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I turn now to issues involving users and carers. The Minister of State for Health said on Report in the other place that,

However, Carers UK, in which I declare an interest as its vice-president, is concerned that measures to achieve this vision are not present in the Bill in its current form. Carers should be recognised in the Bill as key stakeholders in the provision and regulation of health and social care services, and the CQC should be given duties to consult and involve them alongside patients, users and the public. At the moment the Bill does not mention carers once. It is essential that we change this, given that the health and social care system relies to a huge extent on the unpaid care provided by families, friends and neighbours. There are more carers than there are health and social care professionals, and the replacement cost of the unpaid care is £87 billion a year. The fact that I give that statistic endlessly does not make it any less important, because it is equivalent to the entire budget of the NHS in England. Carers are more likely to have a thorough knowledge of the quality of services through their role as an advocates and negotiators for the person for whom they care. I remind your Lordships that often carers are responsible for funding care on behalf of a family member.

The Putting People First concordat, published by the Government in December 2007, which sets the direction of policy for social care, recognised the responsibility of service providers in treating carers as experts and partners in care. The Bill should reflect this and other policy developments, not least the forthcoming national strategy for carers to be published in June of this year, which will recognise carers’ places at the heart of the health and social care system.



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The new commission must take full account of particular perspectives of social care in this country, putting human rights values and the views and experiences of people who use these vital public services at the centre of its activities. Otherwise, as currently drafted, the Bill runs the risk of moving the health and social care sector backwards by setting up a regulator that works to yesterday’s policy agenda, to the detriment of those who use such services. These are big issues to be confronted, but we can and must confront them as the Bill passes though your Lordships’ House.

6.08 pm

Lord Walton of Detchant: My Lords, I congratulate the Minister on his extremely lucid introduction to the Bill. Because of time constraints, I shall not devote any of my speech to Part 1, except to say in passing that the new Care Quality Commission will have a colossal task in trying to fulfil the responsibilities of the three regulators that will merge to form that single body. Members of that new commission will have to be told that they will have a colossal burden of work if they are to carry out its responsibilities properly.

I turn particularly to Part 2, which deals with the regulation of the medical profession and perhaps eventually of the optical profession. I declare an interest as president of the General Medical Council between 1982 and 1989. I remember Lord Hailsham, when Lord Chancellor, giving a lecture entitled “How to ruin the professions”. In it, he said that professional self-regulation was one of the glories of a learned and civilised society and that the alternative—namely, regulation by the state—was too fearful to contemplate. However, as the Minister and the noble Lord, Lord Carlile of Berriew, have indicated, a number of situations over the past few years eroded to some degree public confidence in that principle of self-regulation. From time to time, in response to perceived crises, the Government have indulged in the creation of large numbers of new quangos intended to regulate medical matters. Do we really need, for example, the Council for the Regulation of Healthcare Professionals—or as it now is, the Council for Healthcare Regulatory Excellence? Do we need a continuing National Clinical Assessment Authority at a time when the revised GMC is going to undertake the new powers defined in this Bill?

That is water under the bridge and I say that there are many helpful clauses in the Bill. When I was president of the General Medical Council, following the Merrison royal commission, we had a majority of elected members. The revised GMC will have 24 members—12 lay and 12 medical. They are all to be appointed. That is appropriate, though it is paradoxical that the Government have decreed that there shall be no election of doctors to the new body at a time when they are looking towards a wholly elected upper House—but that is another matter entirely. The present Medical Act requires that the president of the General Medical Council should be a registered medical practitioner. I hope that that will be maintained.



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I approve of the proposal made by Lady Justice Smith in her excellent report that we should have an office for the regulation of health professionals and that this should involve panels appointed by that body to hear cases where, for instance, a doctor is alleged to be no longer fit to practise, either because of behaviour or even because of health. When I was president of the GMC, I chaired many hearings of the discipline committee—later the conduct committee. It was an article of faith that on every panel where a doctor’s future was being considered, there should be another doctor from the same branch of practice, on hand to give advice. This is an issue of considerable importance. Some, though not all, paediatricians believe that if doctors in the field of child protection had sat on the panels that heard the cases of Sir Roy Meadow and Professor David Southall, the outcomes may have been different.

In Clause 98 of the Bill, there is, as the noble Lord, Lord Carlile, said, a very helpful proposal relating to legal assessors. I agree that it is not necessary on every occasion to have a legally qualified chairman of the fitness-to-practise panel. That chair could, on different occasions, be held by an experienced doctor or by a lay person. Where I disagree, bearing in mind the fact that the legally qualified chair could be a highly qualified solicitor, is in thinking that in all instances there should be a highly qualified Queen’s Counsel as a legal assessor advising the panel. Clause 99 concerns clinical and professional advisers. I trust that the Minister can assure me that on these panels the clinical and professional adviser will have a status comparable to that of the legal assessor, who is there to advise on points of law. I believe that these advisers should have the authority to advise the panel on issues relating to the field of practice of the doctor who is being examined by that body.

The question also arises of the standard of proof. I, too, believe that the civil standard, applied flexibly, is appropriate. My understanding is that the BMA has begun to recognise that this is likely to be the case. When we come to the responsible officer, the burden of responsibility on the medical director of a regional trust would be enormous. Will the Government consider going back to the old Three Wise Men process, where the responsible officer was a senior doctor, with a lay member, perhaps of the authority, and a doctor, perhaps in another capacity, to advise? To have a single individual is probably going a little too far.

Finally, I comment on the educational issues to which my noble friend Lord Patel referred. The Medical Profession (Miscellaneous Amendments) Order 2008, which I understand from the Minister is likely to be incorporated into the Bill, will remove from the education committee of the General Medical Council responsibility for the oversight and regulation of medical education at all stages. It will hand that over to the General Medical Council. My understanding from consultations with Sir Graham Catto is that the education committee will appoint three committees with the appropriate academic members, looking at undergraduate education, postgraduate education—taking that over from the

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Postgraduate Medical Education and Training Board, which has not been as successful as we wished—and continuing education. I hope that the Government will approve this.

I end by saying that I welcome the provisions of the Bill. I look forward to hearing more about the Darzi report on the future of the NHS. When I was privileged, in 1996, to give the BMA lecture celebrating the 50th anniversary of the passage of the National Health Service Act in 1946, I said that I had lived through 14 reorganisations of the National Health Service. Since 1996, in the past 12 years, there have been 24. May we take it that, if and when the Darzi proposals on the future of the National Health Service are accepted and brought into law, we can look forward to a period of stability and that the Government will leave the NHS alone to get on with its job without developing more quangos? With that comment, I welcome the Bill.

6.17 pm

Baroness Gould of Potternewton: My Lords, I welcome the Bill in principle, if it is to provide a seamless, well organised service better to integrate health and social care and to provide substantial improvements in the quality and level of service provided. There is no question that for many individuals and for many public health issues, better outcomes can be achieved by health and local public services working together. The problem at this stage is that the Bill provides a framework for the establishment of the Care Quality Commission, leaving the detailed implementation to regulations that are to follow. However, as others have said, we appreciate the efforts of the Minister and of the department in providing us with adequate briefings.

Structural reorganisation is complex and takes time. I fully agree with the Healthcare Commission that the transition to a new regulatory system needs to build on momentum established so far, with a consistency of purpose and of approach. I shall concentrate my remarks on Part 3, so far not discussed, and the widening of public health powers. I shall then talk briefly on the regulations governing registration and standards, the patient and the public, and the health and pregnancy grant. I declare an interest as chair of the Independent Advisory Group on Sexual Health and HIV. My first concern with the widening of the public health powers to include all infections—the all-hazards approach—is that, for the first time, this will include sexually transmitted infections instead of confining the application of public health powers to a list of named infections, such as cholera, plague, smallpox and typhus, as was previously the case. HIV was not subject to these powers.

Of course, public health powers are vital to control serious contagious diseases which are spread by everyday contact, and it is understandable that the Government wish to have an extensive set of powers to deal with any future health emergency. It is less clear, however, why such powers should be applied to sexually transmitted infections such as HIV, infections which are not transmissible through everyday contact. Significant human agency from two people is required for the transmission of HIV, and the risk of transmission from a single incident is very low.



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Unfortunately, HIV remains highly stigmatised, and Clauses 123 and 124 of the Bill extend significant coercive powers to include HIV without appropriate justification. I am sure that HIV was not in the Government’s thinking when drafting the Bill but, as it stands, it will have consequences for people living with HIV, as there is no provision to stop the proposed powers being used in relation to such people.

In addition, the coercive powers available to JPs in relation to the risk of infection of disease are extended by the Bill. Under the old legislation, a JP could make an order for a medical examination, the removal of someone with a notifiable disease to a hospital or the detention of a person in a hospital. In this Bill, a JP can now additionally quarantine, restrict where an individual goes or with whom they have contact, order disinfection or decontamination, absent them from work and require an individual to attend training or advice sessions on risk reduction.

The absence of any reporting and monitoring mechanism will have significant implications for civil liberties, particularly given our obligation under the Human Rights Act. It is crucial that there is the means to ensure that the use of these powers is effective, proportionate and consistent. I understand that officials are in discussion with the National AIDS Trust and I hope that a proper monitoring process can be introduced in the regulations that are to follow.

At Second Reading in the other place the Secretary of State said that it is essential that the Bill ensures that the regulatory system can accommodate future patterns of service delivery and that, to do that, the Bill must establish a level playing field for healthcare consumers through registration of all service providers based on common standards. That, for me, raises two questions. First, how will the proposal for a single set of requirements for registration be applied across all regulated activities? Although the compliance criteria supporting the requirements will be specific to the type of service that is being regulated, I still believe that this unified approach to the registration of both social care and health bodies may be difficult to achieve in practice. Only in the most general sense can one relate a large acute hospital to a community contraceptive clinic or a small private care agency. They have differing pathways of care, differing service provision and differing patient requirements. I support the idea that NHS providers should be subject to registration for the first time but a great deal more thought needs to be given to how the registration process will work.

Secondly, Clause 41 gives the Secretary of State the power to prepare and publish statements of standards in relation to the provision of healthcare by PCTs and to amend these from time to time. Under Clause 133, PCTs will have a duty to make arrangements to secure continuous improvement in the quality of healthcare provided by them. The standards will be benchmarks of expected behaviour and good practice, and I believe that they should be defined in the Bill. Against that background, can the Minister clarify for me the commission’s role in monitoring and assessing compliance with these centrally determined standards, and can he say whether the appropriate funding will be made available so that the standards can be met and risk reduced?



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One criticism of the Bill is that it is too provider-focused and does not concentrate sufficiently on the needs of patients and the public. A purpose of the legislation is to provide a truly patient-and-people service, covering all healthcare providers in the public and independent sectors. However, it can fulfil that purpose only if patients and the public have confidence in the work of the regulatory body and in its ability to maintain the public interest and hold professionals to account. The regulator needs to have a stronger duty to involve patients and service users. Currently, the Bill requires the Care Quality Commission only to have regard to the views expressed by, and on behalf of, members of the public. As Which? forcefully expresses in its briefing, there is a crucial distinction between merely “having regard to” and proactively going out to engage with users.

The advisory committee proposed in the Bill will, in the main, be comprised of providers of services, but they will in no way provide the views and experiences of the patients, their carers and their families. In the words of the noble Baroness, Lady Campbell, that does not go far enough. Allied to that, there has to be an adequate complaints procedure which is clearly defined so that people understand the process. Providers should have a statutory function for dealing with complaints, and that function should be part of the registration requirements.

Finally, I wish to say a brief word about Part 4 of the Bill, which provides for the payment of the health and pregnancy grant as a universal benefit. There is clear evidence that universal benefits are likely to reach more women than are grants that have to be applied for. It is encouraging that the financial costs of pregnancy for women and their families have been recognised, possibly for the first time. It is hoped that, with support and advice from health professionals, the grant will encourage pregnant women to lead a healthier life. I had some reservations about the timing of the grant but, having talked to possible recipients, I am persuaded that 25 weeks into pregnancy is about the right time and that it ties in well with other maternity support.

There are many issues still to be resolved, whether they relate to the period of transition and the hiatus caused, the inspection and enforcement regime, the powers and sanctions of the commission, funding concerns or the guarantee of independence from government. All those points will be considered in detail in Committee to ensure that the Bill brings about a more integrated approach to health and social care provision to provide a safe and quality service for the people who use it—the patients.

6.26 pm

Lord Colwyn: My Lords, I congratulate the noble Lord, Lord Darzi, on the way in which he introduced the Bill, and I apologise to other noble Lords for missing some of their speeches. I had to try to juggle my appearance upstairs at the committee of the noble Lord, Lord Sutherland, taking evidence on taxonomy and systematics, and being present to hear the excellent speeches in this Chamber.



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The Bill contains fundamental changes to the way in which healthcare organisations and practitioners are regulated. Some of these changes are of great concern and there is a very real risk that a number of the provisions in the Bill—particularly the reduction in the standard of proof and the creation of responsible officers—will seriously undermine the confidence of healthcare professionals. Patients must be confident that they will receive the same standards of care whether treatment is delivered in a primary or secondary care setting. The Minister must convince us that bringing primary medical care into a national regulatory framework is the right approach.

I declare an interest as a registered dental practitioner who is indemnified by the Medical Protection Society.

A further concern is the establishment of the Care Quality Commission. I note that the Government’s response to their consultation paper, The Future Regulation of Health and Adult Social Care in England, suggested the possibility of bringing NHS primary medical care providers within the regulatory framework of the CQC. The quality of NHS primary medical care is currently monitored, but not regulated, by the Healthcare Commission. The Government have suggested that this additional layer of regulation would be justified because general practice is becoming increasingly complex, with more services being delivered by a diverse array of providers.

I would be concerned if an additional tier of regulation for primary medical care services was so onerous and intrusive as to interfere with the day-to-day care of patients. I also question how the new framework would relate to the new proposals for local regulation in the form of “responsible officers” at PCT level and the existing national system of professional regulation. Changes to the delivery of primary care have already changed the personalisation of the doctor-patient relationship—the provision of out-of-hours care is a good example—and further regulation could make this even worse.

Clause 116 enables the Secretary of State to make regulations requiring healthcare bodies to co-operate with each other, particularly in connection with the sharing of information which relates to the conduct or performance of any healthcare worker and which may show that that worker is likely to constitute a threat to the health and safety of patients. Any policies introduced to overcome the current limitation in information-sharing must include safeguards to protect innocent healthcare professionals from being unjustifiably accused of being a potential risk to patients. I hope that the Minister will be able to specify the type of information that will be recorded, who will have access to it and in what circumstances, and whether it will be publicly available.

Can the Minister also provide some assurance that the regulations will set out the categories of information that can be held and to whom it can and cannot be disclosed? Sharing and collating relevant information is important to protect the health and safety of patients, so the regulations will need to be accompanied by clear guidelines for the quality of

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information to be included and assurance given that unsubstantiated, subjective rumour and gossip will not appear on the practitioner’s record.

The Minister will surely agree that information should only be disclosed where there is a legitimate justification in the interests of patient health and safety. Unrestricted access without regard to confidentiality is not in the public interest as it will only damage relations between employers and employees and could unjustifiably damage individual reputations. It takes many years to build up a reputation and only days to destroy it.

I have serious reservations about the proposal for the creation of a new role of responsible officer which I understand, in practice, would be the organisation’s medical director. While there are benefits in establishing consistent, transparent and fair mechanisms of regulation at a local level, I would like to see provision in these reforms for a better use of existing clinical governance processes and structures at a local level to enhance mechanisms for the early identification and rectification of problems.

The new role of responsible officer will entail a significant extension in a medical director’s responsibility, authority and workload. It is contemplated that responsible officers will be respected, senior doctors who will have the credibility and support of doctors, managers and patients. On a practical level, I cannot see how there will be a sufficient number of senior doctors with the professional standing envisaged who will be not only willing, but able, to assume such onerous responsibilities.

An experienced clinician will not necessarily be endowed with the skills needed to be a successful manager or leader. The wrong approach at local level can have disastrous consequences, including a protracted and adversarial process which is destructive rather than constructive in outcome.

There is currently a lack of high-quality and consistent training for the role of medical director. I hope that the Minister will agree that it is essential that responsible officers are properly trained and bring the necessary qualities of fairness, objectivity and investigative robustness that will enable them to command colleagues’ confidence and respect.


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