The Minister of State, Department of Health (Mr. Ben Bradshaw): I beg to move,

This draft order is the third in a series of affirmative resolutions that form part of the Government’s reform of the regulation of the health care professions, as set out in the White Paper of February 2007, “Trust, assurance and safety”. Members will recall that many of the recommendations in that White Paper followed on from the recommendations of Dame Janet Smith’s inquiries into the Shipman murders. The order in effect makes three sets of minor changes to the framework legislation for the regulation of doctors. Those of us who sat on the Committee in the summer will recall that the more significant changes to the operation of the General Medical Council were made then.

The first set of changes relates to medical education. The order will transfer the statutory functions for the oversight of medical education from the education committee of the GMC to the GMC itself. That will allow the GMC to bring together all four of its interlocking statutory functions under the auspices of the council. In doing so, it will be able to demonstrate that its responsibilities for medical education are central to, and not isolated from, its other regulatory functions. The order will also remove the residual role of the Privy Council in relation to the first year of postgraduate medical education. That is part of the process of giving health care regulators greater independence in performing their functions.

The second set of changes relates to the introduction of licences to practise. Amendments were made in 2002 to the Medical Act 1983 to create a new system whereby all practising doctors would need not only to be registered with the GMC but to hold a licence to practise. Doctors, in due course, will be allowed to keep their licences to practise only if they go through a process known as revalidation—another recommendation of Dame Janet’s—which will be a periodic re-evaluation of a doctor’s fitness to practise. The introduction of licences to practise is therefore an important preparatory step towards the revalidation of all doctors, which is a cornerstone of our regulatory reforms.

The third set of changes relates to specialist registration, and will in due course have a knock-on effect for recertification. The order enables the GMC to allow senior consultants who did not apply for inclusion in the specialist register between January 1997, when it was established, and September 2005, when the current arrangements for access to the register were introduced, to make a late application for entry. That reinstates the powers that the GMC had before September 2005. The current situation, in which some long-standing consultants are not on the specialist register, means that there is the potential for a small number of consultants to avoid recertification. That is because the formal process of recertification will be linked to entitlement to be on the specialist register. Providing a quick and easy route on to the register is a first step in correcting that anomaly.

All these measures are supported by the GMC, and I commend them to the Committee.

Mr. Stephen O'Brien (Eddisbury) (Con): I am grateful for the opportunity to debate these important changes to the operation of our medical profession, and I hope that the Minister will engage in the debate. As with the Health and Social Care Bill, which much of the order complements, this legislation establishes frameworks within which other bodies can operate. I like to think that the Minister would not wish to hide behind that particular point; if he did, we would end up with shadow boxing instead of substantive debate.

In their consultation response, the Royal College of Pathologists went as far as to say that

We are talking about the health and safety of patients up and down the country, and about the livelihoods of the many medical professionals who serve our NHS with such dedication and skill. They deserve a substantive debate. Those who responded to the consultation asked serious questions, and I am sure that the Minister will want to seek to answer the ones that I now put.

I was concerned to read the response of the Postgraduate Medical Education and Training Board to the consultation. As the Minister will be aware, it said:

of late entry to the register

It went on to

Why has the Minister not heeded that call from one of the primary stakeholders?

I turn to the first of three strands of the statutory instrument. PMETB spoke for many of the consultation respondents when it said that its

and it refuses to support it before further consultation. The Conference of Postgraduate Medical Deans echoed that, stating its

It is worth noting that the British Geriatric Society is seeking for the division to be maintained.

Although the British Medical Association supports the transfer of statutory powers of the education committee to the GMC’s council, in its contribution to the consultation it called for the GMC to continue operating an education committee, particularly as under the current arrangements the BMA’s medical students committee contributes to GMC discussion of the regulation of undergraduate education through its seats on the education committee. Can the Minister confirm that that avenue of influence will be preserved for the BMA? I hope that he will acknowledge that that is as much a matter for him as for the GMC, as he is proposing the legislation that could adversely impact on the BMA in that way.

It is concerning that the Government have not won the argument among their key stakeholders. I hope that the Minister will send a clear message to the GMC that the expertise of the education committee should be retained in that change, as the Medical Protection Society and others have called for, and I hope that he will work to allay the concerns that he has been made aware of.

Licence to practise and revalidation is by far the most controversial aspect of the order and another step towards licensing, revalidation and, by extension, responsible officers being part of a professional medical career. That builds on the discussion we had, during the debate on the Health and Social Care Bill earlier this year, on the decade old plans to reintroduce revalidation, and the inquiries and recommendations in the aftermath of the Shipman inquiry.

Again, serious concerns were expressed during the consultation—the Minister has not addressed them—about revalidation and the pilots that this legislation is intended, initially at least, to enable. Can the Minister explain why the legislation, if it is to enable pilots, does not have a sunset clause? Surely it is wrong for the House to make an open-ended legislative commitment to something as yet untried and substantially undebated. In its submission, the BMA sought clarification on where the pilot sites will be and which speciality they will be within. It questioned what outcomes are being measured; what success will look like there; and whether, if a doctor should fail, his case could be referred to the fitness to practise procedures. I hope that the Minister can answer those questions.

The British Association for Counselling and Psychotherapy asked what provision will be made for doctors who do not apply for licences to practise, but who continue to practise. Can the Minister tell us how long it will take for an alert to be generated when a doctor is practising without a licence?

I highlight to the Committee the cost-benefit analysis that states that the revalidation pilots will cost £4 million. Can the Minister tell us where that money will come from? That calculation is based on 5,000 sessions at £400 a time. Does that mean that revalidation will also cost £400 a time? Assuming that 160,000 doctors get revalidated every year, that would generate a cost of £64 million per annum. The explanatory memorandum points out that the estimated 160,000 doctors currently practising will receive licences without charge. What is the cost of that and who will bear it? Will new doctors likewise receive licences free of charge?

Furthermore, the regulatory impact assessment for the Health and Social Care Bill put the cost of creating responsible officers at £3.1 million to £16.7 million per annum, and that does not even address the local costs that the Government are forcing on to PCTs without making any extra provision. I am concerned that the RIA reflects neither the costs to PCTs, which, after all, are funded with taxpayers’ money, nor the costs in time and money to GPs and doctors of undergoing the extra regulatory burden. Can the Minister provide some estimates?

Concerns about how revalidation will work emerged in the consultation responses from practitioners of integrated health and doctors who are NHS managers. In addition, there is a lot of scepticism. Dr. Alan McLean stated that

He was echoed by Mr. J. C. Pollock, cardiac surgeon at Glasgow’s Royal hospital for sick children, who went on to express his concern that it will create a disproportionate bureaucracy. Even the director of the Minister’s own NHS work force review team notes a

During the passage of the Health and Social Care Bill, the Lords Delegated Powers and Regulatory Reform Committee agreed with Conservative amendments—that regulations conferring responsibilities on responsible officers should be subject to the affirmative resolution procedure on their first exercise by each of the appropriate authorities. Given that responsible officers will be a key aspect of the revalidation process, can the Minister tell us when that order is coming and how the pilots will progress in its absence?

The Government’s failure to consider properly the role of responsible officers has created unease across the board. The Minister will recall that Lady Justice Smith told the Committee:

Will the Minister confirm that the pilots will flesh out the role of responsible officers? Furthermore, will they cover options allowing responsible officers not to be medical directors? Lady Justice Smith continued:

Part of her desire for it to be a separate role arises out of her concern that

In addition, the role of responsible officer could cause serious conflicts of interest if combined with a medical director role. For example, suppose that a local doctor prescribes an essential cancer drug for a patient, which puts strain on the PCT’s budget. Suddenly, that doctor finds himself at the wrong end of an inquiry by the local medical director/GMC affiliate. How does the GP know that the inquiry is genuine and not contrived? How does the medical director/GMC affiliate know that he is not being influenced in his regulatory decisions by pressure from his PCT chief executive?

Lady Justice Smith noted the reverse issue:

Dr. Meldrum, of the BMA, said:

PCT medical directors are themselves employees of PCTs, so their impartiality in the regulatory management of local doctors cannot be guaranteed. The responsible officer should be completely independent of the local PCT. That way, he or she is more likely to command the trust of local doctors, thereby ultimately making the scheme more successful.

Responsible officers provide an opportunity for a dedicated individual to pick up the early warning signs in, for example, prescribing practice. That could alert someone to the opportunity to improve performance. In an open system of benchmarking, that could be an effective asset to the local and national health economy, and to the professionalism and morale of local doctors. Can the Minister confirm that the revalidation pilots will look at the positive benefits that revalidation could bring to continuing professional education?

Will the Minister tell the Committee the Government’s position on training for responsible officers? That must necessarily be a precursor to the pilots, but who will fund that training and at what cost? When does he expect the expert advisory group to agree on the competences, and when will negotiations with providers on training begin?

During the passage of the Health and Social Care Bill, I expressed concern about “soft” information sharing—responsible officers being able to share information without an employee’s knowledge. That information could be either unproven, in that there had been no investigation, or damaging, in that it could affect an employee’s reputation. It could form the basis of a claim that the employer had breached an implied term in his or her employment contract of trust and confidence. Will that matter also be addressed in the pilot schemes?

What impact will revalidation have on the annual retention fee? Not only has it gone up—by nearly £100 this year in the case of the General Medical Council—but the costs of the office of the health professions adjudicator could well add another £20 to £30, according to figures that the Minister sought to bury during the passage of the Health and Social Care Bill. The Minister will also be aware of the impact of equality legislation on the GMC’s ability to provide a reduced rate for non-practising doctors over 65 years old. What actions are the Government taking to ameliorate that?

I turn now to the specialist register provisions. It is unsurprising that the consultation responses were broadly supportive of the measure, given the mess that the Government have made of the situation. Dr. Stephenson called it a “ludicrous anomaly”, and in its consultation response, the British Association for Counselling and Psychotherapy said, rather dryly:

I hope that the Minister will accept that this is a U-turn that reverses legislation passed by the Government only in 2005. It is yet another example of their utter failure effectively to manage the education, training and registration of doctors—a failure epitomised by the Medical Training Application Service and modernising medical careers debacles.

Given that the explanatory memorandum calls the reinstated set-up a

can the Minister tell us how many doctors were adversely affected by it, and whether they will be recompensed? Will he address the concerns raised through the consultation?

PMETB again bemoaned the lack of detail or clarity regarding when the GMC will publish guidance. It asked for the protocol where an individual is practising in a speciality different from that in which they practised prior to 1 January 1997, and what is required to appear on the specialist register. That point was picked up by other respondents. Dr. John Stephenson’s response raised the issue of whether the registration process has enough flexibility within it to allow for career changes and alternative routes to specialist recognition. Perhaps the Minister could confirm that point.

The Royal College of Obstetricians and Gynaecologists asked whether specialists outside the training grades and not on the specialist register will be allowed to practise in the UK without recertification. I would be grateful for the Minister’s response to that.

In conclusion, both I and the Government’s consultees are looking for assurances that the expertise that is on the education board today will not be lost, and that the U-turn on the specialist register will, this time, deliver what the profession needs. Concerns are still outstanding on revalidation, and I await the outcome of the pilots with interest. It would be useful if the Minister gave us some indication of the timetable for those pilots. There are serious questions about costs, particularly if they could be as high as £64 million and involve not only the Department’s budget, but trust and practice budgets, too. I hope that the Minister will address the many issues that I have raised.

Greg Mulholland (Leeds, North-West) (LD): I will not detain the Committee long, but I wish to make a few brief points. Some common-sense changes are being proposed through these measures, the obvious one being the late entry on to the specialist register. However, questions about some of the other changes remain unanswered, and the Government have yet to convince sufficiently several organisations, as was mentioned by the hon. Member for Eddisbury. It is important, whenever possible, to try to take such organisations with us when making changes that will affect them on a day-to-day basis. My biggest concern is that that has not happened sufficiently on some of the issues before us.

I would like to reiterate two concerns raised by several organisations: first, a lack of clarity remains about the revalidation pilots and several questions need answering, which I hope that the Minister will do today. The biggest concern is about the pilot’s insufficiently clear statutory status. What would happen to a doctor who fails during this process? That is a serious matter, but it has not been properly addressed. Secondly, questions about the retention of the education committee should be properly considered. Would it be viable and sensible to retain the committee with—obviously—a different role following the transfer of overall oversight to the General Medical Council? It is especially important to recognise the importance of the BMA’s medical students committee. We do not want to lose its input into this very important process. I know that the Minister has many questions to answer, but I hope that he will bear those points in mind.

Peter Bottomley (Worthing, West) (Con): I welcome the Minister’s explanation of the order, and I congratulate my hon. Friend the Member for Eddisbury on the way in which he raised issues to which I am sure that the Minister will want to respond. I do not think that hon. Members will mind if they receive some of their responses by letter, because it is better to get the detail right than to have complicated issues dealt with in a sentence.

For the record, about 10 years ago, one of my children was elected to the GMC and served on the president’s committee, although I have not discussed all the issues before us with her.

Paragraph 11 of the explanatory memorandum, under the heading “Licence to Practise”, is ambiguous to me—it might not be to those who drafted it. It reads:

In simple terms, does that mean the 240,000, including the 80,000 thought not to be actively practising, or just the 160,000 thought to be actively practising?

I shall deal briefly with the education committee. The GMC is made up of a majority of non-doctors. It would be bad if the educational work were to be done by such a committee. If the GMC is considering having an education committee to do that work, I hope that the Government will ask it to ensure that the majority of committee members are involved in the education of doctors, and that the GMC itself, having transferred its constitutional authority to that committee, will take seriously, without rubber-stamping, the views of those involved in the current education of doctors. I see no justification for a majority of non-doctors being involved in the detail of preparing the work on the education of doctors.

I want to deal with a worry arising from a particular case, but it is not in my constituency, so I shall not go into it in depth. It would be interesting to know how the General Medical Council is advising the Government on how it deals with cases referred to it either on revalidation or, exceptionally, about people who are thought to deserve a disciplinary case. I was looking over the shoulder of another MP, at a constituency case involving a doctor, who was transferring information from one part of the NHS to what appeared to be an NHS project—