Health and Social Care Bill — Committee (14th Day) (Continued)

House of Lords, 19 December 2011.

Lord Patel (Crossbench)

My Lords, I shall speak to Amendments 338 and 340, to which I have added my name in support of the noble Baroness, Lady Emerton. For those of your Lordships not familiar with the amendments, they are to do with the regulation of healthcare support workers. As many noble Lords will know, these workers were introduced into the health service just over a decade ago, and they are untrained, unqualified and unregulated. There are 300,000-plus of them in the health service, with many more working in nursing homes.

Any debate about the regulation of healthcare support workers will need to take account of current workforce trends. In April 2011, the Royal College of Nursing reported that NHS trusts were increasingly looking to reassess nursing roles in order to deliver short-term reductions in the wage bill without a full clinical assessment of the impact of this action on patients' safety and the quality of patient care. The RCN reported a notable change in the skill mix of teams, with an increased reliance on unregulated healthcare support workers.

The other workforce in nursing is trained and regulated. It is made up of registered general nurses and registered midwives, and we also used to have state-enrolled nurses. The view could be taken that it is the responsibility of employers to make sure that their workforce is adequately trained and has the skills to deliver the care, but many recent reports with which noble Lords are familiar highlight poor-quality nursing care. Some of them have appeared in the press and include the failings at Stafford Hospital, where hundreds died unnecessarily, and at Winterbourne View care home, where staff were filmed abusing vulnerable patients, as well as a series of critical reports, most recently from the Care Quality Commission, which has condemned NHS care for the elderly. Some, including regulatory authorities and particularly the Council for Healthcare Regulatory Excellence, favour the employer-led model of training of healthcare support workers or of those who are not trained yet provide nursing care. This model was introduced in Scotland. The important thing is that it has never been evaluated. That needs to be done first. Secondly, and more importantly, the ratio of trained nurses to untrained support workers is quite different in Scotland. Anyone who promotes this model needs to look at that first.

I return to some of the issues. The noble Baroness, Lady Emerton, made all the points in an excellent introductory speech. It is a pity that we did not have a continuation of the debate so that we could have heard her comments and responded to them. However, the Bill proposes that the regulators of healthcare professionals should have the ability to establish voluntary registers for currently unregulated workers and professionals who are, or have been, engaged in work that supports or otherwise relates to work engaged in by members of the profession that the body regulates.

In proposing voluntary registration, the Government have accepted that unregulated workers supporting healthcare professionals represent a risk to public protection that needs to be addressed. If they did not, why would they even consider voluntary registration? It must be because they think it is a risk. Voluntary registration for healthcare support workers carrying out tasks delegated by nurses or midwives is not sufficient to protect the public.

The other argument used is that it is the trained nurses-the registered nurses-who supervise these support workers who are not trained or regulated. How can a nurse, or two nurses, in a ward of 15 or 16 intensive care patients, supervise three or four unregulated, untrained workers, who then carry out nursing tasks? The noble Baroness, Lady Emerton, cited a real case of such a worker measuring blood pressure who did not understand why she was doing it. If one is going to have people who look after ill, frail people, one needs to make sure that they are trained properly, that their training is assessed, and that they are regulated. I understand that this cannot be done overnight, particularly as we now have nearly 400,000 such people working in the health service, but there ought to be some mission to do this in a relatively short time, maybe even in two or three years. To go after voluntary registration is not the answer.

There is currently no consistent UK-wide training standard for healthcare support workers. Courses can range from an hour-long induction up to NVQ level 3. Assistant practitioners are experienced health support workers. They are different, and they may receive training up to NHS-level band 4, which is equivalent to the level of the previous state-enrolled nurses, but, again, there is no consistency across the UK. Clause 231 gives no indication that a voluntary system will be underpinned by consistent UK-wide standards of training that will assure the public that employers who employ health support workers have the knowledge and skills that they need to practise safely. I strongly support this amendment. Whenever the noble Baroness wishes to call a vote, I will join her.

Lord MacKenzie of Culkein (Labour)

My Lords, I have long been an advocate in the cause of statutory regulation and registration of healthcare support workers. When one has been around the health service for a long time, it is not unusual to see the wheels turn full circle. We went from support staff to auxiliary nurses, to nursing assistants, to state-enrolled assistant nurses. Then the word "assistant" was dropped and we had state-enrolled nurses. Then, as the noble Baroness, Lady Emerton, said earlier, the roles of the state-enrolled nurse and the registered nurse became very confused and the titles became interchangeable, which should never have happened. Then we moved to Project 2000 and the move from hospital-based training to higher education, and we are now moving from diploma to an all-degree profession, which is right and proper.

In 1999, my union, the Confederation of Health Service Employees, supported Project 2000, but we foresaw a gap that would be left by the ending of enrolled nurse training, which would lead to there being many more auxiliaries or healthcare assistants, as they became. We called for support workers to have about a year's training to an agreed national standard and statutory regulation by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting, as the regulatory body was called. We did not get that. The idea was opposed because it was argued that it would replicate the then existing confusion between enrolled nurses and registered nurses.

Where are we now? We have an explosion in the number of support staff who have taken the place of enrolled nurses; there are far more than any of us ever envisaged at the time. As the noble Lord, Lord Patel, said, more than 300,000 support workers are now employed in various roles with a number of job titles. One figure that I saw in research produced by UNISON said that there were more than 120 different job titles for healthcare support workers, which is astonishing.

We have a situation in which the patients do not know who is caring for them. It is not just a question of uniform, although that is important. Support staff carry out many duties that were previously the role of regulated nurses. Many of those roles, such as nasal gastric tubes, cannulation, catheterisation and blood pressure, are intimate and invasive, as we have heard. Almost uncannily, in view of what the noble Baroness, Lady Emerton, spoke about, I spent some time in hospital a couple of years ago when I had my blood pressure taken sitting in a chair beside the bed and my diastolic pressure was down to 40. I said to the healthcare assistant who took that blood pressure, "I had better get back to bed and I think you'd better call a senior nurse and doctor". She said, "No, you are going down for an MRCP scan; just sit where you are". Fortunately, being a nurse, I knew what I was talking about and I was able to get a doctor and a nurse, and before very long I had massive amounts of fluid pumped into my veins to restore my blood pressure. Had I not understood the situation, that could have resulted in a serious condition. It is quite frightening. You can be trained to take blood pressure, but not trained in the skills of observation and in understanding the readings that are being taken.

With the drive to reduce costs, there is, and will be, more substitution of registered nurses by healthcare workers. In effect we have a new second level, but that new second level is not regulated and not registered and the staff are not professionally accountable for their practice. That is not good enough. That is not in the interests of patients' safety or protection. Nor will assured voluntary registration deal with the matter. Voluntary registers already exist for other professions and there are very real concerns about their inadequacies. They have no teeth, and staff can leave a voluntary register, particularly if there is any investigation for possible discipline.

The registration and regulation of healthcare support workers is supported by the Nursing and Midwifery Council, by the Royal College of Nursing, and by UNISON, although in fairness I should say that UNISON would prefer registration by the Health Professions Council. Registration is supported by the Queen's Nursing Institute, by the health committee in another place and, most importantly, by healthcare assistants themselves.

In the Nursing Times of 6 December, I was interested to see in a small article about the Mid Staffordshire NHS Foundation Trust public inquiry that Robert Francis QC spoke of 20 issues that he would consider when drawing up his recommendations, which are due to be published next year, and the regulation and training of healthcare assistants was to be first on the list. I hope that that does not mean that they will carry the can for all the problems in Mid Staffordshire because that is certainly not the case; they go to a much higher level than that. Counsel to the inquiry, Tom Kark QC, said that the lack of regulation of healthcare assistants appeared to be surprising and dangerous.

There is inexorable pressure for this matter to be dealt with-and dealt with soon. It is not something that can be put on the long finger. If there is a strong recommendation from the Mid Staffordshire inquiry, we cannot leave it to be dealt with in a future Bill because we will not be getting another health service Bill for some time. This Bill gives us the opportunity to do this and to get it right. I strongly support the amendment by the noble Baroness, Lady Emerton. Healthcare assistants who have work delegated to them by nurses should be properly regulated and registered.

Baroness Pitkeathley (Labour)

My Lords, I am very sorry to take issue with the opinions of noble Lords with whom I usually agree most heartily. I remind the Committee of my role as chair of the Council for Healthcare Regulatory Excellence. I should make it clear that I am in no way taking issue with noble Lords' concerns about the practice of healthcare assistants, nor with the emphasis-given particularly by the noble Baroness-on the need for proper training. The only thing I take issue with is whether statutory regulation is the correct solution to the problem.

I am not aware of any body of evidence that demonstrates that the risks of future harm presented by the practice of healthcare assistants could not be successfully managed by the existing processes and governance systems if they were applied effectively. That is the point. Healthcare assistants are already supervised by other staff who have the professional responsibility to supervise them. As we have heard, they almost always work in supervised settings, with supervision usually being the responsibility of staff who are statutorily regulated. Statutorily regulated professionals have a responsibility to ensure that the staff whom they manage offer safe care, conduct themselves professionally and are delegated only tasks that are within their technical competence. For example, the Nursing and Midwifery Council's code states:

"You must establish that anyone you delegate to is able to carry out your instructions ... You must confirm that the outcome of any delegated task meets the required standards ... You must make sure that everyone you are responsible for is supervised and supported".

In other words, we already have in place a governance system to ensure that healthcare assistants work safely and with proper delegation, supervision and support from a statutorily regulated professional. Employers are required to ensure safe systems of work, which will include providing support in delegating and supervising effectively.

Creating a list of people is not in itself an effective safeguard. Effective regulatory conditions are often much closer to home. For example, in an environment that is poorly managed and distant from scrutiny, poor standards of care can become the norm, with staff being drawn into collusion with poor care. We have seen many examples of this recently, particularly of the process of collusion, with people working in a poorly managed environment unable to resist the downward spiral of standards. The most effective way to invert the spiral is by employers properly managing the specific environment, not by establishing another structure.

Winterbourne View was referred to several times in this short debate. Perhaps it is worth reminding noble Lords that registered professionals were involved in delivering poor care there. Statutory regulation did not prevent it. We should always bear that in mind. Regulation is not necessarily the answer. Further, we cannot ignore the fact that statutory regulation would be expensive and cumbersome for a large, low-paid workforce with a high annual turnover. It is not proportionate to the risk, which can be managed by effective training, delegation and supervision.

The recent announcement by the Secretary of State about improving standards of training and the potential to develop a voluntary register of healthcare assistants is encouraging. I also welcome the Nursing and Midwifery Council's announcement that it will fully engage with the project that the Secretary of State announced, and with any further developments around assured voluntary registration for this particularly valuable group in the healthcare workforce. It is important that we make sure that we value this group, who are of such importance in the front line of the nursing and patient care environment.

Lord Warner (Labour)

My Lords, I am speaking because my name is also on this amendment. We need to reflect on several aspects relating to the context of this issue. I do not think that there is much doubt that we have a problem of some significance, or any doubt that the problem has been growing over a long time. I also do not think that it is an easy fix simply to jump to statutory regulation. I went through the process when the whole issue of regulating social workers arose, and that proved extremely difficult to introduce. I do not doubt that we will end up with statutory regulation of some kind, but we might have to go through some processes before we get to that point.

I do not want to duplicate the history that other noble Lords have put forward most expertly. I came into this story as a very young civil servant at the end of the 1960s when the Salmon committee was set up. Some noble Lords may be old enough to remember the Salmon committee-I was assistant secretary to the committee. This was in the days when civil servants could not hold a job for long and were moved on at a tremendous rate. While doing this work we saw how things worked at the ward level. In those good old days of the 1960s and early 1970s there was a ward sister, state-registered staff nurses, nursing auxiliaries and state-enrolled nurses. We also had a set of arrangements in which oversight of cleaning was largely the duty of the ward sister. Furthermore, bank working was not that common.

What has happened since those "good old days" is that hospitals have become used more intensively. Bank working has meant that there is a higher flow of different people moving through the wards, and the profession, with good reason, has wanted to make itself a graduate profession. The context has changed a lot, so the dynamics of those wards has changed quite a lot.

Alongside that we have been growing another industry in the community: in nursing homes, residential care homes and-not quite as fast as one would like, within the health service-a district nursing service. One of the problems in both these areas, whether acute hospitals or the community, is that with the demand of patients for services, and the demography which has gone alongside that shift in time, the qualified and registered nursing profession has inevitably had to look for help from sub-professional groups to help carry the load. In the community there is not a strong management structure to oversee this, so to some extent it is difficult for district nurses to oversee any work done by unqualified personnel. Such oversight might be the theory but in practice it will often be difficult to achieve.

Community services are burgeoning, the hospital service has changed, and we have a problem of a growing need for more people who are not qualified and registered nurses to work alongside such nurses to provide some of the care. We are looking to the Government to produce a comprehensive review that examines the situation that we face now rather than the situation we faced 10 or 15 years ago and which was very different.

I suspect that we will have to move by interim steps towards statutory registration, and perhaps voluntary registration is an interim step. However, I am not convinced that we have a comprehensive set of answers to a continuing and serious problem. The Government need to think about how they will deal with this very serious problem.

Lord Alderdice (Liberal Democrat)

My Lords, I also have some scepticism about assured voluntary registration, but I will come back to that when we debate the subsequent amendment. I have some sympathy with the noble Baroness's amendment. I had not intended to speak on this amendment until I heard a number of noble Lords speak, and I take a slightly different lesson from the history of the past number of years in the development of the nursing profession.

Like the noble Lord, Lord Warner, I remember sisters, state registered nurses, state enrolled nurses, nursing auxiliaries and so on, but one of the key things was that all those professionals described themselves as nurses. Indeed, I very well remember as a young doctor that nurses would not say, "I looked after that person", or "I was on the ward when that patient came in before", but said, "I nursed that patient". There was a quality of compassion and relationship that was critical to the profession. I think that not only nursing as a profession, but many other professions went down the wrong road when they took the view that the future was in tighter registration and a graduate profession because that was not fundamentally the need. I heard my right honourable friend in another place being asked questions in the past few days about poor care of patients with dementia, and he made a very important point. He said that you can find two wards beside each other in a hospital with nurses with exactly the same level of training and qualifications but in one of those wards the patients are cared for with compassion and in the other ward they are not. When we move to healthcare support workers, it seems to me that whatever we move to, we do not move to a title that expresses compassion and care for the patients who are being nursed.

My gratitude to the noble Baroness is not for the specific terms of her amendment, and I do not think that they were the burden of her bringing the amendment forward. It is that we engage in a serious, proper debate about this issue, not just for nurses, but for other professions. There are some for whom I believe that statutory registration is the proper way ahead, but there are others for whom it does not seem to be the case that always moving to graduate professions with training and registration is the sole and most important way of dealing with these questions. It is quite clear that making nurses graduates and having registered nurses only has simply opened a door that has had to be filled with other, less qualified and, it has to be said, less expensive employees. Now we have a problem with them not measuring up to the professional standards of compassion that all of those-or at least, almost all of those-who aspired to be nurses at whatever level in the past aspired to in the best sense.

I welcome the fact that the noble Baroness has tabled this amendment; I am not quite sure it is the precise solution, but I hope we find ways to come back to the serious ongoing debate that the noble Lord, Lord Warner, has pointed to because there is a crisis in this area. I remember saying this two, three, four years ago in your Lordships' House and noble Lords who are now on the Benches on the other side thought it was simply a party-political attack. It was not-it was a genuine sense of concern that things were deteriorating. They have continued to do so, and it will not be dealt with solely by registration, training and academic qualifications because a quality of care and compassion and a culture of compassion are necessary. That is not to take away from the question of assured voluntary registration, which I wish to explore in a further amendment.

Lord Hunt of Kings Heath (Labour)

My Lords, I, too, pay tribute to the noble Baroness, Lady Emerton, for her perseverance and determination in this very important area. Rather like the noble Lord, Lord Alderdice, I am clear that the role of healthcare assistants has to be seen in the context of a much more general debate about nursing care, including the compassion that he talked so eloquently about.

As the noble Baroness said to us rather earlier this afternoon, we had an excellent debate on nursing on 1 December, and we are presented with something of a paradox: on the one hand, we should not ignore the huge advances in the nursing profession over the past 20 years. There has been the move to a graduate profession and nurses have taken on much greater responsibility, including for complex care and specialist care, and I think that, overall, the public have welcomed that increased responsibility. At the same time, there has been real and mounting concern about basic standards of care and issues to do with hygiene, feeding of patients, nutrition, dignity and even face-to-face contact-the kind of compassion that the noble Lord, Lord Alderdice, has just spoken about. We have seen the reports from unannounced visits of various bodies. Recently, the CQC has undertaken important visits to many of our hospitals. There seems to be real evidence and concern about a falling of standards of basic care.

The reasons for that are not clear. It is possible that nurse training is now too focused on academic performance rather than on practical nurse training. It is also at least possible that the drive for specialist nurses and modern matrons has taken from the ward the many experienced nurses who, in retrospect, might be better placed in leading their ward as ward manager or senior sister. What is not in doubt is the need for serious thinking about how we can enhance the overall quality in standards of basic care that nurses give.

That brings us to the role of healthcare assistants. Again, in our debate on 1 December, the noble Earl, Lord Howe, in responding, referred to the concerns that had been expressed about nursing in the acute sector in particular. He said he felt that that,

"related to inappropriate delegation by nurses to healthcare",

assistants. He continued:

"Wherever there is a multidisciplinary team of regulated professionals and unregulated healthcare workers, appropriate delegation and supervision is vitally important. This is an area ripe for formal review".

He also said that the Government welcomed,

"the NMC's plans to update its guidance on delegation",

and that they have,

"asked Skills for Health and Skills for Care to accelerate production of a code of conduct".-[Official Report, 1/12/11; col. 419.]

I am sure that those actions by the Government are very generally welcomed. The question before us is whether they are sufficient. From what the noble Baroness, Lady Emerton, has said, it is clear that she does not think that they are. Powerful support for that argument has been received from the Nursing and Midwifery Council, which argues that a system of regulation for healthcare support workers should contain provisions for consistent UK-wide standards of training and practice that would assure the public and employers that they have the knowledge and skills to practice safely. It further suggests a mandatory register to ensure that workers who have been struck off the nursing and midwifery register are not re-employed in a healthcare support role, which has been the subject of some concerns. It is also notable that the House of Commons Health Committee supports mandatory statutory regulation of healthcare assistants, which it believes is the only approach that would maximise public protection.

However, we have heard from my noble friend Lady Pitkeathley, chair of the Council for Healthcare Regulatory Excellence, who has put a different view. It will be interesting to hear the response of the noble Baroness, Lady Emerton, on why she thinks that a voluntary register for healthcare assistants is the way forward. I should like to ask her whether she would support NHS bodies which require healthcare assistants to be voluntarily registered as a condition of employment. If that were the case, what safeguards does she think could be put in place as regards a worker who was dismissed because of poor conduct towards a patient? How could we ensure that in those circumstances that person could not then work in another part of the care sector? That seems to me to go to the heart of the issue of whether a voluntary register could work.

I have no doubt that NHS employers could be encouraged to make it mandatory but the problem with that is that too many people could slip through the net. I would also ask the noble Baroness to respond to my noble friend Lord Warner. I share his view that, clearly, we are crying out for a fundamental review of these issues around nursing quality and care, compassion, and dignity of care being given to patients, and that relationship to healthcare assistants. If the Government are not prepared to move on this and on the point about only going as far as a voluntary register, can they at least give some comfort and assurance that they recognise that this matter needs close attention?

I am not a great believer in royal commissions-I think it was Harold Wilson who said that they could be established in a minute but take years-but there is a strong case for a fundamental review of the nursing profession, embracing healthcare assistants. Would the Government be prepared to give us some comfort on this?

Baroness Northover (Liberal Democrat)

My Lords, these amendments seek to extend compulsory statutory regulation to healthcare support workers. I thank noble Lords for the amendments because they raise important issues about the ways in which we assure the quality and safety of those who work in support of our regulated health professionals. The Government are publishing a fact sheet on this issue that will contain further details about their proposals, which I hope will be helpful to noble Lords.

There are more than 200,000 nursing assistants and approximately a further 1 million people working in similar jobs in adult social care in England alone. The majority of support workers give the highest quality of care. However, a minority let patients down. This is rightly a cause for concern, although as a former historian I have to say that I do not fully recognise the notion of everything having been perfect in earlier periods but everything breaking down at this point. One needs only to look at what has been said since Florence Nightingale onwards about what happened during the interwar periods, during times of war and so on. This has always been more varied than perhaps noble Lords are allowing for. Nevertheless, it is extremely important that we try to drive up quality and ensure that quality holds good right across the health service and social care. It is right that there is discussion and debate about the best way of ensuring that high standards of care are delivered at all times.

As the noble Baroness, Lady Pitkeathley, pointed out, there are already existing tiers of regulation that protect patients and service users. Professionals struck off by their regulator or sacked by an employer who pose a risk to vulnerable adults or children should be referred to the Independent Safeguarding Authority, which has been very clear that it expects this to happen. In the same way, employers should make referrals about individuals from unregulated groups where they pose a risk of harm to vulnerable adults or children. Providers and employers also play a key role in ensuring safe, high quality care that patients and service users can be confident in, being both responsible and accountable for the staff they employ. Under the registration requirements of the Care Quality Commission, providers must take steps to ensure that at all times there are sufficient numbers of suitably qualified, skilled and experienced persons employed for the purpose of carrying on any regulated activity.

An individual being on a list does not alter this and would not remove employers' responsibility to undertake a range of checks on the suitability of any persons who they appoint, including qualifications, relevant registrations, employment history and reference checks to ensure that an individual is competent for a specific role. Equally, appropriate delegation and supervision is a necessity within teams made up of both regulated and unregulated professionals and workers. Guidance by the Nursing and Midwifery Council is being updated so that nursing staff know how to delegate appropriately and safely.

We are not ruling out compulsory statutory regulation for healthcare support workers, but our view is that the case has not yet been made for imposing further compulsory statutory regulation, given the tiers of existing regulation and the duties on regulated professionals. There is no solid evidence that demonstrates that healthcare support workers and adult social care workers should be subject to compulsory statutory regulation. Research by King's College London concluded that little evidence could be deployed to show that regulation of healthcare support workers would reduce the risk to the public, although it was clear that some healthcare workers were undertaking roles that had traditionally been done by nurses. The point is that quality is not always what is delivered. Therefore, we have to try to tackle that concern and not simply assume that regulation will deal with it. As the noble Baroness, Lady Pitkeathley, mentioned, there are regulated professions which are in some instances letting us down. We must focus on the real problem and figure out ways of tackling it.

The Government's view is that high standards for healthcare support workers and other professional occupational groups can be assured without imposing compulsory statutory regulation. That is why, in the wider context of supporting providers, we are creating through the Bill a system of external quality assurance for voluntary registers. To pick up the point made by the noble Lord, Lord MacKenzie, there are various examples of voluntary registration for groups of professionals. We are proposing a quality-assured voluntary approach, looking at how those registers are set up and operated and what training is offered and so on. A quality-assured voluntary register will set standards for training, conduct, competence and ethics that all registrants must meet.

Lord Hunt of Kings Heath (Labour)

My Lords, if the Government are putting so much faith in the quality-assured voluntary register, surely the evidence from King's College would show that that was not necessary. They cannot have it both ways. Either regulation, and what comes with it, provides advantages or it does not.

Baroness Northover (Liberal Democrat)

Regulation and training are often put as two words in one sentence. Regulation may indeed include training; assured voluntary registers may also include training. The noble Baroness, Lady Emerton, talked about that. Perhaps I may come on to it, because it is potentially relevant here.

I am particularly grateful to the noble Baroness for her contribution to this debate, not only today but throughout her time in the House of Lords. We agree that common standards of training are needed for those working in both health and social care, as well as more role-specific training, and that this will lead to a more capable and flexible group of support workers. As we seek to integrate health and social care more effectively, this area deserves a lot of scrutiny.

We expect work on the standards to begin by April 2012 in terms of training, and for them to be agreed ahead of the establishment of voluntary registers for healthcare support workers and adult social care workers, which could be operational from 2013. This will allow unregulated workers to demonstrate that they meet a set of minimum standards for training and are committed to a code of conduct.

Lord Hunt of Kings Heath (Labour)

My Lords, I still do not understand this. If it is so important that the voluntary registers are established, for the reasons that the Minister has given, why on earth not go the full hog and make registration compulsory? If the Government do not think that it is important, they would not be pursuing the voluntary register approach. However, by taking that approach, they will leave lots of people outside the net.

Baroness Northover (Liberal Democrat)

As the noble Baroness, Lady Pitkeathley, and others have indicated, one has to be proportionate about this and not think that simply going down the route of regulation is going to crack it. Nevertheless, training and making sure that people are well prepared for the work that they are doing is clearly of great importance. We would expect a voluntary register, quality assured in the way that I have described, to provide a way for employers to assure what they are offering in terms of staff. There will therefore be greater take-up. Those who are on the quality-assured register will find themselves more employable, which will move things forward. Meanwhile, if, as we continue to debate this, voluntary registration does not seem sufficient and regulation seems the route to go down, the Government do not rule that out. However, it is extremely important to focus on the end point, which is to try to drive up quality, and not simply be deflected by thinking that this would crack it.

I assure noble Lords that we will keep this issue under constant review. We are well aware of people's concerns and that standards need to be driven up in a much more even way across the board. As I say, we are developing the education and training which I hope will go some way towards this.

Lord Patel (Crossbench)

I wish to pick up on one point. Can the noble Baroness reassure us on what it is she will keep under constant review? I understood her to say that the Government will rely on employers to ensure that these support workers have some kind of training. There will be no national training standards and, once the employers are satisfied that these people have some kind of training, they will be entitled to go on a voluntary register. As I understand it, the logical thing here is first to establish a national standard of training; then to ensure that those national standards are implemented; and then to allow people to register. If they register, the next step would be regulation. The first step is not immediate regulation but national standards of training and assessment that those standards are being met, before people can go through any kind of registration. What is the noble Baroness agreeing to keep under review?

Baroness Northover (Liberal Democrat)

I should perhaps explain that more precisely. This issue will be constantly under review so that if there are concerns in this area they will be flagged up. The Government will of course continually consider how best to respond and make sure that standards are of the quality that we need. The noble Lord is right: national standards of training are indeed the start. Then people are admitted to a register and so on. A voluntary-assured register would demand that kind of national level of standards in training. I hope that in that regard I can at least reassure the noble Lord.

Lord Warner (Labour)

One question has puzzled me more and more as the noble Baroness has progressed. My noble friend Lady Pitkeathley laid great stress on the position of the regulated nurses and the fact that they will have to ensure that people working in the healthcare assistant type of roles under their supervision do not take on roles that they are not competent to fulfil. Going back to my description of the way the NHS works in reality, particularly in acute hospitals, there is a constant flow of different people on these wards-regulated and registered staff, agency or bank staff, are there particularly in the evenings, for unsocial hours and at weekends. We have heard a lot about employers. I am still puzzled about how the statutory regulated nurses satisfy themselves about the competence of the healthcare assistants working under their direction. They seem to be the people most exposed-at least theoretically-to cop it from their regulatory body if they have not made extensive inquiries about the competence of these healthcare assistants. How does the noble Baroness square that particular circle if we do not have much knowledge of the training of these people and they have not even registered on a voluntary basis?

Baroness Northover (Liberal Democrat)

The noble Lord will be familiar with being on wards at changeover time and when there is a pooling of information about who is on the ward and what the problems are. Issues are flagged up and one team passes information on to the next.

Lord Warner (Labour)

I have seen changeovers at weekends, when visiting relatives. It is not a pretty sight.

Baroness Northover (Liberal Democrat)

I have seen many, many changeovers. The proposal is being brought forward so that registered, regulated nurses have a better idea of when and how to delegate, and that is extremely important for the reasons that the noble Lord has just indicated. As I have indicated, the training and national standards of healthcare workers, to which the noble Lord, Lord Patel, referred, are also important-as is taking that forward so that the registered nurses are aware of the kind of training that those healthcare workers have had. I want to pick up on the case that the noble Baroness, Lady Emerton, mentioned about the healthcare worker who was taking a patient's blood pressure but did not know what the reading meant. Surely, it was for the person to whom that was reported to take action on the significance of that. That information was to be passed on to somebody else to read, understand and interpret.

Lord MacKenzie of Culkein (Labour)

But if that healthcare assistant does not have the basic training or an understanding of the reading that she or he has just taken, they may not see the importance of reporting it to another nurse.

Baroness Northover (Liberal Democrat)

I am not suggesting that they would. What I am suggesting is that the registered nurse might go and check the chart.

Baroness Emerton (Crossbench)

My Lords, perhaps I could be helpful at this stage. I am grateful to noble Lords who have contributed to this debate. A large number of issues have been brought forward; I shall start with the title "nurse". As noble Lords have mentioned, a person who is nursed-and feels that they have been nursed-experiences care, compassion, respect and dignity. There has been a lot of discussion among the public, and indeed in this House, about registered nurses becoming graduates and whether they will be too posh to wash, to put it colloquially. To me, a nurse who is a graduate would be only too grateful to be able to attend to the basic needs of patients, because that is part of holistic care. When you do various intimate things for patients, you learn a great deal about their condition.

The point that has been raised about the nurse is very important. We talk about support workers but we cannot talk about support nurses, because the term "nurse" is completely left for the statutory requirement of a regulated nurse. We are looking for a support worker who is able to do tasks which they understand, with the skills of the graduate nurse-because by 2013, we will be producing all-graduate nurses-within holistic care. That is the point I was trying to make this morning: it is the holistic care we are looking for in the delivery of care. However, it is not only holistic care in the acute sector; we are looking at the holistic care which is integrated with social care, because we are now looking at patients going into the community. Indeed, people working in the acute sector need to understand that the patients they are discharging patients are going into the community, which is a different scene and which may require not only a nurse but social care support. Therefore, somewhere in our education we need to bring together a basic core of understanding healthcare, nursing care and social care.

The point that the noble Lord, Lord Warner, made is very important. We need to conduct this review. On the other hand, the research evidence shows us that as regards highly qualified registered staff, the higher the proportion, the less likely it is that patients will have a longer stay in hospital. They will have a better clinical outcome. I hope that the Government are not going to ignore that research. If possible, we should carry out a truly safe cost-benefit analysis into increasing the number of trained staff, seeing where they are needed, rather than having a higher proportion of support workers.

The Royal College of Nursing has been resolute in putting forward the regulation of healthcare support workers because it feels that that is the way to ensure that they are answerable to a registered nurse. We talk about employers but I am not sure who the employers are going to be-social workers, managers or the nursing profession. This whole issue needs to be taken away and looked at, and perhaps we could return to it. I do not know whether these comments are helpful but I feel strongly about this issue, as noble Lords may have gathered. I pass it back to the Minister.

Baroness Northover (Liberal Democrat)

I hear what the noble Baroness says. She is extremely well informed, as ever, and I hope that she will continue to engage as we take this forward, as she has done up to now. However, at this point I hope that she will withdraw her amendment.

Baroness Emerton (Crossbench)

My Lords, I am prepared to withdraw but we will probably come back to this on Report. I beg leave to withdraw the amendment.

Amendment 338 withdrawn.

Amendment 338ZA

Moved by Baroness Thornton

338ZA: After Clause 205, insert the following new Clause-

"Power to regulate clinical physiologists in England

(1) Section 60 of the Health Act 1999 (regulation of health care professions) is amended as follows.

(2) In subsection (1) after paragraph (b) insert-

"(ba) regulating the clinical physiology profession in England,".

(3) In that section, after paragraph (bb) insert-

"(bc) regulating clinical physiologists in England who appear to require regulation in pursuance of this section,"."

Baroness Thornton (Labour)

My Lords, I shall speak also to Amendments 338ZB, 338F and 339ZB. We return to a regulatory issue. Amendments 338ZA and 339ZB are new clauses relating to the power to regulate clinical physiologists in England. Amendment 338ZB is a new clause requiring clinical physiologists to be registered by the Health Professions Council. Amendment 338F says that the Health Professions Council, in exercising its functions, shall co-operate with the regulation of clinical physiology in England and with the provision, supervision or management of services of people engaging in clinical physiology in England. The noble Baroness, Lady Finlay, has an amendment in this group and we support what she is proposing.

I am sure that other noble Lords have received the helpful briefing note from the Registration Council for Clinical Physiologists, which highlights that the Government's current approach-a preference for voluntary registration, as the Minister outlined in the previous debate-has been applied to clinical physiologists, despite a recommendation from the Health Professions Council in 2004 for statutory regulation. The RCCP has a substantial amount of evidence suggesting that, in the case of clinical physiologists, voluntary self-regulation is not as effective as statutory regulation.

In the Command Paper Enabling Excellence: Autonomy and Accountability for Health and Social Care Staff, the Government stated that statutory regulation would be considered for those professions where a compelling patient safety case could be made and be supported by an evidence-based cost-benefit risk analysis. Ten months later, though, no such risk assessment has been undertaken, and the RCCP continues to believe that clinical physiologists should be statutorily regulated.

The disciplines that are covered by clinical physiology are audiology, cardiology, gastrointestinal physiology, neurophysiology and respiratory physiology. Clinical physiologists work directly with patients, performing sensitive procedures such as assessments of pacemakers, testing lung function and assessing and diagnosing hearing loss. Many of the procedures performed by clinical physiologists in the UK are performed by statutorily regulated professionals in much of western Europe and by clinicians in the United States.

A body that I have mentioned, the Registration Council for Clinical Physiologists, maintains a voluntary register of clinical physiologists in the UK and Northern Ireland. It has more than 5,000 registrants across a number of different disciplines in clinical physiology. These professionals play an integral part in the process of diagnosis and treatment, undertaking procedures such as ECGs, which pose significant risks to patients. That, really, is the point here.

While the profession as a whole enjoys an excellent reputation and high standards of working practice, the continued lack of statutory regulation for its registrants means that there will continue to be gaps in its oversight, which comes with inherent risks to patients. Therefore, we believe that the Government's preference for regulation through assured voluntary registration is not sufficient for this particular group of healthcare workers. They need to be statutorily protected; a voluntary scheme is not sufficient and there is a threat to patient safety. I hope that the Government will consider this a reasonable request on the profession's part. I have to say that I fail to understand why this has not been taken forward and I hope that the Minister will be able to explain to the Committee why clinical physiology cannot have statutory regulation in the context of patient protection. I beg to move.

Baroness Masham of Ilton (Crossbench)

My Lords, I should just like to add my support for this amendment. Clinical physiologists, who perform some very invasive procedures, feel that they need statutory regulation. They have had a voluntary scheme, which they say is not adequate.

Lord Walton of Detchant (Crossbench)

My Lords, I should like to ask the Minister to clarify a point of some importance. Many years ago, in the early stages of my neurological career, I was involved in interpreting electroence- phalograms. Subsequently, I was heavily involved in the pursuit of electromyography-a technique for measuring the electrical activity of the muscles in health and disease-and in measuring nerve conduction velocity. I also looked at evoked nerve potentials. A group of individuals grew up in that field originally; it was called the EEG Society. Then there was the Electrophysiological Technologists' Association-the EPTA-of which I was briefly president. Eventually they came together to form the association of clinical neurophysiologists.

The Health Professions Council regulates 15 health professions, including biomedical scientists and clinical scientists. My understanding is that clinical neurophysiologists, like other clinical physiologists, are not included in or embraced by the term "clinical scientist". However, I wish to know whether they are covered by the Health Professions Council. If they are not, it is important that they should be regulated. For that reason, if they are not included at present under the terms of the Health Professions Council, I strongly support this amendment.

Lord Rea (Labour)

My Lords, in supporting this amendment I declare an interest. Not only my former patients but I, as a patient, have received skilled help from clinical physiologists. The pacing unit at St Mary's Hospital, which is run by clinical physiologists, has monitored my pacemaker since it was fitted four and a half years ago. My life has literally been in their hands while they periodically adjust my heartbeat to get the best setting.

The Registration Council for Clinical Physiologists, which has been described, has been trying to persuade the Department of Health to include the profession in the mandatory regulatory framework for health professionals for the best part of a decade. The Health Professions Council recommended in 2004 that clinical physiologists should be included in its regulatory regime, as well as other clinical scientists whose work involves a potential impact on patient safety. The then Secretary of State accepted this recommendation but still no action was taken and has since not been taken despite frequent reminders from me, among others. On my count, 30 parliamentary Questions have been tabled on this issue. It has also been raised in your Lordships' House in a debate on an order to do with the Health Professions Council. I hope that this amendment will serve to speed up the process by focusing the Government's attention on an overdue step that we feel needs to be taken.

Baroness Finlay of Llandaff (Crossbench)

My Lords, this group of amendments is very interesting as it reveals the enormous number of people involved in healthcare who literally hold the lives of others in their hands and are not subject to any statutory regulation but are voluntarily registered. I have an amendment in this group which seeks to establish,

"a statutory register of Physicians' Assistants (Anaesthesia)"

and of other healthcare professionals. I will speak about that in a moment in relation to clinical perfusion scientists.

Physicians' assistants in anaesthesia already have a voluntary register in place and they applied to the Health Professions Council for registration and had their application accepted. However, that all went on hold with the emergence of this Bill. The Royal College of Anaesthetists does not allow physicians' assistants in anaesthesia to become associates as they are not registered with the General Medical Council, but it permits them to have affiliate membership. However, the college does not have a regulatory role as such; it is tied up with education and standards.

Physicians' assistants in anaesthesia urgently need statutory regulation, given the range of invasive, and potentially life-threatening, procedures that they perform and the knowledge and autonomy of practice required in the roles that they carry out. These practitioners perform tasks that, in the UK, were previously carried out only by doctors. They cannot get indemnity insurance for their practice or apply for prescribing rights, even though they sometimes have to be able to respond in a matter of seconds, not minutes, if something goes catastrophically wrong with an anaesthetised patient while the anaesthetist is outside the theatre for whatever reason. They are on a voluntary register, which provides some reassurance for patients and employers, but that cannot realistically be seen as an alternative to statutory regulation. I think that in 2009 they were identified by the Department of Health as being urgently in need of registration. The Health Professions Council felt that these assistants fulfilled sufficient of its criteria to warrant the recommendation for statutory regulation being accepted.

Irrespective of whether Members of this House have undergone a procedure requiring anaesthesia, would they consent to being rendered unconscious by an individual who was neither bound by a stringent professional code of conduct nor properly registered to practise? After all, we would not get into an aeroplane if we did not know that both the pilot and the co-pilot were appropriately qualified to a very high degree, with ongoing continuing professional registration. We trust them just as we trust these physicians' assistants, but if something goes wrong in theatre it does so with catastrophic rapidity. When I did my training in anaesthesia, on more than one occasion I saw these physicians' assistants recognise problems arising before the trainee anaesthetists had done so. They carry enormous responsibility during complex procedures.

I have included other healthcare professionals in my amendment as I am well aware that the Government do not like to have enormous lists in a Bill. My amendment would therefore leave the door open to include clinical perfusion scientists-the other group involved in theatre-whose role is primarily to maintain a patient's circulation during open-heart surgery, during a period of surgical repair when the heart has been stopped. They were recommended in 2003 for statutory regulation.

There have been two high-profile cases involving clinical perfusion scientists. The first fatality, in 1999, led the Southwark coroner to recommend the immediate statutory regulation of clinical perfusion scientists. The second fatality, in 2005, was attributed to inappropriate drug administration by a clinical perfusion scientist during an operation on a five-month-old baby at Bristol Royal Infirmary. That led to the publication of the Gritten report, which concluded that:

"The incident occurred because of latent weakness that lay dormant for years hidden by healthcare professionals compensating for inadequacies within national and local systems".

The report recommended that action at national level should include,

"regulation and guidance on perfusion practice in cardiopulmonary bypass".

More recently, there have been fatalities that have led to clinical perfusion scientists' actions being questioned by coroners-the most recent of these incidents occurring in 2010 at Nottingham City Hospital.

I do not want to scare people from going in for surgery and I do not want to scare Members of this House who may be going in for surgery, but in the current climate people need to know that these very critical roles are being undertaken by people who are on a voluntary register but do not enjoy indemnity, as they would if they were on a statutory register and subject to the rigours of being statutorily regulated.

Baroness Pitkeathley (Labour)

My Lords, I do not want to sound like a broken record in always resisting more statutory regulation or in disagreeing with colleagues with whom I normally agree, but I want to emphasise the application of light-touch regulation. We should use only the minimum regulatory force to achieve the desired result. Therefore, we should be considering extending regulation only where the risks to patient safety and public protection are such that other mechanisms such as those I previously mentioned-employer's guidance, clinical governance, appropriate delegation and multidisciplinary teamworking-are unable to manage those risks.

When the Council for Healthcare Regulatory Excellence becomes the Professional Standards Authority for Health and Social Care, it will be accrediting voluntary registers as a more proportionate and targeted approach to developing high standards of care for people working in health and social care who are not statutorily regulated. I remind your Lordships that statutory regulation can be expensive and it is important that we explore and develop a range of options for maintaining and improving the quality of care delivered by people working in health and social care. It may be more proportionate, for instance, to promote greater co-operation and sharing of good practice. We seek to find the most efficient and common-sense solutions to the kind of problems that your Lordships have identified.

Baroness Oppenheim-Barnes (Conservative)

What proportion of voluntary persons employed in operating theatres are expected to be affected? Is it not the case that the great proportion of them are specialists who are subject to statutory regulation?

Baroness Pitkeathley (Labour)

Currently, a great proportion are in statutory regulation, given that voluntary regulation is being developed. The CHRE is currently working on that.

Lord Alderdice (Liberal Democrat)

My Lords, I should like to press this question in the context of the amendments in this group. What is the Government's rationale for making a difference between statutory registration and quality-assured voluntary registration? The noble Baroness, Lady Pitkeathley, has used terms such as "light-touch", "proportionate", "appropriate", "not so expensive" and so on. However, I have difficulty in seeing consistency here.

On the one hand, we can see that there are very small groups such as clinical perfusion scientists who are employed in only a few centres where open-heart surgery is being done. One could see that there may be a degree of expense in setting up a whole scheme of statutory registration. However, when it comes to groups such as clinical scientists and physiologists, there is a much larger number, but almost all of them are employed in the National Health Service. I understand the argument that they are all, or almost all, operating under the supervision of people who are statutorily registered and are operating in the context of the NHS, which deals with financial claims and so on.

However, as noble Lords will know, I have raised repeatedly-perhaps even tiresomely-the question of statutory registration of psychotherapists and counsellors. When I raised it again not so long ago with the Minister, he responded that, no, the Government did not want to go ahead on that front; they wanted quality-assured voluntary registers. The same kind of rules do not apply. Why? First, there is a huge number of these people-certainly enough for it not to be a financial question, as small contributions from all of them would be enough to set up a statutory registration scheme. Secondly, the majority of psychotherapists and counsellors work outside of, and therefore are not subject to the kind of regulation that takes place in, the National Health Service. On top of that, a large proportion of them work on their own, so they are not supervised by statutorily registered colleagues and they are not employed by employers who, Ministers have assured us, would consider their qualifications and supervision.

Although, in the context of the current crop of amendments, the argument has been made on the basis of expense and on the basis that these people operate within and are employed by the health service-and are therefore under the supervision of statutorily registered senior colleagues-none of those arguments applies to those who are working in the private sector on their own account. Such people are employed only by the patients who are consulting them, and there is a large number of them.

What requirements help Her Majesty's Government to judge whether a profession has statutory registration or quality-assured voluntary registration? None of the arguments that have been adduced is applied consistently.

Lord Walton of Detchant (Crossbench)

What is troubling me about this whole exercise is that, under the Health Professions Council, statutory regulation applies to art therapists, biomedical scientists, chiropodists, clinical scientists, dieticians, hearing-aid dispensers, occupational therapists, operating department practitioners, orthoptists, paramedics, physiotherapists, practitioner psychologists -in what way do practitioner psychologists differ from the psychologists to whom the noble Lord referred?-and many others. A lot of these people are already regulated. Where the statutorily regulated bodies end and the voluntarily regulated bodies begin is very unclear.

Lord Alderdice (Liberal Democrat)

It may seem a little unclear to the noble Lord, but it is not so unclear. Psychologists are qualified as psychologists, not as psychotherapists or as counsellors-they belong to a different professional body and have different qualifications and requirements. Psychologists themselves campaigned for many years for statutory regulation and finally got it through the Health Professions Council. Arts therapists and so on went through the HPC because many of them were occupational therapists, but try as I might-and I have been doing so for well over a decade-I cannot get successive Governments to address the question of psychotherapists and counsellors, despite the fact that they constitute a far larger number of people.

My dilemma with the current set of propositions is that, of the arguments adduced to try to persuade noble Lords that a quality-assured voluntary registration scheme is appropriate because the people referred to-the physiologists, the perfusion scientists and so on-are operating within the health service under supervision, are employed there and are smallish in number, none of them applies to this other group of people, for whom I have had precisely the same reply from the Minister. Therefore, I am keen to hear from the Government what the set of criteria is. Is it simply that this Government are not keen to pursue anything in the way of regulation except at the most modest level? If so, that is a legitimate argument but it needs to be made. If not, then I do not quite see the consistency of the current application.

Baroness Finlay of Llandaff (Crossbench)

Perhaps I may add a small point. I do not know how many physicians in anaesthesia are employed in operating theatres in private hospitals, where an enormous amount of private surgery is done. One of the main reasons for people going to a private hospital is for surgery-particularly elective orthopaedic surgery. Therefore, although I cannot put any figures on this, I do not think that it is correct to assume that these people are necessarily operating only in the NHS and are subject to current NHS structures.

In the new world where we will have a broad range of providers, it will become even more important to know that there is a minimum standard and that all the people at each step of the way will be answerable. The patient may well choose to go to an organisation where these people are employed but the patient will not know that. No one gives him a list and says, "Of all these people looking after you, these will be statutorily registered but these may or may not be on a voluntary register". If we are thinking about patients taking informed decisions regarding their future, I suggest that the coroners' reports that we have had to date should already be sounding alarm bells.

Lord MacKenzie of Culkein (Labour)

My Lords, I support this group of amendments. I want to make just a couple of points, as I think that most of the others have already been covered.

I am looking at some information sent in an open letter from the Registration Council for Clinical Physiologists to Anne Milton, the Parliamentary Under-Secretary of State in another place. Interestingly, in that open letter the registration council, which operates a voluntary register, takes the view that the council is rather toothless. It says that the professions covered by clinical physiologists will continue to be,

"saddled with a toothless system of voluntary registration, in which those managing the registers are exposed to unacceptable legal risk when attempting to enforce the meagre sanctions at their disposal and maintain professional standards".

It says it is evident that those administering the current inadequate voluntary registration process are being threatened with civil action by those whom they are forced to reprimand. It is a pretty poor state of affairs when those who are trying to enforce professional standards are themselves threatened with legal action.

I know from talking to people involved with the registration council that people leave the register when disciplinary issues come to the fore. I gather that in one instance a person left the register when faced with discipline, emigrated to Australia, continued to practise and got in trouble there. As I understand it, the Australian statutory body that exists for clinical physiologists was astonished to discover that there was no statutory regulation in force in this country.

I do not think that we can continue with this so-called voluntary system and light touch. We need to do what other countries do and have statutory responsibilities and statutory training and registration for these very important groups of staff.

Baroness Northover (Liberal Democrat)

My Lords, these amendments seek to extend compulsory statutory regulation to physicians' assistants in anaesthesia and clinical physiologists and to make changes to legislation to further provide for the compulsory statutory regulation of clinical physiologists.

I make it clear at the start that healthcare scientists such as clinical physiologists play an important and highly valued role as part of clinical teams, and this is also true of physicians' assistants. It is a testament to their professionalism that the Department of Health is not aware of any general concerns about the standards of practice of either group. Furthermore, we need to be absolutely clear that the purpose of regulation is to protect the public, not to support the development of a profession.

Given the wider systems of assurance in place such as the Care Quality Commission's registration requirements, and the vetting and barring scheme, the Government do not consider that the case for compulsory statutory regulation of these groups of healthcare scientists not already subject to regulation, and physicians' assistants, has been made. However, we agree that there need to be processes to ensure high standards of care, and assured voluntary registration overseen by the Professional Standards Authority for Health and Social Care has the potential to provide this. It will ensure that there are robust standards of conduct and training. It will be open to employers and commissioners to insist on only recruiting staff on voluntary registers. Those doing so would secure many of the benefits of compulsory regulation. Both healthcare scientists and physicians' assistants already have established voluntary registers and would be well placed to seek accreditation from the authority.

The noble Baroness, Lady Thornton, asked why we were not taking forward the regulation of clinical physiologists as recommended by the Health Professions Council. The recommendations of the Health Professions Council were not based on an assessment of the risk presented by a profession, but rather on whether that profession had already developed processes of assurance which prepared them for professional regulation. There is therefore no evidence that compulsory statutory regulation is necessary to mitigate the risks posed by the professions recommended for such regulation by the Health Professions Council. This is probably why the previous Government did not decide to regulate, although this is an issue that has been flagged up for a number of years. The professions recommended by the Health Professions Council for compulsory statutory regulation will be well placed to join the system of assured voluntary registration that we are proposing.

The noble Baroness, Lady Thornton, asked about research in terms of regulating clinical physiologists. We are not planning on commissioning research into the case for regulating them, but we will review the case for introducing compulsory statutory regulation for clinical physiologists and, obviously, others in the light of experience of assured voluntary registration, and the evidence about risks available.

Baroness Thornton (Labour)

Perhaps the Minister could tell us what sort of timescale she envisages for this, or whether it will have to wait until an accident happens like the noble Baroness, Lady Finlay, recorded and then the Government will deal with it.

Baroness Northover (Liberal Democrat)

The noble Baroness will be fully aware, because she was a health Minister, that if there is no evidence of there being a risk then you do not choose to regulate. That is presumably why the previous Government chose not to.

The noble Baroness, Lady Finlay, flagged up the position of anaesthetists' assistants. I had interesting discussions yesterday with an anaesthetist and an anaesthetist's assistant, and it was very enlightening. As the noble Baroness will know, the anaesthetist is of course ultimately responsible. Assistants must always be supervised by a consultant who needs to be available within two minutes. The issue that the noble Baroness raises is one of quality assurance. As she knows, the Royal College of Anaesthetists runs the training and the registration for those assistants. After they have done a science degree, generally it is 27 months of practice. If the Royal College of Anaesthetists judges that that is inadequate, on the basis of the kind of concerns that the noble Baroness raises, then it is clearly for it to say that there are risks, it has encountered risks, and that needs to be addressed. If this system comes under the quality assurance system that I mentioned earlier, there will be another body looking at whether that kind of training, assurance and registration is adequate. However, there have not been cases flagged up as causing concern. I also point out that there are few anaesthetists' assistants. They are more generally used in other countries, I gather, but not so much in the United Kingdom. The noble Lord, Lord Alderdice, asked why there is not more statutory regulation. In some ways I think I have addressed that. Although compulsory statutory regulation is sometimes necessary, one has to look at the risks and at what is proportionate.

Baroness Thornton (Labour)

The health Minister Anne Milton said that those professions in which a patient safety case can be made, including that of clinical physiologists, will be considered for statutory regulation subject to a cost-benefit risk analysis. Will the Government carry out that analysis and, if so, when and in what time? I do not particularly want an answer about what my Government may or may not have done or may or may not have decided. The noble Baroness's own Minister has pronounced on this matter since the general election so it seems to me that she needs to answer the question: when will they do the risk analysis?

Baroness Northover (Liberal Democrat)

I have already mentioned to the noble Baroness-she is probably totally familiar with this-that the Department of Health does not have evidence of there being a risk in this regard. Clearly, as I mentioned on the earlier group, these issues will always be kept under review. If the concerns that she has flagged up and if the association, which is particularly encouraging the regulation of clinical physiologists-that is fine; it is all part of professionalisation-flags up particular concerns that emerge from other evidence, then of course the department will take that very seriously. However, things need to be proportionate.

Baroness Finlay of Llandaff (Crossbench)

I have listened very carefully to what has been said about the assistants relating to anaesthesia, but I also used the more catch-all phrase about the clinical perfusion scientists. I would be grateful if, after this debate, the noble Baroness would write to me and explain why coroner recommendations in relation to clinical perfusion scientists are not considered to be enough of a risk to take action. If one is trying to assess this on a risk spectrum, it would be helpful to understand why a coroner's decision to recommend that this small, contained group of clinical perfusion scientists should be regulated does not constitute enough of a risk to go down that route to regulate them and to have them on a statutory register.

Baroness Northover (Liberal Democrat)

I am very happy to take away what the noble Baroness has said and to discuss the situation further with her.

We expect the assured voluntary registration to be up and running by 2012. Therefore, afterwards that would need to be assessed to see whether anything further is required, as noble Lords have figured might be the case. We are hoping to see how it all works.

The noble Lord, Lord Walton, flagged up various groups which were regulated and he could not quite see why others were not. Given that I used to bump into the noble Lord, Lord Walton, in the Wellcome Library for the History and Understanding of Medicine, I think he will fully understand that the way in which regulation has grown up has not necessarily been logical or consistent. Therefore, I flag up the 2005 Hampton review on regulation which says that it should be proportionate to the risks that it seeks to mitigate and various other provisions. That is what we are seeking to do. Of course, we shall keep under review what we are doing to see whether it is adequate. In the mean time, I hope that the noble Baroness will be willing to withdraw the amendment.

Baroness Thornton (Labour)

My Lords, I thank the Minister, but this is not yet a satisfactory situation. We might be moving towards one but we are not there by any means. If I were on the register of clinical physiologists I would find it slightly offensive for the Minister to suggest that I was asking for statutory regulation as a kind of professional development of the organisation. Physiologists are very clear in all of their briefings that they think that this is important for patient safety. That is why they want statutory regulation and that is why we need to listen to them very carefully.

Baroness Northover (Liberal Democrat)

I am extremely happy to acknowledge that.

Baroness Thornton (Labour)

I thank the noble Baroness for that. The noble Baroness, Lady Finlay, made a graphic and powerful case. I thank my noble friend Lord Rea, the noble Baroness, Lady Masham, and the noble Lord, Lord Walton, for their support for the amendment. My noble friend Lady Pitkeathley and the Minister are coming at it from a different point of view. It is entirely possible that an arbitrary decision was taken, quite possibly by my Government, that there was enough statutory regulation. It is possible that this Government need to think that that was an arbitrary decision in the history of regulation and that exceptions need to be made.

There are questions about the limits of assured voluntary registration. Do clinical physiologists carry out invasive procedures that could harm patients? Yes, they do. Are clinical physiologists incentivised to join the voluntary register? No, they are not. A small number of NHS and private employers notionally require applicants to be on their register but there is no mandatory requirement for this. Are professionals incentivised to maintain the voluntary register? No, their activities are carried out on a voluntary basis by the chair and other officers. Does the voluntary register empower patients to make formal complaints? No. While the Health Professions Council operates a system whereby anyone can make a complaint about the fitness to practise of a professional on its register, in most instances members of the public are not aware of the existence of voluntary registers. Finally, does the voluntary register have any powers of enforcement? No, it does not. The RCCP operates a disciplinary code and procedure but it cannot protect patients from continuing to be treated by practitioners who have not been registered and who are potentially unfit to practise. I beg leave to withdraw the amendment.

Amendment 338ZA withdrawn.

Amendment 338ZB not moved.

House resumed.

Lord Hunt of Kings Heath (Labour)

My Lords, we come to one of the most important parts of the Bill-the regulation of social workers. Although the Bill is entitled the Health and Social Care Bill, the reality is that most of our debates have been about the National Health Service. It is right that in these latter stages of Committee we give a little attention to social care and specifically the condition of social workers.

I do not think that anyone in your Lordships' House will be in any doubt about the scale of the responsibility placed upon social workers or the pressures that they come under. Although Professor Munro's review was centred on the child protection system, what she had to say about social workers would apply more generally to the profession. I was particularly struck by the conclusion, which stated:

"While well intentioned, attempts in the recent past to improve the child protection system have not secured the improvements children and young people deserve. Professional practice with vulnerable children and families has been driven too much by compliance with regulation and rules".

The review found that,

"frontline social workers in particular operate within an over-standardised framework that makes it difficult for them to prioritise time to form relationships with children and to understand their needs. In parallel, it has becomes more difficult to provide the range of help and services to respond to the wide variety of needs and circumstances presented".

The Government have said that they will,

"oversee a radical reduction in the amount of regulation, working with partners to see a corresponding reduction in locally designed rules and procedures".

They have also said that they want,

"to improve radically the knowledge, skills, and expertise of social workers from initial training through to continuing professional development".

The Government said in July that they will,

"work with higher education institutions, employers, the General Social Care Council",

to ensure that the specific capabilities identified by Professor Munro will,

"explicitly inform social work training, professional development and performance appraisal".

I am sure that that is welcome and would be generally supported. It is interesting that only five months ago the Government were happy to acknowledge the role of the General Social Care Council. It must surely follow by implication that if the Government are seeking to enhance professional expertise and give social workers more discretion on the front line, it needs to be done in the context of a proportionate, though robust, statutory regulation of social workers. That is what the General Social Care Council exists to do. After a difficult start, which many would acknowledge was difficult, it is performing well. This is not the time to tear the General Social Care Council up by its roots and start again, but that is precisely what the Government propose to do in this Bill, by transferring social worker regulation to the Health Professions Council.

Currently, the council has a register of around 200,000 people, covering 15 health professions. If it takes on social workers, it will have a further 100,000 on the register from a single additional profession. I understand that the reason for which the Government have put forward these proposals is related to cost, not the current performance of the General Social Care Council, which the Government, in the form of the Department of Health, have acknowledged to have improved its performance considerably.

The argument on costs falls away immediately. Registration with the General Social Care Council currently costs £30 per registrant. This is a low figure compared to other regulators, and the Government subsidise the council's operations to the tune of around £16 million a year. The Government want to get rid of that subsidy and their original aim was to transfer the function to an independent body that it was acknowledged would need to charge higher fees to cover costs. Originally, it was intended to make the General Social Care Council independent and for it to recoup all its costs from its registrants. However, the Government argued that an independent self-financing council would be unaffordable for social workers because registration charges for individuals would be in the region of £200 to £300. This calculation did not take on board the work that the General Social Care Council has done in developing a financial plan for independence. My understanding is that the latest calculation from the GSCC is that the actual cost would be far lower, and not dissimilar to the current HPC charges of £76 per annum. I hope that the noble Baroness will answer that point when she responds and not cite those higher figures for costs. I am clear from the evidence I have received that it would be possible to provide independent regulation in a single body for the kind of figure that the Health Professions Council charges.

Concern has been expressed about the Government's intentions. First, within the social care sector, the transfer of the General Social Care Council to the HPC, a multiple profession regulator with generic professional standards, threatens to dilute the unique identity of the social work profession at a time when, as we know, the profession has come under considerable pressure. Some critics cite the reduced representation of social workers within the new Health Professions Council and the fact that the name of the regulator will not contain the term "social work". There are also concerns that a generic, multi-professional regulator will not be well suited to deal with the complexities of social work and the social model, which underpins the practice of the profession.

There are also concerns about changes to the regulation of social work students. Like the General Social Care Council, the HPC does not currently register students of the professions it regulates. I understand that consultation is being or will be undertaken by the HPC on this matter, but it is widely expected that it will conclude that the way in which students are dealt with-in other words, that they are not registered-will continue and that, therefore, social work students will not be registered in future.

That is one problem that we face. I make no criticism of the Health Professions Council, but it has a one-size-fits-all approach to regulation. Its philosophy is that it does not really matter who you register-it could be social workers, clinical psychologists or any profession you like-its model will fit. I am worried about that approach for social workers. That is why I have tabled a number of clause stand part amendments. I think social workers need to have regulation that is geared entirely to the social work profession. My amendments are intended to tease out the Government's approach to how, if social workers come within the Health Professions Council, they are to be given special provision. My Amendments 338B, 338C and 338D are aimed to do that by, first, establishing a statutory committee within the Health Professions Council to oversee the social work regulation, to ensure that the appropriate person will be director of social worker professions' regulation. That is to ensure that a senior officer is directly responsible for social worker regulation and recognised as such in statute. Next, it is important that there are social workers on the council of the Health Professions Council. I do not understand why the council of the HPC is not being dissolved and a new council formed. The number of social workers coming over to the Health Professions Council suggests that that is what should happen: not simply that the council carries on. There should be specific recognition and social workers should be on the council.

Lord Mawhinney (Conservative)

My Lords, a couple of minutes ago, the noble Lord said that he was not going to make any criticism of the HPC. He then sets out amendments which tell the HPC how it is supposed to behave. Is there not a smidgeon of contradiction between those points?

Lord Hunt of Kings Heath (Labour)

I cannot see any contradiction, although I will of course search my mind to see whether I have been guilty of such. I wanted to make it clear that I do not seek to criticise the Health Professions Council as a body. As I set it up, I have a certain feeling of support for it. I am not sure that its approach to generic regulation, which essentially says that it can regulate any profession in the health service and does not in any way need to change how it does it, should apply to social work, which is a different profession to which different matters apply.

Lord Mawhinney (Conservative)

But is the noble Lord not in effect saying that he does not trust the HPC properly to discharge its responsibilities, so he has to tell it how it should go about it?

Lord Hunt of Kings Heath (Labour)

If I were to say that I did not trust the Health Professions Council, that might be taken as rather pejorative, and I would not seek to do that. It has done a good job on the health professions it regulates. I simply do not feel that it is right for it to regulate social workers. I do not think that it is prepared for it. Its philosophy is not attuned to it. That is why, if the Government insist on going ahead, some protection needs to be given.

My final amendment relates to the name of the new HPC, the Health and Care Professions Council. I am puzzled why "social worker" is not in the title. Why was it felt that when bringing 100,000 people into this body, it was not thought worth putting "social worker" in the title. I do not think that Health Care Professions Council can possibly describe a body that will regulate 100,000 social workers.

I hope that the Government will be prepared to consider the matter again. I know that they want to reduce the number of quangos and regulators, although, if the noble Baroness had been here for the Statement on the banking system, she would have discovered that all Governments start by having a bonfire of the quangos and then inevitably they start to grow again. We saw in the past few minutes a good example of the Government starting to grow some new regulators. In this case, I do not think that the issue of money comes into it-the cost of the balance sheet is taken off the public purse, because it will be funded by registering. Because I am satisfied that the General Social Care Council can fund this through fees which would be similar to those of the Health Professions Council, I hope that the Government will give this further consideration.

Baroness Meacher (Crossbench)

My Lords, I support the opposition of the noble Lord, Lord Hunt, to Clauses 206 and 208 to 211 standing part of the Bill, and will also speak to Amendment 338B. The noble Lord, Lord Hunt, has elaborated these issues extremely comprehensively and powerfully. I want to avoid duplication and will therefore concentrate on a few specific concerns that, for me, are the most serious, although the matters raised by the noble Lord, Lord Hunt, are also important to me.

Social work carries onerous public protection responsibilities that, to my mind, differentiate it importantly from the other professions regulated by the Health Professions Council. One issue that highlights that problem is the registration of social work students referred to by the noble Lord, Lord Hunt. This and other key matters are left to regulation under Clause 208 without any clarification of what that will mean in practice.

It is important to bear in mind that social work students have direct and unsupervised contact with vulnerable people, including children, whose lives may be at risk. That is rather different from the contact that other professionals tend to have with individuals. Following an impact assessment, the GSCC, not surprisingly, concluded that compulsory student registration was necessary. At present, the GSCC makes grants to the universities providing social work training. Those grants are conditional on the registration of students. The result is that 95 per cent of students are in fact registered. I am not sure what happened to the other 5 per cent, but in essence it is a form of compulsory registration of students.

As a result, any serious complaint about the conduct of a social work student can be referred for investigation by the GSCC. Although the number of serious complaints is small, it is larger than that of complaints about other professions. It is very important that these individuals are picked up early before they can do any severe damage to young children, or indeed other children. If a student is found guilty of misconduct and dismissed from their course, they cannot simply go across to the other side of London or to Newcastle and register on a different course, as this will be picked up by the GSCC. However, that will be lost in the new system. This system of student registration seems to be an important safeguard in public protection.

As I understand it, the HPC is consulting on whether the registration of students should be purely voluntary, as it is in the other health professions regulated by the HPC and as mentioned by the noble Lord, Lord Hunt. The concern is that the consultation includes all the health professions, which of course will say that registration does not need to be compulsory, and indeed it does not for these other professions. Any social work profession will recognise the importance of the compulsory registration of students, but of course they will be outnumbered by all the other professions. As a result, social work registration is likely-in fact, almost certain-to become voluntary. I understand that Paul Burstow, the Minister in the other place, has some concerns about this. Can the Minister tell the Committee what progress has been made to ensure that social work registration remains, de facto, compulsory under the new arrangements?

It is worth flagging up that Northern Ireland, Wales and Scotland will continue to have compulsory registration of social work students, and England will be out of line if this provision goes ahead. As a result, inappropriate students-potentially dangerous social workers-will come across the border into this country and practise. Do we really want that to happen?

Another issue is the assessed and supported year in employment-the ASYE. This is not yet in place but has been recommended by the Social Work Reform Board and is supported by the GSCC. I understand that senior social work professionals do not expect the HPC to introduce the assessed and supported year for newly qualified social workers because they want a common system for all professionals, as alluded to by the noble Lord, Lord Hunt. This provision is not necessary for professionals without a public and child protection responsibility.

Again, there is a problem here because of the differences between social work on the one hand and all the other professions on the other. As someone who practised social work-albeit briefly and many years ago-I fully appreciate the importance of a year immediately following qualification when social workers carry a lighter case load and receive support with more hands-on supervision to enable them to consolidate their knowledge. You could say that this was all a bit heavy-handed if it were not for the public and child protection duties of these workers. However, it really is important that those people know what they are doing and that they do not miss high-risk cases.

The GSCC wants the assessed and supported year to be a registration requirement in the future. Northern Ireland has this system. Of course, this would need to be tied in with some control over the number of social work trainees, but in my view it is a very important matter. What are the Minister's plans in this regard?

My third area of concern is the standard of social work training. Those at the head of the GSCC would agree that we need more, rather than less, rigorous regulation of social work training. Social work standards set by the Department of Health have already fallen over a period; certainly they are quite unrecognisable to me. I think all of us who are aware of the Baby P report would agree with that assertion. We can expect these standards to fall further under the HPC because, as the noble Lord, Lord Hunt, mentioned, the HPC has basic standards across all professions at roughly NVQ level 3-not a degree level and not, in my view, a sufficiently high level-and just a few generic standards for each profession. It is not looking for intellectual rigour and does not have practice standards. Its focus is on outputs, which we all recognise and think are a thoroughly good thing. However, we all know that outputs based on book learning without any fieldwork requirements will miss absolutely essential elements of effective social work professional practice. The Social Work Reform Board is setting higher standards but these will not be regulated. Only the most basic standards set by the HPC will have that regulatory framework.

The Government are, I believe, leaving it to the yet-to-exist College of Social Work to promote excellence in social work. The BASW is challenging the establishment of the college, I understand. Will it exist and, if it does, will it be delayed? If so, for how long? I gather that even when it does exist, the college will be toothless-it will have no powers to regulate training at all. It may set standards of excellence but it will have no powers to ensure that those standards are met. Does the Minister agree that social work standards need to rise, not fall? If so, will she agree to take away these concerns and consider how best to ensure meaningful progress on the issue? That is vital to the protection of children and to avoid more Baby P scandals, with huge embarrassment to the Government. I trust that the Minister will take this seriously.

Finally, I ask the Minister what will become of the GSCC code of practice for social care workers, which is another group altogether. It is important that this code of practice is retained as an element in the standards framework for social care. This is all about standards and the quality of provision. Will this code of practice be hosted by Skills for Care in the interim before any registration of these workers, or will it be lost? I reinforce the point made by the noble Lord, Lord Hunt, about the spurious financial justification for the abolition of the GSCC. I, too, understand that, financially, keeping the GSCC would stand up perfectly well-it could be self-funding on a similar basis to the HPC. I hope that the Minister will be able to explain this.

Very real risks arise from this planned merger. England will move out of line with its neighbouring countries, and we will reduce standards and safeguards in a profession at the front line of child protection. Is it really too late to rethink this high-risk plan?

Baroness Pitkeathley (Labour)

My Lords, I have interests to declare other than being chair of the Council for Healthcare Regulatory Excellence in that I chaired the advisory body that led to the setting up of the General Social Care Council, and I was its first chair.

It is not for me to question the Government's decision on these matters, but I draw your Lordships' attention to the fact that neither the decision nor its implementation have been easy for those involved. I pay the warmest possible tribute to colleagues at the General Social Care Council and the HPC for the way in which they have dealt with this difficult situation. In particular, I acknowledge the role of the oversight group, which is chaired by Harry Cayton, the chief executive of the CHRE, and consists of colleagues from both organisations and other interested parties. However difficult those discussions may have been at times, the professionalism and commitment of those involved to the safety and interests of the end users of social workers' work have been exemplary, as has been the commitment to ensuring that there should be as little disruption as possible to their functions during any transition period. Thanks to that professionalism, these reforms will allow for the greater integration of health and social care regulation through the renamed Health and Care Professions Council. Regulation by the HCPC-I shall have to get used to the new initials-will extend regulation to the competence of social workers, as well as to their conduct, and thus improve public protection.

I have some concerns about the proposals for the governance of the HCPC, as they do not reflect the general direction of travel in recent reforms across professional regulation. These have emphasised and focused the regulator's governance and operations on the primary duty of public protection, not of professional representation. Historically, allowing reserved places for particular professionals in councils and committee structures was thought to be damaging to public confidence in regulators and in their decisions about standards and fitness to practise. These proposals might therefore represent a step backwards and not demonstrate good governance principles for professional regulation.

The HPC has a strong track record in taking on new registers, and has established quality assurance mechanisms to facilitate appropriate input from professional expertise, where appropriate. I hope that we shall be able to see that this is an important development, and one that protects all those professions, as well as, most importantly, the public, in the integration of social care and health in the way that we have been calling for in so many debates during the course of this Bill.

Lord Walton of Detchant (Crossbench)

My Lords, I shall be brief because most of what I would hope to say has already been said by the noble Lord, Lord Hunt, by my noble friend Lady Meacher, and by the noble Baroness, Lady Pitkeathley. This Bill, in Clause 209, will abolish the General Social Care Council and place social worker and social care assistant regulation in the Health Professions Council, which is to be renamed the Health and Care Professions Council. This is highly undesirable for a profession that faces enormous challenges and which has only had its own regulator for just over two years. Is it possible for the Government to turn back from the brink? To take the regulation, education and performance standards of social workers and social care assistants-100,000 of them-into a body such as the Health Professions Council is likely to overload considerably the administrative procedures and activities of that council.

If this change is inevitable, the amendments that have been tabled by the noble Lord, Lord Hunt, and others are worthy of very serious consideration. They would give social care and social workers a very special and identifiable voice in the Health Professions Council. Is it really appropriate that this mass of social workers should be regulated by a body that already regulates art therapists, biomedical scientists, chiropodists, clinical scientists, dieticians, occupational therapists, physiotherapists, and many others-people who all work primarily in the health field? I quoted many of the bodies regulated by the Health Professions Council earlier today. It seems that putting the social care profession under this council is going to make it a very uncomfortable bedfellow.

I wholly appreciate the Government's wish to have a bonfire of the quangos, and I understand why they wish to reduce the number of regulatory authorities, but there is no doubt that their last mechanism for doing this, when they brought together three major bodies and cumulated them into the Care Quality Commission, has been struggling to fulfil its responsibilities. It is functioning very effectively, but it has had a massive task in taking on all the additional responsibilities that have fallen to the Care Quality Commission since that merger. I fear that the same problems might well emerge in relation to this proposed merger, about which I therefore feel very uncertain and somewhat uncomfortable. I only wish that the Government felt able to think again.

Lord Newton of Braintree (Conservative)

My Lords, prompted only by the debate, I ask one simple question of my noble friend on the Front Bench. What assurance can she give me, in the light of the concerns that have been expressed, that this move will not end up with the same problems that we have had with the CQC, which was asked to take on too much, too fast, and proved incapable of doing it effectively?

Baroness Northover (Liberal Democrat)

These amendments on whether the clauses should stand part relate to the transfer of the regulation of social workers in England from the General Social Care Council to the Health Professions Council, and I thank noble Lords for them. The regulation of social workers in England is a very important issue, and I welcome the opportunity to discuss it.

The noble Lord, Lord Hunt, having played a key role in the establishment of various of these bodies, argues his usual very strong case. We are committed to the development of the social work profession and the transfer of the regulation of social workers in England to the Health Professions Council as part of the ongoing work to reform the profession and to ensure that such regulation is effective and sustainable. Like the noble Baroness, Lady Pitkeathley, I, too, pay tribute to those who have been involved in these changes. I have met a number of them and find impressive their commitment to the profession and to making sure that, whether they supported the changes in the first place or do now, they are doing their very best to make sure that this works as effectively as possible. The noble Baroness's tribute to them is well deserved.

The purpose of compulsory statutory regulation is to assure the quality and safety of the regulated professions. That, of course, is separate from the development of the profession itself. We are clear that if we separate professional regulation from professional representation, action needs to be taken to ensure that social work has a strong professional voice, and that is why we are supporting the development of the College of Social Work and the appointment of a chief social worker. The proposed transfer of functions to the Health and Care Professions Council will bring a number of further benefits in the form of standards of proficiency, many of which will have been developed by and tailored for the profession, and a fitness to practise process that will look at conduct and competence in the round.

The noble Lord, Lord Hunt, raised some issues about the General Social Care Council and the costs and so on. The council has made progress in developing the organisation since the discovery of a backlog of contact cases in June 2009. However, while the council is improving, there is still a lot of work to be done to bring it into line with the other professional regulators, such as the Health Professions Council. In addition, the council estimated that its costs would significantly rise as a result of these changes, and it would have been challenging for individual social workers to meet those costs.

Lord Hunt of Kings Heath (Labour)

The noble Baroness says that, but my understanding is that the latest estimate given by the GSCC is that as an independent regulator, the cost to registrants would be no different from that to the cost of registrants under the HPC, so I just do not understand the costs issue.

Baroness Northover (Liberal Democrat)

As the noble Lord will be aware, the figures provided by the General Social Care Council indicated that the costs would rise from £21 million to £25 million per annum, which would indeed cost about £250 per social worker. I realise that the council later revised this downwards, but the noble Lord knows as well as I do that those were the original figures based upon what the council estimated at the time. Even with the revision downwards, it was still not in line with the HPC, as I am sure the noble Lord is well aware.

However, it is extremely important to make sure that the arrangements that are in place regulate the social work profession properly and separate out the professionalisation of social work. The noble Lord will remember that he asked a question on this, and I drew the distinction for the medical profession with which the noble Lord, Lord Walton, will be familiar; the GMC regulates the medical profession, and the royal colleges do a fantastic job in promoting the profession and taking it further. The original arrangements that the noble Lord introduced were an earlier stage for social work, and the task now is to take it to the next level of development.

Regulation by the Health and Care Professions Council will bring social work regulation in England within the scope of the professional standards authority, with the added scrutiny that that will bring. It is our view that it would be wrong to require the Health Professions Council to move away from its tried and tested system of regulation solely for the social work profession.

Baroness Meacher (Crossbench)

May I ask the Minister whether she agrees that the standards set by the HPC are just lower than standards that social workers are used to and require to do the job properly?

Baroness Northover (Liberal Democrat)

I am not sure that I would agree with that. If the noble Baroness bears in mind that the HPC will regulate the profession and that other means will be used to drive further forward the training standards and the education of the profession in conjunction with the regulator, it may very well be that those two things have become conflated and it is important that they are separated out.

Baroness Meacher (Crossbench)

Would the Minister be willing to write to me to explain how these things will work? As I understand it, some standards might be set elsewhere but the standards that will be regulated will be those of the HPC, which will be very low. The HPC is the one with the regulatory powers and therefore it will not regulate the higher standards that might be set, for example, as good examples by the college. It would be helpful if we could have an explanation of how that will work in practice.

Baroness Northover (Liberal Democrat)

I am more than happy to write to the noble Baroness. In the discussions that I have had with various organisations, including the HPC, that is not the conclusion that I come away with. I hope that she is reassured.

Lord Walton of Detchant (Crossbench)

I apologise for interrupting and I do not wish to prolong the debate but the noble Baroness was kind enough to refer to my presence at the General Medical Council, which ended in 1989. Things have changed a little since that time. Of course, the GMC was concerned primarily with standards of education and ensuring that those who were properly educated and qualified were fit to practise in the first instance. Secondly, it was concerned with fitness to practise and with individuals in the profession who deviated from proper standards of practice as defined by the standards committee. It was concerned with the ethics of the profession and with ongoing and further education as well as with many other responsibilities. My understanding was that all those matters were within the ambit of the General Social Care Council in relation to its responsibilities. When the General Social Care Council transfers to the Health Professions Council, can we be assured that all those responsibilities that fall to the General Social Care Council, which is very young and only just finding its way, will be taken on board?

Baroness Northover (Liberal Democrat)

I will write with all the details so that noble Lords can see that there is no falling back in terms of the standards that people need to reach. We would hope that this separation out will drive standards up further. I will write to the noble Lord so that he can see that for himself.

On whether there should be a specific mention of social workers in the HPC and on the other points raised by the noble Lord, Lord Hunt, currently none of the professions regulated by the Health Professions Council has their own committee, director, or representation on the council. Neither is any profession mentioned in the council's title. Ultimately, it should be for the Health Professions Council to decide how best to regulate social workers and it has already established committees and appointed staff. It is very actively involved with the organisations involved in the transfer to see how best they need to gear things so that they are dealing with social workers appropriately.

The Council for Healthcare Regulatory Excellence has made it clear that in its view it is important that council members are focused on the governance of the organisation rather than on representing particular professional interests. We agree with this. The proposed new name of the council was decided upon with reference to the views of the Social Work Regulation Oversight Group, which includes in its membership Moira Gibb, chair of the Social Work Reform Board. None of the professions that the Health Professions Council currently regulates are specifically mentioned in the name and it would not be right to single out one profession now.

The Health Professions Council does, of course, recognise how vital the expertise and knowledge of social workers will be if it is to regulate them well. Its draft standards of proficiency for social workers have been developed by a professional liaison group which included representatives of social workers, their employers and educators. In addition, it uses members of a profession as partners to support its work. These partners have a role in approving training courses, hearing fitness to practise cases and assessing continuing professional development. They will ensure that decisions made about social workers are informed by an understanding of the complexities and challenges facing the profession.

The noble Lord, Lord Hunt, and particularly the noble Baroness, Lady Meacher, flagged up the issue of students. We are mindful that there should be no gap in the assurance of the standards of social work students and intend to provide for the transfer of the voluntary register of social work students to the Health and Care Professions Council pending a full consideration of the best approach to assuring the safety and standards of student social workers. We are acutely aware of that concern. The council has committed to undertaking a review of the risk in relation to students and if, indeed, as the noble Baroness, Lady Meacher, indicates, there is a significant risk, that is something that the Health Professions Council will take on board. It is looking at the risk to students of all professions that it regulates, including those of social work students.

The outcome of this process will set out the risks and issues relating to social work students. The Health Professions Council has assured us that it will seek to ensure that the outcome of its review is informed by social work expertise and evidence. If the noble Baroness wishes to send in information, I am sure that the HPC will be pleased to receive it. The Health Professions Council is currently consulting on this issue and we expect it to report on the results of this by spring 2012.

The noble Baroness, Lady Meacher, asked about the situation in relation to Scotland, Wales and Northern Ireland. She is absolutely right: the regulation of social workers is devolved, so each country can develop a system that best fits its delivery of social care. Therefore, there may well be divergences in the systems adopted. However, she is absolutely right that it is important that that divergence should not prevent, for example, the free movement of social workers or the necessary sharing of information between regulatory bodies. The Health Professions Council is working with the care councils of Scotland, Wales and Northern Ireland to establish a memorandum of understanding. That memorandum is expected to address such issues as cross-border fitness to practise, the recognition of programmes of education and training, information sharing and consistency on standards and their development. To support the Health Professions Council to develop those systems, the Bill imposes a duty on the council to co-operate with the care councils. I hope the noble Baroness will find that reassuring.

Following up on one or two other points on students, the General Social Care Council of course enforces its register of student social workers through the criteria of eligibility for an education support grant, which funds the practice placements of student social workers. The Health and Care Professions Council will not have that particular lever, but it will have other means, such as the council's approval of pre-registration courses, through which the Health and Care Professions Council will be able to encourage student registration if, following consideration, voluntary registration is considered the most appropriate way.

Baroness Meacher (Crossbench)

I wonder whether the Minister would consider that there should be a compulsory requirement. If the HPC is registering these courses, could it not be made compulsory that the course must register the students?

Baroness Northover (Liberal Democrat)

As I just said, the HPC is currently consulting. I strongly suggest that the noble Baroness feeds in to the consultation her recommendations and the evidence on which they are based so that they can be properly considered.

The question was raised of how social workers might be linked to the wider reform programme. The Health Professions Council is represented on the reform board and will be able to contribute its expertise to the ongoing reform of social work. Moira Gibb, chair of the reform board, is also a member of the Social Work Regulation Oversight Group. Her professional expertise and knowledge is contributing to the transfer process. Many organisations on the HPC's professional liaison group, which has developed draft standards of proficiency for social workers in England, are also on the Social Work Reform Board, which has ensured that the development of standards has been informed by wider developments in social work in England.

I hope that noble Lords will see that a lot of attention is being focused on trying to ensure that the change will operate as effectively as possible and will be in the interests of those with whom social workers work. It is exceptionally important that we protect the vulnerable people whom social workers look after, and we are acutely aware of that. On the basis of what I have said, I hope that noble Lords will not press the amendments in this group.

Lord Hunt of Kings Heath (Labour)

My Lords, I am very grateful for the noble Baroness's response. Of course I agree with her last point that the end result will be the impact on people to whom social workers provide a service. However, she did not respond to her noble friend Lord Newton, who asked whether creating this new body would not repeat some of the issues that were faced by CQC. I am left with puzzlement. I have not heard one point in favour of this happening. It is beyond me to understand why it is being done. No argument with any thought behind it has been put to suggest that this will improve the regulation of social workers.

On the question of costs, whatever the original estimate, the General Social Care Council produced new work. The noble Baroness shakes her head. Is she saying that the General Social Care Council is misleading Parliament on the issue? It stated clearly that it can produce a regulatory system that will cost the Health Professions Council very little.

Thirdly, on the question of student registration, the problem is that I know what the outcome will be of the work that the HPC will do. It will continue with the system that it applies to the health professions. It is clear that the HPC, although it is a good body, is completely inflexible and will not change its approach because a new profession has been added to it. There is no trust out there-I have fallen into the trap set by the noble Lord, Lord Mawhinney. I am talking about the professions. There is no trust because the record of the HPC is simply to embrace profession after profession, which all have to be moulded into the system that the HPC has set. While that will work for health professions, my concern is that social work is a completely different profession. This point was put by the noble Lord, Lord Walton.

I understand why my noble friend Lady Pitkeathley is concerned about an amendment that stresses the importance of having social workers on the council of the HPC. However, because of the very new nature of the body, when one brings in a completely new profession some protection needs to be given. There needs to be some assurance that the HPC will have people at a very senior level who understand social work. I still do not know why a new council is not being appointed. If good faith was being shown by the Government to the social work profession, the current council would have been stood down and a new council appointed. That is why I tabled my amendment.

Finally, I turn to the name. The noble Baroness said that we cannot put "social work" in the name of the organisation because none of the other professions covered by the HPC is in the current HPC name. If that is the case, why does Clause 210 refer to the Health and Social Work Professions Order? The Government have no problem whatever recognising "social work" in an order before Parliament. Surely it is not up to the HPC to depart from that view. Clause 219 refers to the Professional Standards Authority for Health and Social Care. Therefore, if the noble Baroness does not like "social worker" in the title of the organisation, why would she not accept "health and social care professions"?. Why is there an attempt to completely remove the concept of social work and social care from the title?

Unfortunately, an existing health body is simply taking over the social work profession without any genuflection whatever to the need to embrace social workers in the new organisation, whether in governance, remit or title. It is very disappointing that the Government are not prepared to reconsider the matter.

Clause 206 agreed.

Clauses 207 to 210 agreed.

Clause 211 : The Health and Care Professions Council

Amendment 338A not moved.

Clause 211 agreed.

Amendments 338B to 338D not moved.

Amendment 338E had been withdrawn from the Marshalled List.

Clause 212 : Function of the Council in relation to social work in England

Amendment 338F not moved.

Clause 212 agreed.

Clauses 213 to 217 agreed.

Amendments 339 to 339ZB not moved.

Clause 218 to 224 agreed.

Clause 225 : Establishment of voluntary registers

Amendment 339A

Moved by Baroness Masham of Ilton

339A: Clause 225, page 224, line 46, leave out "voluntary"

Baroness Masham of Ilton (Crossbench)

My Lords, we now have another bite at a very important cherry. My amendments in this group seek to provide for a mandatory register for healthcare assistants and assistant practitioners by doing away with "voluntary". The Government are setting out a framework to establish a voluntary register for all unregulated health professionals. In doing so, they are making a mistake and missing an opportunity. Healthcare assistants and assistant practitioners are carrying out more and more of what are seen as nursing procedures. It is not always possible to supervise them on a busy ward or in somebody's own home. Surely there should be a mandatory register accompanied by a programme of basic standardised training.

This proposal is supported by the Royal College of Nursing and the House of Commons Health Select Committee. The Select Committee's report expresses concern about the Government's proposals for a system of voluntary registration:

"The Committee endorses mandatory statutory regulation of healthcare assistants and support workers and we believe that this is the only approach which maximises public protection. The Committee notes that the Government intends to give powers to the relevant regulators to establish voluntary registers for non-regulated professionals and workers, but would urge it to see healthcare assistants, support workers and assistant practitioners as exceptions to this approach who should be subject to mandatory statutory regulation".

A voluntary register is likely to be too weak and in any event it will be avoided by the very people about whom there is most concern. The recent horrifying scandal at Winterbourne View in Bristol underlines the issues around the registration of healthcare assistants. This view is supported by the Health Select Committee. The main benefit of ensuring that every care worker and healthcare assistant is regulated by a regulatory body is that the code of practice associated with their registration must be followed or they could be subject to disciplinary procedures.

It should also be noted that the rate at which people register with a voluntary system is open to question. A similar situation arose in the UK when seat-belt wearing was voluntary. It was only when wearing seat belts became compulsory in 1983 that the rate went from around 30 per cent to its current 95 per cent. It is highly likely that the same would happen here.

If the existing regulators are too hard-pressed to take this on, I am sure that there are other willing providers who would do this job. My interest in this is the safety and well-being of patients and the morale of those who give the service that should be given with tender loving care.

I cannot accept the Minister's statement that we have not got the evidence. What about all the recent reports from the Audit Commission, the Patients Association and the CQC, the "Panorama" programme on the appalling situation at Winterbourne View care home, the review of Mid Staffordshire NHS Foundation Trust, the deaths and poisoning with insulin at Stepping Hill Hospital and many other serious incidents in hospitals and the community? I beg to move.

Lord Ramsbotham (Crossbench)

My Lords, I wish to speak to my two amendments to Clause 225. I must admit that they are probing amendments that ask a question. I am confused by the situation that appears to be being proposed, and I am speaking in the context of two particular groups of people: Armed Forces veterans and prisoners.

As is well known, there is a huge pool of psychiatric morbidity in prisons, which I mentioned this morning. It is also known that a considerable number of veterans suffer from a variety of mental health problems-anxiety, depression and alcoholism-but added to them is the extra spectre of post-traumatic stress disorder. Psychotherapists and counsellors are employed particularly to help with PTSD, anxiety and depression. Unfortunately, as far as veterans are concerned, they are currently denied the choice that is available to citizens in the United Kingdom because Combat Stress, which tends to be the blanket organisation for their treatment, follows rigidly the NICE guidelines in recognising only CBT and EMDR. The care and treatment that Combat Stress provides does not meet all the cases of soldiers, veterans of other services and prisoners, and other organisations, such as the Human Givens Institute, have been having enormous success with them. Those organisations currently function under the auspices of the UKCP and the BACP, which operate voluntary registers-indeed, many organisations working in this area are registered with both.

As I understand Clause 225, the HPC, established by the previous Government, will no longer exist and instead we will have two new organisations: the Professional Standards Authority and the Health and Care Professions Council. Between them, they are going to be responsible for establishing the statutory regulation, the accreditation and, we are led to believe, the voluntary registers. This is where my question comes in. The trouble with that is that it could cause confusion because you cannot have two organisations running parallel voluntary organisations if you are going to give clarity to the people who need their services. I understand that a consultation is taking place, that the outcome is due in April or May next year and that other organisations, such as the Human Givens Institute, have been invited to attend this consultation, which they are very glad of because they have at last been able to put their case on the table.

The case is very interesting because those organisations are able to prove the success of what they have done by measured outcomes, whereas organisations that follow the NICE guidelines cannot prove anything by outcomes as they have not got them. All they can say is that they have conformed to the guidelines. One of the problems in this area is that the guidelines, which I understand were originally meant to be guidelines, are being taken as tablets of stone. That is thoroughly unfortunate in this area, particularly when we are facing the need for the Department of Health to conform to the demands, for example, of the Armed Forces covenant, which will certify that all the things needed by veterans will be available-housing, of course, but also in the health area.

It is very important that this issue is resolved and that there is clarity. People should know who is responsible for setting up which register and who is responsible for accrediting whom, so that there can be no doubt in the minds of the users. Therefore, I should be enormously grateful if the Minister could clarify that. If necessary, perhaps we could meet before Report for clarification on this matter because the organisations concerned are in doubt.

Lord Walton of Detchant (Crossbench)

My Lords, I shall be brief but, as always, my noble friend Lady Masham was very persuasive. I have always felt, as indeed she does, that there is a powerful case to be made for the statutory regulation of healthcare assistants not only in hospitals but in homes, particularly old people's homes. As we heard during the debate on the amendment tabled by my noble friend Lady Emerton, the Government are entirely persuaded that at present the regulation of such individuals could not be done by statute. I must say that I feel uncomfortable about that.

Is there any means by which the Government can suggest a mechanism whereby, perhaps in consultation with the Care Quality Commission, the terms of voluntary registration of healthcare assistants could be based on a set of agreed principles which were accepted generally by all the professions concerned? As it exists at the moment, voluntary registration is not adequate or strong enough and needs to be strengthened. Therefore, while I support in principle the ideas put forward by my noble friend Lady Masham, I think that for the present we will have to be satisfied with voluntary registration, which should be strengthened by whatever mechanism can be introduced.

Baroness Barker (Liberal Democrat)

My Lords, I have a great deal of sympathy with what the noble Lord, Lord Walton, has said. If noble Lords look at A Vision for Adult Social Care, a document published by the Government last year, they will see that the principles underpinning health and social care have been set out perhaps more clearly than they have been for some considerable time. I do not think the problem is that the principles are not there or are not known; it is that the training that brings those principles to life for a practitioner is not there.

I am torn on this issue. I listened to the noble Baroness, Lady Pitkeathley, and I was persuaded by what she said. I know of organisations which use staff who are not registered but who are exceptionally well trained and have very high standards. If the Government are reluctant-I am sure that my noble friend will again say that they are-to go down the path of full registration, I would understand that position if my noble friend would give a commitment to the development of training. That would go a long way to meeting the point to which I think all noble Lords are trying to get; namely, that the training of people involved in the direct care of those who, usually, have long-term conditions is of a high enough quality. That is the most helpful thing that my noble friend might be able to say.

Baroness Pitkeathley (Labour)

My Lords, in response to the two noble Lords from the Cross Benches who have spoken, the thinking of CHRE, which is to become the Professional Standards Authority, on the accreditation of voluntary registers is quite well developed. We would be very happy to participate in any meeting of the kind suggested.

Lord Hunt of Kings Heath (Labour)

My Lords, that is a very helpful offer from my noble friend. I welcome the debate and I am grateful to the noble Baroness, Lady Masham, for moving the amendment. It seems to me that there are two issues. First, we have already had a debate about whether certain professions, particularly healthcare assistants, should be statutorily regulated. No doubt, the noble Baroness, Lady Emerton, will bring that back on Report. Secondly, notwithstanding whether one might agree or disagree about which profession should be statutorily regulated, is there some benefit in a voluntary register alongside statutory regulation or is there a halfway house, as the noble Lord, Lord Walton, has suggested, of strengthening what voluntary registration means? I have not sought to amend on the principle of voluntary registration. However, if it is accepted that there is benefit in having a voluntary register-the noble Baroness gave some powerful reasons in relation to healthcare assistants in our debate before the Statement-and if it is taken further and statutory bodies such as the NHS say, "We won't employ you unless you are on a voluntary register", there is then the problem that people could move on to other places and work in other care settings. Such people might have been sacked or removed by a trust. There is no guarantee of safeguards for the public. I have a sense that, once you have gone down the pathway of acknowledging that there is benefit in voluntary regulation, you are acknowledging that there should be statutory regulation.

I was very interested in what the noble Lord, Lord Ramsbotham, had to say and he will know that I have a particular interest in prison healthcare. I think that the involvement of the National Health Service in prison healthcare has led to a great improvement but more needs to be done. The points that he raised are very important.

I have put my name to Amendment 339BZA, which is in the name of the noble Lord, Lord Low, who, unfortunately, is unable to be here today. Perhaps I may briefly say that he has some strong arguments in relation to rehabilitation officers for the blind. He has pointed out that such officers work within the same legal framework as occupational therapists and social workers. They case-manage clients, devise and manage packages of care, oversee the work of lower skilled workers and manage risk-intensive situations with already vulnerable people. In Wales, statutory regulation for rehabilitation officers is due to be finalised at the end of this year. The noble Lord, Lord Low, would like some recognition that at least voluntary registration could be considered for this profession under the terms of the Bill. On that basis, I hope that the noble Baroness may be able to give some positive response to the noble Lord's amendment.

Baroness Northover (Liberal Democrat)

My Lords, I thank noble Lords for these amendments, which raise important issues about the ways in which we assure the quality and safety of our health and social care workforce. It is another bite of a very important cherry, as the noble Baroness, Lady Masham, put it, which is a wonderfully graphic image. We had a full discussion of this issue earlier. Perhaps I may emphasise again that the Government are committed to embedding quality of care and patient safety at the heart of health and social care provision. These are the key drivers of our policy on workforce assurance.

I fully agree with the noble Baroness, Lady Masham, that we need to drive up quality, which has run through a lot of our debates today. In considering how we achieve this, we need to ensure that any system is proportionate and effective and properly balances the need for local responsibility for providing high-quality, safe services, and the need for consistent and rigorous national standards. I assure noble Lords that we are not ruling out compulsory statutory regulation for any groups of workers. Compulsory statutory regulation will be considered where there is a clear body of evidence that the risks presented by specific groups cannot be mitigated by assured voluntary registration alongside other existing systems of assurance of standards, such as supervision of workers by qualified professionals, enforcement of standards by employers, registration with the Care Quality Commission, and the vetting and barring system.

However, compulsory statutory regulation, as we discussed earlier although we did not all agree, is not a panacea. It is no substitute for good leadership at every level and proper and visible management of health and social care services. The best protection for the public is, of course, well run services focused on the individual and delivered by qualified staff and appropriately trained and supervised care workers. Employers, commissioners and managers must take responsibility for ensuring this and we need to make sure that local service providers and commissioners are held to account for managing problems effectively and promptly.

The Care Quality Commission sets standards of care for all providers of regulated activities and takes action when they are not met. These standards include a requirement that providers use suitable numbers of appropriately trained and qualified workers. In the rare cases where health and social care workers present a risk of harm to service users, the vetting and barring system can be used to ban individuals from working with vulnerable adults and children. In this context, our view is that the standards of unregulated groups of health and social care workers can generally be assured without imposing compulsory statutory regulation. However, we recognise that we need to ensure that commissioners, employers, supervisors and individual users of services have the knowledge needed appropriately to employ, delegate to and supervise health and social care workers. The Government believe, as noble Lords have clearly picked up, that assured voluntary registration enables this to be achieved.

The amendment tabled by the noble Lord, Lord Low, and spoken to by the noble Lord, Lord Hunt, seeks to enable regulatory bodies to establish and maintain voluntary registers of unregulated rehabilitation officers for the blind in England. The assured voluntary registration of this important group of workers would enable standards to be set for entry to and practice of the profession. I hope that I can reassure the noble Lord, Lord Low, through the noble Lord, Lord Hunt, that the amendment is unnecessary as we are confident that the provisions which enable voluntary registers as social care workers in England to be established by the Health and Care Professions Council and accredited by the Professional Standards Authority for Health and Social Care are already wide enough to include such officers.

The noble Lord, Lord Ramsbotham, flagged up key areas with his particular concern about prisoners' mental health and the mental health of those coming out of the Army. The Health and Care Professions Council will be given the power to set up voluntary registers of workers. Perhaps I may clarify for him the possible confusion over the roles of the various bodies. The council can set up voluntary registers of workers. The Professional Standards Authority for Health and Social Care will not hold registers, but will have the function of accrediting them to ensure that they are robust. However, I am happy to write with further details to clarify the situation for the noble Lord so as to ensure that he is quite happy with the way that things will be organised.

In referring back to our earlier debate, perhaps I may assure my noble friend Lady Barker, who is absolutely right in terms of training, that we place great importance on improving the training of health and social care workers, and especially on further integrating it, something flagged up not only by my noble friend, but also earlier by the noble Baroness, Lady Emerton, and others.

I hope that I have been able to reassure noble Lords of our commitment to assuring the quality and safety of health and social care workers and the contribution assured voluntary registration can make to the existing systems of assurance of the standards of health and social care workers. I hope, therefore, that the noble Baroness will feel able to withdraw her amendment.

Baroness Masham of Ilton (Crossbench)

My Lords, I thank all the supporters of the amendment. In an ideal situation, what the Minister has said might work, but it is not an ideal world. The important point is that of picking up those people who will not come forward for voluntary registration. What does one do with them? Some agencies might not take people on who have not voluntarily registered, but others take on anyone without even taking up references. There must be safeguards, as the noble Lord, Lord Hunt, has said. We live for the Report stage. With that, I beg leave to withdraw the amendment.

Amendment 339A withdrawn.

Amendments 339B to 340A not moved.

Clause 225 agreed.

Clause 226 : Accreditation of voluntary registers

Amendments 340B to 340G not moved.

Amendments 340GA to 340GC had been withdrawn from the Marshalled List.

Amendments 340H to 340V not moved.

Clause 226 agreed.

Clauses 227 and 228 agreed.

Schedule 16 agreed.

Clause 229 agreed.

Schedule 17 : The National Institute for Health and Care Excellence

Amendment 340W

Moved by Lord Hunt of Kings Heath

340W: Schedule 17, page 413, line 15, leave out sub-paragraph (2) and insert-

"( ) The Chair will be appointed by the Secretary of State with the consent of the Health Select Committee of the House of Commons."

Lord Hunt of Kings Heath (Labour)

My Lords, this amendment brings us to NICE. I start by paying tribute to its work, and I should say that I much appreciated the commendation for the institute made by the noble Earl, Lord Howe, in the Oral Question last week. NICE was established because of the slowness of the NHS to take up proven new treatments and drugs, and although there was concern at the time of its establishment, I do not think there is any doubt that it has done a good job and that it has achieved global recognition for aspects of its work. It is important to build on this in the future and not to put any qualifications or impediments in its way or undermine its independence. That is why Amendment 340W would provide that the consent of the Health Select Committee ought to be required for the appointment of the chairman of NICE. This is a very important appointment, and I would have thought that parliamentary scrutiny will enhance confidence in the independence of NICE's role.

Amendment 340X would remove the current provision in Schedule 17 to give the Secretary of State a veto over the appointment of the chief executive of NICE. Given the Secretary of State's desire to take a hands-off approach and given also the enhancement in the status of NICE, I remain somewhat puzzled as to why the Secretary of State wishes to maintain a veto power over the appointment of the chief executive, and I wonder if the noble Earl would consider removing it. Surely it would be appropriate to leave it to the good sense of the chairman and members of the board to appoint the chief executive.

Amendment 344ZA ties in with Amendment 344, to which my noble friend will speak in a moment. It is important that NICE should continue to assess the cost-effectiveness to the health service of new pharmaceutical products, and certainly until this matter is incorporated into a system of quality standards as provided for in Clause 231. I assume that this is also tied to proposals on value-based pricing which we debated a little at Second Reading. Essentially, however, I would like some assurance from the noble Earl that in the current circumstances, appraisals by NICE will be subject to directions so far as implementations are concerned and that clinical commissioning groups will be required to implement such guidance. The point here is this. The other reason NICE was established was to try to remove postcode prescribing as far as possible, so it is important to ensure that this continues under the Government's new proposals. I beg to move.

Lord Warner (Labour)

My Lords, Amendment 344 in this group, in my name and that of the noble Lord, Lord Patel, and the noble Baroness, Lady Thornton, has been prompted by the Government's apparent wish to remove NICE from technology appraisals of new drugs to assess their cost-effectiveness.

I join my noble friend Lord Hunt in paying tribute to the work that NICE has done. These technology appraisals were the original purpose of NICE when it was set up, against the wishes of the pharmaceutical industry. It has done sterling work in this area which has provided it with an international reputation. One of the strange ironies of this is that the pharmaceutical industry has come almost to love NICE, because the commercial value and standing given to some of its new products when companies receive a positive appraisal by NICE has been considerable. When I went to America to make my peace with some in the pharmaceutical industry after cutting their prices, and after they sometimes broke down in tears over the drop in their profits, they would say that if the mean NHS was willing to pay for those drugs, they must be good things in themselves.

Value-based pricing still looks to be some way off and it seems premature to many to remove NICE from the sphere of technology appraisals-here, I should declare my interest, because I have been a Minister with responsibilities for NICE. I want to press the Minister to tell us more about the arguments for removing NICE from this work, particularly given the financial challenges faced by the NHS, and whether the Government will think again about technology appraisals and NICE's responsibilities there. That is the purpose of the amendment; I look forward to hearing the Government's views.

Lord Owen (Crossbench)

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 (Crossbench)

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 (Conservative)

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.

In our response to the Future Forum report, we also confirmed our intention to maintain the effect of the funding direction in the new value-based pricing arrangements from 2014 to ensure that the NHS in England consistently funds medicines with a value-based price. This means that NHS patients can be reassured that they will continue to have a right to clinically appropriate, cost-effective drugs and treatments as set out in the NHS constitution and handbook. Quality standards bring clarity to quality and are a resource that supports clinicians and commissioners in driving quality improvement locally. They serve a different purpose from the technology appraisal guidance that NICE provides on drugs and treatments.

There has also been some debate around the promotion of innovation by NICE. It has been a recurring theme in the Committee. A few days ago we published Innovation, Health and Wealth, which recognises the key role that NICE guidance should play in supporting the adoption and diffusion of innovation and sets out a range of measures to support and improve implementation of NICE's guidance, such as the establishment of a NICE implementation collaborative.

There has also been discussion about whether it is appropriate for NICE to have a training function. I can reassure noble Lords that there is a clear need for this provision. I am looking here at Clause 236. Among its important functions, we intend that NICE will undertake work historically delivered by the National Prescribing Centre, which provides support for high-quality, cost-effective prescribing and medicines management across the NHS through the development of a range of tools and services. NICE, in its current statutory form, absorbed the NPC in April of this year. The Department of Health has previously commissioned from the National Prescribing Centre specific support and tools to support policy delivery, including training. The department or the NHS Commissioning Board may in future direct NICE to provide similar services.

There have also been suggestions that we amend some of the provisions relating to the chair and non-executive directors in Schedule 17. I can understand why the noble Lord, Lord Hunt, suggested that the Health Select Committee should approve the appointment of the chair of NICE but this provision has not been made for the other bodies being established in the Bill and I do not believe it is necessary for NICE. Under the Bill, the Secretary of State will be responsible for appointing the chair of NICE, as is the case for NICE in its current statutory form. To require Health Select Committee authorisation would be to add a further layer to the appointments process for the NICE chair to little obvious benefit.

I can also appreciate why noble Lords have asked me to clarify Schedule 17(3). It may at first glance appear to contain an unusual level of detail for primary legislation but I should point out that this provision is here for a serious purpose: to ensure that in the very serious but, we hope, unlikely eventuality that a non-executive officer of NICE is suspended there can be no argument about whether they have been properly informed of that decision. This provision is consistent across the arm's-length bodies being established in the Bill.

Finally, I briefly speak to the amendments that I will seek to move. They are all minor and seek to: clarify some of the wording around NICE's additional functions; ensure that public consultation for quality standards produced now will be recognised as effective consultation following NICE's re-establishment; and remove an amendment to Welsh legislation in the consequential provisions that is considered unnecessary. I hope that the noble Lord will feel reassured by my explanations of these issues and that he will withdraw his amendments.

Lord Hunt of Kings Heath (Labour)

My Lords, I am grateful to the noble Earl. At heart, there are two key issues here. One is the independence of NICE-I am grateful for what the noble Earl said on that. I certainly support the change in status. The reason there is some anxiety about independence is that in two parts of the Bill the NHS Commissioning Board has powers of direction over NICE. We will come on to this in relation to Clause 231 on quality standards,-it applies also to Clause 236 but this is where some of the concern comes from. I am very dubious about whether quangos, to put it kindly, should have power over NICE. That is where the concern comes from and why scrutiny by the Health Select Committee of the chair would be important.

The noble Earl has reassured us that the technology appraisals will continue and that, until value-based pricing is introduced, there will be a clear understanding that NHS bodies will implement the technology appraisals. He said that it would not be appropriate for those directions to the health service to be in the Bill, but can he clarify that the current order will be amended so that instead of directions to health authorities, primary care trusts and NHS trusts in England, clinical commissioning groups will appear in the title of the order? It is quite clear that although this will be done by secondary legislation, clinical commissioning groups will be required. I take his point about the need for discretion when it comes to primary legislation, but I would like to ask him about that point.

My third point to the noble Earl is about value-based pricing. One of the joys of talking about value-based pricing is that no one understands it, and, frankly, having read all the reports and the original OXERAreport, I confess that I am still rather puzzled by it. It sounds good, but I caution the Government that the PPRS has served us reasonably well. It has allowed the Government to cap the profits of the pharmaceutical industry but has given them complete discretion about the price of individual drugs-the advantage being that prices set in the UK have then been influential throughout the rest of Europe. My concern about value-based pricing is that, combined with issues around the regulation of medical health research, it makes the UK a less attractive place for the industry to invest in R&D.

My noble friend Lord Warner toured the boardrooms of New York and New Jersey, and I followed him to sweep up-

Lord Warner (Labour)

The mess.

Lord Hunt of Kings Heath (Labour)

-not the mess, my Lords, but my noble friend's vigorous discussions-because of the wish to ensure that those global companies continued to invest in the UK. The problem with the Department of Health is that while it sponsors the industry, its real concern, when it comes down to it, will always be the cost of drugs to the National Health Service-hence my concern that powers of direction by the NHS Commissioning Board will not be used in a way that is conducive both to the independence of NICE and to the continued R&D spend on pharmaceuticals in this country. I do not really want to institute a debate on value-based pricing at this point, but I hope that the Government will look very carefully at its introduction and all the consequences from it. Having said that, unless the noble Earl wishes to answer the point on direction, I certainly beg leave to withdraw.

Earl Howe (Conservative)

My Lords, I will drop the noble Lord a letter on the funding direction, but it is our intention to place this in secondary legislation, appropriately amended as he indicated. It is possible that this will be incorporated in the standing rules as a fixture. On value-based pricing, I can tell him only that quite detailed work is currently under way on the model and that, while I agree in many ways with his comments on the PPRS, it has two unsatisfactory features. One is that it does not recognise fully the factors that society values; the other is that it does not incentivise research sufficiently to address areas of unmet need. If we can achieve both those things, it will represent an advance, but the noble Lord is right that there is still some way to go before this model is finalised.

Lord Hunt of Kings Heath (Labour)

My Lords, I am grateful and beg leave to withdraw my amendment.

Amendment 340W withdrawn.

Amendment 340X not moved.

Schedule 17 agreed.

Clause 230 : General Duties

Amendment 341 not moved.

Clause 230 agreed.

Clause 231 : Quality Standards

Amendment 342

Moved by Lord Warner

342: Clause 231, page 232, line 11, leave out "may direct NICE to prepare statements of standards" and insert "shall each year agree with NICE a programme of clinical quality standards to be completed or revised"

Lord Warner (Labour)

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 (Crossbench)

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 sometime.

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 (Crossbench)

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.

Lord Hunt of Kings Heath (Labour)

My Lords, I follow on from the noble Lord, Lord Owen. Clause 231 says:

"The relevant commissioner may direct NICE to prepare statements of standards in relation to the provision of ... NHS services".

In relation to a quality standard regarding the provision of NHS services, the relevant commissioner means the Commissioning Board.

I come back to the point about independence: surely it should be the Secretary of State who should direct NICE to prepare statements of standards in relation to the provision of NHS services. Surely, under this architecture, the concern of the Commissioning Board will be money. It is going to have to ensure that the NHS delivers what the Secretary of State requires in the mandate, which is growing ever longer as we debate the Bill, and that will mean quite a lot of pressure on it. I am worried that because it can direct NICE to prepare statements of standards, it is bound to be governed by finance; in fact, it is bound to relate the number of standards that it directs to the resource issue.

Of course one has to take account of resources, and the very fact that NICE's technology appraisals are concerned with cost effectiveness is a recognition that we have to make judgments about the use of resources, but I would have thought that there was benefit in there being a distance between that direct concern of the Commissioning Board and the overriding leadership of the service that the Secretary of State must provide.

I wonder if the Minister would be prepared to give this further consideration. In this part of the Bill and in Clause 236, where the board can give directions to NICE, one simply has anxieties that, at least visibly, the independence of NICE might be compromised.

Earl Howe (Conservative)

My Lords, NICE's independence is the foundation of its reputation as an authoritative source of evidence-based advice. To guarantee that independence, to pick up the point made by the noble Lord, Lord Hunt, the Bill contains no direction-giving power to enable NICE to be directed as to the substance of a quality standard, and explicitly prohibits regulations from enabling the Secretary of State or the NHS Commissioning Board to direct NICE on the substance of its advice, guidance or recommendations. I reassure noble Lords that the independence of NICE's advice is assured by the very mechanism by which it formulates it-through public consultation and collaboration with respected authorities such as medical royal colleges.

I shall explain in a moment how we propose that the NICE quality standards should be commissioned, because there are different arrangements for different types of quality standard. However, the amendments begin to chip away at what we want to see-that is, a clinically led process-by specifying what really does not need to be specified, as the evidence of the quality standards published to date shows. I appreciate that many people have an interest in this programme, and that is why subsection (7) not only requires NICE to establish a process for its quality standards programme but requires a consultation on that process. That gives ample opportunity to patients, clinicians and other interested parties to have a say in how the programme is delivered.

NICE is expected to develop a broad library of between 150 and 175 quality standards, spanning the domains of the NHS outcomes framework and commissioned by the NHS Commissioning Board. The Secretary of State will have responsibility for commissioning quality standards for social care and public health. For integrated pathways of care covering NHS treatment together with public health and/or social care interventions, the Secretary of State and the Commissioning Board will be able to commission quality standards jointly. So, NICE will prepare quality standards when commissioned to do so by the board for NHS healthcare services, by the Secretary of State for the public health service and social care and jointly by the Secretary of State and the board for integrated pathways.

The noble Lord, Lord Warner, expressed his disappointment at the rate of progress of the rollout of NICE quality standards. Actually, there has been a steady start to this: we have some two dozen quality standards at the moment and, as I mentioned, we will have between 150 and 175 of them over a five-year programme. We agree with the noble Lord that it is crucial to maintain momentum with this important work, and NICE has told us that it believes that the programme is realistic. It is unnecessary to undertake to agree a programme of quality standards each year. The current programme that is being overseen by the National Quality Board is ideally placed to deliver that steady steam of quality standards over the agreed timescales.

The noble Lord, Lord Patel, asked how we will ensure that standards will stand the test of time. NICE regularly reviews its products, including guidelines and standards. This is an established part of NICE's working procedure that has helped it to attain its high standing with patients, clinicians and, indeed, the industry. NICE is keen to take into account any new evidence and to be responsive to changes in circumstances.

As I said earlier, NICE quality standards bring clarity to quality, providing definitive and authoritative statements of high quality care and based, as the noble Lord, Lord Patel, rightly said, on the evidence of what works best. As we move towards a system that will focus on improving the outcomes that matter most to patients, it is vital that quality standards reflect these.

Amendment 343, which places a particular emphasis on long-term conditions, is understandably motivated but it may have the unintended consequence of excluding other conditions. While I sympathise with the sentiment, it is probably undesirable to specify that in the Bill. That is why the National Quality Board is overseeing the development of a process for selecting topics for the rest of the library that will integrate and build on the current process for selecting the NICE clinical guidelines. This process recognises the importance of ensuring that smaller specialties are taken into consideration. I have a long list here of topics in the proposed programme that address long-term conditions. I am happy to let noble Lords have that. This reflects the fact that these quality standards are needed to help the NHS improve outcomes in this area, as we envisaged in the NHS outcomes framework.

NICE recently completed an engagement exercise on the proposed library of quality standards. The responses were overwhelmingly positive about the programme and the role of quality standards in the new system. This feedback is reassuring, and I hope it reassures the noble Lords sufficiently to enable them not to press their amendments.

Baroness Emerton (Crossbench)

My Lords, could I just interrupt to ask a question about the evidence-based quality standards? Where do we fit in the culture change that is so important when we look at quality standards? It is very difficult to measure a culture. We talk about trying to integrate health and social care in all the standards in primary, secondary and tertiary care. An evidence base is essential for NICE, but we have not mentioned culture at all today in this context. It is absolutely fundamental, particularly with the long-term conditions, to talk about or to include some measurement of culture.

Earl Howe (Conservative)

The noble Baroness is quite right and no legislation can provide for that culture change, as she will appreciate. At the same time, we can put in some important building blocks to encourage a change of culture. One is to have maximum clinical input into how the quality standards are framed and formed and, indeed, input from patient representative groups. It is very important to see things from their perspective. We can create duties, as we have in the Bill.

The work that my department has done on accelerating the uptake of innovation is relevant here. The NICE implementation collaborative-the NIC-that was part of our announcement about the growth agenda some days ago is designed to bring together the relevant stakeholder groups to see how the uptake of innovation can be accelerated and how people can be made to look at working practices in rather a different way so that cultures shift. However, it is easy for me to stand here and say that; it is less easy to drive this forward. I would not pretend that the Government are necessarily in the best place to do that, although we are clear that this shift in approach, which largely underlines the QIPP agenda as well, has to take place. However, it will take a little time.

Lord Warner (Labour)

My Lords, the total purpose of my Amendment 342 was to inject some momentum into the process of delivering these quality standards. I am much reassured by what the noble Earl has said. I think my noble friend's point about directions for the national Commissioning Board is important. It can be misleading. I hope that the revelations of the noble Lord, Lord Owen, about the chairman of NICE's past associations will do no damage to his reputation. I beg leave to withdraw the amendment.

Amendment 342 withdrawn.

Amendments 343 and 343A not moved.

Amendment 343B had been withdrawn from the Marshalled List.

Clause 231 agreed.

Clauses 232 and 233 agreed.

Clause 234 : Advice, guidance, information and recommendations

Amendment 344 not moved.

Clause 234 agreed.

Amendment 344ZA not moved.

Clauses 235 to 239 agreed.

Clause 240 : Additional functions

Amendment 344A

Moved by Earl Howe

344A: Clause 240, page 237, line 23, leave out "its functions" and insert "any function it has under or by virtue of any other provision of this Part"

Amendment 344A agreed.

Debate on whether Clause 240 should stand part of the Bill.

Lord Naseby (Conservative)

My Lords, the Deputy Speaker called the amendment and it was agreed, but I did not specifically hear that Clause 240 should stand part. If I may, I will intervene briefly on whether the clause should stand part, particularly the additional functions under subsection (1)(a). It states:

"NICE may do any of the following ... acquire, produce, manufacture and supply goods".

I have a query for my noble friend on the Front Bench. We are well aware that in the past some hospitals have manufactured certain generic medicines and marketed them, which has caused the normal market for medicine and pharmaceuticals to be disrupted. Secondly, we are aware, particularly recently, of certain hospitals that have been selling medicines in another market, which has caused disruption to that market and particular difficulties for parts of the country where there has been a shortage of medicines.

I may be wrong but, as I read it, this clause means that NICE will be in a position to manufacture directly, maybe even under a licence. I see that under paragraph (f) NICE will be able to,

"exploit ideas and exploit intellectual property".

Can we be quite clear? Is my noble friend really saying that NICE, the adjudicator of value for money and all the other dimensions in the Bill to do with pharmaceuticals, medicines et cetera, will manufacture certain medicines on the side? That does not seem to be part of the role of the regulator. It seems, frankly, to be virtually direct labour within the context of NICE. I would be most grateful if my noble friend would respond. If he is not able to respond today, perhaps he will respond on Report or write to me.

Earl Howe (Conservative)

My Lords, I hope I can assist my noble friend. Clause 240 enables NICE to undertake additional functions, such as supplying new services and exploiting intellectual property. These functions must be related to the provision of health and social care. They seek to reproduce the income-generation powers that NICE currently enjoys as a special health authority and do not therefore represent an expansion of its powers. NICE may do this for any number or type of organisations, including the private sector and overseas Governments. This clause allows NICE to charge for carrying out these additional functions on an appropriate commercial basis.

In the White Paper Liberating the NHS: Report of the Arm's-Length Bodies Review, the Government stated that,

"where appropriate, arm's-length bodies will be expected to exploit commercial opportunities and maximise commercial discipline across the sector".

NICE may carry out these additional functions provided that they do not have an impact on its ability to carry out its functions. We do not envisage, and nor does NICE, that the performance of any of these functions will interfere with its normal work programme. I hope that that is helpful to my noble friend. It is certainly not the case that NICE will be manufacturing medicines, as I think he feared.

Lord Hunt of Kings Heath (Labour)

Is not the point that NICE enjoys a global reputation for the excellence of its work, as we discussed earlier? I do not know how many hits it has on its website every day but I understand that it is a considerable number. Is this not a huge advantage for the UK and that all the Government are seeking to do is to ensure that NICE can exploit that so that its work in the UK can be developed elsewhere?

Earl Howe (Conservative)

The noble Lord is exactly right. He will know from his time as a Minister with responsibility in this area that NICE has steadily grown its reputation overseas, and that with that have come opportunities to sell its services in a number of quarters. We simply want to see that continue.

Lord Naseby (Conservative)

I understand that and I understand the point made by the noble Lord, Lord Hunt. Nevertheless, to the best of my knowledge, NICE has never manufactured, and presumably from what my noble friend has said is not going to manufacture, in which case perhaps "manufacture" can be deleted from the Bill when it returns on Report.

Earl Howe (Conservative)

I will take advice on why "manufacture" is in the Bill and come back to my noble friend.

Clause 240, as amended, agreed.

Clauses 241 to 245 agreed.

Clause 246 : Consequential and transitional provision

Amendment 344B

Moved by Earl Howe

344B: Clause 246, page 239, line 16, after "Consultation" insert "with any person"

Amendment 344B agreed.

Clause 246, as amended, agreed.

Schedule 18 : Part 8: consequential amendments

Amendment 344C

Moved by Earl Howe

344C: Schedule 18, page 420, leave out lines 22 to 26

Amendment 344C agreed.

Schedule 18, as amended, agreed.

Baroness Rawlings (Conservative)

My Lords, I beg to move that the House do now resume. We are most grateful to noble Lords for their brevity. As a result, we have reached our target for today so noble Lords do not need to return after the dinner break this evening for further debate on the Health and Social Care Bill.

House resumed.