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

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Department: Department of Health and Social Care

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

Lord Scriven Excerpts
Tuesday 21st October 2025

(1 day, 23 hours ago)

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

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

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 I offer the Government our general support for the core principle of modernising an outdated legal framework to unlock clinical capacity.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

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

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

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

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

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

“due regard to patient safety”,

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

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

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

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

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

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

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

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Baroness Merron Portrait Baroness Merron (Lab)
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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 Portrait Lord Scriven (LD)
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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 Portrait Baroness Merron (Lab)
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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.