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

Debate contribution by Mr Danny Donnelly on 23 June 2025.

MLA

Mr Danny Donnelly

Party at the time

Alliance Party

Date

23 June 2025

Type

Debate contribution

Business

Executive Committee Business

Heading

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

Assembly identifier

Official Report component 5045863

Read the official Assembly record

Text

At their core, these regulations aim to deliver greater flexibility and efficiency and to potentially allow for better allocation of clinical capacity in pharmacy services. By enabling medicine assembly to take place centrally in regulated specialised hubs, there is a reasonable expectation that pharmacists in community spoke pharmacies will have more time for direct patient care, medicine optimisation and preventative work. Those areas are increasingly important as we seek to build multidisciplinary approaches to primary care, particularly given the Minister's plans to shift left. It is also important to recognise the vital role that community pharmacies play in our healthcare system and the increasing pressures that they continue to face. While I am hopeful that these measures will help to alleviate some of those pressures, it is essential that we continue to support the sector and listen carefully to its concerns. Having engaged with the sector, I believe that, of the two options that were presented, the current model, model 1, was the preferred option. During consultation, stakeholders in Northern Ireland expressed significant concerns about model 2, which presented a hub-to-patient approach that removed the traditional community aspect from community pharmacies. While model 1 is the more acceptable option, it is not without its challenges. I therefore urge the Minister and the Department to undertake a full impact assessment of that model. I understand that, currently, the regulations are optional and that pharmacies are under no obligation to adopt them at this stage, but legitimate concerns remain in the community pharmacy sector. Should that approach become widespread, we should ensure that any system that is adopted is fair, robust and, above all, safe. I make it clear that we should welcome steps forward in improving aspects of our health service and that I recognise the potential benefits of the proposals, but I am also mindful of the valid concerns that have been raised. If we move towards implementation, it is vital that we continue close engagements with pharmacists, Community Pharmacy NI and the wider sector and give serious consideration to the issues that they have raised. Currently, under the existing model, the responsible pharmacist, the spoke pharmacy, has legal and professional responsibility for all medicines supplied to patients. In a hub-and-spoke model, however, that pharmacist may not have directly overseen or verified the assembly of the medicines at the hub. While the final checks will still be made at the spoke, separating assembly from supply introduces additional complexity in determining who is liable for a dispensing error, if one should occur. Other members and I highlighted those concerns during the Health Committee's scrutiny. In response, the Chief Pharmaceutical Officer from the Department of Health confirmed that, while legislation does not itself specify where the legal responsibility lies, it will rely on the contractual agreements between the hub-and-spoke parties. However, it is not yet clear how consistently or thoroughly those agreements will set out the responsibilities in practice, especially in cases where an error occurs during assembly at the hub. That highlights the need for clear, detailed guidance to ensure that hubs and spokes have shared understanding of their respective roles and responsibilities. The request for an impact assessment is, I feel, reasonable. Such an assessment would be important in informing the development of detailed guidance in collaboration with the sector, providing pharmacists with confidence that they can remain protected within a framework that reflects the operational realities of hub-and-spoke models. In particular, further clarification is needed on how contractual responsibilities will align with the continuing statutory obligations of the responsible pharmacist under existing regulations. In conclusion, my understanding is that Community Pharmacy is cautiously supportive of these measures and welcomes this model over the direct hub-to-patient model. The proposals offer an opportunity to modernise aspects of pharmaceutical practice while strengthening the clinical role of community pharmacies. While the regulations are being introduced on an optional basis, the concerns raised are valid and should be addressed. An impact assessment should be carried out to inform clear operational guidance, define lines of responsibility and accountability and address potential operational challenges in order to ensure safe and effective implementation and safeguard the continued safe supply of medicines by community pharmacies. If we can get this right, we can deliver innovation and support for a sector that is desperately in need, but we can do so only by working in partnership with Community Pharmacy and ensuring that robust protections are firmly in place. It now falls to the Department to provide clear guidance and safeguards that will give pharmacists the confidence to move forward.

760 words. Text as published by the Northern Ireland Assembly.

Assessment

Not flagged

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Assessed 21 October 2026 at 12:50 UTC by jev-1.13.0 (requested as typesafe/jev) under rubric 2026.10-r9, methodology 1.9.

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