NHS: Antiphospholipid Syndrome (APS)
Earl Howe Excerpts(9 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin by congratulating the noble Baroness, Lady Drake, on securing this debate about a condition that, it is fair to say, receives little parliamentary attention either in this House or the other place. I also thank the noble Baroness, Lady Morris, and the noble Lord, Lord Hunt, for their excellent and powerful contributions. I listened with care to all that they have said.
Many of us—other than perhaps the two noble Baronesses—will be unfamiliar with antiphospholipid syndrome, or APS, so at the risk of repeating the information so usefully set out by the noble Baroness, Lady Drake, it may be helpful if I begin by explaining a little more about the condition.
APS, also known by some as Hughes syndrome, is a disorder of the immune system which causes an increased risk of blood clots. APS can affect people of all ages, including children and babies. However, it usually affects adults aged 20 to 50, and affects three to five times as many women as men. It is not clear how many people in the UK have the condition, although some estimates say that it affects at least 1% of the population.
People with APS may experience myriad symptoms. These can include headaches and fatigue as well as problems with mobility, vision, speech and memory. People with APS are also at risk of developing potentially life-threatening conditions, such as deep vein thrombosis—a blood clot that usually develops in the leg—and arterial thrombosis, a clot in an artery, which can cause a stroke or heart attack. It is estimated that APS is responsible for one in every six cases of deep vein thrombosis, strokes and heart attacks in people under 50. As has been said, pregnant women with APS also have an increased risk of having a miscarriage, although the exact reasons for this are uncertain. Some women, sadly, suffer recurrent miscarriages, defined as three or more miscarriages, and APS is thought to be the cause of this in around one out of every six cases.
Diagnosing APS can be difficult as some of the symptoms are similar to those of multiple sclerosis. Therefore, blood tests designed to help identify the antibodies responsible for APS are essential in diagnosing the condition. When a blood test is done, APS is easily distinguishable from MS at that point. On the difficulty around diagnosis generally, certainly in terms of how easily it can be picked up by a GP, my advice from NHS England is that, if a patient went to see their GP complaining of some of the low-grade symptoms of headache and fatigue, it is unlikely that APS would be something that the GP would immediately suspect and test for.
There is currently no cure for APS, as has been pointed out. However, if it is correctly diagnosed, the risk of developing blood clots can be greatly reduced. Anticoagulant medicines such as warfarin, or an antiplatelet such as low-dose aspirin, are usually prescribed. Treatment with these medications can also help pregnant women improve their chances of having a successful pregnancy. With treatment, it is estimated that there is about an 80% chance of a woman with APS having a successful pregnancy.
I turn to the specific issue the noble Baroness has raised—ensuring that the medical profession is sufficiently aware of APS. As I am sure noble Lords know, the content of GP training is decided by the medical royal colleges and approved by the General Medical Council. The noble Baroness suggested that GPs are not confident enough to recognise APS. I do not doubt that there have been cases where diagnosis of APS has been too slow, but I hope that she will agree that it is not possible to generalise in this area about the number of doctors who are alert to the condition.
The noble Baroness, Lady Morris, said that APS is not included in GP curricula. I understand that the Royal College of General Practitioners curriculum covers thromboembolic disease, which would include the understanding of predisposing factors for autoimmune conditions such as APS, so GPs should be sufficiently informed about the condition. NHS England assures me that APS is also widely recognised in general medicine, neurology, haematology and obstetrics. I also understand that the British Society for Haematology, the Royal College of Physicians and the Royal College of Obstetricians, provide guidance on how to manage APS.
I think that it was the noble Baroness, Lady Drake, who asked about the absence of NICE guidance on APS. In fact, NICE’s guideline on hypertension in pregnancy covers APS. Its document on reducing hypertension in pregnancy, published in August 2010, advises clinicians that women at high risk of pre-eclampsia, including women with APS, should take 75 milligrams of aspirin daily from 12 weeks of pregnancy until the birth of the baby. When the NICE guidelines on acute stroke and transient ischaemic attacks were in development, the inclusion of a management of APS was considered, but it was not taken forward as no studies were found that could form the basis of recommendations at that time. However, the 2016 edition of the Intercollegiate Stroke Working Party guidelines are currently in development, and NHS England’s national clinical director for stroke will discuss with the relevant clinical leads whether APS can be included.
The noble Lord, Lord Hunt, suggested that this was a problem that was down to a commissioning issue and that it should be for NHS England to have a uniform policy on blood testing. I differ from him in that I do not see this as a commissioning issue. It relies above all on doctors treating patients following the guidance that they are given.
I know that there are calls for screening for APS. In fact, UK testing for thrombophilia is offered on a selective basis during early pregnancy based on clinical risk factors, including previous foetal loss, still-birth, a history of pre-eclampsia and severe intrauterine growth retardation. However, as noble Lords may know, the UK National Screening Committee advises Ministers and the NHS in all four countries about all aspects of screening policy and supports implementation. The UK NSC reviewed the evidence for antenatal, newborn and adult screening for thrombophilia, including APS, in March 2010 and recommended that population screening should not be offered. Also, the UK NSC did not recommend antenatal screening. However, the UK NSC is due to review its recommendations on antenatal, newborn and adult thrombophilia screening this year. A public consultation will be held on the review and any stakeholders or individuals who would like input into the consultation should contact the UK NSC for a copy of the review’s timetable.
I understand all that the noble Baronesses said about the need to support women with APS who suffer miscarriages. We know that pregnancy is a time of huge emotional significance. Sadly, some pregnancies end in miscarriages. Families who have to cope with the distressing event of miscarriage need sensitive support and care from services and the people around them. That is precisely why the Royal College of Obstetricians and Gynaecologists has set out clear standards for NHS service organisations and levels of care that should be provided to help patients who experience problems in early pregnancy, miscarriage, ectopic pregnancy and recurrent miscarriages.
We still need to understand more about how APS affects people and how best to treat it. I am pleased to say that there is some research under way to help do just that. The National Institute for Health Research Clinical Research Network recently hosted a trial comparing the anti-coagulant effects of rivaroxaban and warfarin in patients with thrombotic APS. The trial closed to recruitment in November last year and is now in follow-up. In addition, the network has a new study in set-up that will look at the impact of fatigue and physical inactivity in people with APS.
I close by assuring noble Lords that this Government are determined to ensure that people with long-term conditions such as APS receive the help and support they need. I understand that noble Lords feel that gaps exist which should be bridged. I would be very happy to talk to the noble Baronesses, Lady Drake and Lady Morris, and the noble Lord, Lord Hunt, if they would like to come and see me about this. It is for this reason that through the mandate we have asked NHS England to make measurable progress in supporting people with ongoing health problems to live healthily and independently, with much better control over the care they receive. NHS England is taking action to make sure progress is made. For example, its business plan Putting Patients First sets out key actions to improve services for people with long-term conditions over the next two years. It has also recently published three handbooks to provide practical support for good management of long-term conditions and guidance on population risk-stratification. The aim is to help commissioners identify those patients who will benefit most from a personalised care planning approach. This, to be sure, is generic but I hope that it indicates the stress that we are putting on the importance of supporting those with long-term conditions, particularly those with multiple conditions.
In tandem with this, the Five Year Forward View, developed by the partner organisations that deliver and oversee health and care services, sets out that long-term conditions are now a central task of the NHS. Once again, I thank the noble Baroness for tabling this debate, which will help raise the profile of APS in a helpful way.
Gender-based Violence: Screening
Earl Howe Excerpts(9 years, 8 months ago)
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Baroness Gould of Potternewton
To ask Her Majesty’s Government what steps they are taking to improve screenings at healthcare settings, including HIV clinics, to screen for gender-based violence and to provide the necessary support for affected women.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
Routine inquiry of domestic abuse is in place in maternity and mental health services. It will be introduced in maternity services for FGM from April 2015 and for child sexual abuse in some targeted services next year. Accident and emergency departments in England have been sharing data on attendances involving body injuries with their local police forces to help prevent violent crime.
Baroness Gould of Potternewton (Lab)
I thank the Minister for his reply. Currently, there is professional guidance on screening, particularly for domestic violence, for health visitors, school nursing programmes and antenatal clinics. Does he not agree that such guidance should be expanded to HIV clinics, because we know that there is a correlation between women who have HIV and domestic violence, so that they can get the help and support that they need, because they have two problems to sort out for themselves?
Earl Howe
I do agree. Sexual health and HIV services are already sensitive to the risk of domestic violence, including gender-based violence, in their routine consultations. One of the most important elements in that is to have an environment and atmosphere that is welcoming, comfortable and calm, so that it engenders a sense of trust. Most sexual health clinics have developed local templates to identify those at risk of domestic violence, with signposting and referral to police and other support services if needed.
Baroness Knight of Collingtree (Con)
My Lords, could there be a greater example of gender violence than the acceptance that it is perfectly legal to abort an unborn child who is a girl? There is so much disagreement about that—I know my noble friend agrees that it is a wrong policy and ought to be illegal—but the fact is that abortion nursing homes do it every day, and there is great uncertainty about whether this is illegal or not. Ought it not to be quite clear that it is an illegal practice?
Earl Howe
My noble friend has emphasised an issue which I am sure all noble Lords feel equally strongly about. The Department of Health has been quite clear that abortion on grounds of gender alone is illegal. We reissued that guidance last year in no uncertain terms. It is a pity if there is any misconception about that.
Baroness Barker (LD)
My Lords, health and well-being boards have a responsibility under the Health and Social Care Act to commission sexual and reproductive health services and HIV services. Are they being asked to include gender-based violence in the commissioning formats that they put forward to the NHS?
Earl Howe
Most certainly. Gender-based violence is one of the issues which sexual health clinics, and indeed all parts of the NHS, are now alert to. New guidance from NICE was issued in February last year on domestic abuse and how health and social care services and the organisations with which they work can spot and respond to abuse earlier in a more joined-up and preventive way.
Baroness McIntosh of Hudnall (Lab)
My Lords, does the noble Earl agree that not all domestic abuse results in physical symptoms? In his Answer, he mentioned mental health services. What is being done to deal with emotional abuse and to discover and refer people who suffer from it?
Earl Howe
My Lords, the provision in the Serious Crime Act on controlling behaviour is one of the ways in which we have addressed that. The noble Baroness is absolutely right: abuse can take many forms. It can be physical, sexual, emotional or psychological. Thirty per cent of this abuse starts in pregnancy, and existing abuse may get worse during pregnancy or after giving birth. In the context of health and care services, the challenge is to alert staff to all those possibilities in a way that avoids them stereotyping the person sitting in front of them.
Baroness Wheeler (Lab)
My Lords, more than 26,000 women in the UK received HIV care in 2013. What are the Government doing to assess the relationship between women with HIV and domestic violence, so that effective counselling, advice and support can be given to the women at greatest risk?
Earl Howe
My Lords, NHS England is working with the Department of Health to identify the right pathways, access to and availability of psychotherapeutic support for victims of sexual abuse and, in that context, the risk factors at play for women who have HIV. It is vital that the support services that we have and the alerts in the system are sensitive to the issue which the noble Baroness raises.
Baroness Farrington of Ribbleton (Lab)
My Lords, would the Minister care to reassure the House on the progress towards parity between mental health services and the rest? It is no good identifying people who need mental health service support and psychological support if those services are not there, and in many parts of the country they have been decimated.
Earl Howe
My Lords, we are concerned about the sometimes patchy provision of mental health services in certain parts of the country, and we have channelled additional money to address that in recent months. One of the main ways in which we have demonstrated our commitment to parity of esteem is by introducing, for the first time, waiting-time standards for mental health treatment. That it is a landmark.
Baroness Manzoor (LD)
My Lords, can the Minister please give an assurance that FGM is given a high priority in the health commissioning groups’ plans?
Earl Howe
Yes, my Lords. The Government hosted the first ever Girl Summit last year on ending female genital mutilation as well as forced marriage and other issues. We set up a specialist female genital mutilation unit following that summit. We provided money last year for the FGM prevention programme, and as part of this we introduced the first ever data collection in the NHS for all acute trusts, which are now required to record in a patient’s healthcare record whenever FGM is identified. We have also said that front-line professionals will in future have a mandatory duty to report cases of FGM in those under 18.
The Earl of Listowel (CB)
My Lords, following on from my noble friend Lord Laming’s question on children in these circumstances, is the Minister ensuring that where gender-based violence is at play, any children in those circumstances are being identified and getting the help and support that they need?
HIV/AIDS
Earl Howe Excerpts(9 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I am most grateful to my noble friend for today’s debate on this important issue. All of us know how much he personally has done to ensure that HIV and AIDS remain firmly on agendas, both at home and abroad. I may not be able to give him a medal, but I congratulate him on his book AIDS: Don’t Die of Prejudice, which is very timely and draws on his great experience. It is most welcome given that there is still, as we have heard today, much to do around the world to reduce the stigma and prejudice associated with HIV. I welcome, too, his appointment as a member of the International AIDS Vaccine Initiative.
Compared with many other countries, HIV prevalence in the UK remains relatively low: just under three per 1,000 of the adult population were living with HIV in 2013. Thanks to the Government’s early efforts and the leadership of my noble friend back in the 1980s, we have been spared the higher prevalence rates seen by other European countries and countries in other continents. Our confidential sexual health clinics are doing more and more HIV tests—more than a million in 2013, up 5% from 2012. The NHS continues to provide excellent, high-quality HIV treatment and care for everyone, with 90% having an undetectable viral load. Diagnosed early, the outlook for people with HIV in the UK is very good and most people can expect a near normal life expectancy. We also benefit from government’s sustained investment in Public Health England’s comprehensive HIV surveillance systems.
A 2014 report for the National AIDS Trust by Ipsos MORI reported that overall public support for people with HIV is higher than ever, with 79% of adults agreeing that people with HIV deserve the same level of support as people with cancer. Today, it is much easier to get an HIV test, with virtually all NHS sexual health clinics providing the option of same-day testing results. Like many other countries, we have virtually eliminated mother-to-child transmission of HIV.
However, we are acutely aware that challenges remain in how we tackle HIV. Although overall HIV prevalence in the UK is very low, there are marked variations. In London, HIV prevalence in men who have sex with men—MSM—is much higher, and in 2013 one in eight men were living with HIV, compared to one in 26 outside London. In 2013, the prevalence rate of HIV was approximately 30 times higher for MSM and black African men and women compared to the general population in England. New diagnoses in MSM continue to increase, with 3,250 MSM diagnosed in 2013. Some of this increase will be due to increased testing but there is evidence of increasing risk-taking behaviours, which prevention services and community groups must address, taking into account the latest research and evidence. Achieving sustained changes in risk-taking is challenging for all.
Today, HIV prevention is just as important as it was in the 1980s. Investment in prevention also makes good economic sense, as noble Lords have argued, given that each new HIV infection represents between £280,000 and £360,000 in lifetime treatment costs alone. I will pick up a point made by the noble Lord, Lord Cashman. Although we have excellent NHS HIV treatment and care services, and antiretroviral treatment is highly effective, we are still seeing too many people diagnosed late, after treatment is recommended. This means they are unable to benefit from that treatment and risk transmitting HIV to their partners. Although we have seen improvements, HIV still attracts stigma, which is unacceptable and can deter people from getting tested and, if positive, taking their medication. I listened with care to my noble friend Lord Black on that theme.
In 2013, the department published A Framework for Sexual Health Improvement in England, setting out our ambitions to improve sexual health and well-being for all. These include reducing the rate of sexually transmitted infections, including HIV, using evidence-based prevention and treatment initiatives; tackling HIV through prevention, including increasing access to testing to enable earlier diagnosis and treatment; and tackling the stigma, discrimination and prejudice often associated with sexual health and HIV.
Late diagnosis is included as an indicator in the public health outcomes framework and progress is being monitored. Since we published the framework, we know that HIV testing services are changing and becoming more innovative and focused around the needs of people. A good example of that is self-sampling HIV tests to reduce undiagnosed and late diagnosis of HIV.
Self-sampling HIV test schemes, such as those provided through the HIV Prevention England programme and the 56 Dean Street clinic in Soho, show that new types of tests are acceptable. Importantly, they appeal to people who choose not to use traditional services, and they are picking up undiagnosed HIV. An assessment of more than 4,000 people using self-sampling HIV testing services in November 2013 indicated that the majority had never had an HIV test, yet were reporting high-risk behaviour. It is encouraging that the rates of late diagnosis are improving, albeit slowly—down from 57% in 2004 to 42% in 2013. However, I agree that we need to do more to reduce this. Last year, we removed the ban on the sale of self-testing kits, which will eventually provide further options for testing.
Healthcare services, including general practice, especially in high-prevalence areas, have a key role in offering HIV testing. We were pleased to fund the Medical Foundation for HIV & Sexual Health to produce a web-based interactive tool to make testing easier in primary care. That was launched by MEDFASH last November.
Finally, my noble friend Lord Fowler referred to the prevention budget. We are committed to protecting the national HIV prevention budget for next year. I agree with him that we will need to be more ambitious and innovative in our plans to prevent the spread of HIV. We will be announcing our plans very shortly and these are likely to include a contract with the Terrence Higgins Trust for the HIV Prevention England programme, but we are also keen to be more innovative and ambitious in our response. At that time, the answer to one of the questions posed by the noble Lord, Lord Collins, will become clearer.
I will endeavour to answer as many questions as I can in the time available but I will of course write to noble Lords whose questions I cannot answer today. The noble Lord, Lord Collins, referred to a lack of clarity, as he perceives it, in the overall responsibility for commissioning these services. We recognise that the public health and NHS reforms have presented some challenges for sexual health services, and a number of actions have been taken or are planned. Public Health England has worked with partners, including the Local Government Association, and last summer published Making it Work: A Guide to Whole System Commissioning for Sexual Health, Reproductive Health and HIV. It is planning to undertake a review of commissioning arrangements for sexual health and HIV, similar to the one just published for drugs and alcohol.
My noble friend Lord Fowler called for a new campaign to promote testing. As I mentioned, the level of testing in sexual health clinics is increasing, which is encouraging. More than 1 million tests were carried out in 2013, which was an increase on the previous year. I agree that that level needs to increase, with action by local authorities, especially in high-prevalence areas. We need to offer new ways of testing, as I mentioned—for example, home sampling.
The noble Lord, Lord Cashman, rightly said that engagement with HIV charities was vital in determining the way forward. We see 2015-16 as a transition year towards a longer-term plan for sexual health promotion and HIV prevention. Public Health England will engage with key stakeholders on their new strategy, and my department has been discussing 2015-16 contracts since last November.
My noble friend Lord Black mentioned stigma. I remind us all that it is not just the NHS or the Government who have a role to play here, it is everybody. Community and faith groups, the media and individuals all have a part to play in eliminating HIV-related stigma. We should not forget some of the good news, part of which is that people with HIV are now protected by UK equalities legislation. The department’s framework for sexual health improvement is clear that there is a need to build an honest and open culture, where everyone can make informed decisions and responsible choices about relationships and sex.
The noble Lord, Lord Cashman, referred to the role of local authorities. We believe that local authorities are best placed to make decisions on investment in HIV health promotion services and primary prevention services. Reducing the late diagnosis of HIV is included in the public health outcomes framework, as I mentioned. We have provided local authorities with £8.2 billion of ring-fenced funding for public health, including HIV prevention. I completely understand the arguments in favour of the ring-fence; it has played an important part in ensuring a smooth transition of services and will continue to apply through the next financial year. We have always intended to review the need for it after that. We will do that during discussion on the next spending round, but of course it is for the next Government under the ensuing comprehensive spending review to decide on the continuation of the ring-fence.
In primary care, there is evidence that HIV testing is acceptable to patients and healthcare professionals. My department was pleased to fund the Medical Foundation for HIV & Sexual Health for its HIV testing in primary care project, launched last November.
I just mention the issue of PrEP and Truvada, referred to by my noble friends Lord Fowler and Lord Black and the noble Lord, Lord Collins. The recent results from the trial are encouraging. Further work is needed, and NHS England has set up an expert committee to consider the results of the PROUD study and whether PrEP should be provided by the NHS. Some outstanding issues are being considered in that process which prevent us forging ahead immediately with any action. For example, there is the evidence supporting use in other higher-risk groups, such as black African groups, and whether the recommendation should be for daily treatment, as in the study, or only to protect individuals for a certain high-risk event. The service model is also important here. I can write further on that to noble Lords.
I hope that I can reassure my noble friend Lord Fowler on the continuation of methadone and reducing the harm that drug-taking can cause. Again, I shall write to him on that subject, as I shall to the noble Lord, Lord Crisp, and all those who have spoken about global issues. For now, my time is up. I thank all contributors for their expert speeches, to which I shall respond.
Maternity Services in Morecambe Bay
Earl Howe Excerpts(9 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, with the leave of the House, I shall now repeat a Statement made earlier today by my right honourable friend the Secretary of State for Health in another place about maternity care at the University Hospitals of Morecambe Bay NHS Foundation Trust. The Statement is as follows.
“With your permission, Mr Speaker, I would like to make a Statement on the independent investigation into the care of mothers and babies at the University Hospitals of Morecambe Bay NHS Foundation Trust, which is being published today. I commissioned this report in September 2013 because I believed there were vital issues that needed to be addressed following serious incidents in maternity services provided by the trust dating back to 2004.
There is no greater pain than for a parent to lose a child, and to do so knowing it was because of mistakes that we now know were covered up makes the agony even worse. Nothing we say or do today can take away that pain, but we can at least provide the answers to the families’ questions about what happened and why, and in doing so try to prevent a similar tragedy in the future.
We can do something else, too, which should have happened much earlier. That is, on behalf of the Government and the NHS, to apologise to every family that has suffered as a result of these terrible failures. The courage of those families in constantly reliving their sadness in a long and bitter search for the truth means that lessons will now be learnt so that other families do not have to go through the same nightmare. We pay tribute to those brave families today.
I would especially like to thank Dr Bill Kirkup and his expert panel members. This will have been a particularly difficult report to research and write, but the thoroughness and fairness of their analysis will allow us to move forward with practical actions to improve safety, not just at Morecambe Bay, but across the NHS.
Before we discuss the report in detail, I know the whole House will want to recognise that what we hear today is not typical of NHS maternity services as a whole, where 97% of new mothers report the highest levels of satisfaction. Our dedicated midwives, nurses, obstetricians and paediatricians work extremely long hours providing excellent care in the vast majority of cases. Today’s report is no reflection on their dedication and commitment, but we owe it to all of them to get to the bottom of what happened so we can make sure it never happens again.
The report found 20 instances of significant or major failings of care at Furness General Hospital, associated with three maternal deaths and the deaths of 16 babies at or shortly after birth. It concludes that different clinical care would have been expected to prevent the death of one mother and 11 babies. The report describes major failures at almost every level. There were mistakes by midwives and doctors, a failure to investigate and learn from those mistakes, and repeated failures to be honest with patients and families, including the possible destruction of medical notes. The report says that the dysfunctional nature of the maternity unit should have become obvious in early 2009, but regulatory bodies including the North West SHA, the PCTs, the CQC, Monitor and the PHSO failed to work together and missed numerous opportunities to address the issue.
The result was not just the tragedy of lives lost. It was indescribable anguish for the families left behind. James Titcombe speaks of being haunted by ‘feelings of personal guilt’ about his nine day-old son who died. ‘If only’, he says, ‘I had done more to help Joshua when he still had a chance’. Carl Hendrickson, who worked at the hospital and lost his wife and baby son, told me that he was asked to work in the same unit where they had died and even with the same equipment that had been connected to his late wife. Simon Davey and Liza Brady told me the doctor who might have saved their son Alex was shooed away by a midwife, with no one taking responsibility when he was tragically born dead. In short, it was a second Mid Staffs, where the problems, albeit on a smaller scale, occurred largely over the same time period.
In both cases perceived pressure to achieve foundation trust status led to poor care being ignored and patient safety being compromised. In both cases the regulatory system failed to address the problems quickly. In both cases families faced delay, denial and obfuscation in their search for the truth, which in this case meant that at least nine significant opportunities to intervene and save lives were missed. To those who have maintained that Mid Staffs was a one-off ‘local failure’, today’s report will give serious cause for reflection.
As a result of the new inspection regime introduced by this Government, the trust was put into special measures in June 2014. The report acknowledges improvements made since then which include more doctors and nurses, better record-keeping and incident reporting, and action to stabilise and improve maternity services, including a major programme of work to reduce stillbirths. The trust will be reinspected this summer, when an independent decision will be made about whether to remove it from special measures. But patients who use the trust will be encouraged that the report says that the trust,
‘now has the capability to recover and that the regulatory framework has the capacity to ensure that it happens’.
The whole House will want to support front-line staff in their commitment and dedication during this difficult period.
More broadly, the report points to important improvements to the regulatory framework, particularly at the CQC, which it says is now,
‘capable of effectively carrying out its role as principal quality regulator for the first time … central to this has been the introduction of a new inspection regime under a new Chief Inspector of Hospitals’.
As a result of that regime, which is recognised as the toughest and most transparent in the world, 20 hospitals—more than 10% of all NHS acute trusts—have so far been put into special measures. Most have seen encouraging signs of progress, with documented falls in mortality rates, but there remain many areas where improvements in practice and culture are still needed. Dr Kirkup makes 44 recommendations—18 are for the trust to address directly, and 26 for the wider system. The Government received the report yesterday and will examine the excellent recommendations in detail before providing a full response to the House.
However, there are some actions that I intend to implement immediately. First, the NHS is still much too slow at investigating serious incidents involving severe harm or death. The Francis inquiry was published nine years after the first problems at Mid Staffs, and today’s report is being published 11 years after the first tragedy at Furness General. The report recommends much clearer guidelines for standardised incident reporting, which I am today asking Dr Mike Durkin, director of patient safety at NHS England, to draw up and publish. However, I also believe that the NHS could benefit from a service similar to the Air Accidents Investigation Branch of the Department for Transport. Serious medical incidents should continue to be investigated locally, but where trusts feel that they would benefit from an expert independent national team to establish facts rapidly on a no-blame basis, they should be able to do so. Dr Durkin will therefore look at the possibility of setting up such a service for the NHS.
Secondly, although we have made good progress in encouraging a culture of openness and transparency in the NHS, this report makes clear that there is a long way to go. It seems medical notes were destroyed and mistakes covered up at Morecambe Bay, quite possibly because of a defensive culture where the individuals involved thought they would lose their jobs if they were discovered to have been responsible for a death. However, within sensible professional boundaries, no one should lose their job for an honest mistake made with the best of intentions. The only cardinal offence is not to report that mistake openly so that the correct lessons can be learnt.
The recent recommendations from Sir Robert Francis on creating an open and honest reporting culture in the NHS will begin to improve this, but I have today asked Professor Sir Bruce Keogh, medical director of NHS England, to review the professional codes of both doctors and nurses and to ensure that the right incentives are in place to prevent people covering up instead of reporting and learning from mistakes. Sir Bruce led the seminal Keogh inquiry into hospitals with high death rates two years ago that led to a lasting improvement in hospital safety standards and has long championed openness and transparency in healthcare. For this vital work he will lead a team which will include the Professional Standards Authority, the GMC, NMC and Health Education England, and will report back to the Health Secretary later this year.
The report also exposed systemic issues about the quality of midwifery supervision. While the investigation was underway, the King’s Fund conducted a review of midwifery regulation for the NMC, which recommended that effective local supervision needs to be carried out by individuals wholly independent from the trust they are supervising. The Government will work closely with stakeholders to agree a more effective oversight arrangement and will legislate accordingly. I have asked for proposals on the new system by the end of July this year.
For too long the NMC had the wrong culture and was too slow to take action, but I am encouraged that it has recently made improvements. Today it has apologised to the families affected by the events at Morecambe Bay. The NMC is already investigating the fitness to practise of seven midwives who worked at the trust during this time, and it will now forensically go through any further evidence gathered by the investigation to ensure that any wrongdoing or malpractice is investigated. Anyone who is found to have practised unsafely or who covered up mistakes will be held to account, which for the most serious offences includes being struck off. The NMC also has the power to pass information to the police if it feels a criminal offence may have been committed, and it will not hesitate to do so if its investigations find evidence which warrants this. The Government remain committed to legislation for further reform of the NMC at the earliest opportunity.
The report expresses a ‘degree of disquiet’ over the initial decision of the Parliamentary and Health Service Ombudsman not to investigate the death of Joshua Titcombe. I know the Public Administration Committee is already considering these issues and will want to reflect carefully on the report as it considers any improvements that can be made as part of its current inquiry.
Finally, I expect the trust to implement all 18 of the recommendations that have been assigned to it in the report. I have asked Monitor to ensure that this happens within the designated timescales, as I want to give maximum reassurance to the patients and families who are using the hospital that no time is being wasted in learning necessary lessons. We should recognise that, despite many challenges, NHS staff have made excellent progress recently in improving the quality of care, with the highest ever ratings from the public for safety and compassionate care. The tragedy we hear about today must strengthen our resolve to deliver real and lasting culture change so that these mistakes are never repeated. That is the most important commitment we can make to the memory of the 19 mothers and babies who lost their lives at Morecambe Bay, including those named in today’s report: Elleanor Bennett, Joshua Titcombe, Alex Brady-Davey, Nittaya Hendrickson and Chester Hendrickson. This Statement is their legacy, and I commend it to the House”.
My Lords, that concludes the Statement.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the noble Earl for his well-judged Statement and entirely echo the sentiments he expressed. Families in Barrow and the wider Cumbria area were badly let down by their local hospital and the NHS as a whole. He was right to apologise to them on behalf of both the Government and the NHS, and I do the same for the previous Government. It is hard to imagine what it must be like to lose a child or partner in these circumstances, but to have the suffering intensified by the actions of the NHS is inexcusable. Bereaved families should never again have to fight in the way that these families have had to fight to get answers. The fact that they found the strength and courage to do so will benefit others in years to come, and I pay tribute to them all, but particularly to James Titcombe. The report finally gives families the answers they should have had many years ago. It explains in detail both what went wrong and the opportunities missed to put it right.
I echo the noble Earl’s praise for Dr Bill Kirkup, the investigation team and the panel which assisted them. Our shared goal must now be to ensure that this report changes this hospital trust and the NHS as a whole for the better. Its recommendations are powerful but proportionate. We support them all, and the noble Earl can rely on our full support in introducing them at the earliest opportunity.
People’s first concern will be whether services are safe today. Clearly there are parts of this report where the alarm bell is being rung. It identifies the root cause of the failures as the dysfunctional local culture and the failure to follow national clinical guidance. There are suggestions in the report that this problem has not entirely disappeared. It says that,
“we also heard from some of the long-standing clinicians that relations with midwives had not improved and had possibly deteriorated over the last two to three years”.
It goes on,
“we saw and heard evidence that untoward incidents with worryingly similar features to those seen previously had occurred as recently as mid-2014”.
I am sure the fact that problems have been acknowledged means there is improvement. I very much take the latter point the noble Earl made in that regard, but can he say more about those findings and what steps are being taken to ensure that the trust now has the right staff and safety culture?
After safety, people will rightly want accountability, not just for the care failures but for the fact that problems were kept hidden from the regulators and the public for so long. When information did come to light it was not acted upon. Lessons were not learnt and problems were not corrected. The investigation recommends the trust formally admits the extent and nature of the problems and apologises to those affected. I am sure that this House, as well as the other place, will endorse that and want to see it done both appropriately and immediately.
Can I ask the noble Earl to ensure that any further referrals to the GMC and NMC are made without delay? Will he ensure that any managerial or administrative staff found guilty of wrongdoing are subject to appropriate action? I wonder whether it is time to revisit the issue of the regulation of managers and administrators because of this concern about staff moving on to another organisation and still being in the employ of the service, seemingly without being subject to accountability for their actions. We know a number of staff have left the trust in recent years, many with pay-offs. Will the noble Earl review those decisions in the light of the report and take whatever steps he can to ensure that those who have failed are not rewarded?
One of the central findings of the investigation is the particular challenges faced by geographically remote and isolated areas in providing health services. The investigation warns of the risks of a closed clinical culture, where,
“practice can ‘drift’ away from the standards and procedures found elsewhere”.
Given that, is not the report right to recommend a national review of maternity care and paediatrics in rural and isolated areas, and will he take that forward? Will the noble Earl comment on the concerns about the sustainability of the Cumbrian health economy? My honourable friend the Member for Copeland has today written to Simon Stevens, the chief executive of NHS England, to call for a review of the specific challenges it is facing. I hope that Ministers will be sympathetic to this call.
On the question of the CQC, the role of the regulator is to be a champion for patients, to expose poor care and to ensure that steps are taken to root it out. It is clear the regulator failed in that duty in this case. Given what was known, the decision to register the trust without conditions in April 2010 was inexplicable, as was the decision in 2012 to inspect emergency care pathways but not maternity services. In doing so, it failed to act on specific warnings. The report says there was, and remains, confusion in the system as to who has overall responsibility for monitoring standards, with overlapping regulatory responsibilities. We support the moves to makes the CQC more independent, but does the noble Earl agree that the journey of improvement at the regulator needs to continue and that there is a need for further reform, as recommended?
Will the noble Earl ensure that NHS England draws up the recommended protocol on the roles and responsibilities for all parts of the oversight system without delay and does he agree that the CQC should take prime responsibility? Does he also agree that the answer to a number of the problems identified is a much more rigorous system of review of deaths in the community and in hospitals than currently exists? Is it not the case that the reform of death certification and the introduction of a new system of independent medical examination are well overdue? We know Ministers have previously said that they are committed, in principle, to bringing this in but nothing has happened. I hope that the noble Earl will agree to bring this new system in without delay. It needs to go further, too. We need to look at mandatory reporting and investigation as serious incidents of all maternal deaths, stillbirths and unexpected neonatal deaths. We need to see how we can move to a mandatory review of case notes for every death in hospital. We have asked Professor Nick Black to advise us and inform a review which we want to conclude by the end of the month. I hope the noble Earl will support us in that review.
There are two other points I would like to raise with the noble Earl. I want to ask him about leadership of the profession nationally. He will know that maternity services are coming under great pressure at the moment. With the increase in the number of births, many maternity services are facing huge difficulties and challenges, particularly in recruiting midwives to work in those units and in making sure that they can respond to the pressures that are undoubtedly there. We do not have a chief midwifery officer, either at the Department of Health or at NHS England. I wonder whether we need a leader of the profession who can really start to raise the morale and tackle some of these issues which have been around for many years. There will be a head of profession within his department who will be working with the Chief Nursing Officer, but I wonder whether we need a more visible leadership of the profession.
The noble Earl also mentioned the work of the NMC and the King’s Fund review into midwifery supervision and regulation. I very much understand those recommendations and am very sympathetic to the need to look at this carefully. That clearly has major implications for the current supervisory role of midwives. I take the point he and, indeed, the King’s Fund report make, about that role needing to be independent of the employing authority. Can he confirm, though, that much of what supervisors do is of value and that, in moving to a new system, we would not want to lose the value of the work that current supervisors undertake? I echo the noble Earl’s views on the work of the NMC. Under the current leadership it has shown great signs of improvement, and it needs to be supported.
Finally, I pick up the point that the noble Earl made about the acceptance of honest mistakes as long as people and organisations are open. I agree with that, but could he reassure me that he believes that that philosophy is consistent with the Private Member’s Bill of the noble Lord, Lord Ribeiro, in relation to the issue of doing no avoidable harm? I believe that it is. Perhaps we will come back to this when we debate the noble Lord’s Bill, but if the noble Earl was able to say that it is consistent, it would provide considerable reassurance to those health organisations that have reservations at the moment.
Earl Howe
My Lords, I welcome the measured and constructive comments of the noble Lord, Lord Hunt. He asked me a series of questions and I shall answer as many as I can. First, on how things are today at the trust and the safety of its services, clearly the CQC is the body best placed to make judgments about the quality of services. At the last inspection of the university hospitals of Morecambe Bay in February last year, safety in the maternity service at Furness was rated as good but overall the maternity services were assessed as requiring improvement. As a whole, the trust has been rated as inadequate. This demonstrates that, while the trust is making progress, there is still a long way to go, and it is clear that embedding changes of this nature takes time. The CQC will reinspect the trust in May 2015 and will make a judgment on whether it has made the required improvements.
The noble Lord asked about referrals to the NMC and the GMC. Where there are failings by a member of staff, they must be held to account. If an allegation is made about a medical doctor, a nurse or midwife, who may not meet the professional standards required in the UK, the relevant professional regulator has a duty to investigate—and, where necessary, to take action to safeguard the health and well-being of the public. The Department of Health is aware that the NMC and the GMC have each received a number of fitness to practise referrals linked to maternity and neonatal services provided by the University Hospitals of Morecambe Bay NHS Foundation Trust. As an independent body, each of them is responsible for operational matters concerning the discharge of its statutory duties. I would hesitate—in fact, I think it would be wrong of me—to comment further on those fitness to practise cases. However, we are confident that the NMC will take account of the recommendations and findings in the report.
The noble Lord made a number of comments about managers. As he well knows, the NHS is a huge and complex service staffed by committed people who often work under a huge amount of stress. I believe that those tasked with leading our NHS organisations, whether in management positions or clinical ones, are committed to making good decisions on behalf of patients. When it becomes clear that they are not up to the job, they should be replaced. Many senior leaders at Morecambe Bay have now been replaced. The current leadership should be allowed a period of time to refocus the trust on those values that are so vital to good patient care—staff morale, sound governance, strong leadership, team working and a focus on delivering high-quality care.
On the issues that are particularly pertinent when you have NHS services that are geographically remote, NHS England has today announced details of a major review of the commissioning of NHS maternity services as promised in the five-year forward view. The review will assess current maternity care provision and consider how services should be developed to meet the changing needs of women and babies. Recent advances in maternity care, changes in the demographics of women having babies and preferences of where they want to give birth will form the key focus. This review, which is expected to report by the end of the year, will be led by an external chair, supported by a diverse panel, and will include a review of UK and international evidence on safe and efficient models of maternity services.
I listened with interest to the noble Lord’s comments on the Cumbrian health economy as a whole. I am not in a position to comment on that at the moment but, if I may do so in writing, I shall be happy to. As for further reform of the CQC, we will examine the recommendation on this score in detail and publish a full response in due course. Further consideration is needed to ensure that the overall responsibility for patient safety sits in the right part of the system and the department has already committed to consider with relevant organisations the options for transferring NHS England’s responsibilities for safety to a single national body. We will also continue to look for opportunities to improve both the operation of the oversight arrangements in place at present and the understanding of those arrangements by NHS organisations and the public.
On the matter of reviewing all deaths and picking up the recommendations around death certification, a number of the recommendations in Sir Robert Francis’s Mid Staffordshire inquiry report refer to our planned reform of the death certification system and the introduction of the role of medical examiner in England and Wales. A new system of medical examiners has been successfully trialled in a number of areas around the country. The work of the two flagship sites in Gloucestershire and Sheffield has been continued and extended to operate a medical examiner service on a city and county-wide basis on a scale that will be required for implementation by local authorities when legislation is introduced. We will publish shortly a report from the interim national medical examiner, setting out the lessons learnt from the pilot sites. I hope that that gives the noble Lord an indication that this is work very much in progress.
On mandatory reporting of maternal, stillbirth and neonatal deaths, the Government are committed to doing further work to review avoidable deaths. We are working with NHS England to introduce a national standard approach for undertaking case-note review. This has the potential to enable NHS trusts to develop a better understanding of avoidable deaths. However, a top-down approach to ensuring that every trust reviews every death is not, in our view, appropriate. Our aim is to ensure that trusts focus their efforts on improving patient safety through learning about the root causes that have led to avoidable death. A systematic, but not necessarily burdensome, approach is needed, which is why we are moving ahead to develop a national rate and produce an estimated number of avoidable deaths for each hospital. The numbers will be made public. Trusts will be expected to report annually to the Secretary of State for Health on their actions to reduce avoidable deaths.
The noble Lord made a very interesting suggestion about the possible appointment of a chief midwifery officer. I would be happy to consider that idea. Of course, he knows that there is a head of maternity in NHS England at the moment.
On the performance of the NMC, it is, as the noble Lord is well aware, an independent body accountable to Parliament, via the Privy Council, for the way in which it carries out its responsibilities. In addition, its performance is monitored by the PSA, and the Health Select Committee has also chosen in recent years to hold an annual accountability hearing with NMC leadership. So there are a variety of robust measures in place to hold the NMC to account. I am aware that the performance of the NMC has a troubled history, which is why Ministers commissioned the Professional Standards Authority’s predecessor body, the CHRE, to undertake a full strategic review in 2012. As noble Lords will remember, the final report of the strategic review was published, putting forward 15 high-level recommendations for improvement in delivering the NMC’s regulatory functions, with the expectation that demonstrable improvements should be seen within two years. We welcome the new NMC chair and we hope that, under Dame Janet’s leadership, it will continue to make improvements to become a confident and capable regulator.
Baroness Barker (LD)
My Lords, back in 2006 the Minister and I had the unhappy experience of being in opposition when the NHS Redress Act went through your Lordships’ House. We are both on record as saying at the time that we felt that it was a fairly inadequate piece of legislation. I think the 44 recommendations in this report are searing evidence that that is in fact the case.
In the wake of the reports by Dame Carol Black, Sir Robert Francis and Sir Bruce Keogh, does the Minister agree that it is now time for a thorough root and branch review of the legislation underpinning the NHS complaints system? I have very little time in which to deal with the great many points in this report, but I wish to ask the Minister about two, which are important. First, in recommendation 27, the regulatory bodies, the GMC and the NMC, are asked to reconsider the guidance to professionals about what to do if they suspect that clinical standards or services are not being fulfilled. It seems to me that in this case there was a failure at every level in that respect. That is unacceptable. Secondly, the report points to the breakdown of the relationship between the CQC and the Parliamentary and Health Service Ombudsman. They had no communication and the consequence was that the families had nowhere to go to seek redress. It is difficult because that ombudsman is both the parliamentary and the health service ombudsman for Members of Parliament to make recommendations about ways in which the health service might be reformed. Will the Government act quickly on the recommendation of this report that there should be a memorandum of understanding between the CQC and that ombudsman?
Earl Howe
I am grateful to my noble friend and I do indeed recall our debates on the NHS Redress Act. It is telling that the previous Government chose not to bring that Act into force in the end. The recommendation in the report that there should be a fundamental review of the NHS complaints system is one that we will consider very carefully. We agree that there are still challenges to improving NHS complaints handling, including improving the culture around complaints. Those challenges have been well documented. Our work to improve complaints handling across the board was set out in our update on progress in response to the Francis inquiries in February. Complaints and how they are handled is now one of the key strands of inquiry in all inspections of the CQC.
On my noble friend’s point in relation to recommendation 27, the GMC, the NMC and the PSA have guidance in place on how to raise and act on concerns about patient safety. We will work with these bodies to determine whether this guidance needs strengthening in the light of this report. The GMC has been undertaking its own review of how it deals with doctors who raise concerns in the public interest.
On my noble friend’s final point about the disjointedness of the CQC and the Parliamentary and Health Service Ombudsman, a new MOU was signed in September 2013 which outlined how the two organisations would collaborate, co-operate and share information relating to their respective roles. It is without question that the lack of co-ordination between the CQC and the PHSO was a contributory factor to the ongoing inability of the wider system to identify and act on failings at the trust.
Baroness Emerton (CB)
I thank the Minister for repeating the Statement. I want to pick up two points. The report by the King’s Fund relating to the supervision of midwifery said that there was a risk in changing the situation because there might be no one ready to take on the job. That is a very telling phrase in what is a very long and sad report about what has been going on. We need to be very clear. I hope that the noble Earl will be able to reassure us that the supervision of midwives, which has a long history, from 1902 to now, but in very changed circumstances, will be sustained in a way that is going to be to the benefit of mothers for the safe delivery of babies. A report like this always sends shock waves through the profession and is very sad for the families involved. We need to be clear that the action being proposed in the Statement is taken forward quickly. I notice that the supervision is supposed to be concluded by the end of July. That is a very short time to sort out a very complex system.
The second point I want to pick up is the one made by the noble Lord, Lord Hunt, about a chief midwifery officer. The Minister said that he would look at that. It is not something that has been thought of very carefully. We have a Chief Nursing Officer and a director of public health and so it would be sensible to give this serious consideration, especially in light of the present situation. I ask the Minister to take that away and consider it.
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 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.
Baroness Masham of Ilton (CB)
My Lords, what will happen if the 18 recommendations are not put into practice? Will they apply to all hospitals across the country? The maternity service at the Friarage Hospital, Northallerton, which is my local hospital, has recently been downgraded to midwives only, to the anxiety of the local people who live in a very rural area. I hope that the noble Earl can give some assurances on safety as there are so many worried people and there will be more after this report.
Earl Howe
My Lords, as regards Northallerton, our approach as Ministers and in the department is that service reconfiguration has to be a matter for local decision-making. We do not, as a rule, interfere with those decisions unless there is a referral from an overview and scrutiny committee in the statutory manner. I hope the noble Baroness will therefore understand that I am rather precluded from commenting on that local situation. Nevertheless, on her first point, we have asked the trust to implement the recommendations that have been assigned to it in the report. We have asked Monitor to ensure that this happens within the designated timescales to give maximum reassurance to the patients and families who are using the hospital that time is not being wasted. At a local level, the trust is in special measures. It has put in place a largely new management team, which is working towards delivering against its agreed improvement plan. Progress against that plan is being closely monitored by the quality surveillance group, thereby ensuring that the trust, CCGs, regulators and others are working together in the best interests of the local population.
Health: Rare Diseases
Earl Howe Excerpts(9 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I congratulate the noble Lord, Lord Turnberg, on securing the debate and raising this issue. I am acutely aware that access to treatments for patients with a rare disease is of great importance to him and many others. We have had some excellent contributions from noble Lords this evening.
The Government are committed to improving the life of all those affected by rare disease. The UK is a recognised leader in research, treatment and care for rare diseases. We are at the forefront of the genomics revolution, which has the potential to radically transform the way that we diagnose and treat people with rare conditions. The UK strategy for rare diseases, which my noble friend Lady Bottomley kindly mentioned, is a high-level framework that sets out our strategic vision. I am sure she will know that raising awareness of rare diseases is a key aim of the strategy. To that end, the department has worked with Health Education England to produce two videos: one aimed at parents and patients, the other aimed at healthcare professionals, particularly GPs. These were launched last week at the Rare Disease Day event, which the noble Lord, Lord Walton, referred to.
I was interested to hear about lymphangioleiomyomatosis, or LAM. Access to treatment for that condition, as for others, is based strictly on clinical need, as set out in NHS England’s published clinical policies, irrespective of tariff arrangements. The key in so many cases such as this is what is often referred to as the diagnostic odyssey—the delay that patients experience before getting a diagnosis.
I listened with huge interest to the noble Lord, Lord Rogan, talking about ITP. The UK Strategy for Rare Diseases sets out our strategic vision for improving the lives of all those affected by rare diseases, including ITP, the autoimmune disease. He will be impressed to know that my officials furnished me with an extensive note on ITP as he was speaking.
NHS England has been charged with taking forward many of the strategy’s commitments and in the Five Year Forward View it sets out a contextual backdrop for the strategic work during the next few years. Due to their rarity and their low patient populations, services for rare conditions in England are directly commissioned nationally by NHS England as specialised services. I am sure that the noble Lord, Lord Patel, will agree that commissioning these services nationally means that NHS England can commission each service to a single national standard with single national access criteria. It ensures that patients have the same access to specialised services regardless of where they live in England. NHS England has made significant progress in developing a set of nationally consistent service specifications and commissioning policies which ensure equity of access to high-quality services across the country.
Since April 2013, the National Institute for Health and Care Excellence, or NICE, has been responsible for the evaluation of selected high-cost, low-volume drugs under its highly specialised technologies programme, as has been mentioned. This plays an important role in ensuring that commissioning decisions are based on a robust and thorough assessment of the available evidence. NHS commissioners are legally required to fund treatments recommended by NICE in its highly specialised technologies guidance. Until NICE’s guidance is available, commissioners make their funding decisions based on the available evidence.
Topics are referred to that programme by Ministers, following a topic selection process that is overseen by NICE. At the core of the topic selection process is a set of prioritisation criteria that are used to determine whether a topic is suitable. These criteria are published on NICE’s website. The process for deciding which topics to refer to NICE is carried out with as much transparency as possible and includes consultation with stakeholders once a topic has passed the early stages of the process. However, it must be recognised that some degree of confidentiality is required, particularly early on in the process, as information on new drugs can be commercially sensitive before they are licensed. The noble Lord, Lord Turnberg, might be interested to know—as he was asking me about this—that NICE has recently taken steps to improve the level of transparency in the topic selection process, and has begun to publish more detailed information about the rationale for its topic selection decisions.
NHS England’s Clinical Priorities Advisory Group formulates recommendations on commissioning of new treatments for rare diseases in England. In order to ensure that the maximum number of patients benefit from innovative treatments coming on stream, hard choices need to be made about which of these to fund routinely. Patient groups asked NHS England to consult on changes to the principles and processes by which it makes these decisions. At its board meeting on 17 December, NHS England decided that a 90-day consultation would be carried out on the prioritisation framework and decision-making process that NHS England should use to make commissioning decisions on new treatments and interventions. The length of that consultation period reflects the importance of these decisions and the advice received from patient groups. The decisions on prioritisation will not be completed until the consultation has closed and the responses have had due consideration. The consultation was launched on 27 January, and it is open for responses until 27 April.
In carrying out its public consultation, NHS England will ensure that the principles and processes for making these decisions are well informed, evidence-led and in line with the expectations of patients and the public. I am sure that the noble Lord, Lord Turnberg, will agree that it is important that NHS England has a robust decision-making process in place and that that process must be followed to ensure that NHS England is treating all patients with rare diseases fairly.
Lord Turnberg
I just wanted to check that the Minister is aware that there are no fewer than seven serial committees that it has to go through. That does not seem very efficient.
Earl Howe
I note that point, my Lords, and I will reflect carefully on it. If NHS England has a comment to make, I shall be glad to write to the noble Lord about that process.
Clearly, once the prioritisation consultation finishes, and in the light of NICE assessments, NHS England will take stock of its position in relation to new treatments.
Our priority must always be to ensure that patients with rare conditions have access to new and effective treatments on terms that represent value to the NHS and the taxpayer. I am sure noble Lords will agree that it is very important that NHS England has a robust decision-making process in place and that, as I have described, it makes sure that all patients with rare diseases are treated equitably.
I also recognise that it is vital that we speed up the discovery, design and take-up of new, innovative 21st-century medicines and treatments in the NHS. We will continue to work with industry and our European partners to increase access to these innovative medicines for patients with rare conditions. In April last year, we launched the early access to medicines scheme, which aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, or licence, when there is a clear, unmet medical need. More generally, our Strategy for UK Life Sciences sets out an ambitious, long-term programme of action to improve the wider environment for health life-sciences companies and overcome the barriers that prevent discoveries being translated into commercial opportunities and new treatments with real benefits for patients.
The noble Lord, Lord Rogan, stressed the importance of research. Undertaking research into rare diseases requires effective partnerships between patients, their families, clinicians, researchers and industry. Of course, health research holds the promise for breakthroughs and improvements in the way that we diagnose and treat people with rare diseases. For example, the NIHR’s world-class Rare Diseases Translational Research Collaboration, launched in parallel with the UK rare diseases strategy, is just about to start 14 new projects. We also want to make it faster to start rare disease research in the NHS. That is why we asked the Health Research Authority to bring in a new single approvals process. This will speed up access for patients to new and effective treatments.
I will cover as many questions as I can in the time available. My noble friend Lady Thomas referred, very powerfully, to the value of hydrotherapy and the importance of appropriate equipment being commissioned by CCGs. As she will know, CCGs are autonomous statutory bodies. Decisions are made locally but I am happy to look into the matters she raised and will write to her on what I fully agree is a very important issue.
The noble Lord, Lord Patel, asked about the successor arrangements to AGNSS. Responsibility for evaluating the use of new and existing highly specialised medicines and treatments within the NHS in England transferred from the Advisory Group for National Specialised Services—AGNSS—to the National Institute for Health and Care Excellence in April 2013. So far, that is working satisfactorily. However, there is the other group—the Rare Diseases Advisory Group—which was referred to by the noble Lord, Lord Walton. Where does that fit it? In terms of rare diseases and highly specialised services, the RDAG makes recommendations to NHS England and the devolved Administrations on issues related to highly specialised services. Its further role is to have an overview across the four countries on the development and implementation of the UK strategy for rare diseases and highly specialised services. It makes recommendations to the Clinical Priorities Advisory Group about how highly specialised services should be commissioned.
The noble Lord mentioned the cancer drugs fund, which has helped more than 60,000 people with cancer to get life-extending drugs that would not otherwise have been available to them. NHS England is now responsible for the operational management of the fund. It is currently working to ensure the very latest, most clinically effective drugs can be made available to patients. We will carefully consider with NHS England what arrangements should be put in place for the fund in the longer term.
The noble Lord, Lord Turnberg, questioned the inconsistency in funding arrangements for different conditions. He mentioned tuberous sclerosis and kidney tumours. Over the next few weeks, the six programmes of care responsible for advising NHS England on specialised services will draw up the work programme for 2015-16, which will include developing a number of policies. Two policies—one for the provision of everolimus for tuberous sclerosis complex-related renal angiomyolipoma and the other for subependymal giant cell astrocytoma or SEGA—will be considered for inclusion in this process.
The noble Lord asked about commissioning through evaluation. That programme was established by NHS England in 2013 as an innovative mechanism to capture further evaluative data and I will write to him further about progress on that front. As regards negotiation on patient access schemes, companies that are members of the pharmaceutical price regulation scheme have the opportunity to propose a patient access scheme to improve the cost effectiveness of their drug, as part of a NICE appraisal. Departmental officials stand ready to meet with any company that wishes to discuss its options.
Time has run out. I conclude by saying that I am committed—indeed, the Government are committed—to ensuring that patients with rare conditions get the same quality, safety and efficacy in medicines and other treatments as those who have more common conditions.
Jimmy Savile: NHS Investigations
Earl Howe Excerpts(9 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, with the leave of the House, I shall now repeat a Statement made earlier today by my right honourable friend the Secretary of State for Health in another place on the investigations into the activities of Jimmy Savile in the NHS. The Statement is as follows.
“With your permission, Mr Speaker, I would like to make a Statement on the NHS Jimmy Savile investigations.
This morning, a further 16 investigations into the activities of Savile in the NHS were published. These include the main report from Stoke Mandeville Hospital and reports from 15 other hospitals. One report relates to Johnny Savile, the older brother of Jimmy Savile. These reports have now been placed in the Library. While no system can ever be totally secure from a manipulative and deceitful predator such as Savile, we learned last year that there were clear failings in the security, culture and processes of many NHS organisations, allowing terrible abuse to continue unchecked over many years.
Some victims are, sadly, no longer with us and others continue to suffer greatly as a result of what happened. On behalf of the Government I apologised to them last June and today I repeat that apology: what happened was horrific, caused immeasurable and often permanent damage and betrayed vulnerable people who trusted us to keep them safe. We let them down. As one of the Stoke Mandeville victims said,
‘there are so many messed up lives—although people have built up lives, you have children, you make a life, it ruins everything, your relationships with another human being—the things you are supposed to have’.
Today we must show by our deeds as well as by our words that we have learned the necessary lessons.
The new reports, like those released last year, make extremely distressing reading. In total, 177 men and women have now come forward with allegations of abuse by Jimmy Savile, covering a period from 1954 to just before his death in 2011. At least 72 people who gave evidence were children at the time of the abuse, with the youngest being only five years old. The allegations included rape, assault, indecent assault and inappropriate comments or advances. Allegations were made not in one or two places but in more than 41 acute hospitals—that is almost a quarter of all NHS acute hospitals—as well as five mental health trusts and two children’s hospitals. Further investigations have happened at a children’s convalescent home, an ambulance service and a hospice. There are three new investigations under way at Humber NHS Foundation Trust, Mersey Care NHS Trust and Guy’s and St Thomas’ NHS Foundation Trust. Any further allegations will, of course, be investigated as serious incidents.
In addition, the Department for Education has today published 14 reports on investigations in children’s homes and education settings, and the review by Dame Janet Smith into Savile’s activities at the BBC is ongoing. These investigations have been deeply harrowing for victims but also for the investigators. I would like to put on record my thanks to everyone involved, particularly Kate Lampard and the NHS Savile legacy unit, which provided robust oversight and assurance in an incredibly difficult job.
I now turn to Stoke Mandeville, the hospital with which Savile was most closely associated. The report published today reveals shocking abuse of 60 victims that took place over more than 20 years between 1968 and 1992. From the brave victims who have come forward we know that Savile’s activities there included groping, molestation and rape of patients, staff and visitors. Victims were predominantly but not exclusively female, 20 were vulnerable patients disabled with severe spinal injuries, and one was a child as young as eight. Savile deliberately exploited these people because he understood that their reliance on specialist care they might be able to receive only at Stoke Mandeville made it even harder for them to speak up. This was calculating behaviour of the most abhorrent kind. Victims included 26 visitors and six staff. Six victims reported being raped, one as young as 11 or 12. Most victims were too frightened to come forward, but there were nine informal complaints and one made formally. None was taken seriously.
There is no suggestion that Ministers or officials knew about these activities, but accepted governance processes were not followed in the decision to allow Savile to acquire and maintain a position of authority at the hospital. In particular, Ministers made the expedient decision to use Savile not just to raise funds to redevelop Stoke Mandeville’s National Spinal Injuries Centre, but to oversee the building and running of the centre even though he had no relevant experience. Because of his celebrity and useful fundraising skills the right questions—the hard questions—simply were not asked, suspicions were not acted on and patients and staff were ignored. People were either too dazzled or too intimidated by the nation’s favourite celebrity to confront the evil predator we now know he was. Never again must the power of money or celebrity blind us to repeated, clear signals that some extremely vulnerable people were being abused.
I spoke last June about how changes to processes, policies and laws over the last 30 years have made it much less likely that a predator like Savile would be able to perpetrate these crimes today. Charity legislation is much tougher, setting out specific requirements for the auditing and examination of NHS charities’ accounts, and the safeguarding system now in place is significantly improved. The Children Act 1989, the first child sex offender register, Criminal Records Bureau checks and the Disclosure and Barring Service have all provided further protection. From 1 April, for the first time, the Care Act 2014 puts adult safeguarding on a legal footing and safeguarding adults boards will ensure that local safeguarding arrangements act to help and protect adults. We have also enshrined the right to speak up in staff contracts. We are amending the NHS constitution and have changed the law to make employers responsible if whistleblowers are harassed or bullied by fellow employees. We are also consulting on how best to implement the recommendations in Sir Robert Francis’s whistleblowing review.
However, proper policies and processes will not succeed if they do not go hand in hand with a change in culture, whereby patients and staff alike feel able to speak out with any concerns and can be confident that they will be listened to. It is particularly important that children and those with physical and mental illnesses are listened to, because they are the most vulnerable. While we are proud to live in a society in which people are innocent until proven guilty, we have a collective responsibility to investigate all serious allegations properly in a way that simply did not happen, time after time.
In the light of these disturbing reports, I also asked Kate Lampard to outline key themes across all the NHS investigations and to consider any further action that needs to be taken. She considered the extent to which Savile was a product of the culture of his time and concludes that, while he was a one-off, there are important improvements that need to be made to protect patients today. It is a thoughtful and comprehensive report, and I am today accepting in principle 13 recommendations she makes, including on access, volunteering, safeguarding, complaints and governance.
Trusts should develop policies on visits by celebrities and internet and social media access in hospitals. They should review voluntary service arrangements, safeguarding resources and the consistency of employment practices, ensuring clear executive responsibility. They should consider whether policies on the impact of volunteers on a trust’s reputation are adequate. The department, with its arm’s-length bodies, will examine: the possible development of a forum for NHS voluntary service managers; raising awareness of safeguarding referrals among NHS trust staff and volunteers; and to what extent NHS trust staff and volunteers should undergo refresher training in safeguarding.
I know some trusts which produced reports last summer have started to make improvements. One trust has already encouraged staff to raise concerns, updated the trust’s whistleblowing and complaints policy and published policy on the recruiting and management of volunteers. It is this kind of sensible, swift action that I want to see across the NHS. I have therefore asked the chief executives of Monitor and the TDA to ensure that all trusts review their current practice in three months against these recommendations and to write back to me with a summary of plans and progress at each one. These plans will be fed into the Government’s ongoing work to tackle child sexual exploitation.
One welcome practice that Kate Lampard’s report highlights is the growth in volunteering to support the work of the NHS. Overall, across the NHS we estimate that there are 78,000 volunteers, including 1,500 at just one trust, King’s in London. They do a magnificent job in improving patient care every single day throughout the NHS. We welcome this civic revolution and today need to make sure that any safeguards put in place support its further growth by helping to protect the reputation of volunteering as well as the safety of patients. Hard cases make bad law, and it would be the ultimate tragedy if Savile’s legacy was to hold back the work of the NHS’s true heroes, who give so much to their local hospital by volunteering their time. So while I agree that all volunteers working in regulated activity, typically having close or unsupervised contact with patients, should have an enhanced DBS check, I am not today accepting the recommendation that this should apply to all volunteers. As Kate Lampard acknowledges in her report, such a system may not in itself have stopped Savile. Rather, trusts should take a considered approach to checks on all volunteers, particularly using the enhanced DBS service if there is a possibility they will be asked at a future date to work closely with patients. They should also ensure that proper safeguarding procedures are in place locally as well as the DBS process, because it would be wrong to rely on the national database as a substitute for local common sense and vigilance.
The report also recommends that DBS checks are redone every three years. I believe the report is correct to say that trusts must make sure that their information on volunteers is up to date, but they can achieve this through asking volunteers to make use of the DBS update service, which enables trusts to check DBS information regularly and avoids volunteers having to go through the DBS process multiple times. We will be advising all trusts to do this.
Finally, I intend to take action in one area of great concern that the report highlights—namely, the responsibility and accountability of staff working with vulnerable people to take appropriate action when alerted to potential abuse. As the report recognises, the Government have substantially strengthened safeguarding arrangements since these dreadful events, but it is clear from these reports that there should have been a much stronger incentive on staff and managers to pass the information on so that a proper investigation happened. This is clearly unacceptable, and the Government have already said that we will consult on introducing a new requirement for mandatory reporting of abuse of children and vulnerable adults. The outcome of such a consultation must take full account of the need to avoid unintended consequences.
Let me conclude with a tribute to the victims who have had the courage to come forward. Without them, these investigations would not have been possible. It is our society’s shame that you were ignored for so long, but it is a tribute to your bravery that today we can take actions to prevent others going through the misery you have endured. As a result, our NHS will be made safer for thousands of children and vulnerable adults as we learn the uncomfortable lessons from this terrible tragedy. I commend this Statement to the House”.
That concludes the Statement, but since it was delivered in the other place, I have been advised that two passages require clarification. In repeating the Statement I said in relation to the victims at Stoke Mandeville that:
“20 were vulnerable patients disabled with severe spinal injuries”.
That should have read: “20 were vulnerable patients, some of whom were disabled with severe spinal injuries”. In addition, I said at the start that the reports that I mentioned had been placed in the Library. In fact, copies of the Stoke Mandeville and lessons-learnt reports have been placed in the Library. The remainder of the reports are available on the GOV.UK website.
Earl Howe
My Lords, I am very grateful to the noble Baroness for her comments and for the constructive way in which she has approached these distressing matters. She referred to the issue of accountability and, of course, that is one of the first issues that springs to mind when hearing about these dreadful events. The noble Baroness said that there were people who knew and failed to act. The tragedy was that there were so many victims who knew exactly what had happened but whose cries were left unheard. As she said, picking up on the Statement, there were nine informal complaints and one formal complaint, none of which was followed through. I understand that the investigators have not been able to trace the members of staff involved in those complaints, so that with the passage of time it is difficult to establish exactly what was said and when. However, the facts speak for themselves.
The noble Baroness also asked about the value left in the Jimmy Savile estate. My advice is that last March the Jimmy Savile Charitable Trust had a capital balance of just short of £3.5 million. I understand that that balance may be a little less now, but that trust is being used to compensate the victims. If and when the money runs out, the Department of Health will step in. Although the compensation scheme has now officially closed, it is open to anyone else who has not yet come forward to make a claim, and they can also do so to the NHS Litigation Authority. Public funding is there to underpin the money from the Savile trust.
The noble Baroness also asked about the possibility of a further inquiry. Kate Lampard’s lessons-learnt report will feed into the findings of the national group on sexual violence as well as the work of the Independent Panel Inquiry into Child Sexual Abuse. This inquiry, chaired by Justice Lowell Goddard, will consider whether public bodies and other non-state institutions have taken seriously their duty of care to protect children from sexual abuse.
Regarding support and counselling for victims, which the noble Baroness also mentioned, people who have experienced abuse and need advice or support can contact the free confidential support line from the National Association for People Abused in Childhood. They can also contact the National Society for the Prevention of Cruelty to Children’s free confidential support line. During the investigations, each part of the investigation was responsible for ensuring that victims and vulnerable witnesses had access to appropriate support as required. Kate Lampard and the Savile Legacy Unit assured that these processes were put in place. Sir Bruce Keogh, the medical director of NHS England, wrote to all CCGs in May 2013 to ensure that all GPs within each area were alerted to the possibility of victims and witnesses presenting for help and support. He also asked that arrangements should be put in place with mental health services in each area so that the victims and witnesses could have their support needs, of whatever degree, met in a timely and appropriate fashion.
As regards compensation, slightly more than £58,000 has been paid out so far by the NHS Litigation Authority on behalf of the Secretary of State, of which a third is damages. As I have said, the NHSLA will meet the balance of valid NHS claims on behalf of the Secretary of State.
The noble Baroness asked about the proposal for mandatory reporting of suspected abuse. We have said that we will consult on this issue, which is essentially one of whether people feel that there is a need for legislation. It will be a full 12-week public consultation on the advisability, the risk, the nature and the scope of any reporting duty, including questions on which forms of abuse it should apply to and to whom it should attach. Inevitably, the process of consultation on this issue is complex. It requires careful handling and we believe that it should not be rushed. It will be critical that we consult as widely as possible. The available evidence is inconclusive as to whether mandatory reporting regimes help or hinder or make no difference to child safeguarding outcomes. The Government have no preconceived view on this. However, we are clear that we should consult on the matter as soon as possible.
Reverting to the point made by the noble Baroness at the start of her remarks, the report concludes that it was reasonable for Ministers to pledge government support for the rebuilding of the National Spinal Injuries Centre. However, the processes did not work as they should. It is the job of civil servants to provide full and impartial advice, and it would appear from the surviving documentation that DHSS officials may not have presented the full spectrum of issues concerning the NSIC to Ministers at the outset of the project. That served to minimise the complexity of the situation. It did not specify any potential consequences. It set the scene for the project to be agreed with minimal strategic planning in place that took into account what we would expect to see today, which is both long-term service forecasts and revenue costs. That had the effect of placing a dependence on Jimmy Savile as a continuing fundraiser from that moment on.
I simply say again that the investigation concludes that there was no evidence that either Ministers or officials knew about Savile’s predatory behaviour. Clearly, a number of people within the NHS had strong suspicions about it, but the celebratory status of Savile and the fact that everyone knew that Stoke Mandeville in particular depended on his fundraising skills clearly acted as a brake on people’s ability to speak up when they should have done so.
Baroness Barker (LD)
My Lords, there is one fact about this excellent report on a very difficult subject which is so obvious that it is in danger of being overlooked. We are talking here about events within the NHS and specifically about events within NHS organisations which had among their staff people who, due to their professional expertise, should have been able to spot the signs of abuse, as they are experts to whom people turn for treatment when they have been abused. I am not talking about the BBC; I am talking about the NHS. Repeatedly they did not see it or did not speak about it. That makes me draw an uncomfortable conclusion which goes to the heart of a couple of the recommendations—that is, that it is possible, even in the best of organisations which exist for the best of reasons, for there to be a culture so powerful that people can ignore things which are bad almost to the point of disbelief.
Therefore, when the Government consider their response to all this, I ask them to look at recommendations R5 and R8 in the lessons-learnt section. Those recommendations talk about trusts having a review process of their own procedures. They also make reference to the local authority designated officer and the role that he or she might play. I put it to the Minister that, in order to break a culture of silence, it must be possible to bring in a reference to an external expert. If victims and staff had access to such a person as a backstop, it would be a very important means of ensuring that we never saw organisations operating in this way again.
Earl Howe
My noble friend makes a series of extremely powerful and pertinent points and I am in agreement with the thrust of them. She is absolutely right that this is a matter of the culture of an organisation. While I think we can say hand on heart that the culture in the NHS has in many respects changed for the better in recent years, we must never be complacent about this. This matter was particularly identified by Sir Robert Francis in his recent report on whistleblowing, and we have accepted his recommendations. For example, we will ask every NHS organisation to identify one member of staff to whom other members of staff can speak if they have particular concerns and are not being listened to. We will also consult on establishing a new independent national whistleblowing guardian as a full-time post within the CQC to fulfil the kind of independent role that my noble friend refers to. In that context we are legislating to protect from discrimination whistleblowers who apply for NHS jobs. Therefore, I think that there are things that we can do with the mechanisms to ensure that the NHS is a more benign place for people who would otherwise feel too frightened to speak up.
Nevertheless, the further consultation on mandatory reporting which I have undertaken we will carry out will, I am sure, bring all this into the frame again. I have no doubt—at least, I hope—that my noble friend will feed into that consultation in the way that she has just indicated.
Baroness Masham of Ilton (CB)
My Lords, I declare an interest as I have been a patient at the Stoke Mandeville spinal unit since 1958, when I broke my back. I knew Jimmy Savile to some extent over the years. He was very autocratic and very clever, but I never saw his dark side. Many of the people working at Stoke Mandeville did not see that side of him because he was so clever.
There is a problem with hospitals. They do not like bad publicity and there can be cover-ups. We need openness and honesty. I should like to ask the Minister about the present procedure for patients, who need an easy and quick way of raising their concerns. That is very important because many patients are at risk of having bad things done to them. Sometimes those bad things may be done by people on the ward, so patients need to bypass the ward but they cannot just be told that they have to go to the health ombudsman. That takes too long. Therefore, I hope that the procedure for patients will be given great consideration in the future.
Earl Howe
The noble Baroness has our admiration for the way in which she has coped with her spinal injury over these many years. She is, of course, absolutely right about the way in which Jimmy Savile duped so many people. He was a forceful character as well as somebody with a superficial charm, and he got away with what he did. She is, of course, correct that the protection of patients lies at the centre of all this and we must ensure that we have proper systems in place to make them feel confident that they can come forward.
I take the noble Baroness’s point about patients perhaps not feeling able to complain to the ward staff. The answer to her question is that the patient, or someone on their behalf, can complain to the chairman of the organisation or trust or to a member of the board, and thus bypass the clinical staff. There should always be a member of the board at the hospital whose responsibility is the protection of patients above all. In the end, it is for that organisation to investigate its own supposed failings. If somebody is not satisfied with the result of that investigation, it is then open to them to go to the ombudsman. We believe that complaints should be investigated at a local level, either with the provider of the service or, if that is not thought appropriate for any reason, with the commissioner of the service.
Baroness Manzoor (LD)
My Lords, in relation to the protection of patients, I ask the Minister whether it would it be possible, each time a patient is seen by anyone—whether it is an external visitor or, indeed, a doctor—to ensure that there is another person present, such as a nurse. Just recently, a colleague went for a breast examination. She was seen by only one person, a male doctor; no safeguarding was available there. As part of that consultation, I would welcome this assurance.
Earl Howe
I take my noble friend’s point. However, I would hesitate before committing to a situation where, in every instance that a doctor or nurse examined a patient, they had to have somebody with them. In the real world, I do not think that is going to be practical. What one should have, however, is an assurance that whoever examines the patient, or performs some intimate caring service with the patient, should have been checked for both a criminal record and a previous employment history. I will take my noble friend’s point away, but I think that what I have said would be accepted by those in the National Health Service as the only practical way forward.
Baroness Hollins (CB)
My Lords, senior hospital administrators were criticised in these reports, but senior civil servants were also responsible for facilitating Savile’s influence and access to Broadmoor and Stoke Mandeville hospitals. Have the civil servants been identified? How have they been held accountable? Have the survivors received an individual apology for the governance failures that allowed this catalogue of abuse to take place? I understand the Secretary of State’s general apology, but I think an individual apology would be appropriate for each and every survivor.
Earl Howe
My Lords, I agree with the noble Baroness’s last point. My understanding is that each survivor and each victim has had an apology, but I will look into the possibility of my right honourable friend adding to that.
As regards the civil servants involved, only one has been identified: Mr James Collier, who was, at the time, deputy secretary of the DHSS. Dr Gerard Vaughan, who was the Minister most closely involved with the building of Stoke Mandeville’s spinal injuries centre, assigned Mr Collier to ensure that the project went ahead. The inquiry found that Collier’s role was essentially to remove obstacles to the project. In effect, he was both an enabler and an instrument of the whole project. However, the report says:
“If criticism is to be levelled at James Collier it is because he did not just sweep aside bureaucracy to enable the project, he was instrumental … in sweeping aside some legitimate concerns raised by statutory bodies such as the Oxford Regional Health Authority”,
once he had been placed in charge of the project. So the duty of a senior civil servant to “speak truth unto power” was not, I am afraid, one that he fulfilled. Mr Collier is still alive, and I do not think that it would be proper for me to criticise him other than in the terms that the inquiry has done, but essentially the investigation concludes that,
“it would appear that Savile’s authority was given at the behest of politicians and then made possible by senior civil servants”.
Lord Brooke of Sutton Mandeville (Con)
My Lords, in congratulating my noble friend and his department on the fullness of the information contained in these reports—their very fullness makes one wonder how so much of the evidence passed people by—perhaps I may make one suggestion of presentation. When you read the two reports side by side, the grey-blue report about Stoke Mandeville contains far more upper-case letters as the initial letters of words. The pale mauve report of Kate Lampard is not addicted to that. The consequence is that it is much more difficult with the Stoke Mandeville report to recognise the comparative importance of the information given because it is always in headline elements.
Earl Howe
I understand the point made by my noble friend. At the same time, it is clear from the executive summary of Kate Lampard’s report that Stoke Mandeville is by far the most important and salient element of the report and I had hoped that that would have guided readers’ attention towards the section of the report that deals with Stoke Mandeville. Nevertheless, I am sorry that my noble friend has found it necessary to say that and I understand why he has.
Baroness Walmsley (LD)
My Lords, the Statement referred to inadequate systems and the need for a culture change. Does the Minister accept that many people are of the view that what we have is inadequate law and not only inadequate systems? I do not know whether my noble friend heard the “Today” programme this morning in which Mr John Humphrys, in interviewing a lawyer acting for one of the many Jimmy Savile victims, was astonished to discover that there is no offence of ignoring knowledge of child abuse that has been reported. Indeed, a majority of the British public think that it is already the law but the Minister knows that it is not.
I welcome the commitment to a public consultation that resulted from an amendment I tabled to the Serious Crime Bill, but several months have passed since that commitment was made by the Government and we still do not know which department will lead the consultation. Will it be the Home Office, the Department of Health or the Department for Education, or will it be a combination? I heard that in another place the Minister undertook that the consultation would be complete and the Government’s response given within 18 months of the Bill becoming an Act. Can the Minister confirm that that undertaking stands and say whether there has been any progress on which department will lead on this consultation?
Earl Howe
My Lords, I cannot give a specific undertaking on the timescale that we envisage for the consultation or on any legislation that might ensue from it because that raises the question of whether any legislation is necessary. That is what we want to know from the consultation process. However, I can tell my noble friend that the Home Office will be leading the consultation in conjunction with all the other relevant government departments.
Baroness McIntosh of Hudnall (Lab)
My Lords, the noble Earl repeated a phrase in the Statement referring to Jimmy Savile as a one-off. Although that is qualified in the sentence that follows, nevertheless the reference is made. Does he consider that describing these incidents as a one-off characteristic of an unusual individual is tremendously helpful? We know that he was not a one-off because a number of other people working in NHS settings engaged in similar behaviour and have already been convicted. Many other people who were not working in NHS settings but doing other kinds of job—for example, in the rock music business—were also engaging in this kind of behaviour. Perhaps we need to take more account of the fact that, hard as it is for us to recognise, there are circumstances in which people, given the opportunity, will engage in this kind of behaviour and will continue to do so. Thinking of them as, as it were, bad apples does not help us to grapple with that reality.
Earl Howe
My Lords, the noble Baroness is right. It is with that thought in mind that Kate Lampard did not simply pigeonhole Savile as a one-off but has come forward with recommendations, most of which we have accepted, as to the wider lessons we should learn from this sorry saga. We know that, while the scale of Savile’s activities was probably unprecedented, there are others who have been found guilty of similar offences.
Baroness Seccombe (Con)
My Lords, my noble friend the Minister referred in the Statement to the review by Dame Janet Smith into Savile’s activities at the BBC. This review is ongoing. Of course, it was the BBC which gave Jimmy Savile this extraordinary platform in the first place. Will my noble friend confirm that this ongoing review is entirely independent of the BBC’s management and the BBC Trust? Can he also indicate when the review will be completed?
Earl Howe
My Lords, I have only limited information about the BBC review. Dame Janet Smith’s review was established by the BBC, in October 2012, as an independent review of its culture and practices during the years that Jimmy Savile worked there. It will receive evidence from those who may have been the subject of inappropriate sexual contact by Jimmy Savile. As my noble friend knows, Dame Janet is a former Court of Appeal judge. The review has been in contact with approximately 740 people. It has had more than 350 telephone conversations with witnesses and almost 190 witness interviews have taken place. The completion of the review has faced delays due to criminal proceedings and new evidence. One instance was that of Stuart Hall, who pleaded guilty to 14 charges of indecent assault. Another was the Dave Lee Travis case, but I do not want to go into detail about that. I do not have information about when the review is likely to be concluded, but if I can find out I will write to my noble friend.
Health: Obesity
Earl Howe Excerpts(9 years, 8 months ago)
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Lord Brooke of Alverthorpe
To ask Her Majesty’s Government what assessment they have made of the Local Government Association’s report Tackling the causes and effects of obesity.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, we welcome the Local Government Association’s report, which provides a valuable contribution to this debate and demonstrates the contribution that local authorities can make and are making. This Government see local authorities as key to tackling obesity and other public health issues. Local communities know best how to tackle obesity, based on local understanding and need. To support this, we have given local authorities £8.2 billion of ring-fenced funding over three years for public health.
Lord Brooke of Alverthorpe (Lab)
My Lords, I am grateful for that reply, but as the Minister will recall from his reading of the report, LEAs say they are the people to do the job but they simply do not have the cash to do it. They have had a 40% cut in their grant aid over the past five years and they do not have the money available to carry out this work. Will he look again at whether, particularly with what is happening in Manchester, some freedom might be given for people at LEA level to raise additional funding themselves?
Earl Howe
My Lords, there is always scope to raise additional funding from charities and, indeed, from industry. Alongside the ring-fenced budget we have given to local authorities—it is the first time that this has been done for public health—we have a number of programmes in train which can work side by side with local authorities, such as the work going on in NHS England’s five-year forward view programme. Public Health England, in conjunction with the Local Government Association and ADASS, is commissioning work to support local authorities to take a whole-systems approach and look more widely in the way that the noble Lord has suggested. Public Health England’s Healthy Places programme is also relevant here, looking at how we can use the planning system to promote public health.
Lord Walton of Detchant (CB)
My Lords, in light of the alarming increase in type 2 diabetes, which is closely related to the incidence of obesity, what advice are the Government giving to the population at large about the dangers of overeating? When I was in clinical practice I used to advise my overweight patients to take a large dose of will power three times a day with meals.
Earl Howe
My Lords, the noble Lord very eloquently makes an important point. There is no simple answer to the problem of obesity: it is multifactorial. However, in recognising that we need to communicate our messages to health experts and, indeed, members of the public—which is his central point—my department and Public Health England are leading work with a group of experts to consider how to make the Chief Medical Officer’s guidelines easier to communicate to health professionals and the public. That work is progressing well, but we do need to progress it.
Lord Lawson of Blaby (Con)
My Lords, I agree with the noble Lord, Lord Walton, and I speak from personal experience. The problem of obesity is simply a matter of eating less and drinking less and that is 100% a matter of will power. It is not a matter of giving more money to local authorities, much as I understand their desire to have it.
Lord Winston (Lab)
My Lords, have the Government taken into account the issue of epigenetics in their advice on obesity? For example, is the Minister aware of the research by Gregory Dunn of the University of Pennsylvania which has shown that a great-grandmother can pass on imprinted genes which affect her great-grandchildren, but only the females and not the males? That argues environmental influences that we do not yet understand. Is that being factored in with the advice that the Department of Health is giving? It will be an increasingly important issue. This is not only a question of overeating; it is a very complicated problem.
Earl Howe
Yes, my Lords, that is being factored in, but I do not think that we should confuse that point with a certain sort of fatalistic approach to obesity. There are things that people can do with their lifestyle to influence their own states of health in all sorts of areas and we have to help people understand what those things are.
Lord McColl of Dulwich (Con)
Does the Minister agree that this report is a model of its kind? It is brief and free of waffle and it emphasises the important point that obese people do not need to increase their activity one iota in order to lose weight; all they have to do is to eat less.
Lord Faulkner of Worcester (Lab)
My Lords, has the Minister had the chance to study this morning the reports of the research from the health campaign group Action on Sugar, which demonstrates that enormous quantities of sugar are found in so-called sports and energy drinks and that these are targeted at children in particular? One particular drink produced by a well known high street grocery—
Lord Faulkner of Worcester
Yes, Sainsbury’s. It contains up to 20 teaspoons of sugar in every can—far, far over the recommended limit.
Earl Howe
Yes, my Lords, I was aware of that report. We certainly know that some energy drinks are very high in sugar. That is partly the reason why we have been so keen on making labelling work better. Public Health England is currently considering the evidence in relation to potential actions to reduce sugar intake generally. That includes a review of the evidence on fiscal measures; looking at marketing and promotions; and looking at incentives that have already been implemented internationally and at how effective they are. This is an important area.
Mental Health Services
Earl Howe Excerpts(9 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I thank the noble Earl, Lord Listowel, for securing this important debate and for speaking to his Question so powerfully and with such authority.
Improving the mental health of children and young people is a key priority for the Government. It is part of our commitments to achieving parity of esteem between mental and physical health and to improving the lives of children and young people. Since 2010, we have raised the profile of mental health to unprecedented levels. We have produced the mental health and suicide prevention strategies and worked, through Time to Change, to reduce the stigma attached to mental health issues.
Although there has been much progress, the Government have been open about the scale of the challenge and acknowledge that there is still much to do. This includes action to improve outcomes for looked- after children and care leavers. Around 68,000 children are looked after by a local authority. For nearly two-thirds of these, the primary reason for being looked after is abuse or neglect. Although looked-after children have many of the same health risks and problems as their peers, they tend to have poorer outcomes. Almost half have a diagnosable mental health disorder and two-thirds have special educational needs. I can reassure my noble friend Lady Tyler, in particular, that it is the responsibility of the local authority, as corporate parent, to assess each looked-after child’s needs and draw up a care plan that sets out the services which will be provided to meet those needs. It must make arrangements to ensure that the child has his or her health needs fully assessed, and a health plan developed and reviewed.
At the end of last year, we consulted on revised statutory guidance on promoting the health and well-being of looked-after children. In that guidance, which will be published in its final form shortly, we emphasise the need for parity of esteem between mental and physical health. My noble friend Lady Stedman-Scott spoke about the social isolation felt by those leaving care. The guidance stresses the importance of ensuring continuing support for those leaving care, and that suitable transition arrangements are in place so that the young person’s health needs continue to be met.
That leads me to the concern expressed by the noble Earl about the problems that can arise during transition from children’s to adults’ services, a point touched on by the noble Lord, Lord Bradley. Indeed, ending the unacceptable cliff edge that some young people—not just those in or leaving care—face of support being lost as they reach the age of 18 is a key priority for action. I am delighted that NHS England has now published new service specifications for child and adolescent mental health that give guidance to local commissioners on how to improve transition practice. The Children and Young People’s Mental Health and Wellbeing Taskforce, to which I shall return in a moment, is also considering how to deliver more seamless transition built around the needs of young people. Our statutory guidance on promoting the health and well-being of looked-after children stresses the importance of ensuring continuing support for those leaving care and that suitable transition arrangements are in place, so that the young person’s health needs continue to be met.
The noble Earl asked how specialist mental health services for looked-after children, including psychotherapy, can be protected and, indeed, expanded. Rather than mandating mental health services targeted at specific groups such as care leavers, our aim is to ensure that everyone has timely access to evidence-based services when they need them. That is why—as mentioned by the right reverend Prelate—we have invested £54 million over the last five years in the Children and Young People’s Improving Access to Psychological Therapies Programme. This has transformed children’s mental health services throughout the country through the use of evidence-based therapies alongside session-by-session outcome monitoring, so that both therapist and patient know how well therapy is working toward a goal. We are strengthening the statutory guidance to make it clear that service commissioners must make sure that services provide targeted and dedicated mental health support to looked-after children, according to need. How they do that is for local determination, but it could include a dedicated team or seconding a CAMHS professional into a looked-after children multi-agency team.
The Government are clear that lack of investment in children and young people’s mental health services is not acceptable. Last November, we provided £7 million of additional funding to NHS England, allowing more in-patient tier 4 CAMHS beds to open. So far 53 new beds have been commissioned, taking the total to over 1,400 beds, more than ever before. We are well aware that there is variation across the country in investment in services provided by local authorities, schools and clinical commissioning groups. The noble Baroness, Lady Uddin, and other noble Lords have mentioned funding. We have legislated for mental health to get its fair share of local funding and this year’s NHS planning guidance is clear that spending on mental health services must increase. It is not enough simply to provide more and more beds. In order to ensure that improvements are sustainable, we need to focus on preventing issues arising, or taking action before hospital treatment is required. The task force is considering how best we strike this balance.
In addition, I can tell my noble friend Lord Addington that we have produced MindEd, which is an online platform designed to give those who work with children and young people every day the skills and knowledge to recognise the earliest signs of mental health problems. Health Education England is working with the Royal College of General Practitioners and others to improve training on CAMHS and the task force is also looking at the capacity and capability of the workforce. The Department of Health is commissioning a new prevalence survey of child and adolescent mental health, giving us something that we have needed for years: an accurate picture of mental ill health in youth.
I shall now try to cover as many points as I can that have been raised in the debate. I will of course write to noble Lords whose questions I have not been able to address in the time available. The noble Earl spoke very eloquently about the need for proper supervision of staff. All staff working in a children’s home should receive supervision of their practice from an appropriately qualified and experienced professional. In the majority of homes the supervisor will have experience or qualifications in the mental health field. The national minimum standards for fostering services expect them to ensure that foster carers receive the support and supervision they need. Programmes such as Multidimensional Treatment Foster Care can provide support, both to the child and to its foster carers. We expect to lay before Parliament next week new quality standards regulations for children’s homes in England, to come into force on 1 April. The regulations will require all staff in a home to receive practice-related supervision by a person with appropriate experience.
The noble Earl also referred to the qualifications of managers and staff. The Department for Education introduced new mandatory qualifications for children’s home managers and staff from this January. These include requirements to be able to support the well-being and resilience of children and young people.
The noble Baroness, Lady Warwick, referred to the reported drop in investment in CAMHS. As she knows, we have taken difficult economic decisions to protect the NHS budget and there have been no central government funding cuts to children and young people’s mental health services. We have been clear that a lack of investment in mental health services for children and young people is not acceptable, as I have said, and the child and adolescent mental health task force was commissioned to identify how to improve the quality of and access to children and young people’s mental health services.
My noble friend Lady Tyler asked what practical steps the Government are taking to ensure access to school counselling. The Department for Education is producing new guidance on good school counselling. We anticipate that this will be published in March. She also asked what we are doing to promote PSHE in schools. The Department for Education has funded the PSHE Association to produce new guidance for schools on teaching about mental health.
The right reverend Prelate the Bishop of St Albans spoke very powerfully about young people who self-harm and who commit suicide. Indeed, in January this year we issued a call to every part of the NHS to commit to a zero suicide ambition. In addition, the Government announced £150 million over the next five years to improve services for eating disorders and self-harm. He will know, I am sure, that preventing suicide in children and young people is a central part of the cross-government suicide prevention strategy published in 2012. That is backed by £1.5 billion of funding for research on suicide and self-harm.
As regards Mind’s call for talking therapies to be available within 28 days, the five-year plan for mental health sets out the ambition to have new waiting time standards across all mental health services by 2020. The Department of Health and NHS England are working to do this, and I think that introducing those waiting time standards is a landmark for mental health services that we have not seen hitherto.
The noble Baroness, Lady Uddin, spoke about the need for CAMHS for autistic children in particular. The new statutory framework for children and young people with special educational needs and disability is designed to greatly improve integrated working across health, education and social care, to deliver improved outcomes for the child and their family. CCGs and local authorities have joint arrangements for assessing, planning and commissioning services for children and young people with special educational needs.
The noble Lord, Lord Ramsbotham, asked how best we should address the lack of co-ordination across CAMHS. On 11 December last year, eight pilot projects were announced that will look to accelerate new collaborative commissioning approaches for children and young people’s mental health. These new pilots will be in various parts of the country—I will not read them out—and have each been awarded up to £75,000 to develop their plans. They have until April to get their new approaches up and running.
Time prevents me from covering the questions posed by the noble Lord, Lord Bradley, in particular. I undertake to write to him and other noble Lords, as I said. But I would just like to touch on the subject of parenting, which the noble Earl, Lord Listowel, mentioned, as did the noble Baroness, Lady Warwick, and the noble Lord, Lord Bradley. The CYP IAPT programme includes a focus on parenting for three to 10 year-olds with conduct disorder. It currently works with services covering 68% of the population and the ambition is for nationwide coverage in 2018.
The task force is a crucial element of our plans. It brings together experts from across health, social care and education to look at how to improve the way children and young people’s mental health services are organised. It has a particular focus on the needs of the most vulnerable children and young people, including looked-after children. We will publish the Government’s report of the task force’s findings shortly. I hope that noble Lords will be reassured that there is much going on in this area. The Government are very focused on the subjects that we have heard about this evening. I very much hope that the progress we have seen over recent years will be continued under the next Government.
Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
Earl Howe Excerpts(9 years, 9 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the purpose of the regulations is to enable women to have their own genetic children, free of terrible disease caused by disorders in their mitochondrial DNA. The regulations do so by allowing healthy mitochondria from a donor to replace the unhealthy mitochondria in a woman’s egg or embryo.
Mitochondria are present in almost every cell in the body and produce the energy that we need to function. This is why they are often referred to as the “powerhouse” of the cell. Unhealthy mitochondria can cause severe medical disorders known as mitochondrial disease, for which there is no cure. There are 37 genes in the mitochondrial DNA, compared with more than 20,000 in the nuclear DNA. This represents less than 0.1% of the total genetic make-up. The techniques provided for by these regulations offer the only hope for some women who carry the disease to have healthy, genetically related children who will not suffer from the devastating and often fatal consequences of serious mitochondrial disease.
Provision to make these regulations was introduced by Parliament into the Human Fertilisation and Embryology Act 2008. It followed an amendment that recognised the progress being made in research. In 2010, researchers at Newcastle asked the Department of Health to take forward steps to develop regulations. Over the last five years, there has been extensive engagement and consultation with the public on this issue, including, first, an ethical assessment by the Nuffield Council on Bioethics in 2012; secondly, a highly commended, respected and wide-ranging public dialogue and consultation exercise carried out by the HFEA in 2012-13; and, thirdly, a public consultation on draft regulations carried out by the Department of Health in 2014. There have been three separate reports into the safety and efficacy of these mitochondrial donation techniques by an expert panel convened by the HFEA, published in 2011, 2013 and 2014. The expert panel members were selected for their broad-ranging scientific and clinical expertise, and for having no direct or commercial interest in the outcome of the review.
This process was commended in a recent letter to the Guardian from eminent scientists and Nobel Prize winners from the UK and across the world. The letter included this sentence:
“the UK has run an exemplary and internationally admired process for considering benefits, risks, ethical issues and public consent, which must properly precede a change in the law”.
Given the extensive scrutiny given to this issue during the life of this Parliament, I believe it is appropriate to allow this Parliament to decide whether to take the next step for mitochondrial donation, which can make meaningful progress to actually help families only with the passing of these regulations. The two proposed techniques that would be allowed under these regulations are maternal spindle transfer and pronuclear transfer. These replace the mitochondrial DNA, which contains a small number of unhealthy genes, with healthy mitochondrial DNA. Mitochondrial DNA is just 0.054% of our overall DNA. One important point to emphasise here is that none of the nuclear DNA, which determines our personal characteristics and traits, is altered by mitochondrial donation.
I know that many noble Lords will have their own tributes to pay, but I would like to make my own acknowledgment of the ground-breaking work that the scientists at Newcastle University have led, which is world-leading in the development of these new techniques. It is also very important to praise the Lily Foundation, a charity founded by families who have lost their children to serious mitochondrial disease, which has reminded us about the human story that inspired this scientific advance.
I turn now to the detail of the regulations made under powers in the 1990 Act which, as I said, were added in 2008, with Parliament’s express agreement, in anticipation of the advancement of science to this point. These powers would permit mitochondrial donation in order to prevent the transmission of serious mitochondrial disease.
Lord Hunt of Kings Heath (Lab)
My Lords, I sense that the House wants to come to a decision.
Just over 14 years ago, I asked the House to agree that embryology research could be extended to cover diseases such as Parkinson’s disease, Alzheimer’s disease, cancer and diabetes. This provision had been anticipated and included as a regulation-making power in the Human Fertilisation and Embryology Act 1990, which had allowed embryology research but only for conditions such as infertility and congenital diseases.
The 2001 regulations were passed following a Motion moved by the noble Lord, Lord Alton, to whom I pay tribute for his integrity and perseverance. However, his Motion to establish a Select Committee prior to the regulations being approved was defeated by 212 votes to 92.
The 1990 Act followed the work of a committee led by the noble Baroness, Lady Warnock, which made recommendations on developments in science and medicine in relation to human fertilisation and embryology. I pay tribute to the noble Baroness for her outstanding work in helping us get the balance right between the respect owed to human embryos and the potential for the use of embryos in research and treatment for devastating illnesses.
The 1990 Act was a model in the regulation of certain infertility treatments and embryo research. It reflected the need to have a strict framework in which regulation could be conducted to take account of the advances in medicine anticipated by both the noble Baroness, Lady Warnock, and Parliament in 1990.
Since 1990, the science and research have developed, just as has the need for Parliament to keep up and anticipate further developments. Thus, in 2001, we passed emergency legislation to put it beyond doubt that human reproductive cloning could not take place in the UK. In 2004, we passed regulations in which the identity of the donor of eggs, sperm or embryos could be given to the adult donor-conceived person under certain circumstances.
We have heard about the 2008 Act, which amended the 1990 Act to include restrictions on the types of embryos that may be placed inside a woman. Importantly, the 2008 Act amended the 1990 Act to insert a regulation-making power to enable techniques which were under development at that time to be used in treatment to prevent a child being born with serious mitochondrial disease. Surely, the noble Viscount, Lord Ridley, and the noble Lord, Lord Walton, are right—at every significant stage of embryology research and potential treatment, Parliament has been asked to give its approval and thus ensure public confidence in our scrutiny of these most difficult decisions. My view is that Parliament has discharged that responsibility thoroughly and well. However, I am glad that the noble Lord, Lord Deben, has given us the opportunity to have this debate. Of course, we would have had a debate but the noble Lord has served a great purpose in encapsulating the core argument and I am grateful to him for so doing.
We find ourselves asked to make a crucially important decision, with powerful contributions having been made on both sides of the argument. On the one hand, we celebrate the triumph of science that these new techniques represent. We have within our reach the possibility of eradicating mitochondrial disease from families who have been blighted by it for generations. On the other hand, we are grappling with serious moral, legal and ethical questions that are raised by the proposed introduction of such techniques for treatment. We on this side of the House have a free vote. Speaking for myself, and myself alone, I will vote in favour of the regulations.
The noble Earl, Lord Howe, will respond to many important points that have been raised, but I ask him to focus on a number of very important considerations that have also been raised. On the question of continuing research and the comments of the expert panel, will he confirm that the panel said there was no evidence to suggest that the techniques proposed in the regulations are unsafe? Will he also confirm that the panel has agreed that further research and reviews could take place either before or after the regulations are approved?
As regards whether this matter is being rushed through Parliament and would benefit from further scrutiny by a Select Committee, the question here is: what would be gained by delay? Will the noble Earl confirm that the principles that we are discussing were approved by Parliament in 2008 after thorough debate? I do not need to go over the work of the Nuffield Council on Bioethics or that of the HFEA and its expert panel because noble Lords have mentioned that, but I should comment on the 90-minute debate that took place in the House of Commons. I agree with the noble Lord, Lord Alton, that 90 minutes is too short. However, I have read that debate and it seems to me that it was thorough and well informed and that the points on both sides were put forcefully and interventions were made. My honourable friend Luciana Berger was asked a number of very tough questions, as was the Minister. Could anyone say that at the end of those 90 minutes MPs were not in a position to come to a conclusion? Indeed, can anyone say that we are not in a position to come to a conclusion following a debate which has lasted at least three and a half hours?
We have heard from eminent lawyers on both sides of the argument on the legal questions. We have had written submissions from the Department of Health and the legal advice of the Wellcome Trust, and other legal propositions have been put to us. However, you reach a point when it is time to make a decision. I think that we are in a position to make such a judgment.
A number of noble Lords, including the noble Lord, Lord Alton, referred to the two techniques and how one should be considered in relation to the other. I understand the point that the noble Lord, Lord Alton, made. However, will the noble Earl, Lord Howe, confirm that the panel believes that at present there is insufficient evidence to choose between the two techniques? Does he consider that that is still the Government’s position? The noble Lord, Lord Deben, said that this was a question of resources. I have not seen evidence to suggest that that is the case. The important question is: can the Minister refute that? Can he say that the sole issue is that at the moment we are not in a position to judge which technique is likely to be more effective, and that it is solely for that reason that we are permitting the two techniques to be in the regulations?
Finally, we come to the position of the HFEA. At every point of our debates—this goes back to 2001—we have relied on the robustness of that body. The robustness of the HFEA is absolutely essential. There have been discussions and debates about how effective it is; my noble friend Lord Winston is a well known critic of some of its activities. Fair enough—but I believe that the HFEA has proved itself a highly effective and robust regulator over 20 years. I ask the Minister to confirm that it is the Government’s intention to continue to support the robustness of that regulatory approach.
As for the Chinese experience, will the Minister confirm that, although there are issues in connection with the techniques used, one big difference between the UK and the Chinese position is the regulatory framework and the robustness of the HFEA? I suspect that that was not the case in China years ago when those developments took place.
The question is whether the benefits of trying to eradicate this dreadful disease by preventing the transmission of mitochondrial disease, in view of the likelihood that otherwise children will continue to be born who will die in infancy, outweighs the risks of the techniques, which some noble Lords have described tonight. The scientific community—on the basis not of some kind of cosy consensus but of hard evidence—and the families experiencing this disease are clear that we are right to support the regulations. It is now up to us individually to decide whether we agree them. I, for one, am convinced that it is the right thing to do.
Baroness Scotland of Asthal
My Lords, before the noble Earl starts his speech, may I apologise to the House? The noble Lord, Lord Alton, has clarified the fact that it was the Lord Chancellor and the current Attorney-General who voted against this measure in the House of Commons. I was told that two Law Officers had voted against, and I assumed that the two Law Officers must have been the right honourable Dominic Grieve and the current Attorney-General. It was not: it was the Lord Chancellor and the current Attorney-General. I should apologise for that; it was a misunderstanding of the information that I was given.
Earl Howe
My Lords, as I fully expected, this has been a debate of very high quality, with a range of views, both for and against the regulations, eloquently expressed. My principal job now is to respond to the Motion moved by my noble friend Lord Deben and to some of the additional points raised by other speakers.
My noble friend’s Motion covers three main points—safety, compliance with EU and UK law, and the key definitions in the draft regulations. My noble friend and the noble Lord, Lord Brennan, in his legal opinion, argued that there was some doubt about whether the regulations were compliant with EU law, in particular the EU directive on clinical trials. With respect to both noble Lords, the Government do not agree. The EU clinical trials directive does not apply here because it is concerned with medicinal products, and mitochondrial donation techniques simply do not fall under that definition.
My noble friend asked whether we had checked our position with the European Union. The simple answer is no. Within a framework of subsidiarity, it is entirely the responsibility of each member state to ensure that its own legislation is consistent with EU law. That is what we have done. The EU would be inundated with extensive queries from member states if a “legal advice” facility existed, and there is no such facility.
Lord Gordon of Strathblane
Is the noble Earl equally confident that the regulations are compliant with the European directive that is due to come into force in 2016, and which might explain the timing?
Earl Howe
My Lords, I think I can make an unequivocal statement that all the legal advice I have received is that the regulations we are considering are fully compliant with European law.
As has been said, any legislation agreed in Parliament could be subject to challenge, and it would be up to the Government at the time of challenge to defend their position. The noble and learned Lord, Lord Hope, made that point. Let me reassure noble Lords that we have considered these issues very carefully, and we are confident that the regulations are compliant. I am pleased that other noble Lords who have spoken agree with that.
The noble and learned Baroness, Lady Scotland, cited the European charter. The EU charter does not apply in this context, because Article 51 says that it applies to member states,
“only when they are implementing Union law”.
This means that a state must be either directly implementing an EU law obligation or acting within the scope of EU law. The regulations do not do either of those things.
We have considered the issues raised and, as I have said, we are very confident that these regulations do not contravene European law. The issue comes back to whether the clinical trials directive is engaged here. It is not. Our view, incidentally, was agreed with independent legal advice commissioned by the Wellcome Trust from Thomas de la Mare QC: mitochondrial donation simply does not come within the definition of medicinal products, to which the directive applies.
Baroness Scotland of Asthal
In the context of the horizontal articles of the charter, Articles 51 and 52, have the Government considered how Article 6.3 changes things, because it consolidates what the law was then? There is a difficulty, and I do not know whether the noble Earl has had specific advice on those matters. I know that this was not contained in the opinions that were promulgated earlier.
Earl Howe
I can only say again that the legal advice I have had is that the charter cuts in only when there is an issue of European law. We do not consider that treatment services, which are what we are talking about here, are covered by EU law. The noble Baroness made a point of saying that my right honourable friend the Attorney-General did not vote in favour of the regulations, but it is difficult for me to comment on that. There was, rightly, a free vote in the other place, just as there is here. I cannot comment on the personal view of the Attorney-General—and I have to say that I do not think that anything said or quoted by the noble and learned Baroness threw much light on that issue.
I repeat that my department is confident that these regulations are necessary and have a sound legislative base in the Human Fertilisation and Embryology Act 1990, as amended. As my noble and learned friend Lord Mackay rightly pointed out, it was the clear intention of Parliament that this provision would enable mitochondrial donation to take place in a clinical setting.
On the issue of safety, my noble friend Lord Deben urges us to delay until further research is carried out. However, we could wait indefinitely for research and follow-up and still not have a 100% assurance about safety, because that is the nature of science and research. The standards of assurance that some are seeking are considerably higher than those for cancer treatment or heart disease. As far as the expert panel convened by the HFEA is concerned, there is no evidence to suggest that these techniques are unsafe. The critical experiments are progressing positively.
As I said, the mitochondrial donation regulations require the HFEA to assess each application for mitochondrial donation on a case-by-case basis. That will include consideration of the evidence on safety and effectiveness. As a statutory independent regulator, it is for the HFEA to determine its own procedures for assessing applications to carry out treatment regulated by the 1990 Act. Applications to provide mitochondrial donation treatment are no exception to this rule but, clearly, the HFEA will not authorise the treatment if it does not consider it safe to do so.
It is never possible to answer every safety question before new medical procedures are used in people for the first time. New techniques can be refined and reviewed. Even the most exhaustive research can establish only that a technique is sufficiently likely to be safe to justify “first in human” treatment. However, if medicine is to progress, clinicians should in my submission be permitted to use new techniques when evidence suggests these are sufficiently safe and effective. It is the Government’s view that medical knowledge in the field of mitochondrial disease and donation has now reached this stage and it is time to progress. The legislative framework of the HFE Act provides for Parliament to endorse the Government’s view before proceeding and, following the extensive process of consideration that I have already set out, we have properly brought this to Parliament for debate on affirmative regulations.
I listened with care to the noble Baroness, Lady Hollins. I absolutely concede that there is a balance of risks to be considered. As I have said, it is not possible to be certain that new medical procedures will be 100% safe or effective. These risks must be balanced with the risk of ongoing suffering for families with mitochondrial disease. For me, the simple point is this: scientific 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. As the noble Lord, Lord Patel, pointed out, ultimately it will be up to affected families to judge the balance of these risks with advice from their clinicians and then to decide whether they choose to proceed with treatment, subject to authorisation by the HFEA.
My noble friend Lord Deben mentioned the Chinese study. That study has not been published and we understand that it will not be. It concerns one pregnancy, using an earlier form of pronuclear transfer. One of the clinicians involved gave a full interview to the Independent recently and explained that the complications that occurred related to multiple pregnancies from multiple embryo transfer, rather than from the mitochondrial donation process. As I understand it, there were no genetic abnormalities in the foetuses.
Turning again to the speech by the noble Baroness, Lady Hollins, the HFEA-convened expert panel considered the issues that she raised: if the patient and the donor have different mitochondria, known as haplotypes, the donor’s mitochondria may not, as it were, “talk properly” to the patient’s nuclear DNA, causing health problems. The panel considered that as part of its third scientific review. However, it was of the view that the data submitted to it about this potential problem were not relevant enough to raise safety concerns. However, the panel has recommended, as a purely precautionary step, that consideration be given to the mitochondria haplotype when matching donors to patients, even though the risks of not doing so are assessed to be very low.
The noble Baroness questioned whether successive generations, particularly girls, could have the same problems arise from unhealthy mitochondria. The principle behind the treatment is that the mitochondrial DNA that the child will inherit will be the disease-free mitochondrial DNA of the donor, not the faulty mitochondrial DNA of the mother, although there is a small risk that the low level of unhealthy mitochondria may be carried over when the patient’s nuclear DNA is moved from her egg or embryo to the donor’s. Evidence continues to be reassuring that carryover after mitochondrial replacement is very low and unlikely to be problematic. The risk of mitochondrial disease being present in these generations will, we believe, be low.
The noble Baroness also said that we still do not know enough about the relationship mitochondria have with the human body. This is true of many aspects of human physiology, not just mitochondrial DNA. The majority of the evidence indicates that mitochondria are primarily concerned with generating the power that every cell in the body needs to function. It is generally accepted that, as vital as the function of the mitochondria undoubtedly is to the human body, they do not play a role in developing a person’s physical appearance or personality traits, which are derived solely from nuclear DNA.
Lord Elton (Con)
Before my noble friend leaves the question of risk, may I ask him to close a little chink in the reassuring curtain that he is drawing before us? We are assured by the HFEA that there is no evidence of risk in what is proposed, but it also proposes quite a large phalanx of experiments that should be completed before proceeding. First, there appears to be a slight logical discontinuity there. Secondly, can we be reassured that, in the Minister’s view, the HFEA will not proceed to licensing anybody until they have completed that programme of experiments?
Earl Howe
My Lords, I can confirm to my noble friend, and to the noble Lord, Lord Hunt, who asked a similar question, that the expert panel stated that the further experiments that it recommended could take place either before or after the passing of these regulations. However, they must be done before treatment can take place. I hope that that is sufficient reassurance.
The noble Lord, Lord Alton, and the noble Baroness, Lady O’Loan, spoke about the risk of ovarian hyperstimulation syndrome. OHSS is a well recognised side-effect of the drugs used to stimulate a patient’s or donor’s ovaries to collect multiple eggs for use in fertility treatments. The risks of OHSS are very well understood, with patients and egg donors carefully monitored. The HFEA’s code of practice requires women undergoing ovarian stimulation to be given information about the possible side effects and risks, including OHSS. Women are informed of the symptoms to look out for and are warned to contact their clinic if they feel unwell. Women donating eggs for use in mitochondrial donation will not be at any increased risk of developing OHSS.
The noble Lord and the noble Baroness both questioned the practice of paying for donated eggs. I submit that there is nothing sinister in that. Within the legal framework of the HFE Act, the HFEA sets the rates for compensation to donors of eggs or sperm; £500 for an egg donor is well within those limits. It certainly is not a sign that Newcastle University is anticipating the introduction of the regulations to allow mitochondrial donation. It is continuing its research and has an ongoing need for donated eggs for that purpose.
I turn now to the issue of definitions. In making the regulations, the Government have been clear about their approach, the definitions used and the source of their material. The Government’s consultation on the detail of the regulations set out very clearly: the definitions of scientific terms; the detail of the techniques that the draft regulations would cover; the terms that others might use, such as “genetic modification”; and the proposed approach to information for donors and those conceived through mitochondrial donation.
Care and Support Regulations
Earl Howe Excerpts(9 years, 9 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I thank both noble Baronesses for their thoughtful questions and comments. I will seek to address as many as possible today and respond to others in writing as need be.
These 17 sets of regulations give full expression to many of the key aspects of the reformed care and support system envisaged by the Care Act. First, there are two sets of regulations that set out important details of people’s rights as they progress through the pathway of care and support envisaged by the Care Act. The assessment regulations specify further matters about carrying out an assessment under Section 9 of the Care Act, while the direct payment regulations largely replicate the existing regulatory framework around this, but with some changes to make the framework more flexible and less bureaucratic.
The noble Baroness, Lady Pitkeathley, asked about charging for carers’ assessments. The joint implementation programme has commissioned the ADASS carers policy network to produce a document on the economic case for investment in carers which will expand on the case set out in the Care Act statutory guidance that charging carers for services needs to be considered carefully. It can often be a false economy to charge carers beyond, of course, the moral case for recognising and supporting the extraordinary contribution that carers make to our society. We are putting in place a robust set of measures to monitor the implementation of the Care Act and I will of course keep this matter under review, as will my department.
There are five sets of regulations that help to ensure that people pay a fair amount for their care and support and have adequate choice in the way their care and support needs are met. The charging and assessment of resources regulations set out how a local authority must conduct a financial assessment when seeking to calculate what a person can afford to contribute towards the cost of their care and support. The choice of accommodation regulations set out conditions regarding the choice of placement in residential care. The deferred payment regulations set out the circumstances in which local authorities may or must enter into deferred payment agreements. They also make provision as to the operation and content of the agreement. As the noble Baroness, Lady Wheeler, mentioned, these regulations were the subject of a specific debate in your Lordships’ House in December, following two Motions tabled by the noble Lord, Lord Lipsey. In addition, there are two smaller sets of regulations that specify whether certain types of services can be charged for and on certain costs to be excluded from personal budgets.
There are a further four sets of regulations that relate to general local authority responsibilities, as opposed to duties regarding individual people set out elsewhere, such as in the assessment regulations. The advocacy regulations set out the considerations for determining whether a person would experience substantial difficulty in doing certain things connected with being involved in the care and support process, which may trigger a local authority’s duty to provide an independent advocate. The instrument also establishes the requirements of an advocate and the manner in which they must carry out their functions.
The market oversight information regulations make provision for the Care Quality Commission to obtain information to help it assess the financial sustainability of providers. The sight-impaired and severely sight-impaired adults regulations specify the persons who are to be treated as such for the purposes of local authorities’ duty to maintain registers of these groups.
There are a further two statutory instruments that set out important details of local authorities’ interaction with NHS bodies. The provision of health services regulations essentially set the boundary between care and support functions on the one hand and healthcare on the other, while the discharge of hospital patients regulations cover the details of the regulatory framework for the discharge of hospital patients with care and support needs.
I come last to the five statutory instruments that relate to ensuring there are clear procedures and responsibilities when people move between areas. The first two primarily concern ordinary residence, which is a mechanism for allocating responsibility between local authorities for meeting needs. The ordinary residence specified accommodation regulations make provision about the types of accommodation to which provisions in the Act deeming ordinary residence apply, while the ordinary residence disputes regulations set out the procedures that must be followed if a dispute concerning ordinary residence, continuity of care or provider failure arises.
There are a further two statutory instruments that make provision about similar issues, but arising from a placement from one UK country into another, rather than within England. The first sets out how disputes will be handled, while the second makes provision around business failure duties for Scotland, broadly to ensure reciprocity of duties across the UK.
Lastly, the continuity of care regulations set out the matters that a local authority must consider in fulfilling its duty to meet the care and support needs when a person moves home to its area, where the authority of previous residence was meeting such needs and a new assessment has not been conducted.
The noble Baroness, Lady Wheeler, asked me about the reference in the ordinary residence regulations to the phrase “needs can only be met”. The guidance makes clear that needs should be judged to be able to be met through a specified type of accommodation only where the local authority has made this decision following an assessment and the care and support planning process involving the person.
I wanted to make noble Lords aware that we propose to introduce a short set of amending regulations to make several small changes to some of the regulations I have described; and, in answer to the noble Baroness, Lady Wheeler, that includes the uprating of certain allowances in the charging regulations in line with existing practice on annual uprating of figures and some minor corrections of cross-references and terminology in two of the regulations. We are also making a change to the deferred payment regulations to make clearer that the provisions concerning disposable income do not apply if the local authority ceases to make deferrals. We will make a change to the list of local authorities that may make a direct payment for accommodation in a care home to reflect developments in the pilot scheme relating to this.
We will make a change to the regulations on specified accommodation so that the ordinary residence deeming principles apply only from the date a person living in the accommodation receives care and support under the Act. The purpose of the amendment is to ensure that the deeming rule does not apply when a person is living in a specified type of accommodation, such as a care home, before they begin to receive care and support from the local authority. In such a situation the normal ordinary residence rules should apply. That is the position under the current legislation and it has always been the intention that the Care Act should not change this.
The noble Baroness, Lady Wheeler, asked me whether guidance will be clear that local authorities should backdate the care account if an assessment is delayed. We will ensure that guidance provides clarity on this point. If I can elaborate on that in a letter I will certainly be happy to do so.
I hope I have been able to address at least some of the main points raised today, but as I said at the beginning, I shall write after this debate to noble Lords with any further points that I have not been able to cover.