The government has announced it will introduce legislation to enable two models of hub-and-spoke dispensing across the UK.

The proposed legislative amendments are intended to come into effect on 1 January 2025 “to give the pharmacy sector time to explore the relevance of the new hub-and-spoke models to their businesses”.

The two different models of hub-and- spoke dispensing that will be enabled are:

Model 1. The patient presents a prescription to the spoke. The spoke then sends the relevant information on to the hub so that they can carry out their agreed dispensing actions. The hub then sends these dispensed medicines back to the spoke, which may have further responsibilities to perform such as providing advice on the medicine to the patient, before supplying them to the patient.

Model 2. The patient presents a prescription to the spoke, which then sends the relevant information to the hub. The hub then assembles and prepares the medicine before supplying the completed order directly to the patient.

The DHSS is also proposing to enable dispensing doctors to access hub pharmacies.

The move follows a UK-wide consultation in the spring of 2022 which sought views on removing the barrier that currently limits hub-and-spoke models to pharmacies within the same legal entity, and to ensure the safe and effective implementation of the policy.

Enabling hub-and-spoke across different legal entities was agreed in the now expired Community Pharmacy Contractual Framework 2019 to 2024 in England, and referenced in the Primary Care Recovery Plan and the NHS Workforce Long Term Plan.

Subject to approval of the statutory instrument by the Houses of Parliament and the Northern Ireland Assembly, the proposed legislative amendments will come into force on 1 January 2025, to tie in with the commencement of the Windsor Framework and to allow sufficient time for secondary legislation to be amended.

Response the announcement has so far been limited. Company Chemist Association chief executive Malcolm Harrison said: “We are pleased that the Department has taken forward the proposals, but also taken on feedback from the sector. The changes should allow new business models, without increasing the burden on existing processes or adding confusion to patients.

“However, given the huge upfront capital investment and ongoing operating costs of hub-and-spoke dispensing models, and the financial strain all pharmacy businesses are currently facing, we think it is unlikely the sector with be able to benefit from these changes.

“We support the Department’s intention to release clinical capacity in community pharmacy. Unfortunately, however, the proposed changes will not release any capacity unless the government’s funding for medicines supply is increased”.

The fine print

The government intends to progress the proposals to enable hub-and-spoke models across different legal entities as soon as possible by using the enabling powers in Part 2 of the Medicines and Medical Devices Act 2021 (MMDA) to make amendments to the Medicines Act 1968 and the Human Medicines Regulations 2012 (HMRs).

The proposed amendments to be made to the Medicines Act 1968 are:

• amending section 10 of the Act, to remove the restriction that a medicine dispensed at a registered pharmacy must be sold or supplied by that pharmacy or another registered pharmacy forming part of the same legal entity
• removing section 131 of the Act, which covers the definitions of wholesale dealing, retail sale and related expressions. Therefore, by virtue of section 132 of the Act, the definitions of those terms will now be those found in the HMRs to ensure clarity across the legislation

The proposed amendments to be made to the HMRs include:

• the creation of two new models of hub-and-spoke by creating new regulations in the HMRs - regulations 222A (for model 1) and 222B (for model 2)
• the creation of two new types of retail sales to sit alongside a retail sale as it is currently governed. In models 1 and 2, a ‘deemed retail sale’ will be created to allow the movement of assembled or part-assembled medicines between the hub and the spoke. In model 2, a ‘parallel retail sale’ will be created between the spoke and the patient.
• that there must be written arrangements between any hub and spoke, which must include a comprehensive statement in relation to their responsibilities and details of which party will be named on the medicine label. There will be flexibility for the hub and spoke to determine whether the label will feature either the hub or spoke’s details, but never both.
• that the spoke must conspicuously display a notice in relation to hub-and-spoke models, if utilising them. If a pharmacy (including a distance selling pharmacy and/or a dispensing doctor has an online presence and utilises a hub-and-spoke model, their website should display the same information conspicuously
• that dispensing doctors will be able to act as a spoke under the new regulations
• the creation of an information gateway in the HMRs (as a new regulation 222C) - this achieves several purposes, including the provision of an assurance that the data sharing across the different legal entities is lawful.

The government will not require hub-and-spokes to meet MHRA general distribution practice standards, saying that the movement of prepared or assembled medicines between hub and spokes is already covered by existing regulatory standards.

It says that existing regulatory arrangements for community pharmacies across the UK guarantee end-to-end regulatory oversight of hub-and-spoke models and no further changes are needed. It adds, though, that where dispensing doctors form a spoke, end-to-end regulatory oversight will be established either through existing arrangements or the relevant devolved administrations taking appropriate action.

As regards Controlled Drugs, the government says Schedule 3, 4 and 5 CDs can be included in hub-and-spoke model 1, while only Schedule 4 and 5 drugs can be included in model 2.

The Department of Health says that it intends to explore with the Home Office the inclusion of Schedule 2 drugs within either hub-and-spoke model, and Schedule 3 drugs within model 2.