Arrangement of Business
The Deputy Chairman of Committees (Lord Haskel) (Lab)
My Lords, if there is a Division in the Chamber while we are sitting, this Committee will adjourn as soon as the Division Bells are rung and resume after 10 minutes.
Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025
(1 day, 23 hours ago)
Grand CommitteeRead Hansard Text Read Debate Ministerial Extracts
Baroness Merron
That the Grand Committee do consider the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025.
Relevant document: 34th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, the legislation before us today is part of a wider programme of common-sense reform to modernise pharmacy regulation and to cut red tape, which will enable pharmacies to thrive and will make pharmacy services quicker and easier for patients to access, as well as maintaining high levels of patient safety.
The Government recognise that the current legislation we have in place is outdated and restricts practice, putting restrictions on the quality of service to the public. So I am very pleased to bring forward today another measure that, if approved, will mean that pharmacists will be able to spend more time delivering clinical care and registered pharmacy technicians will be able to manage more dispensing processes autonomously.
I draw your Lordships’ attention to the fact that these measures are voluntary, and take-up will of course vary across the measures that I will describe.
I turn to the detail of the SI. It proposes to amend the Human Medicines Regulations 2012 and the Medicines Act 1968, using powers under the Health Act 1999. The legislation broadly extends across the UK, but I point out that some of it does not in practice apply to Northern Ireland—I will return to that.
I wish to set out three core proposals. The first covers who must supervise the dispensing of pharmacy and prescription-only medicines. Currently, the situation is that a pharmacist must carry out or supervise all stages of the preparation, assembly, dispensing, and sale and supply. Case law has led to restrictive practice and different interpretations of the law. Many of these activities can and should be delegated to registered pharmacy technicians, who are competent and ready for these changes.
The first proposal will allow a pharmacist to authorise a registered pharmacy technician to undertake or supervise others to undertake these activities without the pharmacist needing to supervise. In giving an authorisation, the pharmacist can set conditions. For example, they may wish to exclude certain categories of drugs and ensure that staff know when to consult the pharmacist.
The law demands that a pharmacist must have due regard to patient safety when giving an authorisation. This means in practice that a pharmacist will be authorising only staff who are trained, competent and confident to undertake a task. The pharmacist will still be expected to undertake a clinical check, which is critical to make sure that a medicine is safe and appropriate for each patient. A further reassurance is that professional standards and guidance will be updated to support the safe implementation of these changes in practice.
The second proposal aims to stop the only-too-familiar situation we will all know about, whereby patients who arrive at a pharmacy find they cannot be handed their medicine because the pharmacist is absent for some reason or another. For example, they may be with a patient or taking their well-earned lunch break. This will be resolved by allowing a pharmacist to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in their absence. This change in the regulations allows the pharmacist to decide who it is professionally appropriate to authorise to hand out medicines in their absence. This is likely to be a pharmacy technician, or a dispensing or counter assistant. Again, the pharmacist is required to have due regard to patient safety and to have already done a clinical check—in other words, they must be content that the medicine is appropriate for that patient and no further consultation is required.
The third proposal relates to how hospital aseptic facilities are managed and run. These are highly specialised services delivering sterile medicines for cancer patients, premature babies and other vulnerable patients. At the moment, the law states that only a pharmacist can run this type of facility. But the reality is that pharmacists are not the only staff capable of running such facilities. There is a cohort of pharmacy technicians who have undergone additional education and training and who are competent and capable of managing these important facilities. So, this legislation will allow registered pharmacy technicians to lead these facilities. The Royal Pharmaceutical Society is updating its 2016 professional standards for the quality assurance of aseptic preparation services. This will define the required knowledge and training for both professions to support and ensure safe implementation.
I turn to the scope and timescales. It is important to note—I made reference to this earlier—that, while the statutory instrument extends across the UK, proposals one and three will not apply in Northern Ireland until pharmacy technicians become a registered profession in Northern Ireland. At this point, we will, of course, work with the Department of Health, Northern Ireland to bring in these measures as soon as possible.
With regard to timescales, we are proposing a phased implementation. The measures relating to the handing out of completed prescriptions in the absence of a pharmacist will enter into force 28 days after the regulations receive royal approval. This means that patients will benefit immediately, thereby taking pressure off already busy pharmacy teams. The aim is to bring the other measures into force following a one-year transition period. This will be enacted by a separate Order in Council. This will allow time for the development and publication of professional standards and guidance and will ensure that these measures are implemented into practice safely.
I hope that I have been able to set out the purpose, alongside a clear rationale on the need for change. I look forward to what will be, I am sure, an informed and constructive debate. I beg to move.
Baroness Hollins (CB)
My Lords, some concerns about the order have been drawn to my attention, so I have a few questions for the noble Baroness. Pharmacy technicians, on entry to the register, have an NVQ 3 qualification, which is equivalent to two A-levels. By contrast, pharmacists have a level 7 qualification, a master’s degree, which is a different basic training, with pharmacists obviously having much greater scientific and clinical knowledge. There is a worry that large pharmacy corporations could create pressure or targets which result in pharmacy technician supervision replacing pharmacist supervision for financial gain, which could put patients at greater risk because of the knowledge gap between the pharmacist and the pharmacy technician.
With 16% of 237 million drug errors annually being due to dispensing errors, I ask the Minister, who will, after all, be legally responsible in the event of any patient harm, why supervision is not defined in legislation or in the draft SI. I could not find any evidence of definition. The noble Baroness said in her introduction that pharmacists would be required to make a clinical check, but I cannot see that in the order.
I understand that, in the government consultation, 58% of all respondents and 76% of pharmacist respondents opposed allowing pharmacists to authorise pharmacy technicians to supervise the preparation, assembly, dispensing, sale and supply of prescription-only medicines in pharmacies. Also, 51% of respondents and 65% of pharmacists disagreed with allowing pharmacy technicians to supervise the preparation, assembly and dispensing of medicines at hospital aseptic facilities in the way that pharmacists do under current law.
That generates a few questions. First, what is in place to prevent any one pharmacist—for example, one working centrally across a chain of stores—writing an authorisation for large groups of pharmacy technicians on the register to supervise medicines preparation, assembly, dispensing, sale and supply from, potentially, every pharmacy on the register, implying indirect supervision en masse? If this cannot be done in a single authorisation, could any one pharmacist write multiple authorisations to the same effect? Is it correct that an authorisation can be made without the explicit consent of the technician, and that, once made, it can be withdrawn or varied only by the pharmacist who gave it? If that is correct, individual pharmacists in pharmacies would be powerless to withdraw the authorisation if they were not the one who gave it, even if they were the pharmacist on the premises and had concerns. It seems that, even if the on-site pharmacist was not the one who issued the authorisation, they might be liable for something that occurred but which they were powerless to prevent. It just does not seem clear enough; that is the reason for my questions.
The government website states:
“Although the presence of a pharmacist in retail pharmacy is not explicitly stated in law, section 70(2) of the Medicines Act 1968 requires that a responsible pharmacist must be in charge of what happens at a retail pharmacy. This means, in law, the ‘physical presence’ of a pharmacist is inferred”.
Can the Minister confirm whether this inference is drawn from the responsible pharmacist regulations 2008, which have been revoked? The General Pharmaceutical Council’s rules are expected to allow for a pharmacist to be absent from a pharmacy, and for a pharmacist to be responsible for more than one pharmacy and, therefore, not physically present in all of them. How will authorisations be tracked so that a local pharmacist can know whether a given authorisation is current or has been withdrawn orally or in writing or varied? The authorisation could have been given by a different person, on a different date and on different premises.
It looks as if a pharmacy technician can hold two or more different authorisations—one of which could be oral, which may be useful in times of emergency or great pressure—but this order requires either verbatim recording or video recording at the time, stating either a date of expiry or that this overrides the previous authorisation. What happens if authorisations conflict? How will a conflict be resolved if, for example, one pharmacist allows the supply of certain drugs and another prohibits it?
This brings me briefly to the Terminally Ill Adults (End of Life) Bill, which, in its current form, provides sweepingly extensive powers for the Secretary of State to amend the entirety of the Human Medicines Regulations 2012 and to make regulations regarding the preparation, assembly and supply of lethal substances —particularly in Section 37(4). This could allow pharmacy technicians to supervise, prepare, assemble and supply highly toxic lethal mixtures. Many medicines are incompatible when taken together, which is a concern.
I apologise for the complexity of the questions and the confusion that this order has provoked.
Baroness Ritchie of Downpatrick (Lab)
My Lords, it is a pleasure to follow the noble Baroness, Lady Hollins, in this debate. First, I declare an interest as a member of your Lordships’ House’s Secondary Legislation Scrutiny Committee. Only last week, I met the Company Chemists’ Association, which very much endorses this order. This morning, I chaired a round table on vaccinations, which showed quite clearly that, if community pharmacies are able to execute vaccinations on a widespread basis, their other work in terms of dispatching and gathering together prescriptions can be done by fully regulated pharmacy technicians.
However, I take on board the point from the noble Baroness, Lady Hollins, in respect of qualifications and the wide gap in those qualifications. There are also issues to do with terminally ill adults and medication and prescriptions, particularly around contraindications. If that happens, it could have severe consequences for the patient.
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—
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?
Baroness Merron (Lab)
My Lords, I thank all noble Lords for their valuable contributions to today’s debate. I noted the discussion between noble Lords about whether they could agree with several noble Lords at one time; the answer is yes because I can do so, too. I feel that the questions asked will shine a useful light.
I am grateful for the support that this order has received and for the understanding that it is about releasing capacity and meeting what people need these days, as compared to the situation in 1933—or, indeed, at any time since then. This is about our move from hospital to community; our reliance on and welcoming of the whole pharmacy sector; and what that sector can bring to us. This sector is a tremendously important part of our National Health Service and allows us to provide services when, where and how we need them; I add my thanks to pharmacists, pharmacy technicians and their professional bodies for their work in this area. I hope that, overall—I picked this point up—noble Lords will see that this order is about supporting pharmacy services, supporting patients and cutting the red tape that frustrates both the sector and those who use it.
I turn to the specific questions asked by noble Lords; I will of course be glad to write if I do not manage to address any of them. The noble Baroness, Lady Hollins, my noble friend Lady Ritchie and the noble Lord, Lord Scriven, raised concerns about the order, particularly in respect of pharmacy technicians’ qualifications. Let me say at the outset—this is quite a good framing, really—that pharmacists are of course absolutely critical in delivering pharmaceutical services, but the fact is that they cannot deliver without a dedicated team. That is what we are building on.
Pharmacy technicians are ready for these changes. Their training and expertise enable them to take responsibility for many activities that would previously have been the sole responsibility of the pharmacist. I can certainly say that post-registration training and professional guidance will be supporting these changes into practice. I say this to noble Lords: the answer to a number of the questions that have been legitimately asked is the professional guidance, because, as I know noble Lords will understand, this cannot all be laid out in legislation.
The noble Baroness, Lady Hollins, and the noble Lord, Lord Kamall, asked about definitions in respect of clinical checks. Let me start by talking about the professional guidance, which will set out what the pharmacist’s role is to be—including when and how there will be a need for a clinical check. It is important to say that the sector wanted pharmacy technicians to be able to work autonomously; that falls outside what “supervision” traditionally means. Therefore, we are introducing a second form of delegation, which will allow pharmacists to authorise a pharmacy technician to undertake or supervise dispensing activities without the need for direct supervision by the pharmacist. We are aware that we need to give the sector the legal clarity that noble Lords have asked for with regard to what “supervision” means in this context; I can refer noble Lords to a detailed annexe that was published alongside the consultation, but the point is well made.
The noble Baroness, Lady Hollins, my noble friend Lady Ritchie and the noble Lord, Lord Scriven, raised various questions in respect of what I will refer to as indirect supervision en masse and the need for a responsible pharmacist. So let me give the reassurance that these proposals do not remove supervision or change the legal requirement that a responsible pharmacist must be signed in at a registered premises when dispensing activities are taking place and when open to the public. We have stressed at every stage of formulating this policy our commitment to maintaining the legal requirement that noble Lords are rightly concerned about, whereby every community pharmacy must have a pharmacist on the premises.
The noble Lord, Lord Scriven, asked why there is a reference to “any member of staff”. The reason is that pharmacists will be able to authorise any member of staff to hand out checked and bagged prescriptions but they must be authorising only staff who are trained, competent and confident to undertake a task. There will be updated professional standards and guidance to ensure that good governance supports the safe implementation of these changes in practice. Therefore, it could not be, for example—the noble Lord might have had this in mind—an assistant in a supermarket who happens to be working in the pharmacy. That would not meet what is required. Again, that is an important point.
The noble Baroness, Lady Hollins, asked how authorisations will be tracked and what happens if there is conflict. I go back to my opening comments that practice matters cannot be set out in law. They will be addressed in professional standards and guidance, as I have said. That will be set by the regulators and professional leadership bodies to support the implementation of these changes into practice, and we look forward to working with those bodies. That should include professional expectations for record-keeping requirements when an authorisation is given. Training is to make clear to all staff—I return to the point raised by the noble Lord, Lord Scriven—that they need to follow standard operating procedures for when the authorisation is given, when they should consult the pharmacist and when a supply should not go ahead. That will all be part of that.
My noble friend Lady Ritchie and the noble Lord, Lord Kamall, asked about matters relating to Northern Ireland. As I mentioned, when pharmacy technicians become a registered profession in Northern Ireland, which is expected by April 2027, we will work with the Northern Ireland Department of Health to enact the other changes as soon as possible.
Baroness Ritchie of Downpatrick (Lab)
I thank my noble friend Lady Merron for that helpful information. Initially, up-and-running pharmacy technicians were to be registered by 2025. Why the two-year delay in terms of Northern Ireland? Maybe she would be so good as to ask Minister Nesbitt.
Baroness Merron (Lab)
I cannot give a specific answer, but I will be pleased to write to my noble friend and other noble Lords about the timetable rather than land Minister Nesbitt in it in any way, which I would never wish to do. But I can give the assurance to noble Lords that officials are in regular contact with their counterparts in Northern Ireland, and the measures we are talking about have been developed in collaboration with the devolved Governments and the four chief pharmaceutical officers across the UK. I hope that will be helpful.
The noble Baroness, Lady Bennett, asked about a focus on improved training before the regulations. Pharmacy technicians undertake two years of focused training in clinical settings, and they can provide clinical and dispensing services that are appropriate to their level of training at the point of registration. However, additional post-registration training is widely available to support technicians to prepare for these new roles. Assurance is also provided by the annual revalidation for all pharmacy technicians across the country. If we combine this with robust standard operating procedures and professional guidance, it will provide a clear frame- work to ensure that pharmacists can be confident to authorise pharmacy technicians to carry out, or to supervise others carrying out, activities while ensuring patient safety, which is at the heart of this, as well as service.
Baroness Hollins (CB)
Given the high number of drug errors due to dispensing errors currently, will there be some monitoring of the frequency of drug errors to see whether they increase or decrease as a result of the changes?
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.
Financial Services and Markets Act 2023 (Mutual Recognition Agreement) (Switzerland) Regulations 2025
(1 day, 23 hours ago)
Grand CommitteeRead Hansard Text Read Debate Ministerial Extracts
Lord Wilson of Sedgefield
That the Grand Committee do consider the Financial Services and Markets Act 2023 (Mutual Recognition Agreement) (Switzerland) Regulations 2025.
Lord in Waiting/Government Whip (Lord Wilson of Sedgefield) (Lab)
My Lords, these regulations are a vital step in implementing the UK’s commitments under the Bern Financial Services Agreement, signed with Switzerland in December 2023. This agreement is a landmark in our financial services relationship, reflecting the UK’s status as a leading global financial centre and our long-standing ties with Switzerland.
The purpose of these regulations is straightforward. They create a legal framework to allow Swiss investment service firms to supply certain cross-border services directly to UK clients, including sophisticated and high net worth individuals, without the need for UK authorisation.
This new market access is based on mutual recognition. This means that each party recognises the other party’s regulatory and supervisory regimes and deems that the other party’s regulatory and supervisory regime achieve equivalent outcomes to its own. These outcomes relate to market integrity, financial stability and the protection of consumer and investors.
Mutual recognition is underpinned by enhanced supervisory co-operation between the Swiss Financial Market Supervisory Authority, or FINMA, the Financial Conduct Authority, the Bank of England and the Prudential Regulation Authority. For UK insurers, the Swiss offer under the BFSA allows them to provide certain insurance services directly to Swiss clients, including sophisticated and high net worth individuals, without the need for Swiss authorisation, subject to the same principles of mutual recognition and supervisory co-operation.
To ensure this new access is safe and well-managed, the regulations also equip our financial regulators—the Financial Conduct Authority, the Prudential Regulation Authority, and the Bank of England—with new powers and duties. These include the ability to request information from Swiss firms, intervene if risks to UK consumers or financial stability arise, and oversee an orderly wind-down of Swiss firms’ UK activities if the agreement is terminated. The FCA is also required to maintain a public register of Swiss firms operating under the agreement, ensuring transparency for UK clients.
The regulations also establish enhanced co-operation arrangements between UK and Swiss regulators, including a formal memorandum of understanding. This will support regular information sharing, joint supervisory work and effective dispute resolution. The FCA and PRA will work closely with their Swiss counterparts to address any risks or issues that may emerge.
Importantly, these regulations do not diminish the UK’s high standards of consumer protection, market integrity or financial stability. Safeguards are in place to allow UK regulators to act swiftly and decisively if a Swiss firm’s conduct threatens our financial system or clients. Swiss firms will remain subject to supervision by the Swiss regulator, but UK authorities retain the right to intervene where absolutely necessary and if co-operation with the Swiss regulator has failed. These are backstop powers and will therefore be used only as an absolute last resort.
Industry stakeholders, including TheCityUK, have welcomed the agreement and these regulations as a positive development for cross-border financial services. They provide greater certainty and flexibility for firms, while maintaining robust oversight and protection for UK consumers.
In summary, these regulations deliver on our international commitments, strengthen our financial services partnership with Switzerland, and ensure that new market access is accompanied by appropriate regulatory powers and safeguards. I beg to move.
Baroness Bennett of Manor Castle (GP)
My Lords, I thank the Minister for introducing this statutory instrument, which, as he said, implements the UK’s commitment to the agreement between the UK and the Swiss Confederation on mutual recognition in financial services.
I note that the explanation of the SI says that it will, as the Minister said, allow the Financial Conduct Authority and the Prudential Regulation Authority to essentially oversee and ensure that nothing is going wrong and have oversight of Swiss operations here. That is perhaps not as reassuring as one might hope. I note a report in the Times yesterday that the Financial Conduct Authority had privately shared concerns about the 79th Group with the City of London Police eight months before the group collapsed, owing thousands of people more than £200 million. It is, to quote the Times,
“suspected of being one of the largest Ponzi schemes in British history”.
I note for the record that the company denies any wrongdoing. None the less, the Financial Conduct Authority appears to have had concerns but did not share those with consumers, who are clearly now very much paying the price.
It is worth reflecting that it is a little bit surprising that, as the Minister said, this reflects an agreement that was struck in December 2023 by the previous Government. They said that this was a
“ground-breaking pact on financial services cooperation”
and that it would enable
“frictionless, cross-border provision of financial services between the UK and Switzerland”.
It is interesting that a Government who have been elected on a promise of change now appear to be delivering exactly the agenda with the same kind of terminology as that of the previous Government who they replaced.
It is important to put on the record and focus on the reality of Swiss banking, which is deeply corrupt and non-transparent. If we take, for example, the Tax Justice Network’s financial secrecy index, Switzerland ranks second, and that is not a good result—it is second worst. The UK ranks at number 20, which is relatively good comparatively. Yet we now appear to be seamlessly linking up these two systems, linking our system into a more secret system, with considerable risks. Switzerland also ranks fifth on the Tax Justice Network’s corporate tax haven index, so it is complicit in multinational companies’ tax abuse in particular. The Tax Justice Network estimates the cost to other countries of the Swiss operations to be $21 billion a year.
Perhaps this is a specific question to the Minister. As regards the worldwide rise of automatic exchange of information notes in the past decade or so, in which Governments are supposed to exchange relevant financial information with their peers to help them enforce criminal and tax laws, Switzerland has carved out exceptions to these so-called AEOI notes. So, Article 47 of the Federal Act on Banks and Article 127 of the direct federal tax Act, which still provide for secrecy, have not changed. That is going to be accessing our system and under Swiss law we will not be able to see what is happening. There has been talk of using trusts to replace some of the secrecy instead, but of course trusts are one of the issues that are a major problem.
I note in particular the work of Maria-Gabriella Sarmiento—I do not know whether the Minister has seen this, but I certainly encourage him to look at it—who completed a PhD at the University of Zaragoza about the estimated losses of between $20 and $40 billion for corruption practices, of which Switzerland is a significant destination for that money. Over 20 years,
“assets from at least 33 jurisdictions have been traced to Swiss banks … primarily proceeds of grand corruption, money laundering and other crimes”,
with their estimated values ranging between $112 billion and $514 billion.
The reality is, of course, that the UK and Switzerland are quite similar: they have expansive banking sectors, sophisticated wealth management services and market high-value assets. They are prime destinations for the corrupt to stash their money. To take one practical example from Transparency International, Carlos de São Vicente, a former CEO of a partially state-owned insurance company in Angola, embezzled more than $1.2 billion through Bermuda-registered companies; he then transferred substantial sums to Switzerland. That is one case where someone has been found out, but it is a sample of what a great many people we know are doing without being found out and without me being able to name the details.
I note also that, in 2023, Swiss regulators inspected their institutions and found that 50% had largely unsatisfactory anti-money laundering systems. I do not know whether the Minister can tell me whether there have been significant improvements in that area of money laundering since then.
It is very sad that this important statutory instrument is getting so little attention and focus and that it is happening in this Room, because it is crucial. We have to situate this in the context of the grave concerns—it is not just me who is expressing them—about the state of financial stability in our current system, for all kinds of reasons that I will not go into here. This is about linking up two systems that have great problems with corruption and a lack of transparency—two of the biggest systems in the world—and I cite a former Conservative Minister saying that 40% of the world’s dirty money goes through the City of London and the British Crown dependencies. I do not have a comparable figure for Switzerland, but I have no doubt that it is significant. We are linking up these two sets of money flows, which has to be a concern.
Baroness Neville-Rolfe (Con)
My Lords, this statutory instrument gives legal effect to the mutual recognition agreement between the UK and Switzerland known as the Bern financial services agreement. As the Minister has so clearly outlined, the agreement enables the UK and Swiss financial firms to provide services to each other’s markets, particularly in wholesale sectors, such as investment services, insurance and banking, without needing to establish a local presence or duplicate regulatory approvals.
The UK’s position as a global financial centre depends on maintaining strong transparent relationships with trusted international partners. We therefore welcome this agreement with Switzerland, developed on our watch. Mutual recognition, when accompanied by effective supervision and regulatory co-operation, can deliver meaningful benefits to both markets. Under this agreement, Swiss firms will be able to operate in the UK under the supervision of Swiss regulators, with the FCA and PRA granted powers to step in if issues arise—as the Minister explained. The same applies to UK firms offering services in Switzerland.
With that in mind, I would be grateful if the Minister could address the following points. First, I would like to probe the Swiss end. Has Switzerland yet put in place what is needed there to allow UK firms to benefit from mutual recognition? If not, when will this be done? What are the nature and scale of benefits to the UK financial institutions? That seems an important point.
Secondly, turning to our end, how confident are the Government that UK regulators have the necessary tools to monitor Swiss firms’ activities and act swiftly if concerns emerge? What protections are in place for UK clients—not only high net-worth individuals but small firms—should something go wrong?
Thirdly, on timing, why has it taken nearly two years from signing the agreement in December 2023 to putting this framework in place? Has there been a problem with the regulators not being ready or is the Treasury not working at pace?
I was grateful for the reply of the noble Lord, Lord Livermore, to my Question on 16 September, reporting that, by July this year, 51% of assimilated EU law—most of it in financial services—had been repealed, amended or replaced. This was a much lower figure than I had hoped for, given the importance of financial services to growth. I am not sure whether the Swiss regulations—the one set that we are debating and the negative set that is not being debated—will be included in the count in that definition, but the point about pace generally is important. The Official Opposition have been supportive of the transformation process, and there is no excuse for delay.
No doubt the Minister will respond on some of the reservations of the noble Baroness, Lady Bennett, and perhaps explain how things have improved in Switzerland over time. But I note that there will be information sharing as part of the deal, which is important. However, how will Parliament be kept informed of the operation of this agreement, particularly in the event of regulatory diversion or dispute, or a bad case of the kind that was asked about?
In conclusion, we support efforts to deepen co-operation with trusted international partners in financial services, but it is vital that it is done without compromising consumer protection or financial stability, and that it delivers the trading benefits that we all hope to see. I look forward to the Minister’s response, ideally today but otherwise in writing.
Lord Wilson of Sedgefield (Lab)
I thank both noble Baronesses for their comments on this SI, which were gratefully received. This is an important SI because it is all about growth and building a relationship with a trusted trader in Switzerland that we can build on into the future.
On security and trust, the UK and Switzerland have a strong and established relationship in financial services, and last year we increased the number of transactions et cetera by 27%, and the amount by £4.9 billion. I cannot give a figure for how that is going to extrapolate into the future, but we are doing this to make it easier to have growth. Those figures will hopefully improve—they will improve, in my view—over the coming years.
In response to the noble Baroness, Lady Bennett, the agreement includes, for us, robust safeguards. Swiss firms must be authorised and supervised by FINMA, and the UK regulators retain powers to intervene if risks arise, including restricting activities and managing wind-downs, which both noble Baronesses raised. The FCA and the PRA act swiftly in urgent cases and collaborate closely with Swiss authorities. These measures ensure that, for UK consumers, market integrity and financial stability remain protected, while enabling the benefits of cross-border market access.
How they will be held to account was another issue raised by both noble Baronesses. Regulators will be held to account through clear statutory duties set out in regulations requiring transparency in their actions and co-operation with His Majesty’s Treasury. Their decisions, such as interventions against Swiss firms, are subject to oversight and include the right of affected firms to refer matters to an independent tribunal. The FCA public register will provide visibility of Swiss firms’ activity, supporting scrutiny by clients and stakeholders. Regular engagement with industry and reporting to the joint committee further ensures regulators’ accountability in implementing and managing the agreement. On the anti-money laundering aspect that was raised, Swiss firms will still need to comply with the UK anti-money laundering regime that we have in place.
On timing, it has taken two years—longer than that, actually, because the negotiations have been going on for a few years. Ultimately, we want to get this right. It is not just us but Switzerland that wants to get this right. There are two different kinds of regimes that have to agree this. After it was agreed by the Swiss Parliament, they had to allow 100 days for a potential referendum to be held. It was not held—it was not called for, so it did not take place—but that is 100 days of that two year period that the noble Baroness mentioned. International agreements often take time. We have to get it right.
Baroness Bennett of Manor Castle (GP)
I will ask a fairly technical question, so I will entirely understand if the noble Lord wishes to write to me about it. In his response, he said that this SI avoids duplicating regulatory burdens, but he also said that the Swiss companies would be covered by our anti-money laundering laws. As I referred to in my original contribution, my understanding is that transparency is avoided under Swiss law. I do not claim to be an expert on Swiss law; obviously I am taking advice here. Article 47 of the federal Act on banks and Article 127 of the direct federal tax Act effectively allow Swiss institutions to avoid scrutiny and reporting. But we are then saying that this will have to be covered by our anti-money laundering laws. As I said, I am not expecting the noble Lord to give me a response now, but could he commit to write to me about that issue of transparency and anti-money laundering, as well as how we can avoid duplication and ensure that we have our own anti-money laundering regulations?
Lord Wilson of Sedgefield (Lab)
Obviously, I will write with further detail but, as I said, the regulators will be held to account for what they do. This requires transparency—that is one of our stipulations—but I can write to the noble Baroness with further detail about that.
Baroness Neville-Rolfe (Con)
I am grateful to the Minister for explaining the scale of the opportunity to date and, therefore, our ambition for more; this is very good news. I am not sure that it has been quite quick enough for me—from May 2024 to today seems like quite a long time—but, of course, the Government are new and have been very busy with many things, so it is understandable.
Perhaps I could just come back to the point about parliamentary scrutiny. The Minister mentioned a Joint Committee; I am not sure which Joint Committee that was. Clearly, it is important that parliamentarians should be able to see the progress of important financial agreements such as this. I am not quite sure what the mechanism is. Is there an annual report from the FCA that covers this? That would be the FCA and the PRA. I am interested in how parliamentarians will be able to scrutinise this. What will be the best approach?
Lord Wilson of Sedgefield (Lab)
I will write to the noble Baroness with a fuller answer to her question.
Private International Law (Implementation of Agreements) Act 2020 (Extension of Operative Period) Regulations 2025
(1 day, 23 hours ago)
Grand CommitteeRead Hansard Text Read Debate Ministerial Extracts
Baroness Levitt
That the Grand Committee do consider the Private International Law (Implementation of Agreements) Act 2020 (Extension of Operative Period) Regulations 2025.
Relevant document: 36th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Ministry of Justice (Baroness Levitt) (Lab)
My Lords, the purpose of the instrument before your Lordships is to extend the powers to make regulations to implement private international law agreements for a further five years from 13 December 2025. This instrument may not have a very snappy title, but it is an important one because, if these powers are not extended, they will permanently lapse.
As your Lordships are doubtless aware, private international law rules are applied by courts and parties involved in legal disputes that raise cross-border issues. They generally apply in the context of civil and family law. In other words, private international law agreements help govern how we live, work and trade across borders. In the past, the domestic implementation of new private international law agreements generally required primary legislation, but most domestic provisions implementing private international law agreements concern technical matters and are limited in scope: therefore, implementation can appropriately be handled via secondary legislation. This is because policy issues are often settled when the private international law agreement is negotiated, so the implementation process focuses largely on the procedural changes needed to give effect to the policy decisions reached during negotiations.
The Committee will be interested to know that the Government have carried out a consultation with experts from across the UK. The vast majority of respondents considered that these powers have been used properly to date; that the safeguards are effective; and that the continued use of the powers is in the public interest because they provide a single, clear means of implementing private international law agreements and make proportionate use of parliamentary time.
The purpose of this instrument is to extend the powers to make regulations under Section 2 of and Schedule 6 to the Private International Law (Implementation of Agreements) Act 2020. Section 2 allows the “appropriate national authority” to make regulations for the purpose of implementing international private international law agreements; to apply those regulations to the UK’s different jurisdictions; and to extend these regulation-making powers for a further five years. The Scottish and Northern Irish national authorities can grant permission to the Secretary of State to make regulations on their behalf, including regulations extending the five-year operative period in their jurisdictions, as they have done in this case.
I very much thank those noble Lords who sit on the Secondary Legislation Scrutiny Committee for their review of this instrument and for their clear, concise summary in their 36th report, which I commend to the Committee.
I turn now to the reasons for extending the powers. We suggest that these powers provide a single, clear method for implementing private international law agreements. They protect the public interest by ensuring that parliamentary time is used effectively, and they retain the effective safeguards and limits on the powers provided by the Act. The powers are vital in ensuring the UK’s credibility with its international partners by reassuring them that private international law agreements can be implemented in a timely way.
By way of example, the powers were used to implement the Hague Judgments Convention of 2019. Without the powers granted by the Act, primary legislation would have been needed, thereby delaying implementation. Our ratification of Hague 2019 was warmly welcomed by the legal sector—and, indeed, by Members of your Lordships’ House—as an important step for international, civil and commercial co-operation.
The Government are now proposing that the powers would be used, for example, to implement the Singapore Convention on Mediation, which would allow cross-border commercial mediation settlements to be recognised and enforced more easily before the UK courts. Furthermore, in July 2023, the Government confirmed their intention to implement two model laws that had been adopted by the United Nations Commission on International Trade Law—UNCITRAL—of which the UK is a member state.
I will say a brief word about the consultation. The Act imposes a duty on the Secretary of State to consult such persons as he or she considers appropriate before using the powers. As your Lordships will be aware from the Explanatory Memorandum, the Government consulted targeted experts on whether to extend the powers for a further five years. These experts included academics, lawyers and professional bodies, some with very large memberships, from all parts of the UK; the vast majority agreed with the extension of the powers, for the reasons I outlined earlier.
On safeguards, as the noble and learned Lord, Lord Keen of Elie, doubtless remembers from his involvement in the passage of the Act, several noble and learned Lords raised concerns about the extent of the powers, which led to amendments introducing various safeguards. These include the prohibition on granting legislative powers, the banning of the creation of imprisonable offences and the establishment of a five-year extendable time limit, which is the subject of the instrument before your Lordships today.
In addition, most regulations made using the powers will be subject to the affirmative procedure or equivalent processes in the devolved legislatures. Therefore, Parliament and, where appropriate, the devolved legislatures retain the ultimate say regarding the use of the powers. I would like to take this opportunity to reassure noble Lords that this instrument does not affect those safeguards. I should also add that several consultees noted the proportionate use of powers to date, as well as the effectiveness of the safeguards, and judged that the benefits outweighed the concerns raised during the passage of the Act.
I thank the noble and learned Lord in advance for his contribution, as I cannot see anybody else present who looks as though they want to say something; I very much look forward to working with him. I beg to move.
Lord Keen of Elie (Con)
My Lords, I thank the Minister for her introduction of the regulations, which extend the powers conferred by the Private International Law (Implementation of Agreements) Act 2020 in order that Ministers may implement private international law provisions contained in international agreements in accordance with our dualist system of law.
Private international law is, of course, a vital extension of our domestic legal framework. It enables businesses, individuals and families to operate confidently and lawfully across borders. That is why the previous Conservative Government championed the 2020 Act. It expands the sphere in which reciprocal legal treatment can be upheld, with flexibility and indeed a degree of agility, as indicated by the Minister.
The Act is also one of several measures introduced to address the legal and legislative gaps following our departure from the European Union, filling the gaps in a way that minimised the burden on parliamentary time while continuing to promote the UK’s commitment to international legal co-operation. At the time, concerns were raised, as the Minister indicated, by the then Opposition about the potential for executive overreach. In practice, however, the power has been used very sparingly—only twice, I understand, since 2020—and the requirement for parliamentary renewal every five years provides an important check on its use. Far from becoming a tool of unchecked executive authority, it has functioned within very clear and indeed limited boundaries.
If the instrument is to continue serving our interests, we must be confident that it is both effective and proportionate. I therefore ask the Minister whether the Government will consider undertaking a formal impact assessment to provide clarity on how they see the instrument being used in the coming years. Clearly, we must ensure that the instrument becomes neither a dormant provision nor a vehicle for unchecked executive action. I thank the Minister for her introduction.
Baroness Levitt (Lab)
My Lords, I am extremely grateful to the noble and learned Lord for his contribution to this debate. He is a lawyer of great distinction, and his comments were listened to carefully by me.
He made an important point about the necessity of ensuring that all legislation of this sort does not succumb to overreach or indeed become dormant but must remain both effective and proportionate. He asked whether we would consider an impact assessment. I may have to come back to him on that and write when there has been an opportunity to consider this. I will take it away and think about it carefully, because it seems that the points made are important.
As I set out, these powers are an important tool that will support a clear and effective implementation mechanism for private international law agreements. In turn, these agreements will provide greater clarity and confidence for UK businesses, families and citizens who work and live across international borders.