General Medical Council (Fitness to Practise and Over-arching Objective) and the Professional Standards Authority for Health and Social Care (References to Court) Order 2015
Lord Patel Excerpts(9 years, 4 months ago)
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Lord Patel (CB)
My Lords, I rise briefly to support the order. I declare an interest that, maybe for a short while only, I am a licensed practitioner and a registered practitioner, and the rules of the GMC may not be sufficient for me to revalidate.
However, the issue to which I want to refer is the separation of the functions, of which I approve—we have discussed that many times—but for the fact that the GMC can appeal against the decision made by the MPTS. Its role becomes that of an adjudicator as well. I would like the noble Earl to clarify that. I know that in the consultation process there were the same number of responses—39, as mentioned by the noble Earl.
Another issue that we have discussed before is that these changes are welcome, but there are other changes that the Law Commission identified in its report, published in April 2014, on the regulation of health and social care professionals Bill. The Government indicated that they would bring in legislation to deal with all the issues. This is obviously a piecemeal measure taken out of that Bill, so the noble Earl may want to comment on that.
Lord Hunt of Kings Heath (Lab)
My Lords, I, too, thank the noble Earl for introducing the order. I shall say at once that the Opposition support it. Like the noble Lord, Lord Patel, we are disappointed that it is yet another Section 60 order being considered in Committee. We should have had the Law Commission Bill, either in pre-legislative scrutiny or in its substantive form. It is disappointing that we are having to deal with these various professional regulation bodies in such a piecemeal fashion.
That said, on the question of the overarching objective, we very much support that and the three pursuits set out in Article 21(1B),
“to protect, promote and maintain the health, safety and well-being of the public … to promote and maintain public confidence in the medical profession, and … to promote and maintain proper professional standards and conduct for members of that profession”.
I want to pick up the point raised by the noble Baroness, Lady Finlay, and the British Medical Association. I suppose it is an issue of proportionality. In its report, the Law Commission expressed concern about examples given, suggesting that regulators were inappropriately imposing moral judgments in essentially private matters under the guise of maintaining confidence. The BMA has raised the issue of whether the order might end up punishing doctors who pose no threat to the health and safety of the public, on the basis that failure to do so might incur the public’s disapproval. The Law Commission has urged regulators to look carefully at regulatory interventions that do not take some colour from the need to protect the public.
This is a very important point. I have been very impressed with the GMC and the way in which it has improved its procedures and processes—and certainly with its current leadership. However, there are other regulators, perhaps not so much in the health sector, which clearly lack confidence and which are very much influenced by the flow and ebb of media comment and potential political interventions. I think that we have to be very careful about regulators which, in a sense, lose confidence in their own ability to make common sense judgments, and then have knee-jerk reactions in the face of media storms. I hope that the noble Earl will agree that that is not the intention in the case of the health regulators, and like me, he will express confidence, particularly in the GMC to apply common sense judgments in response to the points raised by the noble Baroness, Lady Finlay.
I now come to the question of the Medical Practitioners Tribunal Service. The Minister referred to the fact that the consultation demonstrated strong support for enhancing the GMC’s investigative and adjudication roles, but that 52% of respondents took the view that creating an entirely independent body would be preferable, with only 27% supporting the proposal to put the MPTS on a statutory footing.
We must refer in particular to the evidence of the Professional Standards Authority. It,
“did not agree that the proposals to establish the MPTS as a statutory committee of the GMC would achieve the aim”,
of appropriate separation of function. It commented that,
“former and current members of GMC staff should be excluded from sitting on medical practitioner tribunals or interim orders tribunals … The PSA also asked about the ability of the GMC to make rules delegating functions from the MPTS committee to ‘officers of the Council’”,
and it,
“referred to the fact that case managers will be paid by the GMC, but case managers will be performing a statutory office”.
The PSA was obviously concerned that because those managers were paid by the GMC, they might come under undue influence. As the Explanatory Memorandum points out, the PSA,
“conducts annual performance reviews of each of the health and care professional regulatory bodies”.
I would like the noble Earl to explain why the views of the PSA, above all others, were ignored in relation to this issue.
To pick up the point raised by the noble Baroness, Lady Finlay, about guidance, again, the Explanatory Memorandum says that:
“The Department does not intend to publish any guidance in respect of”,
this statutory instrument but that the GMC,
“will publish guidance as appropriate”.
Is the Minister in a position to respond to the noble Baroness about what kind of guidance will actually be produced?
However, overall I believe that the GMC has made great strides in recent years. It deserves to be supported for what it is doing. I accept that this will speed up processes to protect the public and provide more and better information about doctors on the register. It will improve doctors’ education and training and increase efficiency, and on that basis we are very glad to support the order.
Maternity Services in Morecambe Bay
Lord Patel Excerpts(9 years, 4 months ago)
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Earl Howe
On the noble Baroness’s second point, I shall of course take due note of her recommendation. It is something to which we will give very careful thought. On the principal issue that she raised about supervision, as she knows, the statutory supervision of midwives was designed more than 100 years ago—in 1902, I believe—to protect the public. In our view, it no longer meets the needs of current midwifery practice. The King’s Fund was commissioned by the NMC to review midwifery regulation following the findings of the ombudsman that midwifery regulation was structurally flawed as a framework for public protection. The current structure does not differentiate between the requirements of regulation and clinical supervision.
If, as I anticipate, legislation is needed to change this—I think it is clear that it is—that is likely to take up to two years, even on the best estimate. During that time the Department of Health will work with the UK chief nursing officers, the NMC and the Royal College of Midwives to develop a four-country approach, which it has to be, as the noble Baroness will understand, to midwifery supervision that will replace the current statutory midwifery supervision. I hope that that is helpful.
Lord Patel (CB)
My Lords, I have to admit that, as an obstetrician, when I read this report, my immediate response was intense anger, anger at this systems failure on a grand scale. None of these things should have occurred. This is not an example of failure of a mild degree or of a relationship. This is failure on a major scale. No maternity unit in the country would tolerate these kinds of tragedies occurring in their own unit.
I commend the report. I have worked with the chairman and several of the expert advisers. Dr Kirkup worked with me when I carried out the inquiry on cancer services in Gateshead. He was a member of the team and I know the others, particularly as they come from my own hospital. Professor Stewart Forsyth was neonatologist with me, and I know James Walker, whose father is responsible for all the successes I have had in obstetrics and none of the failures. His name was also James Walker.
What can we do? There is the idea of mandatory reporting of unexpected maternal deaths and stillbirths. We have a stillbirth rate in the antenatal period that has not reduced in this country for 40 years. We have unexpectedly high numbers of normally formed babies who die in the interpartum period but who should not die. If that kind of tragedy ever occurred in my unit, there was a major investigation immediately afterwards. Mandatory reporting may highlight this issue because we need to address it.
I will focus on one recommendation of the several that are addressed regarding the professional organisations in medicine and midwifery. They need to step up to the plate and respond positively to this report on what their role will be in making maternity services safer in this country. The noble Earl referred to an airline-type investigation for root cause analysis. I accept that that is absolutely necessary but it requires experience and training and it must be done soon after the event to learn the lessons that might be applicable to other maternity units. I am encouraged to hear that NHS England will carry out a review of maternity services and I hope that it will be an in-depth review with the specific purpose of making maternity services safer. It should not be about demarcation issues with which we got ourselves tied up previously between different professional groups. It should not be about relocating services. It should be about making maternity services safer.
I have lots of questions but they are not for today and I will save them for another time. I hope all of us—no matter who the Government are—will now work to make maternity services in this country among the best possible.
Lord Winston (Lab)
Does the noble Lord not agree that one of the key issues is that nurses as midwives and obstetricians no longer work together as a team? They work separately and conflict with each other instead of seeing patients together. Would that not solve many of the problems identified in this shocking report?
Lord Patel
The noble Lord is absolutely right. That is why I said that the review must address how to make maternity services safer and not address any of the demarcation issues. I work with midwives. Midwives taught me—I have said that before in this House—so there should be no issues between different professional groups, whether they be nurses, midwives, doctors, neonatologists, anaesthetists or whoever.
Earl Howe
My Lords, anyone who reads this report will not fail to alight on the phrase that Dr Kirkup uses—that what we had at this hospital was a “lethal mix”, comprising, among other things, substandard clinical competence, poor working relationships in the maternity unit, a move among the midwives to pursue normal childbirth at any cost, shooing obstetricians away at various points, and failures of risk assessment and care planning that led to unsafe care. All these things should pull us up short and, indeed, do so. They are shocking. We certainly expect the relevant professional regulatory bodies, including the GMC and the NMC, to review the findings of this investigation report and act on the recommendations. Those organisations should review the findings of the report concerning the professional conduct of registrants involved in the care of patients at the trust to ensure that appropriate action is taken against anyone who has broken their professional code, but building on those lessons to see whether there are wider matters around safety to be considered.
On mandatory reporting, I can only add to the remarks that I made to the noble Lord, Lord Hunt, by saying that we remain totally committed to the principle of the reforms. Further progress will be informed by reconsideration of the detail of the new system in the light of other positive developments on patient safety since 2010 and by a subsequent public consultation exercise. We are working with the health departments in the devolved Administrations, NHS England and the professional bodies to consider how standardised reviews for all perinatal losses might be introduced.
Health: Rare Diseases
Lord Patel Excerpts(9 years, 4 months ago)
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Lord Patel (CB)
My Lords, it is nice to see the noble Lord, Lord Rogan, looking so well. The thought that he might have a platelet count of two, which I have never come across, surprises me. I am pleased that his treatment is working. I thank the noble Lord, Lord Turnberg, for initiating this debate. Listening to him and to the comments made by the noble Lord, Lord Walton of Detchant, it is clear that the system of funding for treatments is not working and neither are the services that are being delivered, as has just been highlighted by the noble Lord, Lord Rogan, in his words about postcode lotteries. I shall focus in my remarks on the need for greater collaboration and cohesion in the planning and management of services for the rarest conditions—the extremely rare diseases.
With greater national collaboration, treatments for rare diseases can be taken up more quickly, with swifter patient access. Over the past two days I have met many members of the Specialised Healthcare Alliance. As a coalition of more than 100 patient-related organisations and 15 companies, the alliance has been campaigning on this issue for a number of years and has clear priorities for improvements to benefit patients. Collaboration is extremely important for these services. We know that very rare diseases affect only a small number of patients who may well be living in any part of the United Kingdom. Services for these patients cannot sensibly be available in every local hospital. Highly specialised services that typically cater for fewer than 500 patients in England can be provided in only a small number of hospitals across the country, partly due to the sophisticated expertise involved in delivering those services. I am familiar with the work undertaken in my own hospital where very complex dermatological testing is conducted on patients from across the UK. It is a member of the UK Genetic Testing Network. Indeed, networking arrangements of this kind are a vital component of highly specialised care delivery. It is therefore crucial to strengthen networking arrangements of all types, be they between specialist centres as in the UK Genetic Testing Network or between specialised centres and local hospitals based closer to where patients with rare conditions live.
The complex mix of highly specialised care delivery I have described requires sophisticated planning and oversight on the part of commissioners. It is in this area that concerns have been raised. Many are aware of the good work that was undertaken by the Advisory Group for National Specialised Services. Prior to 2013, it developed multidisciplinary expert advice on highly specialised services. The work of AGNSS and the national specialised commissioning team which it advised covered many areas of service delivery and management. It reviewed potential service developments and brought in specialist expertise to consider whether they should be prioritised for funding. The expertise included input from expert clinicians, patient representatives, health economists, health ethicists, commissioners and others. This function has now passed to NHS England. However, apart from a weakened advisory group for these services, all decision-making takes place within the context of specialised services as a whole. This means that services for the smallest patient populations can be competing for resources with very large services. There are also concerns that the expertise formerly vested in AGNSS is not present within these new decision-making processes.
AGNSS also appraised new treatments for rare diseases, many of which are inextricably linked with the associated services. Again, it brought a variety of expertise to bear, as well as an appreciation of the different paradigm for appraising those treatments, which often cannot produce the kind of randomised control trial evidence that is seen for more common therapies due to the small number of patients who are involved. This function has now been passed to NICE, which has been asked to develop a bespoke, highly specialised technologies appraisal process and methodology. While NICE’s rigour in appraising medicines is not in doubt, its ability to run two separate processes with vastly different QALY thresholds may present a challenge. It is also crucial that NICE should collaborate extremely closely with NHS England, given the strong links between treatments and services for the rarest conditions.
Also, the national specialised commissioning team used to commission the providers of highly specialised services directly. This meant that a single national team oversaw delivery and assured quality across the country. Should one provider experience problems, the national team would be aware of it and could liaise with other centres to ensure that they responded accordingly. Now the function is spread across a number of different teams all around the country without any clear national leadership. This involves greater complexity and, most importantly, introduces more clinical risk for these services. NHS England’s ability to evaluate the outcomes of its commissioning, including the outcomes arising from new treatments for rare diseases, would also be strengthened if this was rectified. Greater cohesion in the appraisal, planning and delivery of services for patients with rare diseases is crucial. I hope the Minister will be able to provide some specific assurances on each of the functions that I have outlined above.
The noble Lord, Lord Turnberg, referred to the problem of access to medicine. As the noble Lord, Lord Walton, referred to, there are seven routes through which licensed medicines for rare conditions can be evaluated. NICE’s topic selection criteria do not currently recognise conditions defined by genetics, biomarkers or a difference in clinical presentation. This means that the full range of medicine that could benefit patients with rare conditions is ineligible for HST evaluation. Let me give you an example. Ivacaftor, or Kalydeco, is a medicine developed to treat 5% of cystic fibrosis patients and their specific genetic mutation. NICE’s current criteria mean that it would not be available to patients.
Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
Lord Patel Excerpts(9 years, 4 months ago)
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The Deputy Speaker (Lord Geddes)
I assume the noble Lord would like to move his amendment.
Lord Patel
My Lords, I am sorry for rushing in, but the noble Lord, Lord Deben, excited me so much with the comments he made that I have to answer some of his points, particularly on safety. I hope that noble Lords will have patience, because I need to go through each of the points he has made on safety, as I have no doubt that they will come back again in subsequent debate.
It is important that I put down some ground work. What are we talking about? We are talking about a mitochondrial DNA disease that commonly affects multiple different organs. Symptoms include severe muscle weakness, diabetes, heart problems, cardiac failure and sudden cardiac death, as well as central nervous system problems, which include dementia, epilepsy, stroke and such other horrible conditions. It results in death, which can occur early in childhood or after a prolonged period of incapacity and pain that can last for years.
It is important to have some facts about mitochondrial DNA genetics and inheritance. Mitochondrial DNA is strictly inherited maternally, via the egg. The mitochondrial DNA copy number and the number of mitochondria vary between cell types, with more than 200,000 in the egg and early embryo down to perhaps as few as 10 to 20 in many cells of the two to three-week old embryo, and hundreds to thousands in most cell types in adults, where the number tends to correlate with energy demand. Cells can have a mixture of two or more types of mitochondrial DNA sequence, a condition referred to as heteroplasmy, in contrast to homoplasmy, where each copy has the same sequence. More than 300 distinct mutations of mitochondrial DNA have been found in patients with mitochondrial disease. Although some mutations are far more common than others, if an individual is heteroplasmic, with a mixture of mutant and normal mitochondrial DNA, the proportion of the former determines whether they show symptoms of mitochondrial disease. Some women at risk of transmitting mitochondrial disease to their children are heteroplasmic and may have levels considerably below the disease threshold, but their eggs can have very high levels of mutant mitochondrial DNA or even be homoplasmic. This can be explained by the so-called bottleneck, which I will not go into in detail, but, during the development of the egg, only a certain number of mitochondria go into fertilisation, and that causes a bottleneck that sometimes results in only the mutant mitochondria getting through.
It is estimated that at least one in 200 children in the UK is born with some faulty mitochondrial DNA—so quite a lot of them may well have some faulty mitochondrial DNA. It is estimated that one in 6,500 babies goes on to develop serious mitochondrial disorders. The severity varies from mild to extremely debilitating and may result in early childhood death. Almost 2,500 women of child-bearing age in the UK are at risk of transmitting mitochondrial disease to their children. Estimates based on this figure suggest that between 100 and 150 births a year in the UK risk passing on mitochondrial disease to the child. If today we were discussing cancer or dementia, and how we could modify those diseases with some form of genetic or mitochondrial manipulation so that people would not get it, everybody would be in favour of it; but as mitochondrial disease affects 100 to 150 people a year, we do not take it so seriously—or so it seems.
I will now go on to what the noble Lord, Lord Deben, said about the two techniques that we are likely to be discussing—the maternal spindle transfer, which the noble Lord prefers, and pronuclear transfer—and I will say why I believe it is necessary that currently the HFEA, as a regulator, is allowed to decide which method might be appropriate for a given patient in a given centre. We do not know which technique is the more efficient and safer, despite what some others may believe. In fact, they may not be equally efficacious in every woman.
Pronuclear transfer has been used successfully in animals for more than 30 years with no evidence of adverse effects. On the other hand, maternal spindle transfer is a newer technique, which is likely to result in less carryover of mitochondria but has a higher risk of chromosomal abnormalities. That is an important point: pronuclear transfer may have more carryover of mitochondria but maternal spindle transfer has a higher risk of chromosomal abnormality. Maternal spindle transfers are very sensitive to manipulation. The embryo is less sensitive in its early stage to such manipulation.
Furthermore, both techniques have been found to be variable for avoiding mitochondrial disease. Which technique will be used for each individual patient will be a decision for the patient, based on their informed consent, their clinicians, the evidence from research and the safety aspects. In my view, it would be inappropriate for Parliament to make a scientific judgment as to which technique should be able to be used. One thing is certain: the scientists and the clinicians will go with whichever method is the safest and most efficacious. If it turns out, through research that is currently going on, that we can make maternal spindle transfer safer and less likely to lead to chromosomal abnormalities, that is the method that the scientists and the clinicians will choose. Research is going on to make that process safer. There are many ways of doing this. I am not being flippant when I say that one of the methods that has been tried is to use a small amount of caffeine to make the maternal spindle transfer more stable. Eventually, we will get that research right and whatever method is safest will be used. However, it would be wrong to opt now for one method which is not as successful as others.
Issues have been raised about the health and safety risks of some of the techniques. I agree with the noble Lord, Lord Deben, that it is never possible to be certain that new medical procedures will be 100% safe or effective. That applies to the whole of medicine—drugs, devices or surgery. Risks have been assessed in detail. As the Minister said, there have been three separate reviews of the scientific evidence on the technique’s safety by a specially convened independent panel of experts. It would be wrong to suggest that these experts might be biased when none of them has any financial interest in mitochondrial research or treatment, or that they might not have understood the issues and that we in this Parliament are more likely to understand the science which underpins this research, which has led to the point where it is now possible to use this technique to help women to have normal babies.
Decisions on safety and efficacy should be taken by the statutory regulatory authority created to do this—the HFEA. Risks must be balanced. Evidence suggests that any risks of mitochondrial donation are proportionately less than the significant risk that children will continue to be born who will develop severe mitochondrial disease if these techniques are not used. Ultimately, it will be up to affected families to judge the balance of these risks. They are the ones who will take the risks.
I would like to explore some of the health risks that the noble Lord, Lord Deben, mentioned, although he did not mention that of the potential effects of the donated mitochondrial DNA on the rest of the cell. I turn first to traits attributed to mitochondrial DNA. On variations in the 37 well studied genes, a whole mitochondrial genome has been sequenced for all these genes and they have all been found to have one function in expressing the protein that produces energy. No other trait has been identified from the sequencing of the whole mitochondrial genome. Therefore, the variations have been well studied. Although this is still contentious among mitochondrial experts, theoretically—I admit—it is possible that a child born after mitochondrial donation might have a slightly different energy metabolism compared with his or her female ancestors. However, none of this has resulted in devastating mitochondrial disease.
Evidence has also been cited that a mismatch between the DNA in the donor’s mitochondria and the mother’s nuclear DNA might have a negative impact, namely sterility and impaired growth—the noble Lord mentioned sterility—in the resulting child, as well as slow metabolism. This issue was considered in great detail by the HFEA scientific panel. In normal human populations the mixing of nuclear DNA during sexual reproduction means that there can be a complete exchange of nuclear and mitochondrial DNA type over a few generations—I calculate it to be about six generations. Given that I married an English lady, the mitochondria of my children have changed dramatically. My ancestors’ mitochondria are no longer in my children—they have English mitochondria. However, I am glad to say that they have produced terrific children. Evidence of mismatch between nucleus and mitochondrial genomes has come mostly from research where new combinations have been made experimentally across animal species that have been separated for many hundreds of thousands of years or longer—for example, rats and mice. Within species, such as in some experiments involving mice or fruit flies, evidence of mismatch is seen only when particular sub-strains of a species have been reproductively isolated from each other and each inbred. The one species, the human race, is the most outbred species there is. Some of us are examples of that.
Lord Gordon of Strathblane (Lab)
Would the noble Lord comment on the HFEA’s recommendation that, as available data are limited, an extensive range of pre-clinical research should be carried out before proceeding?
Lord Patel
The data that the report suggested were not available were actually presented to the committee. They have not been published because, as any scientist would know, if you publish—
Lord Winston (Lab)
I wonder whether I can help my noble friend Lord Patel. Does he agree with me that there were very few available data for the first in vitro fertilisation babies, and that that was a step in the dark, as were pre-implantation diagnosis and sperm microinjection? Before he concludes his speech, would my noble friend be kind enough to answer an important question asked by the noble Lord, Lord Deben, about the possibility that we might be making infertile children? Was that not the accusation made when infertility was treated by in vitro fertilisation, and was there not a widespread fear at that time, too, that we would be making infertile children?
Lord Patel
I thank my noble friend for that interruption. It was worse than that: it was suggested not only that those children might be infertile, but that they might be half monsters of some kind. To answer the question raised earlier about the HFEA’s evidence—yes, it did ask, and the evidence was verbally produced. The reason why it is not published is that anything that is published, even in the form of an extract, cannot then be published in a reputable journal. I know that that evidence has now been sent for publication.
To go back to the subject of the evidence requested, if we were to go down that road and do those experiments, what would be required in the human population is the deliberate creation and destruction of many hundreds, if not thousands, of embryos—to prove a point that does not require proving. Hundreds and thousands of human embryos have already been tested and found to go to a blastocyst state, and I hope my noble friend Lord Winston will agree that if we see them in that state, the embryo will be satisfactory. He nods slightly.
The alternative would be human population genetic studies to fulfil that requirement for evidence. What that shows is that exchange of mitochondrial DNA haplotypes by normal reproduction should reveal combinations that are deleterious. Human population genetic studies will do that. Such studies include genome-wide association studies and whole genome sequencing projects looking at many specific diseases and syndromes. Those kinds of studies will be required. They do not require embryos to be created, nor is it necessary to do these studies before this treatment is available.
I know I am going on a bit, but other points were made. If there are points about epigenetics et cetera, those are also spurious and have no basis in science.
Let me go now to something that the noble Lord, Lord Deben, mentioned twice: the Chinese example. The technique that was used in the United States and in this Chinese example is called cytoplasmic injection. No doubt the noble Lord, Lord Winston, is more familiar with it from his work than I am. It is a technique that is not allowed in the United Kingdom. That is the first point. It is completely different in design and intent from what we are talking about in mitochondrial replacement; it is nothing to do with it.
What was done in China was a cytoplasmic injection not for replacing mitochondria, but for infertility treatment in older women. That was also the case in the United States; it was an extra cytoplasm with possible mitochondria in older women, where both are at risk of producing chromosomal abnormality. In China it was used in only one study, which was conducted by an American, Professor Grifo. They inserted five embryos. We do not allow that in the United Kingdom because of the risk of multiple pregnancy. It resulted in a multiple pregnancy. They then tried to reduce the number of foetuses by injecting one of them to reduce the number of foetuses from three to two. I do not know what kind of technique they used—
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.
Baroness O'Loan
I thank the noble Lord for that intervention. However, the research shows that there is a shortage of women donors.
Eggs used have to be extracted from women’s ovaries by a process known as controlled ovarian hyperstimulation, which can lead to complications for women. According to the Royal College of Obstetricians and Gynaecologists, it affects up to one in three women to some degree. It says that between 3% and 8% of IVF cycles are complicated by either moderate or severe OHSS, which can cause a variety of painful and upsetting symptoms such as abdominal pain, nausea, diarrhoea, haemoconcentration, thrombosis, pleural effusion and respiratory distress. It can be further complicated by ovarian rupture and renal insufficiency. In some cases, it can be life-threatening.
The Newcastle Centre for Life conducted research on the prevalence of OHSS and published the results. It found that the risk of hospitalisation increased massively if more than 20 eggs were collected. We do not know whether the pattern that it established is repeated at other research centres because the data have not been compiled. There is a gap in the evidence base. The really important point is that, as I understand it, the collection of 20 or more eggs is very common in the UK. Tens of thousands of women have been through the process, so there is a substantially increased risk of a serious medical condition.
Mitochondrial donation is impossible without a supply of donor eggs. The procedures rely on the willingness of women to undergo a process which may bear serious health risks and about whose safety there are not extensive data. Two Answers were given in Parliament last summer which suggested that the monitoring of the incidence of ovarian hyperstimulation syndrome is inadequate. On 9 July, the Health Minister in another place said:
“The HFEA does not, therefore, hold definitive data on the number of women admitted to hospital with OHSS, including non-patient egg donors and egg-share donors”.—[Official Report, Commons, 9/7/14; col. 313W.]
On another occasion, it was said that,
“licensed fertility clinics are only required to report instances of OHSS to the authority that require a hospital admission with a severe grading”.—[Official Report, Commons, 24/6/14; col. 157W.]
It was stated that other cases were reported as well. I do not think that the Government have given enough consideration to the effects of the legalisation of mitochondrial donation on the donor’s health. There is a possibility that it will lead to further problems.
This concern is underlined very effectively by the fact that the Newcastle scientists pressed Parliament very hard to sanction legislation to permit the creation of animal hybrid embryos. Parliamentarians who recall that debate will remember that the principal justification for changing the law was to allow the creation of admixed human embryos in order for research to be conducted without it being dependent on human eggs because of their limited availability. The legislation was passed; the research is dead.
Lord Patel
I thank the noble Baroness for giving way. It is important to clarify that point, particularly as it was crucial in the debate on that amendment. Admixed embryos were required for the research to be carried out then in order to study the diseases in embryonic stem cell lines without using human eggs. She is correct in saying that. On why that research has been abandoned, as the noble Lord, Lord Alton, may well remember, I made the comment in closing that the utopian dream of the scientist would be that, one day, we might reach a point where we were able to take a skin fibroblast and down-regulate it so that it behaved like a pluripotent cell. That dream came true two weeks after that legislation was passed, when Yamanaka in Japan published an article saying how it could be done. That is why the research stopped; it was not because it could not be done.
Baroness O'Loan
I thank the noble Lord for his intervention. It remains the case that there is a shortage of donated eggs. My concern is for the women who are asked to donate eggs.
Lord Patel
I think that the noble Lord was asking him to reply to my comment. He is quite right that China has used pronuclear transfer techniques, but the disaster was upsetting to me.
Lord Winston
I am very concerned that the noble Lord, Lord Patel, might get into trouble with the Whip sitting on the Front Bench. I am always in her bad books, and I would not want to allow him to be in her bad books as well.
Let me answer the noble Lord, Lord Alton. It is true that, two years ago, I said that it was unpredictable; of course, these things are unpredictable. In the context in which I was speaking, that was correct. To be fair, however, the noble Lord, Lord Alton, knows that, with the case of Jacques Cohen in New Jersey, 17 babies were born after mitochondrial transfer. Therefore, there has been some other evidence—other than that evidence from China—that suggests that this is not quite as daft as proposed. Added to which, of course, in two years, a huge amount of research has been done by our colleagues in Newcastle. They have been working flat out on a whole range of tests which, I think, have made a very big difference. Since the statement that I made in the House, three different committees have looked at the safety.
Science does not have the truth; we have a version of the truth. We have to interpret what we can as best we can.
I deeply respect the noble Lord, Lord Alton, as he knows very well. We both come from a very strong view about what is the right thing to try to do wherever possible. However, I feel here that, apart from the issue of preserving healthy life, if we decide not to vote for the amendment of the noble Lord, Lord Deben, we are doing something really important. We are expressing our concern—our compassion—as a House for people who are faced with an invidious and horrendous choice.
Under those circumstances, given that this will be a limited procedure affecting very few people, it would be utterly wrong for this House to turn down the democratically elected Chamber and not to support what the Government propose.
Baroness Hollins (CB)
My Lords, I take a rather different view from some of my eminent medical colleagues. I have worked for over 30 years with families of severely disabled children. As a psychiatrist—and as the mother myself of a child born with a severe developmental disability—my heart goes out to those parents facing the prospect of inherited mitochondrial disorders. As a mother, I understand what is called the moral imperative to try to help. However, our first responsibility must be to the children who may be created through these proposed interventions: the most important moral imperative must be to do no harm.
A new technology of such potential importance must take as long as is needed to be as sure as possible of its safety. Being first is not always best. I have carefully read the HFEA 2014 review of scientific methods. It has been implied that the scientific reviews have not raised any concerns, but in paragraph 3.7.25 the review states,
“although the results with the two techniques continue to be promising, further experiments need to be carried out before introducing either into clinical practice to provide further reassurance about efficiency and safety”.
I asked a Written Question in December asking whether clinical trials were being planned and I am grateful for the helpful reply from the Minister and the mention he made of it in his opening remarks—although I disagree with his interpretation of medicine, which is defined much more broadly in the European directive. The Minister also explained that,
“for any new IVF technique there will need to be careful monitoring of the procedure and, subsequently, any pregnancies”.
But we are not talking about pregnancies primarily; this is me as the psychiatrist talking now. As the noble Lord, Lord Deben, pointed out, we are talking about children—children who will, we hope, grow up to be healthy human beings, and who will themselves be able to have healthy children. But what if they do not?
In paragraph 3.7.29 the HFEA expert panel said:
“Until knowledge has built up that suggests otherwise, the panel recommends that any female born following MST or PNT”—
maternal spindle transfer or pronuclear transfer—
“should be advised, when old enough, that she may herself be at risk of having a child with a significant level of mutant mtDNA, putting her child, and if female, subsequent generations at risk of mitochondrial disease”.
The science is complicated, but there is apparently a real possibility that resulting embryos from a woman born after MST or PNT could be heteroplasmic—
Lord Patel
May I ask the noble Baroness what experiments she would propose to determine that the children born through this procedure will be healthy in every way, including reproduction-wise?
Smoking: E-Cigarettes
Lord Patel Excerpts(9 years, 5 months ago)
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Earl Howe
The noble Lord makes an extremely important point. It is one that is addressed in the tobacco products directive, which is due to come into force next year. The EU Commission is clear that any e-cigarettes sold need to be tamper-proof, particularly as regards children interfering with the contents.
Lord Patel (CB)
My Lords, it is good to know that the National Institute for Health Research would support a larger randomised study, but what the noble Viscount, Lord Ridley, said is true. The current evidence from the Cochrane analysis—the most robust method we know of analysing whether a product, device or a drug is effective against the desired outcome—is that, although the studies were small, 14 observational studies and two randomised trials show that e-cigarettes are more effective than nicotine patches or a placebo. Would the Minister agree that the industry should now also address a standard dosage of nicotine and ensure that the quality of the nicotine used in e-cigarettes is standardised across the industry to avoid subsequent risks?
Earl Howe
The noble Lord makes some important points. He has highlighted the fact that many products on sale are of, shall we say, variable quality. There are risks around the extent to which the dose of nicotine delivered varies; the quality of the ingredients can be suspect; and there is a question mark over the electrical safety of some products. We cannot make a general statement about products that are currently on sale. Nevertheless, it is right that the European Union has taken this matter in hand. From May 2016, only licensed e-cigarettes will be able to contain nicotine in strengths greater than 20 milligrams per millilitre. That will introduce some standardisation.
HIV
Lord Patel Excerpts(9 years, 6 months ago)
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Earl Howe
My Lords, in November 2013 DfID conducted a review of our 2011 HIV position paper. The review paper highlighted three areas of particular focus in the international context. They were to identify the key affected populations—girls and women—and the integration of HIV responses into the wider health system, as well as broader development priorities. That of course includes tackling stigma and the unacceptable things that we see in certain overseas countries, including discriminatory legislation.
Lord Patel (CB)
My Lords, did the Minister refer to 26,000 people being undiagnosed? What is that number based on?
Earl Howe
My Lords, these figures inevitably have to be estimates but they rely on data from three surveys that measure undiagnosed HIV infection among sexual health clinic attendees, pregnant women and people who inject drugs. Comprehensive clinical data from sexual health clinics relating to patients newly diagnosed with HIV are also used to infer the risk of undiagnosed infection.
NHS: Five Year Forward View
Lord Patel Excerpts(9 years, 7 months ago)
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Earl Howe
My Lords, I will have to take advice about that question. What I can say is that we now have in place a system of workforce planning that is better than its predecessor. I do not think there can ever be such a thing as a perfect system of workforce planning. We now have a national body, Health Education England, that is responsible for making sure that we have adequate numbers of professionals with the right skills. However, we also have local education training boards whose members include representatives from the acute trusts. It is up to those boards to make clear what the requirements are for trained staff and feed those requirements up to Health Education England so that planning over the coming years can be done in a rational and sensible way. I would expect that spinal units should make their case in that fashion so that if there is a need for physiotherapists in spinal units, and those physios are—for any reason—not available, then they will come forward in adequate numbers in years to come.
Lord Patel (CB)
My Lords, the Minister started his Statement by saying that the Government recognise the importance of life sciences in both economic growth and in delivering mental health care. Of course, I would agree with that and I take it from the Statement that the Government therefore have no intention of cutting the budget of either clinical or medical research in the spending review to come. I welcome the suggestion that the Government will recruit more people to decode genetic information. Of course, we will need that if we are to develop better biomarkers or drugs for treatment, but the personalised medicine that would lead to is expensive and the budgets it will require will be far greater that what we have now.
I also welcome the idea that we integrate the care of patients and do not have a demarcation between primary care, community care and hospital care, but the model that he suggested might not quite do that. He might like to reassure us that the model he has in mind is of complete integration of care, otherwise we will not win the battle for better care for people suffering from long-term conditions.
The comment about future budgets requires a greater debate. I have read the review in detail and it is a bold statement to say we can conduct a five-year review of healthcare without any further restructuring. I, for one, do not mind some restructuring if it will lead to better delivery of healthcare.
Earl Howe
I think that the restructuring the Government believe is necessary is the restructuring of the delivery of care and the culture, as the Statement made clear. What we do not think necessary is a restructuring of the architecture of the National Health Service. That has been done and, as I have said, we are set fair for the future. As regards integration, will it be complete integration? “Integration” is a word that is bandied about and it will mean different things in different areas, depending on what is necessary. We are clear that the better care fund plans, for example, which focus on this idea of integration, should most definitely involve the acute sector and social care along with primary and community care, and in many cases other disciplines as well. Pharmacy, for example, has a major part to play in reducing unplanned hospital admissions and I could cite many other professional disciplines. It depends on what each area requires.
I cannot give an answer on the research budget in the next spending review because that spending review will be conducted by the next Government, whoever they will be. Meanwhile, we are clear that the research budget is an absolutely essential part of the NHS’s future ability to provide quality care for patients over the long term. As the noble Lord knows, we have protected that budget during this Parliament.
NHS: Funding
Lord Patel Excerpts(9 years, 8 months ago)
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Lord Patel (CB)
My Lords, as it is nearly Christmas I have not given the Minister the advantage of seeing the question beforehand, but with his dexterity in answering I am sure that he will answer it straight. Can he predict which party, elected into government next May, will keep the NHS free at the point of need?
NHS: Health and Social Care Act 2012 Reforms
Lord Patel Excerpts(9 years, 9 months ago)
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Earl Howe
I take issue with the phrase “grotesque mess”. If the noble Lord cares to look at the figures, he will see that waiting times are low and stable, MRSA and C. diff infections are at record lows, mixed-sex wards are down by 98% and the number of people waiting a long time for treatment is massively reduced. Yes, we know that many A&E departments are under pressure but many are coping. The work that we are doing, including channelling more money into the system for this winter, should, we hope, relieve the worst of the problems.
Lord Patel (CB)
Now that general practitioners will have incentives to diagnose dementia, will it lead to a better and more accurate diagnosis? Will it increase the number of people diagnosed with dementia or will it increase the number of people falsely diagnosed with dementia? Let us remember that there is no cure or treatment for any of them.
Ebola
Lord Patel Excerpts(9 years, 9 months ago)
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Lord Patel (CB)
My Lords, I thank the noble Earl for his Statement. I have two quick questions. One relates to the staff who have volunteered to go out to Sierra Leone and to all soldiers. If any of them get infected while they are working there, will they be brought back to the United Kingdom for treatment? My second question relates to the treatment. While there are likely to be early trials of the vaccine that is being developed, it may well prove ineffective. But there are other companies developing other treatments. Are there plans to fast-track approval of these drugs if they are found to be effective? We know that the stock of ZMapp is now exhausted; further monoclonal antibodies development is likely to take some time.
Earl Howe
There is a limited amount that I can say to the noble Lord about his second question. A general answer is that we would naturally want to give as fast a passage as possible through the regulatory process to any breakthrough treatment for Ebola. It should be borne in mind, however, that safety is the paramount concern. This is why it is important that the vaccine, which is now in clinical trials, is thoroughly tested for safety as well as efficacy. If there is further news on this that I can impart to the noble Lord, I will be happy to write to him.
The noble Lord asked whether staff who volunteer will be repatriated if they contract the disease. My advice is that decisions on repatriation would be taken on a case-by-case basis, taking into account the clinical condition of the person and the benefit they may gain from repatriation. Repatriation involves a long journey that can potentially be dangerous for the patient. Once there is high-quality treatment available in Sierra Leone, it will not necessarily be in the best interests of the patient to be repatriated. That is why we are building the 12-bed unit specifically for national and international healthcare workers.