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Baroness Noakes: My Lords, I thank the Minister for his comprehensive explanation of the order. It is clear that it is basically non-contentious, and it has the support of the General Medical Council, which is itself the object of reform in the order. Indeed, it is fair to say, as the Minister has generously pointed out, that the GMC has been active in the development of the ideas behind the order. The GMC is keen to see these reforms progress.

Let me make it clear that we on these Benches support the important principle underlying the order; namely, self-regulation. Control of regulatory processes has always been one of the hallmarks of a profession, and we are glad that the solution agreed between the Government and the GMC does not impair this fundamental rule.

It would be tempting to stop here and say, "Thanks very much, all agreed". The Minister will know, however, that life is rarely that simple and I should like to address three aspects of the order.

The first is the restructuring of the GMC. It will be a much smaller council—the number of members will be reduced from 104 to 35 and the proportion of lay members will be increased from 25 per cent to 40 per cent. All of that seems to be going in the right direction of travel. But I do question whether the journey has gone far enough. In particular, when the Government set up the Council for the Regulation of Healthcare Professionals and the Nursing and Midwifery Council earlier this year they chose a different end point for those bodies; namely, a council size of 23 and lay representation just short of 50 per cent.

Will the Minister explain why it is that doctors are different? Is there not just as much need for lay representation on a body involving doctors as there is with other healthcare professionals? And while the reduction in the number of council members to 35 goes some way towards streamlining the GMC's

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deliberations, I rather doubt that any objective study of the effectiveness of organisational structures would endorse as many as 35 on the governing body. A number of the bodies consulted by the Department of Health came to that conclusion. Indeed, I would not even point to 23, as on the HPC and the NMC, as being the last word in organisational fitness. Can the Minister explain the rationale behind the figure of 35?

Can the Minister give some idea of whether the new structure will be reviewed; and, if so, when? The objectives are clear—greater lay involvement and speedier processes in the public interest. But what if this largish body, with its rather individual governance structure, does not deliver the goods? When will the Government look again at this?

I now turn to a second aspect of the order; namely, the new processes around fitness to practise, and in particular the new investigation committees and fitness to practise panels. I think it fair to say that much of this has met with general approbation, but it has been recognised that much of the detail of how the panels and committees will work in practice will not be known until the rules themselves are published. Will the Minister give an assurance that those rules will be subject to public consultation? The Consumers' Association in particular made this point.

The Minister will be aware that the issue of a warning for less serious offences is a controversial one. This new sanction may not easily be understood by the outside world. Does it mean that a doctor is not guilty, or only a little bit guilty, or what? It does not necessarily sit easily alongside existing clinical governance processes that have been introduced into the NHS with much care and effort over the past decade or so. The Government have pressed ahead with this aspect of the reforms despite the concerns of, for example, the Joint Consultants Committee. Will the Government be keeping this new sanction under review? If so, when does the Minister expect the first review to be available?

The third aspect on which I wish to focus is the issue of revalidation. We fully support the thrust of this proposal, but the devil is in the detail of the rules, as several consultees pointed out. When will the detailed rules be published and will they be consulted on? Again, the Consumers' Association feels that it is important to expose this area to public scrutiny before finalisation.

My principal concern in this area is a practical one. Over the next few years, over 100,000 doctors will be seeking revalidation, plus the new intake from the medical schools and from overseas. The revalidation exercise will work well only if there are robust systems in the NHS on which revalidation can be based. What steps have the Government taken to ensure that NHS appraisal systems will be fit for that purpose, including achieving the elusive element of consistency? Are the Government satisfied that the necessary resources will exist within the GMC to undertake this task?

The Minister will be aware that when the Nursing and Midwifery Council attempted its ambitious process of registration earlier this year, it got itself into

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a bit of a pickle and the registration timetable went off the rails. Is the Minister sure that nothing of the same ilk could happen with this revalidation exercise? What would be the position of a doctor whose revalidation had been held up for some reason outwith his own control—perhaps as a result of imperfections in registration processes?

I am conscious that this is quite a long list of questions for the Minister, but these are important issues. I stress that we very much want to support the order and hope that the Minister will be able to give constructive answers to our questions.

Lord Clement-Jones: My Lords, as the GMC admits in its annual report, it has suffered criticism over the years. I agree with the Minister and the noble Baroness, Lady Noakes. Given the speed of changes in medical practice and the new elements of regulation that have been needed, many of us admire how the GMC has reformed itself, starting under the presidency of Sir Donald Irvine and then Sir Graeme Catto. Most of that reform has been instigated from the inside. With some caveats, therefore, I congratulate them on what we have before us today, the extensive consultation process that they engaged in throughout 2000 and 2001 to get there, and the principles that they have enunciated as being central to the reforms—effectiveness, inclusiveness, accountability and transparency—allied with the principle of professionally led regulation.

Throughout, however, we must remember that the essence is to ensure good medical practice and that the system has the confidence of the public, patients and professionals. We welcome the changes, rather more unreservedly than the Opposition Benches in terms of the changes to governance. Specifically, I do not believe that one size for a regulatory body fits all. We welcome the fitness-to-practise changes and the introduction of revalidation. We also welcome the fact that the GMC will now have its report laid before each House and that the protection of the public will now be explicitly at the heart of the GMC's activities.

Key, too, is ensuring that there is no duplication with other clinical governance, appraisal systems and quality assurance systems, whether carried out by the Royal Colleges, the NPSA, the National Clinical and Assessment Authority, health authorities or NHS trusts; otherwise, that will simply add to the burden on doctors without producing benefit. Professor Ian Kennedy, the new chairman of CHAI, talked of doctors being free of the "confetti of interference". As he said, they must be free from the pressure of multiple visitations by a variety of bodies. I am reassured by the conversations that I have had with the various agencies, but I would like to hear the Minister's assurance on that point.

My one serious regret about the order is the way in which it is drafted—the Minister touched briefly on that. It is a nightmare. I speak as a lawyer quite used to reading regulations. The drafting, without any available concordance, is a model of how not to draft

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legislation. It has not been made easy to comprehend the changes made; it has almost been made as difficult as possible in the circumstances.

My concerns about the order are essentially practical. I wish to discover what groundwork has been done to introduce it. I have a series of questions, and I apologise in advance for throwing them at the Minister. I know that, in his usual capable fashion, he will have anticipated half of them and I have no doubt that he will be able to answer them.

To what extent were the revalidation process pilots carried out? How many doctors took part? How much time have the Government calculated will be taken up by assessors and individual doctors during, and in preparation for, the assessment? How many, and what percentage of, doctors failed the revalidation pilot process and subsequently were offered warnings, additional guidance and advice by assessors? That is an important factor in assessing the benefits of revalidation. What extra resources have been, or will be, made available by the Government for the revalidation process? The process requires locums to be engaged to meet patients needs. Will the GMC have the requisite resources to deal with fitness to practise cases in a timely fashion?

Under the new electoral system, why is the GMC setting up different regions? Will the GMC handle future complaints on a regional basis also? An important point relating to Schedule 4(3A)(1) on page 36 is that the continuity of the presence of members of the investigation committee, the interim orders panel or the fitness to practise panel is not required when hearing cases. So it appears that members of the panel do not have to be present throughout a hearing. How can that be valid? Surely, in those circumstances, a defendant has the right to know that those hearing evidence against him or her have heard all the evidence and have been present throughout the case. That may be a misinterpretation, but I hope that the Minister can clarify it.

I notice that now, consistently throughout the legislation as amended by the order, as a result of the interpretation Act being changed, the definition of registered medical practitioner in every case includes a fully registered person who holds a licence to practise under the Act. Is that consistent throughout the legislation? The very long list of legislation makes that point in a very confused manner.

I shall now discuss registration and changes to Section 19 of the Medical Act 1983. We had a lively debate in this House in June as part of the National Health Service Reform and Health Care Professions Bill prompted by St George's University School of Medicine in Grenada. As anticipated in the reply to my amendments by the noble Lord, Lord Filkin, Section 19 is indeed being changed so that there will no longer be the status of recognised university qualification for EEA nationals. This means, I assume, that under the terms of the new section all students who are UK nationals, since they are not exempt, will have to take PLAB and IELTS rather than the GMC being satisfied that certain institutions have provided

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sufficiently high-quality pre- and post-clinical medical training. As I pointed out in the debate in June, it seems perverse to do that when there are high-quality institutions around the world where quality of training can be assured. I very much regret—both for those institutions, which could attract many more UK aspirant doctors, and for the individuals themselves, who will now have to jump through more hoops—that the approach that we on these Benches suggested back in June has not been adopted.

I have two final comments. First, the consultation on these regulations has been a model. I very much hope that the consultations carried out over other medical reform, such as the establishment of the medical education and training board, which will have major implications for doctors, will follow a similar process.

Secondly, it is deeply ironic that, while we are establishing an important new fitness-to-practise regime for the United Kingdom through the order, the proposed new directive on mutual recognition of professional qualifications will potentially drive a coach and horses through the regime and allow totally unregistered doctors to work here for 16 weeks. In contrast to some member states, the Government have not been energetic in resisting these proposals. I hope they will become much more vigorous. I very much look forward to hearing what the Minister has to say.

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