(3 days, 18 hours ago)
Lords ChamberMy Lords, in speaking for the first time in Committee, I refer to my interests as a professor of politics and international relations at St Mary’s University, Twickenham, where I teach an MBA module on healthcare policy and strategy, and where I also co-operate with the school of medicine, which will start accepting students later this year. I also work as an honorary fellow at the Vinson Centre for the Public Understanding of Economics and Entrepreneurship at the University of Buckingham, which also has a medical school but with which I have no direct connection.
I tabled Amendment 22 to facilitate a wider debate on the level of provision of medical training places and its impact on the outcomes for doctors and, by extension, patients, as well as the need for regular review. We all agree that the NHS and other health providers need highly qualified staff if they are to deliver the quality care that people expect of them, but that means that policymakers should seek to establish an education system that encourages young people to see the benefits of medicine as a career path, supports those going through medical training every step of the way and removes barriers to those who want to be doctors. As my noble friend Lord Howe said earlier, currently, too many young doctors reach the point at which they need to secure a medical specialty training place but find themselves disappointed, either because they are unable to access a training place or because the training place they are able to secure does not meet their needs.
A 2023 study by Tomas Ferreira on the career intentions of medical students found that many medical students finishing their foundation programme do not intend to take up medical specialty training places. The report says
“we report an increase in intention to not take up specialty posts immediately after the Foundation Programme, with an increase from 6.75% … of first-year students to 35.98% … of final year students. A contributing factor to this scenario could be a significant increase in competition ratios for specialty training posts, partly due to increasing medical student places and no corresponding increase in the number of training posts available”.
The lack of specialty training places to retain those medical students within the NHS is a challenge that the Government and we all face—something, I concede, we realised perhaps too late when we were in government. If the issue is not tackled, we will continue to see talented young doctors who might otherwise prefer to stay in the UK and work within the NHS, and maybe other health providers, leaving the UK to complete their training elsewhere.
The Government have announced their offer to the BMA to expand specialty training posts by 4,000, with 1,000 of them brought forward this year. That expansion in training places is welcome and necessary. I ask the Minister to confirm whether there will be any delay in their delivery and whether they will be delivered this year.
In May last year, I tabled a series of Written Questions on resident doctor medical training places, and the responses showed that very small numbers of training places are available in some regions. For example, in 2024, just one medical oncology specialist training stage 3 post was offered in the whole of the north-east region. The figure for the Wessex region was two places. For the earlier specialist training stage 1 posts in gynaecology, the Wessex region had just 11 places in 2024, while the whole of the south-west region had just 16 of those places. Can the Minister say whether those numbers are meeting the needs of those regions and whether there is a gap? What are the key factors that restrict the number of training places that can be offered in those regions?
The overall number of training places is probably the most important challenge young doctors face, but there are other considerations that affect talent retention. The geographical distribution of training places is also something that we all know needs attention. Last month, the Government announced that they will introduce new training places targeted at trusts with the biggest workforce gaps, prioritising rural and coastal areas, where patients currently struggle the most. We welcome that. That is good news. But, in designing this policy, I ask the Minister what assessment the Government have made of the number of medical students who actually want to train in these rural areas and whether that is a factor in some UK medical graduates choosing to go abroad or is irrelevant.
In response to concerns from the BMA about the challenge of doctors having to cover the upfront cost of their training, the Government have offered cost-related measures in their offer to the BMA, including reimbursement of exam fees. I ask the Minister for a little transparency and to give the Committee more detail on how reimbursement would work if the BMA were to accept that offer.
I hope that the Minister is able to answer these questions, either today or later in writing. I assure her that we look forward to working constructively with the Government as they face up to these workforce challenges. I beg to move.
My Lords, to help the Committee to assess the need for this further report that the noble Lord, Lord Kamall, just set out, it would be helpful if we could hear from the Minister when the Government will produce their replacement long-term workforce plan for the 2023 edition, which itself was deemed to be long term but ended up having a half-life of less than two years. How imminent is that and will it deal with the sorts of points that the noble Lord, Lord Kamall, rightly brings to our attention? When will we see the follow-on to the excellent Medical Training Review: Phase 1 Diagnostic Report, authored by the Chief Medical Officer and the previous National Medical Director of NHS England, published in October, which sets out these issues extremely well? The clue is in the title: it is the diagnosis. But when do we get the prescription? When does the treatment begin?
In a sense, the problem that we are dealing with through the Bill—again, as the noble Lord, Lord Kamall, just set out for us—owes its antecedents to the disconnect between the provision of NHS services and the ability to make smart, long-term workforce decisions. Unfortunately, for the period 2012 to 2022, those decisions on medical training were outwith the NHS and in effect were being controlled by the Treasury, which was constantly saying no to Health Ministers who were at the time trying to bring forward constructive solutions. Indeed, it was only when a former Secretary of State for Health became Chancellor that the situation was unblocked and we got the medical school expansion. Perhaps that is an inspiring example for the current Health Secretary—I do not know; perhaps he aspires higher. The fact is that we need that whole-government engagement on these kinds of questions to bring coherence and deal with these problems at root. Therefore, in responding to the noble Lord, Lord Kamall, any light that the Minister can shed on when precisely we will have line of sight to these sorts of questions would be, I think, of great benefit to the Committee.
My Lords, I am grateful to all noble Lords who spoke on this amendment. I recognise the answer that the Minister gave about the impact report that the Government have announced. I will reflect carefully on whether what I intended with this amendment aligns with that impact report. If this is just a problem of synchronisation of when data is available with the report then, if the impact report that the Minister mentions does not provide information, perhaps we could find an amendment. We could look at syncing that data to make sure that it is a meaningful report that meets both our needs. Obviously, I will need to do a careful review, but at this stage I beg leave to withdraw the amendment.
My Lords, in the absence of my noble friend Lady Coffey, who is not in her place, I hope it is acceptable if I move Amendment 26 and speak to Amendment 27. Both amendments seek to bring forward the commencement of the Bill rather than leaving its provisions to be implemented by regulations.
The Government say they need the Bill to pass as soon as possible but then refuse to commit to a date for commencement. Given that there is no date for implementation, noble Lords will rightly ask: what is the hurry with this Bill? There is a fundamental constitutional point here. Emergency legislation should be avoided as far as possible and, where it is necessary, it should be delivered urgently. In this case, we have been asked to fast-track the Bill without there being any apparent urgency to implement it.
The Minister sought to partly address this concern at Second Reading. Could she please explain exactly why the training allocation system will be unable to cope with the changed prioritisation arrangements introduced by the Bill if the BMA continues with its strike action during the coming months? What factors would frustrate the rollout? Would it be systems? Would it be the availability of officials? Would it be the ability of trusts and institutions to engage with the Department of Health and Social Care in a timely way? Or are there other reasons that noble Lords should be aware of? I hope this gives the Minister the opportunity to explain some of those reasons.
While we agree with the principle of giving UK graduates priority, and many noble Lords across the Committee have said this, we should take the time to have a proper debate on whether any other students should also be prioritised and in what order. We should have a debate to consider and debate questions such as: while qualifications may be similar, whether graduates from overseas branches of UK universities really do have similar experience to those who studied in the UK and worked in the NHS, or whether the country in which they studied has a patient profile similar to the UK, and whether in fact any of these distinctions are actually important. Another possible question that we should be looking at is whether historical prioritisation is still valid for today’s world, and whether it is worth while or too much effort to revisit some international agreements.
Instead of this much more considered debate, the Government tell us that they need to get the Bill on the statute book as soon as possible, but they are not forthcoming—perhaps not transparent—when it comes to implementation. Given this lack of clarity, I must say that there is a suspicion that the timing of the Bill and the Government’s rush to get it on to the statute book may appear to be not entirely unconnected with negotiations with the BMA resident doctors.
Whatever our politics and whichever Bench we sit on, legislation should be about making the lives of British people better. Although this Bill has the potential to help British citizens who are graduates of UK medical schools, the lack of transparency on implementation gives the impression that this legislation is more about giving the Secretary of State a negotiating chip in discussions with the BMA. I gently suggest that this is not a good enough reason for rushing such legislation, which is why my noble friend and I tabled these amendments. I look forward to hearing the Minister’s response.
My Lords, I will speak to Amendments 26 and 27 on commencement, proposed by the noble Lord, Lord Kamall. I confess that we are conflicted on these. This brings us back to the tension at the heart of the Bill. We have UK graduates urging immediate implementation to resolve their uncertainty; conversely, we have international medical graduates asking for delay or transition because the rules are changing mid-cycle. If the Government eventually accept the amendments in group 2, providing a fair transitional arrangement for those with NHS experience, then immediate commencement becomes less punitive. However, if they persist with the blunt ILR proxy for 2026 then rushing to commencement simply accelerates an injustice.
I urge the Minister to clarify when precisely the regulations for the 2026 cycle will be laid if this Bill passes and whether they will include the transitional protections we have argued for. I am somewhat pessimistic on that. Certainty is needed, but it must not come at the expense of fairness.
In that context, as we are at the end of Committee, I must ask the Minister to confirm that she is going to meet the cross-party group of those of us who have spoken at Second Reading and in Committee before Report takes place. I have kept my diary free for the Monday before Report and I know that the noble Baroness, Lady Gerada, mentioned that earlier. We would all welcome a face-to-face meeting with the Minister. She talked about us being co-operative, and we all realise the Government’s desire for speed, particularly in the context of the industrial dispute, but, quite frankly, it takes two to tango.
I am grateful for the noble Lord’s advice in his last comment.
I thank noble Lords for their contributions. The noble Lord, Lord Kamall, spoke about what I am going to call the tension between emergency legislation and the commencement clause. I will start on that point. I hope he is aware that our intent is, of course, to commence the Bill as soon as we possibly can, subject to its passage through Parliament. That is why I am so grateful to noble Lords and to Parliament more broadly—both Houses—that they have agreed to expedite the progress of this Bill.
I will come back on to this later in a bit more detail but, as I have already stated, there is a genuine question about operational feasibility, if strikes are ongoing, due to the strain that they put on the system. I am sure everybody in your Lordships’ Chamber would understand that. I will now refer to the amendments, and I have some other points to answer some of the questions that were raised.
Amendment 26, tabled by the noble Baroness, Lady Coffey, and spoken to by the noble Lord, Lord Kamall, and Amendment 23, tabled by the noble Lord, Lord Mohammed, and spoken to by the noble Lord, Lord Clement-Jones, relate to the date upon which the Act comes into force. Both would remove the provision that allows the Secretary of State to appoint the commencement date.
We cannot accept these amendments, as they remove an important element—and I emphasise this point—of operational flexibility, should it be needed. The commencement provision within the Bill is not a mechanism for delay. It is, we believe, a necessary safeguard to ensure that systems planning and operational capacity are in place before the Act is brought into force. Noble Lords will also appreciate that it is a material question, as referred to by the noble Lord, Lord Kamall, about how possible it is to proceed if industrial action continues, given the strain that strikes put on the system.
It is our intention to commence the Bill as soon as we are able, but it is essential that the Secretary of State is able to take all the circumstances, including operational readiness, into account when deciding when the Act should come into force. I think that it is honest to say this. Amendment 26 also seeks to require the Act to come into force one month after it is passed. Specialty training offers must be made from March. Delaying commencement by even one month would leave insufficient time to implement prioritisation for this year’s application round. In short, fixing a commencement date one month after Royal Assent, as Amendment 26 suggests, would create a situation where the Bill comes into force too late to tackle the bottleneck problem that we seek to resolve—the one that it is designed to remedy for the 2026 year—while also removing our ability to commence the Act only when systems are ready to deliver it effectively.
On the comments about industrial action made by the noble Lord, Lord Kamall, I reconfirm that the Government have been in intensive and constructive discussions with the BMA resident doctors committee since the start of the new year. The aim is to try to bring an end to the damaging cycle of strikes, and to avoid what is undoubtedly further, unnecessary disruption for patients and NHS staff. We continue to hope that those talks result in an agreement that works for everyone, so that there will be no more strike action by resident doctors in 2026.
With regard to the noble Lord’s request for more detail on operational readiness, I know he understands that introducing reforms to such a large-scale recruitment process is a big undertaking. We do not want the risk of creating errors that could lead to further uncertainty for organisations, for educators and, most importantly, for our trainees. An effective commencement demands clear processes for delivery across the health system. The reality is that industrial action will put this at risk because it is a diversion of resources, as it always is.
The noble Lord, Lord Clement-Jones, asked about further engagement. I have already had engagement with a number of noble Lords, including both Front Benches. If it is possible to do so before Report, I will write again. Time is extremely short, so while I am always glad to do so, if the noble Lord will allow me to look at that in a practical sense, I will be pleased to. With that, I hope that the noble Lord will withdraw the amendment.
I thank the noble Baroness for that considered response to the discussions. I thank all noble Lords who have spoken, not only to this group of amendments, but today. I also thank the staff for being here to look after us while we stay to this hour.
I should perhaps clarify for the noble Lord, Lord Clement-Jones, that when I laid the amendment it was with the amendment from my noble friend Lord Howe in mind. If we can address some of the perceived injustices or unfairness in the system, we should implement as soon as possible. I was not seeking to create a tension there.
I am grateful to the Minister for explaining that there are operational issues. I think that it would help the Government, and help this Bill to go forward, if the Minister were able to explain in a letter to noble Lords some of those operational issues, because sometimes it may be that we think that it is quite easy. I know, having been in government, that there are a number of issues. I can see that the Minister is looking forward to spending her Recess formulating that letter with her officials. The noble Lord, Lord Mohammed, talked earlier about a holiday, but I do not think that Ministers ever get a holiday. I am giving the Minister a challenge during the Recess to explain some of the operational challenges that lead to the Government not being able to accept this amendment to implement the Bill as soon as possible.
With that, I thank the Minister for her response. I thank all noble Lords who have spoken today and I beg leave to withdraw the amendment.
(5 days, 18 hours ago)
Lords ChamberMy recollection from debating that point previously is that we are looking at the evidence and the best way to tackle the issue that the noble Baroness raises: in other words, what best supports children to have that healthy and best start in life? We are looking at this in the round and I am sure that we will return to it, but I will also be pleased to follow up in writing to the noble Baroness.
My Lords, many noble Lords would support the objectives of the Better Start longitudinal programme, with its focus on improving children’s diet and nutrition, social and emotional development, and speech, language and communication skills. But can the Minister explain how, rather than with a top-down, Whitehall or Westminster-knows-best attitude, it is working with local civil society organisations, such as BRITE Box, which works with families and local communities to help them learn how to cook healthier meals on a budget to improve their nutrition and well-being?
This will not be a top-down approach. We are ensuring that Best Start Family Hubs and Healthy Babies are in every local authority area. That is a major development, because from April it will reach more than 500,000 more children. It will also help us transition to neighbourhood health services. However, all of this will, as ever, be more successful by working together with other groups, including third-sector organisations such as BRITE Box.
(5 days, 18 hours ago)
Lords ChamberI can certainly confirm that to my noble friend. The new Best Start in Life hubs will take the best from previous programmes, including Sure Start. We are providing information through an online service that has had 4.5 million hits so far, and we are working closely with the Department for Education on that. But yes, we will be taking the best of Sure Start.
My Lords, when a Government restrict the sale of products to some but not all customers for whatever reason, it is essential to pre-empt the effects on businesses that will be at the sharp end of enforcing this ban, especially corner shops and small retailers. What engagement have the Government had with small retailers, especially small corner shops, some of which do not always feel represented by the Association of Convenience Stores, to understand their concerns over violence or abuse when they ask for ID from customers who may appear to be underage?
As we discussed on the Tobacco and Vapes Bill in this Chamber, the whole issue of age verification is crucial. I feel that businesses are used to seeking age verification. What matters is that they feel empowered to ask for it and that staff are trained. That is why we are indeed working with businesses in the way the noble Lord says. Many of them responded to the consultation and we are very pleased to have their voice in that.
(2 weeks, 3 days ago)
Lords ChamberI 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.
(2 weeks, 4 days ago)
Grand CommitteeMy 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 completely understand if the Minister cannot answer this now, so maybe she could write, but can she explain why the Government have committed to the full impact assessment then, rather than now?
(3 weeks, 5 days ago)
Lords ChamberMidwives 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.
(4 weeks, 2 days ago)
Lords ChamberMy Lords, I tabled Amendments 56 and 57. Amendment 57 is to do with
“acting for the primary purpose of avoiding physical pain”,
while Amendment 56 is about someone
“acting for their own sake rather than for the benefit of others”.
The two amendments are distinct, although they are linked somewhat because, to some extent, the issue of physical pain—or avoiding it—is a clear-cut way of limiting the scope. I accept that my noble friend Lord Markham does not think that the scope should be limited in this way; indeed, many others may well think the same. I also bear in mind what the noble Baroness, Lady Royall, said about the fact that people are dying anyway. However, this is about a new way of accelerating death rather than the situation that we have at the moment, including, for example, “Do not resuscitate”; as I say, I am relieved that we no longer have the Liverpool care pathway.
Without revisiting the entire palliative care debate, one thing I was struck by in the words of noble Lord, Lord Stevens of Birmingham, is that element of choice—that is, whether this is a real choice and can be considered objectively, in terms of the primary purpose being avoidance of pain. If palliative care were widely available—I know that there are people who feel that palliative care may still not be enough—Amendment 57 would still allow for that.
Where the second element comes in—I appreciate that noble Lords may feel, “We’re back here again talking about coercion”—is in relation to motivation. I was struck somewhat by what the noble Baroness, Lady Whitaker, said, which was almost, “I don’t want to be a burden—my children know this—so let’s just get on with it”. However, this issue keeps coming back, I am afraid.
I thank the noble Lords who signed my amendments; one of them, the noble and right reverend Lord, Lord Harries of Pentregarth, has left because we have gone past 3 pm. I was motivated to table them by the debate in the name of the noble and learned Lord, Lord Falconer of Thoroton, in this Chamber on 7 November 2014, with the same Peer, going back to this understanding of what “voluntary” is. Back then, the noble and learned Lord referred to the aspect of people not wanting to be a burden. I intend to quote him, if that is okay; I appreciate that he may not have the Hansard to hand. Another Peer asked the noble and learned Lord, “How do you know?” The key thing is that, although that Bill was admittedly about a judge-led process, it was also about conducting
“in-depth discussions with the patient and the other doctors”
where the voluntary bit had to be voluntary, with
“he or she … not being forced into it either by coercion or by the sort of guilt that we referred to earlier”.—[Official Report, 7/11/14; cols. 1955-56.]
The “earlier” was that feeling of being a burden. So, my question for the noble and learned Lord, I guess, is: has something changed? Is it just that society has moved on and that autonomy is now more important than our concerns, which are still there, around why people want to accelerate the end of their life even though they know that it may come quite soon?
I am still concerned with making this issue clearer. Most of the stories that have led to the debates and Bills that we have had have been about pain and suffering; that is why, to be candid, I prefer Amendment 57, to avoid the issue highlighted in Amendment 56.
My Lords, this has been another rather long but interesting debate. It is important that noble Lords who wanted to speak had their voices heard. It touches on something we touched on very early. Noble Lords will remember when we debated another version of motivation and talked about coercion. A number of noble Lords put forward amendments to talk about encouragement. In that debate, we saw how difficult it was to distinguish between encouragement and coercion, to say whether encouragement is a form of coercion, and to legally define something such as encouragement.
Now we have the very same issue with motivation. In some ways, as the noble Baroness, Lady Cass, said, motivation is the internal version: it is self-encouragement or self-coercion, not wanting to feel a burden. We have debated what it means to feel like a burden. It is important that we understand the motivation. As the noble Baroness said, professionally, doctors need to do that to understand what help or assistance that patient could be given. It could be, if this Bill passes, that they are allowed or helped to progress to assisted dying, but it could be that they are offered something else that they feel very comfortable with that gives them a bit longer to live and to have that quality time that the noble Baroness, Lady Fox, talked about having with her family. When I was a Health Minister, one of the things that I learned about palliative care from the noble Baroness, Lady Finlay, when I first spoke to her was that people who live longer, even though they may have wanted their life to end “now”, appreciated that extra time with their family, once they entered palliative care, to close those unclosed things, to make up with friends and family they may have fallen out with, and to bring closure to their life before they went. It is important that we recognise that. I do not want to go back into the whole debate about palliative care, but it is important that it is seen as an option to give that closure to people, even if they do not want it and they decide, “I’ve made my mind up”. That is probably a more informed choice.
We need to be very careful about trying to define exactly what the one word that sums up the debate is. If it is about choice and only choice, pretty soon after the Bill reaches the statute book, people will say, “I only have 12 months to live. Why can’t I have the same choice as people who have six months?” Surely it is about not just choice or suffering but a combination of factors. That makes it incredibly difficult for the lawyers, but also for the medical people, to determine. We need to unpick some of that.
Noble Lords who have spoken on this group have picked up a number of issues: people feeling like a burden, mental health disorders, disabilities, and remembering that not all disabilities are visible. On that point, I welcome back the noble Baroness, Lady Campbell of Surbiton—I should know her title because she lives down the road from me; next time she sees me on the high street, she will probably prod me on that. There are also financial considerations, self-motivation and avoiding physical pain. The Bill does not require a specific motive as part of the eligibility criteria. Obviously, the whole Bill is about eligibility—the first few words are about who is eligible to seek assisted death services or terminally ill adult services—but it would be helpful if the noble and learned Lord, Lord Falconer of Thoroton, could expand on the thought process behind his very tight definition of “eligibility”.
I must say to noble Lords who have teased the noble and learned Lord a little bit about things that he may have said in the past that we are all entitled to change our mind when we learn new facts or hear a different view. I do not see it as a weakness in an argument if someone changes their mind when they have heard new facts. I find myself defending the noble and learned Lord, but I do not think we should be too harsh. I should remind people that I am personally very torn on this Bill, and I have not made up my mind. I am waiting to see the outcome of this debate before I make up my own mind about how I vote on this.
We also heard about dignity. I teach at a Catholic university, and dignity is a very important concept in Catholic social teaching. But what is dignity? It can be subjective. One person could be told that they have to wear incontinence pads for the rest of their life, and someone else could be told, “I’m sorry, you can’t walk for the rest of your life”, but other people have quite a full life even if they face those challenges or find themselves disabled. It is really difficult to define dignity; in many ways, it is subjective.
I have read many of the papal encyclicals about all this. By the way, I am a Muslim teaching at a Catholic University; in many ways I am the diversity, if you like. It is important that we consider what we really mean by dignity. We all think we know what it means, but we all have a different perspective on what it is.
A point that has come up many times in the debate is that we hear the words “pain” and “suffering”, but they are not in the Bill. We have to ask the noble and learned Lord, the sponsor of the Bill, about the thought process behind why he decided not to put “pain” and “suffering” in the Bill so that we can all understand, given that many noble Lords have asked that question about pain and suffering, why they are not explicitly there.
I ask the Minister this very carefully. A number of times during Committee, we have put questions to the Government but they have constrained themselves as to what they answer. It is important that the Government tell us what the implications would be if the Bill were to pass into law and what that would mean for resources in the department and for decisions that the Department of Health may have to make, as well as what it might mean for other departments of government. That is important. We cannot just say, “I’m going to confine myself to these few clauses”, because this will have implications. Some will say that it may have implications for wider society—a society that allows people to take their lives earlier or encourages death. It changes the sort of society we live in. Many people will welcome that and will say it is a society of choice, while others will say, “No, we don’t want to live in that sort of society”. We have to remember the implications of this Bill.
I ask the Minister to set out the Government’s considered view. I know that the Minister will say that some of these amendments as drafted are not legally sound—we understand all that—but these are probing amendments. This is a Committee stage and the amendments are not meant to be completely technically sound. We need to know, if they were to pass and were to be tidied up by the government lawyers or the officials, what that would mean for the workability of the wider health and care system and not just in respect of these issues that we are debating or the individual clauses in the Bill. We need to have a clear view of how this will change things and of the challenges that any Government will face when a new Bill comes in. That would be helpful.
I will stop there. I have asked a few questions to the noble and learned Lord, Lord Falconer of Thoroton, about the motivations for some of the decisions that he made in drafting the Bill, but also to the Minister speaking on behalf of the Government to answer the very real implications for resources, et cetera, not only in the Department of Health and Social Care but more widely across government.
My Lords, I, too, welcome back to the Chamber and to this House the noble Baroness, Lady Campbell. It is a pleasure to see her back with us and I thank her and other noble Lords for their contributions in this group of amendments.
I once again make it clear that I will keep any detailed comments limited to amendments on which the Government have major legal, technical or operational workability concerns. It is important to remind your Lordships’ House of that. I say to the noble Lord, Lord Kamall, that the Government are doing only what any Government would do, which is to be scrupulously neutral, as your Lordships would expect us to be, and to handle it in that way. If Parliament passes the Bill into law, of course we will ensure its safe and effective implementation, but until that point I am afraid that I will be sticking scrupulously to what the role of any Government would be. I am sure that the noble Lord understands.
Amendment 30, tabled by the noble Baroness, Lady Foster, was spoken to by the noble Lord, Lord Weir, and Amendment 30ZA, in the name of the noble Baroness, Lady Lawlor, seek to prevent a terminally ill person in England or Wales from being eligible for an assisted death if they are motivated by certain specified factors. These amendments would introduce uncertainty around definitions and concepts, such as what constitutes “adequate housing”. They would also create an internal inconsistency in the Bill, as they are not reflected in later provisions that set out the assessment process. Drafting difficulties and internal inconsistencies are likely to result in confusion on eligibility, and significant further consequential amendments and policy development would be needed to produce predictable legal effects.
The Government also have some further practical operational concerns, which I will note for the Committee’s consideration. The amendment’s exclusion of those
“substantially motivated by… a disability”,
while excluding terminal illness from “disability”, would be potentially complex to operationalise. It may also be that somebody has multiple motivations. It is unclear how these could be separated or who would be able to make a final judgement.
My Lords, I have been very clear throughout this debate that any noble Lord who wants to speak and participate should be allowed to do so.
As I said earlier, it is absolutely fine to break mid-group on these amendments.
While that is absolutely a legitimate thing to discuss, and I would always defer to doctors on that, it makes no difference to this part of the argument of whether we call it dying. The noble Lord may well want to raise the question of whether we can ever be sure that someone is dying, although I have to say that I cannot be the only one who has been with someone where it is jolly clear that they are not going to live till the end of the week. There are times when you absolutely know that someone is going to die. While he may well be right that there are other cases, that is not the issue of this word. This word in the Bill is to give to the public the understanding that we are talking about whether there is a way of helping either the final timing or the way of those final days. We are not talking about someone who just decides to commit suicide for some other reason; we are talking about people who are dying from some sort of terminal illness.
My Lords, I remind the Committee that I am one of those who are still balancing the arguments on the overall Bill, and where I get put off some arguments is when people heckle those who are trying to make a point. I do not think it helps their cause. On the other side of the argument—I am trying not to sound as if I spend my life sitting on the fence—those who speak much longer than they need to in making a point also make it difficult to support some of the points that are being made. On future Committee days, I would like to see a bit more mutual respect between the different sides of the debate, with shorter points made but also less heckling of those who want to make a point. It is important, if we are going to say that we are doing our job in scrutinising the Bill, that everyone who wants to make a valid point, relevant to the amendments, is allowed to make it.
I thank my noble friend Lord Frost for tabling the amendments in this group. I recall that at Second Reading my noble friend Lord Moylan spoke about the importance of language. Language is important, especially clarity of language, so I understand my noble friend’s intentions in tabling these amendments. One could argue that there is a distinction to be made between the terms “assisted dying” and “assisted suicide”. “Assisted dying” on its own, before you even consider the Bill, does not necessarily mean consent on the part of the person whose life is being ended. The Bill introduces that element of consent, but “assisted dying” on its own does not mean consent, whereas it could be argued that the term “assisted suicide” conveys some form of intent—that it is a person seeking to end their own life, they want to do so and are not being assisted to die, regardless of whether or not they want to die. That may seem to be a philosophical point, but it is important that there is a distinction between assisted dying and assisted suicide. As the Official Opposition, we have no collective view, but it is a legitimate challenge by my noble friend to the language of the Bill, seeking clarity or, as the noble Baroness, Lady Fox, said, transparency.
Noble Lords have argued that people in this country should be able to access the services that people can access from Dignitas in Switzerland. However, Dignitas is described as offering physician-assisted suicide. Looking at the Dignitas website—not because I have lost the will to live after trying to get through a day of debates, but to look at the language—I see that it uses the phrase:
“Legal assistance for suicide with DIGNITAS”.
So we have to ask ourselves: if we are trying to be consistent with Dignitas, why is it okay for Dignitas to use the language of “suicide” but, when people want that same service in this country, we cannot use that language?
That is exactly because it will take people who are not dying. This is not what this Bill does.
That is a fair point to be made. It is why the question was asked, and I thank the noble Baroness for answering it.
I thank my noble friend Lord Frost for provoking this debate, because there are still other arguments for using the phrase “assisted suicide”, particularly in terms of clarity. I look forward to the consideration of the arguments made by my noble friend Lord Frost from the noble and learned Lord, Lord Falconer, and the Minister.
My Lords, I will be very brief. The amendments tabled by the noble Lord, Lord Frost, do not present significant workability concerns. As noble Lords will be aware, the amendments have not had technical drafting support from officials. Therefore, further revision and corresponding amendments would be needed to provide consistent and coherent terminology throughout the Bill.
(4 weeks, 2 days ago)
Lords ChamberMy Lords, I begin by thanking the noble Baroness, Lady Elliott of Whitburn Bay, for introducing this Bill in such a clear and moving manner. I thank all noble Lords who have spoken in this debate and echo the sentiments that they expressed. It is pretty clear that many of your Lordships from all Benches, if not all who spoke, welcome this Bill—as did Members in the other place.
I also thank Dr Scott Arthur, who introduced the Bill in the other place. If noble Lords have not already done so, I strongly encourage them to read Hansard on the Second Reading debate in the other place from 14 March last year. Just like the debate today, it contained many powerful and personal contributions sharing the devastating impact on patients and their loved ones. I particularly thank those noble Lords who have shared their own experiences, however difficult and emotional it may have been. I could sense a few tears being shed around the House.
I also have a personal story. I lost my mother-in-law and, despite growing up in an era of Les Dawson jokes about mothers-in-law, I loved her very dearly. Sadly, she died from a cancerous brain tumour a few years ago.
The noble Baroness, Lady Elliott, has clearly and persuasively set out the purpose and content of the Bill, but it is important to look at its three important tasks. The first is to place a legal duty on the Secretary of State for Health and Social Care to promote research into rare cancers, driven by a national cancer specialty lead for rare cancers. As was mentioned by two of the experts in this House, the noble Lords, Lord Kakkar and Lord Patel, and by my noble friend Lord Randall, a role—a specialist lead—to drive this forward is really important. An example was given of the effectiveness of specialist leads in other areas.
The second task concerns the importance of improving access to clinical trials, particularly through the use and better sharing of data. From some of the stories that we have heard today, people cannot believe that we are still not sharing some of that data, which should be available.
The third task is the requirement for the Government to conduct a UK-wide review of the regulatory framework for orphan medicine and products used to diagnose, prevent or treat cancers.
These three objectives are sensible and laudable, but how do we deliver them? How do we move from aspiration to implementation? As the excellent briefing from the Library makes clear, we are dealing with a stark reality because rare cancers, despite the name, account for almost half of all cancer diagnoses in the UK each year. My noble friend Lord Blencathra made the point that there are over 200 rare cancers and he referred to how many people they affect, yet they are often harder to diagnose and treat than the most common cancers. There are many reasons for this, a few of which were explained today.
Patient populations are smaller and more dispersed, which makes recruiting sufficient numbers for clinical trials very difficult. That point was made by my noble friend Lord Moylan and the noble Lord, Lord Mendelsohn, and it was addressed in the review by my noble friend Lord O’Shaughnessy. Another reason is that there are fewer commercial incentives to develop new treatments compared to medicines that may be used more widely.
I apologise for not declaring my interests at the beginning: I am a professor of politics and international relations at St Mary’s University in Twickenham, and I am helping to open a new medical school there. I am also teaching a module to MBA students on healthcare policy and strategy. I also have an academic link to the University of Buckingham, although not to the medical school there, but I just want to make sure that I have covered all bases.
As an academic, I was looking at some of the papers around this. A 2024 paper by Danielson, Prime and Larter found that the cancers that are most common in teenagers and young adults are different from the cancers that are common in children and older adults. Their survival rates for the same cancers can differ. This shows how incredibly difficult it is to tackle this issue. Crucially, the Teenage Cancer Trust reports that cancer treatments can be less effective for young people, as there is less research and fewer clinical trials for this age group.
The range of rare cancers—my noble friend Lord Blencathra said that there are more than 200—is vast. There are blood cancers, cancers of the female reproductive organs, head and neck cancers, pancreatic cancers, brain cancers and many more besides. That shows what a complex and challenging problem this is, but it should not be an excuse for inaction. As all noble Lords have said, the call for action is now.
By introducing this Bill, the noble Baroness, Lady Elliott, is shining a light on an issue that too often receives insufficient attention. She is proposing a measured, thoughtful and practical set of steps to make medical progress. Quite often, at the Dispatch Box, whether in government or opposition, we hear about government aspirations rather than firm steps, but this is a very practical proposal to the Government.
In discussing progress, we should acknowledge the extraordinary work of all those campaigners and charities who play their role in different ways, with some funding research, some advocating, and some supporting families and loved ones, as the noble Baroness, Lady Morgan, acknowledged. I thank them for their engagement with the Bill but, more importantly, for their tireless efforts on behalf of those living with cancers.
Although we are supportive of the Bill, it would be helpful to understand the view both of the Government and of the noble Baroness, Lady Elliott, on a few issues. The first issue, raised by a number of noble Lords, is funding. Although the Bill places an important duty on the Secretary of State to promote research into rare cancers, it does not seek to ring-fence or guarantee specific funding. Could the Minister say a little about how the Government envisage this duty being reflected in future funding decisions, and how we ensure that rare cancers do not continue to lose out when resource is allocated? I should declare that we understand the challenge of trying to fund all this research. Of course, it would also be interesting to learn of the view of the noble Baroness, Lady Elliott.
Secondly, on clinical trials, one of the challenges that patients and clinicians frequently raise is simple. As my noble friend Lady Browning said, not all clinicians are aware of all relevant trials, particularly where those trials are highly specialised or geographically distant. Could the Minister share the current thinking of the department on what steps could be taken to improve awareness and signpost rare cancer trials, especially for clinicians and patients in rural or remote areas? Related to that, even where new treatments or trials are available, access is often concentrated in a small number of specialist centres. Could the Minister comment on the thinking in the department on ways to address these disparities in access, so that patients are not disadvantaged simply because of where they live?
Turning to the proposed review of the regulatory framework, could the timeframe be cut to less than three years, and what are the implications of doing that? Looking at the issue of medicinal products, on the three-year timeframe, do the Government or even the noble Baroness, Lady Elliott, have any views on whether the period of three years could be shortened, given the urgency that many noble Lord have raised? Also, would the proposed review include consideration of NICE’s pricing and appraising processes, and will it consider wider societal impact, as we debated last week? Many stakeholders have highlighted the difficulty of balancing affordability with price points while supporting innovation in rare cancers. It would be really helpful to understand those points.
Finally, although the Bill rightly focuses on rare cancers, many of the issues it seeks to address, such as delayed diagnosis, limited research, small patient populations and a need for specialist care, also affect people living with other rare conditions. Could the Minister say a little about how the Government are thinking more broadly about rare diseases, and whether the lessons learned from this Bill might inform wider policy in this area? We also heard about a few other issues thrown in by noble Lords. One is timelines; another is the abolition of NHS England. I know this point was raised in the other place. What is the Government’s thinking on that issue?
The Bill is thoughtful and important, commands broad support across the House, and addresses an area of clear and long-standing need, but it does so in a careful and proportionate way. It reflects the voices and experiences of patients and families who too often feel overlooked, particularly those affected by rarer and less well understood cancers, which we should remember, despite the name, account for 47% of all cancers. This alone is an important and welcome development, and I commend the Bill’s sponsors for that. The questions I pose are not intended to delay; they are intended to be constructive, to understand how the Bill would operate in practice, how ambitions could be turned into reality, and how principles might inform and provoke wider thinking across government. I hope that my questions will be seen as constructive. Once again, I thank the noble Baroness, Lady Elliott, for her leadership on this Bill, and I look forward to working with her and supporting its progress through the remaining stages.
(1 month, 1 week ago)
Grand CommitteeMy Lords, I thank the noble Baroness, Lady Ritchie of Downpatrick, for securing this timely and important debate and for the eloquent way in which she laid out her argument. We saw the value of vaccines during the Covid-19 pandemic. Millions of people rolled up their sleeves, with the impact not just on patients and hospitals but on the wider economy. I thank my noble friend Lord Bethell, who was a Minister during that time, given some of the challenges Ministers faced in making sure that we found the vaccine solution and then were able to roll it out. That rollout was a turning point that allowed restrictions to be lifted and our country to try to get back to normal, but we know that we are still feeling the effects in some places, and some people are still feeling them.
When respiratory illnesses such as flu and Covid strike, people are forced to stay off work and children miss school. I thoroughly recommend the excellent briefing by the House of Lords Library; in fact, I may well use it in my teaching. At this point, I probably should declare my interest. I am a professor of politics and international relations at St Mary’s University in Twickenham, and I will be teaching an MBA module on healthcare policy and strategy this semester. The excellent Library briefing quotes the Office of Health Economics, which estimates that such absences cost employers around £850 per employee annually. As the noble Lord, Lord Rennard, said, that amounts to about £44 billion across the UK.
The Royal College of Paediatrics and Child Health suggests that reducing vaccine-preventable illnesses helps children to stay in school more consistently, improves access to education and supports better educational outcomes overall, as the noble Baroness, Lady Goudie, alluded to. In the Lancet, Professor Philippe Beutels wrote about the “peace of mind” that vaccination can bring, particularly for the clinically vulnerable. Knowing that you or your loved ones are protected matters enormously, yet this assurance is often overlooked in formal evaluations.
But there is a challenge. Taking account of wider societal and economic benefits within the current health technology assessments is not straightforward and is often subjective. We should also be aware of any unintended consequences, whether for healthcare budgets or for the cost of vaccine development. We will have read of the example of Portugal, when the argument was that it increased productivity so the pharmaceutical company said, “In that case, you can pay more for the vaccines given the wider societal impact”.
At the moment, vaccines are assessed in a more focused way. NICE and the Joint Committee on Vaccination and Immunisation largely operate from what is known as a health sector perspective. Health technology assessments focus on the direct impacts on the healthcare system, with wider societal and economic effects considered only in exceptional cases. NICE’s economic evaluations usually look only at the cost to the NHS and care services. While savings within the health system, such as short hospital stays, can be counted, the wider impacts such as productivity or keeping people in work are explicitly left out. The case for capturing some of these wider benefits within health merits careful consideration, as my noble friend Lord Bethell laid out.
While recognising concerns about broadening the criteria and the unintended negative consequences, as in the Portuguese example, there is also a practical challenge. We simply do not have enough good-quality data on the wider social and economic impacts of vaccines. As an academic I know, and others will know, that the quality of data really matters. You can make whatever argument you want if you have data that is too subjective or if it is contested, but neither is that an argument not to contest the data or some of the theories that come out. This is hardly surprising, given that these impacts are not currently captured as part of the health technology assessment and there is no agreed way of measuring these wider effects. Estimating the socioeconomic impact is inherently difficult, particularly for complex areas such as the role that vaccines play in reducing AMR, for example, or even putting a value on unpaid work, such as caring for family members. Once again, the noble Baroness, Lady Goudie, mentioned this.
There are and will be debates over what should be included and how; whether and how different factors should be weighted; and how far across society and the economy we should go. On many of these points, scientific consensus would be difficult. In measuring these effects, there will also be a challenge in ensuring that the data collected is robust and reliable. Achieving data of sufficient quality and certainty is itself a challenge.
The Office of Health Economics pointed out the siloed nature of public sector budgets, as the noble Lord, Lord Rennard, mentioned. This leads to a focus on clinical outcomes and healthcare alone. NICE has asked why, if health technology assessments were expanded to take account of the impacts on other sectors, those other sectors should not also routinely assess the health impacts of their own policies. Without that wider responsibility, there is a risk of the burden all falling on NICE or on the health part of government, when it is actually a wider societal gain. Finally, considering the broader challenge set out by the noble Baroness, Lady Ritchie, we should recall that in 2022 the NICE review judged that expanding this work further
“would be disproportionate to any expected benefits to the quality of NICE decisions”
given the flexibility that already exists to take “relevant wider effects” into account.
It is clear that this debate is important but also on a balanced issue. It raises serious questions about the wider benefits of vaccination, not always considered by current health technology assessments, but also exposes some of the methodological and resource challenges. This should not be an excuse for a lack of action or for not investigating these ideas in more detail.
One crucial point should not be overlooked: the benefits debated today, economic, social and clinical, can be realised only if people actually get vaccinated in the first place. I was concerned, as I am sure the Minister was, to see that by the end of week 50 of 2025, only 36% of pregnant women and only 39% of under-65s in clinical risk groups had received the flu vaccine. Within the NHS, as of late October—I hope that the Minister has more up-to-date figures—fewer than three in 10 nurses working in secondary care had received the flu vaccine. This sends the wrong message to patients but also puts patients’ health, and even lives, at risk. Given the concerns over the flu outbreak this winter, we should consider why these vaccination rates are so low.
I really want to ask the Government about their strategy, so I shall end by asking some quick questions. Can the Minister explain why the vaccination rates are so low? What are the primary reasons? Is it about communications, access or convenience? What assessment has been made of each of these factors? What assessment has the Department of Health and Social Care made of the wider benefits of achieving high vaccination coverage, especially among school-age children? We know that this can be a sensitive topic at times, but has the department considered the broader societal and educational impacts?
Can the Minister also set out whether any work is under way within the department to ensure that the wider assessments we have debated today are carried out more regularly? Has it looked into that in more detail? Given that the NICE 2022 review concluded that the current system already has sufficient flexibility to consider wider impacts on an ad-hoc basis, is the Minister aware of whether such assessments have been used more regularly since then, and does the department judge them to be a helpful and effective part of decision-making? These are really important questions that I think we need answers to, but I close again by thanking the noble Baroness, Lady Ritchie of Downpatrick, and all noble Lords who contributed today. I also thank the Minister in advance for her response.
(1 month, 4 weeks ago)
Lords ChamberMy Lords, I begin by thanking the Government for their sensitive language in handling this delicate issue. I recall the noble Baroness, Lady Cass, telling the House that puberty blockers are currently licensed only for much younger children with precocious puberty or older adults with certain cancers. Trials are therefore needed to determine whether they are safe for adolescents with gender incongruence and to understand the interaction with the different processes of puberty. I understand that children taking part in the trials must have their parents’ consent, but can the Minister clarify two points that are clearly raising concern? First, what is the maximum and minimum age of children taking part in these trials? Secondly, what assurances can the Government definitively give that children taking part in these trials will not experience fertility issues or loss of sexual function or any conditions that are irreversible later in life? I also wish all noble Lords, staff and officials a merry Christmas, happy Hanukkah, happy new year and, as our American cousins say, happy holidays.
My Lords, I am grateful to the noble Lord for acknowledging the sensitive language. This is indeed a sensitive issue. For all the division and divided opinion that I know there is, there is also a determination—including across the House, I am sure—that we get this right. The clinical trial is just part of the PATHWAYS study. With regard to the clinical trial, it is extremely unlikely that anyone under the age of 11 will qualify as a potential participant and it runs up to the 16th birthday, so I hope that that is helpful. Can the noble Lord remind me of his second question?
What assurance can be given so that any health developments under these trials are not irreversible?
I thank the noble Lord. Before participants enter the trial—and it is an extremely high bar, as it should be; there will be at least 226 participants required, but that is not a target and there will be no drive to get up to that number—certainly any possible impacts such as those the noble Lord describes will be fully discussed and mitigations will be explained and made available, particularly in terms of fertility. I absolutely take the point that the noble Lord raises.