Covid-19 Vaccination: Coronary Disease

Baroness Finlay of Llandaff Excerpts

Tuesday 23rd April 2024 Lords Chamber

[Lord Markham (Con)]

Deaths from heart disease among those under 75 are down by about 20% compared with 2010, which is a clear trend. Notwithstanding that, we are very aware—Sir Chris Whitty is concerned about this—that Covid meant that a lot of people did not get basic heart and blood pressure checks. That is why we have introduced the Midlife MoT, which is designed to give people a 10-year risk analysis; have put blood pressure devices in pharmacies and all sorts of other places to get 2 million checks; and have a workplace heart disease strategy check. All this is designed to get that prevention in place so that people are aware of and understand the risks.

[Baroness Finlay of Llandaff (CB)]

My Lords, does the Minister agree that, although we are talking about heart disease, we must also remember pulmonary embolism from clotting disorders, which can persist for up to six months after even a mild Covid infection? A massive pulmonary embolus is another cause of mortality in people who have Covid. One of the problems with the virus is its ability to mutate, but the evidence is that vaccination, even if it does not give you complete protection, moves you from obtaining serious Covid to having milder Covid. That risk of thromboembolism also needs to be monitored in the long term in relation to Covid infections, including for those who have had a mild infection and those who have long Covid.

[Lord Markham (Con)]

The noble Baroness is absolutely correct: a vaccine helped you avoid not just heart disease but all the other impacts of Covid that she mentioned, including long Covid and a whole list of other things. Again, the undeniable advice is that it is much better to have the Covid vaccine.

NHS: Long-term Sustainability

Baroness Finlay of Llandaff Excerpts

Thursday 18th April 2024 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interests as an NHS consultant and chair of the Bevan Commission. I congratulate the noble Baroness, Lady Ramsey of Wall Heath, on her very moving speech and on reminding us of the hardship of the pre-NHS days and why the NHS is so important to us. The contribution of the noble Lord, Lord Patel, in opening this important debate was characteristic of his great speeches.

I had the pleasure of being a member of the Times Health Commission, where we were given the task of suggesting reforms to improve the NHS. It was a very interesting experience, taking evidence from a wide range of people, including previous Ministers. At the end of our deliberations, we came up with a 10-point plan for health, which I will briefly outline now. For patients, it is clear that digital health accounts, such as patient passports accessed through the NHS app, are crucial for the future. Patients need to be able to co-ordinate their appointments, manage any medication and view their own records in full. We cannot expect people to take control of their own health if they do not have their test results, referral letters and vaccination and intervention records, or the ability to review, in their own time, the outcome from different consultations. Patients retain a small percentage of what they are told in a consultation, so it is very important that people can review things in their own time and with their families.

In Wales, we established Talk CPR to address the very important conversations around end of life and resuscitation procedures, which establish whether somebody wants ongoing treatment and intervention. We found that, by giving patients video books to take home, they were much more comfortable discussing issues than trying to have all that discussion in the context of a short consultation. In the Times Health Commission, we focused on the workforce—including the need to reform the GP contract and to write off student loans for people who continue to work in the NHS rather than leaving it—and the importance of no-blame compensation approach to errors, rather than the current blame culture that demoralises.

We addressed the need for mental health support and tackling obesity in particular. It is a precursor to so much disease, and the antecedents of illness can be decades before a patient presents. The importance of research and investing in it became more and more evident. Data collection is crucial for us to monitor and understand better the course of health in our own country, but also as a basis for inward investment from pharmaceutical and technological innovators. The NHS could be a major test bed, with integrated information and fast-track processes, to attract and retain researchers from around the world with inward investment, but unless we speed up the processes for investment we will never reach our goals.

One of our recommendations was to have a healthy lives committee to look at the impact of improved public health and a healthy life expectancy, addressing the antecedents of poor health. But whatever we do, bad things happen: people have accidents, severe illness hits out the blue and new infections emerge. Although palliative care is now in legislation as a core service, contracting is not the same as ensuring that patients have access, yet it is cost effective to involve palliative care services early. We need a national funding formula to support integrated care boards in establishing contracts with palliative care providers. Services must be rapidly responsive seven days a week; without that, the sad toll of inappropriate transfers to emergency departments out of hours will not decrease.

In recovery from a serious accident or devastating illness, early rehabilitation becomes crucial to improve outcomes and decrease costs. Next Monday, I am hosting a drop-in on rehabilitation with the full range of professionals involved. Rehabilitation is cost effective for the NHS, yet, like palliative care and hospice services, it is very patchy in provision. As such, we allow distress and ongoing, avoidable morbidity to accumulate and jeopardise long-term outcomes, in both the patient and the bereaved. Fair access to help in response to need is essential; we must never forget the patient.

Cass Review

Baroness Finlay of Llandaff Excerpts

Wednesday 17th April 2024 Lords Chamber

[Lord Markham (Con)]

I remember that it was the noble Lord who, in the round table that we had on this, made very clearly the same point I was making earlier about puberty and age. It is only when you are right the way through it that you really are in a position where you start to know your own mind and your own body. I agree with the noble Lord that it can be as late as 25, and that is why that is definitely the intention behind the eight clinics that are being set up—that they can provide that continuity right up to the age of 25, given that there is such a state of flux in a young person’s life.

[Baroness Finlay of Llandaff (CB)]

My Lords, I thank the Government for giving us this opportunity. Dr Cass’s report is incredibly important. She has taken a scientific, as well as a kind, humane and humanitarian, approach to the children affected and to the way the report is written. In the recommendations, as well as the discussion over puberty blockers there is the importance of ongoing research, research capacity and data. One finding that emerged for her was that there was a lack of consistent collection of data, which means that for many of these children, the people who were looking after them were, in effect, flying blind. That cannot be allowed to continue in future.

Her recommendation 17 is that:

“A core national data set should be defined for both specialist and designated local specialist services”.


Recommendation 18 is that:

“The national infrastructure should be put in place to manage data collection and audit and this should be used … to drive continuous quality improvement and research in an active learning environment”.


My question to the Government is whether, among the organisations listed, there are also discussions with the Royal College of Surgeons, because there is also surgical intervention undertaken in some of the processes. Without a database of the numbers that undergo a surgical intervention, the type of intervention and the complication rates, and monitoring the effect of that surgery on quality of life, we risk carrying on flying blind with clinical treatments that are literally life changing.

[Lord Markham (Con)]

I thank the noble Baroness. She is absolutely right: it is only in that lack of data environment that, dare I say it, ideology can fill in the vacuum and start to drive the sorts of behaviours that we see. Data is always the best way to cut through and provide light when there is a lot of heat in an argument. She makes an excellent point about the Royal College of Surgeons. I am sure that it has been contacted along with all the other bodies, but we need to make sure that is covered off. As ever, I will come back in detail in writing to all noble Lords who have raised points. I will make sure that point is addressed as well.

Sodium Valproate and Pelvic Mesh

Baroness Finlay of Llandaff Excerpts

Monday 25th March 2024 Lords Chamber

[Lord Markham (Con)]

I thank the noble Baroness. I will provide the precise figures, but the incidence has gone down by 34% in terms of the amount that has been prescribed. At the same time—and this is particularly fitting, as tomorrow is National Epilepsy Awareness Day—for some people, this is the only treatment for epilepsy that will work for them. It is therefore important to make sure that protocols are in place for prospective mothers and prospective fathers to make sure that, in those cases, they are not being prescribed sodium valproate, because in other cases it is often the only medicine that works.

[Baroness Finlay of Llandaff (CB)]

My Lords, given that, sadly, errors and problems repeatedly occur in the NHS, how are the Government working with the devolved Administrations to ensure that a redress scheme is designed to be fit for the future as well as fit for the recognition of harm that has occurred? What will they do to ensure that trust in the NHS is maintained by an approach that encapsulates prospective monitoring and listening to patients and relatives for early detection of adverse events and avoids cumulative errors?

[Lord Markham (Con)]

I thank the noble Baroness. I was actually speaking to Minister Caulfield about this just this morning, because she is in regular touch with the affected patient groups. They were talking precisely about some of the things around the Scotland NHS scheme in place in terms of redress. It is fair to say that there are some concerns in patient groups on some aspects of this, but underlying what the noble Baroness says is making sure that, whatever we do, we are trying to do it consistently across the UK because there should be one consistent approach. Likewise, we are learning lessons from these things as well.

Cancer: Staffing

Baroness Finlay of Llandaff Excerpts

Thursday 14th March 2024 Lords Chamber

[Lord Markham (Con)]

I totally agree that it is a range of things. I completely agree with the noble Lord that a good employer should be looking to make sure that employees have good working conditions and feel valued, and that there is an understanding culture in the workplace as well as decent pay. I say all this in the context that the workforce in the cancer space has actually increased by 56% since 2010, so it is not as if there have not been massive increases here. The actual number of treatments and diagnoses has gone up by more than 20% from pre-pandemic levels. So we are doing a lot in this space, but I agree with the noble Lord’s basic premise that we need to ensure that staff feel valued so they will want to carry on working.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interest as being employed in part by the Velindre Cancer Centre in Cardiff. Do the Government recognise that continuity of care is absolutely essential for patients to be able to spot when things are changing and to allow sensitive conversations to occur? Will he therefore undertake to have urgent discussions with the Royal Colleges and with Health Education England to look at the training rotas for doctors who are working in oncology, allowing them to provide better continuity of care with less disruption to their own lifestyles, and better support? Will he also look at recommending that they might draw on the Welsh experience of Talk CPR, which allows early conversations about very difficult topics, providing video books and so on that patients can take home and then come back to see the same person again some time afterwards, providing continuity of care and better communication?

[Lord Markham (Con)]

First off, I completely agree about continuity of care—in any treatment, to be honest. I was just saying, in answer to a maternity question the other day, that continuity of care in the midwifery space is another vital example. On the question of learning lessons from what the noble Baroness mentioned, we have some meetings set up, so I look forward to discussing it further then.

NHS: Neurology Care

Baroness Finlay of Llandaff Excerpts

Monday 26th February 2024 Lords Chamber

[Lord Markham (Con)]

I thank my noble friend, and I proudly wear the Epilepsy Action badge from the meeting I was just at. As my noble friend says, it is all about trying to get that early diagnosis. If you can get that and help people get the right treatments, that is exactly the right direction of travel because it can make a huge difference to outcomes. The progressive neurological condition toolkit I mentioned earlier sets out that pathway and the model of integrated care for all the ICBs, which they will all then be held to account on to make sure patients with all these conditions—and there are 600 of them including epilepsy—are getting the right treatment in their neighbourhood.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interests in palliative care. Do the Government recognise that many of the patients with neurological disease are living with palliative care symptoms such as pain, breathlessness, worry and fatigue, which could be managed in the community with good integration between palliative care services and neurological services? Therefore, have the Government given specific commissioning guidance to integrated care boards to ensure that they look to see how the integration is developing in their own areas to enable these patients to improve their quality of life and their ability to live actively for as long as possible?

[Lord Markham (Con)]

Yes, that is precisely what I was referring to: the progressive neurological condition toolkit is all about the pathways for that integrated approach to it all. Again, there are 15 million people affected—I think this statistic was mentioned earlier—and one in five deaths come from related conditions, so making sure we have that integration with palliative care as well as the other services is key.

Anaesthesia Associates and Physician Associates Order 2024

Baroness Finlay of Llandaff Excerpts

Monday 26th February 2024 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare that I am a doctor registered with the General Medical Council, a member of the BMA and a fellow of the Royal College of General Practitioners and the Royal College of Physicians.

We have physician associates and anaesthesia associates seeing patients, examining them and advising them, who are as yet unregulated. All responsibility for their behaviour rests with the doctor who is their supervisor from whom they have delegated responsibility. The professional scope of practice for these associates can vary widely across the country. It is determined at a local level and patients have no idea about the variation.

There is a golden thread in clinical care that the most experienced person delegates down. They delegate down tasks that they know the relevant team member has the skills to undertake. A key skill in medicine, gained with extensive experience, is the integration of all the relevant information, evaluation of risk and prioritisation. Currently a problem in the whole of the NHS is that we expect staff to refer upwards and the boundaries are unclear.

A case of non-accidental injury in a child has been brought to my notice where the expert evidence was provided by a physician associate whose relevant experience is unclear at best. This blurring is misleading to non-medical professionals, including the police, judiciary and legal professionals. Supervision must be mandatory and stipulated in the GMC’s Good Medical Practice.

The junior doctors’ discontent, which we have heard about already from the noble Baroness, Lady Bennett, is boiling over. After training, medical graduates emerge with huge student debts to work a 40-hour week for just over £32,300, only to find that after a two-year postgraduate programme a physician associate typically earns between £3,000 and £11,000 more, for only 37.5 hours a week. All this has inflamed tensions—although I would say that direct verbal attacks on physician associates and anaesthesia associates, who have trained in good faith and with good intent, are not appropriate and I would not condone them.

Doctors are the only healthcare professionals who must undergo extensive, nationally stipulated postgraduate training before being appointed to a permanent senior role. Without long-term job security, these juniors rotate through departments, sometimes commuting many miles. They find that they do not belong and do not feel part of the team or valued, while patients miss out on continuity of care.

Very importantly, patients seen by a physician associate sometimes think that they have seen a doctor. The term “physician associate” gets muddled with the specialty and associate specialist doctor, who often has years of experience. Can the Minister clarify whether the term “physician associate”, which is so misleading, will become a protected title after this order passes? How can the name then be changed to revert to the more accurate “physicians’ assistant”? Currently, no medical titles are protected: “doctor” is not and grades up to and including consultant are not, which is another source of confusion. How is that going to be cleared up?

The cost-efficacy basis for these posts has been questioned in a recent paper, showing how the cost of one consultant anaesthetist supervising two operating theatres with an anaesthesia associate in each—that is, three staff—is more expensive than having two consultants doing one list each. The risk is higher if a problem arises in both theatres, especially in an anaesthetic emergency, when deterioration and brain damage can happen in minutes.

This crisis has been 20 years coming because we failed to expand medical school places or to register these new healthcare roles and define their scope of practice. What is the solution?

I fear this order will not solve all the problems. Yes, physician associates and anaesthesia associates must be regulated. It seems an outrage that people with such responsibility have been around for 20 years, unregulated, and a decade after that was recommended. The General Medical Council, in taking responsibility for regulation, must keep the register completely and clearly separate from that of medically qualified doctors. Can the Minister confirm that this clarity will be a legal requirement?

I tabled my regret amendment because it must be clearly on the record that the concerns exist, that some current regulation around the Medical Act needs updating urgently and that the GMC must be held accountable to Parliament, as has been explained by the Minister. Regulation is essential, but it is not the end of the issue; it is only the beginning.

The GMC must tackle the inappropriate way that some courses are advertised, which state that they train PAs

“to work as a safe and competent medically trained healthcare professional”

or to

“be a medically trained, generalist healthcare professional”

—which sounds awfully like a GP to me. Some courses describe working under a senior physician, but others say nothing about supervision. The anaesthesia associate courses differ slightly. They make it clear that, at present in the UK, only doctors who have specialist training in anaesthesia can administer anaesthetics and that the anaesthesia associate works as part of the anaesthetic team.

Next, the scope of practice must be clearly defined and agreed at national level, so that any employer is aware of what the associates should be doing and how the senior doctors must supervise them on site. Employers must also ensure that all patients know the qualification level of the person seeing them. Seven-day services are essential for patients.

Medical postgraduate training itself is in crisis. The royal medical colleges, the Academy of Royal Medical Colleges and the GMC must get together urgently to address postgraduate training. Perhaps it could be shortened, with post consultant-level fellowships to develop highly specialised skills and bring innovation to healthcare. Lifelong learning is essential; it is the essence of growing a good medical workforce in the long term. Medical schools, as they welcome the increased numbers, must look at how those who might wish to convert to a medical degree can be credited with their prior learning and experience, and tackle regulatory blocks in funding and timing.

Importantly, the title must be reviewed. The terms “physician assistant” and “anaesthesia assistant”, in use until 2014, clearly denoted the role as having delegated responsibilities from a supervisor. If “physician associate” and “anaesthesia associate” are to be protected terms, then we need a designation of medicine that clearly identifies a medical degree—similar to the American MD designation, for example. Patients must know who has seen them.

To summarise: patients must know the level of training of the person whom they have seen. Physician associates and anaesthesia associates must be regulated with appraisal and ongoing learning, including revalidation. The scope of practice of this new workstream must be defined to ensure that they have clear boundaries and supervision must be defined as being closely supervised on site to ensure patient safety. People must not be misled into believing that they are completely independent practitioners.

[Baroness Brinton (LD)]

My Lords, I am grateful to follow both the noble Baronesses, Lady Bennett and Lady Finlay of Llandaff, and I have been crossing out large chunks of what I was going to say, which I hope will be helpful to Members of your Lordships’ House.

As both of the other noble Lords have, I want to start by saying that this is not an attempt to discredit the many PAs and AAs who do an extremely good job. We need to understand that, and we need to understand that our health system must change and modernise. The issue is what is happening in our NHS and how the role of PAs and AAs is impacting not just on patients—I will come to the detail of that in a minute—but on the working of supervising doctors and junior doctors. All of those groups are in crisis, and this just seems to be adding further problems.

I echo the points made by, I think, the noble Baroness, Lady Bennett, about the Secondary Legislation Scrutiny Committee, which the Minister referred to in his introduction. In the committee’s report to us, it says three times that the Explanatory Memorandum assumed understanding and that it was not good enough. I ask the Minister if he will work with his officials to ensure that any more Explanatory Memorandums that come forward, not just on this issue but on others, are very clear and do not assume prior knowledge.

All of us have said that PAs and AAs—I am not going to keep saying physician associate and anaesthesia associate because it takes too much time—are not a replacement for doctors, though not one of us believes that that is the case. I am going to start with the title. The Royal College of Physicians and the Faculty of Physician Associates, which sits within the RCP, has guidance on the associate title and introduction guidance for PAs, supervisors, employers and organisations. What it says is in complete contradiction to what is happening on the ground:

“It is our view that, when a PA introduces themselves to a patient or staff member, they must make it clear at the start of the interaction that they are a physician associate, as well as explain the use of the term ‘PA’ … PAs must correct patients and staff if they refer to them as a … doctor, nurse or other professionally protected role title. This includes verbal, written and other forms of communication”.


Like other noble Lords, I have been inundated with letters from doctors and patients saying that they have been misled—not in the deliberate sense, but that PAs have not been correcting the record when someone has called them a doctor. The BMA, in its very helpful briefing, said that:

“To patients, PAs and AAs and doctors may look the same and appear to be doing a similar job”.


The problem, as the noble Baroness, Lady Finlay, said, is that the title is confusing. “Physician associate” perhaps implies that they have the same level of expertise as doctors. Unfortunately, as the noble Baroness, Lady Bennett, said, this has already led to a tragedy. Emily Chesterton died, aged 30, after two appointments with a PA who she believed was a GP, where mistakes were made.

A further difficulty, particularly in GP practices, is that GPs are beginning to worry that they are going to spend their entire time supervising PAs, as well as seeing patients with chronic diseases, and will not see ordinary people at all. Trainee GPs are worried about how they are going to be supervised. How is the Minister going to ensure that the issues of supervising and training, which are very serious, will be dealt with after the passage of this SI—because I do not think any of us are planning to call a vote today?

We have heard that, across acute trusts and GP surgeries, doctors have reported 70 instances of avoidable patient harm and near misses caused by PAs. That includes fatalities, missed diagnoses resulting in terminal diseases, missed DVTs, sepsis, heart attacks and haemorrhages. Missed cancer diagnoses in primary care has therefore emerged as a significant issue. In England, 74 acute trusts have replaced doctors with PAs on the doctors’ rota. Even if those PAs are supervised, that means that doctors who should be seeing patients are supervising more and more people. It is not a zero-sum game. One trust—I think it was Leeds, from memory—had a paper on how much more beneficial PAs were on the rota because they were much cheaper than doctors.

Doctors at 24 trusts reported witnessing PAs illegally prescribing medications, including controlled drugs. That is a particular worry because they are not permitted, under their current training and qualifications, to prescribe any drugs. That must be done by the doctor. The PA can recommend to the doctor what they think, but it should be signed off by a doctor. In addition, 42 acute trusts in England have witnessed PAs introducing themselves as doctor or failing to correct errors.

We have heard about a number of issues. I conclude by saying that, earlier on today, on the Victims and Prisoners Bill, we were talking about the duty of candour, which the NHS introduced nearly a decade ago. One issue related to this is that every regulated member of staff must report whenever they believe that something has happened that either possibly will cause damage or has caused damage. One of the good things about regulation for PAs and AAs is that they will come under the duty of candour. However, in all the cases that we have been told about where things have gone wrong, there is no evidence that there were reports to the CQC by the supervising doctors about things going wrong. Therefore, yet again I say to the Minister that my real concern is about current practice inside our extremely pressed and busy NHS, to make it safe. Just providing regulation for PAs and AAs will not in itself do that. I hope that he can help your Lordships’ House to understand.

--- Later in debate ---

[Lord Markham (Con)]

That is something I will pick up on. On the point raised by the noble Baroness, Lady Fox, I say that the GMC, with the CQC, should be able to give the ongoing quality assurance.

The noble Lord, Lord Hunt, said very well that the discussion on mistakes has not been useful. We are all aware that, regrettably, mistakes happen in all areas, and we need to make sure that we understand and learn from them, rather than using them to point fingers. Moving into the regulated space, where there is duty of candour, is useful.

I do not think anyone could be failed to be moved by the passion with which the noble Lord, Lord Winston, spoke about his experience. It was a very telling story. As reassurance I cite the noble Lord, Lord Patel, on the scope of the practice: it is one anaesthetist to two AAs, and the role of the AA is very much to maintain, as he explained well. In a similar way, the PAs really do need to work under GP supervision. The numbers are set out in the long-term workforce plan. We have a foot on the throttle for those training places, particularly in regulating them. We will make sure that things are properly managed so they cannot get out of control.

I absolutely agree with the points made by the noble Baronesses, Lady Watkins, Lady Harding and Lady Bloomfield, that this is a people management issue, and a lot of the heat from this debate is a feeling from junior doctors and others that they are unloved and uncared for. I freely admit that there is a wider issue that we need to look at, concerning things like hot meals; clearly, it is something trusts need to look at it as well.

I echo the points made by the noble Lord, Lord Hunt, that passing this order is the best way to ensure the safety of patients. As we develop, there is perhaps scope to be more ambitious, but let us try to do this step by step, to make sure we really are happy and that the scope of practice works. As ever in a debate as long as this—it has been a very thorough one—I will write to fill in any details that I have not managed to cover. At this point, I hope and trust I have provided sufficient answers to the questions, and have demonstrated—

[Baroness Finlay of Llandaff (CB)]

I hesitate to rise because the House clearly wants to end the debate, but I am not sure whether the Minister, in summing up, said whether the titles of physician associate and anaesthesia associate will be protected titles when the order goes through. Are they negotiable? I ask that question specifically because I had a lot of discussions with different people involved in this, particularly the GMC, and I have been concerned that if those are the only protected titles of all the grades registered by the General Medical Council, we may be storing up further problems for the future. If this is to be a protected title, can the Minister provide assurance that further statutory instruments could be brought forward if, in the light of the consultation advised by the noble Lord, Lord Allan, a different title is suggested? Could it then be changed?

[Lord Markham (Con)]

It is a protected title. The point I was trying to make about the general overhaul and understanding of the titles, however, is that there will be the scope to do this, as doctors and consultants are not protected titles today. I think we need to develop clarity on that, which is why the further reforms and SI changes will set out to protect other titles as well.

--- Later in debate ---

Tabled by

[Baroness Finlay of Llandaff]

At end to insert “but regrets that the draft Order refers to “associates” rather than “assistants”, which would more properly reflect the role, scope and responsibilities of such staff and reduce patient confusion.”

Amendment to the Motion not moved.

NHS Dentistry

Baroness Finlay of Llandaff Excerpts

Monday 19th February 2024 Lords Chamber

[Lord Markham (Con)]

There will be a schedule of when the mobile vehicles will visit each area, with the ability to pre-book so, if someone calls up with an issue, they will know that a truck will come to their area in a week or two’s time. That is the idea, or people can queue to receive those services as well. I hope this will be successful. It has worked quite well in some areas already. The case will prove itself and the 14 will be just the start. We can do much more from that, because we all agree that we need to expand supply.

[Baroness Finlay of Llandaff (CB)]

Given that over 8,800 new oral cancers were diagnosed last year, and a fifth of those were in people under the age of 65, do the Government recognise that it is a false economy not to increase dentistry provision, dental hygienist screening for oral cancers and advice on prevention, such as by cutting down on smoking and so on? The cost of treating this, and of early morbidity to the country, is huge.

[Lord Markham (Con)]

Yes, absolutely. That goes back to my noble friend’s point about outcomes. I know that a lot of places, if they are fortunate enough to have an NHS dentist, give you check-ups every six months as a matter of course. In fact, NICE says that if you are in good oral health you will need that only every 24 months, with the idea being that you can create more space for other people to come in, because prevention and screening are vital in all this as well.

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

Baroness Finlay of Llandaff Excerpts

Tuesday 6th February 2024 Grand Committee

[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.

[Lord Allan of Hallam (LD)]

My Lords, I was grateful to the Minister for his description of in vitro devices, which is not necessarily obvious from the regulations. I hope that he can confirm that the “in vitro” bit is misleading; we are talking about lots of tests that are done in plastic and no longer glass, so it is a Latin hangover. I think that I am right in thinking that this applies to everything, whether it is a stick test or whatever device it is; it applies to any kind of diagnostic test.

On the regulations, I shall offer a one-sentence Brexit whinge, which is just to say: “Oven-ready, ha ha ha!” Looking at these regulations, we are now in legislative spaghetti territory, where to do something quite small and simple requires pages and pages of legislation to enact it. We are in a very messy regulatory situation, and it is only going to multiply over time. That was the first point that I wanted to raise.

It would be helpful if the Minister could say, for the health area for which he is responsible, the extent to which the Government have assessed how far there will now be divergence between Northern Ireland and Great Britain in the relevant health areas. There are two different scenarios. In one, the UK stands still, but the EU moves on, which is effectively what has happened here: the EU has updated its law, and we are now having to respond, because it will apply in Northern Ireland. So even if we do nothing, there will be change, and we should be reasonably capable of extrapolating that by looking at past behaviour and the EU’s legislative programme. Of course, the other scenario is where we actively diverge from the EU.

I hope that, in both scenarios, the Minister will be able to confirm that there is somebody—or a team somewhere in DHSC—who has all this mapped out. It may not have been possible before Brexit, when we were still living in la-la land—but, since we have had the experience of the retained EU law Bill, where the number of laws that we found tripled from the first exercise to the current iteration, it is important for businesses out there that we understand how much retained EU law there is in the health area, how much of it will be relevant and how much will require this kind of statutory instrument to ensure that we can respect both the Northern Ireland and the Great Britain settlement.

I am also curious: the Minister referred to the fact that the EU’s updated law was implemented as a regulation, which of course applies directly, rather than a directive, which needs transposition. He said that it applied from May 2022, but we are regulating only now. I am genuinely curious as to what happened in the intervening period. Is it the case that if somebody had been selling non-conforming devices, they would get away with it for that period because the law did not catch up? I am curious to hear what the Government’s intention is. Presumably, this scenario is going to be repeated: there will be new bits of EU law and we have to follow on and make sure that they are implemented for Northern Ireland. I am genuinely interested in the Minister’s comments on the Government’s strategy: are they concerned at all that there may be these gaps, or is it something we just have to live with now?

--- Later in debate ---

[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?

Pharmacy First

Baroness Finlay of Llandaff Excerpts

Tuesday 6th February 2024 Lords Chamber

[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.