Medical Innovation Bill [HL]

Lord Saatchi Excerpts

Friday 23rd January 2015 Lords Chamber

[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.

[Lord Winston]

My Lords, as this is probably the last opportunity I will have during the passage of the Bill, I thank the noble Lord, Lord Saatchi, who has behaved with extreme courtesy throughout the debate on this Bill. We do not entirely agree, but I think we have come to respect each other’s point of view and we are in total agreement about this issue.

I was surprised that the noble Baroness, Lady Gardner, raised this concern, because a representative body of medical opinion is exactly what courts ask me to give and to be mindful of. I am very grateful to the noble Lord, Lord Pannick, for his quotation, which is of course now on record, because on the number of times that I have been an expert witness in court, that is exactly what my Silk, in taking evidence from me, has required me to recognise—whether I am doing something that is recognised by a responsible body of medical opinion. That is a phrase which is firmly in our minds and was therefore firmly in my mind when I set this amendment down.

I therefore really am disappointed with the response from the noble Earl, Lord Howe, on behalf of the Government. If the Government really want to protect patient safety—I have no doubt about their absolute commitment to that—this would be a very good way of doing that. It seems to me that there is a risk of mavericks operating without that control. This is a very shocking issue. We do have desperate patients seeking all sorts of treatments, sometimes at the end of life but often perhaps because they are infertile— which is hardly at the end of life—and they will go through anything that they think might be of benefit, even though it is not proven. That is innovative treatment and sometimes it is possible that for various reasons that innovative treatment might work; sometimes, purely biology works and random effects happen. The amendment is designed to deal with that issue.

I do not think it would be appropriate to divide the House. I am grateful to see so many of your Lordships here late on a Friday afternoon, which is a great credit to this House and something we should be proud of. I am sure that the noble Lord, Lord Saatchi, is grateful as well. However, I feel that this is something that will need to be teased out. If the Bill now proceeds to another place, I very much hope that some consideration will be given to the patient safety aspect. Of course, it is really in the Government’s interests, particularly at the moment, when we are increasingly concerned, understandably, about our health service, which we all want to see survive and prosper. For the moment, I will withdraw the amendment.

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[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.

[Lord Hunt of Kings Heath]

My Lords, it has been a very good debate; I am sorry that it has happened so late in the day. I, too, echo the words of the noble and learned Lord, Lord Woolf, in paying tribute to the noble Earl, who has been extremely helpful during the passage of the Bill. Of course, I am well aware that Sir Bruce Keogh, medical director of the NHS, has himself been extremely helpful in assisting with the drafting of some of the clauses in the Bill.

I will make three or four points. First, the noble Lord, Lord Ribeiro, was very helpful in giving us a practical example of why a register was necessary. The register that he referred to was a voluntary one and was used by most surgeons, but of course not by all. My contention is that, in the specific circumstances of the use of the Bill, we need greater reassurance by having a mandatory register. The noble Lord was concerned in essence that a mandatory register would be a disproportionate requirement, and that in so being it would discourage doctors from using the provisions in the Bill. I disagree with that. All of us have received, at every stage of the Bill, extensive letters from just about all the medical bodies you could think of, all of which have expressed some concerns about the provisions of the Bill. They recognise that the noble Lord has moved a very long way and in a very helpful way, but they remain concerned. My view is that the kind of amendments being proposed today would go a very long way to reassuring those bodies. In the end, the more that those bodies are reassured, the more likely it is that they would provide the advice that would allow their members to consider use of the provisions in this Bill.

We have had a very interesting debate, with contributions from the noble and learned Lords, Lord Woolf and Lord Brown, and the noble Lord, Lord Pannick, on the provisions of the Bill and their relationship to the Bolam test. I make it clear that my amendment refers only to the provisions of this Bill. At Report, my amendment was criticised by the Government because they thought that in its wording it might go wider than the Bill, which is why I have rewritten the amendment to make it clear that it provides only for the Bill. It may well be that, as the noble and learned Lord, Lord Brown, suggested, we should discuss the use of a register in relation to all innovation. However, that is not today’s argument. I believe that we are justified in seeking a specific requirement in relation to the use of this Bill because of its special provisions and, in particular, because of concerns raised by many responsible medical bodies.

On the question of the GMC, I agree with the noble Lord, Lord Saatchi, that it is not beyond the bounds of possibility that the Department of Health and the GMC can come to a sensible outcome within the confines of my amendment. In the end, it may well be that, in the circumstances to which my noble friend Lord Winston has referred, whereby rogue doctors use this legislation inappropriately, it should fall to a fitness to practise committee.

In the end, as the Minister said, we need to engage with the medical community. Many of us have been engaged with it for a long time and we have come under great criticism for seeking to help the Bill. Most of the letters that we received from very responsible medical bodies have asked your Lordships’ House to make sure that the Bill does not proceed. We have tried to be as fair to them as to the noble Lord, Lord Saatchi, and it is through these kinds of amendments that the Bill can go to the other place considerably enhanced. For that reason, I move the amendment.

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Moved by

[Lord Saatchi]

That the Bill do now pass.

[Lord Saatchi]

My Lords, I shall not delay the House, as it is late, but I want to express my enormous gratitude to my noble friend the Minister and to his team at the Department of Health, who have been unfailingly courteous and professional in the most admirable way. One hears that this is a scrutinising House and that it is its particular skill to look in detail, line by line, at legislation in a careful way. I do not know of a case in which that has been better demonstrated than in this Bill, and I take my hat off to your Lordships’ House. I beg to move.

Bill passed and sent to the Commons.