Health: Birth Defects
Lord Turnberg Excerpts(10 years, 6 months ago)
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Earl Howe
My 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.
Lord Turnberg (Lab)
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?
NHS: Walk-in Centres
Lord Turnberg Excerpts(10 years, 6 months ago)
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Earl Howe
My 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.
Lord Turnberg (Lab)
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?
Earl Howe
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.
Tobacco: Packaging
Lord Turnberg Excerpts(10 years, 7 months ago)
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Earl Howe
I 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.
Lord Turnberg (Lab)
My Lords, is there any evidence that has not been published and examined in great detail that we have to wait for?
Earl Howe
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.
Health: Tuberculosis
Lord Turnberg Excerpts(10 years, 7 months ago)
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Earl Howe
My 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.
Lord Turnberg (Lab)
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.
Earl Howe
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.
Health and Social Care (Amendment) (Food Standards) Bill [HL]
Lord Turnberg Excerpts(10 years, 7 months ago)
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Lord Turnberg (Lab)
My Lords, I, too, am extremely grateful to the noble Baroness for bringing forward this Bill. There are many people out there who believe that she deserves a medal, and I would certainly subscribe to one for her for having introduced the Bill.
Ever since I started working as a young doctor in the NHS in the 1950s and 1960s, 50 or 60 years ago, hospital food has been something of a joke—a joke that is not particularly funny for patients, many of whom either refuse to eat it because it looks so unappetising or, having tasted it, can eat very little of it. No one who listened to my noble friend Lady Gibson and the noble Baroness, Lady Masham, could possibly doubt that. It is hardly surprising to find that many patients lose weight in hospital and that there is enormous waste as so much has to be thrown away. I fear that it is becoming pretty obvious that I, too, have read the excellent briefing that has been placed before us.
However, that is not for want of trying to improve matters. According to the report by the Campaign for Better Hospital Food entitled Twenty Years of Hospital Food Failure, there have been numerous government initiatives, over many years, urging hospitals to pay attention to the standards of their food. There have been no fewer than 21 different initiatives in 20 years, which is more than one a year and two for each of the 11 Secretaries of State for Health who have held office during that time.
Each of those initiatives has urged a voluntary improvement by hospital trusts but these seem to have fallen on deaf ears. We are just as bad as ever, according to reports from Age Concern and the Royal College of Nursing. And it is not just the appearance and attractiveness of meals that are wanting; the nutritional value is even more problematic. Insufficient fresh fruit, vegetables and fish, and too much fat and salt, as we have heard, are far too commonplace. It is hardly surprising that patients often rely on family and friends to bring in food for them, and this is all happening despite efforts to enlist the help of a number of celebrity chefs. Sending now for Jamie Oliver without some form of regulation or legislation will simply not work.
It is the case that fewer than half the meals are cooked on site and that only a minority are made from British produce. There is of course an additional problem which is not tackled in the Bill and that is the complaint made, in too many places, of either food and drink being placed out of the reach of infirm patients at the end of their beds where they can see it but not reach it, or perhaps the food is within their reach but they need help to cut it up and spoon it into their mouths. Age Concern found that over 40% of patients needing this sort of help actually got it. That problem has to be solved by better training and the culture change that we keep banging on about in this House.
So far as the Bill of the noble Baroness, Lady Cumberlege, is concerned, there seems little doubt that voluntary initiatives have not worked and that we desperately need something more. We need to mandate better food and catering, and it is clear that this will not cost any more. We also need a proper inspection system. It is interesting to note that food standards are mandated in prisons and schools but not in our hospitals. It is even more interesting that there are mandatory standards for hospitals in Scotland and Wales, and that much of the food offered in English hospitals would not meet their standards. We need also a robust inspection regime, although perhaps not too robust. Perhaps the CQC in its regular inspections could simply sit down to lunch or dinner with the patients and make an assessment. That should not impose too much bureaucracy. It might cause some nausea.
I am strongly in favour of the Bill. We have spent far too long on voluntary initiatives. They just do not work. We must do more to correct this dangerous and seemingly everlasting problem. As my friend, the noble Lord, Lord Willis, who I met when coming in this morning, said, “It is a no-brainer”.
Antibiotic-Resistant Bacterial Infections
Lord Turnberg Excerpts(10 years, 11 months ago)
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Lord Turnberg
My Lords, this has been a remarkable and important debate. I am grateful to the noble Lord, Lord Crisp, for laying out the issues so clearly, and for the many valuable contributions made by other noble Lords.
The noble Lord, Lord Crisp, spoke very persuasively about the global impact of infectious diseases, especially in the third world, a point re-emphasised by the noble Lord, Lord Trees. However, I am going to narrow my focus to the problems in the UK. There is little doubt that infectious diseases that we once thought had been conquered never really went away. They are rearing their collective head once again. With about 5,000 deaths a year from gram-negative sepsis in the UK alone, we cannot afford to be complacent. No sooner have we managed to get a grip on one set of antibiotic-resistant bacteria, MRSA and Clostridium difficile, than another set has appeared, but the fact is that we managed to have an impact on MRSA through a concerted and focused effort. That suggests at least that we can do something if we put our minds to it.
However, we are now faced with a new set of antibiotic-resistant germs that pose a major threat to the population, in particular to highly susceptible subgroups of the population. These are the gram-negative bacteria, particularly E. coli and Klebsiella species, which make up more than a third of all causes of bacteraemia reported to the Health Protection Agency—now the public health laboratories. It is worth noting that septicaemia due to E. coli has a 30% mortality rate. These bacteria are now the biggest threats, but others are creeping up on us. We are seeing more cases of resistant gonorrhoea, a very common disease, and multidrug-resistant TB, which is much less frequent at least in the UK but still very disturbing—a point well made by the noble Baroness, Lady Masham. The reasons for all these rises are complex and multiple. They include the increase in the number of vulnerable patients—the very young and the very old, and those with diseases that lower their resistance, such as cancers and leukaemia—and the powerful immunosuppressive treatments that they need. Bringing them close together in a hospital or a care home increases their risk. We have heard about the overprescribing of broad-spectrum antibiotics that allow the evolution of resistant strains.
Perhaps the major impact of inappropriate or over- prescribing has been felt in Asia, particularly in China and the Indian subcontinent, with their huge populations, as the noble Lord, Lord Trees, emphasised. Here, there has been a dramatic rise in antibiotic-resistant strains and they are increasingly being imported as international travel grows. There are now no more frontiers that can stop the spread of germs. So what is to be done?
It is possible to reduce the spread of antibiotic resistance. We reduced the incidence of MRSA and C. difficile by a combination of spreading good practice—with handwashing or alcohol hand rubs at the bedside, and nasal swabbing of all admissions to pick up carriers—and better management of intravenous lines and better infection-control measures. They all played a part. The noble Lord, Lord Trees, spoke about the zoonoses. Stopping a few years ago the practice of using antibiotics in animal feeds to promote growth must also have been very valuable. Concerted action can therefore work. We must once more pay attention to the recommendations of the Chief Medical Officer in her admirable report of 2011. Here it was proposed that we should ensure that NHS trusts and their chief executives manage, report and audit infection rates. That was successful before, and we must place even more emphasis on it in the duties placed on NHS England and CCGs. Spreading the message yet again about thoughtful prescribing of antibiotics, both in general practice and in hospitals, has never been more important.
However, we also need some different approaches. We desperately need better and quicker diagnostic tests for bacteria and their resistance. It now takes about 48 hours or more to get a report from the laboratories on what bacteria are responsible for an infection. Meanwhile, one is faced with treating a serious infection blindly or not at all—a point made by the noble Lord, Lord Crisp, and the noble Baroness, Lady Masham. Tests are becoming available, using genetic profiling or next-generation sequencing, that will bring the time for diagnosis down to a very few hours. If we can get there, antibiotic prescribing will become much refined and we will be able to avoid giving ineffective antibiotics. There is also a desperate need for new antibacterials.
It is unfortunately the case, as has been emphasised by a number of noble Lords, that the pharmaceutical company pipelines are pretty low at the moment. The cost of the development of new drugs is prohibitive and too often drug companies are inhibited by overregulation and cost. The noble Baroness, Lady Masham, mentioned that and the noble Countess, Lady Mar, underlined the point. It has been suggested that the Government might encourage investment in R&D by industry through such measures as prolonging the period during which the patents for new antibacterial drugs may be retained, or by a more favourable tax regime for companies developing those drugs. Perhaps we should take note, too, of the ideas expressed by the noble Countess, Lady Mar, about a multipronged attack; I found those very attractive. It seems to me that we must do more in these two areas: more research into rapid diagnostic techniques and more engagement with and encouragement for industry to develop new antibacterials.
My questions for the Minister are as follows: what efforts are the Government making to ensure that NHS England, the CCGs and hospital trust boards are keeping infection control high on their agenda? In what way are the Government ensuring that the laboratories of Public Health England are given the necessary research funds to develop new rapid diagnostic tests for bacterial resistance? Have the Government paid any attention to the incentives they need to provide for the pharmaceutical industry to invest in a search for new antibacterials? I have not spoken about the area of vaccines, although clearly it is very important. The noble Countess, Lady Mar, drew to our attention the issue of the meningitis B vaccine, and I hope that the noble Earl will be able to respond to that.
This has been a valuable debate on an important subject and I look forward very much to the noble Earl’s response.
NHS: Association of Medical Research Charities Report
Lord Turnberg Excerpts(11 years ago)
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Lord Turnberg
To ask Her Majesty’s Government what is their assessment of the report by the Association of Medical Research Charities, Our Vision for Research in the NHS.
Lord Turnberg
My Lords, one of the biggest problems facing a Government is how to get their policies implemented when, as always, that depends on others putting them into action. The world is full of people with bright ideas but rather fewer who can make sure that they are put into practice. Such is the case with the good intentions of the noble Earl and his colleagues to embed research in the NHS, which may be frustrated by poor take-up by those on the ground who have to implement them. But help is at hand. It is here in the AMRC’s report on a vision for implementation.
Here I express my interest as scientific adviser to the Association of Medical Research Charities. I should mention, too, that the AMRC is an umbrella body for more than 120 medical charities covering a wide spectrum of diseases, including Cancer Research UK, the British Heart Foundation, Alzheimer’s disease, Parkinson’s disease and diabetes, as well as the Wellcome Trust, and as such, speaks for a very large number of patients and their carers. They are desperately keen to see research into their diseases actively pursued to the extent that they pump £1.2 billion into research every year. It is that commitment to research that prompted the publication of this vision.
Of course, it did not come out of the blue; it came on the back of a number of government initiatives to promote research in the NHS. We have had many a fine word from Ministers, the Treasury and even the Prime Minister about the value of medical research, and we now have the duties spelt out in the mandate for NHS England and the CCGs to promote research. It makes economic sense, too, as we know, that there are excellent economic returns from investing in research—a fact that new figures that are about to be published will no doubt confirm.
Public funding of research is very successful in leveraging private capital input too. The Government’s investment proposals announced today and yesterday, including protection of the science budget and investment in health research infrastructure, including regenerative medicine, are very welcome. The scientific community is, of course, extremely pleased by that. The National Institute for Health Research and its networks and centres are poised to do great work. Couple all that with our very strong background in basic biomedical research and the fact that we have a National Health Service in which every patient is involved and available to engage in clinical trials and you have a fantastic opportunity to conduct research of benefit to patients. I do not have to explain today how research has enormous potential to improve the care not only of future patients but also of those who take part in research themselves today.
However, achieving these ambitions is not straightforward and there are several uncomfortable barriers that can get in the way. They range from the need to maintain adequate public funding—and we have had some of that today—improving and rationalising the complex regulatory network—here the new health research authority’s role will be critical—and improving taxation policy to encourage more private and venture capital investment. Perhaps one of the biggest barriers is trying to change the culture within the NHS. The AMRC’s Vision document focuses on the people who have to do the implementing—the patients, doctors, nurses and other healthcare workers. Are they ready to take advantage of the valuable basic work going on in Newcastle on mitochrondrial disease, as that becomes ready to be translated into treatments?
The report envisages a future in which, first, every patient is given the opportunity to engage in research; secondly, every health professional understands the value of research and ensures that innovations in treatment are transcribed rapidly into practice, and thirdly, the NHS as a whole conducts high-quality research and adopts new treatments. We have a long way to go because there is a very patchy, variable picture in practice now.
There is a statement in the NHS constitution that commits the NHS to inform patients of,
“research studies in which you may be eligible to participate”.
Yet despite that, a mystery shopper survey by NIHR revealed that barely 10% of NHS trusts provide patients with any information and there were very few notices about it anywhere. Another survey, by Breast Cancer Campaign and Arthritis Research UK, found that very few patients ever asked their doctors about research or clinical trials and many doctors were unaware of existing sources of information they could give to their patients. This survey also confirmed, as many had suspected, that GPs were not all switched on to doing research or even supporting others to do research. While 80% of GPs contacted felt that research was important, only 20% thought that they should be involved themselves. They quote a lack of time as a major disincentive, but equally a lack of support and a lack of information about where to get that support. This is all true, albeit to a lesser extent, of hospital doctors. Perhaps equally disturbing is the observation that only a third of GPs thought that research was of any value in helping them to offer their patients more treatment options.
There is much to do at the coalface if we are to deliver on our potential but there are causes for some optimism. The academic health science centres and networks funded by the National Institute for Health Research are enormously valuable in engaging with healthcare workers. Figures published today show that, in the past year, NIHR engaged a remarkable 630,000 patients in 1,592 studies, a considerable increase from the previous year.
Another good example is the Greater Manchester network that I visited. It has managed to get every GP and pharmacist in Salford signed up to clinical trials—to the extent that GSK has seen fit to invest heavily in trials there. It has also managed to get the rate for R&D approvals for clinical trials down from 60 days in 2011 to 17 days in 2012. Many other good examples of what can be achieved are described in this report, but there is very much more to do to change the culture more widely across the NHS.
The Vision document makes a large number of recommendations but I shall mention just a few where the Government may be able to help. First, can we encourage NHS England to appoint someone at board level who can take responsibility for promoting research, and can we make sure that the CCGs have the leadership and guidance they need to promote research? How do we make sure that non-NHS providers are encouraged to engage in the research agenda?
Then there is a clear need to spread more and better information about research opportunities to patients and doctors, so can the noble Earl encourage the NIHR to get relevant information out to NHS trusts and GPs to ensure that both patients and staff know more about research, including its benefits? He may find that he is pushing at an open door there. Can he ensure that employment contracts for consultants include sufficient time for research, and can he help to reduce discrimination against those who engage in research by ensuring that those responsible for giving out clinical excellence awards at the local and national levels take this into account by including research activities in their assessments?
Can the noble Earl reassure us that the responsibilities of Health Education England and of the local education and training boards that we are debating in the Care Bill will incorporate the specific need to include research in the training programmes of all clinical trainees? Training programmes should be flexible enough to allow time out for them to undertake research.
Can we make sure that GPs are encouraged to share their practice data with the Clinical Practice Research Datalink in a safe and secure way? Can we also encourage them to respond positively to requests to invite their patients to take part in research trials by other researchers? There has been a fair amount of resistance at that level.
Finally, dare I say that perhaps we can make the AMRC’s Vision document required reading by everyone in the NHS? After all, it comes from organisations made up largely of patients themselves.
I look forward to hearing the speeches of noble Lords and, of course, the noble Earl’s response.
Care Bill [HL]
Lord Turnberg Excerpts(11 years ago)
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Lord Turnberg
My Lords, I strongly support my noble friend in Amendments 58B, 58C and 59. This clause is about taking note of the regulation and the regulation of research activities, but not of people who are engaged in research. It is important to involve those who regulate the professions—the General Medical Council, the General Dental Council, the Nursing and Midwifery Council—as well as the nurses. I agree entirely with the statement that the nurses should be included. In saying this I should also mention the pharmacists, who play an important part in research. I have been approached by those involved in pharmacy regulation to indicate that they also have an interest here.
I wish to speak particularly to Amendment 60, which is in my name, and to Amendments 61 and 62. On Amendment 60, I emphasise the important part played by the local R&D committees of NHS trusts, which the noble Lord, Lord Hunt, mentioned. We now have the Health Research Authority, which is doing a really remarkable job in speeding up the process for approval of research by bringing together the different research ethics committees and the special ethical approval for research, using data where patients are no longer able to give consent. It has developed a single portal of entry and a single application, which is having an enormously helpful effect, but there remains one major hurdle in the way of those trying to carry out multicentre clinical trials: the local R&D committees of NHS trusts. Some are good and speedy while others are slow and capricious, and the whole clinical trial is determined by the slowest and most capricious of those who have to give approval.
When the Academy of Medical Sciences reviewed research regulation, it identified the local R&D committees as the most difficult and time-consuming concerned, with delays of almost a year in too many instances, so in Amendment 60 we are trying to give the HRA the responsibility of rationalising and improving the approval processes in R&D committees. If it can get the approval of all trust R&D committees to rely on and accept a single robust assessment, covering all their various concerns, it will not only relieve them of that burden but give them the confidence that the review has been properly performed. It will also speed up the process for researchers. I hope that we can include this message in the Bill at a time when I know that the HRA itself is working hard to achieve it. The amendment is simply intended to offer it the support that it needs for its efforts.
Amendment 61, in the name of the noble Lord, Lord Willis, who unfortunately still cannot be with us, gets at the problem of ensuring that all providers of services for the NHS, including the private sector, should have the same responsibilities for research and innovation as the rest of the NHS. The HRA should have a role in ensuring that they do. It is important that their staff have opportunities to engage in research; certainly, they should be encouraged to introduce innovation into their practice.
Amendment 62 is also in the name of the noble Lord, Lord Willis. We welcome the explicit mention of the responsibilities of NHS trusts in the Bill. However, there is further need to ensure that trusts not only have regard to guidance issued by the HRA but actively comply with such guidance. I would welcome further clarification of how the requirement to have regard to such guidance will be ensured and how trusts’ compliance with such guidance might be strengthened.
Lord Walton of Detchant
My Lords, I was uncertain whether to speak on these amendments in the presence of two past presidents of medical royal colleges, the noble Lords, Lord Turnberg and Lord Patel. I feel unable to support Amendment 58B because the medical royal colleges are not regulatory bodies. They are essentially educational bodies. They play a role in producing and monitoring the standards of qualifying examinations for those seeking to be specialists, but they are essentially educational and do not have a regulatory role, although, of course, they play an important part in advising on a whole range of health service issues.
However, I believe it is right that Amendment 58C should be inserted, because the bodies mentioned are regulatory authorities. The General Medical Council, for instance, can play a crucial and important role in disciplining doctors who have been found guilty of fraud and misconduct in medical research. This is very relevant to the qualities and responsibilities of the HRA, and for that reason I believe it right for this amendment to be included in the Bill.
Baroness Jolly
I will speak briefly in support of Amendments 59, 61 and 62. We have had this debate about lists—sometimes they are good, and sometimes not. There is no way of knowing when they are good and when they are not. However, I welcome the additions suggested in the amendments, in particular the amendment in the name of the noble Baroness, Lady Emerton, on the Chief Nursing Officer. That is absolutely critical. Everybody knows about doctors, but the amendment sends out the key message that nurses play a role in collecting an evidence base to improve care for patients. That is very important. I have seen some very nice research done by nurses, who work in the community, about care. That really makes a difference and, of course, it is then shared among their colleagues.
I will also speak briefly to Amendments 61 and 62, in the name of my noble friend Lord Willis. These are about the guidance that the HRA produces and who should pay heed to it. Here we have a mini-list, but the not-for-profit and private sectors were missing from it. Anybody who does work for the NHS should be included. The wording should be strengthened from “have regard” to “comply with”. It currently makes no sense whatever. I would be grateful if the Minister can confirm that.
Lord Turnberg
My 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?
Earl Howe
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.
Earl Howe
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.
Lord Turnberg
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.
Earl Howe
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.
Care Bill [HL]
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Baroness Cumberlege
My Lords, I congratulate the noble Baroness on the enormous amount of work that has clearly gone into this amendment and on the way that she introduced it, drawing on a lifetime’s experience in this field. My one reservation is about having to consider what the fundamental purpose of Health Education England is. As I see it, if HEE works well, then in future it will be the engine that delivers a better healthcare workforce in England, thereby improving the quality of care for patients. It is responsible for the education, training and personal development of all NHS staff and for recruiting, from our schools and into our universities, suitable people to carry on these tasks within the NHS. It is employer-led and it is there to provide the right workforce with the right skills and values, in the right place and at the right time, to better meet the needs and wants of patients.
The NHS has more than 300 different specific jobs and more than 1,000 employers nationwide, and the workforce needs to be educated and trained to exacting standards. Its task now is to prepare students for a very different NHS in the future: more care out of hospitals, more focus on long-term conditions, greater integration of health and social care, and new technology and techniques, all of which require planning and changes to curricula, as well as more of a focus on student choice towards NHS needs. It has an enormously difficult and comprehensive job to do. As I understand it, Health Education England accepts and supports the concept of mandatory training for healthcare assistants and the introduction of some sort of certification scheme that would allow HCAs to prove that they had attained the required levels of education and training.
It is a matter for Parliament to decide a view on regulation that goes beyond that recommended by the Government, but I do not believe that Health Education England would be an appropriate regulator. It is not created to have such a role, and that would not sit effectively with its core role of education and training. Therefore, although I very much understand the spirit of the noble Baroness’s amendment and appreciate the knowledge that she brings to the subject, I do not think that HEE is actually the tool to do this with.
Lord Turnberg
My Lords, I, too, welcome the principle behind the noble Baroness’s Amendment 16 but I agree with the noble Baroness, Lady Cumberlege, that Health Education England may not be the right place for this. At various times in our debates I have banged on about the regulation of healthcare assistants, because not only would it reassure employers and patients that standards were being met but being on a register gives individuals a degree of self-respect and sense of identity and it boosts their morale. In a way, it is a pity that we got rid of state enrolled nurses some time ago when we moved to university-educated nurses. In effect, that has been very successful and nurses have done very well—they do a marvellous job—but we have left a gap where the SENs were.
Amendment 23, which moves slightly along this same route, may be as far as we can go but, if we do have mandatory training, that will inevitably mean that someone has to produce a register of those who have received such training. This may not be quite the right place for it but we might get there by another route.
Lord Patel
My Lords, I rise briefly to support my noble friend Lady Greengross. It is not that her sentiments about registration are not right but we debated this at great length during the passage of the Health and Social Care Bill and to a degree I felt that we lost the battle about registration then. What is now important is Amendment 23A, which, with all due respect, is a better amendment because it focuses much more on training and the responsibility of the employer. I agree with the noble Baroness, Lady Cumberlege, that HEE is not the right organisation to be a regulator of registration.
Lord Turnberg
“(b) the use of research evidence to ensure the rapid uptake of innovations into practice”
Lord Turnberg
This group of amendments, to which I have attached my name, is all about putting into practice the brave words we have heard about the need to place research at the centre of what the NHS does.
We have had the important and impressive inclusion in the NHS mandate to NHS England and CCGs of the duty to promote research, and we have had the recent publication of the Association of Medical Research Charities of a vision for research in the NHS with its three proposals. First, every patient should be offered the opportunity to be involved in research. Secondly, all NHS staff should be made aware of the importance of research. Thirdly, the NHS should conduct high-quality research and adopt innovation in healthcare rapidly. All the good intentions were spelt out in the earlier Bill and subsequently, but we seem to have lost sight of that in the current Bill.
Amendment 17 simply makes clearer what seems to be rather vague and perhaps less forceful in the current wording about accepting research evidence and putting innovations into practice. The Bill states that HEE must promote, which is a good word,
“the use in those activities of evidence obtained from the research”.
That has to be read several times to be understood. My amendment suggests something rather clearer, and what I hope is intended, which is,
“the use of research evidence to ensure the rapid uptake of innovations into practice”.
Amendments 20 and 32 aim to ensure that Health Education England also makes it clear that all who work in the NHS should understand and be able to play a part in research and innovation by including a new responsibility, to ensure that research and innovation are incorporated into the Bill. Amendments 37 and 39 point to similar responsibilities for the LETBs. My name is attached to these amendments, which are in the name of the noble Lord, Lord Willis, who unfortunately cannot be with us today because he is unwell. We wish him well. There is considerable danger that the LETBs in particular, dominated by local provider interests, will not unnaturally focus on their need to provide a clinical service and their requirement for sufficient numbers to fill their workforce needs. In so doing, they may not see that a service that is constantly evolving and changing needs a workforce that is fully switched on to the research agenda. They may not see that the future leaders of change—those who can undertake research and introduce new and better treatments year in, year out need to have their training needs met, too.
There are at least two types of need. The first is that of future academic clinicians, professors, senior lecturers, lecturers and the like in medicine, surgery, obstetrics and so on. The second is the need of all practising clinicians, be they doctors, nurses or technicians, if they are to integrate innovations and change into their practices. The academics need training programmes that are sufficiently flexible so that they can do their clinical training for some of the time and their research at others. They will almost certainly need to take three or more years out to do their PhDs, and they often need to do their purely clinical training over a longer period than others, as they slot periods of research into their clinical training.
Those going on to straight clinical practice—always the majority—need to understand what research entails, and will need to have some contact with research. Some may even take full time out for research, and in that way can appreciate new research findings as they come along. All those factors need to be considered by those in charge of education and training locally. I fear that unless something to that effect, as proposed in the amendments, is incorporated into the Bill, it will be so easy for it to slip out of view under the considerable pressure simply to provide services for today, with no thought for the needs of tomorrow.
I am not encouraged by the Department of Health’s document which is the mandate from the Government to Health Education England, in which the section headed “Flexible Workforce, receptive to research and innovation”—a brave heading—spells out what is intended. There is little here about how the intention of encouraging the development of a research-receptive workforce will be carried out. There is much about generalism, flexibility across service divisions and so on—all highly desirable—but nothing about producing those capable of doing the research and engaging in the clinical trials needed to make innovation possible. I hope these amendments will help to fill those gaps.
Lord Patel
My Lords, I support these amendments. My name is attached to Amendments 17, 20 and 32 in the name of the noble Lord, Lord Turnberg, and to Amendments 37 and 39 in the name of the noble Lord, Lord Willis of Knaresborough, who, as we have heard, was taken to hospital yesterday. I spoke to him in his hospital bed just before we started and he was beginning to feel better. I am sure we will want to wish him well.
I strongly support the amendment because, through the Health and Social Care Act, we gave prominence to the need to promote research and innovation in the health service, and it is right that we did that. It would be a pity now if the only gap in that duty would be for it not to apply to the key body, Health Education England, and the local education and training board committees. As the noble Lord, Lord Turnberg, so eloquently put it, the amendments are about education and training by research, and about making sure that LETBs also have a responsibility to make sure that they conform to the functions of the HEE. They are all related to research, training, innovation, continuing training and research and supporting research. They cannot be wrong and I hope the Minister will accept them. They are well meaning and promote research further.
Earl Howe
My 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.
Lord Turnberg
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.
Care Bill [HL]
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Lord Turnberg
My Lords, I strongly support my noble friend’s amendments, which would ensure that local authorities and, in particular, patients and carers can be represented on the LETBs. I have three amendments in the group. Amendment 38 adds to the list of bodies from whom LETBs need to seek advice—namely, the local university medical and nursing schools. I know it is hardly likely that their advice will not be sought since they are so intimately involved in delivering educational programmes, but in case that message is not clear, we need to have it clarified somewhere in the Bill. I recognise that there has not always been unlimited delight felt by the trusts about the way the universities, particularly the nursing schools, have provided education suiting their products to the trusts’ needs. Nevertheless, it would be clearly wrong to ignore them.
Amendment 41 draws attention to the need to include postgraduate deans in the local education and training boards’ activities. It surprises me, to say the least, that the deans are not mentioned at all in the Bill, despite the fact that they are absolutely crucial to the oversight of education and training. I am sure they will be involved but we must have the comfort of knowing that their crucial role is acknowledged by seeing them clearly mentioned in the Bill.
Amendment 50 makes it a requirement for LETBs to include in their list of bodies from whom they need to take advice, the local universities in their patch. It is not enough to include these bodies in the catch-all phrase of subsection (4)(e),
“such other persons as the LETB considers appropriate”.
The medical schools need to be named in that list.
Baroness Pitkeathley
I speak in support of Amendment 51 on the patient and carer voice. I know that there is sometimes resistance to patient and carer representatives on bodies such as this. One often hears professionals say, “They only speak from their own experience”. Yes, they do speak from their own experience—and that is actually the powerful and most informative bit. That is not to say that patients and carers can only speak from their own personal experience; they speak from the wider experience too of other patients and carers with whom they are in contact. That is the most important voice and we should give it a hearing, because very often it is a way of approaching a situation entirely differently from the way in which the professionals would come at it. I am sure that there is a great deal that most professionals, either trained or in the process of being trained, could learn from that.
Lord Turnberg
The 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.
Earl Howe
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.
Lord Turnberg
My Lords, after that tour de force by my noble friend Lord Campbell-Savours, there can be hardly anyone who does not believe that the training of healthcare assistants should be mandatory. Indeed, most of the public would be surprised to know that they are not trained or may at least get through without any training whatever.
I strongly support the amendments. They are a slightly less strict version of Amendment 16 from the noble Baroness, Lady Greengross, in that it focuses heavily on the mandatory nature of the training, and that is of course the basic requirement. It omits the need for statutory registration, but the case for mandatory training is incontrovertible; I cannot see anyone believing that it is not.
I hope that the Government are open to this proposal. It is a valuable step in the right direction, even if we cannot have registration at the moment. I sincerely hope that the Minister will be open at least to this proposal, which has such merit and such strong support from almost everyone; I do not know of anyone who argues against it. I do hope that he might see this sympathetically.
Baroness Hollins
My Lords, my interest is as the parent of two adult disabled children who receive publicly funded care. I did not speak to the earlier amendment on the need for the regulation of health and social care assistants, but I strongly believe that some such staff are currently poorly served by the lack of an adequate professional framework. Many have poor pay and variable conditions of work, and perhaps poor protection for themselves. They also have varying access to training, supervision and education.
To give one example, a care assistant was employed to work with an autistic person without receiving any autism-specific training, even though it was specified in a support plan. One would hope for some basic mandatory training that also specified what future training might be needed to support specific people with specific needs. That seems to be common sense.
My noble friend asked clearly for mandatory training in basic standards of care, and that these candidates should then be registered as suitably trained. It is a neat solution to the problems that we are facing and it makes very good sense. I have one more example: in the interests of more integrated health and social care, care assistants are often required to support disabled or elderly people to access healthcare, but they are not very good at doing that. The confidential inquiry into the premature deaths of people with learning disabilities found that it was often the lack of persistence of people who were supposed to be supporting learning-disabled people that led to a failure in follow-through of their healthcare investigations and treatment.
I have a question about how personal assistants employed directly by people who are in receipt of direct payments would fare under such a system. Disabled people would need assurance that the personal assistant applying to work with them also had basic skills. One would hope that disabled people employing personal assistants would be reassured by the knowledge that someone had been registered as having a certificate of basic standards of care. I add my support to these very good amendments, particularly Amendment 23A.