Health and Social Care (Safety and Quality) Bill

Lord Hunt of Kings Heath Excerpts

Friday 13th March 2015 Lords Chamber

[Baroness Masham of Ilton (CB)]

I agree that there should be a culture of openness, honesty and transparency. When things go wrong, most people say, “I don’t want this to happen to anyone else”. There should be lessons learnt from mistakes, not cover-ups. This should be made as clear as possible.

[Lord Hunt of Kings Heath (Lab)]

My Lords, as noble Lords know, the Opposition support the Bill. However, issues have been raised which I hope the noble Earl, Lord Howe, will help to clarify.

I should like to pick up my noble friend’s point about whether this issue is raised at institutional or individual level. It looks as though the Bill focuses on individuals. Will the noble Earl confirm that it is his view that responsibility ultimately lies with the corporate boards which are responsible for the activities taking place in the National Health Service? If that is so, why does the Bill not list those bodies which it covers so that it would be clear who should take corporate responsibility?

Secondly, I take the noble Earl back to the Statement he made last week about Morecambe Bay. It was very telling when he talked about the concerns raised by Dr Bill Kirkup about the lack of a culture of openness and transparency. He said that,

“this report makes clear that there is a long way to go. It seems medical notes were destroyed and mistakes covered up at Morecambe Bay, quite possibly because of a defensive culture where the individuals involved thought they would lose their jobs if they were discovered to have been responsible for a death. However, within sensible professional boundaries, no one should lose their job for an honest mistake made with the best of intentions. The only cardinal offence is not to report that mistake openly so that the correct lessons can be learnt”.—[Official Report, 3/3/15; col. 160.]

Will the noble Earl say very clearly that that point, which I agree with, is not in conflict with the Bill, and in particular with Clause 1? It is very important—the last thing we want to do is discourage people from being open about mistakes. We do not want that to be an unintended consequence of the Bill.

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[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, I shall first address a concern that several noble Lords have flagged up most prominently: that the regulations are not sufficiently clear that the duties that we are talking about here are duties on providers rather than individuals. The regulations apply to registered persons. Schedule 1 to the Interpretation Act 1978 makes it clear that in legislation “person” includes not only natural persons but legal persons, such as companies. Under the Health and Social Care Act 2008, the registered persons are providers, not individual members of staff.

The noble Lord, Lord Hunt, asked why the clause does not list the bodies covered by the Bill. The clause amends Section 20 of the Health and Social Care Act 2008. It is the 2008 Act which sets out who the regulations apply to. They apply to registered persons who, under the Act, are the providers, not individual staff, as I said. He also asked whether almost all providers would be likely to be in breach of the regulations for one reason or another. The clause amends the Secretary of State’s regulation-making powers. It would not by itself impose requirements on providers. Those requirements will be as laid down in the fundamental standards regulations, to which I shall come in a moment. On the specific example that the noble Lord gave, where a surgeon did not engage meaningfully with the WHO checklist prior to an operation, my answer is that that would be a disciplinary issue for the employer and/or the professional regulator, if it became known.

[Lord Hunt of Kings Heath]

That is an extremely helpful answer, but will it be made absolutely clear to employers in the guidelines to be issued alongside the regulations that they have not only a right to take disciplinary action but a duty to do so? If that is set from the centre, that will give a lot of authority to boards, which they sometimes feel that they do not have at the moment.

[Earl Howe]

That is a very important point, which I shall be happy to take away.

Amendment 1, tabled by the noble Lords, Lord Turnberg and Lord Warner, would replace the reference to “no avoidable harm” with “take steps to reduce” avoidable harm. I accept that in some settings regulated by the CQC, including the NHS, that phrase may better reflect the scale of what can be achieved. However, regulation by the CQC is not just about the NHS. In the case of some health and adult social care services, I believe that it is reasonable to strive to eradicate all avoidable harm. It is for that reason that I prefer the current wording. Yes, it is more ambitious, but its ambition contains an incentive to strive towards a continuous reduction of avoidable harm across all settings regulated by the CQC.

The amendment would also result in requirements on providers to monitor the steps they take to reduce avoidable harm and to train staff in the reduction of avoidable harm. That is clearly desirable, but I must question whether it needs to be a duty set out in primary legislation. The training of staff in reducing avoidable harm is important, and Section 20(3)(d) of the Health and Social Care Act 2008 already expressly provides for regulations to include requirements on the training of staff.

The fundamental standards regulations, to which I referred a minute ago, which were passed by this House in November and come into force in April, already meet the test of the Bill, and no change to regulations is required. The fundamental standards require that care and treatment is provided in a safe way for service users. They give the CQC power to take action against providers where a failure to take steps to provide care in a safe way results in avoidable harm.

The regulations are breached not whenever avoidable harm occurs, but where there has been a significant failure effectively to manage the risks of harm. They are clear that that involves assessing the risks and taking steps to mitigate them. They ensure that staff have the right skills and qualifications, that premises and equipment are safe and that medicines are properly managed. They also require providers to have systems in place to assess, monitor and improve the quality and safety of services.

Noble Lords have cautioned that the clause might lead to staff taking a risk-averse approach. The noble Lord, Lord Hunt, expressed the concern that it could encourage staff to lose sight of the patient and instead focus on covering up mistakes. I firmly believe that the reverse is the case. What it does is to underpin our efforts to strive for the very thing so strongly advocated by the noble Lord, Lord Turnberg: an open reporting culture where identifying errors helps organisations to improve the safety of care. Where providers take the steps to manage the risk to safety, front-line staff can focus on the needs of patients and service users, content in the knowledge that the environment in which they work promotes safety and quality.

Our debate up to now has perhaps given the erroneous impression that the fundamental standards are just about the systems and processes. They are not. They focus on the outcomes of care and treatment. The new regulations, which come into force in less than three weeks, place patients and service users at the heart of service provision. They require that treatment and care meet the needs of service users and reflect their preferences. They prohibit providers from providing care without consent. They also put in place a new duty of candour that requires providers to inform service users where there have been failings in their care.

In those ways, patients and service users are central to the fundamental standards. Clause 1 rightly ensures that safety and the reduction of avoidable harm will always be the foundation of the regulatory system operated by the CQC.

I turn to Amendment 4, in the name of the noble Baroness, Lady Finlay. I am confident that all noble Lords share the same objective as that of Clause 1, which is to place patient safety at the heart of the delivery of services. The Committee will be aware of the importance that the Government place on improving safety. The recent report of the Morecambe Bay investigation has re-emphasised that that is the right approach. Moving towards the reduction of avoidable harm requires action across the health and social care system.

I agree with those who say that the main way to reduce avoidable harm is through changes in culture. None the less, there is also a role for legislation. The role of the law in this area is straightforward: it can define minimum acceptable standards and introduce ways to protect patients who are put at risk when those standards are not met. It provides a safety net that protects people from harm.

I stress that the regulations issued under Section 20 of the Health and Social Care Act 2008, which Clause 1 amends, apply to registered providers of health and adult social care in England. There are two important points here. First, the regulations do not apply to individual members of staff but to the providers of care. In that respect, they offer protection to staff as well as to patients and service users. Secondly, the scope of the regulations is not restricted to the health service but applies also to adult social care. In that respect, the scope of the clause is broader than that of the noble Baroness’s amendment. For that reason, I prefer the current wording, which offers the same protection to patients and service users wherever they receive care, not just in the NHS.

The noble Baroness asked whether the clause applies to all care organisations, including those in the voluntary sector. All providers of regulated activities must register with the CQC and meet the registration requirements, including voluntary sector and independent sector providers. She also asked whether the regulations will be consulted on and subject to affirmative resolution. The answer to both questions is yes, but having said that, the fundamental standards regulations are consistent with the objective of Clause 1. Those regulations were consulted on and were subject to affirmative resolution. Any future regulations amending or replacing those regulations would also be consulted on and, unless the changes are minor, would be subject to affirmative resolution.

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[Lord Turnberg]

My Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.

[Lord Hunt of Kings Heath]

Perhaps I may say to my noble friend that I think that the noble Lord, Lord Ribeiro, should wind up first and then he should come back.

[Lord Ribeiro (Con)]

My Lords, I thank the noble Lord for that intervention, and I thank my noble friend the Minister for his succinct answers in respect of Clause 1 and the four amendments that have been tabled. Before I respond to the amendments in the names of the noble Lords, Lord Turnberg and Lord Warner, and the noble Baroness, Lady Finlay, I would point out that I have heard reference in the Chamber again today to zero harm. Clause 1 is not about zero harm but rather about reducing harm. It is very important that we make that clear right at the beginning as well as right at the end.

The noble Lords, Lord Turnberg and Lord Warner, do not object in their amendments to placing a clear duty on the Secretary of State, as defined in the Bill, and they recognise that the clause places an obligation on the Secretary of State to include steps to reduce avoidable harm in the requirements for registration with the CQC. However, they argue against including the term “no avoidable harm” and would prefer it to be replaced by “reducible harm”. We will get there. It is important to note that it is the providers of health and adult social care services in England that are required to register with the CQC, not individual members of staff. Again, the concerns that the noble Lord, Lord Turnberg, expressed at the beginning were about the perception that this obligation would fall to individual practitioners or health and care workers. It does not. It is very much defined as being on those who are registered with the CQC. That cannot be clarified enough. I think that my noble friend the Minister made that point.

At Second Reading, the noble Lord, Lord Willis of Knaresborough—he is unfortunately not here today, but has been supportive of the Bill—and I attempted to blow away the myth of zero harm, which implies something negative that will impact adversely on healthcare professionals when something goes wrong. The fundamental standards, which have been referred to, become law on 1 April. They will not be changed by the Bill, which places a duty on providers to ensure that safe systems are in place for the care of patients. It is about putting safe systems into place, just as in the airline industry you need safe systems in place to ensure that disasters do not occur.

Clause 1 is in no way critical of the new fundamental standards, which meet the demands of the clause. As the noble Lord, Lord Warner, said, NHS providers have sought assurances on this point, and I think they have been given. In their report, they also asked how the Government will avoid the clause creating a clinical culture with staff fearful of taking controlled risks and reporting mistakes. I think that education and training of the workforce will be used to ensure that that does not happen.

The noble Lord, Lord Warner, was also concerned about some aspects of Clause 1 and the effect that the Bill will have on the Secretary of State’s position. The Bill removes the Secretary of State’s discretion in determining whether the legal minimum standards for providers of health and adult social care cover the requirement to move towards no avoidable harm. This is so central to the quality and safety of services that it is right that there is no possibility of future Secretaries of State electing not to cover this area in the registration requirements. That is one of the principal reasons why it is important to have Clause 1 in the Bill and not just rely on the fundamental standards.

I mentioned training and education. The noble Lord, Lord Turnberg, expressed his considerable concerns about the culture, fear and frustration that the Bill will create, rather than openness and willingness. I will address his Amendments 2 and 3 by referring to the Department of Health’s response to the Francis report in its document Culture Change in the NHS, which recognises the importance of health education and safety. The Berwick advisory group has been mentioned a lot during our discussions, along with the health foundation. The Berwick review recommended that,

“all healthcare professionals receive initial and ongoing education on the principles and practices of patient safety, on measurement of quality and patient safety, and on skills for engaging patients actively”.

Health Education England’s commission on education and training for patient safety, chaired by Sir Norman Williams, a past president of the Royal College of Surgeons, and Sir Keith Pearson, the current president of NHS England, set out proposals for enhancing safety training for all health and care professionals covering four themes: how to raise concerns about patient safety; human factors, which are increasingly important for patient safety, particularly in surgery; mandatory training to improve patient safety; and service improvement for patient-centred outcome and patient safety.

The noble Baroness, Lady Finlay, expressed concern that the Bill might stifle the reporting of errors. Berwick recommended a number of measures to ensure the effective reporting of serious incidents and prompt action in response. Many such measures, such as the new national patient safety alerting system, are already in place, and 17 alerts have been issued in the past year. I believe that the learning and training tools are in place, and NHS England is working with the Health Foundation to implement Berwick’s recommendations. Where a provider takes the necessary steps to mitigate the safety risks, this will allow front-line staff to focus on the treatment and care needs of patients and service users. Far too often we have heard it said that practitioners are looking up to managers rather than looking down at their patients. This Bill, if implemented, will provide them with the knowledge and comfort that safety systems are in place and that, if they fail, it will be the provider who stands accused, not the professional. I hope that that will give some reassurance to the noble Lord, Lord Turnberg.

I was heartened to see the heading of Amendment 4, which was tabled by the noble Baroness, Lady Finlay. Although I do not agree with the substance of the amendment, it does make the point that “reducing harm in care” is what this Bill is about. Many speakers in our earlier debate, including my noble friend the Minister, referred to reducing avoidable harm. The noble Lord, Lord Hunt, also talked about the checklist. At Second Reading, in response to the point about checklists, I said that colleges and speciality associations totally support the proposal. As the Minister pointed out, the checklists are mandatory and disciplinary action will be taken if they are not followed.

[Lord Hunt of Kings Heath]

Does the noble Lord agree that there is a problem at the moment in that organisations feel somewhat inhibited in taking action against consultants? There are two things—the checklist itself, and then the consultant’s approach and attitude to the checklist. It would be very helpful to have support from the Royal College of Surgeons and other bodies alongside that of the Government to put a bit of backbone into the boards of organisations.

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In concluding, I reiterate that there is an opportunity here to improve the experience of disabled people in hospital and care settings through a greater understanding among professionals of their needs. I hope that the Minister can provide reassurances today and that guidance will reflect this. I hope also that the noble Earl will commit to an ongoing dialogue with the charities that I referred to earlier, the professionals with expertise in this area, and, of course, disabled people and their families.

[Lord Hunt of Kings Heath]

My Lords, this has been an interesting debate. I thought that the noble Baroness, Lady Finlay, raised some important points in relation to the definition of “best interests”. Because she referred to a number of identification streams within the health service, I ought to declare my interest as president of GS1 UK, the barcode association. Barcoding is, of course, another indicator that can be used.

I recently had an interesting discussion in Solihull with people who are helping the integration board that is aiming to bring health and social care together to provide integrated services. It was interesting to get an insight from a company that is helping the statutory providers to do this by confronting situations in which individuals are provided with services from a number of different statutory agencies but where there is, seemingly, no co-ordination at all between them. One often gets professionals arriving at the same time but not communicating with each other. This is partly due to the problem over information systems.

I should like to ask whether the noble Earl considers that the passage of the Bill will help the integration of that information, provided that the public have confidence in the process under which information is shared. There is clearly a balance to be drawn between the benefit of information sharing between statutory bodies in terms of integrating provision, alongside the safeguards necessary to the public. One should be in no doubt that this is quite a tension. Yesterday, the parliamentary Intelligence and Security Committee published a report on the holding of information by the security services. Reading it gives some cause for concern, in many cases, about the amount of information available about individuals. Although, as I understand it, the committee report says that that information is often never referred to or used, it none the less could be. The whole issue regarding the integrity of confidential information is important. On the other hand, we know that we have considerable failures in service because there is no sharing of information. The point that the noble Baroness raised about what we mean by “best interests” and the issue of how we can ensure public confidence is extremely important.

I support the amendment in the name of the noble Baroness, Lady Hollins, which offers an opportunity to debate the importance of including people’s communication needs in the information shared between health and care professionals. I have received helpful briefing from Mencap, the RNIB, the National Autistic Society and Sense. It has become abundantly clear that failure to understand the best way in which to talk to individuals can result in misunderstandings, misdiagnosis and, ultimately, poor care. Accessible and easy-to-read information, perhaps with pictures, to which the noble Baroness, Lady Hollins, referred, and the presence of family, advocates or interpreters, can make the difference between diagnosis and misdiagnosis.

It would be very helpful if the noble Earl could clarify that the communication needs of disabled people and the reasonable adjustments that they might need will be an important part of the health information that should be shared between professionals. I certainly hope that he is willing to place on record that guidance associated with the Bill will reflect this and that it will reach the relevant professionals.

[Earl Howe]

My Lords, let me turn first to Amendment 5. I understand the noble Baroness’s concern that there should be no confusion over the “best interests” wording in the Bill and the more technical and prescribed “best interests” checklist test in the Mental Capacity Act 2005. The key point for me to emphasise straightaway is that in this Bill the phrase “best interests” is ascribed its ordinary meaning: the consideration of a range of factors, including the wishes of the individual. Nothing in the Bill detracts from patient autonomy or the importance of supportive partnership working between clinicians and patients. This is in marked contrast to the “best interests” test checklist found in the Mental Capacity Act, which the noble Baroness was instrumental in shaping. In that Act, which concerns individuals who lack capacity, the term is not defined. A checklist of considerations helps professionals to determine what a patient’s best interests are.

The information-sharing provisions of the Bill respond to concerns expressed by the National Data Guardian. Dame Fiona Caldicott, in her 2013 review of information sharing, identified a risk-averse culture and concluded that the duty to share information for a person’s own direct care should be considered as equally important as the duty of confidentiality. I quote from her review:

“Health and social care professionals should have the confidence to share information in the best interests of their patients”.

These provisions seek to establish that sentiment in law.

The presence of the phrase “best interests” in this Bill ensures that it complies with the central principle of the Data Protection Act and the Caldicott review: to share information only where necessary and relevant. The term “best interests” is used elsewhere in primary legislation, including in the Human Fertilisation and Embryology Act 1990 and Section 38 of the Medical Act 1983. It was also used more recently in the Charities Act 2011, the Legal Services Act 2007, and in the Pensions Schemes Act 2015, which received Royal Assent last week—all are without reference to the checklist in Section 4 of the Mental Capacity Act. It is a term used across a wide-ranging legislative landscape with its ordinary meaning.

The “best interests” test in this Bill is no different from that in the pensions Act or the Legal Services Act. It requires a professional to apply a common-sense approach. I appreciate the noble Baroness’s concern that the use of the word “best” could herald a return to a “doctor knows best” kind of paternalism and to disempowering patients in the process. I sincerely hope that I can convince her that this is neither the intent nor the effect of this Bill. I am sure that the whole House will agree that the focus of information sharing should be on the needs of the individual, rather than defensive, risk-adverse behaviour of the type we have sometimes seen in the past.

I can confirm that the Department of Health will provide guidance to support the interpretation of these new duties. This will include a clarification that the term “best interests” is ascribed its ordinary meaning. The Government will also amend the Explanatory Notes to that effect.

[Lord Hunt of Kings Heath]

My Lords, that was a very helpful response. May I just ask the noble Earl whether explicit examples will be given in the guidance? The issue of professional defensiveness is very important. He will know that, out in the field, people often have a different view about data protection. Sometimes it gets in the way of sensible, professional working together. I urge that the guidance should be as practical as possible and that it should be aimed at field workers, rather than just the organisations they work for. Let us take as examples care workers, health service workers, health visitors and nurses, in regard to whom it is clearly in an individual’s best interests that information is shared about visits, and that sometimes responsibilities are shared, and that they are not inhibited because of some myth about their inability to share information.

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[Lord Elton]

My Lords, given the undertaking that we are not going to divide on this, I am tempted on to my feet to remind your Lordships that, although we have talked about the Climbié case, this goes back to the case of Maria Colwell in 1975, when Lord Goronwy-Roberts, the Labour Minister for Health in this House, was successful in beginning the setting up of at-risk registers. That was a long time ago and yet we still have not solved the issue of the breakdown of information sharing between agencies, voluntary and otherwise. I encourage my noble friend to leave a note on his desk, to which we all hope he will return after the election, reminding himself to get on with this.

[Lord Hunt of Kings Heath]

My Lords, I am not sure about the noble Lord’s latter point. I think my noble friend has done us a great service in raising this issue. Since we are talking about unique personal identifiers again, perhaps I may first remind the House of my presidency of the bar-coding association, GS1.

As a resident of Birmingham, I thank my noble friend for his work as the Children’s Commissioner, which has been invaluable. Your Lordships will have a great opportunity to discuss these matters further on Monday night after we debate standardised packaging of cigarettes, because I have a Motion to Take Note on the Birmingham electoral order, which changes the electoral cycle in Birmingham following the work of the three commissions and the Permanent Secretary at the DCLG.

On the substantive point, my noble friend raised the case of Victoria Climbié, on which I well remember making the Statement to this House a long time ago now. What was so striking in that report was that she went through, I think, at least eight or nine public agencies. If any one of them had talked to another, it is likely that she would still be alive today. It was a shocking report, because there were so many failures by so many different organisations. Although, inevitably, the local authority always tends to be the focus of concern, neither the health service nor the police covered themselves in glory. I am not really in a position to commit the Opposition in exactly the way that my noble friend wants, but if the noble Earl would like to institute some urgent cross-party discussions with my noble friend, we would certainly be very happy to take part.

[Earl Howe]

My Lords, to start with a given, I am sure I speak for the whole Committee when I say that we are all committed to taking whatever steps are necessary to protect children from abuse and neglect. Clauses 2 and 3 are, as they stand, based on long-standing policy intentions. They have real buy-in and support from those who will need to deliver them.

As regards children’s social care and wider children’s services, the difficulty with proceeding without delay in the direction that the noble Lord, Lord Warner, is advocating is that we do not yet have robust evidence on the impact of the potential burdens and risks of an extension of these duties. Moving to the use of a common identifier for the education and children’s social care sector would represent a substantial change. In the discussions that I have had on this, I have been persuaded that it is only right that we fully understand and assess the impact before considering legislation.

However, I can give the noble Lord, Lord Warner, some hopeful news. I am pleased to inform him that the Department for Education has committed to undertake an evidence-gathering exercise to understand fully the impact of adopting a consistent identifier for these types of provision. That exercise is expected to report before the end of the year. I hope the noble Lord will understand that we would not want to pre-empt the outcome of that or make decisions now on behalf of Ministers in the next Government, who will wish to consider the evidence once it is available.

The amendment would also have the effect of creating a power to extend Clauses 2 and 3 to other public bodies where there was evidence that this would benefit the health and well-being or protection of children. I recognise and welcome the sentiment and reasoning behind the desire to extend the information-sharing duty under this Bill to encompass child protection issues. As I have already assured the noble Baroness, Lady Finlay, there are clear requirements on professionals to share information to protect children. I hope that reassurance is helpful.

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[Baroness Pitkeathley (Lab)]

My Lords, I thank the noble Baroness, Lady Finlay, for tabling these amendments to Clause 5 and for her characteristically clear introduction. As noble Lords may remember from Second Reading, I too have concerns about Clause 5 in my role as chair of the Professional Standards Authority. I said then that there had been a misunderstanding of the role of the authority and that I was afraid that the Bill would make our objectives unclear and narrow the scope of our work. I was also concerned lest the Bill would in any way make it less clear that the primary and overarching role of the Professional Standards Authority is public protection. The Minister said then that his officials were happy to continue discussions, and I am pleased to say that there have been helpful conversations and meetings with the noble Lord promoting the Bill, the Minister and his officials. I am grateful for the care and attention that have been given to our concerns.

None the less, I take the opportunity that the noble Baroness’s amendment gives me to ask the Minister again to clarify that the Professional Standards Authority will never be required to prioritise the objective of promoting public confidence in the professions over its primary purpose of protecting and promoting the health, safety and well-being of patients, service users and other members of the public. In other words, could there ever be circumstances in which public confidence might conflict with public health, safety and well-being? Such circumstances might be where the authority identified a poorly performing regulator. If the Minister could give me this clarification, it would help the authority address any arguments that might in future be raised that it should conceal a regulator’s poor performance or otherwise prioritise the objective in new paragraph (b) over that in new paragraph (a).

The confusion about the hierarchy between the objectives in new paragraphs (a) and (b) may have arisen because of the conflation of the PSA’s role with that of the regulators which it oversees. It may have arisen also because Clause 5 does not follow the Law Commission’s recommendation, which proposed a clear main objective for the authority followed by two general objectives. Although the Minister has acknowledged the role of the authority as an overseer of the regulators, it would be helpful if he could provide an assurance that under Clause 5 the main and primary aim and focus of the authority will continue to be to promote the health, safety and well-being of patients, service users and other members of the public.

[Lord Hunt of Kings Heath]

My Lords, some very important points have been raised by the noble Baroness, Lady Finlay, and my noble friend Lady Pitkeathley. My regret is that we are dealing with these regulatory matters in this Bill. A number of statutory instruments will also come through your Lordships’ House, one from the GMC, in the next few days.

We had a Law Commission draft Bill which should have been a fifth Session Bill and would have enabled your Lordships to look at the statutory regulation provisions in the round. However, because of the Government’s decision not to proceed with that Bill, not even in pre-legislative scrutiny, we now have to look at this matter in a piecemeal way. It is wholly unsatisfactory. I am very sorry that we are having to deal with these issues in this way without enough time to focus on them properly. I am worried about Clause 5; I think that we are going to let it through without understanding its implications. We would be very grateful for anything that the noble Earl can do to clear this up.

[Earl Howe]

My Lords, I very much hope that I can allay the concerns of both noble Baronesses and the noble Lord. In its report, the Law Commission recommended a consistent main objective for professional regulators and the PSA around patient safety. It also recommended two subsidiary objectives: maintaining confidence in the profession and proper professional standards and conduct. The Law Commission’s report describes this proposal as restating the existing legislative position that public protection is the regulators’ main objective. The Government’s view is that public protection is sufficiently important that it should be expressly adopted in the legislation.

The noble Baroness, Lady Pitkeathley, asked whether public confidence might conflict with public health, safety and well-being. In the example of the Professional Standards Authority identifying a poorly performing regulator, it is clear that the interests of public protection and public health, safety and well-being would require the PSA to take action. In this example, any argument that the objective of promoting and maintaining public confidence in the professions would require the PSA to conceal poor performance would clearly run counter to public protection. The objective of promoting and maintaining public confidence in the professions does not mean that the PSA or the regulatory bodies should be promoting the reputation of the professions generally. Rather, it is about taking action where there is a risk that confidence in the profession as a whole is undermined to the extent that it may deter people from seeking the treatment or care that they need and impact on public protection. This example highlights the fact that while the objectives are all linked to public protection, in practice they may not always necessarily be relevant, or relevant to the same extent in particular cases. It is not a case of one objective overriding another or preventing it being considered but ensuring that they are pursued only where they are relevant to public protection.

The Bill does not prioritise or weight one element of public protection over another. It is for the PSA to determine how it applies those elements in carrying out its functions in relation to the regulators and considering the issues of the case. My view is that health, safety and well-being will always be relevant to public protection when the PSA is carrying out its functions in relation to the regulators. It will be for the PSA to determine how to apply the objectives appropriately.

The noble Baroness asked whether the objective to promote and maintain public confidence might inadvertently lead the regulators to be less transparent in highlighting bad practice. Equally, that might lead to regulatory committees and panels punishing professionals who do not pose any threat to the public. If the actions of a doctor appear likely to reduce confidence in the medical profession and influence the decision of individuals as to whether to seek medical help at all, it may be right to take action. However, panels and committees will be asked to reach their own objective judgment as to whether particular acts or omissions would affect public confidence if no action were taken. A subjective view, uncritically influenced by public opinion or the media, would be an unacceptable basis for a decision.

Turning to the term “well-being”, the BMA has raised concerns with my ministerial colleague Dr Dan Poulter about how it would be interpreted by fitness to practise panels and committees. Well-being has been a long-standing and established feature of the legislation for three of the regulators. It encompasses those aspects of a professional’s role that may have an impact on individual patients but not directly impact on their health or safety. Dignity, compassion and respect are all important in delivering care, and it would not be right to disregard them.

It will be for the regulators to formulate and issue guidance for fitness to practise panels on interpreting and applying the objectives in practice, including the term well-being. The legislation makes clear that those objectives are considered only under the umbrella of public protection.

My officials will draw the regulators’ attention to those concerns should the overarching objective become law. That is in order to inform any guidance that will be needed to implement both this Bill and the secondary legislation for the GMC.

The noble Baroness, Lady Finlay, also asked about how we view the definition of “public” in the Bill. It of course includes patients and service users, as well as other parts of the collective public. I hope that that reassures the noble Baroness that the objectives in relation to well-being and public confidence will not be pursued outside the regulators’ objective to protect the public.

Health Service Commissioner for England (Complaint Handling) Bill

Lord Hunt of Kings Heath Excerpts

Friday 13th March 2015 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, the Opposition support the Bill and we are very grateful to the noble Baroness, Lady Finlay, for sponsoring it in your Lordships’ House. Obviously, it is important that investigations are completed as quickly as possible and that those who complain are kept fully informed of their complaints.

My noble friend Lady Hayter raised a very interesting question about the landscape, as she described it, of the ombudsmen. She was so right to talk about the complexity of health and social care provision. It is clear that there is a general movement towards integration of health and social care, as regards both service provision and governance—the Manchester example last week is but one example of that. It would therefore be interesting to hear what the Government think about whether we should have a more integrated approach to the role of the ombudsmen.

I also wanted to raise again with the noble Earl the report of the Morecambe Bay investigation, on which he reported to the House last week. He will know that there was criticism of the Parliamentary and Health Service Ombudsman in that report. That was with regard to a complaint from James Titcombe, the father of Joshua, who died in 2008 as a result of an infection that was missed for almost 24 hours despite clear signs. A series of failed communications followed between the Parliamentary and Health Service Ombudsman and the CQC, and, more significantly, within the CQC itself. That led the parliamentary ombudsman to believe that the CQC would take robust action and that a parliamentary ombudsman investigation of the complaint would add nothing significant.

I would be interested to know whether the noble Earl thinks that the ombudsman’s office has learnt lessons from what happened there, and—it is entirely within the context of the Bill—whether he is satisfied that currently and in the future there will be a much more integrated approach between the health ombudsman and the CQC, as well as, of course, in areas where you have an integrated health and care service for the local ombudsman, to take the point my noble friend raises.

Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) and Local Authority (Public Health, Health and Wellbeing Boards and Health Scrutiny) (Amendment) Regulations 2015

Lord Hunt of Kings Heath Excerpts

Tuesday 10th March 2015 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, these regulations mandate the provision of five health and development assessments and reviews as set out in the healthy child programme. The healthy child programme for the early life stages focuses on a universal preventive service, providing families with a programme of screening, immunisation, health and development assessments and reviews, supplemented by advice around health, well-being and parenting. The assessments and reviews are to be offered to pregnant women and children from birth to age five.

These regulations also adjust the 12-month exemption period from the community right to challenge for health visiting, the Family Nurse Partnership and other child health services for reviewing the development and promoting the health and welfare of children under five years of age.

The Local Authorities (Public Health Functions and Entry to Premises by Local Healthwatch Representatives) Regulations 2013 set out steps that local authorities are obliged to take in carrying out their health improvement functions and describe what they must do in the exercise of certain of the Secretary of State’s public health functions. This instrument amends those regulations by prescribing what local authorities must do to provide or secure the provision of universal health visitor reviews, thereby ensuring that certain elements of the healthy child programme are provided by all local authorities in England.

I am pleased to report that according to the most recent management information—from January 2015—published by NHS England, the number of health visitors has increased by 3,736, which is an increase of 46% since May 2010. We will know in due course exactly when the coalition’s commitment of 4,200 has been achieved, but I can say now that an enormous amount of effort, both locally and nationally, has gone into delivering the additional numbers, and those efforts continue as we speak.

It should also be noted that the latest indications show that the Government’s commitment to increase the number of Family Nurse Partnership places to 16,000 will be met. This is crucial, as family nurses deliver the five reviews these regulations aim to mandate to those families under the care of the FNP programme.

The policy document Healthy Lives, Healthy People: Update and Way Forward, published in 2011, sets out the Government’s intention to transfer responsibility and power to local government, allowing local public health services to be shaped to meet local needs. The document set out the progress made to date in developing that vision and identified those issues where further development was needed.

Subsequently, public health services for children and young people aged five to 19 and other mandated functions were transferred in April 2013. The transfer of public health services for children age nought to five was delayed until 2015 to provide NHS England with sufficient time to deliver the Government’s commitment to increase the number of health visitors and transform the service, allowing the transfer of a much improved public health service.

This Government are committed to improving the health outcomes of our children and young people so that those become among the best in the world. What happens in pregnancy and the early years of life impacts throughout the life-course. Therefore, a healthy start for all children is vital for individuals, families, local communities and, ultimately, the whole nation. Health visitors provide valuable advice and support to families and are trained to identify health and well-being concerns. We have supported the profession more than ever before to transform the service.

By introducing these regulations we intend to provide a degree of consistency within local government for the delivery of these services. I am confident that that sends a clear signal to health visitors, family nurses, local authorities and the public of the Government’s ongoing commitment to universal public health support for pregnant women, children and their families.

We have been clear that we need to avoid creating new unfunded burdens. I can confirm that the requirement on local government in this instance to make arrangements for the reviews will be no greater than at the point of transfer. The funding for local authorities will reflect that for services at the point of transfer. However, the regulations require local authorities to act with a view to continuous improvement in participation in the five mandated reviews.

Back in 2010, at the time of the publication of the White Paper Healthy Lives, Healthy People: Our Strategy for Public Health in England, the Government consulted on the funding and commissioning routes for public health services and proposed how the department might create a public health outcomes framework. Over 2,000 responses to the consultation were received from a wide spectrum of individuals and organisations.

Respondents were generally supportive of the proposal that local authorities should commission public health services for five to 19 year-olds. However, a number of respondents commented that having different commissioning routes for children’s public health services from pregnancy to the age of five, and five to 19, could lead to fragmentation. The transfer of commissioning to local authorities from 1 October 2015 and these regulations will address this, and will allow for joined-up commissioning from nought to 19 years, improving continuity for children and their families.

In the period since the formal consultation took place we have continued to work alongside our stakeholders to develop plans for the nought-to-five transfer and to draw up these regulations. We are grateful for their continued input and would like to express our gratitude in supporting us to get to where we are today.

The Government have committed to fund local authorities for their new commissioning responsibilities that will transfer to them. The exact costs of delivering the mandated reviews will vary across the country. However, the funds being transferred—£428 million for the half year from 1 October 2015—are more than sufficient to enable local authorities to deliver the mandated elements as set out in the impact analysis. However, the mandated elements are only part of the nought-to-five service transferring.

Subject to parliamentary approval, the amendments in these regulations provide that a review may be carried out of the performance of local authorities around the five mandated universal reviews. The provisions in the draft regulations confirm that these regulations will cease to have effect on 31 March 2017. However, if a future Government conclude, after considering the results of any review, that the new provisions in these regulations should continue to have effect, the regulations amended by these regulations may need to be further amended accordingly.

The second area covered by these regulations concerns the community right to challenge. The Localism Act 2011 makes provision for a community right to challenge, under which a local authority has a duty to consider expressions of interest made by voluntary and community bodies, and certain other persons, in providing or assisting in the provision of its services. In line with the original government intention to exempt health visiting and other similar child health services for children under five years for one year from the point of transfer, these regulations amend provisions in legislation for the exemption period from the community right to challenge so that it would begin from the revised date of transfer—namely, 1 October 2015—and end on 30 September 2016.

I commend these regulations to the Committee. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the noble Earl for his very detailed explanation of these regulations. I want to ask just a couple of questions.

First, the original plan for transferring the commissioning of services to local government from the NHS was due to start on 1 April and has now been changed to 1 October. I may have missed it in the noble Earl’s introduction, but could he explain the reason for that delay?

Local Audit and Accountability Act 2014 (Special Trustees) Amendment Regulations 2015

Lord Hunt of Kings Heath Excerpts

Tuesday 10th March 2015 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, these regulations are among a number of statutory instruments relating to the audit of the accounts of relevant authorities in the new regime introduced by the Local Audit and Accountability Act 2014. The Act also abolishes the Audit Commission, passing responsibility for auditor appointments to the local public bodies.

I will not take up the Committee’s valuable time by repeating the arguments put forward during the passage of the 2014 Act in this debate. There was broad support across the House during the debates on the Act for creating a more efficient audit system, giving greater responsibility to local bodies while providing greater opportunities for local people to hold those bodies to account.

These regulations introduced today make a minor but important change to the application of the Act, relating to one particular type of local public body—special trustees appointed by the Secretary of State for NHS charities. Special trustees are established by the Secretary of State to administer property or funds held on trust at particular teaching hospitals. There are currently special trustees at only three hospitals— Great Ormond Street Hospital, Moorfields Eye Hospital and Royal National Orthopaedic Hospital. All the special trustees were established to manage charitable funds and they represent some of the largest NHS charities.

The Local Audit and Accountability Act 2014 makes provisions for audit appointment, conduct and regulation for a range of local bodies which are defined as “relevant authorities”. The relevant authorities include local government, parish councils, NHS trusts, clinical commissioning groups and special trustees. The special trustees’ charitable accounts fall outside the account definition in the Local Audit and Accountability Act. These accounts are covered by the Charities Act 2011, which sets the audit and reporting arrangements for all English NHS charities. However, the Local Audit and Accountability Act 2014 applies generally to matters which do not relate to the accounts of trustees. For example, there is a requirement in the Act for relevant authorities, which include special trustees, to have auditor panels. The intention, however, was that the Act should apply to special trustees only if they held non-charitable funds.

These regulations therefore amend the definition of relevant authorities as far as it relates to special trustees so as to restrict its application to instances where the trustees are dealing with non-charitable funds. The amendment would also remove any overlap which exists in relation to matters which are already covered by the Charities Act 2011, and so it will restore the current position, making special trustee arrangements consistent with those for other NHS charities. This amendment will also make the application of the Local Audit and Accountability Act to special trustees clearer. The fact that the Act does not apply to special trustees’ charitable accounts is currently not directly stated. To establish this, readers have to follow two cross-references to other Acts. In preparing these regulations, we discussed the implications with the Charity Commission and the Association of NHS Charities, which agreed that the overlap between the Acts should be removed.

In conclusion, these regulations will amend the Act so that it does not apply to the charitable trust funds of special trustees and applies only where the trustees are dealing with non-charitable funds. I commend these regulations to the Committee.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am sure that we all are grateful to the noble Earl. As he will understand, I laboured long and hard over these regulations. Rather like the previous RIA, they are quite remarkable in that there has been no consultation, guidance or impact assessment, no charities are affected apart from the charitable trustees—I do not think that the special trustees count as charities in that sense—and they do not impact on small and medium-sized enterprises. No doubt if there had been an RIA, it would have been another “Nul points” return.

I think the noble Earl said that as of today the regulations will have no impact because the three special trustees who still exist do not engage in non- charitable activities. I have a genuine question for the noble Earl with regard to the Government having adopted a deregulatory or better regulatory approach. I wonder whether this SI was really necessary and whether a letter from his department to the three special trustees telling them not to engage in non-charitable activities might not have been a better option. I was going to ask him which three special trustees still existed, but he very kindly gave their names. I wonder why they are still special trustees. He may not know why, but it struck me that, with the options that are now available for these trustee arrangements, other NHS trusts and foundation trusts have decided on different options.

Finally, it is worth noting that in some cases we are talking about quite considerable sums of money that, in one way or another, have been left or that special trustees operate. They can therefore have a major impact on the activities of those hospitals, particularly on research but also on contributions to patient comfort. I do not know whether the noble Earl really thinks that these funds are generally in good hands and whether there are any trends in giving at the moment; clearly the NHS finds them to be extremely useful.

NHS: Antiphospholipid Syndrome (APS)

Lord Hunt of Kings Heath Excerpts

Monday 9th March 2015 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to my noble friend Lady Drake for securing this debate and for her forceful speech. My noble friend Lady Morris also made a very powerful case, asking the Government to look at how they will support the improvements that have been spoken about so eloquently tonight.

I acknowledge the work of the Hughes Syndrome Foundation. Its fact sheets were excellent in getting across to me the scale of the issue that we face. I am very glad to hear that it will be circulating more leaflets to GPs in the near future.

We have heard that, if untreated, APS can lead to permanent disability, severe maternal or perinatal morbidity or even death; that symptoms can occur in virtually all organ systems; that venous thrombosis and stroke are the most common thrombotic manifestations; and that in pregnancy the syndrome is associated with adverse maternal and foetal outcomes. The problem is that the syndrome is underrecognised and underdiagnosed and can have, as we have heard, devastating consequences if untreated, mainly because of uncontrolled thrombosis.

Just to go over the ground already covered, these difficulties in diagnosis are compounded by a lack of standardisation of diagnostic tests. As we have heard, early recognition is crucial because treatment can reduce mortality or morbidity in relatively young people who often present with diseases such as stroke, myocardial infarction and deep-vein thrombosis. The example that my noble friend Lady Drake cited, of Mrs A, was very telling about some of the issues that can arise if there is not early diagnosis.

The first issue is, as my noble friend said, the need for a high-quality study of prevalence. My noble friend Lady Morris said that this is not a rare condition, but at the moment there is insufficient information to quantify just how common it is. It would be right for the Government to ensure that a robust study is now carried out to look at the prevalence of this disease.

I come to the simple blood test. What is so striking is that if it is simply left to individual hospitals or clinical commissioning groups—if they ever touch this area, which I doubt—we will not get consistency of approach and the uniform use of blood tests, which the evidence clearly points out that we need. If that is the case—if the noble Earl agrees with me—it is down to the Government or NHS England to start to signal to the NHS that we need to see a uniform policy on these tests.

I do not know whether the noble Earl read the piece in the Telegraph a couple of weeks ago in which there was an interview with Professor Hughes, the pioneering doctor who, with his team, found the evidence for Hughes syndrome many years ago. In that interview, he spoke about areas such as neurology and cardiovascular medicine, where there was less awareness among doctors of APS. He was quoted as saying:

“We know that it is present in one in five men aged under 45 who have a stroke, and one in five women aged under 35 who have a heart attack. Yet, it is simply not being picked up early enough to prevent these illnesses. Because the symptoms can be subtle, patients do get sent round the houses”.

The question therefore arises: given that the cost of the blood test would be a matter of a few pounds, why do we not ensure that those tests take place uniformly within the National Health Service?

We then come to general practitioners and the issue of training and raising awareness among them. In this Parliament, the noble Earl has debated many specific disease areas where issues have been raised about GPs recognising and diagnosing conditions that may not be rare but which they are not used to or do not recognise. One could approach that in a piecemeal way. However, given the pressure on GPs, and given that we know that the curriculum at medical school is very crowded, some other mechanism is needed to help general practitioners understand and recognise illnesses that are not common in the accepted sense of the term but which can have a major impact on many patients. The Government need to think very carefully with the profession, and in particular with GPs, about how we can improve their diagnosis success.

My noble friend said that there are no NICE guidelines and no national service framework. It would be very helpful if the noble Earl agreed that either his department or NHS England would set out what they consider to be the appropriate response of the NHS, as regards diagnosis of testing and treatment, so that we get a much more consistent approach. My noble friend Lady Morris said that investing in such a set of guidelines, including the testing, would be cost-effective. Of course, this syndrome was discovered in the UK by a fantastic British team. It would be ironic if this country, of all countries, was not then able to take advantage of the work that was developed in the UK. The noble Earl will know that, unfortunately, this is not unique in that respect. However, I hope he might be able to agree that something more needs to be done to get a cohesive national response.

The noble Earl has been very generous with his time, but perhaps he might be prepared to meet my noble friend, and perhaps the Hughes Syndrome Foundation, in the very short time remaining before we prorogue, to discuss whether the Government will be able to help in the way my noble friends have suggested.

Maternity Services in Morecambe Bay

Lord Hunt of Kings Heath Excerpts

Tuesday 3rd March 2015 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the noble Earl for his well-judged Statement and entirely echo the sentiments he expressed. Families in Barrow and the wider Cumbria area were badly let down by their local hospital and the NHS as a whole. He was right to apologise to them on behalf of both the Government and the NHS, and I do the same for the previous Government. It is hard to imagine what it must be like to lose a child or partner in these circumstances, but to have the suffering intensified by the actions of the NHS is inexcusable. Bereaved families should never again have to fight in the way that these families have had to fight to get answers. The fact that they found the strength and courage to do so will benefit others in years to come, and I pay tribute to them all, but particularly to James Titcombe. The report finally gives families the answers they should have had many years ago. It explains in detail both what went wrong and the opportunities missed to put it right.

I echo the noble Earl’s praise for Dr Bill Kirkup, the investigation team and the panel which assisted them. Our shared goal must now be to ensure that this report changes this hospital trust and the NHS as a whole for the better. Its recommendations are powerful but proportionate. We support them all, and the noble Earl can rely on our full support in introducing them at the earliest opportunity.

People’s first concern will be whether services are safe today. Clearly there are parts of this report where the alarm bell is being rung. It identifies the root cause of the failures as the dysfunctional local culture and the failure to follow national clinical guidance. There are suggestions in the report that this problem has not entirely disappeared. It says that,

“we also heard from some of the long-standing clinicians that relations with midwives had not improved and had possibly deteriorated over the last two to three years”.

It goes on,

“we saw and heard evidence that untoward incidents with worryingly similar features to those seen previously had occurred as recently as mid-2014”.

I am sure the fact that problems have been acknowledged means there is improvement. I very much take the latter point the noble Earl made in that regard, but can he say more about those findings and what steps are being taken to ensure that the trust now has the right staff and safety culture?

After safety, people will rightly want accountability, not just for the care failures but for the fact that problems were kept hidden from the regulators and the public for so long. When information did come to light it was not acted upon. Lessons were not learnt and problems were not corrected. The investigation recommends the trust formally admits the extent and nature of the problems and apologises to those affected. I am sure that this House, as well as the other place, will endorse that and want to see it done both appropriately and immediately.

Can I ask the noble Earl to ensure that any further referrals to the GMC and NMC are made without delay? Will he ensure that any managerial or administrative staff found guilty of wrongdoing are subject to appropriate action? I wonder whether it is time to revisit the issue of the regulation of managers and administrators because of this concern about staff moving on to another organisation and still being in the employ of the service, seemingly without being subject to accountability for their actions. We know a number of staff have left the trust in recent years, many with pay-offs. Will the noble Earl review those decisions in the light of the report and take whatever steps he can to ensure that those who have failed are not rewarded?

One of the central findings of the investigation is the particular challenges faced by geographically remote and isolated areas in providing health services. The investigation warns of the risks of a closed clinical culture, where,

“practice can ‘drift’ away from the standards and procedures found elsewhere”.

Given that, is not the report right to recommend a national review of maternity care and paediatrics in rural and isolated areas, and will he take that forward? Will the noble Earl comment on the concerns about the sustainability of the Cumbrian health economy? My honourable friend the Member for Copeland has today written to Simon Stevens, the chief executive of NHS England, to call for a review of the specific challenges it is facing. I hope that Ministers will be sympathetic to this call.

On the question of the CQC, the role of the regulator is to be a champion for patients, to expose poor care and to ensure that steps are taken to root it out. It is clear the regulator failed in that duty in this case. Given what was known, the decision to register the trust without conditions in April 2010 was inexplicable, as was the decision in 2012 to inspect emergency care pathways but not maternity services. In doing so, it failed to act on specific warnings. The report says there was, and remains, confusion in the system as to who has overall responsibility for monitoring standards, with overlapping regulatory responsibilities. We support the moves to makes the CQC more independent, but does the noble Earl agree that the journey of improvement at the regulator needs to continue and that there is a need for further reform, as recommended?

Will the noble Earl ensure that NHS England draws up the recommended protocol on the roles and responsibilities for all parts of the oversight system without delay and does he agree that the CQC should take prime responsibility? Does he also agree that the answer to a number of the problems identified is a much more rigorous system of review of deaths in the community and in hospitals than currently exists? Is it not the case that the reform of death certification and the introduction of a new system of independent medical examination are well overdue? We know Ministers have previously said that they are committed, in principle, to bringing this in but nothing has happened. I hope that the noble Earl will agree to bring this new system in without delay. It needs to go further, too. We need to look at mandatory reporting and investigation as serious incidents of all maternal deaths, stillbirths and unexpected neonatal deaths. We need to see how we can move to a mandatory review of case notes for every death in hospital. We have asked Professor Nick Black to advise us and inform a review which we want to conclude by the end of the month. I hope the noble Earl will support us in that review.

There are two other points I would like to raise with the noble Earl. I want to ask him about leadership of the profession nationally. He will know that maternity services are coming under great pressure at the moment. With the increase in the number of births, many maternity services are facing huge difficulties and challenges, particularly in recruiting midwives to work in those units and in making sure that they can respond to the pressures that are undoubtedly there. We do not have a chief midwifery officer, either at the Department of Health or at NHS England. I wonder whether we need a leader of the profession who can really start to raise the morale and tackle some of these issues which have been around for many years. There will be a head of profession within his department who will be working with the Chief Nursing Officer, but I wonder whether we need a more visible leadership of the profession.

The noble Earl also mentioned the work of the NMC and the King’s Fund review into midwifery supervision and regulation. I very much understand those recommendations and am very sympathetic to the need to look at this carefully. That clearly has major implications for the current supervisory role of midwives. I take the point he and, indeed, the King’s Fund report make, about that role needing to be independent of the employing authority. Can he confirm, though, that much of what supervisors do is of value and that, in moving to a new system, we would not want to lose the value of the work that current supervisors undertake? I echo the noble Earl’s views on the work of the NMC. Under the current leadership it has shown great signs of improvement, and it needs to be supported.

Finally, I pick up the point that the noble Earl made about the acceptance of honest mistakes as long as people and organisations are open. I agree with that, but could he reassure me that he believes that that philosophy is consistent with the Private Member’s Bill of the noble Lord, Lord Ribeiro, in relation to the issue of doing no avoidable harm? I believe that it is. Perhaps we will come back to this when we debate the noble Lord’s Bill, but if the noble Earl was able to say that it is consistent, it would provide considerable reassurance to those health organisations that have reservations at the moment.

[Earl Howe]

My Lords, I welcome the measured and constructive comments of the noble Lord, Lord Hunt. He asked me a series of questions and I shall answer as many as I can. First, on how things are today at the trust and the safety of its services, clearly the CQC is the body best placed to make judgments about the quality of services. At the last inspection of the university hospitals of Morecambe Bay in February last year, safety in the maternity service at Furness was rated as good but overall the maternity services were assessed as requiring improvement. As a whole, the trust has been rated as inadequate. This demonstrates that, while the trust is making progress, there is still a long way to go, and it is clear that embedding changes of this nature takes time. The CQC will reinspect the trust in May 2015 and will make a judgment on whether it has made the required improvements.

The noble Lord asked about referrals to the NMC and the GMC. Where there are failings by a member of staff, they must be held to account. If an allegation is made about a medical doctor, a nurse or midwife, who may not meet the professional standards required in the UK, the relevant professional regulator has a duty to investigate—and, where necessary, to take action to safeguard the health and well-being of the public. The Department of Health is aware that the NMC and the GMC have each received a number of fitness to practise referrals linked to maternity and neonatal services provided by the University Hospitals of Morecambe Bay NHS Foundation Trust. As an independent body, each of them is responsible for operational matters concerning the discharge of its statutory duties. I would hesitate—in fact, I think it would be wrong of me—to comment further on those fitness to practise cases. However, we are confident that the NMC will take account of the recommendations and findings in the report.

The noble Lord made a number of comments about managers. As he well knows, the NHS is a huge and complex service staffed by committed people who often work under a huge amount of stress. I believe that those tasked with leading our NHS organisations, whether in management positions or clinical ones, are committed to making good decisions on behalf of patients. When it becomes clear that they are not up to the job, they should be replaced. Many senior leaders at Morecambe Bay have now been replaced. The current leadership should be allowed a period of time to refocus the trust on those values that are so vital to good patient care—staff morale, sound governance, strong leadership, team working and a focus on delivering high-quality care.

On the issues that are particularly pertinent when you have NHS services that are geographically remote, NHS England has today announced details of a major review of the commissioning of NHS maternity services as promised in the five-year forward view. The review will assess current maternity care provision and consider how services should be developed to meet the changing needs of women and babies. Recent advances in maternity care, changes in the demographics of women having babies and preferences of where they want to give birth will form the key focus. This review, which is expected to report by the end of the year, will be led by an external chair, supported by a diverse panel, and will include a review of UK and international evidence on safe and efficient models of maternity services.

I listened with interest to the noble Lord’s comments on the Cumbrian health economy as a whole. I am not in a position to comment on that at the moment but, if I may do so in writing, I shall be happy to. As for further reform of the CQC, we will examine the recommendation on this score in detail and publish a full response in due course. Further consideration is needed to ensure that the overall responsibility for patient safety sits in the right part of the system and the department has already committed to consider with relevant organisations the options for transferring NHS England’s responsibilities for safety to a single national body. We will also continue to look for opportunities to improve both the operation of the oversight arrangements in place at present and the understanding of those arrangements by NHS organisations and the public.

On the matter of reviewing all deaths and picking up the recommendations around death certification, a number of the recommendations in Sir Robert Francis’s Mid Staffordshire inquiry report refer to our planned reform of the death certification system and the introduction of the role of medical examiner in England and Wales. A new system of medical examiners has been successfully trialled in a number of areas around the country. The work of the two flagship sites in Gloucestershire and Sheffield has been continued and extended to operate a medical examiner service on a city and county-wide basis on a scale that will be required for implementation by local authorities when legislation is introduced. We will publish shortly a report from the interim national medical examiner, setting out the lessons learnt from the pilot sites. I hope that that gives the noble Lord an indication that this is work very much in progress.

On mandatory reporting of maternal, stillbirth and neonatal deaths, the Government are committed to doing further work to review avoidable deaths. We are working with NHS England to introduce a national standard approach for undertaking case-note review. This has the potential to enable NHS trusts to develop a better understanding of avoidable deaths. However, a top-down approach to ensuring that every trust reviews every death is not, in our view, appropriate. Our aim is to ensure that trusts focus their efforts on improving patient safety through learning about the root causes that have led to avoidable death. A systematic, but not necessarily burdensome, approach is needed, which is why we are moving ahead to develop a national rate and produce an estimated number of avoidable deaths for each hospital. The numbers will be made public. Trusts will be expected to report annually to the Secretary of State for Health on their actions to reduce avoidable deaths.

The noble Lord made a very interesting suggestion about the possible appointment of a chief midwifery officer. I would be happy to consider that idea. Of course, he knows that there is a head of maternity in NHS England at the moment.

On the performance of the NMC, it is, as the noble Lord is well aware, an independent body accountable to Parliament, via the Privy Council, for the way in which it carries out its responsibilities. In addition, its performance is monitored by the PSA, and the Health Select Committee has also chosen in recent years to hold an annual accountability hearing with NMC leadership. So there are a variety of robust measures in place to hold the NMC to account. I am aware that the performance of the NMC has a troubled history, which is why Ministers commissioned the Professional Standards Authority’s predecessor body, the CHRE, to undertake a full strategic review in 2012. As noble Lords will remember, the final report of the strategic review was published, putting forward 15 high-level recommendations for improvement in delivering the NMC’s regulatory functions, with the expectation that demonstrable improvements should be seen within two years. We welcome the new NMC chair and we hope that, under Dame Janet’s leadership, it will continue to make improvements to become a confident and capable regulator.

Health: Rare Diseases

Lord Hunt of Kings Heath Excerpts

Tuesday 3rd March 2015 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, my name was inadvertently missed off the list, so I am going to speak in the gap. I will give the noble Earl his full 12 minutes. Perhaps I may put two points to him.

First, will the noble Earl agree to my noble friend’s recommendation that the Ministers institute a thorough review? I stress that this should be done by Ministers. NHS England has shown itself incapable of doing the job properly. Ministers are much more accountable and much more aware of the rare disease issue and I really do think they need to take charge.

Secondly, in the new agreement with the drug industry, any increase in the cost of drugs over five years is being met by the industry through rebates. Why on earth are those rebates not being used to fund innovative new drugs for rare diseases? Can it just be that the NHS is under such financial pressure that this money has had to be raided, when it should have been used for innovative new drugs?

Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015

Lord Hunt of Kings Heath Excerpts

Tuesday 24th February 2015 Lords Chamber

[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.

[Earl Howe]

My Lords—

Francis Report: Update and Response

Lord Hunt of Kings Heath Excerpts

Wednesday 11th February 2015 Lords Chamber

[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.

Health and Social Care (Safety and Quality) Bill

Lord Hunt of Kings Heath Excerpts

Friday 6th February 2015 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I declare an interest as president of GS1, which is the bar-coding association of the United Kingdom. I am sure that the suggestion made by the noble Lord, Lord Willis, will be given every consideration it deserves. I, too, congratulate the noble Lord, Lord Ribeiro, on bringing the Bill to your Lordships’ House. He knows that the Opposition support the Bill, and we will adopt a constructive approach to it.

However, I would like the noble Lord and the noble Earl, Lord Howe, to clear up this point about the remaining stages of the Bill in your Lordships’ House. My noble friend Lady Pitkeathley made a very important point. I do not understand why there is not time to give the Bill proper scrutiny. This is essentially a government Bill; it is therefore up to the Government to find the time. We know that this House has plenty of time until Prorogation on 26 March. At the moment, the noble Earl and I are enjoying many Questions for Short Debate, and I understand that there are many more to come. That is because there is virtually no legislation left. The Government say there is not time, but that is not so. I offer our good offices through the usual channels to see whether we cannot find time for a proper Committee and Report stage. That would be the right path. I understand what the noble Lord, Lord Elton, said—that in the past he has been very strong about the role of the House of Lords in the scrutiny of legislation, and has criticised the way in which Governments have tried to get legislation through. We have to be cautious about this. I want to see the noble Lord get his Bill by the end of this Parliament, and we will do everything we can to help, but the evidence that has come particularly from the Berwick committee shows that there should at least be some debate, especially on Clause 1, although there are other issues as well.

Some debate on Clause 1 would be helpful. Although we support the clause, it would be helpful to hear a little more from the noble Lord about what is meant by “zero harm”. The noble Lord, Lord Willis, says that those words are not actually used in the Bill. The problem is that those words were used in the briefing on the Bill, and now it has come to be known as “zero harm” in the health service. It may be that that is part of the issue around Clause 1—not so much what it contains as how it is perceived. I hope that we can clear that up as well as we go through the Bill.

I have one question for the noble Earl. As he knows, I and the noble Lord, Lord Patel—he cannot be here today but will be for later stages—have both chaired the National Patient Safety Agency. We encouraged NHS bodies to report near misses and patient safety incidents. I assume that many of those incidents would come within the definition of “avoidable harm”. Given that, can the noble Earl say whether that means that, once the legislation is passed, almost every NHS body in this country would fall foul of the provision? If that is so—and it might be argued that it should be so—does he think that there is a potential perversity in that people will try to hide these incidents in the future, whereas our whole learning experience, which came from the airline industry, is to encourage people to own up to mistakes? It is a very important point. I think it lies at the heart of what the noble Lord, Lord McColl, said earlier and, indeed, the evidence which we have received from the Berwick advisory group.

My noble friend Lord Young made a very important point about good practice, and I am not sure whether the Bill helps one way or another. He mentioned the WHO checklist in dealing with wrong-site surgery, which has a lot of support from various institutions, including the Royal College of Surgeons. We know that not every surgeon is prepared to do it; there is no question but that some surgeons refuse to take part in those checklists and that sometimes, if they do, they do not take part with wholehearted enthusiasm. Whether this Bill helps that or not, I would be interested in hearing from the Minister how he thinks we can encourage very powerful clinicians who, I suspect, think that it is beneath them to take part in what they call a box-ticking exercise. How can we encourage them to do so? My noble friend is absolutely right—one of the besetting sins of the health service is its inability to spread good practice quickly. That is why we invented NICE.

I find it really disappointing that, in relation to NICE technology appraisals, as an example, even now many clinical commissioning groups refuse to implement them, despite a legal requirement to do so, and have set up their own silly little committees to try to second-guess what NICE is doing. I know that that goes outside the Bill, but it does answer my noble friend on a really important issue that we need to tackle. We all know that we have excellence and we have problems in the health service, and the scale of transfer of excellence to the health service is just too slow.

On the subject of data-sharing, as the Minister knows, the Opposition are very supportive of the sharing of patient information, which is clearly in the best interests of patients. Indeed, we took through the original provision in, I think, the 2003 health Act, although there were many others that we might have taken it through in, to allow for this to happen. The care.data project ran into a few problems, as we know, and has now been rolled out in a kind of pilot way in order to secure public confidence. But I think that it would be fair to say that there are still concerns about whether, in the end, the public and GPs are going to be prepared to sign up to this. As he will know, we think that the National Data Guardian must be made a statutory post. It was the subject of amendments in the other place. I am delighted that Dame Fiona Caldicott has become the National Data Guardian; that is an excellent appointment, and the Government should be congratulated on making it. We know that the Secretary of State for Health has said that her appointment would be put on a legal footing at the earliest opportunity—and this is the earliest opportunity. Surely, this is the time to do it.

Noble Lords will have received briefing from Mencap —I certainly have—about the information-sharing clauses. Mencap wants Clause 4 amended so that the health information includes the person’s communication needs, which means that professionals are more aware of the ways in which people can communicate their health and care needs. Perhaps the noble Lord, Lord Ribeiro, could give some consideration to that.

On the issue of children and why they are not included in terms of a national identifier in the Bill, I assume this is because of the split in government responsibilities between the Minister’s department and that of another department. Perhaps that is not the case, but it would be interesting to know about that. On national insurance numbers, as my noble friend Lord Young whispered to me, children of course do not have national insurance numbers until I think the age of 16. That may be a problem.

I come back to Clause 5. A number of noble Lords have raised the issue of why provisions have not yet been brought forward relating to the Law Commission’s draft Bill. We all know why the Government was not prepared to bring forward a health Bill in the fifth Session—not even a draft Bill—which is why the noble Lord, Lord Ribeiro, has very kindly taken on a Private Member’s Bill. It has been very disappointing; at the very least we could have had pre-legislative scrutiny, which would have been very helpful. I am not going to suggest that we amend the noble Lord’s Bill with 300 clauses suggested by the Law Commission, but I hope that the noble Earl, Lord Howe, will be able to say something about what the Government are going to do with those clauses.

My noble friend Lady Pitkeathley raised some interesting points on the PSA and the new provisions. I take what the noble Lord, Lord Willis, said, but I hope that the noble Lord, Lord Ribeiro, will answer my noble friend’s point about whether there has been some misunderstanding of the PSA’s role. Next Wednesday we debate the Deregulation Bill. I have tabled an amendment that seeks to take a number of health regulators out of the economic growth provisions because I believe that they will inhibit the effectiveness of those health regulators. From meetings we have had with the Department of Health it has been made clear that the PSA is included, but not the regulators—the GMC, the NMC et cetera. I wonder whether there is some confusion in the noble Earl’s department about what the role of the PSA is. My noble friend Lady Pitkeathley pointed that out very well.

We support the principle of the Bill. I congratulate the noble Lord, Lord Ribeiro, on bringing it to your Lordships’ House. I wish to see it make progress, but we need to have proper scrutiny as well.