(1 week ago)
Lords Chamber
Baroness Smith of Cluny
That the draft Order laid before the House on 17 December 2025 be approved.
Relevant document: 48th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument)
The Advocate-General for Scotland (Baroness Smith of Cluny) (Lab)
I thank the noble and learned Lord for his amendment and his engagement with me on this matter. I understand the concerns he has raised. However, the Government believe the approach they have taken is appropriate and in keeping with the devolution settlement.
As with all the Scotland Act orders we have considered since the start of this Parliament, this is the result of close collaborative working between the UK and Scottish Governments. The order before us will be made under Section 30 of the Scotland Act 1998, which provides the power for the legislative competence of the Scottish Parliament to be altered. Specifically, it enables modifications to be made to Schedule 4 or Schedule 5 to the Scotland Act 1998.
Orders made under this provision are subject to the affirmative procedure in both the UK and Scottish Parliaments. The order was considered by the Scottish Parliament and considered in the other place earlier today. I welcome the opportunity to set out to the House the purpose of the order. I will explain what it does, what it does not do, and why it is the best way of proceeding with this complicated matter.
The Assisted Dying for Terminally Ill Adults (Scotland) Bill is a Member’s Bill introduced by Liam McArthur MSP and is currently before the Scottish Parliament. It seeks to create an assisted dying regime in Scotland. I am keenly aware of the sincerely and strongly held views on this topic. I would like to emphasise that the UK Government remain neutral on the matter of assisted dying. It is a matter for MSPs in the Scottish Parliament to determine whether there should be an assisted dying regime in Scotland.
The Scottish Government identified areas of this Bill as being outside of legislative competence and, as such, requested a Section 30 Scotland Act order from the UK Government. This was in respect of substances and medical devices which may be used for an assisted dying regime in Scotland. They requested a Section 30 order specifically as they considered that such provisions are a fundamental element of the regime the Bill seeks to introduce. The UK Government considered the request carefully and, following engagement with the Scottish Government, concluded that making a narrow, time-limited Section 30 order would be the most appropriate action.
This approach enables Members of the Scottish Parliament to consider the Bill with clarity as to how the matter of substances and devices could be dealt with, while protecting reserved matters, including medicines regulation. This Section 30 order is time-limited in nature to reflect the circumstances of this Scottish Parliament Bill and the upcoming Scottish elections in May. This time limit applies to the legislative competence of the Scottish Parliament, but this will not affect the future exercise of any regulation-making functions conferred by the Bill beyond 7 May 2026, should the Scottish Parliament determine to do so. The order has been specifically designed to ensure that the Scottish Parliament can create an overall framework for medicines and devices to be used in an assisted dying regime, should they decide to do so.
I am aware that the content of this order has prompted queries about the approach the Government have taken: first, why the Government have taken forward a Section 30 order and not, for example, a Section 104 order; secondly, the scope of this order and the matters which are not included; and thirdly, the likelihood of other orders being brought forward under the Scotland Act 1998 in due course, including possible Section 104 orders.
The Secondary Legislation Scrutiny Committee, which considered the order, as well as the Scottish Affairs Committee in the other place, both raised these points. I take this opportunity to thank them for their scrutiny. Before I deal with the specific issues in detail, I would like to set out the guiding principles that underpin the Government’s approach to this matter. Relying on these has framed and informed our decision to proceed as we have.
There are five principles. First, we are not seeking to alter the devolution settlement with Scotland any further than is necessary to deal with this specific issue. Secondly, the UK Government maintain their neutral stance on assisted dying and do not endorse any particular outcome of the consideration of the Bill before the Scottish Parliament. Thirdly, in supporting the proper functioning of devolution, we should put MSPs in a position to be able to vote on a coherent proposal in the devolved matter that is the subject of that Bill. Fourthly, it is in the interests of all the citizens of the UK for our regime regulating medicines and medical devices to be a UK-wide scheme, delivered in a consistent way in all parts of the country. Fifthly, it is the responsibility of the Scottish Government to ensure that the Scottish Parliament legislates within its competence; it is not the responsibility of this Government.
Relying on these principles, I turn to the detail of the Section 30 order. I am very conscious that the regret amendment tabled is as interested in what is not in the order as it is in the order itself. In setting out the Government’s reasoning, I hope to deal with these concerns, as well as explain why a Section 30 order was thought appropriate.
To provide some context, it may assist to briefly set out the issues that have been raised around legislative competence concerns. There are three: first, the regulation of medicines and medical devices; secondly, the regulation of the medical profession in delivering a scheme, including considerations of training and experience; and, thirdly, the position of the medical professionals who may not wish to take part in the scheme, and the appropriate employment protections they may require.
Lord Keen of Elie
At the end to insert “but that this House regrets that the draft Order is drawn too narrowly, such that the modification of Schedule 5 to the Scotland Act 1998 would be insufficient to render the Assisted Dying for Terminally Ill Adults (Scotland) Bill fully within the legislative competence of the Scottish Parliament.”
Lord Keen of Elie (Con)
My Lords, I am obliged to the Minister for engaging with me on this topic. To be clear at the outset, we are not concerned with the merit, or otherwise, of the content of the legislation in question. However, this raises a somewhat technical issue with regard to the devolved settlement.
I begin with a general résumé of where we are regarding the devolved settlement. Schedule 5 to the Scotland Act 1998 contained expressed reservations to the United Kingdom Parliament. They were very carefully and deliberately identified as areas where it was appropriate that there should be UK-wide legislation, rather than devolved legislation, touching upon certain fundamental and important matters.
The Minister has mentioned medicines and medical devices, as contained in paragraph J of Schedule 5, but that does not sit alone. The regulation of all the health professions and the medical professions is expressly reserved in Schedule 5, as is the matter of employment law, for the very simple reason that uniformity within the United Kingdom was thought important and to take precedence over the desire for devolved competence.
There is a provision in Section 29 of the Scotland Act which makes it clear that, if the Scottish Parliament passes legislation that is not within devolved competence, it is not law. It is as simple as that. The competence of the Scottish Parliament can, of course, be extended by Section 30, and we have heard reference to a Section 30 order. That is an unusual mechanism, last used more than 10 years ago in respect of the referendum on independence. Moreover, it is not a mechanism that has ever been used before in respect of a Member’s Bill. Within the Scottish Parliament, what we understand as a Private Member’s Bill is referred to as a Member’s Bill. In addition, within the Scottish Parliament, when referring to a Bill, one refers not to clauses but to sections; I hope that noble Lords will bear with if I adopt the appropriate references in dealing with this matter.
Interestingly, this is also a Bill in respect of which the Scottish Government have declared themselves neutral. We are being asked to grant a Section 30 order extending devolved competence to a Member’s Bill in respect of which the Scottish Government have declared repeatedly that they are entirely neutral.
Section 30 does and can be used to extend devolved competence for the purposes of passing legislation in the Scottish Parliament. That has to be contrasted with Section 104 of the Scotland Act, which can be used to extend the range of a competent piece of legislation that has already been passed by the Scottish Parliament. In other words, if the Scottish Parliament has competently passed legislation but would wish to see it extended into reserved areas, the Secretary of State of the UK Parliament can make an order under Section 104, so extending the relevant legislation.
A simple example would be where the Scottish Parliament passed legislation for the recognition of gender certificates for 16 year-olds. That was a proposal which came to grief for other reasons. If it had wanted to see that legislation, with those certificates recognised by registrars in England and Wales, it would have required a Section 104 order from the Secretary of State in order that the Scottish legislation could be extended. It is important to keep in mind the distinction between Section 30 orders, which will allow an extension of devolved competence in order that the Scottish Parliament can pass legislation that is then competent and is then law, and the situation in which it is extended after it has been passed by virtue of a Section 104 order.
A Section 104 order cannot make competent a piece of legislation that is not within devolved competence. If the Scottish Parliament passes an Act that is not within devolved competence, then, as I mentioned earlier, it is not law and it cannot be made law by the Secretary of State making an order under Section 104. To give perhaps a poor analogy, if the legislation from the Scottish Parliament is competent but rather sick, it can be made well by a Section 104 regulation. If the legislation passed by the Scottish Parliament is not law—if it is dead—it cannot be brought back to life by a Section 104 order.
We are dealing here with a Member’s Bill in the Scottish Parliament which deals with the regulation of the health professions—the medical professions—in order that they can assist people to die. We are concerned with the regulation of medical substances in order that they can be lawfully administered by medical professionals to assist people to die.
Can the noble and learned Lord explain what he means by that? I think he is saying that there is no impact assessment of the effect of the regulation of devices and substances being in Scotland rather than England. That is all that paragraph 9 deals with.
Lord Keen of Elie (Con)
No, I am saying that there is no impact assessment in respect of the effect of this legislation in Scotland on the regulation of the medical profession, which is also an expressly reserved matter under paragraph G2 of Schedule 5 to the Scotland Act 1998. Because that will be impacted by virtue of this Section 30 order being granted to the Scottish Parliament, that ought to be a consideration in this context.
I think the noble and learned Lord misunderstands what is being said here. It says that there is no impact expected in allowing the Scottish Parliament to be the body that allows regulations to be entered into in relation to devices or substances. That is all that is being said here.
Lord Keen of Elie (Con)
That is my very point, with the greatest of respect, because the reserved matters are not just medical devices but regulation of the medical profession. Therefore, the very fact that it is such a narrow order means that the relevant impacts of this Section 30 order and of the legislation, assuming it is competent and passes, have not been properly addressed in this context.
It is an impact assessment only of this instrument, not the Scottish legislation.
Lord Keen of Elie (Con)
I am underlining the narrowness of this instrument and what it omits. It omits to address properly the effect of passing this legislation through the Scottish Parliament as a consequence of the Section 30 order.
I have sought to make this as clear as possible for at least some of your Lordships. In my respectful submission, this is a situation in which the Government should think again about the course of action they propose to adopt. I therefore express my regret with regard to this instrument.
My Lords, I have a few questions for the Minister. My noble and learned friend Lord Keen has set out pretty eloquently the issue of the narrowness, and the House will be aware that one of the elements of Section 30 orders, and indeed of a variety of subordinate secondary legislation, is that they cannot be amended. As has been pointed out, one thing that is not covered and not clear in the Section 30 order—although the Government have indicated that it will be in the Section 104 order in order to enact the Bill, if the Members of Scottish Parliament decide to go ahead with it—is how, in effect, that will happen. Instead, a number of questions are raised. For example, the MHRA response pointed out that, if this does go ahead, the UK Government and the regulator want this to be one process that would happen throughout Great Britain.
This is a novel approach—this is the first time this has happened—and I am trying to understand whether, if a Scottish Minister puts forward regulations in light of the Section 30 order, it will require the specific agreement of the UK Government Ministers: the Secretary of State for Scotland. The other way around is that the Scottish Parliament hands over powers to the UK Parliament to decide how a Bill it asked for will be enacted. So we are in this novel situation.
I am interested to understand from the Minister how they got to this point. I know that she set out the narrowness, not going beyond devolution, but when this was debated in the Scottish Parliament in May 2025, Scottish Government Ministers said that they would start a discussion with the UK Government. It is my understanding that actually, the Scottish Government wanted a far wider Section 30 to cover the specific issues my noble and learned friend Lord Keen pointed out.
If we put ourselves in the feet of the Members of the Scottish Parliament, if this goes ahead today, as they get to their stage 3, they will start to remove lots of pieces of the Bill that currently sit in that Bill and then hand over, in effect, the decision on how any of this can be implemented to the UK Government and, subsequently, the UK Parliament. It will not be able to be amended by the UK Parliament, but the UK Government can do what they like. So it would be useful to get an understanding of whether there is a memorandum of understanding that could be shared. Is there any correspondence that could be shared between the two Governments, given that both Governments say that they are neutral on this Bill? If they are neutral on the Bill, how do we know what process they are going to undertake to deploy this in future?
Baroness Smith of Cluny (Lab)
I am grateful to noble Lords for their contributions to this debate. I will respond to the specific points raised, but first I mention four overarching points that are important to hold in mind in this debate.
It is for the Scottish Parliament, not the UK Government, to ensure that when it legislates it does so within its competence. That means that our role, in respect of that legislative competence, is necessarily responsive and not proactive. Had we failed to respond to the request made by the Scottish Government, it is our view that MSPs would have been in the position of having to consider whether to vote for an assisted dying scheme without knowing what fundamental parts of such a scheme would entail—in this case, the medicines and devices to be used. While the Government are neutral on the issue of assisted dying, they are not neutral on the issue of devolution. We believe in the proper functioning of the devolution settlement. To have denied this order would have been to deny Scottish MSPs the opportunity to make law in a devolved area, with a clear understanding of how that law would operate. This is not a debate on the issue of assisted dying but it is a debate on the devolution settlement and whether this House is prepared to afford the Scottish Parliament the respect of legislating in the devolved area of health in a coherent way.
I turn to address the specific issues raised, dealing first with the queries of the noble and learned Lord, Lord Keen. He told us that a Section 30 order had last been used with reference to the independence referendum. That is not quite right, although it was round about the same time. It was last used for the reduction of the voting age in the Scottish elections to the age of 16. However, I do not demur from the point that it is unusual—16 have been used since devolution was introduced, and I do not shy away from that. The noble and learned Lord pointed out that it had never been used for a Private Member’s Bill, which is also right. It reflects the particular and unusual circumstances in which we find ourselves, with a Private Member’s Bill and two Governments who are neutral on the issue. It has been a challenging process.
The noble and learned Lord, Lord Keen, tells us that the Bill may not be competent and, if so, will not be law if it is passed without the two further matters of legislative competence questions that I referred to when I set out the relevant matters. These, as I understood the noble and learned Lord to identify them, were the regulation of professions and employment matters.
The difference of opinion really comes down to an analysis. As the noble and learned Lord puts it: what is the purpose of the Bill when one assesses whether or not it falls within competence? That is right. It comes down to an analysis of what you regard as fundamental to the assisted dying regime and what is not. It is this Government’s analysis that the regulation of medicines and devices is fundamental to the scheme, such that it would not be fair to ask Members of the Scottish Parliament to vote on a scheme when they did not have certainty about how that matter would be dealt with. However, it is also our assessment that questions of employment law protections and questions of the regulation of professions, around training and experience, are consequential matters to the regime. They are not of the essence of the scheme; they are consequential matters which can be dealt with after the Bill has been passed and becomes an Act. That is simply a difference of opinion on the analysis of what is fundamental to allow the regime to exist.
The noble and learned Lord also complained that the power given to the Secretary of State is too great and, I think I understood him to say, constitutionally novel and certainly constitutionally problematic. We should remember that the Scottish Government have agreed to this, because they agree with us that some matters are so fundamental that they should be regulated and dealt with on a UK-wide basis for the benefit of all citizens of the United Kingdom.
The noble and learned Lord also asked why we do not simply extend the Bill proceeding through the UK Parliament. I am sure he will appreciate that the Government’s neutral stance means that they are not in a position to lay amendments to a Private Member’s Bill.
On eligibility for the scheme, the noble and learned Lord raised what would happen if the Bill in the Scottish Parliament is passed but the Bill in the UK Parliament is not. This is not a matter for consideration today. That is not what this debate is about; it is about a narrow Scotland Act order. I encourage the House to retain focus on that. This debate is about the devolution settlement, not assisted dying schemes. I also note the discussion he had with the noble and learned Lord, Lord Falconer, and would make the same point that this is not the forum for a discussion about the impact of assisted dying regimes. This is a devolution question.
I will now deal with some of the points raised by the noble Baroness, Lady Coffey. I genuinely welcome the opportunity to respond to her thoughtful comments. She talked about transparency and getting a sense of how it all knits together. If that is not clear, I am delighted to have the opportunity to seek to make it more so.
The noble Baroness raised the necessity of having the agreement of UK Government Ministers. As a point of detail, she mentioned the Secretary of State for Scotland. In fact, the order is drafted simply to say, “the Secretary of State”, deliberately widely, so that it can be any Secretary of State of the UK Government—whoever is the most appropriate person to do it in any given moment. In any event, her greater point was about the measure of control. This goes back to maintaining the integrity of the United Kingdom’s medicines regime. It has been made clear to the Government that this is important, and we share that view. It is so vital that, in our view, it justifies the measures we have insisted on and the measures that are contained in the order and which the Scottish Government agree with.
The noble Baroness asked whether it was correct that the Scottish Government had made a wider request to have the matters contained within the draft Section 30 order. For the record, that is indeed the case. The initial request in September was simply for the narrow order before this House, with the proposal that the remaining matters might be dealt with under a Section 104 order. In November, after some discussion and correspondence, the proposal was made that perhaps all matters could be included in a Section 30 order. We considered this carefully but simply did not agree with the analysis, for the reasons I have given. Our view was that the other matters were properly assessed to be consequential and therefore could be dealt with in a Section 104 order. As I have set out, it was driven by the general principle that we are not looking to extend the devolution settlement more than it needs to be, so if they can be dealt with in a Section 104 order then they ought to be. It was also about the lack of certainty I referred to in opening: this Bill is still progressing through Parliament and is still subject to amendment. We do not know its final form, so it would be rather challenging to include those matters in the Section 30 order, as it would have to be done right now, rather than waiting to see the end form of the Bill.
The Minister mentioned the prospect of maybe producing a draft order but seemed to indicate that the Government would not do so until they had certainty on the Scottish Parliament’s final position on those two issues. Is there not a danger that the Government’s position will create a Catch-22 situation? MSPs will be voting not knowing what the Section 104 orders will be and, on the flip side, the Government will not produce those without knowing what the MSPs will settle on. It creates a contradiction on both sides. If part of the idea is to give as much certainty as possible, would that not be a flaw?
Baroness Smith of Cluny (Lab)
I am grateful to the noble Lord for raising this issue, because I can see that it is creating confusion, and I think that reflects how complicated and difficult the matter has been. The first thing to say is that it is not for the UK Government to draft any Section 104 orders; it is a matter for the Scottish Government to make sure that their legislation remains within the competence of their Parliament, and it is for them to request a Section 104 order and not for this Government to propose it to them. So, it would not be appropriate to draft and publish it, even if the other issues that I have mentioned were not present. But I am very sympathetic to the position of MSPs and others who would prefer to see a complete and neatly tied-up regime before them before they voted on it.
The fact is that it is complicated and strays into reserved areas, and the Scottish Government and the UK Government have sought to deal with that in the most efficient and respectful way towards the MSPs and the devolution settlement. The comfort that I give today is that we are in very constructive and collaborative conversations with them and stand ready to receive any requests for Section 104 orders.
On that note, I think we should celebrate the co-operation of the two Governments on what has been a very tricky issue. This is a Member’s Bill, so it was not a straightforward issue between two Governments that could be dealt with in the usual way. Both Governments are neutral on the issue. It is also a high-profile issue and, indeed, a highly emotive one.
This is what a constructive, mature and respectful reset of the relationship with the devolved nations looks like. I therefore commend this order to the House.
Before the Minister sits down, I asked whether the Government suggested to Kim Leadbeater that she table Amendment 77 back in June, which started to extend parts of the Bill to Scotland. I can always ask the noble and learned Lord, Lord Falconer, about his Amendment 888, but, if she has an answer, I would be grateful if she could share that with the House in some way and at some point.
Baroness Smith of Cluny (Lab)
I would be delighted to write to the noble Baroness. It is important that we have precision on this issue and I do not have that information immediately to hand, so I will write.
Lord Keen of Elie (Con)
My Lords, I will be brief. I am a little puzzled by the proposition that the regulation of the medicines to be employed in assisted dying is to be regarded as the central purpose of the Scottish Bill, while the regulation of those applying those medicines is merely consequential. I would have thought that the hand comes before the content, rather than the content before the hand, but there we are. There appears to be a difference of legal opinion on that narrow point.
I accept the observation made by the Minister that there are aspects of this that are complicated and difficult. I nevertheless am left with an abiding impression that this rather complex mechanism ultimately is designed to ensure that it is the Secretary of State who has the final say over the way in which this legislation is implemented, rather than the Scottish Parliament.
But that is where we are. I have expressed my regret with regard to the scope of the Section 30 order and I leave matters there.