Medical Innovation Bill [HL]

Lord Winston Excerpts

Friday 27th June 2014 Lords Chamber

[Lord Newby]

My Lords, perhaps I may remind the House of what I said at the start of the debate; namely, that it is a firm convention that the House should rise at around three o’clock on sitting Fridays.

[Lord Winston (Lab)]

This is a Bill of colossal importance and to truncate speeches to six minutes, even though it is a Friday, seems to be highly undesirable. It needs to be discussed because there are many implications behind this piece of possible legislation.

[Lord Newby]

My Lords, I am not in any sense trying to curtail the debate. I am reminding noble Lords of the conventions of the House. My experience of listening to debates is that those in which the speeches last for six minutes can be among the best we have.

--- Later in debate ---

[Lord Winston]

My Lords, when I first read the Bill I was deeply impressed and thought how important it was. I congratulate the noble Lord, Lord Saatchi on introducing it. It is a hugely welcome discussion; I am very pleased that we are having it today, albeit in a truncated fashion. When we come to Committee, we will need to tease out a number of issues that the Bill raises. As I think more and more about the Bill, I have increasing misgivings, which I must explain to the noble Lord, Lord Saatchi, whom I deeply respect; I think he has acted with huge dignity and great compassion throughout his speeches on this issue, including on this occasion.

I am not against innovation in any way. In fact, innovation—if I may dare to be so pompous—has really been my entire life. For 40 years in surgery, I have innovated. I produced the finest microsurgical needles, which were not made by manufacturers—we made them on the bench ourselves because we needed them. I designed my own instruments, which subsequently became a general standard throughout the world and were finally designed by a German company. They were not standard in Britain. I swung a microscope over the abdomen of a patient for the first time anywhere in the world—something which most people thought was actually risky because it might introduce infection. It transformed pelvic surgery. I have to say that when laparoscopy came along, I think I was probably the first person to operate down a laparoscope, well before any general surgeon did so. Indeed, it was only with subsequent experience that we realised that laparoscopic surgery—fortunately, not in my hands as a gynaecologist but in the hands of general surgeons—actually caused a number of very serious accidents and even a few deaths. Of course, it took experience to find out that that innovation actually had all sorts of complications which might not have been recognised by any committee assessing the situation to start with.

Also, in the field of in vitro fertilisation, we have clearly been innovative in this country. We introduced hormone treatments, which could not be assessed by a randomised controlled trial initially—one of the points that Onora, the noble Baroness, Lady O’Neill, made was that there are many ways of assessing research. Programmed dosing of drugs in IVF, which transformed that treatment and made it possible to perform retrievals without laparoscopy at all, without a surgical procedure, were started in my unit and are now used world wide. There is also the example of ultrasound replacement of the embryo.

One trial that we did that was not truly randomised was to give patients alcohol at the time of the embryo transfer, because we thought that alcohol might calm the uterus down and therefore stop it contracting. Of course, that was not something you could really submit to an ethics committee, but it is the sort of thing that a woman might take during treatment. We found that white Loire wine had no proven benefit, but a good red from Pauillac was really quite effective.

Subsequently, genetic diagnosis, which was important in how legislation was formed in this House, could not easily be assessed, except by an ethics committee. There was a whole range of innovative procedures there that did not need this Bill. Neither did sperm microinjection nor endometrial abrasion. We now find, for example, that if you make a deliberate injury in the lining of the uterus before in vitro fertilisation, you can improve the success rate. That is completely counterintuitive and might be quite difficult to get through a committee without very difficult scrutiny. We also introduced what is called sham transfer, which prevented a lot of patients having unnecessary embryo transfers.

I feel a little like the noble Earl, Lord Howe, who is sitting on the Front Bench. I do not think that he was in his place during Prayers this morning, when we heard from the right reverend Prelate the Bishop of Birmingham:

“I will lift up mine eyes unto the hills, from whence cometh my help”.

I suspect that he feels that quite often when he is besieged by doctors protesting against legislation or improvements in governance. However, this issue really is causing increasing concern among many practitioners, as the noble Lord, Lord Turnberg, said. It is not quite as simple as was originally thought and we need to be very well aware of that, because it has the possibility of untold consequences. I want to explain what I think those are in just one minute or so.

We can see very well that in the practice of in vitro fertilisation now being carried on, all the governance in the world, including a regulatory framework, does not prevent innovative treatments which risk damaging patients. Let me give just two examples. One of them is embryo biopsy, which is substantially to try to understand which embryo might be better for transfer. What we actually know now, after various meta-analyses of a number of randomised trials, is that this procedure not only decreases the chance of a pregnancy by about 50% but is ineffective in understanding whether an embryo is truly suitable for transfer. Moreover, animal experiments now being done are showing that some mice show changes in their central nervous system, which lead to cognitive impairment when they are adults. Some of them are showing demyelination of nerve fibres in the brain. This potential innovation is one example of in vitro fertilisation—but not the only one—that might cause untold circumstances without all sorts of issues which innovation might risk. Not the least of those is blastocyst transfer, which we know causes changes in gene expression in humans in some cases.

Innovation undoubtedly has risks and we really have to understand that. If this Bill goes through to Committee, as I hope it will, we will clearly need to look at it very carefully to make sure that a number of amendments are made to it. I notice that the noble Baroness, Lady Bakewell, is now not in her place. Sadly, and in spite of what the noble Baroness said, litigation might increase as a result of the Bill as patients might decide to litigate because a doctor has not tried innovation in an unusual circumstance. Whether we like it or not, the problem really is that litigation under any circumstances is extraordinarily damaging to all parties concerned, even when a patient wins the case. It should be avoided not least because of that psychological damage, leaving aside the cost to the national purse.

The massive correspondence which I have received is very concerning. I conclude with the words of Michael Baum, one of the leading innovative surgeons in cancer in this country, whose contribution to breast cancer is second to none. He has said to me that in his view, “Their Lordships are walking over a precipice if they pass this Bill”. We have to listen to that very carefully. Of course I really want to demonstrate my absolute sympathy for what the noble Lord, Lord Saatchi, has said. I congratulate him on bringing forward the Bill but we need to consider it very carefully on the Floor of the House in due course.

--- Later in debate ---

[Lord Woolf (CB)]

My Lords, like those who have gone before me, I congratulate the noble Lord, Lord Saatchi, on his Bill and endorse the view of the law as it is at present, so clearly enunciated by the noble and learned Lord, Lord Mackay. What is important to appreciate—and, possibly, this may not have come through clearly in some of the speeches delivered today, although all of them were carefully considered and moderate in their tone—is the fact that the Bolam test, good as it is in the courts for determining questions of negligence, is not designed to deal with the question of innovation, although it has been tempered so that it does not prevent innovation, as it might otherwise.

Some time ago now, I had the task, given to me by the noble and learned Lord, Lord Mackay, of looking at civil justice and proposing reforms to it. The area in which there was the greatest need for reform was with regard to medical negligence and how such cases were conducted. There was a remarkable situation whereby doctors and patients were unable to speak to each other and had no confidence in what would be the consequence of doing so. The doctors on the one hand said, “We are threatened by these actions, which can ruin our lives and our careers”, and the patients on the other hand said, “All I wished was for somebody to say sorry for what happened, and no doctor came and said that to me”. The reason for that was that the doctors were worried that, if they did say sorry, it would be interpreted as an admission of negligence, whereas no sensible court would ever take that view.

I stress these matters because, at present, doctors do what I would regard as vital work, taking their courage in their hands and doing what they think is in the best interests of their patient, even though it involves innovation, while having no way of telling beforehand whether they can successfully comply with the Bolam test. The other thing that the law does not do at present is to require doctors to do what is necessary if they are going to innovate in a responsible way—that is, to be open about what they are doing, to make it clear that what they are doing is innovating and to take carefully thought-out steps to see that the cleansing effect of openness that we have heard about applies to what they do. One very important effect of this Bill is to set out a course that must be taken by a doctor if he is going to innovate. Those steps have been gone through in turn by the noble and learned Lord, Lord Mackay; they speak for themselves, and I do not propose to say any more about them than this.

In a Bill of this sort, you can try to find a balance between the dangers involved in innovation and the protections necessary in the interests of the patients, albeit that the patient may not be appreciative of that fact, and may be desperate for something to be done, while no responsible doctor should do what an irresponsible doctor would do. There is always going to be a danger, but there can be a balance. That is a word that really has to be applied with regard to consideration of the Bill. I suggest to the House that it draws a proper balance and takes into account the need to encourage innovation and remove barriers to innovation, while at the same time taking into account the risks by doing so.

The final thing that I would say about this Bill is that it is nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors. The doctors with whom I spoke when I conducted my inquiry made that clear, and doctors whom I have met in the course of my social life have equally made that clear. It is something that hangs over them. At the moment, the problem with the Bolam test is that it may provide them with protection when they get to court, but that is little comfort to doctors who have litigation going from stage to stage through the process to the courts, and whose lives are cast into the shadows by what is happening to them. It will be a great benefit that comes from this Bill, if that is removed by the open and transparent steps that it recommends.

[Lord Winston]

I apologise for intervening, as I understand that this is a time-limited debate, but this seems to me a very important issue. Every surgical operation in a sense is innovatory because anatomy varies from patient to patient, and many emergencies are highly innovatory when a patient is bleeding. Is the noble and learned Lord convinced that litigation may not be a problem in those circumstances where a surgeon decides not to innovate to try to save a patient’s life when they are bleeding? That seems a very difficult issue under law.

[Lord Woolf]

Of course, I fully accept that there is a problem in that situation and that not all doctors will be as brave as the noble Lord, given the innovations he told us about in his speech. Other doctors will take the less courageous course and, if faced with an emergency, will take what they feel is essentially the safe route, even though it may not be the best one.