Medical Profession (Responsible Officers) Regulations 2010
(13 years, 7 months ago)
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Earl Howe
My Lords, the purpose of the draft Medical Profession (Responsible Officers) Regulations 2010 is to protect patients and to support doctors to improve the quality of care they give. They require certain designated organisations in England, Wales and Scotland to nominate or appoint responsible officers and to support those responsible officers in carrying out their statutory functions. They give responsible officers statutory functions relating to the evaluation of a doctor’s fitness to practise. In England only, responsible officers will be given additional functions relating to monitoring the conduct and performance of doctors. The regulations set out the connections between doctors and the designated organisation relevant for them.
Under the regulations, responsible officers will have to be licensed medical practitioners with at least five years’ experience. However, this is a statutory minimum. In practice, organisations will want to appoint senior doctors with experience of the management of other doctors as their responsible officers. The responsibilities of responsible officers relating to the evaluation of fitness to practise include ensuring that the designated body carries out regular appraisals, establishing and implementing procedures to investigate concerns and, where appropriate, referring the doctor to the General Medical Council.
Under their duties to evaluate fitness to practise, responsible officers will make recommendations on individual doctors to the General Medical Council. The responsible officer will have to make a recommendation as the basis for revalidation when it is introduced. This will normally be every five years. In England, their additional responsibilities will include identifying any issues arising from information about conduct and performance and ensuring that the designated body takes steps to address any such issues. These functions will enable responsible officers to support doctors to improve the care they give at the earliest opportunity.
Most of the statutory functions are activities already undertaken by medical directors and staff. These regulations do not specify who will take on the role of responsible officer; rather they allow organisations to determine how the functions may best be carried out. In the NHS and independent providers, it is likely to be existing medical directors. Except perhaps in the smallest organisations, we would not expect responsible officers to undertake the tasks, such as appraisals and investigations, personally, but they will be responsible for ensuring that they are carried out appropriately. This will involve ensuring that their designated body has sufficient staff who are appropriately trained, whether in undertaking appraisals or in investigating concerns. The regulations also make provision for the appointment of an additional responsible officer where there is a conflict of interest or appearance of bias between a doctor and the responsible officer.
The Merits of Statutory Instruments Committee has drawn these regulations to the attention of the House and I have no doubt that in the light of the Motion she has tabled, the noble Baroness, Lady Thornton, will wish to raise certain issues and concerns. I stand ready to address them, but in the mean time, I beg to move.
Amendment to the Motion
Baroness Thornton
As an amendment to the above Motion, at end to insert “but this House regrets that the draft regulations may imperfectly achieve the policy objective of the introduction of a revalidation scheme in light of the Government’s proposed changes to the NHS administrative structure which will affect the operation of the revalidation scheme in general, and these regulations in particular”.
Baroness Thornton
My Lords, as the Minister quite rightly suspects, it was a combination of the report of the Merits of Statutory Instruments Committee on 7 October and my concerns that some aspects of the statutory instrument as drafted need further explanation that caused me to put down this amendment to the Motion this evening. I think it is important to say from the outset that as one of the Ministers who guided the Health and Social Care Act 2008 through your Lordships' House with my noble friend Lord Darzi, I am very pleased that this Government are showing determination to push ahead with this agenda because at the heart of this legislation are patient safety and ensuring that all clinical professionals deliver high quality, effective and safe care to their patients.
I fully appreciate that responsible officers are integral to improving care, and the development of their role seeks to raise the already high standards of the overwhelming majority of professionals, but their job is to identify and swiftly deal with the small number of staff who are not able to meet those standards. The public, professionals and the NHS have a right to be assured that licensed doctors are fit to practice.
I have absolutely no desire to delay the important matter of implementing this legislation. However, I think that it is important that the secondary legislation does the job that the original legislation intended. The report by the Merits Committee raises some important questions in this regard, as do some of the important bodies whose membership will, as it were, be on the receiving end of the instruments.
I think that the regulations do a very good job of describing the duties of the responsible officer and, indeed, the connection between responsible officers and designated bodies and medical practitioners, and this leads me to my first set of questions. Part 1 of the schedule contains a list of designated bodies that includes at least two organisations that the Government intend to abolish: strategic health authorities and primary care trusts. I join the Merits Committee in its recommendation that the House seeks clarification on how the Government's proposed changes to the NHS structure will affect the revalidation scheme in general and these regulations in particular.
Since the 2008 Act, the UK Revalidation Programme Board—hosted by the GMC, which I thank for its briefing and comment on this matter—has been rolling out the reform in phased stages, including a number of pilot exercises which aim to produce a well informed and robust system. Can the Minister tell the House how the changes that have been proposed will affect the pilots and their results? For example, the published guidance says that the responsible officers themselves will be assessed by the responsible officer in the strategic health authority, so what will happen now? How will the Government overcome this problem? I anticipate that we can expect some further orders and, if so, when and will they too be piloted? If nothing exists in the structure of the newly reformed NHS between groups of commissioning doctors at local level and the NHS Board at national level who or what will perform this function?
At the time of the original legislation, we had considerable discussion about the GMC and its role in this matter and about not conflating its particular and important role as the independent regulator for doctors in the UK or, indeed, creating conflicts of interest. At the moment, it seems to me that the only body that would appear to have a structure between the very local GP consortia and the national board is the GMC. What is the Minister’s view of this? How will revalidation work under those circumstances?
I thank the Minister for forwarding to me the letter that his honourable colleague Anne Milton sent to members of the Delegated Legislation Committee in another place. In this letter, she addressed the changes of architecture to the NHS. However, I am afraid that I did not find her explanation very comforting. She says:
“The Government’s proposed changes to the structure of the NHS set out in the White Paper ‘Equity and Excellence: Liberating the NHS’, in particular the abolition of PCTs and SHAs, will not affect the majority of organisations designated under Regulations, including NHS and independent hospitals. These organisations need to start putting the systems in place that support doctors, and provide the information that demonstrates the quality of care they provide. Without this, there is a danger that doctors will be inadequately supported for the introduction of medical revalidation in 2012. I believe that the medical leadership and stability provided by having responsible officers in place will also be important during this period of change”.
Well, quite: the two bodies that can provide that leadership are being abolished.
I turn now to concerns that have been expressed by professional organisations, which particularly led the Merits Committee to say that,
“these regulations are drawn to the special attention of the House on the grounds that they imperfectly achieve the policy objective”.
When I was a Minister, I would have regarded that as the parliamentary equivalent of being put on the naughty step and given a detention at the same time. I think that the Minister needs to give some thought to this matter and to put his responses on the record.
The British Medical Association has said that the laying of the order is “premature”. Although I am not one for delaying these matters, the Minister needs to address its concerns. The Royal College of Surgeons has expressed disappointment that many of its concerns were not addressed in the regulation. It raised the issue of potential conflicts of interest to arise from the installation of responsible officers with simultaneous corporate board responsibilities—for example, medical directors.
The RCS seems to think that such officers might be torn between trust obligations and the professional role of the responsible officer. I am sure that the Minister will be familiar with the examples that these organisations have raised. How do the Government intend to avoid the revalidation recommendations becoming the tools of managers and trust management agendas, rather than matters relating to the compliance of GMC and Royal College standards? Will the Minister confirm that it is the responsible officer’s responsibility to examine the doctor’s clinical ability and professional conduct, not his contribution to the meeting of trust budgets or targets? On this matter the regulations appear to be silent. Perhaps the Minister will expand. The RCS has expressed particular concern about the failure to incorporate whole practice appraisal in these provisions. I think that the Minister needs to give the House an explanation and reassurance about the need for the comprehensive protection to which patients are entitled.
On indemnity, will the Minister confirm how the Government will approach the issue of the potential increase in contributions for medical directors who take on the role of the responsible officer?
Finally, the GMC has expressed concern about appeals and that there is a significant omission of local appeals systems. The GMC fitness to practise processes should not be both the first and the last resort for appeal. There should be a viable appeals structure that flows up to fitness to practise. The British Medical Association says that in some organisations progress has been slow in demonstrating the capability to pull together the necessary data to actualise the new system. It says that appraisal has been patchy and disjointed in many organisations, and that that is quite aside from getting around to supporting any appeals system that may arise. I have raised several issues and I suspect that other noble Lords will seek clarification on the various other issues. I look forward to the Minister’s response.
Baroness Finlay of Llandaff
My Lords, we all know the sad history of this, through Shipman, which has led us to where we are today. I do not want to block these reforms because they will improve medicine for patients and for clinicians. But there are some questions which need to be sorted out urgently. One question is the role of the responsible officer in relation to doctors in primary care, particularly with the reorganisation.
In his opening remarks, the Minister spoke about trusts, but I would suggest that hospital practice is very much the easy end of it. The difficulty is where will doctors in primary care sit? How will the responsible officer work in relation to them? Where will academics sit and who will be the responsible officer, because there is sometimes a conflict, as has been pointed out, between academic priorities and the clinical priorities of a trust where that doctor may have an honorary contract? Even more, what about locums? What about the doctors who are constantly moving around? How will they be captured in the system? How will they be adequately and appropriately revalidated? Even with what used to be called 360 degree appraisal—that is, getting opinions from a lot of people—with locums there is a real danger that they will only spot their friends to fill out the forms because they may have had lots of contacts. Those concerns may never be sufficiently in the system to be raised before such a doctor moves on.
There is also a difficulty for those who raise problems. It may be that the doctor who is seen as the sand in the shoe of the trust, the difficult person, is raising real concerns about the way in which management is conducted, which is impeding good patient care. We know that one of the biggest problems is attitude. Often, the biggest problem encountered is not about the ins and outs of technique, because you can retrain on that quite quickly, but is about someone’s attitude. Someone who is whistleblowing, someone who works in the same organisation—I hate to use the term “whistleblowing”, because it is a sad reflection of the NHS as it is today that that term is around—and raises concerns should not in any way potentially be penalised for doing so. We would just go backwards and not forwards if that is the case.
Given that the majority of doctors are doing a really good job and are very flexible and going through changes, the system that comes in must not be too onerous. It must not be just a tick-box exercise. It has to be subtle enough to pick up real issues around performance and attitude. It has to pick up qualitative feedback, so that a bad attitude is detected, including a bad attitude towards patients.
As regards the responsible officer, I am afraid to say that I am sufficiently old-fashioned to think that I would prefer the minimum time after qualification to be a bit longer. It is not until someone has been practising for about 15 years that they really have accrued enough wisdom to be able to take on what will be a very onerous and potentially important role in relation to their colleagues. We need them to have a degree of wisdom. The appeals system is absolutely crucial if this is to work well and fairly. I hope that the Minister will give us a full reply in his response.
We also must be clear that the system will not pick up another Shipman. This is a clinical system and not a criminal justice system, so no one should be fooled into thinking that it will. Dame Janet Smith pointed out two things. First, the most important information about patient safety is doctors watching other doctors. They have to be able to raise concerns easily. Secondly, a good clinical governance system is a system in which questions can be raised at an earlier stage and more readily. So it is the whole system of the NHS with good clinical governance that will make this work. I hope no one thinks that just having responsible officers putting in appraisals will do the job because that will be a wallpapering exercise.
However, my main concern relates to primary care and to financial conflicts. In a privately managed organisation there may well be a conflict between what is actually in the patient’s best interest and what is being put forward as the protocol in that managed care programme. It may well be that the doctor is working in the patient’s best interests, but not in those of the organisation. Again, there has to be a degree of neutrality among the responsible officers. I hope that the Minister will be able to give replies to all these concerns, and like other noble Lords, I look forward to his response.
Lord Walton of Detchant
My Lords, I declare an interest as having been president of the General Medical Council from 1982 to 1989. I know that the GMC is particularly anxious to see these regulations go ahead because the whole question has been smouldering away for very many years. Even during my presidency, we were aware that many doctors who came before the conduct committee of the council, or before that the disciplinary committee, were not so much erring or wicked as actually not practising, in some respects, to a standard of competency appropriate to today’s world. For that reason, we tried very hard to set up a mechanism within the GMC to establish what we called at first a competence committee. However, it was not successful because we could not persuade the profession and other bodies to approve some of the recommendations that we tried to put forward.
Subsequently, the GMC embarked on a programme of performance review. Mechanisms were established to identify doctors who were not performing to an adequate standard in the health service and other bodies, but that programme too did not succeed as well as it might. It was perfectly clear that it was crucial to the interests of the public at large and of patients themselves that there was a mechanism whereby doctors would be required every five years to subject their clinical performance and performance in their appointment to a process of validation. Revalidation then became one of the essential priorities for the General Medical Council. As the noble Earl said in his introduction, the GMC believes that implementing this process of revalidation is an essential step in advancing the quality of medical regulation, improving patient safety and providing patients with greater assurance that doctors are meeting the standards that we set for the medical profession.
I appreciate to the full some of the anxieties expressed by the noble Baroness. She has criticised the nature and content of these regulations. However, as I have said, this mechanism has been smouldering away for over 20 years and it is time to make progress. The statutory basis for the responsible officer is set out in the Health and Social Care Act 2008, which amends the Medical Act 1983. The GMC is now committed to the introduction of revalidation for doctors in order to change the way in which all doctors in the UK are regulated. Under this process, to retain their licence to practise, doctors need to demonstrate to the GMC every five years that they still meet the appropriate professional standards and are continuing to develop their skills and knowledge.
The responsible officer will be the link between the local healthcare organisation, whatever it is, and the GMC, and as such will be an essential component of implementing revalidation. The responsible officer will usually be based in and employed by the organisation for which the doctor works, or with which the doctor is contracted to provide services. The GMC will need to be confident that the recommendations it receives are robust, fair and consistent, but that the process leading to the recommendations and the recommendations themselves will be subject to quality assurance and to audit. The GMC will develop guidance to assist responsible officers in carrying out their role in relation to revalidation.
We have reached a stage at which it is crucial that responsible officers are in place before the rollout of full revalidation commences. This will have the advantage of enabling the GMC to identify gaps in the coverage of responsible officers, particularly of doctors working outside the National Health Service, and to make provision for them. In its response to the government White Paper, Equity and Excellence: Liberating the NHS, the GMC comments that the abolition of PCTs and strategic health authorities, which is not expected until 2013, leaves it unclear as to where the responsible officer role in primary care and sometimes in specialist care will sit, and how the role and functions of the medical directors will be exercised. As the noble Baroness said, this matter needs to be resolved, but it must not be a reason to delay the passage of these long-awaited regulations or to stall preparations more generally. The GMC has confirmed that it will work with the Department of Health to resolve this and other issues so that it can continue to make progress towards the implementation of revalidation. I trust that the regulations will be approved.
Lord Patel
My Lords, I concur with the comments of my noble friend Lord Walton of Detchant. It is important that we allow these regulations to pass. As he has said, the issue of revalidation has been smouldering away, to use his words, for many years. I recall from when I served on the GMC over eight years ago that the revalidation issue predates Shipman and has nothing to do with that issue. As my noble friend has said, this is a process and it is important that the regulations should be passed because we need the responsible officers to be appointed pretty soon so that the GMC can train them up and identify any issues before the process of revalidation begins. I understand that all the devolved Administrations have agreed that it should start by autumn 2012. If that deadline is to be met, we need the responsible officers long before that.
My conversations with officers of the GMC suggest that the council is well aware of the concerns raised. They know that when the legislation to reform the NHS is brought forward, the issue of what happens in primary care with doctors working as commissioners, and how they are to be revalidated, will have to be addressed. They are confident that they will be able to do so.
As for the other professional organisations that have also commented and to which the noble Baroness referred, it is interesting that only one has raised concerns; the others have not. All the other royal colleges have been involved in working with the GMC to identify how revalidation will be carried out in their own specialties and they are satisfied with the mechanisms that will be used. They are also satisfied that the pilots that are now being carried out will identify the issues.
It is important that we now approve these regulations and allow the responsible officers to be appointed. We will have other opportunities to debate the matter again during the next stages.
Lord Alderdice
My Lords, it is always difficult when new Governments come into place and want to make important and sometimes radical changes to structures and arrangements while, at the same time, valuing some of the work that had been begun but not completed by a previous Government. As other noble Lords have said, the previous Government, and perhaps even an earlier one, moved towards revalidating doctors. This is a very complicated and difficult issue, but the Government moved in that direction; timetables were set but became a little delayed. However, if the Secretary of State in this new Government were to take the advice that has been proffered—that until PCTs and strategic health authorities are set aside and the new arrangements are in place we should not move to the appointment of responsible officers—we would be looking at 2014 or 2015, or after the next general election, before we could move forward. It is understandable that people should quite reasonably say that there is a dilemma here, but we must try to keep up the momentum, which is the point that the GMC has made.
It is perfectly correct that a number of matters are not yet clear and resolved. Some affect me, and I shall advert to them in a moment. The proposals for the reform of the NHS have not worked through the process—they have been announced but are not yet through Parliament—and it is not only possible but almost certain that there will be significant changes and developments. I hope my noble friend will be able to clarify some of the issues, but it would be expecting rather a lot for him not only to clarify how matters stand at the moment but to predict how they might stand further down the line when some things may have changed.
In the present situation, in most cases but not all, appraisal processes are already going on. Up until earlier this year, every year I produced a huge lever arch file containing details of all the things that I had been through. So the process is already in place and it is the responsibility of medical directors in trusts to make sure that it is in place. However, they cannot possibly carry it through themselves because so many need to be appraised. They therefore have to devolve the responsibility for the detail and the face-to-face work to someone else. Exactly the same thing will happen to the responsible officer.
Are there potential conflicts of interests? There already are because those who are responsible for the appraisals are also responsible for clinical merit awards of various kinds, for the recognition of a person’s work and for the creation or demolition of their clinics. All these conflicts are already there. That is not to set them aside and say they are unimportant—they are very important and very difficult—but we are facing something that is not in itself radically new but a problem with which we have been struggling for quite some time. Further orders may well come subsequent to this that will help to take the matter forward, but that does not mean that we should delay the current regulations.
Let me put to my noble friend a dilemma of my own on which he may or may not be able to help. What will happen to those who do not necessarily operate all the time only in the NHS in England, Scotland and Wales? I note that Northern Ireland is not included in this and, of course, the movement backward and forward between this part of the world and the Republic of Ireland is substantial. What happens if a doctor qualifies and works here for a while, then goes to work for three or four years in the Republic of Ireland and then comes back to work in the United Kingdom but the process of validation has not operated in quite the same way? Of course, we have free movement not only in these islands but throughout the European Union. What happens to those who have operated outside the UK? These are real dilemmas that have to be dealt with.
We have often heard it said that it is better to start, pilot and work your way through than to produce something that has not been tested out but is a fiat—a fait accompli. My noble colleagues on the Cross-Benches have expressed reasonable concerns and a determination to keep up the momentum for revalidation. In supporting these regulations, that is also very much my mindset, and I hope to see further developments over the next year or two.
Lord Rea
My Lords, I simply report that the two professional organisations to which I belong, the Royal College of General Practitioners and the BMA, basically support the regulations. That is in spite of some doubts about the timing and some of the other points that noble Lords have raised today. It is good that responsible officers will be appointed before the detailed work of setting up the revalidation process is completed. They will play an important formative role before later acting as scrutineers or umpires—I hope not inquisitors—in the revalidation process. I shall be interested to hear the Minister’s response to the cogent questions that my noble friend and almost all other noble Lords have raised.
Lord Kakkar
My Lords, we have heard that the key priority of the General Medical Council for patient safety and ensuring continuing standards and confidence of the public in regulation is the process of revalidation. We have heard in the Chamber today very strong support for the regulations.
The early appointment of responsible officers is critical. It will ensure that the system can be tested. The noble Baroness, Lady Thornton, was absolutely right to raise the structure in which responsible officers in the area of primary care will eventually be able to operate, but this matter can be dealt with when the health Bill is laid before Parliament and the primary care structures in it can be appropriately scrutinised.
As we have heard, if the regulations are in any way derailed at this stage, there is a danger that the whole momentum of revalidation will be disrupted. It could cause anxiety in the profession and lead to unhelpful pockets of resistance. There is now an ideal opportunity for a mechanism and the early appointment of responsible officers to test potential systems and determine where the weaknesses are. This will occur before revalidation comes into force in its fullest form, and will therefore allow the General Medical Council to respond appropriately. I add my voice to those of many noble Lords in supporting the regulations.
Lord Colwyn
My Lords, although the principles behind revalidation, which aims to raise confidence in clinical standards, are welcomed, there are concerns over the ways in which the Department of Health plans to implement the process through the responsible officer regulations. There is also concern about the new regulations coming into force in January 2011, given the proposals in the recent health White Paper to abolish structures that were intended to support the role.
I agree with the noble Baroness, Lady Finlay, that the demands of the role outlined in the proposals will require a person of quite exceptional skills and competences. It is assumed that many medical directors will become responsible officers, which will significantly extend their role by extending their responsibility, powers and workload.
There is already a marked variation in the abilities of medical directors to investigate performance concerns and implement local disciplinary procedures. The additional duties are likely to be onerous. It is not certain that senior doctors with the necessary professional standing will be willing to take them on, or that it will be possible to find senior doctors with the necessary standing and experience to succeed in this role.
It is essential that adequate resource is allocated to support responsible officers and that they are appropriately equipped to carry out their responsibilities. The guidance to the draft regulations emphasises that there must be a “robust” medical management infrastructure to support the responsible officer and sufficient delegation of duties to enable the role to be delivered to a high standard. How will this work in practice and how will it be resourced?
The draft regulations do not reflect the changes proposed in the White Paper. Reference is made throughout to “designated bodies”. These include PCTs and SHAs, which are to be abolished by 2013. There is no detail on what structures will support responsible officers, revalidation and other aspects of performance management in primary care after 2013. This makes the decision to press ahead and appoint 975 responsible officers to strengthen systems in structures that are to be abolished difficult to understand. Surely, given the decision to delay revalidation and the uncertainty around the structures that will support performance management, more time is needed to pilot and evaluate the responsible officer system effectively before bringing these measures into force in January.
Earl Howe
My Lords, I thank all noble Lords who have spoken. In particular, I welcome the positive comments made about the regulations and the rationale for them. I am grateful especially to the noble Lords, Lord Walton, Lord Patel and Lord Kakkar, and my noble friend Lord Alderdice for their strong support and very helpful comments, and indeed to the noble Lord, Lord Rea, for what he said. A number of questions have been asked and perhaps I could begin by addressing the timing of these regulations.
First, I know that medical revalidation was a concern of the Merits Committee, reflecting in turn the concerns raised by the BMA and the Royal College of Surgeons. Noble Lords who are medically qualified will be aware, and other noble Lords may well be aware, that the piloting period for revalidation has been extended for a further year. This will allow time for a better understanding of the costs, benefits and practicalities of implementation and to enable full engagement with the profession, the service and the public. Despite there being issues which the extended period of piloting will help us address, one thing remains clear; recommendations on an individual’s revalidation can be based only on substantiated information. That information will come from doctors themselves, supplemented by information from an organisation’s clinical governance systems. The responsible officers’ roles, in other words, are wider than the process of revalidation. It is important that we have those officers in place to implement improved systems of clinical governance and to ensure that organisations are prepared and doctors are supported, ready for revalidation.
The noble Lord, Lord Rea, was right; having responsible officers in place would help to ensure that doctors are appraised and that systems are in place that will enable the information to be collected and shared as appropriate, such as when doctors move to a new organisation. Where there are concerns, their duties will ensure that the appropriate action is taken, and will continue to be taken, so that patients are protected. The noble Baroness, Lady Thornton, also argued that the regulations had been overtaken by the Government’s proposed reforms of the NHS. It is worth re-emphasising what my honourable friend Anne Milton said in her letter: that the majority of organisations designated under the regulations will not be directly affected by the removal of primary care trusts and strategic health authorities, which of course has not yet happened and is still some distance away. Clinical governance systems are needed regardless of the White Paper proposals.
Now is precisely the right time to introduce the role of responsible officer. I simply repeat that medical leadership and stability are needed if organisations and their doctors are going to be ready for revalidation when it starts.
Of course the regulations will in due course need to reflect the changes in NHS architecture, should those be agreed by Parliament. We are currently exploring options for this and I can repeat the assurances given by my honourable friend Anne Milton in another place. To answer in particular the concern of the noble Baroness, Lady Finlay, about primary care, we will consult on options for responsible officers within primary care as we move to a system of commissioning consortia, and on identifying a responsible officer’s own responsible officer, who in England currently sits within the strategic health authority, as the noble Baroness, Lady Thornton, rightly pointed out.
The noble Baroness also reflected professional concerns about conflicts of interest between a responsible officer’s statutory duties and their duty to their organisation. All doctors who have a management or supervisory role for other doctors already manage on a day-to-day basis any tensions that may arise between the need to ensure high professional standards and values on the one hand and the needs of employers and service provision on the other. Medical directors already address concerns about doctors in their organisations, whether through local performance management, disciplinary systems or referrals to the GMC. The Government believe that, in the vast majority of cases, medical directors will be guided by their professional values to manage such issues fairly and in the best interests of patients. The alternative—an entirely independent structure of responsible offices in every healthcare organisation in the United Kingdom—would replicate the system of GMC affiliates, which was proposed, as noble Lords may remember, in 2007, and which professional bodies rejected during consultation as being disproportionate, impracticable and unaffordable.
I also draw the House’s attention to the evidence given to the Health Select Committee on 4 November 2010 by Professor Peter Furness, who is president of the Royal College of Pathologists and revalidation lead for the Academy of Medical Royal Colleges. Professor Furness acknowledged the potential for a conflict of interest, but he also said that the view that medical directors should not be responsible officers was held by “a minority” of medical royal colleges. He observed that the potential for conflict could be balanced by the fact that medical directors are best placed to resolve any problems that might arise. He also thought that the potential for conflict needs to be addressed by “open processes” to ensure that it does not cause problems.
We must also remember—this is a fundamental point— that responsible officers can make recommendations only about a doctor’s fitness to practise; they do not have the power to remove a doctor’s licence to practise. Their recommendations must be based on evidence, and it should be clear immediately if that is not the case. Further, if responsible officers make recommendations that are not based on evidence, they may be failing in their duties under good medical practice, which requires that doctors must,
“be honest and open and act with integrity”.
In that case, responsible officers could even bring their own fitness to practise into question. These are very serious issues for any responsible officer.
The Merits Committee’s concern that the regulations provide for no process of appeal against the recommendation of a responsible officer has also been raised by noble Lords. First, let me stress that the regulations will result in no change to the current situation, in which every doctor, including the medical director, has a professional duty to report serious concerns about another doctor to the GMC. Under the regulations, the responsible officer will be required to decide what recommendation to make to the GMC about an individual doctor’s fitness to practise. However, the GMC would then need to go through its own processes, which provide the doctor with an opportunity to defend allegations—including through an appeals mechanism—before the doctor can be considered unfit to practise. Under the regulations, local procedures to investigate concerns must provide for a doctor’s comments to be sought and taken into account.
In England, as part of the responsible officer’s role in dealing with concerns about a doctor’s conduct or performance, the responsible officer will also be able to recommend suspension to the designated body. However, the decision on suspension is for the designated body and should engage that organisation’s performance management and grievance procedures. I think that sufficient mechanisms are already in place that protect the doctor’s interests without the need to create an additional bureaucratic structure to allow doctors to appeal against what are, after all, simply recommendations.
Two further issues were raised by, I think, the noble Baronesses, Lady Thornton and Lady Finlay. The first relates to a failure to specify that appraisal should encompass the whole of a doctor’s practice. That is in fact provided for in Regulation 11(3), which states:
“The responsible officer must ensure that appraisals … involve obtaining and taking account of all available information relating to the medical practitioner’s fitness to practise in the work carried out by the practitioner for the designated body, and for any other body, during the appraisal period”.
Nevertheless, I repeat the assurances given in another place that we will consider whether we can strengthen the guidance to make it clearer that appraisals must address the whole of a doctor’s professional practice.
The second issue relates to indemnity and, in particular, to the fact that organisations should provide indemnity for responsible officers. Indemnity payments are already calculated on the basis of a shared risk. At this stage, we understand from the medical defence organisations that there is no suggestion that the contributions from those who take on the responsible officer role would need to rise. However, we are told that the medical defence organisations will keep the situation under review. I assure noble Lords that, if we find contributions rising as a result of these regulations, we will review the position.
Baroness Finlay of Llandaff
Will the Minister clarify that the way in which the regulations are written is sufficiently flexible to allow a doctor to take a career break, to move into a different area or to take a break from clinical practice as it currently stands? Are they also sufficiently flexible to allow the responsible officer role not to be tied to the medical director of a trust, but if the medical director of a trust resigns from that post but is very suitable to remain the responsible officer, they can remain the responsible officer and the medical director can be someone else? Furthermore, are they sufficiently flexible to allow you to be able to get rid of a responsible officer if it turns out that they are not being wise enough?
Although this is slightly irregular, I should point out for clarification that I am not against these regulations at all—I think that they need to go through. My concern about five years is that most doctors are still in training at that stage.
Earl Howe
My Lords, the answer to the first question of the noble Baroness, about career breaks and so on, is yes, the regulations allow for that. In answer to her second question, we are not specifying that responsible officers have to be medical directors. As she knows, we are leaving it up to the organisations to decide that. Therefore, she can be reassured on her other questions.
Baroness Thornton
My Lords, I thank all noble Lords for contributing to this debate, particularly the noble Baroness, Lady Finlay, the noble Lord, Lord Colwyn, and my noble friend Lord Rea. I also thank the Minister for his comprehensive answer. Noble Lords will have heard me say from the outset that I did not intend to delay the implementation of the regulations. However, noble Lords should also acknowledge that if we ignored the reservations expressed by the Merits Committee and various medical organisations, and did not to pay heed to what they had to say about this, we would not be carrying out our duty of scrutiny. I thought that the most important thing was to get on record the answers to the very questions that we have raised.
I thank the Minister for his usual comprehensive and competent answer, which helpfully addressed many concerns. The abolition of PCTs and strategic health authorities is on the “wait and see” bit of this agenda. We can take it that the Department of Health has not yet worked out what it is going to do. I take some comfort from the fact that this, like much else, is in the melting pot of what is becoming the NHS at the moment; it is work in progress. With that and with thanks, again, to the Minister, I beg leave to withdraw the amendment to the Motion.