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

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025.

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The Government recognise that the current legislation we have in place is outdated and restricts practice, putting restrictions on the quality of service to the public.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

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.

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.

Generally speaking, I support this order, because patients will no longer have to wait for a pharmacist to be present to receive prescribed medicines that have already been checked and bagged and are ready to go. Pharmacists will be freed up to focus on delivering more patient-facing care, including NHS services, which patients and the NHS want. Pharmacists will be able to use their hard-earned clinical skills as experts in medication but also in vital preventive and urgent care services, such as Pharmacy First, blood pressure checks and the upcoming emergency contraception service.

In future, as pharmacist prescribers become more commonplace, these changes will allow for pharmacists to deliver more NHS services, which I think will be important, notwithstanding the points made by the noble Baroness, Lady Hollins, and will help to deliver the shift from hospital to community. These changes will also make better use of the skills of pharmacy technicians, allowing them to play a greater role in dispensary management and creating more professional roles in local communities.

Notwithstanding all those issues, I was very interested to learn that the original pharmacy legislation goes back to 1933, when pharmacists themselves made the medicines with a mortar and pestle. That must have meant a great investment of effort. Things have changed and been replaced by pharmaceutical companies. That is all to the good.

Finally, I would like to ask my noble friend the Minister a question in relation to Northern Ireland. She made the point that no statutory registration of pharmacy technicians in Northern Ireland has yet taken place. But the process to make it a legally regulated profession has been approved and is moving forward. In fact, the Minister of Health in Northern Ireland back in 2022 issued a consultation that was actually approved. So why has there been a delay? What discussions has my noble friend the Minister had with the current Minister of Health, or what discussions will she be having in future? What seems to be the obstacle? To me, it seems practical common sense by ensuring that pharmacists can deliver face to face contact with patients, thereby freeing up the NHS and GPs.

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 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.

Sitting suspended for a Division in the House.

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?

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?