Nursing Courses: Reduction in Applications

Baroness Wheeler Excerpts

Tuesday 19th September 2023 Lords Chamber

[Lord Markham (Con)]

The noble Baroness is quite correct that mental health is a particular case in point. When we introduced the £5,000 grant for all nurses each year, we gave additional add-ons, and mental health nurses get an add-on in addition to that £5,000 a year. We also increased the travel and accommodation costs allowance by 50% to cater for those who have to travel far and wide.

[Baroness Wheeler (Lab)]

My Lords, the figures on overall declining numbers are concerning, particularly since this is the second successive steep fall, with, as the Minister said, the Department of Health relying on the UCAS clearing system and future nurse apprenticeships to try to make up the numbers. What changes does the Minister consider need to be made to the NHS workforce plan in the light of escalating problems with both the recruitment and retention of key staff?

[Lord Markham (Con)]

I am sorry to keep coming back to the data, but it suggests a 45,000 increase, which shows that we are doing pretty well. A 20% increase across all the different fields since the pandemic also shows that we are doing a good job on recruitment. Clearly, we cannot rest on our laurels, so we need to look at all those routes in, but I do not understand why people characterise the numbers as dropping when in fact the data shows the overall increase is far greater.

National Health Service: Major Conditions Strategy

Baroness Wheeler Excerpts

Monday 18th September 2023 Lords Chamber

Asked by

[Baroness Wheeler]

To ask His Majesty’s Government what additional funding is being made available for the implementation of the Department for Health and Social Care’s Major Conditions Strategy.

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

My Lords, the Government are providing additional funding of £3.3 billion in 2023-24 and £3.3 billion in 2024-25 to support the NHS in England. The Government have not committed further additional funding specific to the major conditions strategy. However, as part of the strategy, we will be identifying innovative actions to help alleviate pressure on the NHS and support improvement within the current settlement, such as maximising the use of new technology to screen individuals for conditions.

[Baroness Wheeler (Lab)]

My Lords, the major conditions strategy has been well received in both approach and content, particularly the focus on primary and secondary prevention as part of a life-course approach, and bringing together a strategic framework for the six major conditions that drive over 60% of morbidity in England, including cancer, heart disease and stroke. However, key stakeholders have warned that, without adequate resources, NHS trusts and other bodies will struggle to deliver, especially given their current and future focus on trying to cope with ever-escalating waiting lists. Do the Government acknowledge this and how will January’s future strategy address it?

[Lord Markham (Con)]

We are investing about 11% of the economy—£160 billion—in the NHS, and the conditions in the major conditions strategy account for 60% of all the causes of death and long-term illness. What we are really talking about is prioritising spend around prevention and personalised care, as the noble Baroness said, and channelling the money we are already investing towards those aims, on which I think the whole House agrees.

Respiratory Syncytial Virus

Baroness Wheeler Excerpts

Tuesday 25th July 2023 Lords Chamber

[Lord Markham (Con)]

We had this question on MMR just the other day. Some groups are much harder to reach than others. Very young children are the prime at-risk group. There, it is much easier because, naturally, they are seen by their GP and medical staff either prenatally, if it is maternal, or post in terms of the baby check-ups. The group that we are talking more about here is post 75 year-olds, and there those education programmes will be put in place.

[Baroness Wheeler (Lab)]

My Lords, the JCVI advice endorses the vaccine programme for 75 year-olds and for ages above, but we know that evidence shows that there is serious underestimation of RSV infections among older adults and an urgent need to improve testing and treatment of, in particular, those with congenital lung or heart disease or spinal muscular atrophy. What steps are the Government taking to raise awareness among these key groups and to develop information and monitoring systems that identify those most at risk?

[Lord Markham (Con)]

This is where nirsevimab is very promising, in that it gives six months’ protection. The problem with the previous jab is that it needed monthly injections and was only 50% effective. We are talking about 70%-plus effective now, which makes it more practical to have that sort of rollout. To date, we have been looking at the very targeted group of 75 year-olds only, particularly as each course costs £2,000 and has to be given monthly over the winter months. Now that we are opening up to this injection, which is much cheaper and lasts for six months, we can look at a broader range, and then there is a much more general education programme to go with it.

Stroke Care

Baroness Wheeler Excerpts

Monday 24th July 2023 Lords Chamber

Asked by

[Baroness Wheeler]

To ask His Majesty’s Government how they are ensuring that integrated care systems across England implement recommended best practice in stroke care in line with the updated National Clinical Guideline for Stroke, published in April.

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

The National Clinical Guideline for Stroke, published in April 2023, is an initiative of the intercollegiate stroke working party made up of representatives from the professional bodies involved in stroke care. National regional SQuIRe managers, who are responsible for managing stroke services, are working with integrated stroke delivery networks and newly formed integrated care systems to implement the NHS integrated community stroke service and improve the provision of community-based stroke rehabilitation.

[Baroness Wheeler (Lab)]

My Lords, the update of the national stroke guidelines is welcome, particularly its now UK-wide remit, with one of its major changes being significant expansion in the number of patients eligible for thrombolysis and thrombectomy. Given that both these powerful clot-busting interventions are most effective the faster they are used following a stroke, what assessment has been made of the impact of the current NHS delays in the expansion of their respective uses and how will the Government ensure that ICSs address the huge regional variations in both thrombectomy and in the vital post-stroke rehabilitation in hospital and at home that is so necessary?

[Lord Markham (Con)]

First, I thank the noble Baroness for the work that she does in this area; I know that it is very close to her heart. I have set up a meeting with the NHS COO David Sloman and with Sarah-Jane Marsh, and would be delighted if the noble Baroness would like to join me. The benefit of these sessions is always the shining of a light on areas.

It is vital that people are seen within the first hour; currently 59% of people are, which is an improvement on the last couple of years when the figure was 55%. However, we would all agree that we want that number to be as high as possible. The SQuIRe managers’ job is to make sure that all the different integrated care boards are delivering best practice in each area.

Healthcare (International Arrangements) (EU Exit) Regulations 2023

Baroness Wheeler Excerpts

Wednesday 5th July 2023 Grand Committee

[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

Thursday 15th June 2023 Lords Chamber

[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

Monday 12th June 2023 Lords Chamber

[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

Monday 12th June 2023 Lords Chamber

[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.

Medical Devices (Amendment) (Great Britain) Regulations 2023

Baroness Wheeler Excerpts

Monday 5th June 2023 Grand Committee

[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?

--- Later in debate ---

[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.

Sodium Valproate

Baroness Wheeler Excerpts

Monday 5th June 2023 Lords Chamber

[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.