Official Report: Minutes of Evidence

The Chairperson (Mr McGuigan): I welcome from the Department of Health: Karen Simpson, head of the medicines legislation unit; and Chris Garland, senior principal pharmaceutical officer. You are very welcome. I will hand over to you for a brief overview, and then we will take questions.

Ms Karen Simpson (Department of Health): Thank you for the opportunity to brief the Health Committee about proposed legislative amendments to enable all community pharmacies and dispensing doctors to access hub-and-spoke dispensing, should they wish to do so. My colleague Chris Garland can assist me with further clarifications that members may have about the proposals.

Hub-and-spoke dispensing is a pharmacy model where parts of the dispensing process, such as assembling prescriptions, are done in a central hub pharmacy, while patient interactions and final dispensing occur at spoke pharmacies, allowing staff to focus on patient care. Typically, there are many spoke pharmacies to one hub pharmacy. The concept is that the simple routine aspects of assembling prescriptions can take place on a large scale in a hub that usually makes use of automated processes, while maintaining the relationship that patients have with their pharmacist based at the spoke pharmacy.

Under current legislation, a medicine dispensed in one pharmacy can only be sold or supplied by that pharmacy or another within the same legal identity. The regulations aim to enable the use of hub-and-spoke arrangements between hub pharmacies and spokes that are pharmacies owned either by different businesses or dispensing doctors, provided that medicines are returned to the spoke for final supply. That is subject to conditions. For example, written arrangements must be in place between the hub and spoke to give a comprehensive statement detailing their responsibilities, and notices about the arrangements must be displayed to inform patients. Therefore, the proposals aim to remove the barrier that currently limits hub-and-spoke models to pharmacies within the same legal identity, and they also include elements to ensure the safe and effective implementation of the policy by putting in place provisions to ensure accountability, governance and transparency for patients. These additional proposals are designed to make sure that patient safety outcomes from the hub-and-spoke models are equal to those of current dispensing models.

A strategic priority in the Department's 'Community Pharmacy Strategic Plan 2030' is to maintain and modernise systems for the safe and reliable supply of medicines and professional advice from community pharmacies. Hub-and-spoke arrangements will not be mandatory. However, enabling all community pharmacies to benefit from hub-and-spoke arrangements should they choose to do so will help community pharmacies to streamline how they manage dispensing workload and release capacity in their teams to undertake more patient-centred services.

A UK-wide public consultation on the proposed legislative changes to the Medicines Act 1968 and the Human Medicines Regulations 2012 ran from 16 March 2022 to 8 June 2022. As detailed in the SL1, the consultation included proposals on two different models of hub-and-spoke dispensing. Model 1 is where the patient presents a prescription to the spoke, and the spoke sends the relevant information on to the hub so that it can carry out its agreed dispensing actions. The hub then sends the dispensed medicines back to the spoke, which may have further responsibilities to perform, such as providing advice on the medicine to the patient, before supplying to the patient. With model 2, the same pathway is followed in that the patient presents a prescription to the spoke, which then sends the relevant information to the hub. The hub then assembles and prepares the medicine before supplying the completed order directly to the patient.

Responses to the consultation's proposals raised significant concerns about model 2 and outlined the potential to undermine the relationship between pharmacies and patients, along with risks to sharing accountability for supply of medicines and risks to patient safety. Following further re-engagement with key stakeholders, including the Chief Pharmaceutical Officers in the devolved Administrations and representative community pharmacy organisations, the UK Government are proposing to proceed with introducing hub-and-spoke reform, with some amendments to take account of stakeholder views. The revised proposals mean the introduction of only model 1 at this stage, with a view to introducing model 2 subject to further public consultation if there is sufficient stakeholder interest once model 1 has bedded in.

The draft Human Medicines (Amendments to Hub and Spoke Dispensing etc.) Regulations 2025, which will amend the 1968 Act and the 2012 regulations, were laid in Parliament on 29 April 2025 under the draft affirmative procedure. The key amendments to note in relation to this statutory instrument (SI) are as follows. Only model 1 — patient to spoke to hub to spoke and back to patient — is permitted. The spoke pharmacy must have entered into written arrangements with the hub pharmacy. These must include a comprehensive agreement of the responsibilities that each has for the shared dispensing process. The spoke must sell, supply or dispense the medicine to the patient, with the hub having assembled it or part-assembled it under the arrangements. The dispensed medicine must be labelled with the spoke's name and address and the date on which the hub assembled or part-assembled the medicine, as well as the usual information that is required on a dispensing label. The sharing of patient data between the hub and the spoke without the explicit consent of the patient is permitted through an information gateway, which includes a requirement for the spoke to display an appropriate notice for patients and staff at the spoke and the hub to maintain the confidentiality of the patient data.

Taken together, those arrangements for accountability, governance and transparency of information sharing are key to delivering high standards of patient safety and so are integral to the proposals. The proposals address the concerns raised during the consultation period by ensuring that the spoke pharmacy retains responsibility for the final supply to patients and remains the point of contact for patients' queries about their dispensed medicines. The legislation will not come into force until 1 October 2025. That is with a view to providing certainty to the sector and to give time for the Department to consult with community pharmacy representatives on any further requirements, including guidance or any further legislative amendments that may be required to the terms of service and contractual arrangements for community pharmacists as set out in the Pharmaceutical Services Regulations (Northern Ireland) 1997.

With regard to Assembly procedures, the regulations are made under powers contained in the Medicines and Medical Devices Act 2021. In that Act, the Department of Health in Northern Ireland is named as the appropriate authority, in recognition that the regulation of medicines is a devolved matter to Northern Ireland. The proposed SI will be subject to the draft affirmative procedure and will be laid and approved by resolution of the Northern Ireland Assembly. Therefore, an Assembly debate on this SI will be required. As already mentioned, the SI was laid in Parliament on 29 April, with debate scheduled in the House of Commons on 2 June and the House of Lords on 17 June. Following consideration of the SL1 by the Health Committee today on the policy intent of these amendments, if content, the Department will seek to lay the legislation as soon as possible and provisionally schedule the necessary Assembly debate in the week commencing Monday 23 June 2025 to allow the Committee the opportunity for further consideration of the legislation.

Thank you. I am happy to take any further questions.

Mr Donnelly: I am very interested in this. Thank you very much for the presentation. I have just two quick questions. I want to clarify where the legal and professional responsibility lies in this model. The hub prepares the medications, or part-prepares them, and then sends them out to the spoke, which is a community pharmacy, which then delivers them to the patients.

Ms Simpson: Yes

Mr Donnelly: The community pharmacy's name is going to be on it. How does the community pharmacy know or be sure that the medications that were supposed to be prepared at the hub are indeed the right medications? A lot of the time, it will be blister packs, so most likely it will be a sealed box with some tablets in it that you can kind of see through, but tablets can be any colour or shape. Where does the legal responsibility lie for being sure that the right medications are in there? Is it with the hub or the spoke? How does the community pharmacist know that the right drugs are being given to their patients? At the end of the day, they are the patients whom they are dispensing to.

My second question is this. We have heard a lot about ongoing funding difficulties in Community Pharmacy. Has an impact assessment been undertaken on the hub-and-spoke models being rolled out in Northern Ireland?

Ms Simpson: I will take the second question first. Community Pharmacy has asked about an impact assessment. Certainly, an impact assessment was done UK-wide on these, because they are enabling regulations. There is no mandatory requirement for pharmacies to undertake to do this. However, we will work with Community Pharmacy to consider our next steps on implementation. Cathy Harrison wrote to Gerard Greene on 6 May to explain what we are doing with these regulations and to initiate that conversation. Obviously, we will be considering lots of different things: what we are going to do in the Pharmaceutical Services Regulations, and then what we are going to do in guidance. That is probably the best way I can explain that one.

Mr Donnelly: No impact assessment has been done?

Ms Simpson: No impact assessment has been done for Northern Ireland. There has been an impact assessment. That will be associated with this SI and is published online.

Mr Donnelly: OK. And my first question?

Mr Chris Garland (Department of Health): In relation to the first question, Danny, both the hub and the spoke will be registered pharmacies in their own right, so both will be subject to the regulatory oversight of the pharmacy regulator, the Pharmaceutical Society of Northern Ireland (PSNI), and the premises standards that apply to registered pharmacy premises will apply equally to both hub and spoke premises. Both pharmacies will be run under the oversight of a responsible pharmacist who will be responsible for the safe and effective running of that pharmacy. That fits within the existing regulatory framework.

The requirement in the regulations is for a written agreement between hub and spoke which sets out very clearly the relative roles and responsibilities. The purpose of the amended proposals is that the responsibility for the final supply of the medicine —. The final supply is made by the spoke to the patient. That is important, because it maintains that relationship between the pharmacy and the patient.

Mr Donnelly: So, ultimately, they are responsible for the medications that are delivered to the patient?

Mr Garland: They are responsible for making the final supply, but that is not to say that the actions of the hub are not —. The hub is still responsible for the actions that it carries out as a registered pharmacy, in line with the PSNI's pharmacy premises standards.

Mr Donnelly: It occurs to me that pharmacists will have to check. They will feel a responsibility to check everything that comes out. Are there two checks? Is this a double-checking procedure?

Mr Garland: The written arrangements will set out the roles and responsibilities. The legislation is not prescriptive in that sense. It will be for the hub and spoke pharmacies, and it will be informed by the relevant guidance. We know that the Pharmaceutical Society and the General Pharmaceutical Council in Great Britain are considering what additional guidance is required for pharmacy premises as well, as indeed will the professional bodies. The purpose of the legislation is not to be prescriptive in what those arrangements look like or who is responsible for what. That will be for the hub and spoke to agree.

Mr Donnelly: They will just agree that among themselves, then?

Mr Garland: Informed by the relevant professional and regulatory guidance .

Mr Donnelly: Thank you.

Mrs Dillon: My question has just been covered. I had the same concerns about who is responsible if something goes wrong or somebody gets the wrong medication, but you have answered that — sort of. We do not know, because it depends on the memorandum of understanding between the hub and the spoke.

The Chairperson (Mr McGuigan): There are no more questions, so thank you very much. That was very useful.