Medical Innovation Bill [HL]

Debate between Baroness Finlay of Llandaff and Lord Kakkar

Friday 24th October 2014 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I have added my name to Amendment 15 and I hope that the Minister will give it due consideration. It is really important that the process laid out in the Bill is recorded in the patient’s clinical record. That is the one way that you can verify that things have been done properly. It is also important that there is notification to the central register, as referred to by the noble Lord, Lord Saatchi.

I also hope that the Minister will be able to give due consideration to the situations already mentioned by the noble Lord, Lord Winston, and others. It is very important that we do not make it more complicated than it is already for clinicians to be able to treat patients as they feel appropriate. It is also important that patients have the appropriate safeguards in place. While quite a lot will go into guidance, there is merit in having emergency treatment actually in the Bill as a situation where the Bill would not apply and that treatment in the best interests of the patient in an emergency can proceed by whichever means appear to be best at the time.

[Lord Kakkar (CB)]

My Lords, I declare an interest as Professor of Surgery at University College in London and as a member of the General Medical Council. I welcome the interventions of my senior clinical colleagues, the noble Lords, Lord Turnberg and Lord Winston. They have helped us to understand that, although it is hard, this is a vitally important Bill to drive forward the practicalities of innovation in clinical practice. I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking. However, there must be safeguards to ensure the protection of vulnerable patients. A number of amendments in this grouping try to address that issue. When this Bill was first made available for public comment some years ago, I was initially anxious about the fact that there were insufficient safeguards. The approach that I wished to adopt was one that I know has been considered but has been also dismissed. I have, however, become reassured by the process under the supervision of the Medical Director of the NHS, Sir Bruce Keogh. He has consulted widely among the profession and I believe that the amendments in the name of the noble Lord, Lord Saatchi, particularly Amendments 12 and 16, bring us to a place where appropriate safeguards have now been introduced. I hope that they will be judged sufficient to provide the protection that all responsible and reasonable clinical practitioners would want in a Bill of this nature.

There are two other amendments being considered in this group that I believe to be vital, Amendments 15 and 19, dealing with the registration and reporting of the results of innovation. There is no doubt that if this Bill is to achieve what it hopes to, the innovations that are provided as a result of having this provision available to us in clinical practice must be reported widely and be available for other clinical practitioners to consider. I know that, at this stage, the view is that other mechanisms are available that provide the opportunity for that reporting to be made, but I wonder whether the Minister might consider during the further passage of the Bill how very powerful a provision of the kind suggested in the two amendments would be in securing the greatest benefit for the largest number of patients.

Another question to have been raised on this group of amendments is that of being certain that the Bill does not apply to situations of emergency care and does not in any way interfere with the mechanisms available for ethical and appropriate clinical research. A strong research governance structure supported by strong legislation is available in our country, and this Bill should not be seen to impinge on that in any way. I am reassured by the noble Lord, Lord Saatchi, saying that the Bill does not relate to the conduct of research and should not be confused as doing so, nor does it in any way interfere with what are, as the noble Lord, Lord Winston, said, acute and deeply stressful decisions that have to be taken in the situation of providing emergency care. I hope that the Minister will be able to reassure us that other legislation, guidance and mechanisms exist to ensure that the Bill does not impinge on those two areas.

Medical Act 1983 (Amendment) (Knowledge of English) Order 2014

Debate between Baroness Finlay of Llandaff and Lord Kakkar

Tuesday 11th March 2014 Grand Committee

[Baroness Finlay of Llandaff (CB)]

My Lords, I rise, somewhat cautiously, as the third medical speaker in a row. I welcome the order.

It is worth noting that in 2013, the GMC had 13 fitness- to-practise cases that involved concerns about the language skills of doctors. In its 2011 review, the England Revalidation Support Team found 66 cases where the responsible officer has dealt with linguistic concerns. Part 3 of the order is therefore particularly important because it relates to fitness to practise. I hope that we will have an assurance today that in a fitness-to-practise procedure the doctors will not themselves be paying for the English language competence test. I have a bit of a concern, if they are paying for it themselves, that there may be a seeking out of a centre that is different from another centre, so it has to be fully conducted by the GMC, although it seems completely reasonable that the payment for the test prior to licence to practise is borne by the person applying for a licence to practise.

I understand from the GMC that it will be using the International English Language Testing System—IELTS—which costs from £130 to £145 depending on where you sit it, and that that will remain valid for about two years, on the recommendation of the Commonwealth. There is evidence that language skills, if they are not used, begin to decay after about two years.

It is also important to recognise that in this order we are talking about “ordinary” English language; we are not talking about testing medical English. It has been suggested that the dictionary for medical English is about the same size as the dictionary for another European language. It is a huge language. However, many of the words are very similar across the different European languages—although, of course, they are very different in some other languages.

We are talking about the ability of a doctor to take their medical knowledge and translate it into what you could call everyday English so that they can communicate it to patients. One point that I hope will be part of a fitness-to-practise procedure, however, is a recognition that communication involves far more than language. In terms of communication skills and communicating, although about 20% of communication is verbal, much of it is non-verbal. When you look at complaints against doctors in relation to the way they have communicated, although they sometimes have very good English language skills, other aspects of their non-verbal communication might reveal an attitude that is below the standard that one would expect from somebody on the GMC register.

I have to say, from my experience of teaching postgraduate students, that at Cardiff University they are required to sit the IELTS. It is a good test of English language skills. Since it was introduced as a statutory requirement by the university, we have found that it has become easier to teach and to mark the work done by those whose first language is not English. When teaching communication skills, it is easier to separate out the non-verbal problems from the verbal problems.

My view is that this is an important regulation. The ability to look back at those currently practising in the UK about whom there are concerns is crucially important and the GMC needs to be empowered to do so. I would just sound a note of caution following on from the remarks of the noble Lord, Lord Turnberg; of course we do not know what is set out in the curricula of different places. Medical students can graduate from some universities with almost no patient contact at all. If they are moving into training jobs, there is a concern that the baseline level of their medical training may be very different. This order may be the first step towards looking at the competences that we expect of a doctor coming from anywhere in the world in relation to practising in the UK.

[Lord Kakkar (CB)]

My Lords, I declare my interest as a member of the General Medical Council and I would like to take this opportunity to congratulate the noble Earl and Her Majesty’s Government on dealing with this important issue in what I think we can all agree is a very sensitive way. There is no question but that our health services are vitally dependent on a steady flow of doctors coming from all parts of the world, including the European Union. Not only can they learn from our healthcare system, they can also serve in it. But it is absolutely right that a professional regulator must enjoy the confidence of the public, and it is the responsibility of the General Medical Council first and foremost to ensure that patients are protected and that clinical practice in our country is safe.

For that confidence to exist, the public have to be sure in their own minds that the elements of what they would consider to be essential clinical practice—the ability to practise in a responsible and safe way—are met and tested by the General Medical Council whenever it feels the necessity to do so. The ability to communicate effectively, and therefore to use our language in a way that the public and patients appreciate and would expect, is an essential part of the responsibility of the regulator of the medical profession. As we have heard during this short debate, it is anomalous that the GMC is able to ask that question of potential registrants and licensees from outside the European Economic Area, but has not been able to do so of those who come from within the European Union. It is quite right that the Government have focused on this issue and decided to act in this fashion.

The fact that this order makes provision not only for the question at the time of licensing of a professional, when concerns about language skills might have been raised during the provisional registration process, but also that the new category of considering the ability to use language and to communicate becomes part of the broader question in fitness-to-practise considerations, is vitally important. It means that not only at the time of coming on to the register and being licensed to practise in this country, but throughout the practice itself, the public and patients can now feel confident that the General Medical Council will be in a position to act if it needs to do so. The importance of that cannot be overestimated.

We have heard about the additional question of competence skills, which is a matter that your Lordships have considered in the course of a number of debates in the Chamber over the past few years. The issue remains to be addressed, but I think that most would agree that ultimately, wherever a doctor comes from in the world, whether they have trained and qualified in our own country, elsewhere in the European Union or elsewhere in the world, they should be expected to demonstrate their skills to the same standard and to deploy those skills throughout their professional career in a way that enjoys the confidence of the people of our country.

Health and Social Care Bill

Debate between Baroness Finlay of Llandaff and Lord Kakkar

Tuesday 13th March 2012 Lords Chamber

[Lord Kakkar]

My Lords, my noble friend Lady Emerton moves a very important amendment that comes to the very heart of this Bill. The purpose of this Health and Social Care Bill is to ensure ultimately that quality is driven throughout the healthcare system and that standards are driven to the very highest levels. It seems counterintuitive that such an important group of healthcare professionals as healthcare support workers is not subject to any mandatory training or mandatory continuing professional development or, indeed, any form of statutory regulation. I suspect that many of our fellow citizens would find that a very peculiar situation, which they would not automatically recognise, when going into the hospital environment.

I would like to ask the Minister two questions, specifically with regard to proposals for ensuring strong voluntary registration of this particular group and members of other disciplines who are responsible for the provision of healthcare. The first relates to the role that the Secretary of State might play with regard to standing rules and providing guidance to commissioning groups on the action they should take and the requirements they should make of qualified providers. Will it be the case that commissioners will be in a position to demand of a qualified provider that all of their healthcare staff, be it doctors, nurses, or other healthcare professionals, are members of some form of registered regulatory scheme, be it a regulatory scheme for certain healthcare professionals or voluntary schemes for others? Will it therefore be possible for clinical commissioning groups in the future to refuse to commission from a potential qualified provider if that provider was unable to demonstrate that all the staff it employed were registered appropriately?

My second concern relates to a plurality of registers for a single discipline of healthcare worker. That seems counterintuitive: surely, if there is going to be a voluntary register for healthcare support workers, there should be a single register, not multiple ones, because multiple registers would provide less confidence to the general public. The general public should know that there is a single regulatory body and that that body has responsibilities with regard to setting certain standards, with regard to ensuring that there is appropriate training and with regard to the possibility of receiving complaints and disbarring individuals from working in that professional area.

[Baroness Finlay of Llandaff]

My Lords, I agree with those noble Lords who have said that this is a critical amendment. I do not understand how more than one register will ensure a uniform standard across the whole of the NHS. There is a real problem at the moment with healthcare assistants being used as substitutes, rather than having “delegated” tasks, as in the wording of this amendment.

I am concerned about relying overly on the employers themselves. We have seen in the nursing home sector that this has failed. Where there has been substandard care, nursing homes have not got rid of those staff about whom they have had questions and those who have been commissioning services from those areas have not been able even to close down nursing homes because they often have not known where else they could move the residents of that area. In the mainstream hospital sector, it is down to an individual nurse to decide what she delegates to a healthcare assistant. The beauty of having a statutory register is that there will be clear expectations of what healthcare assistants can and cannot do and the level to which they should be trained, with clarity of roles and values, which I believe will also increase their own self esteem, and their own sense of occasional involvement in their role in clinical care. It has been suggested that it would be in the interests of unions to have such a statutory register. I fear that there has even been confusion in the minds of some people between the role of a trade union and the role of a regulatory body. It will be very important that a register is completely separate to any type of union activity. When the Minister comes to answer, I would be grateful if he could explain how the standards to be set by a voluntary registration process will be overseen and monitored, and what levers the Government would have to improve and extend the criteria required by a voluntary register of those who are registered on it, in order to increase standards.

Health and Social Care Bill

Debate between Baroness Finlay of Llandaff and Lord Kakkar

Thursday 8th March 2012 Lords Chamber

[Lord Kakkar]

My Lords, I support the amendment moved by the noble Lord, Lord Phillips of Sudbury, to which I have added my name. I refer to Good Medical Practice, the document produced by the General Medical Council, which sets out the principles and values on which good medical practice is founded. Indeed, it is the document to which we as clinicians are obliged to practise. In so doing, I remind noble Lords of my own entry in the register of interests as a consultant surgeon at University College London Hospital NHS Foundation Trust, an institution that has a private healthcare facility that might avail itself of any change in the cap on private income.

In paragraph 9, Good Medical Practice makes important reference to decisions about access to medical care. It states very clearly that, as a clinician,

“you must give priority to the investigation and treatment of patients on the basis of clinical need, when such decisions are within your power. If inadequate resources, policies or systems prevent you from doing this, and patient safety is or may be seriously compromised, you must follow the guidance”,

elsewhere when raising your concerns. I support the amendment because it provides an important opportunity to place on hospital managements and healthcare systems in the National Health Service the same obligation that currently rests on clinicians: their absolute obligation to provide and take decisions about access to treatment on the basis of clinical need and priority.

It is not entirely clear that hospital managements have that same obligation. In promoting this amendment, one hopes that that obligation will be placed on hospital managements in such a way that in future, when there may be greater opportunity for income from outside the funding of the National Health Service—private income—into NHS institutions, no opportunity arises for pressure to be applied to clinicians. For instance, when there is limited access to operating lists or scanning facilities, and where two patients—one an NHS patient and the other a private patient—need to avail themselves of those facilities, the decision might be taken by the hospital management that preference be given to the private patient because it could provide further income for the NHS institution. When accessing facilities that are essential for clinical care, the same principle must always apply: the clinician uses their clinical judgment to determine on the basis of clinical need alone, rather than any other financial consideration for the institution, that the patient with the greatest clinical need at that particular moment is able to avail themselves of the necessary facilities. I hope that Her Majesty’s Government are able to ensure that that principle is enshrined or at least properly and effectively known so that there may be no misunderstanding in this matter in future.

[Baroness Finlay of Llandaff]

My Lords, I also have my name down on this amendment. I follow the same theme as my noble friend Lord Kakkar, who has just spoken. Good Medical Practice states:

“You must be honest and open in any … arrangements with patients”.

We have already discussed a duty of candour in relation to errors. There is also a requirement to give patients accurate information, as the noble Lord, Lord Phillips of Sudbury, has already said. Giving a patient information about what is available to them can entail informing them, for example, that other drugs are available but not currently funded by the NHS, or that clinical trials are available that they may wish to consider going into. You must answer the question, “Would I get treated quicker?”, honestly and with factual, correct information.

Of course, as has already been said, such stringent criteria do not apply to hospital managements. It would easy for them to see that there is something to be gained by increasing the private patient provision. I hope that this amendment encapsulates within it, in much more sophisticated wording, the spirit that I tried to capture in Amendment 220, which I withdrew. That spirit was to state that the provision should not be to the detriment of NHS patients. That is a fundamental principle that should go right the way through. I know that my wording was inadequate.

Health and Social Care Bill

Debate between Baroness Finlay of Llandaff and Lord Kakkar

Wednesday 9th November 2011 Lords Chamber

[Baroness Finlay of Llandaff]

In intervening in this interesting debate, I shall be very brief. I simply want the Minister to explain where the levers will be in the commissioning decisions to make sure that the principle of research that is being embedded across all the professions happens, given the multiplicity of providers and, as the noble Lord, Lord Turnberg, clearly outlined, the relative paucity of research in primary care but an increased push for more people to be cared for in the community across all the disciplines involved. A simple example of that is the problem that we now have with antibiotic resistance. There is potential overprescribing, but much of that prescribing is going on in primary care in the management of relatively simple conditions. If those are not researched into, we miss a fantastically important opportunity.

[Lord Kakkar]

My Lords, I support many of the amendments in the group. I do so as a biomedical research and clinical academic, therefore benefiting from many of the opportunities that the current systems for biomedical research in the National Health Service provide.

I start by congratulating Her Majesty's Government on having included for the Secretary of State for the first time in a health Bill responsibilities to promoting research. That is hugely important, because it allows us to secure what has been achieved to date in structures and funding going forward in the National Health Service.

There are, of course, anxieties, which we have heard in this important debate, which need to be addressed. Can the noble Earl provide clarification in three areas, notwithstanding the fact that the Bill already emphasises the responsibilities of the Secretary of State for Health? First, how is it is envisaged that the funding for biomedical research will be protected when that fund moves to the NHS Commissioning Board? Secondly, how will the clinical commissioning groups be responsible for promoting research in future, how will that be supervised by the NHS Commissioning Board, and will any form of instruction or performance measure be included in the supervision that the Commissioning Board provides for clinical commissioning groups?

Finally, how, within the proposed structure of the Commissioning Board, will there be encouragement and support for academic health science centres, as they currently exist, and in the future, potentially, academic health partnerships? They provide the opportunity both to drive forward opportunities for biomedical research to improve healthcare and the health gain for our population, and to drive forward the economic opportunities that attend the biomedical sciences industry in our country. However, they also drive forward opportunities for a broader population health gain through a focus on the tripartite mission of improved clinical care, education, training and research.