Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
Debate between Lord Turnberg and Lord Patel(9 years, 3 months ago)
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Lord Patel
“Dangerous”, my noble friend says. It killed the other two and resulted in a premature birth. They never published this, despite being asked if there was a publication. It is wrong to say that the HFEA did not ask them; the review panel did. Professor Grifo sent a letter saying that, in his view, all the foetuses were normal but they died of prematurity. What they died of was an obstetric botch-up. It had nothing to do with what we are talking about today. It was a completely different technique. We should dismiss it completely. It would be wrong to put any credence on it and say that it is a good reason why we should not do this.
I could go on about other safety aspects that were brought up, but let me close by saying that hitherto the science has gone as far as it can in thousands of animal experiments that have resulted in normal pups. In human embryos it has gone as far as it can to produce normal embryos, which, if implanted, there is no reason to believe would not develop into normal, healthy babies who would not carry the defective mitochondria. All we are doing today is allowing the regulator henceforth to decide, on a case-by-case basis, to issue a licence to those clinics for those mothers who request this treatment, and which are allowed to use both techniques that we currently know are safe while further research goes on. None of us stops researching: the noble Lord, Lord Winston, still carries on researching; the noble Lord, Lord Kakkar, still carries on researching. If a chance was given, the noble Lord, Lord Walton, would still carry on researching. We do not stop researching; that is the nature of medicine and of academic medical science. I hope that we will pass these regulations.
Lord Turnberg (Lab)
My Lords, I am extremely grateful to be able to follow the noble Lord, Lord Patel. I am also grateful to the noble Earl for setting out the issues so carefully at the beginning. I listened with great attention to the eloquent and persuasive speech from the noble Lord, Lord Deben, but I am afraid I was not persuaded. I cannot go along with the idea that we should put this regulation on hold for the time being. My reason is the awful position parents find themselves in when they have a child severely affected by one of these dreadful mitochondrial diseases. They are desperate to avoid having more children with the same disease. The noble Lord, Lord Deben, started from the same position but I believe that we are now in a position to move forward.
We have all been bombarded with information about mitochondria to the extent that few of us can be entirely ignorant of what they are and what they do. Yet there is still considerable room for confusion, at least according to some of the correspondence I have received. References to GM crops and cloned animals are way out of line. Suggestions that mitochondrial transfer techniques are a form of cloning when they are nothing of the sort, or that they are on the slippery slope to genetic manipulation and designer babies when there is no conceivable link between them, are very unhelpful and not part of any reasoned discussion about the issues. I could elaborate on that but will leave it for the moment to concentrate on what I think are the more rational arguments that have been and will be made today.
The noble Earl discussed the safety issues, as did the noble Lord, Lord Patel. The suggestion has been made that the techniques may not yet be safe enough. Let me take this a little further. The basic animal experiments have been going on since the 1980s and the specifics of maternal spindle and pronuclear transfer have been very fully researched for the last seven years. We have heard about the three thorough scientific reviews by expert panels set up by the HFEA. In each, further research that needed doing was suggested and each time the research has been actively and successfully pursued. On the last occasion, in 2014, they clearly stated that there were no major safety issues remaining. It is true that they suggested some further tests—and they are all under way, as we have heard—but they pointed to the fact that at the end of the day there will be no substitute for trying it in humans who carry the abnormal mitochondria.
In vitro studies in the test tube with human embryos after mitochondrial replacement have revealed no problems, and experiments with macaque monkeys—yes, they have been done—and maternal spindle transfer are all reassuring. It is interesting that monkeys are not suitable models for pronuclear transfer techniques because research shows that pronuclear transfer in vitro fails in monkeys but works perfectly well in human studies. The only way in which safety can be finally tested is in humans since no procedure or drug can be certainly safe without that. We have gone almost as far as we possibly can before that step is taken. We have heard some issues about the China syndrome, which I believe the noble Lord, Lord Patel, has dealt with perfectly well. Clearly, that was quite something else and not relevant to our discussions today.
Equally important is that these regulations do not simply allow human trials to start now—they do not; they allow the HFEA only to examine applications made to it for full assessment. It will then decide if the science is persuasive enough, that those proposing to do it have sufficient experience and capacity, and that the patients being put forward are clearly those likely to benefit. Remember that the HFEA is no pushover. It has in its membership not just three scientists and a clinical geneticist but three patients who have gone through IVF, a barrister, a professor of philosophy, a bishop and a national security adviser. That is quite an interesting mix but not one likely to be easily moved by faulty argument. It is they and their scientific advisory panel who will be assessing applications when these regulations come into force in October.
Other anxieties have been expressed that we will be disrupting the relationship between the nuclear and mitochondrial genes: the nuclear genes carry the information that determines all the characteristics that make us human, and the mitochondrial genes provide the energy supply for cells. This argument was discussed at great length in the HFEA’s scientific report in 2014 and was found wanting, not least because half the genes in a fertilised egg are derived from the father and are therefore already foreign to the mitochondria, yet they do not interfere with each other. Furthermore, mitochondrial genes are pretty well conserved between different individuals because they perform a limited number of functions, while there are large differences between the nuclear genes of different people, each of whom is made up of a mixture of DNA from a mother and a father.
Care Bill [HL]
Debate between Lord Turnberg and Lord Patel(11 years ago)
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Lord Turnberg
My Lords, I, too, welcome the principle behind the noble Baroness’s Amendment 16 but I agree with the noble Baroness, Lady Cumberlege, that Health Education England may not be the right place for this. At various times in our debates I have banged on about the regulation of healthcare assistants, because not only would it reassure employers and patients that standards were being met but being on a register gives individuals a degree of self-respect and sense of identity and it boosts their morale. In a way, it is a pity that we got rid of state enrolled nurses some time ago when we moved to university-educated nurses. In effect, that has been very successful and nurses have done very well—they do a marvellous job—but we have left a gap where the SENs were.
Amendment 23, which moves slightly along this same route, may be as far as we can go but, if we do have mandatory training, that will inevitably mean that someone has to produce a register of those who have received such training. This may not be quite the right place for it but we might get there by another route.
Lord Patel
My Lords, I rise briefly to support my noble friend Lady Greengross. It is not that her sentiments about registration are not right but we debated this at great length during the passage of the Health and Social Care Bill and to a degree I felt that we lost the battle about registration then. What is now important is Amendment 23A, which, with all due respect, is a better amendment because it focuses much more on training and the responsibility of the employer. I agree with the noble Baroness, Lady Cumberlege, that HEE is not the right organisation to be a regulator of registration.
Lord Turnberg
This group of amendments, to which I have attached my name, is all about putting into practice the brave words we have heard about the need to place research at the centre of what the NHS does.
We have had the important and impressive inclusion in the NHS mandate to NHS England and CCGs of the duty to promote research, and we have had the recent publication of the Association of Medical Research Charities of a vision for research in the NHS with its three proposals. First, every patient should be offered the opportunity to be involved in research. Secondly, all NHS staff should be made aware of the importance of research. Thirdly, the NHS should conduct high-quality research and adopt innovation in healthcare rapidly. All the good intentions were spelt out in the earlier Bill and subsequently, but we seem to have lost sight of that in the current Bill.
Amendment 17 simply makes clearer what seems to be rather vague and perhaps less forceful in the current wording about accepting research evidence and putting innovations into practice. The Bill states that HEE must promote, which is a good word,
“the use in those activities of evidence obtained from the research”.
That has to be read several times to be understood. My amendment suggests something rather clearer, and what I hope is intended, which is,
“the use of research evidence to ensure the rapid uptake of innovations into practice”.
Amendments 20 and 32 aim to ensure that Health Education England also makes it clear that all who work in the NHS should understand and be able to play a part in research and innovation by including a new responsibility, to ensure that research and innovation are incorporated into the Bill. Amendments 37 and 39 point to similar responsibilities for the LETBs. My name is attached to these amendments, which are in the name of the noble Lord, Lord Willis, who unfortunately cannot be with us today because he is unwell. We wish him well. There is considerable danger that the LETBs in particular, dominated by local provider interests, will not unnaturally focus on their need to provide a clinical service and their requirement for sufficient numbers to fill their workforce needs. In so doing, they may not see that a service that is constantly evolving and changing needs a workforce that is fully switched on to the research agenda. They may not see that the future leaders of change—those who can undertake research and introduce new and better treatments year in, year out need to have their training needs met, too.
There are at least two types of need. The first is that of future academic clinicians, professors, senior lecturers, lecturers and the like in medicine, surgery, obstetrics and so on. The second is the need of all practising clinicians, be they doctors, nurses or technicians, if they are to integrate innovations and change into their practices. The academics need training programmes that are sufficiently flexible so that they can do their clinical training for some of the time and their research at others. They will almost certainly need to take three or more years out to do their PhDs, and they often need to do their purely clinical training over a longer period than others, as they slot periods of research into their clinical training.
Those going on to straight clinical practice—always the majority—need to understand what research entails, and will need to have some contact with research. Some may even take full time out for research, and in that way can appreciate new research findings as they come along. All those factors need to be considered by those in charge of education and training locally. I fear that unless something to that effect, as proposed in the amendments, is incorporated into the Bill, it will be so easy for it to slip out of view under the considerable pressure simply to provide services for today, with no thought for the needs of tomorrow.
I am not encouraged by the Department of Health’s document which is the mandate from the Government to Health Education England, in which the section headed “Flexible Workforce, receptive to research and innovation”—a brave heading—spells out what is intended. There is little here about how the intention of encouraging the development of a research-receptive workforce will be carried out. There is much about generalism, flexibility across service divisions and so on—all highly desirable—but nothing about producing those capable of doing the research and engaging in the clinical trials needed to make innovation possible. I hope these amendments will help to fill those gaps.
Lord Patel
My Lords, I support these amendments. My name is attached to Amendments 17, 20 and 32 in the name of the noble Lord, Lord Turnberg, and to Amendments 37 and 39 in the name of the noble Lord, Lord Willis of Knaresborough, who, as we have heard, was taken to hospital yesterday. I spoke to him in his hospital bed just before we started and he was beginning to feel better. I am sure we will want to wish him well.
I strongly support the amendment because, through the Health and Social Care Act, we gave prominence to the need to promote research and innovation in the health service, and it is right that we did that. It would be a pity now if the only gap in that duty would be for it not to apply to the key body, Health Education England, and the local education and training board committees. As the noble Lord, Lord Turnberg, so eloquently put it, the amendments are about education and training by research, and about making sure that LETBs also have a responsibility to make sure that they conform to the functions of the HEE. They are all related to research, training, innovation, continuing training and research and supporting research. They cannot be wrong and I hope the Minister will accept them. They are well meaning and promote research further.
Health and Social Care Bill
Debate between Lord Turnberg and Lord Patel(12 years, 3 months ago)
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Lord Turnberg
My Lords, I rise to speak briefly, because much of what I might have said has already been said by the noble Baroness, Lady Cumberlege. I, too, am very grateful for the way that the noble Earl has listened to us and spoken and written to us with helpful comments, which I hope that he will reiterate today. I just want to make one point about the research undertaken by the current HPA. It is directed predominantly to infectious disease and bacterial and viral infections. In that area, it is really world-beating. Recently, two of its members of staff have been elected fellows of the Academy of Medical Sciences, which is quite an achievement. The idea that it should do all this research in academic research partnerships with universities is unhelpful. Although collaboration and co-operation with university departments is enormously valuable, it should not be a precondition that it should be able to do research only in collaboration with universities. I hope that the noble Earl will be able to nail that problem.
Lord Patel
My Lords, I shall speak very briefly. I spoke at length in Committee and on Report and I shall not repeat what I said. Other noble Lords have referred to the key issues. If Public Health England is to be a strong, high-profile, public health national organisation, it needs strong governance. It also needs the independent ability to bid for research funds, as the HPA currently does, as has been highlighted, both nationally and internationally. At the Report stage, I referred to the fact that the HPA currently gets a significant amount of contract research income from NIH. It is no easy task to get money from NIH for research. If it is forbidden to do that, and, as the noble Lord, Lord Turnberg, said, is allowed to do research only with academic institutions, and not independently, that will be wrong. I hope that the noble Earl, who has listened to the arguments in the meetings we have had, will be able to alleviate those anxieties.
Health and Social Care Bill
Debate between Lord Turnberg and Lord Patel(12 years, 6 months ago)
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Lord Turnberg
My Lords, my name is also attached to Amendment 257ZA. I also do not like the idea that the HPA is to be abolished, so I hope my amendment is not necessary, which it will not be if the proposal that the clause should not stand part of the Bill is agreed.
I have, of course, extolled the virtues of the HPA on a number of occasions in your Lordships’ House. You could say that I would do that, wouldn’t I?, having been the chairman of the predecessor of the HPA, the Public Health Laboratory Service, but it is certainly true to say that it is the envy of the world, and I am not the only one who says that. The Centers for Disease Control and Prevention in Atlanta, in the United States, are a very well funded counterpart with which we collaborated very strongly, and even they recognised this excellence and envied the fact that we, unlike them, had a network of laboratories across the country primed and ready to detect outbreaks of infection wherever they occurred. Those laboratories were linked into a central laboratory at Colindale, where highly specialised tests could be carried out when needed for unusual infections and where epidemiologists could link up outbreaks in one area of the country with outbreaks in another, so that it was possible to track the speed and spread of infections and prevent them developing into epidemics.
The fact that the HPA is hardly ever in the news is testament to its success in protecting the population. If your Lordships think that because it is so good there is now less need for such surveillance, let me point to the fact that just one set of infections—those responsible for food poisoning—remain a considerable health hazard, and gives rise to about 1 million cases per annum in the UK. Although it is usually fairly mild and often not reported, some cases, such as those due to E. coli, can be very severe indeed, and in the particularly vulnerable can be fatal. Food poisoning is, unfortunately, not showing any signs of decreasing, so the need for constant vigilance is high and the role of the HPA remains absolutely vital.
The amendment sets out two of the planks needed for the agency to contribute to its key roles. The first is the degree of independence that it needs to be able to give advice not only to those out in the field who need to act but very specifically to the Secretary of State and the Government. The HPA must not be seen to be simply the mouthpiece of government. It must have the independence that is so necessary to its credibility. It has stood it in good stead over the years. Its advice is respected and accepted, and we should not lose that now.
The other element of the amendment is the need to be able to undertake research. If the agency is to keep ahead of ever-changing bacteria and viruses, which seem to mutate every week, and to be able to develop new ways of rapid detection, it needs access to research funds. For example, it has excellent high quality researchers, two of whom have recently been elected to the fellowship of the Academy of Medical Sciences, which is a demonstration of their esteem. Over the years it has been fortunate to have access to research funds from the Department of Health, and I understand that that will continue. That, of course, has been of enormous value, but the agency has also attracted research funds in fairly large amounts from external grant funders, and this is funding won in open competition. There is a fear that as an authority that is rather more closely identified with the Department of Health, access to those external funds will be denied to it.
The amendment makes the clear case that the agency must continue to have access to these funds in order for it to function at the highest level. I hope that the Minister will accept the case and look sympathetically at the amendment.
Lord Patel
My Lords, my name has been added to Amendment 257ZA and I have tabled Amendment 260 in my own name. I shall try to explain why I have added Amendment 260 to this group. There has been some advice to degroup it, and I have been tempted, but I have left it where it is. First, I agree absolutely with what my two friends, the noble Lords, Lord Warner and Lord Turnberg, have said in relation to independence in research and in the expert advice that Public Health England will be giving, and I shall support that by giving some details.
First, however, I shall refer to the funding issue. I do not understand why it has been suggested that Public Health England should not be allowed to bid for external research funding. I cannot see what the threat would be. I have no doubt that it was the Minister who suggested it, and maybe he was given advice, but I wonder why he was given it. I shall give some examples. The current running costs of the HPA covered by government funds are £145 million. On top of that, the agency receives some capital expenditure and depreciation funding. But the agency itself obtains another £150 million from external sources: funding for research and funding from the services of the HPA which are contracted to other agencies and sectors. These include laboratory services, and nuclear and chemical decontamination services. If I was running a university department and I got £150 million-worth of external funding, I would regard that as pretty good—in fact, as excellent. Most of our universities would struggle to get that kind of research funding.
Where does it come from? The largest source of external research funding comes from the National Institutes of Health in the United States for high containment work on infectious diseases. Both the noble Lord, Lord Turnberg, and I know from experience that to get a grant from the NIH is very tough. The agency also receives external research funding for vaccine evaluation, as well as from the recent licensing of one of HPA’s research-generated products by the Food and Drug Administration in the United States. The agency has a product called Erwinase that is used to treat childhood leukaemias, which clearly demonstrates the commercial benefit of its ongoing research and income-generating potential. That sets out the picture as far as research income is concerned, and I repeat that I do not understand why the agency should not be allowed to bid for it.
The second issue is that of publication. The agency must be independent enough to be able to publish evidence and offer expert advice on all topics in which it has expertise, regardless of government policy. For the public to have confidence in their public health agency, it must have the independence to publish. The Government may not take the advice they are given, but the agency must have the independence needed to be able to publish it, so again I cannot understand why it might not be allowed to do so. Nor can I understand why it cannot publish in any journal it wishes on any of its research or advice. To achieve all this, it is important that it has an independent board with an independently elected chairman. That is one of the crucial amendments I wish to see if we are going to go ahead with Public Health England as an executive agency of the department. That is also why I have tabled Amendment 260, which offers the belt and braces needed if, as the Government intend, Public Health England is established as an executive agency. If it is not given independence in terms of research, advice and its board, what we would then need to do is set up a non-departmental public body. That is the purpose of Amendment 260.