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

Baroness Hollins Excerpts

Tuesday 21st October 2025 Grand 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The Government recognise that the current legislation we have in place is outdated and restricts practice, putting restrictions on the quality of service to the public.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.

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The noble Lord, Lord Scriven, referred to the concerns of individual pharmacists. A lot of the concern has come from individual pharmacists—the noble Lord, Lord Kamall, also made this point—and I understand that because, as ever, change raises concerns, hence this debate. However, I hope and intend that this change will establish the way forward and, in addition, that the ways in which the changes will be implemented in practice will give reassurance, not least because they are coming from the professional organisations. There will be a lot of discussion, and those concerns can indeed be raised.

[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.