Medical Profession (Responsible Officers) Regulations 2010

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.