So what did the response say? And what are the implications for hub and spoke of the early election?

The response was the result of many industry discussions and is interesting from a legal point of view as it involves some amendments to legislation involving a novel “deemed retail sale” framework in effect to remove just eight words from primary legislation.

Read more: ‘Level playing field’: Hub and spoke possible for all pharmacies from January

Section 10 of the Medicines Act 1968 currently restricts the use of hub and spoke models because it requires that a medicine dispensed in one pharmacy can only be sold or supplied by that pharmacy or another within the same legal entity, “forming part of the same retail pharmacy business …” It accordingly prevents hub and spoke arrangements between different legal entities.

To allow arrangements to exist which do not involve wholesale dealing it is proposed that a new type of retail sale is created by amending the Human Medicines Regulations 2012. Both hub and spoke entities would be pharmacies and would require a responsible pharmacist to be in place in the normal way.

The legal definition of a registered pharmacy is that it makes retail sales of medicines to the public. To avoid having a situation where either the hub or spoke do not make a final retail sale it is proposed that that there is a

▪ “deemed retail sale” between the hub and spoke which enables the hub to be a registered pharmacy.

▪ “parallel retail sale” between the spoke and the patient which enables the spoke to be a registered pharmacy if the medicines are supplied from the hub (although it is also possible for a dispensing doctor to acts as a spoke).

In practical terms these “sales” will take two forms: The first model is a supply from spoke to hub and back to the spoke for handing to the patient. The second is supply from spoke to hub and dispensing straight from the hub to the patient. It would not be possible for the hub to supply to a spoke that is not the initiating spoke.

Read more: CCA boss: Hub and spoke ‘one way’ to help solve pharmacy workforce crisis

The proposals mandate a written arrangements between hub and spoke which would be a legally binding contract and would cover matters such as the apportionment of liability, labelling and responsibilities.

What are the questions left unanswered?

There is much in the proposal that needs further development:

• Treatment of controlled drugs - the response is not clear about the inclusion of all controlled drugs saying “We intend to explore with the Home Office the inclusion of schedule 2 drugs within either model of hub and spoke and schedule 3 drugs within model 2.”
• The interface with the NHS regulations – it is possible there would need to be changes linked to market entry, reimbursement, labelling and complaints procedures.
• Guidance from regulators – they would have to look at the professional governance for the responsible pharmacists at each site and the oversight of the complete arrangement.
• The contents of any legal arrangement, although that is specifically said to be left to individual contractors to negotiate.

Meanwhile, the House of Commons Select Committee on Health and Social Care reported on pharmacy the day before parliament dissolved on 30 May.

In a hard-hitting report about the problems facing pharmacy, they said this about the Hub and Spoke proposals (paragraph 92): “While hub and spoke arrangements may be beneficial to some pharmacies, we do not believe this is a ‘silver bullet’ in terms of efficiencies. We urge the Government not to assume that hub and spoke alone will deliver the extra capacity pharmacists clearly need to deliver clinical services. We note the Government’s response to their consultation and intention to proceed with plans to allow hub and spoke systems to be set up across different legal entities, but caution against encouraging, or even mandating, more widespread implementation.”

Read more: HSCC chair ‘fearful’ of ‘disastrous’ government hub-and-spoke decision

What is the effect of the early election?

The implementation of the proposals was intended to be 31 January 2025 which was a generous time scale to tie in with the Windsor Framework and allow time for consideration of changes to NHS legislation.

However, to put the proposals into effect, a draft statutory instrument had to be laid before parliament and debated and there is no indication that this happened before parliament was dissolved.

It remains to be seen whether this is a policy that the new administration will want to pursue.

Susan Hunneyball is a solicitor and partner at Gordons Partnership.

This is a general overview and any views or reflections are the author’s own. Independent legal advice should be sought for any specific concerns.