just ridiculous. I mean, it's obviously just a product of commercial pressure and Chinese nationalism. But the groups that recommended it took it seriously, and that  seems to me most unfortunate, really, and not good either financially or for patients. So my question really is, then what do you do about fringe medical practices? Why do they still get recommended when there is nothing else?

Sir Andrew Dillon: Yeah, I think it’s a fair criticism David. I don't know that there was an explicit process of NICE avoiding, getting into difficult settings, like acupuncture and homeopathy which it managed to avoid completely certainly for the time I was there but then it didn't do a loss either. I take your point about the sort of inconsistent recommendations around acupuncture, but I guess that's the product of the way NICE is established that the independence of this advisory committee is providing they follow the methods and processes, different groups of human beings have the potential to come to different conclusions, and obviously the applications for acupuncture were different. But I think you've got a reasonable point that NICE is a vehicle that could be used explicitly by the health and care system if it wanted to, to address the more egregious approaches to practice, and to come out with very clear recommendations against using things. But for that to happen there has to be a very explicit desire for the system to do that. NICE needs to know that it's doing that with the support of the health and care system, rather than just sort of falling into this and suddenly become a victim, as indeed I remember we were to individual communities. They can get very angry about some negative recommendations about their favourite forms of practice.

Susan Bewley: It's a question about what is the evidence about political influence, if there is one? I clearly remember you saying, if a guideline falls on stony ground, it hasn't worked, and CG190, my intrapartum care guidelines, we're still struggling with the 3 main recommendations of a place of birth. CTGs, a test that doesn't work, and clamping an outrageous intervention, without an invention. I'm still chasing all the tails I can, but do you have any advice, and have you got any titbits about the lobbying behind the scenes?

https://www.nice.org.uk/guidance/cg190/

Sir Andrew Dillon: Yeah, it's interesting, Susan. I think there's a distinction I've made between political interference, you know, which people have expressed concern about, and accused NICE of it being susceptible to, a victim of, and I can genuinely say in the time I was there that there was no successful attempt by politicians to influence the guidance NICE produces. I think it would be quite difficult.

Susan Bewley:  I agree with you. I think you're fantastic on that, but they do then foul it up afterwards. You know I have a leaflet for women interfered with by ministers and Simon Stevens, so that it just messes up the clear advice NICE gave

Sir Andrew Dillon: You know there are ways in which they interfere to make it difficult for recommendations to be put in place and you made the point about a particular professional community of obstetricians, and I mean they too, can both frustrate the development of guidance, and also frustrates implementation if they don't like what's in there. So I mean it is an issue, when overt public influence actually just isn't possible, because actually you as chair and your committee members, just walk away from it if you detected that I was trying to persuade you, or you know in the past or Sam Roberts, now the chief executive, was attempting to twist the arm of an advisory committee on the basis of what politicians wanted. But they are involved, and they do have a legitimate role. Just one quick observation, the safe staffing guidance that NICE produced or the program that we established was pulled as a very specific, deliberate act, by NHS England, not because the guidance was wrong, but because they were worried that they simply wouldn't be able to support the application for guidance because it was too expensive and in one sense it's very disappointing when that happens but in another sense I think, well fine. If you asked us to do it, and if you now don't want us to do it, then you have to be public about why you don't want us to do it, and we'll stop it, and we'll put our resources somewhere else.

Lydie Meheus: It's more a question towards the future, and especially since we now have an opportunity in Europe with a review of the pharmaceutical legislation that hopefully things can be changed, and I wanted to hear your opinion about the system with the FDA that you have those end of phase 2a meetings, where there is a kind of advice for designing the registration trials, because I think the whole idea is that registered trials should be designed better so that they answer, also the questions from the HTAs: the downstream stakeholders. I understood that also from what you said. So what do you think about making that whole concept mandatory?

Sir Andrew Dillon: I don't know about mandatory, and the value of that may vary from one jurisdiction to another; but it ought to be just the sensible thing to do. Because what is the point of everybody spending enormous amounts of money and huge amounts of time developing something and it gets to an advisory committee and the committee looks at is and says, “well, we don't know what the answer to the question is”, the question being: What incremental benefit does this intervention, this technology, whatever it might be, bring and is it worth the health system paying for it? And the reason we don't know is that you haven't brought the data that allows us to answer that question. So it seems to me to be ridiculous to get into that position when through some structured dialogue, 2 years, 3, years, 4 years, 5 years earlier, that could have been rectified and everyone be in a much better position to make a judgment about value, once the technology is being presented to the health care system. So it's sensible it should be promoted. Making it mandatory might help in some circumstances, but I guess that might be jurisdiction specific.

Leeza Osipenko: Andrew, I do want to ask you this question that Damard sent by email because he could not join today's events so I'm posting it in the chat for everyone to see, but I think many people would be interested about the take of innovation by NICE. So the question is “ What evidence and research has informed NICE's move to more explicitly place incentivisation of innovation as a core objective of NICE?”

Sir Andrew Dillon: Yeah, it's interesting actually because the promotion of innovation was built into NICE’s mandates from the Department of Health right from the beginning. If you go back to the founding documents of NICE, back in 1999, and indeed the consultation documents that predated the establishment of NICE back in the 90s. The idea of promoting innovation and NICE being part of a system that did that was built in and assumed, and indeed we were very conscious of it right from the start. So it's not kind of new. I guess the approach that NICE took, certainly the approach I took from the start, was that it couldn't just be innovation for innovation’s sake, you know. Oh, this is new! It's different, therefore you should buy it, and you should start using it. Innovation needs to bring material incremental therapies or diagnostic improvement, and it needs to bring it at a price that makes sense for the health care system. But in those circumstances, it's absolutely essential, that NICE is part of the system for pulling that innovation in and promoting it in the NHS.

Susan Bewley: If one could use the word innovation creatively, it would be very nice to set up new rules and new systems for stopping things. How they get taken out. I mean I'm obviously thinking of screening which has a sell by day and treatment gets better or something else comes along, but nothing seems to be dropped. It's very hard to drop, but I guess there's new ways of building the relationships between health care practitioners and patients, new ways of social prescribing. And in that way innovation may be not doing something 

Sir Andrew Dillon: absolutely and actually there's an interesting point there, Susan, as well about another kind of challenge or criticism that's made sometimes in NICE that we're always pushing new things into the system, but we never actually say we should stop doing something. Why don't you make it clear in your guidance that if you're recommending this, then this new thing (it’s going to be using these circumstances), then the thing that was being used before doesn't need to be used anymore. And I always thought it was quite a sensible idea except I also thought wasn't it kind of blindingly obvious, or surely it wouldn't be the case that practitioners would be using 2 things. You know, if you're recommending a new thing, wouldn't it be blindingly obvious that you stopped doing the old thing. Maybe that's the lesson I never learned because we never move to make those sort of displacement recommendations explicit. That said, if you go to NICE’s website there is, or there used to be, a huge list of do not do recommendations in the guidance, culled from lots of our clinical guidelines. It was through the clinical guidelines program that we focused on the things that were being done that were suboptimal or had limited value, and should either be stopped, or only used in very specific circumstances. The problem with the technology appraisal program, which is what gets all the publicity, is that in general we're promoting or pushing new things into the system, we’re not recommending taking things out. 

Leeza Osipenko: Okay, final question. From current NICE (Francois Maignen) to former NICE (Sir Andrew Dillon).

Francois Maignen: You have a question which is bugging me, I have to say since the start of the seminar. One unfortunate lesson learnt from the from the great pandemic was the spread of fake news. The promotion of establish medicines without conditions, without any evidence. My question to you is do you think NICE could be more involved in the fight against fake news and its spread?

Sir Andrew Dillon: Yeah it’s a short answer, but I think it would require, in the nature of fake news and it’s promotion and speed at which social media disseminates it, NICE would have to rethink how it went about assessing evidence to reach conclusions so you know, something's being promoted, for whatever it might be: you know treating Covid, or anything else that might come up, the news gets out. It's no use NICE saying, “fine we'll list it for review and we'll let you know in 2 years time, or whatever it might be”. There needs to be really rapid processes for NICE to assess the evidence and come out with a conclusion, and that has to be robust if it's going to be trusted and applied, but it is possible to do that, because, of course, the NICE guidelines program put in place a program of lightning fast guidelines on the treatment of people in hospital with Covid, producing recommendation within a couple of weeks in some circumstances. Obviously, that happened almost in the last couple of weeks I was at NICE but I was really excited about that. It seemed to me that that was an immediate to address urgent questions about the treatment of people with Covid 19, but also the opportunity to learn, and perhaps draw broader conclusions and apply those lessons more broadly about how it's possible to safely take an evidence base, that's available on a hugely urging question, and produce a credible answer for the health care system quickly. I don't know whether NICE has done that. It may be that the circumstances for it needing to do are not there, but I think it was a really important piece of work that I think NICE should learn from

Susan Bewley: I just want to say that if you were part of turning NICE into a learning organization that is maintained beyond you of reflecting and learning, then that's an incredible legacy. And I just want to say, having shared the Covid rapid living guideline, I was incredibly impressed by the people at NICE. I was incredibly impressed by the speed of it. I loved it when we did Ivermectin. For the first time I had to have a briefing about death threats, but you know good old NICE. Either nobody's listening, which is a bit of a worry, or slow, deep thinking, is always going to be a bit behind, because it is slow deep thinking done as quickly as possible and as safely as possible and what did NICE say? It said, “Don't use it unless you want to research it”. And nothing terrible happened because that was obvious. Or you know it's dangerous, don’t use it. And we did come up with the research recommendation. We used it in research only, knowing it was not going to happen. That's what we did, so having been involved over the years in a lot of reflective exercises, testing out new processes when we were going from slow to rapid, rapid to living; I think that quality which comes with a cost, which mustn't be shaved, of learning and reflecting, and having seen many other institutions, whether it's the general medical Council or NHS England. That's critical and we are losing it even in the universities. So it's very precious to all of us. 

Sir Andrew Dillon: Just a kind of final thought. That could definitely be less than Number 9, I think, but I don't think NICE ever did it particularly well, when I was there and that obviously was my responsibility, but that hugely important process of sharing, learning, from one bit of the organization across other parts of the organization. The mechanisms, I don't think are really there. There's so much of a focus on those individual engines of production, doing the thing in the way that they do it, being absolutely confident that they are doing it in absolutely the right way and in the most efficient way, can sometimes frustrates cross organizational learning and I don't think I ever kind of had the techniques I have to say, organizationally, to overcome that. There were times when I just thought it was just a triumph for the guidance to be produced in the first place. You breathe a sigh of relief and go on to the next topic, but really important, that that cross organizational learning takes place.