Medical Innovation Bill [HL]

Earl Howe Excerpts

Friday 23rd January 2015 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I, too, welcome the amendment and thank my noble friend for his efforts. I also thank the noble Lord, Lord Saatchi, for the way in which he has been prepared to listen and to support amendments which we see as improving the Bill. This amendment goes a long way to meeting some of the concerns expressed by medical bodies about what might be described as unintended consequences arising from the Bill.

I do not agree with the noble Baroness, Lady Gardner, that this amendment could be seen as delaying action. I think it is rather the reverse. Having this provision and the need to act within it would give confidence to doctors. I think the definition of,

“a representative body of respectable medical opinion”,

is a question of you know what it is when you see it. I would have thought that doctors would have no doubts about to which responsible body they should turn.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, my interpretation of the amendment moved by the noble Lord, Lord Winston, is that it aims to ensure that in obtaining the views of one or more appropriately qualified doctors, a doctor is carrying out a test equivalent to the Bolam test. I recognise that these words are carefully chosen, and I listened closely to what the noble Lord, Lord Winston, said. However, I do not believe that the language of the amendment accurately reflects the requirement of the Bolam test.

To go a bit further, I am concerned that the amendment would create more confusion than clarity for both doctors and the courts. In particular, how would a court determine what is meant by the phrase “command the respect of”? It certainly does not mean agreement. If Noble Lords want an illustration of the difference, I deeply respect the noble Lord, Lord Winston, but, as in this case, I do not always agree with him.

Like my noble friend Lady Gardner, I question what might count as,

“a representative body of responsible medical opinion”.

Again, this wording is not in the Bolam test. The Bolam test sets out that a doctor is not negligent if their decision is accepted as proper by a responsible body of medical opinion. Bolam accepts that a doctor is not negligent merely because there is a body that would take a contrary view. Therefore, the courts recognise that there is not necessarily a representative body of medical opinion. The wording of the amendment would be open to interpretation by the courts.

I recognise that the noble Lord’s aim in tabling this amendment is thoroughly worthy and is to ensure the protection of patients. I assure him that the existing provisions in the Bill seek to achieve that same aim. Therefore, the Government do not consider the amendment moved by the noble Lord, Lord Winston, necessary. The Bill’s provisions boil down to one key test: a test of responsibility. Clause 1(2) states:

“It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly”.

This objective test of responsibility ensures that the decision about whether a doctor has been negligent is based on the same premise as the existing Bolam test: has this doctor acted responsibly? Patient safety is an integral part of this test. Clause 1(3) makes clear that the risks of any innovative treatment must be considered, so if the treatment was likely to compromise patient safety unacceptably, it is highly unlikely that it would be considered a responsible decision when later judged in court. Furthermore, the Bill does not require doctors simply to obtain the views of experts in the field; it requires a doctor to take full account of those views in a responsible way. As such, a doctor could not simply listen to, or note, the views of colleagues and then proceed to disregard those with which he or she disagrees. A doctor can fully expect a court to scrutinise closely how they have taken account of those views and consider whether they had acted on the views in a responsible way.

It is that requirement which ensures that the Bill is the nearest equivalent to that of the Bolam test. I fear that the amendment of the noble Lord, Lord Winston, despite its best intentions, would not add to the operative provisions of the Bill but would only risk creating confusion as to the language of the existing Bolam test. It is not just that the Government consider this amendment unnecessary—which we do—but that we also have serious concerns about whether the language of the amendment will create confusion for doctors and, indeed, the courts.

[Lord Saatchi (Con)]

I thank noble Lords who have addressed this amendment. I happily added my name to the amendment of the noble Lord, Lord Winston, because I believe that it provides helpful additional clarity for Peers and those outside the House about the intention and effect of the Bill.

Your Lordships will be aware that on a number of occasions I have tried to stress that the intention and effect of Clauses 1(3)(a) and (b) are not, as my noble friend was just saying, that a doctor can just ignore the views of anyone who disagrees with the proposed treatment or that he or she can choose to consult only those who are known to agree. I agree with my noble friend that Clause 1(3)(a) and (b) contain a legal duty to obtain views and take proper account of them, and that that is a serious and effective threshold. However, I wonder whether I may encourage my noble friend to share with me the observation that a number of noble Lords, including the noble Lords, Lord Winston and Lord Turnberg, were anxious to see this set out more expressly in the Bill in language that at least resembles, if not copies completely, the wording of the Bolam test, as described by the noble Lord, Lord Pannick. I believe that the amendment of the noble Lord, Lord Winston, does that in a manner that will not change the substantive policy of the Bill, as already agreed by your Lordships, but will perhaps give greater clarity about the intention for those Peers and others who want to see this language expressed in the Bill in the closest approximation possible to the existing Bolam test, which is what we are all trying to preserve.

As your Lordships know, the Bill is all about giving greater clarity and certainty to patients and doctors at the point of treatment, and not forcing them to wait for the unpredictable outcome of possible litigation or disciplinary proceedings. I can only welcome any amendment designed to enhance clarity and certainty about the effect of the Bill itself. I am therefore very happy to support it.

--- Later in debate ---

[Lord Winston]

My Lords, briefly, I support the amendment of my noble friend Lord Hunt of Kings Heath as well. I was reminded by the noble Lord, Lord Ribeiro, of laparoscopic surgery. Of course, we gynaecologists were doing that 20 years before the noble Lord was and we did not have as many deaths. Having said that, what the surgeons did with laparoscopic surgery and recording those events was really important in bringing down the complication rate and the haemorrhages that occurred. That is a very good example and the noble Lord is to be thanked for bringing it to the House. It is exactly what would be covered here.

I would be astonished if the Government seriously opposed this amendment. I was very unconvinced by the noble Baroness, Lady Jolly, in the previous stages of the Bill. She did not seem to take on board exactly what we were trying to say about the need for keeping proper records, which is important in all sorts of ways. If you keep a record and it is done under this Bill then you are effectively legally protected. For that reason if no other that would be important, but in any case we have to build up the knowledge of our experience. We do that automatically in the laboratory. Every single thing we do in the laboratory, whether negative or positive, we record in our laboratory books. If we do not, we are not doing good science or science useful to the public. Here in innovative medicine, we are—whether we like it or not—doing a form of science because we are exploring our knowledge about what a treatment means. That is what science means. I urge the Government to support the amendment. I feel very strongly about this. If the Government were reluctant to support it and my noble friend Lord Hunt were to divide the House, I would certainly join him.

[Earl Howe]

Perhaps I may deal briefly with the question posed by the noble Baroness, Lady Masham, who asked whether the Bill would apply to patients receiving private treatment. The answer is yes. Any departure from the accepted range of medical treatments for a condition, whether that patient be receiving NHS or private treatment, would be covered under the Bill.

The amendment of the noble Lord, Lord Hunt, would change the test of negligence under the Bill. If accepted—and assuming that the appropriate professional requirements were created—the amendment would require a doctor to comply with any professional requirements as to registration of the treatment; that is, to register the treatment with a scheme for the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition. In other words, registering details and results of an innovative treatment on a data-capturing scheme would form part of the steps that a doctor has to take under the Bill.

[Lord Woolf (CB)]

I hope the Minister will forgive me for saying that I do not think he is right in saying that the amendment would in any way change the standard. It is only adding a requirement to keep records. That does not change the standard of care which is required. It puts on the doctor an obligation to do something in addition, but I suggest with respect that it does not change the standard.

[Earl Howe]

I am grateful to the noble and learned Lord. Obviously, I must take account of his expert view, but the fear that I was about to articulate is that if you require a doctor to register the details and results of whatever innovative treatment he or she may have administered on some kind of data-capturing scheme in the way suggested by the noble Lord, Lord Hunt, that would constitute part of the requirement for the doctor to demonstrate that he or she has acted responsibly, and thus not negligently. Therefore, if the amendment were accepted, the result could be that a failure to record would be part of the picture when deciding whether a doctor had acted negligently.

If that point is accepted—I expect the noble Lord, Lord Pannick, to take me to task on it—my submission is that that would be a disproportionate requirement.

[Lord Pannick]

I understand the noble Earl’s concern that if there is an obligation to report the results, that might have an effect on the common law Bolam test, but surely it would not, because of the contents of Clause 2(1), which states:

“Nothing in section 1 … affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion”.

I therefore understand that under the Bill—the noble Earl can tell me whether I am right or wrong—the doctor has two means of defending himself or herself. One is the Bolam test at common law; the other is to take advantage of the procedures of the Bill. If one of the procedures of the Bill is a duty to report, that does not affect the general Bolam test under Clause 2(1).

[Earl Howe]

My Lords, I take the point made by the noble Lord, Lord Pannick. My point was not that the amendment would alter the effect of Clause 2(1). It would not have an effect on the common law, but it would create a more burdensome test under the Bill. That is troublesome to me, because to do that would in itself impose requirements which go beyond the current Bolam test of negligence. It would mean that the test of clinical negligence was more burdensome under the Bill than under the common law.

[Lord Woolf]

There are provisions as to machinery and provisions that deal with standards of care. I think that this is a machinery requirement. You could not sue the doctor because he had not reported something. It is something that the law requires but I do not think it is intended that this should be enforced by criminal sanctions. There is certainly no specific provision of that sort.

However, it would exclude the ability to take advantage of Clause 1. You have to do Clause 1 in a way that complies with the Act, and the requirement that is now being inserted says that if you are going to do so, you have to do this. The implication is that if you do not do it, you will not get the benefit of Clause 1. This does not mean that the doctor is going to be liable for negligence just because he has not signed the register. As the noble Lord, Lord Pannick, has made clear and those who have taken part in the debate so far have emphasised, the common-law position remains the same. This is an additional mechanism to allow innovation. I therefore suggest that a machinery provision does not do anything else than act on a requirement that you have to go through if you want to take advantage of the Bill.

[Earl Howe]

My Lords, I have been in the House long enough to know that when the noble and learned Lord, Lord Woolf, opines on something, it is a matter that all noble Lords would do well to listen to, and I am grateful to him. I agree that the amendment does not change the standard of care, we are agreed on that, but our concern is that a court might look at the requirements under the Act—and this is one of the requirements—as part of the picture that it would form as to whether or not the doctor had acted responsibly. It is merely part of the picture.

If we are agreed on that, and I hope that we are, it does not seem sensible to me that we should impose requirements in the Bill additional to those under the existing law, as that could risk deterring doctors from innovating under the Bill. Let us not forget that a doctor does not have to follow the Bill if he or she does not want to; they can simply rely on the Bolam test later on if they are challenged. Do we want to deter doctors in the form of a test or requirement that obliges them to go further than they would otherwise go? If they were deterred by that, it would defeat the whole object of the Bill and result in less benefit to patients, so I worry about that.

The amendment from the noble Lord, Lord Hunt, specifies that the use of a scheme be enforced through professional requirements. We have sought advice from the GMC about whether professional requirements in the form of guidance might be a suitable route to enforce the sharing of learning from innovation. The GMC has been clear that it is very happy to consider anything it can do to be helpful. However, from those initial conversations, it seems that this may not in fact be an effective route. The GMC’s statutory power is to provide advice. Doctors must be prepared to justify their decisions and actions against the standards set out in its guidance.

Serious or persistent failure to follow the guidance would put a doctor’s registration at risk. So on the one hand, were we to go down this route, a doctor who failed only once to use a data registry might not face any consequences; that would be okay for the doctor. However, this would not address noble Lords’ concerns that the results of each and every innovative treatment, whether or not successful, should be recorded. On the other hand, if a doctor persistently failed to use the data registry, this could result in fitness to practise proceedings being brought against him or her for not having recorded information on an online database designed to foster the sharing of learning from innovation. Should a doctor’s fitness to practise be called in question simply on those grounds, that really does not seem a proportionate response.

For the reasons that I have outlined today—namely, the difficulty of relying on professional requirements and the link, which I hope noble Lords will accept, to the test of clinical negligence—the Government would not be able to support this amendment.

[Lord Giddens]

I am not a medical specialist but I have followed this all the way through. What kind of structure would the Minister envisage being put in place if there is not a formal requirement of this sort? If you do not have some kind of system of dealing with the data produced, the whole thing becomes an erratic exercise and therefore does not contribute to the overall fund of medical knowledge.

--- Later in debate ---

[Earl Howe]

I would not disagree with the noble Lord at all. I was about to say that on Report, my noble friend Lady Jolly suggested that there should be a registry and made a commitment to that effect. I would like to clarify that the Government are committed to exploring what may be useful in the data registry. The key here is to establish what could be workable and beneficial. The Government have heard a range of views on the topic of a data registry from those who argue, as many of your Lordships do, that this is essential to the Bill to others, including eminent clinicians, who argue that informal methods of sharing learning are more effective and that a compulsory registry would be overly burdensome.

With thanks to the contribution of your Lordships, the Government have started this conversation and are committed to continued engagement with relevant bodies. Any method of learning that should develop from the Bill must surely work for doctors to be of benefit to patients and the wider medical community. That is no simple task. It is crucial that any mechanism to encourage learning should be developed with a sufficiently light touch so that clinicians see it as facilitative of good practice, rather than burdensome and bureaucratic. It is also important to consider the costs of a method of learning and how this can be encouraged in the most cost-effective way. While I do not take issue with the end-point which noble Lords want to reach, I really believe that it is wise for us to remain open to all possibilities, rather than committing in legislation to an approach which may discourage doctors from innovating under the Bill and therefore not be of benefit to patients in the longer term.

This is a beguiling amendment and I understand the motivation behind it but I hope that noble Lords will join me in questioning the wisdom of having such an amendment in the Bill and accept instead our preferred approach: to continue to discuss this issue with relevant parties as the Bill progresses and, should the Bill pass, to engage with the medical community as to the best way to ensure that innovation can be translated into learning.

[Baroness Masham of Ilton]

Before the Minister sits down, to do research surely one needs data to see what benefits patients because these are new procedures that we are talking about.

[Earl Howe]

I would just say that the Bill is not to do with research but with innovative treatment, which is rather different. There is no question of the noble Lord, Lord Saatchi, promoting another form of clinical trial so while I accept the principle that the gathering of data is a very good idea, we must be clear that this is not for clinical research.

[Baroness Gardner of Parkes]

Before the noble Earl sits down, from the outset we have been very clear that this was to be recorded. Everyone has wanted someone reputable to come forward and say that they were going to record it. To see that this will possibly now not happen is just unbelievable because what is the benefit, unless people in the future can benefit from it and it is accurately recorded? I am sorry to say that I cannot accept the view that this amendment should not be accepted by the Government.

[Lord Winston]

Before the noble Earl sits down—although I do notice that he has managed to take his seat on the Front Bench—I would argue that of course it is not research; we accept that completely. But it is science within the meaning of the Latin word, which has the notion of knowledge, and of course it is wrong for us to exclude knowledge being dispersed and promulgated. Of course, the Medical Innovation Bill hopes to do this, and that is the point of supporting it. Otherwise, I fear that the Bill when enacted will be almost useless. This has been an issue of great concern and was the cause of correspondence this week from many different medical sources. I hope that the Government will consider that very carefully.

[Earl Howe]

Of course the Government will consider this carefully. Let me make it clear that I do not want to sound negative about the idea of data gathering. I am the first to recognise that that could be a major advantage of the procedures that my noble friend Lord Saatchi is encouraging within the scope of the Bill. I would not dispute that for a moment. My concern is that to build a further requirement into the test of negligence would be the wrong course to take, because that is how this amendment is framed.

Also, what would be the benefit if we do not engage fully with the medical community to make sure that doctors are able to use any registry that might be created easily and simply? If it does not work for doctors, there will be no benefit—so I think that we need to take longer over this. It is not a case of kicking it into the long grass, but in the time available we have not been able to come up with a precise solution, despite our best endeavours in our discussions with the GMC.

[Lord Brown of Eaton-under-Heywood (CB)]

My Lords, before the Minister finally sits down, does he agree that it would be desirable that any professional requirements of registration should deal not only with innovation,

“under the provisions of this Act”,

but also with innovation that may well be outside the provisions of this Bill but are covered by Bolam and expressly contemplated in Clause 2(1): namely,

“a departure from the existing range of accepted medical treatments”.

That, too, needs to be recorded and registered because it may point the way ahead. As matters stand, that is not within the compass of the proposed amendment to Clause 1.

Perhaps I may further ask the Minister whether he agrees with me that the real purpose of this Bill is to carry Bolam a stage further. Bolam applies if a proposed innovation is,

“a departure from the existing range of accepted medical treatments”,

and is,

“supported by a responsible body of medical opinion”.

Clause 1 of the Bill, as was made plain by the first proposed amendment, deals with a situation where,

“a departure from the existing range of accepted medical treatments”,

may not actually be supported by, but has the respect of,

“a responsible body of medical opinion”.

In other words, the,

“responsible body of medical opinion”,

may not support it, but, taking that into account and having regard to patient safety, none the less respects it and therefore implicitly allows it to go forward as a responsible treatment. That is outside Bolam but within the compass of the Bill.

[Earl Howe]

I will reply very briefly, with apologies to noble Lords for speaking so often. I have been troubled by the fact that if we were to build this amendment into the Bill, it would apply to those innovative treatments covered by my noble friend’s process and not to other innovative treatments. It would seem inherently odd if we did not have a database that captured all innovative treatments—so, again, we need to consider that, and the noble Lord, Lord Hunt, referred to that issue himself.

On the second point made by the noble and learned Lord, my concern is that—going back to the previous amendment we were discussing—there was a mismatch of wording that does not quite conform to the Bolam test. However, I will consider what he said carefully and come back to him, if I may.

[Lord Saatchi]

My Lords, I am so grateful to all noble Lords who have spoken on this amendment. I will not in any way detain your Lordships by reciting again what has been brilliantly and articulately expressed by other noble Lords. I will say only one thing about this amendment, which is to pay tribute to Oxford University, whose original concept it was—I refer to Professors Alastair Buchan and Stephen Kennedy at Oxford—that a database should be created to record the results, positive and negative, of innovation under the Bill. The reasons were, as expressed by noble Lords today, to advance scientific knowledge, as the noble Lords, Lord Giddens and Lord Winston, said, and to protect patients with full disclosure and full transparency.

A number of individuals and organisations have told me that any doubts that they had about the utility of the Bill would be removed by the emergence from it of this new and exciting initiative in data collection and sharing. This database will, I hope, be a significant—perhaps enormously significant—development in the field of medical practice. I am confident that my noble friend and the officials in the Department of Health will be able to devise a suitable system, in collaboration with the medical profession and the regulatory bodies, which will achieve what is wanted here.

I will end by saying that I do not remember ever seeing your Lordships’ House in full agreement, on all sides of the House, on one amendment. We have not just had that once, on Report, but have had an exhibition of exactly the same unanimity and strength of feeling again. I very much hope that my noble friend the Minister will not consider voting against the amendment should it be put, but will, as he said, take forward the Government’s commitment to ensure that the register happens and is put in place, and that he will be able to encourage the noble Lord, Lord Hunt, and all the rest of us here that that will happen.