Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025

Viscount Stansgate Excerpts

Tuesday 17th June 2025 Grand Committee

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

My Lords, as I know we all acknowledge, community pharmacies play a vital role in our healthcare system by ensuring that patients have access to medicines and acting as an easily accessible “front door” to the NHS. They dispense around 1.1 billion NHS medicines every single year.

Traditionally, all dispensing processes have been done in a single pharmacy or by a dispensing doctor. In hub-and-spoke dispensing, routine tasks such as sourcing, preparing, assembling and labelling medicines are carried out at a central “hub”, which is separate from the “spoke” pharmacy where the prescription is received. Hubs often make use of automated processes to realise economies of scale and to increase efficiencies. Such arrangements already exist in the UK, but the Medicines Act 1968 restricts their use to community pharmacies that are part of the same legal entity. Not all pharmacy businesses are able to invest in their own hub-and-spoke model, as compared with the larger pharmacy chains.

The Government are committed to supporting the community pharmacy sector and to cutting the red tape that frustrates it. The proposed changes have been a long time coming. If approved today, as I hope they will be, they will allow all pharmacies, including small independents, and dispensing doctors to utilise hub-and-spoke arrangements if they choose to do so.

Staff in hub-and-spoke arrangements report a calmer, more focused environment—I think we would all welcome that. In hubs, there are fewer disruptions and the use of automation reduces the risk of dispensing errors. At spokes, staff have more time for complex cases and patient care, making better use of their skills—something that the Government aim to support. The legislative changes we are debating will help all pharmacies and dispensing doctors realise these benefits, instead of limiting them to a few.

Turning to the details of the SI, we propose to amend the Human Medicines Regulations 2012 and the Medicines Act 1968, using the powers in the Medicines and Medical Devices Act 2021. The proposed changes to the Medicines Act 1968 adjust the definitions of “wholesale dealing” and “retail sale”, and remove the legal restrictions that prevent hub-and-spoke dispensing between different legal entities. The amendments go beyond simply removing the barrier that currently limits hub-and-spoke dispensing to pharmacies within the same legal entity. Noble Lords will, I hope, be pleased to know that the amendments include additional elements to ensure the safe and effective implementation of the policy by putting in place provisions to ensure accountability, governance and transparency for patients.

The proposed changes to the Human Medicines Regulations 2012 create a new model of hub-and-spoke dispensing, establishing a framework for the sharing of patient information between the hub and the spoke, and set criteria for the newly permitted arrangements. These criteria are: that both a hub and a spoke must be pharmacies registered with the pharmacy regulator, unless a spoke is a dispensing doctor practice; that there must be written arrangements between any hub and spoke, which must include a comprehensive statement in relation to their responsibilities, to ensure that each party is clear about the processes and activities for which they are responsible; that the medicine label includes only the name and address of the spoke, so that patients know who to ask any questions about their medicines; and that the spoke must conspicuously display a notice on its premises and online in relation to the dispensing arrangements.

The changes also establish an information gateway. This achieves several purposes, such as the conditions for lawful sharing of the relevant patient data between the different legal entities that operate these arrangements.

On the timescale, it is proposed that all legislative amendments come into force in the October this year across the UK. This will allow time for secondary legislation to be amended, as appropriate, across all four nations, and give the pharmacy sector time to explore the relevance and possibilities of the new hub-and-spoke arrangements to its businesses.

I hope that I have been able to set out what we are proposing and the rationale behind it. I look forward to what will, I am sure, be an informed and constructive debate. I beg to move.

[Viscount Stansgate (Lab)]

My Lords, I broadly support these regulations. I hope that my noble friend the Minister will not mind my intervening briefly to ask a couple of questions; I have no wish to detain the Committee.

Obviously, I understand that community pharmacies have been playing an increasingly expanded clinical role in treating minor illnesses and improving medicines’ safety and optimisation. To improve the efficiency of dispensing, these regulations will help support community pharmacies in taking on a more clinical role. The purpose of these regulations, which is to free up smaller pharmacies and enable them to undertake hub-and-spoke models, is, I am sure, a good one. First, does my noble friend the Minister have any idea of how welcome this will be to smaller pharmacies? Is it expected that a great deal of them will undertake these new arrangements outwith the previous restriction on being in the same legal entity?

Secondly, having recently been to my local pharmacy and having talked to the pharmacists there, I was struck by the strain that they are under, both in terms of their workload and financially. Am I right in thinking that this hub-and-spoke model, which will be made more widely available, will in some way help smaller pharmacies deal financially with the situations that they face? Am I wrong in thinking that there is a financial dimension to this? If there is, I would be very grateful for any reply that the Minister can give, but, in summary, these regulations are a step in the right direction.

[Baroness Finlay of Llandaff (CB)]

My Lords, I am most grateful to the Minister for the comprehensive way in which she introduced this instrument, including how it corresponds with all the documentation that we have. I am glad to see that it applies to Wales; we have many small pharmacies with cross-border flow and many roads going across the border, so this SI will make things much easier.

Like the noble Viscount, Lord Stansgate, I have some questions. I hope that at least some of them will be answered; some of them may need time. One of my concerns is about how the finances of this will work, because pharmacies depend on a dispensing fee. Who will get the fee? Will that be down to local negotiation? Will the fee be split?

However, the principle of freeing up time for the pharmacist to undertake more clinical duties is to be welcomed. They are often the first point of call for patients now. They often know the patient. They spot the person who looks less well and can advise them appropriately. They can also advise on drug side-effects, if a person goes into the pharmacist and asks about new symptoms that they might have.

However, I wondered where the liability sits if there is an error. If I understood right, it would sit with the hub if it were in what is dispensed, but there may be a difference in liability for information given to the patient. One hopes this will never happen, but some of those governance issues need to be thought through in detail.

I note that the pharmacists are already taking impressive extended roles in some areas. For example, there is a scheme in Bristol where pharmacists are taking blood for PSA assessment and reaching a population who would not otherwise present for screening for cancers. If we have pharmacists doing more health screening that would certainly free up GP time. Again, pharmacists will need to be remunerated for that.

I was interested to see that the international evidence is a little variable. Germany, Finland, Belgium and Denmark already using a hub-and-spoke dispensing model but the evidence is not overwhelmingly conclusive. In hospitals, where you have a single large building and a large number of prescriptions, automated pharmacy has in many ways revolutionised the administration of medicines.

One of the concerns is the time lag from a dispensed medicine going from the hub out to the spoke. I hope that will be thought through, so that we do not have patients, perhaps with mobility difficulties, having difficulty getting back to collect their prescription, and that those things will be factored into such arrangements.

Another area that I have a slight concern about relates, not surprisingly, to my own area, palliative care. We know that the availability of controlled drugs is poor at times, yet they are often needed urgently. I hope that consideration has been given as to how the dispensing of controlled drugs in particular can be rapid and efficient, especially when the clinical situation has changed and new medications are required at speed for a patient to be able to remain at home, rather than ending up taking an unnecessary or inappropriate voyage to hospital, with possible admission. Those travel systems also come into it.

The last area that I hope this model will tackle is waste, because there are a lot of things that patients are prescribed but never end up taking. Those of us who have been in a house after someone has died will often have been given several supermarket bags—I will not name the supermarket—full of packs of medicines that have been dispensed. They can be extremely expensive but have not been taken. They cannot be taken back in at the moment and cannot be recycled. The schemes that recycled some of the opioids, such as diamorphine, have not continued over the years. This is an enormous financial waste to the NHS, because some of these medicines have been very expensive.

I hope that this model will free up pharmacists and incentivise them to dissuade patients from accepting prescriptions when they are not actually taking those medicines. I could spend hours relating numerous stories of patients who were either not taking their medicines or giving them to somebody else. I have even once been presented with some children trying to sell me grandmother’s pain relief at the foot of the stairs, which helped me understand why I could not get grandmother’s pain under control. There is a real problem of waste in the system. If this instrument will decrease waste without jeopardising pharmacist’ income from prescribing fees, that would be very welcome.