Medical Innovation Bill [HL]

Lord Winston Excerpts

Friday 23rd January 2015 Lords Chamber

Moved by

[Lord Winston]

1: Clause 1, page 1, line 10, at end insert “(for the purpose of ensuring that the proposed treatment would command the respect of a representative body of responsible medical opinion, having regard to the needs of patient safety).”

[Lord Winston (Lab)]

My Lords, I shall not detain the House for great length. The amendment in my name and that of the noble Lord, Lord Saatchi, addresses patient safety, an issue which is dear to this Government. One of the concerns expressed again and again throughout the Second Reading and Committee stages of this Bill, and subsequently, has been that some patients might in desperation, for various reasons, seek treatment which is innovative but not properly regulated or properly justified. Particularly in the private sector, patients might be tempted to go into treatments which seem attractive but perhaps are overadvertised as sensible. In the end, they may be more futile than more recognised treatments that may carry known side-effects or perhaps be more frightening. I think that that is the case for cancer in particular.

This amendment is designed to make sure that any treatment given under this Bill would get broad support from responsible medical practitioners. There would be an onus, not only on the person doing the treatment, but on the person responsible for advising that the treatment was reasonable to the operator, the medical practitioner concerned. This would fall within that area. Essentially, there would be a legal onus, a responsibility, for that adviser to give advice which was regarded as serious and acceptable to a broad body of medical opinion in that field. That is the essence of this amendment, which we have discussed.

I am delighted that the noble Lord, Lord Saatchi, has agreed to put his name to this amendment. It is helpful. I hope that it will not prevent people participating in trials, particularly in cancer medicine. I also hope that it will make sure that private medicine is carried out responsibly. We all have reservations about this Bill but it covers most of the issues about which we have been concerned. I am concerned about reproductive medicine because I fear that that is now in a burgeoning private area. It worries me still that quite a lot of reproductive medicine done in the private sector is not properly validated and that patients are paying very heavily for it. Beyond that, broadly speaking, this is the amendment that I would like to see on the statute book. I therefore beg to move.

[Baroness Gardner of Parkes (Con)]

My Lords, I am slightly concerned about the wording of the amendment because I would not want it to become a way of dragging things on forever. How do you decide what is,

“a representative body of responsible medical opinion”?

To lay people such as myself, there seem to be heaps of medical bodies and I wonder how that would be determined. I would be interested to be satisfied on those points. The speech of the noble Lord, Lord Winston, was clear that he does not intend the amendment to represent any of those matters, but I would like someone who is more of an expert on the wording of these things to assure me that it would not be only a preventative technique.

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[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.

Amendment 1 withdrawn.

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[Lord Ribeiro (Con)]

My Lords, many noble Lords will remember the disasters that occasioned the introduction of laparoscopic cholecystectomy in the 1990s. Quite a few patients suffered as a result of the innovation of our surgeons playing with a new instrument, new tools and a new operation. At the time, I was secretary of the Association of Surgeons of Great Britain and Ireland. In recognising the problems, we introduced a voluntary register of all surgeons undertaking the procedure and got a very good response. Admittedly, it was not compulsory and not every surgeon introduced their data to it, but the net effect was that when we analysed our data we were able to identify where many of the problems lay. That led to further research and proper control trials in the procedure. We were able to turn to that from an innovation used by a succession of surgeons as and when they felt necessary, without any good evidence on how best to use it. On that basis, and mindful of the benefits that we saw in the 1990s, I would very much support some form of register to ensure that, if an innovation is introduced, we have the information, can go back and refer to it again, learn from the mistakes and improve the outcome.

[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.

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[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.

[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.