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UNCORRECTED TRANSCRIPT OF ORAL EVIDENCE To be published as HC 7-ii House of COMMONS MINUTES OF EVIDENCE TAKEN BEFORE SCIENCE AND TECHNOLOGY COMMITTEE
Human Reproductive Technologies and the Law
Wednesday 8 December 2004 PROFESSOR ALLAN TEMPLETON, PROFESSOR LESLEY REGAN and DR RICHARD KENNEDY Evidence heard in Public Questions 1159 - 1232
USE OF THE TRANSCRIPT
Oral Evidence Taken before the Science and Technology Committee on Wednesday 8 December 2004 Members present Dr Ian Gibson, in the Chair Paul Farrelly Dr Evan Harris Dr Brian Iddon Mr Robert Key Mr Tony McWalter Dr Desmond Turner ________________
Examination of Witnesses
Witnesses: Dr Richard Kennedy, Centre for Reproductive Medicine, Walsgrave Hospital, British Fertility Society, Professor Allan Templeton, President, and Professor Lesley Regan, former member of RCOG Scientific Advisory Committee and Clinical Director, St Mary's Hospital, Royal College of Obstetricians and Gynaecologists, examined. 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 wave of the direction (?) 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 accreditation in other circumstances, so it is from that kind of perspective that I would advise this sense of direction in relation to the regulation aspect. 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 CHE (?) would challenge an under-performing trust and exert the same teeth. Yes, I do believe that bad results should be challenged. Q1180 Chairman: Lesley, what is your view, as a clinical director? Professor Regan: In response to Dr Iddon's comment about why the UK is halfway down that list, I think it is very important to emphasise that this is inherently linked to the way the data is presented and collected. I have not seen the table but to base assessment of a clinic's, if you like, achievements on embryo transplant rates I think is not helpful at all; it should be on live baby rates. As Allan was pointing out, there are concerns regarding multiple embryo transfers and multiple pregnancies; there is enormous attrition (?) in terms of miscarriage and very early, pre-term delivery and serious neurological consequences in triplet pregnancies. Q1181 Chairman: If we had a table of live baby rates, where would the UK be? Professor Regan: I would have to look at the figures, but I think significantly higher. If you talk to colleagues in the United States where embryo transfers can be three and upwards, there are enormous problems in ante-natal pregnancy care and enormous attrition of pregnancies that have been conceived as a result of assisted reproductive technologies with enormous consequences for the health care resources that are needed to look after those babies even if they survive, as they very often suffer from significant neurological disabilities, and that is even before we have got to the point of the trauma of the very vulnerable couples who undergo treatment. Q1182 Dr Turner: Previous witnesses have suggested to us that "the regulatory framework needs to move forward to deal with the unexpected frontiers" - to come back to this discussion we were having earlier, Dr Kennedy. Who do you think should make the decision on what is a standard treatment or a treatment that is pushing at the frontiers? Dr Kennedy: In-vitro fertilisation, for the vast majority of patients in the United Kingdom is a very standardised treatment now; 1 to 2 per cent of all children born have resulted from this treatment. The recently published NICE (National Institute for Clinical Excellence) guidelines did allude to the sorts of areas for which there is no evidence for efficacy, and a number of areas of practice - for example, assisted hatching would be one - for which there is no published evidence but yet is practised fairly widely and would be one area that research should look at and prove conclusively, once and for all, whether it is useful or not. There is clearly the mechanism and the framework within the United Kingdom to establish research studies for unproven technologies or new technologies, and that should be the framework that should apply to new developments in this area. Q1183 Dr Turner: At the moment, the HFEA has to rule on proposals for new treatments for research. Do you think this is satisfactory? Do you think it should be done by a separate body from the day-to-day regulatory body and, if so, how would you like to see it set up? Professor Templeton: The approval of research, I think, has been a reasonably satisfactory process and has permitted embryo research within this country. I think the rate-limiting factors, to a great extent, have been just the nature of the treatment, the lack of embryos to research on and the funding to do it. Within the HFEA framework the capacity to do the research has not been inhibited by the legislation, in my view. Where there is a problem has been where research moves into clinical practice and where clinical practice then is still in the realm of research. A good example is cytoplasmic transfer, which means taking a bit from a healthy egg and putting it into a so-called unhealthy egg. That was actually carried out quite extensively in several clinics, although not many, in the US without any form of regulation, without evidence of safety and without any evidence of efficacy and, in my view, was something that should have been regulated at that stage prior to being offered to patients who, by and large, were paying for treatment that was both unsafe and inefficacious. However, that is the nature of medicine and the way it is delivered in the United States, to a great extent. I think there needs to be, alongside the research processes, processes for clinical trials and here they should really be not on the inhibitory side but encouraging clinical trials. Last week, of course, the MRC/HFEA report very much suggested that we do need to get going with multi-centred clinical trials in this country. So I think that the mechanism can be set up in the same way as for research but more encouraging for clinical trials. Q1184 Dr Turner: Do you think it would be useful to use local research ethics committees for the purpose of judging embryo research proposals, provided they were suitably beefed up, or do you think the public would distrust that? Professor Templeton: My own view is that provided the ethics committee knows what is permitted within the legislation it is perfectly appropriate for the local ethics committee to proceed in the same way they would for any other clinical trial, or research. Q1185 Paul Farrelly: I just wanted to move on to the issue of the welfare of the child. This is really, given the evidence, a question for the two professors but, please, Dr Kennedy, if you want to come in. The Royal College says that the current welfare of the child provisions should be replaced by guidance to ensure that the child is not born into a family where there are reasons to believe it will be at risk. How do you envisage that working in practice? Professor Templeton: It is good medical practice. I am talking here about a patient who needs IVF or donor insemination, or whatever, within the law - therefore it is the welfare of the child - but I may well be seeing another patient who is requesting some other form of fertility treatment, and it is good medical practice to ensure that the treatment we are offering is appropriate to those patients' conditions. I do not actually see that there is a need for specific welfare of the child issues within any act; it is good medical practice. The welfare of the child recommendations came about because of concerns, at that time, of single women having children through assisted reproduction. We actually agreed it is without brackets "the need for a father". That became hugely distorted into an attempt to try and pick and choose which patients were appropriate to be treated on the basis of the welfare of the child, and the outcome of the treatment, and it has been one of the major distractions. I said there were one or two rough edges and irritations, and that has been one of them. It has been a distortion of clinical practice; it has been absolutely beyond any effect at all in terms of trying to enhance the welfare of the child. All the time it was going on, of course, we were having multiple births - triplet births and so on - around the country, and if you want to talk about the welfare of the child start talking about 28-weekers being born in triplet births. So it was a complete distortion of HFEA priorities. Q1186 Paul Farrelly: That is the first part of the question. The second part is how do you see guidance working? Professor Templeton: It is good medical practice. I do not think you need guidance. Why would you need guidance to try and make a decision? It is the same issue as whether you treat an HIV-positive patient or you have two patients who happen to be heroin addicts and whether you should treat those within your clinic. That is the discussion you have. You cannot generalise; it is good medical practice to take a decision about the appropriateness of treatment in any given circumstance. Q1187 Paul Farrelly: So someone, for example, who was on the Home Office register of (let us put sexual offenders to one side) violent offenders would be a relevant consideration? Professor Templeton: It certainly would be a relevant consideration, in my view. Of course, the responsibility is to try and find out if, indeed, that history exists in a particular circumstance. Q1188 Dr Harris: I would like to explore this good medical practice. I understand what you say about the welfare of the child, and thank you for being so clear, but I would like to explore the difference (I was not here earlier but I read your evidence) in approach between infertile and fertile couples in respect of allowing them to breed, from an ethical point of view. What you are saying is it is good medical practice for a doctor to come along and say, "We are not going to let you have a child, though we are not going to sterilise you if you happen not to be infertile, but we are going to use our subjective judgment" (and it may not be someone as progressive and liberal-minded as you; it might be some old, crusty gynaecology professor - I understand some still exist ---- Professor Templeton: There are a few! Q1189 Dr Harris: Is that good medical practice or is that just the application of prejudice in a sort of paternalistic way, not even to the patient in front of you but to some future person? Professor Templeton: The application of prejudice in a maternalistic way is not good medical practice. Chairman: Did you miss that in your training? Q1190 Dr Harris: You have just said there are HIV-positive issues, for example, or heroin addicts. Let us take a doctor who is a heroin addict, and there are many around. What you are saying is that there are two options: to say, "We are going to treat you as a patient; we are going to give you education, information and offer you treatment, and urge you to take that treatment. You have these questions about your fertility, we are not going to stop you from trying to conceive naturally", but instead of taking the approach "I am going to inform social services because there are issues for the child" you are going to make the decision to deny treatment to that person. That is the example you used. I would like to ask Dr Kennedy as well for his view. Professor Templeton: I might. Having discussed that, a good medical practice view, with everybody who could possibly be involved in such a decision you would, particularly, obviously, want to discuss it with the patients. It may be that, from time to time, your view would be that it would be inappropriate from the point of view of the child to treat that couple. It may be. It obviously is a difficult area, and I do not think it is going to be helped by guidelines or legislation, because they cannot legislate or produce guidelines for every clinical situation; there are principles which are laid down in good medical practice, which I would follow in reaching such a decision. Because this patient is infertile and seeking assisted reproduction treatment does not make the approach any different from, perhaps, seeing an ante-natal patient who happens to be a heroin addict and alerting the services and discussing her management with those who can best support that management. It is exactly the same decision, exactly the same process. Dr Kennedy: Yes, I agree with that. I do not think you need to regulate for it specifically. As a doctor, when you discuss with the patient, in the consultation process, the wider implications of whatever it is you are advising or about to undertake for that patient, those wider implications will include the consequences of the treatment, the child that may be born and the background of the person who is seeking treatment. This is part of the normal consultation process. If that involves accessing information from social services or asking the patient if we can access information then so be it, you do so. If it requires additional help to make that decision, then you invoke that additional help, but it does not need regulation to ensure that you conduct that practice. The other issue here is the bureaucratic process which is currently applied in the implementation of the welfare of the child assessment. Q1191 Dr Harris: We have heard plenty of evidence on that. So what you are saying is that you would be happy for some of your colleagues to deny treatment to a man who is a heroin addict where the mother was not, and for some of your colleagues not to (because they might think that) but to notify social services around an at-risk assessment, and you would be happy with two different approaches being taken by different people with a different background and different medical perspective, because you do not support guidelines, and you think as long as they are acting in the interests of society ---- Dr Kennedy: I did not say we did not support guidelines. There have to be guidelines to undertake good medical practice - of course there have to be guidelines. That would require you to take account of certain issues and certain considerations before you make your decision about offering treatment. Professor Templeton: You make the assumption, if I may, that the guidelines would actually prevent what you have just said, and there is no evidence to suggest that you might not treat appropriately one patient quite differently from another patient in that patient's circumstances - something the guidelines could not even begin to help you with. Q1192 Dr Harris: If there was a human rights claim, for example, by a lesbian couple, then guidelines, I would imagine, would swiftly follow to say it is unlawful, if there had been a successful claim, as people think there would be if there was a claim. So some of your colleagues to whom we have spoken who refuse on their own moral grounds to treat lesbian couples would be out-with their terms ---- Professor Templeton: It is just the same as some doctors refusing to do abortions. Q1193 Dr Harris: I am not convinced that there would be a conscience option when there is a human rights claim that you are suffering discrimination and the NHS says, "We will not discriminate ---" Professor Templeton: You have a human rights issue; if you are doing something against your conscience then the proper way of dealing with that is to pass it to another doctor. That, again, is good medical practice. That is enshrined in that code. Q1194 Dr Harris: One more point here. Is an alternative to this welfare of the child provision and, indeed, some guidelines about good medical practice to say that we are not going to discriminate against the infertile, as we do in practice, effectively, by denying them reproductive freedom, for whatever reason, but we are going to say that ---- Professor Templeton: Or, more particularly, denying them funded treatment. Q1195 Dr Harris: So denying the poor infertile from access to reproductive freedom (which I think adds to the strength of my argument because there is an equity issue as well as a human rights issue) and, instead, say "Look, at least we now know what is going on and we have the option of ensuring that social services are there at the birth so they can make a risk assessment and, if necessary, intervene, but we are not going to do it in a prior way." Do you think that is a reasonable approach in cases where there is a history of domestic violence, for example, or there is a drug addiction issue? Is that an alternative approach? Do you see merits in that? Professor Templeton: Do you mean that the guidelines would say that, or do you mean ---- ? Q1196 Dr Harris: The system would be that there would be a presumption of non-discrimination against the infertile, because if they are fertile and there is domestic violence or heroin addiction they can breed, and you do not know there is the risk, whereas here, at least, you know there is the risk and you can bring in social services at the birth. Professor Templeton: I would be very happy if that steer, which is all that we are saying here, was enshrined in the legislation, yes. Q1197 Dr Harris: Finally, if the welfare of the child issue around multiple embryo transfer is so obvious why did it take so long? Professor Templeton: Do not ask me. I have been writing about it since 1995. The RCOG guideline in 1996 recommended two embryos, and the BFS guidelines at that time. It has taken until two years ago for the HFEA to catch up with what was recommended clinical practice. In Scandinavia now, in many clinics, 60 per cent of the embryos are put back one at a time, with no apparent reduction, as that table that has just been passed round shows, in the overall pregnancy rates. So I think it is a big issue and I think we have to ask ourselves why it did not happen more quickly. Certainly the HFEA could have made it happen more quickly but I think they were very concerned about legal challenges; they were very concerned that there was a society view out there that patients were willing to take the risk. That was quite erroneous, in my view but, nonetheless, is part of the reason for this slowness in their eventually making their pregnancy ---- Q1198 Dr Harris: I see Dr Kennedy nodding, for the record. Dr Kennedy: For the record. Q1199 Paul Farrelly: Has Professor Regan been nodding as well? Professor Regan: Yes, she has. I think it might be useful to add as well that one of the delays in entertaining this legislation is that there has been an enormous drive from the private funding sector in the sense of what they have wanted. Whether that is in the remit of this Committee or not, I think it is important to look at this issue and keep that context in mind. Q1200 Dr Harris: I think it is in its remit. Professor Regan: It is very important. Q1201 Dr Harris: Can you be a bit more specific then? Professor Regan: It comes back to how your unit is assessed and where your clients come from, or your patients come from (whichever way you wish to look at it). At the end of the day, if you are given a sheet of paper and you say, "I wish to access in-vitro fertilisation and I am looking for the best place to go", and you look at the pregnancy rate per transfer you will get very different information than if you were to look at what were the successful pregnancy outcomes from that clinic. What we know is that there are higher pregnancy rates per transfer, it is thought, with multiple embryo transfer or two or three transfers. Professor Templeton: May I just say, in relation to this table, there are major reservations about data collection in some of the countries that are well above the United Kingdom. The denominator is a key issue. But if you look at singleton births, even somewhere as far ahead, apparently, of the United Kingdom as the US, the rates are the same. Q1202 Chairman: Are you saying that the data collection is rubbish in this country? Professor Templeton: Not in this country. It is the denominator data. In this country, as soon as an injection of gonadatrophine begins that cycle is registered. We think, probably, most are. Q1203 Chairman: So your defence about the league table is other countries do it badly? Professor Templeton: No, I am just saying that in certain other countries - and I would not want to name them - above the United Kingdom there, we know that data collection is confined to one or two clinics, and that still it is voluntary, so that the clinics do not have to submit their data. Q1204 Dr Harris: Is Sweden one of those countries? Professor Templeton: No, no. Sweden is certainly not one of those countries. Q1205 Mr Key: Is it Iceland? Professor Templeton: It is none of the Scandinavian countries. Q1206 Mr Key: So it is Greece? And Russia and Slovenia? On this point about funding, if you look at pregnancy rates per transfer in this table within the United Kingdom there are also enormous discrepancies between different IVF centres funding in different ways. Have you any evidence that the way in which the clinics are funded makes a difference? For example, quite a lot of the IVF clinics which are within NHS hospital premises are actually privately owned by companies which set up to specialise in this area, and the contract may or may not be with the hospital trust. Is there any evidence that that makes any difference, or accounts for the discrepancy? Dr Kennedy: I think it is quite clear, if we remove the commercialisation of IVF in this country, which undoubtedly has driven practice, and the league tables that have been produced, then we can move very quickly to more sensible clinical practice which is not driven by this desire to be up there in the league table but is there to serve our patients best, to reduce the adverse consequences (ie, multiple pregnancy) and to move to single embryo transfer in selective cases. Q1207 Dr Iddon: Professor Templeton, you or your organisation believe that the media and equipment used in IVF, particularly when new materials are introduced, should be regulated in some way. Who do you think should carry out that regulation? Professor Templeton: I think, again, it is the accreditation system, and I think that the standards set by the laboratory organisations in the context of assessing new media, and so on, should be set down in the accreditation system. So I think it should be done at that level; I do not think it is a matter for legislation, it is a matter for the code of practice or the accreditation system. Q1208 Dr Iddon: I am sorry, could I just be clear about who sets this code of practice? Your professional organisation? Professor Templeton: We would be very happy to contribute to such a code. If we were asked then I think the professional organisations could certainly evolve a code of practice by which clinics in this country could be accredited. Q1209 Chairman: If you were not asked, would you trust it? Professor Templeton: It would depend on who was doing it, I guess. Q1210 Chairman: Is this a moral or ethical judgment? Professor Templeton: If you look at the present code of practice (I forget how many there are) there are six pages referring to counselling, and when I joined the HFEA in 1995 I was astonished that there was about half-a-page which referred to actual clinical practice in relation to egg recovery. At that time there were two recorded deaths in Greece from monitored egg recovery and yet there was nothing in the code. So there were distortions within the code of practice which referred to the origins of the HFEA. One of them was this overly need for counselling and the other was the welfare of the child assessment, with insufficient on clinical and laboratory standards of practice. Q1211 Dr Iddon: There are some clinicians who believe that success rates may be improved by using techniques like assisted hatching and blastocyst transfer. There are other clinicians who believe that that is of little benefit. What is the view of the College? Professor Templeton: The NICE guidelines reviewed both of these issues and the jury, I think, is certainly out on assisted hatching, but the overall indications from the evidence that can be gathered is that there is not major advantage. There may be subsections of patients but it has never been shown in these subsections that it is unquestionably efficacious. So I think there is an issue there. We have got bodies in this country that have the ability: NICE has two processes, it has the guidelines process and it has the HFEA process, and if we are unsure about new technologies they can be assessed in that way. You do not need specific organisations as such to do it; I think it is part of medical practice. Professor Regan: Could I just add, at this point, that the examples you cited were all to do with an IVF unit and the embryo transfer procedures. There are a limited number of units within the United Kingdom that are using multiple forms of additional therapies in order to improve, supposedly, pregnancy rates, none of which have been demonstrated in any random trial to be of benefit and most of which, potentially, have very significant side-effects for the woman who has been given these medications. They include steroids and intravenous haemoglobin infusions, aspirin, heparin injections and a variety of other medications. It would be very helpful, I think, for the future if we were to consider those issues as well as those that are confined to an embryo and laboratory scenario, because they do have very, very significant implications. It is quite horrifying, I think, how many couples are advised to take these treatments because they are desperate and because they have no other way of knowing whether they should or should not, and they turn to the internet, which, as you will recognise, does not have peer reviewed information. Q1212 Dr Iddon: Do you think the present Act and/or the HFEA itself inhibits developments in clinical practice like the ones I have just mentioned? Professor Templeton: The only example I know where I think, in my view, there have been inappropriate inhibitions has been egg freezing. There has been an issue to do with safety and efficacy of egg freezing and certainly there was a very negative view taken by the then New Technology Committee of the HFEA. However, by and large, the look at new practice has been fair and has been balanced. You could say, of course, that had ICSI not been so well developed and carefully developed in Belgium we might still be talking about whether it was an appropriate thing to do in this country, and there is an issue there, but by and large I think new clinical developments are available in this country. Just compare with some other European countries where egg freezing is not available, where PGD is not available, where ICSI even now is not available; I think the relevant new developments, by and large, have been made available. Q1213 Chairman: Is there not an international standards accreditation process? Professor Templeton: Not to my knowledge. Q1214 Chairman: ISO? Professor Templeton: No. Dr Kennedy: If you are talking about standard clinical practice, then the EU Directive will move us in that direction, very much so. Q1215 Chairman: So your view is that it has not even started yet? Dr Kennedy: It is starting but the EU Directive will not be applicable to United Kingdom centres until April 2006. Q1216 Dr Harris: Professor Templeton, do you think the Whittakers would agree with you that the HFEA - of which you are a member? Professor Templeton: Was, yes. Q1217 Dr Harris: Maybe you were involved in this decision. If so, please let me know. Do you think they would agree that the HFEA, other than in egg freezing, has not held back therapeutic advances? Professor Templeton: That is a difficult point, you would have to agree - very difficult. They would probably disagree but others still have their reservations about whether it is an appropriate way forward. Q1218 Dr Harris: Yes, but the HFEA told us that they changed their mind on that on the basis of scientific advance between the first decision and this decision. Professor Templeton: And they changed their mind on Diane Blood as well. Q1219 Dr Harris: Do you think science changed around the safety of PGD between the fist decision and the second decision, or was it the legal judgment that changed in the Court of Appeal on the Hashmi case? Professor Templeton: These are external influences that obviously make people change their minds, and that is all part of the richness of the discussion. It is unfortunate that individual patients are caught up in that decision - Diane Blood having to go abroad for her treatment and the Whittakers not getting treatment but another group getting it - but it is all part of that discussion and it should not be a static discussion. Q1220 Dr Harris: You are not answering my question. My question was: do you think there was evidential development in the safety of PGD for the embryo produced between the first decision on the Whittakers and the decision on the Northern Ireland family where they changed their mind? Or are you not qualified to answer? Professor Templeton: I think I am not qualified to answer. I perfectly understand the question. Q1221 Dr Harris: Can I ask you a general question, then? Should the precautionary principle be that these things should not be allowed until someone else in the world shows they are safe, or should things be allowed - if there is good reason to do them, obviously - unless there is evidence that it is unsafe? How would you like to see us approach that? Professor Templeton: You cannot generalise about it. If we are talking about safety in relation to the welfare of the child, the fact that that child may have to live with something for the rest of its life, then that is a different dimension of decision making. Q1222 Chairman: What good would guidelines be, then, if you are making an individual basis? Professor Templeton: That is what I was saying previously. I think within the legislative framework you have to allow the policy-making body to dissect out and try and discuss these things, reflect what the view of society is, what the need is within society for this particular advance and then to weigh up safety and efficacy. Q1223 Dr Harris: There are two different approaches and they do not merge together; PGD is a good example, particularly when, as in the Whittaker case and the Ashby case, there is another child whose welfare might be considered. Should the precautionary principle operate, in your view, to say that we should not go ahead for the good reason of therapy for the other child until we are more certain that something is safe, or if there is no evidence that it is unsafe should we allow proceeding cautiously, collecting the evidence, database, follow-up and all of that? I think that is two options. Professor Templeton: Yes. Q1224 Dr Harris: The public say they want a precautionary approach, but I say which one? What do you think? Professor Templeton: There are two options but you are talking about two different approaches and I do not think life is like that. You take each case as it comes along and you weigh up the relative risks. For example - again coming back to cytoplasmic donation - there is no evidence that that is unsafe, but there is a lot of circumstantial evidence that it could be unsafe, and if it is unsafe it might have disastrous effects on your children. For that reason, certainly, I took the view - and still do - that it would inappropriate to allow this to happen while there is evidence that it might be unsafe, and certainly there is evidence that it would not do a lot of good. It is the safety issue. Q1225 Dr Harris: So you do more animal work, but at some point someone has got to start. Professor Templeton: Indeed, and it is exactly the same issue with egg freezing; that has been part of the issue: low success rates and safety and trying to weigh up when you think it is reasonable to promote that in clinical practice. I do not think guidelines and legislation in this particular area of ethical decisions about the appropriateness of treatment in individual family circumstances is going to be helpful. Q1226 Dr Harris: Has anyone got a different view on the question I asked, Dr Kennedy, Professor Regan? Dr Kennedy: No. Q1227 Dr Harris: Can I ask you finally, Dr Kennedy, you are an inspector and there are inspectors who are involved in running clinics in competition with other clinics. I am sure you are full of integrity but there is perception among the inspected, and perhaps among those looking on, that you have a vested interest in knocking out the competition, particularly in respect of some techniques that might put them above you in a league table, regardless of whether you are NHS or private yourself - presumably private clinics also provide inspectors Do you think that is an appropriate way forward and would you like to see that changed to a more seen-to-be independent inspection approach? Dr Kennedy: The general observation would be that the inspection process is rather too soft. There is a process to allow declaration of interest, but in answer to your question I think there should be a professional inspectorate which does not necessarily take from those involved in current clinical practice, so there is an independent professional inspectorate which inspects clinics and can do so completely objectively, and has the teeth to say this is right, this is wrong, this is what you have to put right. Professor Regan: Although you could add at that point that if you have individuals who are independent of clinical practice at the present time, are they the best individuals to be inspecting clinics? Dr Kennedy: If you have a professional inspectorate I think you overcome that because you appoint professional inspectors. Q1228 Chairman: The last question - just briefly, because then we have to go to Prime Minister's Questions - is on clinical trials. Are you happy with the state of them in this country, that they are well-funded or what? You have put a lot on evidence and without clinical trials there is no evidence. Are we playing at it or is there a real investment and concern about developing clinical trials? Professor Templeton: It is difficult, but the opportunities are there. I know, perhaps, of three that have gone to the MRC and have been turned down. I know that the NPU recently have put in a proposal to the MRC to set up a clinical trials centre, if you like, which has been turned down, and it is always difficult to know if the reason is the quality of the science or if there is a genuine bias against doing such trials. I am involved in two multi-centre trials that are appropriately funded; they are multi-centred, they do show good collaboration among the various centres in this country and that is a way forward. Perhaps we need to encourage the MRC to look again at some of the proposals that have come forward. Q1229 Chairman: Professor Regan, have you a point to make? Professor Regan: Yes, we do need more trials, particularly on the points I was making earlier, not just on the IVF treatment cycle but on the adjunctive therapies that are being offered. I think it is important to emphasise as well that unless we get more funding of the trials it is going to be progressively more difficult to recruit these patients and their clinicians to encourage those patients to go into trials. Many of them will say "I want to try this treatment anyway, I am prepared to take the risk because it might help me." It is very different when you are wishing to avail yourself of a treatment that may possibly help you achieve your live take-home baby from discussing the TNF alpha drug which may or may not be prescribed for your rheumatism. Q1230 Dr Harris: Why not a levy on private clinics that they could pass on to the patient that could contribute to NHS patient research? Should the private sector contribute? Professor Regan: Yes. Professor Templeton: Do you mean financially or by contributing patients? Q1231 Dr Harris: They can pass it on, obviously, to patients. Professor Templeton: The costs of the research? Dr Kennedy: The licence fee that currently is applied to patients throughout the UK for licensed treatments, you could divert that into research. That would be a very useful use of a licence fee. Dr Harris: Good idea. Q1232 Chairman: Thank you very much for coming and giving us your views and professional judgments and so on, it has been very helpful. Our report will finish some time early next year after we have seen the Minister and the Human Fertilisation and Embryology Authority, for both of whom we will have many questions to ask; you have helped us with that, thank you very much indeed. Professor Templeton: Thank you.
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