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

Debate between Baroness Merron and Baroness Hollins

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The Government recognise that the current legislation we have in place is outdated and restricts practice, putting restrictions on the quality of service to the public.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

--- Later in debate ---

[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.

Mental Health Bill [HL]

Debate between Baroness Merron and Baroness Hollins

Report stage
Monday 31st March 2025 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)]

My Lords, I start by saying how grateful I am to noble Lords for their amendments and for the contributions they have made today. I express my thanks at the beginning of this first day of Report for the generosity of time and expertise of noble Lords from across the House—I have greatly appreciated it.

I turn now to the specifics. As the noble Baroness, Lady Browning, is aware, I agree with the principle behind Amendment 1, but there are limited circumstances where it might be appropriate to use the Mental Capacity Act to ensure that patients get the right support. I am glad that the noble Baroness welcomed my letter and that it was helpful. For people who have recently received treatment for a psychiatric disorder under the Mental Health Act, the Mental Capacity Act may be required to continue to support the individual in hospital in the short term while a community-based placement is being arranged.

Monitoring our reforms will indeed be crucial, as many noble Lords have said today. The NHS England assuring transformation dataset collects data on the number of people with a learning disability and autistic people detained in mental health in-patient settings under the Mental Capacity Act. As the noble Baroness herself referred to, the current number is fewer than five; nevertheless, it is, as she said, important.

I reiterate from this Dispatch Box the commitment that I made in the letter. Ahead of reforms to Part II, Section 3, we commit to monitoring the number of people with a learning disability and autistic people who are detained under the Mental Capacity Act, and will include a line on this in standard publications. Should we see an increase in this number following the reforms and discover that the Mental Capacity Act is being used inappropriately, we will ensure that appropriate action is taken.

I thank the noble Baroness, Lady Hollins, for her work on long-term segregation. Many noble Lords have raised facilities and community resourcing. I will address this, and the concerns about commitments in this Act being applied, when I turn to Amendments 4 to 6. On Amendments 3 and 55, there is a requirement in the Mental Health Units (Use of Force) Act 2018 to publish instances of isolation in mental health units. We have consulted on making this and other restrictive practices notifiable to the CQC within 72 hours for all patients in mental health hospitals, allowing the regulator to take prompt appropriate action.

Practical concerns were raised through the consultation that was held, which we are legally required to consider. I hope noble Lords will understand that because of this I am unable to commit to mandating reporting at this stage or to give a timeline, which I was asked for. However, noble Lords can be well assured that I more than understand the urgency. My officials have written to the CQC to commission it to develop a proportionate reporting mechanism, as has been referred to, and these changes can be made in regulations.

The noble Baroness, Lady Hollins, asked about restricted practice notification. Because this is to be made in regulations, clearly that will be, as usual, when parliamentary time allows. Every NHS-funded organisation is responsible for ensuring that safeguarding duties are applied. The code of practice requires the local safeguarding team to be made aware of any patient in long-term segregation.

On Amendment 56, the code of practice already sets out that a patient’s situation should be reviewed by a clinician at least once every 24 hours and at least weekly by the multidisciplinary team. The CQC has received funding to continue the programme of independent care or care (education) and treatment reviews for two years, and reviews recommenced in May 2024. We need to consider the programme’s impacts and the outcome of the spending review before future decisions are taken. Doing this outside legislation allows for flexibility. The independent care (education) and treatment reviews model has evolved as we have learned about what works best. We want to be able to continue to deliver the right approach. On Amendment 52, we will review the guidance in the code of practice on the use of long-term segregation, drawing on available evidence. This does not require primary legislation.

To my point on drawing on available evidence, we will indeed use the report of the noble Baroness, Lady Hollins, alongside other evidence, to consider changes that need to be made to the Mental Health Act code of practice, which we will review as part of the implementation of the Mental Health Act reforms after Royal Assent. We hope that this, alongside other actions that we are taking—including the continuation of ICETRs and NHS England’s quality transformation programme—will make progress to reduce long-term segregation.

There were points raised about Amendment 53, which we will return to in the debate on the fifth group. On Amendment 57, it is our belief that this duplicates existing requirements. The Mental Health Units (Use of Force) Act 2018, once fully implemented, will require mental health units to have a responsible person who must keep a record of any use of force by staff.

I absolutely understand the concerns that many noble Lords have raised about community support. This has driven Amendments 4 to 6. I also recognise the need for accountability and scrutiny of these reforms—a point that has been made several times.

I say to the noble Lord, Lord Scriven, that I hope I am about to do better by him than, “It will be all right on the night”, but he will be able to judge that. I am pleased with what I can commit, which is that within a year of Royal Assent, and each year subsequently, we will lay a Written Ministerial Statement in both Houses. This will include setting out details of the work that has been done over the preceding 12 months to implement this legislation and plans for how we will implement future reforms. It will include progress on the learning disability and autism reforms and plans for community provision.

Regarding Amendment 68 and the remarks by the noble Lord, Lord Crisp, we have heard concerns about possible unintended consequences, such as the potential criminalisation of individuals or detention via other legislative routes. To avoid such scenarios, we will commence changes to Section 3 only once there are strong community services in place and it is safe to do so, because flexibility is essential.

I hope that these commitments will satisfy noble Lords not to press their amendments.

[Baroness Hollins (CB)]

Will parliamentarians be able to question and amend the plan that will be laid before Parliament every year? The lack of ability to influence that process and that plan concerns noble Lords.

[Baroness Merron (Lab)]

I have heard from noble Lords that they are concerned with having transparency, holding the Government to account and being updated on the situation. I absolutely agree with all those points, which is why I am pleased to make that commitment. Parliament has a number of routes available to it to hold the Government to account. I have just outlined the manner in which we will be transparent and the way the Government will be held to account by having to do that. As always, parliamentarians have the ability to scrutinise in many ways.

Autism and Learning Disabilities: Hospital Detention

Debate between Baroness Merron and Baroness Hollins

Tuesday 11th March 2025 Lords Chamber

[Baroness Merron (Lab)]

I am grateful to the noble Baroness for tempting me to agree with her comments about a mental health commissioner. We have debated that, and the noble Baroness is aware that we do not feel that this is the right way forward. However, I am sure we will return to that on Report.

With regard to not waiting for the Mental Health Bill to become an Act, of course I agree. The number of people with a learning disability and autistic people who are in mental health hospitals is unacceptable, and there are still too many detained who could be supported in their communities. We have taken immediate action in allocating funding to local areas: £124 million for learning disability and autism services. We are making sure that the workforce has the right skills and knowledge through work such as the HOPE(S) model. We are providing for the CQC to deliver independent care (education) and treatment reviews. NHS planning guidance provides a continued focus on improving mental health and learning disability care, with an objective to deliver a minimum—I emphasise minimum— 10% reduction in the use of in-patient care.

[Baroness Hollins (CB)]

My Lords, for 25 years, this woman’s detention was in long-term segregation. My review of this practice, which was commissioned by the previous Government, recommended that people in LTS must have an independent review, should have national support to reduce confinement, and be allocated an independent project manager to co-ordinate their timely discharge. But despite the unequivocal success of the ICETR programme, the HOPE(S) intervention and senior intervenors’ support, funding has been cut at the end of this year. Will the Government commit to funding these vital initiatives to end this rights-depriving restrictive practice?

[Baroness Merron (Lab)]

I am most grateful to the noble Baroness for her contribution and expertise in this area, which I know we all look to in your Lordships’ House, as well as outside it. The points she makes are quite right and important. On this particular case, which is very sad and concerning, I understand that the person is now living in the community with 24/7 care and has been since 2022. I saw at Rampton how people were being supported out into the community with the right support. On the example the noble Baroness gave, we are very keen to improve the uptake of advocacy services, and she will know that all these matters are being addressed in our discussions on the Mental Health Bill.

Mental Health Bill [HL]

Debate between Baroness Merron and Baroness Hollins

Committee stage
Monday 24th February 2025 Lords Chamber

[Baroness Hollins (CB)]

There seemed to be an assumption that long-term segregation would continue and that perhaps ICETRs are not effective, but one thing that emerges from an independently chaired review is some learning about the barriers in place and the reasons why LTS is being used, rather than more therapeutic options. That is the reason for this kind of oversight being necessary. It is not necessarily that the ICETR itself will lead to recommendations being implemented; in my report, we found that the recommendations were not being followed—they were made and then not followed through. There needs to be much more effort to try to learn from what is happening and begin to change the culture of LTS as an okay response to somebody’s distress.

[Baroness Merron (Lab)]

I understand that point, and the noble Baroness makes it very well. I simply refer her to the points that I made about needing to look at evidence, the outcomes and the value of those reviews, and whether that is the right approach for everyone. I take on board her point, but my comments probably tell the Committee that we feel that there is more work to be done in this area.

Health and Adult Social Care Reform

Debate between Baroness Merron and Baroness Hollins

Tuesday 7th January 2025 Lords Chamber

[Baroness Merron (Lab)]

Both the points that the noble Lord makes are very welcome and shine a light on the need to be more flexible in the range of services and care provided. It should not be just an either/or. People have intermediate stages. Some of the issues about discharge are about having a position in the middle, which is more about rehabilitation, and having the things in place to allow people perhaps to return home or to some other setting.

There is also the point about having a range of settings. Currently, the offer is perhaps too restrictive, although not in all places, as there are some excellent examples. We must be much more creative in the kind of offer that is available and in the training of care workers, not just for the service that they offer to patients, which is important, but for their professionalisation and their morale in their jobs.

[Baroness Hollins (CB)]

My Lords, why is there no mention of mental health in the Statement? What happened to parity, I wonder? For example, 12,400 hospital patients a day are well enough to be discharged. I presume that this does not include the 1,500 or so autistic people and people with learning disabilities who are waiting to be discharged from psychiatric hospitals but for whom there is no social care? Community diagnostic centres are mentioned but there is nothing about the need for 24-hour community drop-in centres for citizens who have mental health problems. Social care costs for elderly people may be expected to double, but what about the increasing costs of care for disabled adults of working age?

[Baroness Merron (Lab)]

The noble Baroness makes very real and important points. Some of the points in the Statement cover mental and physical health but, if I might be honest about the situation, this is only one of the things that we are putting forward. As I said at the beginning of this Statement, how I wish that we could deal with everything immediately. It is not possible. This is just the first stage in the journey that we are on. I hope that the noble Baroness is reassured by the direction that we are taking, the commitments and the work that we have already done on mental health. The Committee stage of the Mental Health Bill next week will also be a very significant step forward. I absolutely accept that there is so much more to do, and we will be getting through that.

Palliative and End-of-life Care: Funding

Debate between Baroness Merron and Baroness Hollins

Wednesday 4th September 2024 Lords Chamber

[Baroness Merron (Lab)]

The noble Baroness is quite right to raise this, and I can give her that assurance. She raises the point about identification of people with specific needs. I am interested to see that there are some very good examples of local good practice—for example, in Dorset, where they have proactively gone out to identify who needs palliative and end-of-life care. By so doing, they have raised the percentage of the local population who should be receiving it. That is a model we will want to look at. With regard to those who have particular needs, as the noble Baroness describes, I think that model will be helpful too.

[Baroness Hollins (CB)]

My Lords, the Minister has rightly pointed to the growing need for excellent palliative care close to home, and I am glad of that, but I wonder whether she is aware of the Hospice UK report pointing to the number of redundancies occurring across the sector. In the context of the 2022 Act, which required the NHS to commission adequate NHS care, this seems to be rather urgent, not just to provide good care for people but to reduce the impact on the acute hospital sector of not providing palliative care.

[Baroness Merron (Lab)]

The noble Baroness is right in her observations, and we certainly recognise that times are difficult, particularly for many voluntary and charitable organisations including hospices, for example, due to the increased cost of living. We are working alongside key partners and NHS England to proactively engage with stakeholders, including the voluntary sector and independent hospices, because we want to understand the issues they face and to seek solutions to them.