Medical Innovation Bill [HL]

Debate between Lord Mackay of Clashfern and Lord Winston

Friday 12th December 2014 Lords Chamber

[Lord Winston]

It is very kind of the Front Bench to offer that possibility. If I were to degroup an amendment, I would degroup the stem cell one and put it with Amendment 5, as it would fit better with patient safety. One of my difficulties is that the groupings are slightly odd in terms of the relevance of the different aspects of my amendments.

[Lord Mackay of Clashfern]

My understanding of the groupings system is that those who have views on the amendments should take the opportunity to speak when the relevant group is first dealt with, but it does not preclude a noble Lord who has tabled an amendment speaking when the amendment is called in the ordinary course of events. As your Lordships know, following a debate an amendment is often called as being not moved, but the person who tabled the amendment has the option to move it at that point. Therefore, in that sense there are two opportunities to speak. However, in order to try to make the procedure as economical as possible, the general idea of the groupings system is to enable a group of amendments to be considered as a whole on the basis that, rightly or wrongly, such consideration is facilitated in that way.

Public Bodies Bill [HL]

Debate between Lord Mackay of Clashfern and Lord Winston

Wednesday 9th March 2011 Lords Chamber

[Lord Mackay of Clashfern]

My Lords, I declare an interest as an honorary fellow of the Royal College of Obstetricians and Gynaecologists and as the person who had the privilege of introducing to this House the Bill that ultimately became the Act which has been referred to more than once. As a parent of such a body, it would be strange if I wanted to see it dissolved altogether. On the other hand, a parent who is interested in his child is glad to see him or her develop and possibly make unions with others who seem to be suitable for them. I had the honour of serving on the Joint Committee looking at the recent Bill in this area under the distinguished chairmanship of the noble Lord, Lord Willis of Knaresborough. I strongly supported the decision taken by that committee to recommend against the proposed union between the Human Fertilisation and Embryology Authority and the Human Tissue Authority. I think I am right in saying that the noble Lord, Lord Willis, may have done a slight injustice to the noble Lord, Lord Warner, because I think the noble Lord, Lord Warner, said that he had recommended against it to the Minister. I do not know whether the Minister accepted it immediately, but eventually it was accepted by the corresponding Minister.

The matters that were the subject of the Bill which I had the privilege of introducing are certainly among the most important areas of modern scientific and medical work. But science and medicine have moved on very fast and far since that Bill was introduced and the developments dealt with in the most recent Act show that. That Act moves out of pure human embryology to the transition towards hybrids and, at the extreme end, towards the animal end of embryology. It shows that science has developed in such a way that the distinct field carved out in the original Bill has been altered by progress, if you like to think of it in that way, and I hope that that is what it is. There is a great deal to be said for the view that modern scientific and medical research is very difficult to split up. The embryo is important, but there are other important aspects of that research. I can therefore see a very strong argument for having a research body which has overall responsibility in this area.

There are of course other functions in HFEA which are important, particularly the control of IVF. When the body was originally set up, the practice of IVF was exceptional and a complete novelty, but a lot of water has gone under the bridge since then and it has become much more of a standard clinical procedure. It is true that developments have taken place there, but they have taken place also in other branches of medicine. It is not only embryology or IVF that have moved forward; fortunately, a great number of developments have taken place in the practice and application of medicine and surgery. It strikes me as extremely logical to have a body that would have overall responsibility for that.

If that be right, there is a good deal to be said for the view that the time has come to review the position in regard to the two health bodies that we are discussing and see whether a more integrated approach to research on the one hand and clinical practice on the other could be furthered by having bodies responsible for the whole of the first and the whole of the second. I agree that a good deal of detail needs to be filled in, but I remind myself that we are not deciding today whether this should happen. We are talking about a power for a Minister to decide what to do in the light of the further consultation provided for in the amendments moved by the Government since the Bill has been in Committee. It is a valuable opportunity for these matters to be considered. I can understand a lot of what has been said on the other side of this argument, but I should like to see retained in the Bill the power to deal with these issues in a way that reflects the developments that have taken place in the research and practice of medicine since the original Act came into force.

[Lord Winston]

My Lords, my noble friend Lord Warner has declared support for the Minister sitting on the Front Bench; I suspect that I might in the next few minutes give him even greater support.

We have to understand that research in these areas has now gone way beyond embryology. There was a time when people were very concerned about the status of the embryo, when embryo research was relatively novel. I should like to correct a remark made by the noble Lord, Lord Walton, who very kindly referred to work on pre-implantation diagnosis. That work produced pregnancies before the establishment of the Human Fertilisation and Embryology Authority, and people like me were greatly exercised to establish regulation. In spite of what has been said in this Chamber, we were very much in favour of regulation. Since there was no government regulation, we started a voluntary licensing authority which became a model in time—obviously, a very imperfect model—for the body set up under the splendid Bill introduced by the noble and learned Lord, Lord Mackay of Clashfern.

Stem cell biology covers every aspect of human disease, from cancer to brain research, from human consciousness to the replacement of organs and transplantation, and a whole range of other areas. It is really—forgive the pun—inconceivable that this could be dealt with by the Human Fertilisation and Embryology Authority properly under its present form or any future form. I would argue that with the advent of epigenetics, the recognition that now the environment in which cells are placed in culture and elsewhere is such a universal issue in medicine there has to be a much more global look at this kind of research. I feel that there is a strong case for suggesting that we have to accept that research ethics are universal and that they tend to have the same sorts of problems, whether it is patient consent, the end or beginning of life, or a whole range of other issues. In fact, the end and beginning of life have some very similar moral issues which need to be debated by ethics committees. The noble and learned Lord was right to point out that trying to look at these issues in a new form would be absolutely apposite. I for one am certainly not in favour of a free-for-all. I am not quite certain who in the medical profession is. I do not think that that is true.

The regulation of clinical treatment has been in many examples woefully inadequate. The noble and learned Baroness, Lady Butler-Sloss, pointed out that while she was sitting on the Bench she had the most terrible case of a woman who had the wrong embryo transferred. That was done, of course, under the auspices of the Human Fertilisation and Embryology Authority. No regulatory authority, no matter how perfect or how good, can regulate against every human error. We should have a set of principles in laboratories which keep those mistakes to a minimum, and the regulation of medical practice must also enforce that.

I do not think that there is any evidence from what has happened that the HFEA has done a particularly good job or a particularly bad job. In some areas it has not been very powerful. For example, many things are forbidden under regulation in this country. Patients actively seek fertility tourism in other countries where they can get, for example, donor eggs and perhaps come back pregnant. Very often clinics in this country, although it may be against regulations, refer these patients outside. Of course the HFEA, not unreasonably, is powerless to deal with that sort of problem.

It is also true that the fees charged to patients are often extremely exploitative. I have no doubt that we will come back to this when we come to the pending health Bill, because this is a much bigger issue in terms of how we finance the health service. At the moment, IVF, whether it is done in the private sector or in my view in the National Health Service, is charged on the basis not of what it costs but rather of what the market will bear. That is a very big issue which we will need to discuss, because I suspect that that may apply to a lot of medical practice. It is an issue to which I am sure this House will want to return. Costing the procedure is very important.

Someone mentioned follow-up: one sad thing about the opportunity in 1990 was that we did not—even though we had records of IVF pregnancies, and IVF successes and failures—make any attempt to follow up babies after this procedure for the long term. There have been many reasons why that was difficult, such as data protection. But this lost opportunity means that some of the procedures often in routine use may have unforeseen consequences in children when they are adults. We now know from David Barker’s work, for example, that babies who are born underweight and premature are much more likely at the age of 50 or 60, as the Minister knows, to suffer from heart disease, stroke, hypertension and possibly osteoporosis as well as diabetes and one or two other diseases as well. Of course, we may see more diseases which are likely to be epigenetic due to those early influences.

I have to say that, although it is claimed that the HFEA gives out information to patients, six years after I retired from clinical practice running a very large IVF service, I am bombarded daily with e-mails—I have had several today—from patients who want information about IVF and do not feel that they are getting the information they should from the statutory authority. That remains a problem.

The clinical regulation of non-evidence-based practices has been poor. For example, there is no evidence that the preimplantation and genetic screening of embryos designed “to improve pregnancy rate” works. Yet several clinics charge large fees for doing this under regulation even though there is not a base for justifying its use. That also applies to costly immune therapy, which is highly controversial. Again, this is used in women who sometimes fail to get pregnant, under licence from the HFEA. This is an example of how in fact regulation is really quite limited in clinical practice.