Health and Social Care Bill
Earl Howe Excerpts(14 years, 1 month ago)
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Lord Owen
My Lords, I wish to draw attention to Clause 72(1)(b), which refers to,
“a power to investigate on its own initiative whether the National Health Service Commissioning Board or a clinical commissioning group has failed to comply with a requirement imposed by virtue of section 71(1)(c)”—
which we discussed earlier, the provision to,
“not engage in anti-competitive behaviour which is against the interests of people who use such services”.
I had understood that the decision not to have competition as one of the main functions of Monitor was a considered political decision, but the more one looks at Clause 71(1)(c), and now at Clause 72(1)(b), the more one realises that this has been got round, effectively, by ensuring that anti-competitiveness becomes a prime responsibility of Monitor.
There are a number of objections to this. The noble Lord, Lord Whitty, put his finger on it, that a good regulator does not also become a policeman in an anti sense to the people he is trying to regulate. There is a deep question as to whether you really want a situation where Monitor can be set against the National Health Service Commissioning Board and the commissioning groups. I am very doubtful that this is a sensible power to give to Monitor.
I know it is regulating the whole group, but if you look at the way Monitor is approaching its tasks, time and again it is going to be reliant on good will and an atmosphere of trust between Monitor, the NHS Commissioning Board and the commissioning groups, and now there is this question of anti-competitiveness. It is not as if nobody else is going to be looking at anti-competitive behaviour of the National Health Service Commissioning Board. The private sector wants to go into this whole area and will be looking very carefully at whether or not it is being given an even playing field. It will be taking, and threatening to take, the Commissioning Board to law—I am not even raising the issue of EU legislation, but just under British legislation.
I do not think it is fair to argue that there is unlimited freedom for the National Health Service Commissioning Board or the commissioning groups to operate in this area, particularly the board. You are really setting yourself up for a very difficult situation. Also, to do it “on its own initiative”—does that mean Monitor would not consult the board or a clinical commissioning group but just suddenly involve itself in an investigation? I would be grateful if the Minister could give some indication of how he sees this in practice.
Will some guidance be given not to develop an adversarial relationship? It is very easy for animosities to start coming in to this area. As I say, it is not as if it is free from legal challenge. Their actions can be challenged. However, for another NHS body to be able to question the judgment of the Commissioning Board that in this particular case it is best not to put something out to competitive tender, or to make a judgment when it has been done because somebody feels that it is anti-competitive, is a really dangerous power. In the wrong circumstances, where Monitor might be chaired by somebody who is getting into a bad relationship with the NHS Commissioning Board chairman, something not totally unknown in these areas, this is a tool which could be used in a destructive and adversarial fashion.
It would be very helpful, for future occasions, to hear from the Minister as to how he thinks this would actually work out in real life.
(a) commercial information the disclosure of which would, or might, significantly harm the legitimate business interests of the person to whom it relates;(b) information relating to the private affairs of an individual the disclosure of which would, or might, significantly harm that person’s interests.”
“( ) Where an exemption is granted the Secretary of State—
(a) if the exemption is granted to a prescribed person, must give notice of it to that person, and(b) must publish the exemption.”
Baroness Finlay of Llandaff
My Lords, I have several amendments in this group. I shall start with Amendment 294N, which is a probing amendment. As far as I have understood it, social enterprise bodies which are NHS bodies in all but name are coming into existence. They have evolved from PCTs under the transforming community services programme. They will be subject to special health administration arrangements. I ask the Government to confirm whether the social enterprises that come under the health special administration arrangements are coming under arrangements based on insolvency law and that, as such, that allows assets to be transferred outside the NHS and the redundancy payments are not guaranteed.
Amendment 295CA is intended to ensure that clinical commissioning groups are consulted before the Secretary of State makes regulations that allow Monitor to impose charges on commissioners. The charge imposed can include a levy to fund Monitor’s functions that have to be invoked in the event of failures. Amendment 295CB is intended to ensure that when setting such a levy, Monitor takes into account the impact of the levy on the financial stability of the organisation, especially a financial trust that is already in distress or failing. Amendment 304A requires that the commissioners are considered when the services of a failed financial trust are considered by Monitor and should be involved in the decision as to which should be continued, and that such services must include some continuation of education and training, because in planning for the future workforce, if a whole lot of posts were suddenly lost, it would destabilise the workforce planning. That is in addition to considerations such as the service provision and issues of equity and access. That becomes particularly important because if you do not have the staff with the appropriate training, you cannot, in the long term, provide the service anyway.
Amendment 304B is intended to ensure that commissioners are involved in the board's role in agreeing arrangements to secure continued access to NHS services will be achieved. Will that include the board’s selecting which commissioner would become lead commissioner for the process during a failure?
Earl Howe
My Lords, this has been an excellent short debate on a large number of amendments, but focusing on a critical issue, which is what should happen to providers when they get into significant difficulty. While the debate has focused on the role of Monitor, it is the Government’s firm view that commissioners should lead the process of ensuring there are services available to meet the needs of local communities.
The Government brought forward amendments in another place to improve our proposals for ensuring continuity of services. These included removing provisions to apply an insolvency-based approach to foundation trusts in the form of health special administration. If a provider of NHS services becomes unsustainable, there has to be a legal framework that provides effective safeguards to protect patients’ and taxpayers’ interests. We have therefore taken an evolutionary approach in developing proposals to ensure sustainable local services. The Bill sets out a clear framework to achieve this.
We will maintain the existing regime for foundation trusts but we will improve it significantly. First, we have removed the need to de-authorise a foundation trust. This is because the Government are committed to all NHS trusts becoming foundation trusts, so that all NHS providers have the freedom to innovate and drive sustainable improvements in quality and efficiency, and are accountable locally. I am aware that the noble Baroness, Lady Thornton, has tabled amendments which relate to the issue of de-authorisation and we will discuss those when we reach the appropriate clause.
Further, the Government will also ensure taxpayers’ interests would be protected by securing solutions that make best use of available NHS resources. We do not want patients to use, or taxpayers to subsidise, poor quality, inefficient services or providers. Instead we will ensure an end to the culture of hidden bailouts. That is why Clauses 131 to 143 set out provisions for a transparent financing mechanism to fund continuity of services during a period of administration. In addition, I reassure noble Lords that the existing regime for NHS trusts, as distinct from foundation trusts, set out in the 2009 Act, would remain in place. Through a separate health special administration regime, legislation for the first time will also extend equivalent protection to patients who use NHS services provided by a company. Provisions set out in Clauses 125 to 130 would achieve this.
I turn to Amendment 282ZA. The Bill gives Monitor broad powers to collect financial information for the purposes of monitoring providers’ financial stability. Monitor will be gathering a range of information, including financial, to enable it to undertake an ongoing assessment of risk. Monitor would also be able to intervene in order to support a provider to recover and to prevent failure where possible.
I understand that some noble Lords are concerned about the range of interventions available when a provider becomes distressed. Providers themselves can take a range of actions, including improving the management capability and expertise that they have. Commissioners are responsible for securing access to local services and they can use contractual levers to respond to poor performance and prevent provider failure. Monitor would intervene on a provider on the basis of a predefined distress test to prevent failure where possible. The CQC would monitor providers’ compliance against patient safety and quality requirements.
This locally led approach is especially appropriate where there is a pressing need for services to be reconfigured to ensure sustainability. I am sure that noble Lords will agree that a reconfiguration is more likely to succeed if it is based on close partnership working between commissioners, providers, local authorities and their local communities.
Baroness Thornton
Perhaps I may ask for clarification. The noble Earl refers to providers all the way through. Can we be completely clear that this means all providers —that is, private sector providers, NHS providers, social enterprises and charity providers of health services? Do all these levies and fines apply to them?
Earl Howe
My Lords, when I refer to providers of NHS services, I am referring to NHS providers and non-NHS providers. It is to be determined who will contribute to the levy. That is being worked through and I am sure that the noble Baroness will have noticed from the document that we published the other day that this work is ongoing. We will make further announcements about that in due course.
On Amendment 304B, I say that the board should consult the relevant commissioners but it must make the decision itself, which is what the Bill provides for. The noble Baroness, Lady Finlay, asked whether social enterprises will be within the scope of the health special administration regime. Social enterprises are companies so they will be within the scope of health special administration. It is right that they are not treated as NHS bodies as when assets are transferred from PCTs robust rules apply, as I have set out in detail in previous debates. She asked whether the NHS Commissioning Board would nominate a lead commissioner if a provider becomes unsustainable. The answer is yes.
I hope that noble Lords will find that series of explanations helpful and I ask the noble Baroness, Lady Thornton, to withdraw the amendment.
Baroness Finlay of Llandaff
Before we finish this set of amendments, I want to mention a particular group. I am grateful to the noble Baroness, Lady Thornton, for her intervention, as I want to refer to charitable sector providers who are finding fundraising particularly difficult now. They are beginning to be hit by the downturn in the economy and the downturn in giving, and there is a real risk that some of the charitable sector providers will find themselves in difficulty. If a levy is imposed on them as well, in terms of their registration with Monitor, that may tip them over. My request is that, in looking at all this, there will be separate consideration of the charitable sector providers from other providers.
Baroness Thornton
I thank noble Lords. I will take only a moment, but we will need to return to this. First, this was not looked at properly in the Commons and I can see that that is the case. Secondly, I recall that the chief executive David Nicholson disagrees. He said that he advocates de-authorisation. I believe that the pooling and the levy are bureaucratic and expensive and that the noble Earl does not understand that reconfigurations will not be led locally. I do not think that the Bill adequately approaches how we will manage reconfigurations. To be kind one has to say that the work is ongoing; I am not quite saying that the department and the Bill team are making this up as they go along, but it is definitely an area to which we will need to return on Report. I beg leave to withdraw the amendment.
“( ) If, at the time Monitor discharges the function under subsection (7), the day specified by the Secretary of State for the purposes of section 14A of the National Health Service Act 2006 has passed or section 6 or 178 has come into force—
(a) in the case of section 14A of the National Health Service Act 2006, the reference in subsection (8)(c) to every Primary Care Trust is to be read as a reference to every clinical commissioning group;(b) in the case of section 6, the reference in subsection (8)(b) to the NHS Commissioning Board Authority is to be read as a reference to the National Health Service Commissioning Board;(c) in the case of section 178, the reference in subsection (8)(d) to the Care Quality Commission is to be read as including a reference to its HealthWatch England committee.”
(a) commercial information the disclosure of which would, or might, significantly harm the legitimate business interests of the person to whom it relates;(b) information relating to the private affairs of an individual the disclosure of which would, or might, significantly harm that person’s interests.”
(a) commercial information the disclosure of which would, or might, significantly harm the legitimate business interests of the person to whom it relates;(b) information relating to the private affairs of an individual the disclosure of which would, or might, significantly harm that person’s interests.”
Lord Davies of Stamford
My Lords, I do not want to hold up the House for too long, but I feel that someone should respond to my noble friend Lord Warner’s amendment on behalf of what he rather dismissively described as the elected political class. I am proud to say that I was a member of that elected political class for 23 years, representing Grantham and Stamford. In the course of those 23 years I had to take action to save both Grantham hospital and Stamford Hospital, separately and at different times, when they were threatened with closure. I used all the methods which my noble friend is no doubt familiar with: meetings with Ministers, lining up local government support, petitions, threatening judicial reviews—even potentially funding a judicial review—and heading major marches. I remember leading over 9,000 people through the streets of Grantham and 5,000 through the streets of Stamford. We won in both cases. Grantham is still a very successful local district hospital and Stamford is a smaller hospital—what you might call a cottage hospital.
The point I wanted to make is this: I would have welcomed the sort of report from Monitor which my noble friend is suggesting. If one wants to save one’s local hospital, and one wants to make sure that the right decisions are made about the health of one’s constituents, one wants a warning as early as possible about the financial or clinical problems—or both—that may be arising. There are often all sorts of alternatives that one can find to closure. It is important for democratic confidence in the NHS that all the possibilities are thoroughly explored and everybody is content that the decision has not simply been taken behind closed doors and then announced to the public when there could have been some initiative that might have saved the day. On behalf of the—slightly dismissed—elected political class, I thoroughly support the amendment of my noble friend.
Baroness Thornton
I have a very small piece of advice to give the Minister. I always think that it is best to give in and agree with my noble friend Lord Warner. I have almost always found that this is the best course of action. The noble Earl might recall that, when I was a Minister, on one of the occasions where I did not give in I certainly came a cropper. I urge the Minister to think very carefully and seriously about what my noble friend has had to say. It merits great attention and it merits being in the Bill.
Earl Howe
My Lords, before that intervention I was about to say that I was very pleased that the noble Lord, Lord Warner, had returned us to this issue, which I, like he, regard as extremely important. It is a thoughtful amendment and will certainly prompt further thought on my part after this debate.
I do not think that there is any difference between the noble Lord and myself in this respect. I am certainly all in favour of ensuring that wherever possible there is early intervention and proactive monitoring of organisations well in advance of failure so that failure can be averted. The main difference between us, if there is one, is that we believe that this process should be locally led and not led from the centre, which is how I read his amendment. I probably read it wrongly. When the noble Lord spoke to it, he indicated that nothing in it was intended to run counter to that locally led process. I take that on board.
Why are we so keen on a locally led process? The overall aims that we set out are to put patients, carers and local communities at the heart of the NHS, shifting decision-making as close as possible to individual patients and devolving power to professionals and providers, liberating them from top-down control. This amendment would appear to do the opposite and could lead to an increasing level of decisions being centralised and moved away from local communities and their democratic representatives. The more that one does that, the less likely one is to get local buy-in. In a patient-led NHS, if it is to be worthy of the name, any changes to services have to begin and end with what patients and local communities need.
Baroness Thornton
Does not the experience of the last few years—we can name the hospitals concerned—show exactly the opposite of what the noble Earl is now saying to us, that this has to be locally led? We have to find some mechanism which allows decisions to be taken that does not dismiss or ignore local feelings. Of course people have to be involved in those decisions but, at the end of the day, we know about Chase Farm and several hospitals I could name. In north London, we know that we have too many hospitals. They have not been closed down because it is politically too difficult to do so. If the decision remains at local level, in north London we will still have too many hospitals. I have lots of MP friends who have campaigned to keep those hospitals in place, particularly before the last general election. It seems that what the noble Earl is outlining now will not work.
Earl Howe
Contrary to popular opinion, there have been cases of very successful and rapid reconfigurations of services. Of course, the ones that come to our attention are those that have taken a long time, such as Chase Farm. There is no better or worse example than that.
In reading this amendment, we should be cautious about any process that would significantly weaken both local commissioner autonomy and public engagement. We do not want to conflict with the statutory requirement for NHS bodies to ensure appropriate and proportionate involvement of patients and the public in service changes or reduce the ability for local authority scrutiny to bring effective democratic challenge to reconfiguration plans. I certainly do not think there is a case to reduce democratic accountability in this way.
I agree with the noble Lord that, where it is not possible to reach local agreement on a service change proposal, there should be mechanisms for independent review. We are retaining powers in the Bill for local authority scrutiny functions to be able to refer reconfiguration schemes. As part of the transition, we are also exploring how the NHS Commissioning Board and Monitor can work together to support commissioners and providers. As I have said, the key to successful service change is ensuring engagement with the local community and stakeholders so as to secure as broad support as possible in what can be very difficult decisions.
Health: Neurological Conditions
Earl Howe Excerpts(14 years, 1 month ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, I thank the noble Lord, Lord Dubs, for tabling this Motion, which has provided for such a richly informative and valuable debate. I know that this subject is close to his heart, as it clearly is to all those who have spoken today. The noble Lord made the observation that neurological conditions have enjoyed an unfairly low public profile, and he is right.
As we have heard from the noble Baroness, Lady Thornton, neurological conditions affect a significant number of people—an estimated 8 million in England. They account for approximately 20 per cent of acute hospital admissions, and are the third most common reason for seeing a GP. We have also heard that, despite the existence of authoritative guidance in the shape of the NSF for long-term conditions and NICE guidance, services continue to fail many people living with a neurological condition.
Change is needed, and through the health reforms currently progressing through this House we want to ensure that we have health outcomes that are among the very best in the world. Effective commissioning is key to delivering high-quality services. Commissioning in the past has been too remote from the patients that it intends to serve. Commissioning decisions made by clinical commissioning groups will be underpinned by clinical insight and knowledge of local healthcare needs.
Our commissioning reforms also recognise the needs of patients for specialised services, with the NHS Commissioning Board commissioning such services in future. Additionally, with low-volume services that fall outside the scope of specialised services, there will be flexibility for commissioning groups to decide how to commission—for example, through collaboration or thorough a lead-commissioner arrangement. Commissioners will need high-quality commissioning support, much of which will come from the voluntary sector. At this point, I join the noble Baroness, Lady Thornton, in acknowledging the work of Neurological Commissioning Support, which is helping to ensure that the real experts—people living with neurological conditions—are at the heart of local decision-making.
Quality standards, developed by NICE, will also be at the heart of the system, providing authoritative statements of high-quality care. They will have real traction within the system, linking with tariffs that will see providers paid more for quality care. Quality standards covering epilepsy services for children and adults have already been referred to NICE for development, and quality standards covering a number of neurological conditions including MS, motor neurone disease and Parkinson’s disease featured in the recent engagement exercise run by the National Quality Board on the proposed areas that will initially make up the library.
The NHS outcomes framework will ensure that commissioners, providers and others are better able to identify those things that can drive up performance in the NHS by providing a focused set of national outcome goals and supporting indicators that patients, the public and Parliament will be able to use to judge the overall progress of the NHS. It will inform the Secretary of State’s mandate to the NHS Commissioning Board and, in turn, to the NHS commissioning framework.
Let me give a few examples of the relevant indicators. In domain 1—preventing people from dying prematurely—the overarching indicator is about mortality from causes considered amenable to healthcare. Epilepsy is one of the conditions where there is room for significant progress. Domain 2—enhancing quality of life for people with long-term conditions—addresses such issues as the proportion of people feeling supported to manage their condition, which is important for people with conditions such as CFS/ME, acquired brain injury, MS and motor neurone disease.
The aim of domain 3—helping people to recover from episodes of ill health or following injury—is to capture information on patients’ journeys through the system. Domain 4—positive experiences of healthcare—will look at such things as patients’ experiences of primary care. Domain 5—treating and caring for people in a safe environment and protecting them from avoidable harm—can, for instance, support better medicines management, which is crucial for people with Parkinson’s disease.
We must also have a much clearer split of responsibility—a sense of joined-up access across the care pathways to deliver a less fragmented and more person-centred approach to planning. Integrated service provision is central to our reform agenda to ensure more joined-up thinking and commissioning on these issues, and one might say that there was never a more relevant area for that than neurological conditions. This is being demonstrated very ably in Nottingham, with its community neurology service, which is providing access to a wide range of professionals—specialist nurses, social workers and allied health professionals—to provide effective support and rehabilitation.
Nursing and the role of specialist nurses has been a strong theme in this afternoon’s debate. The Government recognise the valuable contribution made by nurse specialists. However, it remains our view that local providers must have the freedom to determine their own workforce based on local clinical need. We must remember that commissioners will be commissioning for good outcomes. The commissioning groups, led by clinicians, will recognise that nurse specialists have an essential role in improving outcomes and experiences for patients. Again, Neurological Commissioning Support is already proving a powerful advocate for specialist nurses.
The noble Baroness, Lady Pitkeathley, stressed the role of social care. As she knows, we have set out a broad agenda for reform in social care. We want to see care that is personalised; offers people choice in how their care needs are met; supports carers; has a skilled workforce who provide care and support with compassion and imagination; and offers people the assurances they expect of high-quality care and protection against poor standards and abuse. We have been working with stakeholders to look at the fundamental issues for reform in social care, such as improving quality, developing and assuring the care market, integration with the NHS and wider services, and personalisation.
I turn to some of the questions that were posed in this debate. I suspect that there were rather too many for me to answer now. I will, of course, happily follow them up in writing. The noble Lord, Lord Dubs, set us thinking about how clinical advice will be infused into the NHS. He asked whether there would be a lead for neurological conditions in the department and a long-term conditions strategy. The NHS Commissioning Board will determine the clinical advice and leadership to support the five domains of the outcomes framework to which I referred. That, of course, includes long-term conditions. A long-term conditions strategy is in development. It is in its early stages but it will certainly seek to address a wide range of long-term conditions, including neurological conditions.
The noble Lord asked about a national strategy for neurology. We have approached the task of driving up quality from a different angle. NICE quality standards will be commissioned, and I have already mentioned some of them. The NHS Commissioning Board will be tasked with issuing commissioning guidance based on those standards. Local commissioning to meet the needs of the community will address the domains in the outcomes framework. Health and well-being boards will conduct joint strategic needs assessments and produce health and well-being strategies to make sure that the needs of patients are properly prioritised. Local healthwatch and HealthWatch England will be the patients’ watchdogs and the local and national voices speaking up for patients.
Commissioning by clinical commissioning groups does not mean that individual groups will have to commission every service. They can commission collaboratively, as I have mentioned, if that makes sense for them. Commissioners will be supported by clinical networks advising on single areas of care, and the new clinical senates in each area of the country will provide multiprofessional advice on local commissioning plans.
As regards having an advisory group for neurological conditions within the Commissioning Board, we understand that the board will put in place arrangements for clinical advice. One of the domains in the outcomes framework is concerned with the management of long-term conditions, and it would be natural for the board to reflect that in its structure. As regards a national clinical director for neurology, that will be a decision for the board, but it shares my desire for continuity and for ongoing improvements in the care and support of those living with these conditions.
The noble Baroness, Lady Gale, mentioned the value of clinical audits. I agree with her that they are of considerable value and my department regularly reviews the programme, within what we call HQIP. More than one noble Lord, including the noble Lord, Lord Dubs, and the noble Baroness, Lady Thornton, spoke about the number of neurologists, which is of course important in these complex and specialised areas. At the time of the last NHS workforce census in September 2010, there were 1,139 neurologists and 650 neurosurgeons employed in the NHS in England. To better understand the future demand for medical staff and to develop supply strategies to meet this demand, the Centre for Workforce Intelligence provides an assessment of medical supply and demand by specialty, region and care pathway. In August 2011, the centre published its second report on the medical workforce, which included a series of factsheets for each medical specialty, including neurology.
As we hope and expect from her, the noble Baroness, Lady Pitkeathley, rightly praised the role of carers. As I hope she knows, the Government are committed to supporting carers, who have a higher profile than ever before. We set out our priorities for action over four years, focusing on what will have the biggest impact on carers’ lives, in our document Recognised, Valued and Supported: Next Steps for the Carers Strategy, published just over a year ago. We are currently considering what more we can do for carers in the light of the recommendations made by the Dilnot commission on the funding of care and support, and by the Law Commission on the reform of adult social care. We will set out our full proposals for reform of adult social care in the White Paper in the spring.
As regards continued financial support for carers, we recognise the factors that the noble Baroness mentioned about rising costs of living. This again was a subject that we covered in our carers’ strategy last year. We reinforced some key messages in the NHS operating framework for next year. That reaffirms our commitment to supporting carers, including setting out specific requirements for PCT clusters to plan to support carers. The Government have set out further guidance to PCTs on funding carers’ breaks. The information available to carers is also important, as the noble Baroness emphasised, and the gateway for this is through primary care and the strategy. It is emphasised that primary care should support people who are carers or who fulfil that role, even if they do not identify themselves as such. On the Dilnot report, which we debated at some length, the noble Baroness knows that our engagement exercise to inform the future of social care has just ended. That has been extremely valuable. We will continue to work with leaders from the sector to develop policy proposals for the White Paper.
My noble friend Lady Gardner, the noble Lord, Lord Monks, and others spoke about multiple sclerosis and improving the quality of care for those patients. NICE routinely reviews its published guidance to take account of new evidence. Following consultation with stakeholders, NICE announced on 22 June that it plans to update its clinical guidelines. The review will consider new evidence identified in a number of areas which may change NICE’s current recommendations on the diagnosis and management of MS. I do not have a date, because NICE has not yet confirmed when it expects to issue the updated guidance.
The noble Lord, Lord Monks, asked about treatments. Although we strive to ensure that there is national guidance on the most commonly used medicines and treatments, there will always be instances where decisions have to be made locally. Under the NHS Constitution, patients have the right to expect local decisions on the funding of medicines and treatments to be made rationally, following proper consideration of the evidence. In the case of treatments which are not covered by NICE guidance, the local PCT has to decide whether to fund the treatment, based on an assessment of the available evidence and the patients' circumstances.
The noble Lord referred to Professor Richard's report on the extent and causes of international variations in drug usage. That was an extremely informative exercise. The report outlines a number of explanations for low uptake of certain medicines in this country. One was caution and/or scepticism among some neurologists about the benefits of treatment, including long-term effectiveness and concerns about side-effects, which we should not forget. There is also the fact that guidelines on the use of MS treatments are stricter in the UK than in some other countries—for example, the criteria in other countries for the use of disease-modifying therapies are lower. Those are very expensive treatments and we need to ensure that they are used only when they will achieve real clinical benefit. That is why we rely on NICE for its advice.
The noble Lord, Lord Dubs, mentioned Tysabri. That drug has received a positive recommendation from NICE; therefore, the NHS is required to fund treatment for patients whose clinicians consider they should receive that drug and are within the terms of NICE’s recommendation. If it does not fund it, the department expects the relevant strategic health authority to ensure that action is taken.
The noble Lord, Lord Monks, referred to a new drug called Fingolimod. I understand that NICE is currently appraising use of that drug in treatment of relapsing remitting MS and issued draft guidance on 5 August which does not recommend the drug's use. Since then, the manufacturer has proposed a patient access scheme for the drug, and we have agreed that that can be considered as part of NICE’s appraisal.
I have some lines here on stem cell treatments, which the noble Lord, Lord Dubs, mentioned, but I will write to him on that issue, in the interests of time. The noble Baroness, Lady Masham, and the noble Lord, Lord MacKenzie, referred to the especially distressing condition of motor neurone disease. A standard for motor neurone disease was part of the engagement consultation exercise run by the National Quality Board on the proposed areas that will make up the library of standards.
End-of-life care has featured in the debate—quite rightly. We recognise the need to ensure that the care that people receive at the end of life is compassionate, appropriate and supports the exercise of choice by care users. We confirmed our commitment to improving quality and choice in palliative and end-of-life care in the White Paper published in July last year.
We made a commitment in Liberating the NHS: Greater Choice and Control to move towards a national choice offer to support people’s preferences about how to have a good death. We have emphasised that access to good quality palliative care should not be confined to diseases such as cancer. The end-of-life strategy aims to improve care for all people approaching the end of life and includes people with advanced, progressive illness and the care given to them in all settings.
The noble Baroness, Lady Thornton, spoke about epilepsy. Here, the long-term conditions delivery support team developed a resource pack for the commissioners that brings together relevant documents and information from a variety of sources to support the development of epilepsy services. This includes information for commissioners on avoidable epilepsy-related death, which has been provided by Epilepsy Bereaved, the leading voluntary organisation in the UK working to prevent SUDEP. The NHS outcomes framework offers a number of opportunities for improvements at this area.
Spinal injury was a theme taken up by the noble Baronesses, Lady Hollins and Lady Masham. As they know, eight centres in England provide specialised care and treatment for patients with spinal cord injuries. I agree with the noble Baroness, Lady Hollins, that these centres have a key role, not only in acute care, but throughout the lives of paraplegic and tetraplegic patients.
There are no plans to establish any further specialised centres at this stage. It is currently the responsibility of regional commissioners and the individual centres to ensure that they are able to meet the needs of the populations that they serve.
I will need to write to noble Lords on continuing care, which is another subject that has arisen. I acknowledge that this is a source of concern, but the issue is quite complex. In the present system, eligibility for NHS continuing health care is determined based on individual assessment of need; it is not condition-based. There is a single national framework for determining eligibility but, as I say, this is a subject on which I shall write.
The noble Baronesses, Lady Hollins and Lady Masham, and the noble Lord, Lord MacKenzie of Culkein, spoke about the poor quality of wheelchair services. They are correct, which is why we believe that commissioners should be free to identify where choice and competition could have a role in improving services for patients. It is one of the services selected for Any Qualified Provider. I say to the noble Lord, Lord MacKenzie, that this is a good example of where third-sector organisations and social enterprises could make a real difference. We want to encourage that.
Time has moved against me, despite the fact that I have much more to say. I thank all noble Lords who have spoken. I undertake to follow up all the issues that I have not been able to cover; in particular, I am conscious that I have not addressed the pertinent issues raised by the noble Lord, Lord Macdonald, about dystonia but I shall do so in writing. With that, I thank all noble Lords for what has been a richly interesting and informative debate.
Health and Social Care Bill
Earl Howe Excerpts(14 years, 1 month ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, as the House will recall, I have made clear on earlier occasions why the Government do not believe that it is appropriate to reveal the details of my department’s risk registers. This decision was made not solely in consideration of the current Bill but in the wider context of government. It is important for me to emphasise that.
However, in addressing the noble Baroness’s Motion, it may be helpful to put the issues that she has raised into the broader context of the Freedom of Information Act. The overriding aim of the Act is to maintain a balance between openness and confidentiality in the interests of good government. Openness is an intrinsic part of good government and is a principle that I and my fellow Ministers firmly believe is important. At the same time, it is equally important to acknowledge the need for a safe space when formulating policy and the associated risks. Those noble Lords who took part in the debates on the FOI Bill will recall the clear position taken by Ministers of the day about where that balance should be struck in relation to the workings of government. It was made clear that the Act was not intended to change the way that the Government conduct their business by requiring all their deliberations to be made in public. Some element of confidentiality must remain for the proper and effective conduct of that business.
Ministers and civil servants need the space to be able to consider the worst risks—even to broach quite unlikely risks—and to do so openly and frankly, without the threat of disclosure. Without this safe space for open and frank risk assessment, the registers would be in serious danger of becoming anodyne documents and their purpose would thereby be significantly diluted. That is why information relating to the formulation or development of government policy is explicitly exempt from disclosure under the Act. There is also an explicit exemption for information that would inhibit, or be likely to inhibit, the free and frank exchange of views for the purposes of deliberation.
It is my department’s very clear view, and the view of other government departments, that departmental risk registers of this type and nature should be treated as being exempt from disclosure. That was also the view taken on several occasions by health Ministers in the previous Government. I say to the noble Lords, Lord Pannick and Lord Martin—I was grateful to the noble Lord, Lord Martin, for his remarks—that the Government have no wish to be discourteous or obstructive to this House. Quite the opposite.
We are absolutely not using the right of appeal as a delaying mechanism. The department has published and discussed its proposals for reform at every stage of the process; we have debated them at length in both Houses; it has released some detail about the associated risks and what it is doing to address them in its impact assessments. In response to the noble Baroness, I myself have provided the broad issues covered by the risk register in my Statement of 28 November. Incidentally, that Statement was meant to be complete. I assure the House that in taking forward the Bill, no further risks are identified on the register that would fall outside the list of broad issues that I provided. I am therefore satisfied that I have not misled the House as a result of the Government's decision to appeal.
I am very grateful to my noble friend Lady Williams for her suggestion that the case should be expedited. I am as keen as anyone to see the matter speedily resolved. As my noble friend knows, she and I discussed this yesterday privately and I have since pursued the matter actively with my officials. I should say, however, to place my noble friend's suggestion in context, that since we met, the solicitor acting for the Information Commissioner has requested an extension of time to file the commissioner’s response to our appeal notice and has indicated that the appeal raises issues of considerable importance that will require the tribunal's normal target time for listing an appeal hearing in order for the case to be properly prepared.
I should also make clear a further point. For our part, as the House knows, we take the view that this case raises an important matter of principle for the Government as a whole. We took the decision that we have taken after very careful thought and discussion. Now, the burden is on us as appellants to provide accurate and pertinent evidence to the court to support our case. In preparing that case, we need to consider and consult across various parts of government, as indeed we consulted about our decision to appeal. It is obviously important that we have the necessary time to prepare and carry out those consultations. We have not asked for more time, but I suggest that we need enough time.
I completely understand and sympathise with the desire of my noble friends to see the matter resolved, and I undertake to use my best endeavours to pursue the suggestion so helpfully made by my noble friends Lady Williams and Lord Clement-Jones. The decision to appeal the Information Commissioner's ruling has not been taken lightly, but we have taken it because we believe that the commissioner has not given sufficient weight—
Baroness Thornton
Can the Minister give us some times here? How long is it going to take? When does he expect to have the tribunal sit? He keeps saying that it will take time to prepare and to do this, but I think that we need to know how long that will be.
Earl Howe
Having anticipated that question before this debate, I made a point of asking but I am afraid that I do not have a definite answer to give the noble Baroness at this stage. As soon as I am able, I would be delighted to do so.
Our appeal is based on the belief that the commissioner has not given sufficient weight in his judgment to the considerations embodied in the relevant provisions of the relevant FOI Act. As the noble Lord, Lord Butler, made clear on 28 November, the ruling has serious implications across government in the precedent it sets for all risk registers.
Lord Campbell-Savours
The noble Earl said that he could not give us an idea of the timetable, but he does have something under his control: he has control of the timing of Report. He could say, “We will defer Report stage until the appeal result”. Why does he not just do that?
Earl Howe
The noble Lord knows that that is a matter for the House and the usual channels and not for me. However, I have no doubt that his suggestion will be registered in the appropriate places and will be considered. He must understand that it is not solely in my gift to order the business of this House.
I am of course acutely aware of the concerns of noble Lords on this issue. However, I would just ask those noble Lords who may at first blush be inclined to side with the noble Baroness in her amendment to recognise that there is room for an honestly held difference of view on this matter, that the principle involved is very important for the workings of government and that the Government have acted both properly and reasonably in asking the Information Tribunal to reconsider the merits of the case.
Baroness Thornton
My Lords, I thank noble Lords for this very illuminating and important debate, and I feel the weight of that importance. I think that the Minister would admit that over the past four weeks we have been very measured in our approach to this issue. We have not rushed at it; we have not sought to delay the Bill; and we have been very measured and patient in trying to work out the best way forward.
I thank the noble Lord, Lord Pannick, my noble and learned friend Lady Scotland and my noble friend Lord Richard and others for their support on this. I also thank my noble friend Lord Richard for crystallising the point that we should not proceed to the next stage of the Bill until we have the results of the appeal, and perhaps that would concentrate minds. In that context, I think that my amendment, which is a regret Motion, will help.
The noble Lord, Lord Clement-Jones, spoke about a chilling effect. I found the remarks of the representative of our former Permanent Secretaries in the House, the noble Lord, Lord Turnbull, interesting but possibly not to the point. The Freedom of Information Act may need reforming but that is not the point of my regret Motion. Particularly in response to the noble Lords, Lord Clement-Jones and Lord Turnbull, I should like to quote to the Committee from “Yes Minister”. This is from episode one of the first series and is about open government. Bernard, who noble Lords will all remember is the Private Secretary, says:
“But surely the citizens of a democracy have a right to know”.
Sir Humphrey—or maybe we should call him “Sir Andrew”—says:
“No. They have a right to be ignorant. Knowledge only means complicity in guilt; ignorance has a certain dignity”,
although it is not dignity that I would particularly welcome.
I confess that I am disappointed by my colleagues on the Liberal Democrat Benches. I was here with them in the Chamber fighting for the Freedom of Information Act all those years ago, and I know that they would have liked my Government to have gone even further than we did. Therefore, it is a matter of regret and disappointment that they are not joining with us in saying that the commissioner’s ruling is a good and measured ruling, that it takes account of all those issues and that this information should be made available to the public and, indeed, to the House.
Finally, the question is very simple. It is not about the appeals tribunal, and the noble Lord, Lord Pannick, was right. It is about how this House amends legislation to make it good legislation, and it is an amendment to regret the fact that we are not being given the information that we need to help us in that job. It is a very mild rebuke—it is an amendment expressing regret. It is a regret that we cannot do that job because we need this information. My view on that has not changed as a result of this debate. I feel enlightened by this debate to a certain extent and think that we may see a way forward. However, we need to regret the fact that we do not have this risk register, and I wish to test the opinion of the Committee.
Lord Hunt of Kings Heath
I am grateful to the noble Baroness for her helpful intervention and I fully accept what she says. I want to make two points. First, we need an acknowledgment by the Government that there is going to be a kind of intermediate tier that, in the end, they can turn to when there are problems—if CCGs cannot work out a strategic approach or if reconfiguration is not taking place, as well as all the things that arise in the health service generally. My second argument is that I believe the health service is somewhat different from HEFCE in that it touches everybody, and the kind of issues that this intermediate tier will intervene on are likely to concern the public much more. There is then a case for making the intermediate tier a statutory body. Essentially there are two points here. I certainly agree with the noble Baroness about the importance of a helpful enabling intermediate tier which occasionally needs to intervene.
Earl Howe
My Lords, as I have observed on earlier occasions, I believe that this Bill increases Ministers’ accountability for the health service through a range of mechanisms. However, perhaps I may begin by saying to the noble Lord, Lord Hunt, that I agree that the Secretary of State’s annual report is an important mechanism through which he will account for the system. I am sympathetic to the objective behind Amendments 243 and 243A, which seek to specify areas for inclusion in the Secretary of State’s annual report, but I can reassure noble Lords that I expect to see mention of areas such as the reduction of inequalities set out in the report, as these issues are the foundation of a high-performing health service.
The Bill also sets out extensive powers of intervention in the case of failure, which are essential if Ministers are to be able to retain ultimate accountability for the health service. The intervention powers in the Bill are specific to the organisations to which they apply, which is the issue covered by Amendments 245B and 245C. With that point in mind, I believe that the powers set out by the Bill strike the right balance, enabling appropriate freedom for NHS bodies while ensuring that the Secretary of State can intervene in the event of their failure.
The Secretary of State’s duty of keeping performance under review only applies to national arm’s-length bodies. It does not refer to CCGs. The noble Lord, Lord Hunt, questioned why that was. We think that is right; however, the CCGs will very definitely be kept under review. The Bill sets out a robust process for the board to hold CCGs to account and sets out extensive powers for the board to keep the performance of CCGs under review and to step in where they are not performing.
The noble Lord also queried why there was no mention of a range of other bodies, such as senates and field forces. The answer is that they are part of the NHS Commissioning Board, which is specifically mentioned. As regards health and well-being boards, as the noble Lord will know, we intend them to be part of local government. I do not think local authorities would take very kindly to the Secretary of State for Health keeping them under review.
There are also a number of amendments in this group that are concerned with the transparency and accountability of arm’s-length bodies, such as the amendments of the noble Lord, Lord Warner. Much like the Secretary of State’s annual report, each arm’s-length body’s annual report and accounts must be laid before Parliament. I simply remind the Committee that all ALBs are under a duty to exercise their functions effectively, efficiently and economically, and the Secretary of State is required to keep under review how effectively they are exercising their duties and functions.
Finally, I turn to co-operation between the bodies in the system. The Bill sets out a formal duty on each organisation to co-operate, and the department will hold organisations to account for the way they work with each other, not just how they perform their own functions. As regards Amendments 240A, 243ZA, 350 and 351, I hope I can reassure noble Lords that, through these two routes, the department will work to ensure that duplication is prevented and gaps do not emerge. If the Secretary of State believes that the duties of co-operation are being breached or are at significant risk of being breached, he will be able to write formally and publicly to the organisations. If the breach is significant, sustained and having a detrimental effect on the NHS, the Secretary of State will have a further ability to lay an order specifying that the organisation should take certain actions only with the approval of another specified body, other than the Secretary of State himself.
Amendment 245ZA looks to reinstate a power at Section 2 of the National Health Service Act 2006, which would enable the Secretary of State to provide services. We believe that the role of the Secretary of State should be one of oversight, direction-setting and intervention when organisations are failing. We have had many hours of valuable discussion on this topic; so while I fully understand the various concerns raised by noble Lords, I remind the Committee that all sides of this House have agreed to a process of engagement and discussion on this subject. The noble Lord, Lord Hunt, asked specifically in relation to this amendment whether this issue was covered by that process. The Clauses 1 and 4 process, as I call it, is considering the issue of the Secretary of State’s accountability for the NHS in the round rather than specific clauses in the Bill; so, yes, this would be covered by that process.
I hope that I have provided enough detail on these clauses to enable the noble Lord to withdraw this amendment.
Lord Warner
I wonder if the noble Earl could enlighten me, and indeed the House, on the story that is trailed in the Times today that the Secretary of State is going to have 60 benchmarks or indicators—which some of us would think looked like 60 targets. Are they going to be a key part of his process of keeping performance under review? Will he give the House a little more flavour of what that is going to mean?
Earl Howe
My Lords, that story in the press was about the outcomes that the Secretary of State is proposing should form the basis on which the health service is held to account. It is likely that the outcomes framework will form part of the annual mandate. These are proposals which we are hoping for comment upon. Therefore the answer to the question of the noble Lord is that the health service—I am not talking about the ALBs other than the board, but the National Health Service Commissioning Board—will be held to account against those outcome measures.
Lord Warner
My Lords, I have listened very carefully to the Minister. I am disappointed that he cannot agree to put something more specific in the Bill about administrative costs. I am concerned about those getting out of control, when the NHS faces a very difficult set of financial challenges. However, I hear what he says. We may want to come back to this at a later stage, but in the mean time I withdraw the amendment.
Earl Howe
My Lords, with Amendments 244 and 260DA, the noble Lord, Lord Warner, has taken us to the important matter of the relationship between the NHS and social care, and I agree with him that this relationship is in a real sense symbiotic. The noble Lord presented us with some sobering facts and messages about the increasing pressures that are likely to arise in our health and social care services over the next two decades, and it is in large part because of those looming pressures that the Government have brought forward their proposals for health service reform. The noble Lord deserves to be listened to with close attention, and I again pay tribute to his work as a member of the Dilnot commission.
Looking first at Amendment 244, we strongly agree that integrated services are important. The noble Baroness, Lady Greengross, brought home that message compellingly. This is why, throughout the Bill, there are duties to promote and encourage the commissioning and provision of integrated services. It is a vital principle. However, sympathetic as I am to the spirit of the amendment, I feel that the Bill’s current wording already provides for what it seeks to achieve. I would already confidently expect the annual report to cover aspects of service integration, and that is because integrating services, both between different parts of the NHS and between the NHS and other public services, would be essential to providing a seamless and high-performing health service. The change of culture that the noble Baroness, Lady Emerton, and my noble friend Lady Barker spoke of will not happen overnight, but it can be encouraged and promoted by shining a bright light on how well or badly the NHS is performing in this area.
Turning to Amendment 260DA, the Government are absolutely clear that a key objective of social care reform must be to improve outcomes for individuals and their families and carers using social care. Again, I completely understand why the noble Lord has brought forward this proposal, and I recognise that the amendment has been carefully crafted. In explaining the amendment, the noble Lord expressed worry about whether the Government are serious about pressing ahead with reform. The Government have committed to setting out proposals for the reform of social care in a White Paper and a progress report on funding reform to be published in spring of next year, with legislation to follow at the earliest opportunity. I can confirm to my noble friend Lady Barker that this will include our response not only to Dilnot, but also to the report published earlier this year by the Law Commission.
We agree that reform of the system is urgent and we debated these very issues recently and in some depth in a debate led by the noble Baroness, Lady Pitkeathley. If the Committee will forgive me, I will not repeat what I said on that occasion. However, on 15 September, the Government launched Caring for Our Future: Shared Ambitions for Care and Support, which was an engagement seeking views about the priorities for improving care and support. This focused period of engagement has been welcomed by stakeholders and, although it officially concluded on 2 December, we will continue to work closely with the social care sector as we formulate our proposals for reform.
“(hb) a subsidiary of a company which is formed under that section and wholly owned by the Secretary of State,”
Earl Howe
My Lords, this set of amendments is predominantly made up of a series of minor government amendments to Schedules 4 and 5. Many of them make minor or technical changes to these schedules to correct errors, ensure the Bill’s provisions work as they are intended to do and make minor consequential amendments to the NHS Act 2006. They correct a couple of errors in cross-references and the placement of consequential repeal; add references to the Bill’s provisions on transfer schemes to Sections 216 and 220 of the NHS Act, which relate to the transfer of property held on trust by the NHS, such as charitable property; and remove a reference to Section 2 of the Local Democracy, Economic Development and Construction Act 2009, which is being repealed by the Localism Bill.
The amendments also amend the definition of “qualifying company” in Clause 294, so that under the Bill we will be able to transfer property to a subsidiary of a company wholly owned by the Secretary of State, not just to companies owned directly by the Secretary of State. They also amend Schedule 4 to allow such subsidiary companies to be members of the statutory risk-pooling schemes for meeting liabilities of NHS bodies.
This group also includes one other amendment on Schedule 5, tabled by my noble friend Lord Lucas. Amendment 254 amends the Freedom of Information Act 2007 so that the criminal offence of taking certain actions to prevent disclosure of information held by a public authority is expanded to include information held by service providers. I can reassure my noble friend that the Government are committed to extending the scope of the Freedom of Information Act to increase transparency. To do this effectively, we need to spend time properly considering the issues raised. It would not be appropriate to rush through changes that have not received proper scrutiny.
As part of this work, the Freedom of Information Act will be subject to post-legislative scrutiny and the Cabinet Office has recently concluded a public consultation on an open data strategy, which is aimed at establishing how we ensure a greater culture of openness and transparency in the delivery of public services. I understand that my noble friend has already met with officials to discuss his concerns around freedom of information and this Bill, which I hope reassured him. If he has additional concerns following this debate, I would be more than happy to write or to meet him to discuss this further. I hope that that will enable him not to press his amendment when we reach it.
I also hope that I have satisfied noble Lords that this set of government amendments should be made and that my noble friend will feel equally content.
Baroness Thornton
My Lords, I should like to ask one question and to make one remark. Even the Minister smiled when he used the words “openness” and “scrutiny”. Given our previous conversations about the information that the House has not received, I do not intend to rehearse that again but I would look at colleagues in the Liberal Democrat Party and say just how shocked and amazed I am by their lack of willingness to want proper openness and scrutiny on this Bill.
My question concerns the strategy risk-pooling schemes. I understand what those are, but I would like to know who the pooling would be shared with.
“( ) Any function conferred on the appropriate authority by this section may be performed by either the Secretary of State or the Department of Health, Social Services and Public Safety in Northern Ireland acting alone or both of them acting jointly (and references in this section to the appropriate authority are to be construed accordingly).”
Health and Social Care Bill
Earl Howe Excerpts(14 years, 1 month ago)
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Lord Walton of Detchant
My Lords, I give very warm support to these amendments, which were so expertly introduced by the noble Lord, Lord Willis. As he said, the report of the Academy of Medical Sciences, after a long period of study and a committee chaired by Sir Michael Rawlins, made a number of important proposals, which the Government, in principle, accepted.
This takes the matter very much further. Following last night’s very exciting and far-sighted Statement by the Government about the developments in research and their sponsorship of translational research, the need to translate the discoveries of basic medical science into practical developments in patient care, the crucial importance of making access available to the NHS database to enable clinical trials to be carried out, and the crucial importance of more rapid access to new medicines and so on through the NHS, it is crucial to recognise that all those proposals are very important. These amendments would carry that forward.
It is also important that the Health Research Agency, which has already been established, is as yet an inadequate vehicle to further the developments to which the noble Lord, Lord Willis, referred in great detail. It is essential to recognise that to carry forward the developments envisaged in the Government’s Statement last night on translational research on the governance of clinical trials and the overall governance of research as a whole in the NHS, something like these amendments must be put in the Bill.
I want to comment briefly on the proposals set out in one of the amendments, to the effect that it would be sensible to remove from the Human Tissue Authority and the Human Fertilisation and Embryology Authority their research components and that these would much more happily settle in the newly defined Health Research Authority. There is a lot of sense in that, because the research carried out by these organisations is important, and it is research that is in many ways crucial to the development envisaged in these amendments.
However, it is important to recognise too that the Human Tissue Authority in its present existence has a major responsibility for regulation—regulating the departments, for instance, in which anatomical work is carried out, and regulating departments of pathology and other teaching functions which are absolutely vital. Similarly, the Human Fertilisation and Embryology Authority is not primarily concerned with research but also has major licensing functions, in licensing organisations in which work under the Human Fertilisation and Embryology Act can be carried out.
I understand that there has been a proposal by the Government that the functions of the HTA and the HFEA might be transferred to the Care Quality Commission. I would only comment, as John McEnroe said, that you cannot be serious. The Government cannot really be serious. This is not an organisation which is set up to handle that type of information. It is crucial to recognise that the Care Quality Commission has very specific responsibilities. It has taken on the responsibilities of three previous bodies, which were involved in looking at healthcare, social care and psychiatric care. It is carrying a major load—
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
Will the noble Lord give way? I am sure the noble Lord will know that through this Bill we cannot transfer the functions of either the HTA or the HFEA to any body at all. Indeed, that was the substance of my undertakings to this House under the Public Bodies Bill debate—that we would defer consideration of those matters until a later Bill. This Bill simply covers the reform of the health service, obviously, and my noble friend has sought to introduce an amendment to set up the Health Research Authority as a statutory body. But I gave an undertaking to this House that I take very seriously: that the consultation process on the transfer of functions from the HTA and the HFEA has to take place. It would be premature for this Bill to cover that matter. For that reason alone, I urge noble Lords to be very cautious about my noble friend’s amendment, about which, nevertheless, I will say some warm words.
I wanted to specifically cover that matter, as I notice the noble Baroness, Lady Warwick, looks as if she wants to rise to her feet. I can understand why, because it is important for the Committee to understand that the matters to which the noble Lord has just referred are matters which we will reach in due course, rather than today.
Lord Walton of Detchant
I am very grateful to the noble Earl for clarifying the position, but it is important that in the longer term we shall have to learn more about the future of those two very important authorities. In the mean time, the crucial importance of these amendments is to clarify in the Bill the responsibilities of this new organisation which is going to be responsible for regulating research in the UK, and which will streamline and improve the present mechanisms for research approval in many different situations. Therefore, I strongly support these amendments.
Earl Howe
My Lords, the amendments in this group aim to create a Health Research Authority. My noble friend has explained the rationale for the authority very succinctly and I want to make it clear at the outset that I am on precisely the same page as him as to what he is seeking to achieve for health research. We announced in the Plan For Growth in the Budget in March that we would create a body to combine and streamline the approvals for health research, which are at present scattered across many organisations. We also said that wherever we can achieve this simplification without primary legislation, we will. We have already laid legislation to establish the Health Research Authority, which started its work on 1 December 2011 as a special health authority, as was reported in Monday’s Statement on our strategy for UK life sciences. In that form it will take on a number of key functions and I will come to those in a moment.
Looking ahead, as I mentioned earlier, we will be consulting on the future of the HFEA and the HTA. That consultation, as the noble Lord, Lord Beecham, has pointed out, has been delayed but we are still very much intent on launching it and hope to do so shortly. We look forward to stakeholders’ views on the option of passing the research-related functions of the HFEA to the HRA as proposed in the AMS report. In that regard, where primary legislation is required to consolidate functions, we intend to subject it to pre-legislative scrutiny during the next Session and to introduce it as soon as parliamentary time allows.
It may interest my noble friend to know that I am upbeat. I am advisedly upbeat and want to stress to him and other noble Lords that contrary to the apprehensions that have been expressed, the Health Research Authority will have substantive functions as a special health authority. It will combine and streamline approvals for health research through unification of functions and processes wherever that is possible without additional legislation and through co-ordination where it is not. I say to my noble friend without any hesitation that we can achieve a very high proportion of what we wish to achieve with the HRA in this form as a special health authority. It will bring together functions relating to research ethics committees currently performed by the Secretary of State, the National Patient Safety Agency and strategic health authorities. It will operate a single system for researchers to apply for approval to research ethics committees, NHS trusts, the Medicines and Healthcare products Regulatory Agency, the National Information Governance Board and the Administration of Radioactive Substances Advisory Committee.
By April 2013, it is intended also to bring in functions currently performed by the Secretary of State on the advice of the National Information Governance Board’s ethics and confidentiality committee. The Health Research Authority will also work closely with the bodies I have just mentioned, as well as the Care Quality Commission, the Human Fertilisation and Embryology Authority, the Human Tissue Authority and the National Institute for Health Research to co-ordinate relevant functions, processes and standards. That is why, despite my noble friend’s understandable desire to see an NDPB established as soon as possible, I suggest to him that for practical purposes, setting aside the HFEA issue for one moment, the amendment is unnecessary.
However, there is another reason why it would not be right to establish the agency in this Bill—it would not be for the good of research in this country. I say that for the following reasons: it would weaken parliamentary scrutiny by stopping Parliament being able to debate primary legislation on the functions of the agency because it would consign much of the detail to secondary legislation—I do not think that is something that in the past your Lordships’ House has been keen on. It would pre-empt public consultation; for example, on the future of the HTA and the HFEA, and in my view it would put haste ahead of getting it right by dealing with a complex issue without due discussion and consideration.
Lord Willis of Knaresborough
I am listening carefully to what my noble friend is saying. However, Amendment 258 would not compromise in any way the consultations which he has rightly promised on the HTA and the HFEA. The proposed new subsection (3)(a) in Amendment 258 refers to,
“the provision of ethics committee opinions and other approvals”.
It does not state what those other approvals are. Therefore, if the amendment were passed, the Minister could consult in a year’s time or in two years’ time and come to a decision without compromising those approvals.
Earl Howe
I hear what my noble friend says but I cannot agree that his approach is the best for research in this country. Very real risks would accompany trying to shoehorn a very important and complex issue into this Bill in what I have to say to my noble friend is an inappropriate legislative form. The noble Lord, Lord Warner, asked about the view of the Academy of Medical Sciences on this matter. The last time that I spoke to staff at that body, which was not very long ago, they were dead set against my noble friend’s approach. They believe that the approach the Government are taking, which is a step-by-step approach, is exactly right. They recognise that the Special Health Authority can achieve a very great deal, we do not need to rush into primary legislation and we would do very much better to take our time over that process.
My noble friend mentioned the devolved Administrations. We have also directed the Health Research Authority to collaborate with the devolved Administrations in the exercise of its functions. We expect it to maintain effective communications with the UK health departments on the practical implications of implementing legislation, policy and guidance, building on the success of the national research ethics service at developing a single UK-wide system for research ethics committee review. Therefore, I do not regard that problem as at all insurmountable.
We agree with the intention behind Amendment 260C of improving the consistency and efficiency of reviews of the bodies carrying out research. We consider the National Institute for Health Research to be a more appropriate mechanism than the Health Research Authority for taking action to achieve outcome improvements, such as those called for in the Academy of Medical Sciences report. My noble friend may wish things were otherwise but noble Lords need to remember that NHS trusts are autonomous bodies. It is important that there is a clear division between the responsibilities accepted by them when planning and conducting research and the responsibilities of the body that regulates their practice. In this environment, the NIHR is in a strong position to support and influence them. The NIHR has already introduced mechanisms to achieve the effect of Amendment 260C through its co-ordinated system for gaining NHS permissions, its research support services framework of standard operating procedures and good practice guidance and its research passport scheme. It is also introducing benchmarks for NHS trusts’ performance in the initiation and delivery of research. NIHR funding will become conditional on meeting such benchmarks, so there is a direct incentive for NHS organisations to comply with those benchmarks.
As regards the Health Research Authority monitoring developments relating to activities within its remit, I thank my noble friend for raising the horizon-scanning point. I will gladly consider that further to see what can be done.
In sum, I do not see this amendment as appropriate. I appreciate that my noble friend intended it as a probing amendment, but I hope that I have set out clearly why I do not think that this would be the right way to go. Noble Lords can be relaxed that we are already embarked on a course which should deliver major improvements in all the areas where we want to see improvements as regards the clinical trials process in this country. As I say, I am optimistic that we are embarked on the road to the sunlit uplands in this sense. We will in due course—I hope that that will be sooner rather than later—come to a point where we can embody these things in primary legislation. However, I urge noble Lords to consider the need to take our time and to consider those matters very carefully.
Lord Willis of Knaresborough
My Lords, I thank the Minister, as always, for his courteous and passionate reply to this debate. He has used the words upbeat, relaxed and enthusiastic about the amendments and the aim behind them and I appreciate what he said. He made the point—and has made it often—that the Special Health Authority, which was set up on 1 December, will be able to take on, over a short period of time, many of the functions which I have outlined in Amendment 258. I would be grateful if the Minister would put in writing the timetable for delivering all those elements. It would be hugely advantageous to know just how they would fit and dovetail in.
My noble friend Lord Warner—well, he is a friend—commented on the views of the Wellcome Trust and the Academy of Medical Sciences; the Minister said that the Academy of Medical Sciences was against the Willis amendment. In fact, the last time that we met the Academy of Medical Sciences—the noble Lord, Lord Turnberg, and I were on the same platform with it about a month ago—the academy made it clear that, while it did not want to have any detail in the Bill because that would compromise the detailed discussions, it was happy to see the architecture in the Bill. This is something which the Wellcome Trust supported; in fact, I was helped by both the trust and the Academy of Medical Sciences in drafting these amendments. The Association of Medical Research Charities, which I chair, was also incredibly helpful. There are, perhaps, some crossed wires here.
On Amendment 260C, I hear what the Minister says about bringing those two issues together, particularly for the R&D functions of NHS trusts. I said that there is a real issue about autonomous organisations. Why has the NIHR not actually done it? If this is the biggest obstacle to getting clinical trials developed quickly in the UK, why has it not already forged those relationships, and what confidence do we have that it will be able to do so over the next year or so?
This has been a good debate and I am incredibly grateful to noble Lords throughout the House for their support for these amendments. I still believe that the proposals in Amendment 258 could be in the Bill but given the Minister’s assurances and his willingness to debate these issues further, I beg leave to withdraw the amendment.
Health: Oral Cancer Detection
Earl Howe Excerpts(14 years, 1 month ago)
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Baroness Gardner of Parkes
To ask Her Majesty’s Government whether they will make representations to the General Dental Council to raise the priority accorded to oral cancer detection and for its inclusion as a recommended topic in the list of subjects for continuing professional development.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, yes, the department will be raising this issue with the General Dental Council. I understand that the General Dental Council is currently at the early stages of reviewing its continuing professional development requirements for registrants and plans to hold a formal public consultation on its draft proposals, probably in the first half of 2012.
Baroness Gardner of Parkes
That is a very helpful Answer because the profession wants to see that. As the Minister knows, I have encouraged the continuous inspection of people’s mouths whenever they present for some other cause. The really important thing is that when they are referred up, the person seeing that patient knows what the position is. In view of the report last week about the vast increase in hepatitis among young people due to alcohol, will the Minister comment on whether he thinks there is a parallel with our 2009 debate, when that was raised as a factor in the great increase in mouth cancer among young people?
Earl Howe
My noble friend is quite right that the worrying feature of oral cancer is that it is increasingly appearing in the young. The risk factors that have been identified for oral cancer are primarily smoking and consumption of alcohol, but particularly the two combined. It is important that we get to grips with this. A number of public health campaigns are in train, certainly on smoking, and our alcohol strategy is due out very shortly, which will also address drinking among the young.
Baroness Masham of Ilton
My Lords, does the Minister think that HPV and HIV can be first detected in the mouth by dentists, and does he not think that dentists should have more training?
Earl Howe
My Lords, my understanding is that HIV needs to be fairly far advanced before it manifests itself in the mouth. However, the noble Baroness is absolutely right with regard to HPV—human papilloma virus—because since 2009 there has been further research suggesting a link between HPV and oral cancer. There is now a sufficient evidence base to suggest that infection with HPV is a risk factor, particularly for the soft tissues at the back of the mouth. Her point about dentists picking this up is very well made. My understanding is that dentists are very much on the lookout for these symptoms.
Lord Sharkey
My Lords, according to Macmillan Cancer Support, mean survival times for cancers of the stomach, oesophagus, pancreas, brain and lung have barely increased in the last 40 years. These cancers account for 39 per cent of all cancer deaths, but attract only 13 per cent of all cancer research funding. Does the Minister think this is a satisfactory balance and, if not, can he tell us how the Government might be able to help remedy the situation?
Earl Howe
My Lords, I agree with my noble friend that it is not satisfactory. However, the position with research funding from government sources is that proposals are evaluated on the basis of merit; there is no predisposition to any particular kind of research as long as it is high quality. Both the MRC and my department, with the National Institute for Health Research, are open to proposals of high quality to address unmet areas of research.
Baroness Thornton
My Lords, I congratulate the noble Baroness, Lady Gardner of Parkes, because I answered Questions that she asked on this issue in my time. She has shown great persistence and no small amount of success in pushing this issue along. I would like to ask the Minister a question about smoking, because, as he rightly says, smoking is a factor in the incidence of mouth cancer. In the public awareness campaign about tobacco and tobacco regulations, are the Government including the implications of mouth cancer?
Earl Howe
Yes, we are continuing to invest in tobacco control activities. The noble Baroness will know that in March, we published our tobacco control plan for England, which sets out a range of action points. We are running marketing communications campaigns, with a campaign currently on television. In the new year, we will be making Quit Kits available through pharmacies across England; in the spring, we will run a campaign to highlight the risks of exposure to second-hand smoke and to encourage smokers to make their homes and family cars smoke-free.
The Earl of Selborne
Will the Minister tell us whether the tobacco industry is giving full support to this campaign?
Life Sciences
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, I shall now repeat a Statement made in another place yesterday by my right honourable friend the Secretary of State for Health.
“Mr Speaker, the life sciences industry is one of the most promising areas for growth in the UK economy. It has consistently shown stronger growth than the UK as a whole. It accounts for 165,000 UK jobs and totals more than £50 billion in turnover. Pharmaceuticals alone account for more than a quarter of our total industrial research and development spend. Global pharmaceutical sales are predicted to grow by up to 6 per cent a year in the coming years, and in emerging economies medical technology is achieving growth rates of more than 12 per cent. A flourishing life sciences sector is essential if we want to build a more outward-looking, export-driven economy. The partnership between industry, the NHS and our outstanding universities is not just essential to economic growth—it will benefit millions of future and current NHS patients, fuelling more rapid development of cutting-edge treatments and earlier access to those treatments for NHS patients.
Like many industries, the life sciences industry is undergoing rapid change. The old big pharma model of having thousands of highly paid researchers working on a pipeline of blockbuster drugs is declining. A new model has emerged, one that is more about collaboration, the outsourcing of research and early clinical trials on patients. Excessive regulation can mean that the uptake of new treatments and technology is slow. That is a challenge felt acutely by an industry that sometimes feels that the return is not there quickly enough to satisfy investors. It is felt even more acutely by patients, who understandably expect that they should be able to access the latest and most effective treatments and that new innovations in care should be adopted rapidly by the NHS.
We have a leading science base, four of the world’s top 10 universities and a National Health Service that is uniquely capable of understanding population health characteristics. However, those strengths alone are not enough to keep pace with what is happening. We must radically change the way we innovate and the way we collaborate. The life sciences strategy that we launched yesterday, alongside the NHS chief executive’s review on innovation, health and wealth, sets out how we will support closer collaboration between the NHS, industry and our universities, driving growth in the economy and improvements in the NHS. All the documents have been placed in the Library.
Among other key measures, we will set up a new programme between the Medical Research Council and the Technology Strategy Board to bring medical discoveries closer to commercialisation and use in the NHS. There are many medical products being developed to treat patients. The cost of developing them is high because they take a long time to develop and test. Investors want to see at least some evidence that the products might work in people and robust validation of the quality of the research and development work being undertaken, as well as of the capability of the company to bring the product to market, before they will finance the development of the products. That means that some of the best medical innovations are not making it through to patients. We are already providing investment to address that but we believe that we can do more to support the development of these products across funding organisations and the successive stages of product development, which will support the development of promising innovations and help to increase the number of treatments being made available to patients. We are therefore introducing a £180 million catalyst fund for the most promising medical treatments.
It can take more than 20 years from the first discovery of a drug until patients can be prescribed it by their doctor. We have already taken steps to address that. Through the National Institute for Health Research, we are investing £800 million in new research centres and two major translational research partnerships that will help to cut the time between the development of new treatments and their application in the NHS—from the bench to the bedside.
Now we are going further. As part of a major drive to improve innovation and access to medicines in the NHS, we are announcing proposals on a new early access scheme, which could allow thousands of the most seriously ill patients to access new cutting-edge drugs up to a year earlier than they can now. Through the early access scheme, the medicines regulator—the Medicines and Healthcare Products Regulatory Agency—will provide a scientific opinion on the emerging benefits and risks of very promising new drugs to treat patients with life-threatening or debilitating conditions for whom there are no satisfactory treatment options. That will mean that seriously ill patients of any age, who have no other hope of being treated or having their life extended, could benefit from drugs more quickly—around a year before they are licensed.
We must also ensure that we make better use of our unique NHS data capability. It is often said that the NHS is data-rich but information-poor. As a national health service, it contains more data about health than any other comparable health system in the world. However, neither the NHS itself nor scientists developing new drugs and treatments have always been able consistently to make good use of these data, or to use them to drive further scientific breakthroughs. We have seen how powerful the release of data can be. For example, South London and Maudsley NHS Trust and the Institute of Psychiatry now have access to a database covering 250,000 patients. It includes their brain scans, medical records and notes—a wealth of information, all consented to and all anonymised, that is helping them to find new answers in the fight against dementia.
We need powerful data-handling capacity and the skills to write the software to mine them. That is why we are investing in e-infrastructure, which will provide secure data services to researchers. The Clinical Practice Research Datalink is being introduced by the MHRA in partnership with NIHR and will provide a specialised service to the research and life sciences communities. Let me reassure the House that we will take all necessary steps to ensure safeguards for patient confidentiality.
We will also make sure that more UK patients get the opportunity to take part in national and international clinical trials and play a much greater role in the development of cutting-edge treatments. We believe that patients should have the right to access new treatments and be involved in research to develop new medicines. We have responded to calls from research charities and clinicians for the Government to get patients more involved in supporting research. A recent Ipsos MORI poll in June found that 97 per cent of people believe it is important that the NHS should support research into new treatments. In addition, 72 per cent would like to be offered opportunities to be involved in research trials.
We will therefore consult on changing the NHS constitution so that there is an assumption, with the ability to opt out, that data collected during a patient’s care by the NHS may be used for approved research. That would make it clear that researchers and companies with new and potentially life-saving medicines could access the data of patients and could approach patients whom they feel could benefit in order to discuss their involvement in research studies. This would encourage growth in the life sciences industry as more people and more detailed data would be available for the important trials and research needed to get breakthrough treatments used more widely.
Additionally, we have set out actions to improve incentives for investment in innovation and reduce regulatory bureaucracy. With the creation of the Health Research Agency, we will streamline regulation and improve the cost-effectiveness of clinical trials. As the NHS chief executive’s review of innovation has shown, the NHS needs to be quicker and smarter in adopting new technologies and approaches to care that can both save more lives and cut costs. Sometimes, it is a question of evidence. Until recently, we could not say with certainty that telehealth could keep people out of hospital and save lives. There was understandable reluctance among parts of the NHS and councils to invest in untried technology. However, as early results from the Whole System Demonstrator pilots show, the potential of telehealth is nothing short of remarkable, with dramatic reductions in mortality, hospital admissions, emergency visits and the number of hospital bed days. To make the most of this, we will support the NHS and work in partnership with industry and councils dramatically to spread the use of telehealth over the next five years. In doing so, we are looking to transform the lives of 3 million people in this country. We will become a global leader in the management of chronic and long-term conditions, generating massive opportunities for UK companies developing this technology. It will be innovation in practice; and we will foster other proven innovations such as fluid management technology techniques that were developed for use in high-risk surgery and critical care to help clinicians administer fluids and drugs safely.
In March 2011, the National Institute for Health and Clinical Excellence published guidance recommending that this technology should be used for patients undergoing major or high-risk surgery. Currently, it is used for fewer than 5 per cent of applicable patients despite evidence showing that it could benefit 800,000 patients and save the NHS £400 million. We will launch a national drive to make sure that fluid management technology is used in appropriate settings across the NHS. That is one example of many.
The innovation review sets out how we will address all the barriers to innovation in the NHS, whether they involve culture, leadership, training, use of information or lack of incentives and investment. We will also introduce a NICE compliance regime that will mean that medicines approved by NICE will be available on the NHS much more quickly. The plans set out in today’s strategies will help to drive the development of new technologies to diagnose and treat the most complex diseases in this country for the benefit of NHS patients. This is a strong package of measures that will support economic growth and innovation in the NHS and will drive significant improvements in patient care. I commend this Statement to the House”.
My Lords, that concludes the Statement.
Earl Howe
My Lords, if I may I shall pass over that final remark. I am not sure that it is strictly relevant to the Statement. I was happy to hear from the noble Baroness of her support for the initiatives that we have taken and of her welcome for the measures. She said that the coalition Government had lost momentum in this area. From my perspective as a Research Minister, that is not the case. The Office for Life Sciences was an initiative of the previous Government that we eagerly continued. I pay tribute to the noble Lord, Lord Drayson, for his work in establishing the bridge between BIS and my own Department of Health. That relationship remains very active.
We recognised from the outset that a strong research base was vital for our future as a global knowledge economy. I refer both to basic research—curiosity-driven research—and research applied to the challenges that face business and public services. Despite enormous pressure on public spending, the BIS science budget of £4.6 billion a year has been protected; and in my own department the research and development budget is increasing year by year over the period of the spending review. In the current year it is just over £1 billion. That shows our commitment to the sector.
The noble Baroness asked several questions. The first concerned the use of patient data. There are very clear information governance rules that will protect the confidentiality of patients. We are not changing the rules. They will apply to whatever sector a researcher may come from: the public sector, a charity or the private sector. The rules are the same. All approved research is conducted to strict ethical standards. It is subject to robust regulation. Before any data are given out about a patient, the following conditions must be met. There must be confirmation that the data requested will support the health question being researched. There must be approval from an ethics committee to ensure that the research is ethically valid, including a check on the data requested. There must be information governance checks and approvals to ensure that the recipient can receive and process the data legally to conduct their research. There must be confirmation that the data are anonymised. No data will be disclosed to a researcher unless all the conditions are met.
The NHS gives out data in anonymised form. Before they are given out, they will be checked to ensure that reidentification is not possible. The main exception is where a patient gives consent for identifiable data to be disclosed. Except in that instance, companies or other researchers who receive data in anonymised form will not be able to identify the patient. The data will be checked before they are disclosed to any company, and legal contracts for the use of the data will require all recipients to comply with strict controls on using data lawfully. The companies will be subject to spot checks.
The noble Baroness asked whether patients would be able to opt out. The answer is yes. Patients will be able to opt out of their personal electronic health record being used for research purposes in an identifiable form. Patients should tell the NHS that that is their wish. The GP will record this in the patient’s record. We have tested technical ways of delivering this and of enabling researchers to identify patients who might be able to contribute to a research project without physically searching through records. Our pilot projects have been very successful.
The noble Baroness asked how all of us can be sure that our patient data are secure. Both the clinical practice research datalink and the NHS Information Centre will hold data securely. They are governed by strict access protocols to ensure that the data are processed lawfully, including when information is disclosed to researchers. Services are subject to the highest levels of independent audit and to regular checks. The data are held in a secure data centre not connected to the internet and are managed to the highest standards of information governance. I hope that that reassures the noble Baroness.
She also mentioned the European Court of Justice ruling on human embryonic stem cell patenting. As she knows, the UK is a world leader in the research and development of stem cell therapies, and the Government will continue to support and fund this work. The judgment of the court applies only to human embryonic stem cell lines, not to other stem cell sources such as adult or induced pluripotent stem cells that are used in stem cell research and regenerative medicine. The judgment does not impact on the regulation of embryos and embryonic stem cells in the UK. However, it is a landmark judgment and we will work with BIS and the Intellectual Property Office to further explore the options on how to address the issues from the ruling. The noble Baroness will understand that the ruling is recent and it is important that we consider the implications very carefully.
Earl Attlee
My Lords, we have plenty of time but perhaps I may remind the House of the need to avoid the trap of making a detailed speech rather than asking a short question.
Lord Walton of Detchant
My Lords, I congratulate the Government on this excellent and far-sighted Statement. It was anticipated to a degree by the article in yesterday's Times by Mr David Willetts and by the Times’s first leader today that highlighted the importance of these developments. I was very glad to see that it was stressed that excellence in health service research is not entirely in the south-east of England. The leader picked out Newcastle University Medical School as another centre of excellence in this programme of research.
Some 15 years ago I chaired the House of Lords Select Committee inquiry into international investment in UK science. We found that 40 per cent of all American overseas investment in science came to the UK and 42 per cent of all Japanese investment came to the UK because of the perceived strength of the UK science base. The science base remains strong and powerful, as the Statement makes clear. However, at the time we recognised that translation of the results of the research into effective changes in patient care was inadequate. The Statement makes it clear that the Government intend to support translational research to the benefit of our community.
I will ask the Minister one or two questions. We live in an era in which genomic medicine and the results of molecular biology are being translated into new developments that may benefit patients with many severe crippling diseases and long-term conditions, not least some that are genetically determined. Genomic medicine is identifying the gene defects and medicines are beginning to be introduced that may overcome these genetic defects.
The catalyst fund is crucial. I would rather not call it a valley of death fund but a postponement of death fund, because if the drugs that are introduced as a result of this major research come to market, it is very important to recognise that in many instances the number of patients likely to benefit, particularly those suffering from rare diseases, will be small, and therefore commercial exploitation will be extremely difficult. The drugs that are now emerging are known as orphan and super-orphan drugs. The previous Government put money into a cancer drugs fund because of the expense of many of the new drugs that were being developed. Will this Government consider the possibility of developing a fund for the exploitation of these orphan and ultra-orphan drugs, because today's discovery in basic medical science will bring tomorrow's practical development in patient care?
The previous Government produced the Technology Strategy Board as a major halfway house between universities and science institutes on the one hand and commercial exploitation by companies on the other. The Statement takes that one step further with the catalyst fund. Will the Government consider funding orphan drugs for the treatment of these rare diseases?
Earl Howe
The noble Lord makes an extremely important point. He will know that the Government have already established a cancer drugs fund which is designed to enable patients to access drugs that their doctors feel they should receive but which the NHS will not otherwise fund. We are putting £200 million a year for the next three years—totalling £600 million, in other words—towards this fund. That fund is there for orphan medicines and for the treatment of rarer cancers as much as it is for more common cancer treatments. So, as a temporary device, that fund exists.
We have taken the view that the development of a value-based pricing structure for medicines should enable us to move to a situation where drugs are assessed for value in their broadest sense and priced accordingly. In that way, if the value is computed as being high for patients, the NHS will pay the corresponding price and the patient will be able to access that drug. I would, however, say that in the case of orphan medicines the work is at an early stage. It is clear that some orphan drugs are likely to be priced very high, and it is of course necessary to ensure that the value of those drugs as reflected in the price is one that the NHS is prepared to pay. As I say, we have work to do. I can update the noble Lord as time goes on in that area. However, I can tell him that this is very much within our sights.
Baroness Sharp of Guildford
My Lords, I should like to thank my noble friend for repeating the Statement and say how much I, like other noble Lords, welcome it. In so far as the new strategy being adopted gives earlier access to new drugs and new technologies for patients, it can only be a very good thing. I have a number of questions for the Minister.
Quite a few NHS hospital data are already available to researchers. One example is the link-up between Yale University and University College, London, where data on cardiac medicine are being mined and exchanged. With the NHS we have cohorts that can be followed through, which is not available in the United States. Am I right in thinking that the difference is that GP data as well as hospital data can now be mined in the same way, enabling cohorts to be followed? If so, and if we are developing these huge computerised databases, how confident can we be that they will not go the way of Connecting for Health, the £13 billion project that hit the ground well over six years behind schedule and which the coalition decided was no longer worth pursuing?
Finally, how confident can we be that these new proposals will change the trend in clinical trials? There has been a dramatic decrease in clinical trials in the UK, from something like 6 per cent of trials done in 2000 to only 1.4 per cent today. Part of the idea behind these new developments is to bring some clinical trials back to the UK. Can the Minister explain precisely how this is expected to be done, and how confident can we be that it will reverse this trend despite the advantage of the growing markets in the Far East, in particular, in attracting clinical trials?
Earl Howe
My Lords, my noble friend has asked some extremely pertinent questions. In answer to her first one, data from GP practices as well as data from hospitals are available today. However, the clinical practice research datalink, which is the new service for researchers being established under the umbrella of the Medicines and Healthcare products Regulatory Agency, will for the first time enable researchers to access very much larger banks of information on a population basis and to target their questions appropriately at the database. I do not see that there is any risk to the technological aspects of that system. The CPRD is using existing data structures in the NHS. It is not changing systems as Connecting for Health attempted to do and has done.
Will this make a difference to clinical trials in the UK? I believe that it is one ingredient of a package that will make the UK more attractive. On its own, perhaps it is not enough. When I recently visited Japan and spoke to pharmaceutical companies there they were extremely interested in this, but of course they take into account the wider picture. That has to include the fiscal environment, where we are introducing a patent box which will protect patents, at a very advantageous rate of tax, on intellectual property invented in this country. There are various incentives aside from that including the corporation tax rate, with ours being the lowest in the G7 in a few years’ time. Also, the establishment of the Health Research Authority is designed to streamline the ethical approvals for clinical trials. The establishment of the National Institute for Health Research also is designed to streamline the all-too-slow process that we have been used to over the past few years. We are determined that, across the piece, we must make this country and the NHS, in particular, the platform of choice for clinical trials in the world. I believe that this can be done, but of course it will not happen overnight.
Lord Patel
My Lords, of course I am extremely biased but I absolutely commend the Government for bringing about this strategy. It was necessary to highlight our leadership in all these areas of stem cell therapy, regenerative medicine and other areas of drug development. Those who are concerned about the development of a clinical, practice-based research data bank need not be concerned. We have developed and used such a bank for many years and it works. The unfortunate thing about it is that it has been local. We now need a nationally based clinical-practice research data bank. Such a bank helps not only with clinical research but to improve patient care. Diabetes is an example where such a bank has been used, and where it has worked it has produced improvements in patient care. Last year, for example, it reduced peripheral limb loss by 40 per cent in diabetics. The current figures show that it will probably do the same for eye complications in diabetics. I commend the Government for this strategy.
I am biased because I am a member of the Medical Research Council. I am also a chairman of Cancer Research UK’s Dundee cancer research centre, which co-ordinates clinical research, basic research and clinical practice to deliver better research. For five years I was also chair of the Stem Cell Oversight Committee and developed the stem cell bank, which is the world's biggest stem cell bank. Other countries are envious and want access to our stem cell bank. We are the only country that has clinical-grade stem cells lodged in our bank. No other country has them. It is the clinical-grade stem cells that we will need to use for therapy, and next year we will be the first country to carry out clinical trials for age-related macular degeneration using embryonic stem cells. I do not worry about the patients ruling, either. I know that as scientists we do worry—but somehow we will overcome.
One strategy that the noble Earl did not mention was that of synthetic biology—I am also excited about that, because there was a risk that we would fall behind. The strategy states that an independent panel will be established to produce a road map for technological development in synthetic biology, which is a means of sequencing the effective things that occur in plants and other areas from which drugs can be developed. There are already examples of these in the United States, which have been used there to produce drugs. We will fall behind if we do not develop our research.
The idea of developing an independent road map for synthetic biology is commendable. I therefore ask the Minister, what is the timeline for developing that road map because, otherwise, others will leapfrog over us?
Earl Howe
My Lords, I am pleased that the noble Lord mentioned that part of our initiative. As he rightly said, we have undertaken to develop a strategic road map that will set out the timeframe and actions required to establish a world-leading synthetic biology sector. That will be published in spring 2012. To oversee the delivery of the road map, we will establish a synthetic biology leadership council, co-chaired by my ministerial colleague David Willetts, the Minister for Science and Innovation, and Dr Clarke of Shell Global Solutions. I am told that the total timeline for this is 12 months. We therefore intend to move forward on this with some speed. I share the noble Lord’s enthusiasm for its potential.
Lord Brooke of Sutton Mandeville
My Lords, first, I congratulate my noble friend on having omitted a reference in his Statement to a valley of death fund. Secondly, having picked up the reference to big pharma in this welcome Statement, I called to mind the historic and dramatic decision of the late Austin Bide of Glaxo to increase the planning horizon for research in that company from five years to 25 years. The Statement makes clear the acceleration that we shall see in drug development. Can my noble friend hazard any estimate of what effect today’s announcement will have on the planning horizon of research, in the manner of the late Mr Bide’s remarkable extension?
Earl Howe
The planning horizon for research, as my noble friend will know, has always been a long one. With the increasing cost of research, particularly in later stage clinical trials, companies end up making an extremely significant investment in order to bring one molecule to the market. What we seek to achieve for big pharma in this package of measures is a sense that we in the UK have, as it were, an unrivalled ecosystem that brings together business, researchers, clinicians and patients to translate discovery into clinical use for medical innovation within the NHS. What we want them to appreciate is that the UK provides an environment and infrastructure that supports pioneering researchers and clinicians to bring innovation to the market earlier and more easily so that this country becomes the location of choice for investment. I am thinking here particularly of our proposals for setting up academic health science networks that will span the NHS. That is our ambition. I am thinking of the early access scheme for medicines, which was mentioned in the Statement. We want to break down the regulatory barriers to speeding up clinical trials that have beset the industry. For all those reasons, I should like the industry to see this as facilitating a shorter time horizon. However, we cannot do anything to get around the essential safety and quality standards that the patient and the citizen rightly insist upon.
Lord Willis of Knaresborough
My Lords, I welcome the Statement from my noble friend. I realise that other noble Lords want to get in. I should like to ask a few brief questions. First, we have to recruit patients on to trials. It is interesting that there is a proposal automatically to opt patients in to trials—or at least have access to them. How will that be achieved? Will it be achieved through this Bill? Secondly, will the £180 million catalyst fund for the valley of death replace the Health Innovation Challenge Fund that currently operates between the Department of Health and the Wellcome Trust? If not, where will the £180 million come from?
Earl Howe
My Lords, I shall answer the second question first. The £180 million biomedical catalyst fund is a completely new fund for industry. Its object is to nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms in order to attract private equity. I shall probably need to write to my noble friend with further details of where the money is coming from. It is coming from the budget of BIS, rather than my own department, and it is therefore necessary for me to ask my colleagues in BIS precisely where the money emanates from. I am happy to let my noble friend know.
The proposal to which he referred is only a proposal. We are suggesting that the public should be asked whether the NHS constitution should be changed so that patients are aware that their data, as now, can be used in anonymised form for research. Our intention is to ask more patients whether they wish to be approached for research if that research is relevant to them. As the Statement made clear, we know that more than 70 per cent of the public wish to be informed if a piece of medical research is relevant to them. Patients are keen to be involved in this. It is important to have a public dialogue about the extent to which patients may be approached so that they may know in advance that there is a possibility of a project being relevant to them. We are formulating these proposals now and it will be some time before we issue the consultation. I shall make sure that I let my noble friend know as our proposals crystallise in this area.
I can, in fact, answer my noble friend’s earlier question as to whether the Health Innovation Challenge Fund is being replaced. No, it will continue.
Nursing
Earl Howe Excerpts(14 years, 1 month ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, on occasions like this, I reflect on how lucky we are in this House to have the noble Baroness, Lady Emerton, in our midst. She has allowed us to appreciate once again why she is such an unquestioned authority on this crucial subject of nursing care. I, for one, am very grateful to her.
The wording of her Motion is of course carefully chosen. Front-line nursing—in acute settings, in the community, in schools and in people’s homes—is a part of all our lives and has always been an essential element of patient care in the National Health Service. Patients are clear about what good nursing care should look like. They want to be confident that their nurses are knowledgeable, safe and competent. They expect their nurses to be caring and compassionate. They want to be treated with respect by nurses who genuinely care for them and about them.
We in Government are also clear about what we expect from a front-line nursing workforce. I cannot better the description offered by the noble Baroness, Lady Warwick. We expect high-quality, safe and knowledgeable care for all; we expect dignity and compassion for all; and we expect nurses to make the most of each and every interaction they have with patients to improve their health and well-being, and their experiences of care.
What makes a good nurse? The first requirement is a point raised by my noble friend Lord Bridgeman. We should attract people into the profession who not only have academic ability, but also have the right values, attitudes and behaviours. Education commissioners expect universities to demonstrate that their recruitment processes embrace this approach. Employers will also look for this as part of their selection and recruitment processes when they are helping to interview potential students and are appointing registered nurses. Getting this right at the start will help to reduce attrition and maximise the resources that we put into nurses.
The second requirement, as our debates on the Health and Social Care Bill have amply demonstrated, is that we educate and train our nurses well. The Nursing and Midwifery Council undertook a comprehensive review of pre-registration education and published new standards for pre-registration education in 2010, following extensive and wide public consultation. Importantly, fundamental care is specifically reflected in these new standards. I would say to my noble friend Lord Bridgeman that student nurses spend as much time gaining practical, hands-on experience with patients as they spend in the classroom. In fact, I believe that that ratio has not changed over the past 30 years. I completely agree with the excellent points made by the noble Baroness, Lady Warwick, about degree-level nursing. The first of the new educational programmes began only this year and it will be about three years before the first students emerge from these new programmes. The NMC will evaluate these changes and I look forward to seeing this work.
The next requirement is to enable nurses to nurse. That means doing what the noble Baroness, Lady Masham, talked about so compellingly: finding ways to make sure that we keep senior, experienced nurses beside patients delivering hands-on care and not filling in endless piles of paperwork, which are sometimes of marginal usefulness. That is why we are committed to reducing bureaucracy and empowering our nurses as clinical leaders. The NHS institute’s productive series is helping nurses to reduce unnecessary and wasteful practice at the point of care, which is freeing up nursing time to be spent on essential tasks, such as providing assistance with mealtimes and carrying out interventions to prevent pressure ulcers and falls. Any good nurse will tell you that spending more time with the patient facilitates a better and more timely patient assessment, thus enabling the nurse to spot signs of deterioration or to pick up on small but significant things that a patient often will not think to mention. That is why my officials are working with the NHS institute to explore ways in which areas that are not yet embracing the productive series can be identified and supported with implementation, thus allowing the spread of best practice, about which the noble Lord, Lord Young of Norwood Green, spoke.
A phrase that I have learned recently is “essential rounding”, a system that sees nurses doing planned rounds every one to two hours to check on patients and to deal with any concerns. We are pleased to see nurses embracing that concept. Feedback about it from patients and nurses is very positive, with some studies seeing a reduction in falls and improvement in patient experience since implementation. In fact, a plethora of best-practice guidance is available. But central initiatives can take us only so far, which is why effective nursing leadership at the front line is so important. Matrons and senior nurses are role models and they are pivotal in developing the culture of care in their clinical areas. Through the standards they set for others to follow, to monitoring the performance of individual nurses, they ultimately make the difference between good and bad care.
I welcome the work of the NHS institute in developing a clinical leadership competency framework which will help develop patient-centred nursing leadership. The noble Lord, Lord MacKenzie, whom I welcome to the Front Bench, was right that the vast majority of nurses are extremely professional, care deeply about their patients and do a tremendous job, often under very difficult circumstances. But, at the same time, the noble Lords, Lord Young and Lord Hunt, were right to be honest that this is not always the case. The CQC’s report on its 100 unannounced nurse-led inspections showed how the quality of care—in this case, for older people—can fall far short of what we would want. That problem is far more widespread than we would expect. About half of hospitals visited gave cause for concern. Twenty hospitals were not delivering care that met the essential standards that the law says people should expect. I was alarmed to see that in 14 hospital trusts fewer than half the staff said that they would be happy to see a friend or relative treated in their own hospital.
However, I would say to the noble Lord, Lord MacKenzie, that I do not think that it is right simply to say that this is because of poor staffing. The CQC dignity and nutrition inspections found many examples of excellent practice where staffing was not ideal and cases of poor nursing care where there was a full staffing complement. We are hearing more and more concern from patients and nurses themselves about inadequate staffing levels and inappropriate use of support workers. As I said in our debate yesterday, setting safe staffing levels is not an exact science. These decisions are complex and they are best made by local clinicians and managers on the ground, who understand the needs of their patients. As noble Lords are aware, there is guidance available from the RCN and others to assist clinicians and managers in setting safe staffing establishments.
This same guidance is used by the CQC when determining whether providers have enough suitably qualified, skilled and experienced staff. The CQC can take tough and independent action when an organisation is not taking appropriate steps to ensure that there are sufficient numbers of suitable staff at all times. The noble Baroness, Lady Emerton, mentioned Anne Marie Rafferty’s research. I would be pleased to look at that research in detail and I will ask the Nursing and Midwifery Professional Advisory Board to consider it and report back to me early in the new year.
Much of the concern around nursing in acute settings has been related to inappropriate delegation by nurses to healthcare support workers. Wherever there is a multidisciplinary team of regulated professionals and unregulated healthcare workers, appropriate delegation and supervision is vitally important. This is an area ripe for formal review. We very much welcome the NMC’s plans to update its guidance on delegation so that nursing staff know how to do this safely and are clear that they retain responsibility for their actions. We have also asked Skills for Health and Skills for Care to accelerate production of a code of conduct and recommended core training for healthcare support workers and adult social care workers in England. We expect work to begin by April 2012, with the aim of delivering outputs ahead of the establishment of an assured voluntary register, which could be operational from 2013 onwards.
Nurse leaders, managers and trust boards must take staffing concerns seriously and, where staffing is found to be an issue, they must take immediate action. In the new world of the NHS, there will be two watch words for commissioners: outcomes and quality. This carries the basic point that clinical commissioning groups will want to satisfy themselves that the services they commission have safe and effective staffing profiles. Nurses will have an increasing role in commissioning and in developing the shape of local services—that is exciting.
Safe and effective care has several strands to it, all in the direct gift of nurses. Noble Lords may be aware of the QIPP safe care work stream quality improvement programme—the safety thermometer—which aims to focus nursing attention on four areas of harm: falls, blood clots, pressure ulcers and catheter-related urinary tract infections. We have published the 2012-13 operating framework with strong messages about reducing harm in these areas, making sure that these are firmly on trusts and commissioners’ agendas.
My noble friend Lady Browning spoke of the need for government leadership and she is right. We are making sure that the nursing contribution to quality is being championed at the very centre of government. The SHA chief nurses are leading the nursing contribution to quality improvement at the front line through the energising for excellence quality framework. Much of the success of the quality framework will depend on transparency and, as part of our transparency agenda, NHS North is working towards local publication of nurse-sensitive metrics in areas such as falls and pressure ulcers and is also exploring how best to include patient and staff experience data. The patient experience is absolutely centre stage as we set about measuring the quality of nursing care. Ensuring that patients have a positive experience of care is reflected in the NHS outcomes framework that the new NHS Commissioning Board will use to hold the NHS to account for what it delivers. Everyone who works in the NHS has a role to play in ensuring that patients have a good experience. It is not optional, and it is not “someone else’s job”. The task is to make listening, understanding and responding to patients’ views as commonplace as acting upon clinical audit data, patient safety data or financial data.
Nurse training has, unsurprisingly, featured prominently in this debate. The noble Baroness, Lady Warwick, raised the issue of continuous professional development. Later this month, the Government are publishing our detailed proposals on education and training that will describe the arrangements for continuing professional development, which we recognise is of great importance. My noble friend Lady Jolly spoke about the role of specialist nurses and her concern about downgrading roles without due regard to patients’ needs. I agree that service planning has to put patients firmly at the centre. The Government acknowledges the important role of specialist nurses in improving health outcomes and patient experience. In the end, local organisations must have the freedom to determine the skill mix of their clinical teams. Commissioners, clinicians and trust boards have to work together to ensure that the workforce is capable of meeting the needs of patients and that they have access to continuing professional development.
My noble friend also spoke about the introduction of end-of-life care standards, and I am happy to assure her that we will continue to work towards implementing the end-of-life care strategy.
The noble Baroness, Lady Masham, spoke with her customary force about bringing back old-style matron. That resonated throughout your Lordships’ Chamber, and there is no doubt that strong nursing leadership is essential at all levels for high-quality care. The noble Lord, Lord Hunt, was quite right about that. Directors of nursing and trust boards must set the culture for a hospital, and that includes a leadership style that challenges poor standards and creates an environment for high standards.
My noble friend Lady Browning raised the subject of whistle-blowing. It is very important that the culture of a hospital is right to enable whistle-blowing to happen. Leadership from boards has to set the tone for that. To whistle-blow does require great confidence and support. I believe that more of this will come because of the increase in graduate nurses.
All this has a direct bearing on the point made by my noble friends Lord Bridgeman, Lady Browning and Lord Ribeiro about cleaning. Nurses have a key role to play in ensuring that hospitals are kept clean. The infection control nurse, the ward sister and matron who set and enforce local standards are particularly important. The code of practice for the prevention and control of infections ensures that nurses are involved in all aspects of cleaning standards. The code provides that directors of nursing are involved in all cleaning contract negotiations, which is very important. Matrons have personal responsibility and accountability for delivering a clean safe environment for care.
The noble Lord, Lord Hunt, mentioned supernumerary sisters. The RCN has just published guidance on developing business cases to fund the supervisory status of the sister so she can exercise her leadership role effectively. The guidance is helpful, timely and above all very practical.
The noble Baroness, Lady Masham, spoke of the importance of district nurses—again, absolutely to the point. We acknowledge the enormous contribution of district nurses in helping people manage long-term conditions, keeping people out of hospital and ensuring people are able to access the resources they need, when they need them. We want to make sure that people go to hospital only when they need what a hospital can do. We see a much greater role for district nurses in the future, not a diminishing one.
The noble Baroness, Lady Warwick, and others mentioned the RCN Frontline First report. I do not want to dwell too long on this, but I have to voice some serious criticism about that report. The RCN’s numbers are mainly based on an analysis of just 41 trusts. The trusts identified in the report have disputed the RCN’s figures. The RCN has not offered commentary on the fact that some of these plans are about moving services out into the community to provide better care for people when and where they need it. We are not disputing that some trusts have reduced the number of staff—some have—although many of these are support staff and often it is being done through natural turnover. We do emphatically reject the conflated numbers that the RCN is claiming. I have got some chapter and verse in my brief, but all I would say is that it is up to local trusts to determine their workforce needs. We have made it clear that any reduction in clinical posts must not have an adverse impact on the quality and safety of patient care. We have introduced a quality assurance process for SHAs to complete with trusts.
The noble Lord, Lord Patel, spoke about midwifery. The Government are not reducing the number of midwifery trainees. In 2010-11, 2,488 midwives training places were planned. A further 2,507 training places are available this year—that is a record high. The Government are committed to ensuring that we have the right number of trained midwives, especially given the increased number and complexity of births in recent years. This includes ways of supporting midwifery recruitment and retention to help local organisations which are able to commission the number of training places that they need. We have asked the Centre for Workforce Intelligence to undertake an in-depth study of the maternity workforce starting this year. This will inform the future commissioning of training places, including for midwives.
On specialist neonatal nurses, I took the points that the noble Lord made. The National Institute for Health and Clinical Excellence quality standard and the toolkit for high-quality neonatal services are valuable tools to assist NHS commissioners and providers in the provision of high-quality care for babies and their families. However, I shall take away the points that the noble Lord raised.
We have heard today from my noble friend Lady Jolly, among many others, about the opportunities for front-line nursing. Technology moves on, medical knowledge is constantly advancing and the members of our nursing workforce will need to keep abreast of these changes. But one thing that we know will not change is the importance of the care that nurses deliver; and the key role that nurses can and do play in improving quality of care, patient outcomes and their experiences of care.
Lord Young of Norwood Green
Will the noble Earl comment on my point about a vocational route into nursing?
Earl Howe
In the time available, I shall do so very briefly. Access to nursing is, as the noble Lord will know, already through quite a wide entry gate—through progression from apprenticeships, NVQs and access courses. Universities set the entry standards and do not always rely on A-level qualifications. However, it is important that students must be able to cope with degree-level study—it would be wrong to set them up to fail. However, we are aware that the entry gate about which the noble Lord, Lord MacKenzie, spoke needs to be as wide as reasonably possible.
It is patients who matter most. As a Government, we are committed to bringing about the improvements in front-line nursing care that patients want.
Health and Social Care Bill
Earl Howe Excerpts(14 years, 1 month ago)
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Earl Howe
My Lords, these amendments from the noble Baroness, Lady Emerton, clearly reflect an important issue: that there should always be appropriately skilled staff available to meet a patient's healthcare needs. I appreciate the concern behind the amendments and recognise the central point of principle; nor am I in a position to contest the evidence that has been cited by various noble Lords. I do not wish to do that. Where I am afraid I part company with the noble Baroness is in her argument that it would be appropriate for the board to mandate staffing levels or skills mix within local services. Although she would probably expect me to say this, these decisions really are best made by local clinicians and managers on the ground.
As the noble Baroness will know, determining staff requirements is not an exact science. The number of staff on wards and ratios between nurses and patients, and between nurses and healthcare assistants, will vary according to such things as the individual needs of patients, their levels of acuity and dependency, the nature of the clinical care they require and the layout of the clinical area. It is right that nurse leaders, doctors and managers have the freedom to agree their own staff profiles. This gives them the flexibility to respond swiftly to changes in patient demand to ensure safety and quality. Rigid ratios really are not the way to do this.
In being responsive to different situations, providers of NHS services are expected to meet their obligations under the NHS constitution—which, incidentally, they do not have in California. This states that patients have the right to be treated with a professional standard of care by appropriately qualified and experienced staff. Suggested nursing staff ratios and the proportions of registered to unregistered staff are, of course, available from, for example, the Royal College of Nursing. But it would itself say that these should be used only as a guide and as the basis from which to ask questions about staffing if there are wide variations from the suggested norms. The amendments say the board’s duty is to establish or mandate “the ratio” as a legal requirement. That is simply not appropriate.
The other reason why I resist these amendments is that there is already a regulator overseeing these kinds of safety issues. All providers of regulated activities, including NHS providers, must be registered with the Care Quality Commission and meet the essential requirements around safety and quality. These include a requirement to take appropriate steps to ensure that, at all times, there are sufficient numbers of suitably qualified, skilled and experienced persons employed for the purpose of carrying on the regulated activity. That is an essential standard. Compliance with it is assessed as part of the registration process as well as ongoing monitoring. So it is not, as my noble friend Lord Newton suggested, just a question of a snapshot.
What follows from this is that it is unacceptable for organisations to persistently fail to ensure that there are enough skilled and competent staff to deliver the care required; and the Care Quality Commission can take independent action where an organisation is not taking appropriate steps to ensure that there are sufficient numbers of suitable staff at all times. If the CQC judges that an organisation has failed to comply with any of the requirements for registration, then that organisation has committed an offence. That is a very powerful sanction. So while I completely agree that it is important to monitor these issues carefully, I do not agree that it is necessary to create a role for the board in this regard. A role for the board would prevent the necessary flexibility in local decision-making, and interfere with the role of the Care Quality Commission, and indeed the future role of Health Education England. That would not be desirable.
Various questions were asked of me about other professional groups besides nurses. I happen to know that, in answer to the noble Lord, Lord Walton, clinical psychologists are already subject to mandatory registration with the Health Professions Council under the title of practitioner psychologists. As regards other groups, a number of points were raised about non-registered workers, including their education and training, and the Government’s position with regard to those matters. I suggest that we will come to those matters when we reach Part 7, and it is perhaps more appropriate that we tackle them at that point.
The noble Baroness, Lady Thornton, asked me whether the Department of Health was aware of the problem of down-banding. We are aware of concerns in this area from the Royal College of Nursing and others. We are of course committed to ensuring that safety is a priority across the NHS, and we are looking at the concerns within that context.
That is essentially the Government’s position. It is not that we are unsympathetic to the point of principle to which the noble Baroness has drawn attention, but we think that there are mechanisms already in place to address those issues, and that it is essentially a matter of local and clinical and managerial judgment.
Baroness Emerton
My Lords, I thank the noble Lords who have taken part in this debate, which has opened up many questions. I thank the Minister for his answer. There is one point that I would take issue with, which is the Care Quality Commission, because it is almost too late if the Care Quality Commission comes in when there is a failing. We are trying to prevent failings, and move forward. There is an issue there, in determining the ratios.
I agree that it is for the local commissioners to be involved in the planning, but it is such a complex issue that, as we move into the care quality groups, there is an issue in terms of their expertise in being able to do this. This is why I raise the issue, supported by the Royal College of Nursing, which is very close to the scene. I appreciate that that is where it should be, and perhaps the way forward is to make sure that there is training in the workforce planning issues. It is complex. As has already been said, it concerns not just nursing but also the other disciplines. The evidence that has been shown ought to be followed up, and I ask that the Minister take that away, so that we can look at the evidence. There is an article today in the nursing press demonstrating quite clearly that morbidity and mortality is reduced by a higher level of trained staff. On that basis, I beg leave to withdraw the amendment.
Lord Mawhinney
I share the view expressed by the noble Lord, Lord Beecham, of extending appreciation to the noble Lord, Lord Warner, for raising this issue because it seems to me to be one of some significance. Those of us who strongly support my noble friend and what the Government are doing in establishing commissioning-led services do so because, first, we think patients are likely to get a better deal out of it than they get under the present bureaucratic system and, secondly, because we have concerns about the efficiencies of SHAs and PCTs; in my case, that relates particularly to the activities of the East of England Strategic Health Authority.
I hope my noble friend will not deem a probing amendment about cost to be antagonistic or inappropriate. My reaction to the amendment of the noble Lord, Lord Warner, in its present form is much the same as the reaction of the noble Lord, Lord Beecham. I like the idea, I think it is helpful to this Committee to have more information although I am not sure that this form is actually the way in which that should be done. I hope my noble friend will be as generous as he instinctively and normally is in giving us as much information about costs as he can. If 30 per cent seems very high to him, as it does to me given the realities of setting up a new system, perhaps he would indicate what savings he thinks might be achievable if there was a sufficiently stringent regime in place to control costs.
Earl Howe
My Lords, I recognise from everything the noble Lord, Lord Warner, said that these amendments have been proposed with the best of intentions. I start by making it clear that an independent, accountable, transparent and efficient NHS Commissioning Board is a key component of our proposals, so I hope I can reassure the Committee on these issues. In doing so, I hope my Lords will forgive me if I touch on similar ground to that covered during the debate on Schedule 1.
Let me first assure the Committee that we want to reduce the amount of NHS funding spent on back-office bureaucracy. Indeed, as we stated in last year’s White Paper, the NHS simply cannot continue to afford to support the costs of the existing administrative structure. Management costs in PCTs and SHAs more than doubled in the decade up to 2009-10, to £1.85 billion, increasing by more than £220 million in 2009-10 alone.
The noble Lord, Lord Warner, posed the question: what is different this time? Well, I believe a great deal will be different, and that is exactly why Clause 21 provides the Secretary of State with the power to set a limit on the use of resources by the board itself and by the board and CCGs together in relation to administrative matters. The meaning of what is to be considered as administrative matters will be defined through parliamentary regulations for the first time. The board has the power to set similar limits for individual CCGs. The changes that we are making will cut the overall cost of administration by one-third, and Clause 21 gives us the legislative basis to do that.
The Bill includes clear procedures around the publication of the board’s annual accounts, annual reports and performance assessments of CCGs; and I hope that I can provide reassurance in this area as well. The requirement to publish an annual report applies to all of the board’s functions, including its commissioning and financial functions and its performance assessments of clinical commissioning groups. The board is also under a separate duty to publish a report each year containing a summary of the results of each performance assessment. So I do think that the provisions in the Bill already address the concerns embodied in Amendments 146, 148 and 149.
On Amendment 151, which is grouped here, the board’s power in new Section 13X(b),
“to acquire and dispose of property”,
is necessary for the board to acquire any premises that it needs to accommodate itself for the purpose of carrying out its functions. Likewise, should it find itself with property surplus to its requirements, it would need to be able to divest itself of that property. The power simply replicates the power that PCTs currently have.
My noble friend Lady Tonge asked about the costs of transition. The modernisation programme will have one-off costs of between £1.2 billion and £1.3 billion, spread over the lifetime of this Parliament. It will reduce expenditure on administration by £1.5 billion a year from 2014-15 onwards. That is reducing the administrative spending across the system by one-third, and over this Parliament the modernisation will save £4.5 billion gross, or £3.2 billion to £3.3 billion net. So the up-front costs are expected to be more than recouped by the end of 2012-13. With those explanations, I hope that the noble Lord, Lord Warner, will be somewhat reassured. I am sure that I have not completely reassured him, but I hope that I have done so sufficiently for him to withdraw his amendment.
Lord Warner
Can the noble Earl explain to us, in writing, the comparison between the current costs of the bodies carrying out functions that are going to be transferred to the board, and what the Government’s current estimate is of the first year’s fully fledged activities of the board in discharging those functions? It would be very helpful and certainly more convincing to me and, I suspect, other Members of this House if we could see the comparative figures just for the board. I am not asking him to go into Monitor or CQC; I am asking for the figures just for the board taking on the functions that it will be taking on.
Secondly, his response did not really deal with the issue of how you keep these costs under control as the years go by. Is he relying only on the Secretary of State being eagle-eyed and briefed by his civil servants to do it, or do the Government have in mind an uprating mechanism that would curb unnecessary growth in this area?
Earl Howe
This is one area where the Secretary of State has a direct interest to ensure that administrative costs are kept low. In answer to the noble Lord’s first question, of course I would be happy to write. There is already a great deal in the impact assessment, to which I would direct noble Lords’ attention. However, I shall be happy to write an individual letter to him and copy it to noble Lords in answer to the questions that he posed.
Lord Beecham
When the Minister writes to us about the risk register, would he indicate whether this topic of the cost will be referred to?
Lord Beecham
Does the list of issues that are covered in the risk register include the question of the costs of transition and reorganisation?
Baroness Wheeler
My Lords, I am pleased to speak in support of Amendment 150B from my noble friend Lady Bakewell, requiring the annual report of the NHS Commissioning Board to include an assessment of how effectively it meets the needs of the older population. We know that nearly two-thirds of NHS patients receiving consultant-led care and 60 per cent of people admitted to hospital are aged 65 and over, so it is highly appropriate that this requirement be added in the Bill to the specific items that the board must report on to Parliament and the Secretary of State.
Under the umbrella of this amendment on the needs of older people, I would like reassurances from the Government on how they intend to improve commissioning for essential community and prevention services for older people. It is widely recognised that these are currently undercommissioned, specifically falls prevention, audiology and continence. In terms of community services, I stress the inclusion of older people in residential care. Age UK research shows that nearly 400,000 people living in care homes currently face real difficulty in accessing GP and primary care services.
We know that undercommissioning of community and prevention services is widespread and that the healthcare system needs to be much more effective in commissioning primary health and preventive services. For example, Age UK estimates that falls prevention services could save the NHS £2.3 billion per year in preventing hip fractures alone. Falls represent the most frequent and serious type of accident in the over-65s and are a serious cause of morbidity and mortality. A recent national clinical audit to investigate the organisation of services for patients who have fallen and fractured their hip, wrist, arm, pelvis or spine showed how variable commissioning of falls services is, rarely providing a co-ordinated falls and fractures strategy. Few GPs assess the risk of falling among older patients, and arrangements in hospitals for case finding and secondary prevention are inadequate. Half of all patients suffering a hip fracture never regain their former level of function and mobility. How is this situation to be addressed in future commissioning arrangements?
On hearing, the estimates are that up to 6 million people in the UK would benefit from a hearing aid but that only 2 million have one. Waiting times for hearing aids continue to be a major problem. In some areas people can wait up to one to two years between their GP referral and having their first hearing aid fitted or for a digital upgrade of their hearing aid. Audiology is excluded from the general 18-week NHS waiting time target. How will the current shortcomings in commissioning for audiology services be addressed?
Finally, effective and dignified continence care for older people is an essential service, particularly for those whose long-term conditions, such as cancer, stroke, spinal cord injury, spina bifida, Parkinson’s and other neurological conditions, require continence management to be integrated into their care and treatment pathways. Commissioning for managing these conditions in the home, in residential care and in hospitals, and for general continence services, requires specialist knowledge and understanding of the different needs of continence care in primary and secondary care settings. The system is so often geared towards containment through pads and catheters rather than assessments or treatments of incontinence, or recognition, for example, that patients in hospital using catheters or other products over a short term will need reassessment and probably different products and support to cope with day-to-day life at home or in residential care. As a trustee of our local carers’ support organisation in Elmbridge, I know that effective support for carers who are managing a person’s continence issues can often make the difference between whether that person can be supported and cared for at home or has to go into residential care. Is the Minister confident that clinical commissioning consortia will have the expertise and the will to prioritise much-needed improvements in effective continence care?
My noble friend Lady Bakewell’s separate amendment calls for a commissioner for older people, and I hope the Minister will take this away and give the proposal serious consideration. In particular, we need to see what we can learn from similar posts in Wales and Northern Ireland, and the observations of the noble Baroness, Lady Finlay, are very helpful on this. The intention behind the proposal is to provide a cross-government overview and strategy on the needs of older people. It is why my own party has appointed a shadow Minister for care of older people. We also know that making progress on improving NHS care and treatment of older people, addressing the future funding of social care through Dilnot and other key measures all require champions and leadership at the highest level of government, and I look forward to the Minister’s—we hope sympathetic—response.
Earl Howe
My Lords, let me begin by saying that I am sympathetic to these amendments, moved with customary persuasiveness by the noble Baroness, Lady Bakewell. I completely understand what has prompted them. The improvement of services for older people is vitally important and I can reassure the noble Baroness that this will continue to be a priority for the Government.
I have written to the noble Baroness following the debate in Committee on 7 November on her Amendment 18B, explaining how the NHS outcomes framework will hold the NHS to account for improving the effectiveness of care for older people. It will act as a catalyst for driving quality improvement and outcome measurement throughout the NHS by encouraging a change in culture and in behaviour, including a renewed focus on tackling inequalities in outcomes. There may well also be specific objectives in the Secretary of State’s mandate to the board in relation to services to be provided to older people.
Now, the real question posed by the noble Baroness’s amendments is how can we improve older people’s care and how can we ensure that services are joined up? The UK Advisory Forum on Ageing, co-chaired by my honourable friend the Minister of State for Care Services, Paul Burstow, and the Minister of State for Pensions, Steve Webb, already provides advice across government on the additional steps that the Government and their partners need to take to improve well-being and independence in later life. We already have a champion for older people’s health, and that is Professor David Oliver, the national clinical director for older people. In order to ensure quality outcomes for older people during the transition to the board and CCGs, Professor Oliver and relevant bodies and partners will function as a motor for change to encourage best practice locally and to promote the messages around QIPP—Quality, Innovation, Productivity and Prevention —and long-term conditions.
Professor Oliver’s overall remit is to promote better care of older people across the NHS and social services, and to provide clinical leadership for cross-government work on older people. He is doing good work. Nor, as I say, is he working in isolation. Regular meetings take place between officials, Professor Oliver and organisations including Age UK and WRVS. Recent examples of co-operation include Age UK’s active participation in reference groups chaired by the national clinical director and the director of social care leadership and performance on the draft social care and public health outcomes frameworks.
Lord Marks of Henley-on-Thames
The answer is that we are not at one about the vulnerability of my amendment to judicial review. I rather hope that that is never tested; nevertheless, I hope that the amendments are accepted.
Earl Howe
My Lords, the policy of the Government and the vision that we have consistently set out is that Ministers will be responsible for overseeing and holding to account the national bodies, backed by extensive powers of intervention in the event of significant failure. I say to my noble friend Lord Newton that that is what the Bill provides for. These powers are essential if Ministers are to be able to retain ultimate accountability for the health service, for the very reasons that he stated. I have to say that some of his phraseology was, in my view, unnecessarily extravagant, if I may use that phrase. The Secretary of State will not stand back; nor will he wash his hands of what is going on, as my noble friend put it. The Bill enables the Secretary of State to intervene where he believes that Monitor, the board, the Care Quality Commission, NICE, HealthWatch or the Information Centre are failing or have failed to exercise their functions, and that failure is significant. In the event that Ministers use these intervention powers, they will be required to publish the reasons for doing so, including an explanation of why they consider the failure to be significant. These requirements will provide transparency to the decision-making process.
I will deal with the question posed by my noble friend Lord Marks. Why should we use the word “significant”? The clear aim of its use is, exactly as my noble friend suggested, to stop Ministers intervening in inconsequential matters. There is no case law on the meaning of “significant failure”. The Secretary of State will need to decide whether a failure is significant. However, cases have considered the meaning of “significant” in other contexts and have taken the approach that, while a dictionary definition of “significant”—
“noteworthy; of considerable amount or importance”—
is not to substitute a different expression for the statute, it remains a helpful indication of what the term means. There is a degree of flexibility inherent in the term “significant”, and I believe that that is helpful in the context of the arguments put forward by the noble Lord, Lord Owen—who is not in his place—and my noble friend Lord Mawhinney.
I will first deal with Amendment 152. I respectfully suggest that there is a gap between that amendment and that of my noble friends Lord Marks and Lady Williams. Amendment 152 seeks to amend the Bill to give the Secretary of State wide powers to direct the board and clinical commissioning groups in how they carry out their functions. I said “wide powers”, and that fundamentally cuts across the vision of a health service free from political micromanagement. It therefore gets us back into exactly the territory that we want to get away from.
Of course it is important, as I have said, that there are intervention powers if things go wrong and those powers are in the Bill. The Bill also sets out a robust system by which the board will hold CCGs to account. I will come on to that in a moment. Creating a sweeping power of direction would seriously undermine the autonomy of the board and local commissioning groups and allow Ministers to use directions or indeed the threat of directions to second-guess operational decisions. In addition, any direct power over CCGs would duplicate and undermine the role of the board which is responsible for overseeing local commissioning.
Amendment 153 makes a more subtle point. It seeks to enable the Secretary of State to direct the board should he consider it to be failing to carry out its functions in the best interests of the health service. Let me reassure my noble friend of what I am sure he does not need to be told. We would always expect the board to act in a way that is consistent with the interests of the health service. This is made clear by the duty on the board to promote the NHS constitution and the duty set out by proposed new Section 1E(2), which ensures that the board is also subject to the duty to promote the comprehensive health service. If the board were acting in a way that was not consistent with those duties, then it would be acting unlawfully. That may constitute a significant failure by the board to exercise its functions properly or indeed at all in relation to which the Secretary of State would consider intervening.
Lord Marks of Henley-on-Thames
My Lords, I am sorry to intervene at this stage but does my noble friend the Minister not accept that there may well be two divergent views of what the best interests of the health service are, and that the board may hold one view, the Secretary of State an entirely different view—or, on the other hand, CCGs may hold one view and the board an entirely different view—and that undermines any notion of accountability if the Secretary of State has to stand up in Parliament and say, “I do not believe what the board has done is in the interests of the health service but the board does and I cannot do anything about it”? That is the mischief at which these amendments are directed.
Earl Howe
I take the point but I hope my noble friend will agree that I have an answer. The crucial point is that, while we would expect the board to have a clear shared understanding of what the interests of the health service are, the Secretary of State has mechanisms over the board which he can use if necessary to clearly set out what these interests are. He can do that by setting objectives and he can hold the board to account for those. So he has other levers.
Amendment 277, also in the name of my noble friend Lady Williams, would prevent the Secretary of State from intervening in specific cases where he considers that Monitor has failed or is failing to perform its functions. We believe that it is important for the Secretary of State to be able to intervene in the event of a significant failure by Monitor to perform its functions. That intervention power does not exist at all under current legislation, and we believe it should. We do not believe Ministers should have the power to intervene in individual cases. Such a power would risk politically motivated interference and undermine the independence of the regulator. That point is extremely important.
However, there is an important exception to this rule in relation to the continuity of services. Amendments introduced in another place allow the Secretary of State to intervene in relation to proposals for securing access to services where a provider has become unsustainable. The Secretary of State would be able to exercise a veto if Monitor and clinical commissioning groups have failed to discharge their functions, to follow the proper procedures or to secure access to services.
We are clear that the wording of the clause as it stands strikes the right balance, enabling the Secretary of State to intervene when necessary to address systemic failure, while ensuring that Monitor is able to carry out its functions free from potentially time-consuming and politically motivated interventions relating to individual cases. The NHS Commissioning Board will also have powers of intervention, as set out in new Section 14Z19, to support CCGs and take action where necessary if there is evidence that they are not meeting their statutory duties or that there is a significant risk of them failing to do so.
I recognise that the intention behind Amendments 220ZAA and 220ZAB, which look to ensure that the board only intervenes in a CCG when it is satisfied that the CCG is failing, or is at significant risk of failing, is to exercise a function in the best interests of the NHS. However, as the Bill is drafted, the board can determine when a CCG is not exercising its functions properly and that is surely the better approach. We are giving the board discretion to determine when intervention is necessary, based on the terms of each statutory function that CCGs have, not in relation to a separate criterion. The amendment would actually narrow the grounds on which the board would have power to intervene, which I do not think would be at all helpful.
Finally, I would like to address the point put to me by the noble Lord, Lord Hunt, about waiting time objectives. The noble Lord implies that Ministers would be powerless in the face of waiting times. That is simply not the case. Ministers’ main weapons on this issue would be the standing rules and the NHS constitution. Current contractual requirements relating to waiting times, such as 18 weeks, are covered by the constitution through the handbook and will form a key feature of the standing rules pending passage of this Bill. If the Secretary of State wanted to act on a new waiting time issue, the option is there for the NHS constitution handbook to be revised and the standing rules updated accordingly.
I hope that I have provided enough detail on these clauses to enable my noble friend to withdraw the amendments.
Baroness Armstrong of Hill Top
Will there be issues around the National Health Service that Members of Parliament will not be able to question Ministers about or to get clear answers from Ministers on? I have listened very carefully to the Minister, but I am still very confused about the accountability to Parliament and what the Minister will answer questions on and what he will say is the responsibility of Monitor, the NCB or whatever.
Earl Howe
There are no areas that will be out of bounds to parliamentarians in the sense that the noble Baroness has said. What may happen is that the Secretary of State or other Ministers may respond directly, or in a way that draws upon advice that they have received from, let us imagine, the NHS Commissioning Board; they may quote what the board has said and say that this is the advice that they have received, or they may, as with some agencies at the moment, refer the parliamentarian to that body directly. It will vary. The main question that the noble Baroness asks is whether parliamentarians will be inhibited in some way. The answer is no.
Baroness Williams of Crosby
I should like to add a few words before considering whether or not to withdraw this amendment. The noble Earl, Lord Howe, has obviously made the best possible case he can, but given the very extensive doubts on all sides of the House, I feel that he ought to be asked to address this issue very clearly. It is bound up in many ways with the whole issue of the responsibilities and accountability of the Secretary of State which is under discussion at the present time. I will withdraw the amendment on the understanding that it will come back on Report when we have had an opportunity to see how this fits into the whole structure of responsibilities of the Secretary of State.
Perhaps the most simple answer to the question that was asked by the noble Baroness, Lady Wheeler, is that on the basis of Amendment 153 it would be impossible for the Secretary of State to say, “Not me, guv” in response to the point made by the noble Lord, Lord Newton of Braintree. This is so central, and so serious, that in withdrawing the amendment I make it absolutely clear that I do so in order to give an opportunity to the department and to the Minister to consider how this may be best fitted in to the responsibilities and accountabilities of the Secretary of State over the whole of the health service. I beg leave to withdraw the amendment.
Lord Newton of Braintree
My Lords, I apologise for intervening a second time. I want to link with things I raised the first time, because I have been left in some confusion by the noble Baroness, Lady Wall—which is not her fault—said about what has been happening in London. My understanding is that at the beginning of the year the department issued a document suggesting four possible ways of doing clustering. One was along the lines that the noble Baroness spoke about. I forget what all four were, but one was that PCTs should informally group in clusters, create an informal board, and have one of the chairs, perhaps a rotating chair in some cases, who would oversee the informal cluster board. The legally existing boards would continue.
At the back end of September, the department, at least as interpreted in the east of England, issued an edict saying that there were no longer four options. There was to be one, and it would be clustering, based on appointing the same people to more than one PCT board. That raises a number of issues, as my noble friend Lord Mawhinney has indicated with unmistakeable clarity, to which he and possibly I might wish to return later. Meanwhile, how many legally separate PCT boards exist at the moment, who is on them, and were different policies pursued by the department in different parts of the country? What the noble Baroness—my noble friend—Lady Wall said suggested that a different policy had been pursued in London—not for the first time, I may say—than was being pursued in the east of England at least, and possibly everywhere else. We need some clarity, not just on what the future is going to be, but what the present is.
Earl Howe
My Lords, the principle behind clinical commissioning is that decisions about local services should be made as close to patients as possible by those who best understand their health needs. This is why the membership of CCGs should comprise GP providers, rather than other primary care providers, such as dentists, opticians and pharmacists who do not have the same relationship with patients or responsibility for a registered list. I hope this answers the question posed by the noble Lord, Lord Hunt, in his Amendment 154. However, of course effective commissioning will require the full range of clinical and professional input.
Although the members of clinical commissioning groups will be GP practices, the groups will be required to obtain advice appropriate for enabling them to effectively discharge their functions from a broad range of healthcare professionals. So this is not a matter of other professions being shut out; quite the opposite. Other professionals may also be invited by the CCG to be members of the CCG governing body and, as regards nurses, regulations may require that governing bodies include certain healthcare professionals, such as a nurse and hospital doctor. Also, other clinicians could be directly involved in influencing the decision-making of the CCG through, for example, membership of a committee of the CCG, without needing to be members. The basic point is that the function of clinical commissioning is directly linked to the function of the general practitioner and we should not risk diluting the effectiveness of the proposed approach.
The noble Lord, Lord Hunt, suggested that CCGs will not be led by clinicians. I am surprised to hear the noble Lord say that, especially as he has been paying tribute to the work of the NHS Alliance and Dr Mike Dixon for whom I, too, have a high regard. I understand that when Dr Dixon spoke at the NHS Alliance Conference this morning he said that we stand close to liberation of clinicians on a grand scale. That indicates to me that he believes that this is a huge opportunity for primary care clinicians.
My noble friend Lady Tonge asked what this is all about. The philosophy behind these new organisations is different from what we currently have. Clinical commissioning is about placing the financial power to change health services into the hands of those NHS professionals whom the public trust most and giving GPs the flexibility within the legislative framework to The Bill sets out high-level requirements for working together, including at new Section 14Z1 in Clause 23 provision for CCGs to enter into arrangements with other CCGs to exercise their commissioning functions. That addresses the point that was made earlier about commissioning for groups of patients who are smaller in number in a small area. One has to commission at the right level. These can include both joint and lead commissioning arrangements and this may be a topic which the board chooses to cover in its commissioning guidance.
The process of the local development of commissioning organisations is well under way, with pathfinders—emerging CCGs—coming together to begin to explore approaches to commissioning and building up their organisations, supported by the PCT clusters, about which I will talk in a moment. The board will be responsible for undertaking a rigorous assessment of all prospective CCGs, prior to authorisation, to ensure, for instance, that they are of an appropriate size, that they cover an appropriate area and have put the appropriate arrangements in place to be effective commissioners. I would say to my noble friend Lady Jolly that there will be a presumption in favour of coterminosity with local authority boundaries. But as we have previously discussed, and as advised by the Future Forum, local flexibility must include, in exceptional circumstances, the flexibility to cross a local authority boundary where that is appropriate to patient flows.
I am afraid that I do not agree that we should place arbitrary constraints on the number of CCGs or on their budgets as Amendment 157 would do. I appreciate the keenness of noble Lord, Lord Warner to ensure that the maximum resources available are devoted to patient care. The Government share that concern, but the way to do this is to ensure appropriate controls over administration costs and ensure good governance on how that money is spent and the outcomes that it delivers.
Lord Mawhinney
My noble friend said that they would have to decide on the appropriate size. Does he know what that size is approximately likely to be, and if so could he share it with us? Or is that something that is still to be determined?
Earl Howe
I am grateful to my noble friend and I was coming on to that very point, which was a question posed by the noble Lord, Lord Warner and others—my noble friend Lord Greaves expatiated on that theme. Our starting point is this: we do not wish to be unduly prescriptive about the size of clinical commissioning groups. There have been widespread variations in the size and population coverage of PCTs and there is no evidence to suggest that there is a single right size. If one looks at the history of the National Health Service over the last 20 years it has been an attempt by successive Governments to find a right size and we never quite succeeded. It is important that solutions develop from the bottom up and are not imposed from above.
Lord Greaves
I apologise for intervening, but if that is the case can my noble friend the Minister tell me who told the group of GPs in Pendle, who had been developing proposals for a CCG, that they would have to go in with the other four districts in East Lancashire?
Earl Howe
My Lords, in those instances, and they are very few, where a pathfinder CCG is of a manifestly unviable size, then it is right that they should receive advice to that effect at an early juncture. Advice is the word. The initial thinking is simply suggesting that emerging groups should be considering the impact of their proposed configurations on their organisational viability and the degree of sharing roles and functions or the use of commissioning support that they might need.
Lord Greaves
Is my noble friend, therefore telling me that a well defined borough with a population of 90,000 is manifestly unviable for this purpose?
Lord Warner
I thought I would get my question in before the noble Lord gets warmed up again. He said there is no indication from the evidence from the past of what the right size for a PCT was, but there is some evidence from the past. I do not think that there was ever constructed a PCT of under 100,000 population, which compares with 18,000 in Radlett for a CCG. If you actually look at what happened when we asked PCTs and SHAs to work together and engage in local consultation in 2005-06 on reformulating PCTs, the general thrust of what they came forward with was twofold: it was to be bigger in size and to be a better match with the boundaries of the upper-tier local authorities, which were the social services authorities. So there was some evidence that people themselves, when engaged in an exercise of reorganisation, moved towards bigger organisations and coterminosity with social care authorities.
Earl Howe
Earlier on I noted that the noble Lord drew parallels between CCGs and his attempts when he was a Minister to reduce the number of PCTs. I do feel there is a critical difference. The decision to establish a certain number of PCTs was taken in Richmond House by Ministers. I am not saying those decisions were arbitrary—of course they were not—but they certainly were not bottom-up. With CCGs, the onus is on GP practices to determine the most appropriate size and configuration for their local population. As I have said, the board will then rigorously assess whether this proposal will result in the CCG being able to fulfil its functions. That is a judgment, but it is a proper fitness for purpose test which PCTs never had to go through. I simply do not accept that, come April 2013, there is likely to be a raft of CCGs failing. If a CCG’s proposed constitution is not robust, then it will not receive full authorisation.
Lord Hunt of Kings Heath
I do not think that is quite fair, since I was involved in setting up PCTs. I accept the strictures of my noble friend about whether we made them too small. As for the idea that Ministers came up with PCTs, it was of course the service which, basically, came and made recommendations. Frankly, the same tiers are deciding on CCGs as decided on PCTs. There has been huge pressure on CCGs to come together and merge. Yes, it started as a bottom-up idea, but I have to put it to the Minister that the reason why I quoted Dr Mike Dixon is because he, like many people, knows that the “forces of bureaucracy”, as the noble Earl, Lord Howe, likes to put it, have been very strong and have basically said to CCGs that they will not get anywhere unless they merge.
Earl Howe
Yes, the noble Lord, Lord Hunt, suggested earlier that there was a process of shoe-horning CCGs into certain shapes and sizes, forcing them to take up external support and merge commissioning functions. I emphasise that CCGs will not be forced to take up external support or merge functions. What is happening at the moment is a process of advice and information from the centre. Obviously, the board will not authorise the establishment of any CCG which could not satisfy the board of its ability to discharge its functions and be an effective commissioner. We want to ensure that the process is not too bureaucratic or cumbersome. The noble Lord suggested that it was likely to be, but I do not accept that. We are working with stakeholders to ensure that emerging CCGs can articulate their requirements for commissioning support. I do not accept the picture that he has painted.
My noble friend Lord Newton spoke about the clustering of PCTs. Clusters bring together PCTs to prepare for and support the transition to clinical commissioning. Until PCT abolition in April 2013, they continue to exercise their functions and remain statutorily responsible for their functions until abolition. Pathfinders, or emerging CCGs, can act as sub-committees of PCTs until this time. The role of PCT clusters during the transition is to support clinical commissioning groups, not dictate how they operate. For the reasons that I have stated, it is important that CCGs have the freedom to develop their own solutions from the bottom up and that they are fully supported in doing so. The latest operating framework for the NHS emphasises this and we will see that it is acted upon.
My noble friend Lord James queried the legal arrangements. The process of clustering has been open and transparent. If it is acceptable to noble Lords, I can provide a written update on the latest position, giving the numbers, locations and so on, to save time.
Lord Greaves
If a CCG pathfinder can operate in the mean time as a committee of the PCT, will it act as a sub-committee of the PCT or of the cluster?
Lord Hunt of Kings Heath
My Lords, I thank the noble Earl, Lord Howe, for his response. This has been a really good debate, which has gone to the heart of the Bill and the Government’s intentions. I would like to come back to a point that the noble Baroness, Lady Murphy, made when she reminded us of the central tenet of the Secretary of State. Essentially it is that GPs are responsible, like GPs the world over, for most expenditure in the NHS, either through their referrals or through their prescribing decisions. The clear intent was to put budgetary responsibility with referral and prescribing responsibility, in the hope that it would lead to a more cost-effective system. I think the issue that many noble Lords have is that in the way this has emerged and in the guidance that has been given by the board and the department it is becoming clear that the influence of the individual GPs within this huge structure that is being established is likely to be very limited. On the other hand my Lords, because of the mantra of the Bill and the reforms, patients are likely to believe that it is their GPs who are making the commissioning decisions. Therein lies trouble, because I think the GPs are going to be in a very unenvious position. We as patients will hold them to account for commissioning decisions in a way they have never been held account before, but their influence on commissioning is going to be very limited indeed. I think this has been a very good debate, I beg to withdraw my amendment.
Health and Social Care Bill
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Baroness Masham of Ilton
My Lords, I spoke on Second Reading of the need for safeguards. These are important amendments. They are safeguards which are necessary. Many people are worried about the conflict of interest.
Earl Howe
My Lords, I know full well that noble Lords have some concerns about the potential for conflict of interest in a system of clinical commissioning groups. Those are natural concerns, but I hope to show that the approach that we are advocating has some very specific and robust safeguards within it, which meet the intentions of the amendments in this group.
The CCG constitution provides for dealing with conflicts of interest and specifies arrangements for securing transparency about the decisions of the CCG and its governing body. The governing body must in turn ensure that the group has arrangements in place to ensure adherence to relevant principles of good governance. The CCG’s governing body will have responsibility for ensuring that the CCG adheres to relevant principles of good governance. The Secretary of State can also make regulations for CCGs under Clause 71 of the Bill, which are designed to ensure that in commissioning, CCGs adhere to good procurement practice. These regulations may impose requirements relating to,
“the management of conflicts between the interests involved in commissioning services and the interests involved in providing them”.
These regulations can also confer on Monitor powers to investigate suspected non-compliance. These are the safeguards that the Bill puts in place. My view is that it is unnecessary and indeed undesirable to go further.
Requiring CCGs to adhere to examples of good practice in managing conflicts of interest, such as declarations of interest; or maintaining a register of interests; or the monitoring or registration of hospitality received by members is a temptation, but one that should be resisted. We have got to be very careful about encumbering the Bill and CCGs with inflexible prescriptions as to how CCGs should operate within the statutory framework, or procedure about how they specifically manage potential conflicts of interest. This does not mean that these are not reasonable safeguards. Requiring the governing body to discuss in public choices between potential providers, or publish any decisions made in camera, for example, would remove a necessary discretion around ensuring that sensitive issues, either relating to contract values or performance, or staff matters, were given the appropriate level of confidentiality. I would urge in particular that we do not—as proposed in Amendment 175CC—put restrictions on those from whom a CCG can commission services. Given the importance we attach to ensuring that services are delivered in an integrated way, we cannot afford to cut CCGs off from being able to commission services from local GPs with a special interest, for example, who could deliver secondary care services in a community-based setting.
Baroness Thornton
Will the noble Earl acknowledge that there is a conflict of interest there? There must be a potential conflict of interest there. How does the Bill mitigate that? How does the Bill deal with that? I cannot see from what the noble Earl has said so far that that is going to happen.
Baroness Finlay of Llandaff
Before the Minister responds, I wonder if he could also explain why clinical commissioning groups would not necessarily have to have a register of hospitality, conflicts of interest and so on? Those of us who work for NHS trusts certainly have to complete a register, and if we receive hospitality above a minimum amount or major gifts, not only do we have to declare them, but we actually have to decline them. I think we would be subject to severe discipline if we breached that code.
Earl Howe
I do not disagree with any of these principles, but I am not sure whether the noble Baroness understood what I said earlier: there have to be arrangements for securing transparency about the decisions of CCGs, and governing bodies have to ensure that CCGs adhere to relevant principles of good governance—think of the Nolan principles, for example, and many other ways in which good governance can take place—but there is no need to specify all this in the way these amendments suggest because the arrangements provided for in the Bill will cover these things. As the noble Lord, Lord Warner, said we are not in new territory here. There are very well established procedures for tackling conflicts of interest when they arise. There might very well be a conflict of interest in the kind of situation to which the noble Baroness, Lady Thornton, has alluded, but there are ways of addressing and coping with that.
The key to this is to have in place a rigorous framework of requirements, approved by the board as part of the CCG establishment process, to ensure absolute transparency and to manage conflicts of interest, subject to oversight—the oversight must be proportionate, but it has to be there. We can put on the face of the Bill, as Amendment 176AD would have us do, a detailed list of behaviours that we would expect members of CCGs to observe. Obviously I cannot disagree, as I say, with the stipulations on this list, but they are already provided for in the Nolan principles and indeed the GMC code Good Medical Practice, to which the noble Baroness, Lady Finlay, referred—and adherence to that is a condition of registration for medical professionals. The noble Lord, Lord Warner, was absolutely right: this code is what GPs and doctors in general fear to transgress. Of course, if one looks at that set of behavioural requirements, they are actually only an ideal and they have no specific system in place to ensure that they are met. The sanction on doctors is the threat that they will be referred to their regulator.
The NHS Confederation was very clear about this, and I have to say I agree with it. The Bill has to allow flexibility for the way that conflicts of interest are handled and developed over time, rather than being rigidly set in law. What the NHS Confederation told us was that conflicts of interest need to be managed effectively otherwise,
“confidence in the probity of commissioning decisions and the integrity of the clinicians involved could be seriously undermined. However, with good planning and governance, CCGs should be able to avoid these risks”.
I agree with that. There is a balance to be reached, and we believe the system that the Bill would introduce for managing conflicts of interest—the key points of which I hope I have described—provides that.
Baroness Thornton
My Lords, I thank the Minister. He will know, as will all those who have been Ministers, that when we are first appointed, we are told—the noble Baroness, Lady Williams, will remember this—that not only must we declare all our interests and have probity about the way we conduct ourselves, but we have to be seen to be doing it. A lot of these amendments are about being seen to do the right thing, and in terms of the relationship between GPs and their patients that becomes even more important. I agree with the noble Baroness, Lady Williams, and the noble Lord, Lord Marks, about their amendments and the need to have proper safeguards and remedies on this.
I think that if we co-operate, the noble Baroness, Lady Finlay, and I can probably crystallise these into something on the face of the Bill. I was disappointed that the noble Earl feels that this is satisfactory in the Bill at the moment, because I think the noise outside this Chamber and the comments from GPs tell us that people are very concerned about it. We need to address that in the Bill. I am happy to withdraw this amendment, but we may need to return to this at a later stage.
Lord Greaves
My Lords, I want to say one or two things about the consultation and go back to what I was saying before dinner. The question of patients is a bit of a red herring. To that extent, I think that the noble Lord, Lord Hunt of Kings Heath, was asking to be tripped up over it. Everybody is a patient to some extent, but the important thing is that the residents of an area, or citizens—whatever they are called nowadays—should know what is going on and that there should be an opportunity for a public debate to take place in the normal places—local newspapers, local radio, public meetings—about the future, structure and organisation of the health services in their area.
The noble Lord, Lord Hunt, was absolutely right when he said that there is a huge amount going on at the moment. It is not going on in complete secrecy; people involved in it know what is happening and are telling other people, and people in local authorities and others are having some discussions. However, by and large, there is not a proper process for providing people with open and full—or even partial—information about the proposals that are taking place. I do not think that it is a question of patients being able to tell their doctors which CCG they want to be part of, because the CCGs will be area-based, as we all know, and the doctors will be part of the CCG in their area. The questions are: what area is that going to cover, where is the CCG going to be, and how is it going to fit in to the health service? That is a fundamental question. So to that extent the noble Lord, Lord Hunt, is absolutely right. I think that the question of patients is a red herring.
Whenever I go to see my doctor, I consult him about what is happening in the health service, he consults me about that and all sorts of other things, and occasionally we get around to talking about my health; but I do not suppose that I am a very typical patient. That is a fact of life. However, it is a fundamental problem, and the source of a huge amount of the mistrust about what is going on at the moment is that people simply cannot find out what is going on. That is not in the amendments to this Bill. The Minister and his colleagues simply need to tell the health service to be a lot more open and transparent about what is going on and allow local debate on it.
Earl Howe
My Lords, these amendments are all concerned with the process of the establishment of CCGs or changes to the established organisation. The Bill lays the groundwork for the NHS Commissioning Board to establish CCGs. Ensuring the competence of an applicant group to exercise the functions of a CCG is a key part of that process.
In the first instance, the board may publish guidance on the making of applications and this may include details of how it will assess the fitness of CCGs for establishment and therefore their suitability to assume responsibility for exercising their commissioning functions. That is really what Amendment 159 is trying to get at. The whole process is intended to ensure that the CCG has made appropriate arrangements to discharge its functions competently. If the board is not satisfied about that, it will not grant the CCG’s application, or else it will grant it subject to conditions under the transitional arrangements.
I can confirm that we intend to make provision in regulations to require the NHS Commissioning Board to take the views of the shadow health and well-being board into account when they consider the establishment of a CCG. Health and well-being boards will be able to provide insight into the willingness and ability of a prospective CCG to be involved in partnership working and engaging with the local population. That is the theme of Amendments 160A and 162.
However, in my view, wider mandatory consultation with the public, either by a prospective CCG or by the board on receipt of an application to be established, would be completely disproportionate and add unwarranted delay to the establishment of new arrangements. We already have intelligence that early implementer health and well-being boards are engaging in constructive dialogue with CCG pathfinders about the right size, area and configuration to best meet local patient needs. That is fine, but problems arise when you start to mandate it. I am very uncomfortable about that. Consultation with the public has its rightful place but I was completely unconvinced by the argument of the noble Lord, Lord Hunt. For my money he simply has not made the case.
We also need to ensure that we do not have a cumbersome process for agreeing changes to CCGs, which may evolve over time as organisations and may choose to merge formally or to adapt their constitutions, which of course would need to be agreed with the board. A number of amendments in this group seek to require consultation, with the public, the relevant local authority, the relevant health and well-being board and patients receiving primary medical services from providers within the CCG, for different processes: establishment, variation, merger or dissolution of CCGs. The Bill as it stands would set clear duties for patient and public engagement in new Section 14Z. CCGs would have to engage the public in their planning of the commissioning arrangements; in the development and consideration of commissioning proposals, which would have an impact on the manner in which the services are delivered to the individuals; and in the range of health services available. They would also have to engage on decisions of the CCG affecting the operation of the commissioning arrangements where implementation of the arrangements would impact on individuals or the range of services available. The CCG would also have to consult the patients it is responsible for on its commissioning plan. That is quite right and proper and I hope that, in that area at least, there will be some agreement across the House.
As regards local authorities and health and well-being boards, these boards will include representation from the local authority and CCGs. I suggest that is the ideal forum for CCGs to discuss proposals such as mergers with their fellow members. However, it would not be appropriate to impose an explicit requirement for CCGs to consult the board on such matters.
Turning to Amendments 164B, 166A, 166C and 167C, tabled by the noble Lord, Lord Hunt of Kings Heath, I commend the report of the Delegated Powers and Regulatory Reform Committee of your Lordships’ House. These amendments would make the resolution procedure for certain regulation-making powers relating to applications between CCGs and the board affirmative. This approach was rejected by the DPRRC, which found that the negative resolution procedure would give noble Lords ample opportunity to consider regulations laid before the House covering determination of applications for establishment of a CCG, for variation of CCG constitutions and on dissolution of CCGs.
The noble Lord, Lord Patel, asked me about competencies. In September the department published Developing Clinical Commissioning Groups: Towards Authorisation, which sets out our current thinking on the domains that the Commissioning Board may wish to use as indicators to judge the competencies of prospective CCG commissions.
While I know that there will not be a meeting of minds over this, I hope that I have at least fleshed out what the Government’s intentions are. There will, obviously, be opportunity for further reflection on these matters.
Lord Warner
My Lords, I was not convinced by the noble Earl’s views on the number of clinical commissioning groups in our earlier debate. I was even less convinced by what he had to say about competencies. There was a lot of talk about, “The board may wish to do this”, and, “The board may wish to do that”, on competencies. The problem of healthcare commissioning in this country has actually been the lack of competency. That has been the problem for 10 to 20 years, under successive Governments. If we miss the boat again on this issue, we are making a great blunder.
I do not want to go over the ground about consultation with the public at all. I am interested in having in the Bill that the critical requirement of becoming a clinical commissioning group is competency to do the job, and that the board is required to specify what those competencies are, before people make an application. My noble friend Lord Hunt has made the perfectly sensible observation that while we are sitting, chatting about this Bill, people out there are doing the business about who will be clinical commissioning groups. That is what is actually happening. We need to make sure that they are under no illusions that competency is the yardstick by which they will be judged. I am not satisfied with the Government’s response and wish to test the opinion of the House.
Health and Social Care Bill
Earl Howe Excerpts(14 years, 1 month ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, before the House goes into Committee on the Health and Social Care Bill, I should like to take the opportunity to update noble Lords on the latest position with regard to the Department of Health risk registers. The House will recall that my department received a specific request under the Freedom of Information Act to release the transition risk register, which covers risks relating to the development and implementation of our health reforms. There was also a separate request to release the strategic risk register, which covers the most important risks the department faces.
We have taken the view that the information in both registers should be treated as exempt from disclosure under Section 35 of the Act on the grounds that the information contained in the risk registers is integral to government policy-making. Risk registers of this sort are a tool by which information about potential risks—both actual and theoretical—can be recorded in worst-case terms to enable them to be mitigated and managed. The Information Commissioner accepts that the information falls within this category of exemption. Following our decision not to release the registers, the two individuals who made the FOI requests lodged appeals with the Information Commissioner.
In early November, the Information Commissioner published his decision notices in both cases, deciding that the public interest lay, on balance, in full disclosure of both registers. Since then, as is allowed for under the rules, we have been considering whether we should appeal the Information Commissioner’s decisions. As I explained to the House previously, this was not a decision that the Department of Health could make on its own, as the issues which bear upon the decision have significant implications for every government department.
While the principle of openness is one to which we have adhered to the maximum extent through evidence given to the Health Select Committee in another place and the publication of impact assessments, it has been our firm view, and that of other departments, that for risk registers of this type to fulfil their function, civil servants must be free to think the unthinkable and record potential risks and mitigations fully, frankly and with absolute candour, confident in the knowledge that this information will not be publicly disclosed.
The logic of the Information Commissioner’s decision to order the release of information of this nature would entirely undermine the concept of safe space for these sorts of circumstances. The matter has accordingly been the subject of much careful consultation across Government, and a very clear and firm view has emerged that the publication of information in risk registers of this type would be likely, in the future, to undermine the very purpose for which a risk register of this sort is produced, and thus directly threaten the successful implementation of government policy. I can, therefore, tell the House that my department has decided to appeal both decisions by the Information Commissioner.
I would, however, like to respond to the request made on 16 November by the noble Baroness, Lady Thornton, by sharing with the House as much further information as I can about what my department’s transition risk register contains. On that occasion I undertook to examine whether there were any risks covered in the Department of Health transition risk register that are not already in the public domain and on which information could be provided without further ado.
While I cannot share the detailed breakdown of the information recorded in the risk register, or the wording, I am happy to set out for the record the broad issues covered by the transition risk register. They are as follows: how best to manage the parliamentary passage of the Bill and the potential impact of Royal Assent being delayed on the transition in the NHS; how to co-ordinate planning so that changes happen in a co-ordinated fashion while maintaining financial control; how to ensure that the NHS takes appropriate steps during organisational change to maintain and improve quality; how to ensure that lines of accountability are clear in the new system and that different bodies work together effectively, including the risk of replicating what we already have; how to minimise disruption for staff and maintain morale during transition; how best to ensure financial control during transition, to minimise the costs of moving to a new system, and to ensure that the new system delivers future efficiencies; how to ensure that future commissioning plans are robust, and to maximise the capability of the future NHS Commissioning Board; how stakeholders should be engaged in developing and implementing the reforms; and finally, how to properly resource the teams responsible for implementing the changes. I hope that this information will prove useful to noble Lords as the Bill continues its passage in Committee.
Baroness Thornton
I thank the Minister for that statement, of which I did not have more than two minutes’ notice. It is very disappointing indeed. Basically, the noble Earl is saying that the Government are choosing what they do and do not disclose to the Committee on this matter. It is an issue of trust—whether or not we can trust that we will know what we need to know to make judgments about whether this Bill will work.
I thank the noble Earl for the issues that he has decided that the Government can let us know about, but of course I am therefore concerned about what the issues are that the Government have decided that we should not know about. What are the risks that we cannot know about? That is a matter of grave concern to the Committee.
I shall be looking in detail at the Minister’s statement to the House and I reserve the right to return to this matter if I feel that we need to. For example, during the last two days in Committee I put two direct questions to the Minister about whether certain matters—one concerning children—were on the risk register and what the register said about them. I have not received answers to either of those questions. I shall continue to put my questions in that context and I suggest that other noble Lords do the same.
I am very grateful for the Statement as far as it goes but I do not think that this is an end to the matter. I can see why the Government might think that there is a cross-government issue here. However, no other department is in the position in which we find ourselves here—that of discussing a Bill that is going through the House right now. We need full information on this matter in order to be able to make proper decisions but I believe that we still do not have that. Therefore, I thank the noble Earl so far as this goes but I reserve the right to return to the issue in due course.
Lord Campbell-Savours
Perhaps I may ask the Minister a question. He gave us a list of all the areas which he thought it was not possible for Parliament to scrutinise in some detail. Did the Information Commissioner have access to all the document headings to which the Minister has referred, and did he have the opportunity to read all the documentation under those headings? If the Information Commissioner did have access to information on, for example, the handling of the legislation as it goes through Parliament, why did he, throughout the whole report, repeatedly say that these matters should be placed in the public domain? Again, is it not clear that the Government are trying to hide something from Parliament? The Minister’s first reference was to the handling of the legislation by Parliament. Why should not Parliament see what considerations took place within the department concerning how legislation should be handled as it goes through this House?
Earl Howe
My Lords, my clear understanding is that the Information Commissioner had full access to the risk register so that he would be able to see for himself what it contained. I do not believe that anything material was withheld from him. The whole purpose of risk registers of this type is to record all risks, even the unthinkable and the highly unlikely actual risks, as well as potential risks—in other words, risks that may not arise in the future but which could be mitigated with action today. Such risk registers record mitigating actions so that the risks identified do not become a reality. In our clear view, exposing that kind of information could cause needless concern, set hares running and seriously undermine confidence in the programme of work. No Government of any persuasion have routinely made risk registers of this type public for the very reason that to do so would undermine open and frank discussion among policy-makers for fear that the policy would be made public before it was fully developed.
The department has published and discussed its proposals for reform at every stage of this process. It has debated them at length in both Houses. It has even released some detail about the associated risks and what it is doing to address these in impact assessments. Therefore, I firmly believe that the Committee has all the information that it needs to discuss the proposals in detail.
Lord Campbell-Savours
My Lords, I understand there is a precedent—a Department of Transport one. Therefore, there is a discretion and the Government are in a position on this occasion and not on a further one. I do not really see that that case is relevant.
Earl Howe
My Lords, I am very grateful to the noble Lord, Lord Butler, whose understanding of these matters is one that noble Lords will respect greatly. He is absolutely right—this is not an issue that solely affects the Department of Health: it affects all government departments. That is why the stance taken by the BMA to this Bill was not material in our decision. We regret that stance but it did not come into our thinking in any way.
On the question of precedent, I am aware that during the course of the last Government three separate recent requests were made to the Department of Health to release risk registers. All three requests were declined. I have the letter here that was sent when the right honourable Andy Burnham was Secretary of State, citing exactly the same kinds of reasons I have given.
I was asked how long the appeal would take. I do not know but my understanding is that the process should come to a conclusion reasonably early in the new year. I cannot be more definite than that because it is not up to us—it will be up to the tribunal to order its business as it sees fit. Will the Government accept the result? Clearly, we will have to take a view whatever the result; I cannot pre-empt the decision today. My noble friend Lady Williams asked whether we had considered releasing a redacted version—the decision before us was whether to comply with the Information Commissioner’s decision in full, or not to and appeal. We did not have the option of redaction but I am grateful to my noble friend for her suggestion, which I will take away and consider.
Earl Howe
My Lords, I am grateful to the noble Lord, Lord Butler, and my noble friend Lord Newton for prompting this debate, which brings us back to a key theme in this Bill: namely, the extent to which we can reconcile central prescription with local flexibility.
Our White Paper, Liberating the NHS, set out the case for change, and with the help of this Bill we will put patients at the heart of everything the NHS does, focus continuously on improving patient outcomes and empower and liberate clinicians to improve the quality of healthcare services. In doing so, we will build on the successful quality framework pioneered by the noble Lord, Lord Darzi, including the quality standards programme that plays such a central role in providing robust evidence for quality improvement under this Bill.
I am naturally sympathetic to the spirit behind the amendments in the name of my noble friend and the noble Lord, Lord Butler. First, I can reassure them, and indeed the noble Lord, Lord Walton, that the Bill does not impose blanket requirements to implement NICE quality standards or any other NICE guidance, or to comply with indicators in the outcomes framework—nor should it. The board will have to have regard to NICE quality standards, including in relation to those services it will be responsible for commissioning. CCGs will similarly be required to have regard to the board’s commissioning guidance, which will be based on NICE quality standards and other accredited evidence. That is a strong duty. It means that they must consider that guidance and if they do not follow it they have to have a good reason why not. I will be coming on to an explanation of the duty to have regard in a moment. The guidance will explain rather than dictate how to improve quality, efficiency and fairness.
I will just say to the noble Lord, Lord Turnberg, that when it comes to NICE technology appraisals, the Government have undertaken to ensure that the NHS continues to fund drugs that have been recommended in NICE technology appraisal guidance and to maintain the effect of the funding direction in the new arrangements for value-based pricing. So there will be no weakening of NICE’s role here, as the noble Lord suggested.
In this way, the Bill gives us a framework to improve outcomes through recognising and rewarding high-quality care based on evidence of what works best. That comes from encouraging innovation and balancing the independence that is desirable for achieving good outcomes with the responsibility to improve, which I think is the intention behind my noble friend’s amendment.
On this occasion, I am afraid I cannot agree with the noble Lord, Lord Patel, that quality standards should be mandatory for rare diseases. We strongly believe that it should be local areas that lead in setting priorities for their own patient population. Making all quality standards for rare diseases mandatory would essentially cut across that approach. We feel that a more effective way to improve quality is to provide commissioners with all the necessary support and evidence that they need to plan how best to meet the needs of their local population.
I can sympathise with the intention behind Amendments 110ZA and 137B. The Government absolutely acknowledge the important contribution that nurse specialists make to patient care, and the value that patients, their families and indeed other members of the clinical team place on having their specialist expertise and support. I am of course well aware of the value of specialist nurses to people with epilepsy and I also completely understand the close interest of the noble Baroness, Lady Royall, in prostate cancer specialist nurses.
Under our proposals, commissioners will have the freedom to commission pathways of care designed around the patient and delivered by a multiprofessional workforce that includes specialist nurses. Of course, they will have the benefit of commissioning guidance on best practice, but in the end we are committed to empowering clinicians and giving them the freedom to determine how best to meet the needs of their patients. This will include decisions about which member of the healthcare team should deliver which aspects of care. These decisions are complex and we believe that they are best made by local clinicians and commissioners working in partnership, so although I have sympathy with much that the noble Baroness, Lady Royall, said, I do not agree that the board should have the sort of role envisaged in her Amendments 110ZA and 137B. We think that they are too prescriptive.
Turning to Amendments 144 and 145, I would say to the noble Lord, Lord Patel, that safety is a key domain of quality, and I have outlined before our intention to embed a culture of patient safety in the NHS by giving the board responsibility for managing the systems for reporting and learning from patient safety incidents that are currently operated by the National Patient Safety Agency. However, I agree that it is important that information which can inform and enhance patient safety in the NHS should be made available to all those who would benefit from it, as he suggests. The NPSA currently shares information with a number of bodies with a particular role in relation to patient safety, such as the MHRA and the CQC, and this will continue to be the case. Indeed, if it did not make important information available to those who it thought could reasonably benefit from it, the board would be in breach of its duty.
In addition to NHS bodies, the information is currently also used to develop products for use by non-NHS organisations, by the devolved Administrations and by international organisations, for which the board may determine it appropriate to charge a fee. It is for these reasons that we have framed the duty to share information in broad terms, and we would not want it to be more prescriptive or restrictive than that. This is the perennial problem of trying to insert a list in a piece of legislation.
Where the board does disclose information that relates to an individual, it is essential that their confidentiality is respected whenever possible and that information is disclosed only where there are compelling reasons to do so. I can reassure my noble friend Lord Marks that disclosures would be subject to the provisions of the Data Protection Act 1998 and the Human Rights Act 1998, so any disclosures of personal information would need to involve the minimum amount of information necessary to serve the purpose. To ensure that this is clear, it may be helpful to my noble friend to know that we are working with the BMA on issues to do with confidentiality and the application of the common law in relation to the board and other bodies. We intend to bring forward any necessary changes to the Bill on Report.
Lord Walton of Detchant
My Lords, I thank the noble Earl for confirming that the Government are working with the BMA. Is it not also very important, in relation to confidentiality, that they should also work with the General Medical Council which, after all, has provided very detailed advice to doctors about confidentiality issues?
Earl Howe
My Lords, the noble Lord is quite right, and my understanding is that we are doing that as well. Meanwhile, I can tell my noble friend Lord Marks that we will consider the provisions highlighted by Amendments 153ZZA and 153ZZB as part of this process.
My noble friend also raised the issue of inequalities. In earlier debates I highlighted the very significant departure made in the Bill that, for the first time ever in this country, the Secretary of State will be legally obliged to have regard to the specific need to reduce health inequalities, whatever their root cause. The board and the CCGs will also have this duty, which clearly emphasises our commitment to equity and fairness across the health service. We believe that the phrase “have regard to” completely captures the intention of the legislation; that is, that the board and the CCGs must consider the need to reduce inequalities in every decision they take. That, I hope, addresses the essence of Amendment 118. This is consistent, as I think it should be, with the public sector equality duty, which is phrased in exactly the same way. As the board already has a responsibility for all patients in the population, its general duty on inequalities also applies this widely.
Under Amendment 119, the board would have to have regard to the duty on inequalities in allocating resources to CCGs. We recognise fully the importance of ensuring that allocations give CCGs the resources to meet the distinctive needs of their local population. Again, our preference is not to place particular weight on one factor or set of factors in legislation. In fulfilling this duty, the board will also need to work in collaboration with health and well-being boards and local authorities. We have already debated the various duties on the board to participate in certain activities of health and well-being boards.
On Amendment 137A, of course it will be important to ensure that all providers contribute to the fulfilment of these duties. Some public sector duties, such as the duties under the Equality Act, already apply to anyone exercising a public function, which includes private providers who supply NHS services. The specific duties in the Bill are placed on the board and CCGs, and they remain responsible for exercising them even when they contract with another body to provide services. It is, therefore, incumbent on them to ensure that these commissioning arrangements, and the ongoing monitoring of services provided under them, support the fulfilment of their duties.
I am not sure whether the noble Baroness, Lady Royall, spoke to her Amendment 343A, but if I cover it briefly, it may be helpful to her. The amendment probes how long it will take NICE to produce the full range of quality standards. As the noble Baroness probably knows, the ambition is to create a core library of NICE quality standards that covers the majority of NHS activity, and supports the NHS delivering against the outcomes in the outcomes framework. The programme is ideally placed to deliver a steady stream of quality standards over the agreed timescales and this will lead to a comprehensive library of quality standards within, we hope, about five years. Therefore, I am afraid the timescale envisaged in her amendment is too short.
I turn now to the group of amendments introduced by my noble friend Lady Cumberlege on maternity services. I am grateful to her and, indeed, the noble Baroness, Lady Thornton, for giving us the opportunity to consider this question. I hope I can provide some reassurance that the new commissioning arrangements will provide a very secure basis for quality improvement in these services. Women should always expect—and always receive—excellent maternity services that focus on the best outcomes for them and their babies, and which optimise women’s experience of care. Getting maternity care right from the start can help tackle the negative impact of health inequalities and begin to improve the health and well-being of mother and baby.
We are committed to improving outcomes for women and babies, and for women’s experience of care. Three of the improvement areas in the NHS Outcomes Framework for 2011-12 focus on improving maternity services, by reducing perinatal mortality, by reducing admissions of full-term babies to neonatal units and by improving the experience of women and families of maternity services. My noble friend spoke of variation in services and that was the theme of the very powerful speech by the noble Lord, Lord Mawson. We are committed to ensuring consistency in the quality of maternity services. From April 2012, a maternity experience indicator will be introduced as part of the NHS outcomes framework. It will allow us to chart a woman’s experience of care through antenatal care, labour, delivery and postnatal care.
To support the NHS in improving outcomes in pregnancy, labour and immediately after birth, the National Institute for Health and Clinical Excellence is developing new quality standards based on the best available evidence on antenatal care, intrapartum care and postnatal care. It is outcomes and quality that matter, and the NHS Commissioning Board will be publishing a commissioning outcomes framework for clinical commissioning groups. The commissioning outcomes framework will rely on the national outcomes framework set for the board and NICE quality standards. On top of that, the NHS Commissioning Board could decide to include guidance on the matter in the commissioning guidance that it must publish for CCGs and to which CCGs must have regard.
Baroness Barker
My Lords, can my noble friend tell me where in the legislation it is made clear, if a CCG were to have a conflict—that is, a disagreement—with the commissioning support organisation, where and how that conflict would be resolved?
Earl Howe
My Lords, in the interests of time I suggest that I write to noble Lords on those questions, and I am happy to do so. However, I say to my noble friend Lady Cumberlege that I recognise the particular importance of the maternity quality standard. I will try to find out for her what stage NICE has reached or is likely to reach within a certain timescale, and if I can provide her with any further information I will be happy to do so.
Lord Butler of Brockwell
My Lords, I am grateful to the Minister for his comments in response to Amendment 109A and I thank the other noble Lords who have supported it. The noble Lord, Lord Newton, said that this is a probing amendment. As the Minister has said, there is a question of balance here: we want the Commissioning Board to be an effective promoter of standards, but on the other hand we do not want the arrangements to put an unnecessary brake on innovation. I am sure that the noble Lord will consider carefully what the Minister has said. In the mean time, I beg leave to withdraw the amendment.
Baroness Wheeler
My Lords, I am pleased to support the spirit, intention and thrust of all the amendments in this very large and, I hope, uncontroversial group, which are intended to ensure that provisions in the Bill to involve the public, patients, carers and specialist professionals and patient groups in the development and decisions about services, care and treatment are reinforced and strengthened. We recognise that the duties proposed by the Government for the NHS Commissioning Board and clinical commissioning groups—to promote the involvement of each patient and to enable patients to make choices on the services provided to them and obtain advice from specialist professionals—are a significant step forward from the original provisions in the Bill. They build on the foundation work on this issue undertaken by my own Government. However, it is clear from this excellent debate that these general duties do not go far enough to mark the significant step change that we need in getting genuine shared decision-making and participation of patients, carers, and patient groups in decisions about care and treatment, and on how services are planned and developed.
We also now have the added complexity of the reorganisation itself. Senates, networks and health and well-being boards are acting as the system integrators, all alongside our newly enlarged CCGs with their giant private sector support organisations behind them, as we now know from the Government’s recently issued draft guidance on commissioning which was referred to in the previous debate by the noble Baroness, Lady Williams. This will be a highly complex raft of interactions and interconnections with no notable route to accountability. I would be grateful if the Minister could give me some insight into how he envisages the voice of patients being heard among all the clamour and shouting that will go on between these different spheres of interest.
We must try to achieve real involvement. For individuals, that means involvement in care planning and support for patients with their carers, relatives and support groups to manage their conditions and share in the choice of treatment. On collective involvement, this means that knowledgeable patients’ groups should be able to advise commissioners on how to design services, rather than to have token consultation after decisions have already been made, which is the case now in so many situations. We must make sure that we harness fully the collective experience and knowledge of patients and specialist care organisations.
We recognise that this will involve a major cultural change in the behaviours, approaches and attitudes of key professionals from across the specialisms, moving away from seeing patients as units of disease, not as people with rights to information and to participation in discussions and decisions about their care and treatment, as the Health Foundation puts it. We need to change the way that patients and clinicians, in particular, relate to each other, and change the way that the NHS relates to patients in terms of, for example, information provision and the organisation of clinics, and in the style of consultations that professionals have with patients.
In respect of the NHS Commissioning Board, we support Amendment 121, which calls for the board to have the duty to secure rather than promote the involvement of patients, carers and their representatives in decisions about the provision of health services. This is important, and Amendment 150C—which seeks to ensure that the board’s annual report includes accounting for how it has carried out its duties in involvement, choice and advice—complements and underlines the importance of this duty.
Amendments 125 and 126, tabled by my noble friends Lord Warner, Lady Thornton, and Lord Patel, turn the focus on clinical commissioning groups and call for a published guidance to CCGs to ensure that they are clear about what is required of them to meet the duty to promote the involvement of each patient. I also pay tribute to the work of National Voices on the principles of integrated care and on other patient and involvement issues relating to these matters.
We know that many commissioners, both nationally and in CCGs, are unaware of the increasing evidence that involving individual patients in their care and treatment is proven to be more clinically effective, provides better patient experience and makes much better use of healthcare resources. In other words, it is the vital underpinning for the Nicholson challenge and for commissioners’ other duties to improve quality. A far stronger signal is needed in the Bill and in statutory guidance to draw commissioners’ attention to the proven interventions that they require from their providers. I would be grateful to hear from the Minister how he intends to do this.
Clearly, many CCGs will not make the changes that we need without help and support. Amendment 125 is therefore crucial, as it calls on the NHS Commissioning Board to draw up guidance to CCGs which will enable patients, carers and their representatives to make informed decisions. This includes patients having the means to express their views on the quality of services provided, opportunities to consult with service providers, access to appropriate information about their care and treatment, opportunities to consider available treatment options and their risks and benefits, and to participate in decisions about their care and treatment and its managers. The information they receive about these areas must be simple and well presented—not league tables or comparison charts, but clear information about treatment options, how effective they are and what the consequences might be for the patient. As other amendments underline, these rights of patients must be accessible to all patients.
Amendment 126 stresses how important it is to have information on access and location and about the providers of health services and performance if informed decision-making is to become a reality for the majority of patients. We fully support Amendments 127A and 197A, which would give expert patients’ organisations equal status to professionals in providing advice to commissioners. This would help ensure a patient voice in the clinical senates and networks. It is an approach that was supported by the clinical work stream of the Future Forum but overlooked in the Government’s response. We also strongly support Amendments 175A and 175B from the noble Baroness, Lady Finlay, which calls for regulations providing for the governing bodies of CCGs to include individuals who are fully aware of the different aspects of specialist provision in the areas covered by CCGs.
Amendments 140 and 142, tabled by my noble friends Lady Thornton and Lord Hunt, require the Commissioning Board to ensure that patients are involved and consulted in the development and planning of commissioning and in the consideration of how proposals for change in health services are organised and delivered. Most importantly, Amendment 205 secures the involvement of the local healthwatch in these decisions, vital if HealthWatch is to be able to fulfil its key watchdog and patients role. The importance of this role was ably underlined by my noble friend Lord Harris, so I will not expand further on it.
On patient choice, we support Amendment 127, which proposes a definition of patient choice. Research shows that patients care most about being able to exercise choice about the care and treatment they receive, but currently the NHS performs poorly in involving patients in this way. A full definition of patient choice should be included in the Bill to ensure that commissioners provide opportunities for patients to exercise choices that go beyond the choice of provider. Does the Minister accept the need for this definition in the Bill, and if not, how will he seek to achieve the cultural change in systems and attitudes that we all want to see?
All these amendments seek to ensure that the NHS Commissioning Board and CCGs understand fully their responsibility, and that they commission for involvement. These changes would give a clear signal to the system that the Government mean business in wanting meaningful patient participation and involvement, and that real change can be achieved.
Earl Howe
My Lords, this large group of amendments all relate to the different ways in which patients, the public and others will be involved in decision-making, and although I shall be suggesting that noble Lords should not press them, I am very much in listening mode on the themes that they raise. The only thing that I cannot promise to take forward is the suggestion of the noble Baroness, Lady Masham, that I should introduce an amendment on the death penalty, but, no doubt, she can persuade me.
The issues that noble Lords have covered are central to our vision of informed and empowered patients, and responsive commissioning that is clinically led. These are also issues that were considered in great depth as part of the listening exercise, in response to which significant improvements were made. Those improvements created much stronger duties than currently apply to primary care trusts, so it is important to begin by recognising how this Bill takes us forward from the current position. Nevertheless, I recognise that some confusion remains about what we mean when we talk about involvement, and what the different duties in the Bill are intended to achieve. The noble Lord, Lord Warner, has tried to frame an all-embracing definition of involvement through Amendment 125, and I find little to criticise as regards the purpose and intent of that amendment. However, I would argue that much of what the noble Lord intends through this amendment is already provided for in the Bill. Indeed, it is because there can be different elements to involvement that would be appropriate in different situations that I would be cautious about trying to wrap them up in a single definition.
It will be helpful to begin by considering the duties on the board and clinical commissioning groups to involve patients in decisions about their own healthcare. The noble Lord, Lord Harris, made some useful distinctions on this point. These new duties reflect our vision of shared decision-making, referred to by the noble Baroness, Lady Finlay—“no decision about me without me”, and an NHS where patients are involved fully in decisions about their care in partnership with clinicians. This is primarily about the relationship between the individual patient and their clinician; it does not extend to commissioning decisions. Therefore, I do not think that it would be appropriate for HealthWatch or indeed any other body to have a role in what are meant to be sometimes very personal decisions.
There is clearly a role for CCGs as commissioners, as distinct from the role of general practitioners, in supporting and encouraging this personal involvement. However, it is not completely within their control, so I do not think that it can be for them to secure, as the amendment proposes. Nor do I think that there should be any sort of hierarchy, where the board is in the lead with a weaker duty on CCGs. That would run counter to what we are trying to achieve, which is after all a more personalised service. Therefore, I am afraid that I cannot agree with Amendments 121, 123, 124A, 191 and 192. However, such a service might include giving patients greater control over their medical records, as Amendment 124 suggests. The noble Lord, Lord Patel, may know that this was a key theme of our consultation on an information revolution. Responses to that consultation showed a clear desire to enable people to be more in control of their care, supported by greater access to the information held about them in their care records. We are committed to this and our forthcoming information strategy will set out how we propose to achieve it.
These duties are of course closely linked to those relating to enabling choice. As noble Lords will be aware, patient entitlements to choice are set out in the NHS constitution. These are underpinned by directions by the Secretary of State, which will in future be the standing rules and regulations under Clause 17 which we have already discussed.
I reassure noble Lords that, as now, the role for commissioning bodies in respect of enabling choice in the future will include acting with a view to making people aware of their rights and entitlements, giving them the information that they need to make informed decisions and working with providers to ensure that these are delivered. I did, however, listen with considerable care and sympathy to the noble Lord, Lord Neill, regarding patients who need advocates to speak on their behalf. This will be further reinforced by the new duty that the board and clinical commissioning groups will be under in relation to promoting the NHS constitution among both patients and staff. The board will set the choice offer, establishing the parameters for choice and competition, based on the choice mandate that the Secretary of State will set as part of the annual mandate to the board. I remind the Committee that we recently sought views on these issues through the consultation, Liberating the NHS: Greater Choice and Control. This is an important approach because it allows the Secretary of State and the board to manage the rollout of choice in a controlled way—something that I know many noble Lords are anxious to ensure. That is why we have deliberately used broad terms in describing the types of choice that patients can exercise. Indeed, I think that defining them in more detail, as some of the amendments attempt to do, could paradoxically limit their scope. They could also be unsuitable or indeed unfeasible in particular circumstances, and that is why, although I am in sympathy with the spirit behind them, I am unable to agree with Amendments 126, 127, 193, 196, 197 or 197ZA.
Greater choice means, among other things, patients being able to choose between a greater range of providers. Amendments 125A, 125B, 195A and 195B are particularly concerned with the impact that greater choice and provider plurality might have on the viability of existing services—a matter that we discussed at our last session in relation to amendments tabled by noble Lords opposite about the interdependency of services. That is an issue that I completely understand. In securing healthcare services to meet the needs of their patients and populations, commissioners must have regard to the stability and financial viability of those services, including taking account of the interlinkages between services, where relevant, on an ongoing basis. Commissioners will need to commission high-quality integrated care that will deliver value for money for local communities and promote opportunities for patients to exercise choices in relation to their care. In taking commissioning decisions, they will have to consider what the noble Baroness, Lady Pitkeathley, reminded us of—that is, what will be in the best interests of their patients. This would always be their primary concern, and we would expect the board to ensure sufficient competency over these issues in authorising CCGs to take on their new responsibilities and in holding them to account for doing the job.
Lord Warner
I am sorry to interrupt the noble Earl’s flow but I have been extremely restrained today. Can he clarify for me the point that he has just made concerning clinical commissioning groups’ constitutions? As I understand it—he can correct me if I am wrong— they have a considerable amount of freedom on how they frame the obligations in those constitutions. Is the Minister saying that there would be some requirements on them centrally from the board to cover areas such as patient involvement and patient choice?
Earl Howe
I am. The intention is that no clinical commissioning group will be authorised in the first instance unless it can demonstrate to the board that it can fulfil the legal duties that the Bill places on it. That is key to our thinking. Indeed, as time goes on, it will be under a continuous duty to show it is abiding by those duties. In the first instance, it is very important that clinical commissioning groups demonstrate they are fit for purpose in that sense.
I also appreciate the concern to ensure that the board and CCGs benefit from as wide a range of advice as possible. The Government have been clear that everyone with a role to play in securing the best possible services for local people should be able to do so. The definition used in the duties to obtain advice is that used to define the comprehensive health service. It would encompass the areas covered by Amendment 127C. Indeed, I do not think it would be possible to cast it in broader terms. These duties will apply to every function the board or a clinical commissioning group will exercise. Again, within those broad parameters it is important to retain some discretion for the board and CCGs to determine how best to exercise this duty.
The board and CCGs will certainly have to work closely and effectively with all the providers with which they contract as Amendments 127B and 197B suggest. I would say to my noble friend Lord Clement-Jones that that most certainly would include pharmacists. I also agree as to the expertise and the unique perspective that patients and their representative bodies can bring not just to the commissioning process but also to the way the board and clinical commissioning groups approach many of their functions. The same would apply to many other groups, including academic institutions, as the noble Lords, Lord Kakkar and Lord Walton, have highlighted.
The noble Lord, Lord Kakkar, spoke powerfully in favour of academic health partnerships. Academic health science centres have been successful at developing these partnerships within their local areas but understandably have been less successful in spreading innovation across the NHS. As the noble Lord set out, the NHS chief executive’s innovation review is due to be published next month. That will set out how we can accelerate the adoption and diffusion of innovations across the NHS. It will include a mix of bottom-up, horizontal and top-down incentives and pressures that will drive adoption and diffusion of innovation and behaviour change. The role of academic health partnerships may or may not feature in this review. I hope the noble Lord will forgive me if I do not at this stage anticipate or pre-empt what the report will say by elaborating any further. However, I counsel noble Lords to play close attention to what the noble Lord said in his speech.
While these duties refer to obtaining advice from people with expertise in relation to the health service, that is not confined to clinical expertise. Indeed, in fulfilling these duties we envisage a role for clinical senates, as we have already discussed, in providing not just clinical advice but multidisciplinary advice from professionals in health, public health and social care backgrounds alongside patient and public representation and other groups as appropriate.
I am sure we all share a desire that these duties are effective. However, I am not convinced that imposing specific duties as to where the advice should come from, including through the membership of governing bodies, or how the advice should be acted on is the right way to proceed. If we become too prescriptive we risk overburdening CCGs with so many duties and obligations that they could never be sure whether they were doing enough and in reality we must trust them to build these relationships themselves and judge them on the outcomes they achieve.
The noble Baroness, Lady Finlay, asked me about the secondary-care doctor role on CCGs and whether it had to be somebody from outside the area or retired or whether it could be a local person. We are looking carefully at that question. The secondary-care doctors on CCG governing bodies will not be able to have a conflict of interest in the decision-making process of the CCGs. That is where the noble Baroness, Lady Murphy, was absolutely correct. We will use regulations to set out more detail about this and we will work with stakeholders, including pathfinders, to develop these proposals. The noble Baroness referred to the secondary-care doctor coming from either outside the CCG area or being retired. Those are two ways in which a conflict of interest could be avoided but they are only examples and do not represent an exhaustive list.
I want to finish by returning to a point raised earlier by the noble Lord, Lord Warner. We too are aware of the very good work of National Voices, as well as a range of other organisations, on how patient and public involvement could be strengthened in the Bill. While I have explained why I think these specific amendments are not necessary, I am happy to go on listening. I feel that the Bill is already strong in this area but we are always open to new ideas and I look forward to further discussions on this general topic. It is for those reasons that, while sympathetic to the intention behind the amendments, I am unable to accept them and I hope noble Lords will agree not to press them.
Lord Patel
My Lords, on behalf of all noble Lords who took part in the debate I thank the Minister for his comments. He excited us all by first saying that the only thing he would not be able to accept would be the death penalty. He finished by saying he could not accept most of what we were saying, partly because it was already in the Bill, which most of us did not think was the case. He demonstrates a commitment that patients’ voices and public involvement will be paramount and that all the commissioning boards and commissioners will be expected to demonstrate that they listen to the voices of patients and the public. We will watch and see how they are made accountable.
The Minister referred to innovation. Of course, the next group of amendments focuses on innovation, so we may come back to it and also the involvement of the academic health centres. We have had a good debate and maybe after reading Hansard some of us can decide whether we will come back to some of these issues. In the mean time, reluctantly, I beg leave to withdraw the amendment.
Lord Turnberg
I wish to speak to some of the amendments that are in my name. I would also like to comment briefly on Amendments 128A and 129, dealing with innovation. We know that we are quite slow in taking up innovations in the UK. It is not simply that there is a bit of sluggishness in the system—there are hurdles in the system. I want to mention two examples of very simple innovations that would not cost any money to the health service, but which have been blocked by the systems under which we operate.
One example is a consultant colleague of mine, a gastroenterologist—my own field—who set up a clinic in which he took phone calls from GPs and patients and was able to answer many questions without actually having to see the patients. It had a rapid turnover. It was considered to be innovative but was blocked because it did not earn any money for the hospital trust which found that it was not getting the patients referred. The second example concerns a similar situation in which the same consultant saw new patients from 8 am until 9.30 am. He sent them away for tests, scans, endoscopies and so on, and saw them again at about 11 am with the results of the tests and gave them the treatment that was necessary. This, too, was considered not to be earning money for the PCT, because it was paid for items of service, and it would have got twice the money with the normal system. This is a hurdle to innovation which we should surely be able to overcome. We have discussed that with the Minister. He expressed sympathy for the idea so I hope that it can be acted upon. It is not simply that we are slow; we have hurdles.
I come to Amendments 130, 131 and a number of others in my name. I have no doubt that the Government have firm intentions to promote research and innovation. It is mentioned in several places in the Bill and I know that the noble Earl’s heart is in the right place on all this. The amendments in my name are simply there to help the Government in their own aspirations by emphasising and reiterating the need to keep research and innovation at the forefront. I simply emphasise the points made so eloquently by the noble Baroness, Lady Morgan, and the noble Lord, Lord Willis. The amendments make it clear that innovation and research are of such central importance that they should be explicit in the board’s business plans, in reporting its activities and in clarifying how it is going about achieving these aspirations. The amendments make sure that the board actively promotes research as against simply having regard to it. I hope that the Minister will find the amendments helpful in the light of the Government’s intentions.
Amendment 131 returns to the issue of research that protects the public’s health. Here I make two particular points that the Minister might consider answering in one way or another. First, how will it be possible to ensure that the local authorities taking over the directors of public health also promote research? What levers will there be with the local authorities? Secondly, I ask a question that has been posed before. How will we ensure that the Health Protection Agency, which engages in much important research, will have access to external funds? We have discussed this before, but it would be nice to know whether it is clear that the HPA will have access to grants from external funding bodies.
Earl Howe
My Lords, the NHS has a long and proud track record of innovating and delivering better care for patients. That must continue—we all agree about that. That is why new Section 13K of the 2006 Act places a duty on the board to promote innovation when exercising its functions, including innovation in the provision of services and the,
“arrangements made for their provision”.
That last phrase means the commissioning of services. As a result, although we completely sympathise with the principle behind Amendment 128A, it is not necessary. The duty is intended to support the delivery of quality and productivity improvements across the NHS to help transform healthcare for patients and the public. In response to the noble Lord, Lord Warner, I say that I expect that innovation in procurement of goods and services will be an essential part of this. The duty certainly allows for it as it stands. It is an important part of the QIPP programme at the moment, and I am sure that it will continue to be. If we were to specify one area of activity in which the duty should be exercised, as Amendment 129 suggests, we would face the perennial problem of listing those areas where the duty should be exercised to the detriment—
Baroness Thornton
I am sorry to interrupt, but it strikes me that if none of us understood that that was what those words meant—that was what led us to table the first two amendments in this group—maybe the Minister should look at those amendments, because they offer more clarity.
Earl Howe
I am always keen to accept the wise suggestions of the noble Baroness, and I will of course go away and consider the words that she has proposed.
I was just referring to the amendment proposed by the noble Lord, Lord Warner, on procurement, and saying that we would face the perennial problem of listing those areas where the duty should be exercised to the detriment of those not listed.
Lord Warner
I have an uneasy feeling that we are going to hear a lot about lists today. On lists, some things are more important than others, and I think that the argument about lists does not hold a lot of water unless the Minister can show us some other items that will be missed out that are as powerful as procurement of goods and services in further research and innovation. If there are others, I would be happy to consider the matter, but the reason why the amendment has been tabled is because it is a very powerful way in which to promote something that the Government want. Many of the other things may not be as powerful in delivering that.
Earl Howe
I recognise that and, after what I said a moment ago, we know that procurement can be an important lever in the innovation agenda. Indeed, that will be recognised in the innovation review, which is due to be published next month. Furthermore, we are planning to launch a procurement strategy by April 2012. I will not go into huge detail about it, although I have it here, but it will consist of three elements—system levers, standards for procurement and system level support. We can look to take forward some of the ideas that the noble Lord, Lord Warner, put forward in his speech.
All this goes to show that there is a substantial amount of work already under way to create the right conditions for innovation to flourish. These include dedicated regional innovation funds to support front-line innovation and innovation challenge prizes to recognise and reward ideas that tackle some of the biggest health and social care challenges facing the NHS and in future. I have named only two from a long list of current initiatives.
I will just say to the noble Baroness, Lady Finlay, that the Secretary of State already has a power to awards prizes. New Section 13K of the 2006 Act, inserted by Clause 20, simply gives the board the same power. Should it choose to use the power to make payments as prizes—and it is a power rather than a duty—this is one way in which it might decide to promote innovation in the provision of health services. Recently I presented the very first group of innovation challenge prizes, and it was a very heart-warming and exciting occasion.
The noble Lord, Lord Warner, rightly made the point that the NHS was slow to take up innovation and that people were forced to go elsewhere to take their new ideas forward. Again, this is an issue that we are tackling with considerable energy in the NHS chief executive’s review of adoption and diffusion of innovation, which will be published next month. I look forward to talking more to the noble Lord about what is in that review in due course.
I say to the noble Baroness, Lady Morgan, in particular that the main way in which the board will collaborate with research funding bodies is to fund the treatment costs of patients who are taking part in research funded by government and research charity partner organisations.
The existing innovation funds were not put in primary legislation; there is no need to put a specific power in the Bill, as Amendment 129A seeks to do, to enable the board to establish an innovation fund. As with prizes, establishing innovation funds is only one way in which the board might seek to exercise its duty to promote innovation; innovation funding is being considered as part of the chief executive’s innovation review.
Amendments 130 and 131 reflect the similar and previously debated Amendments 39 and 41 on the equivalent duty on the Secretary of State in Clause 5. I agreed to undertake a closer consideration of that duty and I shall do that. I reassure noble Lords that our discussions will include the board’s duty. Work is under way to look at these duties ahead of future stages of the Bill. Indeed, I undertake to reflect carefully on the points raised by the noble Baroness, Lady Morgan of Drefelin, and to write to her with answers to her questions. I have also written to all noble Lords who spoke in that earlier debate, picking up points that I was not able to cover at the time. I explain in that letter how public health falls within the definition of the health service, which was one of the points touched on by the noble Baroness. It will therefore be covered by the existing duty on the board to promote research in proposed new Section 13L of the 2006 Act.
The noble Lord, Lord Patel, spoke about the role of the tariff in promoting innovation. He is absolutely right to do so; the new tariff could indeed play a key role in encouraging innovation. The Bill introduces a new, independent, transparent and fair pricing system where the board and Monitor would collaborate to set prices for NHS services. That would create a more stable and predictable environment, allowing providers and commissioners to invest in technology and innovative service models to improve patient care. We are actively looking at the way in which the tariff could drive that.
My noble friend Lord Willis and, indeed, the noble Baroness, Lady Morgan, asked how exactly the board will go about promoting research. As previously set out, we will make sure that the systems and processes for commissioning used by the board and clinical commissioning groups ensure that research is promoted, supported and funded by the NHS. That will include the tariff, the commissioning guidance and the processes for authorising and supporting development of clinical commissioning groups. However, noble Lords will be aware that a great deal of the practical detail of the board's role is still under development. Further detail will be published in due course and we must respect the autonomy of the board in devising for itself how exactly it will undertake this function.
I turn to Amendments 147, 149A, 150, 215 and 218. Given the wide range of statutory duties placed on the board and CCGs, the approach we have taken in the Bill is to emphasise a few key duties that the board must look at—in particular, in its business plan, annual report and its performance assessments—and that CCGs must, in particular, look at in their commissioning plan and annual report. We feel we have chosen the right duties to emphasise, not because they are the most important but because they are duties about which any annual report, business plan, commissioning plan or assessment should provide explicit evidence, specifically linked to the exercise of the board’s or CCGs’ functions.
That said, with respect to clinical commissioning groups I say to my noble friend Lord Willis that the department has published Developing Clinical Commissioning Groups: Towards Authorisation and that, to be authorised, a CCG will need to demonstrate that it has in place the systems and processes both to promote patients’ recruitment to and participation in research, and for funding the treatment costs of patients taking part in research, so this will not be overlooked. However, we are clear that an annual report, business plan, commissioning plan or annual assessment should provide an assessment of all the body's functions, including the exercise of its innovation and research duties. There is also nothing to prevent the documents going into significant detail about the exercise of a specific duty. I add that the board has the power to issue guidance to CCGs on the contents of commissioning plans and directions as to the form and content of the annual report. I hope that those remarks are helpful in answer to the questions and points from noble Lords, and that they will be sufficiently reassured by what I have said not to press their amendments.
Baroness Thornton
I thank the Minister for those remarks and all other noble Lords for theirs. This has been a very high-quality, expert debate. I do not want to delay noble Lords from their supper and, indeed, on this side, from an opportunity to defrost—we have hypothermia on this side. The Committee has again shown its great expertise, commitment and enthusiasm to innovation and research and there is great consensus across the Committee about this. This suite of amendments would have given practical action and voice, and would have strengthened this part of the Bill on innovation and research. We need to look at what the Minister has said. I am grateful for those areas where he said that he would reflect upon these issues and let us know. However, it is safe to say that because of the consensus in the Committee on these issues, we would all be keen to make sure that the issues of innovation and research are, indeed, put beyond doubt in this Bill. I beg leave to withdraw the amendment.