New hub and spoke terms of service set out conditions for contractors

The terms of service for incoming hub and spoke legislation have been laid before Parliament, setting out the conditions that contractors must meet for dispensing.

These come into effect on 1 October 2025 – the same day as the Human Medicines Regulations 2012 (HMRs) hub and spoke changes – announced in April this year.

Both apply to owners of NHS ‘spoke’ pharmacies/contractors when the ‘hub’ pharmacy is owned by a different legal entity and must be complied with.

The ‘spoke’ pharmacy is responsible for selling, supplying, or dispending medicine to patients, the hub having assembled or part assembled it. Only Model 1: patient – spoke – hub – spoke – patient, is permitted.

The new terms of service state that contractors may not subcontract ‘core dispensing activities’ – the assembly of any prescription item, including labelling and bagging – via hub and spoke unless certain conditions are met.

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This includes that contractors must ensure that the owner of the hub is ‘a fit and proper person’ to carry out the core dispensing functions on their behalf.

In addition, contractors must also use the NHS England-approved written notification form to give notice to their integrated care board (ICB) of the hub and spoke arrangements.

And they should confirm that the written arrangements with the hub owner will contain specific information, including the responsibilities of the hub and spoke and a data sharing agreement between the two parties.

This must be done 28 days before the hub and spoke arrangements begin.  If the ICB issues a notice of objection, the hub and spoke arrangements cannot go ahead until that notice is withdrawn.

To carry out hub and spoke dispensing, owners of NHS spoke pharmacies or contractors must comply with the requirements of the HMRs and with the new hub and spoke terms of service.

The HMRs is the main legislation in the UK covering medical products for human use to ensure their safety, quality and efficacy. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for upholding the MHRs.

There is recognition in the new terms of service that NHS hub and spoke dispensing may also include non-medicines, such as appliances.

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Ashley Kilgas, chief commercial officer of hub and spoke solution provider Centred Solutions, recently told The Pharmacist that trust between hubs and spokes will be key to the success of these changes.

Some independents, he added, might be concerned about sharing dispensing information ‘with effectively a competitor’, and the long-term impacts of entering into relationships with other companies.

The recent NHS 10-year plan for England places emphasis on scaling up robotics in pharmacy ‘where they can fill prescriptions far more quickly than and accurately than humans’.

While pharmacy leaders, including the Royal Pharmaceutical Society (RPS) and National Pharmacy Association (NPA), have welcomed the government’s focus on this, they have also stressed the need for appropriate workforce training and sector funding.

There have also been concerns that using hubs for some or all of the dispensing process will not be affordable for independent pharmacies.

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Gareth Jones, director of corporate affairs at the NPA, said in May: ‘Some independent pharmacies may find hub and spoke to be a useful mechanism for releasing time for patient care.

‘However, this is certainly no silver bullet as far as pharmacy finances are concerned.’

CPE will include more information in a briefing to be released this week.