CAROLINE FLINT MP, PROFESSOR SIR LIAM DONALDSON AND DR MARK BALE

28 FEBRUARY 2007

  Q320  Chairman: The issue then, Sir Liam, in terms of the Down's mouse where you have human chromosomes into a mouse to create the Down's mouse, that would be banned, would it?

  Sir Liam Donaldson: The hybrid whereby you put human sperm together with an animal egg and fertilise a half person/half animal I think is something that Parliament may have a view as to whether it is appropriate to leave such decisions to the HFEA. There is existing legislation banning it. It is the question of this spectrum from which, at the hard end of the spectrum there are interesting techniques (which people might want to perform but I cannot see what benefit they would ever have and may be considered morally or ethically unsound) set alongside something which is clearly a development of science moving in a positive way.

  Chairman: I appreciate that.

  Q321  Adam Afriyie: Was the HFEA right to delay the assessment of the proposals from Newcastle University and from King's College, London, given the current climate? Do you think they were right to delay their assessment of those proposals?

  Caroline Flint: That is not for me to have an opinion on. We have had no influence in that whatsoever; that is for the HFEA to decide.

  Q322  Adam Afriyie: Do you agree with the HFEA that the licensing of human-animal chimeras and hybrids is within their remit? They appear to have drawn a conclusion that it is within their remit; I think most people would agree that 99.9% human is pretty much human so it is within their remit. Do you agree it is within their remit?

  Sir Liam Donaldson: I did not get a chance to answer the Chairman's question on that, is it human or is it not human, and I am not going to give you a yes/no answer, but I am going to answer it directly.

  Q323  Adam Afriyie: Is it within the HFEA remit?

  Sir Liam Donaldson: I will give you a direct answer to that. When Parliament considered and introduced the regulations containing the term "human fertilisation" it had in its mind a report that I produced where the leading edge and controversial technique was cell nuclear transfer human to human. In my view it depends what was in the minds of the parliamentarians at the time. I would argue that in their minds was that human meant human to human and not involving animals. I do not remember anybody asking how broad the spectrum was, should they include animals because at that stage the animal element was ruled out in the report and nobody challenged that so in my view it is something that needs to be clarified and no sane person could give a yes/no answer to it.

  Q324  Dr Iddon: Sir Liam, I know you have a very broad remit but how often do you talk to people involved in stem cell research?

  Sir Liam Donaldson: I talked to them extensively when the original report was produced and I have kept in touch with developments both reading the medical literature when I go on visits, when I meet leading scientists, when I talk to our own director of research and development. I worked very closely with Sir John Pattison who produced the stem cell bank recommendation. I am a generalist and I would not claim to have the sort of in-depth knowledge that specialist scientists would have in this field, but I do think as a generalist I have kept reasonably well in touch and interested in this field.

  Q325  Dr Iddon: There has obviously been an explosion in stem cell research, have you been aware recently that the scientists involved in this research feel that research is being restricted by the shortage of human embryos?

  Sir Liam Donaldson: Yes, I have been aware of that view point.

  Q326  Dr Iddon: Have you talked to either the King's group or the Newcastle group or anyone else who is thinking along those lines of somatic cell nuclear transfer to produce cytoplasmic hybrids as a potential new route to stem cell lines?

  Sir Liam Donaldson: I have tended not to have direct discussions with groups that are currently submitting research applications in case there should be any accusation that I am trying to influence them getting permission. I have kept in touch with the science at various times when I have felt there has been a neutral period as far as live applications are concerned and have talked to scientists involved in this field.

  Q327  Dr Iddon: Are you aware of the potential I have just mentioned?

  Sir Liam Donaldson: I am indeed, yes.

  Q328  Dr Iddon: Are you sympathetic to that? Are you changing your mind from your original report?

  Sir Liam Donaldson: I would not go further than to say that I think the process that we are embarked on now to clarify all of this and getting it on a proper sound footing and re-visit some of the earlier ideas is the right one and I am a strong believer—given my past experience with the earlier report—of the role of Parliament in this. I actually think it is quite vital, given that there is so much else that needs to be clarified, apart from the specific technique that you have been talking mainly about this morning.

  Q329  Dr Iddon: Do you agree that there is a danger of damaging this research if we get the wrong messages across to the public through the media that are here this morning and that we have to be very careful that the honest and correct message is given to the public so the general public out there can make their own mind up about this research based on knowledge rather than ignorance?

  Sir Liam Donaldson: I absolutely agree with that but I think that I would argue, based on the earlier report, that the only reason we are out in the front of most other countries on an issue which at the time was highly controversial is because we took the public with us and because we had parliamentary backing. If it had just been me who had chaired a committee recommending and advocating these things I think there would be much more fire power directed against research in this country and researchers would be unwilling to come here from America and other centres in the way that they have. That is why I feel so strongly that if we are going to clarify this whole rather confused territory we need parliamentary backing and then we get the solid foundation for researchers to feel confident that this is not some flavour of the month commitment, it is a deep-seated democratic commitment to foster this sort of research in this country.

  Dr Iddon: That is a very positive message, thank you.

  Q330  Graham Stringer: Picking up on something Sir Liam said, how do you know that you have taken the public with you? How do you measure it?

  Caroline Flint: I think partly we see arguments we make in Parliament and that debate but also if we look at the last 10 years and the implementation of the present legislation I would say there is a good example there of where there has not been a situation where we have had public demonstrations, campaigns against IVF, campaigns against the decisions that sometimes the HFEA have made and debated that the Act did not allow for (I think they have taken a very pragmatic but cautious approach but not a limiting approach in that area). I think clearly of areas where we have not had judicial reviews every five minutes of the legislation. I think that is one test but I also think another test is the fact that in relation to stem cell research, as Sir Liam said, we are recognised as a country that has a strong regulatory framework. There are other countries which do not and I think that an indication of the impact of that is that they do not get the same confidence by the scientific community to go and work in those countries because it is not a framework that they feel comfortable with.

  Q331  Graham Stringer: I agree with you that we have a very good international reputation in this area. Are you concerned that the statements you have made about bans, albeit with some of permissiveness at the end of it, have damaged our international reputation in this area? How important to you is the competitiveness of our research establishments and industry in this area?

  Caroline Flint: I do not think it has. When taken in the context of what we were saying we wanted to make a clear point in relation to hybrids but you see from what you have said that we recognise there were other techniques, how we define what name we give to them, we are opening doors in a way that we were just at the frontiers of in that respect. What worries me is that a lot of what we said has been taken out of context and I do not think that is helpful, to be honest.

  Q332  Graham Stringer: Do you think our reputation has been damaged?

  Caroline Flint: No because I think actually what we are going through at the moment is a process of coming to good foundations for the next 20 years or so and that will be finally a bill in Parliament. My greatest wish is that it is as successful as the bill it will be replacing. When government consults and when you produce a White Paper it is only when you get down to the nitty-gritty that you really get the sort of public engagement. It sometimes polarises a position but within that polarisation we need to try to find that common ground to take us forward. I think this area is just one part of the proposals we are making that will create a debate over the months ahead. That is why I stand by the fact that we did not come forward and say, "That's it, we've got a bill; we're going into committee". We felt we needed this sort of scrutiny because I believe that we would not have this debate if we had just gone forward with the bill or the debate would have been limited. I just think that is the way it is, to be honest, and that is the way Parliament works. You often do not get the debate until you actually have something for people to debate around.

  Q333  Graham Stringer: The research and technology that led to the creation of Dolly the sheep most of that work is now being done in the United States and we have lost it. Do you have an explanation for that? Are we worried that this interregnum of research into stem cells is going to lead to a similar loss of leadership in this area?

  Caroline Flint: Again I think there has been some misrepresentation in relation to another parallel track in terms of science in relation to animal hybrids, animal chimeras and animal cybrids or, for the matter, a transgenic animal because all of those areas are actually covered by the Home Office in terms of how they are regulated and licences given. During the course of the consultation and the White Paper, as I said before, we consulted every government department on this issue. We engaged with the Home Office particularly and none of our proposals affect what is currently happening within the sphere of the Home Office. I am pleased to have the opportunity to make that clear today in this Committee because again that in some quarters has been misrepresented and I am pleased to put that right. The Home Office is happy with our proposals in relation to other areas they currently regulate and licence for. None of what we are saying impacts on that.

  Q334  Graham Stringer: You did not really answer my question because what I was concerned about was not the relationship between the licensing of the Home Office compared to your Department, it was how we keep our leadership in science and whether understanding that leadership and what had happened to the development of cloning following the creation of Dolly—we seem to have lost that to the States—are you concerned that the same might happen with stem cell research?

  Dr Bale: If I could just add to something that Sir Liam said, in 2005 the Chancellor established the UK Stem Cell Initiative which was led by Sir John Pattison and we supported him. That covered a whole range of issues around translating pure research into benefit to patients and none of the issues around hybrids and chimeras that we have had now were really seen to be key weaknesses or key areas that had to be addressed, although there was a recommendation to clarify what would be allowed in terms of putting human embryonic stem cells into animal embryos to test the potency of those stem cells. That is an issue which is as much to do with how the Medical Research Council self-regulates stem cell research by the stem cell bank as to do with the Home Office licensing arrangements. We did undertake on behalf of the Government to try to lead a number of recommendations there of which the clarification around human and animal hybrids is one.

  Q335  Chris Mole: It seems to me, after our weeks of consideration of this, it has come down to whether we should have a permissive regime in which the HFEA prohibits specific actions or a prohibitive one which the HFEA where the HFEA permits specific research and how that is encoded in legislation. Would you agree that what has really led to the misrepresentation is the consideration of a breadth of hybrid and chimerac possibilities being generalised from the specific examples that are related to the applications that the HFEA have recently had around cytoplasmic hybrid would work?

  Caroline Flint: Sorry, do you mean that the definitions we have used do not relate in the same way to the application?

  Q336  Chris Mole: You are looking at a big picture but that big picture has been represented by these two specific examples as if it is the whole picture. You are only talking about banning parts of the other whole picture.

  Caroline Flint: Absolutely. For all I know there may be other processes or ideas that have not come forward yet but might come forward in the future. I think it is about the spectrum here about which there are probably different arguments for and against and clearly that is why I had hoped that our view—which was to leave the door open for defining that and regulating some of these areas—was a positive step forward; in fact it is a positive step forward, it is liberalising where we are now.

  Q337  Chris Mole: So the lesson to be learned is that people should seek before they say anything.

  Caroline Flint: That would be helpful.

  Q338  Chairman: Minister, could you finally tell us when you expect the draft bill to be published?

  Caroline Flint: We are looking at around May for the draft bill. As far as these things go, that is what we are working to.

  Q339  Chairman: Our report will be completed by April.

  Caroline Flint: The HFEA is July and September for responses. It has been a helpful opportunity to clarify what we were saying and what we were not saying. I think everyone agrees that it is that mixture of the scientific evidence that taking the public with you in the most positive sense is important for science to progress.

  Chairman: Could I say, Minister, we have very much enjoyed the hour with you and Sir Liam and Mark Bale. Thank you very much for having a vigorous dialogue with us. I am sorry that time only permits you to get to some of the issues but we are very grateful.