Draft Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025

Luke Evans Excerpts

Monday 2nd June 2025 General Committees

[Dr Luke Evans (Hinckley and Bosworth) (Con)]

It is a pleasure to serve under your chairmanship, Mr Stuart.

I will not go through everything the Minister set out, but we are amending the Human Medicines Regulations 2012 and the Medicines Act 1968 to enable hub and spoke dispensing.

The regulations before the Committee will improve seven key areas. They will enable cross-business outsourcing; clarify the legal definitions of wholesale dealing and retail sale; extend outsourcing to NHS GPs; establish hub and spoke frameworks, legally defining what the hub and spoke model is and enabling hubs to assemble medicines; tighten up labelling and information rules; introduce data-sharing provisions; and clarify premises-based supply.

The pros of doing that, and the reason why the previous Government were introducing legislation to do so, is that it will provide efficiency gains, improve access, modernise the legislation, and improve patient safety and data protection. There are some cons and concerns, however, particularly regarding the complexity of implementation and whether pharmacies will need to invest in new systems. There are data privacy risks, as the world is seeing an increasing number of cyber-attacks, which is a concern as we are adding more areas for data sharing. In addition, the regulatory ambiguity resulting from removing definitions from the 1968 Act may cause initial confusion during the transition.

Between 16 March and 8 June 2022, the previous Government consulted on legislative proposals to allow pharmacies and dispensing doctors to access hub and spoke dispensing models. Two different models were proposed:

“Model 1 is where 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.

In model 2, the same pathway is followed in that 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.”

On Monday 13 May 2024, shortly before the general election was called just over a year ago, the previous Government published a response to the consultation. The majority of respondents, being medium and larger pharmacy chains, representative sector organisations and other related businesses, supported the proposals. However, a majority of individuals, smaller pharmacies and independent pharmacies did not support the policy change.

At the time, the proposed next step was to make several amendments to the 2012 regulations, including the creation of two new models: spoke-hub-spoke and spoke-hub-patient. The previous Government intended to lay a final statutory instrument before Parliament and the Northern Ireland Assembly with a view to the legislation coming into force on 1 January 2025. However, because of the election, that statutory instrument was not laid.

The Minister reiterated this Government’s position in response to a question from the hon. Member for Warrington South (Sarah Hall):

“A wide range of community pharmacies and representative organisations fed into the public consultation on hub and spoke reform, and I am pleased to confirm that their responses were overwhelmingly positive in support of model 1 of hub and spoke, which we will be going with.”—[Official Report, 25 March 2025; Vol. 764, c. 774.]

There are two problems here—the implementation and the principle—and I will take them in turn.

The impact assessment, which was updated in April 2025, found uncertainty about the potential costs of establishing the hubs, the operating costs and the level of uptake of hub and spoke dispensing. Paragraph 78 stated:

“It has not been possible to determine the initial set up costs for hubs, due to the variety of different hub solutions and because we do not have a concrete assessment of the number and types of hubs that might open due to this policy.”

Paragraph 136 said:

“The key uncertainties in this IA are around the level of take up of hub and spoke arrangements and the net level of savings to dispensing costs that could arise”.

And paragraph 137 said:

“Ultimately hubs are private businesses who would need to conduct their own analysis and research into the level of market interest when deciding how much to invest in building hub capacity.”

In the light of that, can the Minister tell us whether there will be any further funding to implement this change? How will he record data on uptake and changes? And what incentive is there for businesses to take this up? Will it be mandated? Given the abolition of NHS England, where will the data be collated, who will collate it, and when will it be published?

I have now addressed the practical part, so I will now focus the Committee’s attention on the other part. The previous Government proposed to take forward both models: model 1, which was patient-spoke-hub-spoke-patient; and model 2, which was patient-spoke-hub-patient. I have been contacted on the latter by Pharmacy2U, which is the largest online distance-selling pharmacy.

Every month, Pharmacy2U dispenses more than 3 million items directly to the homes of 1.5 million customers, so it offers an alternative for patients. It asks why there was no formal consultation on the changes from the previous Government’s position, whether Ministers had considered whether this change excludes the perspectives of distance-selling pharmacies, and what the expected impact of excluding model 2 will be.

[Sadik Al-Hassan (North Somerset) (Lab)]

It is a pleasure to serve under your chairship, Mr Stuart. I refer hon. Members to my entry in the Register of Members’ Financial Interests as a registered pharmacist, and previously a superintendent pharmacist of a distance-selling pharmacy. Although it is great to hear the hon. Member refer to distance-selling pharmacies in this august place, I remind him that he is representing the views of only one, admittedly large, distance-selling pharmacy, and that there is perhaps a wider range of views among distance-selling pharmacies.

[Dr Evans]

Of course, and I thank the hon. Gentleman for that point, with his august history as a pharmacist. My job in the Opposition is to raise these issues with Ministers for consideration. At the heart of my point is that, by choosing only one model and not offering two, we are closing down the opportunity for not only patients but businesses. If we want to invent in the NHS, that seems a bad way of doing it. It is why the last Government suggested that having a couple of models allows people to invest in, invigorate and improve our system, because otherwise, innovation will fall behind. That is at the heart of the questions I am posing to the Minister.

That leads me nicely on to my follow-up question. Does this mean that the Minister will choose not to introduce model 2? Is that likely to be in line in the future, and if so, when?

Those questions go to the principle of this. The last Government decided that there were two options to accommodate all different fields, be it dispensing GPs, community pharmacies, large-scale chemists and pharmacies or, indeed, distance-selling pharmacies. It is really important to take into account the whole environment we have in the health service. We will not divide the Committee, but we would like answers to those questions about the practicalities and policies behind the regulations.