Health and Social Care Bill

Baroness Thornton Excerpts

Monday 19th December 2011 Lords Chamber

Moved by

[Baroness Thornton]

338ZA: After Clause 205, insert the following new Clause—
“Power to regulate clinical physiologists in England
(1) Section 60 of the Health Act 1999 (regulation of health care professions) is amended as follows.
(2) In subsection (1) after paragraph (b) insert—
“(ba) regulating the clinical physiology profession in England,”.(3) In that section, after paragraph (bb) insert—
“(bc) regulating clinical physiologists in England who appear to require regulation in pursuance of this section,”.”

[Baroness Thornton]

My Lords, I shall speak also to Amendments 338ZB, 338F and 339ZB. We return to a regulatory issue. Amendments 338ZA and 339ZB are new clauses relating to the power to regulate clinical physiologists in England. Amendment 338ZB is a new clause requiring clinical physiologists to be registered by the Health Professions Council. Amendment 338F says that the Health Professions Council, in exercising its functions, shall co-operate with the regulation of clinical physiology in England and with the provision, supervision or management of services of people engaging in clinical physiology in England. The noble Baroness, Lady Finlay, has an amendment in this group and we support what she is proposing.

I am sure that other noble Lords have received the helpful briefing note from the Registration Council for Clinical Physiologists, which highlights that the Government’s current approach—a preference for voluntary registration, as the Minister outlined in the previous debate—has been applied to clinical physiologists, despite a recommendation from the Health Professions Council in 2004 for statutory regulation. The RCCP has a substantial amount of evidence suggesting that, in the case of clinical physiologists, voluntary self-regulation is not as effective as statutory regulation.

In the Command Paper Enabling Excellence: Autonomy and Accountability for Health and Social Care Staff, the Government stated that statutory regulation would be considered for those professions where a compelling patient safety case could be made and be supported by an evidence-based cost-benefit risk analysis. Ten months later, though, no such risk assessment has been undertaken, and the RCCP continues to believe that clinical physiologists should be statutorily regulated.

The disciplines that are covered by clinical physiology are audiology, cardiology, gastrointestinal physiology, neurophysiology and respiratory physiology. Clinical physiologists work directly with patients, performing sensitive procedures such as assessments of pacemakers, testing lung function and assessing and diagnosing hearing loss. Many of the procedures performed by clinical physiologists in the UK are performed by statutorily regulated professionals in much of western Europe and by clinicians in the United States.

A body that I have mentioned, the Registration Council for Clinical Physiologists, maintains a voluntary register of clinical physiologists in the UK and Northern Ireland. It has more than 5,000 registrants across a number of different disciplines in clinical physiology. These professionals play an integral part in the process of diagnosis and treatment, undertaking procedures such as ECGs, which pose significant risks to patients. That, really, is the point here.

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[Baroness Northover]

My Lords, these amendments seek to extend compulsory statutory regulation to physicians’ assistants in anaesthesia and clinical physiologists and to make changes to legislation to further provide for the compulsory statutory regulation of clinical physiologists.

I make it clear at the start that healthcare scientists such as clinical physiologists play an important and highly valued role as part of clinical teams, and this is also true of physicians’ assistants. It is a testament to their professionalism that the Department of Health is not aware of any general concerns about the standards of practice of either group. Furthermore, we need to be absolutely clear that the purpose of regulation is to protect the public, not to support the development of a profession.

Given the wider systems of assurance in place such as the Care Quality Commission’s registration requirements, and the vetting and barring scheme, the Government do not consider that the case for compulsory statutory regulation of these groups of healthcare scientists not already subject to regulation, and physicians’ assistants, has been made. However, we agree that there need to be processes to ensure high standards of care, and assured voluntary registration overseen by the Professional Standards Authority for Health and Social Care has the potential to provide this. It will ensure that there are robust standards of conduct and training. It will be open to employers and commissioners to insist on only recruiting staff on voluntary registers. Those doing so would secure many of the benefits of compulsory regulation. Both healthcare scientists and physicians’ assistants already have established voluntary registers and would be well placed to seek accreditation from the authority.

The noble Baroness, Lady Thornton, asked why we were not taking forward the regulation of clinical physiologists as recommended by the Health Professions Council. The recommendations of the Health Professions Council were not based on an assessment of the risk presented by a profession, but rather on whether that profession had already developed processes of assurance which prepared them for professional regulation. There is therefore no evidence that compulsory statutory regulation is necessary to mitigate the risks posed by the professions recommended for such regulation by the Health Professions Council. This is probably why the previous Government did not decide to regulate, although this is an issue that has been flagged up for a number of years. The professions recommended by the Health Professions Council for compulsory statutory regulation will be well placed to join the system of assured voluntary registration that we are proposing.

The noble Baroness, Lady Thornton, asked about research in terms of regulating clinical physiologists. We are not planning on commissioning research into the case for regulating them, but we will review the case for introducing compulsory statutory regulation for clinical physiologists and, obviously, others in the light of experience of assured voluntary registration, and the evidence about risks available.

[Baroness Thornton]

Perhaps the Minister could tell us what sort of timescale she envisages for this, or whether it will have to wait until an accident happens like the noble Baroness, Lady Finlay, recorded and then the Government will deal with it.

[Baroness Northover]

The noble Baroness will be fully aware, because she was a health Minister, that if there is no evidence of there being a risk then you do not choose to regulate. That is presumably why the previous Government chose not to.

The noble Baroness, Lady Finlay, flagged up the position of anaesthetists’ assistants. I had interesting discussions yesterday with an anaesthetist and an anaesthetist’s assistant, and it was very enlightening. As the noble Baroness will know, the anaesthetist is of course ultimately responsible. Assistants must always be supervised by a consultant who needs to be available within two minutes. The issue that the noble Baroness raises is one of quality assurance. As she knows, the Royal College of Anaesthetists runs the training and the registration for those assistants. After they have done a science degree, generally it is 27 months of practice. If the Royal College of Anaesthetists judges that that is inadequate, on the basis of the kind of concerns that the noble Baroness raises, then it is clearly for it to say that there are risks, it has encountered risks, and that needs to be addressed. If this system comes under the quality assurance system that I mentioned earlier, there will be another body looking at whether that kind of training, assurance and registration is adequate. However, there have not been cases flagged up as causing concern. I also point out that there are few anaesthetists’ assistants. They are more generally used in other countries, I gather, but not so much in the United Kingdom. The noble Lord, Lord Alderdice, asked why there is not more statutory regulation. In some ways I think I have addressed that. Although compulsory statutory regulation is sometimes necessary, one has to look at the risks and at what is proportionate.

[Baroness Thornton]

The health Minister Anne Milton said that those professions in which a patient safety case can be made, including that of clinical physiologists, will be considered for statutory regulation subject to a cost-benefit risk analysis. Will the Government carry out that analysis and, if so, when and in what time? I do not particularly want an answer about what my Government may or may not have done or may or may not have decided. The noble Baroness’s own Minister has pronounced on this matter since the general election so it seems to me that she needs to answer the question: when will they do the risk analysis?

[Baroness Northover]

I have already mentioned to the noble Baroness—she is probably totally familiar with this—that the Department of Health does not have evidence of there being a risk in this regard. Clearly, as I mentioned on the earlier group, these issues will always be kept under review. If the concerns that she has flagged up and if the association, which is particularly encouraging the regulation of clinical physiologists—that is fine; it is all part of professionalisation—flags up particular concerns that emerge from other evidence, then of course the department will take that very seriously. However, things need to be proportionate.

[Baroness Northover]

I am very happy to take away what the noble Baroness has said and to discuss the situation further with her.

We expect the assured voluntary registration to be up and running by 2012. Therefore, afterwards that would need to be assessed to see whether anything further is required, as noble Lords have figured might be the case. We are hoping to see how it all works.

The noble Lord, Lord Walton, flagged up various groups which were regulated and he could not quite see why others were not. Given that I used to bump into the noble Lord, Lord Walton, in the Wellcome Library for the History and Understanding of Medicine, I think he will fully understand that the way in which regulation has grown up has not necessarily been logical or consistent. Therefore, I flag up the 2005 Hampton review on regulation which says that it should be proportionate to the risks that it seeks to mitigate and various other provisions. That is what we are seeking to do. Of course, we shall keep under review what we are doing to see whether it is adequate. In the mean time, I hope that the noble Baroness will be willing to withdraw the amendment.

[Baroness Thornton]

My Lords, I thank the Minister, but this is not yet a satisfactory situation. We might be moving towards one but we are not there by any means. If I were on the register of clinical physiologists I would find it slightly offensive for the Minister to suggest that I was asking for statutory regulation as a kind of professional development of the organisation. Physiologists are very clear in all of their briefings that they think that this is important for patient safety. That is why they want statutory regulation and that is why we need to listen to them very carefully.

[Baroness Northover]

I am extremely happy to acknowledge that.

[Baroness Thornton]

I thank the noble Baroness for that. The noble Baroness, Lady Finlay, made a graphic and powerful case. I thank my noble friend Lord Rea, the noble Baroness, Lady Masham, and the noble Lord, Lord Walton, for their support for the amendment. My noble friend Lady Pitkeathley and the Minister are coming at it from a different point of view. It is entirely possible that an arbitrary decision was taken, quite possibly by my Government, that there was enough statutory regulation. It is possible that this Government need to think that that was an arbitrary decision in the history of regulation and that exceptions need to be made.

There are questions about the limits of assured voluntary registration. Do clinical physiologists carry out invasive procedures that could harm patients? Yes, they do. Are clinical physiologists incentivised to join the voluntary register? No, they are not. A small number of NHS and private employers notionally require applicants to be on their register but there is no mandatory requirement for this. Are professionals incentivised to maintain the voluntary register? No, their activities are carried out on a voluntary basis by the chair and other officers. Does the voluntary register empower patients to make formal complaints? No. While the Health Professions Council operates a system whereby anyone can make a complaint about the fitness to practise of a professional on its register, in most instances members of the public are not aware of the existence of voluntary registers. Finally, does the voluntary register have any powers of enforcement? No, it does not. The RCCP operates a disciplinary code and procedure but it cannot protect patients from continuing to be treated by practitioners who have not been registered and who are potentially unfit to practise. I beg leave to withdraw the amendment.

Amendment 338ZA withdrawn.