Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 820 - 839)

WEDNESDAY 27 OCTOBER 2004

DR MICHAEL WILKS AND DR VIVIENNE NATHANSON

  Q820  Dr Turner: Your evidence also highlights the possibility of vulnerable people being exploited or abused by, shall we say, less scrupulous practitioners. To the best of our knowledge there has been no recorded incidence of this since 1990. Do you think this is proof of the effectiveness of the regulation?

  Dr Wilks: I am not sure that we would necessarily say that just because there has been no reported evidence it has not happened. I think this is another issue around earlier questions around reproductive freedom. Unless we are going to suggest—and I doubt whether you are—that there should be some restrictions on those normal reproductive freedom rights (and I presume you are not) then we have to ask why we would want to regulate and control various forms of assisted reproduction. I think it comes back to the basic principles that we set out before. Particularly, I think, we do have to have some concern for the safety of those procedures, and if a service is being offered to the public which has dubious safety, is completely unregulated and uncontrolled and can be sold, as it were, as a service to patients without any medical assessment then we have to ask whether that does not, actually, have the potential for creating vulnerable groups of people. So we would argue that anything in which the technology involves the creation of an embryo, or a child, in any artificial way, where there is a question about the safety and competence of that process, then we think it should come within a regulatory framework.

  Dr Nathanson: Just to say we would also be concerned, in terms of vulnerability, about donated gametes, particularly donated eggs, because a woman who either cannot produce her own eggs—or, for other reasons, hers cannot be used—is particularly vulnerable at a time when we know that in society generally that internationally there is a shortage of eggs and egg donors, and at the same time we have groups of women who can produce eggs but who may not have financial access to the treatment. So, for example, one of the groups of particularly vulnerable people we are concerned about is women being persuaded against an offer of free treatment to give eggs, and I think we do need to look at those because there are risks associated with the treatment and because, in a sense, those individuals have difficulty in making a truly free choice at a time when they are under considerable emotional, financial and other pressures.

  Q821  Geraldine Smith: Does the HFEA need to change? Would you favour the establishment of a national bioethics committee to undertake ethical decision making?

  Dr Nathanson: If we can start with that last one, we think a national bioethics committee is a good thing but not to take the decisions on behalf of the Human Fertilisation and Embryology Authority. I think there are different issues about whether a national bioethics committee would be useful to contribute to the ethics debate on a very broad set of fronts, but in terms of the HFEA one of the things it does is it does not just look at ethical principles, it also looks at clinical practice and it makes an interesting and careful balance between principle and pragmatism, and I do not think a national bioethics committee would be able to encompass that area. So that a national bioethics committee would lose some of the interpretations that put it into a practical context, and I think that would mean that the ability of clinics to carry things forward would be compromised in a way that would be unacceptable to most of us.

  Dr Wilks: I think that is absolutely right. There is a huge difference between bioethical advice at that sort of level and the actual regulation, and the balance, as Vivienne says, between good ethical principles and how they work in practice through an actual practical process of licensing is very important. We support this process of review not because of some concern about the efficiency and the balance that the current HFEA Structure creates but more because it is right to review this whole area of regulation when the technology has changed so much. We have great confidence, historically, that the majority of decisions that the HFEA have made have been well-balanced; they have balanced the interests of the children to be born with the interests of society generally, they have addressed safety issues through licensing, and we think that system has actually, basically, worked well. We have said that in our evidence, but that is a very strong point we would like to make.

  Q822  Geraldine Smith: Who should make the ethical decisions at the end of the day?

  Dr Wilks: Ethical decisions in terms of what actually happens at the moment—

  Q823  Geraldine Smith: At the moment, the majority of the HFEA are lay people and they have a lay chairman. On the HFEA, at the moment, if you are opposed to embryo research you cannot take part, you cannot be a member. So is it not a bit one-sided and should we not have a more open debate about some of these ethical considerations rather than just leaving it to people with a certain view?

  Dr Nathanson: Firstly, the law allows for embryo research, so it is not that the HFEA is making a decision on whether embryo research is allowed, it is whether they will license an individual or an individual clinic or organisation to carry out research that is covered by the law. So they are not looking at, if you like, the fundamental ethics underneath whether we should allow embryo research. It is, in fact, a matter on which Parliament has made the decision, but if there were to be further debate on it then, by all means, a national bioethics committee—

  Q824  Geraldine Smith: I guess at times we make decisions on how far research should go. It is where you actually draw the line, surely.

  Dr Wilks: It is making decisions about how far things should go and, obviously, things like decisions about preimplantation genetic diagnosis may change within the HFEA in terms of who regulates that activity because it is then convinced it is more safe (that is what the recent decision of the HFEA has been). The HFEA works within existing legislation, so it can license embryo research. If there is a concern about the ethics of that then the debate needs to be much wider about what is regulated. We would hope that a regulatory body that made these kinds of decisions would be sensible enough to have the right make- up and the right advice given to it so that it knew what clinical and scientific research ethical boundaries were around that work. So I would hope it would take that sort of advice. We would not have much confidence if it was not set up in that way or did not operate in that way.

  Q825  Geraldine Smith: What about the fact that people are barred from being on the HFEA if they are opposed to embryo research? Does that really help constructive debate? Should we not have all views represented?

  Dr Nathanson: The difficulty is that if you have those views represented then every time that an application for a licence to carry out research which was entirely legitimate and entirely within the legislation came forward then the chances are that that could be barred, which would effectively mean that that person's membership of the HFEA could actually turn back what Parliament has decided to allow in the legislation. I think that is the difficult balance that you have when you have a regulatory body of this sort. I think it is extremely important that the bigger debate carries on and informs both any changes to the legislation and, separately, that the bigger debate carries on and, when the HFEA is considering individual licences, that broader debate is considered as part of their policy making, as part of their licensing, but not within the actual committee structure because the danger there is that you stop all licences being granted, and I do not think that is what Parliament wanted when it passed legislation to allow embryo research.

  Q826  Bob Spink: Could I just step in here, Geraldine? Is it not the case that the HFEA has actually gone further than Parliament expected them to go in the legislation on procedures and in giving certain licences? They have gone further not just than legislation allowed them to go but they have gone further than public opinion would suggest they should have gone.

  Dr Nathanson: One of the difficulties when the technology and the science is moving so quickly is that the way in which the current legislation is written leaves areas where you can argue that they are silent on or that there is no law either prohibiting or allowing the HFEA to make decisions.

  Q827  Bob Spink: In that circumstance would you expect, therefore, the HFEA—this, we have already heard from you, biased body that does not represent society as a whole—to make these decisions and to push it forward, or would you expect them to be precautionary and to take the view of society and to consult and to go through Parliament to seek guidance?

  Dr Nathanson: I would expect them to consult widely, to engage in ethical debate, to encourage ethical debate and to encourage the participation in that debate by the widest possible group of stakeholders. That means people with an interest, both as ordinary members of society, as potential parents, as people who can benefit as scientists and, indeed, as opponents and to listen to those debates. However, in an ideal world they would not have to step into areas on which Parliament has not legislated because they are meant to be working within the legislative framework.

  Bob Spink: Thank you, Geraldine.

  Q828  Geraldine Smith: The majority of these people are lay people, so they are not even experts. Should there be a greater proportion of experts? I think, perhaps, that the role should be split. I do think it is important to have some sort of bioethical committee that could debate the wider ethical issues and then you need some sort of expert body.

  Dr Wilks: That may be a way forward, but I would illustrate it by the way, for instance, that my medical ethics committee works at the BMA. We have experts, we have doctors who are experts in some things and we have experts who are experts in other fields. What we do is we have debates based on ethical principles which are then translated into ethical procedure so that we can advise members of the BMA how they should practically approach a particular dilemma in a very practical way. So we do actually go through that process of what are the basic principles, what are the issues, how is society changing, what is public opinion (and we do consult if we do not know the answer), how might things change in the future, what is the balance of risk on this particular technology and then what is best to do in terms of advice to doctors? Obviously, we are not going to regulate that treatment but we do give very strong advice about it. I think it is difficult to separate the ethical principles, particularly as those change with the technology. As I say, one of the reasons we are here today is because things have changed so much in little more than ten years. Unless you actually work within the very broad principles that Parliament has established, I think a regulatory body has got to be given the freedom to advance the boundaries, as long as it is within the basic principles that are set out.

  Q829  Dr Iddon: The majority of the population, at some time in their lives, have had almost complete reproductive freedom. Why then do we impose a "welfare of the child" provision on the infertile?

  Dr Nathanson: There are a variety of answers to that, including the fact that we always have, in the sense that if you want to adopt or foster we actually assess your suitability to be parents but we do not assess people who produce children naturally, as it were, without any help. I suppose the answer is that, in the same way, when we are looking at assisted reproductive technology, there is the question of the harm to any child that might be created using that technology. However I would emphasise that we do not believe in blanket exclusions and we do not believe in idealised family concepts; we believe that every individual should be looked at separately and every individual case or every individual person involved, and that the exclusions should be truly exceptional, where there is very good evidence that there would be a serious risk to the welfare of any child created to that individual. So it would be truly exceptional. It is different in that society does have a role, as society is encouraging and supporting in some way the use of this technology and, therefore, the creation of a child in a way which is different to natural reproduction.

  Q830  Dr Iddon: Is it not a dangerous precedent to enshrine a moral question under the law?

  Dr Nathanson: I think the law enshrines moral questions a lot of the time. It says things are wrong and very often the reasons why we consider them wrong have a moral basis.

  Q831  Geraldine Smith: Can I come back on the inspections? I would like to ask about the inspections of clinics under the HFEA. Do you think people that are actually carrying out the inspections are suitably qualified to do that? Do you think it would be better if, perhaps, that was undertaken by experts?

  Dr Nathanson: We do not have the expertise on that element of it. That is for the clinics and for the people who actually do inspections to say.

  Dr Wilks: May I come back to Dr Iddon's point about the issue of reproductive freedom? Obviously, on the face of it, it seems odd that we create these hoops that people have to go through to get what most of us will have obtained naturally. I think the issue of the safety of the techniques used and the future techniques that may need to be assessed in terms of their safety and their clinical effectiveness is something that does put a responsibility on a regulatory body to allow it to happen or not to allow it to happen, or to allow research on it until they are confident that it is safe. I think society obviously moves in terms of, for instance, what it sees as an ideal family in which this child will be brought up in, so the best interests of the child might vary according to society's view of a family. For instance, we have taken a view in the last few weeks that our view on being opposed to the posthumous use of gametes should change towards favouring posthumous use of gametes where explicit consent has been given before death for use after death, simply because we have looked at evidence about the welfare of children brought up in different types of family and we certainly have some scepticism that the "family unit" as many people might define it is the only environment in which a child can be brought up, loved and nurtured. That is why we have a little bit of concern about this maintenance of this "need for a father" that legislation has and whether that should be reviewed.

  Q832  Dr Iddon: We have a dilemma as a Committee because, obviously, you support the retention of "welfare of the child" and that is clear from the evidence today and especially from the written evidence you have given us. However, the Royal College of Obstetricians and Gynaecologists have given us in evidence the following quote. They believe that the "welfare of the child" provision, "has proved unworkable and may be considered discriminatory". So we have a dispute between two organisations working in the same area. How do we resolve that dispute, as a Committee?

  Dr Nathanson: I would suggest that we need to look very carefully at what they mean by discriminatory and why it does not work. We would suggest that people are, perhaps, trying to draw rigid rules from the "welfare of the child" rather than looking at each individual case on its merits and that there are in some people's minds assumptions that the welfare of the child requires these rather formalised, particular types of family setting, rather than an assumption that most people who are seeking infertility treatment are just normal people in a range of family and other circumstances who just happen to need medical help to produce pregnancy. In the majority of those cases their children will enjoy all the benefits that other children enjoy, and it is only in rare and exceptional cases that the welfare of the child is genuinely at risk. I think that is the key; some people saw the "welfare of the child" issue in this part of the process as being a common reason, as it were, for excluding people—that you would frequently see children who were at very great risk. Obviously, the potential for children to be at great risk we would see as an exceptional circumstance, and I think that in itself becomes non-discriminatory. I think on discrimination we have to be careful. If we are discriminating against people on the grounds of the welfare of the child and there is a serious risk I do not see that as a negative form of discrimination; it would be very negative if we were discriminating on the grounds of the race, or sexuality or whatever else of the potential parents, and that is where we are absolutely firm that we should not be making decisions; that is not an issue that would affect the welfare of the child.

  Dr Wilks: It would also be discriminatory if people seeking treatment felt that they had to prove they were going to be good parents. That would be ludicrous. Presumably one could make the assumption generally that people who are seeking this type of assistance desperately want to be parents and be good parents and one could make the assumption that a child so produced would be loved in a happy environment. However, I do not think you can get away entirely from the issue of the safety of the technology and I think that is why we argue, particularly, for flexibility of approach—each case considered on its merits—and a very wide view of what a "family" actually is.

  Q833  Dr Iddon: The safety of the technique cannot be influenced by the suitability of the prospective parents, surely?

  Dr Wilks: No, no, I was arguing for a process of regulatory inquiry that included the welfare of the child as well as the assessment of safety. I was arguing for the overall construction.

  Q834  Dr Iddon: My final question is the BMA does, therefore, believe that there are measurable benefits from having this provision in the Act. Is that correct? If so, what are they?

  Dr Nathanson: I think it is extremely difficult to measure them because the nature of measurement would be, in a sense, trying to measure a negative, because the assessment would be whether the potential child has been saved from disbenefit, as it were, or harm by not being created, and it is extremely difficult to prove that kind of negative.

  Dr Turner: We have, in fact, got minus time to finish this session. We have two important areas still to cover, so please can I ask my colleagues to be very brief and you to be as succinct as possible in your answers?

  Q835  Dr Harris: Can I just remind colleagues on the Committee that I am a member of BMA Medical Ethics Committee but I did not take part in the formulation of this evidence, otherwise I would seem to be arguing against myself—which I am more than capable of doing. I just wanted to pursue this important point. Can you give me examples of circumstances where you think that the welfare of the child requires that a couple, say, or a patient, cannot be treated?

  Dr Nathanson: I suppose the most obvious example is where the potential parent has recent convictions for child abuse.

  Q836  Dr Harris: So in those circumstances would you go out and make infertile such couples who were not already infertile? Would you use castration?

  Dr Nathanson: Of course not.

  Q837  Dr Harris: So, in those circumstances, we rely on social services and the "at risk" register to intervene. Do you feel that those social services are incapable of acting even when there is prospective notice that such a couple may have a child? Indeed, where there may be greater ability of social services to intervene, why do you use the withholding of medical treatment to do something that social services could do?

  Dr Nathanson: Because you are asking doctors to interfere to use powerful technology to create a child into a situation of risk where you know that the management of that risk is very far from perfect.

  Q838  Dr Harris: Can you think of any other circumstances where the "welfare of the child" provision should be used in this way? Otherwise you could just draw into the regulation that people with recent convictions should not be treated, and then we would not have to have this "welfare of the child" which serves, we have heard, to discriminate—as you have said yourself—potentially against classes of people who may actively be denied treatment or may feel that they will be given a rough time on the basis of their sexuality or their age or their disability.

  Dr Nathanson: I would not want to start to create a specific category and an absolute set of rules to say that in these circumstances or these individuals should always be denied access to technology. Our thesis throughout is that every individual must be considered on their own merits and that you have to look in a holistic sense at the potential child and its welfare—looking at the potential parents, looking at the circumstances and so on. I do not want to start trying to create a list of specifics that would say "This group of people should not be allowed access to this technology".

  Q839  Dr Harris: You have said that before. Dr Wilks, can you think of any circumstances where the "welfare of the child" provision should be used to prevent a child because their life would be so terrible that it would be better that they were not born?

  Dr Wilks: No, I think it is very difficult to do that but, I suppose, what I would be concerned about would be if it were to be suggested that the "welfare of the child" provision was of no value whatsoever and that, therefore, it should be completely removed and that, therefore, it was to be of no concern to either the HFEA or individual clinicians about the welfare of a potential child, in the sense that the rest of society takes a very strong interest in the welfare of the child at all sorts of levels of education and social services. So I do not think it is inconsistent that a regulatory authority should also do that.


 
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