Oral evidence: Regenerative medicine, HC 275Tuesday 19 July 2016

Oral evidence, 19 July 2016.

Witnesses

Dr Rob Buckle, Director of UK Regenerative Medicine Platform, Research Councils UK, Professor Jeremy Pearson, Associate Medical Director, British Heart Foundation, Professor Neil Hanley, Professor of Medicine, University of Manchester, and Professor Anthony Hollander, Head of Institute of Integrative Biology and Professor of Stem Cell Biology, University of Liverpool, gave evidence.

Chair

I am sorry to have kept you waiting. You were probably present at the earlier panel. There are some questions we would like to ask you, and we never have enough time, so I hope you will bear with us if after this meeting we write to you with further questions. For the sake of people who do not have your biographies in front of them, perhaps you would briefly tell us your background in regenerative medicine, starting with Professor Pearson.

Professor Pearson

I am representing the British Heart Foundation. We are the major funder of cardiovascular research in the UK, and actually the major funder in Europe, although that is a separate question. My own background is as a basic scientist working on blood vessels—how they work and go wrong—but now I am research director at the British Heart Foundation, so I am in charge of the research funding process by which we decide on the priorities of what we fund, including regenerative medicine.

Professor Hollander

I am a cartilage tissue engineer, not a clinician. I grow cartilage for arthritis, airway disease and so on. I am head of the Institute of Integrative Biology and professor of stem cell biology at the University of Liverpool. I am also associate pro-vice chancellor for enterprise for the university, and I have a spin-out company that has taken a stem cell therapy for torn knee cartilage through to clinic, so I have a particular interest in the commercialisation of stem cell therapies.

Chair

In this country.

Professor Hollander

Absolutely.

Professor Hanley

I am Neil Hanley, professor of medicine. I am a clinician; I am a hormone doctor and endocrinologist. In the hospital, I am also an R and D director for seven hospitals in Manchester. In the laboratory, I study very early steps in how human organs are put together, and that is allied to aspects of stem cell biology in a dish.

Dr Buckle

I am Rob Buckle. I work for the Medical Research Council as a research funder. I was trained as a biomedical researcher but joined MRC in 2000. I am director of science programmes, at the moment looking after strategy and science funding. In this particular context, I am the administrative director of the UK regenerative medicine platform on behalf of three research councils.

Chair

Beginning with Dr Buckle, where do you see regenerative medicine in the next 10 years? Do you think there is a financial impact on regenerative medicine as a result of us leaving the EU?

Dr Buckle

In terms of development in the next 10 years, we certainly hope that there would be proof of clinical efficacy of regenerative medicine. In truth, the number of clinical trials in the next 10 years will be fairly limited, but the translational landscape, as you heard from the first panel, has changed significantly in the last few years. There is real opportunity around the interdisciplinary mix that has been brought together, and the tools and technologies are in large part now there. I think we should be optimistic that there will be good progress in the 10‑year timeline, but whether that translates to clinical products is an open question.

Chair

Do you think there will be any financial impact on regenerative medicine as a result of us leaving the EU?

Dr Buckle

Potentially. It remains to be seen how it shakes down, but the EU provides a big funding source for researchers in this area. I looked at the EU consortia that are funded in this space right now. The UK has leadership in eight large consortia on a scale of €5 million or bigger, and we are involved in another eight. That is probably about three quarters of the consortia in this space. We are very successful. We lead two big innovative medicines initiative programmes in this space that involve bio-pharma at European level, with €90 million of investment between the two. These sorts of consortia are of crucial importance in providing capacity and connectivity. That does not mean they will not exist in the post‑Brexit landscape, but we have to be worried about making sure that the connections we have do not dissipate in the interim and that the funding currently going into Europe is available for the research that might be undertaken in this country.

Professor Hanley

I have now got to the stage where I have forgotten what the original question was. I will start on the European bit.

Chair

We are looking 10 years ahead and at whether EU funding will have an impact.

Professor Hanley

We are where we are with the European thing, so I now try to view it as an opportunity. As you have heard repeatedly, people who set up links are not going to stop them suddenly. It will happen. There is an opportunity now to look at some of this outside Europe perhaps more attentively, but it is contingent on Government support—there is no getting away from it—and recognising that this is a sector of UK business and activity that is good and strong and we want to promote it.

Chair

Would you agree with the 10-year view of clinical trials coming more into play?

Professor Hanley

Yes. As a clinician, there is a risk of giving a glib answer to that. We have done bone marrow transplantation for decades and that is a stem cell therapy, and we are now making inroads into treating retinal and corneal disorders, so I do not think you can put it in a simple 10-year envelope. There have been great advances, there are advances currently and there will be advances. It is a question of making sure that it is at the right time for that particular area in a safe and responsible way.

Professor Hollander

We are at a critical time over the next 10 years in the evolution of this very young area of therapeutics. It feels to me that we are moving beyond the early exciting stage where everyone sees the potential and we know enough to understand how difficult it is to get from the exciting science into the clinic in a scaled-up meaningful way. There will be a real need on the part of Government, the public and patients while we do the really hard work of making this a very effective area of expansion of therapeutics. As to the EU, in addition to what has been said, wearing my commercial hat and thinking about a small company like mine with not much money, there is a risk that, if we are going for market authorisation of a product in a few years’ time, we will certainly want to enter the EU market. Will we also have the money to enter the UK market? I am not sure. There is a risk that UK plc will invest a lot of money in developing therapies that will not see the light of day in the NHS because we are putting them out in Europe, possibly in America. They may eventually get to the UK when there is enough money in the company to tackle that market as well. I speak for myself, but I see a potential problem.

Professor Pearson

In terms of the 10‑year vision, I go along very much with what Rob and the others said. We are at a pivotal stage in the science, which is advancing rapidly, with the potential for real development into clinical efficacy, but, as the first panel made clear, there is a lot more science yet to be learned to enable that transition to work fluidly and across a wide range. My vision, like Rob’s, would be that we will get as far as clinical trials in some areas but not in all in the next 10 years. In my own field of cardiovascular biology I think there will be some, but small numbers. The critical thing going forward is to keep the infrastructure we have and improve on it, such as UKRMP and our own centres for cardiovascular regenerative medicine founded at the same time as UKRMP.

Chair

When was that?

Professor Pearson

Remind me, Rob.

Dr Buckle

It was in 2012-13.

Professor Pearson

We will be renewing those in some form, and I hope the research councils will renew UKRMP in some form, but the key thing, as we heard, is that they are multidisciplinary; they attract all sorts of science to make sure these interactions work to take it towards translation. Those are the things that I think are really important going forward. In terms of the EU, the BHF raises its money from the British public entirely, so you could say that the EU does not affect us directly, but it will, because all the research we fund is within UK universities. We are free to fund outside the UK, but clearly we do not do it very much because we raise money in the UK. If you look at the number of people we fund, currently 25% are EU citizens working in the UK. A greater number than that collaborate with people in the EU, and that will go on happening regardless, but to make it happen we need the Government to ensure that it can happen as well as it does now.

Chair

That is a very well made point.

Professor Hanley

I am conscious that one thing was not touched on in the previous panel, and I missed it just now. There is a key aspect of regenerative medicine that is not about cell therapy and putting things into people; it is the allied bit with stem cell biology in a dish. The bit you may not hear about so prominently is that, as we learn to make these cells in a dish, they get adopted for drug screening, drug discovery and toxicity safety testing all the way through. That is a huge area. In many ways that is almost the first game because it is far safer; it is in a dish and is not going into patients.

Chair

That point is well made.

Professor Hanley

I am just conscious that we had not mentioned it.

Chair

We had missed that. Thank you.

Jim Dowd

Before I go to the main thrust of the questions, I understand that you are here to represent yourselves and we selected you to come, but I notice that all the seven witnesses today are men. Is this not an area that attracts women scientists particularly?

Professor Pearson

I suspect you asked Fiona Watt, but she was too busy to come. She is very eminent in this field and undoubtedly would have given you her opinions. I am not sure there is a good answer to your questions. There are not enough women in science, full stop.

Professor Hollander

We have Sian sitting over there.

Jim Dowd

Yes, but she is on our side.

Professor Pearson

Are there sides in this? I hope not.

Jim Dowd

No. It is the broader question of getting women into STEM, with WISE and all the rest of it. I suspect there are also differences within the disciplines in science itself, where there are huge disparities. To come to my main point, I asked the previous panel about the gene and cell therapy catapult. How well do you think it facilitates the link between research and innovation in regenerative medicine, or does it not?

Professor Pearson

From the perspective of the BHF, we have not had many practical examples of that linkage for the people we fund, but we have had a lot of conversations and we find them very helpful. We think they are in the right space to assist that translation, as and when it occurs, but it has not quite got there yet. It is a very valuable piece of the ecosystem.

Professor Hollander

The cell and gene therapy catapult is a partner in an Innovate UK‑funded project linking my spin-out company with my university and other partners. It is hugely valuable to us on the one hand as an expertise resource. On the other hand, I think that in future it will help us collectively to figure out how we scale up commercially and turn the discoveries into something that can reach large numbers of patients. I am not sure the model is perfect yet. The catapult is still developing its own self-vision, but we are getting there.

Jim Dowd

The direction of travel is optimal.

Professor Hollander

For me, it is absolutely right and very valuable as the link between fundamental research space and clinical research on the one hand and commercialisation on the other.

Jim Dowd

Professor Hanley, you mentioned in an earlier reply that you thought Government support was crucial, whatever arrangements there are post-Brexit, if it ever comes to pass. There are large amounts of British industry that believe the same thing. Given Innovate UK’s preference or plan to introduce loans instead of grants, what do you think the likely impact of that will be?

Professor Hanley

For the catapult, or more broadly?

Jim Dowd

More broadly.

Professor Hanley

There is a range of funders in the UK and that is one model. As ever, the breadth of the models for how you do things is important and varies according to the stage you are at in the pipeline. When it comes to those sorts of ventures, I do not have a lot of interaction with the catapult, but it is a good thing. We have to try to do the right thing, which is to take basic science and translate it, so we need to do something in that area. The big issue is making sure it is as efficient, streamlined and successful as possible. You could, therefore, make a case for saying that a loan-type agreement may be a way of securing that, so I have no problem with it.

Jim Dowd

It would have no significant difference.

Professor Hanley

If everything switched to that, yes, but my point is that there is a breadth of options available from different funding agencies, be they Government, the Wellcome Trust or the BHF, so that mixed model is probably the right way.

Jim Dowd

Can I look briefly at the issues relating to intellectual property? Are there particular difficulties in regenerative medicine regarding intellectual property and the work of individual researchers?

Professor Hanley

There are challenges. It is easy to say from one area that, yes, we have particular challenges, but I suspect that if you had anyone here from any area they would give you fairly similar answers in terms of IP.

Jim Dowd

For example, would the patents be more complicated, difficult and technical than in other areas?

Professor Hanley

Potentially, but in any area involving IP coming out of the academic sector on an international level, patent lawyers all over will be picking holes in whatever you have put together. There are always complications and difficulties in it. Perhaps that is so, but my personal feeling is probably not.

Jim Dowd

Professor Hollander, you became rather animated.

Professor Hollander

I had a rather bruising but ultimately successful battle recently with the American Patent Office around some IP. That battle was over a complete misunderstanding of some of the fundamentals of cells and tissues, not the biology but in the translational sense. I will not bore you with the details, but in effect I had to educate the patent examiner on what they were getting wrong. That worked and the American system allows that. You can keep going back and forth until they get it, but the European system does not allow so many iterations. So far it has been okay, but there is an educational process to go along.

Jim Dowd

Do you mean there is greater difficulty in dealing with people who know what they are talking about?

Professor Hollander

Or at least pretending they do.

Dr Buckle

The sector has different characteristics in terms of patentability and type of commercial investment. As regards patents, there is a lot of know-how in this area that is probably as effective a way forward as individual patents. These are very complex processes when you get to the manufacturing stage and they are probably very difficult to replicate. This emerged when there was discussion around the European Court of Justice decision on the issue of patentability of human embryonic stem cells. We have not seen much impact from that decision in reality. Part of that is because the companies in this space, such as Anthony’s, are generally small and medium-sized enterprises. The business model is different; the money will probably be recovered short term in licensing deals rather than returns on patents. Of course, when we get to the loans issue, it is hard to know what the impact of that change will be, but for small and medium-sized enterprises it might be significantly different from big pharma, and we have to watch this through. To go back to the original question on the catapult, the UK regenerative medicine platform and the catapult were set up at pretty similar times. We set them up to be complementary, and to a large extent they are. I was quite interested in some of the responses to your inquiry saying that maybe the boundaries between the two were not discrete enough. Primarily the catapult’s role is to commercialise. It is a company and therefore the demarcation between the academic research and how it crosses over into the catapult is reasonably clear. There are a lot of projects—for example, Stuart Forbes’s trial in liver repair and Martin Birchall’s vitrogen, which is larynx repair—that were originally MRC-funded projects that are now being picked up and supported by the catapult. There is a way to go, but it is a good pipeline and model.

Jim Dowd

Finally, can I go back to the IP arrangements? As they currently stand in the UK, are they helping or hindering research into regenerative medicine and progress in the area, or are they broadly satisfactory?

Professor Pearson

I am not an expert, but from talking to people who work in this area I think the effect is neutral; in other words, there is nothing particularly wrong or right in regard to this particular area in the way the law works.

Chris Green

In inquiries there is always concern about R and D and innovation and getting ideas into products, in this instance getting regenerative medicine to deliver in the hospital or clinic. Professor Hollander, do you think we have the right infrastructure to take regenerative medicine from the laboratory to the hospital or clinic?

Professor Hollander

Clearly, we can do it because we have. My spin-out company has taken through to the clinic a therapy for torn knee cartilage that was trialled in a hospital in Bristol. We went through the usual regulatory process; we engaged with the NHS, and that happened. Has it been straightforward? No. It has been a fairly complicated process and perhaps it is becoming more complicated, but it can be done. Others have done it as well. The area where it will become particularly challenging is NHS adoption of these therapies. A lot is talked about that, but I am not convinced that enough work is being done to understand what cost model would be used in the future to adopt a therapy when it costs a fair amount up front but the benefits may happen over 20 years if it stops people coming back to the clinic year on year with a chronic disease. Those of us doing translational activity are quite happy to move it through the different challenges, but there is a risk, as I mentioned earlier, but now for a different reason, that we will do all this and not get it into the NHS, and it may benefit other countries or just the private sector.

Chris Green

There are definitely concerns about regulation and uptake, but in terms of the infrastructure and our abilities—the number of people and the laboratories that can do the work—is there a problem at the moment?

Professor Hollander

Not so much with laboratories. Particularly with the catapult’s delivery coming on board, laboratories are probably not the road block right now, because we are not scaled up to the point where labs are at capacity. In terms of skills, maybe we will hit a road block in the future, but we are not there at the moment.

Dr Buckle

The majority of research centres are embedded in or very close to hospitals, and there is an NHSBT support network that could be repurposed to allow delivery of therapeutics when they become available. There are different concerns according to the different areas of therapy. If we look at the ophthalmology model, which is a very tractable area in regenerative medicine terms, because Moorfields is a tertiary referral site for a large region, they have the throughput of patients and the clinical support structure to envisage that they could run the trials in that way. In other areas—for example, Parkinson’s disease, which is showing some promise now—it will be far harder to bring patients to one place. The trials will be done in very closely defined populations, and there will need to be a cluster of different centres and different standard routines to get the therapies to them. We have to be conscious that there are very different models out there. The signs are that the connection between the Department of Health investments in its research infrastructure and what has been put on the rails as a result of the regenerative medicine expert group activity is going in the right direction, but we do not have the pipeline of studies yet to start testing it out.

Chris Green

Do we have an adequate facility to cultivate clinical grade stem cell lines?

Dr Buckle

We have certainly made enough clinical grade embryonic stem cell lines to fuel the immediate need in terms of clinical trials. There are efforts under way to make clinical grade induced pluripotent stem cells. The adult stem cells are used largely to develop autologous-type work, where cells are removed from the patient and put back into the patient, and that is done more locally. Going back to pluripotent stem cells, the supply of those lines to the trialists is potentially in place when that happens. At the moment there is enough capacity in manufacturing facilities, but, as you will be aware, the cell and gene therapy catapult is creating new manufacturing capability with a view to the future, but the current model is that capacity is robust enough to do the necessary small-scale early phase studies.

Professor Pearson

The capacity and the vision of what the capacity might need to be are in place. The critical question as it accelerates will be whether there is enough resource to make it accelerate at the rate it needs to. We just do not know that yet.

Chris Green

That is one to watch out for in coming years. The Government have supported projects such as the UK stem cell bank. Are these Government-supported facilities fully utilised by UK regenerative medicine researchers?

Dr Buckle

The Medical Research Council is one of the main funders of the UK stem cell bank. It was set up primarily to manage the ethical characterisation and distribution of human embryonic stem cell lines. It does other work around that, but its main focus is on human embryonic stem cell lines. It was the first stem cell bank globally, and internationally it still has one of the highest profiles of a stem cell bank. In terms of human embryonic stem cell lines, there is a very well-managed process by which the bank’s role is to ensure that there are quality-controlled samples that the research community can use. The research community does not have to use the bank; it can source these cells from anywhere else, but it is very important in this area that people are going back to very well-characterised stem cell lines, because if you start to develop research projects at this point that are nothing to do with the clinic, without that quality that is where things go wrong, and there are examples of that. The more recent activity of the UK stem cell bank has been to bank the clinical grades, or what they would call the EU cell and tissue directive-compliant cell lines, of which there are 38. That is the world’s biggest collection of those sorts of lines. Whether they will be used for clinical trials going forward is an unknown at this moment because we do not have the pipeline, but it is pretty clear in terms of the number of lines that go out from the bank that, once they go to a research laboratory, the laboratory does not have to go back to the bank, so they are there. Nearly all the UK labs working in this space have access to lines that are either through the bank or on the bank’s registry.

Professor Hanley

There are certain things we can be proud of in how we have dealt with this over about two decades. The way our collection of funders has approached this in the UK has been fantastic. Things like the stem cell bank have been a fantastic force for good in UK science.

Victoria Borwick

Can I take us back to dealing with Government and the strategic approach? One of the recommendations of the regenerative medicine expert group was the setting up of a ministerial group to take forward a strategy on regenerative medicine. Do you have any views on whether or not that would be a good idea?

Professor Hollander

To go back to my comments in response to an earlier question, we are at a very critical stage. Developing any new area of therapeutics is going to be challenging. There are particular aspects of using cells to treat people that make it an extremely complicated area of science and translation, and we need to keep that on the agenda. If the ministerial group can work with this community in doing that, it will be timely and valuable.

Dr Buckle

The developments since the setting up of the regenerative medicine expert group and the House of Lords report, in terms of there being a one-stop shop for regulation, and the fact that we have early access opportunities for therapeutic delivery and so on, are all good ones and were brought about by ministerial focus. As we move from the research domain into adoption, with the steps that have to be put in place there, there are certainly some benefits in having oversight of that. Whether it is a ministerial group or some other mechanism is an open question.

Professor Hanley

There are two things. I reiterate what Professor Andrews said earlier. We must never allow the bottom‑up approach to be hindered, but the flip side is that ministerial, Government or MP involvement in this area is very important, because engagement is key. That is one of our strengths in the UK.

Victoria Borwick

If you were setting up such a group, who would be providing the strategic leadership?

Professor Hanley

It depends on what you want the strategy to be.

Victoria Borwick

As you say, if it is communication that is driving the agenda forward, as Professor Hollander said, I suppose it is a slightly different group.

Professor Hanley

It is a mix. This is another example where our funding structure in the UK is very proactive. For example, the MRC talks to the Wellcome Trust and has good relationships. As we move into clinical translation, as we talked about earlier, there are relationships with NIHR, for example. There are well-placed structures and individuals.

Victoria Borwick

While we are talking about funding, inevitably there is always a debate about further constraint on health budgets and suchlike. How would you see your area being constrained, or not constrained? Where could you find alternative funding? Is there something the Government should be doing to encourage more private investment? We have talked about the 10‑year strategy. How do you see the funding for that?

Professor Hollander

It depends on whether you are talking about the fundamental research, which is very well looked after and well served by the research councils and leading charities. Of course, we always want more, but it does what it does. As you go down, up or along the translational pathway, funding issues become more challenging. For example, there was a question earlier about Innovate UK and loans versus grants. There are pluses and minuses for both from a commercialisation angle. We will potentially lose the SME-friendly European pathways if we do not get a good agreement with Europe on Horizon 2020 and what follows it. At the moment, there are SME-only or SME-led calls, which I do not think have an exact equivalent in the UK, so there are risks at that end of things, moving forward.

Matt Warman

This question is mostly for Professor Hollander. In the interests of comprehensive disclosure, I should say that my wife’s PhD supervisor was Allen Goodship, who I think is on the board of Azellon, but she has recovered now so it is all right. I want to talk about Claudia’s trachea, which happened in 2008—in Spain rather than in this country. Can you tell us a little about why that groundbreaking tissue engineering took place abroad, and whether it would be easier now to do something like that in this country?

Professor Hollander

How long have you got? The simple answer is that the initial concept came from Paolo Macchiarini, the Italian surgeon, in Barcelona at that time, who had been developing the concept of tracheal transplants and was in close contact with my colleague Martin Birchall, who is now at UCL but he was at that time in Bristol where I was. It was simply initiated there. It was not research. We did not have a grant to create Claudia’s trachea. She was a patient who the clinicians judged was dying. I am not a clinician, but that was their view. A number of us were asked whether we would pool our technologies—two technologies from Italy, my technology and Martin Birchall’s at Bristol, along with other technology in Barcelona—and in a matter of three months find a way to create this tissue-engineered trachea. By the way, my first reaction was that we could not possibly do that, but that is another story.

Matt Warman

Was that a technical rather than an ethical reaction?

Professor Hollander

Ethical is another story. I took some weeks to satisfy myself ethically. No, the answer was technical and regulatory. I had no idea how to get through this from a regulatory perspective, but on the question why it was led from Barcelona, that was where it started, but it became possible because of the stem cell biology and other aspects we were developing in the UK, and that was what we brought to the party.

Matt Warman

If it were to happen now and it was an English suggestion, do you think it would be easier to do than it was then, or possible or impossible?

Professor Hollander

I suspect it would be impossible. Remember, this was in 2008 and six months before the advanced therapy and medicinal products regulations came in. Under ATMP, the kind of get-out clauses we had on various aspects to create that so quickly would not have happened, even on the basis of saving the patient’s life. We can argue whether it was right or wrong. We were allowed to do it then, but I do not think it could happen now.

Matt Warman

Is that kind of regulation in your view an improvement? Presumably, Claudia would doubt that it was an improvement.

Professor Hollander

Regulation in general is good; it means we know where we stand. There is always tension between protecting the patient from a cavalier attitude, on the one hand, and a long historical tradition of experimental medicine, which is in a sense disappearing because of regulation, on the other. We have to find the right point for that, and I am probably not qualified to say whether it was better before or now. I do not think we could now do the trachea case in the way we did at that time.

Matt Warman

It does not sound like progress. Does anyone else on the panel have a view on that?

Professor Pearson

I think the regulatory framework around experimental medicine, as you call it—first-in-man studies—has become more and more complicated as time has gone on to a state where we are doing less of it because it is so complicated to do. That is holding back necessary steps in early translation at the expense of people doing larger trials which then fail. I think there are things wrong with the legislation in that regard at the moment, but it is slightly off the main tack of where we are.

Matt Warman

Yes and no. After Government concerns in this country about red tape, we had IRAS—the integrated research application system. Has that helped or hindered this?

Professor Pearson

Ask a clinician.

Professor Hanley

It is a bit like the earlier conversation about experiments involving animals, and Home Office regulation and licensing. Of course regulation is required, and some of it is a bit like the one-stop shop we talked about earlier in terms of regenerative medicine. Anything that tries to simplify a pathway is good. There are always people behind all of this, and we need continuous scrutiny to make sure that people are acting to make everything as streamlined and joined up as possible. For example, one of the good things we have done in regenerative medicine is that when we recognise an area with potential, which may take some time, we do not wait until we have something we think may be good before we talk to the regulator. That sort of partnership is of critical importance. My personal belief in a number of these areas is that we could streamline things further and strip it back to the fundamentals. I do not think we would lose public support for the work that is done or the treatments we carry out.

Matt Warman

That last sentence prefaces my next two questions, which is rather awkward. In that sense, do you think that as we come out of the EU we have the opportunity to do the kind of streamlining you are talking about?

Professor Hanley

Yes.

Matt Warman

Is that a real opportunity? It sounds like something you think we should be seizing.

Professor Hanley

We have been forced to look at it, and we do have to look at it. Clearly, you will be held according to the market you are trying to sell in. If we are looking to sell into a European market, that still exists. It should always be a continual process. It is a team. It is not them and us; it is not us versus the funders, and it is not us versus the regulators. We are all in it, so we should be continually studying it.

Professor Pearson

I hesitate slightly, in the sense that in lots of areas of medicine, even regenerative medicine, we will need to run trials on a multinational basis to make sure they work. Therefore, we have to have legislation and governance that is compatible with what other people use. If we have something very different we cannot do that any more, so we have to be careful.

Matt Warman

Are we now able to look more broadly than the European Union, or was that something that was always perfectly possible?

Professor Pearson

That is what we are doing now.

Professor Hanley

It is the same as selling into a market, isn’t it? It is a question of working out what we want and then making sure it is fit for purpose, and we have that opportunity.

Matt Warman

Following on from something you mentioned earlier, all the surveys seem to show that the public support a tightly regulated version of all the kinds of treatments and therapies we have been talking about. Do the Government need to do more to examine those attitudes, or to try to make the case, or do you feel that the work you are doing is adequately understood and accepted in the wider world as well?

Professor Hanley

Both scientifically and clinically, it is pretty good. I do not see there being a big problem about engagement, and I have not seen that in the course of my work over the past 20 years. I always feel that the public have been very supportive. In the UK, it is quite nice that we also have a very strong network of medical research charities that sit on both sides. A lot of public engagement and patient advocacy takes place through AMRC members. It is a really good environment.

Professor Hollander

Absolutely. I do not remember a single negative comment on this area of research from any engagement I have had with the public. Admittedly, I do not personally work with embryonic stem cells and there may be particular issues there, but the whole debate around stem cells that has gone on over the years has created a positive environment.

Matt Warman

It seems to me that a lot of that public engagement is driven by the fact that it is not Government or people making money out of it; it is people like the British Heart Foundation, or whoever, who are making the case. Is there anything else where we have done particularly well, or should be doing more of, to make sure we keep the public on the track we are likely to be going down?

Professor Pearson

As funders, researchers and Government we have continually to inform the public as to where the success stories and developing stories are, and that the media are reporting them appropriately. We still get mad stories in the media every other week— ears on the back of a mouse or whatever—and we have to try to counteract that and proactively make sure that what we feed in that direction continues to build the public trust behind us. You are right that on an individual patient level they are all behind it, because they know it might cure them of something, but out there, as informed by the press, that is not necessarily the case. There is an ongoing need for people like the Science Media Centre to make sure this works well.

Dr Buckle

We last looked at public opinion in this area very closely around the time of the 2008 renewal of the Bill, but two events since then at least show that continued dialogue puts us in a good position as developments come. One was the mitochondrial transfer debate, but more recently I have been involved in the gene-editing discussions. They touched the public nerve and journalistic inquiry about the embryonic angle. It has been quite intriguing, in so far as the same arguments that were present before have come back. Being involved in international meetings around this, it has become clear that the level of public dialogue and understanding, and to some extent our forward thinking in legislative terms, is envied around the world. The Nuffield Council is doing a big consultation on that element. Continual dialogue is the key thing. We do a good job, but it is important for parliamentarians to support that as well and make sure debates happen.

Professor Hollander

Can I say a positive word about the Science Media Centre, which Jeremy mentioned? It is a fantastic example of how we can work together to be very effective in communicating with the public.

Matt Warman

What more could we be doing to try to make sure that the press is as well informed as it possibly can be in this area?

Professor Pearson

From our perspective as a funder, we try to be absolutely open about what we are funding and why, and to explain it to the press on every occasion we can. I think that is the best we can do.

Professor Hanley

For me, it is a long-term thing. In our media, by comparison with others overseas, there are journalists who have learned a bit of science as journalists rather than science graduates who have then gone into journalism. It’s back to science in schools and your hope that they’re watching.

Chair

Thank you very much indeed. You have been very helpful. The science has been very well explained, and it is exciting to hear how competitive we may still be. The Committee will be returning to this—it is not our only session—because regenerative medicine is incredibly important. If we ask for written submissions, I hope you will be patient with us and answer our questions. Thank you very much on this incredibly hot afternoon. Oral evidence: Regenerative medicine, HC 275 11