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(da)   the procedures to be followed in relation to brain stem tests for the purpose of confirming death;'.

Amendment No. 12, in page 14, line 35, at end insert—

'(ja)   activities authorised by or under section 44;'.

Government amendment No. 66.

Amendment No. 13, in page 28, line 7 [Clause 44], at end insert—

'(4A)   This section shall not be read as making unlawful anything which is lawful apart from this section.'.

Government amendment No. 47.

Amendment No. 6, in page 33, line 19 [Clause 55], after 'Act', insert

'except section [duties to persons who stood in a qualifying relationship in relation to transplantation]'.

Dr. Harris: I am grateful for the opportunity to raise the question of presumed consent and I am grateful to those hon. Members who have put their name to the amendment for their indication of support. I hope to set out in my opening remarks the current situation with regard to organ transplant, explain the proposed change, briefly explain what each new clause and amendment would do and then set out the reasons for the change. Finally, I shall deal—in advance, if I may, for a further occasion—with some arguments that Ministers, among others, have used against the proposals.
 
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I hope also that the Minister responds to my "prebuttal" of her points, if she feels I have them right, rather than simply repeating them without reference to some facts that we seek to express.

Mr. Andrew Mackay (Bracknell) (Con): Optimistic.

Dr. Harris: The right hon. Gentleman claims that that is optimistic, but I know that we want a good debate rather than simply a repeat of what was said on Second Reading, which, like consideration in Committee, provided an opportunity for differences to be aired. I respect the strong views of those on the other side of the discussion, and I know that those who share my view also respect their strong views. We need to have an exchange of views. If there is an area where the Government feel that the proponents of this measure have it wrong, I am keen that we accept that and revise our position.

The current arrangements, which are best described as relatives' consent with opt-in, stem from the Human Tissue Act 1961. Although it has been described, in shorthand, as an opt-in system, it is best described as seeking relatives' consent, often on a guess, as to what the person would have wanted, with an opt-in to guide them. If someone is in such a position that their organs could be used after their death for transplantation purposes—that is, they have died and their death has been confirmed by brain stem testing on a ventilator in the intensive care unit with no medical contraindications to organ donation—doctors may approach relatives to seek permission so to use the organs.

At the moment, relatives, often at the height of their grief—such deaths are often of young people following a road traffic accident or other trauma—are asked to decide whether the organs can be used. In a small minority of cases, the potential donor would have made clear to relatives his or her opposition to donation. That is generally and rightly respected by those relatives, although it need not be if relatives choose not to do so.

In a larger minority of cases, but still a minority, the potential donor will have indicated a wish to donate by telling relatives, carrying a donor card and/or registering on the organ donor register. Relatives still have to give consent, and in a significant minority of those cases relatives withhold their consent: in the potential donor audit, relatives refused in 11 out of 226 cases in which the organ donor register was consulted. That is not a virtual nothing, in terms of that frequency, but a problem with which both systems must deal. We should not think that it is not also present in the current system.

In the majority of cases, as recognised by the potential donor audit carried out by UK Transplant, the wishes of the potential donor are unknown. In those cases, relatives are forced to second-guess the wishes of their loved one. In about half those cases, permission is withheld—again, those data come from UK Transplant's potential donor audit for the first few months of 2003. If we make a comparison with previous research, that proportion has increased in the last 10 years from 30 per cent. to nearly 50 per cent.

Dr. Murrison: On a point of clarity, I think that the hon. Gentleman said, as I think that the record will say,
 
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that relatives have to give consent. I am not sure whether he meant that. Perhaps he might like to think again about precisely what he meant. In fact, they do give their consent, and it is always sought, and rightly so. We need to be absolutely clear about the letter of the law.

Dr. Harris: I will repeat what I was seeking to get across: in a larger minority of cases, the potential donor will have indicated a wish to donate, as in the examples that I used, and relatives still have to give consent, or they still have to be consulted for that consent. I will clarify that. As I explained, in a significant minority of cases—each one is significant for the person or people who will die because that organ is not available, so even one case is significant—relatives withhold their consent.

Under the proposed change, the system would be one in which consent by the potential donor was presumed unless he or she had registered or made known an opt-out. The plan would be that after a widespread media and education campaign, which would be prompted by the change in the law but would take place before it came into effect, every adult would be given multiple and continued opportunities to register their objection to their organs being used after their death for transplantation, and to discuss that view with their relatives. As I described previously, were it the case that someone's organs could be used after their death for transplantation purposes, doctors would have a legal duty to check the opt-out register, to see whether the person had registered an objection. If so, no approach other than the explanation that might be required would be made to relatives, and the wishes of the deceased would be respected. If no opt-out had been registered, relatives would be approached and asked whether they knew of any objection of the deceased that had not been registered. If so, organs would not be taken for transplantation, as previously. If no objection had been registered, and if no objection was known by relatives, medical staff would express an intention to use the relevant organs for life-saving or life-transforming transplantation, in line with the presumed or, where relevant, expressed wishes of the potential donor.

At that point—this is the soft opt-out proposed by me, and supported by the British Medical Association and others—if relatives demonstrate that they would suffer significant distress as a result of the use of organs in that way, the organs would not be taken. This veto opportunity for volunteered distress by relatives is called the soft system of presumed consent, as used in Belgium, which is to be contrasted with the harder system, with no such veto, as used in Austria, for example.

Ian Lucas (Wrexham) (Lab): Can the hon. Gentleman clarify who, in those circumstances, would assess whether the distress was significant?

Dr. Harris: The same people would make that judgment who make the judgment now when there is indecision or a disagreement among the relatives—the doctors who were caring for the deceased person. It would not be, as in other jurisdictions, doctors with a vested interest for the recipient, but doctors and nurses
 
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who have invested their time in looking after the deceased and caring, post-bereavement, for the relatives.

Mr. David Wilshire (Spelthorne) rose—

Mr. Kevan Jones (North Durham) (Lab) rose—

Dr. Harris: I give way first to the hon. Member for Spelthorne (Mr. Wilshire), who has a particular interest in this matter.

Mr. Wilshire: Following the previous intervention, do I understand the hon. Gentleman correctly? Is he telling us that somebody somewhere, even if they were not involved in the particular case, would have the power to overrule relatives who were distressed? How on earth can anybody measure the amount of distress coming from the bereavement as distinct from the amount of distress coming from the request to object to a transplant?

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