Draft Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025
(Limited Text - Ministerial Extracts only)
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The Minister for Care (Stephen Kinnock)
I beg to move,
That this Committee has considered the draft Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025.
It is a pleasure to serve under your chairship, Mr Stuart. These regulations amend the Medicines Act 1968 and the Human Medicines Regulations 2012 to enable hub and spoke dispensing for pharmacies and dispensing doctors that are not within the same legal entity.
Pharmacies play a vital role in our healthcare system, ensuring that patients have access to medicines and acting as an easily accessible front door to our NHS. This Government recognise the importance of community pharmacies and are committed to supporting the sector. That is why we have increased the core contract for community pharmacy funding to £3.073 billion, with the deal representing the largest uplift in funding for any part of the NHS in 2025-26—over 19% across 2024-25 and 2025-26.
Community pharmacies work hard for the NHS and the patients they serve. In England alone they dispense around 1.1 billion NHS medicines every year, and that number grows year on year. Dispensing of a medicine is not just handing out a package, but covers a number of processes: the receipt of a prescription; clinical and accuracy checks to ensure the prescribed medicine regime is suitable and safe for the patient; sourcing and buying the medicines on behalf of the NHS; the preparation, assembly and supply of medicines; and advising patients to ensure they know how and when to take the medicine. It is complex and important work.
As the number of prescriptions rises, we need to support our pharmacists to focus on the provision of advice and support to patients in order to optimise their use of the medicines on which the NHS spends nearly £10 billion in primary care each and every year. That is why the Government have introduced these regulations to allow all pharmacies, should they choose, to make use of hub and spoke dispensing.
In hub and spoke dispensing, the routine elements of dispensing—such as sourcing products, the preparation and assembly of medicines, and labelling—take place on a large scale in a hub pharmacy, separate from the pharmacy at which the prescription was handed in, which is the spoke. There are typically many spokes to one hub. Existing hubs often make use of automated processes to realise economies of scale and increased efficiencies. Not all pharmacy businesses are able to invest in their own hub, and businesses are currently not able to engage a hub that they do not own. The Government propose changes that would level the playing field in community pharmacy by enabling all pharmacies and dispensing doctors to use hub and spoke dispensing, if they choose.
Hub and spoke arrangements already exist in the UK, but the 1968 Act restricts their use to community pharmacies that are part of the same legal entity. That has limited the use of hub and spoke arrangements to the larger pharmacy chains. The proposed changes to the 1968 Act and the 2012 regulations will remove that legal restriction and allow all pharmacies, including small independents and dispensing doctors, to utilise the arrangement as and when best suits them, levelling the playing field and cutting red tape.
We propose to amend the 2012 regulations and the 1968 Act using the powers in the Medicines and Medical Devices Act 2021. The amendments go beyond simply removing the barrier that currently limits hub and spoke dispensing to pharmacies within the same legal entity, and they include additional elements to ensure the policy’s safe and effective implementation by putting in place provisions to ensure accountability, governance and transparency for patients.
We propose to amend the 1968 Act to remove the restriction that prevents a medicine from being sold or supplied from a different pharmacy from the one at which it was dispensed, unless those pharmacies belong to the same legal entity, and to remove section 131 of the Act, which covers the definitions of wholesale dealing, retail sale and related expressions. The definitions of those terms will now be those found in the 2012 regulations to ensure clarity across the legislation.
The proposed changes to the 2012 regulations create a new model of hub and spoke dispensing. They establish a framework for the sharing of patient information between the hub and the spokes and set the following criteria for the newly permitted arrangements. Both a hub and a spoke must be pharmacies registered with the pharmacy regulator. There must be written arrangements between any hub and spoke that must include a comprehensive statement about their responsibilities to ensure that each party is clear about the process and activities for which they are responsible. The medicine label must include the name and address only of the spoke so that patients know where to address any questions about their medicines. The spoke must conspicuously display a notice on its premises and its online presence about hub and spoke dispensing arrangements, where they are in use.
The changes also establish an information gateway that includes conditions for lawful sharing of relevant patient data between the different legal entities that operate hub and spoke arrangements. There is potential for this model to increase patient safety. Evidence shows that, where businesses have implemented hub and spoke systems with tracking technology, automated systems in the hub have had a dispensing error rate six times lower than manual processes.
During the consultation on the proposals in 2022, respondents shared evidence suggesting that the working environment in both the hub and the spoke can be calmer and more focused, reducing some of the stresses on our valued pharmacy workforce. Providing space and time at the spoke gives staff more time to deal with complex issues and carry out patient-facing work, including explaining to patients how to get the best outcomes from their prescribed medicines.
All the amendments will come into force in October 2025. They will apply across the UK, and the timescale allows time for secondary legislation to be amended, as appropriate, across the four nations. It also gives the pharmacy sector time to explore the relevance of the new hub and spoke arrangement.
I hope I have explained the rationale behind amending the 2012 regulations and the 1968 Act to enable hub and spoke dispensing arrangements across different legal entities. I commend the regulations to the Committee, and I hope hon. Members will join me in supporting them.
Stephen Kinnock
I will endeavour to answer all the questions that have been asked, but there may well be some that I am not able to. I will be more than happy to write to hon. Members accordingly.
Let me say a word on the rationale for choosing model 1. The main driver was the view that the most important aspect is the interface between the pharmacist and the patient. We felt that the spoke-to-hub-to-spoke-to-patient model best ensured the connection, at high street level, between the pharmacist and the patient, whereas the spoke-to-hub-to-hub-to-patient model would somewhat cut the high street pharmacist out of the loop. That was a balanced judgment—it was not a slam dunk.
That leads on to one of the questions asked by the hon. Member for Hinckley and Bosworth, which was about whether the Government are still open to looking at model 2. We certainly keep things under review, and we want to see how model 1 goes. If there is a feeling that it needs to be reviewed, we would be happy to do so. However, as things stand, we do not have any plans to do anything other than go with model 1, for the reason that I set out.
The hon. Member also asked about further funding. We have set out a pretty substantial uplift— £3.073 billion—for the pharmacy sector. We are hopeful that that will go some way to easing the tremendous pressures that the sector is facing. We also feel that the hub and spoke model will drive productivity, which we hope will enable pharmacies to do more with less. That will be a good way to address some of the funding challenges.
On recording data and where the data will be held, I will write to the hon. Member. I do not have that technical information to hand.
On the incentives, we are clear that this is a flexible business arrangement. All we have said is that we need to see set out in writing how the relationship between the hub and the spoke will work. That is in the draft regulations. Letting that business relationship work with the greatest possible flexibility—rather than trying to micromanage it too much with incentives set from the centre—is the best way for it to work. As I say, however, every time we will want the assurance of a clear written relationship between the two.
I thank my hon. Friend the Member for North Somerset for his kind words. I have absolutely welcomed his relentless lobbying during various Divisions over the past few months—I promise him that is the truth and nothing but the truth. On VAT status, however, I will dodge the question, because of course decisions on VAT are the responsibility of His Majesty’s Treasury. I strongly encourage him to ask his question of my ministerial colleagues in the Treasury.
Finally, I thank the hon. Member for South Antrim for his engagement. We have had excellent engagement with his colleagues in the Northern Irish Government. He has my absolute, 100% assurance that we will continue that engagement and, given the time available, which I set out in my speech, we will ensure that all nations are able to take this legislation on board and make the necessary changes in a way that works for devolution and for the entire system across the UK.
Question put and agreed to.