Committee
10:08
Relevant documents: 43rd and 45th Reports from the Delegated Powers Committee
Clause 1: “Appropriate consent” to adult transplantation activities: England
Amendment 1
Moved by
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 Portrait Lord McColl of Dulwich (Con)
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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.

10:15
Mindful of this and of the desire to limit the numbers of people who opt out, I propose through my Amendment 1 that we should provide potential donors with the reassurance that the opinion of their families carries more weight than the state’s opinion in the event that they clash. This should be set out both in legislation and in the code of practice. It will make it less likely that people take offence, and less likely that they withdraw and sign the opt-out register. I understand that the Government are keen to avoid divisions, and so am I, so it is not my intention—certainly today—to divide on this issue, but rather to seek reassurances from the Government on the record.
The key part of the Bill that is relevant here is new subsection (6B), introduced by Clause 1(4). At the moment it states:
“The person concerned is to be deemed, for the purposes of subsection (6)(ba), to have consented to the activity unless a person who stood in a qualifying relationship to the person concerned immediately before death provides information that would lead a reasonable person to conclude that the person concerned would not have consented”.
The key consideration here is the word “information” and what we mean by it.
Lord Anderson of Swansea Portrait Lord Anderson of Swansea (Lab)
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The noble Lord, as always, puts his case very well. What is the position if the family is divided?

Lord McColl of Dulwich Portrait Lord McColl of Dulwich
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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.

10:30
That leads me to my second major concern: such money would be far better spent making changes for which there is robust evidence of success. Although the evidence on the efficacy of deemed consent is profoundly contested—as I said, we know that more than 180,000 potential donors have withdrawn from donation in Wales—the evidence on specialist nurses in organ donation is clear. As NHS Blood and Transplant has shown, where specialist nurses are available to speak to the deceased’s family, the family either donate or authorise donation in 68% of cases. Where specialist nurses are absent, the figure is just 27%. That is a huge and incontrovertible difference. I am also mindful that the organ donation and transplant activity report for 2017-18 demonstrated that specialist nurses in organ donation did not approach potential donors in about 10% of cases of potential donation. Finding the money to address this shortfall would constitute a much more responsible, evidence-based way to spend scarce resources efficiently.
Mindful of those considerations, my conclusion is that the people of England should be afforded the same reassurance in our legislation that there will be ongoing funding to make people aware that if they do nothing, they are agreeing to donate. However, I do not think that it makes sense to try to raise the kind of money that would be required to credibly—
Baroness Barran Portrait Baroness Barran (Con)
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I wonder whether the noble Lord could be mindful of the time taken for his remarks.

Lord McColl of Dulwich Portrait Lord McColl of Dulwich
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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 Portrait Lord Carlile of Berriew (CB)
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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?

Baroness Randerson Portrait Baroness Randerson (LD)
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My Lords, I want to make it clear that I oppose firmly Amendment 1. I believe that it fatally undermines the concept of deemed consent and ignores the processes that will be put in place if and when the Bill becomes law.

In some circumstances when people die, medical practitioners have a short window of opportunity to deal with organ donation, and it is simply impossible to get permission from the people who were near and dear to the deceased. Very sadly, some people also die having no one in that category. As it is written, the amendment undermines the principle. If the intention is to write into law that, where possible, family and friends must be consulted about the wishes of the deceased and their own wishes, that would be a different matter. However, as I read it, that is not how Amendment 1 would work.

The noble Lord, Lord Carlile, has been a brief but powerful advocate of the Welsh system. I want to say one or two other things about it. Because we were pioneers on this within the UK, it was very much a matter of taking a belt and braces approach—take no risks. There were years—and I mean years—of public consultation on this issue and then years were spent preparing the resources to make sure that, when it was implemented, it would be done properly. That is why it took over five years from inception to the time when the system was put into place.

The Government need to publicise and inform. I support the noble Lord’s intention in Amendment 3, and I hope the Minister can confirm that the Government would consider incorporating this provision into the Bill—perhaps not in its current wording but in its intention. There would need to be a wide and repeated publicity campaign for the reasons that the noble Lord outlined.

The process of deemed consent will not reduce the pool of donors. Look around the world for the evidence. The top 10 countries in the world for deceased donors per million of population are Spain, Portugal, Belgium, Croatia, the USA, Italy, France, the Czech Republic, Austria and Belarus. Only the USA has an opt-in system; nine out of the 10 do not—there is the evidence. In those countries, in so far as I have been able to look back historically, there has been a great increase in the number of donors following the introduction of an opt-out system. I will not repeat the statistics that the noble Lord, Lord Carlile, has given the House, but the history in Wales is clear. Since 2015, the numbers have increased considerably year on year. Although we in Wales had been lagging behind the rest of the UK in our donor numbers, we are now well ahead.

The rate in Wales of those who choose to opt out is currently 6%. When we held our public consultation, we believed that the rate could be as high as 19%. It is a triumph of the publicity that people have understood it, but an important thread in that publicity was the fact that people were encouraged again and again to talk to their families and make their wishes known, so that due sensitivity could be paid to the wishes of families.

The British Heart Foundation, Kidney Care UK, the BMA and dozens of other organisations deal with this situation day in and day out. They all support this Bill, and I urge noble Lords to do so as well in due course.

Lord O'Shaughnessy Portrait Lord O’Shaughnessy (Con)
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My Lords, I want to make a brief contribution because I was in my noble friend’s position at the Second Reading of this Bill. It is important to reflect on the theme of the amendments tabled by my noble friend Lord McColl: they are about trust. He is of course absolutely right that in the course of any changes we make in the future and whatever system we create, we must maintain the trust of British citizens, patients and their families. I agree completely with him in that intention. That is why, as the noble Baroness, Lady Randerson, has just said, I support the intention of having a good campaign, although I do not think that it is the sort of thing which ought to be put into legislation, for the obvious reasons. Indeed, as the noble Lord, Lord Carlile, pointed out, it would be barmy for any Government to undertake this kind of policy change and not pursue that, because to do so would be to fatally undermine the trust that already exists. At the moment, we have a very strong system in England which we intend will only get better.

I am sure my noble friend the Minister will confirm that it has always been our intention to provide a thoroughgoing, lengthy and extensive campaign for every new generation coming through in support of the idea of deemed consent. This policy has been supported by successive Prime Ministers: Gordon Brown supported it, David Cameron had an interest in it and Theresa May has made it a personal commitment. Given the benefits that such an approach yields, as has been demonstrated in Wales and elsewhere, it is inconceivable that any Government would not put the necessary resources into it. Indeed, we have an excellent record on public health campaigns and information campaigns in this country. The intention behind Amendment 3 is right, although I do not think that it is appropriate to put it into primary legislation.

10:45
Perhaps I may touch briefly on Amendment 1. My noble friend has talked about the opt-out rate in Wales. He sees that as a potential flaw in the system. However, I see it as a benefit of the scheme because it means that, under a deemed consent system, people are actually able to express a preference not to have their organs donated, which they are unable to express now. That is good because it is about control and agency. Under the system we have now, it must be the case that some people’s organs are being donated because their families have agreed even though they would not have agreed. That cannot be right. I used to be sceptical about opt-out systems but the proposal in this legislation, which has been demonstrated to work in Wales, strikes the right balance, giving people power and control while making sure that they can make a positive choice if they are well informed.
The original wording of the clause gets the balance right because it provides an opportunity for family members to give information that could lead a reasonable person to believe that the patient would not have consented to donation. The change that my noble friend seeks to make would put a hard block on any donation where it is not possible to contact a person in a relationship with the deceased person in the immediate hours after death. We must bear in mind that this has to happen within minutes or hours of someone dying in order for organs to be donated. As the noble Baroness, Lady Randerson, has said, that fatally undermines the intention of the Bill, because it would mean that the donation would not happen unless someone could be contacted. As the noble Baroness said, in some circumstances people do not have anyone who can be contacted but they may have been happy to consent. That again is the opposite of personal choice.
While I absolutely understand and respect my noble friend’s intentions in his amendment and his very strong desire to make sure that we maintain trust, on which I commend him completely, I do not think that Amendment 1 would have the effect that he is looking for. I believe that it would actually be counterproductive because it would restrict the choices that people had made under a much more informed system. I am sorry that I am not able to give him that support but I join with him in asking for confirmation from my noble friend the Minister that enormous efforts will be made to make sure that discussions with family members are held, that people are well informed and that there is adequate staffing. Moreover, as is the case now, it should be made clear that if family members object, no donation will go forward. I have never come across anyone in those circumstances whose professional ethics would allow them to proceed, regardless of what the governing primary legislation says.
Baroness Jolly Portrait Baroness Jolly (LD)
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My Lords, I will be brief, not least because I have a cold and I am not sure how long I can keep going. First, I apologise to the Committee that I was unable to speak on Second Reading.

We know that up to 80% of the public would consent to this selfless act, but unfortunately less than half that number take the necessary steps to do so. My party approved this opt-out campaign in 2002 and it has been put in place in Wales.

What plans does the Minister anticipate being put in place to ensure that this campaign is carried out at least annually? The noble Lord, Lord McColl, was somewhat dubious about the small amount of money that was going to be put into an advertising campaign. All sorts of things might happen, but to do advertising campaigns online using Facebook and things like that will reduce the price hugely, although it is absolutely important that at least one shot—a letter or leaflet—should go to each household. Can the Minister give us some idea of the type of campaign that might be run, but also whose responsibility it would be? Would it be the department or NHS England? The noble Lord, Lord O’Shaughnessy, suggested that it might be Public Health England. I do not know.

As a House, we need to be aware that not everybody is in favour of this idea. One of my colleagues made it absolutely clear to me yesterday that he believes the decision should be his and his alone and that these proposals are illiberal. If the decision is to be made, he believes that it is he who should make it and not the state. Those were his words, not mine. He said the state should not have control of his body after he had died. Would it be possible to carry an opt-out card, which might be a sensible way around this?

My personal view is that having an organ donated is the best gift that those in desperate need of one will ever receive—not just the patient but their family, friends and those who care. We have seen the success of the opt-out system in Wales, so we on these Benches believe it is high time we followed suit in England to prevent people dying for lack of an organ.

Lord Lansley Portrait Lord Lansley (Con)
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My Lords, I think I am with the noble Lord, Lord Hunt, and others in having been sceptical of an opt-out system, not least when we came to discuss it at some length—I see the noble Lord, Lord Reid, there—during the passage of the Human Tissue Act back in 2003 or thereabouts. We looked at it at some length. That prompted the pursuit by subsequent Governments, including the coalition Government in which I served, of every available opportunity to try to increase donor rates, not least by improving the system of transplant co-ordination and the supply of specialist transplant nurses.

My first point, to which I hope my noble friend the Minister will respond positively, is that I do not share the view that under this Bill resources for information and for the transplant system—in particular for an increase in specialist transplant nursing support—are in any sense in competition. We need to do both, and I hope the Minister will be able to confirm that we will seek wherever possible to have exactly that support through transplant nurses. It is really important that we do. I think the noble Baroness, Lady Randerson, was referring to that when she referred to Spain. At the time, we looked in some detail at the Spanish example. Spain said to us that probably the bigger element in its success was not that it was an opt-out system but that it had really effective transplant co-ordination and strong support for families through trained nursing and support staff. That is the most important thing.

However—not to rerun Second Reading, to which I contributed—we have an ethical obligation to secure the maximum availability of organs for those waiting for them, some of whom, sadly, continue not to get access to organs and to die while waiting. We have an ethical conflict, because it is right to say that the state does not own our bodies. We have a right to determine what happens. My noble friend Lord O’Shaughnessy was absolutely correct in pointing out that the Bill offers an opportunity for those who wish to control what happens to their organs and bodies after death to make that explicit.

This brings me to my final point, which is to further thank my noble friend Lord McColl for raising these issues. If we are to go down this path, it is absolutely essential that the families of everyone who may be—sadly after death—a donor must be aware that they had an opportunity to consider this. Whether they took any action is a matter for them. We must be confident that the information, not only in the first instance but subsequently, is such that nobody could reasonably be expected not to have been presented with this as an issue they should consider. The noble Lord, Lord Anderson, asked what happens if the family disagree. They may, but the law is then very clear that the transplant co-ordinator, nurse or whoever must take the decision must do so seeking to determine what the loved one who has died would have thought. The evidence is not: what do you think, as the person in a qualifying relationship? It is: what can you say about what the view would have been of the person who has died and whose organs are potentially to be donated? That is the issue and the judgment that has to be made, and of course that is where the ethical issue really bites. It is not what we might think about our loved ones, but what we know about what they themselves thought about what should happen to their own organs. For those reasons, my noble friend’s amendments—I know he will not press them, and I think that is absolutely right—have very helpfully given an opportunity for the Minister to give us reassurance on both those points.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I shall say just a few words. The noble Baroness, Lady Randerson, and the noble Lords, Lord Carlile, Lord O’Shaughnessy and Lord Lansley, have made the arguments extremely well, so there is no need to repeat them. I just make the practical point that if we want this on the statute book it has to be unamended. We can have these discussions— they are helpful—but that is the truth of the matter. We will all have received a briefing yesterday from Kidney Care UK, which stated that three people die every day waiting for a kidney. That is what we need to bear in mind.

Baroness Manzoor Portrait Baroness Manzoor (Con)
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I was expecting the noble Baroness, Lady Thornton, to talk for a little longer, so I thank her very much.

I thank my noble friend Lord McColl for initiating this discussion on the role of the deceased’s loved ones under the proposed new system. This is an important issue that has rightly been the focus of much of the debate in the other place and here. My noble friends Lord McColl and Lord O’Shaughnessy rightly stress the issue of trust. As both my honourable friend the Member for Thurrock and the noble Lord, Lord O’Shaughnessy, have confirmed on a number of occasions, the family will remain at the heart of the new arrangements, as now. I believe this reassurance has also been given in correspondence to my noble friend and has been confirmed by NHS Blood and Transplant’s medical director and national clinical lead for organ donation. I am happy to give further clarification on this point.

The legislation sets the framework for consent to organ donation and reflects what we already know—that most people support donation and agree that the decision of the potential donor should be paramount. We have, however, always said that, as now, organs and tissues will not be taken without full consultation with persons in a qualifying relationship—that is, the deceased’s close family and friends. There will always be a personal discussion between the specialist nurses for organ donation and the family. This is NHS Blood and Transplant’s current policy and will not change under the new system.

In addition to this policy, the Bill as drafted allows for a person in a qualifying relationship to the deceased to provide information about the deceased’s wishes on donation of their organs and tissues. This is an important safeguard, to find out what the deceased would have wanted and the best way forward. I remind the House that healthcare professionals have a duty of care not only to the patient but to the family. Specialist nurses for organ donations are highly trained professionals from an intensive care or emergency medicine nursing background. When nurses join NHS Blood and Transplant, they initially receive extensive training over a six-month period. This covers supporting families to make end-of-life care decisions, including on organ donation. A key focus of the training is to enhance their skills in supporting acutely bereaved and grieving families.

11:00
In the light of the practical reality of the application of the Bill and the many medical processes and protocols that have been put in place since the Alder Hey scandal—which I know may still be a concern for some—and given that the Bill already allows the family to provide information if the deceased would not have wanted to donate their organs and tissues, it is not clear what my noble friend’s amendments will achieve. I say this to him very respectfully. He may be concerned that donation will still go ahead if no family or friends are accessible but I can categorically confirm that this will not be the case. As my noble friend will know from his medical training, to enable a safe transplant doctors need someone’s medical, social and sexual history. Without such important information about the deceased, it would not be safe to proceed with a transplant and I wish put it on record that donation will not go ahead.
More detailed guidance about the role of the family will be included in the new code of practice, which will be developed by the Human Tissue Authority in formal consultation with stakeholders. This will include case studies and examples so that the public and healthcare professions can be clear that the family will continue to be involved in discussions about donation. The code will be laid before Parliament, so parliamentarians will have the opportunity to consider the guidance for healthcare professionals before the system comes into force if they wish. We expect healthcare professionals to act properly and in accordance with their relevant professional standards and guidance, part of which will be the new code. In addition, as part of the information available to the public about the new system, NHS Blood and Transplant will set out its internal protocol in an easily digestible way so that the public have all the right information and feel reassured.
At Second Reading much reference was made to the letter my honourable friend in the other place, Jackie Doyle-Price, wrote to the Board of Deputies of British Jews, which further explains the role of the family under this proposed system. A copy of this letter was circulated to all noble Lords who spoke at Second Reading and has since been placed in the Libraries of both Houses. The Government are committed to introducing a new code of consent that is practical, ethical and enables the public to maintain trust in the system. The role of the family will be a key aspect of this. No family will be forced to agree to organ donation if they are strongly opposed to it.
One of my noble friend’s questions concerned Wales. Wales has seen a steady rise in donor numbers, from 52 in 2012-13 to a high of 74 in 2017-18. In 2017-18 Wales had the highest consent rate in the UK of 70%, compared to England, Scotland and Northern Ireland where consent rates were 66%, 57% and 66% respectively. We need to concern ourselves with the consent rate. A higher consent rate allows a bigger pool of available organs and can therefore lead to more high-quality transplants for patients who need them. Numbers, of course, will fluctuate. The family will continue to be at the heart of the new system; I put that firmly on the record.
The noble Baroness, Lady Randerson, raised the issue of what would happen if someone was not contactable by the NHS. The NHS staff will of course make every effort to identify the next of kin of any patient admitted to hospital in a serious condition. This starts with the ambulance service and can also involve the police. The specialist nurses at NHSBT will undertake further investigations such as contacting the GP, searching the organ donor register and contacting embassies and overseas record departments if the patient is not UK-born.
Lord Hughes of Woodside Portrait Lord Hughes of Woodside (Lab)
- Hansard - - - Excerpts

Can the Minister confirm that the carrying of a donor card short-circuits the long process of finding relatives and so on, or is that simply a figment of my imagination?

Baroness Manzoor Portrait Baroness Manzoor
- Hansard - - - Excerpts

My Lords, I will come on to donor cards. I hope that with the enactment of the Bill more people will be able to take proactive action to record their decision on organ and tissue donation and discuss it with their family.

It is fully recognised by the Government that the new system must be well publicised for the changes to have the greatest effect. As part of developing the code of practice, the Human Tissue Authority will propose what information the specialist nurse should consider. The principle, however, will be that such information represents the wishes of the deceased rather than those of the family.

Without wanting to prejudge discussions with the stakeholders in the planned public consultation, we are aware that organ donation in some cases may be against someone’s culture, faith or belief, as my noble friend Lord McColl pointed out. It is for this reason that I confirm again that the Government will launch a 12-month communications campaign after the Bill receives Royal Assent. We are working with NHS Blood and Transplant on plans to reach out to as many people as possible. Plans are already in train to write to each household in England; to use different advertising channels, including TV, radio and social media; to promote the campaign in health settings; and, through partners, to engage the media in work to ensure that we reach hard-to-engage groups so that as many people as possible in England are aware of the changes.

My noble friend also raised the question of foreign students. The regulator will work with the Universities and Colleges Admissions Service to raise awareness with them.

We are also keen to work and align our message with the many charities that are already doing great work to promote organ and tissue donation. Key stakeholders are now part of the NHS Blood and Transplant communications advisory group and they are considering how best to do this.

Baroness Randerson Portrait Baroness Randerson
- Hansard - - - Excerpts

The Minister has given a list of organisations that she will be working with but I have not heard the word “schools”. The noble Lord made a good point about young people coming up to the age of 18 needing to be fully informed. Schools are an effective way of passing on information about basic rights in our society.

Baroness Manzoor Portrait Baroness Manzoor
- Hansard - - - Excerpts

I agree. Schools and universities will be included. It is important that the message is carried in those settings and institutions. I have already said that NHSBT will work closely with universities and other organisations to ensure that key messages are available.

On donor cards and short-circuiting the family, there is no name on the card but it is a good starting point to knowing the wishes of the deceased. Efforts will be made to track down the family to determine lifestyle history.

Lord Berkeley Portrait Lord Berkeley (Lab)
- Hansard - - - Excerpts

I may have misheard, but I do not think the Minister answered my noble friend’s question about donor cards. If she does not have an answer, will she write to him?

Baroness Manzoor Portrait Baroness Manzoor
- Hansard - - - Excerpts

I thought I had, but if my answer was not clear enough, I will of course write to the noble Lord.

A campaign will take place before the new system is brought into force. The Government fully understand that changing the culture around organ donation requires continuous engagement with the public and that the communications campaign alone will not achieve this.

My noble friend Lord McColl raised the important issue of a zealous doctor taking the organs of one’s loved one without consulting the family. I reassure him that it is unlawful to remove organs and tissues for transplantation purposes without appropriate consent as defined in the legislation. The Bill sets out the system of deemed consent, and families will play an important role in establishing the views of the deceased. If organs and tissues are removed without proper consent, an offence is committed. This is clearly set out in the Human Tissue Act 2004.

The noble Baroness, Lady Jolly, asked about opting in and opting out. I understand the point she made about having an opt-out card, and my noble friend also made that suggestion. People do not usually carry the card at the time of donation. That is why it is vital to record a decision on the organ registry, which nurses always check. It will show what the deceased wished.

As set out by my noble friend Lord O’Shaughnessy at the Bill’s Second Reading, the Secretary of State will continue to uphold his duty to promote organ and tissue donation, as set out in the National Health Service Act 2006. This duty has been delegated to NHS Blood and Transplant which, after the initial national communications campaign, will promote deemed consent as part of its ongoing awareness-raising activity each year. The Government are planning to spend around £18 million on communicating until 2021-22 and to fund follow-up campaigns after that. The campaigns and the relevant information made available to the public will cover all aspects of how the new arrangements will work, including the role of the family.

My noble friends Lord McColl and Lord Lansley and the noble Baroness, Lady Randerson, spoke about funding the system. We will make sure that the system is funded as it should be. I assure noble Lords that we are working closely with NHS Blood and Transplant on its operational costs, which we will fund.

My noble friend Lord McColl mentioned that specialist nurses do not attend donors in 10% of cases and do not speak to the family. Specialist nurses for organ donation attend to speak to the family whenever they are informed of a potential donor. In a very small number of cases the nurses are not contacted, but this is often because the family has already raised the issue with their doctor and stated that they do not want donation to occur and do not wish to speak to a specialist nurse. NHS Blood and Transplant is working to achieve 100% referral and family approach.

I thank the noble Lord, Lord Carlile, for his support. Our ambition is to reach 80% of the population of England, so we are very ambitious. It is important that we do this. As I said, the Government intend to spend around £18 million on communications in 2020-21.

I hope that I have given noble Lords enough reassurance. If even one life is saved as a result of this change in culture—and we are looking for a change in culture—it must surely be worth it. I hope that, with the further assurances that I have given my noble friend and have categorically put on record, he will be able to withdraw his amendment.

11:15
Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab)
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I am very grateful to the Minister and, in particular, the noble Lord, Lord McColl, for raising these important issues. He asked for reassurance, and I hope that in a moment he will be able to say that he has received it.

I shall make four quick points. First, I agree with the noble Lord that in the relationship between the patient and the doctor, trust is critical. He mentioned Alder Hey. I was a Minister who had to deal with the Alder Hey situation. It was very different. There was a rogue pathologist, unsupervised by the NHS or the University of Liverpool. Many parents affected had the tragedy of three times having to bury parts of their child’s body. That situation has left an indelible mark on anyone who had anything to do with it. But what happened at Alder Hey is very different from transplant services. People in those services are very responsible and operate under a code of practice and the law. While the noble Lord is right to raise that situation—and some of the families who were affected are watching the debate in your Lordships’ House today—there is a difference.

Secondly, the Welsh experience is instructive in its success in increasing the rate of donation. As the noble Lord, Lord O’Shaughnessy, said, it allows people to opt out, but the number of those who do so is much smaller than the noble Baroness, Lady Randerson, and her colleagues in Wales thought it would be. That shows that the system is working.

Thirdly, at the heart of the Bill we are encouraging a change in culture, so that we as individuals talk to our families about our intentions. This is why having the card and signing the register are so important, as they are a clear indication to our families that we wish to donate our organs. Nothing in the Bill will move away from the important discussion with the family and from families being listened to in the way that the Minister said.

Finally, on the education campaign, I do not wish away £18 million. It is a good sum to start with, but we will have to see how it goes. If it is apparent that we need more campaigning, I will be the first to knock on the Government’s door. We should also remember what the noble Lord, Lord Lansley, said: it is not just the campaign. We need to make sure that our transplant service will be able to meet the increase in donations that we expect to see. That means, first, that we make sure that we have enough of the crucial specialist nurses, who do a fantastic job. We also need to make sure that the transplant service will be able to respond to what I hope will be an increase in the number of donations.

I hope that the noble Lord feels he has received the reassurance he rightly asked for.

Lord McColl of Dulwich Portrait Lord McColl of Dulwich
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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.
Clause 1 agreed.
Amendment 2
Moved by
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 Portrait Lord McColl of Dulwich
- Hansard - - - Excerpts

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 Portrait Lord Hughes of Woodside
- Hansard - - - Excerpts

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 Portrait Lord McColl of Dulwich
- Hansard - - - Excerpts

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 Portrait Baroness Manzoor
- Hansard - - - Excerpts

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.

11:30
NHS Blood and Transplant will continue with its ongoing data collection and analysis and its annual report on a range of different organ donation statistics. However, I can see the value of an independent evaluation, which my noble friend is seeking, to look at other wider aspects such as how the new system has been implemented and, indeed, whether it is working in practice. I would therefore like to confirm that we also have plans for a fuller evaluation once the new arrangements are up and running. The evaluation is intended to look at the first 12 months after the new system has been introduced. Officials have started considering this work.
My noble friend asked what the evaluation could cover. He is quite right that wills give us a good starting point. As I said, we are keen to look at all aspects—for example, public perceptions, the impact of communication campaigns and how the front line is working—to get a good understanding of how the system is working. I want to reassure my noble friend and other noble Lords that the process will be fully transparent. I am very happy to confirm that the Government will lay the report before Parliament. I hope that my noble friend will be pleased with that commitment.
My noble friend also asked whether there is value in carrying a donor card. Yes, there is value. On the question of Jewish and Muslim cards, NHS Blood and Transplant has worked with faith leaders to improve the cards and include a faith option on the organ donor register. Furthermore, as part of the Bill’s post-legislative scrutiny, we will be required to submit a memorandum to the relevant Select Committee, reporting on key elements of the legislation’s implementation and operation, three to five years after it receives Royal Assent. I hope this further confirms our intentions.
Given the current duty on NHS Blood and Transplant to report annually, which goes beyond the commitment set out in this amendment, and given the Government’s plans to do a formal evaluation after the new arrangements are up and running—which we fully recognise is good practice in policy-making—I hope that my noble friend feels reassured and will withdraw his amendment.
Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath
- Hansard - - - Excerpts

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 Portrait Lord McColl of Dulwich
- Hansard - - - Excerpts

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.
Amendment 3 not moved.
Clause 2 agreed.
Clause 3: Extent, commencement and short title
Amendment 4
Moved by
4: Clause 3, page 3, leave out line 5 and insert—
“(1) Sections 1, 2 and 3 extend to England and Wales.(1A) Sections 2(2), 2(3) and 3 extend also to Northern Ireland.”
Lord Morrow Portrait Lord Morrow (DUP)
- Hansard - - - Excerpts

My Lords, I will be very brief. I accept that this Bill is primarily about what happens in England, but it includes references to Northern Ireland in Clauses 2 and 3. It is the latter clause that my amendment explores and to which my interest turns.

To give some background to my comments, I should first say that there were discussions about introducing deemed consent in Northern Ireland in 2015-16 but considerable concerns were raised and the Bill did not become law. The Department of Health continues to take its responsibilities seriously to promote organ donation in Northern Ireland, has recently consulted on this topic and, in December, announced a £250,000 programme of co-ordinated activities to increase organ donors across Northern Ireland.

Secondly, health matters continue to be delegated to the Northern Ireland Assembly, which is acknowledged by paragraph 44 of the Explanatory Memorandum accompanying the Bill and paragraph 28(c) in the Government’s memorandum concerning the delegated powers in the Bill. Thirdly, I want to thank the Minister for taking the time this week to discuss my amendment and his officials for being in touch with me regarding it. What they sent to me and what they said was quite reassuring. However, I want to put my comments to the Minister today. To be quite frank, getting them on the record is what I am about.

I return to my concerns about Clause 3 and the purpose of Amendment 4: Clause 3(1) says that the Bill extends to Northern Ireland, which I would expect to mean that all three clauses apply to Northern Ireland. However, the title of Clause 1 is “‘Appropriate consent’ to adult transplantation activities: England”. There thus appears to be something of a contradiction in the Bill, which my amendment seeks to resolve. I recognise that Section 3 of the Human Tissue Act 2004 extends to Northern Ireland, but I want to be very clear that the proposed changes to that section, set out in Clause 1 of this Bill, do not. For the sake of complete clarity, I am proposing an amendment that excludes Clause 1 being extended to Northern Ireland and hope that the noble Lord, Lord Hunt of Kings Heath, who is the sponsor of the Bill in this House, and the Minister, will put on the record that there is no intention of Westminster bringing in deemed consent for organ donation in Northern Ireland.

Baroness Manzoor Portrait Baroness Manzoor
- Hansard - - - Excerpts

My Lords, I thank the noble Lord, Lord Morrow, for raising the issue of territorial extent and its application in this Bill. I clarify that that the Bill does not change the rules of consent in Northern Ireland and introduces deemed consent only in England. The reason Northern Ireland is included in the extent is because the Bill amends an existing piece of legislation, the Human Tissue Act 2004, which extends to England, Wales and Northern Ireland. While the Bill has been drafted to have a matching extent to that Act, which is the recommended approach when an existing Act is amended, we are changing the law to introduce deemed consent in England only. Deemed consent will not apply to Northern Ireland.

On the second part of the noble Lord’s amendment, the Bill as drafted ensures that organs removed in England under deemed consent can still be stored and used in Northern Ireland as now, even if Northern Ireland does not have deemed consent. This is why Northern Ireland is included in Clause 2(2) and (3). However, for such a provision to have effect in Northern Ireland, there will be a need for a legislative consent Motion from Northern Ireland.

I hope this reassures the noble Lord that we have not undermined policy in Northern Ireland in any way, and reassures the Committee that this amendment is not necessary. I hope the noble Lord will withdraw his amendment.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath
- Hansard - - - Excerpts

My Lords, the noble Lord has asked me to confirm the view of the Minister, and I so do.

Lord Morrow Portrait Lord Morrow
- Hansard - - - Excerpts

My Lords, I thank the Minister and the noble Lord, Lord Hunt. To put it very succinctly, I am reassured. I beg leave to withdraw the amendment.

Amendment 4 withdrawn.
Clause 3 agreed.
House resumed.
Bill reported without amendment.