My Lords, when I spoke in the debate on the Queen’s Speech last week I concentrated on care of the elderly in the community which is one of the most critical issues facing society, as we have heard from some remarkable speeches today. If anyone has any doubt about the scale of the problem they will just have to read Hansard. I will not repeat what I said the other day, save to reiterate my specific plea that we pay attention to the screening of vulnerable elderly people in the community by primary care and social services staff so that we can introduce simple preventive measures to keep people at home. I hope the noble Earl might say something about that.
Tonight I want to concentrate on the proposals in the Bill to establish Health Education England and the Health Research Authority as non-departmental public bodies. These are, of course, extremely welcome proposals but inevitably there are a number of aspects where we need to seek clarification and improvement. The roles of the HEE and the associated local education and training boards—inelegantly abbreviated as LETBs—are spelt out in the Explanatory Notes but I fear that the Bill itself is fairly silent on how it will ensure high quality and standards in education.
For example, much is made of the fact that the LETBs are provider-led and dominated by the needs of NHS trusts for sufficient numbers and range in the workforce to meet those needs. So far so good, but what is missing is a proper recognition that the quality of training, the curricular content and the skills and knowledge of those going through training programmes will be taken care of. Where, for instance, is reference made to the need to include postgraduate deans on the boards of LETBs? It is not in the Bill and given only passing reference in the Explanatory Notes. Where is reference to the need to engage closely with local universities or training colleges—that is, with those whose whole raison d’être is education and all that that entails? Content of training programmes and maintenance of standards is their special expertise and for providers to ignore that aspect will be to their detriment. I am sure they are aware of that but we need mention in the Bill of a need to involve universities, either in the membership of the board, albeit in a minority, or, if not that, then an obligation to seek their advice in formulating their programmes of training.
At the national level, in the HEE, there is some recognition in the notes to the Bill, but not in the Bill itself, of a need to seek advice from the royal colleges—here I have to express my interest as an ex-president of a royal college—the GMC, the GDC and the NMC in developing its policy. It seems to me that all those bodies have considerable expertise in education and training. Indeed, the main functions of the medical royal colleges, for example, are in the development of all the curricula for medical trainees and in setting their exams and assessments to make sure that they have reached an acceptable level of skills, aptitudes and knowledge. Every cardiologist, orthopaedic surgeon and psychiatrist has to go through a training programme devised and run by a royal college. The regulatory bodies have responsibilities for the oversight of training and education to ensure that it is fit for purpose. Yet despite all this remarkable body of expertise, no mention
is to be found in the Bill that the HEE will draw on any of this for advice and assistance.
Then there is a further issue of the need to take account of the importance of clinical researchers in programmes of training and education. We have heard much helpful comment from Ministers about the need to embed research in the NHS and to make every health professional a researcher and every patient a willing participant. The noble Earl was extremely helpful in getting research high up the agenda for the NHS in the Health and Social Care Bill. It is, of course, through research that we may in due course find some answers to the major diseases from which we suffer such as dementia, diabetes and Parkinson’s, so it is vital that research really is in the middle of the NHS.
While the new Bill is very helpful in stating that the HEE must promote research into matters relating to its activities, which is rather subtle, it hardly takes account of the need for LETBs to take account of this in their training programmes. Those embarking on a clinical academic career have to be able to take time out from their purely clinical training to train in research, perhaps for up to three years if they are going to do a PhD. All other trainees, at least in medicine, need to be able to carry out some research so they have experience of what research is about. They are then in a better place to take advantage of the results of research and not resist the rapid introduction of innovations when they go on into practice. I fear that the dominance of provider-led interests in LETBs will lead them to paying little attention to this aspect of training unless they have access to advice from their local universities and the research community. I fear very much that the shadow body of the HEE has shown little sign so far that it is aware of this particular point.
I come now to the Health Research Authority. I believe we are extremely fortunate in having Professor Jonathan Montgomery as its first chairman. He is clearly switched on to the need to be able to protect the public and the patient interest, while at the same time encouraging high-quality clinical research and not putting unnecessarily burdensome regulation in the way. It might be thought that these twin responsibilities—the need to protect patients and ensure their safety and confidentiality on the one hand while promoting and encouraging research on the other—are opposed to each other but they are closely aligned. Patients want not only to be safe but they are very keen for research to be done on their diseases. Furthermore, surveys of patients’ attitudes show that more than 90% of patients want to be involved in research themselves in clinical trials. They are desperate for innovations in treatments arising from research to be applied to them. Of course they want to be safe and protected but they also want high-quality research, so the two go hand in hand. It is pleasing to know that Professor Montgomery is well aware of this and the need for proportionality in regulation.
I welcome the clear statements in the Bill on this and in particular in Clause 98(3) where it is proposed that the HRA must promote standardisation of the regulation of research across England and ensure that such regulation is proportionate. It is clear, too, that for the HRA to gain credibility with the public and
patients it cannot simply pontificate about safety from on high. It must actively communicate with the public and have processes in place for it to be able to listen to the views of the wider public. It needs access to the public view and should put in place mechanisms to achieve that.
I come now to another aspect of transparency. In addition to its own transparency, the HRA should also be encouraging transparency of researchers engaged in clinical trials in academe and industry and their results should be published as expeditiously as is reasonably possible. Results should become freely available, after careful checking for reliability, whether they are positive or negative. It is helpful to know that GSK is leading the way in industry by publishing its data more openly and others are beginning to follow. We do not want the HRA to be given too rigid a formula. That would be counterproductive, but we do want to be able to encourage and support the HRA in its efforts to use measured persuasion.
Finally, it is good to see in the Bill the confirmation that the HRA will continue its good work in co-ordinating the work of the ethics committees and in taking on the roles provided until now by the Secretary of State and what was PIAG in ensuring the safe use of patients’ data. It is gratifying to know, too, that the HRA is moving towards a single application process for entry into the jungle of research regulation. There remains at least one major barrier to research and that is the local R&D approvals that have to be given by each trust where clinical trials are being done. This is where we need a rational, proportionate and national system and if the HRA can incorporate trust R&D approval into that national scheme, the research community would heave an enormous sigh of relief.
I hope I have not given the impression that I am unhappy with this part of the Bill. I think the proposals to set up HEE and the HRA are extremely valuable but of course there is always room for some improvement.
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