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

Debate contribution by Mr Mike Nesbitt on 23 June 2025.

MLA

Mr Mike Nesbitt

Party at the time

Ulster Unionist Party

Date

23 June 2025

Type

Debate contribution (made as a minister)

Business

Executive Committee Business

Heading

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

Assembly identifier

Official Report component 5045849

Read the official Assembly record

Text

I beg to move

Thank you, Madam Principal Deputy Speaker. I seek the Assembly's approval of the draft statutory instrument (SI), which will amend the Medicines Act 1968 and the Human Medicines Regulations 2012 — the "HMRs". The amendments are aimed at enabling all community pharmacies to access hub-and-spoke dispensing of human medicines, should they so wish. Hub-and-spoke dispensing is a pharmacy model whereby some routine parts of the dispensing process, such as assembling prescriptions, are done in a central hub pharmacy, while patient interactions and final supply occur at spoke pharmacies, allowing staff in those pharmacies to focus on delivering patient-centred services. Typically, there are many spoke pharmacies to one hub. 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. Meanwhile, the relationship that patients have with their pharmacist continues at the spoke pharmacies. Under current legislation, the medicine dispensed in one pharmacy can be sold or supplied only by that pharmacy or another within the same legal entity. The proposed legislative amendments will enable pharmacies belonging to different legal entities to set up hub-and-spoke arrangements. That will unlock the hub-and-spoke dispensing model for smaller pharmacy businesses and level the playing field so that all pharmacy businesses can avail themselves of the model, should they choose to do so. The legislation will also make it possible for dispensing doctors to act as a spoke, giving them access to the knowledge provided by pharmacists in the hub. Hub-and-spoke arrangements will not be mandatory. Enabling all pharmacies to avail themselves of hub-and-spoke dispensing arrangements, should they choose to do so, aligns with a strategic priority in my Department's community pharmacy strategic plan 2030, which aims to modernise systems for the safe and reliable supply of medicines and professional advice from community pharmacies. The legislative changes, along with other changes such as previous amendments to the Human Medicines Regulations, which provided flexibilities to pharmacists for the dispensing of medicines in their original pack, will help community pharmacies to streamline how they manage the dispensing workload and release capacity in pharmacy teams to undertake more patient-centred services that align with Health and Social Care (HSC) priorities.

A UK-wide public consultation on the proposed changes to the Medicines Act 1968 and the HMRs ran from 16 March to 8 June 2022. The consultation included proposals on two models of hub-and-spoke dispensing. In model 1, the patient presents a prescription to the spoke, and the spoke sends the relevant information to the hub so that it can carry out its agreed dispensing actions. The hub then returns the dispensed medicines to the spoke, which may have further responsibilities to perform, such as providing the patient with advice on the medicine before ultimately supplying it to them. In model 2, a similar pathway is followed whereby a patient presents a prescription to the spoke that is sent to the hub. After the hub assembles and prepares the medicine, the completed order is supplied directly to the patient. Responses to the consultation proposals raised a number of significant concerns about model 2: its potential to undermine the relationship between pharmacy and patient; risks posed by the sharing of accountability for the supply of medicines; and risks to patient safety. Following further re-engagement with key stakeholders, including the Chief Pharmaceutical Officers of the devolved Administrations and community pharmacy representative organisations, the UK Government propose to proceed with the introduction of hub-and-spoke reforms with amendments that take account of those key stakeholders' views. The revised proposals will mean the introduction of model 1 only at this stage, with a view to introducing model 2, subject to public consultation, if there is sufficient stakeholder interest once model 1 has bedded in. To ensure patient safety, having taken into consideration the consultation responses, the legislation seeks, through several measures, to enhance the governance, transparency and accountability to patients of participating pharmacies. First, hub pharmacies and spoke pharmacies will be mandated to enter into written arrangements with one another when adopting that dispensing model. The written arrangements will be a comprehensive agreement on the responsibilities of each pharmacy for the shared dispensing process. Secondly, the spoke must sell, supply or dispense the medicine to the patient, the hub having assembled or part-assembled it under the arrangements. Third, the dispensed medicine must be labelled with the spoke's name and address plus the date on which the hub assembled or part-assembled the medicine, along with the standard information that is required on any dispensing label. Next, the sharing of patient data between the hub and spoke without the explicit consent of a patient is permitted through an information gateway that requires the spoke to display an appropriate notice to patients and staff at the spoke and the hub to maintain the confidentiality of the patient data. Finally, with the aim of providing full transparency to patients, the spoke is required to display a notice on its premises and its internet presence. The legislation will not come into operation until 1 October of this year. That helps to provide certainty to the sector and gives time for the Department to consult community pharmacy representatives on any further requirements, which could include guidance or further legislative amendments that may be required to the terms of service and the contractual arrangements for community pharmacists, as set out in the Pharmaceutical Services Regulations (Northern Ireland) 1997. Hub and spoke pharmacies will operate as registered pharmacies under the regulatory oversight and standards of the Pharmaceutical Society of Northern Ireland (PSNI), as they currently do. The timescale will allow the PSNI, working in tandem with the General Pharmaceutical Council in Great Britain, to consider how best to ensure that any additional professional guidance is available in time to support safe and compliant implementation of the potential new legal framework. I am pleased to inform Members that the Health Committee considered the policy intent of the statutory instrument (SI) at its meeting on 28 May, confirming that it was content that the SI be laid in draft form in the Business Office. When the SI was laid in draft, the Committee considered it at its meeting on 12 June and, again, indicated that it was content. It is therefore with the Committee's support that I bring the statutory instrument before the wider Assembly today. I commend the motion to the Assembly.

1,069 words. Text as published by the Northern Ireland Assembly.

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