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

Baroness Merron Excerpts

Tuesday 21st October 2025 Grand Committee

Moved by

[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The Government recognise that the current legislation we have in place is outdated and restricts practice, putting restrictions on the quality of service to the public.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.

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I conclude by repeating that these Benches support the aims of the legislation to modernise pharmacy supervision and enable the workforce to operate at the top of their licence. But we want to see, as all noble Lords have said in this debate, that these reforms are implemented with clarity and equity and with safety at their very core. I look forward to the Minister’s responses.

[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.

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[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.

Motion agreed.