Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025
Debate between Viscount Stansgate and Baroness Merron(2 weeks, 4 days ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, as I know we all acknowledge, community pharmacies play a vital role in our healthcare system by ensuring that patients have access to medicines and acting as an easily accessible “front door” to the NHS. They dispense around 1.1 billion NHS medicines every single year.
Traditionally, all dispensing processes have been done in a single pharmacy or by a dispensing doctor. In hub-and-spoke dispensing, routine tasks such as sourcing, preparing, assembling and labelling medicines are carried out at a central “hub”, which is separate from the “spoke” pharmacy where the prescription is received. Hubs often make use of automated processes to realise economies of scale and to increase efficiencies. Such arrangements already exist in the UK, but the Medicines Act 1968 restricts their use to community pharmacies that are part of the same legal entity. Not all pharmacy businesses are able to invest in their own hub-and-spoke model, as compared with the larger pharmacy chains.
The Government are committed to supporting the community pharmacy sector and to cutting the red tape that frustrates it. The proposed changes have been a long time coming. If approved today, as I hope they will be, they will allow all pharmacies, including small independents, and dispensing doctors to utilise hub-and-spoke arrangements if they choose to do so.
Staff in hub-and-spoke arrangements report a calmer, more focused environment—I think we would all welcome that. In hubs, there are fewer disruptions and the use of automation reduces the risk of dispensing errors. At spokes, staff have more time for complex cases and patient care, making better use of their skills—something that the Government aim to support. The legislative changes we are debating will help all pharmacies and dispensing doctors realise these benefits, instead of limiting them to a few.
Turning to the details of the SI, we propose to amend the Human Medicines Regulations 2012 and the Medicines Act 1968, using the powers in the Medicines and Medical Devices Act 2021. The proposed changes to the Medicines Act 1968 adjust the definitions of “wholesale dealing” and “retail sale”, and remove the legal restrictions that prevent hub-and-spoke dispensing between different legal entities. The amendments go beyond simply removing the barrier that currently limits hub-and-spoke dispensing to pharmacies within the same legal entity. Noble Lords will, I hope, be pleased to know that the amendments include additional elements to ensure the safe and effective implementation of the policy by putting in place provisions to ensure accountability, governance and transparency for patients.
The proposed changes to the Human Medicines Regulations 2012 create a new model of hub-and-spoke dispensing, establishing a framework for the sharing of patient information between the hub and the spoke, and set criteria for the newly permitted arrangements. These criteria are: that both a hub and a spoke must be pharmacies registered with the pharmacy regulator, unless a spoke is a dispensing doctor practice; that there must be written arrangements between any hub and spoke, which must include a comprehensive statement in relation to their responsibilities, to ensure that each party is clear about the processes and activities for which they are responsible; that the medicine label includes only the name and address of the spoke, so that patients know who to ask any questions about their medicines; and that the spoke must conspicuously display a notice on its premises and online in relation to the dispensing arrangements.
The changes also establish an information gateway. This achieves several purposes, such as the conditions for lawful sharing of the relevant patient data between the different legal entities that operate these arrangements.
On the timescale, it is proposed that all legislative amendments come into force in the October this year across the UK. This will allow time for secondary legislation to be amended, as appropriate, across all four nations, and give the pharmacy sector time to explore the relevance and possibilities of the new hub-and-spoke arrangements to its businesses.
I hope that I have been able to set out what we are proposing and the rationale behind it. I look forward to what will, I am sure, be an informed and constructive debate. I beg to move.
Viscount Stansgate (Lab)
My Lords, I broadly support these regulations. I hope that my noble friend the Minister will not mind my intervening briefly to ask a couple of questions; I have no wish to detain the Committee.
Obviously, I understand that community pharmacies have been playing an increasingly expanded clinical role in treating minor illnesses and improving medicines’ safety and optimisation. To improve the efficiency of dispensing, these regulations will help support community pharmacies in taking on a more clinical role. The purpose of these regulations, which is to free up smaller pharmacies and enable them to undertake hub-and-spoke models, is, I am sure, a good one. First, does my noble friend the Minister have any idea of how welcome this will be to smaller pharmacies? Is it expected that a great deal of them will undertake these new arrangements outwith the previous restriction on being in the same legal entity?
Secondly, having recently been to my local pharmacy and having talked to the pharmacists there, I was struck by the strain that they are under, both in terms of their workload and financially. Am I right in thinking that this hub-and-spoke model, which will be made more widely available, will in some way help smaller pharmacies deal financially with the situations that they face? Am I wrong in thinking that there is a financial dimension to this? If there is, I would be very grateful for any reply that the Minister can give, but, in summary, these regulations are a step in the right direction.
Funerals: Death Certificate Delays
Debate between Viscount Stansgate and Baroness Merron(3 months ago)
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Viscount Stansgate
To ask His Majesty’s Government what steps they are taking to reduce reported delays in holding funerals because of changes in the provision of death certificates.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Merron) (Lab)
My Lords, the death certification reforms are increasing scrutiny of deaths and patient safety, and supporting the bereaved. We are taking steps to reduce the time to register a death, through active monitoring of the reforms, using weekly data from the ONS to target the challenges and the necessary support. We are also working with faith groups and the funeral sector to identify and reduce any obstacles, and sharing any concerns we receive with NHS England so that they can be swiftly resolved.
Viscount Stansgate (Lab)
I thank my noble friend for that Answer. When my dad died—incidentally, he was born 100 years ago today—it was possible to arrange his funeral in two weeks. That is not now possible. I have talked to the National Association of Funeral Directors, and I understand that there is a lot of confusion around the country about the new procedures, although everyone understands why they are there. Is there more that could be done in hospitals or by GPs to help families who are having to cope with the unfamiliarity of the new procedures at the time of their own grief? More widely, might it be possible for the Government to start considering regulating the funeral profession, as has happened in Scotland?
Baroness Merron (Lab)
I am sure that we all wish to pay tribute to the memory of my noble friend’s late father. I appreciate the points that he has made. It is not the case that delays to funerals can be identified and formally linked with the changes in death certification. My noble friend raised a lot of points, many of which are valid. In a bereavement, it is more important than ever that any official processes—as well as the funeral sector itself—work as seamlessly and sensitively as possible. I assure my noble friend that not only are we driving improvement by implementing the death registration reforms but we are very focused on supporting the bereaved. On my noble friend’s point about regulation, I am not aware of any plans at present.
Health Research
Debate between Viscount Stansgate and Baroness Merron(4 months, 3 weeks ago)
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Baroness Merron (Lab)
As we move towards the 10-year plan, it will be key. Research, the contribution of life sciences and innovation will help us deliver an NHS that is fit for the future. I agree with the noble Baroness about the major contribution that is made to the UK economy. This is not just about healthcare, important though that is; it is also about growth. There are some 6,800 businesses generating more than £100 billion in turnover. Life sciences is one of the most dynamic and significant sectors. It drives economic growth, but it also provides a future in terms of the quality, availability and efficiency of the healthcare that we can provide in this country.
Viscount Stansgate (Lab)
My Lords, I hope the House will understand me when I say that I deeply regret the fact that my noble friend has had to ask this Question in the first place. The cuts to which it refers have been described as an apocalypse for American science, but that is a matter for them. What do the Government think the consequences might be of the United States’ withdrawal from the World Health Organization? And does the Minister not agree that, in the event of an emerging global health threat, we will be less well placed to deal with it, to contain it and to understand what may be done without the United States in the World Health Organization? Are the Government already beginning to plan for this very sad eventuality?
Baroness Merron (Lab)
My noble friend has made the point which I would emphasise: withdrawal from the World Health Organization is a matter for the United States to decide. The UK, however, will continue to work with all international partners and the WHO. It is a key factor in ensuring we have a healthier and safer world because disease does not respect borders. The UK Health Security Agency is carefully considering the impact of proposed changes in the United States, including its proposed withdrawal from the World Health Organization.