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Lord Walton of Detchant: My Lords, most of what has been said has covered the points that I wished to contribute to this short debate. Regulation of the independent sector is long overdue. Approximately 15 per cent. of the population of this country will now be covered by insurance for private medical care. I wholly agree that the majority of the doctors who work in the private sector and who give their services in private hospitals also hold consultant posts in the NHS; but there are some who do not.

When I was president of the General Medical Council, which is now more than 10 years ago, we had a number of serious concerns about small private institutions which were employing doctors who had not undergone a full programme of training in the NHS and who were not properly qualified to carry out in all respects the procedures which they were performing.

Some of those doctors came before the General Medical Council on disciplinary grounds. But it seemed to me that if there had been a proper statutory system of regulation to cover the whole of the independent sector, particularly those hospitals providing acute and specialist services, many of which give a quite outstanding quality of service to the community, problems of that nature would have been avoided.

Bearing in mind the report in The Times in which it was said that the Secretary of State proposes to regulate the private sector, would it not be best to have an

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enabling clause in this Bill? When the Select Committee has reported and the Secretary of State has decided upon the kind of regulation that he wishes to recommend, would it not then be appropriate, under such an enabling clause, for those procedures to be introduced by regulation?

Lord Winston: My Lords, I hesitate to detain the House, given that I heard a rumour that there may be a Division, and I know that no one wants to miss his tea. However, I have one or two questions for the Minister on this issue.

I work in an area of medicine where there is a huge amount of private practice. In fact, it is the area in which there is probably more private practice than any other sector because, sadly, it is not funded by the National Health Service to the extent that it might be. Consequently, we see a significant number of patients who have been treated in an unregulated way.

Of course, with regard to in vitro fertilisation, there is a Human Fertilisation and Embryology Authority which does a good regulatory job. I say that with some reservations. But it cannot regulate the whole of reproductive medicine because it is not empowered to do so. Therefore, for example, if a patient goes to a free-standing in vitro fertilisation clinic in the private sector, she and her husband are likely to get in vitro fertilisation even if it is not the most suitable treatment for the couple. There may be alternative, more effective treatments. That pattern is extremely common in the private sector.

Of course, the standard of private medicine in this country is high. Indeed, it is. But unfortunately there are places where standards are poor. Therefore, I wish to support what the noble Lords, Lord Walton and Patel, said. It is extremely uneven. There are occasions when people who would not be employable in the NHS are practising privately and carrying out surgical procedures about which we should have considerable concern. I see on a regular basis a number of patients who I feel have been badly damaged by some of those procedures.

I do not know whether this Bill is the vehicle to use to introduce such legislation. However, is there not a place for better regulation of the private sector in general? What does she intend to do about that? In many areas in private medicine there is extremely poor audit of what goes on.

The second question is as to what is the exact status of private medicine in NHS hospitals. A large number of hospitals, including my own NHS trust, need and do excellent private practice. I am not quite certain whether or not those patients will be covered by the Bill. If we contract out to a private hospital, those patients would still be NHS patients. Therefore, although the Minister will answer the question. I believe that the answer to the noble Baroness, Lady Masham, is that they will be covered. Lastly, it is not only fertility services which are concerned. For example, plastic surgery falls into that area which is not funded by the NHS. Therefore, there is a certain advantage in achieving evenness in the private sector.

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Another reason for regulation is the fact, as has been pointed out by the noble Lord, Lord Walton, that a large number of patients are privately insured, mainly by BUPA and PPP. Often it seems they arbitrarily decide whether or not they will fund patients at a particular hospital, often to the detriment of patients who come to an individual doctor.

I believe that those are very poor decisions by the insurance companies. If there were an audit of what those hospitals were doing, there would be a yardstick by which one could say that a particular private sector hospital was doing a good job. Perhaps that might be looked at in legislation, although I accept that the Government may not see this Bill as the right one in which to do that.

4 p.m.

Baroness McFarlane of Llandaff: My Lords, I rise to support the amendment, as many others have done. As far as concerns nurses, we are anxious that every patient should have the right to minimum standards of quality, care and safety, irrespective of the sector in which they are treated.

There is still a considerable amount of confusion regarding the Government's proposals on quality for the independent sector. Many important questions remain to be asked. We are still unclear, for instance, whether the duty of quality will apply to independent healthcare providers. Perhaps the Minister could give us an assurance on that. Her reply in Committee seemed to indicate that, but we were uncertain about the details of what she said. It is not clear whether the duty of quality will apply to the independent sector institutions.

We are also interested to have further clarification about how the commission will work to ensure that National Health Service-funded patients who receive their care in the independent sector will be guaranteed the same standards of care. We are conscious that the Government intend to consult on the future regulation of the independent healthcare sector. Without pre-empting the consultation, it would be good to have reassurances that the consultation will look at options for improving the regulation of independent healthcare and that deregulation is not on the agenda. Perhaps the Minister could give us information about the timescale for launching and completing that consultation.

As Amendment No. 47 stands, it seems that nursing homes would not be included. That gives me cause for concern. Perhaps we could have clarification about that as so many National Health Service patients are nursed in nursing homes.

Lord Harmsworth: My Lords, will the Minister, in her reply, help the House on the legal position of the Secretary of State in this matter? My memory is that the National Health Service Act 1946 makes no distinction between public and private sector health, but that the Secretary of State is responsible for the health, both physical and mental, of the people of England and Wales. Could the Minister tell the House how that fits

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in to the amendment put forward by my noble friend Lord Howe, who raised this important legal point when he spoke?

Baroness Berners: My Lords, I also rise to support the Bill and the amendment tabled by the noble Earl, Lord Howe. I also agree with all the points put by other speakers. The general public needs to have confidence in the overall quality of both medical and nursing care throughout all sectors of health. I hope that the Government will feel able to put this amendment on the face of the Bill.

Baroness Hayman: My Lords, we have had an interesting follow up to the important debate that we had on these issues in Committee. Issues such as the regulation of the independent sector, whether the commission for health improvement has a role to play in the regulation and safeguarding of standards within that sector, and how we can ensure quality of services in the independent sector, which I fully accept are matters of responsibility, are all important.

I have no grave disagreement with the tenor of any of the contributions made in the debate today. The Government have made clear their recognition of the real concerns about the inadequacies of the existing regulatory structure. We should not pretend that there is no regulatory structure at all for the independent sector. It is regulated under the Registered Homes Act. It is a responsibility of health authorities and a responsibility of such authorities in regard to nursing homes--to take up the point made by the noble Baroness, Lady McFarlane--as well as to acute sector providers.

Much of this debate has been sparked off because we have a set of proposals before us for the regulation of the nursing homes sector. I suggest that the reason the noble Earl, Lord Howe's amendment does not extend to the nursing home sector is that he accepts, by implication, the need for a coherent and comprehensive look at registration, monitoring, inspection and sanctions in that sector, and I would argue that we need to do the same for the independent sector.

We need to ensure, and the Government have a duty to ensure, that independent healthcare services are appropriately regulated. We need to protect all members of the public. I take the point made in the debate that that includes private patients as well as patients in NHS hospitals. Perhaps I can clarify the position. It is important that patients who choose to use the independent sector are reassured that they receive services that are safe.

It is because of the concerns expressed about the various issues--the issues that the noble Lord, Lord Walton, raised, the issues about complaints procedures and the issues about whether the Registered Homes Act is too creaky a vehicle to do the job properly--that a Select Committee in another place is looking into those matters. Department of Health Ministers will give evidence to the committee after Easter. Officials have already done so.

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As I have told the House, currently we are working on a consultation document to be issued shortly about regulation of the private sector in health. I want to assure the House that we do not take a minimalist view of regulation in this area. There are concerns that there has been too much framework and not enough flesh and bones in terms of the Registered Homes Act, and that we need to look carefully at standards of clinical care in that sector.

I also recognise the anxiety that the drive for quality in the NHS should have an effect in the private sector. I believe it will do so. The national institute for clinical excellence is not included within the Bill, but everything that it does will be publicly available. I recognise the desire--the noble Earl, Lord Howe, made this point--of the healthcare sector to improve standards and it will be able to access and take up the recommendations. The clinical governance guidance on quality in the NHS, published this week, is equally available. I am certain that those clinicians who work across the two sectors will bring their experience of clinical governance in the NHS into the private sector.

The strengthening of professional self-regulation under this Bill will apply to all professionals and will improve the protection of patients in the private sector as well as the NHS.

To those noble Lords who have said that we should act now and that in some way the Government are behaving less than responsibly in not doing so, perhaps I may say that it is my belief that the issues surrounding the improvement of regulation in the private healthcare sector justify a coherent approach and that the Government intend that such an approach will be the outcome of the consultation process on which we are about to embark.

The noble Lord, Lord Clement-Jones, somewhat chastised me for not giving assurances about the exact route that we intend to take or about exactly what model we shall adopt for the private sector. I suggest that I would equally be chastised if I pre-empted now the results of the consultation and of the Select Committee inquiry in another place about the right way forward. Equally, again, noble Lords should not assume that what is being done in the context of a managed health service for the NHS can be picked up wholesale, transposed into the private sector and give adequate protection across the whole range of issues.

It is clear that although we have responsibilities for patients receiving care in the private sector, their situation is different from that of NHS patients receiving care. The Government have a particular responsibility to NHS patients--I am talking about responsibilities under the 1977 Act--as a result of being a provider of national health services. The Government's responsibility to private patients and private establishments is as a regulator of the independent care sector. We must ensure that we have the appropriate mechanisms and systems for ensuring that standards in both are coherent, comprehensive and enforceable.

It is clear that a regulatory system for the independent healthcare sector would need to exercise three broad functions: a licensing or registration function, a

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monitoring or inspection function, and an enforcement function. Those elements cannot be dealt with in isolation. An inspection might reveal unacceptable standards which call for sanctions. Those might relate to the continuation of registration. That is not an area in which the commission--if that was the body that found things wrong--would be able to take action. That is a serious concern. It is different in the National Health Service because the Secretary of State can take action either by direction or by removing the chairman of the institution concerned. The Secretary of State has direct responsibility.

If we are to put responsibilities on to the private sector, we have a responsibility for ensuring that there is an enforcement mechanism. It is salutary to take the example of the nursing home sector. The Government have proposed to establish regional commissions for care services, as set out in the White Paper, Modernising Social Services. That is an example of the range of functions needed in any statutory regulation system. The commissions will deal with a range of care services, including nursing homes.

Perhaps I may use nursing homes as an example of how the commissions will carry out their task. The commissions will have to register nursing homes, setting out specific conditions, criteria and standards that must be met before registration is given. That is, in effect, a licence to trade, and it will be unlawful for a nursing home to operate without having a registration with the commission for care standards. The commissions will also have to monitor and inspect nursing homes, both on a routine basis and in response to any concerns or allegations. The aim of those inspections will be to demonstrate that registration conditions and standards are continuing to be met. The commissions will also have to take enforcement action against a nursing home that is failing to meet the required standards. That would include serving improvement notices, prosecuting through the courts for specific offences and, if necessary, deregistering the nursing home, causing its closure.

The commissions for care standards will therefore have the power to control entry to the market and to take out of operation any providers that are not up to standard. Those statutory powers and procedures are essential to proper registration. Inspection--the role of the commission--is not the only or even the crucial part of the system when we are dealing with a commercial operation rather than with the NHS government- managed system.

However, the commission for health improvement, which we are setting up under this Bill, is not a regulator. We have not designed the commission and the duty of quality to fit that model. The commission monitors standards, but it does not have enforcement powers. That will be a matter for the NHS and, if necessary, the Secretary of State through directions under Clause 7. However, the Secretary of State's general ability to issue directions does not extend to the private sector, so under this amendment there is no way of enforcing the commission's recommendations.

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I take the point raised by the noble Lord, Lord Skelmersdale, and I understand that in this amendment noble Lords have tried to take on board the fact that this might not be the way forward. However, I believe that if we "pick and mix" the provisions for regulation and legislate now, we shall probably get it wrong and would have to relegislate in the future.

Perhaps I may give the noble Lord a couple of examples and I shall then give way to him. We are giving the commission powers to inspect but without any sanctions or powers of enforcement. We would have to consider an appeals mechanism if, for example, sanctions were involved. We have to recognise that that is designed to fit in with the NHS systems and that we need to design a system that fits what is in one way a market transaction. I quite understand that the service being bought is of crucial importance and that we must safeguard standards within it. That applies in this area more than to many other services. However, we are not talking about the same situation as in the NHS--

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