Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 1159 - 1179)



  Q1159  Chairman: Thank you very much for being patient; we are slightly late and we hope to finish by half-past eleven, so the Committee will be short, sharp and as ugly as ever, I guess, in the questioning. If you could be the same in your answers it would help us get through more material, which would be very useful because we do recognise your importance in our inquiry. You will have seen the evidence that we have taken and seen what we have been doing. The Committee has been to the Vatican, been to Sweden and is very knowledgeable, I guess, about the whole issue now, across the board, and you are going to add to that, I hope. Would you like to start up, Allan?

  Professor Templeton: Yes, thank you very much. Thanks for the invitation. If I could start just by giving an RCOG perspective, which I think is one of the main reasons I am here—

  Q1160  Chairman: Do not be long because we have some questions. Okay?

  Professor Templeton: Do you want two minutes?

  Q1161  Chairman: One-and-a-half. I am timing now.

  Professor Templeton: By and large, we think the Act has worked—by and large. There are rough edges and the rough edges include the database, the need for confidentiality, the welfare of the child, particularly, and then the accreditation process. If there is an opportunity to revisit some of these things within a revised Act then I think that Act should reflect the difficulties with the current Act. So, broadly, we think it has worked, we think there are various issues that could be put right, if the opportunity arose. Another issue, of course, which I understand that you re not considering but is tied up with the HFE Act of course, is the aspect of the upper gestational limit for abortion, and I think we would probably advise that that was taken out of any revision of the future—

  Q1162  Chairman: You would like abortion to be considered separately from this?

  Professor Templeton: Separately. I think that appears to be the gathering feeling, although of course there are many issues, as you well know, to do with abortion at the present time, and not just the upper gestational—

  Q1163  Chairman: I would like to question you on why, but that is not within our remit at the minute. You could argue it might be or should be but the Committee has decided to concentrate on one particular area. I will ask you the first question about the proposal to merge the HFEA with the Human Tissue authority. This will be a new regulatory authority, in a sense. What do you think about that proposal? Hare-brained, or do you think it is sensible?

  Professor Templeton: Neither of those. I think it is something we need to think through a lot more. It is not a completely daft idea in that much of the activity to do with the HFEA—

  Q1164  Chairman: Had you considered it at all as a possibility?

  Professor Templeton: We had not considered it until the proposal came up with the review of the arm's length bodies, in fact. If it is going to be a reality then, of course, someone needs to sit down and work their way through how that would work in practice. I do not think any of us have really done that thoroughly enough to give informed answers. It is going to have to work, I guess, and we are going to have to do that in due course, but I am not convinced it is necessarily a good approach in the sense that I think there is public concern, particularly, about reproductive technology and reproductive matters. I think there should be a focus on that, from the public reassurance point of view. I should say that the one thing the HFE Act has achieved is it has allowed the progress of clinical practice and science within this country within a framework that has been broadly reassuring to the public. Of course, that was one of the major—

  Q1165  Chairman: Another area within this issue is animal experiments. You would not guess it by the publicity, of course, but in terms of the Home Office issuing licences and so on, that is closer to Parliament and Government and so on. Would not a model like that be satisfactory to you?

  Professor Templeton: I think it might well work. The analogy in the medical field might be the inspection and regulation of the abortion clinics, for example, which is the other area of our practice that is covered by legislation. It may well be that that approach—a sort of hands-off, professional inspectorate and a much more focused approach, informed by a more professional input into the accreditation system standards—

  Q1166  Chairman: Allan, do you not think you are catching the wrong wave? It is all happening around you now, and it is going to be decided. People are blinking and deciding on these things and you are still thinking about it. What does that say about you and your pro-activity levels?

  Professor Templeton: It may be the direction of the wave but I think it does, in honesty, require a little more thought. I have not heard very clear indications of how the whole thing would work. We are putting our view, which is carefully thought through in the sense that we have 15 years or so of experience of regulation, but we also have very considerable experience of visiting and accreditation in other circumstances, so it is from that kind of perspective that I would advise this sense of direction in relation to the regulatory aspects.

  Chairman: The canny Scot approach, I guess.

  Q1167  Dr Turner: We are interested in exploring the ethical boundaries, for instance, of what is possible and what is legislated against. So if it comes to a position such as whether you permit a couple the freedom to choose the sex of their child, who do you think should be making that decision? Should it be Parliament, should it be a regulator or should we leave it to the couple or the clinician? Who do you think should take that decision?

  Professor Templeton: There has to be some sort of legislative framework which allows the decisions to be taken in an appropriate environment. If it is new technology, if it is a new treatment that might threaten public anxiety or that might have safety and efficacy issues, there first of all has to be a system backed up, in my view, by legislation, that allows you to take these decisions. Having settled that then, I think that in the approach that the HFEA have adopted—leave aside the composition of the actual 21 good members and true for the moment—there has been insufficient clinical and scientific input into those discussions (and we can touch on that if you wish). I think these individuals reflecting, to some extent, science practice, the public and society, should be in a position to provide some guidance. That guidance can be translated into the regulations or accreditation systems, however we decide it is to be done, in due course. I think Parliament for the framework and then these decisions, such as sperm selection. I personally have no problem with sperm selection (I ask myself "Why not?" and I do not come up with a good reason why not), but I do have a problem with sex selection where it would require either abortion or even PGD. I just have reservations for that particular reason, but that is a personal position. One would have to look collectively at what would be permissible within society. You need, I think, a responsible body that can move and reflect on these issues.

  Q1168  Dr Turner: At the moment, we have, effectively, a body that is responsible both for policy and for regulation of that policy.

  Professor Templeton: Yes.

  Q1169  Dr Turner: What is your feeling about it? Do you think it right it should be the same body or do you think the functions should be separated? What do you think would be the effect on public confidence if we did that?

  Professor Templeton: I think probably they should be separated. However, that is changing. I think the HFEA themselves have recognised that the regulatory processes rather than the structures have been less than satisfactory—in fact, have been quite inefficient in many respects, and we have seen examples of that. So I think the two should be separated, essentially. Coming back to the model the Chairman was indicating, of an animal inspectorate kind of separate inspectorate, following standards and guidelines produced mainly by the relevant professional societies and so on, it may be that policy down to that regulatory body—should sperm selection be in or out, for example—could be fed into it, but I do not think the policy-making body, if you like, should be very much involved in the regulatory process. I do not think that is a model that I have seen working satisfactorily.

  Q1170  Chairman: If your fellow witnesses want to jump in, please indicate.

  Professor Templeton: I know that Richard has had a go in the past.

  Q1171  Dr Turner: Given that Parliament sets out in legislation the boundaries, do you think you actually need a separate policing-making body? Can we not leave it to clinicians to make decisions in the light of the particular circumstances of the given patient?

  Professor Templeton: You could but I think, probably, in many instances the clinicians would welcome a view that they felt reflected the views of, in the broader sense, society on what would be acceptable because it gives them some protection as well in what they can offer as a treatment and what they can reasonably turn down, if you like, as a treatment. Something just one step removed clinicians also find helpful.

  Q1172  Dr Turner: Dr Kennedy, you have told us previously that if they were to set up a human genetics commission that they could take on the role of policy making. Would you want its decisions to be binding? Would Parliament have to accept its advice? What is your view of the actual constitutional role of a human genetics commission?

  Dr Kennedy: I am not so sure I am expert enough to answer that question. I agree with Allan that policy should be determined by a body such as that we have previously referred to. Parliament's duty and role is to provide the overall overarching regulatory framework within which that policy is constructed.

  Q1173  Dr Turner: So you would not favour a model whereby the commission advised Parliament on what is reasonable at a given time and then Parliament actually did the regulation because Parliament was reflecting, if you like, the will of the populace?

  Dr Kennedy: That would then infer that the legislation would have to be altered from time to time and the legislation should have sufficient latitude and flexibility to allow a policy-making body to work within an overarching framework and to adapt policy according to particular needs and particular issues that come forward. Research will make new findings that will determine whether particular procedures are safe or not safe and the policy would then adapt accordingly. Then the inspector and licenser would police that policy.

  Dr Turner: That is a useful view.

  Q1174  Tony McWalter: That latitude that you want in the law potentially might allow such a body to end up taking decisions that depart very widely indeed to what the public would assent to and we might get into a rather disparate conflict situation between that body and the sort of general view of the public as expressed through the people they elect to Parliament. So, clearly, whatever latitude you want, I am suggesting, needs to be, in fact, itself quite closely articulated if those taking these decisions are not to start removing themselves quite markedly from public opinion, which, as you indicated, is a source of consolation to them when they are trying to take difficult decisions.

  Dr Kennedy: The current legislation does provide some very strong reassurances to the public and it provides some boundaries within which policy can be determined. I would not envisage there being great alterations in those boundaries, particularly as referenced to the embryo and care of the embryo. In answer to your question, that would depend on the construct of the policy-making body and its representation. Presumably that would require due care and attention to ensure that that policy-making body properly reflected the wide opinions in society and wide medical opinion—scientific advice.

  Q1175  Dr Iddon: I have a table here showing pregnancy rates per embryo transfer—otherwise known as parameters of excellence—expressed in terms of IVF treatment and ICSI. It shows that the UK is more than halfway down the table. Why is the quality of assisted reproduction that low in the UK?

  Dr Kennedy: I have not seen that particular data and I suspect that that data needs to be examined closely in respect of the epidemiological background to the material that is entered into the data and aspects of treatment such as the number of embryos that are replaced. (Copy handed) Thank you. So I think, looking at that data baldly and saying that "in comparison with . . . we are such-and-such" you have to look inside the data and determine whether or not there are aspects of care that we are providing which are different and whether clinical practices differ from country to country.

  Q1176  Dr Iddon: Assuming there is a problem (I accept that is a big assumption) do you think there is any way that Parliament could regulate to improve that?

  Dr Kennedy: I do not think Parliament could regulate, but I think it is up to the professional bodies, such as the Royal Colleges and other professional organisations, to ensure that the clinical standards and laboratory standards of practice are such that they strive to produce the highest standards of care and the best possible results of practice.

  Q1177  Dr Iddon: Would restricting single embryo transplant to the NHS help, for example? Would it bring more care in the transplant procedure and bring better results?

  Dr Kennedy: One of the important adverse consequences of assisted reproduction in the United Kingdom is multiple pregnancy, and this is clearly an issue that we have to address—urgently, in my opinion. There is increasing data to suggest that single embryo transfer produces pregnancy rates in selected groups which is similar to the pregnancy rates produced with higher numbers of embryo transfer. I think that requires very careful examination and, indeed, there are proposals currently to conduct within the United Kingdom a clinical trial to look specifically at that issue.

  Q1178  Dr Iddon: Are there any other improvements in practice similar to that which we could recommend in our report?

  Dr Kennedy: I think the European Directive which is on our imminent horizon is going to require standards of laboratory practice to be reached across the European Union. I actually believe that the standards of laboratory practice in the United Kingdom are very high but, clearly, there are areas within which we can look at improving techniques and improving quality management. The EU Directive will add momentum to standardising quality management across United Kingdom laboratories.

  Q1179  Dr Iddon: Do you think there is any sense in striking off clinics that have rather bad rates of success?

  Dr Kennedy: I think the inspectorate and licensing process has to have the teeth to be able to challenge under-performing clinics, in the same way as CHI would challenge an under-performing trust and exert the same teeth. Yes, I do believe that bad results should be challenged.

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