Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023

Lord Markham Excerpts

Tuesday 6th February 2024 Grand Committee

Moved by

[Lord Markham]

That the Grand Committee do consider the Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

My Lords, I am grateful to be here today to debate these important regulations. Before I begin, I draw the attention of noble Lords to my entry in the register of interests regarding my shareholding in a company which conducts private sector health screening.

To discuss this SI effectively, I must first set out some context. The provisions in the instrument concern in vitro diagnostic—IVD—devices. These are medical devices that test samples taken from the human body to monitor a person’s overall health or to treat and prevent diseases. Examples of IVD devices include blood tests to detect HIV or hepatitis, tests for cancer biomarkers and more commonly known tests such as pregnancy tests. The Medicines and Healthcare products Regulatory Agency—MHRA—is the UK regulator for medical devices, including IVD devices.

This SI is necessary first and foremost because it enables the MHRA effectively to enforce regulations in Northern Ireland, protecting patient safety. Without this SI, the MHRA will lack important powers equivalent to those in place across the rest of the UK.

Secondly, the SI is particularly beneficial given that life sciences and medical technology are major growth sectors in Northern Ireland, and this Government are committed to making Northern Ireland thrive. The SI will unblock UK-wide clinical studies of medical devices and IVD devices that include Northern Ireland locations. Northern Ireland has a unique regulatory position under the Windsor Framework, including access to the EU single market. By providing for a stable regulatory environment in Northern Ireland, this SI will further enable the whole of the UK to remain an attractive market for research and development of medical technologies.

In May 2022, the EU replaced its regulatory framework for IVD devices with a new regulation, the EU in vitro diagnostic regulation, which I will refer to as the EU IVDR. The EU IVDR has automatically applied in Northern Ireland since 2022 under the terms of the Windsor Framework. The Command Paper published last week reaffirms our commitment to unfettered access. This SI facilitates consistency in the operation of device regulations in Northern Ireland and GB, where beneficial to Northern Ireland, and reflects the unfettered access of Northern Ireland IVD devices to the GB market.

I will now take a moment to summarise the key provisions this instrument introduces. The SI lays down proportionate penalties and gives the MHRA powers to serve compliance notices for breaches of the EU IVDR in Northern Ireland. Although the MHRA previously had the necessary tools to respond to safety concerns, the statutory instrument further strengthens this toolkit. It gives the MHRA powers to designate and monitor notified bodies in relation to the EU IVDR and charge fees related to these activities. Notified bodies in the UK can carry out the technical conformity assessment of IVD devices for EU regulatory compliance, allowing the manufacturer to affix the “CE” and “UK(NI)” marks for placing their devices on the market across the UK.

Sponsors of performance studies for new IVD devices in Northern Ireland will need to apply to an ethics committee in the UK for an ethical review and hold sufficient insurance to meet any potential financial liability in the event of injury or death from participation in the study. The instrument also creates an arbitration procedure for refused performance study applications. It allows studies of IVD devices and clinical investigations of medical devices taking place in both Northern Ireland and Great Britain to require only a contact person to be established in Northern Ireland, rather than a legal representative, supported by a sponsor or legal representative established in Great Britain. This reduces the burden on businesses and makes it straightforward for studies and investigations to include sites across the whole of the UK. It will enable more studies and investigations to go ahead in Northern Ireland.

The SI allows a coronavirus test that complies with the EU IVDR and the new EU common specifications to be placed on the Northern Ireland market without needing to obtain separate approval from the MHRA, as is the current UK requirement. This will reduce burdens and avoid duplication of costs for Northern Ireland businesses wanting to place Covid tests on the market across the whole UK.

The SI includes specific provisions to ensure unfettered access of qualifying Northern Ireland IVD devices to the Great Britain market with no additional barriers or burdens to Northern Ireland traders. This product-specific legislation sits alongside general protections for Northern Ireland’s unfettered access to the rest of the UK under the United Kingdom Internal Market Act 2020.

These provisions allow us to honour our current commitments under the Windsor Framework and will strengthen the regulation of IVD devices in Northern Ireland, to the benefit of patients and businesses. For these reasons, I am content to bring forward this legislation today. I commend these regulations to the Committee.

[Baroness Finlay of Llandaff (CB)]

My Lords, I should declare that my son is a cardiologist and founder of Rhythm AI and Echopoint Medical—I think those medical devices do not completely fall within the scope of this, but I declare it anyway just in case.

It is notable that the medical devices road map from the MHRA, which set a future regulatory framework for devices and was published on 9 January, talks about four statutory instruments. Does this form part of those four? Are others due to come, and if so, when?

Despite the Government’s warm words about us being an attractive market, the problem is that the UK is becoming an increasingly less attractive market because our application-to-approval time has extended beyond that of other countries such as the US and Australia and, I think, Japan. Clinical trials in general are not being brought to the UK. During the pandemic, we showed that MHRA approval could allow us to be the fastest in the world with vaccine development and, more recently, with treatment of sickle cell disease. However, low numbers of patients are now enrolled in studies. For the life sciences to develop, trial and test new technologies, they need to be able to do so rapidly. How will the MHRA have adequate workforce to deal with an increased workload from Northern Ireland? Has that been factored in?

How will the risk assessment be set? It is important to recognise that some developments will fail and fall by the wayside. A realistic risk assessment recognises that a whole population needs to be studied. That is best done with post-market surveillance, which is key to evaluating the implementation of any new technology in the real world.

There is a view that our regulations have become tighter, making it too hard and burdensome for device development to be brought to the NHS; as the UK market is small, we need to make it particularly attractive for innovation. The eventual market, being small, would allow us to keep our innovations and market them abroad once they had gone through full approval processes. What steps are in place for mutual recognition agreements to be taken forward?

A paper from Birmingham Health Partners, Alternative Routes to Market for Medical Devices, suggests there are three routes. I gather that Switzerland has now undertaken to adopt the Food and Drug Administration approval systems from the US, registering the file—for us, it could be registered with the MHRA—with a post-market surveillance plan in place. Of course, the initial safety standards must be met, but it is in the real world that benefits and risks are revealed.

For our deficits and gaps in the NHS, there are problems that we need to solve by pulling new technology and diagnostics in. But the golden age of innovation will happen only if there is fast approval to evaluate, with good surveillance so that those innovations with problems are rapidly dropped and those with promise and better patient outcomes continue to be developed. This innovation has to happen across primary and community care as well as hospital specialty services. It requires the recognition of intrinsic risk by adjusting the risk threshold, including that not to innovate is also a risk.

The public understands the need to innovate. In the related areas of clinical trials, which I think is an important but salutary comparator, we have dropped from being fourth in the world to being 10th in the world, which is much to the loss of our NHS and our patients, as well as, obviously, innovation business. Our time for the regulatory review is greater, so we are slower than many other countries. How will these regulations strip out unnecessary processes and bureaucracy and speed up processes to make us attractive to innovators? Northern Ireland being in the unique position that it is now in could be a very important market for innovation, with its fast and easy access and attractions for those developing in vitro devices.

--- Later in debate ---

[Baroness Merron (Lab)]

My Lords, I also thank the Minister for setting out the provisions in the regulations and for trying to unravel the many pages before us. This seems to be one of those innocuous measures that are needed just because that is where we are, but I very much take on board the comments of the noble Lord, Lord Allan, which are worth wider government consideration.

Clearly, these regulations are needed to support the implementation of new EU regulations that came into operation in Northern Ireland in May last year. They are important in that we have to secure continuity of supply and trade in medical devices within the UK and the EU, and the draft regulations affect a diverse range of equipment and systems to examine specimens in vitro, including items such as blood grouping reagents, pregnancy test kits and hepatitis B test kits, to give just a few examples.

As the noble Baroness, Lady Finlay, said, it is important that we support innovation. The medtech sector provides a huge contribution to our health service and our vibrant life sciences sector, from catching killer diseases early all the way through to preventing infections. The products we are talking about are found in doctors’ surgeries, hospitals and our own homes. They are part of our daily lives. We certainly know from the pandemic how difficult it can be to replace them if supply is disrupted, so we are here to ensure that supply disruption does not happen.

As has been said, the Explanatory Memorandum sets out that these regulations should affect only some 19 businesses in Northern Ireland and cost less than £5 million to implement, but it is important to acknowledge and put on record that they are a valuable part of the UK medtech ecosystem. On these Benches, we certainly support the regulations, which we believe will secure unfettered access to the British market for Northern Ireland businesses and ensure continuity of supply.

I also have a few questions that I hope will be helpful for the Minister. It is welcome that the previous fee structure is being retained to reduce disruption for Northern Ireland operators, but could he say what assessment has been made of any impact on the MHRA’s responsibilities as a regulator? Could he also confirm that it will be resourced to fulfil those responsibilities?

Previously, Ministers have talked about future realignment of regulations on medical devices following our departure from the EU, including consideration of alternate routes to the British market. Can the Minister say a bit more about what opportunities there might be in this area? What is the timeline for the future regulatory regime that the Government want to bring into force? As the Government have not yet set out their proposals, is there a timeline for doing so?

I note that medical devices did not receive attention in the Windsor deal, which was understandably disappointing to some suppliers, which cited the complexity of navigating the current system. Is the Minister considering adding other product classes, such as other devices, to its scope? Will he also clarify the status of devices on which a conformity assessment has been performed by a UK notified body? Following on from the questions from the noble Lord, Lord Allan, in this regard, will it be possible to place devices bearing a “CE” conformity mark, as well as the EU Northern Ireland mark, on to the EU market? Is it the case that no UK notified body has been appointed? If that is the case, when will this be dealt with and what is the delay down to?

In summary, we are pleased to support these amendments to the regulations to secure continuity of supply for the critical medtech sector. I look forward to hearing the Minister’s response.

[Lord Markham (Con)]

I thank noble Lords for their contributions and the spirit in which they were made in terms of helpfulness and trying to make the market as open and productive as possible.

I shall try to answer the questions in turn. To the noble Baroness, Lady Finlay, I say, yes, this is part of the four SIs.

On the noble Baroness’s whole question about making the UK market attractive to innovation, that is exactly what this is all about. On her point about clinical trials, my understanding is that there was a period when we slipped down the league on timings. I am told that a lot of that was because we were trying to prioritise Covid issues but, as I understand it today, we are now back within the timeframes. While we slipped down to 10th place in the league, the understanding from recent business coming in is that we think that we are making our way back up into the champions league spots, for want of a better phrase. I am assured that we have seen quite an improvement in the time taken in clinical trials.

On the noble Baroness’s question about what this means for the MHRA—the noble Baroness, Lady Merron, asked a similar question—we do not believe that this should have a significant impact. At the same time, I am totally with the sentiment that we do not want the MHRA to be a bottleneck, not just in this area but generally because speed to market is important here. In the last Budget, we agreed quite an increase in the MHRA’s budget, exactly so that it is able to pass such things through more quickly.

On the points about mutual recognition, it is absolutely our direction of travel. We are looking to do that with other authorities. Again—this also goes to the question of the noble Lord, Lord Allan—we are recognising the “CE” marks until 2030. That is probably a good example of mutual recognition.

[Lord Allan of Hallam (LD)]

The “CE” mark recognition is an example of one-way recognition, not mutual recognition, because it does not go the other way.

[Lord Markham (Con)]

Absolutely. Clearly, we would like it both ways, for obvious reasons. There are a number of areas where we are still being open about our rules—not just to the EU but to other countries as well, with the hope that there is some reciprocation down the line. That is definitely the intention. Talking to the regulators, I know that the situation is crazy. We know that the Australian, Canadian or Singapore regulators are top-notch, so we should be satisfied with their work in many cases. The feeling often is that stage one towards that recognition is that, while we might have slightly different standards, recognising that where they have conducted tests, rather than reconducting those tests, we should at least recognise that each other has done the tests correctly. We should take that data and that should speed things up.

In answer to the question of the noble Lord, Lord Allan, we are talking about any type of diagnostic test—

[Baroness Finlay of Llandaff (CB)]

May I intervene before the Minister moves off the subject of mutual recognition? Perhaps I may clarify whether he envisages this being similar to the Orbis project for drug approval recognition, particularly regarding oncology and cancer drugs, where FDA approval is recognised. There are different levels, so that things can come through to clinical application quickly. What is the position as regards us recognising FDA approval for development? Do the Government intend for that to be adopted by the MHRA, rather than devices having to go through all of our processes as well? Will we recognise the FDA system, with increased focus on post-marketing surveillance?

[Lord Markham (Con)]

I am probably not qualified to speak specifically about the Orbis project read-across but, at the general level, that is definitely the direction of travel, if you speak to the MHRA. As I said, there are almost two levels to it. The complete level is where you just take it lock, stock and barrel. That is the slightly harder one, but at least the preliminary step towards that is recognising when they have done a batch of tests. I know from a previous life—during Covid, for instance, when a lot of tests were about—that you have to do a number of samples, test them against a control group and see where they come out against that. Those were internationally recognised tests, so if the US, Canada or Australia have done tests on those devices, rather than doing our own tests, let us at least accept them. Those are the two stages of that.

On the point about divergence, this SI tries to make sure that the GB and Northern Ireland markets are as similar as possible. My understanding of how we used to regulate EU “CE” devices was that we would take the “CE” marks and then often tweak them slightly to make them relevant for the domestic market. Apparently, France, Germany and all the countries do that. With this SI, as I mentioned, we are recognising “CE” marks generally until 2030 on a voluntary basis—so, obviously, we can tweak them as much as we like. Northern Ireland generally has to accept those devices because of the Windsor agreement, but it still has that tweaking ability, for want of a better word, that we always used to have when we were in the EU. The idea behind this SI is to allow us to tweak it from both ends—the GB end and the Northern Ireland end—so that it is common, and we have read-across so that the product will work under the “CE” mark in both Northern Ireland and across in GB.

This was explained to me this morning, so my officials can tell me later whether I have been a decent student. For general clarity, as ever, I will happily write this all down, but I hope that makes sense.

[Lord Allan of Hallam (LD)]

It does; that was a helpful and clear explanation. However, if somebody has tweaked their test for Northern Ireland and they also want to sell to the EU, are they able to do so? For example, can they send it south of the border into the EU? Or would that require an untweaked “CE” mark, and, if so, who gives them that? That is really the heart of it.

[Lord Markham (Con)]

My understanding of all this—again, I will tell the noble Lord to the best of my knowledge and correct it if I am wrong—is that we always used to tweak it when we were part of the EU. It was generally accepted that we would tweak a bit, and so would France and Germany. That did not stop products being sold across, so I do not believe that they will need to untweak it, for want of a better word. Again, if I am wrong about any of that, I will clarify it.

On the question of what happens between March 2022 and now, I will let the noble Lord know in writing about what happens during that period.

My understanding is that the MHRA is neither a notified body nor an approved body. It does not set “CE” marks or “UKCA” marks itself; it tests them and looks at the conformity, but it does not establish any, for want of a better word.

On the questions raised by the noble Baroness, Lady Merron, that I did not pick up on before, we do not think the fee structure will have much impact on the MHRA.

The noble Baroness also asked what the opportunities are and what kinds of visions will come from this. I freely admit that this is a complicated space. However, one area where I have seen an opportunity is around the precision medicine space. For example, for the next set of cancer treatments, it will be possible to take a sample of the malignant tissue or cells and adjust the messenger RNA to, effectively, get your own body to attack those cells. The problem is that each one of those medicines you produce is individual to you, so it becomes difficult to regulate each individual medicine under the regulatory framework, as it would take ages and destroy the point of the exercise. The MHRA, however, has developed an umbrella mechanism, allowing it to treat all the individual medicines as regulated and approved. That is a major opportunity. My understanding is that the EU has not managed to be quite as fleet of foot, so it is not there yet. That is just one example I have seen; it is very important, as it allows us to charge ahead in terms of the precision medicine space. Moving forward, that will help us establish ourselves in the clinical trials and life sciences fields. I understand the points the noble Lord makes about all the complications due to some of these post-Brexit situations, but, actually, this is one area that is very positive. It will be a huge benefit for us going forward.

On the question asked by the noble Baroness, Lady Merron, about the future vision, I think it is sensible to agree a baseline based upon what we see in reputable countries with standards—such as Canada and Australia —making it as easy as possible to regulate. It would not be ideal if that meant we had to do it just one way, as we would prefer to do it both ways. However, it would still make us attractive as it would be possible to do clinical trials for our products here and know that it will work. However, where we can forge ahead in areas such as precision medicine, where you need tailored and expert help, let us really try and do that. So I think there are some really exciting possibilities.

I hope that gives a flavour of our vision and how we are trying to progress matters in this space. I realise I have not answered every question, but it has been quite a useful debate. I have definitely found it useful to tease out the details. If I may, I will go back to my notes.

I trust that I have provided sufficient answers to the questions and, as I said, I will write to follow up. I hope and trust that I have demonstrated the necessity of these regulations to honour our current commitments under the Windsor Framework agreement. With that, I commend this instrument to the Committee.

Motion agreed.

Pharmacy First

Lord Markham Excerpts

Tuesday 6th February 2024 Lords Chamber

[Lord Allan of Hallam (LD)]

My Lords, the holy grail for health policy is a change which improves the service for patients at the same time as reducing the cost of delivering that service. I think we can all see the potential for Pharmacy First to be such a move, if executed well. I have a few questions for the Minister and his answers will help us to understand whether he is on the right path in this grail quest.

First, I understand that there will be a payment per consultation, if the consultation meets criteria that the Government have set, but that there will be a cap on the total budget. Can the Minister explain how this cap will work? Is it per pharmacy or per integrated care board, and what happens if it is exceeded? I do not think that we want people going back to more costly channels simply because of an accounting feature. Secondly, can he explain how the Government will assess value for money in comparing the cost of the Pharmacy First consultations with the estimated savings on the GP and A&E side?

Thirdly, while we are discussing urgent care today, can the Minister also say whether the Government are looking at using pharmacies for approving repeat prescriptions—this was raised by the noble Baroness, Lady Merron—for drugs such as statins that people may be on for many years? The current protocol requires them to go back to their GP for regular reviews. Are there any plans afoot to move some of that medicine review process for long-term conditions also into the Pharmacy First programme?

Can the Minister also explain how instructions will be given to NHS 111 services so that they can properly direct people, in light of Pharmacy First now being an available option? It could make a real difference to the pressure on A&E services if 111 moved appropriate cases over to pharmacies. There are concerns that 111 has a natural tendency to be risk averse and refer people to A&E. If we are going to ask it to refer people now to pharmacies, we need to understand how that shift in direction will take place.

Finally, I have a digital question. It is not the one about the joined-up records that we discussed earlier at Oral Questions, as I am confident that the Minister will tell us that the Government are on track for that. What I want to raise is, even when the pharmacy has issued a prescription and dispensed it, at present what happens is that it will then print it off and post it to the NHS Business Services Authority for payment. This happens with all the prescriptions in the pharmacy system at present. My understanding is that the business services authority will then scan them into its system to make the payments—which seems quite farcical in 2024. So I would be interested to hear from the Minister what plans the Government have to get rid of that piece of the equation or to make it more efficient, so that, when a prescribing process happens electronically, it happens all the way through, to the point at which the pharmacy is reimbursed for the work that it has done.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

I thank both noble Lords for their general welcome of what we are trying to do here. My thoughts on this are that anything that we can do to expand supply should be a good thing in this context.

I will pick up on specific questions. As mentioned, we have not managed to achieve 6,000 additional GPs. To specifically answer the question, we have achieved about 2,799. However, through the use of additional staff, we have managed to achieve 50 million additional appointments in GP settings since 2019, so we actually hit our target on that earlier. I think that demonstrates—this goes back to the Question we had earlier today—that we are trying to use people to the top of their professional skills and supplement that with other skilled people coming in. In terms of output, 50 million appointments are a good example.

We are hoping that this will be a boost to community pharmacies. They are, as I mentioned earlier today, seen as a very important asset. They are often the first line in terms of health in the local community. This is intended to not only enhance the health service in an area but give community pharmacies a necessary boost. I think these figures have been reported, but for the sake of completeness I will say that we have had about 10,000 pharmacies sign up—about 95% of them—so clearly it has been welcomed. In the first three days we have had about 3,000 consultations. In answer to the question about pharmacies being overwhelmed, the early indications are that it has been managed well. You could say that the more business they get is a good thing in terms of their viability. Right now, we feel that it is so far, so good.

On privacy—I will try to group the app and IT questions together a bit later—part of the conditions for being available for Pharmacy First is that a pharmacy has a private treatment area available, so that there will not be privacy issues.

My understanding—I will definitely need to write on this—in terms of UTIs is that it applies only up to the age of 64, as they are less complex in those cases. For instance, as you get older UTIs can be a sign of other comorbidities. I think that is the thinking behind the age of 64, but I will follow that up in writing.

The general point was made by both the noble Baroness, Lady Merron, and the noble Lord, Lord Allan, about trying to expand provision. I would say that this is the first step. We have tried to pick the areas that we think suit the situation well. This gives us the ability to expand as the capability increases. Repeat prescriptions is obviously a very good example, as is managing cases such as hypertension and other similar areas. The direction of travel is very much: let us make sure that this works well and then build on that.

I will answer the questions on IT asked by the noble Lord, Lord Allan, together. The overall thinking on the cap is that we are trying to make sure that this does not run out of control—for want of a better word—in some respects, and that goes back to the value for money question. If you can really prove that it is enhancing and substituting for GP appointments, which we all want to boost the availability of, that has to be a good thing. As ever, you need to try to set up budgets at the beginning to make sure that they are sensible in terms of that control.

To give a sense of direction, it is very much the intention that 111—I include the app and other digital approaches in this—will point a person to the right pathway for them. If we then know that they have one of these seven conditions, such as a simple UTI, sinusitis, or something of that ilk, they will be guided towards Pharmacy First. That is very much the intention. I hope that that in some way answers the question. It is intended that more and more volume is put that way.

In terms of trying to make sure that there is a slicker system with the IT generally, obviously it has to be sensible—for example, not printing things off, and that there is an electronic payment mechanism. My understanding is that that is already occurring in some of the digital areas. Noble Lords will be aware of some of the digital pharmacies, which are paperless the whole way. Those sorts of mechanisms are being set up and it is a matter of expanding them, so that there is a complete digital service. I will come back with more detail on that, but I understand that it is happening.

On the IT systems and the holy grail of making sure that they are all connecting—to give everyone the benefit of our conversation in the Corridor—the idea is that it has to be two-way. You want to make sure that pharmacies have access to doctors’ records. That is not ready today, but it will be in the next few months. Likewise, you want to make sure that whatever the pharmacies do gets updated to GP records. Right now, that will be done by a simple PDF. This is not ideal because it involves a rekeying, but in a matter of weeks, it will update the GP records automatically. The value of that is that, obviously, while Pharmacy First is the forerunner, there are all sorts of circumstances it could be replicated for, whether appointments with physios or any other physician relevant to the patient records. I think that will be a positive when it comes in.

I have tried to answer most of the questions about execution. I think we will all freely admit that, as ever with these things, there is a certain amount of bedding in—it is something that I am glad to see everyone welcomes in principle. I hope that in a few months’ time I will be able to update the House on it; I will be happy to do so. If it is executed well, and we believe that this is working well, we will be looking to extend it to further services.

[Baroness Wyld (Con)]

My Lords, I welcome the initiative. It is very good and has been very well thought out and communicated thus far. I would like to pick up the point made by the noble Baroness, Lady Merron, about women’s health. The point about older women was very well made. Equally, for younger women, on the subject of UTIs, I understand that there have been some very successful pilots, but my noble friend will be aware that for women persistent UTIs can be a symptom of something more serious. Symptoms of more sinister diseases can also mimic UTIs. While I have every faith in pharmacists to be able to refer on where possible, it is also important that women feel empowered to go to their GP if they feel something is not right. Women’s health has too often been pushed on to the back burner or ignored. I would like a bit of reassurance on that.

[Lord Markham (Con)]

My noble friend is absolutely correct to bring that up, and that is why it is quite specific on “simple” UTIs. The devil is in the detail, but the reason behind saying simple UTIs is that so the capacity is there, and you can have a referral to a GP.

In this space I speak from personal experience with my partner. It is much harder these days to get antibiotics for UTIs. We know that this is generally a good thing in terms of antimicrobial resistance, but in many cases, as my wife often says, she knows when she has a UTI—and boy does she need those antibiotics.

Some of the things I have started to see in terms of technology, which is relevant to the question of complexity, include point-of-care devices in surgeries or pharmacies that can detect a UTI very quickly, so that you then know you can give a prescription for antibiotics. That is what we see in terms of the direction of travel.

[Lord Hunt of Kings Heath (Lab)]

My Lords, when I had responsibility for community pharmacy more than 20 years ago, one of the schemes we instituted was incentivisation for private consulting rooms and spaces. I wholly endorse what my noble friend Lady Merron said about the importance of this, and the noble Baroness’s intervention reinforces this. It sounds as if most community pharmacies have some kind of private area, but they are not always as good, secure or private as they ought to be. So I very much hope that the incentive that I hear the noble Lord has built into the scheme will actually lead to ensuring that patients have confidentiality, which is really important here.

On the cap, I understand the need for probity and making sure that there are no perverse incentives to overcount, but it would be a bit of a disaster if, nine months into the financial year, a very good community pharmacy ran out of its allocated funding. What would happen? Will integrated care boards at the local level have some discretion to come in at that point to ensure that that service can continue?

On integrated care boards, some clinical commissioning groups were very poor at getting community pharmacy around the table. It always amazed me that, in their winter planning, they seemed to forget the need to have community pharmacies as equal partners. Can the Minister assure me that, when this programme is taken forward, integrated care boards will be clearly told that they are expected to treat community pharmacies as important partners in this and in planning for winter, which, as the noble Lord knows, continues for much of the year?

[Lord Markham (Con)]

I thank the noble Lord and will answer his questions in reverse. On getting the ICBs around the table, I absolutely agree. This is seen as a key part of those initiatives and handling those pressures. Generally, going back to privacy, I would expect to see, as ever with these things, some pharmacies that become very good and set up really nice areas, with a lot of expertise. I am sure they will push ahead. I am making this up, to be honest—this is not policy—but I would not be surprised if it started off with a base level of ones that can do only the seven, with others that are more skilled and show that they can manage more things, such as hypertension. There will be some very successful ones. On the cap, it would be perverse if those really successful ones suddenly hit the buffers, so to speak. As I understand it, the cap looks at this much more in terms of a global presence. In the department as a whole and the Treasury, we are going into this with a budget in mind and with the appropriate safeguards. But, going back to the value for money question, overspending is actually probably good news because it shows that it is working.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my role as chair of the Bevan Commission in Wales. Through the Bevan exemplars, we have supported projects with extended roles for pharmacists. That included a project on urinary tract infection treatment in remote areas, which was very successful in a farming community.

My questions relate to the way in which this will be evaluated, because this project and the rollout sounds as if they are starting off well, but some difficulties may be encountered. One may be in appropriately diagnosing something such as a sore throat when it might be glandular fever. If you give the wrong antibiotics, there could be quite a nasty reaction. But equally important—in fact, often more important—are drug interactions overall. If the pharmacist does not have a list of the medications that a person is on, there is a real risk of drug interactions. Patients often cannot remember the names of things they are taking, particularly when they have multiple comorbidities. Drug interactions can be a really big problem to manage, so I would like to know how this will be evaluated and how adverse events, such as drug interactions that had not been picked up, will be collated centrally and notified.

My other question relates to the programme we developed in Wales. I declare that I am a vice-president of Marie Curie, which has the “Daffodil Standards” for community pharmacy. Our eight standards for community pharmacists have developed the concept of a pharmacy champion for palliative and end-of-life care, to make sure that medication is available and held in stock in a format that the patient can take. This is also linked to paramedics who are trained to administer medication at home, to families being trained to administer medication, and to pharmacists themselves undertaking individual medicines reviews to see what can be discontinued as well as what can be continued or how doses should be affected. Although we start off with this list, my interest in palliative and end-of-life care obviously means that I would like to see these Marie Curie “Daffodil Standards” adapted much more widely, because we know perfectly well that out-of-hours access to medication can be a real problem for families looking after people at home.

[Lord Markham (Con)]

I thank the noble Baroness. Key to her first point on drug use is obviously the functionality to be able to see the whole patient record— I talked about accessing that earlier. At the same time, the plan for the data flow is to look at what is being prescribed by the pharmacies—before the team gets on my back, I will say that “prescribe” is not quite the right word, because it is patient guidance and they are not formally prescribing. What is issued will go through the same data flow as for GP surgeries so that we can generally measure whether we think pharmacy X is overprescribing—or oversupplying—a certain type of drug versus a GP surgery. The idea is that that will be monitored in exactly the same way. Generally, on the overall experience of Pharmacy First, we commissioned the National Institute for Health and Care Research to review that to make sure it is done.

If I understood correctly, the question behind the palliative care point is, as we said about the other services: can we see them extending more, particularly in terms of out-of-hours use? The beauty of all this—there are things we can learn from the services that Wales and Scotland have introduced—is that, once the principle is established and there is a track record of it working well, there will be all sorts of opportunities such as these to extend it based on capability and, sometimes, convenience, with matters such as out-of-hours care.

[Viscount Waverley (CB)]

My Lords, as time is on our side, I will address, if I may, an issue which may or may not be totally relevant to the subject before us. I apologise to the House if it is not, but it does involve pharmacies. Before I venture forth, I offer the utmost fullest support for the principle of pharmacies playing a critical role in the whole system of patient care. My personal experience is absolutely excellent and that pharmacies provide a thoroughly professional service.

I will address a concern around the cost of purchasing non-medical equipment from pharmacies; it may also have relevance to the cost of living challenges. I went into a pharmacy recently and was charged £23.50 for a packet of four Gillette razor blades—shock horror. Of course, I needed them, and I paid, but I thought it was exorbitant, so I called the wholesaler to ask what was its cost of the same packet. It was £6 to £8. I recognise that pharmacies are a private sector set-up and can charge what they wish, but is there any aspect in this Statement that is relevant to the charges that pharmacies pay? I say this perhaps in support of the point of the noble Lord, Lord Hunt, about having facilities in pharmacies. Of course, they need funds, and pay rent and all the rest for all of the types of facilities that are required, but is there any relevance in relation to the costs that these people can charge? It is no wonder we have a cost of living crisis if people are having to pay those sorts of exorbitant prices.

[Lord Markham (Con)]

My understanding is that what we are really talking about here are the seven areas where they are allowed to supply treatments and courses of drugs. I do not think there is any read-across to other areas such as the pricing of medical instruments. I do not think that will help in this instance, but when I write round on the detail, I will make sure that this is clarified. Right now, I do not think that is envisaged by these measures.

[Viscount Waverley (CB)]

I never anticipated it was; I just thought it was relevant to the general circumstances of what people are being charged in purchasing from pharmacies.

[Lord Markham (Con)]

Again, it goes back to the point that, generally, we all agree that pharmacies offer an important service. Obviously, one would hope that they would be responsible; the vast majority of them are and there will not be such—predatory pricing probably is not the right word—hyper-pricing behaviour. Clearly, where those things do happen, I do not think any of us would support it. That is not the sort of thing we would want to be happening in any retail location, let alone one which is providing vital services.

NHS: Fracture Liaison Services

Lord Markham Excerpts

Monday 5th February 2024 Lords Chamber

[Lord Black of Brentwood (Con)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper, and I declare my interest as co-chairman of the APPG on Osteoporosis.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

The Government recognise the value of the quality-assured secondary fracture prevention services, including the fracture liaison services, or FLS. More than 500,000 fragility fractures occur annually in the UK, and up to 40% of fracture patients will suffer from another. FLS are commissioned by integrated care boards, which are well placed to make decisions according to local need. The Major Conditions Strategy: A Case for Change and Strategic Framework outlines that, with NHS England, we will explore supporting the additional provision of FLS.

[Lord Black of Brentwood (Con)]

My Lords, I thank my noble friend for that Answer, but all we ever seem to get are warm words and then broken promises. We were promised money for FLS in the elective recovery plan by the Chancellor himself, with announcements on FLS before the end of last year. A package of measures was promised in the Autumn Statement, as well as a national specialty adviser on osteoporosis. None of those promises has been kept.

To go back to basics, can my noble friend tell me whether he accepts that the 90,000 people who need anti-osteoporosis medication are missing out on it because of no access to FLS; that universal coverage of FLS in England could prevent 31,000 hip fractures over five years; and that investment in FLS would pay for itself in just 18 months? If he does accept those points, can he tell us why on earth these promises have not been honoured, and why the needless suffering of tens of thousands of people has not been brought to an end? When will words finally become deeds?

[Lord Markham (Con)]

First, I thank my noble friend for his tireless campaigning in this space. I agree that there is a very good case to be made. Many of us will know the advantage of the fracture liaison services. A lot of studies show that you are at least 10% less likely to suffer from another fracture, so it is a vital part of the prevention programme. There is a very strong case behind it, and my noble friend can rest assured that it is something that we are really looking to progress.

[Baroness Donaghy (Lab)]

My Lords, would the Government agree to a temporary transformation fund to pump-prime the fracture liaison services? If everyone over 50 had access to a quality fracture liaison service, it would prevent 74,000 fractures, which would help people to stay in work and help to take pressure off hospital beds. Would the Minister agree that this would be investing to save?

[Lord Markham (Con)]

As I mentioned, I agree with the noble Baroness that the FLS has shown many cases of prevention. There is a good argument in terms of investment and the return on it all. That is something that we are working towards and, as the noble Baroness will know, it is part of the major conditions strategy for musculoskeletal. So it is something that we are looking to expand.

[Lord Lexden (Con)]

My Lords, do the Government regret dropping the commitment that they gave in a debate in this House in September to expand financial provision for fracture liaison services? Is the health department considering the introduction of a best-practice tariff to reward those trusts that establish and maintain these vital services?

[Lord Markham (Con)]

I think that the statement made previously has been corrected on this, but, as I mentioned, we accept that these services are very effective in what they do. That is why we have musculoskeletal as part of the major conditions strategy. It was something that we put £400 million behind last year, in terms of a workforce package. We are looking at the effectiveness of FLS and, in ICBs that are not doing it, whether there is a case to expand them further.

[The Lord Bishop of Bristol]

My Lords, I thank the noble Lord, Lord Black, for his dedicated work in bringing this important topic to the attention of the House. Around this time a year ago, the noble Lord asked another Question on the early detection of osteoporosis, which is the leading cause of fractures in those aged over 50, particularly women. In his answer, the Minister, who is answering the Question again today, noted that

“a fractured femur is the second biggest reason for intake into hospitals, in terms of beds”—[Official Report, 19/1/23; col. 1926]

and that he would be happy to report on progress on this to the House. Will he tell us whether any progress has been made since he gave that answer one year ago?

[Lord Markham (Con)]

Yes. Again, I did more research into this and, similar to the point just made, for women over 45 more hospital days are spent with osteoporosis than with conditions such as diabetes, heart problems or breast cancer, so it is recognised that FLS have a very strong part to play. We are trying to pursue a prevention agenda; there is a good cost-benefit argument around it, so we are making a strong case for their expansion.

[Lord Allan of Hallam (LD)]

My Lords, the noble Lord, Lord Black, and the Better Bones campaign have done an excellent job in raising the public profile of fracture liaison services, so I was a little surprised that searching for them on the NHS website returned some general articles about fractures and advice about the Patient Advice and Liaison Service but nothing about fracture liaison services as such. Will the Minister look into this to ensure that people trying to find information about FLSs are given it and directed to their local service?

[Lord Markham (Con)]

I thank the noble Lord. His interventions around the communications side are always welcome, because we recognise that it is one thing having a service and another thing making sure that the world knows about it. I will go and find out more and write to the noble Lord.

[Lord Patel (CB)]

My Lords, the fracture liaison service originally started in Glasgow, with the particular intention of identifying mostly women who had a higher risk of fractures from osteoporosis. In England and Wales, a fracture liaison service audit has been established now for several years. How do the Government receive the learning from those audits and how do they implement the learning that they receive?

[Lord Markham (Con)]

The noble Lord is correct; there has been some good evidence gained. As I mentioned previously, it shows that the probability of suffering from a fracture if you have been in a clinic is 10%—some studies have shown as much as 30% to 40%. It also shows, as my noble friend Lord Black was saying, that there is actually a good cost saving: it is thought that £65 million per annum will give a return of more than £100 million. There are some very good statistics around this, and I assure noble Lords that we are making a strong case for their expansion.

[Baroness Merron (Lab)]

My Lords, the Minister has previously confirmed in your Lordships’ House that just 51% of ICBs have a fracture liaison service, and that the rest of the country has what he described as “different versions of it”. Will he explain what is meant by this, so that it can be understood whether this means a full fracture liaison service or not in the remaining 49%? When will Minister Caulfield’s promise to establish more fracture liaison services actually be delivered?

[Lord Markham (Con)]

I believe that the latest number is 57%, but the general point stands that that leaves 43% which are making other types of provision. The work we are doing right now is trying to understand the success of those versus what we see as prudent with that 57%. That is the case we are making and the case that Minister Caulfield was referring to as well. I believe personally that it is a strong case, so it is something that, as I say, we are looking to work further on.

[Baroness Altmann (Con)]

My Lords, I apologise for adding to the pressure on my noble friend, but half of all over-50s women will suffer fractures due to osteoporosis, and this affects 50,000 working-age women each year, yet too often this disease is just stereotyped as affecting old women. The menopause increases fracture risks for women in their 50s, when many are in the prime of their life. Might such mistaken stereotyping about old women explain the near total absence of osteoporosis from the Government’s laudable women’s health strategy? Will we perhaps see women’s health hubs referring women to fracture liaison services, with further progress in the forthcoming Budget?

[Lord Markham (Con)]

Again, the use of hubs and their importance for getting people back to work is recognised. That is why in 2023, in the major conditions strategy, we announced the £400 million workforce programme to get 100,000 people with employee support back into work. It is absolutely recognised that what we can do with fracture liaison clinics is a major help. We are also looking at digital therapeutics—the app is close to my heart—that can help with MSK as well. There are a range of measures.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my role as president of the Chartered Society of Physiotherapy. Will the Government undertake to work with the physios and Public Health England to look at prevention? This is a public health issue because people have trip hazards in their homes, and a decrease in exercise means that people’s balance generally is not as good, and therefore they are more likely to have a fall. When people do have a fall when they are older, they are more likely to sustain a fracture. Avoiding trip hazards and increasing people’s mobility can be a very important preventive measure.

[Lord Markham (Con)]

The noble Baroness is correct. As well as using a physio to strengthen people’s use of their limbs, there is a strong investment case behind home improvements because of the payback from them. This is all part of the prevention agenda, and we are looking to see if we can put a package of measures together because our feeling is that prevention is the best way to go.

Care of Critically Ill Children

Lord Markham Excerpts

Monday 29th January 2024 Lords Chamber

[Lord Balfe]

To ask His Majesty’s Government what steps they have taken, or propose to take, following the publication in September 2023 of the review they commissioned from the Nuffield Council on Bioethics, Disagreements in the care of critically ill children.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

The department is working closely with other organisations to ensure that recommendations are taken forward and oversight is maintained. Together, we have taken steps on several recommendations aimed at improving the experience families and healthcare professionals have of navigating disagreements. NHS England has introduced regional conflict champions and launched resources and conflict management training on e-learning for health. The Ministry of Justice will hold a round table on how less adversarial court models could be used.

[Lord Balfe (Con)]

I thank the Minister for his reply. This review arose from an amendment to the Health and Care Act 2022, moved by my good friend, the noble Baroness, Lady Finlay, that I helped to draft. What steps have the department taken to establish a task force, as was recommended in the report? Secondly, there are a lot of recommendations in the report—far too many for an Oral Question. Will the Minister meet the noble Baroness, Lady Finlay, and me to review where we have got to with this most necessary look at administrative procedures?

[Lord Markham (Con)]

First, I thank my noble friend and the noble Baroness, Lady Finlay, for their work in this field. Of course I will very happily meet to talk about progress. Minister Caulfield has agreed to chair the task force itself, and we have agreed the constituent parties; we are including the Ministry of Justice, the Royal College of Paediatrics and Child Health, the Royal College of Nursing and health qualification providers, which will all take part in the task force.

[Baroness Finlay of Llandaff (CB)]

My Lords, I am grateful for the compliment paid; it was a privilege to be involved. I declare my interests in palliative care. Given that the number of children with life-limiting and life-threatening conditions has more than doubled in the last 20 years, particularly in the nought-to-19 age group and especially in the under-ones, do the Government recognise the importance of early involvement of multiprofessional specialist palliative care teams, which can support families to come to terms with what they have to come to terms with, help other clinicians to understand the families’ perspectives and avoid some of these disputes happening in the first place? Can the Minister tell us how many of the integrated care boards have commissioned specialist palliative care services that work between hospitals, ICUs and wards, out into the community and into hospices?

[Lord Markham (Con)]

The noble Baroness is correct: the number of young people with life-limiting conditions has gone up, from about 33,000 around 2001-02 to about 87,000 more recently. A lot of that is, conversely, good news in that we have more and more treatments that can keep these children alive for longer. Clearly, that requires the wraparound-type service that the noble Baroness is talking about. It is the responsibility of the ICBs to provide that; I will provide details of the progress of individual ones when we meet.

[Baroness Wheeler (Lab)]

My Lords, I emphasise that the task force recommended by Nuffield to oversee its key recommendations needs to get to work urgently. The family-focused research work with parents, including parent carers, about their experiences of shared decision-making with healthcare professionals on care and treatment, is vital, as is the comprehensive information and guidance for parents and staff that is called for across the 16 Nuffield recommendations. What timescales are the Government envisaging for this crucial work to commence and become operational, including guidance to clinical and ethical committees?

[Lord Markham (Con)]

My understanding, now that the task force composition has been set up, is that this will be arranged shortly. I completely agree with the noble Baroness that these are important, as well as often heart-wrenching, matters, so urgency is required. As I have said, good progress has been made in a number of areas. Already, the MoJ is setting up a round table on this. The regional conflict managers have been established. We have training courses online so that communication can improve. A lot is being done, and the task force will push that forward further.

[Lord Jackson of Peterborough (Con)]

My Lords, the Minister will know that there is currently an imbalance between the resources available to the parents and guardians of children involved in end-of-life care—particularly time, money and legal advice—and that of public bodies such as NHS trusts. Compounding that issue is the routine use of secret transparency orders, which prevent scrutiny and oversight of court proceedings, particularly in the family court. Does the Minister agree with me in that respect: that secret justice is no justice at all?

[Lord Markham (Con)]

Clearly, the processes on these terrible cases have got to be as transparent as possible. As noble Lords probably know, legal aid is automatically available in all these types of cases to make sure that there is a level playing field. I also think we all believe that there is a case for seeing whether we can use mediation more as, obviously, courts should only ever be a last resort.

[Lord Allan of Hallam (LD)]

My Lords, the Minister has already flagged communication as one of the key areas that comes through in the report, around both palliative care and care more generally. Can the Minister assure us that the task force will have the skills it needs to ensure that that communication can take place with parents from a variety of different backgrounds—educational, with different levels of medical knowledge and in different linguistic and cultural contexts?

[Lord Markham (Con)]

Yes, the noble Lord is quite correct. We know that, in many walks of life, so to speak, there are certain sectors of society that do not get the same level of provision and sometimes miss out. We had the debate last week on maternity provision and saw instances in relation to ethnic minorities as well as people with learning difficulties. We need to make sure that all the communications are there and that everyone is armed to provide the right levels of interface and communication in what are some really difficult cases.

[Lord Watts (Lab)]

My Lords, many families with critically ill children find it very difficult to access treatment because often specialist treatment is only available hundreds of miles away from where they live. That puts tremendous pressure on the family financially. Do the Government intend to do any more to help those families?

[Lord Markham (Con)]

Clearly, we would all agree that the families need to be the priority in these terrible cases. What we have tried to do—and I have also done my own research into this—is make available what I call independent funding requests for when there is a new course of treatment which might not be allowed generally by NICE to give opportunities in those instances as well. I will come back to the noble Lord on things such as travel support and other expenses.

[Baroness Altmann (Con)]

My Lords, I declare my interest in and my work with the Teenage Cancer Trust. In connection with the task force, will my noble friend let the House know what input charities that specialise in this kind of work with children and teenagers who, sadly, are in this position and their families will have into the task force? Will he join with me in commending the tremendous work done by this charity and the other charities which specialise in helping children and families going through this traumatic time?

[Lord Markham (Con)]

Yes, I am very happy to add my thanks for everything they do in this. It is clear in these circumstances that the more support we can give families, the better. I will speak to Minister Caulfield to make sure that input is properly there because my noble friend is correct that it should be there.

Maternity Services

Lord Markham Excerpts

Thursday 25th January 2024 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

I too thank the noble Baroness, Lady Taylor, for enabling us to have this debate and I am grateful for all the contributions from Members here with their vast experience and expertise. I too was moved by the words of the mother mentioned by the noble Lord, Lord Patel. The noble Baroness, Lady Merron, put it well when she spoke of the thousands of mothers who have their thanks to give to the noble Lord. I am not sure that there are many fathers who would thank to the noble Lord, Lord Allan, for his advice, but I will take it, should I be in that situation again and I may not take photos of the scenery.

I want to reassure the House that we are committed to ensuring that all maternity services provide safe and compassionate care. As many Members have mentioned, most women have a positive experience of NHS maternity and neonatal services, and outcomes have improved, with over 900 more families welcoming a healthy baby each year compared with 2010 figures. However, all women should feel confident that they and their baby will be cared for safely and, where tragedies happen, that they will be well supported and treated with compassion. We therefore acknowledge that there are unfortunately times when the care provided is not enough.

Recent independent reports by Donna Ockenden on maternity services in Shrewsbury and Telford, and by Dr Bill Kirkup on maternity and neonatal services in East Kent, and previously in Morecambe Bay, set out many examples of poor care over the years. The review into maternity care at Nottingham University Hospitals chaired by Donna Ockenden commenced in 2022, and we expect that report to be published at the end of September 2025. We take those investigations and all elements of maternity safety incredibly seriously. We understand the immeasurable impact that poor care and adverse outcomes can have on a family, and remain committed to supporting trusts to deliver safe, compassionate care and addressing the unacceptable disparities for women and babies.

While maternity services must always seek to learn and improve, I want to recognise the dedication and commitment of the vast majority of the maternity workforce. I know that everyone who joins the healthcare profession sets out to deliver safe and compassionate care, and I acknowledge the efforts and ability of the many maternity professionals who work tirelessly for the women and babies they care for.

The Secretary of State last week announced that improving care during and after pregnancy will be one of her top priorities in implementing the women’s health strategy in 2024. A key tenet of this is continuing to deliver NHS England’s three-year plan for maternity and neonatal services. The plan sets out how NHS England will make maternity and neonatal care safer, more personalised and more equitable for women, babies and families. Since 2021, we have invested an additional £165 million a year to improve maternity and neonatal care. That will increase to £186 million a year from 2024-25.

The Government have also set a national maternity safety ambition to halve by 2025 the 2010 rates of stillbirths, neonatal and maternal deaths, and brain injuries that occur during or soon after birth, alongside a further ambition to reduce the rate of pre-term births from 8% to 6% by 2025. In answer to the question from the noble Baroness, Lady Taylor, on progress to date, there has been a 23% reduction—so it is progress, but I fully admit that it is not enough.

At this stage, I want to address a lot of the points that have been made. Many noble Lords, including the noble Baronesses, Lady Taylor and Lady Warwick, talked about staffing. The noble Lord, Lord Patel, offered to come and help once more, as did the noble Baroness, Lady Watkins—I am sure she is bright enough to do it as well.

We recognise the importance of staffing. There has been a 14% increase since 2010—and, unlike other areas of the health service, the birth rate has remained stable during that time. So that is a real-time increase, for want of a better word. But I completely accept the points made about the importance of training and retention, and the point the noble Baroness, Lady Warwick, made about understanding what numbers are required to make sure we have the right provision going forward. Of course, that is what the long-term workforce plan is all about. On the retention agenda and the points made by the noble Baroness, Lady Watkins, about sabbaticals, loan repayments and smart stuff such as using technology for flexibility, and staff apps, should all be part of the toolkit. Again, I have seen some very good examples of that in places such as Milton Keynes. I am talking more generally about staff here—using a staff app to allow exactly that sort of flexibility. If we want to be a modern employer competing in a modern world, enabling sabbaticals and that sort of flexibility is, I agree, key.

Turning to the noble Baroness, Lady Taylor, and her local services, my understanding is that, hopefully, the Bronte birth unit will open again in April 2024. However, I accept that some issues have arisen there.

I say to the noble Baroness, Lady Cumberlege, that I absolutely believe in continuity of care as a key tenet in what we are trying to do. I accept that that needs to be built into the long-term workforce plan and some of those allocations. As the noble Baroness, Lady Watkins, says, it is vital that we listen not just to the mothers—that the staff are taught to listen not just to the mothers—but the partners as well.

The point made about access to interpreters is a very good one. Among the many things I shall write back on, I shall be pleased to come back on that too. An excellent point was made about ensuring that staff understand the needs of mothers with learning difficulties. That is very important, and I shall come back on the detail, particularly regarding passports.

I absolutely agree with the point the noble Baroness, Lady Donaghy, made about the long-term relationship with staff. You have to avoid a situation of winners and losers, asking, “Did we win the last battle?” All you are doing is creating bad feeling for the next battle.

I turn to the many points made regarding safety, which is key to this whole debate. The noble Baroness, Lady Armstrong, said that that time and how the birth took place defines much of a mother’s relationship with the child. As many noble Lords said, including the noble Baronesses, Lady Armstrong, Lady Gohir, Lady Bennett and Lady Thornton, the disparities experienced by ethnic minorities and those with learning difficulties are a key issue. I remember my conversation in that regard with the noble Baroness, Lady Thornton, very well.

The Maternal Health Task Force is meeting regularly; it met last September and is meeting again next week. It is chaired by Minister Caulfield and is a fundamental tool in this regard. The point made, particularly by the noble Baroness, Lady Gohir, about ensuring that we have the necessary data and analysis is vital. I shall come back to the points made about NHS Resolution. Having said all that, I would not be surprised to discover that it does not show that there are more disputes from people from ethnic minorities, because they may not feel confident enough to use NHS Resolution. There is probably quite a lot to unpack in all that, but I shall come back in writing and make sure that we also cover the point about learning difficulties.

I share the concerns raised by the noble Baronesses, Lady Merron and Lady Taylor, and others around the CQC reports. We are seeing an increase in levels of concern—50% or so—about inadequacy or need for improvement. That is clearly not a good situation.

To respond to the point from the noble Lord, Lord Patel, that it is the action that really counts, I know that the NHS has an implementation plan for each trust where there are inadequacies to make sure that they are being addressed. I have made sure to ask that I can see and understand all those and I have asked for a report in six months’ time on progress, which I am willing to share with all noble Lords here.

On the questions of whether we should be having an inquiry and further work on this and, as asked by the noble Baroness, Lady Donaghy, what would inform my view on that, I personally think that it is about whether we are really seeing progress. I am very aware, as mentioned by noble Lords, that every time you kick off a new inquiry, it can take a long time. If the action and improvement plan is put in place, I will be satisfied that we are on the right track—but, to be very open, my view will change if I do not believe that the plan is there. As we have the benefit of the noble Baroness, Lady Watkins, being an NHS board member, I say to her—I am sure it is something that is happening—that I think this would be an excellent topic for the NHS board to cover as well, because it is on the front line in all this as well.

Regarding maternal deaths, which we all agree is something of serious concern, the Secretary of State has commissioned urgent work on that. I think we all understand that it is a more complex situation; factors such as age, obesity and diabetes all make the underlying situations more complicated. I do get into the data and, just so noble Lords have all the facts, the recent increase that we saw translates to about 35 extra deaths in the period. I note—and I am just giving the data; I am not using it as an excuse at all—that Covid was responsible for 38 deaths. Covid is a big component in all this, but I do not for one moment suggest that that is the only reason. As the noble Lord, Lord Patel, said, analysing thrombosis, for example, which is a leading cause, is vital in this. The introduction of the 14 maternal medicine networks, which are specialist units set up to look at where there are complications and at likely need for things such as thrombosis, is a vital part of this. Again, seeing action on that in the report back will be key.

To respond to the noble Baroness, Lady Donaghy, I look forward to seeing the Birth Trauma Association report. Obviously, we will respond further after that.

On the points made by the noble Lord, Lord Allan, and the noble Baroness, Lady Merron, I see data as having an important role; use of the app to allow mothers to take control of their own health and data is vital. I had a meeting just yesterday to make sure that the baby red book is brought into the app as well so that, from day one, mothers can have access by proxy. I am mindful of the time, so I will cover that in detail in my letter. I will also pick up and write on the other points raised, but I again thank noble Lords. For me, the benefit of having so much experience is that we can hear these sorts of points in debates. I, for one, have found it useful, so I thank the noble Baroness and everyone else for the work they do in this space.

Smoking

Lord Markham Excerpts

Thursday 25th January 2024 Lords Chamber

[Lord Rennard]

To ask His Majesty’s Government what progress they have made towards the ambition of creating a “smokefree” generation by 2030.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

Smoking is responsible for around 80,000 deaths a year in the UK, costs our country £17 billion a year and puts a huge burden on the National Health Service. That is why we will shortly introduce the tobacco and vapes Bill to Parliament in the coming weeks, to create the first smoke-free generation and further crack down on youth vaping. The Bill will be informed by our recent consultation, which we will publish soon.

[Lord Rennard (LD)]

My Lords, all parties have agreed on the need to reduce the prevalence of smoking in this country to below 5% by 2030, so the Bill to prevent young people ever becoming smokers is vital. Does the Minister accept that we need to do more to help the over 6 million people in this country who are addicted smokers, most of whom are struggling to give up smoking and want to? They are damaging their health and that of others affected by smoking. Does he agree that allowing integrated care boards to make further cuts to tobacco dependence treatment budgets will not help us to achieve this target?

[Lord Markham (Con)]

I thank the noble Lord. Actually, Khan recommended four major things to achieve that in his report Smokefree 2030. The first was to increase the anti-smoking spend that the noble Lord refers to. As part of this, we propose to increase that spend from £70 million to £140 million—so we are doing absolutely what the noble Lord suggests. The second was to increase the age of sale, which of course this legislation is all about. The third was to promote vaping to help quit smoking. Again, the legislation will do that. The fourth was to increase NHS prevention methods which, again, we will do from here. So it is very much a range of measures to stop people ever smoking but also to stop many who are currently smoking by helping them to quit.

[Lord Young of Cookham (Con)]

My Lords—

--- Later in debate ---

[Lord Young of Cookham (Con)]

Further to the Question from the noble Lord, Lord Rennard, the Government commissioned the independent Khan review, which concluded that the Government would miss their smoke-free target for England by several years unless an additional £125 million a year was spent on prevention. Given the pressure on public expenditure, the Khan review instead suggested a levy on the profits of the tobacco industry, based on the polluter pays principle. Does that proposal not commend itself to my noble friend?

[Lord Markham (Con)]

As I say, we have tried to answer the four major points that Khan put forward, including doubling the spend from £70 million a year to £140 million. The levy was the one thing that was not so much favoured; there was a lot of modelling done on it and the thought was that the net increase would be only about £25 million or so. That is why it was thought better to look at taxes on tobacco itself as a way of raising revenue, and generally introducing the four major methods that Khan recommended.

--- Later in debate ---

[Baroness Blackstone (Lab)]

My Lords, I refer to my interests as set out in the register. Would the Minister agree that smoking in pregnancy has enormously damaging effects, leading to much poorer birth outcomes than for mothers who do not smoke? Would he also agree that incentives to pregnant women not to smoke have been very effective? In the light of this, could he give a guarantee that the existing scheme, which comes to an end this year, will be continued with adequate resources, so that it is not in any way disrupted?

[Lord Markham (Con)]

I totally agree with the noble Baroness on the importance of stopping smoking—always, but especially during pregnancy. In fact, we have a maternity debate coming straight after this, where this will be one of the things that we discuss. I hope, from showing that we are putting all this spend in place, that we are backing everything that works. As long as the anti-smoking in pregnancy measure continues to work, that will be one of the major features to make sure that we are continuing to stop all activity, but especially in pregnant ladies.

[Lord Patel (CB)]

My Lords, in the light of the last question, I will change my question. What assessment have the Government made of the long-term harm that vaping will cause, particularly to young people?

[Lord Markham (Con)]

The honest answer is that we do not know yet, and that is a problem. As we know, a number of these things take time to play through. That is why we want to make sure we take a precautionary approach. In this legislation, we aim to really stop anything that is targeted at young people in terms of vaping. We see vaping as an important tool to help people quit smoking, but we are equally sure that we never want anyone to start vaping. That is why we will also look at banning anything that targets young people, such as flavouring and packaging. We want to stop anything targeted at youth vaping.

[Lord Naseby (Con)]

My Lords, why are His Majesty’s Government ignoring the experience of New Zealand? That country has found the idea behind this Bill—it had a similar one—to be totally unworkable. Secondly, why are we undermining the existing scheme that has done so well, with under 2% of young people even bothering to take a taste of smoking? Does my noble friend not recognise that there are other, far more important health dimensions that need the resources that are to be wasted on this useless Bill?

[Lord Markham (Con)]

First, my understanding about New Zealand is that one of the biggest bones of contention was that it was looking to reduce the number of smoking retailers from 6,000 to 600; that is where their Bill came into difficulty. I am afraid I must disagree with my noble friend on the importance of this. It costs the economy about £17 billion a year and causes about 80,000 deaths, and 80% of people who have taken up smoking wish that they had never started. I think those are very strong reasons which I know the majority of this House is behind, and that is why I am delighted to be introducing that legislation shortly.

[Baroness Merron (Lab)]

My Lords, it has been reported that the decline in smoking has nearly ground to a halt since the pandemic, with many former smokers lapsing and many more young people now taking up smoking. Now that the smoking cessation drug cytisine is available, what is the Government’s assessment of how its availability will contribute or otherwise to the progress towards the smoke-free ambition by 2030? What plans are there to ensure its availability across the country, particularly among hard-to-reach groups of smokers?

[Lord Markham (Con)]

Hopefully, my previous answer shows that we are investing major money in cessation services. I must admit to not being that familiar with the drug the noble Baroness mentions, so I will follow up in writing to give her the details.

[Lord Allan of Hallam (LD)]

My Lords, does the Minister agree that reducing the number of outlets that sell tobacco products does in fact have a positive effect on the prevalence of smoking? In this respect, can he indicate whether the Government are having any conversations with large supermarket chains, either individually or collectively, about voluntary reductions in the number of tobacco counters in their outlets? If that is not already happening, would he agree that it would be a good use of government time to do so?

[Lord Markham (Con)]

Again, we are mindful of trying to get the balance right. Inevitably, by taking away a major market, which the over-18s will become as we go into it, smoking sales through retail units will go down more and more. We expect them to reduce as a result of that. We think that is probably getting the balance right, rather than trying to be overburdensome by saying, “No, you shall not be licensed to do that any more”. We think that will happen naturally through the market, because we are of course taking out a whole segment of future customers.

[Lord Moylan (Con)]

My Lords, is my noble friend aware of the report published this week by University College London, in association with Cancer Research UK, which suggests that banning disposable vapes would lead to fewer adults giving up smoking? Will he give an assurance that any proposals brought forward by the Government will be based on clear evidence and common sense, and not unevidenced enthusiasm?

[Lord Markham (Con)]

I hope I could give my categorical agreement that everything is based on evidence and common sense; I will let people draw their own conclusions as to whether that is always the case. But, seriously, clearly anything we look at must be evidence-based. We will shortly be announcing the results of the consultation, which has a 28,000-strong evidence base, to show that we are really doing rigorous analysis.

[Lord Faulkner of Worcester (Lab)]

My Lords, many Members of your Lordships’ House have received lobbying from tobacco companies over the years. Is the Minister aware that the Daily Telegraph reported last week that Philip Morris had threatened legal action against the Government over the consultation to which he referred in his first Answer. Can the Minister give an assurance that, if this lobbying is undertaken by tobacco companies, the Government will ignore it and go ahead with their very sensible and welcome plans?

[Lord Markham (Con)]

Yes, I am aware of the moves, and I am sure there will be many more. I was advised that it was a fairly unusual legal challenge on consultation, which I believe was withdrawn quite quickly. Yes, there will be opposition, but we are determined, because of the importance of what we are trying to do.

Dementia

Lord Markham Excerpts

Thursday 18th January 2024 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

I add my thanks to my noble friend Lady Browning not only for bringing this debate but for her commitment generally in this area. I also thank all noble Lords for their contributions. These sorts of debates are always a pleasure, and one thing I have learned in the almost 18 months that I have been involved in the Lords is that it does not matter what the subject is; you always find expertise and learn about colleagues’ experience, such as that of the noble Baronesses, Lady Greenfield and Lady Murphy. I always find having the power of that knowledge around the table a real asset for the Lords and a real contribution to these types of debates.

My noble friend Lady Browning quite rightly said in her introduction that the statistics are gobsmacking, if I can use that word. I note the fact about one in 11 of those over 65. The one that really resonated with me—noble Lords have heard me mention it many times—is the fact that 25% of our beds are occupied by people with dementia. There is a real feeling that not only is that not the right place for them but it is not a good use of money. I therefore totally agree with that sentiment.

We see virtual wards and hospices at home as part of the answer to this. I have seen some good technological advances: at the light end of the scale, for want of a better word, we could look at people’s electricity usage, for example, and start to learn their patterns. For a lot of people, there is a surge at 8 am when they put on the kettle, so if that surge suddenly is not there, that is an early warning that perhaps there should be a call because something is wrong. There are also motion detectors around the house to start to understand their patterns. To my mind there is a spectrum of those sorts of virtual wards from the very heavy intervention ones to just trying to make sure that people are generally fine and going about in their normal way or, if they are not, it can be an early warning.

I will come on to staffing, but a key part of that in the home is dom carers. It is a point that the noble Lord, Lord Allan, made well. We have made a lot of progress in what we are trying to do with career progression, but I want to be assured that we have really got this area right.

My noble friend Lady Browning mentioned the fundamental need for a care plan in all that. In preparing for this, my noble friend Lord Evans said that that was what he needed in his recent situation with his mother. That is what ICSs should be starting to do now. I take the point made by the noble Lord, Lord Allan, that there is probably no better example of trying to learn how they are working than using this as a case study. My general experience of ICSs—of course it is early days, even now I think we are only 18 months or so in—is that, as ever with these things, there are some very good examples and probably some which need to do a bit more work. I am quite happy to take that away to try to find some test cases that we can try to learn from. The NHS has set out best practice guidance that it expects all ICSs to follow. My understanding, which I will check on, is that part of that is having a dementia lead, which my noble friend Lady Browning mentioned.

As the noble Baronesses, Lady Ritchie and Lady Donaghy, and other noble Lords mentioned, diagnosis is key. The target is two-thirds. We are getting quite close to that, but we have been behind, so there has been an investment of £17 million to catch up. I accept the point about whether two-thirds is enough and whether we would accept that in other areas and let one-third go undiagnosed, but step one is making sure that we hit that two-thirds.

The noble Baroness, Lady Ritchie, asked what sort of resource we are putting behind this. CDCs already have the equipment, in terms of scanners, and the ability to do that, but I accept the point made by the noble Baroness, Lady Murphy, that it is probably more about the people. It is less the equipment than making sure that people are trained to do that. I will come on to staffing later, but I take that basic point.

What is the point of diagnosis? First, it is to make sure that people get the right care. Secondly, it is so that we can start to deploy some of these new treatments. Again, it is great to have the expertise of the noble Baroness, Lady Greenfield. In answer to the question from the noble Baroness, Lady Ritchie, we are expecting NICE approval of the drugs to slow dementia down in early summer, and we expect to then roll that out during the summer period. However, we all know that they are only on the nursery slopes, and that is why there is a commitment to research of £160 million per year.

To fuel the moon shot, I am really excited about the power of the data that we own. I was recently on a fact-finding mission to Boston and they were talking about a major $250 million investment that a private venture group had made into the 9 million hospital records in Mayo Clinic. They were saying, “You don’t realise what you have in the UK. You have 50 million records in England, and you have primary care as well”. The whole problem around dementia is that we do not know what we are trying to tackle, in terms of the early causes. The reason we were so good at tackling Covid was that we knew exactly what we were going after. Right now, in things such as dementia and Alzheimer’s disease, it is still a case of shots in the dark.

However, regarding the 50 million records we have, if we look at people who have dementia today, wind back 15 years and ask what they were visiting their GP about then, and throw that all at AI, we can get some of those early-warning indicators. I know some of the anecdotal ones. For instance, as mentioned, urinary tract infections are often an early indicator of dementia because people do not understand that they are there. Throwing all that at AI and making sure that that data exists is a real way to fuel the moon shot so that we know where we should be putting our research efforts to try to find treatments.

On the funding of social care, as I said, the £8.1 billion investment over two years is a major investment. I learned a lot from my noble friend Lady Berridge. I did not realise that being committed under the Mental Health Act is a main way to get there. On the question from the noble Baroness, Lady Wheeler, about CHC transparency, I do not know the answer off the top of my head, but I will come back on that because it is a good point. As ever, I will try to come back and cover it more fully in writing.

The reform plans that we have announced are about making sure that we have the proper staffing to do this. As I mentioned in answer to the earlier Question today, we are starting to turn a corner, although it is early days. On career progression and training, I believe that what we announced last week is a key part of making this a real profession that people will want to stay and progress in. I agree with the point made by the noble Lord, Lord Allan, that paid progression has to come along with those qualifications; otherwise, you will not get people wanting to enter it.

I understand, as a few noble Lords have mentioned, including the noble Baronesses, Lady Wheeler and Lady Pitkeathley, that the role of the carer is vital and often overlooked. As noble Lords know, I have had personal experience of that as a carer. Quite honestly, all I can say is that we are making some early steps in trying to get some of the funding, but I freely accept, from personal experience, that there is a lot more that could be done in that space.

I have tried to give a flavour—before my throat totally gives way—of what we are trying to do in this area. As ever, I will respond fully in writing, but I hope there is an understanding from the Government’s side, as echoed by all noble Lords, that this is something we do take seriously.

[Lord Warner (CB)]

I am sorry to test the Minister’s vocal cords, but he mentioned that there was good practice guidance issued to ICSs. My experience as a Minister is that the department is extremely good at sending out guidance but extremely bad at checking whether anyone ever follows it. What arrangements has the department got to see if that good practice guidance is put into operation?

[Lord Markham (Con)]

The noble Lord makes a very good point, and it is one I have some personal experience of as well. The hope, when setting up 42 ICSs, was that this would be the right size for them to pool resources and take a holistic view, and that 42—while still a lot— would be a manageable number. As Ministers, we have divided those up into seven each that we can get to know, and live and breathe and understand; we also have dashboards that we can use to monitor progress in these areas. That is the way we plan to do that. I freely admit, again, that it is early days; I accept the noble Lord’s point that you can give out guidance until you are blue in the face—and they will receive a lot—but it is the follow-up that really matters.

I thank the noble Baroness again for the debate. I hope there is a feeling that we understand and that we are trying to give the parity of esteem that this deserves, and I look forward to following up more thoroughly in writing.

Committee adjourned at 4.56 pm.

National Immunisation Programme

Lord Markham Excerpts

Thursday 18th January 2024 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

I too thank the noble Baroness, Lady Ritchie, for allowing us to have this debate today. To my mind, this is the right way to do business—for want of a better word. We have smart people who know about the subjects as well as people who have personal experience, and we are having a good conversation about how we can learn the lessons from the situation, make improvements and make sure that we are up to speed with the latest that is going on. Again, I thank the noble Baroness and all the contributors to this debate. I hope that I respond in the right vein.

As many have mentioned, we have a good track record in terms of the standing of the immunisation programme. NIHR is a fundamental piece of that. As mentioned on a few occasions, the horizon scanning by the JCVI is obviously a key part as well. I want to talk later about some of the Covid dividends that I am starting to see in terms of point-of-care medicines, with Moderna and BioNTech using messenger RNA. That goes right to what the noble Baroness, Lady Merron, said about the need to look at the new delivery mechanisms.

The JCVI is key to it all. This debate gave me the opportunity to understand more about the process that it goes through in trying to do that horizon scanning and make sure that we understand what is coming through in the pipeline, what differences it will make and how we evaluate that quickly. We have also commissioned the National Immunisation Schedule Evaluation Consortium to undertake policy research, going upstream even further, looking at the use of different vaccines and schedules.

As I mentioned before, probably the best thing we are doing in terms of the heritage is putting in place the new agreements, which I very much call a Covid dividend, knowing that we will be spending hundreds of millions a year on Covid vaccines for the foreseeable future. Let us make a benefit out of that necessity and get both BioNTech and Moderna to invest in the infrastructure in the UK so that we can do more of this research going forward. That is what I mean by the Covid dividend, as the noble Baroness, Lady Twycross, mentioned. It means looking at the point of care for some cancers, which is particularly exciting. It looks at a person’s particular cancer and cells and then alters and gives personalised treatment. I am sure we are all familiar with some of this. The beauty is that a person’s own body attacks the affected cells, without the blunt instrument of chemo, which kills lots of cells around the cancer as well.

The challenge—this goes right to the point made by the noble Baronesses, Lady Ritchie and Lady Merron, who asked how we deliver and whether the infrastructure is right for doing these sorts of things—is that all of our sudden you are moving from a model of mass production of vaccines in a big factory to individual, tailored creation of vaccines, and often some of the substances are very unstable. In one example I was given, you have only 20 minutes to use it. In that environment, you need to look much more at the real point of care and have a point-of-presence delivery that is not a big factory but where the capability is very close to the patient, whether in a GP or hospital environment, to produce and then deliver those sorts of drugs. In terms of our main learnings, that will be a major dividend from Covid and will transform the whole way in which we deliver our medicines. I hope that, in time, we will see the replacement of chemo in a lot of places with much more specific, delivered medicines.

As I said, I will write about anything I may have missed—as noble Lords will be able to hear, I am very croaky, and I have another debate after this one. In reply to the noble Baroness, Lady Ritchie, I would indeed be interested in hearing the GSK results from the round table. I hope that I have given some reassurance on the infrastructure, but I will give more detail on that as well.

The key point is that, while we can talk about all the sexy stuff in terms of the innovation and treatments, the point made by the noble Baroness, Lady Twycross, from her own experience of issues around MMR, really shows the importance of this. As I mentioned in the debate the other day, I spoke to Chris Whitty specifically about this. It is the most infectious disease out there. We all got used to R rates of 1.1 and 1.2 during Covid. That is a really big R rate, where you know it will be exponential. Noble Lords heard me mention that the R rate on measles is 13, which is massive. One in 1,000 people suffer from brain damage from it, so I completely agree with the noble Baroness that the idea of chickenpox parties is very outdated. I remember them from my childhood. I know that they are reviewing the chickenpox vaccine as we speak.

As I said, we are gearing up on the RSV process. The tender is going out as we speak, and we are looking at delivery this autumn. As I mentioned the other day, it is a different process depending on whether it is for maternal or baby use, or for the over-75s, but we are going through that process.

I will come on to some of the other questions. Thank you for the research; I agree on Steve Russell. The main point made by the noble Lord, Lord Allan, was about user-friendliness. I had my own experience of this when, knowing that I had these debates coming up, I asked the team to get me a schedule of everything that the JCVI has approved. They gave me a list of all these vaccinations, and I had to go back with my tail between my legs and ask, “Can you tell me what all these things are for?”. The noble Lord mentioned AF—I like to think that, similarly, I know quite a few of the abbreviations these days, but I needed them to give me the Noddy guide. The language for those using the app is vital. It is a critical piece to help inform people, especially when they are looking at their records. As the noble Lord is probably aware, the records are currently forward-looking: we need to start getting them to go back historically, and that is something I see a real utility in; it is not there today but it needs to be. The beauty of that is it can be optimised for the target audience. On the question of how we increase uptake in those hard-to-reach areas—as the noble Baroness, Lady Merron, mentioned—the most effective way of doing that to date has been ringing up the parents of under-5s, and then moving on to under-11s and under-25s. Doing that through the app will clearly be more effective in terms of time and money, so that must be the way forward.

The role of community pharmacies is a vital part of delivering point-of-care medicines. I was really interested to hear on one of my trips that GPs in America are really struggling as a profession these days. They cannot recruit them; I asked why not, and they said the problem was that many of the routine things that GPs were making money from had been mass-industrialised by the likes of CVS and Walgreens. This really resonated when the noble Baroness mentioned the app; we need to make sure these vital medicinal and well-being hubs are thriving, and that we do not repeat the American experience. That is why Pharmacy First is a very positive thing for promoting community pharmacies as a place for patients to get care and as a way of improving the finances and commercial viability of these places that I see as key assets.

The question about the AMR benefits of these vaccines was interesting; I do not know the answer off the top of my head, but I will take it away and try to come back with a detailed answer. To conclude—

[Baroness Ritchie of Downpatrick (Lab)]

I thank the noble Lord for giving way. In the fullness of time—I know time is short today—could he give some thought, along with his ministerial colleagues, to the acceleration of the NIP programme so that it is possible to get other vaccines on to it, because of the infrastructure, the funding, the investment and the staff in it, so that we can use the good practice we have to benefit our economy, health and patients generally?

[Lord Markham (Con)]

Yes, I must admit that I need to write to the noble Baroness on the NIP programme because I do not have the detail, but I undertake to do that.

In conclusion, I thank noble Lords; these informed debates have real value. I will take up those points about the use of clear language and acronyms, and make sure that we are accelerating those basic vaccines, which is a vital part of this.

Care Home Staffing

Lord Markham Excerpts

Thursday 18th January 2024 Lords Chamber

[Baroness Pitkeathley]

To ask His Majesty’s Government how they are planning to address current staffing levels in care homes, and any connected delayed discharges from hospital wards and the impact on NHS waiting times.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

We estimate that the number of adult social care filled posts increased by 70,000 in the last 18 months. The Government remain committed to the 10-year vision to put people at the heart of care, making up to £8.1 billion available over two years to strengthen adult social care provision and discharge. Funding is enabling local authorities to buy more care packages, help people leave hospital on time, improve workforce capacity and reduce waiting times.

[Baroness Pitkeathley (Lab)]

I thank the Minister for that reply, but I am not sure that I find it very reassuring. Your Lordships’ House will know that delayed discharges and long waiting times are largely the result of shortcomings in the care sector, especially the shortage of staff in care homes, where international recruitment has been a lifeline. It was therefore a surprise when the Government elected to put further pressure on this sector by increasing the minimum annual salary required for employees applying for a visa, banning them from bringing dependants to the UK and requiring care firms to be regulated by the CQC if they are to sponsor these visas. Far from being broadly relaxed about these proposals, as the Secretary of State for Health claimed, the care sector is most alarmed about how this will affect recruitment, especially as no consultation at all took place before the policy was announced. Will the Minister please further explain to the House how the Government intend to ensure that there are enough staff in the care sector to cover the enormous and growing need?

[Lord Markham (Con)]

The whole point of the title People at the Heart of Care is the recognition that staffing is critical to this. While it is early days, I believe the 70,000 increase in staff over the last 18 months, as I mentioned in my Answer, is a positive step. We had a very positive announcement just last week about the care pathway, setting out a career structure, which has been welcomed. For instance, ADASS, the Association of Directors of Adult Social Services, said that these are

“positive steps to help make adult social care a real career choice now and in the future”.

We really are making advances in this space.

[Lord Allan of Hallam (LD)]

My Lords, as the Minister has likely anticipated, 2024 is going to be a year when we keep hassling him for a long-term workforce plan for social care. Assuming he is not going to announce the imminent publication of one, can I at least ask him to commit to commissioning and publishing an independent report into the potential impact of the visa changes described by the noble Baroness, Lady Pitkeathley? The Government are of course entitled to make it harder to get visas, but they should be upfront and transparent about the downstream effects.

[Lord Markham (Con)]

The Home Office has made an impact assessment of that. It thinks it will impact about 20,000 staff; we recruited about 100,000 last year. The main thing is that, by making sure that only CQC-registered bodies are able to recruit in this way, we are trying to make sure it is done in the correct, ethical manner by high-quality providers, which I think we would all agree is the right approach.

[Baroness Manzoor (Con)]

I welcome the additional care staff that my noble friend mentioned, but there are some real pressures in rural areas where people cannot get carers to come and work. Can he say what is being done about that? Also, because he mentioned it previously, can he give an indication of whether there is a greater number of community hospitals that patients could be discharged into?

[Lord Markham (Con)]

I thank my noble friend for the question. The whole point of trying to develop the career structure that we talk about is to make sure that it is a career that people want to go into across the board, be it in urban or rural areas. Part of that is putting in place about 100,000 training places—this is the first place in the world that has been set up—to try to set up a real career structure. We are starting to see early signs of it working. The number of beds blocked has decreased by 10% in the last few months. It is early days, but it is beginning to work.

[Baroness Murphy (CB)]

My Lords, does the Minister not agree that, while the increase of 70,000 people is very welcome, it is in the context of a turnover of nearly 400,000 every year in care because of the poor career structure? I understand and appreciate that £70 million has been put into training and a care workforce pathway, but does he not agree that it is profoundly inadequate compared with the £11 million a day that is put into NHS nurse training?

[Lord Markham (Con)]

The 70,000 increase is a net increase, so it takes into account the turnover of staff, many of whom rejoin somewhere else in a social care setting. Notwithstanding that, I agree with the noble Baroness that a turnover rate of around 28% is too high in any sector. For about 20% of employers the turnover is only 10%, so clearly some know how to develop a career structure and have motivated staff who will stay there. The intention behind the programme and the career pathway we are trying to set up is to try to get more of that across the system, because retention is key.

[Baroness Wheeler (Lab)]

My Lords, the Minister told the House on Tuesday that hospital discharges have recently been reduced by 10%. However, he knows that this figure goes up and down as some people leave hospital while more come in at the other end, and it depends on which period of time is measured. From July to November last year there was in fact a steady rise, so we need to be specific about dates when we talk about making progress. On the care settings that patients are being discharged to—care homes—how are the Government keeping track of how the extra funding allocated to deal with chronic local staff shortages has supported the discharge process? Will it continue in the longer term?

[Lord Markham (Con)]

The noble Baroness is correct that the numbers are a result of flow. We are seeing thousands more people hospitalised through A&E, so the fact that we have managed to reduce the back end indicates a positive way forward. To measure precisely what the noble Baroness asked about, we have now set up a kind of flight control system for each integrated care board, as I have mentioned, which looks at data across the system to monitor the number of hospital beds and places needed on a case-by-case basis. The noble Baroness is absolutely correct that having that data is key.

[Lord Kamall (Con)]

My Lords, my noble friend the Minister mentioned the importance of a career structure to encourage people to work in the care sector. On the question from the noble Baroness, Lady Pitkeathley, about visas for carers, one issue that has not been addressed is that of personal carers. It is very difficult to sponsor or get a personal carer for individuals, and therefore there is a massive shortage. Can my noble friend the Minister say what the Government are doing to make sure that we can have more personal carers, whether from a domestic workforce or through immigration?

[Lord Markham (Con)]

My noble friend is correct that the recruitment of personal carers is harder. I know that this is close to his heart. I can probably serve him best by giving him a written reply setting out the details of what we are doing.

[Lord Turnberg (Lab)]

My Lords, to make this an attractive job for a care worker, we have to not only give them a pay rise above the national living wage, which is their basic pay, but make this into a profession. If they are professionals, they will then have a career structure that is recognised nationally. Will the Minister encourage that development?

[Lord Markham (Con)]

Yes, I totally agree. That is why we announced this career pathway last week, to try to do exactly what the noble Lord is talking about. It has been welcomed; I quoted from ADASS, but a number of other bodies have welcomed what we are trying to do. We aim to do what the noble Lord said: to make it a profession that people really want to join. There are qualifications for it, advancement and apprenticeships, which are all part of setting up a career structure.

[Lord Swire (Con)]

Does my noble friend the Minister not agree with me that there is still massive potential with the 500 or so community hospitals we have in the United Kingdom? Many are extremely well supported by their local community, and many still retain beds.

[Lord Markham (Con)]

Yes. I have seen a number of really good examples of the kind of step-down care that my noble friend is talking about, or intermediate care that can be used as interim measures. We are trying to bring more of them on board, as well as the very good virtual wards. We have set up 11,000 virtual wards, and they are making a difference as well.

[Lord Watts (Lab)]

My Lords, the Government say that they have done an assessment on the effects of the visa changes. Can he tell us how that was done if the Government did not discuss it or consult with the sector?

[Lord Markham (Con)]

It was a Home Office impact assessment, so I freely admit that I do not know exactly who was consulted; I will happily get back to the noble Lord on that. I know that the assessment looked at all the different parts, including the salary cap and the impact on dependants. For instance, it was not thought that the restriction would have much impact on dependants because not many people come with dependants in the care sector. It looked into each bit, but I will happily let the noble Lord know more in writing.

NHS: Drug Shortages

Lord Markham Excerpts

Wednesday 17th January 2024 Lords Chamber

[Lord Dubs]

To ask His Majesty’s Government what is their response to the reported shortages of NHS drugs.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)]

Medicine supply chains are highly regulated and complex. Supply disruption is a common issue that affects countries all around the world. The department has a range of well-established processes and tools to help prevent and mitigate risk to patients. Most supply issues can be managed with minimal disruption to patients. We work closely with industry, the NHS and others to prevent shortages and resolve any issues that may arise.

[Lord Dubs (Lab)]

My Lords, I am sorry to say that I find that Answer very complacent. We are talking about drugs for the treatment of cancer and comments from the pharmaceutical industry that the situation is the worst it has ever been, with cancer patients and others seriously at risk. Surely the Government should do something to ease the anxiety of people who are seriously ill and depend on these drugs for their lives and their safety.

[Lord Markham (Con)]

I assure the noble Lord that a specific team, the medical supply team, works to manages this across the piece. It is a complex area, as we have said. There are 1,000 notifications a year about supply shortages—that has been consistent over the last so many years—that the team works to resolve. I am sure that, as this debate progresses, we will talk about some of the issues, including getting the MHRA to expedite regulatory approval, working with alternative suppliers, buying internationally where needed—we did that very well last year on strep A—and, where really necessary, introducing serious shortage protocols. It is an issue that we take very seriously, and we are managing it.

[Lord Naseby (Con)]

My Lords, “may” is the wrong word; there is a shortage at this point in time, certainly from the inquiries I have made. Is it not time that we had another look at the existing procedures on recompensing drug manufacturing and maybe producing a new version of the PPRS, which worked extremely well in its time?

[Lord Markham (Con)]

Actually, we recently reached a new agreement with the drug suppliers on this. I think we were all pleased to do that, and it will ensure we continue to get continuity of supply. I have quizzed the team at length on this and asked it to sit down with the British Generic Manufacturers Association, which produced these figures, specifically to understand where there are differences, because I must be honest: the team does not recognise those numbers. We did not see an increase over the last few years. Where there are specific instances, such as ADHD, which I worked with the noble Baroness, Lady McIntosh of Hudnall, on recently, remedial actions are in place to ensure we can manage through the supply issues.

[Lord Cunningham of Felling (Lab)]

My Lords, will the noble Earl please focus—

[Lord Cunningham of Felling (Lab)]

I am sorry; will the noble Lord please focus on pancreatic cancer and say whether he is satisfied with the performance of the National Health Service and others in respect of research into and finding solutions to what in many respects is apparently becoming a notifiable disease and a sentence of death?

[Lord Markham (Con)]

I thank the noble Lord for my proposed promotion. My noble friend Lord Moylan has also raised pancreatic cancer a number of times. To be absolutely honest, this is one of those cases where we are on a journey. I think we have got on top of certain areas, such as prostate cancer, about which we have increased awareness to ensure we get detection early on, but we do not detect pancreatic cancer early enough and, unfortunately, it is then often too late. We are working on something to try to correct that. The noble Lord is quite right to bring it up, and I am happy to write to him to tell him exactly what we are doing.

[Lord Allan of Hallam (LD)]

My Lords, I hope the Minister will revisit his department’s response to the Times today, which comes across as quite dismissive of genuine difficulties that many people across the country have with access to medicines. I encourage the Government to offer a service where people can report their individual experiences of shortages so that they can be aggregated into real-time public reports about what is happening across the country. If he wants an example of what this could look like, he could look at Downdetector, which does something similar for access to internet services.

[Lord Markham (Con)]

I quizzed the team on exactly that Times newspaper report today, because like the noble Lord, they were saying that they did not recognise the numbers that the British Generic Manufacturers Association had produced. I wanted to understand why, and asked the team to sit down with them, and understand the differences, because one side or the other must be right. They are absolutely doing that, and will report back; I will be happy to update the House on the results of that.

[Baroness Manzoor (Con)]

My Lords, the drug Ozempic has been described as a super-drug for the use of diabetic patients, in order to help them reduce weight. My noble friend the Minister will be aware that diabetes costs the NHS 10% of the budget—approximately £25,000 to £30,000 a minute—with 80% of that money spent on treating diabetic complications. Therefore, can my noble friend the Minister say why Ozempic can be prescribed privately but is not available easily to NHS patients as a result of demand and constraints in manufacturing? How can the Government address this?

[Lord Markham (Con)]

My noble friend is correct that this so-called off-label use of these diabetes drugs for weight-loss-type treatments is causing some of the shortages she mentions. That is exactly what we have been tackling, and we have been making sure that the only way you can get the Wegovy weight-loss drug is actually on a very tightly controlled weight management programme normally run through hospitals, and not through normal GPs, exactly to get on top of that issue.

[Baroness Merron (Lab)]

My Lords, there are reports in the media today of pharmacists having to deal with frustrated and worried customers who are faced with shortages of medicines including HRT and the drugs for ADHD, diabetes and cancer. Can the Minister indicate what action is being taken to support and gather feedback from pharmacists who are dealing with such an unsatisfactory situation? What steps are being taken to ensure that, in the future, the supply system is able to cope as soon as demand for medicines increases?

[Lord Markham (Con)]

We find that each one is a different case in point. HRT is an example: we actually saw a 50% increase in demand for it over the last year, so suddenly that is quite a dislocation for the market, and you need to gear up very quickly in terms of the supply chain issues. Strep A was the example last year that we will all be familiar with; normally, it does not come until later in the year, but suddenly there was a very early outbreak in October, which caused the demand there. You find that every single drug tends to be a different case in point. There is a range of tools that they work with; it is working with the NHS, MHRA suppliers and pharmacists, and it is case by case. As I say, sometimes it is the MHRA expediting medicines to get new supply in; sometimes it is working on alternative suppliers; sometimes it is buying internationally—that is what we did in the case of strep A—and sometimes you do have to go as far as the serious shortage protocols, finding substitutes or, in extreme cases, changing doses. There is a range of programmes on it, which by and large are managing to tackle it.

[Earl Russell (LD)]

My Lords, can I ask the Minister specifically about the continued lack of supply of ADHD medication? The department said that the supply shortages would continue until April, when previously it had indicated that this supply issue would have been resolved by now. Do the Government understand the serious impacts that these shortages have, and the impact that the inability some people are facing to get any medication at all is having on their daily lives?

[Lord Markham (Con)]

There are 78 medicines for ADHD, 10 of which are particularly affected. We have put export restrictions in place on that, and we are working it through so that we can hopefully get it resolved by April. It is something we are working very closely on, because we know the importance.

[Lord Bellingham (Con)]

My Lords, I understand the Minister’s department has a cap on total allowed sales of branded medicines to the NHS. I think it will be a 4% cap over the next five years. Is this making the problem worse? Is it exacerbating the problem? Is it something he could look at with his ministerial colleagues?

[Lord Markham (Con)]

I think the cap my noble friend is referring to is actually in terms of the price negotiations on the VPAG and how the rebates kick in. It is not my understanding that is something that is at issue here. We are talking about where there are specific ranges. A study was produced by the Pharmaceutical Research and Manufacturers of America looking at supply issues across lots of countries over the 10 years from 2012 to 2021. The UK was consistently in the top three. Yes, there are some issues that we are working through, but by and large we are consistently in the top three of supply.