Government announces the next steps for Hub and Spoke dispensing

The Government has laid amendments to the Human Medicines Regulations 2012 (HMR) in Parliament as the next step towards Hub and Spoke dispensing for community pharmacies.

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

Key points of the HMR amendments in brief are:

• Only Model 1: patient – spoke – hub – spoke – patient, is permitted. (We announced this previously.)
• The spoke pharmacy must have entered into written arrangements with the hub pharmacy; these must include a comprehensive agreement of the responsibilities each has for the shared dispensing process.
• The spoke must sell, supply, or dispense the medicine to the patient, the hub having assembled 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 required on a dispensing label).
• The sharing of patient data between the hub and spoke (without the explicit consent of a patient) is permitted through an information gateway which includes a requirement for the spoke to display an appropriate notice to patients and staff at the spoke and hub to maintain the confidentiality of the patient data.
• The HMR amendments will come into force on 1 October 2025 but it is likely that hub and spoke dispensing will only be able to start from 29 October 2025 at the earliest.

Community Pharmacy England is discussing with the Department of Health and Social Care (DHSC) associated amendments to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations (PLPS regulations) to permit the NHS spoke pharmacy to subcontract part of the NHS Essential Dispensing Service to the hub. These amendments are likely to include a requirement that NHS spoke pharmacies must notify their Integrated Care Board (ICB) 28 days in advance of commencing hub and spoke dispensing (for NHS prescriptions).

Since the earliest an NHS spoke pharmacy will be able to notify their ICB is the date on which the HMR amendments come into force (1 October 2025), the use of hub and spoke dispensing would only be able to start at the earliest, on 29 October 2025.

We will be providing a briefing on Hub and Spoke dispensing and the new HMR amendments in the coming weeks.

Note 1. Hub and spoke dispensing is already permitted between community pharmacies owned by the same legal entity (the same retail pharmacy business). These changes will permit different pharmacy owners (different retail pharmacy owners) to carry out hub and spoke dispensing if they comply with the relevant requirements.