Medical Profession (Responsible Officers) Regulations 2010

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 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. The noble Baroness, Lady Finlay, suggested that responsible officers should have a minimum of 15 years’ practice after qualification before being appointed to the role. The functions of the responsible officer will require the post to be a senior medical role within the designated organisation, and each such organisation will need to determine for itself, taking account of the regulations and guidance, whether a candidate is capable of carrying out the role. That is the first issue. The requirement for the responsible officer to have been a qualified doctor for five years, as the regulations specify, is a minimum requirement. The noble Baroness also referred to a number of doctors who serve in roles that do not appear to be covered by the regulations, which connect the vast majority of doctors, including all those in healthcare delivery, to a designated body. Because of the variety of settings in which licensed doctors work, it is not practicable or cost-effective to prescribe a link for every doctor who may wish to hold a licence to practise. Licensed doctors are employed in sectors as diverse as human resources, consultancy, journalism and the law. Broadly, the regulations designate organisations that deliver healthcare and those with a role in setting policy and standards for the delivery of healthcare. In its response to its consultation on revalidation, the GMC found that more detail was needed about how doctors in non-mainstream roles will revalidate. On that particular issue, we will, of course, work with the GMC to ensure that all licensed doctors can revalidate on an equitable basis. The noble Baroness referred in particular to academic doctors who are employed by universities but who hold an honorary contract with a national health organisation. In fact, the regulations cover academics who are doctors on honorary contracts. Their contract will be an employment contract, and the regulations provide for a connection between designated organisations and employed doctors under Regulation 10(1)(c). With those reassurances, I believe that I have covered all the questions raised by noble Lords. I therefore commend the draft regulations to the House.