Community Pharmacy England (CPE) has already begun working with the Department of Health and Social Care (DHSC) on how hub and spoke arrangements will work for NHS services in England, it has told The Pharmacist.

This comes as the government plans to allow models of hub and spoke dispensing across different legal entities that could supply medicines both to pharmacies and directly to patients.

Each national government and pharmacy negotiator within the UK will determine how pharmaceutical regulations may need to be amended to ensure new hub and spoke models do not undermine NHS market entry arrangements, as well as how the changes may affect reimbursement, the DHSC said yesterday in its consultation outcome.

This follows concerns raised by the sector that hubs - which do not need to be part of the NHS pharmaceutical list - could disrupt arrangements in place to ensure an equitable spread of pharmaceutical services for patients and could impact the viability of existing community pharmacies.

Gordon Hockey, CPE director of legal, told The Pharmacist last night that the negotiator had already begun working with the DHSC to work out what the planned changes would mean for NHS dispensing in England.

'Hub and spoke reform is long overdue and we are pleased to finally get an indication of the government’s plans for this.' he said.

'However, much still needs to be done to develop a model that works for community pharmacy, and we are already working with DHSC to consider the implications of these changes for NHS dispensing in England,' he said.

What impact could the hub and spoke models have on NHS pharmaceutical arrangements?

When the government’s consultation to allow hub and spoke dispensing between pharmacies from different legal entities was launched in 2022, two models were proposed: model one, that would see hubs assembling prescriptions and sending them back to the spoke for supply to the patient, and model two, that would see the hub send the assembled prescription directly to the patient.

In its original response to the consultation in June 2022, the community pharmacy negotiator said it considered that only model one was ‘appropriate, with manageable risks relating to patient safety' and 'a model that has the potential to allow the whole sector to benefit fairly’.

Concerns were also raised that the proposals could lead to 'a proliferation of hubs', with CPE saying in its consultation response that if premises that are not NHS pharmacist premises provide NHS services, this is 'likely to result in the excessive provision of some pharmaceutical services in areas where demand is already met'.

'This is unnecessary and is detrimental to existing provision of services by established community pharmacies; and may be detrimental to patients if this affects the viability of established community pharmacies providing the full range of NHS pharmaceutical services,' the negotiator added.

‘Remote, national supply pharmacies with no physical access for patients are already available as a choice for patients, for both private and NHS prescriptions.'

And it said it had agreed to work with the government to work towards a model of hub and spoke dispensing that would allow the whole sector to benefit fairly, on the understanding that the DHSC would agree with the negotiator on what that would look like.

Another response to the government's consultation suggested that there could be a 'risk' - albeit 'unlikely' in the current market and landscape - that a hub-to-patient model 'could result in a proliferation of hub pharmacies without NHS contracts, supplying direct to patients while being linked to one spoke pharmacy with an NHS contract'.

'Under this model, hubs could charge for their prescription deliveries and wouldn’t be constrained by the same rules as DSPs [distance selling pharmacies]. There is also a risk that one hub on the NHS pharmaceutical list could supply a proliferation of spoke pharmacies not on the NHS pharmaceutical list,' the response added.

Under the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013, DSPs must fulfil certain requirements that a hub would not be required to do, including providing services to patients anywhere in the country, and delivering essential services (with certain exceptions) via remote consultations.

Impact on pharmacy regulations 'for each administration' to decide

The government said it noted ‘the concern that hub pharmacies would not have to be on the NHS pharmaceutical list and so could undermine NHS market entry arrangements’.

But it said this was ‘outside the scope’ of the human medicines regulations changes that it was consulting on.

‘It will be for each administration to determine - with their respective community pharmacy representative bodies - whether pharmacy regulations need to be amended to ensure that hub and spoke models do not undermine NHS market entry arrangements,’ it said.

And in response to concerns that hubs on the NHS pharmaceutical list would be able to supply spoke pharmacies that are not on the NHS pharmaceutical list, the government noted that ‘under the proposals, the order for medicinal products must always be placed at the spoke’ which ‘must be a registered pharmacy or a dispensing doctor’.

‘To be able to process and dispense an NHS prescription, that spoke must be on the relevant pharmaceutical list in order to be able to provide that pharmaceutical service,’ it added.

The government also said it would monitor the impact of the new hub and spoke arrangements on competition within the market.

It said it recognised ‘the potential for longer-term competition risks in the supply chain if the market develops in such a way that pharmacies’ access to medicines is through an increasingly limited number of hub suppliers’.

‘If, for example, only a few larger hubs emerge, this may have a subsequent effect on the availability of medicines for patients,’ the government said in its consultation response.

And it committed to reviewing ‘the impact on competition once any hub and spoke market is sufficiently established, to assess if action is needed to alleviate any barriers to the development of a dynamic and competitive hub market’, in line with recommendations from the Competition and Markets Authority (CMA).