Health and Social Care Bill

Lord Patel Excerpts

Monday 19th December 2011 Lords Chamber

[Lord Owen]

My Lords, I wish to extol the merits of NICE after watching it from the other side, which is the pharmaceutical industry. It is certainly true that the United States pharmaceutical industry was appalled initially by the appointment of NICE and there are still a lot of people who dislike it intensely. Nevertheless, it has established a scientific credibility which is rare in regulatory activities and which it would be absurd to forgo.

I am worried about a lot of the language used about NICE in this legislation. I know that “direct” will be discussed in another context, but there is an overall intent effectively to bring the body into the Government and make it answerable to them. The important quality of NICE, which was established particularly when it first arose, is its measure of independence. If that measure of independence is lost, NICE’s authority and credibility will go with it. I see a lot of merit in ensuring that the appointment of the chair carries not just the imprimatur of the Secretary of State but the imprimatur of Parliament. The Select Committee on Health, which has shown itself over many years to take an informed and knowledgeable view of the National Health Service, is a credible check on NICE becoming not just another annexe to the Department of Health.

I am also concerned about the additional responsibilities being given to NICE. NICE’s quality came from the fact that it was highly focused. That focus was on the pharmaceutical industry but it was also on science and scientific appraisal. It is a great help to the department to have this authoritative, independent view. We all know how easy it is for so-called wonder drugs to get sponsored by newspapers, individuals or trends. What NICE did was to give an authoritative viewpoint, as far as possible objectively, and to take its time sometimes when there was great pressure for an early pronouncement. It was able to withstand that pressure and say, “Until we get more evidence, we will not be able to form a judgment”. We all know that it is very difficult for the department, for Ministers and for people who are in the front line to have that measure of detachment, but scientific evaluation requires it, as well authority that has been built up over a substantial period.

I hope that the Government will not only listen to the proposers of the amendments but take this issue away and ask themselves whether they are not scoring an own-goal. NICE is an organisation that has worked; not many of our organisations in this field work quite so successfully and build such a substantial reputation within the profession which was sceptical about it. I agree with the noble Lord, Lord Warner, that even the pharmaceutical industry has come to see its value. A lot of other countries are looking at NICE and want something similar to be established. A lot of the language in this part of the Bill goes against that trend. I will listen carefully to the Minister’s reply, but I hope that the Government will have a fresh look at this matter.

[Lord Patel]

My Lords, I have added my name to Amendment 344 tabled by the noble Lord, Lord Warner. NICE should continue to do technology assessments or appraisals. It is not surprising that I should support the amendment, because I was closer to the establishment of NICE than most people may know, although I said so at Second Reading. It was a paper written when I was chairman of the Academy of Medical Royal Colleges, to establish a national institute of clinical effectiveness, which led to the establishment of NICE as an institute of clinical excellence. At the same time as Mike Rawlins, a good friend for many years, started with NICE, I was involved in a similar exercise with SMC, its sister organisation in Scotland.

The key thing about both organisations is that, despite their appraisals of drugs, neither of them has been taken to court about their advice. That says something about the scientific veracity with which examinations are carried out. Although I have views that are sometimes slightly different from NICE—for example, I think that we will have to adjust in due course the QALY from £30,000 a year because we will find with drugs that are more expensive and effective that that price is too low—I go further and say not only that NICE should not be stopped from doing these appraisals but that its remit should be extended to biochemical tests, which should not be used in the NHS unless they are proven to be useful. As genomic medicine advances, more molecular and genetic tests will come on the market. It is already happening in the United States. Tests are used which are not found to be scientifically appropriate and marketed at a ridiculous price. I give the example of a test that is used to predict whether a person with a myocardial infarction will develop chronic heart failure. We use a much simpler test. They charge £8,000 for a test which must be done twice a year; we use a stethoscope to listen to the chest to see whether there are any bubbles in it. If there are not, the person is not in cardiac failure. It is as easy as that and every medical student is taught it. It will become even more important that an organisation that is as respected as NICE is given the task of assessing biochemical, molecular and genetic tests before they are implemented in the NHS, otherwise their cost will be enormous. Every marketing company will come along and say, “This test should be used”, as is happening in the United States. I would therefore extend NICE’s technology appraisal remit beyond drugs. It offers proven, scientifically driven assessments and I cannot see why we should stop them. Besides, we would see one part of the United Kingdom continuing while another part did not. I know that if NICE says a drug produced by a British pharma, particularly a big pharma, is not effective based on QUAL, it might be difficult for that pharma to market the same drug internationally, but that is an issue that needs to be tackled separately. Value-based pricing of drugs may be an area that we need to look at again, but not the appraisals.

[Earl Howe]

My Lords, I know that NICE is held in very high regard by noble Lords in the Committee. The Government share that view. That is why we are putting NICE on a firmer statutory footing in the Bill, extending its role to cover social care as well as healthcare and public health, and putting NICE quality standards at the heart of quality improvement. NICE will continue to play a key role in helping to ensure that decision-making in the NHS is robust and evidence-based.

The noble Lord, Lord Owen, said that the Bill gave the impression that NICE would turn into a kind of annex of the Department of Health. I can assure him that that is not the intention of the Government. A special health authority, as NICE technically is at the moment, is much closer in technical terms to the Department of Health than the non-departmental public body that we will set up. He also said that he felt that the additional responsibilities we were placing on NICE were inappropriate. When I have spoken to Sir Michael Rawlins, the chair of NICE, he does not take that view. He regards what we are doing as a vote of confidence in NICE, which is what it is intended to be.

There has been some confusion throughout the passage of the Bill about the detail of NICE’s future role. This may underlie some of the discussion we have had in the debate around the incorporation of NICE’s technology appraisals into quality standards. First, I can confirm that NICE will continue to appraise new drugs and technologies at least until we implement our plans for value-based pricing from 2014. The Bill enables us to provide for NICE to continue this important work when it is re-established.

As we develop our plans for value-based pricing of new branded medicines, NICE’s role in appraising drugs will inevitably evolve. However, we have been clear that we expect NICE to have a central role in the value-based pricing system, including in undertaking an assessment of the costs and benefits of different medicines. That is highly analogous to its current role. I very much agree with the noble Lord, Lord Owen, that we do not wish to lose—and certainly not downplay—the skills and scientific and analytical expertise that NICE undoubtedly has. We will make announcements on the precise shape of the value-based pricing model in due course but suffice to say for now that we believe that NICE is very well placed to fulfil the role of performing the pharmacoeconomic evaluation that will underpin the value-based pricing assessment.

Alongside that, NICE may also need to continue to undertake some technology appraisal activity after 2014—for example, to review existing recommendations in the light of new evidence or to assess important new non-drug technologies. It is quite wrong to suggest that we will cease that activity within NICE.

I also take the opportunity to reassure noble Lords that we will use powers in the Bill to replicate the effect of the funding direction which ensures that the NHS in England continues to fund drugs that have been recommended by NICE’s technology appraisal guidance. However, it would not be appropriate to place in the Bill such a requirement on clinical commissioning groups—as Amendment 344ZA would seek to do. That would leave no flexibility to alter the requirement in the event that there were clear practical barriers to implementation within three months of the final guidance. Amendments to the existing funding direction have only been made on a small number of occasions but it is important to retain that flexibility and secondary legislation supports this better than putting a requirement in the Bill.

--- Later in debate ---

[Lord Warner]

My Lords, briefly, Amendment 342 is in my name and that of the noble Lord, Lord Patel, who will speak to Amendment 343, which I also support and to which I have added my name.

Amendment 342 was prompted by the rather slow progress that seems to have been made so far on developing clinical quality standards. I accept that these are very important, so there is nothing between me and the Government on the virtue and value of those standards. However, the rate of progress seems to be about five a year, on the information that I have managed to obtain, and at the present rate of progress it looks to be well over a decade before the exercise is completed—and then, I suspect, the whole process will have to start again because standards are likely to be out of date, and science and clinical practice will have changed. This exercise could become rather like painting the Forth Bridge.

I am all in favour of taking care in the preparation of clinical quality standards and of the need for proper consultation to ensure that a spectrum of expertise and discussion is brought to bear on each clinical quality standard. It is important to get clinical support for those standards, but in this area speed is also important if patient care is not to suffer. I wonder therefore whether the processes for preparing these standards do not need some review. It is possible that the resourcing of the work may need to receive some attention. In addition, I believe much work has been done in other jurisdictions—certainly, a lot has been done in the United States—and I wonder whether the Government and NICE could not draw on this work in an effort to speed things up.

To buck things up a bit, Amendment 342 requires the Secretary of State to “agree with NICE” an annual,

“programme of clinical quality standards to be completed or revised”,

in that year. This should ensure that the process and resourcing are kept under review and that faster progress is made. These clinical quality standards are critical to delivering improved quality and efficiency in the NHS at a time of great financial challenge and rapid clinical and scientific advance. We need to press on with their preparation and to ensure that the Secretary of State and NICE give proper priority to this issue. I hope the Minister can agree that an amendment of this kind will help to achieve this. I beg to move.

[Lord Patel]

My Lords, briefly, I support this amendment and Amendment 343, which has been tabled in my name. Although the amendments refer to “clinical quality standards”, I am well aware that the Bill itself refers to them as “quality standards”. It was I and the noble Lord, Lord Warner, who suggested in previous amendments that “clinical” should be introduced, but I recognise of course that these quality standards will concern not only clinical but social care, and there should therefore be a reference to clinical and social care.

I have also made the point before that these standards ought to cover the patient’s journey of care, which goes from diagnosis through primary, secondary and tertiary care and on to social care.

I believe that I know something about clinical quality standards, and while the noble Lord, Lord Warner, referred to standards written in the United States, closer to home there have also been hundreds of standards written over the past eight years. I bet your Lordships now that the methodology that will be used by NICE will be exactly identical, but that is an argument which I will have with the chairman or chief executive of NICE—no doubt over a dinner some time.

What is important about these standards is that they are evidence-based so that it is possible to defend them, just as technological appraisals are evidence based and therefore possible to defend. The evidence that we are looking for is that which will deliver the best outcome for the patient, in terms of safety of treatment, diagnosis, patient experience and outcomes in terms of diseases.

It is also important that they should stand the test of time—that they are written and based on evidence that is tested over time, so that they do not have to change every three months and have people complaining that treatment has moved on. Experience has taught us that it is possible to write those kinds of quality standards, which stand the test of time but, as the noble Lord, Lord Warner, said, they are time consuming to create and therefore they have to be resourced. If you are creating standards for over a patient’s journey of care, it will require several months and expertise to do so. If you intend to have more than five or six standards a year, you require to resource them fully.

Another important issue is that standards have to be tested before they are finalised so that, just as with the technological appraisal of drugs, you do not get complaints from clinicians or anyone else. I can tell noble Lords that doctors are very good at complaining afterwards if they are not consulted. There have to be consultations with both clinicians and the public so that they will feel happier that the standards are evidence-based and will deliver the outcomes that we expect.

A third important aspect is that the standards should be easily understood. I was clear when I did the job that every one of the standards written should get a crystal mark, so that they were written in a language that people could understand. If we are going to evolve and develop information standards, a further value is that each of the quality standards is an opportunity to inform the patient about what they should know about their disease and its treatment. There can be simply written questions that the patients or relatives can use to ask about the problem in question. That gives us an opportunity to use the standards not only to manage the care of the patient but to inform the public and the patients about their disease. That way, you make the public better informed and able to demand the kind of quality care that they should get, so the systems will be operating in a way that delivers care.

My Amendment 343 says that standards should also cover long-term conditions. To me, that deals with the problem of complex long-term diseases, which need to be managed in both the acute sector and the primary or community sector. The standards should therefore be written as a patient journey of care over a longer period of time. Those are the quality standards that we should be embarking on and the numbers that we should provide for.

[Lord Owen]

I thank the Minister for his explanation earlier. I found much of it convincing, particularly his statement that Professor Mike Rawlins thought that this was a vote of confidence in his organisation. I have long had respect for Professor Rawlins—he was an adviser to the SDP many years ago, so I can hardly disavow his advice at this stage. I urge the Minister to consider for one moment that Amendment 342 would go a long way towards reassuring a lot of us. It would take out the word “direct” and put in the concept of agreeing, which would be much more beneficial if he wants to establish the relationship in reality.

Health and Social Care Bill

Lord Patel Excerpts

Tuesday 13th December 2011 Lords Chamber

[Lord Walton of Detchant]

My Lords, I shall be brief in speaking to these amendments. I wholly agree with the principle outlined by the noble Lord, Lord Warner. There are many circumstances in which competition, properly controlled, will benefit the National Health Service and will benefit our community. But, like the noble Baroness, Lady Williams, I too, having worked in the United States, would be deeply concerned if competition were allowed to run riot. Years ago, I saw the affect of this. For instance, in the Massachusetts General Hospital, where I worked many years ago, the president of the hospital told me that they were required to debate and negotiate with no fewer than 47 different insurance companies in order to obtain coverage for the patients whom they treated.

Yet in the United States you still find, in certain communities, perfectly acceptable patterns of community care which are in many ways excellent, not least the Kaiser Permanente plan in California. I also visited an excellent clinic and associated hospital providing a substantial range of primary, secondary and tertiary care to a very wide community in Marshfield, Wisconsin. The Marshfield clinic serves a very large community in that state. All the people in the community pay an annual subscription in return for which they get a full range of primary, secondary and tertiary care of a very high standard. There are islands of excellence.

So far as competition in this country is concerned, I have always believed that the cap imposed upon foundation trusts in relation to private patients was unfair. It was imposed at a particular moment in time and based upon income derived by those individual trusts in a preceding period, and was grossly uneven. I have always favoured a partnership between the public and private sectors. In such hospitals and foundation trusts I believe there is a great advantage to allowing them to have more income from private patient beds: it not only generates income for the National Health Service, it also persuades many consultants to become geographically whole-time, looking after their public and private patients in the same hospital and not having to spend time, as many have in the past, travelling to private hospitals.

I believe in competition and in the public-private mix. But in pursuing that type of programme, it is absolutely crucial that Monitor has the authority to prevent any foundation trust from overstepping the mark and increasing its private provision to the extent that it will harm the services that it gives to NHS patients. I would love to have an assurance from the Minister that Monitor will be able to fulfil the function of controlling excesses which could damage the National Health Service if private provision went too far.

[Lord Patel]

My Lords, briefly, we are getting a bit confused between the amendment of the noble Lord, Lord Warner, which I support and is about anti-competitive behaviour, and people talking against competition. The amendment is quite clear. It asks Monitor, within a year, to identify barriers to quality care that are anti-competitive. The noble Baroness, Lady Murphy, gave one example and there are others, such as optometry services, which can, if given the opportunity to expand, not only provide good diagnostic services but also treat some minor ailments that do not need referral to hospital. Our amendment is about anti-competitive behaviour. It is not about competition.

[Earl Howe]

My Lords, there are some extremely helpful amendments in this group. Indeed, there has been a great deal of valuable debate both inside and outside the Chamber on the roles of competition and integration in the health service. I am grateful for much of what the noble Lord, Lord Warner, said in his introductory speech.

The Government have been clear that both competition and integration can be important tools for commissioners to drive up the quality of services for patients. We have also been clear that it will be for commissioners to decide where and how these tools should be used—not Monitor. There will be no “one size fits all” or a model prescribed by government.

To help ensure that both competition and integration are effective, Part 3 of the Bill seeks to establish appropriate powers for Monitor. Where there is competition, Monitor will have powers to ensure that it operates effectively in the interests of patients and to safeguard against anti-competitive conduct that can work against those interests. The Future Forum concluded that Monitor, as a sector-specific regulator with knowledge and expertise in health services, would be best placed to achieve this. Let me remind the Committee that this is if there is competition. In some circumstances, I freely concede that commissioners may decide that the best way to achieve high-quality services for patients is not to have competition.

On Amendment 265C, I hope that noble Lords will agree that it is the right approach to require Monitor’s focus to be on considering the interests of patients. That will allow Monitor the scope to take account of a broad range of factors. This approach also provides continuity with the requirements of the existing system rules, the Principles and Rules for Co-operation and Competition, which we have committed to retaining and giving a firmer statutory underpinning through Monitor’s sectoral powers. Those powers are the setting and enforcement of licence conditions for providers and the overseeing of commissioning regulations set by the Secretary of State. Along with the concurrent powers to apply the Competition Act with the Office of Fair Trading, they will provide necessary safeguards to ensure that the interests of patients are protected.

To pick up on the sorts of circumstances cited by the noble Lord, Lord Whitty, that would include, for example, safeguarding against providers exchanging information to agree lower levels of service quality than they would otherwise supply if they were in competition; or a commissioner removing a well performing provider from the choices available to patients, or seeking to direct patient referrals to one provider and not another on non-clinical grounds.

However, it is not the case that every arrangement in the provision of healthcare that had the effect of restricting competition would necessarily be anti-competitive. I made that point in one of our earlier debates. I look particularly in the direction of the noble Lord, Lord Whitty, in saying that Monitor’s core duty means that patients’ interests will always come first. For example, in some cases limiting competition by concentrating specialist services in regional centres or in providing services through a clinical network may deliver overriding benefits to patients and would not, therefore, be anti-competitive. Similarly, where an integrated service raises competition concerns, and equally where services offering more choice and control raise concerns over integration, Monitor will always come back to its core duty—to ask itself the question, “What is it that benefits patients the most?”.

Health and Social Care Bill

Lord Patel Excerpts

Wednesday 7th December 2011 Lords Chamber

[Lord Turnberg]

My Lords, my name is also attached to Amendment 257ZA. I also do not like the idea that the HPA is to be abolished, so I hope my amendment is not necessary, which it will not be if the proposal that the clause should not stand part of the Bill is agreed.

I have, of course, extolled the virtues of the HPA on a number of occasions in your Lordships’ House. You could say that I would do that, wouldn’t I?, having been the chairman of the predecessor of the HPA, the Public Health Laboratory Service, but it is certainly true to say that it is the envy of the world, and I am not the only one who says that. The Centers for Disease Control and Prevention in Atlanta, in the United States, are a very well funded counterpart with which we collaborated very strongly, and even they recognised this excellence and envied the fact that we, unlike them, had a network of laboratories across the country primed and ready to detect outbreaks of infection wherever they occurred. Those laboratories were linked into a central laboratory at Colindale, where highly specialised tests could be carried out when needed for unusual infections and where epidemiologists could link up outbreaks in one area of the country with outbreaks in another, so that it was possible to track the speed and spread of infections and prevent them developing into epidemics.

The fact that the HPA is hardly ever in the news is testament to its success in protecting the population. If your Lordships think that because it is so good there is now less need for such surveillance, let me point to the fact that just one set of infections—those responsible for food poisoning—remain a considerable health hazard, and gives rise to about 1 million cases per annum in the UK. Although it is usually fairly mild and often not reported, some cases, such as those due to E. coli, can be very severe indeed, and in the particularly vulnerable can be fatal. Food poisoning is, unfortunately, not showing any signs of decreasing, so the need for constant vigilance is high and the role of the HPA remains absolutely vital.

The amendment sets out two of the planks needed for the agency to contribute to its key roles. The first is the degree of independence that it needs to be able to give advice not only to those out in the field who need to act but very specifically to the Secretary of State and the Government. The HPA must not be seen to be simply the mouthpiece of government. It must have the independence that is so necessary to its credibility. It has stood it in good stead over the years. Its advice is respected and accepted, and we should not lose that now.

The other element of the amendment is the need to be able to undertake research. If the agency is to keep ahead of ever-changing bacteria and viruses, which seem to mutate every week, and to be able to develop new ways of rapid detection, it needs access to research funds. For example, it has excellent high quality researchers, two of whom have recently been elected to the fellowship of the Academy of Medical Sciences, which is a demonstration of their esteem. Over the years it has been fortunate to have access to research funds from the Department of Health, and I understand that that will continue. That, of course, has been of enormous value, but the agency has also attracted research funds in fairly large amounts from external grant funders, and this is funding won in open competition. There is a fear that as an authority that is rather more closely identified with the Department of Health, access to those external funds will be denied to it.

The amendment makes the clear case that the agency must continue to have access to these funds in order for it to function at the highest level. I hope that the Minister will accept the case and look sympathetically at the amendment.

[Lord Patel]

My Lords, my name has been added to Amendment 257ZA and I have tabled Amendment 260 in my own name. I shall try to explain why I have added Amendment 260 to this group. There has been some advice to degroup it, and I have been tempted, but I have left it where it is. First, I agree absolutely with what my two friends, the noble Lords, Lord Warner and Lord Turnberg, have said in relation to independence in research and in the expert advice that Public Health England will be giving, and I shall support that by giving some details.

First, however, I shall refer to the funding issue. I do not understand why it has been suggested that Public Health England should not be allowed to bid for external research funding. I cannot see what the threat would be. I have no doubt that it was the Minister who suggested it, and maybe he was given advice, but I wonder why he was given it. I shall give some examples. The current running costs of the HPA covered by government funds are £145 million. On top of that, the agency receives some capital expenditure and depreciation funding. But the agency itself obtains another £150 million from external sources: funding for research and funding from the services of the HPA which are contracted to other agencies and sectors. These include laboratory services, and nuclear and chemical decontamination services. If I was running a university department and I got £150 million-worth of external funding, I would regard that as pretty good—in fact, as excellent. Most of our universities would struggle to get that kind of research funding.

Where does it come from? The largest source of external research funding comes from the National Institutes of Health in the United States for high containment work on infectious diseases. Both the noble Lord, Lord Turnberg, and I know from experience that to get a grant from the NIH is very tough. The agency also receives external research funding for vaccine evaluation, as well as from the recent licensing of one of HPA’s research-generated products by the Food and Drug Administration in the United States. The agency has a product called Erwinase that is used to treat childhood leukaemias, which clearly demonstrates the commercial benefit of its ongoing research and income-generating potential. That sets out the picture as far as research income is concerned, and I repeat that I do not understand why the agency should not be allowed to bid for it.

The second issue is that of publication. The agency must be independent enough to be able to publish evidence and offer expert advice on all topics in which it has expertise, regardless of government policy. For the public to have confidence in their public health agency, it must have the independence to publish. The Government may not take the advice they are given, but the agency must have the independence needed to be able to publish it, so again I cannot understand why it might not be allowed to do so. Nor can I understand why it cannot publish in any journal it wishes on any of its research or advice. To achieve all this, it is important that it has an independent board with an independently elected chairman. That is one of the crucial amendments I wish to see if we are going to go ahead with Public Health England as an executive agency of the department. That is also why I have tabled Amendment 260, which offers the belt and braces needed if, as the Government intend, Public Health England is established as an executive agency. If it is not given independence in terms of research, advice and its board, what we would then need to do is set up a non-departmental public body. That is the purpose of Amendment 260.

[Lord Walton of Detchant]

My Lords, I too support this amendment, although like the noble Lords, Lord Warner and Lord Turnberg, I would much prefer to see Clause 53 deleted from the Bill. Throughout my professional career I have been familiar with the expertise of the former Public Health Laboratory Service. It conducted research, carried out microbiological surveillance, protected the population of this country from epidemics and so on, looked after the safety of our water supplies, and indeed undertook a huge number of other activities. The noble Lord, Lord Turnberg, chaired that body with great ability and distinction.

I just do not understand the purpose of the Government in abolishing its successor, the Health Protection Agency, which has continued to follow that pattern and to supervise the work of laboratories across the country which were formerly part of the Public Health Laboratory Service. Again, it is difficult to understand what the purpose is of abolishing a body that has proved to be so effective, which continues to give excellent service and which, as other speakers have said, attracts external research funding. If it were to be absorbed into the Government under the Secretary of State, I believe that it would be less able to fulfil its functions and to carry out the distinguished research in which it has been involved over many years. For that reason, while I strongly support the proposal that Clause 53 should no longer stand part of the Bill, if—for the reasons that I hope can be explained by the noble Earl—the Government decide that that clause should remain, it is crucial that we have an amendment such as the one before us in order to preserve the activities of such a vital scientific institution.

--- Later in debate ---

[Baroness Cumberlege]

My Lords, that is great opportunity lost. If we are going to have an executive agency on the lines of the MHRA, that organisation has an independent chairman, not a civil servant. What we really want is an independent chairman. The majority on the NHS Commissioning Board are non-executives. I am very grateful to the Government for going some way, but a little stride further would be very welcome.

[Lord Patel]

I agree with the noble Baroness, Lady Cumberlege. Why does the Minister not think that there needs to be an independent chair?

Health and Social Care Bill

Lord Patel Excerpts

Wednesday 7th December 2011 Lords Chamber

[Lord Walton of Detchant]

I am very grateful to the noble Earl for clarifying the position, but it is important that in the longer term we shall have to learn more about the future of those two very important authorities. In the mean time, the crucial importance of these amendments is to clarify in the Bill the responsibilities of this new organisation which is going to be responsible for regulating research in the UK, and which will streamline and improve the present mechanisms for research approval in many different situations. Therefore, I strongly support these amendments.

[Lord Patel]

My Lords, I hesitated to rise last time because I saw the Minister getting up, and I thought he was about to make a pronouncement to stop the debate because he had a solution to it all, but I realise now that was not the case.

I strongly support the amendment of the noble Lord, Lord Willis. I have my name attached to it. It is crucial that we hear more than just the setting up of the authority, as the Government have announced a few days ago, to take charge of the National Research Ethics Service. I was part of that organisation until I finished my time in the National Patient Safety Agency and was responsible for setting up much of its work, so I take the blame for its shortcomings, if there were any.

The issue we are discussing is why there is a need to set up the Health Research Authority with wider functions than those of NRES. The report produced by the Academy of Medical Sciences identifies serious issues which are important if we are going to deliver on the life sciences strategy announced yesterday and on which I have highly commended the Government; it is excellent. But if we are to deliver on it, we need to streamline the regulatory processes that currently are so cumbersome. For instance, an NHS research and development permission is required at every NHS site where the research is to take place, and the review by the Academy of Medical Sciences confirms that this is perceived to be by far the greatest barrier within the regulation and governance framework. The current process for obtaining research permissions across multiple NHS sites is inefficient and inconsistent. Local negotiation about research contracts and costings is a further source of delay, together with a lack of agreed timelines within which approval decisions are made. Governance arrangements are therefore very important, and the noble Lord, Lord Willis, told us that the report has highlighted that there should be a governance board as part of the Health Research Authority.

The noble Lord gave some examples of delays which had been highlighted by respondents, including in kidney research, stroke research and multiple clinical trials involved in heart research. The solution is to set up an authority which can provide a national research governance service as a part of it. Clinical trials are another example. The noble Lord mentioned how our global share of clinical trials has fallen dramatically. This is particularly related to the fact that it is cumbersome to conduct clinical trials in the UK. To address the challenges identified around clinical trials, improvements are clearly necessary at both the European and the UK level. I know that discussions are going on and that the department is involved in a revision of UK clinical trials, and I hope that they will come to some fruition. The noble Lord also said that the relationship between the new Health Research Agency and the Medicines and Healthcare Regulatory Agency will be crucial in improving the current system. That is an important point, because it was the relationship between the MHRA and clinical trials that at times caused problems.

The problem is that the existing regulation and governance pathways, which evolved in a piecemeal manner over several years, have now become dysfunctional. Although new regulatory bodies and checks have been introduced with good intentions, the sum effect is a fragmented process characterised by multiple layers of bureaucracy and uncertainty in the interpretation of individual pieces of legislation and guidance. This has produced a lack of trust in the system along with duplication and overlap of responsibilities. There is no evidence that these measures have enhanced the safety and well-being of either patients or the public, so the answer lies in now creating a Health Research Authority with multiple functions in order to go forward.

[Baroness Warwick of Undercliffe]

My Lords, I declare an interest as chair of the Human Tissue Authority, whose work is affected by the review of arm’s-length bodies and is referred to in one of the amendments. The desire to streamline the governance and regulation arrangements to support high-quality research underlies both the Government’s intentions and the amendments relating to the new Health Research Authority. These are laudable aims which I certainly support and which the HTA also supports wholeheartedly. Researchers want to get on with their research, and from their perspective what is important is that they see a seamless end-to-end and proportionate process for regulation and governance. The HTA has always striven to do exactly that within its focused regulatory remit relating to research while ensuring that the interests of the public are protected. But transferring the HTA’s work in research to the new body, as Amendment 260A proposes, may undermine these aims. I want to focus my brief remarks on that point.

The Department of Health clearly has favoured an option to keep all the HTA’s functions together, including research, and will consult on that basis shortly. I believe this is to a large extent because of the HTA’s track record of collaborative working to ensure that the regulatory burden on researchers is minimised. I would be happy to provide a range of examples dealing with NRES, the MHRA, the HFEA, tissue banks and clinical pathology accreditation, but in the interests of brevity I certainly will not iterate them now. Suffice it to say that, in the absence of detail at this stage about how the HRA will operate, it would be premature to make decisions now in haste that we may live to regret later. However, I will briefly set out three reasons why I believe that the HTA’s research functions should not be part of the Health Research Authority.

Life Sciences

Lord Patel Excerpts

Tuesday 6th December 2011 Lords Chamber

[Earl Howe]

My Lords, my noble friend has asked some extremely pertinent questions. In answer to her first one, data from GP practices as well as data from hospitals are available today. However, the clinical practice research datalink, which is the new service for researchers being established under the umbrella of the Medicines and Healthcare products Regulatory Agency, will for the first time enable researchers to access very much larger banks of information on a population basis and to target their questions appropriately at the database. I do not see that there is any risk to the technological aspects of that system. The CPRD is using existing data structures in the NHS. It is not changing systems as Connecting for Health attempted to do and has done.

Will this make a difference to clinical trials in the UK? I believe that it is one ingredient of a package that will make the UK more attractive. On its own, perhaps it is not enough. When I recently visited Japan and spoke to pharmaceutical companies there they were extremely interested in this, but of course they take into account the wider picture. That has to include the fiscal environment, where we are introducing a patent box which will protect patents, at a very advantageous rate of tax, on intellectual property invented in this country. There are various incentives aside from that including the corporation tax rate, with ours being the lowest in the G7 in a few years’ time. Also, the establishment of the Health Research Authority is designed to streamline the ethical approvals for clinical trials. The establishment of the National Institute for Health Research also is designed to streamline the all-too-slow process that we have been used to over the past few years. We are determined that, across the piece, we must make this country and the NHS, in particular, the platform of choice for clinical trials in the world. I believe that this can be done, but of course it will not happen overnight.

[Lord Patel]

My Lords, of course I am extremely biased but I absolutely commend the Government for bringing about this strategy. It was necessary to highlight our leadership in all these areas of stem cell therapy, regenerative medicine and other areas of drug development. Those who are concerned about the development of a clinical, practice-based research data bank need not be concerned. We have developed and used such a bank for many years and it works. The unfortunate thing about it is that it has been local. We now need a nationally based clinical-practice research data bank. Such a bank helps not only with clinical research but to improve patient care. Diabetes is an example where such a bank has been used, and where it has worked it has produced improvements in patient care. Last year, for example, it reduced peripheral limb loss by 40 per cent in diabetics. The current figures show that it will probably do the same for eye complications in diabetics. I commend the Government for this strategy.

I am biased because I am a member of the Medical Research Council. I am also a chairman of Cancer Research UK’s Dundee cancer research centre, which co-ordinates clinical research, basic research and clinical practice to deliver better research. For five years I was also chair of the Stem Cell Oversight Committee and developed the stem cell bank, which is the world's biggest stem cell bank. Other countries are envious and want access to our stem cell bank. We are the only country that has clinical-grade stem cells lodged in our bank. No other country has them. It is the clinical-grade stem cells that we will need to use for therapy, and next year we will be the first country to carry out clinical trials for age-related macular degeneration using embryonic stem cells. I do not worry about the patients ruling, either. I know that as scientists we do worry—but somehow we will overcome.

One strategy that the noble Earl did not mention was that of synthetic biology—I am also excited about that, because there was a risk that we would fall behind. The strategy states that an independent panel will be established to produce a road map for technological development in synthetic biology, which is a means of sequencing the effective things that occur in plants and other areas from which drugs can be developed. There are already examples of these in the United States, which have been used there to produce drugs. We will fall behind if we do not develop our research.

The idea of developing an independent road map for synthetic biology is commendable. I therefore ask the Minister, what is the timeline for developing that road map because, otherwise, others will leapfrog over us?

[Earl Howe]

My Lords, I am pleased that the noble Lord mentioned that part of our initiative. As he rightly said, we have undertaken to develop a strategic road map that will set out the timeframe and actions required to establish a world-leading synthetic biology sector. That will be published in spring 2012. To oversee the delivery of the road map, we will establish a synthetic biology leadership council, co-chaired by my ministerial colleague David Willetts, the Minister for Science and Innovation, and Dr Clarke of Shell Global Solutions. I am told that the total timeline for this is 12 months. We therefore intend to move forward on this with some speed. I share the noble Lord’s enthusiasm for its potential.

Nursing

Lord Patel Excerpts

Thursday 1st December 2011 Lords Chamber

[Lord Patel]

My Lords, I note that I am the only doctor speaking in this debate. Noble Lords are right: doctors do as matrons tell them. Therefore, when my noble friend Lady Emerton—the matron—said to me, “You will speak”, I did not argue, but I am very pleased to be able to do so and I thank her for the opportunity.

As most noble Lords know, during my fruitful life my specialty was maternal foetal medicine. I worked in a team that looked after mothers whose pregnancies were complicated by other medical conditions or who developed serious complications during pregnancy or labour. I pay tribute to the most dedicated nursing workforce with whom I had the privilege to work—midwives and specialist neonatal nurses. They were the key members of the team and prevented not only deaths but handicaps among the babies who were born either prematurely or with difficulties, or whose mothers had a difficult labour. They are the most skilful nurses with whom I have ever worked. I still go to my hospital occasionally. I walk through the labour and delivery room and get the usual comment: “Have you come here to work or to drink our coffee?”. I have the coffee, as I do not think that I would be allowed to work. I am going to talk mostly about the current state of affairs in midwifery and neonatal nursing.

We currently have a shortfall in England of between 4,500 and 5,000 midwives. This is partly because of a fall in recruitment but it is also related to an increase of 22 per cent in the number of live births over the past two years. There are now 690,000 births per year in England. Another problem is that the midwifery workforce is ageing. Half the workforce is aged between 45 and 55, and therefore recruiting a younger workforce is extremely important. Not only that, there is a change in the way in which midwives work. Their work has become more complex because of older mothers. There has been a 71 per cent increase in 40 year-old mothers and a 24 per cent incidence of obesity in pregnancy, both of which lead to higher rates of complications in antenatal care and in labour.

There is also a reduction in the overall budget. In 1997-98, the maternity services budget was 3.1 per cent of the total NHS budget. Although the sum might have gone up in total, it was 2.46 per cent in 2010. There is a serious issue of recruitment of midwives and an increase in maternity services. I know that the Government recognise the problem. Even before the election the Prime Minister, as Leader of the Opposition, writing in the Sun pointed out that midwives were,

“stretched to breaking point … overworked and demoralised”.

He promised that when in power, the Government would increase the number of midwives by 3,000. Unfortunately, that has not happened.

I congratulate the Government on the issue of training. They have committed to maintaining the same number of places for student midwives in the 2011-12 academic year as there were in 2010-11, which was a record high. This is welcome as it will help to address the two issues of the midwifery shortfall and the ageing midwifery profession, provided that there are jobs at the other end of the process. Recruitment ought to be part of it.

Last week the Royal College of Midwives published its State of Maternity Services Report 2011, which makes several good points. The key ones suggest steps to address the problem. One is to increase the choice of place of birth—I know that the Government are keen to allow mothers to have a choice—such as midwifery-led units and home births. Births in these settings require less midwife time, and in low-risk pregnancies outcomes are not affected. Other suggestions include: the appropriate deployment of properly trained and supervised maternity support workers to do non-midwifery tasks; a guarantee not to cut midwife training places; and encouraging the health service to increase recruitment and meet the target of 4,000 more midwifes.

There is clear support for more midwives. A recent public e-petition to Parliament calling for the Government to recruit an extra 5,000 midwives has already been backed by 20,000 people. I hope that after today’s debate it might increase to 2 million. I hope that I have made my point that there is a need to address the midwife shortage if we are to deliver quality care to pregnant mothers and newborns.

I turn briefly to the issue of neonatal nursing. As highlighted in the report published on 9 November by Bliss, a special-care baby charity, one-third of neonatal units in England are cutting their nursing workforce, stopping recruitment or downgrading posts. Referenced against the Department of Health’s toolkit for neonatal services, there is a shortage of nearly 1,200 neonatal nurses. Care of the neonates, both premature and following neonatal surgery, is highly skilled, intensive work, and outcomes for those vulnerable babies, including mortality rates, are directly related to skilled nursing care around the clock. Cuts in training and education budgets have led to a shortage of qualified specialist neonatal nurses. We need commissioners and providers to implement NICE specialist neonatal care quality standards. In future we will rely a lot more on NICE quality standards to drive up quality and outcomes in the health service. If they are not implemented—as they clearly are not, in specialist neonatal care— improvements will not come about.

The Government want a reduction in perinatal and infant mortality. Delivering care to neonatal quality standards will go a long way to achieving that. I look forward to the Minister’s comments on both maternity and neonatal services.

Health and Social Care Bill

Lord Patel Excerpts

Wednesday 30th November 2011 Lords Chamber

[Lord Newton of Braintree]

My Lords, I wonder if I might come in on the side of the “sympathy but” brigade, which makes me a member of the same club as all those who have spoken before me. I have a lot of sympathy with the purpose of the amendment of the noble Baroness, Lady Emerton, but I worry about the rigidity of their terms in relation to specifying ratios and a maximum number of people that any nurse can deal with. It seems to me that this is a prescription for a degree of inflexibility that could end up closing wards for reasons that would not be sensible.

I am scarred by something that happened at Birmingham Children’s Hospital in my period as Minister for Health; it arose from a shortage of paediatric intensive care nurses. I do not know whether they are still in short supply but that is the kind of problem that would be exaggerated by this kind of rigidity. Nevertheless, the basic thrust of the amendment must be right.

There is only one other point I really want to make. As I understand it, my noble friend is likely to say that this is not something for the health Commissioning Board, but for the Care Quality Commission. I do not accept that. The Care Quality Commission will be doing snapshots, perhaps a bit more vigorously than it has done in the past, sometimes unannounced and so forth, but nevertheless more often than not there will be a snapshot of the situation at a particular time. I cannot see that the Commissioning Board can commission services without specifying something about the standard at which it expects that service to be provided, and that is relevant to this question of staffing levels in a general sense. So while I believe that it would be wrong to say this is all a matter for the Care Quality Commission, equally I do not believe it would be right to be as rigid as some parts of the amendments are at present.

[Lord Patel]

My Lords, I have my name to this amendment and I support it. I agree with all the comments that the noble Baroness, Lady Emerton, has made. I have only two brief comments. One is based on the evidence and the strength of that evidence. The noble Baroness, Lady Murphy, mentioned California, which passed a law based on the evidence. So what is the strength of this evidence? I have looked at the literature, particularly at meta-analysis of all the literature that is produced relating to staffing levels and patient outcomes, including mortality. Meta-analysis involves looking at all the published literature and its methodology, and only those publications with a methodology that is felt to be good are included in the meta-analysis. The meta-analysis clearly shows that if you look at mortality, infection rates, response to arrest and serious episodes, the staffing ratios of registered, trained nurses to patients—I agree with the noble Lord, Lord Alderdice, that training is important—are important in delivering good outcomes.

The second issue is related to whose responsibility it might be to produce the guidance. If it is not the national Commissioning Board, then it ought to be the commissioners of services—the commissioning groups—that should be asked to consider the staffing ratios of each and every department in the provider’s unit before making contracts with them.

[Baroness Pitkeathley]

My Lords, we shall have extensive debates about regulation at a later stage of the Bill, but it is important to remind the Committee that the ability to regulate healthcare assistants and quality assure them already exists for employers without the need for further statutory regulation. Perhaps in my role as chair of the Council for Healthcare Regulatory Excellence it might be convenient for the Committee and perhaps save the Minister a little time if I respond to the points made by the noble Lords, Lord Alderdice and Lord Walton of Detchant.

The Council for Healthcare Regulatory Excellence, in its new guise as the Professional Standards Authority, will be given the role of quality-assuring voluntary registers. Talks with psychotherapists are already under way and are going very well. The General Social Care Council is going to become part of the HPC, which will in turn change its name and be overseen by what will then become the Professional Standards Authority. That is just for the clarification of the Committee.

--- Later in debate ---

[Baroness Murphy]

I do not disagree with the noble Lord, Lord Warner. It is absolutely true that there is a balance and that size is important. Nevertheless, at the moment we are going back to a size that is approximately the same as the old district health authorities that we had between 1983 and 1992. They survived for quite a long time—

[Lord Patel]

Too small.

[Baroness Murphy]

I agree; they were too small. However, if you want to get that balance and that advantage of the clinical commissioning, it seems that, with a different sort of central support, it would be possible. With some local responses and reconfiguring of commissioning groups and the old PCTs, it can work. I do not feel quite as depressed about the clinical commissioning groups as other people.

Health and Social Care Bill

Lord Patel Excerpts

Wednesday 30th November 2011 Lords Chamber

[Lord Alderdice]

My Lords, I addressed one specific proposal, not the whole world and the whole conduct of the Bill. I addressed one specific proposal, and the noble Lord comes back and tells me, “Has a patient no right to express a view?”. Of course the patient has a right to express a view. There will be public consultation. That is not the issue. The issue is that the noble Lord produced a specific proposal. One of my colleagues found it novel and interesting. I find it novel, but I am not at all persuaded that it has been well thought through, and I am interested that the noble Lord jumped so immediately to defend not the proposal but his posture.

[Lord Patel]

My Lords, I thought that I might get up to say one sentence to stop this conversation from going further. My name is on several amendments, particularly those proposed by the noble Lord, Lord Warner, about competency. I have a simple question, which I am sure the Minister will be able to answer easily. What competencies do the commissioners have to demonstrate before they are authorised to become commissioners? I know that there will be guidance, but what competencies will be looked at that demonstrate that they can be commissioners? I am being very brief today because of being chastised for talking too long; but now I have evidence that suggests that I was not the worst, so I will carry on another time.

[Lord Greaves]

My Lords, I want to say one or two things about the consultation and go back to what I was saying before dinner. The question of patients is a bit of a red herring. To that extent, I think that the noble Lord, Lord Hunt of Kings Heath, was asking to be tripped up over it. Everybody is a patient to some extent, but the important thing is that the residents of an area, or citizens—whatever they are called nowadays—should know what is going on and that there should be an opportunity for a public debate to take place in the normal places—local newspapers, local radio, public meetings—about the future, structure and organisation of the health services in their area.

The noble Lord, Lord Hunt, was absolutely right when he said that there is a huge amount going on at the moment. It is not going on in complete secrecy; people involved in it know what is happening and are telling other people, and people in local authorities and others are having some discussions. However, by and large, there is not a proper process for providing people with open and full—or even partial—information about the proposals that are taking place. I do not think that it is a question of patients being able to tell their doctors which CCG they want to be part of, because the CCGs will be area-based, as we all know, and the doctors will be part of the CCG in their area. The questions are: what area is that going to cover, where is the CCG going to be, and how is it going to fit in to the health service? That is a fundamental question. So to that extent the noble Lord, Lord Hunt, is absolutely right. I think that the question of patients is a red herring.

Whenever I go to see my doctor, I consult him about what is happening in the health service, he consults me about that and all sorts of other things, and occasionally we get around to talking about my health; but I do not suppose that I am a very typical patient. That is a fact of life. However, it is a fundamental problem, and the source of a huge amount of the mistrust about what is going on at the moment is that people simply cannot find out what is going on. That is not in the amendments to this Bill. The Minister and his colleagues simply need to tell the health service to be a lot more open and transparent about what is going on and allow local debate on it.

Health and Social Care Bill

Lord Patel Excerpts

Monday 28th November 2011 Lords Chamber

[Lord Newton of Braintree]

As this is Committee stage, I hope my noble friends will forgive me if I play Oliver Twist and seek a small second bite. I promise to be brief and make only three points. The first picks up on maternity and the remarks of the noble Lord, Lord Mawson, about consultants versus patients, if I may put it that way. I remember, in the far-off days when I used to sign 18th birthday cards to prospective or actual constituents, noticing a remarkable bunching. If you checked back 18 years you would find a correlation with Fridays and particularly the period in the run-up to a bank holiday. Secondly, nobody else has followed up the amendment of the noble Baroness, Lady Royall, about specialist nurses. I have an interest to declare here as—there are probably other things as well—president of the Braintree Parkinson’s Disease Society and the Braintree Multiple Sclerosis Society. The importance of specialist nurses in some of these areas is both extremely great and underestimated. I hope that we will therefore not lose sight of the point made by the noble Baroness, Lady Royall, in her amendment, supported by the noble Baroness, Lady Thornton.

Thirdly, to assure the noble Lord, Lord Walton—who I thought was at one stage going to accuse me of being a wimp for not pressing this to a vote—I do not rule out returning to the matter on Report, unless the Minister is really nice to me.

[Lord Patel]

My Lords, I shall speak to several amendments to which I have put my name, but I shall start with the amendment of the noble Baroness, Lady Cumberlege, to which I have also put my name. The noble Baroness is well placed to talk about maternity services. She has championed their cause, particularly regarding choice, for nearly two decades. It is she who should be credited for getting us to where we are now, whereby choice of where to have their babies is available to all would-be mothers.

The noble Baroness covered most points, and I support them all. The one on which I should like to expand relates to maternity networks. It appears that both the Prime Minister and the Department of Health have accepted that maternity networks are the way to improve maternity services, and I agree. Maternity networks have the potential to increase clinician involvement and service-user engagement in the planning, delivery and, where necessary, reorganisation of services. They also have the advantage of being able to scrutinise the performance and outcomes of all maternity providers within the network, thereby helping to drive up standards and reduce unwarranted variations in outcomes. This will help to develop shared services across the network. Thus a home birth service provided by a modern maternity unit could be made available to maternity units in areas where the home birth rate is very low.

I know that a current review of clinical networks is being undertaken for the Commissioning Board, and is due to report soon. Perhaps the noble Earl can tell us more about it. I hope that the review recommends that maternity networks be established to cover all maternity services in England. The concern is that if providers are expected to self-fund networks, there is a risk that some providers, especially foundation trusts, will not engage in networks, thereby reducing their effectiveness. For this reason, I hope that the Government will accept the case for providing some funding and support for maternity networks in the same way as neonatal networks and cancer networks have been able to access central funding and support.

One other issue that will improve the quality of maternity services, no matter where that care is delivered, is the establishment of maternity dashboards. They are a good way of auditing the outcomes on a daily basis and establishing whether the clinical guidelines have been achieved. I therefore strongly support the noble Baroness’s amendment.

The amendment in the name of the noble Lords, Lord Newton of Braintree and Lord Butler of Brockwell, is saying “comply or explain”, whereby if you do not comply with NICE guidelines you must explain why. I agree. Not all standards should be complied with, because there may be reasons why they are not. If you do not comply, you have to explain why. However, you also have to explain why the outcome for patients will be the same or better, because if the outcomes through not complying are not the same or better, you should not be allowed to fail to comply.

I understand that there might be good reasons why certain NHS bodies do not comply. Another way could be the establishment of an alternative compliance system in which organisations and clinicians are required to justify why they have not complied with the standards or, for that matter, innovations that will aid delivery of the best clinical practice. The Commissioning Board, in conjunction with senates and by way of patient pathways, could develop a compliance regime that measures, monitors and incentivises the use of innovation or compliance where these will improve standards of care. So I support the proposal, and I know that we might return later to the issue that my noble friend Lord Walton raised about innovation, tariffs and the innovation tariff. That is the other side of the coin regarding non-compliance and going beyond the standard of care laid down by NICE.

--- Later in debate ---

Amendments 110 to 120B not moved.

[Lord Patel]

My Lords, the amendments in my name are about patient and public involvement, and accountability to patients and the public. They would amend new Sections 13H, “Duty to promote involvement of each patient”; 13I, “Duty as to patient choice”; and 13J, “Duty to obtain appropriate advice” by the Commissioning Board, in the 2006 Act. I shall also speak to Amendments 141A and 206A. The latter is in the name of the noble Baroness, Lady Hollins, who unfortunately had to leave for another engagement but will return later.

All these amendments are about the requirement for the NHS Commissioning Board and all clinical commissioning groups to engage in meaningful and substantial consultation with users of services, particularly with regard to ensuring that commissioners commission services and pathways that are navigable and coherent.

The current requirement to be placed on the board and the clinical commissioning groups is that they must make arrangements to secure that individuals to whom the services are being provided are involved. It is not enough for the suggested means of doing this to be quite as open-ended as the Bill suggests. The Bill implies that this consultation is really aimed at representatives of patient groups, and I would like clarification from the Minister that both individuals and groups of patients should be able to make representation. It is quite easy to conceive of a situation in which a patient is consulted or provided with information and yet is none the wiser and no more involved in the services that they receive.

--- Later in debate ---

[Lord Clement-Jones]

My Lords, I shall speak to Amendments 127B and 197B. As they relate to pharmacy, I declare an interest as the chairman of the Council of the School of Pharmacy, University of London. The intention of these amendments is to ensure that all relevant healthcare providers, including community pharmacists, are consulted when the NHS Commissioning Board and commissioning groups are discharging their functions and developing their business and communications plans. The essence of these amendments is to retain the long-standing arrangement whereby, under the 2006 Act, commissioning bodies have to consult widely and in good time with all relevant stakeholders, including local service providers or their representatives.

Under the current system, primary care trusts are required to consult widely in relation to their commissioning duties. There is concern in the pharmacy profession that the current provisions under Clause 20, new Section 13J, for the board, and Clause 23, new Section 14V, for clinical commissioning groups, to obtain appropriate advice are too vague. It is important that consultation with all local healthcare providers should be done via local representative bodies as well as directly with providers. Clinical commissioning groups should consult pharmacy professionals when making decisions in relation to the commissioning of relevant services in order that the professional skills, knowledge and expertise of pharmacists are used in planning, commissioning, delivering and evaluating NHS services. They should also demonstrate arrangements systematically to seek the views of all appropriate local clinical groups throughout the commissioning process, in general and for particular services. This would include ensuring that all local representative committees are fully engaged in the commissioning process and signed up to the outcomes agreed.

As part of their local leadership role, clinical commissioning groups also need open and transparent processes for reconciling different professional perspectives and contingency arrangements for seeking the agreement of non-GP professional groups in the case of urgent service change. These processes should be clearly set out as part of the CCG’s governance procedures for commissioning decision-making. The above will be of particular importance in the immediate term, given the influx of new commissioners into the market, to ensure commissioners commission services effectively. Without relevant healthcare providers being consulted, the different contributions that such providers, including pharmacy, can make to local healthcare could be lost.

If used effectively, pharmacy has the potential to deliver a great deal more both to patients and commissioners. For example, it is estimated that some 57 million GP consultations each year involve minor ailments which could be dealt with at a pharmacy. If these patients could be moved to a pharmacy, more than £812 million could be saved annually, and GP capacity could be freed up to deal with more complex cases.

In summary, it is critical that there is a duty on commissioning groups, when developing their commissioning plans, to consult primary care providers such as pharmacists as there is a danger under the proposed legislation that some groups may not do so, leading to ineffective commissioning of services. At the Royal Pharmaceutical Society Conference in September, the Minister said that pharmacists are pivotal to every aspect of the Government’s plans to modernise the NHS. I find those words very encouraging and hope that he can give further encouragement in the course of this debate.

[Lord Patel]

My Lords, I support the amendment of the noble Lord, Lord Warner, on patients holding their own records. Speaking from personal experience, I know that it was not uncommon in maternity services years and years ago for patients to be given their old, shared maternity card. The difference was that that card was extra to the actual notes, so what doctors and midwives wrote in those cards was probably an abbreviation.

For 25 years of my life, I allowed patients to carry their complete set of records, thus avoiding having to write another card. That meant that what you wrote and what you told the patient had to be precise, and clear thought had to be given to the purpose of writing it down. It also taught people not to use abbreviations that do not mean anything, or that might be misconstrued. It is not uncommon for doctors to use abbreviations such as SOB or NAD. They do not mean what you think they might mean. SOB stands for “Shortness of breath”, and NAD stands for “No abnormality discovered”. This also meant that when you were putting the results of diagnostic tests into the notes you were forced to explain to the patient what those results meant. If the results were ambiguous, then you had to explain to the patient what that ambiguity was. That improved the quality of record keeping, communication with the patient and the quality of care given to the patient. In 25 years of allowing thousands of my patients to carry their own notes—and some of the noble Lords sitting today are well aware of my habits—I lost only two notes. One was eaten by a dog in the patient’s house and the other was torn up after being left by the mother-to-be on a bus. Apart from that, there was no loss of notes, while in hospitals usually you can hardly find any notes.

There is a double issue here. How do we make notes that are compatible—easy to write and yet which communicate with the patient. An electronic version is better, but even a hand-written version works. I am convinced that allowing patients to carry notes is not a problem.

--- Later in debate ---

[Earl Howe]

I am. The intention is that no clinical commissioning group will be authorised in the first instance unless it can demonstrate to the board that it can fulfil the legal duties that the Bill places on it. That is key to our thinking. Indeed, as time goes on, it will be under a continuous duty to show it is abiding by those duties. In the first instance, it is very important that clinical commissioning groups demonstrate they are fit for purpose in that sense.

I also appreciate the concern to ensure that the board and CCGs benefit from as wide a range of advice as possible. The Government have been clear that everyone with a role to play in securing the best possible services for local people should be able to do so. The definition used in the duties to obtain advice is that used to define the comprehensive health service. It would encompass the areas covered by Amendment 127C. Indeed, I do not think it would be possible to cast it in broader terms. These duties will apply to every function the board or a clinical commissioning group will exercise. Again, within those broad parameters it is important to retain some discretion for the board and CCGs to determine how best to exercise this duty.

The board and CCGs will certainly have to work closely and effectively with all the providers with which they contract as Amendments 127B and 197B suggest. I would say to my noble friend Lord Clement-Jones that that most certainly would include pharmacists. I also agree as to the expertise and the unique perspective that patients and their representative bodies can bring not just to the commissioning process but also to the way the board and clinical commissioning groups approach many of their functions. The same would apply to many other groups, including academic institutions, as the noble Lords, Lord Kakkar and Lord Walton, have highlighted.

The noble Lord, Lord Kakkar, spoke powerfully in favour of academic health partnerships. Academic health science centres have been successful at developing these partnerships within their local areas but understandably have been less successful in spreading innovation across the NHS. As the noble Lord set out, the NHS chief executive’s innovation review is due to be published next month. That will set out how we can accelerate the adoption and diffusion of innovations across the NHS. It will include a mix of bottom-up, horizontal and top-down incentives and pressures that will drive adoption and diffusion of innovation and behaviour change. The role of academic health partnerships may or may not feature in this review. I hope the noble Lord will forgive me if I do not at this stage anticipate or pre-empt what the report will say by elaborating any further. However, I counsel noble Lords to play close attention to what the noble Lord said in his speech.

While these duties refer to obtaining advice from people with expertise in relation to the health service, that is not confined to clinical expertise. Indeed, in fulfilling these duties we envisage a role for clinical senates, as we have already discussed, in providing not just clinical advice but multidisciplinary advice from professionals in health, public health and social care backgrounds alongside patient and public representation and other groups as appropriate.

I am sure we all share a desire that these duties are effective. However, I am not convinced that imposing specific duties as to where the advice should come from, including through the membership of governing bodies, or how the advice should be acted on is the right way to proceed. If we become too prescriptive we risk overburdening CCGs with so many duties and obligations that they could never be sure whether they were doing enough and in reality we must trust them to build these relationships themselves and judge them on the outcomes they achieve.

The noble Baroness, Lady Finlay, asked me about the secondary-care doctor role on CCGs and whether it had to be somebody from outside the area or retired or whether it could be a local person. We are looking carefully at that question. The secondary-care doctors on CCG governing bodies will not be able to have a conflict of interest in the decision-making process of the CCGs. That is where the noble Baroness, Lady Murphy, was absolutely correct. We will use regulations to set out more detail about this and we will work with stakeholders, including pathfinders, to develop these proposals. The noble Baroness referred to the secondary-care doctor coming from either outside the CCG area or being retired. Those are two ways in which a conflict of interest could be avoided but they are only examples and do not represent an exhaustive list.

I want to finish by returning to a point raised earlier by the noble Lord, Lord Warner. We too are aware of the very good work of National Voices, as well as a range of other organisations, on how patient and public involvement could be strengthened in the Bill. While I have explained why I think these specific amendments are not necessary, I am happy to go on listening. I feel that the Bill is already strong in this area but we are always open to new ideas and I look forward to further discussions on this general topic. It is for those reasons that, while sympathetic to the intention behind the amendments, I am unable to accept them and I hope noble Lords will agree not to press them.

[Lord Patel]

My Lords, on behalf of all noble Lords who took part in the debate I thank the Minister for his comments. He excited us all by first saying that the only thing he would not be able to accept would be the death penalty. He finished by saying he could not accept most of what we were saying, partly because it was already in the Bill, which most of us did not think was the case. He demonstrates a commitment that patients’ voices and public involvement will be paramount and that all the commissioning boards and commissioners will be expected to demonstrate that they listen to the voices of patients and the public. We will watch and see how they are made accountable.

The Minister referred to innovation. Of course, the next group of amendments focuses on innovation, so we may come back to it and also the involvement of the academic health centres. We have had a good debate and maybe after reading Hansard some of us can decide whether we will come back to some of these issues. In the mean time, reluctantly, I beg leave to withdraw the amendment.

Amendment 121 withdrawn.

--- Later in debate ---

[Lord Warner]

My Lords, I will speak in support of Amendments 129 and 129A in the group. First, I will take up the point made by my noble friend Lady Thornton about the long-standing problem of the slowness of the NHS to take up innovative ideas, and the frustration often felt by people in this country who have invented new approaches and created new innovations, only to find that they have had to go abroad to get them projected, promoted and sold, with the NHS being one of the last to take up the innovation, which was often funded in one form or another with public money by the British taxpayer. It is a long-standing problem and not a party-political issue; it has been a challenge for successive Governments. One of the most embarrassing moments one has as a Minister is when one meets foreign delegations or travels abroad to back Britain and is asked, “Has this innovation been taken up in the NHS?”, whereupon one has to shuffle one’s feet and think of a suitably weaselly form of words to avoid answering the question directly. It is a very long-standing and difficult issue.

Amendment 129 draws attention to the importance of the procurement of goods and services in the promotion of innovation, and to the duty that that places on the national Commissioning Board. There are many reports about the importance of public procurement in advancing innovation and in ensuring the take-up of UK inventions and innovative practices. The latest one was by the Science and Technology Committee of your Lordships' House, of which I was a member. The report brought out some of the dilemmas around using procurement to take forward innovation. Yet again it cast doubt on central government's use of their purchasing power and muscle to drive the take-up of UK innovations in public services.

The NHS is not alone in having this problem, but it is part of the problem and it is a big part of the public sector. A major and long-standing problem is that too many purchasing decisions are taken too far down the organisational food chain, with too little intervention at senior level and too little willingness to use large-scale purchasing to spread the use of innovative approaches. Whatever else the national Commissioning Board has, it has a lot of financial muscle. It must use that, through the NHS’s purchasing capacity, to drive innovation, which often comes from publicly funded research. I hope that the Minister, who is well aware of the issue, will see the sense in putting something like Amendment 129 in the Bill. We cannot say too often that public procurement is a way of helping to establish and drive innovation in the NHS.

Amendment 129A seeks to add the idea of an innovation fund to the board's armoury on innovation in new Section 13K. There is nothing novel in this. The amendment continues and builds on the proposals of my noble friend Lord Darzi, which led to regional innovation funds that strategic health authorities currently manage. Again, we need to strengthen the mechanisms in the Bill for driving innovation in an NHS that historically has been slow to take up innovations and apply them to scale for the benefit of patients. We are not talking about huge sums of money in the innovation fund, but relatively modest amounts in relation to the scale of NHS expenditure. However, an amendment of this kind would ensure the continuance of the useful work that has been started by the strategic health authorities following the promptings of my noble friend Lord Darzi.

It is typical of what we sometimes do in this country. We start an initiative with a fund at strategic health authority level and then shuffle the cards so that somehow, along the way, some of the initiatives and their benefits get lost. I hope that we can get some reassurance from the Minister that some kind of innovation fund will be available so that we can continue the work that my noble friend Lord Darzi so ably started to ensure that patients can secure the benefits of UK innovations.

[Lord Patel]

My Lords, I support the amendments tabled by the noble Lord, Lord Warner, to which I have added my name.

First, I will speak very briefly about innovation and procurement. I also contributed to the report by the Science and Technology Committee on procurement. The public sector could learn a lot from the private sector about using procurement to drive innovation. Perhaps the Minister can comment on this. The NHS is a huge organisation that uses about £20 billion-worth of procurement a year and if that was done in a co-ordinated way, it could drive an immense amount of innovation within the NHS.

My second point is about how to drive innovation into clinical care. There are lots of examples I could give, but I will give one from my own specialty. It took us 20 years to take the learning from research into the kind of treatment to be given to the mother in premature labour that would considerably reduce the incidence of respiratory distress syndrome, which causes a lot of harm and death in neonates, and embed that into practice. There are lots of examples of such innovations not being embedded into the NHS and we need to look at ways of doing that faster.

My third point is how to use tariffs to drive innovation. If I as a provider will not be given a higher tariff if I drive innovation or innovate a different way of providing the service, and all that will happen is that the tariff for procuring my services as a provider will be less the following year, there is less incentive for me to use innovation in clinical care to improve patient care and also to make it cheaper.

The fourth issue is about an innovation fund, which I support. Together with the Wellcome Trust, the Government have an innovation challenge fund that asks for tenders in particular areas of innovation. The one I know about is in reducing infection rates. Innovation funds of this kind will drive further innovation; for example, in the United States Medicaid and Medicare have a joint innovation fund to drive improvements in healthcare. So I support that amendment.

[Baroness Finlay of Llandaff]

My Lords, I rise to speak briefly to Amendment 129ZA, which is really a probing amendment. I hope that the Minister will be able to explain what these “prizes” are that are referred to in the Bill. The Explanatory Notes do not really help. They talk about the Bill providing for,

“the NHS Commissioning Board to make payments as prizes in order to promote innovation in the provision of health services”,

and that:

“Innovation will originate primarily from the actions of commissioners and providers but it is intended that the NHS Commissioning Board will take a lead role in promoting it”.

The changes should bring about continuous improvement and innovation often happens outside the main NHS. Indeed, in my own discipline, end-of-life care, the innovations have happened by and large in the third sector, particularly in care in the last 48 hours of life. In some ways, this is where these organisations, the different hospices and those working with them, have felt freed up to pilot different ways of doing things which have subsequently been adopted within the NHS.

There is a huge need for more health services research and for good, qualitative methodology. My only anxiety about the word “prizes” being in the Bill is not that I do not want innovation to happen—I desperately want innovation to improve services for patients—but that I want to make sure that innovations are also properly evaluated; that they are piloted, evaluated and audited in the long term. It is terribly easy for people to have great flashes of inspiration and great ideas but they might not necessarily roll out appropriately across all aspects of the health service. Many of us have seen innovations that seem to be excellent in one setting but when they are rolled out without adequate support and training, mistakes are made and problems arise.

I had the privilege of chairing the commission into medical generalism, and our report noted the shortfall in both funding in primary care and in researching ways of delivering primary care to common conditions. We welcomed the National School of Primary Care Research and the recognition that more funding was needed, but we urged the MRC and other funders to create a dedicated funding stream for clinical research in primary care as it is difficult to secure funding. I hope the Minister will explain what these “prizes” are and say that they will in no way detract from the much needed research funding to really evaluate innovations and innovative ideas, particularly in primary care.

Health and Social Care Bill

Lord Patel Excerpts

Monday 28th November 2011 Lords Chamber

Moved by

[Lord Patel]

133ZA: Clause 20, page 18, line 37, at end insert—
“13L1 Duty in respect of education and training
(1) The Board must promote education and training of the health care workforce, having taken note of the responsibilities of the regulatory authorities, academic and professional organisations, and consulted Health Education England.
(2) In exercising its functions, Health Education England must take steps to ensure that providers of health services in England have due regard to any minimum numbers of training placements that it may specify.”

[Lord Patel]

My Lords, we return yet again to education and training. There is so much anxiety about the issue of education and training and workforce planning that I have had several representations, in particular one from the Royal College of General Practitioners.

Government Amendment 43 places a duty on the Secretary of State to ensure that there is an effective system for the planning and delivery of education and training of the healthcare workforce. In order for this to be an effective system, a duty must be placed on the NHS Commissioning Board to promote education and training. This amendment seeks to do exactly that. As the board is nationally accountable for the outcomes achieved in the NHS and is also tasked with providing,

“the support and direction necessary to improve quality and patient outcomes and safeguard the core values of the NHS”,

it is only right that this duty to promote education and training is included as part of the core responsibilities of the NHS Commissioning Board alongside the existing duties in respect of research, variation in the provision of health services, and so on.

We must try to get education and training structures right so that the long-term sustainability of the health service is maintained with patient care continually improving. This must be reflected in the approach taken to commissioning, with the NHS Commissioning Board taking note of the needs identified by regulatory authorities and academic and professional organisations so that plans are in line with national strategies. In carrying out this important role the board should consult Health Education England as it has a vital role in providing sector-wide leadership and oversight of workforce planning, education and training in the NHS.

The second part of my amendment deals explicitly with the role of Health Education England, as it will oversee the current system for providing education and training via a levy set on providers, and aims to make sure that there is adequate capacity in training to meet the needs of the health service. Under the current proposals, healthcare providers are to work together in provider-led networks to manage the planning and commissioning of education and training. However, if there is no specification of the minimum number of placements—the minimum number of trainees that should be provided in each sector—providers, especially those such as alternative or private providers that might work to make profit, with shareholders to answer to and an increasing range of competitors, will have little impetus to provide adequate numbers in the long term. The future of the NHS depends on having sufficient numbers of trainees in all specialties, including general practice, and the training of the next generation of doctors and other healthcare professionals will be put at risk if these plans are not strengthened. Furthermore, with the likely greater specialisation of some providers, and the non-requirement for all providers to provide educational opportunities, there is a risk that the overall quality of postgraduate generalist medical education will be affected due to reduced opportunities to widen the range of disease types and treatments that the students will see.

The policy of any qualified provider, alongside the pressures of the Nicholson challenge, should not be allowed to affect the provision of education and training by providers, whether they are new or old. Health Education England should therefore be tasked with taking steps to set a minimum number of trainee placements for each sector within the health service and to hold providers to account where necessary.

The amendment demonstrates the anxiety felt by a whole range of people in different parts of training and education. I know that the chairman of the Academy of Medical Royal Colleges, the medical school deans and the postgraduate deans have recently sent a letter to the Secretary of State expressing their concerns. I hope that it will be possible to get this right with a solution that is acceptable to all sides, including the Government, so that we have in the Bill something which does not affect government policy but demonstrates that the Government are serious about making sure that the education and training of the healthcare workforce will be a priority.

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

My Lords, it may assist the Committee if I indicate at this early point in the debate that the Government are extremely sympathetic to this group of amendments. As noble Lords will know, I have already committed to publishing, prior to Report, a much more detailed set of proposals for health education and training in the light of the forthcoming recommendations of the NHS Future Forum, and I hope that this will prove helpful. However, I can now go further.

These amendments focus on how commissioners in the new system will foster high-quality education and training in the health sector and on the potential role of regulators and Health Education England in supporting the education and training system. The Government have listened carefully and we are persuaded by the intent behind these proposals. I therefore now commit to taking away the amendments, considering them in a constructive spirit and bringing forward our own proposals on Report aimed at addressing the issues raised by the amendments. I hope that the Committee will welcome this undertaking. I am of course willing to meet noble Lords between now and Report to discuss the underlying issues further.

[Lord Patel]

I am grateful to the Minister for those comments and am greatly encouraged.

[Baroness Finlay of Llandaff]

I add my thanks for the Minister’s remarks. I look forward to seeing amendments which thread education and training through all parts of the Bill with duties on everybody at every level.

--- Later in debate ---

[Earl Howe]

My Lords, no, because the Bill does not cover the duties of the regulatory authorities themselves, the professional regulators that is to say. My undertaking should be read as relating to the Bill itself and the bodies and structures it sets up.

[Lord Patel]

I beg leave to withdraw the amendment.

Amendment 133ZA withdrawn.