(1 day, 5 hours ago)
Lords ChamberBuilding on from that, that is correct: there are two different approaches here. There are those among us who believe that choice should come first, and within that choice there should obviously be protections and safeguards. Then there are those people who have equally very firm beliefs that the restrictions should be in place first as protections. To summarise, a lot of the amendments in this group are about having certain illnesses and certain groups, such as disabled groups, that should be excluded from the Bill, and that you should be allowed to have this only if you have unbearable pain or suffering, or if there is no chance of treatments to extend life.
I will bring two points in here. Public opinion is overwhelmingly in favour of choice, at 70% in all the different opinion polls. I include disabled groups in that: they show that 70% of disabled people are in favour of it. Then, there are the personal experiences of people who are terminally ill: first, they do not want to die. They would be delighted if there were treatments that would extend their lives beyond six months, or for much longer. But, for them, getting the opportunity to have a death of their choosing is a great comfort and insurance. It does not mean that they are going to rush out and take it as soon as they have it. In a lot of cases—about 30% in other countries—they will not use it at all.
However, the fact is, those people want it to be there, like an insurance policy, so that if, towards the end of their life, they really do have unbearable suffering, however they define it—which might be pain, a loss of dignity, a feeling that they really do not want to go on—then they can have that choice and reason for wanting to do it, whatever their choice is. That is the important thing that we are trying to ensure. Yes, there will be protections, but giving people the ability and autonomy to have the comfort and the choice of being able to die in the way they wish is the most fundamental right of all.
My Lords, I am grateful for the contributions on eligibility and definition of terminal illness. Once again, I will keep detailed comments limited to amendments on which the Government have major legal, technical or operational workability concerns.
First, I will give a reassurance to your Lordships’ House in response to the observations of the noble Lord, Lord Harper, and the noble Baroness, Lady Grey-Thompson, about the modern service framework on palliative care and end-of-life care. We acknowledge that there has been a drafting error, which the noble Lord and the noble Baroness picked up on. The drafting error is in the national cancer plan. I reassure your Lordships’ House that, as has been stated previously, the interim update will be published this spring and the full modern service framework will follow in the autumn. That issue was purely down to a drafting error.
I turn now to the amendments. Amendments 71, 77 and 79 were tabled by the noble Lady, Baroness Finlay, and Amendments 83A, 104 and 105 were tabled by the noble Lord, Lord Polak, my noble friend Lord Hunt of Kings Heath and the noble Baroness, Lady Grey-Thompson. Noble Lords may wish to note the Government’s workability concern with this set of amendments. Key terms and concepts in the amendments are undefined, which may introduce uncertainty when determining who is eligible under the Bill and, particularly under Amendments 71, 77 and 79, what it means to slow a disease. There is a risk that unclear eligibility criteria could result in ambiguity for those applying the legislation, which may give rise to legal challenges to decisions made under it.
Amendment 105 could also give rise to legal challenge on the basis that excluding people with particular conditions from assisted dying may not be justified under Article 2 or Article 8 of the ECHR and may amount to unjustified discrimination under Article 14. Any differential treatment would need to be objectively and reasonably justified in order to comply with ECHR obligations.
Amendments 74 and 94, tabled by the noble Lord, Lord Taylor of Holbeach, would exclude from the definition of “terminal illness” any individual whose condition can be meaningfully halted or controlled by available treatment. Clinically, it may be difficult to determine whether an illness or disease can be “meaningfully halted, or controlled” by treatment, and it is possible that an illness or disease could have a short halt before deterioration starts again. This will make it difficult for clinicians to decide whether a person is “terminally ill” and eligible for assisted dying and is likely to lead to challenges to decisions. These amendments may result in a person becoming ineligible, irrespective of whether they choose to take the available treatment.
Amendment 75, tabled by the noble Baroness, Lady Finlay, would amend the definition of “terminally ill” by removing the test of death being reasonably expected in six months, and replacing it with a requirement that the rate of progress of the disease, with treatment in line with NICE guidelines, indicates that death can be expected within six months. Introducing the concept of treatment in accordance with NICE guidelines may create difficulties, as the amendment would require clinicians to assess the patient’s prognosis as if they were treated in accordance with NICE guidelines. This may result in a person becoming ineligible, irrespective of whether they chose to have treatment in accordance with NICE guidelines. This amendment therefore requires clinicians to make a judgment on a potentially hypothetical basis.
Amendment 80, tabled by the noble Baroness, Lady Lawlor, would provide that a person is “terminally ill” where their death has an 80% likelihood of occurring within six months, according to the written opinion of two specialist, consultant-level hospital doctors. These doctors must be knowledgeable about and have experience of treating patients with the progressive illness in question. This amendment would create significant operational workability concerns. It would require the clinician making a determination about the person’s prognosis to meet a high threshold of certainty. The criteria could be especially difficult to meet for a person who has a rare progressive illness or disease, about which there may not be widespread clinical knowledge or experience.
Amendment 82, tabled by the noble Lord, Lord Polak, would require two consultants to provide a view on an individual’s life expectancy, and for them to determine that their death can be “highly probable” within six months, rather than the current drafting of, can be “reasonably expected”. Several terms are not defined in the amendment and are likely to lead to ambiguity, including operational issues, around which doctors are to assess life expectancy and to what standard.
May I pursue a point the Minister made about my Amendment 85? My understanding of the Bill, as drafted, is that one has to have an inevitably progressive illness or disease, not that one has to have a six-month prognosis of one’s death. The two might be quite separate.
One might, as the noble Baroness said, have a combination of circumstances that means one is likely to die within six months without having a specific, identifiable disease. The Minister seems to be saying that the Government’s interpretation of this clause is that one does not need to have a specific, identifiable terminal illness; one simply needs to have a set of circumstances that together might result in a prognosis of death within six months.
If that is the case—and that is the Government’s view of the meaning of that clause, as the Minister seems to imply—that widens to an astonishing extent the conditions that might qualify for the Bill. I would like to hear the Minister say—and the noble and learned Lord, Lord Falconer, may possibly want to comment on this when he speaks—whether it really is their interpretation that it could be any set of circumstances that lead to a six-month diagnosis without there being an identifiable illness.
I will briefly look at the actual amendment. As I said in my response, the workability concerns are about the specification of a list of illnesses or diseases. I have already outlined why that would be unworkable—because it is often a combination of illnesses, as well as the complications of those illnesses, that are interacting, rather than there being just one. I referred earlier to why it would be extremely difficult. I have been looking at the specifics of the amendment, but to do what it says would create more ambiguity than there is currently. In reality, my response is covering our concerns; where I do not make a comment, there are no workability concerns.
As the Minister will know, I have made it clear that I am concerned about suffering in the last days of life. One of the key elements of that is palliative care. When one talks about treatment, one of the incentives for death is suffering. Does the Minister have anything to say to the Committee about the status of palliative care within the National Health Service? Are there any plans afoot, and when will this particular course of treatment be available to people? Otherwise, many people faced with terminal illness will be tempted to seek assisted suicide, which I think should be discouraged.
We are discussing a group of amendments about the definition of terminal illness. I have already placed a letter in the Library of the House outlining all the work in respect of palliative care. I have also made reference to the modern service framework.
Having listened to my noble friend Lord Moylan respond to what the Minister said, I confess to being a little confused. The Minister seemed to be saying, in her comments about some of the amendments in this group, that the problem with having a list of conditions is that you could quite often have a terminal diagnosis as the result of a group of conditions, circumstances or illnesses. In my reading, the Bill does not say that. The Bill says:
“For the purposes of this Act, a person is terminally ill if … (a) the person has an inevitably progressive illness or disease”—
not lots of them; one—
“which cannot be reversed by treatment, and … (b) the person’s death in consequence of that illness or disease can reasonably be expected within six months”.
I carefully read the amendment, which talks about a specified list of conditions. Incidentally, coming back to the point made by the noble Lord, Lord Markham, twice as many members of the public support that approach than a terminal illness. The Minister’s answer to my noble friend Lord Moylan seemed to be disagreeing with what is actually in the Bill, so I am now more confused than I was before she got to her feet. Can she clear that up?
I am sorry the noble Lord is confused. I know that my noble and learned friend Lord Falconer will be pleased to assist him with any confusion that there is in the case of this amendment.
Lord Pannick (CB)
I suggest to the Minister that the answer to the noble Lord, Lord Harper, is very simple. An unfortunate person may have more than one inevitably progressive illness or disease, each of which will lead to their death within six months. It is a standard principle of statutory interpretation that the singular includes the plural.
My Lords, I am grateful to noble Lords for their contributions to this debate. Amendment 87, tabled by my noble and learned friend Lord Falconer, the sponsor of the Bill, would clarify the intention of the current Clause 2(2), which is to prevent someone becoming eligible for an assisted death due to an eating disorder. Amendment 87 replaces Clause 2(2). The Bill’s sponsor in the other place indicated that they would look to improve the clarity on who is and who is not eligible in this clause. The noble Lord, Lord Harper, asked about interpretation. I hope those comments will be helpful, because the eligibility of people with eating disorders under the Bill is, of course, a policy decision, not one for government. I am sure that my noble and learned friend heard the noble Lord’s point.
This amendment, as is usual practice, has been drafted with the technical support of the Government, within the policy intent of the sponsor and of the other place. The amendment excludes from the definition of “terminally ill” any illness or disease caused by the person not eating or drinking, where not eating or drinking occurs as a result of a mental disorder. It also makes it clear that this expressly covers cases of limited eating or drinking. Given that Amendment 87 replaces Clause 2(2), if noble Lords accept it, a number of the other amendments in this group will, of course, fall away.
I turn to detailed comments on amendments that the Government consider have major legal, technical or operational workability concerns. Amendment 89, tabled by the noble Lord, Lord Polak, would lead to a person not being considered terminally ill under the Bill solely as a result of withdrawing medication, hydration or life-sustaining devices. Amendment 91, tabled by the noble Baroness, Lady Finlay, would mean that those whose refusal of nutrition is due to a mental illness would not be considered terminally ill under the Bill.
Amendment 92, tabled by my noble friend Lady Debbonaire, would exclude a person from eligibility if their terminal illness was
“solely as a result of standard medical treatment being refused or withheld”.
This amendment could have the potential undesirable impact of undermining a person’s autonomy and right to make informed choices about their own medical care. The definition of “standard medical treatment” is unclear here: the exclusion from eligibility could apply to a patient who refuses one standard medical treatment in favour of an alternative standard medical treatment. A refusal of standard medical treatment would mean that a person would become ineligible for ever, even where their refusal had no impact on their prognosis.
Amendment 101, tabled by the noble Baroness, Lady Parminter, would prevent people with physical effects or complications of a mental disorder being eligible for an assisted death. This may be difficult for clinicians to apply, as “physical effects” is an undefined term. The current drafting also layers a “for the avoidance of doubt” provision on top of another “for the avoidance of doubt” provision, which could lead to ambiguity about how the legislation should be interpreted. I heard the noble Baroness say that she was concerned about the drafting, so I hope those comments will be helpful to her.
Amendment 103, tabled by the noble Baroness, Lady Fox, would remove from eligibility people who, because of the effect of a mental disorder, refuse life-saving treatment and develop a terminal condition. Where amendments limit eligibility for specific groups, they could give rise to legal challenge under Articles 2 or 8, with Article 14, of the ECHR if such restrictions are not objectively and reasonably justified. As I have said, it is for noble Lords to consider the amendments in that light, should they wish to.
First, I detect that the mood of the Committee is that I should put my Amendment 87 into the Bill, but subject to the amendment tabled by the noble and learned Baroness, Lady Scotland, and by the noble Baroness, Lady Berger, so I am minded, unless anybody indicates to the contrary, to let that process go ahead. I accept that, in putting it in, there are those who would like to build on it on Report, but I think we should put it in now.
I will deal very quickly with the other amendments in the group. Amendment 88, tabled by the noble Baroness, Lady Grey-Thompson, would leave out “solely”.
My Lords, before the Minister rises to speak, I have a question for her about workability arising from one of the amendments included in this debate. In his Amendment 581A, my noble friend Lord Sandhurst posed a specific question on capacity at the moment when a person is given the substances with which they will take their own life. He is surely right that at that critical moment appropriate safeguards are needed where, for any reason at all, there is doubt about the person’s capacity—for example, where there is a history of fluctuating capacity. The doctor should clearly know how to respond to that situation. Can the Minister say whether she believes that the situation that my noble friend has described would require specific guidance to be issued by the Government over and above guidance already issued under the Mental Capacity Act?
My Lords, I thank all noble Lords for their contributions on mental capacity and eligibility. As usual, I will keep my comments limited to those amendments on which the Government have major legal, technical or operational workability concerns. Indeed, if I do not refer to an amendment, clearly that is not the case, as was just suggested.
I wish to make a point to the noble Baroness, Lady O’Loan, who asked about consideration about compliance with ECHR. It is probably helpful for me to re-establish the consideration about that. It is the role of the Government—this is what I am doing—to highlight where there is a risk of issues in respect of the ECHR. However, it is for the House to decide whether policy choices might create a risk and whether that amount of risk is acceptable or not. The other thing, if it is helpful to the noble Baroness, is that, if it is found that primary legislation is incompatible, there could of course be a declaration of that incompatibility. It would not invalidate legislation. That is probably the main point that I want to emphasise, but this is ultimately a matter for decision by the House.
Amendments 117 and 892, in the name of the noble Baroness, Lady Hollins, would remove Clause 3 and insert a new clause requiring the Secretary of State to make regulations that establish an alternative framework for assessing and determining capacity, based on a psychological assessment, rather than reliance on the Mental Capacity Act. How to make that assessment on capacity—noble Lords have referred to this—is a policy choice and is therefore a matter for Parliament. However, as drafted, Amendment 117 uses a number of undefined terms such as “validated, standardised instruments” and “evidence-based methodology”, which, without further clarification or definition, are likely to create workability concerns. Amendment 892 would mean that the majority of provisions under the Bill could not come into force until the regulations under Clause 3 were made. This would make the backstop provision in Clause 58(4) ineffective.
I turn to Amendment 108, tabled by my noble friend Lord Hunt of Kings Heath. It would introduce a departure from the MCA framework by linking a lack of capacity in one area, to consent to care and treatment arrangements that amount to a confinement, to lack of capacity around another decision, the decision to end one’s life. This could create confusion and require additional guidance and training for practitioners.
It appears that Amendment 119 in the name of the noble Baroness, Lady Grey-Thomspon, would introduce a separate specialist capacity assessment process for adults with a learning disability. This departs from the MCA framework, which requires proportionate, decision-specific assessments, rather than separate processes for particular groups. Operationally, this could create significant training and resource demands, as specialist assessors would need to be identified. The Committee may wish to note that the amendment restricts any publicly funded provider from undertaking the mental capacity assessment, which would mean that individuals with learning disabilities would have to self-fund the assessment from a private sector provider. There are also technical drafting issues, including a lack of definition for “learning disability” and other terms such as “relevant professional regulator”, which could lead to uncertainty in how the legislation is applied.
Amendments 117, 892, 108 and 119 would all involve introducing differential treatment, by treating different groups of people differently. As such, they could give rise to legal challenge on the basis of ECHR obligations, specifically Article 14, which prohibits discrimination when read with Article 8. Any differential treatment, as I said more broadly earlier, would need to be objectively and reasonably justified in order to comply with ECHR obligations.
I turn to Amendment 235 in the name of the noble Lord, Lord Moylan. The effect of this amendment is that certain groups of people would not be able to make a valid first declaration, as the noble Lord said. This could exclude people with learning disabilities, mental disorders, as per Section 1 of the Mental Health Act 1983, and autism from accessing assisted dying. An individual who may experience substantial difficulty in understanding processes or communicating their views, wishes or feelings would also be excluded under this amendment from accessing assisted dying. The definition of “mental disorder” in the Mental Health Act is extremely broad and will include those with conditions such as ADHD, dyslexia, anxiety and sleep disorders. The Committee may wish to note that these groups would be excluded, even if their condition had no impact on their ability to fully understand the relevant information.
I am sure that both I and my noble friend will be very pleased, together or separately, to reply to the noble Baroness.
I shall deal with the issues raised in this debate under the following heads. First, what is the correct test and legal framework to apply in relation to mental capacity? Secondly, how do we deal with the question of particular conditions that people have? Does it make it inappropriate, or should there be exceptional protection? Thirdly, what about Clause 22, which is the independent advocate provision?
First, on capacity, as noble Lords know, the Bill provides that the tests under the Mental Capacity Act 2005 shall be applied to determine whether or not the person seeking an assisted death has the capacity to make such a request. Remember as well, for what it is worth, that, in addition to having the capacity to make that request, the person, in order to get an assisted death, also has to have a clear, settled and informed wish to end their own life, and has made that decision to end their own life voluntarily and has not been coerced or pressured by any other person into making it. Those last two protections—a clear, settled and informed wish, voluntary and no coercion—are separate from the question of capacity.
The question of capacity is: is that person capable of making the decision? The Mental Capacity Act, which has been in force for approximately 20 years, starts from the assumption that a person does have capacity to make a particular decision, and only if it is shown that the person does not have that ability are they not able to make that decision themselves.
Should we change that assumption? There are two big proposals in front of us. First, there is Amendment 115 in the name of the noble Baroness, Lady Findlay of Llandaff, and supported in particular by the noble Viscount, Lord Colville of Culross, who made a speech in favour of it. Subsection (1) of that proposal says:
“In this Act, a person has capacity to make a decision to end their own life if they do not lack capacity to make that decision, and references to “capacity” are to be read accordingly”.
I shall read that again for those who did not get it first time round. In this Act, the proposal is that
“a person has capacity to make a decision to end their own life if they do not lack capacity to make that decision, and references to “capacity” are to be read accordingly”.
That looks almost identical to the existing provisions, and I am quite unable to see what the difference is that is being proposed.
My Lords, I am grateful to my noble friend Lord Blencathra for opening the debate on this group. He is right that we should consider carefully how the most vulnerable will be protected under this legislation. Having a multidisciplinary specialist review before a person in a care home is certified to have capacity seems an interesting and a sensible safeguard. It was not clear to me whether the five working days is from the date of the review or from the date of the findings of the review, but no doubt that could be looked at and clarified.
Of course, generally, social care is a policy area that needs attention. We know that too many older people receive inadequate care in old age, and I must say that it seemed to me that the personal experience of the noble Baroness, Lady Hayter, and that of my noble friend Lord Deben can both be right. It is likely that there are excellent care homes and care homes that need improvement. I am afraid that that is probably the society we live in.
Effective communication is a challenge that older people face. This is an obstacle for the process under the Bill for assessing capacity. It therefore seems sensible for specialists to be involved when the person requesting assistance is in a care home. We also have to consider the risks of institutionalisation, which I know from experience can certainly be a factor for people in care homes. I would be grateful if the Minister could confirm what the Government’s conclusions are on this proposal and its workability. Would it be prohibitively costly or could it be delivered?
On the amendment from my noble friend Lady Eaton, this additional process and heightened evidential standard for persons in care homes is a constructive and interesting suggestion. I invite the Minister to update the Committee on whether the Government have considered the two separate proposals in this group and come to a view on which would be the more workable and effective if implemented. That assessment would not only be helpful to the Committee but might enable the House in due course to make a more informed decision on the best way to improve this part of the Bill on Report. If that assessment has not yet been made, perhaps the most appropriate way forward would be for Ministers to write to the Committee to update it, at some point between now and Report.
My Lords, I am most grateful to all noble Lords who have contributed to this debate on assessing capacity in care homes. As noble Lords will be aware, my remarks will be limited to areas where the Government have assessed that there may be major technical or operational workability concerns.
I say to the noble Lord, Lord Blencathra, that that will include matters relating to the ECHR. The noble Lord, Lord Carlile, already picked that up in his own characteristic way, but I gently say to the noble Lord, Lord Blencathra—I know he is aware of this because of his experience—that Government Ministers have a duty to advise your Lordships’ House of implications. As I explained in the last group, decisions on the ECHR are ultimately for Parliament. I am sorry to frustrate him with repetition, but it is appropriate to the relevant considerations. I will just ask him not to listen if he feels it is very irritating.
This may be helpful to the noble Lord, Lord Wolfson, as well. Amendments 112 and 111, in the name of the noble Baroness, Lady Eaton, spoken to by the noble Baroness, Lady O’Loan, aim to strengthen safeguards for care and nursing home residents by ensuring that capacity in these cases is established through specialist clinical assessment and that capacity assessments seek to rule out reversible medical causes of impaired or fluctuating capacity. The Government consider that Amendment 111 may be inconsistent with the Mental Capacity Act’s assessment framework, which does not require enhanced assessment for certain groups. I dealt with this in more detail in the last group. By requiring expert psychiatric input before capacity is confirmed, Amendment 112 could create inconsistency with the MCA’s presumption of capacity and the principle of proportionate, decision-specific assessments.
Amendment 110A, tabled by the noble Lord, Lord Blencathra, would affect care home and nursing home residents’ capacity assessments and require expert psychiatric input before capacity is confirmed. Again, this could create inconsistency with the MCA’s presumption of capacity and the principle of proportionate, decision-specific assessments.
If passed, each of these amendments would lead to a difference in treatment between care home and nursing home residents and all other citizens in assessments for assisted dying. That difference in treatment—the noble Lord, Lord Blencathra, may wish to close his ears at this point—could give rise to challenge under the ECHR, particularly Article 8, which refers to respect for private and family life, and Article 14, which concerns the prohibition of discrimination. The differences in treatment would need to be justified, necessary and proportionate.
If the Committee decided that the conditions in a care home were such that it would be better to have a system there that was slightly different from the one for those who were not in a care home, surely that is justification enough. As the Minister knows, I am entirely in favour of the ECHR and disagree very strongly with my noble friend, but this seems a bit of a red herring, frankly. The fact of the matter is that, if this was the policy that was put forward, I think it very unlikely that anyone would find it possible to stop it under the ECHR.
It would not be possible in any case to stop it in that way, because it would not invalidate legislation. I am just drawing the Committee’s attention to the fact that it would require further work. As the noble Lord will know, if a court finds that primary legislation is incompatible, it may make a declaration of incompatibility. As I said, although it does not invalidate legislation, it is usual practice for the Government to consider and address these matters.
I am afraid that the Minister is between a rock and a hard place here. If these amendments are not passed, she might find that the Government are in breach of Articles 9, 10 and 11. I would be grateful if she could consult her lawyers in relation to that matter.
I will consult my lawyers with pleasure.
Lastly, all the amendments in this group address complex issues and, if they were passed, considerable further policy and drafting work would likely be required.
I thank the noble Baronesses, Lady Smith of Newnham and Lady Hayter of Kentish Town, for sharing their significant and painful experiences. I thank the noble Baroness, Lady Fox, for doing the same in relation to the last months of her mother’s life.
This group deals with the question of whether there should be special provision for people in care homes. Two routes are suggested: first, in the amendment from the noble Baroness, Lady Eaton, which was spoken to by the noble Baroness, Lady O’Loan, that there be a higher evidential standard; and, secondly, that a series of additional tests should be raised.
I think that everybody in the Chamber is agreed that care homes vary across the country; there are those of the highest possible standards and those that do not have the same high standards. It is also the case—a point made forcibly and effectively by the noble Baroness, Lady Watkins—that one should not confuse the fact that there are people in long-term care and people in high-tech nursing homes who are being rather elided here. People become institutionalised and may suffer long-term cognitive problems from being in care homes for a long time. The question raised is whether additional steps beyond those provided for in the Bill should be put in place to check that such people, particularly those who have been in care homes for the long term, have capacity.
The current arrangements require that the co-ordinating doctor is satisfied, after discussion with the patient and anybody else, that they have capacity, and similarly in relation to the independent doctor. Then, the panel has to be satisfied, and then the co-ordinating doctor has to witness the second declaration of the patient. The co-ordinating doctor can witness that second declaration only if he or she is satisfied that, among other things, the patient has capacity. Fifthly, the doctor providing the assistance also has to be satisfied that the patient has capacity. The question posed is whether, despite the fact that there are five separate occasions on which a doctor or a panel have to be satisfied of capacity, for somebody in a long-term care home, one should make additional provision for separate assessments or have a higher evidential standard.
(3 days, 5 hours ago)
Lords ChamberTo ask His Majesty’s Government what assessment they have made of the provision of corridor care in the NHS; and what plans they have to mitigate any issues arising.
My Lords, we have introduced new data collection on corridor care, which will be published shortly for the first time. We are taking sustained action to reduce the use of corridor care, ensuring that there are safeguards for patients in the interim to still receive high-quality and safe care with dignity and privacy. We are investing £450 million to expand same-day and urgent care services, and to improve hospital flow, as well as introducing new clinical operational standards.
I thank the Minister for her reply, but I want to understand when a credible long-term delivery plan will be published—rather than “in the near future”—to restore year-round resilience, making whole-system patient flow a core performance priority. Unnecessary stays in hospital are linked to worse patient outcomes, and it should be possible to reduce the nearly 13,000 beds occupied on average each day in 2025 by people medically fit for discharge, in turn reducing the need for corridor care.
Let me say at the outset that corridor care should not be normalised; it is not what we want to see as routine. The reality is that we cannot eliminate it entirely—I think that is understood—but the current situation is not as we would want it to be. In addition to the Urgent and Emergency Care Plan 2025/26, which sets out clear actions to deliver improvements, the most challenged trusts are receiving targeted support. Looking to the future, as the noble Baroness asked about, the medium-term planning framework clearly sets out a trajectory to improve the situation. The introduction of clinical guidelines for the first 72 hours will also increase the proportion of people discharged within 72 hours. I very much recognise the situation the noble Baroness describes.
Baroness Kingsmill (Lab)
My Lords, as a former chair of an NHS community trust, I say that the situation often arises because of the shortage of social and community care. What are the Government doing to address those issues?
On social care, we are making progress on building a national care service. Around £4.6 billion of additional funding has been made available for adult social care by 2028-29. Along with other matters, including funds to improve and provide adaptation so that people can return home when they would not have been able to otherwise, we are providing funding of over £1 billion for adult social care with local authorities. This can be used to expand capacity. Of course, we have an independent commission chaired by the noble Baroness, Lady Casey.
My Lords, in a recent survey 78% of physicians reported undertaking corridor care. It is becoming almost the norm all the year round. It affects patients’ dignity, health and safety, and patient outcomes, because there are greater infection rates. I welcome the Minister’s points on the action that the Government are taking, but it is rather long-sighted and there is a real urgency to do something now.
I agree with the noble Baroness. Corridor care is perhaps one of the most visible and distressing symptoms of an NHS that the noble Lord, Lord Darzi, described as broken. We have to fix a number of the processes. I welcome that we are expanding urgent care access, for example, in primary, community and mental health settings, which will reduce demand on services. However, without publicly available data and the clinical operational standards that we are setting, the change will not be made as quickly as we would all like. There are immediate actions, as well as medium and long-term actions.
I agree with the need for more adult social care, but there is a whole range of factors that affect discharge delays, including the number of people who present. What the noble Lord outlined was not right and not the way in which his mother-in-law should have been dealt with. I know he would not expect me to comment further on individual circumstances, but if somebody is being considered for corridor care, that should be appropriately risk-assessed by clinical teams. The exact point he made is something that I have asked about. There should be a named nurse, and the provisions he talked about, such as food and drink, should have been there.
Baroness Gerada (CB)
We know from evidence that you can avoid hospital admission by improving continuity of care by general practitioners. When will the Minister redress the imbalance whereby GPs are funded from only 8% of the NHS budget yet deliver 70% to 80% of its care?
We very much appreciate the role that GPs play. Corridor care is related to a whole range of factors, not only the position of GPs. I have heard what the noble Baroness has said and will gladly relate it to my ministerial colleague.
The Earl of Effingham (Con)
My Lords, the Minister referenced data collection in her previous responses. In November, hospitals carried out 10% fewer operations than in October, but the Government claim the waiting list went down. Is that because the Government are paying hospitals £3 million per month in a process known as “validation”, and so it appears that the health service is treating more patients than it actually is? Is that the real reason that corridor care numbers are up?
No. I hope that the noble Lord would welcome a greater level of activity in this area. The waiting lists are going down. We have delivered, for example, 5.2 million extra appointments since we came into government, when we had promised just 2 million. Waiting lists are going down, and I am very happy to provide the data again to the noble Lord so that he can investigate that.
My Lords, my recent experience in care homes is that there are vacancies—unfilled beds—in private care homes. When are we going to do something about the mismatch of people in corridors, when beds are available? There needs to be some system introduced to get people into them.
The first thing that needs to happen is that people need to be cared for in the hospital. As I said in answer to an earlier question, everybody should be assessed according to their need. If there is a shortage of beds, it is for that hospital to manage. There will always be a difference of demand. However, where there are problems in hospitals that are not responding as they should, we are putting in improvement teams to ensure that change can be made. Of course, it is only when people are well enough, and it is suitable and safe to discharge them, that they will be discharged. It is important to match up availability of social care beds to needs.
(3 days, 5 hours ago)
Lords ChamberTo ask His Majesty’s Government whether they have identified any systemic issues following the discovery of the toxin cereulide in baby milk powder sold in the UK; and if so, what steps they plan to take as a result.
My Lords, Nestlé and Danone launched product recalls of certain infant formula products because of the possible presence of cereulide toxin. This is a live incidence and it is too early to identify any systemic issues.
The Food Standards Agency is working across agencies and with the Department of Health and Social Care to manage the incident response. The FSA has published information on the product recalls on its website, including advice for consumers.
I thank the Minister for her Answer, but I would posit that there is very clearly a well-identified systemic problem that non-mandatory ingredients such as arachidonic acid, which is the source of the current contamination in Nestlé and Danone products, place a burden on infant metabolism and create multiple potential points of microbial and other contamination in the manufacturing process by the four companies that supply the vast bulk of infant formula in this country through complex, for-profit global supply chains. Are the Government going to look into further action on this?
Obviously, we are very concerned about toxins and ensuring that there is no damage done to people: that is the reason for the product recall. The effect of this is that it creates bacteria, so it is like food poisoning in that respect.
With regard to what the noble Baroness has said about ARA oil, the concern of the FSA is very much about safety. What has happened here, as I understand, is that ARA oil is a very common ingredient, but this one appears to have had some contamination, which has affected certain batches, and it is those that are being recalled.
My Lords, what the Minister said is correct, but only partially. Arachidonic acid is the key component that may contain bacillus cereus, which is the product that produces the toxin cereulide, which causes problems for babies including vomiting and diarrhoea. It is the same as any bacteria or virus that causes the gut rot that we often experience. It is a supply chain problem and the current regulatory mechanism relies on self-regulation. That is what needs to be addressed. We had a similar problem in 2008 with another chemical called melamine, which was in milk products and caused kidney damage to babies. Does the Minister agree that it is the regulation of the supply chain and production that needs to be addressed?
As ever, the noble Lord has put things better than I did. I understand the point he is making. The FSA’s role, certainly in the incident response, includes chasing supply chains to identify any additional potential products and businesses. I certainly agree that it is very important to stem any difficulty. But, as it is a live incident, the only point I would make, as I said to the noble Baroness, is that the focus is very much on managing the situation. Therefore, there has not been the opportunity to look into the detail that I agree it needs. That will happen, as it always does, in an incident such as this.
My Lords, is the Minister aware that it took Nestlé four weeks from its first notification of contamination to the Dutch Government to initiate the first product recall on 5 January, following further tests? Does she agree that there should be independent testing, rather than relying on in-house testing by the formula producers? Does she agree that that independent testing should be triggered, at the very least, at the first whiff of any possible contamination?
In my preparation for this Question, which is an important one, I asked a similar question to officials, particularly those from the FSA, and they assured me that testing shows we are meeting the right standards. They also made the point that this is all covered by the Food Safety Act. In their opinion, they have the tools to do the job. I am not aware that there has been something wrong in the management of this live incident, but I am aware that the FSA and the UK Health Security Agency are liaising very closely with the manufacturers to establish the root cause of the possible presence of this toxin. But I can also reassure your Lordships’ House that it is confined to certain batches. That is the information that is going out.
The Earl of Effingham (Con)
My Lords, providing the best nutrition for children of all ages is surely a “must have”. So, why do the Government allow ultra-processed foods to constitute between two-thirds and three-quarters of calories in UK school meals? They are high in fat, sugar and salt. That is not a good combination.
The noble Earl has moved from food safety to what is in food. Food standards applicable to school meals are both monitored and in place. As he knows, the general advice from the NHS on processed foods is that we would all benefit from eating less of the foods that are high-fat, high-salt and high-sugar. But those foods are not presenting the immediate safety concerns. I make that distinction as we are looking here at toxins in products.
My Lords, of course the best food for babies comes from breastfeeding. May I advocate that we should not lose sight of the fact that many mothers do breastfeed? But I understand the anguish and fear that mothers who cannot breastfeed have had in relation to this incident, and the department needs to do more to make young new mothers aware of the issue, because, as the Minister and I know, there is a shortage of community midwives and health visitors.
That last point is something that will be looked at as part of workforce planning. I totally agree with the noble Baroness about the importance of the multidisciplinary team in supporting new mothers to find the right ways that are suitable for them and best for their baby—and I am glad the noble Baroness accepted that breastfeeding is not possible for everybody.
My Lords, as the grandmother of a baby who was born pre-term, I was very interested in this incident. As far as I could make out, it seems to have been well publicised, and those who might be affected got to know of it very quickly. Is there any evidence that harm has been caused, or did the Food Standards Agency, which was set up to deal with these sorts of things, do a decent job on this occasion?
I am certainly convinced that more than a decent job has been done on this occasion. I know that the FSA, along with the department and the UK Health Security Agency, have, as was said to me, been working non-stop since the incident was notified, and I am genuinely reassured by that. What I would say is that alternatives are available, there is no problem with the supply of alternatives and if anybody—grandmothers, mothers, parents, friends, or whoever—has concerns, they should check the NHS website and the FSA website and, if they remain concerned, they should seek guidance from a medical professional. There are people who are potentially affected, but, as I said, this is a live incident and it is being monitored.
Lord Winston (Lab)
My Lords, I have in the past given notice to the Minister about this, with regard not to milk but to other issues: for example, where small humans, such as embryos or babies, come in contact with fluids or chemicals that might be dangerous. It is not only milk that may need better observation. Does she agree that we should look rather carefully at how we regulate the fluids used for culture of human tissues, in particular embryos, where there may be some risks of not getting better results, or possibly even of danger to the embryo?
Safety is paramount, whether we are talking about embryos, adults or children. I would be pleased to hear from my noble friend if there are particular areas on which he would like to be reassured, or at least responded to. But I hope that, in respect of food safety, in this situation, your Lordships’ House will see that all actions have been taken by the relevant authorities, with speed and in line with the laws available.
(3 days, 5 hours ago)
Lords ChamberThat the Bill be now read a second time.
Northern Ireland, Scottish and Welsh legislative consent sought.
My Lords, it is essential that the changes we hope to make in this Bill resolve some of the existing workforce issues within our NHS. I say at the outset that the Bill will not be a silver bullet, and I do not wish to present it as such, but the changes it introduces for foundation and specialty training will lead to a more sustainable medical workforce that can better meet the health needs of our population.
I am most grateful to all those who have engaged with us, including the devolved Governments, to recognise the shared challenges that we face across the United Kingdom. My thanks are also due to noble Lords from across the House for their constructive contributions, time and interest in meeting me and officials. I am also most grateful for the cross-party support that has been demonstrated, both in the other place and in my discussions with the Front Benches in this House. A number of organisations have also expressed their support, including: the BMA, the Academy of Medical Royal Colleges, the Royal College of Physicians, and the Royal College of Surgeons of Edinburgh.
The NHS is beginning to show signs of recovery, following a period of unprecedented strain. Nothing in the NHS functions without its workforce and I am grateful for the dedication and professionalism of our workforce. Supporting, valuing and planning for that workforce is fundamental and, I know, something that your Lordships’ House takes a great interest in—and rightly so. Because the NHS depends on its workforce, we are developing a long-term approach to workforce planning, aligned with the ambitions set out in the 10-year health plan published in July, which set out the intent of this Bill.
That work will culminate in the publication of a 10-year workforce plan in the spring, setting out how we intend to ensure that the NHS has the right people in the right places with the right skills. Staff have been clear for some time that they want change, not only in absolute numbers but in how they are trained, supported and treated at work. We have heard from many who have been exceptionally frustrated by the current application process. There are challenges within medical training that cannot be addressed without legislative change, and that is why we are taking action with this Bill. I am absolutely delighted that my noble friends Lord Duvall and Lord Roe have chosen to make their maiden speeches in this important debate. I, like all noble Lords, very much look forward to hearing from them.
One of the most pressing of those challenges is the severe bottleneck in postgraduate medical training. For several years now, the number of applicants for foundation and specialty training places has grown far more rapidly than the number of available posts. In 2019, there were around 12,000 applicants for 9,000 specialty training places. In 2020, visa restrictions were lifted, and we find this year that this has soared to nearly 40,000 applicants for 10,000 places, with significantly more overseas-trained applicants than UK-trained ones.
This has created intense competition, uncertainty and frustration for many at the start of their careers. At the same time our NHS has become increasingly reliant on international recruitment. This Government deeply value the contribution made by doctors from all around the world, many of whom have played and continue to play a vital role in patient care, and nothing in in this Bill diminishes that contribution. However, it is neither sustainable nor ethically comfortable for the UK to depend so heavily on recruiting doctors from countries that themselves face serious workforce challenges while a growing number of UK-trained doctors struggle to access training posts. Competition for medical staff has never been fiercer. The World Health Organization estimates a shortfall of 11 million health workers by 2030. Shoring up our own workforce will limit our exposure to such global pressures without depriving other countries of their homegrown talent, and this Bill seeks to address that imbalance.
Let me turn to the Bill itself. The Medical Training (Prioritisation) Bill gives effect to the Government’s commitment to place UK-trained doctors and other defined priority groups at the front of the queue for medical training posts. It does so while continuing to allow internationally trained doctors to apply for and contribute to the NHS. Let me emphasise that the Bill is about prioritisation. It is not about excluding people, but it is unashamedly about prioritisation. For the UK foundation programme, the Bill requires that places are allocated to UK medical graduates and those in priority groups before being offered to other eligible applicants. For specialty training, it introduces prioritisation initially at the offer stage for 2026 and from 2027 at both the short-listing and offer stages. That will significantly reduce the level of competition being faced by UK-trained applicants, and it will provide greater certainty at a critical point in their career.
Internationally trained doctors with significant NHS experience will continue to be prioritised for specialty training, recognising the service that they have given. This year, immigration status will be used as a practical proxy for NHS experience in order to allow prioritisation to begin swiftly. For following years, we have taken powers in regulations to enable us to refine this approach in consultation with key partners. I have been asked by noble Lords what this means for those with refugee status. This status is not a stand-alone priority group, although refugees will be prioritised for specialty training in 2026 if they fall within another priority category, such as holding indefinite leave to remain or having completed the foundation programme. Refugees who do not fall within a prioritised group may still apply for specialty training posts and the Bill will not change their eligibility to apply for locally employed doctors’ roles.
I am seeking to address up front some of the concerns that will quite rightly be raised in the course of the debate. One of those is a concern I have heard about why British citizens who have graduated from medical schools outside the UK will not be in the priority group, including some doctors who would be eligible only for provisional GMC registration. I understand the reasons why this is being raised, and I have heard how some would prefer all British citizens, in a blanket sense, to be prioritised. The problem with that is that it would undermine the very intent of the legislation, which is to enable effective workforce planning and the development of our future medical workforce.
The principle is to create a sustainable domestic workforce. It is not about where a student is born; it is about where they are trained, and the fact is that UK-trained doctors are more likely to work in the NHS for longer. In addition, the Government set UK medical school places based on future health system needs. Student intakes and graduate outputs of overseas medical schools are not included in our domestic workforce planning. If we prioritised British citizens in a blanket sense for foundation training places regardless of where they studied, that would undermine our key aim to build UK-trained capacity while ensuring that we do not provide more foundation programme places than we need. I reiterate that this Bill is about prioritisation and not exclusion. All eligible applicants will still be able to apply and will be offered places if vacancies remain after prioritised applicants have received offers, which we expect to be the case on the basis of our long experience.
I have also listened to colleagues expressing concerns around the treatment of applicants graduating in Malta. The UK’s long-standing partnership with Malta on healthcare is valued and will continue. Doctors training in Malta will still be able to come to the UK to gain NHS experience to support their training, for example through fellowship schemes. These arrangements are not affected by the Bill. However, as I stated earlier, for recruitment to specialty training places in the UK, the Government assess that it is important to prioritise to ensure a sustainable workforce that meets health needs.
I turn to the matter of public health specialists, who are particularly identified in the Bill. Public health is a unique medical specialty that draws applicants from medicine and other professional backgrounds who all undergo the same rigorous training. All public health specialists, regardless of professional background, complete the same rigorous medical specialty training programme and are subject to the same high professional standards. The Bill excludes from prioritisation any specialty programmes wholly in the field of public health, as it would undermine the multidisciplinary public health specialist workforce. The Government will monitor the impact on the public health specialist training programme, which currently accepts very small numbers of international medical graduates.
I am aware that there are concerns relating to terms and conditions and mobility for some specialists. We have set out the actions we will take to make the NHS a better and great employer. However, a focus on the NHS alone will not support the whole health workforce, as many public health specialists work outside the NHS with differing employment arrangements. But we are committed to working with the BMA, employers and professional bodies to make public health careers more attractive.
On timing, the Bill includes provisions to allow prioritisation to apply to the current application cycle, with posts commencing this August. That requires Royal Assent by 5 March. It is therefore important to seek timely passage for this Bill to avoid disruption for trainees who need sufficient time to find somewhere to live, sort out childcare and arrange any other aspects of their lives before their posts start, and for NHS trusts that are planning the front-line services. I hear the concerns of some noble Lords about the impact on those applying in the current application cycle, particularly where applicants report that they did not know how prioritisation might affect them. As I said earlier, these concerns are understandable, and they have been carefully considered. However, delaying action would only prolong the current problem by further entrenching the existing imbalance in training competition and it would weaken our ability to plan a sustainable workforce.
The commencement provisions provide necessary flexibility, ensuring that implementation can be carried out in an orderly and workable way, taking account of operational realities. On that point, there is a material consideration, which I am sure will be raised and understandably so, about whether it is possible to proceed if strike action is ongoing. The disruption strikes cause, and the pressure they put on resources, would undoubtedly make it a lot harder operationally to deliver the important measures in this Bill. It is our intention to commence as soon as we can, subject to the Bill’s passage through Parliament, but it is vital to have a safeguard to ensure that the systems planning and operational capacity required for successful implementation are firmly in place.
I conclude by saying that the Bill will not solve every workforce challenge, but it is a very important step towards a more coherent, ethical and sustainable approach to medical training and workforce planning: something that has been called for for many years.
It is estimated that four resident doctors will be competing for every specialty training post in 2026. With the delivery of this Bill, this number can reduce to two resident doctors per place. British taxpayers spend £4 billion training medics every single year. It will be by better aligning public investment, training capacity and long-term service needs that the Bill will give UK-trained doctors a fair chance to serve in the health service they train to support, and to do so in a way that benefits us, the public, across the country. I beg to move.
My Lords, I am most grateful to all noble Lords who contributed to this debate for the support given, including just now by the noble Earl, Lord Effingham, to working with us, because I think there is general recognition that we have a problem that needs to be dealt with. I am very glad, as I said at the outset, to have been the Minister at the Dispatch Box when my noble friends Lord Duvall and Lord Roe made their moving maiden speeches. They both have many years of distinction in public service, and I know that that will continue as they bring their own unique experiences and views on the world to your Lordships’ House, which will be much enriched by their presence.
A strong and consistent theme has come through today’s debate: a shared concern for the well-being of NHS staff, recognition of the importance of workforce planning and the need for a sustainable health service. I am grateful for the thoughtful questions, and I will endeavour to answer as many as possible—I have already referred to some in my opening remarks. I will of course review the debate, as always, and I will be pleased to write to noble Lords on those matters I was not able to get to.
This legislation is about giving future generations of doctors trained in the UK a clearer and more secure pathway into NHS careers. It is about sustainable workforce planning and, as the noble Earl, Lord Howe, referred to, about fairness—to those who train here, to taxpayers who fund that training and to patients. As many noble Lords acknowledged, significant public investment goes into medical education every year, so it is right that we ask ourselves how that investment can be best aligned to what we need.
I have listened closely to the concerns raised today, particularly about the Bill’s impact on those who will not be prioritised. To reiterate, the way I look at this is that the Bill is about prioritisation, not exclusion. I assure your Lordships’ House that all eligible applicants will still be able to apply, and they will be offered places if vacancies remain after prioritised applicants have received theirs. We absolutely expect that to be the case; that is our experience. To be more specific, there are likely to be opportunities in specialties such as general practice, core psychiatry and internal medicine, which historically attract fewer applicants than the groups we are prioritising for 2026. We still need those people.
The noble Baroness, Lady Hollins, asked about possible unintended consequences for the UK’s international reputation. I believe our proud history of welcoming colleagues from across the world will continue and, as I have just said, international colleagues can, of course, continue to apply after prioritisation has taken place and there are vacancies.
On new specialty training posts, we have committed to creating 1,000 of these new posts over the next three years, focusing on specialties where there is greatest need. This is on top of creating 250 additional GP training places each year. The noble Earl, Lord Howe, raised questions about the availability of training places. Expansion will be matched with training capacity. We have not yet confirmed which specialties will receive the new posts, but we will ensure that expansion is targeted where patient demand and workforce pressures are the most acute.
I am glad that the noble Lord, Lord Stevens, made reference to the cancer plan. It was a bright spot in today’s news—I am sure all noble Lords will understand —and has not had the airtime it ought to have had, so I am most grateful to him. What I can tell the noble Lord about the creation of new specialty training posts is that there will be a focus on those with greatest need. We will set out steps in due course and I look forward to keeping the noble Lord informed. Non-prioritised graduates will also continue to have routes into NHS careers through locally employed doctor roles, gaining experience that can support future progression and prioritisation.
Let me turn to some of the specific points that were raised by noble Lords. The noble Lord, Lord Patel, asked about British citizens who have graduated from medical schools outside the UK and will not be in the priority group. I understand why these concerns are being raised but, going back to the core of the Bill, to prioritise them would undermine our aim to build UK-trained capacity while ensuring we do not provide any more foundation programme places than we need. To reiterate, UK-trained doctors are more likely to work in the NHS for longer, and retention is an issue that is much discussed in your Lordships’ House. They will be better equipped to deliver tailored healthcare that suits the UK’s population because of what they understand. Reference was made to the provision extending also to the Republic of Ireland graduates. Their inclusion ensures consistency in workforce planning across both jurisdictions, which reflects the long-standing protocol rights for movement and employment. That was something in which the noble Lord, Lord Clement-Jones, was particularly interested.
On specialty training places starting in 2026, British citizens will be prioritised, because that is one of the prioritised immigration statuses being used as a proxy to indicate someone who is likely to have significant experience of the NHS. Why? Because applications for posts starting in 2026 have already been made. Prioritisation is only at offer stage because shortlisting is under way, so it is a timing matter about implementation. From 2027, immigration status will no longer automatically determine priority, but we have the ability to set out in regulations the persons who will be prioritised based on criteria which indicate they are likely to have significant NHS experience, or based on their immigration status. As I said earlier, we will be engaging with our partners to work out how best to define that.
On the point made by a number of noble Lords, including the noble Earl, Lord Howe, and the noble Lords, Lord Clement-Jones and Lord Stevens, about graduates of overseas campuses, including Malta, which I will turn to presently, having heard the noble Baroness, Lady Gerada, the UK foundation programme applications for 2026 show that there are almost 300 applicants from these overseas campuses, of whom 152 are UK nationals. This is a substantial number and, if we were to do what is being asked—to prioritise graduates of UK overseas campuses—our estimation is that this could encourage universities to establish further international partnerships which would simply increase pressure still further. It also risks creating a loophole that would encourage new overseas partnerships to seek preferential access to the foundation programme across the UK. The noble Lord, Lord Clement-Jones, picked out Liechtenstein in particular, but, as the noble Baroness, Lady Coffey, referred to, we are talking about the EFTA countries, which include Liechtenstein, and they are prioritised simply because of existing international agreements that we are obliged to honour. However, in practice, not all these countries are going to have eligible applicants.
I hope the Minister does not mind. Does the Minister think that the agreement with Malta should be honoured as well?
I am coming on to this, but the agreement in respect of Malta that I would refer to is a reciprocal health agreement. It does not apply in this area. It is about the reciprocal provision of healthcare. I will turn to Malta, however, after saying a brief word about overseas campuses generally.
Just to re-emphasise, overseas campus students are not part of the numbers that the Government are setting. We do not have that control. If we prioritised those graduates as well, that would eat away at the very core of the Bill and the things people actually want us to do.
The noble Baroness, Lady Finlay, and the noble Lord, Lord Clement-Jones, wanted an indication of how this would all align with the international education strategy. The Bill does not conflict with this, because the international education strategy supports universities expanding internationally. It does not prevent UK universities delivering medical degrees overseas. That strategy stays in place.
I turn to Malta for the noble Baroness, Lady Gerada—
Can I just a question? The Minister has suggested that these students could come and work in non-training posts. But the problem, as I understand it—do correct me if I am wrong—is that, for example, St George’s students must complete their foundation year in the UK to be eligible to apply for full registration. Therefore, it means that they cannot complete their medical education without being eligible to apply for the foundation training. While a different contract could potentially be negotiated for future students at an overseas campus, the current students who have this contract and expectation in place need to have that honoured. I do not feel that the Minister has responded to the concerns that have been raised eloquently around the House.
As I said at the outset, I will endeavour to answer all questions, but where I do not have an answer, particularly where I want to look at them in closer detail, I will be very pleased to write, of course, as always.
Still turning to Malta—which is a pleasure—let me say straight away that we do have a long-standing partnership with Malta on healthcare. It is valued and it will continue. Doctors who are training in Malta will still come to the UK, as they do now, to gain NHS experience to support their training, for example through fellowship schemes. This is not affected by the Bill.
As I discussed with the noble Baroness just yesterday, senior officials in my department have met with the High Commissioner of Malta to the United Kingdom in order to assure him of this. But it is important to prioritise in order to ensure a sustainable workforce that meets its health needs. Again, that is at the core of the Bill. Malta has its own foundation school. This is not part of the UK foundation programme: it is affiliated with the UK foundation programme office which administers the UK programme. That means—this point has been made to me—the Malta Foundation School delivers the same curriculum and offers the same education and training as the UK foundation programme. The Bill will not impact this affiliation or the other ways in which work carries on closely with the Government of Malta when it comes to health.
The noble Earl, Lord Howe, also made the point that he believed small numbers of students were impacted. I have referred to the 300 applicants from overseas campuses. I hope it is understood that that is why there is a significance there.
If there are other matters that I have not addressed to the satisfaction of the noble Baroness, Lady Gerada, I will be very pleased to review this, because I suspect there were some more points to address. I will be very pleased to write to her to give her comfort in this regard.
I move on now to the impact on doctors who were part way through the application process—a point spoken to by noble Lords, Lord Patel, Lord Mohammed, Lord Clement-Jones, and other noble Lords. As I stated earlier, delaying implementation of the Bill until next year, which would be required if we were to respond as requested, would mean another full year where we are not tackling the issue of bottlenecks in medical training. It seemed to me that the feeling in the House was that we did need to do that.
I understand the discomfort of noble Lords around this. It is important that I recognise that, but it is also important to recognise when introducing legislation that sometimes it will not work perfectly for everybody. This is about prioritisation, not about exclusion.
Following that point, the noble Lord, Lord Stevens, the noble Baroness, Lady Coffey, and the noble Earl, Lord Effingham, asked about emergency legislation. They asked: why now? As the Health Secretary set out in the other place, he has listened to resident doctors and their concerns about a system that does not work for them. He agreed to bring forward that emergency legislation as quickly as possible, rather than wait—this is key for a number of the points raised—another year to do so.
The noble Earl, Lord Howe, and the noble Baroness, Lady Coffey, asked about the Bill’s commencement and why it will not commence at Royal Assent—that is a very fair question. We are introducing reforms for a large-scale recruitment process. I know that noble Lords will understand what a major undertaking this is. We do not want to create errors or more uncertainty. To make sure that it is effective in commencement, we must have clear processes for delivery across the health system, and I am sure that all noble Lords appreciate that these elements cannot be switched on overnight. As the Secretary of State said in the other place, there is a material consideration about whether it is even possible to proceed if the strikes are ongoing. He is concerned—I share this concern, as I am sure all noble Lords do—about the disruption that strikes cause and the pressure they put on resources, which would make it so much harder operationally to deliver the measures in the Bill.
Lord Mohammed of Tinsley (LD)
I will press the point I made earlier about uncertainty. Not having a commencement date creates a lot of uncertainty for the current batch of students, who are really worried about whether they will they gain a place and, more importantly, where. I want to impress this issue on the Minister; it was raised by the Russell group medical school admissions head with me personally.
I completely understand the point about uncertainty. Uncertainty exists in the current system, and uncertainty may transfer for different reasons. We are keen to get on with this. I am just indicating some of the circumstances—strike action—that would cause difficulty for us in terms of commencement. I hope we can proceed. I think the noble Lord will understand exactly what I am saying.
The noble Baroness, Lady Coffey, asked about the release of more granular detail. I draw noble Lords’ attention to the fact that NHS England already publishes a wide range of recruitment data, including data on country of qualification and nationality groups. It will publish further granular data when possible and monitor the implementation of the Bill, should it pass—that, for me, is the most important point. If the noble Baroness is referring to other information, she is very welcome to raise that with me.
I am of course very happy to meet with my noble friend Lord Stevenson. In general, the 10-year health plan commits to working with professional regulators and educational institutions over the next three years to overhaul education and training curricula.
To answer the question from the noble Baroness, Lady Coffey, on prioritisation, if I can put it in my language: you either are or are not prioritised. There are no tiers of priorities within priorities; it is as it is written in the Bill.
The noble Lord, Lord Mohammed, asked about the impact of prioritisation on harder-to-fill specialties. This approach will not negatively impact recruitment. In fact, it will ensure that priority groups are considered first, while keeping the door open for when we need people. I think it will help get people into the areas in which we need them, because it will direct people to where we do not have sufficient applicants.
At its heart, the Bill is about the UK-trained medical graduates on whom the NHS heavily relies. We are grateful for their skill, commitment and professionalism. It is our responsibility to ensure they are trained, supported and treated well at work. This is a more sustainable and considered approach to the allocation of medical training places. A number of noble Lords said that this is a problem that has been around for years. We are grasping the proverbial nettle. The Bill is a measured step towards the goals of clarity, fairness and opportunity. It will not, on its own, resolve everything—I am fully aware of that—but it will help us with a pressing problem. With that, I beg to move.
(1 week, 1 day ago)
Lords ChamberMy Lords, in the interests of time I do not propose to summarise the many points and questions that have been raised in this debate. However, I wish to speak briefly to Amendment 320A in the name of my noble friend Lord Wolfson. The amendment seeks to set the presumption that the first assessment by the co-ordinating doctor
“must be undertaken in person, except in circumstances where this is not reasonably practicable”.
It is plain from everything that we have heard in the debate that the first assessment is a pivotal moment in the process set out in the Bill. It is the point at which a co-ordinating doctor must satisfy themselves not only of the diagnosis and prognosis but of the patient’s capacity and will and, crucially, the absence of coercion or pressure, as set out in Clause 10. These are human judgments that depend not simply on what a patient says but on the way that they say it, on physical cues and on the broader context in which the conversation takes place.
I listened carefully to the noble Baroness, Lady Finlay, in particular, as I did to other noble Lords, and an in-person assessment undoubtedly allows a clinician to observe matters that may not be apparent on a screen—for example, who else is present in the room, whether the individual appears comfortable speaking freely or whether there are signs, however subtle, of hesitation or external influence. At the same time, I suggest that we need to be patient-focused as well as doctor-focused, which is why my noble friend’s amendment seeks to recognise practical realities. There will surely, from time to time, be circumstances, perhaps in late-stage illness when a person may be in acute distress, where an in-person assessment is genuinely not possible. The reasons for that could be several, but in those cases we need to ask ourselves whether a live video and audio link would be preferable to a delay, or even a complete exclusion from the process.
I emphasise that the amendment is a probing one. If we decide that provision should be made for certain cases then that would surely be a classic area for guidance or codes of practice, but the key test in every instance would be what is reasonable in the circumstances. My noble friend wants to be clear that this amendment is about setting the right default for arguably the most consequential clinical judgment in the entire scheme of the Bill, while preserving professional discretion in response to the needs of the patient where circumstances require flexibility.
I have deliberately spoken in general terms when talking about what might not be reasonably practicable. The question is really the one posed by the noble Baroness, Lady Hayman: how rigid do we wish the Bill to be in prescribing how the system should work? I hope the noble and learned Lord, Lord Falconer, could set out his vision of how this mechanism will work in practice and how he will ensure that the safeguards that we all want to see can still be maintained if an in-person assessment is not possible.
My Lords, I am grateful to all noble Lords for their contributions to this debate. As ever, I will limit my comments to amendments on which the Government have major legal, technical or operational workability concerns.
First, I draw the attention of the Committee to operational workability concerns about Amendments 60 and 65. Under Amendment 60, professionals delivering the service would be responsible for checking whether the person was in England or Wales on multiple occasions before carrying out their duties, even if it had been confirmed that the person was ordinarily resident in England or Wales. That would place a significant burden on professionals delivering an assisted dying service.
My Lords, I express my gratitude to everyone who has taken part in the debate. I make special mention of the noble Baroness, Lady Smith of Newnham, and the noble Lord, Lord Polak, who spoke about the death of their father and mother. Like everyone else, I am grateful for what may have been something that was quite difficult to contribute to the debate. I hope I have not left out anyone else out who has done that.
These amendments fall effectively into two categories. The first is the England and Wales category—what do you have to be in England and Wales to do?—and, secondly, and separately, in what circumstances is a face-to-face meeting between either the patient and the doctors or the patient and the panel required?
I will deal first with the position of England and Wales, raised by Amendment 60, from the noble Baroness, Lady Coffey. Currently, under the provisions of the Bill, the first declaration made by the patient, the second declaration made by the patient, the first assessment of the patient, the second assessment of the patient and assistance being given to the patient all have to take place in England and Wales. There was a range of other things that the noble Baroness wished to take place while the patient was in England and Wales—for example, switching from one doctor to another, which is a process. For my part, I think the Bill has broadly got right when you have to be in England and Wales. Having listened carefully to what the noble Baroness has said, I am not minded to suggest an amendment in relation to that, and I note that it was not picked up as an issue by other people.
The face-to-face issues were much more what the Committee, if I may say so, was interested in through the course of this debate. The effect of the debate has been, in effect, to identify four possibilities. First, Amendment 65 wants each of the occasions, namely the two doctors and the panel, to always involve a face-to-face meeting. Secondly, there should be a face-to-face meeting unless there are—I use this phrase without intending to pick up all the amendments—exceptional circumstances or practicability issues. Thirdly, the third amendment from the noble Lord, Lord Blencathra, which he referred to, is that there should be, to use his language, a “statutory protocol” defining where there can be remote meetings, accepting that the norm is face to face. Fourthly, we could simply rely on the existing provisions of the Bill, which is that codes of practice can be issued by the Minister under the various provisions of the Bill saying when face to face is appropriate and when it is not.
The testimony—that is what it felt like—given of cases where remote has gone wrong have enormous power and I think we are all aware of circumstances where face to face will lead to much greater and better communication. The other side of the coin, which was referred to by the noble Baronesses, Lady Pidgeon and Lady Hayman, my noble friends Lady Jay and Lady Blackstone and the noble Earl, Lord Howe, is that there will be circumstances where, if you insist on face to face, you are, in effect, excluding some people from this right when they should have it. There are arguments on both sides.
I come away with the strongest possible feeling that the Committee thinks that face to face where possible is best but that there will be circumstances where it is not appropriate. That brings me to my third and fourth possibilities. It is wrong and dangerous to try to use a phrase such as “reasonably practicable” or “exceptional”; more is required and guidance should be given. This is not a criticism—it is a congratulation—but I do not think the words “statutory protocol” are right, but I get from what the noble Lord, Lord Blencathra, is saying that he wants something that has the force of regulations or something similar that says, “This is what we have in mind”. Whether that is a code of practice or a statutory protocol, I am not sure. I am sure it is not what is called a protocol, but it might be something quite like that. I think the right course for me is to go away and bring back something that satisfies the Committee that there will be something—a statutory protocol or a code of guidance—that indicates when face to face is appropriate or should be the norm, but gives the circumstances where it would not be, because I get the sense of anxiety about that. I hope, in the light of that approach, noble Lords will feel able to withdraw or not to press their amendments.
My Lords, I thank noble Lords for their contributions on this debate on artificial intelligence. It follows the debate yesterday, as referred to by the noble Lord, Lord Deben. The purpose of Amendment 66, tabled by the noble Baroness, Lady Coffey, is to prohibit artificial intelligence from being used to carry out functions under any section of or schedule to the Bill. This amendment is likely to have major workability impacts that could render the Bill unworkable and/or undeliverable.
While this is a policy matter, I will pick up points and considerations that have been made on the use of AI in practice. Broadly, artificial intelligence is absolutely in use in a number of pathways. It was indeed referred to in the 10-year health plan, and the ways it is being used include imaging and diagnosis. As this amendment stands, it would preclude an improvement in speed and in quality of care for patients.
Following my comments on workability, the amendment would incur an administrative burden that is likely to increase over time. AI is increasingly used across the economy and public services, including in the NHS, as set out in the 10-year health plan. The effect of the amendment as drafted is very broad in prohibiting this use of AI from carrying out any functions under the Bill. In the future, when AI is integrated into NHS systems across the board, it may well be difficult or even impossible to quarantine systems that are used for functions under the Bill. Additionally, this may risk creating a parallel system where voluntary assisted dying services are left behind and are potentially less safe for patients.
I am grateful to the noble Baroness, Lady Coffey, for raising artificial intelligence. There was, broadly, a consensus around the Committee, which the noble Baroness supported, that the amendment is much too blunt, but as she said, fairly, it gives us an opportunity to talk about AI. I will also pick up the right reverend Prelate the Bishop of Hereford’s contribution; he rightly said, as has been echoed around the Committee, that there have been huge benefits for patients from AI.
I think four concerns were raised during the debate. The first was: will AI affect decision-making? I think the underlying point there is that we do not want machines to make the decisions that are referred to in the Bill; we want human beings to make them. In particular, the decisions I have in mind are the decision of the first doctor, the decision of the second doctor, the decision of the panel, and the decision of the doctor, at the point that the assistance is being given, that the conditions are still satisfied. Everybody around the Chamber wants that to be decided by a doctor or a panel, depending on which it is, and I completely and unreservedly endorse and accept that.
Does that need to be made even clearer in the Bill? I will consider it, but I do not think that it does. The acid test for me is that if you fail to comply with your obligations as a doctor or as a panel, you can go to prison for up to five years. It is very difficult to imagine how you could put a machine in prison, so it is pretty clear that these decisions must be made by a human being. For my part and for everybody who supports the Bill, that must remain the position.
The second concern is advertising, which the noble Baroness, Lady Berridge, referred to. She is absolutely right. I have made it clear that I will bring forward amendments. Those amendments, which are almost finally drafted, make provision specifically in relation to digital advertising—they do not specifically refer to AI, but we need to address that in the advertising provision. I will lay those amendments so that the House can consider them.
The third concern is slightly generalised, which is that AI is very persuasive, particularly in persuading people to do things that they do not necessarily want to do. The first thing on that is that there is a wider societal requirement to address the pervasive impacts of AI in a whole range of things. We should all try to contribute to that. More focused on this is the question of the safeguards in the Bill, because they then become incredibly important. In particular, the safeguards require that there is doctor-to-patient discussion in relation to the decision for that patient, and they are specifically required in the preliminary conversation, the first conversation and the second conversation. It is those safeguards that one must see as the antidote to the persuasive aspect of AI, but I completely accept what people said on that.
The fourth issue, which was touched on very briefly, was the operation of devices. That, I think, referred to the fact that quite a number of medical devices can be operated by, for example, the blink of an eye or something quite minor. Again, that needs to be properly safeguarded. Those may not necessarily be AI problems but problems with other sorts of developments in technology.
I thank the noble Baroness, Lady Coffey, for raising this. We need to consider all the points she made. At the moment, apart from the advertising amendment, which I will bring forward, I am not sure that it requires amendment to the Bill.
My Lords, I will be very brief. The Government do not have any major technical or operational workability concerns on the amendments tabled by the noble Lord, Lord Sandhurst, and the noble Lord, Lord Harper, which were originally tabled, as we heard, by my noble friend Lord Hendy. To make the usual point, as noble Lords will be aware, these amendments have not had technical drafting support from officials, so further revision and corresponding amendments would be needed to provide consistent and coherent terminology throughout the Bill.
My Lords, I raised the point that the state could be liable in cases where the companies people worked for were nationalised or owned by the state. It seems not unreasonable that in due course the Minister could express a view on behalf of the Government, because the Government could be directly—and financially—affected by the consequences of the Bill.
I appreciate the point the noble Lord is making—and indeed the points that the noble Earl, Lord Howe, made. However, as your Lordships’ House knows, I correctly restrict myself to commentary on what is before us. Should the Bill include this amendment, we will then respond at the appropriate time.
My Lords, there are effectively two entirely separate issues raised by this group of amendments. The first is whether we should extend the current eligibility to people who have an inevitably progressive illness or disease to somebody who is terminally ill because they have injuries—for example, from a car accident—that might make them die within a specified period.
I was not sure whether the noble Lord, Lord Harper, was pressing that as an amendment, because the thrust of his remarks was much more focused on the effect on the Fatal Accidents Act. Whatever his position, I am afraid that I am not in favour of that amendment because the whole Bill has been put together and the argument for it has been based on people who are terminally ill. That is very different, for a whole variety of reasons mentioned by people, from somebody who is the victim of an injury.
I can see that people might say there was considerable moral equivalence, and the noble Lord, Lord Hendy, was right to say how persuasive he was when I spoke to him in relation to it. However, my clear view is that we should not extend the Bill beyond its current eligibility. I should also make absolutely clear that the wording of the Bill is clear; there is no prospect whatever that a court could construe the words “illness” or “disease” as meaning “injury”. What we send from Parliament will be the way it is read.
(1 week, 2 days ago)
Lords ChamberThat the draft Regulations laid before the House on 16 December 2025 be approved.
Considered in Grand Committee on 28 January.
(1 week, 2 days ago)
Lords ChamberTo ask His Majesty’s Government what steps they are taking to address the shortage of batteries for NHS hearing aids.
My Lords, a single type of Energizer hearing aid battery is under supply pressure due to increased demand. It is still available to order and the NHS supply chain has instituted demand management to ensure a fair supply of available stock across the NHS. The NHS supply chain is working with Energizer and an alternative supplier to maximise stock availability and will take steps to improve future resilience. I am glad to say that the supply issue is anticipated to be resolved by 16 March.
I am grateful for that reply. While this is not the most urgent problem facing the NHS and its patients, 80% of people over 70 suffer from hearing loss. Many of them are now switching off their NHS hearing aids to conserve the batteries, and this has an impact on their quality of life. Last November, supply problems began to emerge and, as the noble Baroness has just said, if you go to the NHS supply chain website, it says that the batteries are subject to “demand management”—a euphemism for short supply. Very worryingly, as the noble Baroness has just said, normal service will not be resumed until March 16. So the question for the Minister is: what resilience is there now in the NHS supply chain for this product and others; why is there so much dependence on one supplier for a fairly basic product; and, related to that, why is it going to take so long to restore normal service?
These are very real issues that the noble Lord is raising. There are only three global manufacturers and we get our supplies from two of them. There are limited places to get them from. In terms of future resilience, we work very much in partnership, through our Supply Resilience Directorate, with industry and the wider sector to ensure continuity. Importantly, I very much welcome that there was recently investment in Tyne and Wear in the factory, on UK soil, in order to enhance our domestic manufacturing capability. But we will also conduct a lessons learned exercise after this.
My Lords, is it not the case that it is not just hearing aid batteries and that the NHS is facing problems with the supply of quite a number of pharmaceuticals? Could the Minister tell us precisely which major pharmaceutical products are affected by this, and is this a consequence of Brexit?
I think my noble friend has heard opinions already expressed on that matter. Certainly, Brexit does give us challenges, without a doubt, that this Government continue to work to resolve. I cannot answer the first question that my noble friend asked about, but I will gladly write to him and can assure him that we are working to overcome some of the challenges that we inherited and have been presented with, and that does include Brexit.
It should go without saying that rationing hearing aid batteries is totally unacceptable for some of the most vulnerable people in our society. The RNID say that the uncertainty of not knowing how long a battery will last can be very stressful, and no one should be forced to ration their hearing aid use because of supply problems. Whatever the cause, for sure this should never be allowed to happen again. What steps are the Government taking to make sure that it does not?
I certainly agree with the concerns about the impact on individuals. Further to the point raised by the noble Lord, in addition to the noble Baroness, I would recommend that people who are using hearing aids do not ration their hearing. That is not where we want to be, but in fact it is about not giving more supplies than are immediately needed. The real issue is that people are being asked to get their batteries more often. If that is a problem for people, they should raise it with a supplier, who will ensure that, for example, the postal service is used or some other way of getting batteries to individuals.
My Lords, in response to that previous answer from the Minister, I understand that, as a result of these shortages, some patients are being required to return to hospitals as frequently as once a week to obtain replacement batteries, while rationing their use in the meantime. Patients have also reported additional travel costs, and even hospital parking charges, because they are going more frequently to the hospital than they otherwise would. What steps is NHS England taking to mitigate these additional costs, particularly for those on lower incomes: for example, by offering, say, free temporary parking if they are going to the hospital only to pick up their batteries, or other mitigations that would help those people?
Well, it is of course a matter for local ICBs to decide what their best response is, depending on their local community. I should emphasise to your Lordships’ House that the reason for the increased demand is that there was a cyber attack on the alternative supply of batteries. That was an unpredictable issue, but is always one for which we need to have resilience. I do recognise what the noble Lord is saying, but that is why I answered to the noble Baroness that there are alternative ways of getting batteries to individuals.
My Lords, I checked my batteries and I am glad to say they were made in England. But we know that the Chinese dominate the world supply of batteries. Will she send a message to the Prime Minister while he is in China to ensure that, overall, our reliance on China for batteries is not increased? It is really important that we supply ourselves.
I am sure that the Prime Minister will be checking Hansard and will hear what the noble Baroness has said. The important point she made was about expanding our domestic manufacturing capability. These particular batteries are very specific in their manufacture—the noble Baroness is quite right—and that is why I welcome the company’s investment in Tyne and Wear: it is a vote of confidence in the British economy, as well as assisting us in our supplies.
My Lords, I love the idea that the Chinese are listening to our proceedings through your Lordships’ hearing aids. But I say to the Minister that there are many people under the age of 70 who suffer from hearing loss, possibly undiagnosed. It can have a huge impact on people’s cognition and on memory loss, but they are unaware of it. Can the Minister update the House on what the Government are doing to encourage youngsters such as myself to have hearing aid tests as a matter of routine?
I hope I share the noble Lord’s definition. I am enthusiastic about our new approach through the community diagnostic centres that noble Lords will have seen come on stream and be established all around the country. I agree totally about the age range, which is why we promote the fact that free hearing tests are available, and I encourage people to do them. The highest ever number of tests was done in October, over 136,000, which shows that the message is getting out, but I think the all-round approach of community diagnostics centres will really help us here.
Does this not once again reveal the fundamental flaw in the Government’s procurement policy, which the Treasury is still pursuing, of going for “cheapest is best” and ignoring all the lessons both of the pandemic and of the Ukraine war, which showed that relying on single points of failure regularly and consistently delivers problems into our system, in the long term at much greater cost? Do we not need a better-balanced programme?
I understand that point. Actually, that is one of the reasons we are encouraging ICBs to move to rechargeable batteries. As my noble friend says, it is about looking to the longer term. As part of the lessons learned, that is one of the things that we will look at to see how we can improve the underlying situation.
(1 week, 3 days ago)
Grand CommitteeThat the Grand Committee do consider the Medical Devices (Fees Amendment) Regulations 2026.
My Lords, I am glad to introduce these regulations, which will take effect from 1 April. These regulations will amend the fees structure for the relevant medical devices regulations and provide for a new annual medical device fee to replace an existing fee. The fee will enable funding for the MHRA’s strengthened post-market surveillance—or PMS—activities in respect of medical devices. I want to clarify that, for 2026-27, the fee will be part-subsidised by the Department of Health and Social Care, with the intention, subject to further ministerial and parliamentary approval, to move to a fully cost-recovering annual fee from 2027-28.
Why are these regulations needed? Post-market surveillance refers to the work that the MHRA does to collect, review and act on safety and performance issues relating to devices on the market. The Independent Medicines and Medical Devices Safety Review highlighted the need for a high-quality PMS framework. That is necessary because the framework strengthens the medical devices safety and surveillance framework, improving patient safety and supporting the Government’s risk-proportionate, pro-innovation approach to regulation. The framework is estimated to increase the MHRA workload by 60% to 70%, at an annual cost of around £17 million, so it is vital to get the right level of funding. Historically, PMS activities have been funded mainly by subsidy from the DHSC, and partly by the current device registration fee.
I should say that subsidising ongoing regulatory activity through general taxation is not the usual approach of the MHRA to fees and services. The usual approach is based on HM Treasury’s Managing Public Money guidance, which states that fees should be set on a full cost-recovery basis. Therefore, as noble Lords will appreciate, these regulations reduce subsidy by introducing an annual fee, so that those who benefit from access to the market fund the regulatory activity that supports it.
I turn to how the regulations are intended to operate in practice. The new annual fee apportions the overall costs of the MHRA activities by using the Global Medical Device Nomenclature system, or GMDN for short. The fee will be calculated using the number of registered devices with the MHRA. In practice, the MHRA will charge based on the number of chargeable GMDN categories in which a manufacturer has registered devices. If a manufacturer has multiple devices within the same category, it will be charged once a year for that category.
A consultation was done by the MHRA on this fee as part of its last statutory fees uplift, so this is a new fee rather than an additional increase to a fee in the last fees uplift. The consultation ran from the end of August to 24 October 2024, and it was widely promoted, including through an SME webinar. In the consultation, the annual fee was proposed at £210 per GMDN code, using the most granular level of the GMDN structure. Several changes have been made following the consultation feedback, which we appreciated, in response to the concerns that were raised. The MHRA set up a group of industry representatives to assist with this, to discuss the approach and to seek advice on implementation. This has been welcomed and has provided useful feedback and assurance.
To meet the concerns that were raised, the fee is being phased in. It will give the sector time to adapt, as I outlined in my earlier comments. The costs have been fully subsidised in 2025-26, and this instrument introduces a part-subsidised annual fee for 2026-27. The fee was remodelled to be charged at a higher grouping of GMDN category, rather than individual codes, resulting in the costs being more equitably spread. The MHRA estimates that 56% of manufacturers will pay £300 a year and 82% will pay no more than £900 a year. Small and medium-sized enterprises are likely to pay only £300 a year, as they are likely to have a more limited range of products compared to larger companies.
Let me put this in context. The medtech sector generated an estimated £48 billion in turnover in 2023-24, and the total PMS cost of £17 million represents about 0.035% of this. I recognise that businesses would prefer to avoid any additional costs, but I am satisfied that moving to a fair, predictable, cost-recovering approach, along with the changes that have been made, will help address the key concerns and make the measure workable and fair.
On implementation and readiness, the MHRA has been working with the sector. The phased rollout has given the sector time to get ready. The MHRA published guidance explaining the new fee, how it will be calculated, what account holders need to do to ensure that their registration data is accurate, and how and when payment will be made. The MHRA is improving its systems currently, so that businesses will be able to see their GMDN categories, which will help them understand what they will be charged for by 1 April this year.
In closing, these regulations introduce a necessary and fair new annual fee from 1 April to help fund the MHRA’s strengthened PMS work. The approach has been improved in response to consultation feedback—for which we are most grateful, as I said—and is being introduced in a phased way, giving the sector the time it needs to adapt while ensuring that the MHRA has the resource it needs to protect patients and maintain confidence in the market. I beg to move.
My Lords, I am grateful to the Minister for introducing these regulations. Although we support a strong and properly resourced system of post-market surveillance for medical devices, I am afraid we have significant concerns about the Government’s approach to this instrument.
As the Minister said, these regulations introduce a significant shift in how medical device registration is funded. As she outlined, manufacturers will now be required to pay an annual fee of about £300 per device category, replacing the previous one-off registration fee of £261. A further annual maintenance fee of £300 will also apply. This is a substantial change to the cost base for manufacturers. Of course, while large companies may be able to absorb these costs, there is huge concern among the small and medium-sized enterprises that make up a large part of the UK’s health technology sector.
The Government argue that these fees are necessary to fund the MHRA’s post-market surveillance functions. We do not dispute the importance of ensuring that devices used across the NHS are safe, effective and properly monitored. We also do not oppose the notion of charging fees. However, the question before us is not whether surveillance matters but whether the Government have provided the evidence and analysis required to justify the scale, structure and timing of these new changes.
I am afraid that, both here and in the other place, we are concerned that the Government fall short on these. The most striking omission is the absence of the full impact assessment. Instead, the Government relied on de minimis assessment on the grounds that the fee remains partially subsidised for one more year. Of course, we welcome that, because it helps to cut the costs for some of the manufacturers but, at some stage, manufacturers have to be weaned off these subsidies—or what some people term “corporate welfare”. Yet Ministers have already confirmed that the subsidy will be removed in 2027-28, when the full recovery model will be introduced. We think that this is an extraordinarily short-term approach for a regulatory change with such long-term consequences. It is difficult to understand how the Government can justify this new fee regime, when it clearly imposes additional costs on businesses without providing Parliament with a full and transparent assessment of its impact.
The Minister will know that industry bodies, including the Association of British HealthTech Industries and the British In Vitro Diagnostics Association, have repeatedly raised concerns about the uncertainty surrounding long-term fee levels. It is only right, therefore, that we raise their concerns here. The BIVDA has warned that, under the original proposals, some IVD manufacturers could have faced fee increases of up to 5,000% due to the granularity of the GMDN categories. Let us be clear: we are grateful that the Government have since moved to a higher-level categorisation—they should be given credit for that—but the underlying uncertainty remains. The MHRA’s own modelling suggests that the full cost recovery could require charges of more than £800 per device category. This is not a marginal adjustment for some of those small companies. It could be the difference between entering the UK market and walking away from it.
The Minister will be aware that these concerns were echoed in a Delegated Legislation Committee in the other place. Yet, despite these legitimate questions, the Government have still not provided clarity on how the new fee structure will affect different types of manufacturers. Unfortunately, they have also still not provided clarity on how they intend to mitigate the risk of reduced product availability, particularly for low-volume devices, including those used in diagnosis of rare diseases.
This is not an isolated change; it follows recent regulations on post-market surveillance on in vitro diagnostic devices. The cumulative effect is a regulatory environment that is shifting rapidly without the stability or predictability that businesses need in order to plan investment and product development.
We are disappointed by these regulations—not really their content but more the lack of the full impact assessment. The Government have not provided clarity on the long-term fee levels, addressed industry concerns about the risk of product withdrawal or given Parliament the information that it requires to scrutinise the consequences of this new fee regime. A proper impact assessment should have been conducted to avoid problems later.
Noble Lords will know that I take an interest in the phenomenon of unintended consequences. They will be aware of the “dash to diesel” when, in 2001, the then Chancellor of the Exchequer introduced a system of car tax to incentivise motorists to switch to diesel cars in order to meet lower CO2 emissions targets. That was understandable, but it was later found to have also led to an increase in emissions of harmful nitrogen dioxide and particulates. The reason I raise this is that, at the time, it had been claimed that some civil servants raised concerns about this consequence but were ignored.
This is not a party-political issue. The question is whether Governments of any colour have learned the lessons from that incident. How do we make sure that, when potential consequences are raised with the Government, they are seriously taken on board, particularly in terms of a full impact assessment? Given the current concerns that have been raised, rather than introducing these new charges now only to find out that, as a result of the consequences, they will have to be reversed or tweaked, surely it would be better for the Government to pause the process to introduce the new charging regime until a proper and full impact assessment has been conducted.
We understand that the running costs of the MHRA have to be met somehow and we agree with the Government that they have to wean companies off those subsidies in the adjustment. However, in the other place, my honourable friend the shadow Minister for Health, Caroline Johnson, pointed out that previous calculations of the cost base of the MHRA had not taken account of, for example, the impact of the rise in NI contributions on the running costs of the MHRA, so the Government have had to find some extra money to plug that gap. Perhaps that is why this SI has been rushed through without a proper, full impact assessment, although it may well not be.
My honourable friend also asked about a consultation that revealed widespread concern, with only 10% support. The Minister replied that changes had been made following discussions with a “trusted advisory group”. My honourable friend then asked:
“Who is in the trusted advisory group? Whose voices from micro and small businesses were heard in that group?”.—[Official Report, Commons, Third Delegated Legislation Committee, 21/1/26; col. 7.]
Unfortunately, she has not had an answer.
I am grateful to the noble Lord for his interest in this important subject and for expressing his concerns, which I will address. I know that he is more than supportive of patient safety and taking a risk-proportionate and pro-innovation approach —I hope that is not putting words into his mouth, but that is my experience of him—and that is what this is about. I have heard his request to defer consideration of these regulations. I would not want to agree to that, not least because of the timetable we have set out. In running the consultation and responding very directly to the concerns raised, which were very real and appreciated, as well as by working with industry and being transparent and prepared, we feel that it is time for these regulations.
The noble Lord, Lord Kamall, referred to substantial additional costs on businesses. The impact on business is estimated at £4.3 million a year in total. Of course, de minimis assessments are not usually published. However, we have included that figure in the Explanatory Memorandum and committed—I hope that this will be helpful—to a full impact assessment for the fully cost-recovering fee in 2027-28. I hope that that will go some way to assist the noble Lord.
My Lords, the noble Lord, Lord Kamall, asked further questions about the timing of the full impact assessment and why it is not being done this year. The reason is that the full impact assessment will refer to 2027-28, when the fees will be paid in full. Currently, because they are being subsidised for one year only, a de minimis assessment is required, but, when we have the full-fat version, that will be the right time for the impact assessment.
The noble Lord raised some questions that had been asked in the other place by Dr Caroline Johnson MP. I assure him that my ministerial colleague with responsibility for this area, Dr Zubir Ahmed MP, will reply to that Member of Parliament, and I will of course make sure that the noble Lord sees a copy of that response.
A question was raised about obsolescence and PMS. In response, I can say that if a manufacturer stops supplying a medical device, the company or its UK responsible person must update the MHRA registration by removing the product or stating that it has stopped being sold. Devices already on the market can stay in the supply chain or be used, as long as they are not recalled, and manufacturers are responsible for post-market surveillance duties. So, if the manufacturer no longer exists and has no legal successor, these duties do not transfer. For manufacturers outside the UK, the UK responsible person has to keep and provide plans and reports if requested. If there are any concerns, the MHRA will continue to monitor device safety and can act. The main summary is that manufacturers themselves or the UK responsible person are responsible for updating the MHRA.
The noble Lord, Lord Kamall, asked about the impact on small and medium-sized enterprises. I recognise, as I said in my opening, that new regulatory costs can be felt more sharply in this area, and that is why the MHRA listened carefully. It is also why the fee has been designed to spread costs more equitably across the sector, and why, once we had the consultation and the feedback, charging is to be based on a number of the GMDN categories that a manufacturer’s registered devices fall into, rather than the much more granular GMDN code. That matters for small and medium-sized enterprises because they are more likely to have closely related product variants that may attract multiple level 5 terms that sit within a single level 2 category. Under this approach, multiple products that are in one level 2 category are charged once a year, reducing repeat charges for minor product variations, which is important to SMEs. To re-emphasise, the MHRA estimates that about 56% of manufacturers will pay a single unit fee of £300 a year. It is SMEs that are most likely to fall into this lower charging group because they typically have a narrower product range than larger companies.
I can say to the noble Lord, Lord Kamall, that, as I said earlier, the charge is designed to be proportionate. I should say that if there were to be any waivers— I know that he did not specifically ask that but raised general concerns—that would simply shift costs elsewhere. We need to keep the charge predictable and proportionate, and to phase it in.
My final point is that SMEs stand to benefit from a stronger PMS framework. It will mean earlier identification of issues, fewer surprises and a more risk- proportionate, predictable regulatory approach. That is what supports responsible innovation, and I know that is of concern to the Grand Committee.
Taken together, these regulations put the funding of a strengthened PMS on a clearer, more sustainable and fairer footing, so that those who benefit from access to the UK market contribute fairly to the ongoing regulatory work that supports that access, because that regulatory work has to be paid for in some way. I cannot emphasise enough how the fee has been redesigned following the consultation. Often, noble Lords question the value of a consultation and whether it really makes change. I can say that, on this one, without a doubt, it has done, and I am grateful to all those who contributed.
Today, these regulations, if agreed by your Lordships’ Grand Committee, will mean that we can maintain confidence in the safety and performance of medical devices, support continued access, and ensure that the MHRA has the capacity to act quickly and proportionately should issues arise. For those reasons, I hope noble Lords will support these changes.
(2 weeks, 4 days ago)
Lords Chamber
Baroness Hughes of Stretford
To ask His Majesty’s Government what action they plan to take in response to the finding in the MBRRACE-UK report Maternal mortality 2022–2024, published on 8 January, that the maternal death rate in pregnancy rose by 20 per cent between 2009–11 and 2022–24.
My Lords, MBRRACE’s report highlights the need to improve maternity safety, to which this Government are fully committed. We have commissioned an independent investigation that will present recommendations in the spring, while the National Maternity and Neonatal Taskforce, chaired by the Secretary of State, will transform these into a deliverable national action plan to drive change. In the meantime, we are taking various actions, including piloting Martha’s rule and expanding the maternal medicine networks.
Baroness Hughes of Stretford (Lab)
I thank my noble friend for that Answer. She will know that the Conservatives promised to halve maternity mortality by 2025. Instead, as the report shows, it has risen substantially, with stark disparities for older women and those from BME and disadvantaged backgrounds. Between 2021 and 2023, over 600 women died either during or shortly after pregnancy—a tragedy compounded by the fact that, in the majority of cases, this was from a preventable complication of the pregnancy itself. I know the Government are taking certain actions, to which she referred. Those are welcome, but they are not being applied consistently in every area. More importantly, trusts are not required to inform NHS England of the plans they are making. In short, I say to my noble friend that there seems to be a lack of robust oversight. How will the Government ensure that the standards and new procedures that they want to implement will be implemented effectively by every trust and in relation to every pregnant woman?
My noble friend is right to use the word “tragedy” in respect of maternal deaths, particularly those from preventable causes. She is also correct that, sadly, most aspects of the maternal safety ambition that was set under the previous Government are very unlikely to be achieved. We have to make sure that, for any future target, the system can deliver. As one example, the maternal care bundle sets clear standards across all services for implementation by NHS providers and commissioners, and is focused very much on the main causes of maternal death and harm, as my noble friend asks for.
My Lords, the Government have launched a maternity inquiry, but we have already had lots of maternity inquiries and reports from the charity sector, such as the Muslim Women’s Network— I declare my interest as its CEO—Five X More and Birthrights, all with similar findings and recommendations. Instead of having more inquiries, why do the Government not just get on with it and implement actions? What do they expect to find that they do not already know? Can the Minister share how she is implementing existing recommendations?
I understand what the noble Baroness is saying and her frustration, which I am sure many of us share. The purpose of the investigation by my noble friend Lady Amos is to pull together all the learning and all the inquiries. She has, for example, given a real voice to those affected, speaking to 170 affected family members. Those voices are what has been missing, and that cannot go on. We are determined to draw a line under where we have unfortunately been and to move forward, while taking direct actions, including, for example, a national programme to support struggling trusts to make improvements.
My Lords, recent Health Service Journal investigative journalism has found that the Chief Midwifery Officer wrote to trusts last year identifying gross failures in home births safety, yet the Government have chosen to keep this information private while women are pushed into unsupported births. Is it acceptable for NHS England to hide this evidence of systematic safety risk from the public when the home birth services of 14 trust have effectively ceased to exist, despite the legal duty to provide them?
I am not fully up to speed with the article that the noble Lord raises, but I undertake to look at it and get back to him, because this is a very important matter.
My Lords, many NHS trusts are facing deficits in midwives. There is not a sufficient workforce. What are the Government doing to tackle this issue? New parents, and new mothers during their birth, are not being supported, and there are significant problems as a direct result of this.
Midwives are absolutely crucial, and I pay tribute to them and to the wider maternity team. As of October 2025, there has been an increase of some 3.6%—that is 878 more midwives—compared to October 2024. Importantly, we are seeing the introduction of a range of initiatives to improve retention in the maternity workforce, including in midwifery. That will include mentoring and giving better advice and support on pensions and flexible retirement options, because we are keen to retain the long years of service that many midwives and other staff have.
My Lords, touching partly on the question from the noble Baroness, Lady Gohir, data from MBRRACE-UK shows that black women are three times more likely to die during pregnancy or childbirth than white women. Do the department and NHS England have any evidence on the reasons for these disparities that the Minister can share with the House? Will she tell noble Lords how NHS England and the department intend to tackle these disparities?
I am glad to say that my noble friend Lady Amos will be very much focusing on this area. I referred earlier to the maternal care bundle, which focuses on the five main causes of maternal death and harm, as well as on setting up best practice. A number of the risk factors are particularly associated with groups who live in areas of greater disadvantage, those who have pre-existing conditions and, as the noble Lord rightly says, sadly, black women, who are three times more likely to die—something that is totally unacceptable in any day and age, but certainly now. We cannot allow this to go on. That is why we have picked up a key recommendation from the Black Maternal Health inquiry for mechanisms for surveillance of severe maternal morbidity. The first data are expected in the summer.
My Lords, a confidential inquiry into maternal deaths is a good indicator of the quality of maternity services. The fact that the rate has gone up from 9 per 100,000 in my time to 12.8 now suggests that there is a failure of maternity services. To use an example, 155 women who had a history of psychiatric problems—mental health problems—died within a year of delivering a baby. That compares to the total number of 611 maternal deaths. It is a significant number, and yet the specialist perinatal maternity health services that are supposed to look after women with a mental health history have failed. It should be a duty on ICBs to produce a plan, so that women with a mental health history are looked after and have a care plan during pregnancy.
This is absolutely crucial. I welcome that, as of June last year, maternal mental health services are available in all parts of England. We also now have 153 operational mother and baby unit beds providing in-patient care to women experiencing severe mental health difficulties during and before pregnancy. In addition, mental health services are available for women who have pre-existing mental health needs, as well as for those who experience challenges because of their pregnancy or labour. The GP check-up six to eight weeks after birth is absolutely crucial.
My Lords, something is happening. In the last decade or so, I have been watching the extraordinary increase in the number of healthy young mothers having C-sections. Why is this phenomenon—if I might call it that, though that is probably the wrong word to use—happening? Is this something that is part of the inquiry? Are people trying to understand whether it is because those in the midwifery world are afraid that natural births lead to more deaths?
This may be something that my noble friend Lady Amos looks at. She is very much focused on maternity services, which will include mortality and looking at the range of options. The noble Baroness will understand that there is an important balance to be struck between the voice and choice of patients, which we respect, and safety, which must be paramount.
(3 weeks, 1 day ago)
Lords ChamberMy Lords, I am delighted to pledge the Government’s full support for this Bill. It is very much aligned with our commitments, it strengthens the research ecosystem and, most importantly—I agree with many comments today—it gives hope to patients and families affected by rare cancers. I am glad that the Bill has the support of the noble Lords, Lord Kamall and Lord Palmer, on behalf of their Benches.
I am most grateful to noble Lords for their points and proposals today. I will be reflecting on them after this debate with the Minister in this area, Ashley Dalton MP, and also Zubir Ahmed MP. I was very touched that so many Peers shared their personal experiences, whether their own or those of their loved ones. I feel that the Bill stands in tribute to the memory of so many, including the late Baronesses, Lady McDonagh and Lady Jowell. It also stands in tribute to the memory of so many who I believe have been brought into the Chamber today by the very touching words and reflections of so many noble Lords. I realise how difficult that is.
I congratulate my noble friend Lady Elliott on her tenacity and clarity in bringing forward this important Bill before the House. I associate myself with the thanks to the many campaigners and charities who have worked on this for so many years, and I know they will continue to do so. My noble friend Lady Morgan made that point particularly clearly. I say to the House, and particularly to the noble Lord, Lord Kamall, that the Government are quite clear that no patient should be left behind simply because their cancer is less common.
The national cancer plan is soon to be published— I heard what the noble Lord, Lord Polak, hopes will be in there, and he will not have to wait too long for it—and it will build on the progress of this Bill. They work very well together, because they both seek to improve outcomes for cancer patients across the country, including those with rare cancers. It is by fighting cancer on all fronts—prevention, diagnosis, treatment and research—that we will make that change.
Much has been said today, and rightly so, about a number of cancers, but I want to say a particular word on how little is currently known about the prevention, diagnosis and management of brain tumours. They remain one of the hardest cancers to treat, and we also know how crucial early diagnosis is for improving survival rates for all cancers, including brain tumours. That is why we have committed to an additional £6 billion capital investment on new diagnostic, elective and urgent care capacity. The noble Lord, Lord Patel, called for genome sequencing for brain tumours. I can say to him that the national cancer plan will include detail on how we ensure that patients have access to the latest treatments and technology, including genetic treatments.
Important points were raised by the noble Baroness, Lady Grey-Thompson, and the noble Lord, Lord O’Shaughnessy, among others, about how the £40 million commitment to NIHR funding for brain tumour research will be met. That commitment absolutely remains in place, but there is no upper limit to our funding of high-quality brain tumour research and we are committed to exceeding the £40 million target. I should also add that there is no limit to our funding of high-quality childhood cancer research.
Clinical research, rightly, is at the core of this Bill. It is one of the most powerful tools that we have. I believe that the Bill will complement the ambitions in our 10-year health plan and the forthcoming national cancer plan to embed that research across the NHS and give patients greater control. It will make it much easier for researchers to connect with patients with rare cancers and streamline the recruitment for clinical trials and will ensure our regulatory framework delivers for those who need it most.
The noble Lord, Lord O’Shaughnessy, and the noble Baronesses, Lady Finlay and Lady Browning, raised the database. The database is live across the UK; it is a UK-wide registry. I urge everyone to sign up to be part of research in order to connect with trials. The noble Baroness, Lady Browning, also asked about strengthening the orphan drug regulations. We must ensure that there is a detailed review before any decisions are made on the regulations.
I say to the noble Lord, Lord Polak, that we will ensure that we do all we can to improve how we use data for research and raise public awareness of consent. I certainly fully support the digitisation of advance consent, which he referred to.
It is key that we incentivise research and continue to support and develop cutting-edge research for rare cancers and other rare diseases through the NIHR. For example, in December, we launched a pioneering new brain tumour research consortium to accelerate research into new treatments through the NIHR, which is investing an initial £13.7 million, with significant further funding expected to be announced shortly. We are also ensuring the effective co-ordination of research from other funders and charities through the Office for Strategic Coordination of Health Research, which is chaired by the noble Lord, Lord Kakkar.
We published Transforming the UK clinical research system: August 2025 update outlining how we fully delivered against all the recommendations in the review conducted by the noble Lord, Lord O’Shaughnessy, who I thank for his work on commercial clinical trials. We will go still further to deliver on our 10-year health plan and cut clinical trial set-up times to under 150 days by March—a target driven by the Prime Minister. We are taking forward the most significant reform of clinical trials regulations in more than 20 years. We need a more efficient and adaptable regulatory framework, and that is what we will deliver.
Concerns were raised about timings of implementation and market authorisation of clinical trials. The timeframe in the Bill is a legal boundary, and we certainly expect to publish the report rather sooner. The noble Lord, Lord Mott, asked about the UK’s ranking for approving orphan drugs. The lessons learned from the review of the regulations will inform how we best approach the regulation of UK orphan medicines.
On the abolition of NHSE, work is under way on primary legislation. That will enable its functions, powers and responsibilities to transfer formally to the department. That will include responsibility for this Bill. I heard loud and clear from a number of noble Lords the wish to see a speciality lead for rare cancers in post and getting to work as soon as possible. I certainly agree on their importance. I heard what the noble Lord, Lord Blencathra, said, but this is the way we will go forward. We will ensure that that appointment is made as soon as possible.
As I said at the outset, many useful points have been made. They will be part of our consideration, but the main thing I want to say is how glad we are to fully support this Bill and how we will do all we can to help progress it. It reflects ambition and our support for the goal for the UK to be the global leader in clinical research, which noble Lords called for. This is about patients, particularly those facing rare cancers. They deserve and need greater choice, speed and opportunity to participate in vital studies. Every breakthrough is key because it means that we can maximise people’s access to the benefits. I thank my noble friend for bringing the Bill forward, all noble Lords who have contributed and all those who continue to champion its cause.
Lord Winston (Lab)
I apologise for keeping the House waiting a moment longer, but I want to ask the noble Baroness something very important. This has been a fantastic debate of a high standard, in the best interests of the House of Lords. There was a great focus on focused research on rare cancers, but does she agree that continued basic research on cell biology, embryology and a whole range of things about cell development, which has contributed so much to cancer research and to rare cancer research, is also important?
As my noble friend said, this has been an extremely valuable, well-informed and moving debate. At present, we are focusing on rare cancers because of the nature of the Bill, but I absolutely take his point about the importance of work outside rare cancers and the overlap with that. I thank him for it.