Medical Innovation Bill [HL]

Lord Hunt of Kings Heath 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.

--- Later in debate ---

Moved by

[Lord Hunt of Kings Heath]

2: Clause 1, page 1, line 24, at end insert—
“comply with any professional requirements as to registration of the treatment under the provisions of this Act with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatments and patients’ experiences),”

[Lord Hunt of Kings Heath]

My Lords, throughout the passage of the Bill the noble Lord, Lord Saatchi, has been enormously helpful to the House in responding to concerns and in his willingness to accept constructive changes to the Bill. I am most grateful to him for adding his name to my amendment.

We had a useful discussion in Committee and on Report about the establishment of a register that could record uses of the Act. This would be immensely helpful to clinicians, regulators and doctors—and, indeed, patients. It would reassure those who have concerns about the implications of the Act. It would enable use of the Act to be tracked. I argue that it would also help spread good practice. It would inform legislators about further changes to the law that might be required in the light of practical uses of the Act.

On Report, I received considerable support around the House. The noble Lord, Lord Kakkar, is here today. He probably will not mind me quoting from what he said—that,

“the register needs to be obligatory, in which all innovation and the outcome of that innovation is properly reported. It would do much to ensure the development of an enhanced culture of innovation, but also, fundamentally, to provide very important protections”.

On Report, the noble Baroness, Lady Jolly, opposed the amendment on four grounds. First, she argued:

“Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent … would impose requirements … additional to those in the existing law”,

and,

“may risk deterring doctors from innovating”.

Secondly, she argued that my amendment,

“would widen the scope of the Bill to cover all innovation. This Private Member’s Bill is not the right vehicle to make provision that would relate to all innovation”.

Thirdly—and quite remarkably—she said that,

“the act of putting something into legislation does not guarantee that doctors will adhere to it”.

Fourthly, she said that she would support a voluntary register,

“but it should be such that doctors would not dream of not recording on the register”.—[Official Report, 12/12/14; cols. 2062-63.]

My response is simply: let us put it beyond doubt by making registration mandatory.

On the question of the amendment going wider than the Bill, I have changed my amendment to make it clear that it relates only to this Bill—or Act, as it will become. On whether having to comply with this provision would dissuade doctors from innovating, I simply do not accept that. I would worry about doctors who were dissuaded because of the need to record an innovation in the register. I would have thought it created the conditions in which doctors would feel more confident in taking innovative action. On the suggestion that doctors will not adhere to the legislation, I simply do not accept that and ask what possible evidence there can be of it.

I do not think it is unreasonable to say that every use of the Act should be captured and available, to check on patient safety from the point of view of regulation but also for the purposes of research. I beg to move.

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[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.

Amendment 2 agreed.