Organ Donation (Deemed Consent) Bill

Lord McColl of Dulwich Excerpts

Committee: 1st sitting (Hansard): House of Lords
Friday 1st February 2019 Lords Chamber

Moved by

[Lord McColl of Dulwich]

1: Clause 1, page 1, line 22, leave out from beginning of line 22 to end of line 2 on page 2 and insert—
“(6B) The consent of the person concerned is only deemed once a person in a qualifying relationship affirms that the person concerned would not have objected to the activity.””

[Lord McColl of Dulwich (Con)]

My Lords, I will begin by speaking to Amendment 1 and will then follow on to Amendment 3. I should point out that I am recovering from an operation—not a transplant—on my eye, and my vision is not as good as I hope it will be. In doing so, I declare an interest as a former transplant surgeon, and as someone who has a close relative currently awaiting organ donation for a far-reaching transplant operation. I also put on record my sincere thanks to the Minister in another place, who kindly met with me to discuss the issues that I will raise today.

The relationship between the patient and the doctor is very precious, but it only works because of trust. When trust breaks down, as it has in the past in relation to organ donation, the cost can be considerable. We need only think of the experience of Alder Hey to realise that, as we are really concerned about organ donation, we must tread carefully. Lest anyone should think that all is forgotten, I should tell the House that I received an email just a few days ago from an affected family.

The principal concern that those who work in the field of organ transplantation have about this legislation is its potential to damage trust between doctor and patient in a way that reduces the total pool of potential donors, for the reasons I explained in my speech at Second Reading. To recapitulate briefly, the key concern is that the introduction of deemed consent will reduce, rather than increase, the total pool of donors.

I will explain why. For anyone who is unfamiliar with the world of organ donations and assumes that only those who have signed the organ donor register can be donors, it is easy to see the huge appeal of deemed consent. If 37% of people have signed the donor register, then introducing deemed consent is clearly attractive; even if this provoked 10% of people to opt out, one would still be increasing the total pool of donors from 37% to 90%—a huge boost.

But this is not how organ donation works. At the moment, anyone in England can be an organ donor apart from the 0.7% who have signed an opt-out register. Crucially, you do not need to have signed the organ donor register to be a donor. In fact, as I set out at Second Reading, most organs donated in England in the past five years came from donors who had not signed the organ donor register or the opt-out register. The key to their donation was their family, who made the donation decision for them. Rather than increasing the total pool of donors, the introduction of presumed consent actually threatens to reduce the total pool of potential donors from 99.3% to something more like 90%—a small but not insignificant minority opt-out.

In Wales, over 180,000 people, all of whom were previously potential donors, have now withdrawn from donation. This equates to 6% of the population. All of those potential organs are now lost to the system. If we are to press ahead with this legislation, the imperative must be to do everything we can to minimise the number of people who take offence and withdraw from donation. That objective is at the heart of everything I have to say, and is particularly central to both of my amendments —Amendments 1 and 3. Rising to the challenge of limiting the number of people who opt out necessitates that we seek to understand why the introduction of deemed consent, and specifically the way in which it relates to the role of the family, provokes a significant level of withdrawal from donation, as mentioned a moment ago.

The principal reason why some people take offence is that they perceive deemed or presumed consent as a mechanism in law whereby the state can claim their organs without securing what they would regard as proper consent, and on this basis suggest that the state better represents the views of the deceased than his or her family. Mindful of this, it is important that we do not pass legislation that gives the impression that the state and its laws can better vouch for what the deceased would have wanted, rather than his or her family.

Neither the Welsh legislation nor the accompanying code of practice states that if the family objects because it does not believe that the deceased chose deemed consent, consent will not be deemed. In this context, these documents assert that the state effectively knows better than the family and, mindful that legal consent has been given, the door remains open for organs to be taken from people who the family believes did not choose to have their consent deemed, and who have signed neither the organ donor register nor the opt-out register. Happily, no doctor has availed themselves of this legal opportunity to transplant organs in the face of family opposition, but there is no statutory guarantee that this will not happen in the future. This is rather risky. It would take only one overzealous doctor to decide to take the organs of someone whose consent has been deemed, against the protestations of the family, for trust in the donation system to break down. It could put back the cause of donation many years.

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[Lord Anderson of Swansea (Lab)]

The noble Lord, as always, puts his case very well. What is the position if the family is divided?

[Lord McColl of Dulwich]

My solution is to have transplant nurses, who are key to this whole problem. They are essential in dealing with the family, explaining the situation and getting it to discuss it in a sensible way. But I agree that that would be a problem.

If the Minister is able to assure me that the Government intend that the word “information” should be widely defined so that, for instance, if someone was to say, “I am convinced that my husband was unaware of the deemed consent law and would have opted out had he known; therefore, you should not take his organs”, this would count as valid information and prevent the deeming of consent. This would reassure many people with concerns about the deeming of consent.

In most cases, there would be no means of proving in a court of law that the husband was unaware, so if that is what the wife says, it should be accepted. If people knew this, they would feel less threatened—that the state was trying to supplant them and their family, and other people and their families—and be less likely to opt out. This approach is entirely consistent with what the Government propose with respect to faith communities. If a Muslim wants to be a donor and carries one of the proposed new faith-specific organ donor cards, it means that they want to donate, but subject to the views of their religion being respected. I simply seek reassurance that people will be assured that the same respect will be afforded to their families and living representatives.

In asking this question, I should stress that I am not asking the Minister to say that no doctor would ever take organs if the family was unhappy. I am of course aware that most doctors would be reluctant to do such a thing. I am asking specifically what the Government intend that the law should mean. I want to establish whether the Government intend that a doctor should, from a purely legal perspective, be able to transplant organs even if the family members provide information, based on what they believe their relative would have wanted, which suggests that consent should not be deemed. If the Minister can confirm that the Government’s intention is that “information” should be widely defined—so that if someone were to say, “I am convinced my husband was unaware of the deemed consent law and would have opted out had he known”, this would count as valid information and prevent the deeming of consent—I will withdraw my amendment.

I turn now to Amendment 3, which places a statutory obligation on the Secretary of State to make people in England aware of how deemed consent works, including through an annual advertising campaign. Quite apart from making all existing adults aware, we must remember that every year, about 760,000 people turn 18 years of age in the UK, and all those in England will need to be written to. Then we must be aware of all the people coming into England each year from other jurisdictions. Crucially, the awareness-raising and advertising provision set out in my amendment is made in the existing Welsh legislation but is missing from the Bill. My motivation in moving the amendment is exactly the same as for Amendment 1: I want us to do everything we can to limit the number of people who opt out of donation as a result of the introduction of presumed consent, for all the reasons I have already set out.

The organs of the 182,519 people who have opted out in Wales in response to the deeming of consent are completely lost from the donor system. No one had opted out previously. If Wales loses this number in a context where there is statutory assurance about advertising, thereby making it more likely that a person whose consent has been deemed really has made a donation decision, how much greater will the risk be in England if we do not provide that same assurance? We must do everything possible to limit the number who opt out in England. In order to have a credible system of deemed consent, one has to put in place the requisite infrastructure to make it reasonable to claim that anyone who has signed neither the opt-out nor the opt-in register has made a deliberate, conscious decision to become an organ donor by having their consent deemed.

This depends, critically, on a huge advertising campaign so that it is credible to suggest that the entire adult population will have seen the relevant adverts and taken on board that if they want to donate, they can give effect to that decision by doing nothing, and that if they do not want to donate they must sign the opt-out register. If one does not have a very large advertising campaign, members of the public will work out that the chances are that a significant number of individuals whose consent will be deemed will not actually make a conscious donation decision; they will have simply done nothing, not appreciating that in this context, the absence of an action is considered a decision and authorisation for organ donation. If members of the public who recognise that the law has changed suspect that the state is underinvesting in advertising and therefore cannot credibly suggest that everyone whose consent has been deemed will have decided to have it deemed, they are much more likely to feel that the state is trying to take organs without proper consent. In this context, it is more likely that people will feel like opting out. It is thus critical to reassure the public that there will be a major and ongoing advertising campaign.

On the basis of the current Bill, we are rather vulnerable on this point. In the first instance, unlike the Welsh legislation, it provides no assurance that there will be proper and ongoing investment in advertising by making it a statutory obligation which cannot be changed without an Act of Parliament. If, however, the Government accept my amendment, they will give the people of England the same assurance that has been given to the people of Wales, and that there will be a serious and ongoing advertising campaign about how presumed consent works. This will give credibility to the claim that everyone who has done nothing in respect of organ donation has made a deliberate and conscious donation decision. As a consequence, there would be less scope for people to feel offended and opt out.

In the second instance, this weakness is reflected in the fact that the advertising budget is £18 million over four years. I have two major concerns about this. First, when one allows for the fact that the adult population of England in 2017 was recorded as 43,752,473, that works out at just 41p per person over four years, or 10p per person per year. I am not convinced that this tiny sum treats people’s consent with appropriate respect. It does not allow us to conclude that everyone who has not opted out has made a deliberate and conscious decision to opt in. Others are bound to think the same, and this risks significant withdrawal from donation, because there is a greater chance that people will think the system unfair and want no part of it. In this context, one option would be significantly to increase the proposed level of advertising, making people aware that if they do not opt out, they will be treated as if they had consented to donate. To secure a credible arrangement, however, would require a lot more money over a sustained period. In contemplating that, we have to ask whether it is worth it.

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[Baroness Barran (Con)]

I wonder whether the noble Lord could be mindful of the time taken for his remarks.

[Lord McColl of Dulwich]

What is the limit? My apologies.

I return to my basic question and ask whether the Minister can confirm—[Interruption.] I am speaking to two amendments; 15 minutes each makes 30 minutes. Can the Minister confirm that the Government intend to define widely the word “information” in proposed new subsection (6B), introduced by Clause 1(4), so that if someone said, “I am convinced that my husband was unaware of the deemed consent law and would have opted out had he known, so you should not take the organs”, this would be regarded as meeting the definition of “information” in the Bill? If the answer is yes, I will happily withdraw the amendment and I will not die in a ditch for my second amendment, but it is entirely reasonable to suggest that the people of England deserve the same statutory assurances on advertising as the people of Wales. I beg to move.

[Lord Carlile of Berriew (CB)]

My Lords, it is always a pleasure to follow the noble Lord, Lord McColl. He has great distinction as a surgeon; I recognise, as I am sure other noble Lords do, both that distinction and the great care he took, perhaps with a little liberality with the rules of the House, in presenting his arguments.

I will be brief. I think that I am one of six former Welsh Members of another place in the House today. At least some of us, perhaps most of those present, were reasonably or very enthusiastic supporters of devolution to Wales. One reason why the law on organ donation has changed in Wales is because devolution has allowed for a much shallower pyramid in the Welsh legislative process. In December 2015, the Welsh Government and the Welsh Assembly changed the system to one of presumed consent. It has worked very well. For me, as a Welsh-born former MP for Wales, it is a matter of great pride to be able to say to your Lordships’ House, on this occasion at least, “Look up to what has happened in Wales”. Indeed, the noble Baroness, Lady Randerson, as a former Welsh Minister, carries some credit for what occurred there.

I offer a few short propositions. First, there is no evidence of sound ethical principles being undermined as a result of the new Welsh legislation. Believe it or not, medical ethics in Wales are at least as good as in England, and patient satisfaction levels are at least as high, if not higher. Secondly, there is clear evidence of a better understanding of organ donation issues among families in Wales. The figures speak for themselves: on 16 November 2018, the Welsh Government announced that the rate of family consent in Wales is now at its highest ever—80.5%. That compares with 66.2% in England, 63.6% in Scotland and 66.7% in Northern Ireland. I suggest that these figures show that understanding of the new organ donation arrangements in Wales among Welsh families and the Welsh public is very high. There is no evidence of any irresponsibility, either legislatively or in the health service, in ensuring that organs are available in Wales.

Finally, I have no particular objection to the ambition of the noble Lord, Lord McColl, that public information levels about the new process of deemed consent for organ donation should be the highest possible. That has happened in Wales, which is why families there understand these issues so much better, as borne out by the figures I just gave. Indeed, can the Minister—who is a she, not a he, by the way—confirm the Government’s ambition for public information levels to be at least as high in England and wherever else the Act will apply, which is a matter for later discussion, as in Wales? The Government would be crazy not to undertake a publicity campaign to explain properly something quite fundamental that needs to be explained to the public. Can she also confirm that patients in other parts of the United Kingdom to which this excellent Bill applies will not be at any disadvantage?

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[Lord McColl of Dulwich]

My Lords, I thank all noble Lords who have taken part in this debate. I have been very reassured by the statements that have been made. I was particularly struck by my noble friend Lord Lansley emphasising the role of transport co-ordination nurses. They are the key people, and I believe that the way to get more donations is to have more of these nurses. That would be a really good investment—an investment which we know works. I am very keen on evidence-based medicine and policies, and they are the key. The Minister mentioned, as I did, that 10% of cases are not attended by these nurses, and I think she said that that was due to the fact that people did not want that. I hope that that is the only reason, but I have a suspicion that it is because we do not have enough of them. Perhaps that could be looked into. We need more of them, for certain.

I am very reassured by all the statements that have been made and I beg leave to withdraw the amendment.

Amendment 1 withdrawn.

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Moved by

[Lord McColl of Dulwich]

2: After Clause 1, insert the following new Clause—
“Five year review of the effectiveness of deemed consent
(1) The Secretary of State must at least once in every five year period beginning with the day on which this Act is passed lay before Parliament a report which includes analysis and evidence on whether the introduction of deemed consent under section 3 of the Human Tissue Act 2004 has been effective in increasing the number of organ and tissue donations.(2) The report under subsection (1) must take into account other developments that may have affected the number of organ and tissue donations.”

[Lord McColl of Dulwich]

My Lords, Amendment 2 is inspired by Section 2(3) of the Welsh legislation. It requires the Secretary of State at least once every five years to lay before Parliament a report that includes analysis and evidence of whether the introduction of deemed consent under Section 3 of the Human Tissue Act 2004 has been effective in increasing the number of organ and tissue donations.

In the context of knowing, first, that the Organ Donation Taskforce expressed real concerns in its 2008 investigation about presuming consent and, secondly, that, as we have mentioned before, over 180,000 people have opted out of donation in Wales, all having originally been potential donors, it is only right that this kind of commitment to review should be set out in legislation. If the people of Wales deserve the reassurance and protection of a robust statutory assessment then the people of England also deserve it.

My Amendment 2 also requires a review not just of whether the level of organ donation has increased but of whether other factors should be taken into account. When there is talk of any proposed policy to increase donation, we often hear words to the effect of, “Of course, doing X is not the whole answer. It is part of the solution”. That sounds very reasonable but those of us committed to evidence-based medicine need to ensure that it does not become the basis for failing to assess the distinctive contribution of the policy in question to increasing donation rates.

The point has been made that the Welsh Government invested a huge amount of political capital in deemed consent. They wanted to do something distinctive and for other parts of the UK to follow them, and they could not allow it to fail. In this context, although there has been a huge amount of publicity around presumed consent, it is very interesting that in the same timeframe there has, I understand, been increased investment in critical care beds, specialist nurses in organ donation and advertising promoting donation, as opposed to presumed consent.

We know that if you increase investment in critical care bed capacity, it increases donation. We know that if you increase investment in specialist nurses in organ donation, that increases donation. We know that increased advertising encouraging donation increases donation. We also know that presuming consent always reduces your total pool of potential donors because some people will opt out. As I said earlier, in Wales that number is 182,519 and it has steadily increased since the introduction of deemed consent.

In that context, it is entirely possible that simultaneously we are doing some things that will increase donation and others that will reduce it. It is also entirely possible that if you have three initiatives that push donation in the right direction and one in the wrong direction, the net effect will still be in the right direction. It is entirely possible too that if, for political reasons, you choose to highlight in publicity one of the four options, people might conclude that the highlighted option is the reason for success, when actually quite the opposite applies.

In assessing the efficacy of deemed consent, it will be really important to highlight the other steps that we take alongside presumed consent so that there is an honest attempt to find out whether the downside of deemed consent—the withdrawal of potential donors—is offset by positive changes resulting from deeming consent or whether it is offset only by other, less high- profile initiatives that have nothing to do with deeming consent.

In moving this amendment, I particularly congratulate the Welsh Government on the hard-hitting television campaign they introduced for organ donation in the last two years. What is really striking is that it make no reference to deemed consent. It is basically designed to encourage families to talk about organ donation so that family members are familiar with each other’s donation wishes. It is a great advert that could be run in an informed consent jurisdiction such as England. Although the advert has nothing to do with presumed consent, one would expect it to have made a very positive contribution to donation in Wales in the period since presumed consent was introduced.

In that context, I ask the Minister to acknowledge that there is a real challenge here and to commit to putting in place a really robust assessment process that seeks, with energy and determination, to isolate the distinctive contribution of deemed consent from the contribution of other, less controversial mechanisms for increasing donation, such as more critical care beds, more specialist nurses in organ donation, more adverts encouraging donation, et cetera. If it transpires in five years’ time that the policy lever for maximising donation is not presumed consent, I hope that we will be ready both to move on from it and to focus the resources thereby released on organ donation policies for which there is a robust evidence base.

[Lord Hughes of Woodside]

Can the noble Lord say precisely whether there is any value nowadays in carrying a donor card or whether that is now obsolete?

[Lord McColl of Dulwich]

We have always encouraged the carrying of donor cards. We used to keep a whole stack of them in our pockets and hand them out to the patients at Guy’s. As for the evidence, I am not sure, but they cannot do any harm and I would certainly encourage people to carry them.

Finally, and keeping in mind the need for review at a more general level, I ask the Minister in passing whether consideration has been given to extending the proposal that Muslims and Jews should be able to carry donation cards that say that they wish to donate but only subject to their faith being respected. On the basis of the views I have encountered, I think that this would provide reassurance to members of other faith communities as well. I beg to move.

[Baroness Manzoor]

My Lords, I thank my noble friend for introducing this amendment, which relates to a very important issue. Like him, I believe in evidence-based medicine.

The Government have maintained, and have been clear, that a change in the law by itself is unlikely to lead to an increase in the number of organs and tissues available for donation. However, it is an important measure in addressing the tragic death rate due to a lack of organs and tissues available for donation, and we hope that this will be a significant step towards changing the culture regarding organ and tissue donation in England, as I said previously.

I point out to the Committee that NHS Blood and Transplant already has a legal duty to report to the Secretary of State on all its activity and is a world leader in collecting and analysing data on organ donation, retrieval and transplantation. The ongoing data collection encompasses data regarding the registrations on the organ donor register, the number of potential and actual donors, organ retrieval and organ transplantation activity. This data is published in a variety of formats, placed on its website and set out annually in a comprehensive report.

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[Lord Hunt of Kings Heath]

My Lords, I have nothing to add to what the Minister has said, save that robust assessment will be important not only after one year but on a number of occasions. It will be very important to pick up the issue, raised by the noble Lord, Lord McColl, of whether transplant services are keeping pace with the hoped-for increase in donations.

[Lord McColl of Dulwich]

My Lords, I would like to thank everyone who has taken part in this debate. I am very reassured indeed by what has been said. It might perhaps be appropriate to repeat something that I said at Second Reading, in view of all the commotion and anger about Europe. When I was transplanting kidneys, the French kidneys were always the best. I say that because, when I connected the artery and the vein and took off the clamps, the urethra would immediately start peeing on the table, which was amazing. None of the other kidneys did this. I said, “What is it about these French kidneys?” The reply was, “Oh, it’s the wine”. I beg leave to withdraw the amendment.

Amendment 2 withdrawn.