Medical Innovation Bill [HL]

Lord Hunt of Kings Heath Excerpts

Friday 12th December 2014 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thought that it had been agreed that Amendment 13 would be grouped with Amendment 5, so the noble Lord needs to respond to it then.

[Lord Saatchi]

I am sure that that will be done. I will return to Amendment 13 when I respond to a later group.

Amendment 14 relates to the preservation of the Bolam test, an extremely important point. The amendment is in my name and deals with the fact that concern was expressed in Committee about whether in emergency situations, as we discussed earlier, doctors will realise that they are not expected to follow the procedures set out in the Bill—the point made by the noble Lord, Lord Winston. Amendment 14 accordingly introduces a reference to “emergency” and makes it expressly clear that a doctor treating an emergency can and should rely on the existing law. The amendment would achieve this by giving emergencies as an express example of a situation in which the existing common-law Bolam test would apply and a doctor might not engage in the procedures of this Bill.

Amendment 15, again in my name, is a most important amendment in relation to the preservation of the general Bolam test. It deals with the principle that the Bill does not force doctors or require them to rely on its procedures, and they can simply rely on the existing Bolam test in all cases. It recasts the proposition to meet concerns expressed as to whether the intention of existing Clause 2(2)(a) was sufficiently clear. I shall return to Amendment 13 on a later group.

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Moved by

[Lord Hunt of Kings Heath]

5: Clause 1, page 1, line 24, at end insert—
“( ) comply with any professional requirements as to registration of the innovation 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, before speaking expressly to the terms of the amendment, perhaps I may ask a question of the noble Lord, Lord Saatchi. He knows that we have enormous sympathy for the intent behind his Bill and have put forward what I regard as constructive amendments. He has been gracious and constructive in his response.

However, I am still left uneasy that a substantial body of medical opinion—noble Lords have read out the list of organisations—is concerned about the impact of the Bill. The noble Lord may well decide just to plough on. Clearly, we will have a Third Reading, which, I assume, will be in the new year because we could hardly have a Third Reading, say, next Wednesday because it would not give enough time for noble Lords to table amendments properly. That must at least put some doubt as to whether the Bill can get through the other place, particularly in view of the intervention of the chair of the Health Select Committee, although I may be wrong about that. However, even more importantly, what has become clear, in the light of the arguments that have come from medical bodies and clinicians at the forefront of innovation, is that we know that before the Bill comes into effect, various guidance will be issued by the Minister’s department and the General Medical Council—and probably by the defence organisations to their members. My assessment at the moment is that the Bill is unlikely to be used by doctors because of the advice that will come from these different bodies.

The point I wish to put to the noble Lord is this: the arguments that we have heard have been between lawyers and doctors. The lawyers—two distinguished noble and learned Lords have spoken—are saying that, by and large, the law is okay in relation to the Bill, and I fully accept that. However, doctors are saying that there will be greater confusion as a result of the Bill and, therefore, they will not use it in the way in which the noble Lord, Lord Saatchi, wants it to be used. There is no meeting of minds. The noble Lord has said that he will talk to my noble friend Lord Winston between now and Third Reading, which I very much welcome, but he surely has to engage again with the bodies he met with the Secretary of State to try to find a way through. We support what the noble Lord wants to do and the need for innovation, but my judgment at the moment is that even if he gets his Bill it will not be used, except by the kind of doctors my noble friend Lord Winston referred to—the kind we do not want to use the provisions.

As far as my amendment is concerned, I will say just this: a number of noble Lords felt that it would be a good idea if there were a register on the use of the Act—if it is used—which could then be followed up by research and regulatory agencies. There was general sympathy for that. I thought the noble Earl, Lord Howe, was, up to a point, sympathetic and said:

“The Government’s view is that it is not necessary in this Bill to require doctors to record their innovation in medical records … The General Medical Council’s Good Medical Practice guidance already sets out requirements on doctors to record their work clearly in clinical records”.

However, the noble Earl then said that he had,

“heard the legitimate concerns of noble Lords today, and I commit on behalf of the Government to explore this issue further”.—[Official Report, 24/10/14; col. 887.]

My amendment essentially seeks to embrace that, to ascertain from the noble Baroness where those discussions have got to, and embrace the requirements likely to come from the GMC over the Bill. That would provide considerable reassurance to noble Lords who raised this matter in Committee. I beg to move.

[Lord Cormack]

My Lords, the noble Lord, Lord Hunt, as he so often does, put his case succinctly and elegantly in what is essentially a probing amendment. It is important that we reflect on the points he made because the whole purpose is to get something on the statute book that will be accepted and used. Two things are essential if that is to happen. First, the notes for guidance on and interpretation of the Bill must be written in the clearest possible English. Sir Ernest Gowers’s Plain Words comes to mind. Also, there must be a version that is designed specifically for patients. In all our discussions this morning—we have heard some fascinating speeches—the word “patient” has not occurred often as it should have done. The Bill is designed, above all—as I understand my noble friend’s intentions—to help patients and their loved ones who are concerned, and who do not wish to fall into the clutches of the quacks but to be treated by sympathetic, empathetic, well trained and qualified medical practitioners.

If the Bill goes on the statute book—I hope it will—I should also like there to be a major conference on the Bill. That must be not only in London, which will of course be necessary, but around the country, in all the great regional capitals of the kingdom, so that doctors and patients will have the opportunity—I am delighted to see the noble Lord, Lord Hunt, nodding assent—to have the Bill explained to them. The Bill does not really pose a threat to any doctor or patient. If it did, it would completely negate its own purpose. Clear explanations are essential. When my noble friends the Minister and Lord Saatchi comment, I hope that they will recognise that there is some validity in the points I seek to make.

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[Lord Ryder of Wensum (Con)]

Will my noble friend accept that there are precedents in other Private Members’ Bills going back several years for such registers being set up?

[Lord Hunt of Kings Heath]

My Lords, I thank all noble Lords for taking part in this short but interesting debate. I say to the noble Lord, Lord Saatchi, about the conference that his noble friends suggest, that it is all well and good to have a conference after a Bill has been enacted, but in my judgment that is too late in relation to his Bill. He needs to engage with the professional medical bodies before the Bill goes to the other House; otherwise, he risks enacting a Bill, if he is able to do so, that will start with a huge defect—all the main medical bodies are opposed to it. I urge him to try to reach consensus with those bodies as the Bill goes through.

On the question of registration, all noble Lords agree that for any treatment that took place under the provisions of the Bill there should be a register—for patient safety concerns, research concerns and audit concerns. The question is how to ensure that that happens. I am disappointed by the Government’s response. This was meant to be a constructive amendment, which I think meets the needs. The Minister is not in favour of compulsion. She said at one stage that she thought that, even if you enacted a provision, there is no guarantee that doctors would use it, but she said later that she wanted a position where doctors would not dream of not registering with a scheme. That seems inconsistent.

On the question of the technical scope of the Bill, the noble Lord has already pointed to other Private Members’ Bills, which is a relevant point. But my amendment relates to the circumstances under this Bill. It says:

“Page 1, line 24, at end insert—”,

so I am very clear that the circumstances of a register relate only to interventions that take place under the auspices of the noble Lord’s Bill. I am not seeking to create a wide-ranging register for other aspects of legislation; I am seeking to give statutory underpinning to a register that one hopes the General Medical Council or a similar body would undertake.

I hear that the Government will consider this again. I will bring this back at Third Reading and I will press it unless we get an absolute assurance that there will be a compulsory register. I beg leave to withdraw the amendment.

Amendment 5 withdrawn.