Health and Social Care Committee
Oral evidence: Future cancer, HC 138
Tuesday 28 November 2023
Ordered by the House of Commons to be published on 28 November 2023.
Members present: Steve Brine (Chair); Paul Blomfield; Paul Bristow; Mrs Paulette Hamilton; Rachael Maskell.
Questions 122 - 186
Witnesses
I: Professor Paul Dalby, Co-Director, Future Targeted Healthcare Manufacturing Hub, EPSRC, and Deputy Head, Department of Biochemical Engineering, University College London; James Hargrave, Vice-Chair, Keep Up With Cancer; and Tony Hickson, Chief Business Officer, Cancer Research UK and Cancer Research Horizons.
II: Julian Beach, Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare products Regulatory Agency; and Sarah Byron, Programme Director, Devices, Diagnostics and Digital, National Institute for Health and Care Excellence.
Witnesses: Professor Dalby, James Hargrave and Tony Hickson.
Q122 Chair: Good morning. This is the Health and Social Care Select Committee. It is Tuesday, 28 November 2023. We are in Committee Room 5 in the Palace of Westminster, and we are picking up our Future Cancer inquiry.
It is a very topical day. There is an awful lot in the news agenda today about cancer, which one of our guests in particular will be interested in elucidating to us. This is our fourth evidence session of an inquiry into Future Cancer. The theme of this session is leveraging cancer research and innovation, including what our guests think that Government and NHS England should be doing to make the most of the opportunities and remove the barriers, now and in the future.
People will know that this inquiry is about lifting our gaze beyond the day-to-day and month-to-month cancer recovery figures, important though they are and important to the Committee’s work, as I think we have proved. This is about the future of cancer detection; the future of cancer research; the future of cancer treatment; and ultimately the future of cancer outcomes for our constituents and our fellow citizens. That is what this inquiry is all about. It has garnered huge interest among the general public, the media and stakeholders. We are very pleased to be doing it, and we are pleased with the guests that we have before us today.
I will introduce them before we get cracking. Professor Paul Dalby is co-director of the future targeted healthcare manufacturing hub and the deputy head of the department of biochemical engineering at University College London. Welcome. James Hargrave is vice-chair of Keep Up With Cancer. Tony Hickson is chief business officer at Cancer Research Horizons and Cancer Research UK. Thank you very much for joining us as our first panel. We have two panels today, so we will crack on.
I mentioned that today is an important day on the news agenda as far as cancer is concerned, and that is because CRUK have today published their manifesto for cancer. Let’s start with you, Tony Hickson, as you are kindly joining us from CRUK on a very busy day. It seems that you are outlining five missions today. It is no coincidence that the very first of those missions is to rebuild the UK’s global position in research. Would you like to say a few words first about the manifesto that has been launched this morning?
Tony Hickson: Thank you. I am Tony Hickson, the chief business officer at Cancer Research Horizons. We are a wholly owned subsidiary of Cancer Research UK. Our focus is on translating the research that comes out of the charity. We are there to bridge the first innovation gap, to help get ideas out of the lab and into the hands of industry and investors. While funding cancer research is vital, we have a duty to make sure that it gets into the hands of the public as products that benefit them.
Cancer Research Horizons is an important part of the charity but, as you have seen, the charity has launched its manifesto today. This is a manifesto that covers five main areas, of which the one you highlighted, Chair, is building leadership in the UK’s biomedical research position. It is really important for us to do that. We need to retain that leadership position going forward. You have seen from the statistics that the Government fund around 38% of the research in the UK, and charities make up the other 62%. That is quite an unusual position in the world. The US Government fund five times per capita more than the UK Government currently fund, so we need to reset the clock here. We need to make sure that the UK remains a leader in biomedical research and a top-tier destination for clinical trials. We want to create an attractive life science environment and keep that life science environment here going forward.
Q123 Chair: What do you think the percentage split that you have just given should be?
Tony Hickson: It is difficult to say as an exact number, but what I would say is that it is highly unusual to see biomedical charities in a country make up so much of the life science research funding. In most countries in the world Governments take a much larger share of that research funding. In this manifesto we are calling for the Government to help address what could potentially be a £1 billion shortfall over the next 10 years. If you look at the 2019 position and project that forward, just to maintain that position would require an extra £1 billion of research investment.
Q124 Chair: You say, as chapter 1, point 1, that the UK Government should set a target in their first 100 days. This is a manifesto and therefore it is looking for the next Government of whatever make-up. In the first 100 days, it should be “to lead the G7 in research intensity”, and the Treasury and the Department for Science, Innovation and Technology should set out a plan for stable and sustained investment to provide long-term stability to the R&D sector. Could you expand “to lead the G7 in research intensity”? What do you mean by “intensity”?
Tony Hickson: I’m afraid I cannot comment on that, Chair. I don’t know the answer to that question.
Q125 Chair: You say you are interested in us maintaining our position as a global leader. Are we currently a global leader in cancer research and innovation?
Tony Hickson: Absolutely. The UK punches well above its weight in terms of its research publications. If you look at the criteria, the quality of papers that we produce from our cancer research community is world leading and up there with the USA. We want to retain that position, but to do that we require a long-term plan and sustained investment in the area.
Q126 Chair: Professor Dalby, as Tony Hickson said, we are currently a world leader. What is the greatest threat to that?
Professor Dalby: One of the greatest powers in the UK is our research and innovation, creating new therapies. One of the big challenges in bringing those to market, at least for industry, is the manufacturing. If you look at the costs of advanced therapies, we have antibody biologics currently pricing up to £30,000. We have had 20 or 30 years of development to get to that point. For new advanced cell therapies, for example, a typical dose looks more like $500,000. A lot of that is recouping clinical trial costs, but much of it is the cost of goods in manufacturing, which is a real challenge at the moment. It takes quite intensive fundamental research innovation to get new technologies to help and make the costs of manufacturing low enough to bring these things to market.
Q127 Chair: James Hargrave, could you explain Keep Up With Cancer for those who are watching? You obviously have different hats, as you also work in the industry. Explain to us what Keep Up With Cancer is.
James Hargrave: Keep Up With Cancer is a coalition of 10 companies working in cancer medicines. We employ 500,000 people globally and we have about 4,000 cancer medicines in production as we speak. We are a coalition that tries to bring together a shared voice of the cancer pharmaceutical industry.
Q128 Chair: How do pharmaceutical med-tech companies, including the one that you work with, view the UK compared to other countries internationally at the moment?
James Hargrave: As Tony was just saying, it is fair to say that the UK punches above its weight. However, it is also fair to say that the UK has been declining somewhat over the past 10 years. Certainly, when it comes to clinical trials, we have seen a pretty stark decline, of somewhere around 40%. The health and life sciences sector is a sensitive ecosystem. If we start to see trouble at the front end of that cycle in trials, that has knock-on impacts for the rest of it.
Q129 Chair: We are obviously interested in writing a report with actionable recommendations for Government. What do you think are the greatest threats and, therefore, the prescriptions that we need to write for Ministers, of whatever colour?
James Hargrave: When considering the threats, it is obviously important to consider what the opportunity is. Companies like ours have approximately 2,000 oncology products on the near horizon, about three quarters of which are biomarker and genetic-driven cancer medicines. We have the relative luxury of almost knowing, to some degree, what is coming at us.
In considering the threats, we need to work backwards from there. It comes down to three key areas, which are essentially kit, people and systems. We know that in the UK we are certainly lacking in kit. Relative to other OECD countries, we have a vanishingly small number of CT scanners and MRI scanners, and a relatively low level of genetic testing capacity for people. We have recently had the NHS workforce plan, which is hugely encouraging but it is still early days. We need to make sure that we invest in the right people, with the specialism to deliver these specialist products when they come. At the moment, we would arguably not have a flexible enough system to license, value and reward the 2,000 products that are coming down the track.
Q130 Chair: Are opportunities being missed to get stuff from what we call bench to bedside?
James Hargrave: Yes.
Q131 Chair: What would be the No. 1 prescription that you would expect us to write as policymakers?
James Hargrave: I can only imagine that Cancer Research UK’s manifesto probably includes some of this. Unfortunately, I have not had the chance to read it yet. A clear plan for cancer would be a hugely important step. We are about 600 days on from when Sajid Javid announced his war on cancer. We have yet to see the major conditions strategy, which is supposed to be inclusive of cancer. Unfortunately, the UK is increasingly becoming a bit of an outlier in the lack of a rallying call for cancer. The EU has its Beating Cancer plan; America has its Moonshot; and Singapore, where I believe you were recently, has its own cancer strategy. There is certainly a theme of having an important and detailed plan for how you get there.
Q132 Chair: Tony, we know that the cancer community and the research community is very disappointed in the fact that there is no specific cancer plan in this country, and that it has been rolled into the major conditions strategy. There is some intellectual coherence to that because people living with cancer live with other comorbidities. That is certainly the argument that the immediate predecessor to the Secretary of State made before us. Is it fair to say, therefore, that CRUK has taken the bull by the horns and produced its own 10-year cancer plan, which is what the manifesto is about, partly as a response to that disappointment?
Tony Hickson: I think it is fair to say. This is the manifesto and it was published today. In it, there is a strong recommendation, as James just said, that we need a 10-year plan to address cancer. It will be the first time that England has not had a 10-year cancer plan for decades. The other devolved nations have them, and we need one in place. It needs to instil a sense of movement and a sense of community. Everyone needs to be joined up: Government, charities and industry. We all need to work together now to address cancer. Cancer is fixable if we work together to address it.
While this is not a 10-year plan in itself, the recommendation is that we form a national committee that will report directly to the Prime Minister and will convene everyone to go after it as a group and a community.
Chair: It makes every sense. Certainly, in Singapore, which obviously has the benefit of very long-term political stability, the clear message we got everywhere we went was a 30-year plan for this, for that and for cancer. As you rightly say, at the moment we do not have that. We thank you for your work on the manifesto and thanks for the opening comments from each of you.
Q133 Paul Blomfield: I want to explore some of those points a little bit further. Tony, just now you described us as a world leader in research. Your chief executive, on the radio this morning, said that we are a world laggard in outcomes. I guess it is about exploring how we get that leadership in every area. James was talking about the personalised treatments that are coming down the track. Is the NHS remotely ready to take advantage of those opportunities and to scale up to do that?
Tony Hickson: We have an opportunity. Cancer research is at an extremely exciting time. We are now seeing brand new developments for understanding and harnessing the immune system; cell therapies; and the potential for cancer vaccines in the future. There are precision medicine approaches that will narrow-target populations, meaning that we will have more drugs that are more effective and with fewer side effects, but there will be more of them targeting smaller populations.
All of that results in more complexity. There is more opportunity, and it will be better for patients, but there is more complexity and more products are entering the system. We need to make sure that we have an NHS that can cope with that, that the staff are appropriately trained and that we have the right manufacturing capabilities with the right regulatory framework. We need to start gearing up the system to cope with what is a good thing—the fantastic new cohort of innovations that are going to come down the path over the next 20 years, to the great benefit of cancer patients.
Q134 Paul Blomfield: Your implication is that we are not in a position to do that at the moment.
Tony Hickson: Not at the moment. That is why the manifesto is recommending a huge scaling-up in what we do.
Q135 Paul Blomfield: What are the key points there? James was talking about kit, people and systems. That is pretty comprehensive. I will come back to James in a moment to elaborate on that, but do you have any thoughts on it, Tony?
Tony Hickson: Yes. The main ones we recommend are more emphasis on prevention, not just curing ill health but trying to prevent it. Certainly, the recent announcements around smoking are a welcome addition, but we need to roll out lung cancer screening in a more effective way and look at FI testing. There are a number of different recommendations in the review.
We want to increase diagnosis and early detection of cancer. As you well know, that is vital. That is where we can make one of the biggest differences. We have made a number of recommendations there. Obviously, we need to address the wait times. I know that is not the main focus for today, but it is important that we not only start meeting our targets but that we make them more ambitious going forward. There is also the area of the national cancer movement, and really convening a sense that we are all in this together.
Q136 Paul Blomfield: Thank you very much. James, would you like to develop your points? You were implying that we are well behind on kit, people and systems. I cannot think what else there is in terms of preparedness. The Chair pointed out that we are going to try to make some helpful recommendations to Government. What do you think are the most significant policy levers that need to be addressed to enable us to be ready to scale up?
James Hargrave: On the kit side, it is quite clearly going to be investment in the kit and to make sure that we buy the scanners that we need to be able to diagnose patients. We then need to scale up the genetic testing capacity, so that we can find the targets for the new treatments that are coming down the track.
The genomic hubs are a hugely important part of how we deliver that. What our sector is seeing, however, is a little bit of a disconnect happening within the genomic hubs between the research agenda and the actual day-to-day delivery of cancer treatment. I think what we are seeing is that the genomic hubs are excellent and leading the way on the research piece, but there is perhaps a bit of a problem in prioritising, and literally turning around a tumour test, so that a doctor can decide which treatment to give. We are seeing that play out in the system in such a way that some hospitals—admittedly, this is anecdotal at this stage and something we are looking into—are now doing the testing in-house because they find it is too slow with the genomic hubs. The problem is that if they then do it in-house you lose the opportunity to scale up the testing that in theory would make it more efficient. We are potentially getting into a little bit of a vicious cycle there. That is one area.
On the systems side of things, we have definitely seen a recent change in the way that NICE assesses cancer medicines, which we think in time will prove to be detrimental to getting access to patients. Forgive me, this is a bit of a technical point. Last year, NICE reviewed the way that it assesses medicines and, in so doing, removed something called end of life criteria, which was a special value weighting largely used for cancer medicines. They removed it in favour of something called the severity modifier. In principle, it was certainly a welcome move to have a more flexible approach to disease severity, but what it appears to be doing in practice is making the bar far higher for cancer medicines to be able to achieve the value weighting that they had under the old end of life criteria.
We seem to have got rid of one cliff-edge value proposition for end of life criteria in favour now of two. You can have no value weighting, medium severity or high severity. We believe the knock-on impact of that will be fewer cancer medicines achieving those thresholds.
Q137 Paul Blomfield: Thanks for that. It is something we can explore with NICE.
Chair: We may have just the people to ask.
James Hargrave: I gather you might.
Q138 Paul Blomfield: Professor Dalby, we are looking at exciting developments and clearly the landscape is hugely exciting. Tell me about your ambition for the manufacturing infrastructure that we need to realise the potential.
Professor Dalby: Currently, to put it in a bit of context, it is an industry that has a very potent therapy that is still being developed. There are many innovations to come, so it will keep changing and evolving and we need to be able to adapt to that. It is currently treating only a few hundred patients per year, usually in blood cancers, but that will expand, potentially rapidly. At the moment, it is delivered through one or two very specialist treatment centres at very high cost. Something needs to change in terms of more treatment centres that are capable of delivering these therapies as the portfolio expands, and the cost of that needs to come down considerably. It is extremely high at the moment. Certainly, you would not be able to afford too many therapies at that price.
Development on that scale is a 10 to 15-year plan, to innovate to that degree. It takes that long. It did with antibodies, and it will with cell and gene therapies. All of that needs to be planned in. The question then is whether we can innovate enough towards closer-to-bedside manufacturing, which is one option, so that every hospital has its own pharmacy-based manufacturing platform. Much of the technology requires close-to-patient manufacturing. That is the paradigm shift that we need to look at, but it will take huge investment over 10 to 15 years.
Q139 Paul Blomfield: What can the Government do to help us achieve that paradigm shift?
Professor Dalby: At present, that industry is coming out of largely academic clinical groups and small companies, SMEs. It is very much a cottage industry that will eventually be adopted by larger pharmaceutical companies as they progress. The innovation is at that level. It is largely in academia and in SMEs. Investment is needed in technology innovation to improve the manufacturing of these technologies, as well as more funding for early-stage clinical trials to enable more of the therapies to come through more rapidly. Ultimately, the investment needs to sit with those types of therapy.
Q140 Paul Blomfield: Can the infrastructure of the healthcare system keep up with that pace of innovation?
Professor Dalby: I think it could if there was enough innovation on the therapy itself and in the manufacturing to make sure that it was deliverable in a more friendly framework, if you like, so that we don’t have to invest in a whole new treatment centre for every new therapy. Innovation up front would help to bring it in, rather than having to create infrastructure in hospitals that is ultimately too big, if you are to have therapies as they currently stand.
Paul Blomfield: Thank you very much.
Q141 Chair: Obviously, the industry environment is global and highly competitive; it is globally competitive. Are there things about Britain’s size and political instability in recent years that are harming us in terms of that global competitiveness, that you hear in your day-to-day work?
James Hargrave: Stability is key. Unfortunately, that is something which has been a little lacking in the UK in recent years. That is partly seen through the lack of a cancer plan. That was something that was committed to some time ago, and we have not seen it. That, in and of itself, is indicative of a bit of a policy gap. Particularly relevant to pharmaceutical companies recently has been the so-called VPAS deal that we are just coming to the end of a pretty tough year negotiating. We had the heads of terms of the new deal only last week, so I am afraid I do not have the full detail of that to be able to discuss with you today.
It is important that there is a new deal. Obviously, that has been a long time coming. The last one had certainly put us in a pretty unsustainable position, where we were seeing rebates of 26% or 27% on pharmaceutical revenues in this country, which made the UK a massive outlier by global standards. Of course, that got the attention of global pharmaceutical boardrooms in the wrong way.
Q142 Chair: I can see that. I am just trying to understand whether we have moved beyond the political instability now, annoying as it was for us domestically, or whether that instability still has a long tail.
James Hargrave: Even in just the past week we have seen some really encouraging announcements from Government. We saw their commitment to fund the Lord O’Shaughnessy review into clinical trials, which is hugely significant. That review by Lord O’Shaughnessy was welcomed by everybody in the sector. I will be honest and say that it is not often when we send a policy note up to our research unit in Japan that they pay much attention to individual UK policy, but this one certainly seemed to get some positive attention from our colleagues over there. It is a really important part of implementing Lord O’Shaughnessy’s review to turn around the 40% decline that we have seen. I gather from recent analysis from the ABPI that there are actually some green shoots now in trial uptake in the UK.
Chair: We hear that too. For those watching, last Wednesday the Government responded in full, accepting all recommendations of the Lord O’Shaughnessy review. If people are interested in that, it is all there online.
Q143 Rachael Maskell: Tony, thanks so much for coming in. Obviously, we have heard about the disinvestment in workforce and infrastructure. When we visited Singapore, the one thing that really hit me was how there was investment in the clinical interface with research, particularly that if you are building a new hospital you build a new research centre adjacent to it. Clinical trials are clearly an issue, first of all, on data technology. Could you talk through what needs to change in that sphere?
Tony Hickson: Clinical trials are not an area of my expertise. I focus on early-stage business creation—start-up creation, investment in start-ups and those sorts of areas. I am afraid that clinical trials is not an area I can comment on.
Q144 Rachael Maskell: Paul, can you pick up the issue of clinical trials, or is James best?
Professor Dalby: It is probably James, I suspect.
James Hargrave: I was just saying to the Chair that we have experienced a pretty extended period of decline in the UK on clinical trials, certainly commercial clinical trials. Lord O’Shaughnessy’s work gives us a pretty clear direction for trying to turn that around.
In the Singapore example, are you talking about clustering and how you bring these things together?
Rachael Maskell: Yes.
James Hargrave: The UK obviously has a massive foundation for that in the golden triangle with Oxford, Cambridge and so on. We know that a lot of that foundation is there to be maximised. What we now need to do is get rid of a lot of the bureaucracy that has been holding that up. When you had Sir John Bell here some weeks back, he was very clear about how the UK used to do it better. We have added a lot of layers of complexity that are now slowing us down and turning approval times from what were 30 or 40 days into 200-plus days. That is not a sustainable place to be.
Chair: John said that we were pedestrian—his exact word—in this space.
Q145 Rachael Maskell: I also want to ask about external investment. We have talked about the balance between Government and charitable funding. The commercial market has real interest as well. Where are we in that space of being able to say, “Come to the UK and invest in the excellent research, which is being carried out to pace, to scale,” and enabling the manufacturing base in particular to take it up? I don’t know who is best to answer. Tony?
Tony Hickson: I think this comes back to the barriers we think we face in getting these great ideas to progress forward and how that leads to attracting industry and investors to work with us.
We see four main barriers. There is the culture gap. We need to encourage our academics to do this more. The Government could help with encouraging universities not only to reward high-quality publication but to signal that they are rewarding entrepreneurship and getting engaged in translation.
Capital is a major theme. Some of the recent announcements from Government are very welcome. We need not only to divert pension funds into the scale-up of this activity, but to ensure that we keep it balanced so that there is equal money going into the early stage and we have a contiguous pipeline of new innovations coming through.
There is the talent issue. We need to continue to make sure that we have sufficient talent for our start-ups. That plays to the point you raised earlier, Chair, about attracting industry to work here. We need an ecosystem. We need the pharmaceutical companies and the biotech companies to locate here because they are a source of talent for our new start-ups. The whole thing works as a supply chain.
Q146 Rachael Maskell: Because there is a skill shortage in that space as well.
Tony Hickson: Yes, absolutely. The final point is on business investment in the UK. We saw from the Harrington review the significant drop in foreign direct investment. We need to create the incentives to make businesses locate here and keep that ecosystem vibrant.
Q147 Rachael Maskell: By having a stronger ecosystem, you will get more investment coming in. Presumably, that is the model that we are pursuing.
Tony Hickson: Yes, it is a virtuous cycle. If you have the capital, you attract the investors. You then attract the talent, and the whole cycle works.
Q148 Rachael Maskell: Paul, if we are looking at Government policy, what more can Government do to back all the work that is happening? In the recommendations of today’s report, you talked about having a committee. Do we need somebody like Kate Bingham to drive this through Government and ensure that we get the clear, through-the-system troubleshooting that perhaps we have not seen over recent years, including the production of a Government commitment, a 10 or 30-year plan?
Professor Dalby: I would say it needs exactly someone like a Kate Bingham. She was instrumental in covid for bringing manufacturing on to the agenda as well, which is actually the thing that often gets forgotten while innovations are being generated and going through clinical trials. Manufacturing sits behind that, which often delays production. It often delays the investment because it is very expensive to produce the first clinical trial batches of materials. Academics and clinicians struggle to get the funding to get that in place in order to carry out clinical trials, even if they have the funding for the clinical trials themselves. That end of the academic space, and I would add SMEs, really needs that kind of investment. I would say that there is a real hunger from academics to go into the commercial sector. There is a lot of spin-out activity. Most of the new therapies come through academic spinning-out companies. It is there, but they struggle on the ground to get the funding and investment to push more through. There could be a lot more.
The other thing that the UK has lost over the last 10 years is some co-ordinated investment in what we call bioprocessing, which is the manufacturing of biologics. We have had investments in the past and that brought the community together. We all know each other in the UK. That is why it worked so well for Kate Bingham to bring that community together and get it working, but it needs funding, and it needs it in a sustained manner. We are looking at something like a 10 to 15-year sustained plan of investment for very fundamental technologies. Every new therapeutic development requires new technologies for manufacturing, analysing and characterising those products. That all needs either to come from what exists, which means that it is done inefficiently, or be reinvented. The investment needs to be there for that, and it takes a long time.
Q149 Rachael Maskell: We have talked about investment. Where is the UK in looking at export opportunity? We know that the growth on a global scale of cancer, particularly with an ageing population across the developed world, will increasingly be in the non-developed world. What is the vision, or is there no vision? I don’t know; I am asking you. Do you believe, looking at our export opportunities, that being a world leader could be a significant investment in our economy and wider infrastructure?
Professor Dalby: The question is what we export. We do not just export the therapies. They are worth in the order of £30 billion a year in exports. We invest in, and produce, technologies to support that. It is the whole infrastructure. In the entire infrastructure in biotechnology, there are something like 500,000 jobs in the UK. It is enormous. It is the analytics, the manufacturing equipment and so on. It all gets developed. We are very good at developing those things in the UK. We have the engineers and the scientists to do that. That creates supporting spin-out companies and other supporting businesses which we can export, but we have a tendency to lose control of those things quite quickly in the UK. We create technologies, and then the US makes them, or Germany makes them. We need to retain that here. We need to retain the skills, the entrepreneurship and the business in the UK.
Q150 Rachael Maskell: What factors do you believe would achieve that?
Professor Dalby: We have good infrastructure. Things like the Catapult investments help, and support new businesses and academics producing new technologies and bringing them to market. We need something to sustain that. We are very good at giving them buildings but not necessarily funding what goes on inside them. That needs to be continued, as well as the on-the-ground innovation, largely in higher education institutes.
Chair: Interesting.
Q151 Mrs Hamilton: Good morning. I apologise for my lateness. I had a bit of an issue in my office. I don’t know if this question has been asked, so if it has been asked, I apologise. It is for Professor Paul Dalby.
I think Rachael touched on collaboration with both the Government and NHSE. Currently, what is happening to foster collaboration between the Government and NHSE? My other question is, if you were going to send Government a message, what would that be?
Professor Dalby: For NHS England, I can only really talk on the manufacturing side, in the sense that they are one of our stakeholders. When we co-ordinated the future manufacturing hub for targeted healthcare, we brought NHS England, NICE and MHRA around the table when discussing things like how to bring CAR-T to market and what the pricing and regulation challenges were. They are definitely involved through our invite to come and join in that discussion. They learn a lot through the kinds of activities that we can do there. I cannot speak beyond that level and what then happens, where they go and who they talk to. What was the second question?
Q152 Mrs Hamilton: I will ask everybody the second question. What you have talked about is really interesting. If you were to send a message to Government that you want them to do something to help your area, what would that be?
Professor Dalby: It is echoing what I said before, really. It is to invest in longer-term strategy on the ground: the new technologies in academia. The clinics and the hospitals in academia are very good at innovating novel therapies, but it cannot just stop there. They need the funding for clinical trials. Then they need commercialisation, with the ability and the funds to do that. That includes the manufacturing capability.
Q153 Mrs Hamilton: Let me ask the other two gentlemen. James.
James Hargrave: At the risk of sounding like a broken record, it is to have a cancer plan. Our sector is awash with strategy. What we lack is an implementation plan. The Government set out some very ambitious goals for cancer in the NHS long-term plan, with 75% diagnosis at stage 1 and 2 and something like 70,000 more patients living five years on from their cancer. What we, as a community, need to understand is how they want to get there. In the UK, as we have just explored, we have a fantastic foundation of research. We have some of the best and most respected patient groups in the world in the UK, with Macmillan, Cancer Research UK, Breast Cancer Now and so on. We have a dedicated pharmaceutical sector. If we were given the right rallying cry, we could all work together more effectively to achieve it.
Q154 Mrs Hamilton: Last, but by no means least, Tony.
Tony Hickson: In my own area of early-stage innovation, the main things are those I mentioned affecting academic culture, and really signalling and encouraging engagement in translation going beyond research. It is also getting the capital correctly allocated, with the right size capital at the right time so that we do not lurch from, “Let’s address a scale-up problem,” to, “Let’s address the early-stage problem.” We need a contiguous pathway of capital.
That is my own area. To echo the point James made, of course for cancer patients we need that long-term, consistent 10-year plan. We really do need that to make a difference.
Q155 Mrs Hamilton: That is awesome. Finally, as long as the Chair doesn’t mind—I did come in late, so he could say no—I love the bright young things who are coming out of university and what they have to offer. Tony, do you believe that in the UK we really encourage those young people, or even older people, to stay with us and grow in the UK?
Tony Hickson: Absolutely. I think we are seeing a change. We are seeing a generational change in that culture and an attitude to really trying to want to grow start-ups and new spin-outs to engage with industry. Within Cancer Research Horizons, we run an entire programme of entrepreneurship programmes all round the country to encourage that activity. We could do more. We could signal more that we want those people to form their start-ups here and we want them to stay here.
Certainly, scale-up capital is a vital thing needed to keep those start-ups resident in the UK, but we need to address things like the Nasdaq issue, where many companies leave and move to US stock markets because our own stock markets are not specialist in nature. They do not look at biotech, biopharma and things like that. It is about addressing that gap in investment—high-quality specialist investors—to get people to list here, put down roots and stay here. You have to do all of those things if we want to keep companies in the UK.
Q156 Mrs Hamilton: I will tell you why I asked that question. We went to Singapore recently, as I am sure everybody has already said. What I admired about Singapore, which is, I think, a negative for us, was that the bright young things went to countries like the UK, learnt their trade, developed their skills at Oxford, Cambridge and all over, but then went straight back to Singapore. Even though we were doing the training, we were not able to keep them in the UK. That is why I asked the question. What do we need to do to keep those people here? It can’t just be about money. What are we not giving them that other countries, or their own countries, are able to give them? They come here, get the brains from here but then just go back home.
Tony Hickson: It is all the things I mentioned. It is creating an ecosystem, an environment, so that they want to stay here. It is making it easy for them. Many of the problems academics face are that it is too difficult and the barriers are too high. If we can lower those energy barriers so that they can be successful academics and be successful entrepreneurs at the same time, they are more likely to stay here.
Q157 Mrs Hamilton: Is there anything you want to add, Professor?
Professor Dalby: That is exactly what I would have said. Clearly, the appetite is there. Many of the new start-ups come from PhD graduates in the UK. They learn their trade in a lab and create a new product. Then they think, “Yes, I really want to go and commercialise this.” They have all of the training to do that in terms of entrepreneurial expertise within the kind of programmes we have, but then they do not have the funding that can help them so easily on to those next steps.
There is a decline in the number of doctoral students in the sector. That will also eventually lead to a drying-up of the bright young thing talent that you are talking about.
Q158 Mrs Hamilton: It is only that I am jealous. Last but by no means least, and then I will hand back to the Chair, James, do you want to add anything, or do you think it has all been said?
James Hargrave: All I would add is that on the research/entrepreneurial side—Paul and I were discussing this the other day—some of it is a bit of a cultural thing. The US is very good at creating a culture in its universities that, when you create, you can also commercialise and own that. We are less good at that over here. That is something that probably warrants looking at.
On the clinical side, in attracting the talent, obviously the workforce plan is hugely helpful. Trying to solve some of the crises that we are experiencing in the NHS is a huge part of that. It has to be somewhere that doctors want to work. That is obviously an issue at the moment.
Mrs Hamilton: Thank you all. Chair, thank you for allowing me in.
Chair: Concluding with the two Pauls, do you have a quick supplementary point on what we were just discussing?
Q159 Paul Blomfield: On Paul’s point about the drying-up of doctoral students in the sector, I thought life sciences was the really exciting territory. What is happening?
Professor Dalby: The capital for the funding of doctoral training has decreased, so the number of training centres in any given area has decreased. The total number of doctoral students in the country has dropped. What is administered through UKRI has decreased. We are fighting across all sectors for ever smaller numbers, and to be honest it is suffering.
Paul Blomfield: We need to chase that up.
Chair: That is a very good point. Thank you.
Q160 Paul Bristow: Tony, I want to ask you a question about your engagement with Government. What sort of engagement have you had with the development of the major conditions strategy?
Tony Hickson: I really can’t answer that question. I am not on the policy side; I am on the early business side of the charity.
Q161 Paul Bristow: I am assuming that Cancer Research UK have been involved with Government and offering their thoughts on the major conditions.
Tony Hickson: Absolutely.
Q162 Paul Bristow: You may wish for there to be a 10-year cancer strategy, but surely you have taken the opportunity to engage with Government on the development of the strategy?
Tony Hickson: Absolutely. Our policy team have regular dialogue with the Government about these things. Certainly, we are very aware of what the Government are trying to do in their policy development and their major conditions strategy. As the Chair mentioned at the start, we advocate that there should be a specialised cancer strategy rather than its being part of the overall major conditions strategy.
Q163 Paul Bristow: I understand that. I have read your document this morning and I understand where you are coming from, but I guess what I am asking is whether your engagement is limited to, “We need a cancer strategy,” and that’s it, or are you proactively helping the Government to develop what you would hope to be a coherent, five-year major conditions strategy?
Tony Hickson: Very much the latter. We want proactively to engage. We want to be part of the team working with Government to develop the 10-year cancer strategy. In fact, we want all the stakeholders in the room. We want patient advocates, we want other charities, we want Government and we want industry. We believe there now needs to be a collective effort to address cancer. Just saying, “It’s up to you, Government, come up with something,” is not going to work, especially when you consider that charities are funding 62% of the cancer research in the country, if you exclude industry.
Q164 Paul Bristow: The same question to you, James. Have you been involved in helping the Government develop their major conditions strategy?
James Hargrave: I think the short answer to that is, not as much as we would like to be. Many of us put in submissions to the initial 10-year cancer plan consultation done 600-odd days ago. When they then ran the second consultation on the major conditions strategy, if you went to the cancer part of that consultation it said something along the lines of, “If you’ve already made a submission to the previous consultation, you don’t need to this time, but if you really want to you can put in 300 words.” I am not sure that 300 words covers it.
Q165 Paul Bristow: That is extraordinary. Obviously, you contributed to the idea of a 10-year cancer strategy when that was previously the plan, but a major conditions strategy is different from a cancer strategy. Surely, the Government would want to hear from you, and you would want to feed in to the Government.
James Hargrave: Absolutely. That is why we keep going back to the call for having a plan that we can all see, and then work out together what we can bring to seeing it implemented.
Q166 Paul Bristow: I guess what I am trying to get at is this. As you say, we have highly respected patient groups and a good cancer community. Has the attitude of the wider cancer community been, “Right, okay, we want a 10-year cancer strategy and that’s it. We’re just going to focus on our call for a 10-year cancer strategy,” or is there a proactive effort to try to help the Government create a five-year major conditions strategy?
James Hargrave: It is a very fair question. I think the challenge that we are all having is finding the bandwidth in Government to think that far ahead. One of the important things about this inquiry is that it is forward-looking. We are all sympathetic to the challenge at the moment, but the clear focus is on elective recovery, on the emergency services recovery plan and so on. There has not been the capacity to consider what we need to be ready to do in the next five years or 10 years.
Q167 Paul Bristow: Do you mean capacity within Government or the broader healthcare community?
James Hargrave: Probably more within Government and the Department. I know that certainly in the community a lot of us are thinking all the time about what we need to get ready to do for the next five years.
Q168 Paul Bristow: Tony, do you want to add something?
Tony Hickson: In addition to this document, which is the public-facing one, there is a 200-page recommendation document to Government that is coming out as part of the manifesto. We are not taking a passive stance and saying, “Here are a few recommendations. Sort it out.” We are proactively suggesting concrete actions.
Q169 Paul Bristow: It is much easier to try to persuade the Government to do what you want them to do if you can show that, by doing what you want them to do, they can meet their own objectives, if you understand what I mean. What I don’t want to see happen—you have kind of reassured me that’s not the case—is the cancer community saying, “We need a 10-year strategy,” and that is the only thing you are saying to Government. I want you to be able to help Government in terms of what it is they are actually doing and in terms of the long-term major conditions strategy.
Tony Hickson: Agreed.
Q170 Paul Bristow: It has been widely reported that Denmark were very poor at one point, maybe 10 or 15 years ago, but they have made a concerted effort to get much better. What specifically did Denmark do? If there are three things that happen in Denmark that do not happen here in the UK, what would they be?
Tony Hickson: I don’t know. I am aware of the data that showed that Denmark was in an equal position to the UK over 10 years ago, and had a concerted plan to address this and is now well ahead of the UK. I am unaware of how Denmark solved that problem.
Q171 Paul Bristow: Professor Dalby, do you have any thoughts on that?
Professor Dalby: I am not sure I can really comment on that. I know that their university infrastructure is well supported.
Q172 Paul Bristow: James?
James Hargrave: I wouldn’t pretend to be an expert on Denmark. I recall that they were certainly some way behind the UK in their uptake of cancer medicines. That is something that they have now overtaken us on, I believe, in terms of actually getting the medicines to the patients. I also believe that Denmark takes a slightly different approach to some of the ways that it gets patients into the system. I think they have at least some pilots, if they are not actively running a programme, of direct referral, so there are some things that they do differently.
Chair: The Secretary of State will be sitting where you are sitting very shortly, honouring the commitment of her predecessor to sit before us. You can be sure that the issue of the cancer plan, or lack thereof, will come up. What you have said this morning has been incredibly insightful, both to that and to our ongoing Future Cancer inquiry.
James Hargrave, Professor Paul Dalby and Tony Hickson, thank you so much for giving up your time on a busy day. Good luck with your launch this evening at the Crick. Sadly, I shall be here voting, but I will be with you in spirit. Thank you for that.
Examination of witnesses
Witnesses: Julian Beach and Sarah Byron.
Q173 Chair: Welcome. This is today’s second panel in the fourth session of our Future Cancer inquiry. We heard earlier from University College London, Keep Up With Cancer and Cancer Research Horizons, which is a wholly owned part of Cancer Research UK. The second panel is Julian Beach, who is interim executive director of healthcare, quality and access at the MHRA, the Medicines and Healthcare products Regulatory Agency, and Sarah Byron, who is the programme director of devices, diagnostics and digital at NICE, the National Institute for Health and Care Excellence. I think this is the first time that we have had your organisations before our Committee together, which is good. Thank you for coming. You listened to some of the evidence that has been given this morning and the very clear messages that we have been given.
I will start with the MHRA, Julian, if I may. As mentioned, last Wednesday, in their response to the O’Shaughnessy review, whose recommendations they accepted, the Government stated that “backlogs in research approval applications have been cleared by the” MHRA. Anecdotally, I hear that, too. People say, “Things have really sped up at the MHRA.”
What are you having for breakfast? What is going on? Something has changed. There has been a step change in turnaround at the MHRA. I am praising you. I am giving you an opportunity to say how that has happened.
Julian Beach: It is a pleasure to be here. The focus on clinical trials is because we recognise their importance to innovation. We want to make sure that we are delivering on our core remit, which is to be world leading in innovation across the ecosystem in the UK. It is absolutely recognised that the front door of that process, as opposed to the research or the molecules, is looking at making sure that we can translate them, to see whether they are both safe and efficacious, and that we can then get on to the manufacturing of them. That starts the ecosystem going, as we heard this morning.
From the MHRA point of view, I believe that in the last six to 12 months we have been focusing on how we define new ways of working. You are absolutely correct, Mr Chairman. Over the summer, we cleared about 2,400 clinical trial applications. Now we do not have a backlog. We are monitoring that on a day-to-day basis and bringing in new processes to look at how we can increase our risk-proportionate review of the clinical trial applications, and the associated amendments that come in from them, and at how we review our licence applications for medicines that come through to us following successful clinical trial completions at a later stage. Those are ongoing right now.
That is driving the strategy. We have a three-year strategy, where we look at making sure that we are delivering on an operational performance metric and being a lot more visible about what is going well and what is not going so well, because there are both sides of things. We are making sure that we are very clear in that delivery, to ensure that patients get the medicines that they need.
Q174 Chair: Obviously, you have worked really hard. Professor Bell has given you credit as well. That is good credit from John, who—let’s be honest—tells it like it is. What have you learnt from that process in the last 12 to 24 months to mitigate backlogs appearing in the future?
Julian Beach: We are looking at how we develop capability in our staff. They are doing an absolutely excellent job right the way across the agency, focused on the core commitment of public health and patient safety. Translating that means having the right skills development and talent retention and looking to bring the right expertise into the MHRA. All of those are critical factors in how we see that we can deliver longer term.
We need to have a strategy for flexible resource if there are increases in demand, as we project there will be. This morning we have heard about personalised immunotherapies and about the increasing number of potential therapeutic agents that may be coming through to us with a narrower indication. That means going from broad spectrum approvals that will be available to everybody to bespoke medicine, and that there will be a lot more of that. It is then about developing systems for platform regulation, and understanding how we can support the innovation by changing the regulation. We need the skills, in the people, to have the competence to be able to develop the longer-term changes that we need right now.
It is really exciting. It is an absolutely great place to be in terms of how we influence the global infrastructure for that. We are liaising and working with global partners in regulation. We are demonstrating guidance development, with things for the International Council for Harmonisation. The active engagement of the agency in those broader spaces is welcome and recognised. Those sorts of things will enable us to come back to maintaining that resource—the development and engagement of staff—because it is both the assessment of medicines and the development of innovation that keeps staff happy, engaged and delivering.
Q175 Chair: We will explore international collaboration in just a moment. I will bring in Sarah. James Hargrave from Keep Up With Cancer talked about the criteria against which NICE judges its outcomes. He said that as a result of the change in those criteria fewer cancer medicines are getting from the bench to the bedside. Fair?
Sarah Byron: I don’t think that is what we are seeing. The important thing is that we reviewed the end of life criteria. We listened to stakeholders and our feedback was that end of life is a really important consideration, but so is the quality of life that someone experiences and the severity of their disease, particularly in rare diseases. There was a cliff edge with the end of life criteria. That is why we have moved to severity criteria, which enable more flexibility to take into account what we might see in other diseases, as well as cancer, and allow us to capture the severity of the disease, as well as the quality of life extension that you might see. It is not all about the end of life. That is why we changed it.
We did extensive consideration of what the impact would be, looking back at some of our assessments. We did not see a big change in that, but we are monitoring it to see whether there is any impact that we have not foreseen yet.
Q176 Chair: The fear is that you have replaced one cliff edge with another. I think James referred to that. Can you address that?
Sarah Byron: Yes. It is a challenging area. We are saying that we are willing to pay more for these areas because we recognise their importance. That is the piece that we are trying to say. We have worked hard to look at something that balances all of that in the disease area, not just in cancer. We have not seen the cliff edge in the same way, but it is something that we monitor as we move things and societal preferences change. We review our methods regularly. If we see a big, distinct difference, obviously we will look at it and review again, to see what we need to change. At the moment, we are not seeing a big difference in that.
Q177 Chair: Okay. Earlier this year, we were in Stanford in California. We were talking about AI, particularly in digital reads. They were talking about the challenge of AI software as medical devices, which, of course, have to go through the regulatory process. What is your view on that? What challenges does it present to your organisations?
Sarah Byron: We have evaluated some of the AI technologies at the moment. We developed a new approach called early value assessment particularly with some of the digital technologies in mind. That is where we are seeing promising technologies that address the needs of patients in the NHS, but their evidence is not quite there yet and we need to be a bit more confident before we can recommend wide-scale adoption. With this new approach, we are giving conditional recommendations to say, “Yes, this looks promising. You can use this, as long as these measures are put in place and you can collect evidence for the future so that we can make that decision.”
At the moment, the AI coming through still has clinical oversight. We have not seen a big change because our focus is very much on patient outcomes, but what we know about AI, and have factored in more, is the greater focus on efficiencies that it offers, such as getting through lists quicker and speeding up patients’ diagnoses. We are looking very much at AI. It is a big focus of our work.
The plans for the future are for when AI replaces clinical decision making and how that would work. That is the piece we are looking at. Because we are focused on patient outcome, for NICE it is about looking at how the information which the AI produces informs clinical decision making and what impact that has. That is similar to our thinking at the moment when we look at it, but we are keeping a very close eye on whether there are other differences.
In evaluating the AI, we look at evidence on whether it is relevant to the population. We do that anyway for any technology. There is work going on about the data in AI and whether there are potential biases for the population and how that would work. As I said, in the current AI situation you have clinical oversight, so those risks are managed, but we are also looking to the future and what would need to be done.
We have looked at AI for CT and AI in stroke. It is a really exciting area. When you go through a diagnosis approach, it is often a sequence of tests, not necessarily just one. What we see with AI, which may be really valuable, is that where there is real confidence in an image, so we definitely know that it is negative, the AI could perhaps interpret that. Then the workforce are supported and can focus on the bits where there is something that really needs looking at. There are lots of opportunities in that.
We are developing our methods. We evaluated a lot of digital in the past, anyway, and are bringing in more measures to check the AI. At the moment, it is exciting to look at how it informs clinical decision making. That is quite a lot of our bread and butter.
Q178 Rachael Maskell: Julian, perhaps I could start with you. Clearly, the quality of what the MHRA does is indisputable. Before I look at the international space, I am curious with regard to your relationship with NICE and what you would want to see change at NICE to ensure that we can be world leading across all the areas that we have been discussing today, in that regulatory space.
Julian Beach: I think it is about communication between the infrastructure across the whole network. That is something we are absolutely focused on, so that we have regular communication and collaborations as things develop. Sarah commented on the NICE methodology for looking at medical devices. Similarly, we are looking at an AI airlock for development of those device-type aspects, to ensure that they meet the criteria for safety and efficacy. It is about looking at it from the point of view of how we can pull the innovations through and enable that. That is our fundamental purpose. We have to look at what the UK’s strengths are and how we link NHSE into that. How do we bring in the strong backbone that we have in the NHS, in terms of the research that goes on there? How do we link that through?
It is about communication across the piece, to enable that innovation. You do not assume that it happens. Sometimes we have strict commercial sensitivities and we have to be cognisant of the fact that we need the consent of the organisations we are working with. We are working collaboratively with NICE to ensure that that flow and, therefore, the take-up of the medicine can be very much speeded up. It is about looking at the pathway for development and then use. That area is a constant focus, and rightly so.
Q179 Rachael Maskell: That is really helpful. I want to ask about the international context. Obviously, quality is quality and safety is safety, and we all aspire to the highest standards, but, as we heard in the first panel session and have heard at other evidence sessions, we are not where we want to be as regards clinical trial and being able to advance technologies. How much more could we work with the international community? I have seen that there are collaborations. Not only are there bilateral discussions with the US, but you are looking at approvals with a number of countries: Australia, Canada, the EU, Japan, Switzerland, Singapore and the US. Is there more that can be done in that global collaborative space to ensure that we see innovations and technologies come forward at pace and in a stronger way, not least because we still have some weaknesses within our scaling-in to clinical trial?
Julian Beach: To answer that question, there are a number of factors. The international pathway for recognition of a regulatory approval in another jurisdiction is something that will enable us to have more focused targeting of our resources. It is a precious commodity. That is one way of developing it, but we also have to look at what we are doing in the UK to develop guidance to contribute internationally to the standards that are being developed.
To take the new technologies, we have talked about personalised immunotherapy, we have phages coming through, and we have genomic medicines. There is a wide suite of different technologies, which is what makes it a really exciting space. For example, we have established a cancer expert working group within the MHRA, which brings together 32 leading experts from industry, academia and the MHRA to provide a view and a fast-tracking collaborative space to bring innovation to the UK where we do not yet have robustly set international standards. That enables the agency, as a spokesbody for the UK, to say, “This is what we think. This is how we think the infrastructure should be generated. This is how we think we can contribute globally.”
That comes back to the standard, so that we can focus. With international recognition, we can bring medicines through to patient access more quickly. Equally, the challenge is there to bring them through nationally, without the recognition. We want to sponsor innovation in the UK, so we want those pathways to be functioning in the UK. The recognition piece is expanding our assessor pool by using other competent authorities we work with. It is quite a dynamic space.
Q180 Rachael Maskell: That is fascinating and really helpful. Something that we should pursue throughout this inquiry is looking at those opportunities.
Turning to NICE, in the number of approvals of global medicine launches since 2016, the UK has been very much lagging behind what we would like to see as comparable nations, such as Germany, Italy and France. What does NICE need to do to ensure that we are up there with the best of them and that all the work we have heard about up to that point comes to fruition and there are more launches of world-leading pharmaceuticals and other technologies?
Sarah Byron: We are about the third-fastest globally in terms of recommendations, but there is obviously more to do. We can be faster. We are collaborating with MHRA to make sure that the timeliness of approvals is appropriate. Last month, we published our recommendation at the same time as the marketing authorisation for the drug for advanced lymphoma. We are definitely transforming and looking at ways we can be quicker, which is one solution. About 80% of our recommendations in the last few years have been positive, so a good number of drugs are being recommended in that space.
The other part relates to health technologies in particular. It is about looking at how we can support companies and the NHS to generate the evidence that we need so that we can be confident that they are offering benefits to patients. That will drive up positive approvals as well. As I mentioned, we have introduced a step in the path to better support companies to do that, linking with the NHS. We are collaborating with NHS England on that as well.
We have just refreshed our new NICE advice approach, which offers advice to companies on how to navigate the system for gaining approval and tells them what evidence they need. We have a multi-agency advice service for AI and digital as well, to help companies to know how to navigate quite a complicated landscape to get to adoption and to help them drive the approval to get into the NHS.
In terms of speed from the regulatory perspective, we are looking at a wider context. As I said, we are working with MHRA and aligning very well, but sometimes, once companies have gone through the MHRA approval process, some of them request a bit more time to gather more data so that they can come through NICE, where they can demonstrate the benefits to patients as well. There is a broader stakeholder investment in that.
You mentioned some of the international recognition routes. We are working with the companies to make sure that they give us good notice of their plans to go down those routes, so that we can schedule and align with that, both to get more through the system and to make sure that they have a better chance of approval.
Q181 Rachael Maskell: I have a very quick question to end, although it probably deserves a long answer. Often NICE is seen as having many limitations placed on it. It can sometimes be the brake, not the accelerator, to seeing innovations come forward. What are the limiting factors? Is it purely budget and cost? Is it the lack of investment from venture capital or others? What are the real pressures coming down to limit the decisions that you are making?
Sarah Byron: One of the drivers, particularly in marrying up health technologies, is around the requirement for companies to generate evidence to show that their technologies work and are value for money. It looks a bit different from medicines. As we have heard, there should be the infrastructure in the NHS to have sandpits or testbeds, but with a consistent and sustainable offer to industry to enable it to know, when it comes to the UK, “These are the regulatory requirements for NICE. This is how you can get them. This is what the reimbursement is and what the approaches are.”
At the moment, we are working with our partners at NHS England, MHRA and NIHR to set up a much clearer pathway to adoption for health technologies. Our role is to make sure that we identify and recommend excellence in healthcare. We need evidence to be confident, without being over the top about it, that those technologies are working and that we are getting value for money for the NHS. A lot of the challenges that we see at the moment are around that evidence piece.
It is also about making sure that we help and facilitate adoption routes. Some of the health technologies implementation needs a bit more. You might need to change a protocol. Some of the effectiveness is dependent on how you use it, so what do we need to put in place? How does the NHS need to change in order to accommodate the new technologies and innovations? Sometimes NICE can get caught up in the wider picture of the challenges that we are facing to get those technologies into use.
Chair: Very good. Well done, Rachael.
Q182 Paul Blomfield: One of our earlier witnesses was from Keep Up With Cancer. In its written evidence, it highlighted that in the UK “only 54% of”—EMA—“approved products available in England can be accessed by all cancer patients” and that that was strikingly behind Germany, Italy and France. Why?
Sarah Byron: That is a good question. On implementation, there are challenges at the moment. At NICE we are producing guidance looking at how, as you heard this morning, we can triage patients to make sure that they get to the right treatment appropriately. For example, this morning you heard about tumour profiling. At the moment, we are looking at tests that may say that some people do not need chemotherapy. If those patients do not need it, you can free up resources to treat other people with chemotherapy.
One of the challenges that we have with the NHS is that we are seeing a lot of brilliant innovation in drugs, but how do we help the NHS and support healthcare professionals to keep pace with that and make sure that they can implement it? The cancer alliances take account of all the different chemotherapy drugs that are coming through and how we can do that. There are different-pronged approaches to helping the system to implement them and to improve our access to the cancer drugs as well.
Q183 Paul Blomfield: Can you elaborate on that a little? What are you doing at NICE to tackle those prongs?
Sarah Byron: At NICE we are very much looking to ensure that, where we produce guidance, it is useful to the NHS and is providing the right information. We are also looking at innovations that could help the system to adopt those medicines. Medicines that are recommended can be used and made available in terms of funding, but administering those medicines may require more workforce and resources in the NHS. We are looking in parallel at what technologies are available to help the workforce to deliver them. Are there things that we could be using to help to reduce the burden on the NHS? We want to produce guidance on those technologies as well to support the infrastructure to get those medicines used.
The other part concerns access to medicines. We have the cancer drugs fund, where drugs can be used earlier. We have alignment with NHS England in working on commercial deals to help to get value for money for the taxpayer on prices as well. There is a lot of work going on. At NICE we have a new clinical directorate, headed by a chief medical officer. We have a renewed focus on implementation and support for our guidance, to say, “How can we work with the system and our partners to make sure that our guidance is actually implemented? What can be done?” Some of that is timing, aligned investment and that type of thing. There is a lot of work going on at the moment to transform not just the way we work but how we collaborate, partner and work with people to address some of the challenges in the NHS.
Q184 Paul Blomfield: You mentioned the cancer drugs fund. We have heard, and you know, that a lot of these fantastic, innovative new drugs are also hugely expensive. Is the budget allocated to the cancer drugs fund enough to keep up with the innovative products that are available?
Sarah Byron: I am not sure that I am best placed to answer that, to be honest. I am not over the medicines team, but I can certainly get some evidence sent back to you on that.
Q185 Paul Blomfield: I don’t know whether you will be able to answer my next question either. Part of the evidence that we received was about the problems with the current pricing inflexibilities and the consequence of disincentivising investment in treatments that could lead to significantly improved outcomes for people. Keep Up With Cancer argued that we should be moving to multi-indication pricing. Do you have a view on that?
Sarah Byron: I think that is part of our remit, but it is also for the commercial side of things at NHS England to address the question of multi-indication pricing. At the moment, we have a price for the drug that is available across the piece. I think those are the deals.
Q186 Chair: We will leave it there. We have covered quite a lot of ground in the time we had. Is there anything else that you wish to add, Mr Beach, particularly on the AI conversation that I had with Sarah? I know that you were listening intently at that particular point.
Julian Beach: No. AI is a very strong area of focus for the agency right now. We are looking strongly at writing and bringing legislative change and developing regulation in that field for medtech generally. That is a very clear focus for the agency. We are really looking at that.
I want to highlight the fact that in the cancer EWG that we have set up we are looking very strongly at patient engagement. That is something that we truly feel is needed to get a rounded view of how we can develop innovations that patients will take up. We are going through that landscape change from where we are at the moment.
Chair: Thank you both for coming in, Sarah Byron from NICE and Julian Beach from the MHRA. Thank you so much for rounding off today’s session of our Future Cancer inquiry. We appreciate your time.