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Lords ChamberI beg leave to ask the Question standing in my name on the Order Paper and declare my interest as chief executive of Cerebral Palsy Scotland.
My Lords, the Government are reducing reliance on international recruitment in adult social care and working to improve domestic recruitment and retention. In England, we are introducing the first fair pay agreement for adult social care, implementing the first universal career structure and providing £12 million this year for staff to complete training and qualifications. These changes will help attract staff to the sector, and provide proper recognition and opportunities for them to build their careers.
I thank the Minister for her Answer and apologise if it feels like Groundhog Day, because I know she answered a very similar Question from the noble Lord, Lord Wood, on Monday. As the Minister well knows, solving the recruitment and retention crisis in this sector is long term, will take cross-party work and has many regional variables. In her Answer, she referred to what the Government are able to do in England, but in Scotland, where at the moment a quarter of rural and island carers come from outside the UK, we have a real issue. One provider said to me, “It’s not just about money. Despite paying above-average wages, we haven’t interviewed a British person for over three and half years”. In many rural and remote areas, agency staff are both unaffordable and unavailable. Will the Minister feed back to her colleagues in the Home Office that any cliff edge or one-size-fits-all approach that fails to take into consideration regional challenges threatens to devastate an already fragile service?
First, I pay tribute to the noble Baroness for her leadership of Cerebral Palsy Scotland. As I know she is aware, adult social care is devolved, which is why I made reference to England only. I am very happy to raise the points the noble Baroness made with the Foreign Office—sorry, with the Home Office.
Well, I will raise them with whoever the noble Baroness likes.
The other point that comes to mind is that we will also be discussing with our colleagues over the border how they can boost the domestic workforce, because it is so important that we do, and that we reduce reliance on international recruitment.
My Lords, my noble friend may have hinted at this already, but one of the ways in which we might encourage retention and attraction to the job of being a care worker is to ensure that they have a nationally registered professional qualification. Is that going to be the case?
There are a number of ways that we are promoting opportunities to develop skills and knowledge, which will improve morale but also the attractiveness of working in adult social care. To that point, I am particularly pleased that apprenticeships are available for young people, so that they may see the benefits of working in the social care service.
The three main areas are an expanded care workforce pathway; the launch of the adult social care learning and development support scheme in September, which will allow funding for eligible care staff to complete courses and qualifications; and the new level 2 adult social care certificate scheme, which has been backed up by some £12 million this financial year. In all of this, we are seeking to professionalise and recruit—as well as retain—valued social care staff.
My Lords, the spending review promised £4 billion for social care, but not until 2028-29, and it is being carved out of the NHS. Until then, there is nothing in the spending review, so all that is going to happen is that social care employers will have bits and bobs of sporadic announcements of limited pots of funding. How on earth can they build a skilled workforce which is adequate and up to the demands that are going to be placed on it?
Perhaps I could assist by clarifying that the spending review, which allows for an increase of over £4 billion of funding available for social care, is by 2028-29; it is not a matter of waiting for that long. That is in comparison with 2025-26. I hope I was helpful to your Lordships’ House in identifying a number of actions we have already taken to professionalise, upskill and allow people to build careers in the social care workforce. That is absolutely crucial. That, aligned with stopping international recruitment in this area—with a period of time for transition of some years—will shift to improve and increase the adult social care workforce in this country.
My Lords, while there are legitimate concerns over the levels of immigration, it is important to recognise the contribution that immigrants have made to our great country, not least to recall that after the war, our public services were saved by immigrants, especially from Commonwealth countries. We should not forget that.
My question is about the NHS and Care Volunteer Responders programme, which was set up during the pandemic and extended to adult social care in 2023. Unfortunately, the Government recently closed the volunteering service without an obvious alternative. While I recognise that volunteering will not make up for workforce shortages, what action are the Government taking to ensure that those who wish to volunteer in the social care sector can make a worthwhile contribution?
While I absolutely agree about the value of volunteering, as we have discussed before, I should make clear that volunteering is not a substitute for employment on the right pay, the right terms and conditions and with the right status. I also absolutely agree with the noble Lord about the contribution that has been made by those from overseas to supporting our care services, and indeed by all care workers.
As we have discussed in this Chamber, the scheme was not simply closed. It was something that was appropriate for when we were in a pandemic but not for now. In fact, we have introduced a whole range of measures which I will be very pleased to remind the noble Lord of, to ensure that we can have more volunteers who are better used and more highly regarded. They are a complement to our workforce, and very valuable they are too.
My Lords, as we have heard, concerns around low pay and insecure contracts are long-standing in the social care sector. The Minister made mention of the fair pay agreement; can she explain how this will ensure that a living wage, living hours and living pensions will be paid to staff among the private social care providers?
As noble Lords will be aware, the Employment Rights Bill establishes a framework for fair pay agreements. That will mean an agreement through which adult social care sector pay, as well as other terms and conditions, will be established through negotiating bodies. The negotiations will be reached by employers, workers’ representatives and others, in partnership. That will provide the opportunity to negotiate this in a responsible manner and help address the recruitment and retention crisis in the sector and support the delivery of high-quality care.
My Lords, I am sure the Minister will agree that we have an enormous challenge to overcome the belief that all you need to do this work is a kind heart. A kind heart is important, but there is a huge range of skills that are necessary over and above that. It is important therefore that we do all that we can to provide the opportunities to develop these skills and work incredibly hard to improve the status of these workers.
I wholeheartedly agree with what the noble Lord said. I find that a kind heart is a good thing in most professions, but we also require more skills in many professions. That is why we have set out and launched a whole range of new measures in skills, training and development—and paying and treating people properly will also hugely raise their status.
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Lords ChamberThat the draft Regulations laid before the House on 3 April and 29 April be approved.
Relevant documents: 23rd and 25th Reports from the Secondary Legislation Scrutiny Committee. Considered in Grand Committee on 17 June.
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Lords ChamberTo ask His Majesty’s Government what steps they are taking to develop and maintain the specialist branch of learning disabilities nursing.
My Lords, we recognise the vital role that learning disability nurses play in supporting those with learning disabilities, and we are committed to developing that workforce. We continue to work with partners to attract people into the profession through various routes, including apprenticeships, and provide a non-repayable grant and additional learning disability nursing payment. Later this year we will publish a refreshed workforce plan to ensure that the NHS has the right people with the right skills in the right places.
I thank the Minister. The Darzi report highlighted that people with learning disabilities have greater health inequalities than the general population and are four times more likely to die from treatable causes. The Mencap campaign Nurses Not Hearses confirmed that services where there are learning disability nurses have fewer such deaths. However, this nursing workforce has reduced by 42%, universities are closing their courses—there is not one left in the south-east—and the profession is at risk of extinction. Will the Minister commit to ensuring that learning disability nursing is embedded in upcoming policies, including the 10-year plan?
I pay tribute to the noble Baroness for her work as a campaigner in this area, particularly through Team Domenica. I know that through my office she will be meeting the Minister for Care next month to discuss all these important issues. It certainly is the case, and is totally unacceptable, that people with a learning disability die earlier on average than the general population. In England alone, we are talking about 1.5 million people with a learning disability, and they have significant health inequalities. Learning disability nursing is one of the four specialist fields of nursing, and those areas will be attended to in the forthcoming workforce plan. That will tie in with the 10-year plan, which is the first plan that will be published and noble Lords will not have to wait too long for it. The commitment to improving care for those with learning disabilities, and, if I might say so, with autism, is absolutely going to be in there; the noble Baroness will recall the discussions that we had, for example, on the Mental Health Act. I hope that this will show the way in which we are going, but I certainly agree with her about how much more there is to do.
My Lords, will the Government undertake to ensure that in their workforce plan the training of undergraduate nurses in all courses, and for undergraduate medics and allied health professions, includes training on managing a situation where people have degrees of impaired mental capacity, and that judgmental views on disability are removed from any aspect of discussion because they are prejudicial to the way that people are handled when they present as emergencies? The problem is that people with learning disabilities can present at any time of the day or night to any of the services.
The noble Baroness is quite right. One of the difficulties is that sometimes there is misdiagnosis, where it is incorrectly assumed, for the very reasons that the noble Baroness gives, that the presenting condition is the learning disability when actually it is a different condition. I agree about the need that the noble Baroness outlines. In reports such as the LeDeR review and Transforming Care, there is a national focus on reducing health inequalities and increasing awareness of this very point about diagnostic overshadowing. I will ensure that that is key to what we are doing.
My Lords, the Minister just referred to the LeDeR report, which points out the persistent avoidable deaths of people with learning disabilities. Yet we now have a seven-month delay for the latest annual report, which shows a lack of urgency. Does the Minister agree that this leads to a genuine perception that the sector’s critical concerns are not being prioritised, and that this in itself hinders promotion of learning disabilities nursing?
It is probably helpful to say to your Lordships’ House that there have been significant changes to how we respond to care for individuals with learning disabilities within the UK. Like in other specialist areas, there is a move towards multidisciplinary teams, which I certainly welcome. I also emphasise the role of learning disability nurses, who are absolutely key, as is the training of all staff. That is why we are so committed to rolling out the Oliver McGowan training, which I know is highly regarded by all staff.
My Lords, we inherited a shortage of nurses and doctors, and it is important that we train and recruit new nurses. But does the Minister agree that, in the meantime, we have some marvellous people from the Philippines who are acting as our nurses and supporting our health service, and that it is important that we do not cut them off while we train our own people?
I agree. We have many excellent staff from countries around the globe who are very committed, professional and hard-working. I presume my noble friend is referring to changes in international recruitment. I can assure him that that is why, certainly in respect of care staff, there is a transition period until 2028 to make sure that we have the recruitment in the right place.
My Lords, the NHS England 2025 best practice guide has a number of suggestions for growing the learning disability nursing workforce, including requiring CQC-registered providers to provide staff with training for learning disabilities and autism. Can the Minister say what the Government are doing to ensure that this is implemented equitably across the integrated care systems?
We are very focused on that, and NHS England is working with all areas of the country and local services to ensure that that is the case. There is a national plan for learning disability nursing that has been developed with key partners and focuses on four priorities: attracting, retaining, developing and celebrating the workforce. It is very important that we elevate the standing of learning disability nurses, to whom we are all grateful.
My Lords, I thank my noble friend Lady Monckton for raising the important issue of a workforce that understands how to deal with those with learning disabilities. Given the importance of this, will the Government consider committing to a targeted health promotion strategy, perhaps in partnership with local community organisations and sections of the private sector, to enable all children with a learning disability to access early promotion, intervention and prevention services to help them develop healthy habits and to improve long-life health outcomes for this vulnerable group?
This is indeed a vulnerable group, as the noble Lord says, and it is probably best that I refer to the upcoming 10-year plan, which will deal with inequalities throughout a number of sectors, including the most vulnerable and including this group.
My Lords, coming back to original Question, in which the noble Baroness, Lady Monckton, alluded to a drop in recruitment of 42% and only one place where such learning disability nurses are trained, is there not a need to expand ways of getting more people to train for learning disabilities without the penalty of fees for three years and for them instead to train as apprentices, where they do not have to incur such fees? Is that not an impediment to the recruitment of more nurses?
Certainly, apprenticeships are important, and that is one of the ways we have expanded the routes into the nursing profession, including learning disability nursing. That means that the apprenticeships we are applying allow opportunities for people from all backgrounds and in underserved areas, which is another important area of ensuring that we remove the barriers to training in clinical roles.
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Grand CommitteeThat the Grand Committee do consider the Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025.
Relevant document: 25th Report from the Secondary Legislation Scrutiny Committee
My Lords, as I know we all acknowledge, community pharmacies play a vital role in our healthcare system by ensuring that patients have access to medicines and acting as an easily accessible “front door” to the NHS. They dispense around 1.1 billion NHS medicines every single year.
Traditionally, all dispensing processes have been done in a single pharmacy or by a dispensing doctor. In hub-and-spoke dispensing, routine tasks such as sourcing, preparing, assembling and labelling medicines are carried out at a central “hub”, which is separate from the “spoke” pharmacy where the prescription is received. Hubs often make use of automated processes to realise economies of scale and to increase efficiencies. Such arrangements already exist in the UK, but the Medicines Act 1968 restricts their use to community pharmacies that are part of the same legal entity. Not all pharmacy businesses are able to invest in their own hub-and-spoke model, as compared with the larger pharmacy chains.
The Government are committed to supporting the community pharmacy sector and to cutting the red tape that frustrates it. The proposed changes have been a long time coming. If approved today, as I hope they will be, they will allow all pharmacies, including small independents, and dispensing doctors to utilise hub-and-spoke arrangements if they choose to do so.
Staff in hub-and-spoke arrangements report a calmer, more focused environment—I think we would all welcome that. In hubs, there are fewer disruptions and the use of automation reduces the risk of dispensing errors. At spokes, staff have more time for complex cases and patient care, making better use of their skills—something that the Government aim to support. The legislative changes we are debating will help all pharmacies and dispensing doctors realise these benefits, instead of limiting them to a few.
Turning to the details of the SI, we propose to amend the Human Medicines Regulations 2012 and the Medicines Act 1968, using the powers in the Medicines and Medical Devices Act 2021. The proposed changes to the Medicines Act 1968 adjust the definitions of “wholesale dealing” and “retail sale”, and remove the legal restrictions that prevent hub-and-spoke dispensing between different legal entities. The amendments go beyond simply removing the barrier that currently limits hub-and-spoke dispensing to pharmacies within the same legal entity. Noble Lords will, I hope, be pleased to know that the amendments include additional elements to ensure the safe and effective implementation of the policy by putting in place provisions to ensure accountability, governance and transparency for patients.
The proposed changes to the Human Medicines Regulations 2012 create a new model of hub-and-spoke dispensing, establishing a framework for the sharing of patient information between the hub and the spoke, and set criteria for the newly permitted arrangements. These criteria are: that both a hub and a spoke must be pharmacies registered with the pharmacy regulator, unless a spoke is a dispensing doctor practice; that there must be written arrangements between any hub and spoke, which must include a comprehensive statement in relation to their responsibilities, to ensure that each party is clear about the processes and activities for which they are responsible; that the medicine label includes only the name and address of the spoke, so that patients know who to ask any questions about their medicines; and that the spoke must conspicuously display a notice on its premises and online in relation to the dispensing arrangements.
The changes also establish an information gateway. This achieves several purposes, such as the conditions for lawful sharing of the relevant patient data between the different legal entities that operate these arrangements.
On the timescale, it is proposed that all legislative amendments come into force in the October this year across the UK. This will allow time for secondary legislation to be amended, as appropriate, across all four nations, and give the pharmacy sector time to explore the relevance and possibilities of the new hub-and-spoke arrangements to its businesses.
I hope that I have been able to set out what we are proposing and the rationale behind it. I look forward to what will, I am sure, be an informed and constructive debate. I beg to move.
My Lords, I broadly support these regulations. I hope that my noble friend the Minister will not mind my intervening briefly to ask a couple of questions; I have no wish to detain the Committee.
Obviously, I understand that community pharmacies have been playing an increasingly expanded clinical role in treating minor illnesses and improving medicines’ safety and optimisation. To improve the efficiency of dispensing, these regulations will help support community pharmacies in taking on a more clinical role. The purpose of these regulations, which is to free up smaller pharmacies and enable them to undertake hub-and-spoke models, is, I am sure, a good one. First, does my noble friend the Minister have any idea of how welcome this will be to smaller pharmacies? Is it expected that a great deal of them will undertake these new arrangements outwith the previous restriction on being in the same legal entity?
Secondly, having recently been to my local pharmacy and having talked to the pharmacists there, I was struck by the strain that they are under, both in terms of their workload and financially. Am I right in thinking that this hub-and-spoke model, which will be made more widely available, will in some way help smaller pharmacies deal financially with the situations that they face? Am I wrong in thinking that there is a financial dimension to this? If there is, I would be very grateful for any reply that the Minister can give, but, in summary, these regulations are a step in the right direction.
My Lords, I thank the Minister for introducing this statutory instrument in her usual succinct way and all noble Lords who spoke in this debate. We on these very efficient Benches—so efficient that we have only one person here today, which is very good for productivity—recognise the Government’s intention to modernise pharmacy through the introduction of hub-and-spoke arrangements and to increase efficiency and free up pharmacies to focus more on patient care, finally getting away from the 1945 model that we have been stuck with where patients try to get an appointment with their GP in the morning and, if they are fortunate enough to see them, get triaged off to a pharmacist or to secondary care. This is much more efficient, and we welcome it.
I also welcome what many other noble Lords have said about more diagnosis and testing occurring at the level of the pharmacy. As we saw, one of the silver linings of Covid was the fact that people got more used to home testing. If we can see more home testing and more pharmacy testing out in the community, maybe we can reach those communities that we have found very hard to reach until now. We thought about this lots when I was in government; all Governments think about how to reach those hard-to-reach communities.
That said, while the aim is understandable and commendable, we have some concerns. First, the Government have chosen to proceed with only one model—the patient-spoke-hub-spoke-patient model—rather than the two models proposed by the previous Conservative Government, the other of which was patient-spoke-hub-patient. We see this as a significant narrowing of options, particularly when the consultation revealed a divided response from stakeholders. As the noble Lord, Lord Scriven, said, while large pharmacies were very much in favour of the model that the Government ended up choosing, many smaller and independent pharmacies remained opposed, as well as patients and providers who may have benefited from the second model, where patients are dispensed to directly.
In the world that we live in, with Amazon, eBay and the advent of direct-to-consumer online pharmacies, which will dispense only if there is a valid prescription—they are not just selling stuff off prescription—it is really important that we encourage that innovation. It would be wonderful for patients, particularly those with limited mobility who find it difficult to get to pharmacies, to be able to order on the NHS app, have it approved and know it will be delivered to them within so many hours or days. That would be a far more efficient model. I hope that we are not inhibiting online pharmacies with all those safeguards.
I completely understand that there is always a balance between innovation and safety and precautions. Can the Government explain why they chose only one model? Was it because of concerns over safety, good lobbying or the interests of larger pharmacists being heard over the smaller pharmacists? We would be very interested in that. We are concerned about limiting it to a single model, particularly when we know that community pharmacies dispensing for GPs and distance sellers are finding innovative solutions.
Secondly, there is funding and support. The updated impact assessment openly admits that there is considerable uncertainty over the cost of establishing these hubs, their operating expenses and the level of uptake. Once again, there is an impact on smaller pharmacies. How do the Government intend to avoid the risk that smaller providers could be left behind or forced out of the market, reducing choice for patients and challenging the role of small community pharmacists? Are they concerned about this? In addressing that, have they looked at any incentives or ways to help smaller pharmacists who may not have the resources for that upfront investment?
Thirdly, the question of oversight and transparency remains. The Minister will be aware that I ask a lot of questions on patient data and accountability of data. The Government are yet to clarify who will be responsible for collecting and publishing data on the implementation and impact of these new arrangements, particularly in light of the abolition of NHS England. This oversight is crucial not only to ensure patient safety and quality of service but to understand the broader impact on costs and service delivery.
Let me be clear: we support the idea of the single patient record and the federated data platform. One of my jobs when I was a Minister was to make sure that we joined up and digitised the data as quickly as possible. We know what efficiencies that could lead to in our healthcare, but patient safety and data protection must be addressed with rigour. The framework for sharing patient information between hubs and spokes is a key feature of this reform, yet the SI and the supporting documents provide limited detail on how patient confidentiality will be maintained and how the risk inherent in multiparty data sharing will be mitigated.
We do not oppose the principle of modernising pharmacy dispensing through the hub-and-spoke model. We were disappointed that one model was chosen, as we thought we could have some innovation with the other model. Without clearer information and incentives to smaller providers, we worry about smaller community pharmacies being pushed out, particularly in the light of having only one model. How will the Government make sure that that risk is avoided? We urge them to engage more fully with all stakeholders, clarify their plans for funding and data governance, remain open to innovation and not close down other options prematurely. With that, I look forward to hearing from the Minister.
My Lords, I thank noble Lords on all sides of the Committee for their helpful contributions to today’s debate. I get a sense of support for where we are going and questions about how it will happen, which I completely accept. This instrument is part of a package of measures to relieve pressure in community pharmacy and improve patient care and the ability of the NHS to serve patients, particularly in a community setting—one of the main pillars of change for our NHS fit for the future. It builds on legislation that is already in place to enable pharmacies to increase efficiency by dispensing medicines in their original packs. Pharmacy technicians are now able to act under patient group directions to supply medicines, and the Government will shortly bring forward legislation to enable them to be authorised to do more in the pharmacy.
My noble friend Lord Stansgate raised a number of issues; he asked how it has been received and raised the financial sustainability and attraction of these measures. I reiterate that the changes being introduced are enabling. They are purely voluntary. It is entirely up to pharmacists, which are independent businesses—it is important to remember that—to decide whether they feel that engaging one, two or several hubs is going to be beneficial to their business model. It is up to them to decide.
I appreciate the response from the Minister. She said that she will keep this under review. As part of that review, are the Government or officials looking at ways in which they could mitigate concerns about model 2 in terms of those relationship and safety concerns? That would perhaps enable investigation of a future model 2.
It would be fair to say that the review will be on how well this is working rather than an attempt to move to model 2. In all the modelling, we believe this is the best way to go. Patient safety is paramount, as it always should be, as is the expansion of services to individuals, but we will keep the whole matter under review.
There were two other questions. The noble Lord, Lord Scriven, asked about the fee structure. The spoke will still receive the fee for dispensing and the paying hub for the services it provides. We are not planning to dictate how the fee structure will work between hubs and spokes, as I said in an earlier answer.
This is an important point. This could create market distortion. If there was a hub with a number of community pharmacies as part of its parent group, is the noble Baroness saying that it could give an advantage to those pharmacies against an independent pharmacy that was not part of the hub group and therefore could charge that pharmacy a higher fee for providing exactly the same service? That could create market distortion. It is important that we understand that that could not happen within these regulations. If the Minister cannot give that answer, I ask her and her officials to go away, think about this carefully and write back. It is an important point.
The whole point of the regulations, as well as cutting red tape, is about levelling the playing field. I understand the point the noble Lord is making, and I re-emphasise that arrangements between hubs and spokes are for them to make, rather than us to set. I am happy to look at the point the noble Lord makes and to write to him further with more detail.
I will pick up on this because it is a concern. In her summing-up speech, the Minister spoke about the business interests of the hub and the spoke. A concern is whether you could have a hub, which will be a large, possibly even multi- national, provider that could create a monopoly. As has been recognised during this debate, in rural areas, in particular, dispensing doctors are often a small group. Pharmacy services have a relatively low turnover but are important to such communities that are a long way from other places and where the services provided by the pharmacist are particularly important. Yet, as a small spoke, they may not have the power to negotiate with a strong central hub that may well be driven by shareholders and profit. There is a little bit of me that would really like this to somehow be a not-for-profit arrangement over the whole of it, but I realise that that is not feasible.
Perhaps it might be helpful to noble Lords if I refer to the Competition and Markets Authority in this regard because it noted that the proposed amendments that we are speaking of today are broadly competitive. It also acknowledged that there could be potential long-term competition risks if the market develops in such a way that pharmacy access to medicines, for example, is through an increasingly limited number of hub suppliers.
As the noble Baroness, Lady Finlay, suggested could happen, we might have only a few larger hubs emerging. I understand the concern that that could affect the availability of medicines for patients and their pricing. However, because of the recommendations from the Competition and Markets Authority, the department has committed to review the impact on competition once the hub market is sufficiently established. We will then assess whether action is needed to alleviate any barriers to the development of what, I believe, we all want to see: a dynamic, competitive hub market.
I am sorry to pursue this, but, in the impact assessment, the Government do not state how many hubs will be created. How can they reassure communities that these regulations will not distort the market? It is a very important issue for community pharmacies, which are dispersed. There is now a genuine concern that the Government do not even know how many hubs will be created—that links to the exact point that the Minister just made on the number of hubs.
It is not possible to predict—although I do not think the noble Lord, Lord Scriven, is asking me to do so—how many pharmacies will take up this arrangement, because it is an enabling piece of legislation, not a requirement. It is also a matter between those businesses. To remind noble Lords, we already have provision in place for suitable pharmacy provision across the country, whether it is rural or urban, and that sits outside the regulations we are talking about today.
The noble Lord, Lord Scriven, asked about the regulation of hubs, and I can assure him that they will be registered pharmacies regulated by the General Pharmaceutical Council in Great Britain or the PSNI in Northern Ireland. The General Pharmaceutical Council has great experience in inspecting hubs and has substantial intelligence on what practical arrangements have been adopted by hub-and-spoke operators that work well. The pharmaceutical council will also ensure that all standards for registered pharmacies are met and—to the point raised by a number of noble Lords, including the noble Lord, Lord Kamall—that patient safety is protected.
To conclude, I emphasise that hub-and-spoke arrangements are not new, as large companies already operate their own hubs. This is probably a discussion for another day, but some people might suggest that that was an example of some market influence, if I can tactfully put it like that. In the meantime, I thank all noble Lords for their contributions, consideration and questions, and I beg to move.
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Grand CommitteeThat the Grand Committee do consider the Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025.
Relevant document: 23rd Report from the Secondary Legislation Scrutiny Committee
My Lords, I am grateful for the opportunity to debate these regulations, which I think can fairly be described as routine. The Medicines and Healthcare products Regulatory Agency charges fees for most of its services and, to ensure continued cost recovery, updates its fees every two years. This regularity provides certainty to customers and enables better financial planning. This statutory instrument helps to achieve this by doing three things.
First, it updates the fees that the MHRA charges in relation to its activities in regulating medical devices and blood components for transfusion. These fees were last updated in April 2023. The implementation date for the proposed changes is July 2025 and they will ensure cost recovery until 2027. This will apply UK-wide, with the fees being the same across the United Kingdom. The total cost to those who pay the MHRA’s fees from this instrument is estimated to be £0.7 million per year after inflation.
Secondly, the instrument introduces a fee for a new, optional service: a regulatory advice meeting for medical devices. In addition to publishing guidance and addressing written inquiries, this new service will further support manufacturers in their understanding of the application of the UK’s regulatory framework to their products. I am glad to say that this service was well received in the consultation. It will be mainly for those developing novel and/or complex products where the application of legislation is not as straightforward or easily understood as it might be. We have had many discussions on removing obstacles to getting products to market which support better care for patients. I hope that this will make a contribution in this regard.
Thirdly, the instrument will introduce a new payment easement for small and medium-sized enterprises for the MHRA’s medical device clinical investigation fees. While this easement will not reduce the overall fee, which would require cross-subsidisation, it will enable the fee to be paid in two instalments, providing flexibility and, I hope, supporting the businesses concerned.
It might be helpful if I highlight the important role that the MHRA plays in safeguarding public health and the importance of the agency continuing to be properly funded to deliver its role. The MHRA is a world-leading regulator of medicines, medical devices and blood components for transfusion in the UK. It plays a vital role in protecting and improving public health. It is, I suggest, an engine for UK growth and innovation; it is certainly an indispensable part of the UK health system and plays a major role globally, working with international partners.
The principles for how the MHRA charges fees are set by HM Treasury in its guidance, Managing Public Money. The basic principle is to set statutory fees to recover full costs. This means that the regulated bear the cost of regulation and that the MHRA does not profit from fees or make a loss that would then have to be subsidised by government departments or the UK taxpayer. It is, of course, standard practice for government bodies that operate on a cost-recovery basis to update their fees. It is also standard practice for other regulators, which is the reason why I described this statutory instrument as “routine”.
All fees are set by taking into account various factors that reflect the cost of the activity—for example, the activities involved in delivering a service, the time taken and the number and grade of staff involved. This process is informed by the recording of staff activity, which is the practice of monitoring and recording certain activities performed by the MHRA’s staff to establish how long they take and, so, how much they cost. In addition, also in line with the HM Treasury guidance, the MHRA includes the costs of necessary corporate overheads and system investments. Regular fee uplifts ensure financial sustainability and enable the MHRA to deliver the responsive, efficient service that its customers rightly expect.
It is worth noting that this instrument does not change the MHRA’s fees in relation to medicines regulations. Given the different legal positions in relation to the powers to make regulations about fees relating to medicines, medical devices and blood components for transfusion, two statutory instruments have been used for the MHRA’s fee uplift. A second instrument for human medicines fees has, therefore, already been laid before the UK Parliament and the Northern Ireland Assembly and has already come into force.
In summary, ensuring that the MHRA is sufficiently resourced will help it to deliver its services more reliably and to provide patients, the public and industry with the service that they expect. I beg to move.
My Lords, I thank the Minister for outlining the purpose of these regulations so eloquently and succinctly. It is clear that the change to the fee structure for regulating medical devices and medical products is part of a realm of profound importance both to public health and to the future of healthcare in the UK. As Liberal Democrats, we unequivocally support a robust, efficient and well-resourced Medicines and Healthcare products Regulatory Agency, but it is important that our regulatory bodies possess the financial stability to ensure the safety, quality and efficacy of medical products and blood safety, which touch the lives of millions throughout the year.
I am not going to speak on these regulations at great length; I just want to tease out a couple of issues about which I would like a little more information from the Minister. First, increasing the fees will mean that costs will be covered automatically. What mechanisms are in place to ensure that efficiency and effectiveness are in place, rather than just ballooning costs that it would be assumed the industry would absorb? I am not clear from reading the impact assessment or the regulations exactly how the Government will ensure that the cost really is the cost and is not excessive cost.
Secondly, it is clear in the impact assessment that most of those who gave feedback to the consultation question were against these fees. How have the Government taken into consideration the reservations, not just of the “no” element but in particular that the fees were seen in some cases to be disproportionately high and to exceed inflation? How has that developed? Why are these costs disproportionately high and why do they exceed inflation?
Finally, it is important to increase the fees to ensure the agency’s work can continue but, critically, the impact assessment demonstrates a lack of concrete detail on how these increased fees will translate into tangible improvements in these MHRA services. Although the rationale for increased fees is often framed around enhancing regulatory efficiency and speed, the document provides insufficient assurances of the measurable commitments as to how the additional revenue will be specifically utilised. There is no clear framework for accountability that demonstrates how these funds will lead to faster approvals or increased safety. How will the department measure such improvements? In particular, what improvements are expected on the back of this fee increase?
These regulations are a serious matter. They impact on the health of our nation and, to some degree, the vibrancy of our life sciences industry, but we must ensure that our regulatory framework is not only robust but forward thinking and truly serves the best interests of every patient in the UK by ensuring that the increased cost will both increase efficiency and, we hope, improve the services that the MHRA provides.
I am most grateful to both noble Lords for their constructive contributions and their support for these measures. I welcome their questions and will do my best to respond to them.
I will first make a few general points that may assist. Noble Lords acknowledged the role of the MHRA, the essential services it offers and the crucial role it plays. It is also understood that it needs financial backing to do that. Therefore, in supporting these regulations, we will enable the MHRA to continue to contribute to the Government’s health mission and to balance its responsibilities to maintain product safety and champion innovation. As the noble Lord, Lord Kamall, said, that is so important to us as a country and an economy, as well as to the National Health Service.
The MHRA is not alone in how it is funded. Most regulators levy charges for their work, and—in response to the question about international comparisons—it is also accepted international practice for healthcare product regulation to follow this trajectory; for example, the European Medicines Agency and the US FDA also charge fees. I certainly feel that the cost recovery approach, which neither noble Lord questioned as a fundamental, ensures that services are paid for by those who use them rather than by the taxpayer—namely, patients.
The noble Lord, Lord Kamall, raised some questions about small and medium-sized enterprises. While I understand that increases in costs can place more relative strain on SMEs compared with larger companies, the MHRA has existing SME payment waivers and easements, and the instrument creates a new SME payment easement for some fees for the medical device clinical investigation service. We have sought to be responsive in this regard.
On supporting innovation and maintaining the UK’s attractiveness as a place to develop and launch medical products, I certainly want to see the UK as the go-to country for that. It does this in several ways— for example, by providing scientific advice and stream- lining regulatory processes to help reduce costs and the time to market. This is a high priority within our Government.
The noble Lord, Lord Scriven, raised questions relating to where costs have exceeded inflation, why this is and what the Government are doing about it. All fees are set to recover costs and it is the case that some services were found to be underrecovering more than others, so this is putting it back in the right place. It is not related directly to inflation but to the real costs and, in some areas, there are concerns about that.
Maybe I was not clear in my questioning. It is not about where it goes but this: if there is an automatic assumption that industry will cover the cost, what mechanisms are in place to make sure that there is efficiency, rather than a bloated approach where people think that, as costs will be recovered, they can do whatever they wish? That was the question, particularly regarding the inflation issue.
That is understood. I am going to come on to that, because I think it is important. Of course, with any uplift in fee, I would expect that to be the case, but I have a particular response as I continue. The uplifts we are speaking about today ensure ongoing, reliable delivery. They are necessary for the continued delivery of initiatives that promote growth and innovation. We are not just standing still; we are looking to the future. To the noble Lord’s point, industry has been clear that it supports these fee uplifts as long as they are accompanied by reliable performance.
Although noble Lords have not specifically raised this, I add that the MHRA recognises that there have been some delays in some of its regulatory services of late and these delays were felt by those who pay fees. I am pleased to say that, from 31 March this year, all backlogs were cleared that relate to its statutory functions. Throughout its work to eliminate these backlogs, the MHRA put patients first and prioritised licence applications according to public health need, including those needed to avoid medicine shortages. Importantly, the MHRA is working to ensure that this continues, so that we have predictable, optimised and sustainable services across all the functions.
I can assure the noble Lord, Lord Scriven, that the MHRA is taking steps to improve its performance and efficiency, not least because it does not wish to get into the situation of a backlog again. This includes a modernised RegulatoryConnect IT system and improved agency structures and processes. On accountability, it will also publish performance targets and report against them online and in its annual report and accounts. There are also mechanisms in place for monitoring the impact of these changes. Ministers, including me, meet the MHRA regularly and the MHRA and the department monitor the impact via stakeholder feedback and ongoing performance and finance reporting. I assure the noble Lord, because I know it is a particular interest, that we have key performance indicators in place to monitor the delivery of these services.
I return to the point about small and medium-sized enterprises that the noble Lord, Lord Kamall, raised. In most cases, SMEs are dependent on grants from the NIHR and others, so there is no cost to them as a company when they submit an application to the MHRA. The noble Lord also asked about the assessment of increased fees on SMEs. Benchmarking fees compared to those of other regulators is somewhat difficult, to be quite honest, because of the difference in the way that the regulators operate and their different funding models. For example, a different model is where the regulator is subsidised, which is not the case here. With regard to employer national insurance contributions, the noble Lord is correct that the MHRA is subject to the increases in employer national insurance contributions. The agency believes that these fees will cover the costs of the increase in NI contributions. If there are any shortfalls, efficiency savings will have to be used to manage them appropriately.
If fees equal cost, I am not clear how calculations have been made that say that the NIC increases have not been put into that cost to be part of the fee increase, because it is a known cost. I am not clear why that suddenly becomes a potential cost reduction or inefficiency gain within the service.
I may not have been as clear as I would like to have been. I will try again. The national insurance contributions increase is an increased cost and that will have been factored into the new fees that are being put forward. The gentle challenge from the noble Lord, Lord Kamall, was about whether the MHRA could manage it. I am saying that if there were any difficulty in management, it would not be a case of putting up the fees further; it would be a case of managing efficiency costs within the MHRA.
Just for clarity, is the NIC cost known and has it been included in these fee increases? It is an important point. I do not want to push the Minister in terms of the actual figures, but I assume that the NIC figure is known and has been included in this fee increase. Therefore, there would be no need for the agency to deal with any difference, because it is a known figure and will be in the fee structure.
Perhaps it would be best on this occasion if I review what the noble Lord has said and what I have said and write to him to clarify anything that is not quite clear.
In conclusion, I thank noble Lords for their contributions and for their support for the MHRA to ensure that it has the resources that it needs to continue delivering reliable services and can deliver its important public health role.
Motion agreed.
(3 days, 9 hours ago)
Lords ChamberTo ask His Majesty’s Government what steps they are taking to remedy skills shortages and workforce gaps in the provision of adult social care.
My Lords, the Government are committed to recognising the adult social care workforce as the professionals they are. In April we expanded the care workforce pathway with four new role categories providing guidance on care workers’ career development. We are continuing the learning and development support scheme, backed up by up to £12 million in funding, and introducing new digital workforce tools. That is in addition to introducing legislation for the first ever fair pay agreement for care workers.
I thank my noble friend for that Answer. I draw the House’s attention to my interests in the register. Social care workers do an extraordinary job, including with my own mother, but there are huge skills shortages in this sector, estimated at over 130,000 at present. Partly as a result of that, the sector is dependent on foreign workers, who make up 20% to 25% of the workforce, yet last month the Government said the recruitment of overseas care workers will end in 2028. That is the year when the report by the noble Baroness, Lady Casey, on the future of social care will be published. What is the Government’s strategy in the interim period now that 2028 is the cut-off date for recruitment from overseas—before the plan for reform of the sector has been published?
It is probably worth me saying that, while the changes announced in the recently published immigration White Paper mean that overseas recruitment for adult social care will end, as my noble friend said, that is because, as he will know, the Government wish to reduce reliance on an overseas workforce. That is why there is a transition period. Until 2028 the visa extensions and in-country switching will be able to continue. The Government are also taking a range of actions to make the sector more available, more highly professionalised, more skilled and better rewarded than we have seen thus far. In all these ways, the transition period is important. The estimate is that the transition period will allow this change to be made, and better support and professionalisation for domestic as well as existing international workers can continue.
My Lords, can the Minister go a bit further on that very helpful reply? Taking into account the range and nature of the personal care that these social care staff provide daily, is it not time that we got on urgently to professionalise the service, to make sure that they all get the proper training and that their status is rewarded with appropriate recompense?
Yes, indeed. I pay tribute to the adult social care workforce who work hard, day in, day out, to provide the standards that the noble Lord refers to for those in our communities who are often the most vulnerable. I could give a range of examples but will refer in particular to the learning and development support scheme, which was launched in September 2024. It provides funding for eligible care staff to complete courses and qualifications, including a new level 2 adult social care certificate, and has been backed by £12 million this financial year. I give that as just one example; I am sure the noble Lord will be welcoming of the other actions that the Government are taking.
My Lords, the spending review announced £4 billion for social care, but that £4 billion will come from the NHS and not until 2028. Can the Minister confirm that there was nothing in the spending review about the two intervening years, in which local authorities are supposed to implement the fair pay award?
Your Lordships’ House will be aware of the financial situation that we inherited and seek to put right. The Government have made available up to £3.7 billion in additional funding for social care authorities in 2025-26, and the noble Baroness is right that just last week the spending review allowed for a further increase of over £4 billion to be made available for adult social care in 2028-29. We are taking a whole range of actions. The Employment Rights Bill, which we will come back to later today, seeks, for the first time ever, to bring in fair pay and professionalisation for those in the adult social care workforce. So it is not that nothing is happening in the meantime. We are making progress and ensuring that the funding will be available so that we have not just a decent adult social care workforce but a way of tackling what no Government have managed to tackle before.
My Lords, given the persistent workforce gaps in adult social care over many years, and given the concerns that there are over immigration—even though immigrants often do the work that local people do not want to do—can the Minister outline what plans the Government have, with a clear structure, to make this a more attractive career, particularly to young people in the UK? What are the Government doing in partnership with social care providers, which are stretched at the moment, to look at alternative ways of funding training and skills development and to make sure that this is an attractive career for those in the UK, rather than always having to rely on immigration?
As the noble Lord rightly outlines, this is a move, over a number of years, to reduce the reliance on international recruitment. I am really glad that just a couple of weeks ago the Department for Education announced the launch of a health and social care foundation apprenticeship, set to begin in August this year. This is focused on young people and will give them a paid route into the sector so that they can earn as well as gain skills and experience. It will be a wonderful foundation for young people, ensuring that they are encouraged into what is an extremely valuable sector and will have the right skills, including technical skills, and the ability to carry out the job. That is just one of the measures but it is an extremely positive initiative, as the noble Lord calls for.
My Lords, given the well-documented regional and social economic disparities in access to adult social care, in what way are the Government, in focusing on the shortages in the workforce, focusing their efforts on tackling this inequality in access?
In general terms, of course, the independent commission into adult social care will be part of our critical first steps towards delivering a national care service. The commission, as the right reverend Prelate is well aware, will be chaired by the noble Baroness, Lady Casey. I agree with the right reverend Prelate that there are particular demands in certain local areas, and the strategy will take account of that, including the fact that, based on the growth of the population aged 65 and above, the sector may need 540,000 extra new posts by 2040. That is a big challenge, but by setting up the professionalisation, the training, the skilling and the fair pay for people, it is one that we will be in a much better place, across the country, to be able to deliver on.
In supporting the noble Lord, Lord Laming, I ask the Minister whether anything can be done officially to raise the status of care workers. Status is often very important for people wondering what sort of job to have.
The noble and learned Baroness is absolutely right about status, which assists retention as well as recruitment. Clearly, the first ever fair pay agreements will make that possible. The need to work with various partners across the sector was raised in an earlier question. The way in which those negotiating bodies will work will absolutely bring together all the partners in the sector to get to the right place. That will certainly include fairer pay, which we will see through the Employment Rights Bill, but also training and skills and the care workforce pathway, the care certificate and having a skills record. These represent a comprehensive package to raise the status in the way that the noble and learned Baroness asks for.
(1 week ago)
Grand CommitteeMy Lords, I associate myself with the congratulations to the noble Lord, Lord Booth, on securing such an important debate. I am very grateful to him for doing that on the back of his personal experience. It shines a light and, while I realise that it is difficult, what he has done is worthwhile. Many of us will be affected by cardiovascular disease, either directly or indirectly, which is why we heard the noble Lord’s message so clearly.
As we have all said, too many lives are cut short by CVD. In 2023, an estimated 6.4 million people were living with cardiovascular conditions and almost a third of CVD-related deaths in England occurred among the under-75s, which gives us the scale of the challenge. Over 1 million people report cardiometabolic conditions as being the main or secondary reason for being out of work due to long-term sickness. This is a challenge on so many levels.
I thank the noble Lords, Lord Kamall and Lord Weir, for understanding that this requires a systematic approach across government, which we seek to have. In seeking to build a health and care system that is fit for the future, we are shifting the focus of our NHS from sickness to prevention. That is supported by the investment and direction of the Chancellor’s spending review of just yesterday. It is also why our health mission sets out an ambition to reduce premature mortality from heart disease and stroke by a quarter within a decade.
It is important to go straight to the points that have been raised. Many noble Lords rightly raised prevention. As they are aware, around 70% of CVD cases are linked to preventable risk factors such as obesity, high blood sugar and smoking, to mention but a few. The noble Lord, Lord Moynihan, talked about the importance of exercise and I certainly share his view on that. I assure him that we work across government on this and I take his point that this is not particular to my department. We work very closely with the DCMS to ensure a joined-up approach.
I remember hearing the noble Lord’s solution some years ago, I think on the Health and Care Bill. We have not committed to it, but the principles behind what he says are absolutely right. For example, we are working on better health resources, which include free evidence-based apps, websites and other digital tools, which will help people make and sustain improvements to their health. To take one example, I know the popularity of Couch to 5K. We will continue this work.
The noble Lord, Lord Rennard, referred to the landmark Tobacco and Vapes Bill that is progressing through your Lordships’ House, which will help deliver our ambition for a smoke-free UK. We need to remember that smoking still claims some 80,000 lives every year. It is a cost not just to individuals and their families and communities but of some £3 billion to the economy, yet this is a preventable cause of death. Noble Lords will have heard in yesterday’s spending review that we are investing at least £80 million per year in tobacco cessation programmes and enforcement to support the Bill.
The noble Lord also referred to obesity. There is a wide range of weight management services, from behavioural support in the community to hospital-based specialist services. This year, we will extend the NHS digital weight management programme to people living with obesity and awaiting knee and hip replacement surgery, which picks up on his point about preparation for treatment where necessary.
The noble Lord, Lord Rennard, expressed disappointment in the Government’s response to the Lords committee report on food and nutrition, which I very much welcomed. I am sorry that he is disappointed, but I have drawn to the attention of his noble friend the noble Baroness, Lady Walmsley, that, just this week, following a recent Question in the Chamber, there was a change in the advice given by the department on the use and appropriateness of prepared baby foods, which she was rightly concerned about.
A number of noble Lords talked about the NHS health check. It supports people to manage their risk through referral to weight management or smoking cessation. It is free and aimed at those aged between 40 and 70. It prevents around 500 heart attacks or strokes a year. It is about identifying early.
I absolutely accept the points made by my noble friend Lady Winterton and the noble Lord, Lord Kamall—I am particularly interested in this matter—about the National Audit Office report and the Health and Social Care Committee’s inquiry on doing more to extend engagement with and take-up of the check. One of the things is a new development that will be piloted from this summer: a new NHS health check online, which people can complete at home. It will be piloted through the improved NHS app and, specifically, we will be independently evaluating the impact on equalities to inform the development and rollout.
We have also engaged community pharmacy by investing heavily in blood pressure checks. Nearly 3 million checks have been delivered in over 9,000 pharmacies in the past year, and we are also embarking on new trials. So we are looking at ways in which we can engage better and, if I may say so, improve the NHS check as well.
The noble Lord, Lord Weir, rightly raised the great potential of AI and technology. I can tell him that a considerable announcement on this was made just this week when I was in Cambridge. We are slashing red tape that currently inhibits innovation while protecting patient safety and encouraging innovation—something for which the industry and many others have been calling for some time. We are also getting the regulatory regime in the right place and investing in research, innovation and being up to date. Some years ago, we could not have dreamed of regulating AI but, now, we are absolutely right to look at how we do that. As the noble Lord said, technology and AI are absolutely key.
I turn to the points on inequalities made by the noble Lords, Lord Weir and Lord Kamall, and my noble friend Lady Winterton. Our approach is called Core20PLUS5 and it is a national approach to support the reduction of healthcare inequalities at both the national and the local system levels. One of the five clinical priorities in that framework is the treatment and management of high blood pressure, which is, of course, a key risk factor for CVD. That is just one of the areas.
Noble Lords, in particular my noble friend Lady Winterton and the noble Lord, Lord Weir, asked whether we would commit to a CVD action plan. We have already set the ambition. We are committed, as noble Lords are aware, to publishing a 10-year health plan in the not-too-distant future and to delivering that shift from sickness to prevention. In all of that, we are considering policies—along with, of course, our workforce plan, which will be published in the summer on the back of the spending review, as well as all that will follow from that. We are carefully considering the policies, including those that have an impact on people with CVD, as we develop the plan.
The noble Lord, Lord Weir, rightly raised that men may be less likely to come forward to seek advice. We are in the consultation phase of developing a men’s health strategy, to which I hope he will contribute, and part of that is about recognising the point that he made. We are determined to close the gender gap in care. We also know that, among people with CVD, women are less likely than men to achieve target cholesterol levels. That has to change, so we will pursue it.
I congratulate the noble Lord, Lord Polak, on his work in this area. I believe he introduced me to Hilary in the House. I heard his request for a meeting, and I will pick that up with the department. While I never like to disappoint him, the position at the moment follows the advice given by the UK National Screening Committee, which concluded that introducing population-level screening for sudden cardiac death in young people would run the risk of causing more harm by misdiagnosing some people and by providing false reassurance to those at risk of sudden cardiac death whose risk may not be picked up by screening tests. However, I am sure we will have the opportunity to pursue this further.
A number of other points were raised, which I will of course review. In closing, I say to the noble Lord, Lord Booth, that I absolutely hear what he said about recognition, diagnosis and issues in aftercare. We will address this through the number of future developments that I referred to and the NHS long-term plan that is already in existence. I hope that he will be less disappointed should he or a loved one have to seek treatment, care or aftercare in the future, and I thank him.
(1 week, 6 days ago)
Lords ChamberMy Lords, I thank my noble friend Lord Moylan again for bringing to our attention the issue of the reliability of statistics on the complications of abortion. It is absolutely right that, in all healthcare, we have correct and accurate data that health service providers can use to understand the safety of procedures.
It is the usual practice for Committee to include discussion of the amendments that have been tabled to the Bill, but here, of course, there is only the proposition that the only substantive clause should not stand part. This, therefore, has necessitated a general discussion of the underlying principles behind the Bill in a restatement on this side of the Chamber of our positions.
At Second Reading, I said that our view was that the Bill performs “an important service” by highlighting
“the absence of accurate, comprehensive statistics in respect of abortions”,—[Official Report, 13/12/24; col. 1990.]
but I explained in the same speech that improved data collection and reporting does not require legislation for it to be delivered. In short, I do not depart from that view, but this Bill has allowed an informed debate to emerge about data in this field. It presents an opportunity to urge the Government to do more to rationalise data recording and collection, so that proper evidence-based medicine can be implemented. In this respect, I endorse what my noble friend Lady Finn said about data collection and statistics more generally.
In answer to a Written Question asked by my noble friend, the director-general of the Office for Statistics Regulation stated that that office—the OSR—had not completed a compliance check on the abortion statistics collected by the Office for Health Improvement and Disparities since as long ago as 2012. That raises important issues of data quality. I am glad to note that it has now been agreed that the OSR will carry out a long-overdue compliance check on those statistics, but only after the Department of Health and Social Care has been able to update the design of the abortion notification system. This seems, to me and to others on this side, the wrong way round. Surely it would make more sense to complete these compliance checks before making alterations to the ANS. That way, the department will be able better to understand any deficiencies in the system—and we know there are some. I hope the Minister will be able to comment on this and address it.
Overall, my noble friend has raised an important concern. I suggest that the Government must now take steps to ensure that the data are gathered on a more reliable and consistent basis.
My Lords, I thank the noble Lord, Lord Moylan, for tabling this Private Member’s Bill and my noble friend Lady Thornton for tabling an amendment. I very much appreciate the contributions made by a number of noble Lords.
The stated main purpose of the Bill is to impose a legal duty on the Secretary of State to
“publish and lay before Parliament an annual report on complications from the termination of pregnancy in England under the Abortion Act 1967”.
The purpose of such an annual report, as I understand it, would be
“to inform policy and safe practice regarding the termination of pregnancy”.
I know that noble Lords appreciate that this Government are entirely committed to the priority of patient safety.
For clarification, is the Minister saying that the digitising and adapting of the abortion notification system that her department plans to carry out will be done in collaboration with the Office for Statistics Regulation? Or is the intention that the department does the work in its own box, so to speak, and then the Office for Statistics Regulation comes in and checks it? She seemed to hint that, for the first time, it might be the former, which would be quite encouraging.
As I said, we are developing work with the OSR. As with all ways of developing work, that means working in a way that will get us to the place we wish to get to. I do not quite recognise the latter way forward that the noble Lord referred to, but I will be happy to write him further on this matter.
I can assure the noble Baroness, Lady Finn, that our focus in the women’s health strategy is on turning those commitments into action. I draw the noble Baroness’s attention to the provision of free of charge emergency hormonal contraception at pharmacies from October this year. We are also setting out how we will eliminate cervical cancer by 2040 through the new cervical cancer plan, we are and taking urgent action to tackle gynaecology waiting lists through the elective reform plan. Those are all tangible improvements to women’s health. I assure the noble Baroness that the women’s health strategy is very much kept under review to see how and where it can be improved.
The noble Baroness, Lady Finn, asked about the linking of records. It is not currently possible to link the abortion notification system with wider health records data, because of the unique identifiers on the abortion notification system data. However, as I said earlier, we are reviewing the wording of the form so that it will be easier for clinicians to complete, which will, I hope, bring about some improvements.
I say to the noble Baroness, Lady Freeman, that the Government are focused on moving the NHS from analogue to digital across all areas of healthcare, in order to provide the improved data collection that many noble Lords have called for during the debate.
The noble Baroness, Lady Bennett, called on the Government seriously to consider the implications of money flowing in from the USA with a view to obtaining influence—a point also referred to by the noble Baronesses, Lady Brinton and Lady Barker. I can confirm that this matter is being considered more widely across government.
As noble Lords may remember, the Government have expressed reservations about the Bill as legislation is not required to produce an annual report. We believe that the aims of the Bill can be achieved through existing routes, thereby rendering further legislation unnecessary. In 2023, the department published a report on abortion complications and could choose to do so again. However, it has no plans to publish ongoing separate additional annual reports on abortion complications as there is no operational need to do so. I hope noble Lords will understand—some have made this point—that we have to uphold a duty of care not to legislate when other reasonable processes are available, as there are in this case.
(1 week, 6 days ago)
Lords ChamberMy Lords, I am sure I speak for all of us when I say that it feels somewhat overwhelming at the end of a debate such as this, not least because noble Lords have been very generous and open about their personal experiences and those of their friends and families, and I am grateful to all noble Lords for being willing to do that. Of course, I join in all the thanks to the noble Lord, Lord Patel, not just for his expert chairing of the committee, which has given us the quality of report that we have got, but for his introduction today. My thanks are also due to all members of the committee; I am sure they are proud of the report.
I heard that this is a report that should not sit on a shelf, and I quite agree. It has shone a light on many of the challenges. As the noble Earl, Lord Effingham, said, no one action on its own will make a difference. Having given evidence to the committee, read the report and overseen the response of the Government, I feel that that the more we look into this, the greater the complexity we find.
We have sought to take each item as best we can. Is there more to do? Completely. Do we start in a difficult place? Yes, we do. So I am grateful for the report. I also associate myself with the thanks that were given to all those who provided evidence. I am sure it will have been an extremely affecting experience to hear from parents and others who have been affected in this way. What the report is about, and what I wish to be about, is protecting the most vulnerable—the babies, the women and their families—and I know that everybody has come from that place today.
I say to the noble Baroness, Lady Wyld, that, as she knows, I welcome the challenge that she and the committee make to the Government, and I will seek to be as helpful as possible today. I know I will not be able to provide every answer, but it is right that the questions are answered. If there are particular areas that I do not get to address, I will of course pick them up afterwards.
I say to the noble Baroness, Lady Brinton, who I know was deeply affected by the words she shared, that she affected us all. I am sure it was hard for her, but the noble Baroness brought into the Room exactly why we are here.
What is the scale of the problem before us? In 2023, the year for which we have the most recent figures, there were almost 4,600 preterm births. That is just over 8% of all births, a very considerable amount. I share the view that rapid improvements are needed to improve not only outcomes but the experience of women and their babies.
We have heard today about the many risks that contribute to preterm birth, which include pre-existing health conditions such as high blood pressure and diabetes, multiple pregnancy, factors such as smoking and obesity, maternal age, and assisted reproductive technology such as IVF. We also know that preterm birth is more prevalent for women from black and Asian groups and for those women living in the most deprived areas, and that situation cannot be allowed to continue.
The impact of being born pre term is significant, as we have heard. Not least, preterm babies are more likely to die in their first 28 days or their first year of life, and in fact the number of child deaths from prematurity rose between 2019 and 2023. We know the scale of the challenge before us. Preterm birth increases the risk of chronic conditions, and babies born pre term require more hospital-based care in infancy and childhood. I was interested to hear put on record by noble Lords, including by my noble friend Lady Goudie, that preterm birth can place significant emotional, financial and logistical stress on families. I welcomed and was glad to support the launch of the Create Health report that shone a light on many of those matters.
This is an important point to make, and it was made to some extent in the debate, but in some cases preterm birth is medically appropriate—this is something I can recall discussing with the committee—because, in that instance, it is safest for mother and baby. One of the difficulties with the target from the previous Government, I felt, was that it did not make that distinction, so it is important that we get any further targets right.
So what actions are under way? My department works with NHS England and across the sector, including with the charities referred to by the noble Earl, Lord Effingham, and I add my thanks to those charities and third-sector organisations. We are working on a range of actions for now and into the future to tackle some of the deeply entrenched issues.
The noble Lord, Lord Patel, and others made positive reference, which I share, to the Saving Babies’ Lives care bundle. This has been co-developed with clinical experts and professional societies, and it draws very much on front-line learning and experience to provide a package of interventions to reduce variations in care, which we know are out there, and to improve neonatal care quality and outcomes. The implementation of the care bundle is one of the conditions required to ensure compliance with safety requirements.
The noble Baroness, Lady Brinton, raised the point that, as of May this year, some 97% of maternity services were fully compliant with the care bundle. That figure has increased by 10% since last year. I assure her that the remaining small percentage is nevertheless significant, and we are following up with them to ensure that they will become fully compliant. The elements of the care bundle address the committee’s recommendation, but we seek to go further.
Noble Lords, including the noble Earl, Lord Effingham, raised the two-year and four-year assessment checks for children who were born pre term. They are extremely important and we are looking at what further actions are needed to ensure that children receive those follow-up assessments, because of their importance.
All 150 maternity and neonatal units in England are taking part in the NHSE perinatal culture and leadership programme. A number of noble Lords, including the noble Lord, Lord Patel, and the noble Baroness, Lady Wyld, were absolutely right to highlight the importance of the maternity and neonatal estate in supporting parents being fully involved in their babies’ care. So I am glad that, just last week, the allocation of some £750 million through the estates safety fund was announced. This is to start tackling—it can only be a first step—the maintenance backlog. The £750 million will support 400 hospitals, mental health units and ambulance sites. I say very specifically that it includes over £100 million for maternity units to enable better care for mothers and their newborns. I know that the noble Baroness, Lady Seccombe, is rightly exercised about this.
I say to the noble Baroness, Lady Wyld, and other noble Lords that I understand the frustration about the time that has been taken for NHS England to publish the findings of the maternity and neonatal estates survey. Noble Lords will not have to wait much longer for that, and I too look forward to seeing it.
A number of interventions rightly centred on the workforce. There are still shortages across the workforce. Overall, the refreshed workforce plan, which will be published in the next few months—in answer to the questions—will seek to transform the services over the next decade to ensure better care for patients.
My noble friend Lady Blackstone asked what is happening to understand obstetrics staffing and managing the workforce more broadly. As I say, that will be covered by the workforce plan. However, it is the responsibility of trusts to ensure that they have the right staff in place.
On the workforce, the noble Baroness, Lady Wyld, asked about professional development, and other noble Lords, including the noble Baroness, Lady Sugg, asked about the inclusion of midwifery. I completely agree that it is crucial that staff have the training they need to make sure that they have the right knowledge to provide the right care. The new workforce plan will follow the 10-year health plan and the spending review. Noble Lords will understand that I cannot pre-empt exactly what it will say, but I can say that it will look at the wide range of issues that face the workforce, and that will of course include midwives. Colleagues across NHSE and the department remain committed to delivering on this in respect of the workforce, and I will be very much focused on having the midwifery service that we need.
On the survey, I understand the concerns that were raised about trainee midwives being very worried about their future employment prospects. This was raised by a number of noble Lords, including the noble Baronesses, Lady Bennett, Lady Penn and Lady Sugg, and my noble friend Lady Blackstone. I can share with your Lordships’ House that there is, in some way, a positive position—this is not a way of glossing over the difficulties—in that there are fewer vacancies currently because of improved retention. In fact, the NHS nursing and midwifery workforce has grown in recent years, so we have branches of nursing and midwifery where the new graduate supply is greater than the number of posts available this year. I appreciate the tension, and I assure noble Lords that NHS England is working with educators, employers and regional teams to support newly qualified nurses and midwives in securing employment. This includes developing resources to support learners through the recruitment process and identifying suitable opportunities and support.
The noble Baroness, Lady Penn, asked about NHS England’s abolition and where responsibility will lie. The specifics are being worked through, but the central team leading the change will ensure that nothing is lost in terms of what we need to do. The service that we are concerned about here—provision—will remain a priority. The abolition of NHSE will remove duplication, and I therefore expect to see improvements in this area.
The noble Baroness, Lady Seccombe, made an important point about nurses training to be midwives. I am grateful that the noble Baroness spoke to me about this separately. I agree that nurses who train to become midwives bring a whole wealth of experience, and NHSE offers funding to support this shift. However, I recognise that we may need to go further in order to support nurses to remain on the relevant courses and to take up posts in maternity units. So the funding offer for this will be reviewed later this year.
The noble Lord, Lord Patel, spoke about the importance of community services and health visiting services. Through our plan for change, we will ensure that children and their families are cared for by the right professional. We will strengthen health visitor services.
The noble Baroness, Lady Bertin, spoke very sensitively about mental health issues, as well as a number of other points. Specialist perinatal mental health services are now available in all 42 integrated care systems, and very important they are indeed.
I agree with noble Lords, including the noble Lords, Lord Weir and Lord Patel, on the importance of a woman’s health before pregnancy. More work is required to improve awareness of pre-conception health and pregnancy, taking into account—this is another key point—that many pregnancies are not planned. That is why the point about early education and support is so crucial. The 10-year plan, which we will see shortly, will set out how we will tackle the inequities that lead to poor health.
Research was raised by my noble friend Lord Winston, the noble Baronesses, Lady Owen and Lady Bertin, and the noble Lord, Lord Weir. Since the committee hearing in September 2024, the NIHR has commissioned three new research awards, including research to investigate the prevention of preterm birth as well as interventions to improve health outcomes for preterm babies. Over the last five financial years, research programmes invested in 77 research awards focusing on preterm birth. Again, across their full duration, that was a total of £93 million of funding—and, yes, I totally agree about the importance of research. I will write to my noble friend Lord Winston, following up on his point urging the Government to use opportunities that the biobank presents.
On the important matter of miscarriage, I share the view that my noble friend Lord Winston and other noble Lords set out. We are taking steps to improve data on miscarriage and fill the very considerable current gaps. There is a new digital standard which will record new information on previous miscarriage and baby loss. I am looking at how effectively that is being applied, and I am also looking forward to the review of the Tommy’s graded model of care in respect of miscarriage, so I very much take the points on board.
A number of further actions are being taken to improve maternity safety, including the maternity outcomes signal system, the maternity safety support programme and the avoiding brain injury in childbirth programme. I am pleased to say that all local areas have published equity and equality action plans, which set out tailored interventions for those from ethnic minority backgrounds and those living in the most deprived areas. This will be another important focus for the 10-year plan. Fourteen maternal medicine networks have been set up across England, made up of 17 specialist medical care centres, and high-quality neonatal care is being networked together across England. We are investing £45 million in increasing neonatal cot capacity and assigning care co-ordinators. We are taking further actions to tackle obesity and smoking—and again, that will be referred to in the 10-year plan.
I say to noble Lords, in closing, that there was much richness in the committee report and in today’s debate, for which I am entirely grateful. I look forward to using what has been written, what has been said and further discussions, so that we can provide the service that we all want to see.
(2 weeks ago)
Lords ChamberTo ask His Majesty’s Government what steps they are taking to support primary and community care settings to integrate in vitro point of care diagnostics.
My Lords, we recognise the value of point-of-care diagnostics in enabling earlier detection, reducing avoidable hospital admissions and supporting more personalised care. As part of our 10-year plan, we will ensure that more tests, including in vitro point-of-care diagnostics, take place in the community, which will be closer to people’s homes. Use of in vitro point-of-care testing is encouraged where clinically appropriate, including in community diagnostic centres, and is supported by the development of 27 pathology networks.
I thank my noble friend the Minister for her very positive reply, but I will take it a little further. Do the Government appreciate the enormous potential benefit of in vitro diagnosis for the National Health Service and patients? On the latter, patients would be able to go to their local pharmacy, away from the queues in their GP surgery or local A&E department, and be diagnosed and treated in a matter of minutes. My second question is: what government funding support will be given to pharmacies having to buy the diagnostic machines or boxes, which cost about £2,000 each, and to support the necessary training for pharmacy staff?
This is a good news story, and I certainly share my noble friend’s view of the benefits that he outlined. Community diagnostic centres are now delivering additional tests and checks in 169 sites across the country. They have delivered almost 4.5 million tests, checks and scans since last July, and we have committed to expanding the number of existing CDCs and their opening times. In England, Pharmacy First clinical pathways have been developed closely with various experts, including pharmacists. The funding for the core community pharmacy contractual framework has been increased to over £3 billion, representing the largest uplift in funding of any part of the NHS. We are grateful for the role that pharmacies play.
My Lords, does the Minister agree that, when we discuss in vitro testing, we should also talk about in vivo testing? That involves taking a history and doing a thorough physical examination of the patient on the spot, but it seems to be going out of fashion. I will illustrate that with the story of a member of staff who had consulted me. He had been investigated at the “St. Elsewhere” hospital for six months, but they had missed the fact that he had ruptured his Achilles tendon. I did an in vivo spot diagnosis. I put my index finger down his Achilles tendon—with his permission, of course—and I could feel the gap in his Achilles tendon where it had ruptured. They had not examined him. Is it not time that we did this inexpensive business of taking a history and doing a thorough physical examination?
I am very glad that the noble Lord asked for permission. I take his point. I know that he understands the value of in vitro point-of-care testing, but he makes the good point that what matters is what is clinically appropriate in the circumstance. We would all expect that to happen for the benefit of the patient.
My Lords, I will follow on from the Minister’s Answer. While being supportive of the general trend, what metrics and measures have the Government put in place to ensure that those tests indeed create positive patient outcomes and healthcare efficiency to help future induction of the tests in the NHS?
We will ensure, through our 10-year health plan, that the additional tests, including in vitro point-of-care diagnostics, are taking place in the community. I look forward to being able to provide more information to the noble Lord.
My Lords, we on these Benches welcome the Government’s stated commitment to innovation in primary care and the commitment to continue the rollout of community diagnostic centres, which were started by the previous Government. However, unfortunately, last year the Patients Association highlighted barriers to the rollout of point-of-care diagnostics, particularly in rural areas. Is the Minister aware of those concerns, and what plans does the department have to tackle those barriers?
Our commitment to moving towards a neighbourhood health service obviously allows for attention to be given to different circumstances, including in rural areas. It will mean that more care can be delivered locally and that problems can be spotted earlier, including any problems with rollout. We will shortly provide details of a national neighbourhood health implementation programme. We liaise with various groups, including the Patients Association, and I am grateful for their input and for flagging up any difficulties, which we absolutely seek to resolve.
My Lords, while I accept that in vitro diagnosis at the point of care has great benefits, it is important to address the challenges that we will need to face. They include quality control and the standardisation of equipment used, as well as making sure that the appropriate people are trained, that assessments are made of the results obtained and that proper, good outcomes are delivered. Who will be in charge of delivering this, at the integrated care board level and the national level, to make sure that it is effective?
The noble Lord is right that it is one thing to provide a service; it is another—and so important—to make sure that it is provided appropriately and accurately. ICBs will have their own arrangements. Within that, NHS England is currently responsible for ensuring that this takes place. We will ensure that there are regular updates. If any noble Lord is aware of particular difficulties, I would be very pleased to hear about them; for example, if there is a problem with quality control.
My Lords, does the Minister agree that even deeper and wider embedding of diagnostics across the NHS, including more in community pharmacists and GP surgeries, would help in the fight against not only antimicrobial resistance but other infectious diseases? In addition, it would stimulate the venture capital business in diagnostics. All these factors together have the potential to boost NHS productivity dramatically, and would therefore help to boost the country’s growth trend.
I certainly agree with the very strong points that the noble Lord has made. This is obviously a health improvement policy for patients and to support the NHS, but it is also about developing growth and the opportunity for new ways of doing things. We welcome and support innovation.
Building on a point made by the noble Lord, Lord Hacking, and others, there are many examples where the ideal place to do a diagnostic test is in a primary care setting. Urinary tract infections are a typical example of that, because you can solve it quickly in that setting, avoiding future hospital visits and much pain and suffering. However, that means taking budgets away from secondary care settings and giving them to primary care GPs, pharmacists, et cetera. Are the Government prepared to do that to see these benefits arise?
We are constantly reviewing how best to support where we need to go. In this case, it is about getting tests done closer to home. The noble Lord is right that, for a number of people, the GP practice is a good place to do that, but not in all cases. What matters is doing what is appropriate. We announced an £889 million uplift for general practice in 2025-26, which is the largest uplift to GP funding since the beginning of the five-year framework in 2019, and we have also agreed a new GP contract. The noble Lord will be aware that we recently announced over £1 million to help the quality of the primary care estate, to ensure that we can provide some 11 million further appointments this year. While I accept that this issue is about configuration, I assure the noble Lord of our support for GPs.