Medical Innovation Bill [HL]

Lord Winston Excerpts

Friday 12th December 2014 Lords Chamber

Moved by

[Lord Winston]

1: Clause 1, page 1, line 3, at end insert—
“( ) The provisions of this Act shall not apply where a doctor, in the pursuit of a treatment, is required to take action where time or place does not allow the required consultation.”

[Lord Winston (Lab)]

My Lords, in moving Amendment 1, I wish to speak also to Amendment 6. The Bill states that for the purposes of taking a responsible decision to depart from existing treatment, a doctor must,

“obtain the views of one or more … qualified doctors in relation to the proposed treatment”,

and there are a number of other issues related to that. It is very clear that it is not always possible for a doctor to do this. For example, in Committee, the noble Lord, Lord Turnberg, mentioned the case of a patient on an aircraft who had a pneumothorax. That was dealt with in a way which could not possibly have involved consultation beforehand: it was a completely unexpected event. Indeed, in my view, that would apply to any emergency treatment where there is no time to undertake consultation or the doctor is not in a place where he can consult others—for example, if he is at a bus stop, in the outer islands of the Hebrides or various other such places. That would be extremely muddling for a doctor and would increase difficulties in trying to understand the appropriate thing to do under those circumstances.

Previously, I gave the example of the unconscious patient that I dealt with when I clamped off an ectopic pregnancy without an anaesthetic because my anaesthetist refused to give an anaesthetic to the patient because he felt that she might die and he did not want to be responsible for that. That is a good example of where you can have a conflict of interest or a conflict of opinions with doctors in an emergency situation. I took the view that the anaesthetist was wrong. I opened the patient’s abdomen without an anaesthetic, immediately clamped off the bleeding point and her blood pressure became recordable. She was already, of course, having a rapid blood transfusion but the blood loss inside her abdomen was so great that her blood pressure was unrecordable until that artery was clamped. Once it had been clamped, my anaesthetist admitted that the patient needed an anaesthetic and he intubated the patient. It would be very difficult for a doctor who was cognisant of the terms of the Bill to do that.

In the case of a neonate, there is the real issue, of course, that from time to time you have fractions of a minute in which to deal with an emergency. I say to the noble Lord, Lord Saatchi, that if this Bill goes through he may have a number of brain damaged children on his conscience because of the need to give oxygen to a child in emergency circumstances using unusual procedures, perhaps when it is being delivered. Each of us has undertaken the most dangerous journey that all humans take—the four and a half inches down the birth canal. To this day, that still results in a large number of children being damaged. Indeed, in this country the commonest problem leading to babies dying or being damaged is brain damage at birth. I say to the Government that it is also a grave source of litigation. Indeed, it costs the National Health Service a large sum of money. If there is doubt about how to handle this situation in an emergency and a doctor is confused, there is a very grave risk that this could interfere with his better judgment. As I pointed out to the noble Lord, Lord Kakkar, it also applies to certain surgical procedures where there are anatomical abnormalities that require innovation—in particular, when dealing with unexpected haemorrhage.

I remember an amazing occasion when I was in training with a surgeon who had removed a kidney. He was a real surgeon, dealing with bleeding in the pelvis. He asked me, “What’s the most important instrument in the operating theatre?”. I had no idea what he was talking about. He pointed to the surgeon’s stool. He said, “That stool needs to be five metres away from the operating table and you go and sit on it”. That is not in the textbooks, but what he had done was put a pack into those bleeding vessels, leave it there, and he did not fiddle. He was, therefore, not actively involved in the consequences. That innovation by the late Dr Magri, who was my amazing teacher, helped me to understand how one could deal with haemorrhage in the pelvis, which for a gynaecologist is an important point. Therefore, I would argue that my Amendment 1 will allow a surgeon in particular, but other practitioners in general, to conduct required treatments without considering the measures proposed in the Bill, if it becomes an Act of Parliament.

Rather than detain the House for too long, I now turn to my Amendment 6. It was briefly dealt with in Committee in relation to the use of drugs. Unfortunately, we did not discuss it in any great detail. However, noble Lords will see that it is necessary—indeed, I think it is essential—to define what we mean by an innovative treatment. Innovation can mean a whole lot of different things to different people. This is not in any way a wrecking amendment. It is designed to clarify the Bill and make it rather more workable and safer. We will come back to patient safety later.

It seems to me that there are four areas where one can define innovation. The first is a medical treatment where there has not been any peer-review evidence for the benefit of that treatment or a clinical trial. In the debate on that issue, the noble Baroness, Lady O’Neill, pointed out that randomised control trials were not the only method of dealing with medical evidence—and she is, of course, absolutely right. She is the most brilliant individual and I bow to the point she made. None the less, she did not say in her argument that we should not have evidence based on some form of proper clinical appraisal. That is an important aspect.

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[Baroness Gardner of Parkes (Con)]

My Lords, I do not really understand the proceedings, in so far as the noble Lord, Lord Winston, spoke only to two of his amendments. These are all grouped together. I have just consulted with the clerk, but they should really have all been covered. I do not know whether he intends to find some way of coming back to it, but I thought we could speak only once on these things on Report. I am particularly interested in the exact meaning of his Amendment 13. I seek information on this as I read it: would Amendment 13 possibly prevent people using new innovative stem cell treatments, for example? What is the intention of Amendment 13? As he did not speak to either Amendment 12 or Amendment 13, I feel that the House should be informed as to what he means by those amendments, as this is the only opportunity to discuss the group that has been put together.

[Lord Winston]

Before the noble Baroness sits down, I wanted, for clarity, to speak to two amendments at a time. I will speak to Amendment 13 in due course and say exactly what I meant. If the noble Baroness wishes me to speak to those amendments now I will do so.

[Baroness Garden of Frognal (LD)]

To clarify for the noble Lord, the amendments are grouped together, so he is required to speak to them in the group. He will, of course, have the right to come back at the end of the group and he may wish to include them at the end.

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[Lord Winston]

I am very happy to speak to those amendments now. They are very simple. The question of the dental practitioner is simply that dental practitioners also are involved in maxillofacial surgery and other treatments that may require innovation. With regard to other practitioners who are not medically registered, we are going to require more and more nurses and other workers with university qualifications who will be conducting treatments, and it is therefore important that we clarify whether they will be able to innovate.

[Baroness Garden of Frognal]

I must point out to the noble Lord that it is not in order for him to speak twice to a group of amendments at Report stage.

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[Baroness Garden of Frognal (LD)]

My Lords, I notice that the noble Baroness, Lady Wheeler, has spoken to the amendments which the noble Lord, Lord Winston, did not speak to. I will seek advice from the Clerk as to whether the noble Lord may wish to degroup the amendments to which he did not speak. I think that that would be up to the noble Lord. For the convenience of the House it might be clearer if he degrouped the amendments to which he did not speak. Does the noble Lord, Lord Winston, wish to do that?

[Lord Winston]

It is very kind of the Front Bench to offer that possibility. If I were to degroup an amendment, I would degroup the stem cell one and put it with Amendment 5, as it would fit better with patient safety. One of my difficulties is that the groupings are slightly odd in terms of the relevance of the different aspects of my amendments.

[Lord Mackay of Clashfern]

My understanding of the groupings system is that those who have views on the amendments should take the opportunity to speak when the relevant group is first dealt with, but it does not preclude a noble Lord who has tabled an amendment speaking when the amendment is called in the ordinary course of events. As your Lordships know, following a debate an amendment is often called as being not moved, but the person who tabled the amendment has the option to move it at that point. Therefore, in that sense there are two opportunities to speak. However, in order to try to make the procedure as economical as possible, the general idea of the groupings system is to enable a group of amendments to be considered as a whole on the basis that, rightly or wrongly, such consideration is facilitated in that way.

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[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.

[Lord Winston]

My Lords, I apologise for my infelicity in getting the groupings wrong. I am very grateful to the Front Bench for making their proposal, which is very helpful.

I realise that I have been in your Lordships’ House since 1995 and this is the first time that I have ever proposed amendments at a Report stage. I should have learnt by now how to handle a Report stage, but I have to admit that, due partly to inexperience and partly to lack of attention to your Lordships during other Report stages of different Bills, I do not. Be that as it may, I shall not go on for long.

I was pleased to hear a degree of support for my Amendment 1, about emergencies, because I think that that approach is necessary. If the noble Lord, Lord Saatchi, is prepared to talk to me about that and see what we might do perhaps at Third Reading, I would be very happy to see how we might get more effective wording for some of these ambiguous areas in the Bill.

I am disappointed that we are not defining “innovation”. That is important because, clearly, these are issues which doctors will need to consider. It is clear from a large number of responses from doctors that there is very considerable confusion about the Bill. What is extraordinary is the number of bodies that show this confusion and say how right doctors are to be confused. Although the Royal College of Ophthalmologists is apparently worried about a particular drug—I bow to the knowledge of the noble Lord, Lord Saatchi, about this; I did not know that it was—the list of concerned bodies includes the Academy of Medical Sciences, of which I have the honour to be a fellow, the Academy for Healthcare Science, the Medical Research Council, the Wellcome Trust, the British Medical Association, the Royal College of Physicians, of which I am also a fellow and therefore I have an interest, the Royal College of General Practitioners, the Royal College of Radiologists, the Royal College of Psychiatrists, the Royal College of Surgeons of Edinburgh and, to some extent, the Royal College of Surgeons of England, the Association of Medical Research Charities, Action Against Medical Accidents, the Medical Defence Union and the Medical Protection Society. I know that it has been suggested, rather irrationally, that somehow the lawyers want to leave things as they are so that they can make more money but, in fact, the Medical Defence Union and the Medical Protection Society are most involved in litigation and they clearly want a reduction in litigation, which is why they are not in favour of the Bill.

Also concerned about the Bill are the British Pharmacological Society, the NHS Health Research Authority and the NHS Litigation Authority—I checked its website this morning to confirm that—Healthwatch and, rather importantly, Cancer Research UK, which raises about £700 million a year for the treatment of cancer in this country. Also concerned are the Motor Neurone Disease Association and, to some extent, the National Institute for Health and Care Excellence. They are mostly concerned about the confusion to doctors, but some would go further than that. They say that the Bill is unnecessary and, as I shall seek to explain, may endanger patient safety.

The reason why I tabled the two amendments about medical practitioners is that it is fair to say that, in future, the National Health Service will have to rely more and more on people who are graduates other than medical graduates. Therefore, the Bill should recognise that they will sometimes need to innovate. It may be worth clarifying their position at this stage.

For the moment, I will not divide the House on Amendment 1, but I would very much value further discussion with the noble Lord, Lord Saatchi.

[Baroness Manzoor (LD)]

My Lords, before the noble Lord sits down, will there be any consideration of the nursing profession and others to be included when he is thinking of medical practitioners who are not qualified?

[Lord Winston]

I personally think that that is very important. That is why I tabled the amendment, because I wanted discussion on the issue—in particular, for health visitors and more senior nurses, whose position means that they often have to be innovative. The real issue here concerns midwives, because midwives—particularly district midwives, when they do not have a medical practitioner with them—are often presented with horrendous situations where they have to act innovatively. We hear from the Department of Health that it would like to extend home delivery. That may be a very good thing—I do not know; although I am a qualified obstetrician, I have concerns about that—but if that extension happens, as seems likely given that the health service is strapped for income, it is important to consider other health professionals who may be confronted with those problems. At the moment, the Bill does not do that, and I think that that will cause problems in future.

[Lord Saatchi]

My Lords, on behalf of our team and, I am sure, that of my noble friend and the Department of Health, I greatly welcome and would appreciate the opportunity to discuss the points that he has made between now and Third Reading.

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Moved by

[Lord Winston]

2: Clause 1, page 1, line 5, at end insert—
“( ) This Act shall not apply where the body of responsible medical opinion considers that the innovative treatment being considered is likely seriously or unreasonably to compromise patient safety.”

[Lord Winston]

In another place on Tuesday evening, there was an Adjournment debate moved by the honourable Member for Totnes, who is a qualified medical practitioner. In her outstanding speech, she raised serious concerns about the issue of patient safety. In particular, she cited her concern that patients, particularly those with cancer, may be at serious risk from quack practitioners who are offering a quick-fix solution for money rather than a course of authentic treatment, and possibly entering a clinical trial. The effect of this on cancer treatment could be disastrous. First, not only might we end up endangering patients by their entering a treatment that is not valid or appropriate. Secondly, research may be inhibited because we cannot fill the clinical trials needed to prove that cancer drugs are effective.

We are now in the age of genomic medicine. Genomic medicine means, more and more, that each cancer is different. Essentially, we are understanding that there are more and more mutations. As each of us in this Chamber gets older, we develop more and more mutations, so we are more liable to get different cancers in different cells. Of course, there are the common ones, but it is worth bearing in mind that more than 50% of cancers are actually quite rare. It is important to understand that each individual rare cancer makes a massive difference to life expectancy and health in Britain. Indeed, about one-third of us in this Chamber will suffer with a cancer and, on the figure I just quoted, roughly half of those will be rare cancers.

We are beginning to understand that each of these cancers can be targeted with a specific genomic medicine which may apply only to that cancer. A classic example was the case of vemurafenib, which was used for a rather unusual form of skin cancer and resulted in metastases massively drying up—but it would not work for other cancers, because the mutations were different.

It is imperative, as Cancer Research UK clearly says, that we get patients who are able to go into trials. Apart from the fact that it would be disastrous for the safety of the patients who are being treated irrationally by illogical treatments, there is also a question of patient safety generically for our entire British population. That is the purpose of the amendment.

I have focused on one area in my Amendment 13, which is the use of cells and tissues that are biologically derived. The reason I included that is because stem cells will clearly be an important use in future. Already, we are seeing practitioners setting up quack medicine which is not proven, where they are injecting cells into patients without proper validation. That is clearly dangerous. It is being used for dementia, some forms of motor neurone disorders and other neurological disorders, such as disseminated sclerosis. A number of cancer patients have also had these horrendous treatments. That is likely to burgeon, so it must be taken very seriously by the House.

We have to be absolutely clear that whatever we do, we do not endanger patient safety. There are some interesting examples in the history of medicine. The noble Lord, Lord Walton, who comes from Newcastle, told me yesterday that he is hugely against the Bill. He is very concerned that it will damage patient safety, but for health reasons—as your Lordships know, he is now 92—he felt unable to come down from Newcastle today. He reminded me of a case which I knew of way back in the 1950s. In Oxford, where he came from at that time, there was a Dr Honor Smith. Dr Smith thought that the injection of tuberculin into the spinal cord of patients with neurological disorders—in particular, with disseminated sclerosis—might alleviate their condition. In fact, it did not.

[Baroness Garden of Frognal]

My Lords, I apologise for intervening, but is the noble Lord now speaking to Amendment 13 as well? Is he speaking to Amendment 13 in this group?

[Lord Winston]

I am speaking to both.

[Baroness Garden of Frognal]

No, no. We are in the second group. The noble Lord is moving Amendment 2 in the second group, but he seems to be speaking also to Amendment 13 in this group. Is that correct? If it is, then other noble Lords will want to respond to Amendment 13 as well. Perhaps the noble Lord could clarify which amendments he intends to speak to in this group.

[Lord Winston]

I am sorry. At the moment, I am speaking to Amendment 2 on the question of endangering patient safety, but of course the injection of stem cells is also relevant to patient safety, for the reasons that I stated. Let me continue with patient safety—or am I out of order?

[Lord Cormack (Con)]

May I try to help the noble Lord? He did refer to Amendment 13, because it had been suggested earlier that it would fall more happily into this group—so it seems to me that he is conforming to that suggestion.

[Baroness Farrington of Ribbleton]

My Lords, if it may help my noble friend, the noble and learned Lord, Lord Mackay of Clashfern, referred to the fact that my noble friend could speak to Amendment 13 in its place on the Marshalled List. Therefore we cannot reach Amendment 13 until we have gone through the others.

[Lord Winston]

I am now totally confused but, if I may say so with great politeness, it sounds as if I may not be the only person in the House who is confused. The key thing here, which applies to both these amendments, is the question of patient safety. Amendment 2 argues that wherever “responsible medical opinion” regards that patient safety might be compromised, that needs to be considered in the Bill. That is an important issue and would certainly include the use of stem cells in particular, for the reasons that I have stated.

I was going to refer to a few medical examples where in fact innovations have been done without proper scrutiny. For example, Dr Smith felt that she could inject tuberculin into the spinal cord; the result was in fact disastrous for those patients. The noble Lord, Lord Walton, thought that this was a very good example. What was reported was that the tuberculin recipient had constitutional illness with meningitis, more alarming complications from their nervous system, vomiting, retention of urine, dysphagia, dysarthria, and a whole range of other symptoms which were actually made worse. It was a scandal at the time and a very good example of where, if you have innovation which is not properly controlled, there is serious risk.

I found it quite amusing, by the way, that the lady at Oxford, Dr Honor Smith, was the daughter of a Member of this House. She was the daughter of a Baron—so, technically, she was the honourable Honor Smith. However, I do not think that she ever used that title.

This came up again in the House of Lords later on when the noble Lord, Lord Brabazon, supported a quack treatment in 1995 of a Dr William Crofton, which was also for neurological disorders and used something rather similar. One of the problems was that people with these neurological disorders, which as we know are terrifying and untreatable, flock to practitioners in the hope that they may have an unsuccessful condition successfully treated. That is still a real issue for us all in this House.

In response to the honourable Sarah Wollaston, the Member for Totnes, in the other place this week, the Under-Secretary of State for Life Sciences at BIS, who was replying on behalf of the Government, mentioned that the Government were determined—let me get the exact quotation for the record, if I can find it in Hansard. In answer to the debate on this Bill, he said:

“I reassure the House that the Government are committed in all this work to putting patient safety first and developing a landscape of evidence-based medicine”.—[Official Report, Commons, 9/12/14; col. 850.]

I suggest to your Lordships that the Bill does the reverse. It tends to risk patient safety in certain cases where patients are desperate for a treatment. It will also reduce the chance of evidence-based medicine.

I thought about this long and hard last night. I must tell the noble Lord, Lord Saatchi, that I did not sleep last night. I woke at about 1 am, having gone to bed at 12.30 am, and could not sleep for thinking about the Bill. I understand that he has been extraordinarily courteous and very gentle in introducing the Bill. He has also been very helpful in trying to ensure that the Bill is as safe as possible and very good at listening to our concerns. I understand, too, that he has had a great tragedy that has made him feel very strongly about this issue. I fully understand and deeply respect that, and I wanted to tell him something about myself, which he may not know.

When I was not yet nine, my wonderful, amazing, chess-playing, musical instrument-playing, polymath craftsman father died. He had a minor infection that was treated by an innovative antibiotic which was quite inadequate. He then had an innovative removal of a chest drain too early, so that he developed an abscess in the pleural cavity. Finally, within six months he had an innovative operation, which was not evidence-based, in which his brain was opened and an abscess removed. This man of 42 died, leaving my mother desperate and financially destitute. I was the eldest of three children; I had a sister aged four and a brother aged three. My mother was amazingly in love with my father, so I know something of the tragedy of seeing what happens when somebody is destroyed in front of you. I do not take this as an issue that leads me to oppose the Bill—that is not the case at all—but I am very concerned that we should not use innovation where we might compromise patient safety.

One of my concerns is that we often think of the National Health Service as a football. I take strong objection to my own side when it says that it is the only side that wants to support and protect the health service. That is nonsense; we all want to protect the health service and to see a health service that is efficient. Unfortunately—and I say “unfortunately” because I mean it—at the next election, I know that the health service is bound to be something of a political football. These issues are going to come up and therefore I want to make certain that we have the chance to innovate in a responsible way. Ultimately, I am not convinced by the arguments that the noble Lord, Lord Saatchi, has put forward. There are cases where treatment that is authentic and should be offered will be compromised in response to patients who are so desperate that they are prepared to try anything which has not been fully, or even partially, tested. For that reason, I beg to move Amendment 2—and I have spoken also to Amendment 13.

[Baroness Gardner of Parkes]

My Lords, I was particularly keen to hear the explanation of this amendment because the more I read it, the less I understood it. I would appreciate clarification from the noble Lord because I did not, and still do not, understand whether by putting this clause in on this sort of thing, we might be preventing treatment for that man who has just walked in Poland and the people who can suddenly see again because of the treatments for their eyes. If we tend to bottle this up completely, it would mean that all the marvellous advances which have changed people’s lives completely might be slowed down by this amendment. Now, if I am wrong in that, that is a different matter.

The noble Lord, Lord Winston, spoke very movingly about his own personal circumstances. However, where I disagree with him is when he talks about these desperate people who will try anything. That is one of the issues that the Bill is designed to help with. It covers only the cases of people who are already in a terminal condition. The one thing that many of these people do not have is any hope of progress, and in most cases they are willing—certainly in the cases requesting this sort of innovative treatment—to take the risk with what is only a very short piece of life remaining, in the hope that either the treatment might cure them or it might do something to advance research at a faster rate and therefore help other people in the future.

Reading this amendment, I was not clear whether it was pro-advance or anti-advance. As I say, I am still not clear. As it stands, I have grave doubts about supporting it; I think it would take away hope, which is about the last thing that remains for a lot of people.

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Amendment 13, in relation to cell and tissue insertion, tabled by the noble Lord, Lord Winston, would have the effect of disapplying the Bill to innovative treatments involving the insertion or injection of cells, tissues or certain other material. To take guidance from my noble friend the Minister, she expertly summed up why the Government feel that it is hard to support the amendment—and the same applies to me. I listened with great respect to what the noble Lord said on this issue today and on many other occasions. At this moment, I am not clear that the fundamental principles of the Bill in relation to what is reasonable needs to be different in relation to treatments of this kind. However, I accept that he explained a context that is most certainly a specialist one. I have understood what he said but I have also heard what my noble friend the Minister said. I have to invite noble Lords not to accept Amendment 13 and I hope that, on reflection, the noble Lord, Lord Winston, might feel able not to press the amendment.

[Lord Winston]

My Lords, first, let me thank the noble Lord, Lord Saatchi, for his gentle and helpful comments, which I am sure are appreciated not just by me but by the House in general. I felt great difficulty in talking personally on this issue and I debated with myself whether I should do so. I look forward to talking to the noble Lord about the amendments we have been discussing outside the House as soon as possible and I shall make arrangements to do so. I am at his disposal.

I am astonished by the Government’s response. It is not adequate for quite different reasons. It is nothing to do with the noble Lord, Lord Saatchi, but the noble Baroness, Lady Jolly, does not seem to understand that the regulatory framework we have does not encompass my objections. She mentioned, in particular, the Human Fertilisation and Embryology Authority—I have no doubt we will have this debate repeatedly over the next months—but perhaps she is not aware that two weekends ago I went to the Fertility Show at Olympia, where there were a number of stands of private clinics offering their wares to patients. Offered on their big posters are treatments which are illegal or not regulated in Britain, including, for example, sex selection and some cell treatments. Practitioners who are registered with the Human Fertilisation and Embryology Authority, some of whom will be involved with stem cells, are in relationships with clinics outside this country which are not under the jurisdiction or regulation of the Government. I am happy to name but I shall not do so in the House.

The Government must understand that regulation does not cover all these issues. There are many examples where experimental treatments are being carried out in this great city of London at huge expense. This week I have received two e-mails, one concerning a woman who spent £11,000 for a single treatment and another where a woman spent £69,000 for three treatments. These treatments were not validated but would be regarded as innovative. That is why I am concerned about this. I shall not divide the House.

Amendment 2 withdrawn.

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[Lord Kakkar (CB)]

My Lords, I declare my interest as professor of surgery at University College London. I also support the amendment very strongly. It comes to the very heart of innovation and sharing the results of that innovation openly, whether they are negative or positive. Therefore, 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.

[Lord Winston]

My Lords, as far as patient safety is concerned, it is clear that there is a need to keep a record so that other patients do not receive a misguided innovative treatment following an unsuccessful one. That is very important.

[Baroness Jolly]

My Lords, Amendment 5, moved by the noble Lord, Lord Hunt, and supported by the noble Baronesses, Lady Wheeler and Lady Masham, and the noble Lord, Lord Turnberg, seeks to require the registration of innovations that are carried out under the Bill as part of the steps that a doctor should follow when taking a responsible decision to innovate. The Government have listened carefully to the concerns expressed by noble Lords and several key stakeholders, including the Royal College of Physicians, with regard to the collection of data resulting from innovation. We agree that it is vital that doctors are able to share learning about innovation that results from the Bill. However, we do not think that a requirement to record the results of innovative treatments should be included on the face of the Bill. Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent, as Amendment 5 would require, would impose requirements that go beyond the current Bolam test of negligence. We are reluctant to impose requirements additional to those in the existing law as this may risk deterring doctors from innovating.

A stand-alone clause that would require doctors to register the results of innovative treatment 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. Broadening its scope in this way risks the Bill becoming the receptacle for a host of measures on innovation that are unrelated to the subject of clinical negligence. What is more, such an amendment may lead to confusion as doctors associate the Bill with clinical negligence and may therefore wrongly assume that the recording of innovation is tied in with the test of clinical negligence under the Bill. This additional burden may dissuade a doctor from innovating. It would be unclear to those doctors who choose not to innovate under the Bill whether they would be required to register the details of their innovation on the registry or whether the provision applies only to those innovating under the Bill. If the provision applied only to those innovating under the Bill, this would create an anomalous position for those acting under the Bill. More importantly, the act of putting something into legislation does not guarantee that doctors will adhere to it. We need to focus on incentivising doctors to use the registry and make such a registry work for their needs. It would be unwise to put something into legislation that does not work for doctors and that they would therefore not be able to adhere to.

I am sorry, but I have lost my place.