The draft statutory instrument that will allow hub and spoke legislation to take place between different legal entities, has been laid before Parliament and the Northern Ireland Assembly. It was approved by a resolution of each House of Parliament and the Northern Ireland Assembly.
Statutory Instrument to be Debated
The draft statutory instrument will now be debated by a committee of MPs on Monday, June 2. This is in line with standard process for statutory instruments, the most frequently used type of secondary legislation used to add information or make changes to an existing Act of Parliament. According to the Government legislation website, the statutory instrument allowing dispensing between different legal entities is still due to come into effect on October 1, 2025.
The statutory instrument will make amendments to the Human Medicines Regulations 2012 and the Medicines Act 1968. The changes modernise the legal framework around the licensing, assembly, and supply of medication in the UK. The key aim is to enable “hub and spoke” dispensing, where one pharmacy (the hub) assembles medicines on behalf of another (the spoke).
Main Changes to Legislation
Pharmacy-to-Pharmacy Outsourcing Allowed:
- Registered pharmacies will be able to outsource medicine assembly to any other registered pharmacy, not just within the same business group (amendment to section 10 of the 1968 Act).
Definition Updates:
- Definitions of “wholesale dealing” and “retail sale” will be removed from the 1968 Act.
- Instead, definitions from the 2012 Regulations will apply to both laws, aligning them with the new hub and spoke model.
Dispensing Doctors Outsourcing:
- NHS dispensing GP practices, known as dispensing doctors, will be able to outsource medicines assembly to registered pharmacies.
Hub and Spoke Framework Legalised
- Regulation 222A will define the exchange of medicines between hub and spoke as a retail sale, not wholesale.
- Hubs must be registered pharmacies. Spokes can be pharmacies or NHS dispensing practices.
- Spokes must display notices informing patients of the hub and spoke arrangement (including online, if applicable).
Data Sharing Enabled:
- Regulation 222B will create a legal basis for sharing patient data between the hub and the spoke.
- If confidentiality or data protection requirements are breached, this exemption no longer applies.
Labelling Requirements Updated:
- Dispensing labels will need to include the spoke’s name and address, not the hub’s.
- The supply date on the label will be when the hub sends the medicine to the spoke.
Clarification on Supply Location:
- Terminology changes clarify that medicines can be supplied “from” rather than just “at” a pharmacy site which aligns 2012 Regulations with the 1968 Act.
The legislation will enable the wider use of hub and spoke creating a level playing field for smaller groups and independent pharmacies. Read the full draft statutory instrument.
Prepare for Hub and Spoke
The pharmacy sector is on the cusp of significant transformation in the way it dispenses medication. This long awaited shift has the ability to redefine how community pharmacies operate, but it means major change for community pharmacy and there will be a lot of noise to cut through. As experts in hub and spoke, we've created a comprehensive guide, "Hub and Spoke Is Coming", to help pharmacy teams understand the upcoming changes and how to make the most of them.
