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

28 FEBRUARY 2007

  Q300  Chairman: Minister, in terms of the 1990 Act, do you regard the cytoplasmic hybrid as human? Yes or no?

  Caroline Flint: I think, as far as I understand it, it is something that could end up being 99% human.

  Q301  Chairman: In terms of the Act.

  Caroline Flint: What I was advised was that within the Act it was not something that was provided for within the legislation.

  Q302  Chairman: Is it human as far as the Act is concerned?

  Dr Bale: I do not think the Act specifies whether things are human in that way. This certainly was not a technique that was envisaged when the White Paper that preceded the Act was put together.

  Q303  Chairman: Is the view of the Department that in fact it is not human?

  Dr Bale: No, I do not think that is our view.

  Q304  Chairman: So it is human.

  Dr Bale: That is right, but I do not think that is the way the Act is constructed.

  Caroline Flint: The Act could not determine that because it was not something that was part of that discussion.

  Q305  Chairman: The Act is there as an umbrella.

  Caroline Flint: The problem is that the science was not there then. The Act and the debates and committee did not cover these things. I was not there, but these issues were not covered and that is why the regulator has been given certain powers to make judgments outside of what the legislation provides for within the spirit of the legislation.

  Q306  Chairman: The HFEA, the organisation that was set up as far as the 1990 Act is concerned, considers it is human.

  Caroline Flint: That is a viewpoint. We need to look at what the Act says in the future and how that can be better defined. An Act of course cannot decide on something they could not think of creating.

  Q307  Dr Harris: Can I just pursue that? The legal advice that the HFEA has, according to the minutes that are on their website that we can discuss and the legal advice that we know you have seen because you sit on the HFEA, indicate that these cytoplasmic hybrids are probably within the remit of the HFEA and that the second most likely option is that there is a free for all, not that they are prohibited by the 1990 Act. Can I ask you if you have had other legal advice that would trump that general view which was, I think, shared by the Ethics and Law Committee of the HFEA?

  Caroline Flint: Not as far as I am aware. They take legal advice on a whole number of issues.

  Q308  Dr Harris: The legal advice that is out there within the HFEA/Department is that these things are human, therefore it is up to the HFEA, if it wishes to eventually, to consider whether to give a licence to these applications. So the door is open at the point of the regulator to those specific applications on cytoplasmic hybrids or pseudo-hybrids.

  Caroline Flint: Yes.

  Q309  Dr Harris: It is also the case, I think, that the wording of your White Paper in paragraph 2.85 combined with everything else is that your White Paper position is that there will be a ban on everything including that, with the opportunity later on for regulations to permit something. Is it fair to say, therefore, that you are going from an open door at the point of the regulator—or a door that is the regulator—to putting in an extra door if your White Paper gets into force which is that there have to be regulations first and then the regulator would have to look at it? You are not making the door more open, you are acting an extra barrier. Is it fair to say that?

  Caroline Flint: Applications come in and we have no control of when applications go in to the HFEA so the timetable for that, with the best will in the world, is something we do not control and clearly when we had our consultation, when we produced the White Paper, this issue around the application had not got to the point where the HFEA were even making a decision. Clearly these applications have come in, they have created a debate and I am sure the consultation the HFEA are doing will inform how we move forward as part of that pre-legislative scrutiny. The point is that we still do not have a situation, we believe, where the present legislation adequately covers this area and that is what we are trying to do. The other point I would make is that the HFEA have taken their own legal advice and they will make a judgment in relation to that, but they are still open to judicial review and for that none of us knows where that might end up. That has been the process that has happened wherever the HFEA has taken a decision that the law itself does not quite clearly define—

  Q310  Dr Harris: I am keen not to interrupt you but I would like you to answer my question.

  Caroline Flint: I thought I did.

  Q311  Dr Harris: I will put the question again, do you accept that having a ban as envisaged by the White Paper, even with a regulation making power, creates an extra barrier to the sort of research that are subject to these applications on which the HFEA's view is that it is capable of considering at the moment? Do you understand the question?

  Caroline Flint: Yes, I do understand the question.

  Q312  Dr Harris: Is that an extra barrier or is it less of a barrier to have a statutory ban?

  Caroline Flint: If it is just left to the regulator to decide on a lot of these issues then that is probably the most simple process. What I would suggest is that Parliament has a view on some of these issues and wants to have a sense that should Parliament decide—and it is down to Parliament to decide—that the regulator should just decide, that is for them to debate. I think that what we were saying in the context of where we were was that actually a general prohibition but with powers to regulate is in itself not something that prevents the development of this science. Clearly how it is regulated needs to be worked through. What particular types when we define hybrids and chimeras and cybrids and so forth needs to be part of that discussion. Let us take today, for example, the issue of the cybrid, as part of the discussion if that is developed whereby we think that that is an area that can be regulated, that might be a simple process, but some of the other areas of hybrids and chimeras may pose other questions that nobody necessarily wants to go down.

  Q313  Dr Harris: So the position that you have put that there should be a statutory general prohibition with this regulation making power when the Act comes through, is that a position in which you have the support now—not in the consultation or in 1990 because I do not think your 2000 position, Sir Liam, was unreasonable so I do not think you need be defensive about it—are there any scientific or ethical bodies that do not oppose all embryo research or at least all cloning who agree with you that a general prohibition with a regulation making power is the right way forward?

  Caroline Flint: I think that is part of the debate we are having at the moment. What I do know, having read some of the transcripts of comments from individuals—Sir David King and others—is that there is a recognition that there needs to be strong regulation in this area and we need to work through what that will mean and what form that will take.

  Q314  Chairman: I do not think anybody is disagreeing with that. I think the point that my colleague is making is why did you start with the statement that they would ban it and then go for permissive regulation afterwards rather than by conforming the current position?

  Caroline Flint: There are examples in legislation where there is a general ban but with exemptions, for example. That is not new but it is also part of the detail of what we are talking about here for Parliamentary Counsel and the drafting it is important to get this right. It might be that there are certain areas where everyone is very clear that that should not be allowed but there are other areas where there needs to be some flexibility and that is what we are trying to reflect.

  Q315  Dr Harris: We do understand that but the record will show that my question was, can you give us any ethical or scientific groups that support the position you are taking of a general ban with regulation making powers as opposed to letting the HFEA regulate it as at the moment.

  Caroline Flint: I do not think per se there is a view on that. I think there is a technical parliamentary drafting procedure in all of this. There clearly are views and I have quoted some to you about insufficient scientific justification for creating human-animal hybrid embryos. There are others who then say they do not define a cybrid in that category, they think that should be allowed. I just think that that is the complexity of this area which I have to say justifies totally my decision to have pre-legislative scrutiny because, with the best will in the world, within a general consultation covering over 70 areas in the White Paper, this sort of debate does emerge. I have to say that the detailed responses from some of those who are making very detailed representations now were maybe not as full as they might have been.

  Q316  Dr Harris: I absolutely agree with you on that and I have made the point myself to those organisations, but we are where we are now and you have the opportunity with the draft bill following our report, to read our report and consider that the pre-legislative scrutiny that we all want to see might start from a different basis which is that there is not a ban in the draft bill and that there is still that pre-legislative scrutiny, but given that no recognised scientific or ethical organisation that is not opposed to cloning already does not support the idea of starting from a ban, would you consider—is it a least an option—that the draft bill might change its position for the pre-legislative scrutiny? Or are we wasting our time on this Committee?

  Caroline Flint: To be fair, I made it clear when we made our announcement about the pre-legislative scrutiny in the draft bill that one of the reasons was that we did want to get the final bill to be the right bill. I am not at all defensive of a position we currently have based on how we came to that decision, but clearly you are having this inquiry, the HFEA are having their inquiry as well, we have agreed through Sciencewise to provide some funding to support the HFEA in creating that public engagement debate which is very important in all of this, between science and the public. Of course we will have the pre-legislative scrutiny line by line as we go through as well. As you said on the Today programme this morning, Evan, I think it would be wrong of me at this stage to say that that is it, on the basis of what the press reported and the media and so on I am going to say that this is what we are going to do, but we are open—as I have always said when I agreed that we would have this pre-legislative scrutiny and a draft bill—to taking on board views. As I said, we are in a position of, I suppose, trying to create the opportunity for these sorts of processes to be part of future potential research and we are certainly not closing the door on it.

  Q317  Dr Harris: Just to clarify—if you do clarify this, this will be my final question on this topic—this Select Committee is going to issue a report. We do not know what it is going to say, but if it said that we think you should change the draft bill to have no ban and to have the HFEA regulate hybrids and chimeras, is that a feasible thing that you would consider or are you absolutely committed to having the draft bill translate exactly what you have said—or near enough—that is from the White Paper? Is it a possibility?

  Caroline Flint: We will take on board all the views.

  Q318  Chairman: So it is a possibility.

  Caroline Flint: Yes. Basically I think there has been misrepresentation on what the Government position has been which has not helped debate.

  Sir Liam Donaldson: Could I add something briefly to that in response to Dr Harris? If the suggestion was that it was more permissive and incorporated the concept of a hybrid in which human sperm were mixed with animal eggs I think some people might have a problem with that, leaving the HFEA to decide something like that. I think it would be seen as something which Parliament ought to have a view on, given that there is already legislation banning that.

  Q319  Dr Harris: Parliament could reverse that then for those particular hybrids within 14 days, but have you heard from any scientist who says that you need a ban because the HFEA cannot be trusted?

  Caroline Flint: With respect we have to think about what people might think might happen as well as what we do not know yet. I have to agree with Sir Liam, in some of these areas we might feel that we can be absolutely clear that a ban should be on the face of the bill but we need to leave the door open for some other forms of science development.