New: Hub and Spoke dispensing NHS Terms of Service

This week, new hub and spoke dispensing Terms of Service (The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Miscellaneous Amendments) Regulations 2025) were laid before parliament.

The new Terms of Service come into force on 1 October, the same day as the Human Medicines Regulations 2012 (HMRs) hub and spoke changes announced in April this year (the Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025). They complement each other and apply when the hub and spoke are owned by separate legal entities, by two different pharmacy owners.

To carry out hub and spoke dispensing, owners of NHS spoke pharmacies/contractors must:

• comply with the requirements of the HMRs, which were listed briefly in our April announcement (Hub and Spoke dispensing: Government announces the next steps – Community Pharmacy England), and
• The new hub and spoke Terms of Service, the requirements are listed briefly below.

(Hub pharmacy owners must comply with the HMRs and may be impacted by contractors complying with their Terms of Service.)

New hub and spoke dispensing Terms of Service

The new Terms of Service provide that contractors may not subcontract ‘core dispensing activities’ (broadly the assembly or part assembly of any prescription item, which includes labelling and bagging) unless certain conditions are met. Briefly, these are as follows: The contractor (spoke) must:

1. Take reasonable steps before entering into hub and spoke arrangements to ensure that the owner of the hub (the other retail pharmacy business) is a fit and proper person to carry out the core dispensing functions on their behalf.

This may include, for example, that the hub owner has confirmed suitably qualified and trained staff are in place, has appropriate indemnity cover in place, and has a business continuity plan, etc.

2. Using the NHS England-approved written notification form:

1. Give notice to their ICB of the hub and spoke arrangements, not less than 28 days before the hub and spoke arrangements are intended to commence.The contractor may commence the hub and spoke arrangements if there is no objection from the ICB within those 28 days. So, if the contractor’s notification is by email on 1 October and there is no objection from the ICB, the arrangements may commence on 29 October 2025.

   The ICB can agree a reduced notification period, but this is only likely if there are valid reasons for urgent commencement of a new or other hub and spoke arrangements.

2. Confirm that the written hub and spoke arrangements with the pharmacy hub (owner) will include the following:

1. A comprehensive statement of the responsibilities of the spoke and the hub for the core dispensing activities.
2. A provision that the hub will assemble or part-assemble patients’ prescribed medicines, and these will be dispensed/supplied at or from the spoke. The arrangements must not allow the hub to fulfil the order directly to the patient.
3. A data sharing agreement between the parties, setting out the prescription data that will be shared between the spoke and hub (and that the data must be in accordance with the relevant NHS England information standard once it is published).
4. A clear exit clause so that the spoke can discontinue the hub and spoke arrangements (sub-contracting agreement) at the request of the ICB (in addition to any patient safety or commercial grounds either the spoke or the hub may have for discontinuing the arrangements).
5. Provision that the hub may not further sub-contract any of the core dispensing functions that they perform on behalf of the spoke.
6. Confirmation that the spoke has a business continuity plan which contains provisions specific to the hub and spoke arrangements that will seek to enable them to continue provision to patients/resume provision to patients as required following any temporary or permanent discontinuation or disruption of the service provision by the hub.
7. A requirement for the hub to cooperate in any investigations by the spoke, commissioner, or regulatory body in relation to any issue or incident arising from the sub-contracted functions

The spoke/contractor must also confirm that they have undertaken due diligence to ensure the owner of the hub is a fit and proper person as above.

A link to the NHS England- approved notification form will be provided as soon as it is available.

There is provision for ICBs to raise objections to proposed hub and spoke arrangements by issuing a relevant notice, for dispute resolution with the contractor, and, at the contractor’s request, the involvement of the LPC. If the ICB issues a notice of objection, the contractor must not commence the hub and spoke arrangements until or unless that notice is withdrawn.

Additional provisions

There is some overlap between the HMR and Terms of Service requirements because NHS England is seeking confirmation that certain actions required by the HMRs have been completed.

There is recognition in the new Terms of Service that NHS hub and spoke dispensing may include non-medicines, such as appliances, and may use, for example, Serious Shortage Protocols, and appropriate provision for this.

Any temporary discontinuation of hub and spoke arrangements that amounts to a suspension or permanent discontinuation must be notified to the ICB, either before or as soon as is reasonably practicable after it occurs.

More information will be included in a Community Pharmacy England Briefing to be issued next week.