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20 Nov 2008 : Column 147WH—continued

3.19 pm

Dr. Evan Harris (Oxford, West and Abingdon) (LD): It is a pleasure to follow the hon. Member for Birmingham, Edgbaston (Ms Stuart)—I hope to engage with some of her arguments—and the hon. Member for Eddisbury (Mr. O'Brien), who has demonstrated today that his interests go beyond the excellent work that he does in the field of malaria, for which many of us are extremely grateful. His work has been widely recognised.

I thought that it would be appropriate to declare interests at the outset. I co-chair the all-party kidney group, which has members from all parties and does not have a particular line on the issue. The group is supported by the National Kidney Federation, which supports an opt-out system for organ donation. In turn, it is supported in its work with the all-party group by donations from Roche, although the firm has no input into the output, as it were, of the all-party group.

I am also a member of the British Medical Association medical ethics committee, and have been for some years. At the BMA conference in 2000, I proposed a motion calling for the association to support an opt-out system of organ donation based on an ethical imperative and evidence of effectiveness. It was endorsed by the BMA, and since then, the BMA and its ethics committee have campaigned for an opt-out system of organ donation together with all the other things, because it is not an either/or situation. There is complete consensus about things that must be done. In 2002, I proposed a motion at the Liberal Democrat party conference, which is an unusual beast because policy is made on the basis of representatives’ votes. It has been Liberal Democrat policy since then to support an opt-out system for organ donation, although with a free vote for parliamentarians.

The issue should, of course, be subject to a free vote. I will come on to express my views on the Government’s current position, but I would like the Minister to give an undertaking that if they decide in future to recommend a move to an opt-out system or that Parliament should have the opportunity to decide—of course Parliament can seek to take that opportunity whenever a suitable occasion arises, although the Government are perfectly entitled to give their view as forcefully as they like; I have not noticed the Department of Health holding back from giving its view on such issues—there should be a free vote for MPs. I hope that that will be accepted in this case.

As the hon. Member for Eddisbury said, I proposed an amendment, with cross-party support, to the Human Tissue Bill in, I believe, 2003. The Bill became the Human Tissue Act 2004. It was disappointing that the hon. Member for Ealing, North (Stephen Pound) was reported in The Independent as saying that MPs had been told that they would be whipped into the No Lobby on the Monday. I fear that either the Prime
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Minister has changed his mind, which I welcome, or he has not changed his mind but was whipped into the No Lobby on the amendment, which I would regret. Of course, he does not need me to look after his interests, particularly now.

I shall make the case for an opt-out system, and I wish to pay tribute to some of the parliamentarians who have supported it in the past: Tam Dalyell, who was mentioned by the hon. Member for Birmingham, Edgbaston; the right hon. and learned Member for Rushcliffe (Mr. Clarke); the hon. Members for Mitcham and Morden (Siobhain McDonagh) and for Broxtowe (Dr. Palmer); the hon. Member for Ealing, North, who won a “Today” programme listeners’ poll on the subject and threw himself into the campaign; and the Prime Minister, who it would appear had the courage to consider the advice of the chief medical officer and say that he had changed his mind.

Because of my position on the all-party kidney group, I attend meetings of the Kidney Alliance, which represents all the organisations that have an interest in renal affairs. It does not take a particular line, and it has agreed that it will not rule out opt-out, but it wants all the things that are the subject of consensus to be introduced first, or at least at the same time.

Ms Gisela Stuart: Will the hon. Gentleman accept that a different argument could be made for kidney transplants, as it is possible to have a live transplant of one kidney? There was an attempt in the House of Lords to introduce a transplant Bill that applied just to kidneys. The argument for such transplants is slightly different.

Dr. Harris: I did not understand why the House of Lords Bill was restricted to kidneys. I looked into the matter but could not understand it. It was something to do with one kidney but it did not make sense ethically or practically.

Obviously, we are talking about cadaveric donation, but there is the opportunity for live donation for a series of solid organs, most commonly kidneys. I believe that there is broad consensus about the efforts that need to be made to increase such donation. Indeed, there have been changes in the past few years that enabled live donation—for example, of a kidney—to go ahead, and we have seen the advent of things such as domino donation and altruistic donation. They are not as straightforward—these things are never completely straightforward—as a donation from a family member, but it is now at least possible for people who are unrelated and do not know the recipient to donate organs, although the numbers of those who do so are small.

I have always thought it peculiar that it was more difficult for someone who could not be coerced by the family to give their organs. It was more difficult, if not impossible, for someone who was doing it purely altruistically to donate. In fact, there were greater restrictions on people who were not related than there were on people who were related, yet coercion can occur in families on all kinds of issues. I am sure that we can all think of how arms have been twisted in our own families on more trivial matters, but on such serious things, there is a feeling that one has to help.

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Changes were put in place, and there has been an improvement in the number of live donations. Clearly, that is within the remit of this debate. I welcome those changes, but I do not think that anyone is arguing that that in itself will solve the problem—for hearts, for which it is not possible, for lungs and livers, for which it is extremely difficult, or, indeed, for kidneys—even if the maximum number of donations were obtained. There is active debate on the subject in the Kidney Alliance and the renal community.

I would like to take the opportunity to pay tribute to Chris Rudge, the Department’s transplants tsar, who may be listening to this debate. He has done an enormous amount in his current job and in previous jobs to promote all the issues, even though he recognises, I am sure, that there is not full agreement, and that good people can have different views on opt-out. I had not realised that I would have so much time in this debate. I reassure hon. Members that I will not seek to fill out the available time, although it is tempting and I could. [Interruption.] I accept those sedentary comments. However, I do have an opportunity, with the permission of the House, to go into some detail on the taskforce report on opt-out. I hope that I will not overdo it.

Several things need to be said about opt-out. I am now of the view that “presumed consent” is the wrong terminology, from whichever direction one comes. It is the wrong terminology for several reasons, which I shall not go into—indeed, they are set out in an important part of the report. Although I do not speak for the BMA on this matter, it will probably seek to engage with the Government on changing the wording. We are not talking about a consented thing. There is not consent under the current system. It is an authorisation, and that is why Scotland—as I always say, “as so often”—has got it right. This is an authorisation process; it is not consent. It is not possible for relatives to give consent, let alone informed consent, for someone who is dead. They do not have ownership or the right to do that.

What they can do under the current system is authorise—they are invited to authorise. An opt-out system would have default authorisation. It is much healthier to get away from the use of “consent”, popular though it was when the Human Tissue Act 2004 was going through Parliament, because we were talking about events in Bristol and Alder Hey in which consent was the issue and consenting processes had not been adequate. However, I never argued, and other people should not have argued during the passage of that Bill, that we were talking about an issue of consent.

It is important to stress that the current system is not one of informed consent. Therefore, no one is proposing to move from a system of informed consent to one of non-informed consent or presumed consent. Under the current system, even if someone puts their name on the organ donor register, there is no record of the basis on which they do so. When people sign a consent form for an operation, under best medical practice there are clear professional guidelines and doctors have a duty to ensure that the consent is valid and appropriate. We do not know on the basis of what information people choose to have a donor card or put themselves on the organ donor register. Putting their name on the register is an indication of their preference. It is wrong to imply
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that that is informed consent, when we do not even require informed consent in the American sense in normal medical practice. We require appropriate consent. Consent is a process, and the amount of information that patients want will vary from case to case. For that reason, it is wrong to call the process of registering on the organ donor register “informed consent”. If it is informed consent, it is hard to understand why relatives are invited to veto that, as they are, for practical reasons.

Mr. Stephen O'Brien: The hon. Gentleman makes an interesting point. I have looked at my donor card, which has the word “donor” on it, but neither “consent” nor “authorisation”. It simply says

it is a request by those who are living—and that is it. Of course, the strapline is,

Is that consent or authorisation, or simply a request?

Dr. Harris: Indeed. I hope that there is broad consensus in the House—or at least among right hon. and hon. Members in the Chamber today—that we can change the terms. There is clearly a difference between an authorisation being an opt-in or an opt-out. I am not seeking to change the terms of the debate. There is clearly a difference. The issue is what the default position should be.

Why should one support an opt-out system, and what factors are necessary in order to do so? It has been suggested that it would have to work for it to be the right thing to do. I do not think that that is the case. I happen to think that it would work. However, we would never know; we would have to look at what the evidence suggested. There is good evidence that it would work, and I will say later why I do not agree with all the conclusions of the taskforce report. But that is not the only issue.

What is the right thing to do? There is an argument in principle, which I accept must be countered by practical arguments, because even if an opt-out system was ethically right in principle, if there were risks in pursuing that and we did not have the evidence that it would work, those would be good arguments for not going with the principle. However, I feel strongly that the default position should be to save lives. I am not happy with a system in which the default position is not to use organs that could be used because someone has not specified that they do not want them used. It is wrong to allow so many organs to be buried or cremated with their owners when those people would not have objected to the saving of lives.

The default situation at the moment means that people die while waiting. With an opt-out, whatever the other arguments, it has to be recognised that the default—the do-nothing position—is saving lives. Then one gives people an opportunity to express their autonomy by withdrawing that authorisation and opting out. The moral arguments for moving to that position are strong and, if they were the only arguments I would say that they were irresistible. I was disappointed not to see that discussion in the summary report, although it may be in one of the 447 pages of annexes, of which I have only read a couple of hundred so far. They are not available
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in print, so I had to print them off or read them online. I regret that that issue was not raised in the summary report.

The other question is, does an opt-out system work? I was surprised by the conclusions in the summary report, which said that it did not work, because I remember seeing good evidence that it did. So I went to the systematic review, which is a process that I strongly commend. There is nothing methodologically wrong in seeking a systematic review of the methodology of published peer-reviewed papers on the subject. Opinion can be safely excluded. There are plenty of opinions published in review articles on both sides of the argument, including a number by Dr. Matesanz, who is cited many times in the summary report. But opinions do not pass muster in a systematic review of the evidence. So his opinion that it does not work is, like my opinion, discounted when looking at the evidence.

The summary set out clearly the inclusion criteria for the studies that were considered. It explains what are good methodologies and what it is hoped that studies would comply with and then it analyses which studies do comply. It lists the studies that are excluded and included. Some of the studies are between-country studies, trying to control for all the factors that vary between them, including road traffic accident rates, to see if there is a difference that can be aligned with an opt-out system, compared to countries with an opt-in system.

Then there are in-country studies, where the rates of organ donation are looked at before and after a change in the system. The summary says this, on page 33 of annex N, paragraph 3.3.3, in respect of the between-country trials:


In other words, such studies are a clue, but one cannot say that something is definitely so, although if one has tried to adjust for confounding factors, they are informative. The summary continues:

Three out of four found that association after a regression analysis and found that it was significant. It continued:

So it does not go the other way. It was not three versus one; it was three versus nought and one with no comment. The summary said:

per million population. The summary concludes, without saying much else in between, I have to say:

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I do not disagree with that. I have never argued that it would close the gap. I looked at all the papers that the review looked at before it looked at them—I have them here in a fat file—and came to the same conclusion. I find it curious that the summary report does not seem to reflect that conclusion on the between-country studies.

It is important to look at the between-country studies—the before and after studies. The overall conclusions say:

I cannot find the details at the moment—

Even the before and after studies show exactly the same conclusion.

Those are the two sorts of study that the evidence group examined, and that is all that anyone will ever get from such studies. A prospective controlled study cannot be carried out experimentally; any study must be observational with a control for confounding factors. I cannot understand how that was translated into the summary report in the way that it was, and I should be grateful if the Minister commented on that.

The between-country studies are interesting. Belgium is the key country, because it introduced a soft system of opt-out, which is what is being proposed for this country. What Austria does is not as directly relevant to the debate in this country. Two studies in Belgium found a significant increase in organ donation, and they show that that was sustained. I do not understand why Dr. Matesanz—I understand why the hon. Member for Eddisbury quoted him—said that he did not know of any country where increased organ donation rates were sustained after the change of law to an opt-out system, when it is clear from the taskforce’s figures and the studies that it reports that Belgium is one such country.

I am not saying that that is clear evidence or proof that that resulted from presumed consent or opt-out, but Dr. Matesanz made a different point, and it cannot be sustained. That is why opinion should not be given the same weight as published studies. Time and again in the report, the opinion of one person from Spain is cited over and above the summary of the evidence from the systematic review. Given what I have just said about sustained rates of donation, one problem with opinions—I say the same about my opinion—is that they are not as valuable as studies. I am sure that if Dr. Matesanz went through what I have said, he would be able to pick holes in it.

The studies conclude that the system works in Belgium, although cause and effect cannot be proved. However, we must consider something that was not studied. Antwerp did not introduce the soft opt-out system, even though the rest of the country did so, and Belgium changed the law. The hospital in Antwerp found that there was no increase in organ donation, which suggests that it was the change in the law and the operation of that change that made the difference, not simply a national publicity campaign that was associated with the change. If presumed
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consent is introduced, the donation rate may increase because of all the fuss, public debate and information, and that would be welcome. But Antwerp was not cut off from the national media, or from the parliamentary and media debate, or from information campaigns. It just did not operate the system, and it did not get the change. That is powerful evidence, but it was not included because it was observed and was not part of a study. There is therefore even more evidence for what I am saying.

Turning to the taskforce’s report, I should like to make a few comments on its approach. This is not a criticism of any individual—and I regret that because we are having this debate so soon after publication, I have not had a chance to write to the taskforce, but I intend to do so—as I admire and know many of those who serve on the taskforce, but some of the things they say are strange. Paragraph 1.15 says:

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