MBRRACE-UK Report 2025

Lord Scriven Excerpts

Thursday 23rd October 2025 Lords Chamber

[Baroness Merron (Lab)]

I can give that assurance in respect of services across the country. The independent maternity and neonatal investigation will act at pace. It is an independent investigation and will be chaired by the noble Baroness, Lady Amos. In addition, the Secretary of State, Wes Streeting, is showing how high a priority it is for us to provide urgent action on this by chairing the maternity and neonatal task force himself. These projects will work at pace to bring about the change we need to see.

[Lord Scriven (LD)]

My Lords, I am pleased to hear the Minister say that this is urgent. While waiting for the review to take place, the report called for improved interagency working. While the Government are waiting for that review, are there any specific changes to information sharing and co-ordinated care pathways between maternity services, social services, specialist domestic abuse services and other statutory agencies that the Government will ask to be implemented on an interim basis, to ensure that as many women as possible live?

[Baroness Merron (Lab)]

It is important to say that we are not waiting for the results of investigations or task forces in order to take action. A number of projects are already in train and making a difference. For example, we are rolling out maternal mental health services and specialist perinatal mental health services in every area across the country. I will give one example to address the point that the noble Lord raised. A single patient record will ensure that maternity teams have all the information they need about previous consultations. That will be of great assistance in improving safety and efficiency.

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[Lord Scriven (LD)]

While we are talking about Leeds, can the Minister explain, following on from the previous question on leadership, how the former chief executive of the Leeds Teaching Hospitals, who was in post at the time that this was happening, can then go on to become the chief executive of the CQC? Do recruitment processes need to be looked at, particularly for chief execs who have been leading failing services such as the ones in Leeds?

[Baroness Merron (Lab)]

I note what the noble Lord says and will take his comments back to the Secretary of State.

Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025

Lord Scriven Excerpts

Tuesday 21st October 2025 Grand Committee

[Baroness Bennett of Manor Castle (GP)]

My Lords, I thank the Minister for her very clear introduction of this SI. It is a pleasure to follow the noble Baronesses, Lady Hollins and Lady Ritchie, and to say, perhaps counterintuitively, that I agree with both of them. It is very clear that there are arguments for steps forward because of the way in which circumstances and technology have changed: there is an argument for reform. But the questions put by the noble Baroness, Lady Hollins, are very important and we have to put those into context.

I note that a survey put out in August by the National Pharmacy Association and Community Pharmacy England said that 63% of pharmacies could close in the next year and only 6% of pharmacies were profitable. Only 25% of pharmacies are independent; the rest are either corporate or supermarket-owned pharmacies.

The concerns are obvious when we are talking about that last group. There is a risk of seeing one pharmacist having effective control and providing authorisation to a large number of pharmacy technicians where there might be corporate structures that put a large amount of pressure on financial returns rather than ensuring absolute safety and the controls that are needed. So we need to understand this SI in that context. Obviously, in some ways that is what is driving the SI, but we also need to think about the controls and where there is huge financial pressure on independence. A majority of prescriptions now come through giant corporate companies with very distant methods of control.

My second question is on timing. I note that on 1 October the General Pharmaceutical Council opened its consultation on overhauling the pharmacy technician training framework, including plans to move study from level 3 to level 4. It rather feels that we have just opened a consultation on changing the training, yet here we are bringing in regulations that almost seem to be assuming that that training has already been stepped up. Would it not be a better idea to step up and overhaul the training and then bring in the different regulations? The consultation suggests there is a very clear understanding that there is a need to improve the training of pharmacy technicians.

My final set of questions has to go back to physician and anaesthesia associates and the Leng review. I would like to understand how this SI fits within the broader framework of regulation of all the medical professions. I note, looking back over the history of this, that we go back to 2014 and the Law Commission recommendations about the regulation of a new single legal framework for health and care professionals. Under the previous Government we had consultations in 2017, 2019 and 2021, all of them in this space. So far as I have been able to discover, they did not seem to cover physician technicians: certainly not in much detail. This whole physician and anaesthesia associates débâcle, I have to say, was supposed to be part of a whole process of looking at all stages of medical regulation right across the board. How does this SI fit within that framework?

Finally, I have to note that, in the Chamber on 16 July, I was told that the Government would be delivering an implementation plan for the Leng review in the autumn. I have noticed that quite a lot of leaves seem to be changing their colour at the moment. I know that the government definition of “autumn” can be quite extended, but perhaps the noble Baroness could update us on when we can expect to see that implementation plan.

[Lord Scriven (LD)]

My Lords, it is a pleasure to follow the noble Baroness, Lady Bennett. In fact, it is a pleasure to follow all noble Baronesses who have spoken and to be the first Baron to speak in this debate. A bit like the noble Baroness, Lady Bennett, I counterintuitively support quite a lot of what has been said, even though some of it is quite contradictory and does prompt questions, even though the generality is supported.

I also thank the Minister for outlining in a clear and understandable way the order before the Committee. In my role as vice-chair of the APPG on Pharmacy, I have been able to speak not only to a number of organisational groups but to individual pharmacists to understand some of the differences of opinion within the sector.

This is without doubt a pivotal moment, marking a significant shift in pharmacy regulation. I offer the Government our general support for the core principle of modernising an outdated legal framework to unlock clinical capacity. As the noble Baroness, Lady Ritchie, pointed out, for far too long—in fact, since 1933—regulations have been rigid, forcing highly qualified pharmacists to oversee tasks that can be safely and competently managed by other registered professionals.

This order, by introducing the concept of authorisation and delegation to pharmacy technicians, corrects this historical anomaly. The benefits are clear; it empowers pharmacists to fully embrace clinical roles: prescribing, consulting and administering services, probably as part of the new neighbourhood health services that the 10-year plan suggests. It validates the expertise of pharmacy technicians, providing them with greater autonomy, particularly in complex environments like hospital aseptic facilities. It introduces, to use the Minister’s phrase, common sense measures of allowing trained staff members to hand out pre-checked, bagged medicines in the pharmacist’s temporary absence, ending needless patient delays.

However, the consultation process responses, which saw over 5,000 replies, revealed a sector divided. Although professional bodies and pharmacy technicians largely welcomed the proposals, we must not ignore the fact that many individual pharmacists expressed profound concern, as quite rightly highlighted by the noble Baroness, Lady Hollins. It is here in the detail and the perceived risk that we must focus our scrutiny. Indeed, while welcoming the statutory instrument, there could be some unintended consequences. The issues raised are not frivolous; they are structural and require ministerial assurance.

I wish to highlight three major areas of risk. The first one is patient safety, training and accountability. The core objection from many pharmacists relates to the level of initial education and training required by pharmacy technicians to take on these new autonomous roles. As the noble Baroness, Lady Bennett, pointed out, the consultation has just started. It ends on 24 December. It will not pick up pace until at least early 2026, and then there will be the training, the qualifications for the training and the accountability for the training. Are the Minister and the Government convinced that there is enough time to roll out not just the training but to assure its quality before technicians are allowed to do this?

The noble Baroness, Lady Hollins, has really highlighted the problems that could come around with vague authorisation. If a pharmacist gives a general or oral authorisation without clearly defining the scope, conditions and limitations for the technician, it could lead to confusion and mistakes, particularly concerning high-risk medicines. I was going to ask similar questions to the noble Baroness, Lady Hollins, but I will leave those to one side.

There also is, potentially, an accountability gap. While the order notes that a pharmacist’s failure to have a

“due regard to patient safety”,

may lead to professional misconduct, establishing clear accountability when a technician makes an accuracy error under general supervision could be challenging for regulatory bodies. There is a contradiction there that needs to be understood.

Also, on dispensing queries, the new rule allowing a sale supply of ready dispensed products in the pharmacist’s absence creates a challenge. For example, will a shop assistant who has been there for one day and works in the pharmacy be allowed to do this? It does say “any member”, so I am pleased that the Minister is shaking her head. I seek reassurance on that particular point.

What if a patient has a question about the medicine? The person carrying out the transaction must know when they are qualified to answer and, crucially, when they must stop the transaction. How will this be addressed and understood by all concerned? The safety mitigation is reliant on the General Pharmaceutical Council-strengthened guidance and rules—work that is still pending, as we have heard. We must ensure that this guidance provides absolute clarity on the minimum competence standards required for authorisation and, crucially, that the professional indemnity cover for those roles is appropriate for the new scope of the responsibility.

Secondly, on the risk of undervaluing dispensing services, as the Minister said, the changes are enabling and not mandatory, yet the risk of financial exploitation is real. Pharmacies are already funded below cost for dispensing. My concern mirrored—

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[Lord Scriven (LD)]

My Lords, as the noble Baroness said, the changes are enabling and not mandatory, yet the risk of financial exploitation of the regulations is real. Pharmacies are already funded below cost for dispensing, and my concern, mirrored by many in the sector, is that the department or NHS England may interpret this regulatory freedom as an automatic justification to reduce dispensing fees based on the assumption of a cheaper skill mix that may be automatically adopted. Any such reduction would threaten further the financial viability of community pharmacies, particularly small independent ones, risking closures and access issues.

The third issue is the ambiguity of supply “at or from” a pharmacy. Some in the sector feel that the proposed change to allow the supply of medicines at or from a pharmacy, while intended to cover home deliveries, introduces ambiguity. This phrase is viewed by some as a potential gateway to unsupervised remote supply models, such as unstaffed collection lockers in remote locations. The Government must emphatically stamp out any interpretation that undermines the fundamental principle that a pharmacist’s professional clinical input or availability is the bedrock of safe supply.

To ensure that we implement this modernisation safely and successfully, I ask the Minister for clear answers on these three points. On professional assurance, what guarantee can the Minister give to individual pharmacies that the new GPhC standards will explicitly address the concern over minimum competency and mandatory continual professional development, and that the accountability split is clear before the main authorisation provisions come into force?

On financial stability, can the Minister offer an unequivocal commitment that NHS England and the department will not use the new skill mix freedoms as a mechanism to unilaterally reduce the dispensing fees paid within the community pharmacy contractual framework?

On the safety of supply, given the sector-wide apprehension, will the Minister commit to publishing restrictive statutory guidance that clearly defines “supply at or from” a pharmacy to rule out any future implementation of unsupervised off-site collection points for pharmacy and prescription-only medicines?

This is a reform that will have good outcomes if implemented correctly. The move forward for progress must address the potential risks, ensuring support for the entire pharmacy team and financial stability for dispensing as well as, crucially, protecting patient safety and access to local dispensing community pharmacy.

[Lord Kamall (Con)]

My Lords, I also thank the Minister for the way she introduced this SI. I begin by also thanking the thousands of pharmacists and pharmacy technicians who deliver vital services to patients every day in both the community and hospital settings— I can see that your Lordships all agree with that.

From these Benches we support the principle behind this statutory instrument. As the Minister said, in many ways it is common sense. It reflects the evolution of community pharmacy practice, which has changed significantly since the original 1933 Act was introduced—a time when pharmacists still routinely compounded medicines by hand. Over the years, that role has evolved and medicines are now largely pre-packaged and supplied via global supply chains. Pharmacists increasingly play a critical role in delivering NHS services, from vaccinations to blood pressure checks, emergency medications and, of course, Pharmacy First consultations—which many noble Lords agree with. Given the Government’s priorities on moving from hospital to the community, they also play a vital role here.

This legislation rightly seeks to release capacity, allowing pharmacists to spend more time with patients, and it allows pharmacist technicians to take on more responsibility in line with training and regulation. As the noble Baronesses, Lady Hollins and Lady Bennett, said, there were concerns about the technicians and the differential in training level, and taking that on. In some ways, that takes us back to the physician and anaesthetist associates debate. Although the noble Baroness, Lady Bennett, and I were on different sides in that debate, I think that we would all agree that it was not right that those who were not qualified were taking on the role of those who were more qualified and taking on roles above their qualifications. What can the Minister say about that, given the experience of anaesthetist and physician associates? We welcomed that. Some of them were being asked to do roles for which they were not qualified. How do we make sure that pharmacist technicians are not repeating that?

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[Baroness Merron (Lab)]

It is important to keep all matters under review—and I would want more than that—because we need to see how things are going. Certainly, the monitoring will continue. However, I would counsel a bit of caution: increases may not be directly related. As the noble Baroness well knows, it is always a complex situation, but certainly monitoring will continue. We will want to see how these reforms are working.

On training, I say to the noble Lord, Lord Scriven, that initial education training is assured by the regulator. Post-qualification training is a responsibility of NHS England. No pharmacy technician should be acting outside of their competency, and pharmacists have the responsibility that I outlined of ensuring that they are delegating tasks appropriately.

On accuracy errors, which the noble Lord, Lord Scriven, raised, pharmacists and pharmacy technicians remain professionally accountable for their actions. There is no change to that. On the question from the noble Lord, Lord Scriven, about a patient having a question about their medication, the pharmacy technician, or the other professional handing out the medication, will be trained to refer this back to the pharmacist. So, again, that assurance can be given.

I make reference to pharmacy funding because the noble Lord, Lord Scriven, raised it. We have been quite clear that funding community pharmacy is a priority. The new community pharmacy contractual framework, which has been secured by this Government, is the first step in rebuilding community pharmacy as part of our plan for change. There is a £3.1 billion deal; it is the largest uplift in the funding of any part of the National Health Service, which shows, I believe, our commitment to supporting community pharmacy and building a service that is fit for the future.

[Lord Scriven (LD)]

I know that the sector welcomes the commitment from the Government to the uplift—that is not in doubt—but that fact is that, even with the uplift, dispensing fees are still below cost. The question was quite specific, because it is causing a bit of worry in the sector: can the Minister assure the sector that, because this measure is enabling and not mandatory, the Government will not use a skill-mix change as a way of trying to reduce dispensing costs?

[Baroness Merron (Lab)]

I will be pleased to write to the noble Lord in greater detail, if he will allow that, because his question raises a whole range of points, and I would like to be accurate in my response to him.

I move on to the points made by the noble Lord, Lord Kamall, about the transition period. I hope that it is helpful for me to say that, following the approval of the Privy Council and royal approval, provisions on handing out checked and bagged prescriptions in the absence of a pharmacist will apply, as I mentioned earlier, some 28 days later. The other measures will be brought into force after a one-year transition period, which will be enacted by an Order in Council to be agreed with the Privy Council. This will allow time for the professional regulations and guidance that are absolutely crucial to making this work to be updated; we cannot do this without that time.

Noble Lords have made extremely helpful and important points today. I know that there is more work to be done to ensure that the sector is fit for the future so that we can deliver the change described in the 10-year health plan. I am grateful for noble Lords’ support for innovating and modernising the regulatory framework, because pharmacy services must be sustainable, deliver quality services and deliver the outstanding patient care that we all deserve. I thank noble Lords for their contributions and questions.

HIV: Testing and Medical Care

Lord Scriven Excerpts

Monday 20th October 2025 Lords Chamber

[Baroness Merron (Lab)]

I certainly can assure my noble friend that, in our discussions with the devolved Governments, we highlight this area and will continue to do so.

[Lord Scriven (LD)]

My Lords, I have a question about regional variations. Some 37% of all community tests were carried out in London in 2023, but only 1.1% in the north-east. What action will the Government take to deal with this regional variation?

[Baroness Merron (Lab)]

The UKHSA supports local areas to improve delivery, not least through data monitoring and reporting, which is vital. Without commenting on specifics, I will say that there will be variation because of incidence and the needs of local populations. We account for this in our funding and direction. What really matters is equality of access and outcome, which will remain a real focus of the plan that I look forward to presenting to your Lordships’ House.

Healthcare Provision: Inequalities

Lord Scriven Excerpts

Monday 20th October 2025 Lords Chamber

[Baroness Merron (Lab)]

I can indeed give that assurance, and I am grateful to my noble friend Lady Brown for her voice on the matter of women’s poor hysteroscopy experiences. These are unacceptable and part of a wider issue of women’s pain being normalised. Women must be given the opportunity to discuss pain relief with a clinician before the procedure. While I am glad to say that updated guidelines from the Royal College of Obstetricians and Gynaecologists do emphasise minimising pain, it is clear that more action is needed. I assure my noble friend that we are updating the Women’s Health Strategy for England to address what I believe is a wider issue, and to improve the experiences of women across the country.

[Lord Scriven (LD)]

My Lords, clinical evidence has established that poor health care directly contributes to the current 22-year life expectancy gap between people with learning disabilities and the general population. Why is this unacceptable inequality simply becoming a grim statistic that the Government continue to pay millions of pounds to measure, but are reluctant to take statutory measures to end?

[Baroness Merron (Lab)]

It is an unacceptable situation, as the noble Lord says. However, I refer him to the national approach, which will inform action in communities, including for people with a learning disability and those who are autistic. The Core20PLUS5 informs the reduction of healthcare inequalities among a range of groups; and, extremely importantly, it supports NHS organisations in identifying who might be at risk of poorer experiences, and in addressing this. I agree with the noble Lord that this must include those with a learning disability and those who are autistic.

Suicide Reduction

Lord Scriven Excerpts

Monday 8th September 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Baroness is quite right to speak as she has done. The suicide prevention strategy and the seven priority groups it identifies does include autistic people. As the noble Baroness will know, I think that is particularly key and I will certainly be pleased to look out for the report to which she refers.

[Lord Scriven (LD)]

My Lords, first, I welcome the Minister back to her place and wish her rudimentary health in the future.

Internationally, a co-ordinated government approach, as the noble Baroness said, is a proven factor in reducing suicide. She said moments ago that two-thirds of people who commit suicide are not actually involved in mental health services. In light of international practice, where the best success rates are when co-ordination is dealt with not by one department but across government, would the Government look at potentially moving this to the Cabinet Office, rather than it being led purely by the Department of Health?

[Baroness Merron (Lab)]

I thank the noble Lord for his warm welcome back to the Dispatch Box in full health. The noble Lord makes an interesting suggestion. I will be co-ordinating a cross-government suicide prevention approach. It is the case, as the noble Lord alludes to, that this cannot be solved by DHSC alone. However, it is where it is placed presently and I assure him of the cross-government commitment we are making, and also how that will be developed so that it is much more meaningful than it is at present.

Diabetes: 10-Year Health Plan

Lord Scriven Excerpts

Thursday 26th June 2025 Lords Chamber

[Baroness Merron (Lab)]

Fracture liaison services do an incredible job. I refer the noble Baroness to the words of the Secretary of State—I will not quote them because I do not have them to hand and there is nothing worse than misquoting somebody, particularly the Secretary of State—who has made his intentions quite clear on fracture liaison services. We certainly appreciate their value and the need to make that kind of provision available across the country.

[Lord Scriven (LD)]

With regard to what the Minister said about the DNA database of children with diabetes and other conditions, what are the mechanisms in place if a child, at the time they reach Gillick competence, no longer wishes to have their data on that DNA database? Will there be mechanisms so that the child can at that point withdraw their data and prevent it being used?

[Baroness Merron (Lab)]

All the usual provisions will apply, but, as we develop the system, all that detail will be confirmed. I will ensure that the point the noble Lord raises is fed into that consideration.

NHS: Private Equity

Lord Scriven Excerpts

Wednesday 25th June 2025 Lords Chamber

[Baroness Merron (Lab)]

I am grateful to the noble Lord for his suggestion. This was another area I raised with officials who have been in contact with Assura and the proposed new company, Primary Health Properties plc. The implication, I believe—I am sure the noble Lord will happily correct me outside the Chamber if this is not the case—is that somehow the Government should take on this responsibility. This would be a significant cost because the Government would have to offer in excess of the £1.79 billion currently offered by PHP and, in addition, take over £2 billion of debt raised against the properties which is secured against future rental income streams. I hope that gives some idea of the scale. There is also no strategic imperative. I understand the concerns, but the market is currently delivering, and it is expected to continue to do so.

[Lord Scriven (LD)]

My Lords, this raises a wider question regarding the NHS primary care estate. Will the Government look seriously at implementing new controls and transparent pricing benchmarks to prevent overseas investors not just imposing exploitative rents but producing punitive dilapidations, which is where they will make their money when they return the estate to the public sector?

[Baroness Merron (Lab)]

The noble Lord raises an important point. I assure him that rent and service charges continue to be set in line with the original terms if there is a change of owner. Whatever the ownership, properties occupied by GPs are required to be professionally valued by the district valuer. The service advises commissioners on whether levels of rent are value for money and align with market rents in a particular area. The other thing I might add, which I mentioned in answer to an earlier question about the mixed model of the general practice estate, is that nearly half of them are in any case GP-owned and 26% are GP leasehold. We do not currently see a problem in the way the noble Lord describes, but if there are particular examples to follow up, I am very happy to do so.

Perinatal Mental Health

Lord Scriven Excerpts

Wednesday 25th June 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Baroness raises a very important point, particularly on voices not being heard. I am sure she heard the announcement on maternity safety made by the Secretary of State on Monday. He highlighted the issue of women’s voices and that women are so often not listened to. That is particularly the case among the minority ethnic groups the noble Baroness referred to. I assure her that that is taken into account. I am glad to say that there are record numbers of women accessing community perinatal mental health services. On the point raised, that is why it is for local areas to serve their local communities in the way she describes.

[Lord Scriven (LD)]

My Lords, given the £8.1 billion annual cost of untreated perinatal mental illness, will the Government mandate a ring-fenced, inflation-proof budget for perinatal mental health services within ICBs to ensure sustainable long-term investment, rather than relying purely on discretionary funding?

[Baroness Merron (Lab)]

I do not share the view that it is discretionary funding, not least because what matters are the outputs, which are, as I described, that a record nearly 65,000 women accessed a specialist community perinatal mental health service or maternal mental health service in the 12 months to April 2025. That gives some idea of the scale—that is a 95% increase compared with four years earlier. So the output is absolutely there. Was it ever the case that all needs were met? No, it was not, even before the change to the planning guidance and the ring-fencing. I emphasise again that this Government’s whole approach is to ensure that local communities are properly served. That is why ICBs can make decisions about how they provide what I regard as first-rate services.

Learning Disabilities Nursing

Lord Scriven Excerpts

Tuesday 17th June 2025 Lords Chamber

[Baroness Merron (Lab)]

The noble Baroness is quite right. One of the difficulties is that sometimes there is misdiagnosis, where it is incorrectly assumed, for the very reasons that the noble Baroness gives, that the presenting condition is the learning disability when actually it is a different condition. I agree about the need that the noble Baroness outlines. In reports such as the LeDeR review and Transforming Care, there is a national focus on reducing health inequalities and increasing awareness of this very point about diagnostic overshadowing. I will ensure that that is key to what we are doing.

[Lord Scriven (LD)]

My Lords, the Minister just referred to the LeDeR report, which points out the persistent avoidable deaths of people with learning disabilities. Yet we now have a seven-month delay for the latest annual report, which shows a lack of urgency. Does the Minister agree that this leads to a genuine perception that the sector’s critical concerns are not being prioritised, and that this in itself hinders promotion of learning disabilities nursing?

[Baroness Merron (Lab)]

It is probably helpful to say to your Lordships’ House that there have been significant changes to how we respond to care for individuals with learning disabilities within the UK. Like in other specialist areas, there is a move towards multidisciplinary teams, which I certainly welcome. I also emphasise the role of learning disability nurses, who are absolutely key, as is the training of all staff. That is why we are so committed to rolling out the Oliver McGowan training, which I know is highly regarded by all staff.

Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025

Lord Scriven Excerpts

Tuesday 17th June 2025 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)]

My Lords, I am grateful for the opportunity to debate these regulations, which I think can fairly be described as routine. The Medicines and Healthcare products Regulatory Agency charges fees for most of its services and, to ensure continued cost recovery, updates its fees every two years. This regularity provides certainty to customers and enables better financial planning. This statutory instrument helps to achieve this by doing three things.

First, it updates the fees that the MHRA charges in relation to its activities in regulating medical devices and blood components for transfusion. These fees were last updated in April 2023. The implementation date for the proposed changes is July 2025 and they will ensure cost recovery until 2027. This will apply UK-wide, with the fees being the same across the United Kingdom. The total cost to those who pay the MHRA’s fees from this instrument is estimated to be £0.7 million per year after inflation.

Secondly, the instrument introduces a fee for a new, optional service: a regulatory advice meeting for medical devices. In addition to publishing guidance and addressing written inquiries, this new service will further support manufacturers in their understanding of the application of the UK’s regulatory framework to their products. I am glad to say that this service was well received in the consultation. It will be mainly for those developing novel and/or complex products where the application of legislation is not as straightforward or easily understood as it might be. We have had many discussions on removing obstacles to getting products to market which support better care for patients. I hope that this will make a contribution in this regard.

Thirdly, the instrument will introduce a new payment easement for small and medium-sized enterprises for the MHRA’s medical device clinical investigation fees. While this easement will not reduce the overall fee, which would require cross-subsidisation, it will enable the fee to be paid in two instalments, providing flexibility and, I hope, supporting the businesses concerned.

It might be helpful if I highlight the important role that the MHRA plays in safeguarding public health and the importance of the agency continuing to be properly funded to deliver its role. The MHRA is a world-leading regulator of medicines, medical devices and blood components for transfusion in the UK. It plays a vital role in protecting and improving public health. It is, I suggest, an engine for UK growth and innovation; it is certainly an indispensable part of the UK health system and plays a major role globally, working with international partners.

The principles for how the MHRA charges fees are set by HM Treasury in its guidance, Managing Public Money. The basic principle is to set statutory fees to recover full costs. This means that the regulated bear the cost of regulation and that the MHRA does not profit from fees or make a loss that would then have to be subsidised by government departments or the UK taxpayer. It is, of course, standard practice for government bodies that operate on a cost-recovery basis to update their fees. It is also standard practice for other regulators, which is the reason why I described this statutory instrument as “routine”.

All fees are set by taking into account various factors that reflect the cost of the activity—for example, the activities involved in delivering a service, the time taken and the number and grade of staff involved. This process is informed by the recording of staff activity, which is the practice of monitoring and recording certain activities performed by the MHRA’s staff to establish how long they take and, so, how much they cost. In addition, also in line with the HM Treasury guidance, the MHRA includes the costs of necessary corporate overheads and system investments. Regular fee uplifts ensure financial sustainability and enable the MHRA to deliver the responsive, efficient service that its customers rightly expect.

It is worth noting that this instrument does not change the MHRA’s fees in relation to medicines regulations. Given the different legal positions in relation to the powers to make regulations about fees relating to medicines, medical devices and blood components for transfusion, two statutory instruments have been used for the MHRA’s fee uplift. A second instrument for human medicines fees has, therefore, already been laid before the UK Parliament and the Northern Ireland Assembly and has already come into force.

In summary, ensuring that the MHRA is sufficiently resourced will help it to deliver its services more reliably and to provide patients, the public and industry with the service that they expect. I beg to move.

[Lord Scriven (LD)]

My Lords, I thank the Minister for outlining the purpose of these regulations so eloquently and succinctly. It is clear that the change to the fee structure for regulating medical devices and medical products is part of a realm of profound importance both to public health and to the future of healthcare in the UK. As Liberal Democrats, we unequivocally support a robust, efficient and well-resourced Medicines and Healthcare products Regulatory Agency, but it is important that our regulatory bodies possess the financial stability to ensure the safety, quality and efficacy of medical products and blood safety, which touch the lives of millions throughout the year.

I am not going to speak on these regulations at great length; I just want to tease out a couple of issues about which I would like a little more information from the Minister. First, increasing the fees will mean that costs will be covered automatically. What mechanisms are in place to ensure that efficiency and effectiveness are in place, rather than just ballooning costs that it would be assumed the industry would absorb? I am not clear from reading the impact assessment or the regulations exactly how the Government will ensure that the cost really is the cost and is not excessive cost.

Secondly, it is clear in the impact assessment that most of those who gave feedback to the consultation question were against these fees. How have the Government taken into consideration the reservations, not just of the “no” element but in particular that the fees were seen in some cases to be disproportionately high and to exceed inflation? How has that developed? Why are these costs disproportionately high and why do they exceed inflation?

Finally, it is important to increase the fees to ensure the agency’s work can continue but, critically, the impact assessment demonstrates a lack of concrete detail on how these increased fees will translate into tangible improvements in these MHRA services. Although the rationale for increased fees is often framed around enhancing regulatory efficiency and speed, the document provides insufficient assurances of the measurable commitments as to how the additional revenue will be specifically utilised. There is no clear framework for accountability that demonstrates how these funds will lead to faster approvals or increased safety. How will the department measure such improvements? In particular, what improvements are expected on the back of this fee increase?

These regulations are a serious matter. They impact on the health of our nation and, to some degree, the vibrancy of our life sciences industry, but we must ensure that our regulatory framework is not only robust but forward thinking and truly serves the best interests of every patient in the UK by ensuring that the increased cost will both increase efficiency and, we hope, improve the services that the MHRA provides.

[Lord Kamall (Con)]

My Lords, I also thank the Minister for introducing these regulations succinctly, as the noble Lord, Lord Scriven, said. Perhaps in common with the Liberal Democrats, we on these Benches—the numerous people on these Benches—do not seek to oppose this statutory instrument. Rather, we just wish to reflect on its purpose and practical implications, and ask a few questions for clarification that I hope the Minister will be able to answer.

As noble Lords have said, this instrument amends three pieces of legislation. We understand that these changes are intended to enable the MHRA to increase the fees to manufacturers, suppliers and other regulated entities involved in the approval of medical devices and blood components. Noble Lords understand that the current model relies primarily on contributions from industry and that the MHRA’s fees were last comprehensively reviewed in April 2023, as the Minister said. Of course, we have seen a rise in operational costs, particularly relating to staff and overheads, so we completely understand that the intention behind these regulations is to bring the MHRA’s income more closely in line with the cost of delivering its services. It is also to place the agency on a more sustainable financial footing, thereby reducing its reliance on central government funding, which I think is something on which we all agree.

As the noble Lord, Lord Scriven, said, the impact assessment accompanying this instrument identified the primary benefit of this additional income—to enable the MHRA to continue fulfilling its responsibilities —but, as was raised by some in the industry and in the other place, it is less clear how these changes will directly benefit patients, healthcare providers or, indeed, medical innovators, in particular those operating in the small and medium-sized business sector. We understand that the Government decided to pause their proposed reforms to the medical device registration fee following concerns raised by stakeholders. That decision is welcome, and I thank the Minister and the Government for that. The paused proposals would have had a disproportionate impact on companies registering a large number of products, particularly due to the proposed fee model linked to the global medical device nomenclature codes. However, the broad uplift in the other fees will still go ahead, and it is in this wider context that we seek some reassurance about these changes.

I shall look at some of the areas on which some clarity would be welcome. First, we recognise the MHRA’s need for stable funding, but we want to make sure it does not create barriers to innovation, in particular for start-ups and SMEs, which, as we know, often operate on much narrower margins and already navigate a complex regulatory environment. What assessment has been made of the cumulative impact of these fee increases on smaller firms? Do we know how these changes compare with the regulatory costs faced by manufacturers in other major markets, such as the EU, the US or Asia? Is the Minister able to give some international context here?

Secondly, the impact assessment confirms that the staffing costs remain the largest cost driver for the MHRA and assumes a 2.2% annual pay increase through to 2027—below the current rate of inflation. Has any thought been given to whether that is a realistic assumption and basis for planning? If the actual costs prove higher than forecast, how will that impact the MHRA’s progress towards the full cost of recovery? Would the agency be forced to scale back its services, or would the taxpayer be expected to cover any shortfall?

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[Baroness Merron (Lab)]

I am most grateful to both noble Lords for their constructive contributions and their support for these measures. I welcome their questions and will do my best to respond to them.

I will first make a few general points that may assist. Noble Lords acknowledged the role of the MHRA, the essential services it offers and the crucial role it plays. It is also understood that it needs financial backing to do that. Therefore, in supporting these regulations, we will enable the MHRA to continue to contribute to the Government’s health mission and to balance its responsibilities to maintain product safety and champion innovation. As the noble Lord, Lord Kamall, said, that is so important to us as a country and an economy, as well as to the National Health Service.

The MHRA is not alone in how it is funded. Most regulators levy charges for their work, and—in response to the question about international comparisons—it is also accepted international practice for healthcare product regulation to follow this trajectory; for example, the European Medicines Agency and the US FDA also charge fees. I certainly feel that the cost recovery approach, which neither noble Lord questioned as a fundamental, ensures that services are paid for by those who use them rather than by the taxpayer—namely, patients.

The noble Lord, Lord Kamall, raised some questions about small and medium-sized enterprises. While I understand that increases in costs can place more relative strain on SMEs compared with larger companies, the MHRA has existing SME payment waivers and easements, and the instrument creates a new SME payment easement for some fees for the medical device clinical investigation service. We have sought to be responsive in this regard.

On supporting innovation and maintaining the UK’s attractiveness as a place to develop and launch medical products, I certainly want to see the UK as the go-to country for that. It does this in several ways— for example, by providing scientific advice and stream- lining regulatory processes to help reduce costs and the time to market. This is a high priority within our Government.

The noble Lord, Lord Scriven, raised questions relating to where costs have exceeded inflation, why this is and what the Government are doing about it. All fees are set to recover costs and it is the case that some services were found to be underrecovering more than others, so this is putting it back in the right place. It is not related directly to inflation but to the real costs and, in some areas, there are concerns about that.

[Lord Scriven (LD)]

Maybe I was not clear in my questioning. It is not about where it goes but this: if there is an automatic assumption that industry will cover the cost, what mechanisms are in place to make sure that there is efficiency, rather than a bloated approach where people think that, as costs will be recovered, they can do whatever they wish? That was the question, particularly regarding the inflation issue.

[Baroness Merron (Lab)]

That is understood. I am going to come on to that, because I think it is important. Of course, with any uplift in fee, I would expect that to be the case, but I have a particular response as I continue. The uplifts we are speaking about today ensure ongoing, reliable delivery. They are necessary for the continued delivery of initiatives that promote growth and innovation. We are not just standing still; we are looking to the future. To the noble Lord’s point, industry has been clear that it supports these fee uplifts as long as they are accompanied by reliable performance.

Although noble Lords have not specifically raised this, I add that the MHRA recognises that there have been some delays in some of its regulatory services of late and these delays were felt by those who pay fees. I am pleased to say that, from 31 March this year, all backlogs were cleared that relate to its statutory functions. Throughout its work to eliminate these backlogs, the MHRA put patients first and prioritised licence applications according to public health need, including those needed to avoid medicine shortages. Importantly, the MHRA is working to ensure that this continues, so that we have predictable, optimised and sustainable services across all the functions.

I can assure the noble Lord, Lord Scriven, that the MHRA is taking steps to improve its performance and efficiency, not least because it does not wish to get into the situation of a backlog again. This includes a modernised RegulatoryConnect IT system and improved agency structures and processes. On accountability, it will also publish performance targets and report against them online and in its annual report and accounts. There are also mechanisms in place for monitoring the impact of these changes. Ministers, including me, meet the MHRA regularly and the MHRA and the department monitor the impact via stakeholder feedback and ongoing performance and finance reporting. I assure the noble Lord, because I know it is a particular interest, that we have key performance indicators in place to monitor the delivery of these services.

I return to the point about small and medium-sized enterprises that the noble Lord, Lord Kamall, raised. In most cases, SMEs are dependent on grants from the NIHR and others, so there is no cost to them as a company when they submit an application to the MHRA. The noble Lord also asked about the assessment of increased fees on SMEs. Benchmarking fees compared to those of other regulators is somewhat difficult, to be quite honest, because of the difference in the way that the regulators operate and their different funding models. For example, a different model is where the regulator is subsidised, which is not the case here. With regard to employer national insurance contributions, the noble Lord is correct that the MHRA is subject to the increases in employer national insurance contributions. The agency believes that these fees will cover the costs of the increase in NI contributions. If there are any shortfalls, efficiency savings will have to be used to manage them appropriately.

[Lord Scriven (LD)]

If fees equal cost, I am not clear how calculations have been made that say that the NIC increases have not been put into that cost to be part of the fee increase, because it is a known cost. I am not clear why that suddenly becomes a potential cost reduction or inefficiency gain within the service.

[Baroness Merron (Lab)]

I may not have been as clear as I would like to have been. I will try again. The national insurance contributions increase is an increased cost and that will have been factored into the new fees that are being put forward. The gentle challenge from the noble Lord, Lord Kamall, was about whether the MHRA could manage it. I am saying that if there were any difficulty in management, it would not be a case of putting up the fees further; it would be a case of managing efficiency costs within the MHRA.

[Lord Scriven (LD)]

Just for clarity, is the NIC cost known and has it been included in these fee increases? It is an important point. I do not want to push the Minister in terms of the actual figures, but I assume that the NIC figure is known and has been included in this fee increase. Therefore, there would be no need for the agency to deal with any difference, because it is a known figure and will be in the fee structure.

[Baroness Merron (Lab)]

I am just waiting for a bit of inspiration.

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[Lord Scriven (LD)]

Does the Minister want me to continue talking?

[Baroness Merron (Lab)]

Perhaps it would be best on this occasion if I review what the noble Lord has said and what I have said and write to him to clarify anything that is not quite clear.

In conclusion, I thank noble Lords for their contributions and for their support for the MHRA to ensure that it has the resources that it needs to continue delivering reliable services and can deliver its important public health role.

Motion agreed.