My Lords, I beg to move that this Bill be now read a second time. The Bill contains a number of vital measures to improve and enhance the regulatory arrangements for health and social care. I am pleased by the number of noble Lords who are due to speak today, as that demonstrates the amount of interest in these important issues. The Bill has enjoyed a full debate in the other place, where it benefited particularly from the informed comment during evidence-giving sessions. I know that the Bill will further benefit as it makes its progress through this House from the wealth of knowledge and expertise that so many noble Lords have in this field.

The primary concern of the Bill is to improve and enhance the quality and safety of the care that patients and users receive. Its focus is on regulation, both of the health and adult social care system and of health and social care professionals who work within that system.

As noble Lords will be aware from the interim report that I published in advance of the next-stage review, I am passionate about the quality of care received by patients and service users. I understand that some concerns have been raised about the timing of the Bill and how this will fit in with my next-stage review. It is my view that this is the right time for the Bill, as it will introduce a framework that focuses on reforming regulation so that it is adaptable to the changing priorities of patients and users. The next-stage review will build on this vital regulatory framework to ensure that quality becomes the connecting thread running through everything that we do.

I turn now to the specific provisions in the Bill. Part 1 creates the Care Quality Commission, which brings together the existing Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission. The commission will be an independent, responsive and proportionate regulator with safety and quality at its core.

I believe that this move is very positive. The creation of the integrated regulator is a necessary step in creating the right legal framework for the development of high-quality health and adult social care services. The existing systems have worked well, and we are building on their achievements, but changes to the way in which health and social care services are delivered through the reform programme mean that a more integrated, flexible regulator is needed.

Increasingly, the boundaries between health and adult social care are becoming less defined. A person’s treatment will often require care in a range of settings. Patients want to receive the same protection from the regulatory system wherever they receive that treatment. Bringing the regulation of health and adult social care together will ensure that the same levels of quality and safety can be expected for all users of health and adult social care.

It is necessary to stress the importance that the Government place on the role of the Care Quality Commission in dealing with social care matters. There is no question but that social care will be at the very core of the regulator’s functions. The Commission for Social Care Inspection currently regulates around 24,000 services, so the regulation of social care will represent a significant proportion of the work of the new regulator. The Care Quality Commission will be responsible for ensuring that all registered services—whether in health or social care—are safe and of a suitable quality.

Equally, I place on record the importance that we attach to the commission carrying out the functions currently carried out by the Mental Health Act Commission—a body chaired by my noble friend Lord Patel of Bradford. Clause 2 states explicitly that the Care Quality Commission’s functions will include those currently carried out by the MHAC. We will work with all three commissions to ensure that the organisational structure, leadership, culture and ways of working that the commission develops are effective in protecting the rights of all vulnerable groups under its remit, including those detained under the Mental Health Act. We will stress how important it is that the skills and expertise required to carry out the MHAC’s statutory functions, including appropriate visiting arrangements, are retained within the new body.

Chapter 2 of Part 1 of the Bill introduces a new registration regime, which, for the first time, will include the registration of NHS providers. This is an important step. It is right and proper that NHS services should be subject to the same rigorous registration regime as applies to providers in the social care or independent sector setting. Providers will be able to offer regulated health or social care services only if the regulator assesses them as meeting the registration requirements, giving patients an assurance of safety and quality wherever they choose to be treated across the health and adult social care system.

A key component of the registration regime will be the scope of registration which Clause 4 and the registration requirements in Clause 16 provide for. The Government have today published a consultation on the framework for the registration of health and adult social care providers. Noble Lords will be able to draw on this consultation document when considering the registration elements in the Bill and I urge all those who have an interest in this important area to contribute to the consultation.

The Bill also gives the commission a wider range of enforcement powers than those available to the existing regulators, giving it greater powers to ensure compliance, as well as being able to cancel registration where absolutely necessary. The regulator will have the freedom to decide how to use its powers of enforcement where services are failing, including for breaches of infection control requirements. The new powers will, for example, allow providers to be fined up to £50,000 for each individual breach of a registration requirement.

The Care Quality Commission will also continue to carry out assessments of providers and commissioners. This will provide an independent view of performance and support both patient choice and local decision-making. These powers, set out in Chapter 3 of Part 1, include measures to ensure that periodic reviews are carried out of health and adult social care provision.

I also want to touch on an issue that has been raised by the Joint Committee on Human Rights and others in connection with the Care Quality Commission—namely the Human Rights Act and its application to publicly arranged health and adult social care. I can confirm that we are currently considering this issue again, in the context of the Bill, in consultation with key stakeholders, with a view to reporting back as the Bill progresses through its Committee and Report stages. In addition, we intend to use the Bill to ensure that the Care Quality Commission can enforce regulatory requirements which are in line with the spirit of the European convention.

Part 2 of the Bill focuses on professional regulation. As a practising clinician, it is appropriate for me to declare an interest at this point. I should also declare that I have an academic interest in the field of the objective technical competency assessment of clinicians, and my clinical department advises the GMC and other bodies on the subject.

I remind your Lordships that the Shipman inquiry, under the chairmanship of Lady Justice Smith, found that in the 24 years during which Harold Shipman worked as a doctor, in addition to the 15 patients of whose murder he was convicted, he killed 200 patients. In a further 45 cases, real cause was found to suspect that Shipman might have killed the patient. These shocking facts, along with the findings of the Ayling, Neale, Kerr/Haslam inquiries, seriously questioned the trust that patients have in the system that is there to protect them. I know from my own experience that the vast majority of healthcare professionals are dedicated to the caring of their patients to the very best of their ability, but these measures will help to identify earlier and tackle more robustly that small number of professionals who pose a threat to patient safety.

The Government therefore consulted on what changes needed to be made to professional regulation, both in light of the recommendations of the Shipman inquiry and the need to modernise the system more generally across the whole health and social care workforce. The White Paper, Trust, Assurance and Safety, published on 21 February 2007, reflected that consultation.

The creation of the Office of the Health Professions Adjudicator responded directly to Lady Justice Smith’s Recommendation 51 of the Shipman inquiry that the adjudication function of the General Medical Council should be undertaken by a body independent of the GMC. The General Optical Council has also indicated its support for this new body. The OHPA will be a statutory body, which will undertake fully independent adjudication of fitness to practise cases initially for doctors, and in due course for opticians and optometrists. Independent adjudication, carried out by the OHPA, will mean that patients and professionals can have confidence in the impartiality and consistency of fitness to practice decisions.

Related to fitness to practise cases, the Bill changes the standard of proof to be applied to the finding of facts in fitness to practise proceedings from the criminal standard of “beyond reasonable doubt” to the civil standard of “on the balance of probabilities”. That responds to Recommendation 81 of the Shipman inquiry and reflects the fact that eight out of the 11 existing regulators already use the civil standard of proof. This will build on existing best practice in other sectors such as police complaints and child welfare.

Having followed carefully the debate in the other place on this issue, I am aware that certain organisations have suggested that the change to the standard of proof could lead to doctors practising more defensively; that is, to be less likely to choose more risky, but potentially more effective, clinical interventions. I do not believe that this is true. As a clinician who has the privilege of treating patients, I tend to focus only on what is likely to make my patients better. I am sure that it will not affect the way my colleagues do their jobs either.

To help to close what has often been called the “regulatory gap” between national regulators and local clinical governance arrangements, the Bill seeks to put best practice in clinical governance on a statutory footing by creating the role of responsible officers. Responsible officers will be senior doctors in healthcare organisations responsible for dealing with local professional performance and conduct issues for medical staff, in liaison with the national GMC.

The Bill also removes the restriction preventing a Section 60 order of the Health Act 1999 introducing a lay majority for the regulatory body councils. In addition, Part 2 introduces the following important measures: first, it enables the removal of the regulatory functions of the Royal Pharmaceutical Society of Great Britain and the transfer of those functions to the proposed new General Pharmaceutical Council, which creates a much-needed separation of professional leadership and professional regulatory function; secondly, it strengthens the Council for Healthcare Regulatory Excellence to help it become an authoritative voice for patients; and thirdly, it creates a regulation-making power to allow changes to the regulation of social care workers by secondary legislation, which will allow the regulation of social care professionals to keep pace with the regulation of healthcare professionals.

In relation to Part 3 of the Bill, the Public Health (Control of Disease) Act 1984 consolidates earlier legislation, much of it dating from the 19th century. Not surprisingly, many of its assumptions, both about risks and about how society operates, are now out of date. It provides for only a limited range of actions when other measures could be more effective in terms of protecting public health, and more convenient and less intrusive for those concerned. In addition, internationally, the World Health Organisation has set out the case for taking an all-hazards approach to dealing with health threats. This is reflected in the new International Health Regulations (2005), which are concerned with infectious disease and with contamination from chemicals or radiation.

We consulted widely on updating the 1984 Act. In light of that, the new legislation contained in Part 3 will provide for a comprehensive set of public health measures to help prevent and control the spread of disease caused by infection or contamination which present, or could present, significant harm to human health. This will enable a quick response to new or unknown diseases or threats, such as the ones we have seen in recent times, for example SARS or Polonium 210. Some of the measures proposed could impact on an individual’s human rights. That is why we have provided significant safeguards in the legislation to protect individuals. Human rights require a balance to be struck between the freedom of the individual and the health and safety of other people; we are confident that we have struck the right balance.

Part 4 introduces the health in pregnancy grant. This will be a one-off payment of £190, available to all expectant mothers ordinarily resident in the UK, which can be claimed from the 25th week of pregnancy. The grant will be payable per pregnancy, and entitlement will be conditional on mothers receiving maternal health advice from a health professional. We know that women face additional costs during pregnancy and that there are competing financial pressures in the final trimester, which can lead to some difficult spending choices. The grant will provide support to all expectant mothers, in recognition of these extra costs. Linked to the requirement to receive maternal health advice from a health professional, the health in pregnancy grant is designed to help pregnant women to invest in their pregnancy to meet their individual needs, while providing them with flexibility to choose where they spend this money.

Part 5 contains a number of smaller miscellaneous issues relating to: the financial arrangements for pharmaceutical services; indemnity schemes in connection with the provision of health services; direct payments in lieu of provision of care services for people lacking in capacity; abolishing the liable relatives rule; the definition of ordinary residence, as applied to the National Assistance Act; payments to social enterprises; the creation of a national information governance board; and the functions of the Health Protection Agency in relation to biological substances. I shall not go into further details here, but I look forward to these issues being discussed in more detail in Committee.

The Health and Social Care Bill contains a number of important measures that will enhance the regulatory system to ensure that first-class professionals are able to work in a first-class organisation. By putting safety and quality at the very heart of the agenda, the Bill will be crucial for service users and patients alike. I commend the Bill to the House.

Moved, That the Bill be now read a second time.—(Lord Darzi of Denham.)

My Lords, I declare a number of health interests, unpaid, save for my company, Cumberlege Connections. I thank the Minister for taking this Bill through your Lordships’ House, and for the clear and concise way in which he introduced it. It is long and it is complicated. With the Minister’s professional background and his responsibility for reviewing the NHS, we could not have a more distinguished or well-informed Minister at our Dispatch Box. We are indeed most fortunate. I also thank all those organisations which have been so diligent in their briefing for this Bill. I enter this debate with trepidation. I am fearful of overregulation. I am distrustful of those legislators whose tidy minds tie up all possibility of innovation and the freedom to act appropriately but differently. Life is untidy.

My most recent experience has been working with the Catholic Church on safeguarding children and vulnerable adults—visiting 22 dioceses and meeting the most remarkable people, many of whom are volunteers working with children or visiting the old and infirm. These people are now subjected to CRB checks. The impact has been costly, both financially and—much worse—in the loss of some remarkable people who have been respected and trusted within their parishes for decades. As one middle-aged woman told me, “I only sharpen the pencils for the children’s liturgy. I loved the children and I think they loved me”.

My husband drives for the old people’s day centre. He was out one day when someone rang me, asking, “Is Paddy there? We have been let down”. I said, “I’m afraid he isn’t, but I can do it”. “No, you can’t”, was the reply. I have lived in my village since the age of four. My father was the local doctor, and as a former parish, district and county councillor, I am known to the village. At the moment, I even have a clean driving licence. But there is a presumption that I will mug the old folk because I do not have the right CRB certificate. I am not to be trusted, and they, poor souls, are left languishing in the day centre wanting to get home. Of course, the safety of children and vulnerable adults is of the utmost importance, but we the legislators can get carried away. In Section 59 of the Safeguarding Vulnerable Groups Act 2006, we widened a perfectly sensible definition of a vulnerable adult to, among many other things, a person who receives,

“any form of health care”,

including medication and so on, and to a person who has,

“particular needs because of his age”.

I suppose that we are a House inhabited largely by vulnerable adults, but it has never felt like that to me.

Four years ago legislation was introduced requiring residential homes to comply with such high environmental standards that at a stroke we successfully closed countless small, comfortable places that were truly home to their residents. Later the law was relaxed but the damage was done. I am wary of the overconscientious. For me, less means more. Regulation should have a light touch; it should be proportionate, flexible, fair, and risk-assessed; and, above all, it should allow for judgment. Regulation is only necessary when all else has failed. For me, part of that all else is professionalism. When chairing the task force for the Royal College of Physicians, Doctors in society—Medical professionalism in a changing world, I was struck by the evidence we received from many quarters, but particularly from Harry Cayton—then the patient tsar and now a regulator—who told us, “Opinion polls suggest that doctors are among the most trusted people in society … My own observation is that leaders of medical colleges and organisations are resolutely and seriously self-critical in a way that no other group of employers, experts, workers or advisers have shown themselves to be”.

We carried out a survey of 2,000 trainees, 98 per cent of whom thought medicine was a profession; 80 per cent thought it a vocation; and that altruism was essential as was humility. I understand that the world is increasingly complicated. We have international mobility, new emerging professions, an evolving health and social care market and an emphasis on human rights in a demanding but ageing consumerist society. Human beings are frail. We can err and stray, but society requires standards to be set and kept. Surely as legislators it behoves us to simplify and clarify legislation to make it understandable to those who are protected and to those who are to be regulated. The Bill does not do that.

The regulation of three distinct parts of health, social welfare and mental health are being scrambled into a single pot. Those three very different entities have three different cultures, and deal with three different markets. There could be a case for bringing these regulators together—but not now, for, unlike the Minister, I believe that the timing is all wrong. In the short time that these regulators have existed, they have shown themselves to be effective and respected. They have driven up quality standards and, above all, are modest enough to insist that they still have a lot to learn. Yet again, however, it is all change. On the whim of the Chancellor who is now the Prime Minister, disruption is the order of the day.

We will seek to do our best on these Benches, of course, to ensure that the Bill respects the progress made and does nothing to jeopardise the future. There is much in the Bill that we will support, but we will seek to ensure that the principles and objectives are on the face of the Bill, that it protects the independence of the Care Quality Commission, strengthens the involvement of patients, carers and service users, dismisses the idea that independent reviews should be held in abeyance until after the next general election, clarifies the impact of appeals to the ombudsman and studies the consequences of a new registration system. We will, no doubt, have debates on the standard of proof and the role of the office of the health professions adjudicator, although the GMC has, to a large extent, already gazumped the Government on that initiative.

We will examine the responsibilities of the responsible officer; tease out the territory between Monitor, the new Care Quality Commission and the trusts; consider the future implications of the competition panel to be established in the autumn; examine the impact of this Bill on public health; ensure the public accountability of commissioners; and, as we are all guardians of the public purse, scrutinise the additional resources required to enact the Bill and the opportunity costs of more disruption. Later, my noble friend Lord Howe will add detail to these themes in his usual exemplary manner.

In conclusion, I foresee long, happy hours in Committee—days, weeks, or even months. Who knows, before this Bill is enacted we might have grown so old that we, too, will qualify as being vulnerable adults.

My Lords, I, too, thank the Minister for clearly laying-out of the territory of the Bill. I also thank all organisations and individuals who have sent briefings and advice in advance of this debate, in which the huge number of us who clearly wish to speak is evidence of the great concern that this legislation is causing in this House. Many of us here have considerable experience in both the health and social care fields; I must declare a few interests here as a former member of the GMC, a former chair of an NHS trust, former chief executive of the King’s Fund and various others—I do not wish to detain the House with the list, for all of them were unpaid except at the King’s Fund.

I also profoundly thank the Minister and the noble Baroness, Lady Thornton, for organising the meeting last week with the Minister in the other place and the Bill team, which many of us attended. It gave us a chance to ask some questions and to get responses, if not always ones that we could regard as wholly satisfactory given our concerns.

Given the pressure on time, I will make six quick points. I remain puzzled by the Government’s wish to press forward now with this legislation. First, we would have to travel a long way to find people who are seriously critical of the present commissions’ work. Of course, things could always be improved, but all the commissions have done sterling work—and made considerable cash savings, as the Government have required of them. Regulation is complex and detailed; it requires long and painstaking work. To destabilise these three commissions now, when they are at the point where they are working so effectively, begs a much broader question; is it really being done because the Government feel that it will improve the regulatory landscape? Or, is it in fact being done because of the pressure of the NHS’s review of its arm’s-length bodies and the desperate desire that exists within the Department of Health to hit the target of reducing their number? If, as I suspect may be the case, it is the latter, this House should ask some fundamental questions about whether that is an aim worth pursuing and whether, provided the commissions work together sensibly and constructively—as they do—that is not enough of an efficiency saving in itself. That question is bothering many of us, quite apart from the question that the noble Baroness, Lady Cumberlege, raised about why this is happening now. Some of us are very puzzled about why the Government should wish to proceed now when the Minister’s review of the NHS is not yet complete. It does not make very good sense. Why merge the organisations at all and, particularly, why now?

Secondly, not only are the Government seeking to merge these organisations, but before the Bill has even gone through Parliament, they have advertised for a chair of the new body. That chair is to be comparable in remuneration terms to the chair of an NHS strategic health authority, which is not senior enough and does not recognise that in order to attract someone of sufficient experience, seniority and stature to chair this huge, unwieldy and probably at first very uncomfortable body, the Government need to offer far more. It is worth asking whether Ministers are serious about remuneration at such a low level and whether they cannot see that other arm's-length bodies pay far more, as do the present commissions—as they should, given what is required of those chairs—Ofcom, the post of First Civil Service Commissioner, the Food Standards Agency and others. There is a real problem about how serious a job Ministers think this is and how much status they wish to give to this new commission and its chair. That advertisement and the thinking that underpinned it suggest a lack of seriousness about how difficult, important and challenging the job is, and therefore suggest a lack of understanding about how important and serious the new commission will have to be. Last week, there was some reassurance from the Minister in another place but it would be good to hear rather more from the Minister here.

Thirdly, there is the worry about structural change per se. The Prime Minister and the Secretary of State for Health promised last summer that they would not disrupt the NHS with another round of expensive structural change. Any of us who have been involved in any of the previous rounds of changes, mergers and reorganisations, or who have commented on them, shouted out a private “Alleluia”. We all know that mergers and reorganisations take some two years to bed down, distract the key players from the very important job in hand and mean that staff start looking for new jobs the minute the legislation goes through, which disastrously disrupt present work. Governments always imagine that the savings from mergers will be enormous, but the evidence is not there, and the bodies concerned can learn to work together and share some back office functions, as those of us in this House and in another place suggested when the merger of the Human Fertilisation and Embryology Authority and the Human Tissue Authority was mooted in the legislation we were scrutinising last summer. Indeed, the Government accepted our view, and that is what will happen. Why go for the merger of those organisations and put up with the disruption that will ensue as sure as eggs is eggs at a time when Ministers are deeply concerned about infection rates in the NHS after Kent and Canterbury hospital case and others?

Fourthly, there seem to be gaps in the legislation. Like the noble Baroness, Lady Cumberlege, I think that we need principles in the Bill, which we argued, only too recently, in the mental health legislation. We need clear, overarching regulatory objectives. I was a member of Sir David Clementi’s review advisory group that looked at the legal services. Sir David is on the record as saying that the first step in defining a regulatory regime should be to make clear what its objectives should be. That is critical for those charged with regulatory responsibility since the objectives represent the criteria against which they must determine the appropriate regulatory action and against which they will be held accountable. Where is that statement of objectives? The present CSCI governing legislation has encouraging improvement in various areas written into its governing legislation, as does the Healthcare Commission. Where is the absolute duty on the new regulator to encourage improvement in services? I cannot find it in the Bill, where it should be. If it is not there, we have cause for concern.

I am sure that Ministers will say that they want lighter touch regulation, and none of us would support heavy-handed, poking-the-nose-in regulation that distracts organisations and staff from their job. But we are talking about regulation for the benefit of patients and service users. This is for the benefit of the public, especially but not only on the social care side for the benefit and protection of the most vulnerable service users and patients. There has to be a duty on the new regulator to encourage improvement in services as well as an assurance that the new regulator will be able to test pathways of care across the piece within PCTs, hospitals, social care and elsewhere. That means being able to look at the purchasing of pathways of care as well.

I can see within this legislation new penalties for the providers of care for breach of contract. Are we not talking about more than contract here? Should not the new regulator have a duty to test these pathways of care across the piece, given that those who are usually caught in the fissures between providers are all too often the very old, the very frail and the very vulnerable? I would be grateful for an assurance that the new regulator will have such a duty and that the penalties will go further than simply those provided for breach of contract.

Fifthly, I am extremely worried that, as I read it, the Bill contains no special measures as it stands for when the regulator carries out an investigation, as it must have the power to do when things are going really wrong. Where special measures exist—they are there for the Welsh NHS and English local authorities but not for the rest—recommendations are made directly to the Secretary of State by the regulator. This is not about breach of contract where the penalties now lie but about really worrying practice. Of course the Secretary of State does not want to know about every dropped bedpan up and down the line. Yet, as in the cases of Northwick Park or Kent and Canterbury hospitals where something went seriously wrong, the regulator needs the power to say so and make sure that the PCTs, SHAs, trusts and any other players get involved in sorting it out immediately. How can that happen given the Bill as it stands? Where the regulator carries out an investigation or a wider review, will it have the power to make recommendations for an instant remedial action across the whole health and social care economy? The burden of proof should not rest purely with the regulator.

My last point has already been made by the noble Baroness, Lady Cumberlege, on the role of users, patients and carers who are not sufficiently represented in the Bill. It is not adequate. We went through all of this in the Local Government and Public Involvement in Health Bill. The patient and user voice is not strong enough here. I have run out of time. Others have much more to say; I look forward to hearing reassurances from the Minister.