(4 days, 9 hours ago)
Lords ChamberI 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.
(4 days, 9 hours ago)
Grand CommitteeMy 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 am most grateful to the Minister for the comprehensive way in which she introduced this instrument, including how it corresponds with all the documentation that we have. I am glad to see that it applies to Wales; we have many small pharmacies with cross-border flow and many roads going across the border, so this SI will make things much easier.
Like the noble Viscount, Lord Stansgate, I have some questions. I hope that at least some of them will be answered; some of them may need time. One of my concerns is about how the finances of this will work, because pharmacies depend on a dispensing fee. Who will get the fee? Will that be down to local negotiation? Will the fee be split?
However, the principle of freeing up time for the pharmacist to undertake more clinical duties is to be welcomed. They are often the first point of call for patients now. They often know the patient. They spot the person who looks less well and can advise them appropriately. They can also advise on drug side-effects, if a person goes into the pharmacist and asks about new symptoms that they might have.
However, I wondered where the liability sits if there is an error. If I understood right, it would sit with the hub if it were in what is dispensed, but there may be a difference in liability for information given to the patient. One hopes this will never happen, but some of those governance issues need to be thought through in detail.
I note that the pharmacists are already taking impressive extended roles in some areas. For example, there is a scheme in Bristol where pharmacists are taking blood for PSA assessment and reaching a population who would not otherwise present for screening for cancers. If we have pharmacists doing more health screening that would certainly free up GP time. Again, pharmacists will need to be remunerated for that.
I was interested to see that the international evidence is a little variable. Germany, Finland, Belgium and Denmark already using a hub-and-spoke dispensing model but the evidence is not overwhelmingly conclusive. In hospitals, where you have a single large building and a large number of prescriptions, automated pharmacy has in many ways revolutionised the administration of medicines.
One of the concerns is the time lag from a dispensed medicine going from the hub out to the spoke. I hope that will be thought through, so that we do not have patients, perhaps with mobility difficulties, having difficulty getting back to collect their prescription, and that those things will be factored into such arrangements.
Another area that I have a slight concern about relates, not surprisingly, to my own area, palliative care. We know that the availability of controlled drugs is poor at times, yet they are often needed urgently. I hope that consideration has been given as to how the dispensing of controlled drugs in particular can be rapid and efficient, especially when the clinical situation has changed and new medications are required at speed for a patient to be able to remain at home, rather than ending up taking an unnecessary or inappropriate voyage to hospital, with possible admission. Those travel systems also come into it.
The last area that I hope this model will tackle is waste, because there are a lot of things that patients are prescribed but never end up taking. Those of us who have been in a house after someone has died will often have been given several supermarket bags—I will not name the supermarket—full of packs of medicines that have been dispensed. They can be extremely expensive but have not been taken. They cannot be taken back in at the moment and cannot be recycled. The schemes that recycled some of the opioids, such as diamorphine, have not continued over the years. This is an enormous financial waste to the NHS, because some of these medicines have been very expensive.
I hope that this model will free up pharmacists and incentivise them to dissuade patients from accepting prescriptions when they are not actually taking those medicines. I could spend hours relating numerous stories of patients who were either not taking their medicines or giving them to somebody else. I have even once been presented with some children trying to sell me grandmother’s pain relief at the foot of the stairs, which helped me understand why I could not get grandmother’s pain under control. There is a real problem of waste in the system. If this instrument will decrease waste without jeopardising pharmacist’ income from prescribing fees, that would be very welcome.
My Lords, I thank the Minister for outlining the purpose behind and need for these regulations.
On these Liberal Democrat Benches, we are of course open to innovation and efficiency in our healthcare system. We recognise the potential for modernising practices to streamline operations, to reduce burdens and, ultimately, to try to improve the delivery of medicines to patients. However, for something as sensitive and fundamental as dispensing medicines, the devil, as always, lies in the detail—as the noble Viscount, Lord Stansgate, and the noble Baroness, Lady Finlay of Llandaff, pointed out—so we must scrutinise these proposed changes with the utmost care.
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.
(1 month ago)
Lords ChamberMy noble friend makes a very important point and I can certainly give her the assurance she seeks. Over 50,000 additional volunteers are recruited by NHS trusts, which they then support directly in the way my noble friend describes. Their roles are totally unaffected by the change to this programme. There are many thousands of volunteers who support the NHS directly or indirectly via other local and national voluntary sector organisations, and I pay tribute to them all.
My Lords, I declare an interest as president of Attend. Can the Minister explain how, in the new system, the Government will work with an organisation such as Attend, which provides insurance, legal advice, financial services and networking to a whole series of agencies that provide volunteers across the country, to ensure that there are rigorously high standards and that those who volunteer are protected in their role, and that they benefit in addition to providing maximum benefit to the recipients?
The noble Baroness raises an important point. I am sure there are many, like me, who have volunteered, or still volunteer, and gained as much as they gave, although they did not expect to. It is important to have standards, and to protect volunteers and everybody involved. That will be the case. A lot of local action builds relationships with local organisations, which is a very successful way of harnessing the benefits of volunteers and volunteering.
(1 month, 2 weeks ago)
Grand CommitteeMy Lords, this is a short—I hope—but technical SI, so it may be helpful to the Committee if I give some context. The Medicines and Healthcare Products Regulatory Agency regulates medical devices in the UK and helps to ensure that those products are safe and perform as intended. That includes ensuring that the legislation governing them is appropriate and keeps pace with advances in science and technology.
The 2002 regulations transposed relevant EU directives into domestic law and is now therefore considered to be assimilated EU law. The regulations contain references to several specific pieces of assimilated EU law that will form part of the regulatory framework for Great Britain. This is an important step towards delivering the Government’s 10-year health plan, in terms of the development of legislation apart from this SI. We need safe and effective medical technologies to achieve the shifts that will help build an NHS fit for the future, to take us from hospital to community-based care, from analogue to digital solutions and from treatment to prevention.
As we know, since the 2002 regulations were introduced, technology has advanced significantly. The MHRA has therefore set out plans to make a number of updates to the regulations—separate to the SI we are debating today, of course—to further improve patient safety and access to medical devices, as well as to keep the UK as an attractive market for medtech innovators. I assure noble Lords that, as part of this, there continues to be considerable engagement with the sector, not least because life sciences manufacturing is vital to the UK’s economic growth. In 2021-22, there were almost 119,000 people employed at life sciences manufacturing sites across the country. We will support the sector to flourish, in line with our growth agenda.
The MHRA is taking a phased approach to the implementation of the future medical devices regulatory framework in order to support system readiness and to minimise the risk of supply disruption for UK patients. A key piece of secondary legislation was made in 2024 to ensure that there is appropriate oversight of a device once it is in use. The further secondary legislation, to which I have referred, is expected to come into force in 2026. That legislation will update the regulatory requirements for devices before they are put on the market and will introduce key measures such as implant cards, unique device identifiers and an international reliance scheme for medical devices; in other words, it will take us forward to the place where we need to be.
In the meantime, the statutory instrument that we are here to debate will help provide continuity for the regulation of medical devices until the subsequent statutory instruments to which I have referred are put in place. I assure noble Lords that this instrument does not make changes to the current regulatory requirements. Instead, by maintaining the regulatory status quo, it will help ensure a smooth transition to a future regulatory framework that protects patient safety, improves access to transformative technologies and supports innovation.
This statutory instrument amends the Medical Devices Regulations 2002 to remove the revocation date of four pieces of assimilated EU law, so that they can continue to apply in Great Britain until such time as they are replaced with the updated law to which I have referred. The measure was consulted on from November last year to January this year. Of the 287 responses to the consultation, 83% were in favour, while a further 12% had no opinion. If this statutory instrument were not agreed to and the provisions expired in May—in other words, this month—there would be a significant gap in the regulatory framework, as well as risks to patient safety.
I will now give the Committee an overview of the four pieces of assimilated EU law for completeness; I know that noble Lords will be interested in this. First, the decision on common specifications for in vitro diagnostic medical devices sets out specifications that certain IVD devices must meet in order to demonstrate compliance with essential requirements.
Secondly, the regulation on electronic instructions for the use of medical devices establishes the conditions under which instructions for the use of medical devices may be provided in electronic form, instead of in paper form.
Thirdly, the regulation on devices manufactured utilising animal tissue, as well as their derivatives, sets out requirements to be met before those devices can be placed on the market.
Finally, the regulation on the designation and the supervision of approved bodies sets out further requirements relating to those bodies, which assess applicable medical devices for conformity with the regulations.
Although we are revoking the sunset dates instead of replacing them—not least because we do not wish to use up any more parliamentary time with debates on short, technical SIs such as this—the Government do not intend for this assimilated EU law to be kept in place indefinitely. I hope that will be a helpful and welcome reassurance. This SI serves as a temporary measure to maintain the status quo until more permanent measures are in place. In the meantime, this is important assimilated EU law that must continue to be complied with.
That will also ensure that unnecessary EU divergence is minimised, which is particularly important in this instance because, as noble Lords will be aware, Northern Ireland continues to operate under the EU framework for medical devices under the terms of the Windsor agreement. More broadly, I reassure the Committee that the regulations for Great Britain do, where appropriate, align with global best practice. As noble Lords will, I hope, be aware, the Government’s aim is to ensure patient safety while minimising unnecessary regulatory burden.
In conclusion, I am glad to say that the UK is a prime location to research, develop and manufacture pharmaceutical and medtech products. We want to continue to attract medtech manufacturing investments that deploy the latest innovations, are highly productive and are consistently high-quality. Key to achieving this objective is proportionate regulation, and implementing regulatory changes must be done in a sensible and measured manner.
As I have set out, the continuation of this assimilated law is necessary to prevent significant disruption to the current regulatory framework and, consequently, negative impacts on patient safety. I beg to move.
I thank the Minister very much for her introduction to this tide-over regulation, which is as it has been portrayed to us. I should declare that my son is involved in medical technology, in cardiology; you could say that our family has a bit of skin in the game, although I do not understand the technology that he is developing— it is so complicated.
I have just a couple of questions. As the new regulations are eventually developed, can the Minister confirm that there will be no more regulatory burden on those trying to innovate and that we might lessen the bureaucratic burden on them? Will there be compatibility reading across to the FDA regulations? The American market, which is subject to a lot of debate at the moment, is a potential market for devices developed in this country overall. In that process, can there be the assurance that we also do not jeopardise our European market, or the Far East on the global scale? We will need to export the technology that we develop.
(1 month, 2 weeks ago)
Lords ChamberMy noble friend raises a very important point. In terms of trials, I will certainly be signing up—and I encourage noble Lords and their friends and families to do likewise—to Join Dementia Research, which is a collaboration between NIHR and a number of excellent charities, including the Alzheimer’s Society and Alzheimer’s Scotland, to take part in trials. There is no need to be a particular age or to have a diagnosis of dementia. I hope that noble Lords will join me in supporting this endeavour.
My Lords, the commission on palliative care that I am currently involved in has found that by integrating services for patients with dementia, such as in the York Frailty Hub, the number of admissions to hospital can be decreased. People can stay at home with families supported and they can carry on living well within limited capabilities while we wait for new treatments and, hopefully, prevention to come along. Will the Minister meet me and Professor Mike Richards to go through some of the details of our findings? They have huge implications in saving finances for the NHS and improving care of patients.
That is a very helpful offer which I will be pleased to accept. I compliment York on its initiatives, which set a very high standard. I will also discuss the points that the noble Baroness has raised with Minister Kinnock, who is the responsible Minister in this area.
(1 month, 4 weeks ago)
Lords ChamberMy Lords, I am grateful to be allowed to speak in the gap.
Laws send social messages. My maiden speech was on the Tobacco Advertising and Promotion Bill, introduced by the noble Lord, Lord Clement-Jones. Having looked after so many people dying young, leaving children bereaved, through lung cancer and mouth cancers, as well as amputees so addicted to cigarettes that they sat in wheelchairs in the snow at the hospital entrance to smoke, I know that addiction is not a choice; it dominates people’s lives.
At that time, we never imagined the tobacco industry’s creativity, developing nicotine vapes with high levels of highly addictive nicotine salts in one disposable vape that is equal to two packs of cigarettes. The companies have seen a transfer of two-thirds of their customers from cigarettes to vapes long-term. Their profits remain. The number of never-regular-smoking vapers—that is, vapers who had never regularly smoked—using the highest strength e-liquids of over 20 milligrams per millilitre has increased dramatically, to almost 45% in 2023-24. Over 81% of those had been vaping for more than six months and over 67% for more than a year. These high levels deliberately promote addiction and alter biological function, and young vapers are now showing damaged lung function.
In sessions of Learn with the Lords, for some time now I have asked every class to vote on vaping and whether vapes should be banned. They overwhelmingly want a ban. In 2023, one in five children used a vape, often at school. Their young brains are particularly susceptible to addiction, and their behaviour changes.
As for our high streets, we promote addiction with vape shops, betting shops and booze shops. The “polluter pays” principle, as so well outlined already, could mean that they pay much higher rates than food and other shops.
The Bill is important. It can ensure that levels of toxins, including addictive nicotine in vapes, are limited, but we need to be alert to the creativity of the tobacco industry.
(2 months, 2 weeks ago)
Lords ChamberThe noble Lord’s observations are correct. As I said, it is so important to be timely and sensitive at a time of bereavement. Governments and Ministers have been working to bring in the system over the last 50 years—in fact, it has been overdue for reform for that long, so I am very glad to have taken this action. Introducing this robust system means working with medical examiners as well as the bereaved, so that we hear from them about what has happened. We also work very closely across government, including with the MoJ and the Home Office. As the noble Lord will know, the medical examiner system is led by NHS England through the office of the National Medical Examiner. I reiterate that delays are not due solely to this introduction; it is very important to unpick this issue. We now have better data and get weekly reports, which is helping greatly.
My Lords, at the Commission on Palliative and End-of-Life Care, chaired by Professor Sir Mike Richards, we have heard from medical examiners and the bereaved. It is clear that the ability for the bereaved to speak to a medical examiner and go through things in detail is very supportive. However, the delays in notifying the cause of death and transferring the case notes seem to be from the doctor who had seen the patient. The medical examiner cannot start until both those events have happened, and at that point their work begins. So the increasing digitalisation of the health service and of notifications could speed up these processes. Does the Minister agree that the digitalisation proposals from the noble Lord, Lord Darzi, will bring about those changes and simplify the process?
I agree that those changes—the move from analogue to digital, which will be outlined in the 10-year plan—will indeed help in this area, as well as many others.
(3 months, 3 weeks ago)
Lords ChamberAgain, I am sure that the noble Baroness would agree that the important thing is that people ensure that they do not ignore the situation. I agree that the situation that we inherited was hugely difficult, particularly in some areas, around GPs. In the 10-year plan, which will be published in the coming months, there will be a big focus on the move from sickness to prevention, from analogue to digital, and from hospital to community. In all three pillars, greater access to GP appointments will be included.
My Lords, as the Minister rightly highlighted, there are detection gaps, and one in 50 people have aggressive disease at the time of diagnosis. When this proves to be hormone-therapy or chemotherapy resistant, how many centres can offer strontium, which can be very effective for metastatic bone pain, as that is how some people present?
I was glad to have the opportunity to discuss this with the noble Baroness. Having looked into it, we do not currently hold this data. However, where strontium therapy is appropriate and preferred to improve patient outcomes, it will be offered. This is, of course, a clinical decision.
(4 months, 1 week ago)
Lords ChamberThe noble Lord is an exemplar when he describes the quality of care and the joined-up approach of the data and information relating to him. I am delighted to hear that Bedford Hospital was so good to him. I am sure it will appreciate him sharing that with your Lordships’ House, and I add my thanks too.
My Lords, as part of the tailored support that the Minister spoke about earlier, can she explain about the cybersecurity provisions? The ransomware attack on Synnovis last June meant patients’ blood groups were unable to be matched, so there was a call-out for O-negative blood. Patients transfer between the devolved nations of the UK, between Wales and England, and across the border, to a lesser extent, between Scotland and England. Is she having discussions about United Kingdom-tailored cybersecurity support for these rollout systems?
We regularly liaise and work closely with the devolved Governments. More than £338 million has been invested in cyber resilience to date. In March 2023, the department published the cybersecurity strategy for health and social care, which runs until 2030. This is an area of huge importance, as the noble Baroness identifies, and one we continue to press.
(4 months, 3 weeks ago)
Lords ChamberThat point is understood, which is why I thought it important to bring to your Lordships’ House the announcement in the media release from my ministerial colleague Stephen Kinnock. As I mentioned in answer to an earlier question, integrated care boards have a role to play. They should—in fact, they are required to—have regard to the pharmaceutical needs assessment conducted every three years by local authorities. That ought to identify where there are gaps and allow consideration of how to fill any such gaps.
My Lords, given the estimate that community pharmacies save some 38 million consultations that would otherwise have been in general practice each year, and the fact that 97% of pharmacy staff report shortages in accessing different medicines as prescribed, how are the Government planning to allow community pharmacies to adjust medicines—as has been recommended by Community Pharmacy England—so that they can modify prescriptions, rather than spend time recontacting the GP when they are themselves familiar with the items?
The noble Baroness raises a good point and work is continuing to resolve that. It might also be helpful to say that NHS England has commissioned an economic analysis of the cost of providing pharmaceutical services and that will inform future funding arrangements. I say that in answer to the point the noble Baroness made about the potential savings that can accrue if we maximise the role of pharmacies.