(7 months ago)
Lords ChamberMy Lords, I fully recognise the point that the noble Baroness has just made. My right honourable friend the Minister for the Cabinet Office is preparing to engage with members of the infected and affected communities at the beginning of May in a succession of meetings. Further than that, we agree that it is critical for those infected and affected to have a role in the infected blood compensation authority itself. We intend to utilise the provision for committees and sub-committees to make sure that the community is represented on these groups. It is right that the exact committees and board make-up is defined once the shadow body is established, with the input of the infected blood community. The message I would give is that we want to work collaboratively with stakeholders to achieve the right outcome.
My Lords, this has been an unimaginable tragedy, and we must move to compensate those who have been affected by it as quickly and as well as we can. One part of it is worth thinking about, which is trying to ascribe malign intent to those who were involved in giving this product in the hope that it would stop the bleeding and potential death of children. That was the intent in using factor 8 at the time. It had tragic consequences and many mistakes were made, but we must not assume malign intent on the part of the people involved.
The noble Lord makes a very good point. For me to comment further would be wrong. What we need to do is wait for Sir Brian Langstaff’s final report on 20 May, which should, we expect, reveal some of the underlying facts that the noble Lord alluded to.
(9 years, 8 months ago)
Lords ChamberMy Lords, I hope your Lordships will allow me just one minute. I do not intend to oppose this Bill, but in Committee I expressed some concerns about the possible unintended consequences of Clause 1. In fact, I have withdrawn an amendment I had intended to move that would have tried to mitigate some of these consequences by pointing to a rather better way of avoiding harm to patients by proper education, training and supervision within hospitals and care homes which would lead to a continuing, progressive reduction in harm but without stifling innovation. I withdrew my amendment because I was told that I would cause the Bill to fall and I have no intention of doing that. But I do hope, at least, that the noble Earl will be able to offer some reassurances on the points that I have raised.
My Lords, I understand concerns that noble Lords have raised about the Bill potentially stifling innovation and openness. I assure noble Lords that this is in no way the intention of the Bill. Indeed, the Bill does not place any requirements on providers of healthcare and adult social care registered with the Care Quality Commission. This is achieved through regulations and the associated guidance issued by the CQC. My officials have been in contact with the Chief Inspector of Hospitals, who would be very happy to meet noble Lords to discuss the content of the guidance to ensure that the CQC’s approach to inspection supports continuing reductions in avoidable harm, innovation and supervision and training of staff.
(9 years, 8 months ago)
Lords ChamberMy Lords, I listened extremely carefully to what the noble Earl has just said and I am grateful to him for clarifying what a registered person is—I think that it is the word “person” that gets very personal here. I remain somewhat concerned about whether legislation to stop avoidable harm is a feasible proposition.
(9 years, 8 months ago)
Lords ChamberMy Lords, I congratulate the noble Lord, Lord Turnberg, on securing the debate and raising this issue. I am acutely aware that access to treatments for patients with a rare disease is of great importance to him and many others. We have had some excellent contributions from noble Lords this evening.
The Government are committed to improving the life of all those affected by rare disease. The UK is a recognised leader in research, treatment and care for rare diseases. We are at the forefront of the genomics revolution, which has the potential to radically transform the way that we diagnose and treat people with rare conditions. The UK strategy for rare diseases, which my noble friend Lady Bottomley kindly mentioned, is a high-level framework that sets out our strategic vision. I am sure she will know that raising awareness of rare diseases is a key aim of the strategy. To that end, the department has worked with Health Education England to produce two videos: one aimed at parents and patients, the other aimed at healthcare professionals, particularly GPs. These were launched last week at the Rare Disease Day event, which the noble Lord, Lord Walton, referred to.
I was interested to hear about lymphangioleiomyomatosis, or LAM. Access to treatment for that condition, as for others, is based strictly on clinical need, as set out in NHS England’s published clinical policies, irrespective of tariff arrangements. The key in so many cases such as this is what is often referred to as the diagnostic odyssey—the delay that patients experience before getting a diagnosis.
I listened with huge interest to the noble Lord, Lord Rogan, talking about ITP. The UK Strategy for Rare Diseases sets out our strategic vision for improving the lives of all those affected by rare diseases, including ITP, the autoimmune disease. He will be impressed to know that my officials furnished me with an extensive note on ITP as he was speaking.
NHS England has been charged with taking forward many of the strategy’s commitments and in the Five Year Forward View it sets out a contextual backdrop for the strategic work during the next few years. Due to their rarity and their low patient populations, services for rare conditions in England are directly commissioned nationally by NHS England as specialised services. I am sure that the noble Lord, Lord Patel, will agree that commissioning these services nationally means that NHS England can commission each service to a single national standard with single national access criteria. It ensures that patients have the same access to specialised services regardless of where they live in England. NHS England has made significant progress in developing a set of nationally consistent service specifications and commissioning policies which ensure equity of access to high-quality services across the country.
Since April 2013, the National Institute for Health and Care Excellence, or NICE, has been responsible for the evaluation of selected high-cost, low-volume drugs under its highly specialised technologies programme, as has been mentioned. This plays an important role in ensuring that commissioning decisions are based on a robust and thorough assessment of the available evidence. NHS commissioners are legally required to fund treatments recommended by NICE in its highly specialised technologies guidance. Until NICE’s guidance is available, commissioners make their funding decisions based on the available evidence.
Topics are referred to that programme by Ministers, following a topic selection process that is overseen by NICE. At the core of the topic selection process is a set of prioritisation criteria that are used to determine whether a topic is suitable. These criteria are published on NICE’s website. The process for deciding which topics to refer to NICE is carried out with as much transparency as possible and includes consultation with stakeholders once a topic has passed the early stages of the process. However, it must be recognised that some degree of confidentiality is required, particularly early on in the process, as information on new drugs can be commercially sensitive before they are licensed. The noble Lord, Lord Turnberg, might be interested to know—as he was asking me about this—that NICE has recently taken steps to improve the level of transparency in the topic selection process, and has begun to publish more detailed information about the rationale for its topic selection decisions.
NHS England’s Clinical Priorities Advisory Group formulates recommendations on commissioning of new treatments for rare diseases in England. In order to ensure that the maximum number of patients benefit from innovative treatments coming on stream, hard choices need to be made about which of these to fund routinely. Patient groups asked NHS England to consult on changes to the principles and processes by which it makes these decisions. At its board meeting on 17 December, NHS England decided that a 90-day consultation would be carried out on the prioritisation framework and decision-making process that NHS England should use to make commissioning decisions on new treatments and interventions. The length of that consultation period reflects the importance of these decisions and the advice received from patient groups. The decisions on prioritisation will not be completed until the consultation has closed and the responses have had due consideration. The consultation was launched on 27 January, and it is open for responses until 27 April.
In carrying out its public consultation, NHS England will ensure that the principles and processes for making these decisions are well informed, evidence-led and in line with the expectations of patients and the public. I am sure that the noble Lord, Lord Turnberg, will agree that it is important that NHS England has a robust decision-making process in place and that that process must be followed to ensure that NHS England is treating all patients with rare diseases fairly.
I just wanted to check that the Minister is aware that there are no fewer than seven serial committees that it has to go through. That does not seem very efficient.
I note that point, my Lords, and I will reflect carefully on it. If NHS England has a comment to make, I shall be glad to write to the noble Lord about that process.
Clearly, once the prioritisation consultation finishes, and in the light of NICE assessments, NHS England will take stock of its position in relation to new treatments.
Our priority must always be to ensure that patients with rare conditions have access to new and effective treatments on terms that represent value to the NHS and the taxpayer. I am sure noble Lords will agree that it is very important that NHS England has a robust decision-making process in place and that, as I have described, it makes sure that all patients with rare diseases are treated equitably.
I also recognise that it is vital that we speed up the discovery, design and take-up of new, innovative 21st-century medicines and treatments in the NHS. We will continue to work with industry and our European partners to increase access to these innovative medicines for patients with rare conditions. In April last year, we launched the early access to medicines scheme, which aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation, or licence, when there is a clear, unmet medical need. More generally, our Strategy for UK Life Sciences sets out an ambitious, long-term programme of action to improve the wider environment for health life-sciences companies and overcome the barriers that prevent discoveries being translated into commercial opportunities and new treatments with real benefits for patients.
The noble Lord, Lord Rogan, stressed the importance of research. Undertaking research into rare diseases requires effective partnerships between patients, their families, clinicians, researchers and industry. Of course, health research holds the promise for breakthroughs and improvements in the way that we diagnose and treat people with rare diseases. For example, the NIHR’s world-class Rare Diseases Translational Research Collaboration, launched in parallel with the UK rare diseases strategy, is just about to start 14 new projects. We also want to make it faster to start rare disease research in the NHS. That is why we asked the Health Research Authority to bring in a new single approvals process. This will speed up access for patients to new and effective treatments.
I will cover as many questions as I can in the time available. My noble friend Lady Thomas referred, very powerfully, to the value of hydrotherapy and the importance of appropriate equipment being commissioned by CCGs. As she will know, CCGs are autonomous statutory bodies. Decisions are made locally but I am happy to look into the matters she raised and will write to her on what I fully agree is a very important issue.
The noble Lord, Lord Patel, asked about the successor arrangements to AGNSS. Responsibility for evaluating the use of new and existing highly specialised medicines and treatments within the NHS in England transferred from the Advisory Group for National Specialised Services—AGNSS—to the National Institute for Health and Care Excellence in April 2013. So far, that is working satisfactorily. However, there is the other group—the Rare Diseases Advisory Group—which was referred to by the noble Lord, Lord Walton. Where does that fit it? In terms of rare diseases and highly specialised services, the RDAG makes recommendations to NHS England and the devolved Administrations on issues related to highly specialised services. Its further role is to have an overview across the four countries on the development and implementation of the UK strategy for rare diseases and highly specialised services. It makes recommendations to the Clinical Priorities Advisory Group about how highly specialised services should be commissioned.
The noble Lord mentioned the cancer drugs fund, which has helped more than 60,000 people with cancer to get life-extending drugs that would not otherwise have been available to them. NHS England is now responsible for the operational management of the fund. It is currently working to ensure the very latest, most clinically effective drugs can be made available to patients. We will carefully consider with NHS England what arrangements should be put in place for the fund in the longer term.
The noble Lord, Lord Turnberg, questioned the inconsistency in funding arrangements for different conditions. He mentioned tuberous sclerosis and kidney tumours. Over the next few weeks, the six programmes of care responsible for advising NHS England on specialised services will draw up the work programme for 2015-16, which will include developing a number of policies. Two policies—one for the provision of everolimus for tuberous sclerosis complex-related renal angiomyolipoma and the other for subependymal giant cell astrocytoma or SEGA—will be considered for inclusion in this process.
The noble Lord asked about commissioning through evaluation. That programme was established by NHS England in 2013 as an innovative mechanism to capture further evaluative data and I will write to him further about progress on that front. As regards negotiation on patient access schemes, companies that are members of the pharmaceutical price regulation scheme have the opportunity to propose a patient access scheme to improve the cost effectiveness of their drug, as part of a NICE appraisal. Departmental officials stand ready to meet with any company that wishes to discuss its options.
Time has run out. I conclude by saying that I am committed—indeed, the Government are committed—to ensuring that patients with rare conditions get the same quality, safety and efficacy in medicines and other treatments as those who have more common conditions.
(10 years, 1 month ago)
Lords ChamberI accept entirely what my noble friend has said. The surgical aspects of the Bill are quite tricky.
My Lords, this large group of amendments, all in their own separate ways, seek to ensure that patients are protected against negligent or irresponsible treatment. As we have heard, these amendments take many different approaches in seeking to achieve essentially the same goal. The Government are absolutely committed to safeguarding patients. That is why my right honourable friend the Secretary of State for Health asked Sir Bruce Keogh, the medical director of NHS England, to work with the medical profession to devise a package of amendments that would make this Bill safe for both patients and doctors. Like my noble friends Lord Kirkwood and Lord Cormack, I take this opportunity to commend my noble friend Lord Saatchi for listening to concerns and agreeing to table the amendments recommended by Sir Bruce Keogh in full.
I now address the amendments themselves. On Amendments 1, 7, 17 and 33, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in the way proposed. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make it complicated for doctors to follow and less flexible to individual patients’ circumstances. That was well exemplified by the exchange that we have just heard. This might limit the Bill’s usefulness to patients and doctors alike. I say to the noble Lord, Lord Turnberg, that there is no question of the Bill applying to unregulated practitioners: it applies to doctors. In answer to the noble Baroness, Lady Wheeler, about what constitutes an appropriately qualified doctor, we believe that to define the required level of experience and expertise would create an overly burdensome requirement on doctors looking to innovate responsibly. A requirement that a doctor is appropriately qualified provides a sufficient safeguard to patients. New Clause 1(3)(b) requires the doctor to take full account of the views of an appropriately qualified doctor in a way in which a responsible doctor would be expected to do.
The provisions in Amendment 7 outlining the process that a doctor must follow to reach a responsible decision are largely addressed by my noble friend Lord Saatchi’s Amendment 12. The provisions in Amendment 7 which require doctors to consult a specified range of other doctors are too restrictive and would make the Bill complicated for doctors to follow. My noble friend’s amendment for doctors to take full account in a responsible way of the views of one or more appropriately qualified doctors in relation to the treatment is less burdensome and is a better equivalent to the existing law.
The noble Lord, Lord Pannick, raised concern that a responsible decision under the Bill is defined as relating to the process rather than the substance of the decision. I listened very carefully to that point. The steps that a doctor has to take under new Clause 1(3) include taking account of substantive factors as well as process. This includes taking full account in a responsible way of the views of one or more other doctors about the proposed treatment. In addition, the doctor must consider the risks and benefits of the proposed treatment as compared to other treatments and to not carrying out any treatments at all. This strays outside the realm of process.
The Government’s view is that it is not necessary in this Bill to require doctors to record their innovation in medical records as set out in Amendments 7 and 15. The General Medical Council’s Good Medical Practice guidance already sets out requirements on doctors to record their work clearly in clinical records, including clinical decisions made and discussions with patients. On Amendment 19 and the related Amendment 34, the Government believe that requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent is not the right approach. This is too bureaucratic and risks deterring doctors from innovating. As regards the idea put forward by the noble Lord, Lord Winston, that there should be some sort of oversight by a clinical or research ethics committee, that would add a very significant level of bureaucracy. Considering the time it would probably take to receive a response, it would act as a barrier to innovation. As the noble Lord knows, research ethics committees are specialists in considering research proposals and would not necessarily be qualified to comment on innovative clinical practice. They do not necessarily have universal coverage and they would not necessarily have the requisite knowledge to advise doctors on very specialised innovative new practices.
However, I have heard the legitimate concerns of noble Lords today, and I commit on behalf of the Government to explore this issue further and constructively with the relevant professional bodies. It will clearly be helpful to understand, should this Bill become law, what might be useful in terms of record keeping and reporting in relation to medical innovation. Furthermore, I commit to ensuring that any guidance that may be appropriate is developed and made available in a timely manner. I hope the intention to issue guidance will be of help to my noble friend Lord Kirkwood.
Amendments 12, 14, 18 and 21 seek to ensure that consent is sought and that proper consideration is given to the views of the patient. My noble friend Lord Saatchi’s Amendment 12 ensures that to fall within the Bill a doctor must obtain any consents required by law. This amendment also ensures sufficient protection for the views of the patient. Furthermore under the existing law of consent patients already have the right to information about the testing and treatment options available to them.
The noble Baroness, Lady Masham, posed questions about drugs. She asked me whether the NHS would pay for unapproved drugs or whether the patient would have to do so. It is worth noting that nothing in the Bill allows doctors to bypass any processes or requirements set by the trust that they are working for. This would include ensuring that the trust would fund any treatment if it were to be provided within the National Health Service. She was fearful that this could result in a two-tier health system in which a patient would be required to pay for innovative treatment. The Bill does nothing to alter funding arrangements for accessing innovative treatments within the NHS, as I have said. That will be governed by whatever rules apply in the trust concerned. However, the Bill also does not change the ability of patients to pay for private medical treatment, as they are able to do now.
I am sorry to interrupt the Minister’s flow. Does he not think that that is confusing for doctors in an emergency situation, wondering which route to take and about the options at that stage, rather than just getting on with the job?
Personally, no, I do not—although my noble friend may choose to address that point. I believe that what initially motivated my noble friend to introduce the Bill was a perception on his part that there are doctors out there who are afraid to innovate, and perhaps afraid to innovate even on the spur of the moment, for fear of being litigated against. If that situation were to apply, that doctor could regard the Bill as a useful way forward. I do not think that that poses any confusion, because my noble friend is proposing to bring the Bolam test forward, as he has clearly explained, so that the essence of the principle that the courts look at would apply in whichever course the doctor chose to take.
The noble Baroness, Lady Wheeler, made a point about conflict of interest. The Bill makes it clear that the doctor will be protected from a successful claim in negligence only where they have reached a responsible decision. That includes a requirement to consult with one or more appropriately qualified doctors. In choosing which doctors would be most appropriate to consult, a doctor would need to be confident that their views would enable him or her to reach a responsible decision in order to benefit from the protection offered by the Bill. Just to make the point absolutely clear, I say that the Bill does not change the law of consent in relation to children or people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.
Amendment 10 would add a requirement on doctors to act in manner that is reasonable and proportionate. My noble friend Lord Saatchi’s Amendment 11 would ensure that a doctor must be acting responsibly in an objective sense when making a decision to depart from the existing range of accepted medical treatments for a condition. Under the law of negligence, “reasonable” and “responsible” have the same meaning. Therefore, the Government’s view is that Amendment 10 is unnecessary.
Amendment 24 would clarify that doctors would not have to follow the steps of the Bill in an emergency. My noble friend Lord Saatchi’s Amendment 29 ensures that it is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the existing Bolam test, as I have just explained. There is no requirement to follow the Bill.
My noble friend’s package of amendments ensures that the Bill comes as close as possible to achieving the policy intent of bringing forward the Bolam test to before treatment is carried out. The amendments would do this in a non-bureaucratic way by avoiding the creation of new approval structures or alteration of the remit of existing groups such as multidisciplinary teams. They provide a critical safeguard in ensuring that there is both expert peer review of the doctor’s proposal and that the doctor acts responsibly. The Bill would not provide any protection to a doctor who carried out an operation or procedure negligently. The Government would not support any Bill that sought to prevent patients who receive negligent treatment from seeking compensation or which sought to remove the requirement of doctors to behave responsibility and in the best interests of their patient.
I will turn briefly to the questions put to me by my noble friend Lord Kirkwood. First, he asked me whether the Bill would apply to pharmacists who dispense medicines. The Bill applies to a decision by a doctor to innovate, which would include a decision to prescribe an innovative medicine. The Bill does not impact on the reliability of a pharmacist who provides a patient with a medicine in accordance with a doctor’s prescription.
My noble friend also asked whether the Bill would apply in Scotland. It would apply in England and Wales but not Scotland or Northern Ireland. Medical negligence law is within the legislative competence of Northern Ireland and Scotland, but not Wales. He also asked me whether there is a conflict between the Bill and the common law. Under both the Bill and the common law a doctor will not be negligent if they have acted responsibly. The Bill, so far as possible, brings forward the common-law Bolam test, as I have explained, to before the doctor offers treatment. There is therefore no conflict between the requirements under the Bill and the common law. The Bill simply offers doctors a way to demonstrate and be confident before providing treatment that they have acted responsibly and thus not negligently.
As regards the cost of implementing the Bill, which my noble friend also asked me about, my reply to him at this stage is that there is not sufficient evidence for us to arrive at a cost figure. The impact of the Bill is by its very nature hard to predict.
I hope that noble Lords will accept my noble friend’s package of amendments in this group—that is to say, Amendments 8, 9, 11, 12, 16, 20, 25, 26 and 27. It is the Government’s view, based on medical and legal advice, that together these amendments do all that is necessary to protect patients, while freeing doctors to innovate responsibly without undue bureaucratic burden.
My Amendment 36 has a similar effect to that of Amendment 35. Mine seems somewhat simpler, but I am quite happy to bow to Amendment 35 in the name of the noble Lord, Lord Saatchi.
My Lords, this group of amendments addresses how the Bill would come into force. My noble friend Lord Saatchi’s Amendment 35 would ensure that the Bill came into force in accordance with regulations made by the Secretary of State rather than on Royal Assent as under the Bill as introduced. This would allow the Government and the medical profession time to prepare for the changes to the law made by the Bill—for example, to produce any guidance that might be helpful. This amendment also enables transitional and saving provision to be made if necessary. My noble friend’s Amendment 35 achieves the same objective as Amendment 36, which the Government therefore do not consider necessary.
The Government also support minor technical Amendments 37 and 38, which clarify that the section in question comes into force on the day on which the Act is passed. I urge noble Lords to accept Amendments 35, 37 and 38, which would ensure a smooth commencement of the Bill, and I hope that my noble friend Lord Kirkwood will allow me to write to him on the question that he posed a minute ago.
(10 years, 4 months ago)
Lords ChamberMy Lords, there seems to be little doubt that waiting lists will grow. Is the noble Earl aware of the recent King’s Fund report, The NHS Productivity Challenge, which shows that the share of the national cake for the NHS, which was above 8% in 2009, is now about 7% and is set to fall to around 6% by 2021. Is there any justification for reducing the share of GDP for health services?
My Lords, the noble Lord knows of the economic constraints that this country has to contend with at the moment. Despite that, the Government are increasing the NHS budget over the course of this Parliament by £12.7 billion. That should indicate to the noble Lord the priority that we are giving to the NHS.
(10 years, 4 months ago)
Lords ChamberMy Lords, I thank the noble Lord, Lord Hunt, for giving us the opportunity to debate a particularly interesting subject and for having elicited a number of very well informed speeches. In calling for this debate, he has done the House a considerable service by enabling noble Lords, including myself, to bring ourselves up to date on what progress has been made in the development of the polypill concept. As has been said, heart attacks and strokes are major health issues in the western world and a growing issue in the developing world. Reducing mortality for people with cardiovascular disease and improving their outcomes is a key priority for the Government. We have made it clear, through the NHS and public health outcome frameworks and the Government’s mandate to NHS England, that we want to see action taken across the health system to reduce avoidable premature mortality from cardiovascular disease.
The 2013 call to action on premature mortality set out the Government’s ambition for England to be among the best in Europe in tackling the leading causes of early death, including cardiovascular disease. In April this year, we published Living Well for Longer, which brings together what the health and care system will do to meet this challenge.
There has been a great deal of interest in the polypill and its potential for reducing the risk of heart disease over the years. It may surprise some noble Lords that the concept was first introduced into the scientific and public domain as far back as 2003. It was proposed in an article in the British Medical Journal by two people whose names have been mentioned already, Professors Nicholas Wald and Malcolm Law of the Wolfson Institute of Preventive Medicine. Using mathematical modelling, they estimated that a polypill comprising a statin, aspirin, a combination of three blood pressure lowering drugs and folic acid, could reduce heart disease events by 88% and stroke by 80%. Their article concluded that their proposed polypill could,
“largely prevent heart attacks and stroke if taken by everyone aged 55 and older and everyone with existing cardiovascular disease.”
Although the effectiveness of the combined drug and any possible side-effects had yet to be evidenced though patient trials, this captured the imagination of the public health research community, particularly for the prevention of non-communicable diseases such as cardiovascular disease.
Essentially, the polypill is a combination of multiple medicines which aims to prevent or reduce the risk of cardiovascular disease: that is, strokes and heart attacks. Each of the constituent medicines is either at the current recommended dose or at lower doses. The premise is that these combinations should be used in preference to using the same medicines separately. In practice, the polypill can refer to either the fixed-dose combination medicine to reduce cardiovascular risk, patented as the polypill, or any other fixed-dose combination medicine, such as the red heart pill. However, any discussion of polypills is complicated by the huge range of drugs which might be included in any combination.
Polypill active ingredients are licensed separately as medicines and well established in their own right; their use together in fixed combination is what is novel. Just like any other medicine, any application for a marketing authorisation for a polypill needs to be supported by data demonstrating that its quality, safety and efficacy are satisfactory and that the risk-to-benefit profile is favourable for the proposed treatment before such an authorisation or licence can be granted.
My noble friend Lady Brinton drew attention to the side-effects of polypills and statins. She was absolutely right to do so. My information is that the evidence is not yet there on the side-effects of the polypill. Patient safety must of course be paramount in that context.
No polypills are currently licensed for use in the UK for the prevention of heart attack or stroke. I understand that the Medicines and Healthcare products Regulatory Agency has provided scientific advice to a number of sponsors and companies for combination products of this type. However, no application has yet been made to the licensing authorities. In the event that a marketing authorisation proposal is submitted, the data supporting any claims for benefit in the stated patient population, together with any evidence of adverse events, will be carefully reviewed. Only if the overall balance of benefits versus risks is favourable will a marketing authorisation be granted.
Without a marketing authorisation, as the noble Lord will know, doctors can prescribe an unlicensed medicine under their own professional responsibility. That addresses one question raised by the noble Lord, Lord Turnberg, as to whether it is in theory available on the NHS. The answer would be yes, in those circumstances, but any national action to promote the use of a drug that is not licensed is out of the question, as I am sure he is aware. I understand that there are several clinical trials of polypill products in progress in various countries and it will be interesting to see the results.
The noble Lord, Lord Hunt, questioned whether it was the fear of additional workload that was deterring doctors in the context of the polypill. My information is that the evidence on that front is as yet unavailable one way or the other, as regards the primary prevention setting, but that clinical studies are now under way. Indeed, I have in front of me the details of three polypill phase 3 clinical trials which had either completed or were close to completion as of May 2014. I can let the noble Lord have details of those trials if he would like me to do so.
The noble Lord, Lord Turnberg, raised the possibility that the polypill could be prescribed to those people who do not fall into the risk group. That is, of course, the primary prevention group. I am advised, though, that as age advances, the risk of side-effects also increases proportionally. I suggest that before embarking on a course of this nature, we would need evidence that the polypill influences benefit more than risk. We therefore come back to the issue of clinical trials in order to demonstrate that.
Having said that, to answer another of the noble Lord’s questions, I accept that the polypill could be more convenient for some patients and could help them to adhere to their medicines. Whether it would prove cost-effective is something that NICE might in due course consider.
I know that not everyone is convinced by the polypill. There are, for instance, concerns about the medicalisation of otherwise healthy people. Even by its proponents it is seen as secondary to other forms of prevention. Professor Wald himself is quoted as saying:
“This is not the solution for primary prevention … Primary prevention requires education of the public. As a priority this is much more important than any polypill”.
There is a range of population-based interventions that could be put in place to reduce the risk of cardiovascular disease. Each has its pros and cons and may be suitable for some patients and in different circumstances. We know that many premature deaths and illnesses could be avoided by improving lifestyles. The Government’s public health programme includes national ambitions to reduce smoking, obesity, physical inactivity and the harmful use of alcohol—all with appropriate metrics included in the public health outcomes framework.
In addition, through the NHS Health Check programme people between the ages of 40 and 74 are offered a range of tests that include measuring their cholesterol and blood pressure levels. The check has been designed primarily to help healthcare professionals identify cardiovascular risk in the adult population earlier so that steps can be taken to reduce it, but it is worth emphasising that it is also targeted at a range of other conditions.
All 152 local authorities are now offering the NHS Health Check programme, which is a significant milestone in the programme’s evolution. In 2013-14 a total of 2.8 million people—almost 20% of the eligible population—were offered an NHS health check, and just over 1.4 million of them received one, giving a take-up rate of 50%. This is the greatest number of NHS health checks offered and accepted in one year since the programme began.
That is all extremely credible. However, the polypill is aimed at those who have passed the health check with flying colours—that is, they have normal cholesterol and blood pressure, do not smoke and are not overweight. It is with this group of individuals, who are not suspected of having the liability to develop a heart attack or stroke, where it seems to have its place.
Again, that is the primary prevention group, and the point that I was seeking to convey earlier was that we would need evidence that the benefit-to-risk ratio was sufficiently positive before proceeding down that course. That is not to say that it is not, but there is work to be done to prove it.
In March 2013 the Cardiovascular Disease Outcomes Strategy was published. This set out possible actions within the current legislative framework, systems architecture and financial settlement to deliver improved outcomes for people with CVD. It set out a framework for 10 actions that would make a real difference in improving outcomes for patients and their families. While I could expatiate on that subject, I am told that my time is drawing to a close, so suffice it to say that I hope that noble Lords have found today’s debate as interesting as I have.
The polypill is certainly an interesting concept. It may be that this type of approach would be more suitable in developing countries, where the real epidemics of cardiovascular disease are building up and where clinical trials are taking place, rather than in a more sophisticated healthcare system such as ours, where prevention and tailored therapy are more the norm. Time will tell.
On the issue of market failure, which was introduced by the noble Lord, Lord Hunt, I am not convinced that the same arguments apply to the polypill as apply to antimicrobials. For one thing, there are a number of clinical trials of polypills in progress, as I mentioned, and the MHRA has provided scientific advice to a number of companies, so clearly there is commercial interest out there. We do, however, welcome any technologies that contribute to providing the best treatment for people with cardiovascular disease.
In answer to the main question of the noble Lord, Lord Hunt, of whether the Government will consider playing a more active role in this debate, I would certainly be interested in looking at the noble Lord’s proposals in more detail and would be happy to discuss the matter with him at a suitable moment. With that, I thank him once again for introducing this extremely interesting topic for our consideration.
(10 years, 4 months ago)
Lords ChamberMy Lords, I am pleased to say that the number of specialist nurses for multiple sclerosis in the UK has risen from 80 in 2002 to 245 currently. I hope that my noble friend will agree with our view that local healthcare organisations, given their knowledge of the healthcare needs of their local populations, are the people best placed to determine the workforce needed to deliver safe and effective patient care within the available resources. However, it is of interest that NHS England’s service specification for specialised neurology does specify that nurse specialists should be involved in the care of people with multiple sclerosis.
My Lords, 11 drugs are now available for remitting and relapsing multiple sclerosis, three or four of which have been approved only in the past two or three months, which is great news. Is there any chance that these new drugs will be included in the risk-sharing initiative with industry?
My Lords, I think that the answer is almost certainly no because the risk-sharing scheme initiated under the previous Government is quite complex to administer and we would need to be persuaded that the administrative burdens associated with it were worth while. Now that we have the NICE process, it is probably best that NICE should look at these drugs in the context of its new clinical guideline, which is what the stakeholder groups thought was preferable.
(10 years, 5 months ago)
Lords ChamberMy Lords, I pay tribute to the National Rheumatoid Arthritis Society, which is organising Rheumatoid Arthritis Awareness Week this week, between 16 and 22 June. I am aware that Public Health England has run early diagnosis campaigns, which up to now have focused largely on cancer. However, I understand that a broader focus on earlier diagnosis is currently being considered. What might be done to tackle other conditions or symptoms has yet to be decided, but I will keep the noble Baroness informed of developments.
My Lords, one of the problems is that there are still far too many single-handed general practices, which have great difficulty providing a full range of services. Are the Government doing anything to try to bring them into bigger groupings?
My Lords, we are encouraging single-handed practices not to disband but to federate themselves—if that is a good word—with other practices in the area, and certainly to seek the support of their clinical commissioning group. That would ensure that the range of professional training available is utilised and that there is peer support where appropriate. Therefore, while many single-handed practices do a very fine job, there is scope for them to collaborate with their colleagues in the local area.
(10 years, 5 months ago)
Lords ChamberMy Lords, is the noble Earl aware that we have one of the highest rates of bed occupancy in the EU, approaching 90%, and yet we have the lowest average length of stay? All this makes it extremely difficult to think about reducing bed numbers still further.
In fact, average annual bed occupancy rates have been stable at around 84% to 87% since 2000. Of course, that rate goes up and down. We know that winter sees greater pressure on bed occupancy, but the NHS has long experience in managing peaks in demand, particularly over the winter. We do not set optimum bed occupancy requirements on the NHS. As the noble Lord knows well, that is a matter for the local NHS to manage.
(10 years, 6 months ago)
Lords ChamberMy Lords, as regards specialist nurses, the Government have supported the development of a range of specialist roles within the profession. In the end it is for local NHS organisations, with their knowledge of the needs of the local population, to invest in training for specialist skills and to deploy specialist nurses. We recognise that more could be done by some local healthcare organisations in this area, and Health Education England is able to support employers with continuing personal and professional development—but within clear limits. The planning process has created an opportunity for employers, through the LETBs—local education and training boards—to prioritise investment in this area.
My Lords, the number of nurses may have gone up a little, but the main problem is the marked reduction in the number of senior nurses on wards. These are the women and men who are in charge of a ward and make sure that care is properly delivered at the ward level. Does the noble Earl consider that this particular loss is because we do not reward and value these key individuals well enough to recruit or retain them?
My Lords, as the noble Lord will be aware, finances in the NHS are tight. However, as I said earlier, there are now 5,100 more nurses on our wards than there were in May 2010. That must indicate that nursing is still an attractive profession for the brightest and the best of our young men and women.
(10 years, 8 months ago)
Lords ChamberYes, my Lords. As ever, the noble Baroness makes an extremely good point. It is heartening that infection rates have come dramatically down in hospitals over the past few years, but we can never be complacent and it is important that when a patient is moved the infection question is always considered.
My Lords, is it not the case that we have the lowest number of beds per head of population of any OECD country, bed occupancy rates of approaching 90%—a dangerously high level—and, despite all that, the shortest lengths of stay of any European country? Does the noble Earl agree that the idea of closing wards or hospitals can only worsen the situation, unless, of course, we are able to build up the community services before we do any of that?
I agree with the principle that the noble Lord has articulated. Certainly, commissioners and providers of care should reduce beds only where it is clinically safe and appropriate to do so. The NHS is very experienced at flexing the number of beds it has available; it does this every year and every winter. As a principle, I would agree with the noble Lord but I come back to the point that bed occupancy rates have, in fact, remained stable over the past 10 years, fluctuating between 84% and 88% on average, and increasing slightly over the winter period.
(10 years, 8 months ago)
Lords ChamberThe noble Baroness is quite right. Helping commissioners to reduce unwarranted variation in service delivery is one of the key roles of the maternity and children strategic clinical networks, as I am sure she is aware, which are being established and supported by NHS England. Clinical commissioning groups are responsible for commissioning maternity services locally, but they work with local authorities and in conjunction with provider partners to give assurance that processes and service specifications are in place which ensure that midwifery staffing is appropriate for the locality.
My Lords, the number of births has gone up by 25% in the past 10 years. The vacancy rate among midwives is about 11%. That is the long-term vacancy rate. There seems to be a problem with recruitment and retention. Despite the figures that the noble Earl has cited, we are in some difficulty.
The noble Lord is right. We recognised that issue at the outset of the Government, which is why we were determined that the number of midwives in training should be increased. It is now at a record number of 6,000. The number of trained midwives is increasing—that is, full-time equivalent midwives practising in the NHS rather than just on the register. We are heading in the right direction, but there is a long way to go.
(10 years, 8 months ago)
Lords ChamberNo, I do not, but it is worth noting that 49 businesses have signed up to the voluntary responsibility deal pledge on awareness of alcohol units, calories and other information. Those organisations have published calorie information on their websites about every single alcohol product. If one is buying online, it is possible to compare one product with another.
My Lords, is the noble Earl aware that alcopops are rearing their heads again? These sweetened drinks have sugar added to them to make them attractive, in a cynical attempt to bring the young on board to alcohol. They contain more than 170 calories a bottle—about the same as a sweetened chocolate milk drink—as well as the alcohol. Is there anything we can do to bring this to the attention of the supermarkets? I believe Sainsbury’s has alcopops on its shelves now.
My Lords, in fact, sales of alcopops are in marked decline, to such an extent that the market for these products looks like disappearing in the next few years. Nevertheless, I take the noble Lord’s point. It is always a concern if people are putting their health at risk by drinking too much alcohol or consuming too much sugar. At the same time, one should not always assume that an alcopop is a high-calorie drink. For example, ready-mixed gin and tonic is technically an alcopop, but very often low-calorie tonic goes into it.
(10 years, 8 months ago)
Lords ChamberMy Lords, something can be done. First, patient groups can speak up and can speak to commissioners. As I said in my original Answer, we are committed to putting patients right at the centre of services, which means giving them a voice in the services that are commissioned. I am not aware of the situation in the Chelsea & Westminster Hospital, but my noble friend may like to know that there are now more than 3,300 more nurses working on NHS hospital wards than there were in 2010. That is a positive trend.
My Lords, is this not part of a wider problem, in that we have seen a marked reduction over the past few years in specialised nurses working in the community, where they can do so much to help keep patients safe and out of hospital? Should we not be seeing joint funding between the local authorities and the CCGs to fill this gap, which is looming all the time?
Yes, my Lords, that is why we are creating the Better Care Fund, with £3.8 billion worth of shared money between the NHS and social care, starting in 2015, to make care seamless for the patient, whether it is NHS or social care. That fund has scope to do exactly what the noble Lord wishes to achieve.
(10 years, 9 months ago)
Lords ChamberMy Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I declare my interest as scientific adviser to the Association of Medical Research Charities.
My Lords, NHS England’s care.data programme takes forward the ambitions set out in the Government’s information strategy for health and care in England, The Power of Information, published in 2012, in particular elements of chapter 5 of the strategy. The Department of Health strongly supports NHS England’s decision to do more engagement work before data collection takes place. This is a vital programme which will bring real benefits to patients.
My Lords, I am grateful to the noble Earl for his response. Few people doubt that there are enormous benefits to be gained from patient data, both for the care and treatment of patients at the moment and for research into treatment for future patients. However, does the noble Earl agree that NHS England has been remarkably unsuccessful so far in communicating both the benefits and the safeguards to confidentiality? Does he further agree that it is vital that NHS England uses the next six months, which is the delay, to develop some robust and convincing methods of communicating with the public?
I entirely agree with the noble Lord. This is a vital programme which will bring real benefits to patients. It has major potential benefits for research and public health. It commands generally wide stakeholder support. However, there is no doubt that concerns over how this has been explained to patients have been raised and those concerns need to be addressed. I agree that the next six months will be crucial in pursuing that aim but it is essential that this programme commands public support.
(10 years, 9 months ago)
Lords Chamber
To ask Her Majesty’s Government whether they plan to introduce a vaccine for meningitis B in children.
My Lords, the Joint Committee on Vaccination and Immunisation, the independent expert committee that advises the Government on immunisation matters, has not yet made a final recommendation about the use of the meningococcal B vaccine, Bexsero. The JCVI is due to report in March 2014, having reviewed additional evidence at its meeting earlier this month. We will respond to any JCVI recommendation as quickly as possible.
My Lords, I am grateful to the Minister for that response. Meningococcus B causes a very nasty form of meningitis. It affects about 1,000 cases a year, mostly in children. It kills about one in 10 and causes severe and lasting disability in one in three. It is no wonder that it is a parent’s worst nightmare. Yet the safe and licensed vaccine that can prevent most cases was turned down by the JCVI after what seems to have been rather a doubtful cost-benefit analysis. Will the Minister make sure that when the JCVI comes to look at it again, as it is doing, it uses a more relevant discount value for the quantity and quality of a child’s life; and that once the Government have received the committee’s advice, they will make a rapid decision to make the vaccine available?
I can give the noble Lord an assurance on the latter point. We will take a decision as rapidly as we can once we receive the JCVI advice. I appreciate that the JCVI’s interim position statement will have been disappointing to many people. I know the noble Lord recognises that it is important that decisions about the introduction of new vaccines into the national immunisation programme take account of evidence of their effectiveness, safety and cost-effectiveness compared to other healthcare interventions. We need to wait and see what the JCVI’s final advice is. I am aware that it is looking at the cost-effectiveness methodology that is used for vaccines of this type.
(10 years, 9 months ago)
Lords ChamberMy Lords, it has been a good start for the company. It has generated £22 million from sales of surplus assets and savings of £2 million a year on the running costs of those disposed properties. The company is also harnessing economies of scale—for example, savings to date of £1.2 million by standardising the procurement of electricity across the whole estate. The company is now exploring how to make savings across other utilities and services, such as legal services.
My Lords, following the response to my noble friend Lord Hunt’s question, can the noble Earl tell us why the National Audit Office has decided to conduct an investigation so soon after the establishment of this organisation?
My Lords, the National Audit Office is indeed looking at the company—only to assure us and itself that the company is properly organised and structured. We welcome that, as does the company. There was no sinister purpose or concern underlying that process; it is perfectly normal and natural.
(10 years, 9 months ago)
Lords ChamberMy Lords, I completely agree. The noble Baroness is right that a series of reports has shown that the NHS has too often failed to provide the best possible services to older people. We cannot save lives without tackling inequalities. The NHS has a statutory duty to reduce health inequalities and to improve the health of those with the poorest outcomes. A ban on age discrimination in the NHS services was introduced in 2012, meaning that NHS services need to do everything they can to ensure that they do not discriminate against older people. We will hold the NHS to account for that through the mandate and the NHS outcomes framework.
To what extent are these shocking figures due to lack of funding for cancer services? In that light, what is the Government’s plan for the cancer drugs fund?
My Lords, the noble Lord may recall that the Government pledged an additional £750 million to support the cancer strategy. We are doing that, and a range of actions are proceeding there. On the cancer drugs fund, we initially pledged a total of £600 million for the first three years of the fund and we recently pledged another £400 million, making £1 billion in all. I am pleased to say that the cancer drugs fund has so far helped more than 38,000 patients.
(10 years, 10 months ago)
Lords ChamberI am aware that we have looked at the experience of other countries, but, as I am sure the noble Lord will accept, we need to take a decision on this that is right for all of our population rather than another country’s population. That is why we want to make the decision evaluating risks and benefits based on the most up-to-date data of the folate status of our own population.
My Lords, the case for fortifying flour with folic acid is now incontrovertible. It is both safe and effective in preventing spina bifida. I should like to follow up the question of the noble Baroness, Lady Gardner, about vitamin D fortification, as there is a rising incidence of rickets in children, particularly Asian children, and we really should take that seriously.
The noble Lord is absolutely right. I agree with him that the incidence of rickets is a cause for concern. At the same time, he characterises the case for mandatory fortification as incontrovertible. There are risks that SACN pointed out. Its advice to government stated that fortification of flour with folic acid might have adverse effects on neurological function in people aged 65 years and over with vitamin B12 deficiency. Treatment with folic acid can alleviate or mask the anaemia and therefore delay the diagnosis of vitamin B12 deficiency, which can lead to irreversible effects.
(10 years, 10 months ago)
Lords ChamberMy Lords, from April this year, CCGs and NHS England will begin to identify formally those healthcare services that they consider essential to protect in the event of the financial failure of their providers. They will be required to designate such services as commissioner requested services. In doing so, they must have regard to Monitor’s published CRS guidance. Should an independent provider of CRS get into financial difficulty, then Monitor will work with the provider and relevant partners to determine the right solution.
My Lords, what safeguards are in place to make sure that CCGs do not have a conflict of interest when they contract for services in which they may have a direct involvement?
The noble Lord will, I am sure, remember from our debates on the Health and Social Care Bill that NHS England has published guidance for CCGs on managing conflicts. There is also a duty placed on CCGs to have regard to such guidance and CCGs set out in their constitution their proposed arrangements for managing conflicts of interest.
(10 years, 11 months ago)
Lords ChamberMy Lords, as I said, SACN’s recommendations highlighted both the risks and the benefits of this proposal—and I certainly acknowledge that there would be benefits. However, there are also implications. For example, SACN recommended that mandatory fortification should proceed only if accompanied by:
“Action to restrict voluntary fortification of foods with folic acid; measures for careful monitoring of emerging evidence on any adverse effects of long-term exposure to intakes of folic acid … and guidance on supplement use for particular population groups”.
We have to take those recommendations into account before taking any long-term decision.
My Lords, is the Minister aware of a recent publication that suggests that folic acid deficiency in men, too, may lead to birth defects in their offspring? Is this not another good reason for fortifying flour?
(10 years, 11 months ago)
Lords ChamberMy Lords, I cannot give my noble friend the answer because that is not information that we collect in the department but, as I said earlier to the noble Baroness, Lady Wheeler, we expect consultation to take place in local areas so that patients and the public at least have a chance to voice their views.
My Lords, when these centres were introduced, most people believed that they were a very good thing; I think they still think that. They help to take the load off A&E departments and GPs. Does the noble Earl agree that one of the problems is that there is no overarching co-ordination between A&E departments, GPs and these centres? Furthermore, there are no overarching similar funding arrangements. Should we not do something about that?
Yes, my Lords, and that is exactly why Sir Bruce Keogh has been tasked to look system-wide not simply at walk-in centres but at the entire community and urgent and emergency care network to make sure that patients go where is most appropriate for them, that there is not undue pressure on any single part of the system, and that tariffs reflect the right balance of patient flows.
(10 years, 12 months ago)
Lords ChamberI pay tribute to my noble friend for his championing of this cause. I am sure that the main reason people smoke in cars is that they do not understand how harmful second-hand smoke can be for children. Of course we would like to see smoking in cars carrying children eradicated entirely but, at present, we are not convinced that legislation presents the most effective or proportionate approach. Rather than create new offences, we prefer to promote and encourage positive behaviour change, and there is emerging evidence that we are succeeding on that score.
My Lords, is there any evidence that has not been published and examined in great detail that we have to wait for?
My Lords, it is clear from the debates in the other place and from our debates in Committee on the Children and Families Bill, that there is emerging evidence that needs to be considered. That evidence has emerged since the consultation. I am not in a position to make a judgment on that. I think Sir Cyril Chantler is the best person to do it.
(11 years ago)
Lords ChamberMy Lords, the policy now is that migrants to the UK from outside the European Union who apply for a visa for more than six months need to be screened in the country of origin. That work is proceeding, although I have to say that implementation has proved patchy, so we cannot be complacent. That is why it is vital to have services in this country capable of identifying people, particularly with multidrug-resistant TB, who may pose a threat to the community in that sense.
My Lords, is the Minister aware that the cost of treating multi-drug-resistant TB is £100,000 a year, compared with the cost of £5,000 a year to treat non-resistant TB? We now have a new category of extensively resistant TB, which is even scarier. I hope that Public Health England will treat as a matter of urgency getting a national strategy that brings standards up to those of Homerton Hospital, which is completing treatment of most patients whereas the rest of the country lags behind.
The noble Lord is absolutely right. That is one reason why we are placing a particular focus on research into multidrug-resistant TB and diagnostics in that area. We fund UNITAID, which aims to triple access to rapid testing for MDRTB and to reduce drug prices for treating the condition. We have made a 20-year commitment to UNITAID of €60 million a year, subject to performance.
(11 years, 5 months ago)
Lords ChamberMy Lords, I am sorry to rise again, but I have a very brief question. In a clause dealing with promoting regulatory practice, why is the Secretary of State No. 1?
My Lords, a great many points have been raised in this debate, so I may take a little time to respond. I hope that the Committee will bear with me. Amendments 58B to 62 seek to give the Health Research Authority a stronger role in streamlining the management of research, particularly in the NHS. I am the first to recognise that delays in obtaining research approvals in the NHS remain a problem for many researchers and that there is an expectation that the Health Research Authority will help to improve this situation through its relationship with the NHS.
I also appreciate that noble Lords, particularly in relation to Amendments 61 and 62, seek reassurance that all providers of NHS services will be required to pay attention to the guidance that the authority is required to produce under Clause 98(6). This issue was highlighted by both the Academy of Medical Sciences and the Wellcome Trust during pre-legislative scrutiny of the Bill. The clauses in the Care Bill would give the Health Research Authority a unique, free-standing duty to promote the co-ordination and standardisation of practice in the UK relating to the regulation of health and social care research. At this point I reassure the noble Lord, Lord Turnberg, that the duty of co-ordination and standardisation necessarily involves co-ordinating and standardising the practice of NHS trust research and development committees.
In addition, the Health Research Authority will have a reciprocal duty to co-operate with other regulatory bodies or individuals that have statutory functions in the regulation of health and social care research. Statutory functions are an important point. I take this opportunity to address the three amendments listed here that are concerned with this duty. In doing so, it is important to explain why Clause 98(1) would place a duty of co-operation on the HRA and in particular the Chief Medical Officer of the Department of Health. The reason is that the Chief Medical Officer holds functions relating to research under the Abortion Regulations 1991. These require notice to be given to the Chief Medical Officer of any abortion and any information relevant to it.
The disclosure of such information is restricted, except in specific circumstances, which include disclosure for the purposes of scientific research. The Chief Medical Officer is responsible for determining whether disclosure can be made. It is because of the Chief Medical Officer’s functions in approving the disclosure of information about abortions for the purposes of scientific research that the authority, the Chief Medical Officer and the bodies and individuals listed must co-operate with one another with a view to standardising and co-ordinating practice relating to the regulation of health and social care research. Similarly, other bodies and individuals listed have functions relating to the regulation of health or social care research. So it links in those statutory functions.
I listened with great care and a great deal of understanding to the noble Lord, Lord MacKenzie, my noble friend Lady Cumberlege, the noble Baroness, Lady Emerton, and others on their wish to expand the duty of co-operation to include the Chief Nursing Officer. The Chief Nursing Officer is an NHS England role, while the Department of Health has a director of nursing. Neither of these posts has any statutory functions relating to the regulation of health or social care research. That is the key point. For this reason, Clause 98(1) does not create a duty of co-operation on the HRA either with the Chief Nursing Officer of NHS England or with the Department of Health’s director of nursing and the bodies and individuals listed in Clause 98(1). I hope that this explanation is helpful.
On Amendments 58B and 58C, the medical royal colleges, the General Medical Council, the General Dental Council and the Nursing and Midwifery Council do not have such statutory functions in this context either. The noble Lord, Lord Walton, made an important and powerful point about the GMC. However, the Health Research Authority would have powers, under paragraph 13 of Schedule 7, to work with the GMC and the other medical regulators to help and advise them in their work. That, I hope, will reassure the noble Lord that that aspect of the HRA’s work has not been forgotten about.
Amendment 60A would require the Health Research Authority to assess the impact of proposed changes to the system for setting pharmaceutical prices on health and social care research. I pay tribute to the noble Lord, Lord Hunt, for introducing this extremely interesting topic to our debates. I believe that this function is best undertaken by the National Institute for Health and Care Excellence rather than making it part of the authority’s role in promoting the co-ordination and standardisation of regulatory practice. As he will know, we have already announced that NICE will play a central role in the pharmacoeconomic evaluation of new medicines in the context of the framework for value-based pricing, once that is announced.
The noble Lord made a point about value-based pricing, in that it is important for the Government—I agree with him—to take account of the need to attract investment into this country. As set out in our plan for growth and our Strategy for UK Life Sciences, the Government are absolutely committed to ensuring that the UK continues to offer an environment that supports and encourages investment and innovation by the life sciences sector, and where the NHS is a world leader in clinical trials. However, there are some legitimate points of debate here about the impact of medicine prices on companies’ decisions on where to locate investments or conduct research. As highlighted in the 2007 NERA study, Key Factors in Attracting Internationally Mobile Investments by the Research-Based Pharmaceutical Industry, this is a global market. Companies locate where they can find the best science base at reasonable cost, taking into account other factors such as taxation, flexible labour markets and economic stability. It is not self-evident that the pricing of medicines drives decisions of this kind. It is an interesting debate to have, but perhaps it is one for another occasion.
The noble Lord also asked about the cancer drugs fund. It is very heartening that more than 30,000 patients in England have now benefited from that fund, which in total amounts to £650 million over three and a half years. We are committed to building on that success. In the context of developing new pricing arrangements for branded medicines, I can reassure the noble Lord by saying that we are exploring ways in which new patients can benefit from innovative cancer drugs at a cost that represents value to the NHS. NHS England is very much included in that discussion, and we well appreciate how important it is for patients.
To meet the duty of co-operation in this whole area, the Health Research Authority will be required to take the lead in actively identifying ways in which to remove duplication, streamlining the regulation of health and social care research and seeking to ensure that regulation is proportionate. At this point, I reassure noble Lords that the authority must facilitate all types of high-quality ethical research, including research that is multidisciplinary in nature and research by multiprofessionals. In keeping under review matters relating to the regulation of health or social care research, the authority may provide advice to the Secretary of State and must do so on request. Such advice could include recommendations to improve the regulatory landscape for research.
The existing Health Research Authority, the Special Health Authority, has already begun an ambitious programme of work to speed up the research journey in the UK, including the creation of a unified approval process and consistent, proportionate standards for compliance and inspection. I hope that will be welcome news to the noble Lord, Lord Patel, in particular. In doing so, it is working closely with other bodies, including representation from the NHS, to identify and implement effective solutions to make it faster and easier to initiate research.
My Lords, I heard very clearly a strong message from noble Lords on that point. Indeed, I recognised the noble Baroness’s strength of feeling in our earlier debates on Health Education England. Having noted that strength of feeling, I would like to engage with noble Lords between now and Report to see what avenues we can pursue in this area. I cannot make a specific commitment now, but I am very happy to talk further about these issues.
I bring the noble Earl back to Amendment 60 on the research and development committees of NHS trusts. He made some very reassuring comments about the work that is going on in the HRA to try to unify this area. One of the difficulties at the moment is that the foundation trusts are a law unto themselves to a large extent and jealously guard their independence. I wonder whether we need to strengthen the HRA’s arm by including something about this area in the Bill.
I understand the issue that the noble Lord has raised. There are a number of ways of exercising leverage on foundation trusts, if I can put it in that rather impolite way. One of them relates to the funding from the National Institute for Health Research. The noble Lord may well be aware that as from 1 April that funding is conditional on the 70-day timeline for the recruitment of the first patient into a trial. If that timeline is not met, the funding does not follow. I can tell the noble Lord that that has concentrated minds rather effectively across the health service, including in foundation trusts, towards achieving a much more efficient and effective decision-making process.
I am aware that I did not answer a question from the noble Lord, Lord Patel, about rationalising the number of research ethics committees, which may well bear upon this issue in another sense. The HRA and its predecessor have made good progress in reducing the timelines for ethical approval, something that stakeholders have recognised. The current special health authority feasibility study is looking at how to address other delays whereby trust decisions can be made based on their capacity and capability to take part in research. This is ongoing work. I come back to my point about the core function of the HRA, which is, above anything else, to protect the interests of patients and the public. It might not be advisable to load on to it too many other roles that could detract from that core function.
(11 years, 5 months ago)
Lords ChamberI am sorry to interrupt again. I think the noble Earl said that we should leave it to the local providers to decide what or how much CPD individuals should have. We know, however, that at the moment local providers are very variable in how far they are willing to go along that route. The problem is that leaving it where it is certainly does not give any great confidence that CPD will be uniformly available in the service. Hence the amendment of the noble Lord, Lord Patel, which tries to give a little force and pressure to local providers so that they could indeed be sure that CPD was being provided. The noble Earl is full of good intentions, quite rightly, but we need a little more than that.
I probably expressed the position less than well because I was seeking to indicate that CPD is inescapable. There are a whole host of reasons why providers and the LETBs cannot avoid a focus on continuing professional development. Equally, we do not want to prescribe any kind of ring-fenced budget for CPD, for the reasons we debated earlier: we are clear that we must leave it to LETBs to exercise autonomy in the way that they work out their local education and training plans. They will have to prioritise, inevitably, in certain cases and from year to year. It may be that they will have to make hard choices. The great thing about Health Education England is that, as a non-departmental public body separate from NHS England, it will have a dedicated budget which cannot be eroded by those who might wish to siphon money off to patient care, for example. I hope that, in that sense, the noble Lord, Lord Turnberg, can take some comfort. We are very clear that the prescription is there and that local providers cannot avoid addressing the needs of their employees for CPD, but at the same time we do not want to dictate to them how much to spend on this in any one year.
(11 years, 5 months ago)
Lords ChamberThe problem is that I suspect there to be a conflict. There is a desire to devolve responsibility for education to local education and training boards, which are dominated, of course quite reasonably, by local providers. Their desire is to see a trained workforce in the right numbers, and they will be very interested in workforce planning. There is also a drive at the centre to maintain standards across the country, and so there is tension between the two. The noble Earl set out a number of provisions which will help. The amendments we put down were meant to strengthen that capacity in order for the LETBs to inspire confidence that they fully take account of educational standards and all that sort of thing, as well as the need to provide numbers of doctors, nurses, trainees and everything else.
My Lords, I would rather have a creative tension than a disconnect. If we get this right the tension will be there but it will be mutually reinforcing. You will have accountabilities running in both directions, essentially, from the national to the local and from the local to the national. In the past this has been a notoriously difficult area to get right. We hope and believe that the structure we are putting in place, in which the LETBs are committees of the national body but which have their own autonomy to a certain degree, will ensure that the tension that the noble Lord referred to really is creative, rather than the reverse.
(11 years, 5 months ago)
Lords ChamberMy Lords, there is no doubt that education and training can play an important role in creating a workforce that is research literate and innovative, with the skills required to diffuse the latest ideas and innovations. The noble Lord, Lord Turnberg, has focused our minds on some important goals in this area.
Through our investment in the education and training of health professionals, we must seek to ensure that our future practitioners know how to access evidence, use evidence and contribute to the national research enterprise. Developing a flexible workforce that is responsive to research and innovation is one of the key priorities that the Government have set for the Health Education England special health authority in its mandate. To answer the question posed by the noble Lord, Lord Turnberg, Section 63(1) sets out an objective for Heath Education England to support clinical academic careers.
Amendment 17 would require Health Education England to promote the use of research evidence to ensure the rapid uptake of innovations into practice. Amendment 20 would require it to exercise its functions to secure that research and innovation are incorporated into education and training. Amendment 32 would require it to have regard to the desirability of promoting research and innovation in clinical practice when performing its duties under Clause 85(1) to ensure sufficient skilled workers and Clause 87(4) when setting its objectives, priorities and outcomes for education and training.
The Government recognise very clearly the importance of promoting research and innovation. That is why Clause 86(2) of the Bill requires Health Education England, in exercising its functions, to promote research and the use of evidence from research in education and training activity. In response to stakeholder views in consultation and a recommendation from the Joint Committee that examined the draft Bill, we have strengthened the wording so that it is a duty to promote research. This has been welcomed by stakeholders such as the Academy of Medical Sciences and the Association of Medical Research Charities. It also reflects, incidentally, the equivalent duties to promote research already placed on the Secretary of State, NHS England and clinical commissioning groups by the Health and Social Care Act 2012.
The duty requires Health Education England to promote research activity in relation to its education and training functions, and the use of evidence obtained from that research, to secure continuous improvement in the quality of education and training. Those are pretty powerful provisions. I hope that noble Lords will appreciate from what I have said that Health Education England already has the necessary powers under Clause 86(2) to secure that research and innovation are fully incorporated into education and training.
I can reassure the noble Lord, Lord Turnberg, that Health Education England and the local education and training boards will work closely with research and innovation partners such as the academic health science centres and academic health science networks to deliver the duty to promote research. I can also reassure him that Health Education England will ensure that local education and training boards support this agenda and delivery of the duty to promote research. I hope that the noble Lord will feel sufficiently reassured by that to withdraw the amendment.
I shall now respond to the two other amendments to which noble Lords have spoken. Amendment 37 would add to a local education and training board’s main functions the promotion of research and the use of research evidence in the health service. Amendment 39 would require a local education and training board to support Health Education England in exercising its function to promote research into matters relating to social care services, primary care services and other health services so far as it is exercisable. I wholeheartedly agree that the local education and training boards need to take a strong interest in research and the use of research evidence when planning, commissioning and quality assuring the delivery of education and training. As noble Lords know, we have placed the primary duty to promote research on Health Education England but, as committees of Health Education England, the LETBs will be required to support the national body in delivering the duty through their workforce planning and education and training functions. Therefore, we do not see that the amendment is necessary in that sense. Health Education England will ensure that the LETBs support the delivery of key national duties, such as those in Clause 86, to promote research, support the NHS constitution and improve the quality of education and training. I also point out in this context that the appointment criteria that the Health Education England special health authority has used to appoint the existing 13 local education and training boards require the LETB to demonstrate effective mechanisms for partnership working with academic health science centres and academic health sciences networks.
I am sure that noble Lords will also be glad to know that Health Education England and the LETBs are working with the National Institute for Health Research, headed by Professor Dame Sally Davies, to ensure appropriate investment in education and training to develop clinical academic careers and increase the number of staff accessing academic careers programmes across all clinical and public health professions.
I hope that noble Lords will feel reassured that the spirit of the amendments is one which we have already grasped and which is reflected in the Bill and that they will therefore feel able not to press the amendments.
My Lords, as always, the noble Earl gave some very reassuring words on this topic. I am not absolutely convinced that we do not need to strengthen the Bill a little more to reflect what he has enunciated, but, for the moment, I beg leave to withdraw the amendment.
(11 years, 5 months ago)
Lords ChamberMy Lords, I am aware that NICE co-operates with its counterpart bodies not only in Europe but in other parts of the world; its work has an international dimension. As the same time, I say to my noble friend that NICE is seen as a world leader in its field. Many other countries look to NICE for the methodology that it adopts.
I am sure that the noble Earl is aware that Alzheimer’s disease is increasing in frequency as we all age, and is becoming a severe health problem. The Alzheimer’s disease association is certainly anxious for brains to be put into its bank, because it seems that there is the potential for a cure for this disease in a few years’ time. I suspect that the noble Earl is aware that the research that is done on these brains will be extremely helpful in that respect.
My Lords, I absolutely agree with the noble Lord, Lord Turnberg. Dementia is of course a particular focus for research using brain tissue. Also, there are many other neurodegenerative diseases, such as Parkinson’s, which could potentially benefit from this kind of research.
(11 years, 8 months ago)
Lords ChamberMy Lords, we consulted on our proposals for value-based pricing between December 2010 and March 2011, and as part of that process a number of patient organisations contributed their views, which were reflected in the Government’s response to the consultation, published in July 2011.
My Lords, what will happen to the panels of cancer experts that gave such valuable advice to SHAs about which drugs should be provided?
(11 years, 8 months ago)
Lords ChamberMy Lords, I pay tribute to the Oliver King Foundation for its work, as indeed I do to Cardiac Risk in the Young, which for many years has been campaigning very tellingly and successfully in this area. I think that my initial Answer should have satisfied my noble friend on the screening question, because that is now being reviewed by the screening committee. Regarding defibrillators, we have to look at the need to improve survival rates in the most effective way. I understand that the majority of these deaths—possibly as many as 80%—occur in the home. While we agree that the wider availability of defibrillators could save additional lives, CPR skills—cardiopulmonary resuscitation—should save more lives. To that end, the outcomes strategy says that my department will work with the Resuscitation Council, the British Heart Foundation and others to increase the number of people who are trained in CPR.
My Lords, will the noble Earl encourage all schools to incorporate training in CPR for all schoolchildren? A skill learnt there will carry on through the rest of a child’s life.
My Lords, the noble Lord makes a very good point. Again, as the CVD outcomes strategy sets out, basic life-support skills could be more widely taught as part of volunteering programmes; for example, in schools and the workplace. I am aware that bystander CPR doubles survival rates yet is attempted in only 20% to 30% of cases. There is scope for all emergency service personnel to be trained in CPR, and for basic life-support skills to be taught more widely.
(11 years, 9 months ago)
Lords ChamberThat story bears out the importance of employers fulfilling their responsibility to those who are in their care and ensuring that those whom they employ have the competences and skills that are required for the job. I do not want to prejudge that case, but there are systems in place that should ensure that patients are protected. We must deplore cases of this kind but they should not happen—safeguards are already in place.
My Lords, many members of the public find it difficult to understand why healthcare support workers who deal with patients every day are not regulated and registered and do not have to be fully trained in order to take up a job. I, too, am puzzled. Will the Minister tell us whether it is purely a matter of finance?
No, my Lords, it is not purely a matter of finance. Our view is that what really matters in this context is the competence and training of the individual involved. We are not oblivious to the concerns in this area. That is why we have already announced a number of further measures to support healthcare assistants. For example, we have just created an innovation fund of £13 million for the training and education of unregulated health professionals. The Care Quality Commission will undertake a review of inductions for care staff to make sure that nobody can provide unsupervised help without an appropriate level of training, and we have the work currently being done by Skills for Health and Skills for Care. Their report has now been received and embodies suggestions for a code of conduct and induction standards for health and social care workers.
(11 years, 10 months ago)
Lords ChamberMy Lords, I am very interested to hear about the treatment mentioned by my noble friend and I can remind her, although I am sure she needs no reminding, that one of the key roles of NICE is to keep evidence of new treatments under review. I do not doubt that as a result of my noble friend’s intervention, it will wish to look at that particular treatment. Pancreatic cancer can grow initially without any symptoms and it is possible that people might not recognise the symptoms. That is why the “Know 4 sure” campaign, which I have mentioned, highlights four key symptoms including loss of weight and pain, which can be symptoms of pancreatic cancer.
My Lords, is it not the case that the diagnosis of pancreatic cancer is extremely difficult? The organ lies deep within the abdomen and cannot be seen or felt, so by the time the patient shows symptoms, it is often too late. What we really need is research that will provide us with a biomarker which can be used for screening and early diagnosis. Can the noble Earl tell us whether research along these lines is going on within the NHS?
My Lords, via the Medical Research Council we are supporting a study to assess the effectiveness of a new test called the Mcm5 protein test to see if it can help to diagnose cancer of the pancreas, bile duct and gall bladder. I am also aware of a number of other research projects that my department is funding in the field of pancreatic cancer and I would be happy to write to the noble Lord with the details.
(11 years, 11 months ago)
Lords Chamber
To ask Her Majesty’s Government what assessment they have made of the analysis of hospital bed availability in the report Dr Foster’s 2012 Hospital Guide.
My Lords, Department of Health data show that the average bed occupancy rate for all beds open overnight has remained stable, at between 84% and 87% since 2000. Rather than being a cause of concern, this indicates that hospitals are making efficient use of beds. NHS hospitals need to manage beds effectively in order to cope with peaks in demand. We expect to see higher occupancy rates in winter, when these demands are at their highest.
My Lords, in thanking the Minister for his response and his endurance, I believe that we owe a debt of gratitude to Dr Foster for the report, which shows so clearly how severe the stress is that our hospitals are suffering under. With bed occupancies of 95% to 100% for much of the year for many of the hospitals, there are too often no beds available, staff are rushed off their feet, patients are not cared for properly, infection rates rise and mistakes occur. Given that almost one-third of the patients now in hospital do not need to be there and would be better off cared for in the community, and given that the community services cannot provide that care because they are so underfunded, where are we to get the money from? Simply saying that we can close a hospital or two and slide the money across from a cash-strapped NHS before those services are available will just exacerbate the problem. Would it not be better to use those end-of-year surpluses that we have been hearing about instead of returning them to the Treasury?
My Lords, as I mentioned earlier, NHS underspends are not lost to the NHS—they can be carried forward from year to year. But on his central point, I should make it clear that we are struggling to reconcile the Dr Foster bed occupancy figures with those that we have. Dr Foster has stated that bed occupancy is at a dangerous level, at over 90% for 48 weeks of the year. We are looking closely at that analysis and methodology, but we cannot agree with those conclusions at the moment, given that the department monitors the position on a daily basis during the winter and on a quarterly basis at other times. However, I agree with the noble Lord that there are too many people in hospital. We need to ensure that we move more care into the community. I do not see this as insuperable within the current budgetary expenditure limits.
(12 years ago)
Lords ChamberYes, my Lords. While the document to which my noble friend refers does make explicit that the cancer strategic clinical network will be focused around domain 1, which is reducing mortality, nevertheless improvements to patient experience and patient safety underpin all NHS care and those matters will be similarly embedded in the work of all strategic clinical networks.
Does the noble Earl agree that the cancer networks have been invaluable in supporting research into new treatments and that any reduction here would be regrettable?
I absolutely accept that one of the benefits we have seen from the clinical networks is the spread of innovative best practice through the health service, particularly in local areas. That is very much what we wish to preserve. The networks will help local commissioners of NHS care to reduce unwarranted variation in services and encourage innovation. We are determined to see that continue.
(12 years, 1 month ago)
Lords ChamberI am afraid that my message tonight will be rather familiar. Although I listened carefully to the noble Baroness, Lady Cumberlege, whom I respect enormously for her experience, I am afraid that I cannot agree with her. Commissioning services in the NHS is an extremely complex activity. For CCGs to make rational decisions, they need the best data and information available about their populations and how to meet their needs.
I understand that economists talk about perfect and imperfect markets. Perfect markets exist where both the purchaser and provider know exactly what they are getting and giving. This is particularly important when we talk, for example, about packages of integrated care, especially care across the hospital community divide. Who better to provide the data and information that CCGs need than those working locally in our hospitals? CCGs should not only understand the needs of their populations; they also need to know something about what can realistically be provided locally to meet those needs. Relevant questions might include whether the local hospital provider has the relevant orthopaedic surgeons who can do specialised and complicated knee or hand surgery, whether it has the oncologists and haematologists to deal with all cancers or only some, and whether it has the relevant up-to-date scanning facilities. There will be a dozen other questions that only local knowledge can answer.
It seems obvious to many in the field that local specialists and nurses from the local trust are in much the best position to provide the answers, and to engage constructively with GPs in the provision of services. The idea that there is a conflict of interest appears to me to be nonsense. Of course there is local interest. Local consultants and nurses are there to provide local knowledge and information. The idea that consultants and nurses from elsewhere can be parachuted in to provide local information is asking too much, quite apart from the problem of whether another trust will be willing to allow its staff time off to travel around the country.
We do not want or need disinterested clinicians in the CCGs; we need interested clinicians. I hope that the noble Earl will listen if not to my noble friend Lord Hunt then to the royal colleges, which are very strongly in favour of local input from the secondary sector.
My Lords, I begin by thanking the noble Lord, Lord Hunt, for tabling this Motion, which provides a welcome opportunity to clarify the Government’s intentions in making these regulations on clinical commissioning groups—an opportunity that I feel is rather necessary in the light of some of the speeches that we heard this evening.
The regulations set out the legal requirements on the size and membership of a CCG’s governing body. Together with amendments made to the National Health Service Act 2006 by the Health and Social Care Act 2012, they provide a clear legal framework within which CCGs can appoint their governing body and develop appropriate governance arrangements. CCGs will be different from previous commissioning organisations. They will be built on the GP practices that together make up the membership of the CCG. These member practices must decide, through developing their constitution, how the CCGs will operate. They must ensure that they are led and governed in an open and transparent way that allows them to serve their patients and population. It is vital that CCGs are clinically led, with the ownership and engagement of their member practices, so that they can bring together advice, as noble Lords emphasised, from the broadest range of healthcare professionals to influence patterns of care and to focus on patients’ needs.
That is a necessary preface to the subject that has been the focus of much of tonight’s debate: the role of the governing body of the CCG. Following the NHS Future Forum, we introduced measures in the then Health and Social Care Bill to strengthen governance arrangements for CCGs, primarily through the requirement for each CCG to have a governing body that would have responsibility for ensuring that the CCG operates effectively, efficiently and economically, and does so with good governance. As we discussed during the passage of the Bill, our intention was to provide the public with greater confidence that CCGs would have suitable governance arrangements in place, including independent views and strong leadership, and would have proper checks and balances for the stewardship of public money. CCGs will be the guardians of significant amounts of taxpayers’ money. It is therefore only right that there are strict requirements in relation to governance, probity and transparency of decision-making. We must balance the benefits of the clinical autonomy of doctors with a robust management of potential or actual conflicts of interest. It is essential to get this right, and that means a proportionate and reasonable approach.
The Health and Social Care Act already provides real safeguards against conflicts of interest. The CCG must make arrangements in its constitution for managing conflicts and ensuring the transparency of its decision-making process, and it must have appropriate governance arrangements, including a governing body with lay members and other health professionals. These arrangements will be scrutinised by the NHS Commissioning Board as part of the process of ensuring that a CCG is fit to be established as a commissioner.
The requirements in relation to the secondary care doctor and registered nurse are therefore part of an overall package of requirements to ensure that they operate with good governance. We made clear in the Government’s response to the NHS Future Forum in June last year that neither the secondary care doctor nor the registered nurse should be from a local provider in order to prevent any potential conflicts of interest. We did that because a conflict of that nature would be a constant issue for a secondary care provider, given that CCGs will be responsible for commissioning the vast majority of hospital services. In contrast, CCGs will not commission primary care—that will be the responsibility of the NHS Commissioning Board. Therefore, for the most part, GPs on the governing body do not have a conflict of interests, and in any case GPs will not necessarily be in the majority on a CCG governing body.
On any occasion where CCGs consider commissioning local community services, arrangements must be made to manage both actual and potential conflicts of interest in such a way as to ensure that they neither affect the integrity of the CCG’s decision-making process nor appear to do so. The NHS Commissioning Board has issued guidance and a code of conduct for CCGs to deal with that set of circumstances.
What then is the role of the secondary care doctor and registered nurse on a CCG governing body? Their primary role, along with other members of the CCG governing body, will be to ensure that the governing body exercises its functions effectively and with propriety and absolute fairness. However, each member of a governing body will be expected to bring additional perspectives to underpin the work of a CCG. For the specialist doctor and the registered nurse, this perspective will be to provide a view beyond primary care and a broader understanding of health and social care issues—specifically patient care in a secondary care setting for the specialist doctor and, for the nurse, the contribution of nursing to patient care.
That is different from the role of clinicians in commissioning. Involving clinicians in commissioning has been one of the primary goals of our healthcare reform. I need to underline that as it is very much separate from the specific role of the CCG governing body. The detailed work on service design will not be done by the governing body of a CCG: rather, it will be done by the CCG itself, working with clinical networks and other multiprofessional groups. The governing body will have oversight of the governance of this decision-making process.
CCGs have a legal duty to obtain advice from people with a broad range of professional expertise when carrying out their commissioning responsibilities. My noble friend Lady Williams was absolutely right in saying what she did on that score. This could involve, for example, a CCG employing or retaining healthcare professionals to advise the CCG on commissioning decisions. Local knowledge and an in-depth understanding of local health issues will come not only from local GPs and their member practices but from other local clinicians, including local secondary care clinicians, who will work with CCGs to review local health needs and design local services. So the arguments presented by the noble Lord, Lord Hunt, and others around excluding local secondary care clinicians from the governing body as affecting the quality of the CCGs commissioning are wholly misplaced.
As to the restrictions placed on councillors preventing them from serving on CCG governing bodies, I start with a point of principle. We have been very keen from the outset of our reform programme to limit political interference in the day-to-day activities of the NHS. We have always been clear about that. Consequently, in addition to local authority members, we are also excluding MPs, MEPs and London Assembly Members from serving on a CCG governing body. However, our proposals do not mean that councillors are excluded from CCGs. A local councillor may still serve as a member of a committee or sub-committee of a CCG governing body, with the exception of the remuneration committee, as long as a CCG has set out the arrangements for such a committee in its constitution. A councillor falls within the description of an individual “specified in the constitution” as being eligible for membership of a committee. A CCG may provide in its constitution for any function of the governing to be exercised on its behalf by a committee or a sub-committee of the governing body, or by any individual of a description specified in the constitution. These arrangements could therefore allow for a local councillor to play a pivotal role in the CCG’s decision-making without formally being on the governing body.
(12 years, 1 month ago)
Lords ChamberMy Lords, it is important to understand that the EU social partner process, which is driving the discussions at the moment and has been extended to 31 December, is autonomous. It operates independently of both the Commission and the Council and the Government have no formal role in any social partner negotiations. Having said that, we have made it clear to the Commission and to partners in Europe that securing long-term sustainable growth has to be the EU’s key priority. We will continue to work with our partners to ensure that EU measures support labour-market flexibility and do not impose significant costs on member states or burdens on business. The Government would welcome proposals coming forward that would preserve the right for all workers, including those in the NHS, to choose the hours that they work, including in particular flexibility in the areas of on-call time and compensatory rest as well as the preservation of the individual opt-out.
Does the noble Earl agree that the working time directive as it now operates is detrimental both to patient care and doctor training? Is it not time that we stopped at least the nonsense of counting time in the 48 hours as time when one is on call, even though one may never be called? Will the noble Earl make sure that the case is made to the EU that at least this part of the directive is rescinded?
The SiMAP and Jaeger judgments are very much the focus of our representations to the EU Commission. The disquiet about those judgements and the inflexibility that they have brought is shared by other member states. It is also important to recognise that none of us wants to go back to the past, with tired doctors working excessive hours. Tired doctors make mistakes; there is substantial evidence to support that. No one wants or deserves to be treated by tired doctors. There is a balance to be struck. The inflexibilities in the directive need to be addressed, but we should not go back to the bad old days when doctors became too tired to do their work.
(12 years, 8 months ago)
Lords ChamberI am grateful to the noble Earl for giving way. Will this board be an advisory board or the board?
I think that the noble Lord asked me whether the board will be an advisory board or a board. Its function will be to provide advice. It will be a board, but the Secretary of State and the chief executive of PHE will look to the board for that robust challenge and advice that a public health service needs.
(12 years, 8 months ago)
Lords ChamberMy Lords, as noble Lords will know, we have had a number of earlier discussions about education and training and I welcome this new opportunity to return to the subject. As the noble Lord, Lord Turnberg, is aware, we are putting in place what we see as a strong national system for education and training, with a strengthened focus on quality outcomes.
In the Bill we have introduced a clear duty on the Secretary of State to ensure that such a system is in place. We are now making good progress in establishing Health Education England and the local education and training boards. We are acutely aware of the importance of a safe transition to the new system. We are proceeding with care and at a sensible pace to ensure that the new system is fully up and running by April 2013.
We have also introduced amendments to strengthen links with the wider system. Our Amendments 61 and 104, which were accepted in an earlier debate, place duties on the board and on clinical commissioning groups to have regard to the need to promote education and training. They are designed to ensure that commissioners of NHS services consider the planning, commissioning and delivery of education and training when carrying out their functions.
We also accepted an amendment tabled by the noble Lord, Lord Patel, to strengthen co-operation among providers of NHS-funded services, which would place a duty on commissioners to ensure that any person providing services as part of the health service would have to co-operate with the Secretary of State in the discharge of his education and training duty, or with any special health authority discharging that duty—that is, Health Education England. This aims to ensure that providers, too, play an active role in education and training.
The noble Lord, Lord Hunt, spoke with his customary authority on this subject and I agree with what he said. I particularly agree that employers best understand the workforce they employ and the kind of workforce they want to employ. They also understand the need to link service planning and workforce planning. They are able to focus on the whole workforce and to recognise the levels of contact with patients and service users, and the varying local needs. Evidence from other sectors and feedback from providers has been clear that in order to deliver successful and responsive world-class services, employers need to have clear ownership and involvement in the education and training and planning of their workforce. I am entirely at one with the noble Lord on that.
Employers have welcomed our plans for education and training. They believe that this approach should provide real opportunities so that healthcare providers have the right incentives to secure the skills that they wish to have, invest in training and innovate to improve the quality of services that they provide. They welcome the opportunity to have the incentives to align service, financial and workforce planning, and to have greater flexibility to respond to the strategic commissioning intentions of the NHS Commissioning Board and clinical commissioning groups.
The NHS Confederation, NHS Employers, Foundation Trust Network and the Association of UK University Hospitals all support a system that provides greater accountability for employers. Strategic health authorities are working with employers to support them in developing these local partnerships so that they can take full responsibility for workforce planning, education and training.
I hope that that is of reassurance to the noble Lord, Lord Turnberg. What is happening on the ground almost pre-empts the speech he so articulately made. We are rapidly moving towards the kind of system to which he and other noble Lords aspire. Having secured the amendments that are already in the Bill, we do not believe that it is necessary to build in any more. On the strength of what I have said, I hope that the noble Lord will feel comfortable in withdrawing his amendment.
My Lords, I am well aware of the lengths to which the Government have gone to support education and training, for which I am truly grateful. I am also aware that earlier amendments might appear to have covered the points that I raised about the need for foundation trusts: there is a particular recommendation for them. I am a little disappointed that my amendment cannot be accepted but I understand the reasoning. The foundation trusts are key providers and, therefore, it should be clear to them that they have this responsibility. I know that they are willing providers of education and training but it should be in the Bill. However, I beg leave to withdraw the amendment.
(12 years, 12 months ago)
Lords ChamberI 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.
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—
(13 years ago)
Grand CommitteeMy Lords, I thank the noble Lord, Lord Turnberg, for his positive comments on the creation of the HRA as a special health authority and welcome the opportunity of this debate to clarify the role of the authority on its establishment on 1 December. As I said last week when we discussed amendments to the Health and Social Care Bill, the Government have signalled their clear and strong support for research by increasing the research budget of the Department of Health in real terms over the current spending review period. I fully recognise the importance of ensuring that research is promoted within the health service. High quality health research is critical to the ability of the NHS to deliver world-class health outcomes, an end towards which we are all striving.
I think that noble Lords will agree that regulation of research is excessively complex. Both this and inconsistent local practices need to be addressed. As the Academy of Medical Sciences’s report set out, it is still far too difficult for researchers to navigate the complex national and local processes for research approvals. The Plan for Growth, which was published alongside the Budget 2011, announced the Government’s proposals. At the national level, we said that we would create a Health Research Authority to combine and streamline the approvals for health research, which are scattered across many organisations. At a local level, we said that we would transform the incentives for efficiency in research initiation and delivery. These two components are critical and we are already tackling the complex local processes for research approvals. Through the Health and Social Care Bill and the efforts of my department and the National Institute for Health Research, we are seeking to embed a positive and proactive research culture across the depth and breadth of the NHS. The noble Lord, Lord Turnberg, asked me what we are going to do about delays at trust level, and that question was echoed by the noble Baroness, Lady Finlay.
We have developed a co-ordinated system for gaining NHS permission for research that is supported by the National Institute for Health Research. It aims to standardise the checks that lead to trust approval, and centralise those that do not have to be carried out locally. In May we fulfilled our commitment to launch a framework of good practice and standard procedures to facilitate consistent local research management and greatly improve performance.
NHS trusts which adopt these standards will stop unnecessary duplication of checks, a local barrier to getting a research project off the ground that has frustrated researchers for many years. For clinical trials the National Institute for Health Research will publish outcomes against public benchmarks, including—and I address this particularly to my noble friend Lord Willis—an initial 70-day benchmark to recruit the first patient to a trial. Future NIHR funding will be conditional on meeting benchmarks.
I turn back to national-level commitments. The instruments not only fulfil our commitment to establish the Health Research Authority as a special health authority this year; alongside the directions we are giving it, they also ensure that the Health Research Authority will have substantive functions from the outset.
First, the HRA will unify the existing functions of the National Research Ethics Service from the National Patient Safety Agency and strategic health authorities. This will provide continuity and a stable platform for the National Research Ethics Service to build on the achievements it has already made. For example, a major obstacle to conducting research has been the completion of the numerous forms required to gain research approvals and permissions. The Health Research Authority will continue to run the integrated research application system developed by the National Research Ethics Service. It is an online one-stop shop that lets researchers apply for all the research approvals they need, not just to ethics committees but to NHS trusts and other health research approval bodies.
Secondly, in addition to ethical approvals, and from the outset, the HRA will have duties to co-operate with other bodies to improve the whole system: to create a unified research approval process and to promote consistent standards for compliance and inspection. This means it will promote alignment across the whole system, working closely with other bodies, such as other regulators. For example, it will work with the Medicines and Healthcare Products Regulatory Agency on operating a co-ordinated national approval process for research involving medicines or medical devices. It will also work with the National Institute for Health Research on promoting proportionate action to demonstrate compliance with standards that are consistent on both the regulatory and provider sides. Therefore, it will support the work of the National Institute for Health Research to promote improvements in local NHS approval processes.
Thirdly, and most importantly, from the outset the HRA’s role will be to protect and promote the interests of patients and the public. It is crucial that members of the public participating in research are—and feel—safe. The HRA will protect patients from unethical research, and enable patients to benefit from opportunities to participate in research by facilitating research which conforms to ethical standards and the law. Its role in combining and streamlining health research approvals, alongside the work of the National Institute for Health Research with NHS trusts, will improve the timeliness of decisions about research projects. This will increase opportunities for our patients to benefit from research.
The noble Lord, Lord Turnberg, asked about the ethics and confidentiality committee function within the National Information Governance Board for Health and Social Care. The NIGB is an independent statutory body established to improve and monitor information and governance in health and adult social care. It provides advice to the Secretary of State on the appropriate use, sharing and protection of patient and service user information. In particular, it has set up a committee—the ethics and confidentiality committee—for advice on the processing of patient information, including confidential patient information, under the Health Service (Control of Patient Information) Regulations 2002. Confidential patient information may be processed under those regulations only where the processing has been approved by the Secretary of State and, in the case of medical research, also by a research ethics committee. It is intended that the HRA will take on the Secretary of State’s role in approving the processing of such information for medical research as part of its role in combining and streamlining approvals for health research. The establishment of the HRA will help to ensure that the application and review processes are streamlined and, as I have said, follow consistent standards.
My noble friend Lord Willis asked me to summarise the functions of the HRA as a special health authority. I have already mentioned that it will assume the NRES functions from the NPSA as well as strategic health authorities’ functions as the appointing authorities for research ethics committees. In due course, it will perform the Secretary of State’s function of approving the processing of patient information for medical research. My noble friend mentioned the reference to directions in the order. Principally, those directions will relate to the need for the HRA to co-operate in the exercise of its functions with the regulatory bodies that I have referred to and with others.
My noble friend asked whether the Government have any intention to transfer HFEA or HDA functions into the special health authority. The answer is no, because we cannot. As a special health authority, the Health Research Authority is generally restricted to exercising the Secretary of State’s functions relating to the health service in England. Establishing it as an NDPB in due course will enable functions to be conferred on it which are not specific to the health service in England, including giving it functions which go beyond health, including functions relating to social care. The Academy of Medical Sciences’s report proposed that the research-related functions of the HFEA should reside with the Health Research Authority. We will be consulting on the future of the HFEA and on our preferred option that the research-related functions of the HFEA should pass to the HRA. Establishing the HRA as an NDPB will enable it in due course to take on functions relating to embryo research which are not health service functions in England.
The noble Baroness, Lady Finlay, asked me about indemnity for research and the possibility of an all-England risk pool. Trusts are members of the NHS clinical negligence scheme, which indemnifies them in respect of negligence for which they have assumed vicarious liability, whether the negligent activity was standard care or research.
The noble Baroness, Lady Thornton, asked about other functions of the NPSA and, in particular, the National Reporting and Learning Service and the National Clinical Assessment Service. I will write to her on that, but I can tell her that most of the NPSA’s functions are expected to transfer to the NHS Commissioning Board after Royal Assent. Patient safety will of course be at the heart of the new system. Responsibility for national confidential patient inquiries has already moved to the Healthcare Quality Improvement Partnership, which manages the national clinical audit programme.
The noble Baroness also asked me about the cost of the Health Research Authority. The funding will follow the functions. The Health Research Authority will continue the reform of the National Research Ethics Service releasing efficiency savings, we trust, for developing the authority’s other functions.
Looking forward, it is important to ensure that we maintain momentum and build on the advances that the Health Research Authority will be able to take forward as a special health authority. It is our intention to publish draft clauses on the Health Research Authority for pre-legislative scrutiny in the second Session. Future legislation will allow us to establish the Health Research Authority as a stable and independent non-departmental public body. The current regulatory framework for health research involves many overlapping acts and instruments, so there is much work to be done to ensure that we develop legislation that is fit for purpose.
Research has been a core function of the National Health Service since its foundation. It is key to the future of health and healthcare in the UK. The creation of the Health Research Authority as a special health authority is, I believe, an important step on the road to removing unnecessary bureaucracy that could stifle research in this country.
I am most grateful for the support of noble Lords. We will no doubt be returning to these issues when debating amendments tabled to the Health and Social Care Bill. In the mean time, I recognise the value of these exchanges and thank all who have contributed so fully to this debate.
My Lords, the noble Earl said that in future the NIHR will require trusts to have a 70-day limit on the time in which it can consider requests. Does that also reflect on non-NIHR-funded research from other organisations or is it only NIHR research?
My Lords, the precise arrangements for the CSND are being worked through at the moment. I will write to the noble Baroness on that. As I have described, the incentive relates directly to the NIHR funding but the benchmark is measured against other research and all studies that are going on. There is a wider dimension to this.
I should apologise to the noble Earl for burdening his day off from the health Bill during several weeks of hard work. I thank him for his detailed response and will reflect carefully on what he has said. Today’s debate will be useful when we debate this issue in the health Bill proper on the Floor of the House. I hope that it will reduce the amount of time that we discuss the Bill, although I cannot promise that. We will wait and see.
(13 years ago)
Lords ChamberI am most grateful to the noble Lord. In that case I shall not dwell on it at great length.
Amendment 40A, tabled by the noble Lord, Lord Turnberg, and other noble Lords, would require the Secretary of State to have regard to the need to promote the use of information derived from patients for research purposes while taking full account of the confidentiality of information. I welcome the intent behind this amendment, but it is in fact unnecessary. We recognise the important role that patient data, if treated carefully and confidentially—and that I hope goes without saying—can play in improving the quality of health research. I spoke earlier about our consultation document An Information Revolution, in which we propose that the most important source of data is the patient’s or the service user’s care record generated at the point of care. Information in these records also provides much of the data needed for other secondary purposes: for commissioners, for managers, for care professionals and, importantly, for research. We are using the responses that we received to the consultation, together with the findings of the NHS Future Forum, to develop an information strategy for health and social care in England. This will highlight how increased transparency and greater access to information supports improvements in care and research. It is the major work stream. I can reassure the noble Lord that we value the use of patient information where confidentiality is appropriately protected as a source of research and that we are looking at ways to embed its use in our information strategy.
Can the noble Earl give us any idea of the timescale over which we might see something emerging from this? It has been on the agenda for a very long time and we really need to move on it.
I hope that I am not putting my neck on the block, but within a month the noble Lord should hear news that may cheer him on this front.
A great many noble Lords have asked me questions, some of which I have covered, but I suggest that in the interests of time it might be helpful if I followed up this debate in writing and in a way that will enable me to answer the questions in greater detail than I would now in any event.
(14 years ago)
Lords ChamberThey are different skill sets, but I am not aware that Parliament has visited these issues, let alone revisited them. As I said, we will have the opportunity to do that, but the proposals we have outlined will ensure that the teams that are currently involved in inspection activities will be kept together. I see no reason why they should not be.
My Lords, perhaps I may ask the noble Earl about the Health Protection Agency. What advantages does he expect to come out of moving the HPA into the Department of Health?
(14 years ago)
Lords ChamberMy Lords, my noble friend is absolutely right: this is a cross-government effort. It is not simply for the Department of Health to deal with the issue because just about every department has some sort of remit in this area. I would say that, in particular on the attainment of children at school, we will focus very much on children from disadvantaged backgrounds because there is a high correlation between mental ill health and poverty, and mental ill health and deprivation. That will be a major focus.
My Lords, what steps are the Government taking to ensure that GP consortia have access to the expert advice they will need if they are to commission positive mental health messages and the prevention of mental illness?
My Lords, many GPs understand the issues very well and are keen to get on with the agenda. Our proposed model of GP commissioning means that practices will have flexibility within the new legislative framework to form consortia in ways designed to secure the best healthcare and outcomes for their patients. That will include mental health and could involve, for example, taking commissioning decisions collectively with perhaps a lead consortium for mental health.
(14 years ago)
Lords ChamberMy Lords, is it not the case that we have not been able to discover the cause of this very unpleasant disease so far and we have no real effective treatments? While we are waiting for both of those, the best form of management seems to be cognitive behavioural therapy. Does he agree?
My Lords, cognitive behavioural therapy is indeed part of the NICE recommendations, but only a part in so far as it is appropriate for any chronic condition to have such therapy. I am sure that the noble Lord agrees that the NICE guidance recognised a clinical and physical basis to this condition as well. Therefore, a multifactorial approach is appropriate.
(14 years ago)
Lords ChamberDoes the Minister agree that to devolve responsibility for prescribing expensive drugs to GPs faces them with a very difficult ethical dilemma? Should they prescribe a very expensive drug, costing thousands of pounds, with only marginal benefit for the heart-rending patient with cancer facing them, knowing that to do so may prevent them from funding 20 or 30 patients requiring eye operations or hip replacements or drugs for schizophrenia, or should they refuse that treatment? Have the Government thought through the implications of devolving the cost-benefit analysis that NICE does so well?
My Lords, I think the noble Lord has perhaps misunderstood the purpose of the plans that we have set out. Prior to the introduction of value-based pricing, we will continue to ensure that the NHS funds drugs that have been positively appraised by NICE. I hope that that reassures him that clinicians are not going to be placed in an awkward position. We will be consulting on our plans for value-based pricing before the end of the year, but I can assure the House that the point of moving to a new pricing system is to increase patient access to new effective drugs. That is what we aim to do.