Medical Profession (Responsible Officers) Regulations 2010

Earl Howe Excerpts

Tuesday 23rd November 2010 Lords Chamber

Moved By

[Earl Howe]

That the draft regulations laid before the House on 26 July be approved.

Relevant documents: 3rd Report from the Joint Committee on Statutory Instruments, 7th Report from the Merits Committee.

[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

Moved by

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[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.

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[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.