Examination of Witnesses (Questions 1-19)
RUTH DEECH, BARONESS KENNEDY OF THE SHAWS AND SUZI LEATHER
WEDNESDAY 24 APRIL 2002
1. Welcome to our session and thank you very much for coming. We are informed that Baroness Kennedy is hailing it here from court so we will try and phase the questions to the Human Genetics Commission for her. We have been very concerned with these issues on this Committee in the past through stem cells and we had a session a month or so ago, talking to people who are dominant in the field, doing the research, asking them what might be the discoveries that come up that present us with regulatory problems and so on. We are very glad that you have come here to add to that investigation. Congratulations to you, Suzi, on your new appointment and, to Ruth Deech, well done for carrying the flag through some very difficult periods. Ruth, what have your organisation's main achievements been over your period in office?
(Ruth Deech) If I can start on a very broad level, the HFEA maintains the confidence of people and politicians; and in particular, when the very passionate debate on stem cells took place a year ago, it seemed to me that there was an implicit confidence in the strength of the HFEA and its ability to regulate and protect the public that gave Members of Parliament the confidence to vote for extended research and stem cells research. It was a question of maintaining confidence and a reputation, both nationally and internationally. That is on the broad level. On the narrower level, the HFEA moved with the flow of science to investigating and licensing many new developments that never would have been thought of in 1994 when I became chairman. The HFEA examined and coped with new developments like frozen eggs, more extensive use of intra cytoplasmic sperm injection, questions about multiple embryos, great increases in the number of embryos used and the types of treatments used. We moved with the science and the increase. Lastly, the HFEA perhaps with more difficulty had many more new requirements imposed on it which were to be expected with new attitudes towards governance, much more by way of paperwork, things like risk assessment, quality control, performance indicators and so on. Much of that was imposed on the HFEA latterly and, given the rather careful funding, higher expectations of that sort were quite difficult to meet.
2. It is often said that it is a cumbersome organisation in the sense that the paperwork keeps coming and it is caught up in bureaucracy. Is that true? Do you think that you have been caught up in the regulations and it has been a difficult organisation to get moving, to face up to almost a daily change in the science?
(Ruth Deech) We were more regulated against than regulating. The HFEA's policy was to regulate clinics and scientists quite minimally, requiring from them just what was necessary under the statute and in order to keep pace with the modern demand for statistics and after studies. What I found more onerous latterly were the requirements on the HFEA itself by way of paperwork. For example, we had two quinquennial reviews in the space of four years. For anyone who has done some Latin, that is quite surprising. We were always, maybe quite rightly, being held to account for one thing and another. The National Audit Office was looking at us; departments were looking at us. I thought the requirements on the HFEA were almost more onerous than what was required of the clinics. The policy ought to be as little paperwork as possible. I am echoing Baroness O'Neill's reflexures. There ought to be more trust and perhaps less paperwork all round. Sometimes, when there were brand new developments, brand new clinics and areas that were giving rise for concern, it was right for the HFEA to go in and require the paperwork but, in general, the aim ought to be that the departments trust the HFEA and the HFEA should trust most of the clinics.
3. Are you saying that you feel there has not been trust on occasion?
(Ruth Deech) I do not think there is a real lack of trust. The requirements are such that it feels as if there is a lack of trust.
4. Has that been frustrating for you, running the organisation?
(Ruth Deech) I would not say it was frustrating. I just think it takes up an awful lot of time. The HFEA dealt with many wonderful and interesting advances in science but probably 75 per cent of the time of its members and staff was taken up with purely regulatory matters, also very interesting, but growing in weight, with a very small budget.
5. You have just talked about what Parliament intended when it set up the HFEA. I wonder if Parliament really did intend, when it set up the HFEA, that very onerous and fundamental decisions that make basic changes in humanity should be decided by the HFEA under that original legislation. We had a decision from the HFEA a few weeks ago to selectively, by genetic engineering, for the first time ever, give authority for the creation of a new human life for the specific purpose of benefiting an existing human life. That may be good or it may not be good. It certainly has enormous moral, ethical and social consequences, particularly for the new life that has been created that may have impacts throughout its life. It certainly sets a precedent and in this country things operate by precedent, so it was a very important, significant, new decision. Should that decision have been taken by the HFEA or should it have been brought back to the democratically accountable Parliament to be discussed? What do you really think about that?
(Ruth Deech) I think Parliament did so intend the HFEA to take those decisions. The statute rests on the report by Baroness Warnock of 1984, which remains unrivalled in its wisdom, depth and flexibility. Baroness Warnock and her team were wise enough to foresee that there would be very many questions of great complexitythere always are in sciencethat cannot be frozen in any statute of 1990. It is a very flexible, very cleverly drawn statute. The fact that the HFEA took that decision protects Members of Parliament from direct involvement in that sort of thing, which I may venture to say is right. It also protects the clinicians themselves from direct responsibility. It places that responsibility on a body of people who have been chosen after advertisement in the newspapers to do that task, so it is a democratic way of deciding those things.
6. You are now getting confused in your answer. How can it be democratic if you are preventing the democrats, the Members of Parliament who are elected to make difficult decisions on behalf of society as a whole, and protecting them from having to make such complex, fundamental decisions? You said that Baroness Warnock may have anticipated it. I do not think Baroness Warnock ever anticipated or Parliament in 1990 ever anticipated that they were giving the right to create new human life for the purpose of benefiting an existing human life. That debate was never had. I think it is time that debate was had and, in view of that and in view of the HFEA's decision, I would seriously question if the HFEA is still fit for its purpose, as it was established some 12 years ago.
(Ruth Deech) I would argue that it is fit for purpose and that it is acting exactly within the parameters of the statute that governs it. Baroness Warnock's report was foreseeing very many new developments, including that. I would not call it genetic engineering. The HFEA has spent many months considering the question. I would call it the preservation of life. We should remember that many parents, including the parents in this case, will have children naturally. There was the famous case of Nicola Horlick. People will have children naturally in an attempt to help save the life of an older child. It is just the umbilical cord blood which is normally thrown away which is used in that case, no more, no less. We felt pretty confident in making that decision and our understanding was that, like many other scientific bodies, we would make decisions that were within our remit under the statute and that are perhaps, with due respect, too detailed for Members of Parliament to debate on each separate occasion, given that cases like that are coming quite rapidly. Every week there is something new and, humbly, if I may offer the opinion, I think it is right to have an expert, democratically appointed body to take those decisions.
7. I am surprised that a person of your stature should fall back on the use of facile language to cover your embarrassment. It is almost like the killing of a child by abortion being described in some other way because people do not want to face up to the specific consequences of their acts. You said that this was not genetic engineering. This is precisely what it was. It was the selection of certain gene traits to give a particular outcome so that that child would be useful in helping some other child. I am not saying that is a bad thing. I am saying that this was a fundamental, life changing event. It broke new ground in the most fundamental, scientific manner and I am surprised that you should not accept that.
(Ruth Deech) My understanding of genetic engineering is that genes will be manipulated to produce some type of human being that was better in some respect than that which we have already. In the case of the Hashmis, the proportion was that one was likely to get one in 16 embryos of the embryos that were produced by Mr and Mrs Hashmi that would give a child that was not only free of beta thalassaemia but also matched the sick child. The public has been consulted about pre-implantation genetic diagnosis. The public came back saying that they did approve of it as long as it was carefully regulated so that families that suffered from an inherited genetic disease would be able to choose an embryo free of that disease. In a decent, caring, democratic society, scientific developments can be used for the good of all. If we look back, we do see that nearly all scientific developments have eventually improved our lot. If you lived in an authoritarian or dictatorial society, then you would have to be fearful that scientific developments will be put to the wrong use, but I am not embarrassed by the Hashmi decision. We thought about it for many months and we feel it was the right thing to do, that it was ethically desirable and it is limited only to cases where pre-implantation genetic diagnosis is already justified, which is that family suffers from a serious disease already.
8. Could we have on record that there was no public consultation on the case that I have raised?
(Suzi Leather) When the authority made that decision, they set eight conditions under which they would permit PGD with tissue typing. The eighth condition was that embryos should not be genetically modified to provide a tissue match.
9. As a scientist and now a parliamentarian, I sometimes have the feeling that technology is racing ahead of legislation and I am sure you get that feeling as well in making these difficult decisions. Do you ever get the feeling that the HFEA is holding up research or at least inhibiting the pace of it?
(Ruth Deech) I was a bit surprised by Mr Spink's question because usually we are told that we are holding up matters rather than facilitating them. Given that there was criticism from both sides, I think the HFEA was doing it about right. Those who launched on new types of investigation knew that they would have to face peer review, review by a committee of the HFEA and that new developments would not be rushed into public use without very careful scrutiny as to their safety and viability. Given that delegations have come from countries all over the world to see how the HFEA do things, given that Britain is ahead of the world in stem cell research and in many other fields, I think it is no coincidence that British advances in science and the confidence in them go hand in hand with very tight regulation.
10. Do you think you process applications slowly, because that has also been a criticism.
(Suzi Leather) In licence decisions, we process them on average in four months. I do not know whether you think that is slow or not. The procedure does include peer review. I think four months gives applications due weight and proper investigation. If we hurried them through faster than that, we probably would not be doing our job properly and if it was taking much longer than that there would be an issue about holding it up.
11. I do not judge the applications. Do you feel that you are under criticism from the people who do?
(Suzi Leather) It is both the case in science and in regulation generally that services do not always welcome the action of regulators in terms of establishing public confidence it is proper that we always go through due process. To ensure cautious allowance for the due process I think four months is about right.
12. Turning to resources, I have a figure of 1.5 million and 30 staff involved in the HFEA. I do not know whether you want to contradict those figures but do you think your budget is adequate at the moment to do everything you are being asked to do by central government?
(Ruth Deech) I feel it was not, certainly towards the end of my chairmanship. The budget stayed at one point something million for many years and if the HFEA were set up today, in the light of public fears about anything with the word "genetic" in it, whether it is BSE or genetically modified food or whatever, there would be a much more exhaustive approach. I believe that we have the least funding of any comparable organisation. While at the beginning there was not quite so much going on, it has become very difficult to cope with scientific advances, with the more than doubling in the number of treatments, with ever more stringent requirements about inspection of laboratories and so on, on the budget. It was very hard to afford to go to conferences, to get staff that were sufficiently properly paid and so on. Our staff were paid less than you would expect to pay highly qualified scientific staff in other comparable organisations.
13. Does that impinge on the quality of your staff?
(Ruth Deech) No. We have been very fortunate in getting, for example, young graduates, very often PhDs from universities, but we were not able to hold on to them long enough. Things have improved very recently, but it is a question of quite a small amount and it would be money well spent in order to satisfy the fears that might be expressed by parliamentarians and the public. There is a heightened expectation amongst politicians and the public that nothing should go wrong in this field. In a few years' time, teenagers will be able to inquire of the HFEA whether they were born of assisted reproduction and whether they are related to someone whom they propose to marry. In other words, there will be detailed inquiries of our register about paternity and we need to be able to handle those. No doubt the expectations will be even higher in a few years. In my view, the budget was inadequate.
Dr Iddon: What should it be?
14. What is it going to be?
(Suzi Leather) As a newcomer, the HFEA is an organisation which has consistently punched above its weight in terms of what it delivers for the resources and it has delivered extraordinary value for money. If you look at an average of the first ten years of the HFEA, it received about £100,000 a year from government and the rest of its income from fees. I need to check this and get back to you but I think that took it up to an average of 1.4 million. Coming to this from new, when I first heard what the budget was, I thought they had got the decimal point in the wrong place because if you consider the enormity of the task in front of it, many members of the public, looking at how other regulatory organisations are funded, would be surprised that it was being funded on that sort of budget.
15. How do they compare with the Food Standards Agency?
(Suzi Leather) There is absolutely no comparison. The Food Standards Agency is a government department and employs very many people, 600, and indirectly, through the Meat Hygiene Service, a further 1,600. It is not strictly comparable.
16. They got a big budget to start off with, did they not?
(Suzi Leather) A very much bigger budget to start off with. I think it is fair to say that if the HFEA was being set up today it would be funded at a different level. Has that made a difference to the quality of the service provided? I think it is hard to say it has not made a difference. We currently have some IT problems with the register, which I am pleased to say we have just got some money from the Department of Health to help sort out, but it is clear to me that the main reason for that has been under-funding. I know a lot of organisations have IT problems. We could do more with more money. We could do more policy development work, for instance.
17. What should the budget be?
(Suzi Leather) I am coming at this very new and I think it would be wrong for me to pick a figure and say, This is what I think we need. Since I have become chair, I am pleased to say that ministers have approved a one of sum of £2 million this year to support the introduction of new technology for the registry system and that is hugely helpful, as will be the money to support our move, because the offices we currently have are rather strapped. If any of you want to come and visit them, you would be very welcome but there is certainly not room for me to have an office. That perhaps gives you some idea of the working conditions.
18. I am slightly concerned to hear Ruth say that among the things that sufferyou have mentioned information technologywas the inspection of laboratories and that could be quite serious if we were not inspecting laboratories where this work is going on in a serious way.
(Ruth Deech) I would not say inspection of laboratories. There were not so many and they were very thoroughly inspected, but there are almost 100 clinics that have to have an annual licence and they should all have inspection. We were encouraged quite recently to move to a lighter form of inspection in order not to bring the work of the clinic to a halt. On the other hand, all it takes is for one matter to go wrong and the pressure is to inspect that clinic more thoroughly. If I can go back to the budgetary question, I feel free to say this because I am no longer chairman. The latest calculations that would have produced a very good service and well paid staff and a good IT system before I left were more of the order of six million per annum which, in comparison with other similar organisations, is still not very much, but certainly not down at 1.9 million per annum.
19. Brian asked about approving the process of applications. Is it your approach to facilitate new applications for technology by setting the right licence conditions? How many times have you said no outright to something?
(Ruth Deech) Licences for research were approved provided that they fitted into, I think it is now, eight categories of research that are in the statute. There were five originally and two or three more were added a year ago. They were sent out for peer review first. The number of embryos that was likely to be used was always checked and questioned. The laboratory itself was inspected. The CVs of the persons involved were taken in. Comments were sought from scientific peers and a committee would meet in the HFEA to approve the licence. I cannot tell you how often they were refused but I recall several occasions where an application was referred back for more detail or changes in the purpose or further questions were raised or the licence was only granted for six months rather than for a longer period. Almost invariably, a further report was called for from the researchers after, say, six months or a year, in order to see what had been achieved and to make sure that what had been achieved lay within the boundaries of what had been approved.
(Suzi Leather) If it is helpful, we could give the Committee some more detail on that.
Chairman: Thank you.