Hub & Spoke
Published on: 21st May 2024 | Updated on: 21st May 2025
Status: Coming into force 1 October 2025. Overview: Dispensing process can be shared between different retail pharmacy businesses. 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. Only Model 1: patient – spoke – hub – spoke – patient, is permitted. Community Pharmacy England view: We welcome the confirmation that Model 1 will be progressed, as we have concerns with patient safety and regulatory issues with Model 2. (A lack of clarity for patients on which pharmacy/pharmacist was responsible for what, and the potential proliferation of hubs undermining the integrity of the market entry controls). |
The Government confirmed that it is introducing Hub and Spoke dispensing Model 1 and changes to the Human Medicines Regulations 2012 have been laid 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).
Timescales
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.
Hub and spoke dispensing – essentially sharing the dispensing process between two pharmacies – is currently permitted within the same retail pharmacy business (i.e. the same legal entity), but planned regulatory changes will permit it between different retail pharmacy businesses (i.e. different legal entities).
In 2022, DHSC consulted for a second time on Hub and Spoke dispensing between community pharmacy businesses. They proposed two models:
- Model 1, where the medicines are returned assembled from the hub 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)
We responded to the consultation (see our response here) and have since continued to reinforce our view with DHSC that only Model 1 should be introduced.
The full debate on hub and spoke can be found on the Hansard – UK Parliament website: Community Pharmacy – Hansard – UK Parliament
Proposed Models
The Department of Health and Social Care (DHSC) issued a consultation (Government response to the consultation on hub and spoke dispensing) on hub and spoke dispensing, in 2022. The consultation proposed making legislative changes to allow the operation of hub and spoke dispensing across different legal entities, and proposes to introduce two different models for this. Model 1 would involve patients only interacting with the spoke pharmacy, whilst Model 2 would permit the hub to supply medicines directly to the patient on behalf of the spoke.
Model 1
Model 2
Gordon Hockey, Director, Legal at Community Pharmacy England, said:
“Community Pharmacy England broadly supports the introduction of changes that would allow hub and spoke dispensing to occur between different legal entities, but they need to be introduced in a way that is safe for patients and does not lead to a proliferation of hubs that can dispense directly to patients, which would undermine market entry controls. Without controls on hubs, the community pharmacy market could be disrupted.
“We are also concerned that while hub and spoke dispensing may potentially release capacity in community pharmacies, there is no evidence that it will lead to financial savings for the sector. In addition, any activity saving will come at a cost, and given the critical state of pharmacy finances, pharmacy owners may not be able to invest in this at the moment.
“The previous Government published its intent to progress the changes it had consulted on, but this work was paused when the General Election was called. The Department of Health and Social Care is now in the process of briefing new ministers across all policy areas, including hub and spoke. Officials have indicated this process may take some time and the sector will be given more clarity on timescales as soon as practicable.
“In the meantime, the Department has confirmed that it will continue to discuss the relevant issues with Community Pharmacy England. This includes patient safety issues and the potential proliferation of hubs, which are primarily issues with the Department’s Model 2 (patient – spoke – hub – patient) where supply of the dispensed medicine is from the hub direct to the patient.”
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.
Hub and Spoke is one of several important regulatory changes currently underway to help make dispensing more efficient and support capacity for the provision of clinical services. To learn more about these and Hub and Spoke, read our new guide: New Pharmacy Regs: What you need to know
Further information
Community Pharmacy England (formerly PSNC) submits response to Hub and Spoke consultation
View our consultation response in full
For more information on this topic please email regulations.team@cpe.org.uk