Health and Social Care Act 2008 (Regulated Activities) Regulations 2010

My Lords, I echo the remarks of the noble Earl in his appreciation of the Minister, who is trying to take us through the regulations. Like him, I have a degree of sympathy for her because of the complexity of the task that she faces. These regulations are by no means straightforward, and the complexity is to be seen not in the number of pages but in the way that they are approached. I start positively by saying that I am very supportive of and sympathetic to the requirements for professional regulation and the regulation of activities of this kind. In fact, I have spent a good deal of time trying to promote and develop further regulation—for example, in psychological therapies—to which I will return. My colleagues and I are not instinctively against the notion of regulation. I am very supportive of the way that health and social care are being brought together in a relatively integrated way, at least in principle, as far as the regulatory approach is concerned. The integration of health and social care has been a fact in my part of the United Kingdom for many decades, and it has been largely positive for those receiving the care and for the various professionals working together to provide it. However, from then on, I become rather concerned about the way in which the regulation and the integration are being brought forward. Although it is appropriate to integrate health and social care, it may not necessarily be appropriate to provide precisely the same approach to the regulation of a large National Health Service acute hospital as to that of a small individual practitioner or group of practitioners in a rural area, for example. As the noble Earl has pointed out, the difficulty with this rather monolithic body, the CQC, is that it tends to try to produce an approach to regulation that will fit the large, almost industrial, bodies that are many of our acute hospitals, and then apply it to much smaller entities, for which it is not appropriate. Paragraphs G48 to G77 on pages 83 to 88 of the impact assessment—no minor document—look at the impact on small providers but there seems to be no appreciation at all that a small provider may often be much better than a larger one. It is all couched in terms of whether the smaller ones can match up to the gold standard of the large NHS provider. From recent events, including situations where the CQC has given a positive report, it is absolutely clear that the fact that it is a large NHS acute hospital which has the CQC check of approval does not necessarily mean high-quality service at all. Sometimes it can be covering something quite different. I am extremely concerned that a perverse incentive is actively at work, which makes it increasingly difficult for the small provider to survive. The only way in which some of them can survive is by coming together into a larger group, which makes it impossible for them to provide the very personal care that is necessary in some circumstances. Indeed, the level of bureaucracy required is quite extraordinary. I take one example. Many of these matters are predicated on a large acute NHS hospital because that is where the pressure comes from. Another area mentioned in the regulations is the provision of care for those with alcohol or drug addictions. We spoke about this last week in your Lordships’ House. Increasingly, the NHS is not able to provide the services required and there are many such people for whom the NHS is not necessarily an appropriate facility. There are alcohol-free and drug-free therapeutic communities where people provide care and treatment in quite a different therapeutic community context. Healthcare workers and providers may not fall under any of the titles in this relatively long list; they may be counsellors or psychotherapists who are not currently registered. The kind of care which they provide can be quite different. For example—I reflect back to when I spent some time working in one of these situations myself—in order for the patients to connect with the real world and take responsibility for themselves, they are required to participate in the preparation of food for themselves and others. Although that is clearly an important and beneficial part of the treatment programme in a therapeutic community, it is made completely impossible by regulations which require them to undergo training in food preparation in order to operate in the kind of facilities appropriate for cooks in a large NHS acute hospital. Those required to undergo various training programmes under supervision are members of professions which are not currently statutorily regulated anyway. I am very sympathetic to ensuring that there are appropriate standards but I fear that we have now come to a counterproductive point in this process of regulation. The process goes something like this: we add on regulations; inevitably there is a problem somewhere; an inquiry brings forward more regulations; and so the amount of bureaucracy increases. When bureaucracy gets beyond a certain point, those involved feel less sense of responsibility and attend more to ticking the boxes and ensuring that the forms are filled out rather than taking responsibility for themselves. The increasing bureaucracy of regulation leads not to increased responsibility but to a reduction in a sense of responsibility, and therefore problems arise. The more bureaucracy there is, the less attention people give to providing care and the more they attend to feeding the machine. I think that we are very much at this point in the NHS. The question of fees and money also comes into this matter. The result of the organs inquiry, for example, was that the Government had to completely abandon their requirement for 10 per cent of all deaths in hospital to be audited by way of a post-mortem because no one would give permission for post-mortems after that. However, an organisation had been put into being in order to approve, monitor and regulate all mortuaries, so now mortuaries are having to pay thousands and thousands of pounds every year to be regulated and inspected with smaller and smaller numbers of post-mortems being carried out in them. The point has now been reached where some pathologists will end up qualifying without having done very many post-mortems at all. Therefore, the whole process of regulation and bureaucracy is adversely affecting the work. Those are the kinds of concerns to which I believe the noble Earl was pointing, and in general terms—and, indeed, in some very specific terms—I share them. One body does not have to mean one approach to regulation; one body could have a number of different approaches if it got into thinking in a different fashion and began to understand that a very different approach was necessary for the small provider in community non-acute services compared with the large provider, such as an NHS hospital providing acute services in surgery, obstetrics and gynaecology or medicine. There would be a question of fees and the problem of fines, and there would be the burden of the increased number of administrative staff that small practices—not necessarily medical practices; others as well—would have to take on in order to service this machine. I think that that presents a real danger. The one reassurance that I found in this process was when looking at the summary sheet of the impact assessment. The noble Baroness’s right honourable friend in another place, the Minister, Mike O’Brien, says almost as his final comment that within three years there will be a review to monitor how proportionate the burden of regulation is to the mitigation of risks outlined in the impact assessment. Whether it is the noble Baroness, her colleague the Minister, another colleague or another party that ends up supervising that monitoring is of course an open question. However, at least there is an assurance that some review will be undertaken at that point. I mention that specifically because I think it will be important for us to review the whole matter after three years.