Session 2010-11
Publications on the internet
General Committee Debates
Delegated Legislation Committee Debates

Draft Medical Profession (Responsible Officers) Regulations 2010

The Committee consisted of the following Members:

Chair: Katy Clark 

Bebb, Guto (Aberconwy) (Con) 

Chapman, Mrs Jenny (Darlington) (Lab) 

Crabb, Stephen (Preseli Pembrokeshire) (Con) 

de Bois, Nick (Enfield North) (Con) 

Dobson, Frank (Holborn and St Pancras) (Lab) 

Efford, Clive (Eltham) (Lab) 

Milton, Anne (Parliamentary Under-Secretary of State for Health)  

Mulholland, Greg (Leeds North West) (LD) 

Pearce, Teresa (Erith and Thamesmead) (Lab) 

Pugh, Dr John (Southport) (LD) 

Shannon, Jim (Strangford) (DUP) 

Soubry, Anna (Broxtowe) (Con) 

Spencer, Mr Mark (Sherwood) (Con) 

Stephenson, Andrew (Pendle) (Con) 

Stevenson, John (Carlisle) (Con) 

Twigg, Derek (Halton) (Lab) 

Watson, Mr Tom (West Bromwich East) (Lab) 

Wilson, Phil (Sedgefield) (Lab) 

Ben Williams, Committee Clerk

† attended the Committee

Column number: 3 

Fifth Delegated Legislation Committee 

Wednesday 3 November 2010  

[Katy Clark in the Chair] 

Draft Medical Profession (Responsible Officers) Regulations 2010 

2.30 pm 

The Parliamentary Under-Secretary of State for Health (Anne Milton):  I beg to move, 

That the Committee has considered the Draft Medical Profession (Responsible Officers) Regulations 2010. 

It is an honour to serve on this Committee with you in the Chair, Ms Clark. I welcome the hon. Member for Halton to his place on the Front Bench. I start by declaring an interest, as my husband is a medical director and therefore—you never know—might become a responsible officer. 

The purpose of the regulations is to help doctors to improve the quality of the care that they give, to protect patients by requiring certain designated organisations to nominate or appoint responsible officers, and to support those responsible officers in carrying out their statutory functions. The regulations require designated organisations in England, Scotland and Wales to nominate or appoint responsible officers. They also give responsible officers a role in the evaluation of a doctor’s fitness to practise. In England only, responsible officers will be given additional functions relating to monitoring doctors’ conduct and performance. The regulations also set out the connections between doctors and the designated organisation that is relevant to them. 

The regulations require responsible officers to be licensed medical practitioners with at least five years’ experience. However, that is a minimum. In practice, organisations will want to appoint responsible officers who are senior doctors with expertise in the management of doctors. In the NHS and among independent providers, those are likely to be medical directors. The regulations set out responsible officers’ responsibilities. Those that relate to the evaluation of fitness to practise include ensuring that the designated body carries out regular appraisals, and establishing and implementing procedures to investigate and resolve concerns and, where appropriate, to refer the doctor to the General Medical Council. 

Except in the smallest organisations, we would not expect responsible officers to undertake all the tasks personally, but they will be responsible for ensuring that they are carried out appropriately. That will involve ensuring that they have sufficient staff who are appropriately trained for their role, which may be in undertaking appraisals and/or investigating concerns. Under their duties to evaluate fitness to practise, responsible officers will make recommendations on individual doctors to the GMC. When it is introduced, the recommendation will be the basis for revalidation, which will normally take place every five years. 

As hon. Members will be aware, my right hon. Friend the Secretary of State for Health said in his letter of 1 June to the GMC that the piloting period for revalidation

Column number: 4 
would be extended for a further year. That will allow time for a better understanding of the costs, benefits and practicalities of implementation and will facilitate full engagement with the profession, the service and the public. The extended period of piloting will ensure that we get this right, but one thing remains clear: recommendations on an individual’s revalidation can be based only on substantiated information. That information will come from doctors themselves and will be supplemented by information from an organisation’s clinical governance systems. 

The Merits of Statutory Instruments Committee has drawn the House’s attention to concerns raised by the British Medical Association and the Royal College of Surgeons. One of those concerns is that the need for whole practice appraisal has not been set out in the regulations, but I disagree: regulation 11(3) states that responsible officers 

“must ensure that appraisals…take account of all available information” 

in relation to the work carried out for the designated body and any other body. That is the basis of whole practice appraisal. Nevertheless, I assure hon. Members that we will consider how the guidance can be strengthened to make it clearer that appraisals must address the whole of a doctor’s professional practice. 

Derek Twigg (Halton) (Lab):  I would like clarity on this point. The Minister suggests that there will be further strengthening, but she has decided to introduce the regulations at this time. Does that mean that further legislation will be introduced? 

Anne Milton:  I thank the hon. Gentleman for his intervention. We will consider how the guidance can be strengthened to make it clearer that appraisals must address the whole of a doctor’s professional practice. Guidance is crucial to ensure that implementation goes well. 

Responsible officers might find that from time to time they have a conflict of interest with an individual doctor or with the organisation. The regulations make provision for cases in which there is a conflict of interest or the appearance of bias between a doctor and a responsible officer. I stress “appearance”, because it is not only what one does but what one is seen to do that matters. In such circumstances, the regulations place a duty on designated organisations to nominate or appoint a second responsible officer. 

Mr Tom Watson (West Bromwich East) (Lab):  To tease out this point, there is a definition that I would like the Minister to give me confidence about. There is a difference between competence and efficiency. The regulations are about looking at the medical competence of the doctor involved, who might not, however, be an efficient employee. Can the Minister elaborate a little on how the management responsibilities of responsible officers might conflict with their requirement to assess the medical competence of the doctor, because it may be a senior manager in a hospital who is assessing the competence of such individuals? 

Anne Milton:  I thank the hon. Gentleman for his intervention. I think I know where he is coming from. These are professional people, and the responsible officers

Column number: 5 
are doctors. They are looking at the clinical competence of doctors to perform their duties; whether they fulfil management tasks is outside that scope. Also, do not forget—I will come on to this—that the responsible officer makes recommendations to the GMC and is not a decider. He also raised the issue of conflict of interest, and I shall be happy to come back on that, because a number of organisations have had concerns. 

Provision is not made for where there might be a conflict of interest between responsible officers’ duties under the regulations and their responsibilities to the designated organisations; that, I think, is what the hon. Gentleman was referring to. The point was also made by the BMA and the Royal College of Surgeons. Concerns have been expressed that we have made no provision for managing such conflicts of interest. Such provision has not been made, not because we do not think such conflicts of interest will not happen, but because they already do for senior clinical managers and medical directors. When they do, experience tells us that they are properly managed, without the need for legislation, and that should continue to be the case. 

As I said in response to the intervention of the hon. Member for West Bromwich East, we should remember that responsible officers do not have the power to decide that a doctor is not fit to practise; that is an important point. They can only make a recommendation. That recommendation must be based on evidence, and it would be clear immediately if that was not the case. If responsible officers make recommendations that are not based on the evidence, they might be failing in their own duties, under “Good Medical Practice”, to 

“Be honest and open and act with integrity”, 

and bring their own fitness to practise into question. 

Concerns were also expressed about the lack of a process of appeal against the recommendations of a responsible officer in the regulations. That is because, as I have stressed before and stress again, they are only recommendations to the GMC. The GMC would then have to go through its own processes, which provide the doctor with an opportunity to defend themselves against any allegations and include an appeals mechanism, before a doctor was considered unfit to practise. 

Dr John Pugh (Southport) (LD):  If a responsible officer made a frivolous or ill-intentioned referral to the GMC, the Minister has just said that his fitness to practise would be brought into question—he could be subject to referral himself. Would that not be a matter of criticism of his clinical governance, rather than his fitness to practise? In such cases, would he not be referred for failure of clinical governance rather than for failure on the grounds of fitness to practise? They are differentiated in the regulations. 

Anne Milton:  I thank the hon. Gentleman for his intervention. It is important to understand that if a responsible officer was acting right outside his role and remit, making vexatious—for want of a better word—recommendations to the GMC, a number of issues might be called into question. One would be the officer’s ability to hold the post of responsible officer. Secondly, that behaviour might draw attention to other roles that the officer was not fulfilling properly and therefore to their fitness to practise. 

Column number: 6 

The system that we are establishing through these regulations should enable responsible officers to identify at an early stage where a doctor is falling below the high standards that they have set for themselves. The responsible officers would then act to help the doctor to get back on track before a negative recommendation needs to be made. That is an important part of this process; dealing with something before it becomes a problem is really important for continuing professional development and, of course, for ongoing training needs. However, there will of course be some cases where that approach is not possible. 

Mr Watson:  Let me just say to the Minister, before I put my question, that I have a constituent’s interests in mind with regard to this particular regulation; that is where I am coming from. The Minister talked about the early assessment of a doctor’s competence. However, my reading of these regulations is that a review of a doctor’s performance will take place every five years. Therefore, if a doctor were to go downhill quite quickly, there would not be a review for perhaps another four and a half years. Can she give me some clarity about what will happen when a doctor moves to another place of employment, as will happen in many circumstances? Doctors will not stay in employment in the same institution for five years. Will their previous performance records follow them to a new employer? 

Anne Milton:  I thank the hon. Gentleman for his intervention and for pointing out that this issue is of particular concern to his constituent. I should say now that if we do not deal with everything that is of concern, I am happy to deal with outstanding matters in another forum. 

It is important to realise that this is a dynamic process. The recommendations will be made every five years to the GMC. However, it is an ongoing process and to some extent there are already ongoing review and governance processes in place, with many medical directors already overseeing those processes. If we just step back a little from this and asked the general public whether doctors’ practice, professionalism and standards should be checked, they would assume that they were already being checked. It is quite extraordinary that, after doctors qualify, there is not necessarily any formal, statutory and ongoing governance process, although there are of course internal processes with regard to the employer, because doctors are employees. It is slightly odd in some ways that this system has not been put in place before now. 

In cases such as those that I have mentioned, appropriate action should be taken at the point at which concerns are identified—I think that is what the hon. Member for West Bromwich East was talking about earlier—and the issue should not be left until the recommendation on revalidation needs to be made. 

There is a further issue that was not clarified earlier, which is the position on indemnity for responsible officers. That issue may cause concern to some people who are likely to take up the post of a responsible officer. That indemnity should be provided by the organisation. Indemnity payments are already calculated on the basis of a shared risk, but at this stage we understand from the medical defence organisations that there is no suggestion that contributions from medical directors who take on a

Column number: 7 
responsible officer role would need to rise. However, those organisations will keep the situation under review. I assure hon. Members that if we find that contributions rise as a result of these regulations, we will review the regulations. 

It has been suggested that 1 January 2011 is too soon for us to require organisations to appoint responsible officers by then. It is argued that, because there will be major changes in NHS architecture in 2013 and revalidation will not be introduced for some time, we should postpone the start date. However, I believe that in many ways now is exactly the right time to introduce the role of the responsible officer. The majority of designated organisations, including NHS hospitals, will not be directly affected by the removal of primary care trusts and strategic health authorities. Designated organisations need to start putting systems in place that support doctors and that supply the information that demonstrates the quality of care that doctors provide, in time for the start of revalidation in 2012. 

In addition, change can often lead to a degree of uncertainty, and that is exactly when medical leadership and stability are needed. I hope that responsible officers will see part of their role as providing that type of leadership, in particular clinical leadership. Their statutory duties will help to ensure that doctors are appraised and that the systems are in place to enable the relevant information to move to new organisations, where necessary. That is another point that the hon. Member for West Bromwich East raised. 

Where there are concerns, the duties of responsible officers will ensure that the appropriate action is taken and continues to be taken, so that patients are protected, because, although I have not said this yet, fundamentally we are talking about the protection of patients. 

In due course, the regulations will need to reflect changes to the NHS architecture, and we are currently exploring options for that. I can reassure hon. Members that we will consult on options for responsible officers within primary care as we move to a system of commissioning consortia, and on the issue of identifying a responsible officer’s own responsible officer, who currently sits within the strategic health authority. Hon. Members may have questions on the regulations, and I am happy to take any such questions now, Ms Clark. 

2.45 pm 

Derek Twigg:  It is a pleasure to serve under your chairmanship, Ms Clark. I welcome the Minister and I thank her for her kind comments. 

The Minister will know that significant concern has been expressed by professional bodies and organisations about the timing, context and content of the regulations. The seventh report of the House of Lords Merits Committee has described the matter as a serious concern: 

“These Regulations are drawn to the special attention of the House on the grounds that they may imperfectly achieve the policy objective.” 

It is important to explore some of the areas of concern. Although the Minister has satisfied me on a few of them, there are many questions still outstanding. Areas of concern include conflict of interest, whole practice appraisal, indemnity for responsible officers and the local appeals system. 

Column number: 8 

Those areas reflect widespread concern from the key stakeholders—the British Medical Association, the Royal College of Surgeons, the Medical Protection Society and others. The BMA has described the laying of the regulations as “premature”, and the RCS has expressed disappointment that many of its recommendations and queries were not addressed in the regulations. 

There is widespread concern among health professionals about the potential for conflicts of interest to arise from the installation of responsible officers with simultaneous corporate board responsibilities, for instance as medical directors. It would be useful if the Minister could say more on that in winding up. The RCS believes that such officers might be torn between trust obligations and the professional role of the responsible officer. Potential problematic scenarios include pressure being exerted on responsible officers by boards to recommend validation where there is concern about the quality of practice of a surgeon, who is none the less competent in meeting targets and who works fast; or to withhold validation from a surgeon who uses expensive methods of treatment that do not easily fit in with the trust management. 

According to the BMA, 

“Whilst the regulations go some way to addressing the issue of conflicts of interest or an ‘appearance of bias’, we do not believe that they are sufficient in all cases to address doctors’ perceptions of potential conflicts between an RO’s professional responsibilities and the demands of the employing organisation in the legislation.” 

An example given to me is that 

“a consultant may well want to continue to undertake complex cardiothoracic surgery in risky patients, but because this would distort the organisations targets, the trust may choose to question his/her professional competency through revalidation.” 

May I ask the Minister whether the Secretary of State has looked into the viability of separating the trust governance and responsible officers’ portfolios, and of ensuring that the responsible officer does not hold the legal responsibilities that the other directors on trust boards have? She touched on that, but did not clarify the matter. Has the Secretary of State consulted the GMC on the additional remit with which it will be charged of mitigating such conflicts of interest in smaller organisations, where such a separation of roles is not feasible? 

That area relates directly to wider concerns about the integrity of the revalidation and the registration process for doctors and other practitioners. The registration of doctors, rather than employers, with the GMC is at the heart of the accountability and compliance processes of the medical profession, as is the accountability of responsible officers to individual doctors, to the GMC and, by extension, to patients and the wider public. 

A danger inherent in the way the proposals are set out is that the revalidation recommendations might become tools of managers and of trust management agendas rather than matters relating to compliance with GMC and Royal College standards. After all, the responsible officer’s responsibility is to examine doctors’ clinical ability and professional conduct, not doctors’ contribution to the meeting of trust targets. This matter is clearly at the forefront of concerns about patient safety and standards. As such, it is too important to be omitted from the regulations. 

Secondly, I am concerned that the regulations provide inadequate protection for the public because of the failure to incorporate whole practice appraisal in the

Column number: 9 
provisions. Again, that has dismayed organisations such as the Royal College of Surgeons. The Minister touched on that matter but needs to give more reassurance. It is self-evident that the revalidation of doctors can only be wholly accurate and reflect the whole of their work if their other portfolios, outside working for their principal employer, are incorporated in the process, where relevant. Merely recommending the collation of information and omitting a statutory obligation to do it falls short of the rigorous, holistic assessment to which doctors are entitled. Therefore, there cannot be the comprehensive protection to which patients are entitled. 

The point made by my hon. Friend the Member for West Bromwich East about the assessment is important. If a doctor does not remain competent, and is not competent at year 3 or 4, what mechanism will pick that up under the new procedure? When I was involved in education, there was a similar argument about changing Ofsted reports so that they did not happen every five years. I hope that the Minister will address this important point. I think she said that she would write to my hon. Friend. 

Thirdly, there is the issue of indemnity for responsible officers. Again, the provisions are inadequate, because the guidance refers merely to a GMC recommendation to indemnify. There is concern among stakeholders that appointing good responsible officers will be difficult due to a lack of volunteers for the role, which carries great personal responsibility. Why are designated organisations not responsible for providing indemnity for responsible officers? 

Fourthly, there is the significant omission of local appeals systems, which has been discussed. The GMC has concerns about this matter. The GMC fitness to practise processes should not be both the first and last resort for appeal. There should be a viable appeals structure that flows up to fitness to practise. I have heard what the Minister has said, but I am not convinced about how the process will work. Is her mind still open to reconsidering that process? There are strong views about the establishment of a local, external appeals system that is proportionate and that does not involve excessive bureaucracy. That will be an issue for any appeals process, and perhaps that is on the Minister’s mind. I ask her to consider a transparent and robust locally-based appeals mechanism. 

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 is quite aside from organisations getting around to supporting any appeals system that may arise. That lack of preparation is symptomatic of the approach of this Government and this Secretary of State, not only to the regulations and the accompanying guidance, but to their entire health reform agenda. 

Yesterday, the hon. Member for Crawley (Henry Smith) asked about the changes that will result from reorganisation, and in particular about the impact that ending primary care trusts will have on revalidation. The Secretary of State responded: 

“Before the dissolution of primary care trusts, we will consult on options for responsible officers in primary care.”—[Official Report, 2 November 2010; Vol. 517, c. 757.] 

Column number: 10 

Does that mean that there will be further secondary legislation? 

The proposals to abolish primary care trusts and strategic health authorities would have significant implications for primary care governance, and for the connection between responsible officers and their own responsible officer, even if the revalidation regime proposals were not contained in the White Paper. I find it hard to disagree with the BMA’s assertion that 

“there is a perception that further detail on the component parts of the process should have been developed before the statutory instruments were introduced, particularly in light of the implications of the recent White Paper.” 

Regulations 14 and 19 refer to resources. The Department of Health has not prescribed the level of resource to be put at the disposal of responsible officers and has rejected the recommendation of the Royal College of Surgeons that funding should be specified. That leaves the door open to the perverse situation that a responsible officer may be obliged to report his or her organisation to the Care Quality Commission for failing adequately to fund or discharge his or her duties. Could the Minister confirm the resources and tell us whether they will come from unallocated money? What assessment has been made to arrive at the figure? 

There is also the problem of training, which is a significant issue, because some 975 reporting officers are expected to be in place by January. While I am on the subject, could the Minister confirm whether that figure is still the Government’s estimate, following the health service reforms and reorganisation detailed in the White Paper? The BMA has stated that it has 

“grave doubts about how so many ROs will be identified and trained during the coming months. It also remains unclear where the RO role will sit for GPs in England when GP consortia assume full responsibilities from PCTs in 2013.” 

What sort of perverse logic would have it that responsible officers will be charged with strengthening governance systems in organisations that are set to be abolished, only for their future roles to be unclear two years later under the GP consortia regime? That is hardly conducive to staff morale and motivation. That short-sighted vandalism of national health service provision is breathtaking in its recklessness. I believe that will have an impact on what we are trying to achieve; we are talking about a very blunt instrument being deployed by the Secretary of State. 

I have two further questions for the Minister on the regulations. Regulation 8 on page 3 covers conflict of interest. Will she explain how that will be policed, particularly following the changes detailed in the NHS White Paper? Regulation 9 on page 4 concerns cases where 

“the designated body has failed to nominate or appoint a responsible officer in accordance with regulation 5 or 6”. 

The regulation also says that the Secretary of State will be given powers to “nominate a responsible officer”. Does that mean that the Secretary of State will be able to impose somebody from a completely different area on a body that may be having difficulty making an appointment? 

I have a couple of further points on regulation 16 on page 8, which describes ensuring that appropriate references are obtained and checked. The Minister is aware, as we all are, of problems with overseas doctors being employed in this country. How will the regulation ensure that the

Column number: 11 
references of overseas doctors are properly policed? Regulation 16(4)(f) states that responsible officers must ensure that 

“procedures under this paragraph include provision for the medical practitioner’s comments to be sought and taken into account where appropriate”. 

Will that be a right for the medical practitioner, or will it be a matter for somebody else to decide? 

Regulation 17(4)(g)(ii) states that, where appropriate, the responsible officer must take all reasonably practicable steps to 

“recommend to the medical practitioner’s employer that the practitioner should be suspended or have conditions or restrictions placed on their practice”. 

Will such a recommendation be enforceable? 

Finally, regulation 19, which covers the provision of resources, states: 

“Each designated body must provide its responsible officer with sufficient funds and other resources necessary to enable the officer to discharge their responsibilities for that body under regulations 16 and 17.” 

How will that be policed? 

2.59 pm 

Dr Pugh:  Looking at the regulations, I think that we would all agree, no matter where we stand politically, that it is a valuable and important goal for every health organisation in the country to have a responsible officer who can certify that everybody within the organisation is fit to practise and competent at their job. Therefore, I hope that everyone will support movement in the direction of the regulations. 

I have a few concerns, which reflect some of those voiced by the hon. Member for Halton. I have thought about the circumstances in which things go wrong. Although in stable organisations it is perfectly possible to have a deeply embedded pattern of appraisal that is fair, above board and so on, there are certain organisations involved in health—one thinks of out-of-hours services—that are more dependent on casual labour. I am thinking in particular of the case of Dr Ubani, who arrived with some kind of documentary evidence and had been assessed by another PCT, although not the one that employed him when things went seriously wrong. That is why I pricked up my ears when I heard the question about whether assessments of professional medical officers of one kind or another are transferable or need to be begun again. For a resident medical officer in an organisation that is struggling to get staff and dependent upon doctors volunteering occasionally to work ad hoc, it strikes me that the degree of appraisal that they would be able to introduce, assess and be answerable for is fairly limited. I think that it would be helpful to look at the Dr Ubani case and ask ourselves what would have been different had those regulations been in place. 

The second issue, which has been dealt with in part, relates to what happens when an assessment, whether of clinical governance or fitness to practise, is ill-motivated. I am aware of a case, the details of which I will not mention, in which a whistleblower who declared certain things in his organisation to be unsatisfactory was subsequently subject to an appraisal that reduced his status. I know that the Minister will say that such cases, were they to occur, would be referred to the GMC for it

Column number: 12 
to investigate and make inquiries about motivation and so on. However, even being referred is a blot on one’s professional career. 

The defence in the regulation, so far as I can understand it, appears to be that a person who feels that they are being unfairly appraised by a responsible medical officer can ask for someone else to do it. The Minister referred to the fact that, with the changing NHS architecture, that other person will not necessarily be someone from the above tier in the strategic health authority, as some other pattern could be followed. I would like him to explain what would happen. In police forces, complaints that are made against an officer are often investigated by an officer for a different force. What model have we in mind for the NHS? The Secretary of State made some important statements last week on protecting whistleblowers. I am keen to see that whistleblowers, particularly when they have legitimate concerns, are not penalised through an appraisal process—not necessarily at the time, but a few years down the line. I know that such things happen, so I am concerned to see that regulations do something to forfend them. 

My last question is rather technical. It would appear that the regulations by which RMOs will judge people are of two sorts: one relates to fitness to practise, and the other relates to clinical governance. It is not completely clear to me where the dividing line between the two is—I do not know whether it is clear to other Members. The hon. Member for Halton questioned what would happen if one’s fitness to practise trespassed on issues of one’s efficiency and clinical competence. I note that the regulations on clinical governance apply only in England, and not in Scotland. Why is that? It would be helpful to have an answer on that score and some explanation on where the dividing line is, because that line might at times be blurred between professional competence and fitness to practise, which is one thing, and clinical governance, which is a similar sounding thing. 

3.3 pm 

Jim Shannon (Strangford) (DUP):  I have a quick comment to make on the regulations. I am conscious that the decision relates to England, Scotland and Wales, but not to Northern Ireland. That is because the equivalent legislation has already been passed by the Northern Ireland Assembly. What discussions or contact has the Minister and her Department had with the Assembly, its Health Committee and, in particular, the Health Minister to see how that change has moved through the system? It would be good—I am sure that other Members agree—if any hiccups or problems that they encountered could provide some lessons for us when making the legislative change here. 

3.4 pm 

Mr Watson:  Ms Clark, it is a pleasure to serve under your chairmanship. I welcome my hon. Friend the Member for Halton to his new position as shadow Minister. I also congratulate the Minister on her appointment, as I have not yet had an opportunity to do so, and my new Whip, as I believe that this is the first such Committee he has attended in his new role. I defer to him and intend to be brief. 

I mentioned earlier that I had a particular interest in these fiendishly complex regulations, which are difficult to understand, because of a constituent. Honing in on

Column number: 13 
them, my interest is in regulation 16(2), which is in part 3. To give some context, I have a constituent who was the victim of medical negligence. Her doctor was disciplined, sacked and then appointed in another NHS area, and there is some discussion about whether the disciplinary files followed the doctor to the new area. For me, the test as to whether the regulations work is the level of data-sharing that responsible officers can have with each other. The Minister has given me some assurance and although she might not be able to provide all the detail required today, I would gladly take her up on her offer and send her copies of the many letters that I have written to her Department about this matter. 

I think that the regulations mean responsible officers will be involved at the start of the appointment process for all doctors in their designated organisations. One hopes that they will take away such appointments as Dr Ubani, who clearly had problems with language skills at the start. I would like the Minister’s assurance that she is confident that the regulations will remove such difficulties in the system. However, there is no mention of how information can be exchanged between responsible officers. The very detailed briefing note does not appear to give any more detail on regulation 16(2), or on that issue. Can the Minister assure me that the combined regulations—I believe more regulations will be brought before the Committee—ensure that doctors will have adequate information on previous matters when it comes to assessing competence? 

I have one final question. Having looked at the regulations, there seems to be an issue about how the appointment of responsible officers in small practices is managed. The worry in the Shipman case was that other medical professionals had been raising their concerns anecdotally about his behaviour, but there was no formal mechanism to do that within the system. Will the Minister outline how we can make the regulations work in small practices? 

3.7 pm 

Anne Milton:  I thank all hon. Members for raising some important points. I apologise if I deal with them not in order, but as they come to mind. 

Officials do indeed discuss and learn from the experiences of other places, which is important. One of the general criticisms of government is that we do not learn lessons and go on repeating the same old mistakes, which is awfully frustrating for the public. I am always keen that we learn as we go along. In reply to the hon. Member for Halton, I have an open mind, always. I should point out that I served on the Committee that considered the Health and Social Care Bill from which the regulations arise, and a lot of the discussion then was based on Harold Shipman, as the hon. Member for West Bromwich East has mentioned. We have to remember that we can put in place all the regulations and processes possible, but they will not stop everything; it is a matter of getting that balance right. 

I do not recognise the reference made by the hon. Member for Halton to vandalism. We are getting rid of the PCTs and SHAs, and for many people that will be an occasion to cheer. I am not sure that they have fulfilled their roles—particularly, the PCTs—on commissioning services that well, but it is an opportunity to do things better and get them right. 

Column number: 14 

Whistleblowers have been mentioned, and we want to strengthen their position. They provide an important opportunity for us to learn about what is going on in organisations. We have all seen too many disasters—Maidstone and Tunbridge Wells is one, and of course, Mid-Staffordshire is another. Making it a duty to voice concerns and protecting the person who voices them is an important change. 

One of the threads running through many of the points that have been made is that employers already have responsibilities. When they employ somebody as a locum or permanently, the employer has a responsibility to check that individual’s references, which means contacting organisations. 

Mr Watson:  I am grateful to the Minister, but I want to be assured. Will there be an obligation on an institution where someone has been disciplined and lost their job to provide that information to the new part of the NHS? The problem in the case to which I refer was that references were requested, but the information that the individual was sacked did not automatically follow. That strikes me as a failure of the incumbent responsible officers, but I am not sure whether the regulations cover that. 

Anne Milton:  That is a failure on several points. Why did the previous employer not disclose that information and where was the responsible officer? There will also be a process of revalidation. It is envisaged that information will protect patients and will be shared with other organisations under separate regulations. I think that the hon. Gentleman also raised the issue of foreign doctors. 

Derek Twigg:  I raised it. 

Anne Milton:  It was the hon. Gentleman, I apologise. It is important to get the issue right. The GMC and the regulatory bodies are responsible for ensuring that people have the appropriate qualifications. Employers have a duty, however, to satisfy themselves that the person can speak sufficient English in order to do their job. I am not blaming the previous Government, but over the past few years we have, to some extent, lost sight of the fact that employers have responsibilities. There is also such a thing as professional standards, and an important part of the governance is that responsible officers will be responsible for the responsible officers. 

We cannot, however, abdicate our responsibilities. Professions have responsibilities, and professional standards are an extremely important part of delivering safe care. What we have to do as a Government is make sure that we put in place the right levers and regulatory processes and that they are not too burdensome and become yet another tick-box exercise. They have to do exactly what it says on the tin, which is ensure that professional standards are maintained. 

We have been fully involved in relation to devolved Administrations. The Scottish Government took the view that they did not want to make regulatory provision in respect of the clinical governance system. I hope that answers the question asked by the hon. Member for Strangford. The Northern Ireland regulations mirror ours very closely, and it has been confirmed to me that no major issues have been identified, which is important to us as we introduce the regulations. 

Column number: 15 

Most of the functions of responsible officers are already the responsibility of medical directors, so this will not be a huge sea change for many organisations. Medical directors already manage conflicts of interests between their professional responsibilities and their responsibilities to the organisation. Drawing on my own professional experience—I had a long life in the health service before entering politics—the issue of professional responsibility overrides everything else. Doctors swear an oath and it is important to remember that they have clinical responsibilities over and above any management. The regulations will strengthen the opportunity to see where management is oppressing and suppressing clinical opinions, which is one of the reasons why we are introducing the changes and why we got rid of some of the process-driven targets. It is extremely important that clinical decisions should be made by clinicians and that professional standards should be maintained. It does not reflect well on hon. Members’ view of the profession to suggest that it will become commonplace for clinicians to be easily rolled over by the board of a hospital trust to do what it wants them to do. 

Derek Twigg:  I take the view that the vast majority are professional and carry out their duties well, but the fact is that we are here today because that has not happened in some areas. That is why we have these regulations. Professional bodies have raised real concerns about these matters, which cannot be lightly dismissed. We seek a firming up of the regulations to ensure that we do not have the problems that we have had in the past, although no system is perfect. I do not think we can simply say that everyone is being professional; if that were the case we would not be discussing the regulations today. When professional bodies have raised that, we have to take notice. 

Anne Milton:  I thank the hon. Gentleman for his intervention, and I am certainly not dismissing it lightly. He is absolutely right that we are here today because there was a failure. We do not talk about it enough, and we do not remind ourselves and give clinicians the freedom to exercise those professional standards and professional responsibilities. I am sure that hon. Members will have read some of the reports that have been produced following the disasters, and that is what is missing. One wonders where the professions were. The regulations will put in place a regulatory process to ensure that that does not occur, without being oppressive. 

Responsible officers must ensure that appraisals are regularly carried out, and that concerns are acted upon in a timely manner. This is not something that will happen at the end of a revalidation cycle every five years; it is an ongoing and dynamic process. 

On appeals mechanisms relating to the processes that support recommendations, appraisal already exists in the employment and other contexts, and we do not think that further measures need to be taken. It must be stressed that the responsible officer makes a recommendation to the GMC, and the recommendation is not a determination. The GMC already provides for the doctors to be heard and for appeals. 

Column number: 16 

Returning to conflicts, where they exist the regulations provide for that second responsible officer. In cases where things have not gone well, that will be important. We expect that this will be the responsible officer’s own responsible officer in England, which would be the SHA responsible officer. 

We are continually working with the GMC and other organisations fully to understand and realise the impact of revalidation. It is always important for the Government to have the humility to realise that anything they do has unintended consequences. It is important, as the hon. Gentleman has pointed out, that we keep open-minded and realise where changes can be made to improve systems. 

Responsible officers will support doctors to improve clinical governance, which will run clinical governance further up the flagpole. They will be critical to revalidation, but they will be about more than simply validation. 

I hope that I have dealt with many of the concerns that have been raised. The debate has been wide-ranging and important. 

Derek Twigg:  I could, if the hon. Lady wishes, list all my questions that have not been answered. Perhaps she will write to me concerning the areas in which I have not received answers today; clearly she has had a lot to look at. 

We will not oppose the regulations but we have major concerns, not least because of the questions that professional bodies have raised. We think that the Minister has not addressed a number of areas, and perhaps when she writes to me she will address them. 

Anne Milton:  I thank the hon. Gentleman for his intervention, and I am glad that he will support the regulations. 

Mr Watson  rose—  

Anne Milton:  The hon. Gentleman also wants to intervene. Just give me a second to draw breath. I am happy to write to the hon. Member for Halton, because it is important to address the detailed points that he has raised. I hope that I have dealt with everything, and I think I have dealt with most, but perhaps some specifics were not covered. 

Mr Watson:  May I say to the Minister that I have been there, and that I think she has answered the questions as adequately as she can, given that these things are very detailed? However, I do not think she has answered fully the concerns of my constituent, but that is because his concerns are only partially recognised in these regulations. Would she write to tell me what regulations will cover the data-sharing aspect, so that I can persuade my hon. Friend the Whip, the hon. Member for Sedgefield, to allow me to be on that statutory instrument Committee as well? 

Anne Milton:  I thank the hon. Gentleman for acknowledging the complexity of statutory instruments. They are often dealt with rather briefly, but actually they are important. I am always slightly disappointed that they do not get more public exposure. It is often in

Column number: 17 
Committees such as this one that sweeping changes are made, often without sight of the press. I am happy to ensure that he knows exactly which Committee he next needs to sit on. 

Of course, Ministers cannot comment on individual cases, but the case of the hon. Gentleman’s constituent raises more general issues. If he will stick to the generalities of his constituent’s situation, we can deal with them, I hope, to the satisfaction of him and his constituent. 

The regulations will establish a system that will help doctors and their organisations improve the care that they give, and protect patients. As I said in my opening

Column number: 18 
remarks, that is what we are here for. I hope that I have responded to most of the issues, and I thank hon. Members for their contributions to the debate. I commend the regulations to the Committee. 

Question put and agreed to.  


That the Committee has considered the Draft Medical Profession (Responsible Officers) Regulations 2010. 

3.22 pm 

Committee rose.