Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015
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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
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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.
Adult Social Care Contracts
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Lord Laming
To ask Her Majesty’s Government what assessment they have made of the use of an auction-style process by some local authorities to tender for adult social care contracts.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
The new Care Act directs local authorities to put the well-being of people at the centre of all decisions about care and support. Commissioning high-quality social care is ultimately a matter for local authorities. We are aware of electronic marketplace systems that, together with professional judgments by authority staff, help to embody this well-being principle by prioritising quality above cost while achieving value for money.
Lord Laming (CB)
My Lords, I am very grateful to the noble Earl for that thoughtful response. Does he agree that advertising a block of services in an impersonal way is entirely different from advertising a vulnerable individual, stripping them of their humanity and dignity? Would he be willing to take forward the point that he made about the legislation and examine whether these authorities are disregarding the duty placed on them by Parliament to carry out a proper assessment of need for each individual, to produce a care plan and to make sure that that care plan is related to the individual’s developing situation? Will he ask the Care Quality Commission to make unannounced inspections of these authorities to see whether they are complying with the law?
Earl Howe
My Lords, I make it clear that the personal details of would-be service users should not be put in the public domain. The purpose of this system is to develop a tailored care plan that best meets the person’s needs and does not undermine their well-being. Where this has been done well, it has resulted in good-quality care while also, as I said, providing value for money for the taxpayer. We would not wish to make provision for spot checks of local authorities by the CQC but, where there is clear evidence that a local authority’s commissioning practices are leading to poor-quality care—which they should not be—the Secretary of State can order the Care Quality Commission to carry out a special review.
Lord Campbell-Savours (Lab)
My Lords, the Minister will know that self-funders have been subsidising local authority places for decades. Have the Government measured what the impact of the increased cost on self-funders would be in the event that we were to go down the route suggested?
Earl Howe
My Lords, whatever system is chosen for commissioning care in a local authority, there has to be a fair system for setting fees. We expect local authorities to comply with their legal duties to sustain a high-quality market of providers in their area, and that involves paying fair fees. That is a matter for local determination. It has to be because, in seeking an open market, as we do, we are also aware that local market conditions have to be taken into account.
Baroness Campbell of Surbiton (CB)
My Lords, many service user-led organisations—for instance, the National Centre for Independent Living—provide a high quality of service. Does the Minister accept that in order to achieve high quality and high value, local authorities may have to pay a premium in the short term to achieve long-term cost-effectiveness? If he does, can he remind local authorities of this?
Earl Howe
My Lords, the principle that the noble Baroness articulates is, I am sure, applicable in some areas. I hope that she will be reassured to know that the department has developed statutory guidance for the Care Act to support local authorities, including commissioning. The guidance to the Act directs local authorities to ensure that all packages of care and support that are arranged are good quality and do not undermine people’s well-being. Furthermore, the department will, with partners, be developing a set of commissioning standards which will help local authorities to improve their commissioning practices.
Lord Mackay of Clashfern (Con)
My Lords, can the noble Earl tell us whether the Care Act effectively prevents the practice to which the noble Lord, Lord Campbell-Savours, referred?
Baroness Barker (LD)
My Lords, commissioning of social care is changing fundamentally, not least because of increased use of individual budgets and integration with health commissioning. Does the Minister agree that it is time for the CQC to do a thorough review of the commissioning skills and capacities of local authorities?
Earl Howe
I think that that would be premature. As I have said, we are developing statutory guidance for local authorities, as well as commissioning standards. We have no evidence to date that the process to which the noble Lord, Lord Laming, has drawn attention is leading to perverse results. If there is such evidence, we would be interested to hear about it. But until we are aware that there is a problem, I think that the noble Baroness’s suggestion is not timely.
Lord Campbell-Savours
My Lords, I go back to my original question. Will self-funders be further subsidising local authority auctioned places?
Earl Howe
My Lords, it is impossible to give generalisations. As I indicated, it will depend on what happens in a given local area. We know that it happens at the moment but, again, it is impossible for me to make a general statement about how much or how little it is happening across the country.
Francis Report: Update and Response
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I refer the House to the Statement made by my right honourable friend the Secretary of State for Health in the House of Commons, copies of which have been made available in the Printed Paper Office and the text of which will be printed in full in the Official Report.
The following Statement was made earlier in the House of Commons.
“With your permission, Mr Speaker, I would like to make a Statement on the Government’s response to today’s report on NHS whistleblowing by Sir Robert Francis, and on progress to date in implementing previous recommendations from his public inquiry into the failures of care at Mid Staffordshire NHS Foundation Trust.
I asked Sir Robert to carry out a follow-up review because of my concerns that, despite good progress in implementing his original recommendations, the NHS was still not making fast enough progress in creating an open and transparent culture in which staff feel supported to speak out on worries about patient care. As a result, I was concerned that changes are still necessary if the NHS is to protect patients properly by adopting a transparent, no-blame, learning culture as is common in other sectors such as the nuclear, oil or airline industries.
Sir Robert has confirmed the need for further change in his report today. He said he heard again and again of horrific stories of people’s lives being destroyed—people losing their jobs, being financially ruined, being brought to the brink of suicide and with family lives shattered—because they had tried to do the right thing for patients. Eminent and respected clinicians had their reputations maligned. There are stories of fear, bullying, ostracisation and marginalisation, as well as psychological and physical harm. There are reports of a culture of ‘delay, defend and deny’, with ‘prolonged rants’ directed at people branded ‘snitches, troublemakers and backstabbers’, who were then blacklisted from future employment in the NHS as the system closed ranks.
We, of course, recognise the high standards of care day in, day out in much of the NHS, and we know that many staff feel supported in raising concerns about patient care, with many dedicated managers going out of their way to address those concerns. However, the whole House will be profoundly shocked at the nature and extent of what has been revealed today. The only way we will build an NHS with the highest standards is if the doctors and nurses who have given their lives to patient care always feel listened to when they speak out about patient care. The message must go out today that we are calling time on bullying, intimidation and victimisation, which have no place in our NHS.
Before outlining the Government’s response to today’s report, I want to update the House on the progress made in implementing previous Francis recommendations. I have today laid in the House of Commons Library a report showing progress on all 290 recommendations originally made by Sir Robert, as well as the progress made in implementing other recommendations by Professor Don Berwick on safety, by the right honourable Member for Cynon Valley, Ann Clwyd, and Professor Tricia Hart in their complaints review, by Camilla Cavendish in her work on healthcare assistants and by the NHS Confederation on reducing bureaucratic burdens. The progress was recognised this morning by Sir Robert, who said that the priority that must be given to safety, compassion and quality of care is now better recognised and acted on.
I want to highlight the impact of Professor Sir Bruce Keogh’s review of hospitals with high mortality rates. The special measures regime that followed introduced the toughest and most transparent hospital turnaround regime anywhere in the world, with 19 hospitals—more than 10% of NHS acute trusts—having been put into special measures so far. Among the vast array of improvements since the start of the process, those trusts have recruited 109 additional doctors and 1,805 additional nurses, and have made 129 board-level changes. The independent research company Dr Foster estimated this week that excess deaths in those trusts had fallen by 450 in less than a year. That means that between them, they may have saved as many lives as some estimated were tragically lost at Mid Staffs between 2005 and 2009.
We have moved from a system that tolerated or denied high mortality to one that, while it is by no means perfect, seeks out problems, shares them with the public, takes action and saves lives. Today I can announce that the Care Quality Commission, Monitor and the NHS Trust Development Authority have published a new memorandum of understanding to enshrine and further improve the special measures process.
The other measures that we have introduced include giving the CQC, under its new leadership, legal independence and the legal powers that it needs for its chief inspectors to root out failure and highlight excellence. The chief inspector of hospitals has inspected more than half of acute trusts and will have inspected them all by the end of the year.
We have introduced criminal sanctions for those who wilfully neglect patients and those who provide false or misleading information. The new duty of candour for institutions and professionals means that when mistakes are made, patients or their families must be told. Fundamental standards are now in place to ensure that all providers are required to treat people with dignity and respect. All acute hospitals are now asking patients if they would recommend the care that they receive to friends or members of their family. That is being rolled out to other parts of the NHS, including primary care. Two-thirds of hospitals are now implementing the ‘name above the bed’ initiative to ensure that hospital care is better joined up. More than 200 organisations have joined the ‘sign up to safety’ campaign, which involves a commitment to halve avoidable harm and save 6,000 lives by 2017.
The entire NHS is now committed to patient-centred culture change as a key part of the ‘Five Year Forward View’ plans that were put forward by NHS England last autumn. In that plan, we recognise the important point that safe care and efficient use of resources go hand in hand: doing the right things first time in healthcare saves lives and money.
In respect of whistleblowing, the Government have taken significant steps to protect NHS staff, such as enshrining the right to speak up in staff contracts, amending the NHS constitution, issuing joint guidance with employers and trade unions, extending the national helpline to social care staff, and changing the law to make employers responsible if whistleblowers are harassed or bullied by fellow employees.
Today, Sir Robert makes it clear that there is more to do, and I am extremely grateful to him and his team for their work. He sets out 20 principles and a programme of action. I confirm today that I accept all his recommendations in principle and will consult on a package of measures to implement them.
The recommendations include asking every NHS organisation to identify one member of staff to whom other members of staff can speak if they have concerns that they are not being listened to. Drawing on the inspirational work of Mid Staffs whistleblower Helene Donnelly, those ‘freedom to speak up’ guardians will report directly to trust chief executives on the progress in stamping out the culture of bullying and intimidation that Sir Robert today says is still too common. We will consult on establishing a new independent national whistleblowing guardian as a full-time post within the CQC to review the processes that have been followed in the most serious cases where concerns have been raised about the treatment of whistleblowers.
Because too often the system has closed ranks against whistleblowers, making it impossible for them to find another job, I can announce today that the Government will legislate to protect whistleblowers who are applying for NHS jobs from discrimination by prospective employers. With Opposition support, those necessary regulation-making powers could be on the statute book in this Parliament.
We will provide practical help through Monitor, the NHS Trust Development Authority and NHS England to help whistleblowers find alternative employment. Those three bodies have agreed a compact for action on this issue, and will publish detailed arrangements later this year. We will ensure that every member of staff, NHS manager and NHS leader has proper training on how to raise concerns and how to treat people who raise concerns. As a vital last resort, the right of whistle- blowers to contact the press with any concerns they have must always be safeguarded, although it should not have to come to that. Today I will write to every trust chair to underline the importance of a culture where front-line staff feel able to speak up about concerns without fear of repercussions. In addition, Monitor and the TDA will write to trust chief executives today to ask them to ensure that all managers discuss these issues as a matter of urgency with those who report to them.
There must be consequences for trusts that fail to develop a culture of openness, so today I am publishing consultation options to ensure that where hospitals are found to have knowingly withheld information from patients, the NHS Litigation Authority can impose financial sanctions such as reducing the indemnity it offers against litigation awards. The final decision on how we implement these recommendations will be made after proper consultation with NHS providers, whistle- blowers and patient groups to ensure that we honour the spirit of what Sir Robert has recommended, and to avoid unnecessary layers of bureaucracy or financial burden. There is no reason for individual trusts not to get on with implementing Sir Robert’s recommendations right away, particularly in ensuring that staff have an independent person with whom they can raise concerns.
A further foundation of a safe and open culture is one where the NHS and the public have access to meaningful and comparable information about the performance of local NHS organisations. The new MyNHS website has already kick-started a transparency revolution by making the NHS in England the first healthcare system in the world to offer key, up-to-date safety information on every major hospital, including open and honest reporting, nurse staffing levels in every ward, and the number of falls and hospital-acquired infections. Some estimate that we have as many as 1,000 avoidable deaths in the NHS every month, so by the end of March 2016 the NHS will become the first healthcare system in the world to publish an annual estimate of avoidable deaths by hospital trust, based on case note reviews and the safety record of those trusts.
I will strengthen the accountability of trusts by asking the chair of every trust to write a letter to the Secretary of State by the end of May each year, outlining what measures they will be taking to reduce the number of avoidable deaths in their trust. In all cases we will make it clear that this is not a process of naming and shaming but one of learning and improving so that our NHS becomes the first healthcare system in the world to adopt system-wide the safety standards that would be considered normal in other industries. We must also better understand avoidable mortality outside hospital settings, and whether we can adapt the methodology to identify avoidable harm as well as avoidable death. I therefore announce today that the department will fund a national study to establish the extent of avoidable death in community settings, and the feasibility of developing locally attributable death rates.
We will be taking steps to hard-wire transparency into the health and care system, and I am publishing a transparency architecture with plans for further information to be released on MyNHS. That will include comprehensive reporting on the friends and family test, data on residential care home admissions, and a new balanced scorecard on the work of CCGs and health and well-being boards. The Care Quality Commission and the National Information Board have confirmed to me that, starting this year, they will report annually and in public to the Secretary of State and the Health Select Committee on the progress of the transparency architecture, and on any recommendations about how we can improve it. The Secretary of State will report to Parliament annually on progress, and today I am publishing for consultation changes that will enshrine that right in the NHS constitution.
One of the biggest causes of poor care is when no one takes responsibility for a vulnerable patient and the buck is passed. That leads to greater costs and numerous personal tragedies as people are passed unnecessarily around the system. The ‘name above the bed’ initiative has strengthened accountability in hospitals, as has bringing back named GPs outside hospitals, but there is still not enough clarity on the role of professionally accountable clinicians, particularly in community settings. Today I can therefore announce that the Academy of Medical Royal Colleges has agreed to develop guidelines for meaningful clinical accountability outside hospitals. It will publish its findings this spring, and before the end of the next financial year all CCGs will publish how many of their patients with long-term conditions are being looked after by clinically accountable community clinicians in the meaningful way the academy will define. Proper proactive care for our most vulnerable patients will not only reduce hospital costs but reduce avoidable harm and improve the quality of compassionate care.
We can fund the NHS with a strong economy, we can put in place new models of integrated care to support an ageing population and we can champion innovation, but if we do not get the culture in the NHS right, we shall never deliver the ambitions that everyone in this House has for our NHS. Today is about tackling that culture challenge head on so that we build an NHS that supports staff to deliver the highest standards of safe and compassionate care and that avoids the mistakes that have led to both unacceptable waste and unspeakable tragedy. If we succeed, we will be the first country anywhere to put its entire healthcare system firmly on the path to eliminating avoidable harm and death. Our NHS deserves no lesser ambition, so I commend this Statement to the House”.
Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the noble Earl for referring to the Statement in the way that he did. We welcome the Statement and its commitment to improve the culture around tackling poor care in the NHS. The Opposition endorse the principles in Sir Robert Francis’s new report and we will work with the Government to get them on the statute book in the remainder of this Parliament.
In 1998, the previous Government introduced the first legal protection for whistleblowers in the public interest disclosure legislation, reinforced in the NHS constitution in 2008. We see Sir Robert’s new principles building on those foundations. Our shared aim should be to create a climate in which any NHS worker feels able to raise concerns and confident that they will be listened to, that appropriate action will be taken and that they will not face mistreatment as a result. Today’s report establishes a number of new principles to which all NHS organisations should work. We fully endorse these. The call for support for whistleblowers worried about losing their jobs or finding alternative employment, and training in whistleblowing for all staff, is long overdue. Can the noble Earl confirm that this will apply equally to all providers of NHS services, including voluntary and private providers?
Let me turn to the recommendation for an external organisation which staff can approach for advice and support. In response to the first Francis report in February 2010, my right honourable friend Andy Burnham, when he was Secretary of State, established an expert group to update whistleblowing guidance. It reported in June 2010 and the then Secretary of State, Andrew Lansley, announced plans for a “safe and independent authority” to which staff can turn when their own organisations are not acting on concerns. Will the noble Earl say why little progress has been made since then and assure us that there will be no further delays now that Sir Robert has reinforced this recommendation?
Are the Government concerned by Sir Robert’s findings that the NHS culture might have got worse in recent years? As regards the cases he examined, he said:
“Many were relatively recent or current. This is not about a small number of historic high profile cases from a time when organisations might argue the culture was different. We had a significant number of contributions about cases in 2014”.
The report specifically references figures from the latest NHS staff survey, which shows that reports of bullying have increased from 14% of staff in 2011 to 22% in 2013. Over the same period, staff feeling unable to speak out about poor care, report errors or near misses has fallen from 98% in 2011 to 94% in 2013. Those figures suggest that things are getting worse and not better. Will the noble Earl comment on that and give the reasons?
This seems to underline the importance of any moves to improve culture being brought forward in the right sprit, supportive rather than punitive, so as not to reinforce the wrong culture and create a climate of fear. At the weekend, the Secretary of State proposed fines and jail sentences for failure to be open about poor care. We certainly support that zero tolerance approach but is the noble Earl not concerned that this might be perceived on the ground as creating such a climate of fear and therefore having the opposite effect?
I know that the Minister’s right honourable friend frequently quotes the airline industry as a model to be followed. I remind him that the experience in the airline industry has been to create a safe environment in which pilots can report near misses and untoward incidents so that the industry can learn from them. I urge the noble Earl to consider that whatever happens in the future, the encouragement to be open is not lost in this new approach.
Turning to Mid Staffordshire, we supported Sir Robert’s original recommendations and I certainly give credit to the Secretary of State for making progress on this since the report was produced and the recommendations were accepted. However, he will know that there are gaps where progress has not been made and that this is a concern when standards overall in the NHS are recorded to be falling and not rising. I particularly want to ask him about the long-standing need to reform the system of death certification. This goes back to Dame Janet Smith’s proposals which were embraced within the Coroners and Justice Act 2009 to make provision for the independent scrutiny by a medical examiner of all deaths that are not referred to by the coroner. Following successful pilots, Sir Robert Francis reinforced Dame Janet Smith’s recommendations. I was the chair of a trust which ran a pilot scheme, and I can testify to the effectiveness of having a senior consultant as the medical examiner looking at the case notes where deaths have occurred, informing patients, finding out where things have gone wrong and helping doctors to improve their practice. There is concern that the Government have shelved this proposal, and I hope to hear that that is not so.
Can the noble Earl set out a clear timetable for the introduction of medical examiners and comment on the arrangements in hospitals for reviewing case notes when patients have died? Over the weekend, the Government announced plans to introduce an annual review from a sample of patients. While that will definitely help us to develop a more accurate measure of avoidable deaths than the current mortality rates, does he think that it will go far enough? Should not the NHS learn from all serious failings, and will he give consideration to our suggestion that every death in hospital should be given an appropriate level of review?
We welcome the progress which has been made at some of the hospitals in special measures, but I want to ask the noble Earl about the use of mortality statistics. Is he aware that the graph on page 8 of the recent Dr Foster report shows that mortality rates at the Keogh trusts fell faster between 2006 and 2010 than between 2010 and 2014? Perhaps I may also refer him to the plans outlined by the Secretary of State to calculate the number of avoidable deaths for individual hospitals. They were described by Nick Black, a professor of health services research who has produced many of these ideas, as not having any meaning because of concerns about the robustness of the figures. Will he also acknowledge that a recent investigation by the Academy of Medical Royal Colleges into the use of hospital standardised mortality ratios as a means of comparing the quality of US and English hospitals has shown the method to be unreliable? He will know that Professor Jarman made a proposition that mortality rates between English and US hospitals were such as to cause concern about the UK position. The investigation demonstrates very clearly that the data are not comparable and cautions the use of a crude approach towards trying to judge institutions simply on the basis of HSMR statistics.
Finally, does the noble Earl agree that encouraging an open culture where whistleblowers feel secure in being able to raise issues of concern emanates from a culture that must apply throughout the system, starting at the top in his department and then through all the national regulators as well? If the national bodies feel that they are not able to raise concerns about government policy publicly and if the chief executives of NHS organisations know that if they make any public criticism, they will be penalised in one way or another by the system, is it any wonder that they then find it difficult to create a culture of openness? I urge the noble Earl to embrace fully what is being proposed today by acknowledging that if we are really going to grip the system, a culture of openness and of whistleblowing has to go right through the system and must include his own department, the regulators and NHS England.
In conclusion, we welcome the Statement today and we will do everything we can to ensure that the regulations the Government bring forward are able to go through Parliament before the election.
Earl Howe
My Lords, I am grateful for the welcome and support that the noble Lord, Lord Hunt, has given to the Statement. I do of course agree that Sir Robert’s recommendations, which we accept in principle, build on the current safeguards for whistleblowers. But, as the noble Lord knows, Sir Robert did identify some important gaps in those safeguards which we must now address.
The noble Lord asked me a number of questions. First, he asked whether these provisions would apply equally to all providers of NHS services, including to the voluntary and private sectors. Similar provisions will certainly apply to the voluntary and private sectors. We will expect such providers to reflect on how Francis’s recommendations might apply to them, but we will also use the NHS contract in an appropriate way.
The noble Lord asked whether the Government were concerned about an increase in the number of whistleblowing cases over the last few years. There is evidence that safety and compassionate care have in fact improved in recent years. It is also possible that the new emphasis on openness and transparency may lead to more concerns being raised, which is a slightly counterintuitive effect of a better culture. We want to examine Sir Robert’s findings carefully and would encourage NHS organisations to do the same. But it is important to emphasise that however much improvement we see, we must never be complacent about how good the system is.
The noble Lord asked about progress in identifying an authority to whom whistleblowers could turn. I refer him to Sir Robert’s recommendations, which provide for local “freedom to speak up” guardians, who will report directly to trust chief executives and, crucially, to whom members of staff in an organisation can speak if they have particular concerns. There will be a new independent national whistleblowing guardian as a full-time post within the CQC, as a further safeguard in this process—a person who can understand what has happened in a given local case and refer back to that local organisation in an appropriate fashion.
I agree with the noble Lord that we want to achieve, above all, a supportive and learning culture. That is something emphasised not only by Sir Robert but by Professor Don Berwick in his review of patient safety issues. He is also right that if we go too far with a punitive approach to these matters, it could deter people from wishing to step forward. That is why we hope that we have the balance right in the legal provisions that we put through in the Care Act so as to ensure that, while organisations must always be on the line for the extent to which they have complied with, for example, the duty of candour, we do not put employees in a state of excessive fear, lest they refrain from speaking up when appropriate.
All the measures we have taken so far—the duty of candour, the new offence of wilful neglect, the fundamental standards that Sir Robert recommended, which will be coming in, and the fit and proper persons test—combine to shore up the system in a helpful way, without, we trust, making the NHS feel oppressed by regulation.
The noble Lord asked about death certificates. No, the policy has not by any means been shelved. The work is continuing. To be frank with him, progress has been slightly less fast than we would have wished, but the Government remain totally committed to the principle of these 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. A number of recommendations in Sir Robert Francis’s Mid Staffordshire inquiry report refer to that reform of the death certification system. A new system of medical examiners has been trialled successfully in a number of areas across 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 countrywide basis at a scale that will be required for implementation by local authorities when legislation is introduced. We will be publishing shortly a report from the interim National Medical Examiner setting out the lessons learnt from the pilot sites.
The noble Lord, Lord Hunt, referred to the criticism voiced by Mr Nick Black on the way that we interpret statistics on avoidable deaths. The work that we have set in train builds on innovative work at the London School of Hygiene and Tropical Medicine, and we think it has the potential to enable NHS trusts to develop a better understanding of actually avoidable deaths. But we will continue to work with front-line clinicians, national organisations and academics to find ways to support trusts to understand better their levels of avoidable mortality and, crucially, to take effective action to reduce those levels.
The first Francis inquiry emphasised the importance of trusts looking carefully at their mortality rates as part of their overall scrutiny of safety measures. We believe that most, if not all, are now doing that but we want to do more to improve the data and their use to make improvements. I would just say to the noble Lord that we should not let the best be the enemy of the good. Imperfections in data should not get in the way of vigilant local scrutiny of those data, even though they may not be 100% accurate.
The noble Lord concluded his remarks with some questions about culture. In particular, he asked me whether I agreed that the culture of the system starts at the top. Of course, I agree with him fully on that. But I would just say to him that as a Government we have taken a conscious approach not to overemphasise poor care where it occurs but to expose it and to adopt a policy of transparency so that poor care as well as good care can be apparent to patients, the public and the system at large. We have given greater legal independence to the CQC. We want it to speak out without fear or favour, and it has indeed done that.
We believe it is right to confront poor practice where it occurs. The key, however, is to turn around those organisations that are found wanting, and the system of special measures has undoubtedly proved its worth, as the Dr Foster report recently made clear. There was an unequivocal finding in that report that the levels of avoidable mortality in most of the special measures trusts had gone down by a statistically significant percentage. There is undoubtedly a high degree of utility in the special measures process, painful as it may be to some organisations.
Baroness Barker (LD)
My Lords, will the Minister please say whether the proposals in the report relate to the provision of mental health services as well as physical health? The proposals are very much focused on hospitals. Secondly, review after review has shown that in a hospital the one group of staff who know better than anybody else what is going wrong are the junior staff—junior doctors and so on. In the work going forward, will the Government pay particular attention to junior doctors and non-clinical staff who are whistleblowers, and what happens to them? Finally, the report mentions the extension of this work to an examination of avoidable deaths in community settings. Will the Minister say who will be involved in that work and when we can anticipate a report on it?
Earl Howe
We envisage that all NHS providers should be subject to whatever practical measures are agreed. We are not yet in a position to be prescriptive about what those arrangements should be. We will consult on how best to implement Sir Robert’s recommendations in the least burdensome way possible but in a way that fulfils his ambitions to the maximum extent. I totally take my noble friend’s point that junior doctors and non-clinical staff are often in the best position to judge the health and culture of an organisation. Indeed, I am aware that the CQC, when inspecting a hospital, often makes a point of convening a focus group consisting of junior doctors because it knows that there is a great deal to be learnt from that source. On community care, again, we have taken no firm decisions on how this will come about, but we wish to take the advice of those whose views we value.
Lord Morris of Aberavon (Lab)
My Lords, I welcome the Statement and congratulate Sir Robert once again on his most thorough analysis. I also welcome the long overdue proposed change in the law to make employers responsible if whistleblowers are harassed. Does the suggested new duty of candour mean that never again will we see gagging clauses in any NHS contractual arrangements? How long have gagging clauses been tolerated and what is the justification for them?
Earl Howe
I am grateful to the noble and learned Lord. NHS guidance has consistently made it clear that, where confidentiality clauses are used, they should go no further than is necessary to protect the legitimate interests of both the employer and the employee. There are circumstances when a gagging clause is appropriate, but local policies should always prohibit the inclusion of confidentiality clauses in contracts of employment and settlement agreements that seek to prevent an individual making a disclosure in the public interest, in accordance with the Public Interest Disclosure Act. Such clauses are often referred to as gagging clauses. If such clauses were to be included in a severance agreement or settlement, they would be deemed void in any event. We have made it amply clear to NHS organisations where the boundary lies between those two types of confidentiality clause.
Lord Naseby (Con)
Is my noble friend aware that the question of patient safety, which is emphasised, is fundamental to all this? In contrast, the number of claims for medical negligence continues to rise—in the past year, it did so by 18%—and now costs the NHS well over £1 billion. Has the time not come to have a thorough review of how such medical negligence claims are handled and who is behind some of them? Perhaps it is ambulance chasers. In any case, is not arbitration possibly the way forward, such as happens in essence when a coroner looks at a difficult case?
Earl Howe
My noble friend makes a series of very good points. We are, as he knows, extremely concerned about the rising level of litigation costs in the NHS. My department is consulting on proposals for how the duty of candour can be further incentivised by requiring trusts and foundation trusts to meet a proportion of the cost of negligence claims in cases where they have failed to be candid. We are also committing up to £35 million so that the NHS Litigation Authority can support trusts in implementing their safety improvement plans where those plans show a likely reduction in the number of higher-volume and higher-value claims over the medium to long term.
Baroness Masham of Ilton (CB)
My Lords, I congratulate the Government on accepting this second report. The report states that staff working with vulnerable patients should be responsible. How will the Minister make this happen? Patients and carers should be listened to. They can become whistleblowers, but may feel that they will be branded as troublemakers. How can he stop this happening?
Earl Howe
Making every employee responsible goes hand in hand with the duty of candour—the feeling for every employee that they have the freedom to speak up and take ownership of a given situation that is within their control, professionally. We hope that this will gradually show its value in the way that the culture of an organisation changes for the better. Ultimately, though, professionalism depends on training as well. On the whistleblowers, may I ask the noble Baroness to repeat the second half of her question?
Baroness Masham of Ilton
My second question was that since patients and carers could become whistleblowers but might feel that they would be branded as troublemakers, how can the Minister stop this happening?
Earl Howe
I apologise to the noble Baroness. It is very important that that does not happen. This was very much a matter that Sir Robert had in his sights when preparing the report. We have a certain amount of protection for whistleblowers at the moment—the noble Lord, Lord Hunt, referred to this—and the current Government have augmented that protection, not least through the way in which we have improved the NHS constitution. But Sir Robert is clear that we need to go further and, in particular, to ensure that those whistleblowers who find their position untenable in an organisation and are obliged to leave are not thereby blacklisted by the NHS merely for having spoken up. We think that the measures Sir Robert has proposed will achieve this but, more importantly, they will ensure that there is a better form of conflict resolution, able to nip concerns in the bud at an early stage and at a local level.
Lord Touhig (Lab)
My Lords, I had the privilege of introducing the first whistleblower protection legislation when I served in the other place. I regret that it was not successful because the then Conservative Government opposed it. Richard Shepherd, a Conservative Member of Parliament whom I consider a good friend, was much more successful in 1998 when he introduced the Public Interest Disclosure Act, together with the support of the Labour Government. Sir Robert refers to that Act a number of times in his report. On page 9, he says:
“For a number of reasons this legislation is limited in its effectiveness … The legislation does nothing to remove the confusion that exists around the term ‘whistleblowing’ … The legislation is also limited in its applicability”.
He also refers on page 78 to suggestions that PIDA should be strengthened. I agree with him; the Act needs to be reviewed and amended. Will the Government agree to do this, because that would certainly overcome many of the problems that this report has highlighted?
Earl Howe
My Lords, it may be that Sir Robert’s recommendations lead to legislative proposals. At the moment, we have no view on that. We want to consult broadly to seek people’s views, not least from all parties in Parliament. If I understand Sir Robert correctly, he was keen to achieve answers to these questions that do not involve legislative change and can be achieved easily, without too much bureaucracy. However, we would certainly wish to leave the door open if legislation is needed. In fact, there is one particular measure that we will endeavour to put through in the current Parliament, as long as we have cross-party support for it.
Lord Walton of Detchant (CB)
My Lords, I express the thanks of everyone who has worked in the National Health Service for this extremely important and compelling report. Is the Minister in a position yet to say anything about the terms of reference of those who will be the local whistleblowing guardians, what kind of qualifications they will be expected to hold and who will employ them? I take it that the national whistleblowing guardian is to be employed by the Care Quality Commission. Again, it would be helpful to know the Government’s views about the kind of individual who will be sought to fulfil that appointment.
Earl Howe
The noble Lord, as ever, makes a series of very important points. The personal qualities of these guardians need to be considered very carefully. At this early stage, we have made no firm proposals along those lines. As I have indicated, we think that every NHS organisation needs to identify one member of staff to whom other members of staff can speak if they have concerns, particularly if they feel that they are not being listened to. Clearly, the qualities of that local guardian need to be of a kind that inspires trust in the body of employees. As regards the national whistleblowing guardian, that will be a full-time post within the CQC. Again, it will require somebody of stature, sensitivity and trustworthiness so that the system can be seen to be robust.
Lord Framlingham (Con)
My Lords, when I served in the other place, I tried very hard to persuade the then Government to bring back the traditional role of matron into our hospitals. I know that we have modern matrons, but they are not the same thing. It was a most disastrous day when we took matrons away from our hospitals; heaven knows why we did it. If we reintroduced that role, with all its responsibility—and particularly its authority—and an awareness of what goes on the hospital, many of the things that we are talking about today would be resolved.
Earl Howe
I am sure that my noble friend’s comments will strike a chord in many places. I am aware that we have had debates of this kind quite often in the past. Of course, it is open to any NHS organisation or hospital to appoint a matron if it so wishes—and indeed some do that. The key point here is that there should be appropriate leadership in nursing at a senior level in the organisation. The successful organisations of which I am aware have had a senior nurse on the board and someone who has taken direct responsibility for nursing standards throughout that organisation.
Lord Warner (Lab)
My Lords, I am not necessarily of the Hattie Jacques school of nurse management, but will the Minister say a little more about these leadership issues? Those of us who have actually been involved as either a chair or a chief officer of a public body know how difficult it is to keep these agendas alive after they have lost their fashionability in the public eye. What are the Government going to do to ensure that the regulators and the boards keep coming back to this issue and keep bringing to the attention of the front-line staff their enthusiasm—and I use that word advisedly—for learning about failings that are going on in their organisation?
Earl Howe
The answer to that must lie chiefly with the way in which the CQC now operates. One of the domains that it pays attention to in its inspections is the well led domain. Is this an organisation that has leaders in it who are aware of what is going on in the hospital, have a clear vision and a strategy for that hospital and are in touch with patients’ views and experiences, not least through complaints? These, and a whole range of other factors, are what the CQC looks at when assessing the quality of the leadership. The noble Lord is, of course, quite right that this must be and remain a key ingredient of a successful NHS culture and good-quality care for patients. We now have a system in which poor leadership will be exposed quite rapidly.
Lord Stoddart of Swindon (Ind Lab)
My Lords, first, I am quite astounded that people should be treated in this way by one of our great national services. Secondly, will the Minister tell us whether arrangements were put in place whereby people who felt aggrieved or threatened would be able to appeal? Thirdly, will he also tell us what the trade union involvement was, and whether the unions were obstructed from doing their proper job of protecting their members? Finally, are the trade unions going to be consulted about this report to give them ideas about how they could be better involved in protecting their membership?
Earl Howe
My Lords, I agree with the noble Lord, Lord Stoddart, that the examples of poor care exposed by Sir Robert’s report were shocking. In many respects, the work he has done and the recommendations he has made constitute a wake-up call for everybody in the NHS—even those who are providing a very good service, which most of the NHS is providing.
There are many levels of protection for NHS employees. An employee can always lodge an appeal if they feel aggrieved and turn to their trade union for support in that context. We intend to consult widely on Sir Robert’s recommendations, including with the trade unions. We welcome their input to these ideas and look forward to further discussions—which, in the normal course, happen very regularly anyway.
Baroness Pitkeathley (Lab)
The Minister has acknowledged that it should be the responsibility of all staff to support the principles of openness and whistleblowing. However, has he any concern that the creation of these freedom-to-speak-out guardians might—I say only “might”—lead to staff thinking that they could abdicate that responsibility and leave it all to the guardians?
Earl Howe
My Lords, the role of the guardians will be primarily to provide advice to those who have concerns and feel that they are not being listened to. They will be able to report directly to trust chief executives on not just individual issues but on progress in general in stamping out any bullying that may be occurring, or the intimidation that Sir Robert says is all too common. I do not think that the creation of a freedom-to-speak-up guardian will in itself inhibit the process. Of course, we are open to views. If that concern is widely held, we will have to take it into account.
Lord Elystan-Morgan (CB)
Does the Minister agree that while of course it is right and proper that, in relation to whistleblowers, Sir Robert’s recommendations should be given every opportunity to see whether they succeed in removing this scourge from our society, the situation should be monitored and should it be the case that it is not possible to remove this disgraceful practice of victimising whistleblowers, stern, swingeing criminal sanctions should be considered if necessary? It is a drastic proposal, but the practice it would be designed to meet is disgraceful.
Earl Howe
I take full note of the noble Lord’s proposals. Clearly, we will wish to monitor the effectiveness of these new arrangements once they are in place. It will be open to the next Government to make a judgment on that score and, if necessary, to come forward with more stringent proposals that could indeed involve legislation with penalties attached.
Care and Support (Business Failure) Regulations 2014
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Earl Howe
That the draft regulations laid before the House on 3 December and 17 December 2014 be approved.
Relevant documents: 17th Report from the Joint Committee on Statutory Instrument, 19th and 21st Reports from the Secondary Legislation Scrutiny Committee. Considered in Grand Committee on 3 February.
Health and Social Care (Safety and Quality) Bill
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I very much welcome the debate on this important Bill. I thank my honourable friend in another place, Jeremy Lefroy, and my noble friend Lord Ribeiro for their stewardship of this Bill to improve the safety of patients and protection of the public. A productive debate was had in the House of Commons, with support for the Bill from all sides. Parliamentary time is limited. Speaking for the Government, I hope that we can get this Bill on to the statute book as soon as possible.
We must never forget the terrible events that occurred at the former Mid Staffordshire NHS Foundation Trust, which demonstrated what can happen when providers put other priorities before safety. As highlighted by the Francis inquiry report, we have much to improve in patient safety and to avoid a repetition of those tragic events. The Government have thrown their full support behind this Bill in our continuing efforts to improve patient safety and the quality of care. I turn now to the Bill and each of its clauses. I will address most of the concerns from noble Lords; I will write on the others that I am not able to cover.
Safety of care must be the focus of healthcare providers at all times. Regulation by the CQC plays a vital role in assuring that providers are focused on safety and are taking steps to reduce avoidable harm. Section 20 of the Health and Social Care Act 2008 currently provides the Secretary of State with a power to include safety in registration requirements with the CQC, but this is no more than a discretion. It would equally be in the gift of the Secretary of State to put a regulatory system in place for providers of health and adult social care that did not cover safety. The first clause in the Bill will remove that discretion and instead place a duty on the Secretary of State to make CQC registration requirements include safety of care. This is consistent with the Government’s continuing effort to reduce avoidable harms and to ensure services are provided in a safe way.
Parliament has recently passed new requirements for registration with the CQC, which include new fundamental standards. Regulation 12 of the fundamental standards states that,
“care and treatment must be provided in a safe way”,
and it sets out a number of steps that providers have to take in order to reduce the risk of unsafe care. Where a provider fails to meet this registration requirement in a way that results in avoidable harm to a service user, the CQC will be able to bring a prosecution against that provider. It is the Government’s sincere intention that the CQC will make use of this important power to hold providers to account for the most serious failings in care.
It is the Government’s view that this new fundamental standard, which comes into force in April, already meets the requirement of the Bill that we are considering. It is important to emphasise that the Government do not intend to amend the registration requirements in response to Clause 1.
I am aware that concern has been expressed regarding the use of the phrase “avoidable harm” in this clause. The Health Foundation, for example, as we have heard, has argued that Clause 1 will draw time away from understanding risk and preventing harm. I do not share that view. Part of being able to assess the risks of receiving care and treatment in order to prevent harm in future involves examining past performance and understanding the causes of past incidences of harm. It is vital that an organisation can learn from its errors in order to improve services to patients and service users.
Furthermore, I say to my noble friend Lord Willis and to other noble Lords that whatever the perceptions, “avoidable harm” equates not to “zero harm” but to harm that can reasonably be avoided. For example, where harm is an inherent part or risk of a regulated activity and it is in the best interests of the patient to receive that regulated activity, this clause would not seek to prevent that activity. However, in providing the service in question, the provider should still take reasonable steps to prevent any harm that is avoidable, such as harm from the use of unclean instruments. I say to the noble Lord, Lord Warner, that this is exactly about providers seeking a continual reduction in harm, given the intrinsic risk that exists in many treatments.
I hope that noble Lords will support the objective enshrined in this clause of causing no avoidable harm. This clause places a duty on the Secretary of State to impose requirements that he,
“considers necessary to secure that services provided in the carrying on of regulated activities cause no avoidable harm to the persons for whom the services are provided”.
The duty on providers is not imposed by this clause: rather, it will be imposed by the regulations that are issued under this clause. I perhaps need to emphasise that to the noble Lords, Lord Turnberg and Lord Hunt. The regulatory levers are already in operation through the CQC registration requirements on the safety of care. The duty set out in the Bill will not change those regulatory requirements. Indeed, from April a regulated provider may be prosecuted by the CQC if the way in which it provides care or treatment causes avoidable harm to a patient or service user, so this is already the case.
The noble Lord, Lord Young, referred to following best practice. The CQC can take relevant best practice into account when assessing a provider’s performance against registration requirements and in reaching a judgment about rating services. Indeed, the CQC’s guidance to registered providers of health and adult social care about complying with the regulations will point to such best practice.
Turning to Clauses 2, 3 and 4, the sharing of relevant information in a timely and accurate manner facilitates the provision of integrated care and treatment, tailored to an individual’s needs and wishes. This information sharing is essential to the delivery of safe and high-quality care. Dame Fiona Caldicott, in her review of information governance, found a culture of anxiety that prevents information sharing, and the current legislative landscape was found to be a contributory factor. The review recommended that the duty to share information should be as important as the duty to protect patient confidentiality. The information-sharing provisions in the Bill seek to create parity between the need to protect information and the need to share it as part of care.
The second clause in the Bill will place a duty on providers and commissioners of publicly funded health and adult social care to record and use a consistent identifier in health and care records and correspondence. This duty will apply only in the best interests of the individual patient and in the direct provision of their care. A long-standing priority of the Department of Health has been to establish the universal use of the NHS number as a consistent identifier when individuals move between care providers. This will support the integration of medical records, reduce errors and facilitate the co-ordination of care. It is our intention that the NHS number will be specified in regulations as this consistent identifier. Others in the debate referred to the national insurance number, but the NHS number is already a well established identifier and the proportion of people in England without an NHS number is very small. Of course, the number of those without a national insurance number is rather greater.
The noble Lord, Lord Turnberg, asked whether this should not apply also to the private sector. The duty to use the NHS number applies only to providers and commissioners of publicly funded health and adult social care. This means that it will apply to NHS commissioners, local authority commissioners and providers of health or adult social care that are public bodies, or are contracted by an NHS or local authority commissioner. Private sector providers would be subject to the duty only in respect of care they provide that is made pursuant to contracts with NHS commissioners.
The third clause in the Bill would place a duty on providers and commissioners to share information. Where it is in the patient’s best interests, providers and commissioners within scope will be required to share relevant information with staff within their organisation, and with other providers and commissioners directly involved in that person’s care. As my noble friend Lord Ribeiro explained, this will reduce the burden of moving between care settings and having to tell your story over and over again. This is especially true in the case of older people, and people with dementia and other complex conditions. It is the intention of these clauses that using a consistent identifier, and having a duty to share information, will help to ensure that health and care professionals will have the information they need to deliver high-quality care. I must stress that the duties within the Bill are strictly limited to the sharing of information for the purposes of direct care and only in the individual’s best interests.
Turning to Clause 4, these duties will not extend to providers and commissioners of children’s social care or the providers and commissioners of children’s healthcare, for which the Department for Education is responsible. I know that concern has been expressed about this exclusion, not least by the noble Lord, Lord Warner. I understand those concerns. Requiring children’s education and social care settings to use a single identifier would extend the scope beyond that of the Health and Social Care Act 2012, which this Bill seeks to amend. As the noble Lord knows, the statutory framework for children’s social care is different, with the DfE the lead department and Ofsted the regulator. Responsibilities have already been placed on professionals and agencies working with children to share information, particularly where there are safeguarding concerns.
There may be benefits in extending the use of a common identifier from the NHS to wider children’s services but, as yet, these benefits have not been assessed against the costs and burdens on local authority children’s services. Implementing a duty to use the NHS number could create significant burdens on schools, which would have to collect and record NHS numbers from all pupils when they enrol in the school. That is why the Department for Education has committed to undertaking an evidence-gathering exercise to fully understand what the impact of using a consistent identifier would be for these types of provision. This exercise is expected to report by the end of the year.
I now come to the fifth clause and the schedule, which will bring in a consistent overarching objective for both the Professional Standards Authority and the regulators of certain health and care professionals, including dentists, nurses, midwives and opticians. This will ensure that public protection is at the heart of what the Professional Standards Authority and these professional regulators do. This overarching objective of public protection will involve the pursuit of objectives in relation to protecting, promoting and maintaining the health, safety and well-being of the public, and promoting and maintaining public confidence in the professions covered by the Bill and proper professional standards and conduct for members of those professions. This measure will also ensure that regulatory body panels dealing with the disposal of fitness to practise cases—that is, making a final decision or considering appropriate sanctions—will have regard to that overarching objective.
The noble Baroness, Lady Pitkeathley, and my noble friend Lord Willis expressed disappointment at the lack of a government Bill on professional regulation, and I think that that disappointment is widely shared. We of course welcome the law commissions’ 2014 report but, in the absence of a government Bill to implement its recommendations in this Parliament, we have taken the opportunity to consider the report and to work closely with the regulatory bodies and the PSA to build on the important work that the law commissions have done. We accept the vast majority of the recommendations and the Government remain committed to legislate on this important issue at the earliest opportunity when parliamentary time allows. I am therefore particularly pleased to throw the Government’s full support behind this Bill, which seeks to implement in part and for some of the regulators two of the law commissions’ recommendations.
The noble Baroness, Lady Pitkeathley, asked how the PSA can have an objective to promote confidence in the professions when one of its functions is to uncover poor performance. Let me explain this a little further. Under the new overarching objective, the PSA and the regulators will have to act in the interests of public protection. The reference to maintaining public confidence is bounded by this overarching objective of public protection and does not mean that the PSA or the regulators should be actively promoting the reputation of the professions, as this does not necessarily serve public protection. Rather, it is concerned with conduct, performance or behaviour of individual members of a registered profession in so far as this threatens to undermine confidence in the profession as a whole, to the extent that people may be deterred from seeking the treatment or care that they need.
It is clear to me that a robust and transparent way to challenge regulators’ decisions, while it may call into question decisions in individual cases, can only contribute to maintaining wider public confidence in the professions as a whole. In some instances, that may mean that poor performance is uncovered. Sometimes it is necessary to do this to increase public confidence in the professions—and of course that is only right. This is not about requiring the PSA to maintain public confidence in individual professionals or even in the regulators, but confidence in the professions. I hope that that is helpful to the noble Baroness.
The overarching objective does not create any additional functions for the PSA. The PSA is an independent body which oversees the work of the nine regulators of health and social care professionals. Its functions remain unchanged and include auditing investigation stage decisions of the regulators’ fitness to practise procedures, referring final fitness to practise disposals to the relevant High Court where necessary and reporting on the performance of the regulators.
Under this Bill, while discharging particular functions in relation to the regulators—that is, promoting best practice in professional regulation, formulating principles relating to good self-regulation and encouraging co-operation between the regulators, and between them and other bodies that exercise corresponding functions—the PSA must have in mind the overarching objective of public protection. This may involve the PSA, in its role as overseer of the regulators, taking such appropriate actions as may be available to them in the circumstance that regulators have not acted in accordance with their own overarching objectives.
I know that the PSA is particularly concerned with consistency in the legislation governing regulation of health professionals. Ensuring consistency of purpose in professional regulation and how it is overseen through the introduction of a consistent overarching objective was a key recommendation made by the law commissions in their review of regulation of health professionals published last year.
I also know that the department and the PSA share the common principle that any legislative change must have public protection at its core. I would just say that the definition of “public” in the Bill encompasses patients, users of healthcare and social care, and,
“other members of the public”,
as defined in the PSA’s existing objective. I say to the noble Baroness, Lady Pitkeathley, that my officials are happy to continue the discussions which I know have been conducted recently in order to give any further clarification that might be helpful. As the Government set out in our response last week, we support this principle and we hope to see public protection placed clearly and firmly at the heart of professional regulation through this Bill and through parallel secondary legislation for the GMC, which will shortly come before this House.
I should like to clarify the effect of Clause 5 and the schedule for my noble friend Lord Willis. The Bill introduces a duty on regulators’ panels and committees. It does not affect the regulators’ fitness-to-practise processes. My noble friend mentioned the NMC’s fitness-to-practise caseload. I reassure him that the department has recently taken forward secondary legislation in relation to the NMC to help it to carry out its fitness-to-practise and registration functions more effectively. I am happy to write to my noble friend if he would like further and better particulars.
At the risk of overstaying my welcome at the Dispatch Box, I hope that I may be allowed to cover briefly a point which arose as the Bill passed through the House of Commons and which I know is of concern. The BMA has raised concerns about the requirement for fitness-to-practise panels and committees to consider “public confidence” when making final decisions about the application of the term “well-being”. I understand that the BMA recently had productive discussions with my honourable friend the Parliamentary Under-Secretary of State for Health, Dr Dan Poulter, and has been much reassured by the intention for the overarching objective to be set out in secondary legislation for the GMC and in this Bill for other regulators. Indeed, the BMA wrote to my honourable friend yesterday to confirm this and to seek further assurances about the form that guidance might take and how it might clarify how regulators’ panels and committees should apply the overarching objective in practice, particularly the interpretation of the terms “public confidence” and “well-being”. These concerns relate particularly to issues raised by a recent GMC consultation on sanctions guidance.
Noble Lords will understand that the GMC’s handling of fitness-to-practise cases is not within the scope of this Bill. However, these issues are likely to be relevant to the other regulators who will be subject to the new, overarching objective. Of course, I cannot say on behalf of the regulators how they should give guidance on their internal processes, but I will ensure that my officials raise these issues with the professional regulators when considering the implementation of the objectives, as part of both this Bill and the GMC legislation, and can confirm that the GMC will seek views on implementing its secondary legislation through a public consultation.
I think that that is enough from me. I will of course write to noble Lords, as I have promised, on other matters.
Lord Warner
Will the Minister clarify something that he said in relation to what I said in my speech? He said that the Bill cannot cover children in relation to health and social care. I have just read the Long Title and the Title. I can see nothing there that specifies particularly adults or excludes children. I would welcome it if he could write to me to explain what the legal judgment is as to why an amendment that relates to health and social services only—not police, not education—should not be included in the Bill in respect of children.
Lord McColl of Dulwich
Before the Minister sits down, could I ask him about the WHO checklist? When I go into an operating theatre, the operation cannot start until that list is completed by the surgeon, the anaesthetist and the nurses. Could that be put into regulations?
Lord Rea (Lab)
Perhaps I may be the third Member of the House to ask the Minister to answer a question before he sits down. There has been a lot of talk about there being no government time properly to discuss many issues that have been brought up in this debate. The Minister did not answer the point made by my noble friend Lord Hunt, but there is very little government legislation in the pipe now and time could almost certainly be found. I accept that Private Members’ Bills are normally considered only on Fridays—there are not very many Fridays left—but, as this Bill is a quasi-government Bill, I feel that perhaps the Government could make time for it.
Earl Howe
My Lords, I am sure that the noble Lord is aware that the timetabling of business is not a matter for the Government. My understanding from the usual channels is that Private Members’ Bills cannot be given government time or priority treatment. However, I have no doubt that, having listened to the comments made in this debate from all sides of the House, the usual channels will wish to have further discussions.
Women: Postnatal Depression
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, the Government have prioritised improving mental health care and support for pregnant women and new mothers in their mandate to NHS England, with a clear objective to reduce the incidence and impact of postnatal depression. We have taken steps to improve the size and capability of the workforce—there are 2,000 more midwives and 3,200 more health visitors than in 2010. By 2017, specialist perinatal mental health staff will be available to every birthing unit.
Baroness Royall of Blaisdon (Lab)
My Lords, that is welcome news. Too many women who suffer from postnatal depression do not seek help because of the stigma attached to mental illness, together with the guilt and shame attached to feeling that they are not being the sort of mother that society expects. I hear what the noble Earl says about specialist care, but what are the Government doing to ensure that specialist mother and baby units can be accessed by these new mothers wherever they live in this country, so that they do not end up on acute psychiatric wards, separated from their babies or partners, or not receiving the requisite help? At the moment, I fear that parity of esteem for mental health is not a reality for these women.
Earl Howe
My Lords, we know there is more to be done. There are perhaps two key actions here. One is having a sufficient number of trained professionals in place—I have mentioned the increase in the number of health visitors and midwives—and the other is raising awareness of the risks and signs of postnatal depression with mothers-to-be. Extensive training is available and delivered to midwives, both during their initial training and afterwards. The programme of family nurse partnerships commenced by the previous Government is tremendously important in the follow-up stage after birth to ensure that new mothers are monitored closely.
Lord Alderdice (LD)
My Lords, we know that one of the very important elements in support of women in the pre- and post-partum period is the quality of the relationship between the father and the mother of the child, and that where there is a problem in encouraging that, there is frequently difficulty. Given that, is my noble friend satisfied that this element of the relationship is sufficiently addressed, appreciated and nourished in all our facilities?
Earl Howe
The role of the father, as well as of course that of the mother, is emphasised in all the guidance—certainly in the healthy child programme but also in the work done under family nurse partnerships, which targets the most vulnerable families. That programme provides intensive support to young first-time mothers and their babies. It explicitly involves fathers—and/or other family members as well—as long as the mother wants the father to take part.
Lord Laming (CB)
My Lords, does the Minister agree that two elements need to be addressed? First, there is the safety and well-being of the mother but, secondly, there is the important issue of helping the mother to bond with her new baby. That requires quite intensive work at a critical time in the life of the new baby and of the mother. Could he assure us that these matters are being addressed in these new arrangements?
Earl Howe
The noble Lord makes some extremely pertinent points. The family nurse partnership programme that I mentioned is important in this context, and our aim is to expand that to 16,000 places by April 2015. We launched the NHS Start4Life information service for parents. Parenting classes are available through the CANparent network and we are developing a population measure to show child development at two to two and a half years for inclusion in the public health outcomes framework, so that we can measure the progress we are making.
Baroness Nye (Lab)
My Lords, would the Minister agree that midwives had a crucial role to play in identifying and helping women suffering from postnatal depression, so it is regrettable that the Prime Minister’s pledge at the last election that there would be 3,000 more midwives during this Parliament has not been met? The increased number of midwives in training is to be welcomed, but does he agree that valuable mental health care support for new mothers is being lost if some NHS trusts do not have the money to employ them when they finish training?
Earl Howe
It is positive that the number of midwives has increased by 2,000 since 2010, as I mentioned, and there is a record number in training, as the noble Baroness mentioned. But she is right about the role of the midwife before, during and after the birth. The visits that a new mother can expect from a midwife should contain a session where the right questions are asked of the mother about how she is feeling and how her baby is. The signs and symptoms of postnatal depression are ones that every midwife is trained to pick up.
Baroness Howe of Idlicote (CB)
My Lords, as well as the importance of the bonding of the mother and baby, and the other very welcome steps that the Government are taking, I hope the Minister will agree that the needs of the children at home—they are very badly affected, one hears, by a mother who is in a state of mental depression—should be taken into account and met equally.
Baroness Corston (Lab)
My Lords, does the Minister agree that there is still a social stigma attached to postnatal depression? I have heard people say, “She’s got a new baby, what’s she complaining about?”. What steps are the Government taking to increase public understanding of the fact that this is a mental illness, unbidden, which affects women who would like to be able to bond with their babies and be proud of them like the rest of us are?
Earl Howe
The noble Baroness makes an extremely good point. I think that the stigma attached to mental illness is slowly diminishing, although there is a long way to go. But she is right that there are common misconceptions around the baby blues and postnatal depression. One of the most important things we can do is inform mothers-to-be of the risks and signs of those syndromes. If we can do that and prepare mothers for the possibility that they will experience this, we are more than half way there.
NHS: Maternity Care
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, first, I join other noble Lords in thanking the noble Lord, Lord Harrison, for securing this debate. In doing so, I thank all noble Lords who have spoken for their excellent contributions. We cannot overstate the importance of good health and well-being for women before, during and after pregnancy. It is an absolutely critical factor in giving children the best possible start in life and in building the foundations for good health and well-being as they get older. That is why providing high-quality maternity care is a key priority for the Government. In their mandate to NHS England, the Government set out an expectation to see significant progress, by March 2015, in improving the standards of care and experience for women and families during pregnancy, and in the early years for their children.
The noble Lord, Lord Hunt, emphasised the importance of choice for women and we agree. Women should have as much choice and control as possible over decisions about their care while they are pregnant. The mandate is clear that women should be offered the greatest possible choice of providers and that they should have a named midwife who is responsible for ensuring she has personalised, one-to-one care throughout pregnancy and childbirth, and during the postnatal period, including additional support for those who have a maternal health concern. I quite agree with the noble Lord, Lord Harrison, about the importance of continuity. NHS England is working to deliver these commitments through the Maternity & Children Programme Board.
Part of that delivery must lie in increasing the number of midwives. The Government have taken steps to improve the size and capacity of the maternity workforce. There are now more than 22,000 qualified midwives, which is an increase of nearly 2,000 midwives since 2010. Another 5,000 midwives are currently in training, which is a record number, and we expect that this level of midwifery training commissions will be maintained in 2015-16. The number of midwifery-led units has increased from 87 units in 2007 to 152 units in 2013, giving most women a choice of place of birth, and 79 per cent of women of childbearing age in England now live within a 30 minute drive of both a midwifery-led unit and an obstetric unit, which is up from 59 per cent in 2007. We have also taken steps to improve the quality of the environments in which women give birth and are cared for. In 2013 and 2014, we provided a total of £35 million capital funding for the NHS to improve birthing environments.
The Government’s investment represents the single biggest capital investment in maternity care for decades, with more than 100 maternity services benefitting. Across the country, many local maternity services have been transformed. Improvements delivered by our maternity investment fund include almost 40 new birthing pools, which can help to make labour less stressful and painful; nine new midwife-led units, which are less clinical and can be more relaxing places to give birth; more en-suite bathroom facilities in more than 40 maternity units, providing more dignity and privacy for women; more equipment, such as beds and family rooms, in almost 50 birthing units that allow dads and families to stay overnight and support women while in labour or if their baby needs neonatal care; complex needs suites for women who need a more constant care environment due to maternal mental health or substance abuse problems; and better bereavement rooms and quiet area spaces at nearly 20 hospitals to support bereaved families after late pregnancy loss, a stillbirth or an early neonatal death.
The noble Lord, Lord Harrison, spoke of the bumpy road faced by women and the wide variation in quality of service. I recognise that there is variation but we are making progress. According to December’s friends and families test, 96% of women said that they would recommend their maternity service for antenatal care; 97% for their labour and birth care; and 98% for their postnatal community care. However, we are keenly aware that we must not be complacent. Although the birth rate in England fell by 3.6% in 2013-14, we know that complexity of maternity care is increasing with increases in average maternal age, obesity rates and awareness of other physical and mental health concerns.
To meet those challenges, it is important that the maternity workforce continues to develop. This Government established Health Education England, which is responsible for promoting high-quality education and training that is responsive to the changing needs of patients and local communities. For maternity services, this means ensuring that the NHS has access to the right numbers and mix of staff with the right skills, and the right values and behaviours to provide every woman with personalised one-to-one care throughout pregnancy and childbirth, and during the postnatal period
As set out in its mandate, HEE is working with NHS England to establish a vision of personalised maternity care by 2022 across geographical and service settings; to describe the workforce needed to deliver it; and to work with key stakeholders, including the Royal College of Obstetricians and Gynaecologists, the Royal College of Paediatrics and Child Health and the Royal College of Midwives to deliver it.
Perinatal mental health has not previously been given the attention that it deserves. I was grateful to my noble friend Lady Manzoor for emphasising that. That is why we have made creating a maternity service that meets the individual needs of women and supports the prevention, diagnosis and treatment of maternal mental health issues a priority. HEE is continuing to work with the Nursing and Midwifery Council and the Royal College of Midwives to ensure that midwives in training have a core training module focusing on perinatal mental health, which should be in place for those entering midwifery training in 2015. It is also developing a continuing professional education framework for the existing maternity and early years workforce, which will include identifying the care and treatment required by women with perinatal mental illness. It is also continuing to work with the medical royal colleges to support specific perinatal mental health training being incorporated into the syllabus for doctors in postgraduate training.
The noble Lord, Lord Harrison, referred to the midwife to birth ratio, which is an interesting subject. The ratio set by the Birthrate Plus tool of 29.5 births per midwife is not a mandatory ratio. The Department of Health does not recommend a midwife to birth ratio. The midwife to birth ratio is an indication of throughput only and does not indicate the safety, quality or outcome of the service provided. Nevertheless, the National Institute for Health and Care Excellence published draft guidance on safe staffing in maternity settings in October 2014. That guidance proposes that the number and skill mix of midwives needs to be determined by the midwife in charge at the start of every shift or service and sets out the process that midwives should use to determine whether there is sufficient staff to provide for the needs of women and babies. NICE is planning to publish the final guidance this month.
The noble Lord also referred to the importance of maternity networks. I entirely agree with him. NHS England has set up 10 women and children maternity strategic clinical networks which are working with NHS England area teams to support clinical commissioning groups to commission maternity services. These networks can develop action plans and collaborative working to drive improvements in access, quality of care and inter-service communication to enhance the experience of women and families generally and, more specifically, of the large numbers of women who are at risk of poor mental health during pregnancy and following childbirth.
As I have mentioned, my noble friend Lady Manzoor referred to the costs of perinatal mental health problems. She is right to do so. Two fundamental principles articulated in our mandate to NHS England are relevant. The first is equal access for equal need; the second is parity of esteem for mental health. There is no doubt that offering better support to new mothers to minimise the risks and impacts of postnatal depression is a priority. Indeed, NHS England has announced that perinatal mental health will be a priority for it in 2015-16.
To support CCGs, NHS England has just updated its maternity services commissioning guidance, which will be published soon, and include information on commissioning for parity of care for a woman’s mental health as well as her physical health, and there will be more detailed guidance on the development and delivery of perinatal mental health services across a range of geographies and demographics for all commissioners and service providers.
My noble friend bemoaned the lack of maternal mental health outcome data. The Department of Health has commissioned the National Perinatal Epidemiology Unit at Oxford University to develop a maternal mental health outcome indicator to monitor mental health outcomes for women across the maternity pathway. We expect to include this in future NHS and public health outcome frameworks.
My noble friend also referred to the incidence of suicide, about which we are extremely concerned. However, again, this is a focus for both NICE and midwives in training.
My noble friend Lord Farmer referred, rightly, to the importance of fathers in perinatal care. There is no doubt that involving new fathers and partners in a child’s life is extremely important for maximising the lifelong well-being of a child. It is absolutely central to that and our policies are quite clear that pregnancy and birth are the first major opportunities to engage fathers in the appropriate care and upbringing of their children. This is explicitly mentioned in the healthy child programme, which every health visitor has to implement. I referred earlier today to the Start 4 Life information service, the material on NHS Choices, the baby guide and on the online birth-to-five guide. All these signpost parents to wider information about parenting and relationship support. The NICE guidance for health professionals on antenatal and postnatal mental health explicitly mentions the role of the partner, family or carer in providing support.
My noble friend Lady Cumberlege referred to the Five Year Forward View and the need to reconfigure maternity services. NHS England, in that forward view, said that it would look at new models of maternity care. It has set up a programme board, co-chaired by NHS England and Cathy Warwick, the external secretary of the Royal College of Midwives, and the first meeting for this is tomorrow.
Time prevents me, unfortunately, from addressing all the other questions that noble Lords have put to me. I undertake to write as soon as possible to every noble Lord who has spoken. In the mean time, this debate has drawn out some extremely important threads and themes that both the Government and NHS England would do well to follow up and implement.
Autism
Earl Howe Excerpts(10 years, 4 months ago)
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Baroness Uddin (Non-Afl)
My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I draw the House’s attention to my declared interest.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, there are a number of current government-funded research projects linked to autism. These include a Medical Research Council study to identify why certain genetic mutations can cause problems during brain development. By following the National Institute for Health and Care Excellence’s guidelines and toolkits, autism diagnosis can be speeded up. NHS England also has plans to use its local audit teams to provide assurance that people’s experiences of the diagnostic process are acceptable.
Baroness Uddin
My Lords, I thank the Minister for that thoughtful reply. He and I agree completely that there have been massive improvements in diagnosis over past decades. However, according to the Government’s Think Autism document, reports by the National Autistic Society and the BME organisation Include Me TOO, the experience of many parents seems to be that there are significant disparities and underdiagnosis, particularly among the BME communities. Given the crucial importance of timely diagnosis to the future prospects of someone with autism, how does the Minister’s department intend to address this currently patchy and inconsistent assessment service for all those who are identified as needing a full diagnosis on time and according to the Government’s own standards, and how does it intend to monitor progress?
Earl Howe
My Lords, the noble Baroness is right that timely diagnosis of autism is extremely important. I am glad she recognises that progress has been made. I believe that to be true but we know that there is more to be done. The update to the autism strategy, called Think Autism, draws specific attention to the needs of BME communities, and there is a specific action point within that document. I can tell the noble Baroness that we will include that specifically in the statutory guidance that follows on from the strategy. That guidance will be issued shortly.
Baroness Gardner of Parkes (Con)
My Lords, where I live, the daughter of a very nice man in the supermarket has just been diagnosed at the age of six. The problem is not the diagnosis—that has been made—but the fact that there seem to be no facilities of any sort to help him. He has been referred to the local borough by his Member of Parliament—an opposition Member, I might add, but a very nice man—and he has taken up the matter with the council, but nothing has happened. Is this, again, a problem of treatment as between care and health services, and what can be done to bridge the gap?
Earl Howe
My Lords, the answer to my noble friend’s question lies in more professionals being trained in autism and services supporting rather better the needs of children and adults with autism, and a lot of work is going on on those fronts. We are also asking local authorities to focus, in particular, on their own performance and to report back on the progress they are making on autism diagnosis, and indeed on other issues in Public Health England’s national autism self-assessment exercise. That process will draw out the shortcomings that exist in certain parts of the country.
Lord Touhig (Lab)
My Lords, there is evidence that some 25,000 children in England with autism have not been thoroughly diagnosed. The National Autistic Society, of which I am a vice-president, found in a survey that 34% of autistic people had to wait more than three years for a diagnosis. What are the Government doing to speed up this diagnosis and to ensure that it takes place within three months of a referral, which is the NICE recommendation?
Earl Howe
My Lords, part of this depends on the system working in a joined-up way between the National Health Service, local authorities and all the services upon which they depend. A great deal more training is going on, as I have mentioned. In December the Department of Health, the Association of Directors of Adult Social Services and Public Health England issued a new national autism self-assessment exercise, as I have mentioned. Much can be achieved, as we are impressing on local authorities, through low-level preventive support, and there are duties around prevention in the Care Act that local authorities now have in this area.
Lord Addington (LD)
My Lords, what is the relationship between the Department for Education and the Department of Health, particularly in spotting those at the higher-functioning end of the spectrum, for whom it may not become apparent that they have a problem until later in life rather than in the educational system?
Earl Howe
My Lords, the new statutory framework for children and young people with special educational needs and disabilities, SEND, is designed to improve the integrated working across health, education and social care so as to deliver improved outcomes for a child and his or her family. Clinical commissioning groups and local authorities will be working together according to that statutory framework.
Baroness Howarth of Breckland (CB)
My Lords, the Minister clearly accepts that speed of diagnosis ensures that a child or young person gets into treatment faster. The faster they are in treatment, the more likely they are to make some progress in how they are able to function. However, does he accept that there is a disconnect between that diagnosis and the service delivery, particularly with under-fives, where children are waiting a considerable time for their local authorities to sponsor them into nurseries or facilities? What is happening to ensure that that improves?
Earl Howe
The noble Baroness makes a very good point. That is exactly why we have given clinical commissioning groups new duties to commission services for nought to 25 year-olds and young people to ensure that procedures are in place, to agree a plan of action, to secure provision which meets a child’s or young person’s reasonable health needs in every case, and to work with the local authority to contribute to the local offer of services for children in this position. That is now a statutory duty and I think it is a step forward.
Lord Bradley (Lab)
My Lords, the Minister referred to training. Health Education England is one of the bodies charged with delivering the new strategy for transforming care for people with learning disabilities, including autism. Is it not extraordinary, therefore, that it does not keep a record of which universities deliver courses for nurse training in learning disabilities? Will the Minister ensure that such information is available so that training courses are properly monitored, with autism being a key component of such nurse training?
NHS: Financial Tariff for 2015-16
Earl Howe Excerpts(10 years, 4 months ago)
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Lord Hunt of Kings Heath
To ask Her Majesty’s Government what is their response to the rejection by National Health Service Trusts of the financial tariff proposals drawn up by Monitor for 2015–16.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, we recognise the frustration and uncertainty this delay will cause providers and commissioners. My department is working closely with Monitor and NHS England to consider which option to pursue that provides the fairest settlement for different NHS organisations while ensuring that patients continue to receive the best possible care.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the noble Earl for that reply. Can he confirm that this is the first time that NHS trusts have rejected the tariff on the grounds that they can no longer provide safe and quality care and meet financial targets next year on the basis of the tariff laid down by Monitor? Can he also confirm that the finance director of the NHS Trust Development Authority told Monitor that he does not consider that the efficiency requirement for next year can be met without risking quality of care? When will the Government take responsibility for the financial disaster coming upon the NHS?
Earl Howe
My Lords, it should not cause us any surprise that, at a time of financial stringency in the NHS and increasing demand, it should have proved more difficult than usual to arrive at a settled position on the tariff. The process is undoubtedly complex and challenging but we will continue to work with and support Monitor and NHS England in managing this in a way that attempts to be as fair as possible to all parts of the system.
Baroness Barker (LD)
My Lords, given the historic underfunding of mental health services in this country, will the Government make representations to Monitor to ensure that mental health trusts are not required to make savings at the same rate as other trusts?
Baroness Howarth of Breckland (CB)
My Lords, a great deal of concern has been expressed by specialist providers, particularly in the heart field where there is a review ongoing at the moment, that there might well be a reduction in funding. That would be disastrous for services. Can the Minister reassure those groups that there will be a fair assessment in relation to specialist provision?
Earl Howe
It is the view of Monitor and NHS England that providers of specialised services should make every effort to deliver care that is both clinically appropriate and cost-effective in order to manage demand—where, after all, their clinicians have significant influence. NHS England considers the proposed rule to be warranted—this is about the 50:50 split in the tariff—because rapidly growing expenditure that exceeds population prevalence growth is unlikely to reflect efficient and effective services, which, when one thinks about it, are in patients’ best interests overall.
Baroness McIntosh of Hudnall (Lab)
Going back to the question asked by the noble Baroness, Lady Barker, I am sure the Minister will have seen recent reports showing that there is a serious shortage of mental health beds in the health service at the moment. Indeed, I believe that at one point in the very recent past there were no more than four or five available in the entirety of the UK—or certainly in England. Parity of esteem is a fine phrase, but is it really being played out in practice?
Earl Howe
My Lords, it would require a full-scale debate for me to lay out in full all the things that we are doing to promote parity of esteem in the health service. The noble Baroness is right that in certain parts of the country there has been acute pressure on bed numbers, but bed numbers have been increased in some of those areas, and NHS England is paying close attention to the need to ensure that those who need in-patient treatment receive it.
The Earl of Listowel (CB)
My Lords, will the Minister look carefully at the bureaucratic burden on clinicians? A number of clinicians have raised with me the fact that there is too heavy a burden, and that because of that burden, they are not being as efficient as they might be.
Earl Howe
My Lords, yes of course the bureaucratic nature of commissioning needs to be minimised and we do all we can to achieve that. However, the need to ensure that we make a careful distinction between commissioners and providers does, I am afraid, mean that rather a lot of numerical work has to go along with that and, as is right, discussion between commissioners and providers to ensure that the system works smoothly.
Baroness Manzoor (LD)
My Lords, Choose and Book has been a success story for the Government. It is a hidden gem. Will this be affected by the level of tariffs that are to be offered and will patients have a real choice?
Lord Harris of Haringey (Lab)
My Lords, given the appalling performance of ambulance services—certainly in London, and, I suspect, in the rest of the country—what steps are the Government taking to ensure that the tariff means that people will receive the emergency call-outs that they would expect on the basis of the funding that should be being made available?
Earl Howe
This is part and parcel of the discussions going on at the moment. There is a balance of interests here—above all, the interests of NHS patients, but within the system, the interests of those who hold the budget and the interests of those who provide the service. The risks relate, on the one hand, to affordability, and, on the other hand, to financial and service stability, and the need not to sacrifice quality in the process.
Baroness Farrington of Ribbleton (Lab)
My Lords, would the Minister care to comment on his former colleague in his department who views the reorganisation of the National Health Service as the biggest mistake this Government made? As we come towards the end of this coalition Government, some of us watch in horror as an increasing number of people within the coalition stand up and say, “It weren’t me, guv”, and, “I didn’t agree with it”. Does the Minister accept that his party, this coalition and the Liberal Democrats did not actually ask the people whether they should do this? They told them that they would not do it.
Earl Howe
My Lords, I remain a staunch defender of the 2012 Act. In this context, the 2012 Act did two things that were different. It gave responsibility for setting the tariff to an independent body instead of to the Department of Health and Ministers. I believe that that was a good thing. It also provided a statutory right, which did not exist before, for the NHS to be consulted on the tariff. I believe we should keep those two elements of the Act—as well as the rest of it.