Community Pharmacy England (CPE) has confirmed that the government has laid amendments to the Human Medicines Regulations 2012 (HMR) in Parliament, marking a crucial step towards enabling hub and spoke dispensing between separate community pharmacy businesses.
The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 are set to come into force on 1 October 2025.
However, as pharmacies are required to notify their Integrated Care Board (ICB) at least 28 days before commencing hub and spoke dispensing for NHS prescriptions, the earliest possible implementation date would be 29 October 2025.
Currently, hub and spoke dispensing is only permitted between community pharmacies owned by the same legal entity (the same retail pharmacy business).
These new regulatory changes will, for the first time, allow independent pharmacies (different retail pharmacy owners) to carry out hub and spoke dispensing under Model 1 – where medicines are assembled by the hub and returned to the spoke pharmacy for supply to the patient (patient – spoke – hub – spoke – patient).
Model 2, where the hub pharmacy supplies medicines directly to the patient (patient – spoke – hub – patient), will not be introduced due to patient safety and regulatory concerns.
Harry McQuillan, chairman of Numark, described the government's announcement as “a welcome move toward enabling greater flexibility and efficiency in community pharmacy.”
He noted that while the operational model is now broadly understood, the economic model remains unclear, and “that will be critical in determining how this change will truly benefit the sector.”
"At Numark, we are actively exploring how this legislation could open up opportunities for our members.”
“We are working to evaluate solutions that could support them to access the benefits of scale, while maintaining their local presence and patient relationships.”
"As always, the detail will be key,” he added.
He stressed that it is essential for the regulatory and economic frameworks to align in order to offer genuine, practical advantages to the sector.
Meanwhile, the CPE continues discussion with the Department of Health and Social Care (DHSC) for further amendments to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations (PLPS).
These will enable NHS spoke pharmacies to subcontract part of the NHS Essential Dispensing Service to the hub.
Key points of the HMR amendments include:
- Written agreements must be in place between the hub and spoke pharmacies, clearly outlining their respective responsibilities.
- 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, along with all the usual information required on a dispensing label.
- Patient data sharing between the hub and spoke is permitted without the patient’s explicit consent through an information gateway, provided appropriate notices are displayed at both hub and spoke sites to maintain the confidentiality of the patient data.
CPE said that they will be providing a briefing on Hub and Spoke dispensing and the new HMR amendments in the coming weeks.
