Healthcare (International Arrangements) (EU Exit) Regulations 2023
Baroness Wheeler Excerpts(1 year, 4 months ago)
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Baroness Wheeler (Lab)
My Lords, I thank the Minister for his introduction to the SI and the other noble Lords who have spoken to it. For the record, we wanted to look very closely at it, given the discussions, commitments and reassurances made last year by the Government and the then Health Minister, the noble Baroness, Lady Penn, about the Government’s policy intentions on reciprocal health agreements during the passage of what is now the Health and Care Act.
We had strong concerns that any provisions under the Act which reflected post-Brexit arrangements should be confined to the implementation of reciprocal healthcare arrangements, not to the negotiation of international health agreements which could be used for wider and different purposes, such as the privatisation of parts of healthcare. The Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 included explicit constraints to make such agreements on the powers of Secretary of State in this regard. We also had concerns that the new arrangements should not change the definition of future reciprocal healthcare agreements.
Reassurance from the Government that the purpose of the 2019 Act was not to implement trade deals and that reciprocal healthcare agreements do not relate to the commissioning and provision of services for the NHS were very welcome. We are therefore content that the SI properly reflects this; I thank the Minister for his reassurances in his opening remarks. We are also pleased that the affirmative procedure ensures that Parliament is able to be kept up to date with developments and that these issues are properly debated.
The Explanatory Memorandum is very helpful. I look forward to the Minister’s response to the issues raised by the noble Lord, Lord Allan, about scope, because they are important.
We recognise that the regulations are vital to implement international healthcare agreements following our exit from the EU. Reciprocal healthcare agreements support people to access healthcare in the listed countries. Those faced with the stress and worry of a healthcare emergency abroad will rightly expect suitable arrangements to be in place where possible. That is particularly true of people with a disability, those who are older or who live with a pre-existing or chronic health condition.
The amendments to the Act allow the Government to implement more complex agreements with the ability to make financial reimbursement at cost, as the UK currently does with many EEA countries, and confer further powers on the Secretary of State. Can the Minister outline further details about the Government’s plans for other international healthcare co-operation outside the EEA and Switzerland and what these plans might look like?
From our understanding of the SI, we think that payments can be made only if both the following conditions are met: the healthcare treatment is in a country with which we have an international healthcare agreement, and the Secretary of State considers that exceptional circumstances justify the payment. Can the Minister explain the Government’s thinking on what would constitute exceptional circumstances and how the policy framework might work? What guidance is being issued by the NHS Business Services Authority, which has certain administrative functions conferred on it through the SI?
The public consultation on the policy has just closed but we understand that the results and an analysis of it will be published this month. An early indication of the timetable and results would be welcome.
On the role of the NHS BSA, can the Minister provide more detail on the work currently undertaken to establish and maintain the public information and advice service on healthcare provision under relevant healthcare agreements, as set out in the SI? Again, the noble Lord, Lord Allan, mentioned this important function. The importance of transparency has been underlined. It will be crucial in the future to help people understand how reciprocal healthcare agreements work and can be accessed, to ensure they are doing all the right things to be properly covered, and to make claims, as the noble Baroness, Lady McIntosh, said.
I look forward to hearing answers to the questions about the issue of EHIC and GHIC. Specifically, can the Minister update the House on how the transfer from EHIC to GHIC has worked and whether any complications have been experienced—for example, the impact of the non-application to the UK of the EU cross-border healthcare directive, which enabled UK patients to pay for qualifying private healthcare in Europe and to receive reimbursement up to the amount that the treatment would cost the NHS? UK travellers can now no longer seek reimbursement, and I wondered if there had been any instances where the lack of awareness of that has caused problems—for example, for patients needing kidney dialysis where reimbursement for private treatment has not been allowed.
I appreciate that the Minister might need to come back to me on that. I think we are about to have a vote, but I look forward to his response.
Lord Markham (Con)
I will try my best, potential votes notwithstanding. I thank noble Lords for their contributions to today’s debate and for the generally received welcome. To try to answer them in turn, on the point made by the noble Baroness, Lady McIntosh of Pickering, I believe the arrangements made with the EFTA countries were signed on 30 June 2023. The expectation is that they will become operational by the middle of 2024—saved by the bell.
Dementia Palliative Care Teams
Baroness Wheeler Excerpts(1 year, 5 months ago)
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Lord Markham (Con)
Dementia is an important part of the major conditions strategy and obviously there will be more coming out of that going forward. As I said, the Health and Care Act made the ICBs firmly responsible. Some are excellent examples, such as Derbyshire; for the others that are not, it is very much our responsibility in the centre, and I include Ministers in that. I have mentioned before that each of us has six ICBs that we look after, and part of our job is making sure that they are commissioning to the standards they need to.
Baroness Wheeler (Lab)
My Lords, the ONS figures showing that dementia and Alzheimer’s were the leading cause of death last year make it even more urgent to get dementia palliative care right. Given average life expectancy in care homes, what steps are the Government taking to ensure the Care Quality Commission has sufficient oversight of end-of-life care for people living with dementia?
Lord Markham (Con)
It is absolutely one of the things that it has to do. We are at the forefront of this. We are backing the Dame Barbara Windsor Dementia Mission, and have doubled the funding to £160 million to make sure we are doing more research in this space. There is a lot more to do but there are a lot of good examples of work as well.
Mental Health Services: Huntington’s Disease
Baroness Wheeler Excerpts(1 year, 5 months ago)
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Lord Markham (Con)
I have learned in the process of researching this that it is absolutely vital that commissioners understand what the patient pathway needs to be in each area. That is why we have tasked the NHS with a neuroscience transformation programme to set out those care pathways.
Baroness Wheeler (Lab)
My Lords, we know that people living with Huntington’s disease, and their families, are faced with significant challenges throughout their lives. Many young people grow up in the shadow of the disease, are caring for their relative while worrying that they will get the disease themselves, and often face daunting choices around starting a family and genetic testing. All this underlines the need for mental health care and support for all the family. What steps are the Government taking to ensure that NHS mental health trusts take a whole-family approach to this vital issue?
Lord Markham (Con)
The noble Baroness makes a very good point; it is a whole-family problem. The investment we are talking about, in allowing us to access 2 million extra mental health patients, is about making sure we have got the numbers. The digital therapeutics are another way we are making sure there is access. The specific point the noble Baroness makes about looking at the families of people with Huntington’s disease is a good point that I will take back.
General Practitioners: Recruitment and Retention
Baroness Wheeler Excerpts(1 year, 5 months ago)
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Lord Markham (Con)
The primary care plan was a very good example of something new, substantial and backed by £1.2 billion of investment to beat the 8 am morning rush and use technology—which I know the noble Lord is very interested in—to allow people to self-help in a lot of these situations.
Baroness Wheeler (Lab)
The Minister will know that the Health Foundation independent think tank summed up the Government’s recent primary care recovery plan as falling
“well short of addressing the fundamental issues affecting general practice”.
Staff shortages and the sheer number on NHS waiting lists are a key reason for such high demand on GP services. Do the Government accept that, unless they urgently get a grip on waiting lists, the crisis in general practice will only deepen?
Lord Markham (Con)
What we totally accept and believe is that primary care is where a stitch in time saves nine, to take that saying. That is why I believe that the primary care plan is a big step forward. As I said, the fact that we are doing 10% more appointments per day is significant, as is the Pharmacy First initiative that we have announced, which will bring on stream another 10 million appointments a year, allowing people to navigate whether a pharmacy is the best place for them to get treatment, in which case they can go there first. These are all practical plans that are in place and are making a difference.
Sodium Valproate
Baroness Wheeler Excerpts(1 year, 5 months ago)
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Lord Markham (Con)
The regulatory authorities absolutely work closely here. It is my understanding that it is the intent of all the devolved Administrations to make sure that while there are circumstances in which this drug might be the correct treatment, as I mentioned, it is used only when everything else has been tried—and, in our case, in England—that two independent specialists will be required to prescribe it.
Baroness Wheeler (Lab)
My Lords, ensuring that patients’ decisions are based on informed consent and shared decision-making with their doctors and pharmacists is vital, especially in relation to the exception to ensuring that valproate is always dispensed in its original packaging. What steps are the Government taking to raise awareness among the health professionals involved and ensure that there is a properly joined-up approach to the advice and treatment given to the patient? How is data collection on this issue being improved, so that the effects of the safety measures and issues can be fully identified and addressed?
Lord Markham (Con)
The noble Baroness is correct. In terms of data, it is vital: first, that we have a register of all the people who are taking valproate so that we can be sure that the information is there; secondly, that we then keep a record of where patients have signed the annual acceptance; and, thirdly, that we are gaining data on testing. The latest suggestion is that we should also be looking at males taking valproate because there is evidence that it can, through their sperm, cause difficulties in pregnancies. On all those factors, data is central and we should make sure we collect it.
Medical Devices (Amendment) (Great Britain) Regulations 2023
Baroness Wheeler Excerpts(1 year, 5 months ago)
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Lord Allan of Hallam (LD)
My Lords, these Benches also welcome the Minister’s introduction to this statutory instrument. I am starting to get used to being presented with a statutory instrument and told, “You can either support this or the sky could fall in on the heads of some part of British industry tomorrow”. It is a fairly straightforward choice: of course we support the statutory instrument going ahead to allow the medtech sector a little more breathing space.
A number of questions have already been touched on about where we are going. The first is a specific one. The MHRA has said that the start date for the new UK regime is 1 July 2025, after which, as I understand it, no new devices with CE marks will be recognised. The existing ones will roll over, as we are discussing today, but post 1 July 2025, any new devices coming onto the market will need the UKCA mark. I have had representations from people in the industry who think that that is what the collective information they have received means, but it would be helpful if the Minister could clarify that: that after 1 July 2025, the new UK regime is in place and new CE marks will not be recognised after that date.
The second question is one correctly raised by the noble Lord, Lord Hunt: where the capacity to carry out the assessment will come from. Of course, the will is there, but what if the staff are not? The Minister is used to discussing in this House staffing across all different aspects of the health sector. This is another aspect where specialist staff will be needed. I am particularly mindful of the Minister’s introduction, when he talked about the important role of software now in medical devices, many of which are software controlled. That is a specialist and high-value area, and it is important that we get some assurances that there will be the capacity, or the Government have a path to developing the capacity, to have people who can do the approvals, particularly of sophisticated software-controlled devices and—dare I say it—flavour of the month, artificial intelligence-controlled devices, which will be embedded in future. Again, that is a very high value, specialist function. MHRA will need to have the capacity to certify devices that use artificial intelligence and other sophisticated forms of software.
The third question is a very specific one about class 1 low-risk devices, which, as I understand it, are things such as wheelchairs and stethoscopes. Again, it would be helpful if the Minister clarified what is intended here and how they fit into the transitional scheme that is being extended today.
The fourth question is about labelling. It would be really helpful for people in our medtech industry who are seeking to export to understand how labelling will work, and specifically in the context of the Great Britain/Northern Ireland question. The Minister referred to medical devices for the Great British market. There is an issue of intonation here: is it the “great British” market or the “Great British” market? I think in this case it is the latter: the market of Great Britain, not Northern Ireland, because of the arrangements we have there. It is really important that people who are making devices understand how labelling will work, particularly if they are selling devices across the island of Ireland, where they are in the Northern Irish and Republic of Ireland markets, but also exporters more generally.
The final issue I think is interesting is information-sharing and government distributing information to the sector. Paragraph 12.4 of the Explanatory Memorandum says that there will be
“some costs for the industry associated with familiarisation with the regulations”.
I think it is much bigger than that, and the noble Lord, Lord Lansley, was quite right: the industry needs to understand the direction of travel, particularly around convergence/divergence. The sector, which, as the Minister rightly said, is an important one in the United Kingdom as a whole—not just in Great Britain, in this case—is in a very different place and needs the information now that will enable it to plan. For example, if a UK-based entity will in future be trying to conform to two very divergent regimes in the EU and Great Britain, it may well want to structure accordingly. It might want to have separate legal entities in the EU and the United Kingdom. The situation would be quite different if the message the Government are giving is that there will be the kind of convergence the noble Lord, Lord Lansley, talked about, whereby approvals might be transferable.
The sector needs to make those kinds of decisions quite quickly. We are talking about an extension of the CE mark to 2030 but, as I said in my opening question, we are talking about the new British regime kicking in in 2025. That is not far away in business terms, so it is extremely important that we get some clarity from the Government—to the extent that they can give it—about the future direction of travel and whether they hope for or aspire to a regime of mutual recognition or instead anticipate that it would be quite divergent.
We need information not just about the technical details of what these regulations mean today but about the direction of travel and how approval processes may be changing over time, which is important. As I said, we will not oppose a statutory instrument that needs to be in force by 1 July to stop the sky falling on people’s heads, but I hope the Minister will take this opportunity to answer some of the questions that people building businesses in the United Kingdom and elsewhere need answers to in order to get essential devices. That kind of information would help them to plan and be most effective in supporting patients.
Baroness Wheeler (Lab)
My Lords, I thank the Minister for introducing the SI and other noble Lords who have spoken today. Those of us involved in the somewhat tortuous passage of the Medicines and Medical Devices Act 2021, and subsequent SIs designed to bring about the transition from the previous, easily understood CE assessment under EU legislation to the UK conformity assessment marking system for medical devices, knew and predicted that the new and complex system needed much more time to develop the new arrangements and work out how they would work, and that the deadline set by the Government for transition would inevitably have to be extended. This last-minute SI fully recognises this, although many questions and issues remain unclear, as we have heard.
Given the complexity of the assessment marking system and what is proposed in this SI, I thank our Secondary Legislation Scrutiny Committee for setting out concise reasons, which were clearer than the SI’s Explanatory Memorandum, about the key points of what the SI seeks to do and why the seven-year extension for some medical devices is needed. On the reasons, the committee says:
“The extension is partly in response to a Europe-wide shortage of assessment capacity for these and other goods and also due to the Medicines and Healthcare products Regulatory Agency’s intention to strengthen the future regulatory framework for medical devices … in a way that both improves safety while also enabling innovation”.
I would be grateful if the Minister could comment on the Europe-wide shortage and the impact that it is currently having.
We have seen today that nobody is at all clear about what is going to happen, when the work and the timelines for MHRA’s new framework will be ready and when the extensive reform that will apply from 2025 will be published. I look forward to the Minister’s explanation of what paragraph 7.3 of the SI Explanatory Memorandum anticipates are the steps the MHRA will take
“to build approved body capacity to meet the demand for UKCA … marking”—
to which a number of noble Lords referred—in order to achieve the capacity when the transition periods after 2025 expire for the relevant medical devices. The capacity covers in particular the ability to assess higher-risk medical devices which we are not yet in a position to assess.
Paragraph 6.9 of the memorandum refers to the MHRA’s intention to lay “further instruments” under the MMD Act and “significant amendments” to regulations. Can the Minister update the Committee on the proposed timetable for this? Is the consultation exercise undertaken last year still under consideration by the MHRA as part of its developing policy? Will a further consultation on the MHRA’s new framework proposals be undertaken and, if so, what is the timescale for this?
The SLSC points out that the MHRA’s plans for reform are extensive. My noble friend Lord Hunt referred to them: reclassifying products, gathering information at the point of registration, strengthening surveillance, better incident reporting and so on. The committee stressed that these are excellent aims, but how and when the MHRA will achieve them—or try to—remains unclear.
The SLSC also refers to the MHRA’s current slow progress: it still does not have estimates of the total number of registered medical devices that are UKCA rather than CE marked. Of the 789,581 new medical products that were registered with the MHRA between April 2021 and March 2022 only just over 9% were UKCA marked. Is the Minister confident that this rate of progress will enable the MHRA to have a proposed new scheme in place in 2025 for transition to 2030?
Lord Markham (Con)
Yes; that is what I mean by pooling capacity, for want of a better phrase. My noble friend is saying that we can effectively use the EU’s capacity if we are willing to accept that it is doing proper scrutiny and measurement of products. By and large, we would all agree that that is a sensible approach, just as, similarly, there are situations in a lot of clinical research where, even if the regulators want a final sign-off, accepting each other’s data has to be sensible in terms of pooling capacity.
As ever with these things, it takes two to tango. We need to prove willingness on our side. I hope that the recent Windsor Framework agreement is a way to put things on a co-operative basis. Building trust on both sides takes a series of steps but we are trying to put our best foot forward and we hope that that is met in response.
This goes to the point about the EU-wide shortage of approved body capacity, which impacts us all. If, as we all agree, we want the best supply of products here, it must clearly be a concern if they cannot get through that way. If a company is finding that, through a lack of capacity, they cannot get through the EU route because there is no capacity there, it now has the opportunity to take the UKCA route if our capacity is in place, with the increases to the MHRA to which I referred.
Baroness Wheeler (Lab)
When the Minister writes—I understand that this is very complex; I would certainly appreciate having it in writing—could he refer to three things? The first is small businesses; the SI says that it will not have an impact on them but it is clear that it will. When? The second is the timetable for the new MHRA framework being in place, whether there will be consultation around it and whether that process is separate or uses the consultation that took place last year. The final issue is that of the timetable for the new MMD regulations—that is, the timescale by which we will see them coming along. It will help us make sense of the totality of this if we know when all this work is coming forward.
Lord Markham (Con)
It is probably best if I write on those points. In terms of timing, the MHRA is planning a further consultation on its future regime from October, but I will come back on those other points.
New Hospitals
Baroness Wheeler Excerpts(1 year, 6 months ago)
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Baroness Wheeler (Lab)
My Lords, I thank the Minister for reading out the Statement. It has been clear for the last year that we would have to come to this moment of the Government finally admitting that achieving their 2019 manifesto pledge for 40 new hospitals by 2030, under the new hospitals programme, was never on the cards, and that reality would have to take over. The Government must face the reality of the timescales and the scale of the money needed to address the NHS’s crumbling estate, and the reality of needing to prioritise and address the urgent rebuild and major maintenance problems of existing hospitals throughout the country, which are seriously endangering patient safety and the public.
This morning, it was reported that the announcement of the Government’s realisation of not being able to keep their promise was delayed
“because of fears about a backlash from Tory MPs”.
Was that vital information kept from the public because of such fears? Can the Minister tell the House when the target was abandoned internally?
We know that NHS maintenance costs have more than doubled, from £4.7 billion in 2011-12 to £10.2 billion in 2021-22, and about the dire condition that many hospital buildings are in. For example, Leeds Teaching Hospitals saw over 100 raw sewage leaks last year, including faeces leaking into wards and patient rooms; Hampshire Hospitals NHS Foundation Trust was forced to suspend some services because of a rat infestation; and the hospital in King’s Lynn, Norfolk, is one of the most prominent hospitals that has had to be propped up with steel and timber supports to stop its dilapidated roof caving in.
Do the Government have an estimate of how much they expect NHS maintenance costs to continue to rise until 2030? Is there a full overall strategic plan for this and the now-reprioritised 40 new hospitals programme? If so, when will it be published? After government announcements on the programme, only in February described by the Minister opposite as “world-class” and capable of being exported “around the world”, we have become familiar with the idea that the hospitals were not new, that many were not even hospitals and that “new” could include repairs and redecoration.
The Nuffield Trust put the number of new hospitals in the Government’s original programme—meaning those that we would all recognise as new—as three, not 40. The National Audit Office called the programme unachievable, and NHS Providers estimated the real costs of building new hospitals as £20 billion, not the £3.7 billion allocated by the Government. Can the Minister commit to publishing the latest estimate that his department has made of the cost of the now-revised programme? Can he now say specifically which of the new hospitals in today’s Statement are being kicked into the long grass beyond 2030?
The slow progress being made was clearly evident last February when it emerged that only 10 of the projects even had planning permission. Just last week the BBC reported that building work is yet to start for 33 of the 40 projects promised. Will the Minister commit to coming back to the House with detailed implementation, timescales, costs and scope of what is now proposed? The fact is that the programme has been hit with delays and uncertainty for years, and the longer this goes on, the higher the costs soar and the less likely it becomes that they will ever be built. Most of the hospitals in the programme are still waiting to hear what their final budget will be, and none of the six that were supposed to be ready for 2025 has full planning permission or funding yet.
On the seven hospitals built with reinforced autoclaved aerated concrete—RAAC—the Government acknowledged in December the enormous concerns and safety implications and committed to eradicating this from the NHS estate. The Government have now officially recognised what we all knew—that these hospitals are not safe to operate beyond 2030. We welcome the news that they will all be completely rebuilt and the promise that this will be fully funded. Can the Minister tell the House the specific funding that is to be committed to the seven hospitals? Can he also tell the House when we are to receive the full details of the new, reprioritised plan so that it can be properly scrutinised and assessed by this House?
Lord Allan of Hallam (LD)
My Lords, when I worked in business we had a maxim that we should always try to undercommit and overdeliver as a way of pleasing clients. It feels like the opposite is applying here, with the Government scrambling to show that they are not underdelivering on their overcommitment. Of course, 40 hospitals was a classic election promise, oversimplifying a much more complex need, with the reinforced autoclaved aerated concrete hospitals being one of those such complications that emerged once they had turned over the aerated concrete block.
I do not expect the Minister to comment on the election promise, but I hope he can comment further on three aspects of the Government’s programme that he has set out. The first is the modular hospital design approach, which certainly seems a very smart way to proceed if it can provide more and better-quality hospital capacity at lower cost. Of course, any negative impact of failures in design will be multiplied if you are using a similar, consistent design. We should remember that RAAC was the future once, and public buildings were built according to that specification because it was seen to be cheaper and better back in the 1950s and 1960s. What assurances can Ministers give us that they will get it right this time and that the modular approach being used everywhere is the right one? By the way, on branding, 2.0 is now very 1.0, and it might be more appropriate to call it “the metahospital” or “Hospital.AI” these days.
The second is the planning process, which the noble Baroness, Lady Wheeler, raised. It does not matter if the modular design allows much quicker construction if everything is held up in seeking the relevant permissions to build the hospital in the first place. I would be interested to hear how many of the schemes have been given planning permission already and the extent to which the Government see planning as potentially a disruptor to their plans.
Finally, on the risks, if there are delays or cost overruns, which we hope there will not be—but inevitably one sees those with schemes of this kind—I look for assurances from the Minister that the contracts are written in such a way that any additional bills will not fall back on the taxpayer and, crucially, that if some schemes overrun or get into difficulties and incur extra costs, it will not mean that other schemes in the programme have to be cancelled as the overall budget runs short.
Lord Markham (Con)
I thank noble Lords for their comments. On a personal front, this is a project I have been working on directly. It is very close to my heart and is something that I am delighted to be able to put forward. I would like to mention a couple of hospitals that probably did not get quite the prominence they deserved in the earlier Statement, which happen to be quite close to my heart as well: the North Manchester General Hospital, which is one of the Cohort 3 hospitals. I have worked closely with Manchester City Council in the past on the redevelopments around Manchester Mayfield, and that is very much part of the plans. Also, being an ex-deputy leader of Westminster Council, I am excited by the plans around St Mary’s, where we are looking at a couple of alternative sites. That will be in conjunction with the plans for the refurbishments of Charing Cross and Hammersmith so we have got three hospitals in one. Just to clarify an earlier statement: the surgical hub is planned for Chorley and South Ribble Hospital rather than the Royal Preston Hospital.
I am not quite sure on the point from the noble Baroness, Lady Wheeler, about the target being abandoned. What we were saying before was not that at all. We were saying we are positive about how it is progressing. To the point from the noble Lord, Lord Allan, about overpromising and underdelivering, I am sorry for the branding of the hospital 2.0 approach, and I take the blame for that. In terms of MMC, I was at one of the plants the other day, and it really is amazing the way its builds them and the speed with which they will go up. Many buildings have built like that for a long time. When I was up there, I saw them constructing the new Everton stadium, which is just one example. I believe that they will give the necessary speed we need for them all.
In terms of the funding, the estimate, as mentioned, is more than £20 billion. Each hospital has an indicative allocation. They are fully funded. We are not publishing them for obvious reasons: when you go out to tender, you do not want to tell the marketplace what you are expecting to pay. I hope noble Lords understand the reason for that. I am confident that the funding is in place. The hope in all of these things, as we have seen in the prison space and the schools space, is that if the first hospital costs £100 to build, the next one costs £95, the next one £90, the next one £85 as you get the economies of scale. So, you should be seeing 20% to 25% reductions, as you do a large production line. The benefit of all this is that there is such a mass volume of them all that you get the economies of scale. I genuinely hope that this will become the way we build hospitals for generations to come. It is very much cross-party, something that we all believe is a good way forward.
Some hospitals, as mentioned—as part of the timing and to try to make sure it all works in terms of the funding envelope—have been pushed into the 2030-35 bracket. They were mentioned in the Statement, and we have been speaking to them about that. They include Eastbourne, the Royal Berkshire, all the ones around St Mary’s with the complications there, Lancashire and Charing Cross to name just a few. In all those cases, they understand the reasons, and I think most people understand the need to prioritise the RAAC hospitals as a matter of absolute urgency.
On the questions about the planning process, we are on target. Obviously, you do not want to get planning permission too early, given the time it takes. In all the programmes I have seen, we do not yet have planning permission because we do not yet need it. I am confident that we are on track. We know that there are always X factors in these types of projects but, when you have so many, you want the flexibility to move some forward and some back, in a portfolio-type approach. That is well known when you are running as many projects as this.
At this stage, in all honesty I can say that we are as confident as we can be that we are on target to build them. Undoubtedly, there will be bumps in the road, and we are grown up enough to know that there are challenges, but I can say with a high degree of confidence that this really is the best approach. We will have world-class hospitals that will be state of the art, not only in their design but in their use of digital technology. A hospital today that is fully digitised costs 10% less per patient. With these hospitals, we should be looking at savings of 20% or more. That will really make a material difference to how we treat patients, increase productivity and be seen as the real way forward. I am very hopeful that the economics will become so compelling that this programme will not stop at 40 hospitals—in fact, 45, because of the extra ones we have brought in—and will become a rolling programme across the whole estate.
I am sure that we will have many more questions on this. As I say, it is my pet subject, as the priority lead, so I would be happy to talk about it in greater detail at a suitable juncture.
Baroness Wheeler (Lab)
Can the Minister say something about NHS maintenance costs, which I did ask about? I do not have the actual question in front of me, as my speech has just been taken away, but if he would like to write to me on that, it would be helpful.
Lord Markham (Con)
Yes, I will happily write. We are spending a record amount in capital. The current capital budget is about £12 billion, which is a 50% increase on 2019. Speaking of underpromising and overdelivering, believe it or not, we have been hiding our light under a bushel regarding the hospital upgrades. Just this morning I visited Frimley, one of the RAAC hospitals, and they said, “Oh, we’ve just had a new hospital at Ascot”. We have not called that a new hospital but they refer to it as such, and when you see it, it is a new building. It is not massive, but by most definitions it is a hospital.
I will happily provide that extra detail and information. We know that there is a lot to be done on maintenance, but we are putting more resources into it.
Branded Health Service Medicines (Costs) (Amendment) Regulations 2023
Baroness Wheeler Excerpts(1 year, 6 months ago)
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Baroness Wheeler (Lab)
My Lords, I thank my noble friend for his usual expert and comprehensive explanation of his regret Motion on this SI, which is so important for the future of the NHS and the UK’s pharmaceutical industry and life sciences sector.
While the Government’s argument for maintaining equivalence between the two schemes makes sense, we certainly do not want companies to choose to leave the voluntary scheme for better rates. We on these Benches fully recognise the strong concerns about the impact and potential damage that the 27.5% clawback rate will cause to the manufacturer of branded medicines, to the availability of those medicines to the NHS and its patients and to future investment in the research and development of new drugs.
I point out that this is the first opportunity, on such an important subject, that we have had to discuss in depth the key issues my noble friend and other speakers across the House have raised, since the short Grand Committee debate last October on pharmaceutical research and development spending. The Minister will recall that it was his first debate as Health Minister and that he surprised us all by bursting into maiden speech mode when he summed up the debate. He expressed his confidence that the Government
“through Life Sciences Vision … will develop the end-to-end improvements required to attract an ever-growing proportion of pharmaceutical investment to the UK”.—[Official Report, 13/20/22; col. 135GC.]
He also made the acknowledgement that growing the UK’s proportion of global pharmaceutical investment meant improving
“every aspect of the life science ecosystem”.—[Official Report, 13/20/22; col. 133GC.]
As my noble friend and other expert speakers have shown today, this is just not happening.
The continuing dramatic decline in the UK’s share of global pharmaceutical investment is clear evidence of this, causing the loss of billions of pounds to the industry over the past 10 years. We have heard the stark figures. The NHS faces huge challenges and obstacles to becoming an effective innovation partner in supporting the access to and uptake of new and innovative drugs, which are so critical to developing better outcomes for patients and creating a thriving life sciences ecosystem. If the NHS continues to be slow on the uptake of innovative medicines and treatments, the UK could lose its position as a world leader in life sciences, particularly with the rapid advancements in biotechnology and AI.
For the UK to become a destination of choice for cutting-edge research, urgent action has to be taken to reverse the sharp decline in industry clinical research trials within the NHS and to address the standstill we have reached in developing the comprehensive strategy on patient data and research that is vitally needed. We need to balance the safeguards for patients and public engagement with the ability of accredited researchers to access the data they need to develop the valuable research at the heart of innovative medicines and treatments. What consideration are the Government giving to further embedding research within the NHS, both to underline the importance of patient participation and to allow a more direct link between health and science? During Covid we saw how, with the right drive and attitude, this can be done successfully for vaccine development, with life-saving results.
That is why the background and context of the proposals in this SI are so important. Despite the “remote” risk optimism of the impact assessment, and all the flaws that noble Lords outlined, the SI’s proposals for a substantial clawback, in 2023, of net sales income for UK biopharmaceutical companies greatly increases the risk of them reducing their current level of R&D investment. I look forward to the Minister’s explanation of how other countries that have similar clawback schemes—Ireland, Germany and Spain—managed to keep their clawback rates considerably lower than half what is proposed in the UK. This was mentioned by a couple of speakers. What assessment have the Government made of the impact these lower rates would have on investment in the UK? Why do they think that AbbVie and Lilly chose to leave the voluntary scheme?
In 2023, manufacturers of branded drugs in the voluntary scheme will be required to return almost £3.3 billion—or 26.5% of sales—to the Government, up from around £0.6 billion in 2021 and £1.8 billion in 2022. ABPI says that this means that the money spent on branded drugs has declined by 14% in real terms over the past decade, despite rising demand. The noble Lord, Lord Warner, pointed out that, overall, the savings to be made are minor when compared with the likely damage.
On the consultation exercise, I look forward to the Minister’s explanation of how 39 days of consultation over the Christmas period was sufficient to provide this. This is made even starker by the fact that 32 out of 33 respondents opposed the proposals. One thing we know businesses need in order to invest their money is certainty, but they are not getting it.
Finally, today’s discussions have made a convincing case for taking a long, hard look at the current scheme and how it is working. Negotiations are under way for the new voluntary scheme for pricing, access and growth, and we will watch them carefully. The priority must be to find a solution that allows patient access to the best-quality treatments, with good value for the NHS and taxpayer, while ensuring a fair return for the industry. We need to secure arrangements that will build confidence and provide mutual benefit for the NHS and industry. Can the Minister provide an update on the early talks or negotiations that have taken place? I noted the comments of the noble Lord, Lord Warner, about how this SI’s approach could be paused in the light of any significant developments that are likely to take place.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
I thank noble Lords for the debate, and I particularly thank the noble Lord, Lord Hunt, for bringing forward this important subject. It was clear from the contributions of noble Lords that we all want the same thing here, and this is a discussion about how best to achieve it. We all want the UK to be a
“science and technology superpower by 2030”,
as quoted by the Prime Minister. We all want a thriving life science sector, we want access to the best medicines for the NHS and we all want to ensure that the NHS is achieving value, in terms of money for the front line—I think we are united on those things. I also commend the fact that this debate was very much a discussion, so I will respond in that vein, rather than reading out a speech. I will try to discuss this from the Government’s point of view. I apologise if that means that I might not come across as quite as polished, but I would rather respond directly to the points raised.
We would all accept that we are striking a delicate balance here: between having value for the NHS—through, for example, the funding of £2.5 billion this year—and having value and making savings for frontline services, which we all want to see. While we are focusing on those, we also want to make sure that we do not go too far and damage what is, and what we want to be, a thriving sector.
The noble Lord, Lord Hunt, asked whether the Government are being complacent about this. The words of the Prime Minister, saying that he wants a negotiated outcome with the ABPI, are probably the strongest sentiment in terms of wanting a sensible, negotiated outcome. At this point, I say to the noble Lord, Lord Warner, that I am responding on behalf of the Government.
As the noble Lord, Lord Warner, pointed out, just today, the Chancellor is having a round table with the life sciences industry. That, too, is very much about getting a solution that works all the way round. Having said that, please remember that some of the comments I am making in this debate are about a balance. We are all aware that we are entering into a negotiation and obviously, in any negotiation, sides make points—sometimes at the negotiating table and sometimes publicly. Please take my comments in that vein; we want to make sure that a balance is brought to the debate.
Pharmacies: Medicines at Home
Baroness Wheeler Excerpts(1 year, 6 months ago)
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Baroness Wheeler
To ask His Majesty’s Government what steps they are taking to ensure the provision of essential services provided by pharmacies, particularly the assembly of blister medicine packs, to support the safe administration of medicines at home by patients, care workers and unpaid carers.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Markham) (Con)
Pharmacies in England do an incredible job, dispensing over 1 billion medicines every year and supporting patients with their medication. Where appropriate, that includes blister packs or other medicine adherence aids. To support patients with taking their medication, we have introduced structured medication reviews in general practice and extra support in community pharmacy. On 9 May, we announced an additional investment of up to £645 million in community pharmacies over this and next year.
Baroness Wheeler (Lab)
My Lords, given the urgent need to get thousands of people out of hospital and provide care and support in the community and in their homes, it is surprising that the Government do not recognise the importance of having a national or local data overview of the scale of funding for this essential core service for home care, which is being withdrawn from hundreds of chemists across the country. Hard-pressed domiciliary care workers, providing daily care to thousands of people in their homes, depend on blister packs to administer medicine safely. They will not have the time to sort out multiple medicines each day for their clients, or to risk responsibility for possible mistakes and overdosing. Are the Government saying that, in the future, it is okay for the complex task of sorting out daily medicine doses to be yet another burden placed on unpaid carers, on top of everything else that they have to do? How will people living on their own be able to cope and stay safe?
Lord Markham (Con)
NICE and the Royal Pharmaceutical Society are clear that they do not recommend widespread adoption but prefer a case-by-case basis. There are many examples of where blister packs are not appropriate: some pills cannot be stored next to each other, some pills need to be stored in their original packaging and some blister packs cannot have more than four pills. So it is clear that you need a case-by-case review to make sure of what is right for the patient.
Recovering Access to Primary Care
Baroness Wheeler Excerpts(1 year, 6 months ago)
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Baroness Wheeler (Lab)
My Lords, I thank the Minister for reading out the Statement. No one can be in any doubt that patient access to primary care needs a great deal of recovering from the dire situation patients across the country find themselves in today. Millions of patients wait more than a month to see a GP—if they can get an appointment at all. Some 65% of the public think that access to GP services is getting worse, and over 40% report that they have to wait too long to see a GP. The 9 am rush and scramble to get an appointment, or even a response, is the reality for thousands of patients each day. Often, they are waiting in pain and discomfort, unable to go about their daily normal lives. While they wait, an illness goes undiagnosed and untreated, potentially getting ever more serious.
In today’s Statement the Government once again recognise the major role community pharmacies can play in relieving the pressure on GP appointments and primary care. As we have made clear, we fully support and welcome this extended role, including allowing pharmacies to provide prescriptions and routine health checks, and opening up more referral routes to NHS specialists, such as physios for back pain. However, only yesterday in the national media we heard that 670 community pharmacies have closed and the number of pharmacies across England is now the lowest since 2015, and about the impact caused by rising costs, major staff shortages and the 30% cut in government funding to date—all despite growing demand for services. The industry estimates a £1.1 billion funding shortfall each year, and that last year was the worst ever. Does the Minister acknowledge that, for many, today’s plan is too little too late when it comes to fixing the crisis in primary care?
The independent think tank the Health Foundation sums up the Government’s overall plan, saying that it
“falls well short of addressing the fundamental issues”
facing general practice. Of course, the key reason demand for GP services is so high is the sheer number of people on NHS waiting lists. The president of the Royal College of General Practitioners said recently:
“Patients are developing cancers and enduring so much pain that they cannot climb stairs”.
Do the Government acknowledge that, unless they urgently get a grip on waiting lists, the crisis in general practice will only deepen?
More phone lines and better mood music will not fix the fundamental issue: the shortage of GPs. Their numbers have been cut by 2,000 since 2015, and now the Government have abandoned their own target of 6,000 extra GPs by next year. The proposal to ease the current burden on hard-pressed GP reception staff with a £240 million investment in phone and call systems technology over the coming years is welcome, but does the Minister really think that this is a proportionate or urgent enough response to the scale of the crisis? Is the money for the new care navigator staff included in this funding? What role will these new staff play in GP surgeries? When will we have a detailed breakdown of how the overall funding will be spent, and when it will be allocated and delivered?
Even the Government’s own Benches in this House have accused them of being in total denial about the crisis facing community pharmacies. Much now needs to be discussed by the PSNC, the Department of Health and NHS England regarding the promised funding in the recovery plan, and to try to address the crisis; I hope the Minister will keep us as up to date as possible. Can he provide more detail on how the proposed new services for the seven common conditions and oral contraception are envisaged to operate and interface with GP and other primary care services?
Finally, we come back to the question of the all-important workforce plan—what else? We heard from the Minister in Questions today that he now thinks that spring runs to the end of June. On the radio today, the Commons Minister promised that we would have it in a couple of months. As with every other health and social care service and profession we speak about in this House, workforce is core. Pharmacy locum costs have increased by 80% in the past year alone. So I have two simple questions: why is the promised, fully costed workforce plan taking so long, and when will it finally be published?
Lord Shipley (LD)
My Lords, I support the comments made by the noble Baroness, Lady Wheeler, on the Statement. We on these Benches welcome the aspirational nature of what the Government are proposing. During the Covid pandemic, we all learned that community pharmacists play an absolutely key role in supporting the health system. In my personal experience of securing additional injections, I was very impressed by how well the whole NHS system worked in delivering the inoculation service through community pharmacies. One of the good things about it is that you can book a slot, in the same way you book a slot with a GP. However, for this to succeed—and to free up 30,000 GP slots, as the Government intend—booking an appointment with a pharmacist needs to be just as easy. We then need to be very clear about what pharmacists will do, and what GPs will no longer have a contractual obligation to do.
On the workforce shortages that have been referred to, it would help if the Minister could explain whether the manifesto commitment to deliver 26,000 more primary care staff by next March is deliverable. It is difficult to see how the Government will do that unless more money is made available, so I seek the Minister’s confirmation that more resource will be delivered on the back of this initiative to ensure that it happens.
I will ask the Minister three further questions. First, were patients of different backgrounds, genders and geographies involved in drawing up the plan, and can he outline the patient involvement? Secondly, is there sufficient qualified staff of all professions to deliver the multidisciplinary plan? Finally, as the noble Baroness, Lady Wheeler, asked, when does the Minister does expect the new plan to be up and running?