This Autumn brings scrutiny of two big beasts of pharmacy regulation; Supervision and Hub and Spoke dispensing. The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 that will bring changes to pharmacist supervision into effect is scheduled for debate in parliament on the Monday of the Pharmacy Show (13 October 2025) so we will park that for discussion later. The second much discussed change is the legislation on Hub & Spoke Dispensing….
Hub & Spoke Dispensing
From 1 October 2025, the law was amended to allow the hub and spoke dispensing model to take place between different legal entities. As hub and spoke dispensing was previously only able to take place within the same legal entity, the change will open up the model to smaller businesses.
The model involves the patient providing a prescription to a spoke pharmacy, which will send it to a hub to assemble the medicine before returning it to the spoke pharmacy to supply the medicine to the patient. There are provisions to ensure compliance with data protection legislation and specific requirements to ensure and effective and safe arrangement. These include-
- An obligation for written arrangements between the hub and the spoke which must include a comprehensive statement of the respective responsibilities of the hub and the spoke.
- The spoke pharmacy must display a notice about the hub and spoke arrangement. This should include the names and addresses of any other parties involved in the arrangement and a statement about the effect of the arrangement.
- Dispensed medicines should be labelled with the name and address of the spoke pharmacy. The date of supply on the dispensing label is to be the date that the dispensed item is ready to supply to the patient.
There have also been amendments to the pharmacy Terms of Service with requirements for formal notification within a certain time and due diligence checks. Processes for refusal or termination of non-compliant arrangements have been put in place too. Please do not hesitate to contact us if you are unsure whether your arrangement is fit for purpose.
Other news…
Accepted outcomes in Fitness to Practise cases
The Government is currently working on reforms in relation to nine healthcare professional regulators. One change will allow regulators, including the GPhC, to deal with some fitness to practise cases using ‘accepted outcomes’. This is a process in which a case officer makes a determination on whether a registrant’s fitness to practise is impaired and the sanction, if appropriate, without the need for a hearing. However, registrants will have a right to request that their case is dealt with at a hearing, rather than by an accepted outcome.
A case will only be able to be concluded by accepted outcome where the registrant has:
- Agreed to the sanction
- Accepted that their fitness to practise is impaired, and
- Accepted the factual findings
It is also suggested that a “case examiner” will be able to impose a sanction without agreement of the registrant where a registrant does not respond to the offer within a set period of time which is concerning. However the detail of the proposals is currently not clear.
Consultation: Enabling pharmacist flexibilities when dispensing medicines
We have advised in cases (GPhC Fitness to Practise and Inquests) where medicines shortages have been at the heart of the problem raised. SSPs have been around for a while but the DHSC has now opened a consultation which would go further in enabling ‘pharmacist flexibilities’ in certain circumstances. The proposals would allow community pharmacists to supply medicines of a different strength or formulation (which may mean a different quantity) when the originally prescribed medicine is unavailable. The pharmacy professional would need to be of the professional opinion that this is safe, in the patient’s best interest and on the condition that:
- There is an urgent need for the medicine – this includes serious inconvenience to the patient
- It would be impractical to obtain the medicine without undue delay for the patient
- The alternative medicine will allow the patient to have the same medicine at the same dose, dosage regime and treatment cycle
The alternative medicine supplied would need to be correctly labelled and it is proposed that pharmacists should keep records of alternative supplies made.
The proposals will not cover:
- Medicines already covered by a SSP
- Generic substitution
- Controlled drugs, (except Schedule 5 Misuse of Drugs Regulations 2001).
The consultation will close on 11 December 2025.
Robots in Pharmacies – What Landlords and Tenants Need to Know
As dispensing robots become more common in pharmacies, they raise a number of practical and legal issues for both landlords and tenants. Installations often involve structural alterations, which typically require landlord consent, a license for alterations, and early input from surveyors to assess impact on the building.
Tenants should also consider whether planning permission is needed, check insurance obligations, and ensure contractors have adequate liability cover.
For a deeper look at these issues, read our full article by Adrian Jones, Partner in our Commercial Conveyancing team, where he explores how pharmacy robotics are changing the property landscape for landlords and tenants.
This edition’s FAQ
Q – I have received an outcome in my GPhC Fitness to Practise matter that I accept. Can that decision be challenged?
A – We are looking at the review powers of the Professional Standards Authority (PSA) here. PSA oversees the 10 regulators of healthcare professionals, including the General Pharmaceutical Council. This oversight includes reviewing every final decision made by fitness to practise committees. If the PSA considers that a decision does not sufficiently protect the public, the body can appeal the decision.
Bonus FAQ – answer above relates to final hearings – what about at the Investigating Committee stage?
The PSA audits a sample of fitness to practise cases that have been closed by an investigating committee but the PSA is unable to review decisions made at this stage. Instead, it is limited to providing any feedback on audited cases to the regulator.