Medical Innovation Bill [HL]

Lord Woolf Excerpts

Friday 23rd January 2015 Lords Chamber

[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.

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[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.

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[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 Woolf]

My Lords, before the noble Earl sits down for the last time, I am very conscious of the kind things said by the Minister about my interventions, and I can assure him that I hold his approach to all matters of this sort in equally high esteem, if not higher. He is a lesson to us all in the care with which he approaches these matters.

Just before we leave the subject, I want to draw attention to the words,

“comply with any professional requirements as to registration”.

That is a very important limitation in the amendment because—as I understand it; I did not have anything to do with the drafting—it presupposes that there should be professional requirements. Surely we can rely on the medical profession to put in sensible requirements.

[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.