Terminally Ill Adults (End of Life) Bill

Baroness Finlay of Llandaff Excerpts

Friday 14th November 2025 Lords Chamber

Moved by

[Baroness Finlay of Llandaff]

2: Clause 1, page 1, line 4, leave out “capacity” and insert “ability”
Member’s explanatory statement
This links to a proposed change to clause 3.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interest as a consultant in palliative medicine in Wales—I have a paid session there. I have received incidental part-time research support from Living and Dying Well, of which I am a non-remunerated director, and I am a patron of several hospices and hospice services in Wales and across the UK.

Before I start addressing this, I thank the Chief Whip for the message that was sent out previously. I hope that the usual conventions and respect for each other will be observed. It was a pity that clearly there was an error yesterday, with a letter that was sent to the press and was being tweeted about at 3 pm. It was addressed to your Lordships, but we did not receive it until 7 pm, and that was after a blank email had arrived. That was an error, but I hope we can be vigilant about the way that we communicate with each other and that we engage in meaningful and respectful conversations.

I wanted to raise that because there has been a question about the number of amendments that are in my name. I am most grateful to the Public Bill Office, which has worked incredibly hard to support us. Forty-four of my amendments are corrections to wording relating to other bits of the Bill and were tabled at its advice to make the intention of another amendment clear. Please could nobody think that the numbers count? It is the quality of the discussion and the intention behind it that matter, because we are really trying to make this legislation work. It has been difficult because financial aspects relating to palliative care have been deemed to be out of scope.

This Bill is called the Terminally Ill Adults (End of Life) Bill. Every patient who is terminally ill has palliative care needs—100%. Some have them at a minor or relatively easily solved level, others have them at a major and complex level. I worry that we are forgetting the importance not only of palliative care but of specialist palliative care in the way that we talk about services being delivered, and the danger that people will not be able—I go to the word “ability”—to make a proper, informed decision if they do not have the choice to have the care that they need and, if they have complex needs, access to specialist palliative care that has links to pain services, radiotherapy, palliative surgery and all the other aspects of specialist services that I have been privileged to work with over decades. I am well aware they are missing in many parts of the country because we have black holes, I am afraid, in the provision of palliative care in some places. It is literally a postcode lottery.

If you are going to make a decision, and you have the ability to make a decision, you must be able to understand the information given to you. That means that you must have accurate facts that you can understand, be free of pressure and coercion—we will come on to that—and have the capacity to make that decision. We will come on to that.

I will focus on the facts that you may need to make a decision. The diagnosis might be wrong: we know that, at post-mortem, one person in 20 is found to have died of something different from the disease for which they were being treated. The prognosis might be wrong: we know from a really good systematic review that a six-month prognosis has a 48% chance of being right. You might be influenced by fear and experiences from decades ago that do not apply to modern medicine and modern specialist palliative care in these days, or you might have misinformation from the internet. It might even be that you put the wrong wording into the internet. Only last week I heard of a patient who believed herself to be dying because she had misunderstood the information that she had. She thought that she had a terminal illness and would be dead shortly. Actually, it was not a progressive terminal illness, but the communication of complex information meant that, when she heard what she thought she was frightened of, she could not take on any more information. The word “safety”, which my noble friend Lady Grey-Thompson raised, is paramount if we are to enable people to make safe decisions. We know that palliative care can identify remediable causes of distress and misunderstandings.

--- Later in debate ---

[Lord Falconer of Thoroton (Lab)]

I will answer that one. No, you cannot do it by power of attorney. You have to do it yourself.

[Baroness Finlay of Llandaff (CB)]

My Lords, given this very long debate, I will try to respond briefly. I declare that I had the privilege of being the first chair of the National Mental Capacity Forum, which was set up following the post-legislative scrutiny of the Mental Capacity Act precisely because of the problems with its implementation. I worked in that role all through Covid. As the noble Baroness, Lady Browning, said, unfortunately, although it is a fantastically good piece of legislation, its implementation depends on the person who is implementing it. Although there has been training, and we worked very hard to get training in, it has unfortunately not always improved things as much as one might hope.

The other thing I draw to your Lordships’ attention is Section 62 of the Mental Capacity Act, which concerns the scope of the Act. It says:

“For the avoidance of doubt, it is hereby declared that nothing in this Act is to be taken to affect the law relating to murder or manslaughter or the operation of section 2 of the Suicide Act 1961 (c. 60) (assisting suicide)”.


It was with that background that I became concerned that the quality of the information the person has depends on the knowledge of the person giving that information, as well as the ability of the person to retain it. I spoke about choice at the beginning of my speech. I am sorry that the noble Baroness, Lady Thornton, is not in her place, because choice is essential if we are giving patients opportunities to make decisions, but we have to have real choices. That is why I spoke about the black holes where there is no adequately provided palliative care.

Unfortunately, although the Bill has had a money resolution—forgive me if that is the wrong phrase, but there has been a commitment to fund the provision of a service if the Bill becomes an Act—it has not been matched by concurrent funding in the long term for specialist palliative care. That is a concern, but we will come back to it later.

There is another very small point that I want to make: can we please avoid using the term “commit suicide”? It is not a crime to take your own life, and “commit” is a deeply offensive term. We are talking about people who, for whatever reason, decide to take their own lives and end their lives early. We should remember that as we go forward in our debates, out of respect for everybody who has been bereaved by the tragedy of suicide or attempted suicide.

When it comes to life and death decisions, though, I suggest to the Committee that it is fundamentally different to have the decision of accepting that your disease process is going on, that your dying is inevitable and that you wish to withdraw your dialysis or ventilation. Those are decisions in which I have been involved with patients for decades. We can now take people off ventilators very gently and calmly without any of the distress that was previously associated with that, and they die of their underlying disease.

What we are talking about is suicide prevention versus suicide assistance and the point at which you decide, as a clinician with a patient in front of you, whether you are going to be working with suicide prevention, improving quality of life, or whether you are going to stop that because you are going down a different route, and some of the evidence we had was to that effect. However, because of time and the way that things have gone on, I beg leave to withdraw my amendment.

Amendment 2 withdrawn.

Learning Disabilities Mortality Review Reports

Baroness Finlay of Llandaff Excerpts

Thursday 13th November 2025 Lords Chamber

[Baroness Merron (Lab)]

These are indeed tragic deaths, and avoidable in a number of cases, as the noble Lord rightly says. I can do better than agree to meet him and his colleagues—I have already got agreement from Minister Zubir Ahmed, who is responsible for this area and will be very pleased to meet them.

[Baroness Finlay of Llandaff (CB)]

My Lords, will the Government commit to working further with the National Mental Capacity Forum? One of the leads that comes out in this report is a failure to implement adequately, particularly in giving support to people. Parents are often very important in providing support to a person with learning difficulties, but when that person is an adult they can feel excluded, and they are often very worried as to what will happen after they have died and the person remains alive.

Artificial Intelligence: Safeguarding

Baroness Finlay of Llandaff Excerpts

Tuesday 4th November 2025 Lords Chamber

[Baroness Merron (Lab)]

I certainly agree that this is the way we need to go, and discussions happen regularly with companies, as the noble Lord says. It is probably also worth saying that we have already seen some early signs of improvement in terms of protection for users from online harms, and over 6,000 services are implementing what we would regard as highly effective age assurance, which brings protection to millions of children. Of course, DSIT is monitoring and evaluating the Online Safety Act. Where evidence shows that further intervention is needed to protect children, we will not hesitate to act.

[Baroness Finlay of Llandaff (CB)]

My Lords, digital mental health technologies with clinical purposes are classified by MHRA as medical devices. Therefore, what action can the Government take, working with MHRA and Ofcom, to ensure that these chatbots actually promote suicide prevention policies and do not act as suicide promotion sites?

Tobacco and Vapes Bill

Baroness Finlay of Llandaff Excerpts

Committee stage
Thursday 30th October 2025 Grand Committee

[Baroness Watkins of Tavistock (CB)]

My Lords, I broadly support these amendments but also agree with my noble friend Lord Patel that there is probably no reason to have oral pouches at all. It is something that we could carefully consider deleting from our society. If you are trying to withdraw from tobacco, nicotine patches are just as effective as pouches and do not cause the problems that have been so readily described today. While the debate has been going on, I looked back, and it was 1950 when Sir Richard Doll proved the relationship between tobacco and lung cancer. It has therefore taken us 75 years to get to this point, with the Bill. There is sufficient evidence in relation to pouches for us not to decide that we need a 75-year prospective trial to show their damage.

[Baroness Finlay of Llandaff (CB)]

My Lords, I too support the amendment, and I have a question for those who have tabled it, which relates to proposed new subsection (2)(b), saying the product is

“not intended to be inhaled or chewed”.

I am afraid that as someone who has been looking at tobacco control measures for many years now, through legislation, I am slightly concerned that, as we get rid of one thing, the nicotine manufacturers will find another way of bringing in a substance that is, in effect, addictive, which is promoted to young people, and is a way to get them started on the inevitable chain of addiction that leads to promotion.

When we look at the evidence around nicotine, we see that, yes, it is highly addictive, but the other thing that happens with an addictive substance is that you become tolerant to the effect, to that boost. Therefore, the addict seeks higher and higher doses to get a greater and greater hit. In the long term, as my noble friend Lord Patel pointed out, it is not only blood pressure and so on; there is a problem with platelet stickiness. We do not know what this will do in the microvasculature in the brain in the long term, because these high-dose nicotine products have not been around long enough and we have not had enough brains that have come to post-mortems—I am sorry to put it so bluntly—of people who have been using them for a long time. The hit that they get is greater than they would get from smoking a cigarette.

[Baroness Fox of Buckley (Non-Afl)]

I want to clarify how we make policy based on evidence if that evidence is unknown unknowns about what might possibly be the problem with something. It is absolutely the case that, where there is proof of harm, evidence is given and medical papers are produced. They have not been produced on this issue—I have looked—so it would be useful to see lots of peer-reviewed evidence that showed harm. To suggest that something could be a harm because we have not had long enough to find out whether it is a harm does not seem to be the basis of sensible evidence-based policy.

[Baroness Finlay of Llandaff (CB)]

I completely take that criticism; it is a fair comment. However, we know the damage to the brain microvasculature from smoking over the long term and that these substances are highly addictive. We also know that when we previously took through tobacco control measures, we never anticipated vapes or pouches. The evidence therefore is that those producing nicotine products are very imaginative and creative, and there is concern about this being used as a gateway to further addictive products. That is why I question whether proposed new subsection (2)(b) is necessary or adds anything to Amendment 13, which otherwise should be strongly supported.

Terminally Ill Adults (End of Life) Bill

Baroness Finlay of Llandaff Excerpts

2nd reading
Friday 19th September 2025 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my roles in palliative medicine, caring for thousands of dying patients over decades, and in Living and Dying Well.

The Bill as written does not improve patient choice or control. True choice would ensure patients can get the care they need. Control will rest with the doctors who can initiate the conversation and are the gatekeepers on eligibility for lethal drugs.

Supporting a patient who wants to stop treatment is not assisted suicide. Stopping unwanted treatment allows life to close in a timely way. The person dies of their underlying disease; it is good care.

Training in palliative care is lamentably poor across most of health care. Ignorance of pain and symptom control management is widespread across the globe. Morphine to control pain does not kill, although some mistakenly think it does; it provides comfort as life slips away.

Specialist palliative care can save millions a year to the NHS through care that meets need, substantially improves well-being and comfort, and avoids unnecessary interventions. It does not keep people alive who do not want to keep living.

The Bill’s impact assessment suggests that there will be up to 4,500 assisted deaths by year 10. The Bill does nothing for the over half a million people dying each year on whom it will have a profound impact, many with needs not addressed but wanting to live better right to the end of their lives. They are unheard, already often made to feel a burden; they fear being persuaded to take lethal drugs; and they face their local services being further eroded to fund the assisted death service. It is unethical for us to pass poor legislation for a state-provided NHS assisted death service while leaving the care of half a million dying people to be patchy, often inadequate, and, at best, subsidised ad hoc by struggling charities.

Throughout, we have heard horror stories of bad care and inadequate or appalling management, especially out of hours. The Bill does not require any attempt to relieve pain or suffering, even if they are present. It puts power in the hands of the two assessing doctors, who may know nothing about the condition of the person, who cannot detect undue influence or coercion and whose motivation may be opaque. Prognosis is a guess and diagnostic errors are common. These doctors do not need to be certain; only on the balance of probability do they need to believe that the criteria are met. With no oversight of their assessment, how can a panel approve the death with any certainty when there is no ability to appeal against a panel approval and no coroner oversight? How many wrongful deaths a year is acceptable? No system can be 100% safe.

Providing massive drug overdoses in an unlicensed way to end life is not a therapeutic act and has no place in health and social care provision. Evidence, not heard in the other place, from other jurisdictions reveals complications, slow deaths, complex grief in the bereaved and profound clinical distress. Whether or not you feel that some people should be able to have an assisted death or even euthanasia, this Bill, as written, is deeply flawed. It must have essential scrutiny.

Some noble Lords have suggested that a timetable has been agreed. That is not the case. It has been agreed to have a Select Committee that will complete its work in November, allowing the Committee of the whole House to get under way promptly to undertake that scrutiny, which is absolutely essential.

Learning Disabilities Nursing

Baroness Finlay of Llandaff Excerpts

Tuesday 17th June 2025 Lords Chamber

[Baroness Merron (Lab)]

I pay tribute to the noble Baroness for her work as a campaigner in this area, particularly through Team Domenica. I know that through my office she will be meeting the Minister for Care next month to discuss all these important issues. It certainly is the case, and is totally unacceptable, that people with a learning disability die earlier on average than the general population. In England alone, we are talking about 1.5 million people with a learning disability, and they have significant health inequalities. Learning disability nursing is one of the four specialist fields of nursing, and those areas will be attended to in the forthcoming workforce plan. That will tie in with the 10-year plan, which is the first plan that will be published and noble Lords will not have to wait too long for it. The commitment to improving care for those with learning disabilities, and, if I might say so, with autism, is absolutely going to be in there; the noble Baroness will recall the discussions that we had, for example, on the Mental Health Act. I hope that this will show the way in which we are going, but I certainly agree with her about how much more there is to do.

[Baroness Finlay of Llandaff (CB)]

My Lords, will the Government undertake to ensure that in their workforce plan the training of undergraduate nurses in all courses, and for undergraduate medics and allied health professions, includes training on managing a situation where people have degrees of impaired mental capacity, and that judgmental views on disability are removed from any aspect of discussion because they are prejudicial to the way that people are handled when they present as emergencies? The problem is that people with learning disabilities can present at any time of the day or night to any of the services.

[Baroness Merron (Lab)]

The noble Baroness is quite right. One of the difficulties is that sometimes there is misdiagnosis, where it is incorrectly assumed, for the very reasons that the noble Baroness gives, that the presenting condition is the learning disability when actually it is a different condition. I agree about the need that the noble Baroness outlines. In reports such as the LeDeR review and Transforming Care, there is a national focus on reducing health inequalities and increasing awareness of this very point about diagnostic overshadowing. I will ensure that that is key to what we are doing.

Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025

Baroness Finlay of Llandaff Excerpts

Tuesday 17th June 2025 Grand Committee

[Viscount Stansgate (Lab)]

My Lords, I broadly support these regulations. I hope that my noble friend the Minister will not mind my intervening briefly to ask a couple of questions; I have no wish to detain the Committee.

Obviously, I understand that community pharmacies have been playing an increasingly expanded clinical role in treating minor illnesses and improving medicines’ safety and optimisation. To improve the efficiency of dispensing, these regulations will help support community pharmacies in taking on a more clinical role. The purpose of these regulations, which is to free up smaller pharmacies and enable them to undertake hub-and-spoke models, is, I am sure, a good one. First, does my noble friend the Minister have any idea of how welcome this will be to smaller pharmacies? Is it expected that a great deal of them will undertake these new arrangements outwith the previous restriction on being in the same legal entity?

Secondly, having recently been to my local pharmacy and having talked to the pharmacists there, I was struck by the strain that they are under, both in terms of their workload and financially. Am I right in thinking that this hub-and-spoke model, which will be made more widely available, will in some way help smaller pharmacies deal financially with the situations that they face? Am I wrong in thinking that there is a financial dimension to this? If there is, I would be very grateful for any reply that the Minister can give, but, in summary, these regulations are a step in the right direction.

[Baroness Finlay of Llandaff (CB)]

My Lords, I am most grateful to the Minister for the comprehensive way in which she introduced this instrument, including how it corresponds with all the documentation that we have. I am glad to see that it applies to Wales; we have many small pharmacies with cross-border flow and many roads going across the border, so this SI will make things much easier.

Like the noble Viscount, Lord Stansgate, I have some questions. I hope that at least some of them will be answered; some of them may need time. One of my concerns is about how the finances of this will work, because pharmacies depend on a dispensing fee. Who will get the fee? Will that be down to local negotiation? Will the fee be split?

However, the principle of freeing up time for the pharmacist to undertake more clinical duties is to be welcomed. They are often the first point of call for patients now. They often know the patient. They spot the person who looks less well and can advise them appropriately. They can also advise on drug side-effects, if a person goes into the pharmacist and asks about new symptoms that they might have.

However, I wondered where the liability sits if there is an error. If I understood right, it would sit with the hub if it were in what is dispensed, but there may be a difference in liability for information given to the patient. One hopes this will never happen, but some of those governance issues need to be thought through in detail.

I note that the pharmacists are already taking impressive extended roles in some areas. For example, there is a scheme in Bristol where pharmacists are taking blood for PSA assessment and reaching a population who would not otherwise present for screening for cancers. If we have pharmacists doing more health screening that would certainly free up GP time. Again, pharmacists will need to be remunerated for that.

I was interested to see that the international evidence is a little variable. Germany, Finland, Belgium and Denmark already using a hub-and-spoke dispensing model but the evidence is not overwhelmingly conclusive. In hospitals, where you have a single large building and a large number of prescriptions, automated pharmacy has in many ways revolutionised the administration of medicines.

One of the concerns is the time lag from a dispensed medicine going from the hub out to the spoke. I hope that will be thought through, so that we do not have patients, perhaps with mobility difficulties, having difficulty getting back to collect their prescription, and that those things will be factored into such arrangements.

Another area that I have a slight concern about relates, not surprisingly, to my own area, palliative care. We know that the availability of controlled drugs is poor at times, yet they are often needed urgently. I hope that consideration has been given as to how the dispensing of controlled drugs in particular can be rapid and efficient, especially when the clinical situation has changed and new medications are required at speed for a patient to be able to remain at home, rather than ending up taking an unnecessary or inappropriate voyage to hospital, with possible admission. Those travel systems also come into it.

The last area that I hope this model will tackle is waste, because there are a lot of things that patients are prescribed but never end up taking. Those of us who have been in a house after someone has died will often have been given several supermarket bags—I will not name the supermarket—full of packs of medicines that have been dispensed. They can be extremely expensive but have not been taken. They cannot be taken back in at the moment and cannot be recycled. The schemes that recycled some of the opioids, such as diamorphine, have not continued over the years. This is an enormous financial waste to the NHS, because some of these medicines have been very expensive.

I hope that this model will free up pharmacists and incentivise them to dissuade patients from accepting prescriptions when they are not actually taking those medicines. I could spend hours relating numerous stories of patients who were either not taking their medicines or giving them to somebody else. I have even once been presented with some children trying to sell me grandmother’s pain relief at the foot of the stairs, which helped me understand why I could not get grandmother’s pain under control. There is a real problem of waste in the system. If this instrument will decrease waste without jeopardising pharmacist’ income from prescribing fees, that would be very welcome.

[Lord Scriven (LD)]

My Lords, I thank the Minister for outlining the purpose behind and need for these regulations.

On these Liberal Democrat Benches, we are of course open to innovation and efficiency in our healthcare system. We recognise the potential for modernising practices to streamline operations, to reduce burdens and, ultimately, to try to improve the delivery of medicines to patients. However, for something as sensitive and fundamental as dispensing medicines, the devil, as always, lies in the detail—as the noble Viscount, Lord Stansgate, and the noble Baroness, Lady Finlay of Llandaff, pointed out—so we must scrutinise these proposed changes with the utmost care.

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[Baroness Merron (Lab)]

The whole point of the regulations, as well as cutting red tape, is about levelling the playing field. I understand the point the noble Lord is making, and I re-emphasise that arrangements between hubs and spokes are for them to make, rather than us to set. I am happy to look at the point the noble Lord makes and to write to him further with more detail.

[Baroness Finlay of Llandaff (CB)]

I will pick up on this because it is a concern. In her summing-up speech, the Minister spoke about the business interests of the hub and the spoke. A concern is whether you could have a hub, which will be a large, possibly even multi- national, provider that could create a monopoly. As has been recognised during this debate, in rural areas, in particular, dispensing doctors are often a small group. Pharmacy services have a relatively low turnover but are important to such communities that are a long way from other places and where the services provided by the pharmacist are particularly important. Yet, as a small spoke, they may not have the power to negotiate with a strong central hub that may well be driven by shareholders and profit. There is a little bit of me that would really like this to somehow be a not-for-profit arrangement over the whole of it, but I realise that that is not feasible.

[Baroness Merron (Lab)]

Perhaps it might be helpful to noble Lords if I refer to the Competition and Markets Authority in this regard because it noted that the proposed amendments that we are speaking of today are broadly competitive. It also acknowledged that there could be potential long-term competition risks if the market develops in such a way that pharmacy access to medicines, for example, is through an increasingly limited number of hub suppliers.

As the noble Baroness, Lady Finlay, suggested could happen, we might have only a few larger hubs emerging. I understand the concern that that could affect the availability of medicines for patients and their pricing. However, because of the recommendations from the Competition and Markets Authority, the department has committed to review the impact on competition once the hub market is sufficiently established. We will then assess whether action is needed to alleviate any barriers to the development of what, I believe, we all want to see: a dynamic, competitive hub market.

NHS and Care Volunteer Responders Service

Baroness Finlay of Llandaff Excerpts

Tuesday 20th May 2025 Lords Chamber

[Baroness Merron (Lab)]

My noble friend makes a very important point and I can certainly give her the assurance she seeks. Over 50,000 additional volunteers are recruited by NHS trusts, which they then support directly in the way my noble friend describes. Their roles are totally unaffected by the change to this programme. There are many thousands of volunteers who support the NHS directly or indirectly via other local and national voluntary sector organisations, and I pay tribute to them all.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare an interest as president of Attend. Can the Minister explain how, in the new system, the Government will work with an organisation such as Attend, which provides insurance, legal advice, financial services and networking to a whole series of agencies that provide volunteers across the country, to ensure that there are rigorously high standards and that those who volunteer are protected in their role, and that they benefit in addition to providing maximum benefit to the recipients?

[Baroness Merron (Lab)]

The noble Baroness raises an important point. I am sure there are many, like me, who have volunteered, or still volunteer, and gained as much as they gave, although they did not expect to. It is important to have standards, and to protect volunteers and everybody involved. That will be the case. A lot of local action builds relationships with local organisations, which is a very successful way of harnessing the benefits of volunteers and volunteering.

Medical Devices (Amendment) (Great Britain) Regulations 2025

Baroness Finlay of Llandaff Excerpts

Tuesday 6th May 2025 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)]

My Lords, this is a short—I hope—but technical SI, so it may be helpful to the Committee if I give some context. The Medicines and Healthcare Products Regulatory Agency regulates medical devices in the UK and helps to ensure that those products are safe and perform as intended. That includes ensuring that the legislation governing them is appropriate and keeps pace with advances in science and technology.

The 2002 regulations transposed relevant EU directives into domestic law and is now therefore considered to be assimilated EU law. The regulations contain references to several specific pieces of assimilated EU law that will form part of the regulatory framework for Great Britain. This is an important step towards delivering the Government’s 10-year health plan, in terms of the development of legislation apart from this SI. We need safe and effective medical technologies to achieve the shifts that will help build an NHS fit for the future, to take us from hospital to community-based care, from analogue to digital solutions and from treatment to prevention.

As we know, since the 2002 regulations were introduced, technology has advanced significantly. The MHRA has therefore set out plans to make a number of updates to the regulations—separate to the SI we are debating today, of course—to further improve patient safety and access to medical devices, as well as to keep the UK as an attractive market for medtech innovators. I assure noble Lords that, as part of this, there continues to be considerable engagement with the sector, not least because life sciences manufacturing is vital to the UK’s economic growth. In 2021-22, there were almost 119,000 people employed at life sciences manufacturing sites across the country. We will support the sector to flourish, in line with our growth agenda.

The MHRA is taking a phased approach to the implementation of the future medical devices regulatory framework in order to support system readiness and to minimise the risk of supply disruption for UK patients. A key piece of secondary legislation was made in 2024 to ensure that there is appropriate oversight of a device once it is in use. The further secondary legislation, to which I have referred, is expected to come into force in 2026. That legislation will update the regulatory requirements for devices before they are put on the market and will introduce key measures such as implant cards, unique device identifiers and an international reliance scheme for medical devices; in other words, it will take us forward to the place where we need to be.

In the meantime, the statutory instrument that we are here to debate will help provide continuity for the regulation of medical devices until the subsequent statutory instruments to which I have referred are put in place. I assure noble Lords that this instrument does not make changes to the current regulatory requirements. Instead, by maintaining the regulatory status quo, it will help ensure a smooth transition to a future regulatory framework that protects patient safety, improves access to transformative technologies and supports innovation.

This statutory instrument amends the Medical Devices Regulations 2002 to remove the revocation date of four pieces of assimilated EU law, so that they can continue to apply in Great Britain until such time as they are replaced with the updated law to which I have referred. The measure was consulted on from November last year to January this year. Of the 287 responses to the consultation, 83% were in favour, while a further 12% had no opinion. If this statutory instrument were not agreed to and the provisions expired in May—in other words, this month—there would be a significant gap in the regulatory framework, as well as risks to patient safety.

I will now give the Committee an overview of the four pieces of assimilated EU law for completeness; I know that noble Lords will be interested in this. First, the decision on common specifications for in vitro diagnostic medical devices sets out specifications that certain IVD devices must meet in order to demonstrate compliance with essential requirements.

Secondly, the regulation on electronic instructions for the use of medical devices establishes the conditions under which instructions for the use of medical devices may be provided in electronic form, instead of in paper form.

Thirdly, the regulation on devices manufactured utilising animal tissue, as well as their derivatives, sets out requirements to be met before those devices can be placed on the market.

Finally, the regulation on the designation and the supervision of approved bodies sets out further requirements relating to those bodies, which assess applicable medical devices for conformity with the regulations.

Although we are revoking the sunset dates instead of replacing them—not least because we do not wish to use up any more parliamentary time with debates on short, technical SIs such as this—the Government do not intend for this assimilated EU law to be kept in place indefinitely. I hope that will be a helpful and welcome reassurance. This SI serves as a temporary measure to maintain the status quo until more permanent measures are in place. In the meantime, this is important assimilated EU law that must continue to be complied with.

That will also ensure that unnecessary EU divergence is minimised, which is particularly important in this instance because, as noble Lords will be aware, Northern Ireland continues to operate under the EU framework for medical devices under the terms of the Windsor agreement. More broadly, I reassure the Committee that the regulations for Great Britain do, where appropriate, align with global best practice. As noble Lords will, I hope, be aware, the Government’s aim is to ensure patient safety while minimising unnecessary regulatory burden.

In conclusion, I am glad to say that the UK is a prime location to research, develop and manufacture pharmaceutical and medtech products. We want to continue to attract medtech manufacturing investments that deploy the latest innovations, are highly productive and are consistently high-quality. Key to achieving this objective is proportionate regulation, and implementing regulatory changes must be done in a sensible and measured manner.

As I have set out, the continuation of this assimilated law is necessary to prevent significant disruption to the current regulatory framework and, consequently, negative impacts on patient safety. I beg to move.

[Baroness Finlay of Llandaff (CB)]

I thank the Minister very much for her introduction to this tide-over regulation, which is as it has been portrayed to us. I should declare that my son is involved in medical technology, in cardiology; you could say that our family has a bit of skin in the game, although I do not understand the technology that he is developing— it is so complicated.

I have just a couple of questions. As the new regulations are eventually developed, can the Minister confirm that there will be no more regulatory burden on those trying to innovate and that we might lessen the bureaucratic burden on them? Will there be compatibility reading across to the FDA regulations? The American market, which is subject to a lot of debate at the moment, is a potential market for devices developed in this country overall. In that process, can there be the assurance that we also do not jeopardise our European market, or the Far East on the global scale? We will need to export the technology that we develop.

Dementia and Alzheimer’s Treatments

Baroness Finlay of Llandaff Excerpts

Thursday 1st May 2025 Lords Chamber

[Baroness Merron (Lab)]

My noble friend raises a very important point. In terms of trials, I will certainly be signing up—and I encourage noble Lords and their friends and families to do likewise—to Join Dementia Research, which is a collaboration between NIHR and a number of excellent charities, including the Alzheimer’s Society and Alzheimer’s Scotland, to take part in trials. There is no need to be a particular age or to have a diagnosis of dementia. I hope that noble Lords will join me in supporting this endeavour.

[Baroness Finlay of Llandaff (CB)]

My Lords, the commission on palliative care that I am currently involved in has found that by integrating services for patients with dementia, such as in the York Frailty Hub, the number of admissions to hospital can be decreased. People can stay at home with families supported and they can carry on living well within limited capabilities while we wait for new treatments and, hopefully, prevention to come along. Will the Minister meet me and Professor Mike Richards to go through some of the details of our findings? They have huge implications in saving finances for the NHS and improving care of patients.

[Baroness Merron (Lab)]

That is a very helpful offer which I will be pleased to accept. I compliment York on its initiatives, which set a very high standard. I will also discuss the points that the noble Baroness has raised with Minister Kinnock, who is the responsible Minister in this area.